April 5, 2024
Resources Summarize Key Health Care Fraud Rules
Physician health care fraud prosecutions and convictions of physicians like Arizona physician Linh Cao Nguyen, M.D. drive home the need for all physicians to ensure their understanding and ability to defend their compliance with federal and state healthcare fraud laws. This includes, but it’s not limited to proper coding and billing for the use of mid-level in the delivery of care. Physicians and other prescribers should review a recently released resource to get a basic overview of these federal healthcare fraud rules.
Nguyen Health Care Fraud Plea For Billing Delegated Care As Physician Provided
One of literally thousands of physicians and other prescribers prosecuted by federal prosecutors for health care fraud, Nguyen pleaded guilty on March 19, 2024, to Health Care Fraud. Nguyen’s sentencing is scheduled for May 28, 2024, before United States District Judge John C. Hinderaker.
Nguyen admitted that for years, he engaged in a scheme to defraud various health care benefit programs, including Medicare, TRICARE, AHCCCS, Blue Cross Blue Shield, and UnitedHealthcare.
Court documents charged the fraudulent claims generally identified a medical doctor as the treating provider when, in fact, another provider such as a nurse practitioner, social worker, unlicensed psychology intern, or wound care nurse provided the service independently. By billing the medical service as if it were provided by a physician, Nguyen falsely inflated the amount his company was to be paid for the service.
Through these prohibited practices, Nguyen confessed to knowingly causing submission of thousands of false billing claims.Nguyen falsely created patient records to conceal and avoid detection of his fraudulent billing scheme.
Nguyen admitted the loss he caused was at least $3.7 million dollars. He agreed to pay restitution to the private insurance companies totaling over $1 million.
A conviction for Health Care Fraud carries a maximum penalty of 10 years in prison and a $250,000 fine.
Learn Basics From HHS Physician Health Care Fraud & Abuse Educational Resources
Along with ensuring that billing for care properly reflects the identity and legal capacity of the caregiver, physicians also have to negotiate a number of other federal healthcare laws.
The Department of Health and Human Services (“HHS”) Office of Inspector General (OIG) has created the educational materials listed below to assist in teaching physicians about the Federal laws designed to protect the Medicare and Medicaid programs and program beneficiaries from fraud, waste, and abuse:
The presentation summarizes the five main Federal fraud and abuse laws (the False Claims Act, the Anti-Kickback Statute, the Stark Law, the Exclusion Statute, and the Civil Monetary Penalties Law) and provide tips on how physicians should comply with these laws in their relationships with payers (e.g., the Medicare and Medicaid programs), vendors (e.g., drug, biologic, and medical device companies), and fellow providers (e.g., hospitals, nursing homes, and physician colleagues).
Physicians and another prescribers are encouraged to use these resources to help build their awareness of these rules as they relate to their practices. If any questions exist, physicians are encouraged to seek the advice of legal counsel to confirm their compliance.
For Additional Information
We hope this update is helpful. Solutions Law Press, Inc. invites you to receive future updates by registering on here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
If you need have questions or need assistance with this or other cybersecurity, health, benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, to inquire about arranging for compliance audit or training, or need legal representation on other matters, contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of employee benefit, managed care and other health and insurance industry, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Laws Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2024 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
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Posted by Cynthia Marcotte Stamer
April 1, 2024
April is National Minority Health Month, a time to emphasize the importance of improving health care in racial and ethnic minority communities.
Health disparities undermine the health of impacted communities, drive up government, employer, insurer and community health and disability costs, and create needless suffering.
While different organizations and studies use different definitions, health and health care disparities generally refer to differences in health and health care between groups that stem from broader inequities.
The Centers for Disease Control and Prevention (CDC) defines health disparities as “preventable differences in the burden, disease, injury, violence, or in opportunities to achieve optimal health experienced by socially disadvantaged racial, ethnic, and other population groups and communities.”
Healthy People 2030 defines a health disparity, as “a particular type of health difference that is linked with social, economic, and/or environmental disadvantage,” and that adversely affects groups of people who have systematically experienced greater obstacles to health.
The Kaiser Family Foundation reports that although health care is essential to health, research shows that health outcomes are driven by multiple factors, including underlying genetics, health behaviors, social and environmental factors, and access to health care.
While there is currently no consensus in the research on the magnitude of the relative contributions of each of these factors to health, studies suggest that health behaviors and social and economic factors, often referred to as social determinants of health, are the primary drivers of health outcomes and that social and economic factors shape individuals’ health behaviors. Moreover, racism negatively affects mental and physical health both directly and by creating inequities across the social determinants of health.
Helping to reduce health disparities begins with increasing awareness about health disparities that disproportionately impact people from historically marginalized communities, and by sharing resources to help.
Minority and underserved communities often face greater health care challenges including limited access to care, higher rates of chronic conditions, and worse health outcomes, as well as stigma and discrimination in health care settings. For example:
- Black people are 30 percent more likely to die from heart disease, 50 percent more likely to have a stroke, and 30 percent more likely to have asthma.
- Compared to non-Hispanic White persons, Hispanic individuals are 70 percent more likely to be diagnosed with diabetes by a physician and 1.2 times more likely to be obese.
Sometimes disparities are not from disease or actual care but arise from differences between groups in health insurance coverage, affordability, access to and use of care, and quality of care.
Help bring awareness to the health disparities impacting these diverse communities by sharing and making available the following responses from the Center for Medicare & Medicaid Services:
For Additional Information
We hope this update is helpful. Solutions Law Press, Inc. invites you to receive future updates by registering on here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
If you need have questions or need assistance with this or other cybersecurity, health, benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, to inquire about arranging for compliance audit or training, or need legal representation on other matters, contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of employee benefit, managed care and other health and insurance industry, workforce and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and Vice-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on heath benefit and other healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Author of a multitude of highly regarded publications on HIPAA and other medical record and data privacy and scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Laws Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2024 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Health Care | Tagged: Health Care, Health Care Fraud, Health Care Provider, health equity, Medicaid, national minority health month, pharmacy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
November 20, 2023
A Tennessee advanced practice nurse that pleaded guilty to unlawfully distributing controlled substances to two lovers and others and illegally billing Medicare and Medicaid could have been sentenced to serve up to 50 years in prison after already loosing losing her nursing license for her misconduct.
The license revocation and criminal prosecution, conviction and subsequent 36-month prison sentence imposed on a Tennessee advanced practice nurse that pleaded guilty to illegally prescribing controlled substances to her lovers and other patients and defrauding Medicare and Medicaid warns other health care providers of the perils risked from improper patient relationships, controlled substance prescribing and false billing even though her imposed prison sentence is substantially shorter than the maximum penalty authorized under the Federal Sentencing Guidelines.
According to court documents, advance practice registered nurse Kelly McCallum operated Convenient Care Clinic (“the “Clinic”) and held a registration from the Drug Enforcement Agency (“DEA”), which allowed her to prescribe controlled substances.
Court documents reflect McCallum, unlawfully prescribed controlled substances, including oxycodone and hydrocodone, at the Clinic. Over approximately four years from January 2017 until early 2021, McCallum prescribed more than two million opioid pills and more than 900,000 pills containing benzodiazepines. The Justice Department alleged some of these prescriptions were provided to individuals with whom she had sexual or other close personal relationships. She is also alleged to have prescribed dangerous combinations of controlled substances to her patients and, when she was out of the office, left pre-signed prescriptions for staff to distribute controlled substances in her absence. The government charged McCallum continued to prescribe controlled substances outside the usual course of professional practice and not for a legitimate medical purpose even after she became aware a patient fatally overdosed after she prescribed them controlled substances.
Beyond illegally prescribing controlled substances, the government also charged McCallum with health care fraud for allegedly billing TennCare and Medicare for fraudulent office visits on days that she was away from the Clinic, resulting in Medicare and Medicaid paying her approximately $16,234 for services she did not provide.
in June 2021, the Tennessee Board of Nursing summarily suspended McCallum’s registered nurse license and advance practice registered nurse certificate and ordered her to cease and desist from practicing in the state of Tennessee for her professional misconduct.
In May, 2023 McCallum pleaded guilty to two counts of unlawful distribution of controlled substances and one count of health care fraud. For her guilty pleas, McCallum could have faced up to 50 years in prison. She faced a maximum penalty of 20 years in prison on each controlled substance count, and a maximum penalty of 10 years in prison on the health care fraud count. After considering her sentencing report, however, the Court imposed only a 36 months prison term.
Even with her period of imprisonment set far below the maximum allowed penalty, McCallum’s story provides a cautionary tale for other health care providers about the risks and potential liabilities of violating statutory or ethical prohibitions on sexual relationships with patients, prescribing controlled substances and fraudulent billing for medical services.
For More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Co-Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee and VIce-Chair Elect of its International Employment Law Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, and Chair of the ABA Intellectual Property Section Law Practice Management Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on healthcare and life science, managed care and insurance and other workforce and staffing, employee benefits, safety, contracting, quality assurance, compliance and risk management, and other legal, public policy and operational concerns in the healthcare and life sciences, employee benefits, managed care and insurance, technology and other related industries. She speaks and publishes extensively on these and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. Scribe for the ABA JCEB Annual Meeting with the HHS Office of Civil Rights, her experience includes extensive involvement throughout her career in advising health care and life sciences and other clients about preventing, investigating and defending EEOC, DOJ, OFCCP and other Civil Rights Act, Section 1557 and other HHS, HUD, banking, and other federal and state discrimination investigations, audits, lawsuits and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state equal opportunity, equity and other laws.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2023 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Health Care | Tagged: Advanced Practice Nurse, controlled substance, Drug Abuse, Drug Trafficing, False Billing, Health Care Fraud, licensing, Nurse, Opiate, Sexual Misconduct, Sexual Relations with Patient | Permalink
Posted by Cynthia Marcotte Stamer
February 3, 2023
Phoenix-based nonprofit health system Banner Health and its affiliates (“Banner Health”) paid $1.25 million and agreed to take corrective actions to resolve its exposure to potentially much greater Health Insurance Portability and Accountability Act (HIPAA) Security Rule civil monetary penalty exposure for a 2016 cyber hacking breach that compromised the personal health information of 2.81 million consumers. OCR used its February 2 announcement of the Banner Health settlement to warn health care providers, health plans, health care clearinghouses (“covered entities”) and business associates covered by HIPAA to guard their own systems containing protected health information against breach by cyber hacking.
Banner Health Settlement
Banner Health is one of the largest non-profit health systems in the country, with over 50,000 employees and operating in six states. Banner Health is the largest employer in Arizona and one of the largest in northern Colorado.
In November 2016, OCR initiated an investigation of Banner Health following the receipt of a breach report stating that a threat actor had gained unauthorized access to electronic protected health information, potentially affecting millions. The hacker accessed protected health information that included patient names, physician names, dates of birth, addresses, Social Security numbers, clinical details, dates of service, claims information, lab results, medications, diagnoses and conditions, and health insurance information.
OCR’s investigation found evidence of long-term, pervasive noncompliance with the HIPAA Security Rule across Banner Health’s organization, a serious concern given the size of this covered entity. Organizations must be proactive in their efforts to regularly monitor system activity for hacking incidents and have measures in place to sufficiently safeguard patient information from risk across their entire network.
The potential violations OCR identified specifically included:
- A lack of an analysis to determine risks and vulnerabilities of electronic protected health information across the organization;
- Insufficient monitoring of its health information systems’ activity to protect against a cyber-attack;
- Failure to implement an authentication process to safeguard its electronic protected health information; and
- Failure to have security measures in place to protect electronic protected health information from unauthorized access when it was being transmitted electronically.
Under the Resolution Agreement and Corrective Action Plan negotiated to resolve these potential violations, Banner Health paid $1,250,000 to OCR. Banner Health also agreed to implement a corrective action plan, which identifies steps Banner Health will take to resolve these potential violations of the HIPAA Security Rule and protect the security of electronic patient health information that will be monitored for two years by OCR to ensure compliance with the HIPAA Security Rule. Under the corrective action plan, Banner has agreed to take the following steps:
- Conduct an accurate and thorough risk analysis to determine risks and vulnerabilities to electronic patient/system data across the organization
- Develop and implement a risk management plan to address identified risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI
- Develop, implement, and distribute policies and procedures for a risk analysis and risk management plan, the regular review of activity within their information systems, an authentication process to provide safeguards to data and records, and security measures to protect electronic protected health information from unauthorized access when it is being transmitted electronically, and
- Report to HHS within thirty (30) days when workforce members fail to comply with the HIPAA Security Rule.
OCR Warns Other HIPAA-Covered Entities
In the health care sector, hacking is now the greatest threat to the privacy and security of protected health information. OCR’s announcement of the settlement reports 74 percent (74%) of the breaches reported to OCR in 2021 involved hacking/IT incidents.
The announcement also notes OCR offers an array of resources to help health care organizations bolster their cybersecurity posture and comply with the HIPAA Rules,
The settlement and OCR’s announcement warn other covered entities and business associates to use these and other necessary resources to protect their systems with protected health information from cyber hacking and other breaches.
In conjunction with reminding other covered entities of these resources, the settlement announcement quotes OCR Director Melanie Fontes Rainer as a warning, “Hackers continue to threaten the privacy and security of patient information held by health care organizations, including our nation’s hospitals, … It is imperative that hospitals and other covered entities and business associates be vigilant in taking robust steps to protect their systems, data, and records, and this begins with understanding their risks, and taking action to prevent, respond to and combat such cyber-attacks. … Cyber security is on all of us, and we must take steps to protect our health care systems from these attacks.”
OCR’s enforcement record confirms these are not idyl threats. Breaches of the Security or Breach Notification Rules often result in significant civil monetary penalty assessments or negotiated settlements to mitigate civil liability exposures arising out of such breaches. See e.g., Clinical Laboratory Pays $25,000 To Settle Potential HIPAA Security Rule Violations (May 25, 2021); Health Insurer Pays $5.1 Million to Settle Data Breach Affecting Over 9.3 Million People (January 15, 2021); Aetna Pays $1,000,000 to Settle Three HIPAA Breaches(October 28, 2020); Health Insurer Pays $6.85 Million to Settle Data Breach Affecting Over 10.4 Million People (September 25, 2020); HIPAA Business Associate Pays $2.3 Million to Settle Breach Affecting Protected Health Information of Over 6 million Individual – (September 23, 2020); Lifespan Pays $1,040,000 to OCR to Settle Unencrypted Stolen Laptop Breach (July 27, 2020); Small Health Care Provider Fails to Implement Multiple HIPAA Security Rule Requirements (July 23, 2020).
Alerts issued by OCR regarding heightened security risks in recent months and a growing tide of highly publicized breaches send a strong warning to other covered entities and their business associates to reconfirm the adequacy of their own HIPAA privacy, security, breach notification and other procedures and protections by among other things:
- Reviewing and monitoring on a documented, ongoing basis the adequacy and susceptibilities of existing practices, policies, safeguards of their own organizations, as well as their business associates and their vendors within the scope of attorney-client privilege taking into consideration data available from OCR, data regarding known or potential susceptibilities within their own operations as well as in the media, and other developments to determine if additional steps are necessary or advisable.
- Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility.
- Renegotiating and enhancing service provider agreements to detail the specific compliance, audit, oversight and reporting rights, workforce and vendor credentialing and access control, indemnification, insurance, cooperation and other rights and responsibilities of all entities and individuals that use, access or disclose, or provide systems, software or other services or tools that could impact on security; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; and other relevant matters.
- Verifying and tightening technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information and systems.
- Conducting well-documented training as necessary to ensure that members of the workforce of each covered entity and business associate understand and are prepared to comply with the expanded requirements of HIPAA, understand their responsibilities and appropriate procedures for reporting and investigating potential breaches or other compliance concerns, and understand as well as are prepared to follow appropriate procedures for reporting and responding to suspected
violations or other indicia of potential security concerns.
- Tracking and reviewing on a systemized, well-documented basis actual and near-miss security threats to evaluate, document decision-making and make timely adjustments to policies, practices, training, safeguards and other compliance components as necessary to identify and resolve risks.
- Establishing and providing well-documented monitoring of compliance that includes board-level oversight and reporting at least quarterly and sooner in response to potential threat indicators.
- Establishing and providing well-documented timely investigation and redress of reported
violations or other compliance concerns.
- Establishing contingency plans for responding in the event of a breach.
- Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and requirements.
- Preparing and maintaining a well-documented record of compliance, risk, investigation and other security activities.
- Pursuing other appropriate strategies to enhance the covered entity’s ability to demonstrate its compliance commitment both on paper and in operation.
Because of susceptibilities in systems, software and other vendors of business associates, suppliers and other third parties, covered entities and their business associates should use care to assess and manage business associate and other vendor-associated risks and compliance as well as tighten business associate and other service agreements to promote the improved cooperation, coordination, management and oversight required to comply with the new breach notification and other HIPAA requirements by specifically mapping out these details.
Beyond these HIPAA exposures, breaches and other HIPAA noncompliance carries other liability risks. Leaders of covered entities or their business associates also are cautioned that while HIPAA itself does not generally create any private right of action for victims of breach under HIPAA, breaches may create substantial liability for their organizations or increasingly, organizational leaders. For instance, the Department of Health & Human Services has warned health care providers participating in Medicare or other federal programs and Medicare Advantage health plans that HIPAA compliance is a program term of participation.
Health care providers and health insurers can face liability under state data privacy and breach, negligence or other statutory or common laws. In addition, physicians and other licensed parties may face professional discipline or other professional liability for breaches violating statutory or ethical standards.
Health plans also face a myriad of other exposures from failing to use appropriate cyber safeguards. Plan fiduciaries of employment-based health plans covered by the Employee Retirement Income Security Act (“ERISA”) risk liability under ERISA’s fiduciary responsibility rules. The Department of Labor Employee Benefit Security Administration (“EBSA”) now audits the adequacy of the cybersecurity and other HIPAA compliance of health plans and their third-party administrators and other business associates as part of EBSA’s oversight and enforcement of ERISA. Department of Labor Assistant Secretary for EBSA Lisa Gomez confirmed audit and enforcement of cybersecurity obligations is a key priority in EBSA’s current work plan in her February 4, 2023 comments to the American Bar Association.
Meanwhile, the Securities and Exchange Commission has indicated that it plans to pursue enforcement against leaders of public health care or other public companies that fail to use appropriate care to ensure their organizations comply with privacy and data security obligations.
Furthermore, appropriate cyber security practices also may be advisable elements for organizations to include in their Federal Sentencing Guideline Compliance Programs to mitigate potential organization liability risks under federal electronic crime and related laws.
In the face of these risks and warnings, all covered entities and their business associates should reassess and confirm the adequacy of their and their business associates’ cyber security defenses and breach response preparations.
More Information
We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.
Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested in reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
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NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2023 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Cyber crime, data breach, data security, DME, Doctor, Employer, ERISA, Federal Sentencing Guidelines, Health Care Finance, Health Care Provider, Health Insurance, Health IT, Health Plan, Health Plans, HHS, HIPAA, HIPAA Cyber Crime, HITECH Act, home health, Hospice, Hospital, hospitals, Licensing, Meaningful Use, Medicaid, Medicaid Advantage, Medical Licensure, Medical Malpractice, Medical Privacy, Medical Records, Medicare, Medicare Advantage, OCR, Peer Review, Physician Licensing, retaliation, Technology, Telemedicine, Whistleblower | Tagged: ARRA, Breach Notification, CMS, Compliance, Corporate Compliance, Data Breach, Data Security, Doctor, DOJ, EHR, Electronic Health Records, Employer, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Health Care Reimbursement, Health Insurance, Health IT, Health Plan, Health Plans, HHS, HIPAA, HIPAA Privacy, HITECH Act, Hospital, Hospitals, licensure, Medicaid, Medical Privacy, Medicare, OCR, Office of Civil Rights, OIG, PHI, Physician, Physicians, Privacy, Protected Health Information | Permalink
Posted by Cynthia Marcotte Stamer
December 19, 2022
Three consolidated False Claims Act (“FCA”) lawsuits against chiropractor Yury Gampel (“Gampel”), 15 Modern Vascular office-based labs owned primarily by Gampel located across the United States, and five Modern Vascular-affiliated companies owned by Gampel alert other chiropractic, physician and other medical providers using office-based labs send a clear warning to other health care providers and suppliers for services covered or billed to Medicare, Medicaid, TRICARE or other federal health care programs about the necessity to ensure their arrangements don’t involve illegal financial relationships or transactions.
False Claims Act Liability Arising From Participation In Or Filing Claims Involving Improper Inducements
The Justice Department suit against the defendants alleges the defendants both arose from the defendants participation in arrangements involving the offering and payment of illegal remuneration in violation of the federal Anti-Kickback Statute (“AKS”) and that the claims for benefits made to Medicare and other federal programs for care provided involving the arrangement violated the FCA.
The AKS generally prohibits any person or entity from soliciting, receiving, offering, or paying any direct or indirect prohibited remuneration as an inducement or reward for referring, recommending, ordering, or arranging for the purchase of any item or service for which payment may be made in whole or in part by a federal health care program. Parties violating the AKS commit a felony punishable with a fine of up to $100,000, imprisonment for up to 10 years or both.
In addition to any criminal liability arising under the AKS, filing claims derived or involving transactions prohibited by the AKS also can trigger liability for violation of the FCA. The FCA makes it unlawful for any person to submit, directly or indirectly, false or fraudulent claims for payment to the Government by among other things:
- Knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval in violation of 31 U.S.C. § 3729(a)(1)(A) (the “presentment provision”); or
- Knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim in violation of 31 U.S.C. § 3729(a)(1)(B).
The FCA defines the term “knowingly” under the FCA very broadly. As defined, “knowingly” means that a person, with respect to information, (i) has actual knowledge of the information, (ii) acts in deliberate ignorance of the truth or falsity of the information, or (iii) acts in reckless disregard of the truth or falsity of the information. 31 U.S.C. § 3729(b). No proof of specific intent to defraud is required to show that a person acted knowingly under the FCA.
Violations of the FCA subject the defendant to mandatory civil penalties per FCA violation, plus three times the amount of damages that the Government sustains as a result of the defendant’s actions. 31 U.S.C. § 3729(a). Under 42 U.S.C. § 1320a-7(b)(7), health care providers submitting claims to Medicare or other federal health care programs also can face exclusion from participation in federal health care programs for FCA violations.
Health care providers filing claims for Medicare or other federal health plans can violate the FCA by knowingly presenting or causing to be presented claims for items or services that the person knew or should have known were not medically necessary, or were false or fraudulent. 42 U.S.C. §§ 1320a-7a(a)(1).
Moreover, health care providers under the Medicare statute have an affirmative duty to familiarize themselves with the statutes, regulations, and guidelines regarding coverage for the Medicare services. As a condition of program participation, Medicare regulations require providers and suppliers to certify that:
- The provider or supplier meets, and will continue to meet, the requirements of the Medicare statute and regulations, 42 C.F.R. § 424.516(a)(1), including that any claims and underlying transactions made in a claim for Medicare comply with the Federal anti-kickback statute and the Stark law), and on the supplier’s compliance with all otherwise applicable conditions of participation in Medicare; and
- The provider or supplier will not knowingly to present or cause to be presented a false or fraudulent claim for payment by Medicare, or to submit claims with deliberate ignorance or reckless disregard of their truth or falsity.
Additional certifications of continued compliance with these requirements also are required when claims are filed. Accordingly, since health care providers and suppliers are responsible for taking appropriate steps to familiarize themselves with the rules and regulations applicable to their claim and the transactions underlying it and certify in connection with the filing of the claim that the claim and its underlying transactions comply with the law, health care providers filing claims involving prohibited financial incentives or other transactions prohibited by law risk FCA liability.
Gampel, Modern Vascular FCA Complaint
Derived from the Justice Department’s assumption and consolidation of various qui tam lawsuits separately brought by various physicians, the United States filed its complaint in three consolidated lawsuits pending in the United States District Court for the District of Arizona under the qui tam, or whistleblower, provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733 (“FCA”) which allow a private citizen to sue on behalf of the government and share in any recovery. The United States is also entitled to intervene in the lawsuits, as it did in these cases.
The resulting consolidated three consolidated Justice Department lawsuits seek to recover treble damages and civil penalties, and under common law and equitable theories of recovery from defendants for their billing of Medicare, TRICARE and other federal health care programs for claims resulting from transactions involving prohibited remuneration offered and provided in violation of the AKS under Gampel’s alleged schemes Nobility Management LLC; Modern Vascular LLC; Modern Vascular of South Florida LLC; Modern Vascular Management LLC; Modern Vascular Management – East LLC; Modern Vascular Management – West LLC; Modern Vascular Institute LLC; Modern Vascular of Mesa LLC; Modern Vascular of Glendale LLC; Modern Vascular of Sun City LLC; Modern Vascular of Tucson LLC; San Antonio Vascular Specialists Corp. dba Modern Vascular; Fort Worth Vascular Specialists Corp. dba Modern Vascular; Modern Vascular of Denver LLC; Modern Vascular – Navajo LLC; Modern Vascular of Fairfax LLC; Modern Vascular of Houston LLC; Modern Vascular of Indianapolis LLC; Modern Vascular of Southaven LLC; Modern Vascular of St. Louis LLC; and Modern Vascular of Kansas LLC.
The Justice Department complaint alleges Defendant Yury Gampel, a chiropractor, is the founder and former Chief Executive Officer (“CEO”) of a franchise of office-based labs (“OBL”) located in Arizona, New Mexico, Colorado, Texas, Indiana, Kansas, Mississippi, Missouri, Tennessee, and Virginia operating under the name Modern Vascular (collectively, the “Modern Vascular OBLs”). The Modern Vascular OBLs – each its own separate legal entity – focus on the treatment of peripheral arterial disease (“PAD”), particularly through an aggressive use of vascular intervention procedures, such as angioplasty and atherectomy. The complaint claims Gampel and the Modern Vascular defendants designed and promoted the franchises that incorporated a package of management and other services provided by various Modern Vascular defendant companies.
Defendant Nobility Management, LLC, provides management services to the Modern Vascular OBLs. Defendants Modern Vascular Management, LLC; Modern Vascular Management – East, LLC; and Modern Vascular Management – West, LLC, offer
IT and management support to Modern Vascular OBLs. Defendants Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, are corporations controlled by Gampel that have various ownership interests in Modern Vascular OBLs. Through Modern Vascular, LLC, and Modern Vascular of South Florida, LLC, and in his own capacity, Gampel is the majority owner of the Modern Vascular OBLs. (These entities that own and manage the Modern Vascular OBLs are referred to collectively below as “Modern Vascular Corporate.”)
The complaint alleges that Gampel and Modern Vascular Corporate designed and implemented a fraud scheme at Modern Vascular OBLs at the expense of patients and federal payors from at least January 1, 2018 through June 30, 2022. Among other things, the complaint charges Gampel and the Modern Vascular defendants offered physicians the opportunity to invest in Modern Vascular office-based labs to induce them to refer their Medicare and TRICARE patients to Modern Vascular for the treatment of peripheral arterial disease. More specifically, Gampel and Modern Vascular Corporate opened Modern Vascular OBLs in new markets where referring physicians and vascular surgeons had established relationships. Prior to opening an OBL in a particular location, Gampel sought out up to 20 local physicians – usually podiatrists and pain management physicians – who traditionally referred to vascular surgeons and offered each up to a two percent ownership interest in the OBL in order to induce the physicians to refer to the OBL. Gampel and Modern Vascular Corporate selected these particular physicians (hereinafter “physician investors”) to offer ownership investment because Gampel and Modern Vascular Corporate identified them as potential high-referral sources. Once they invested in an OBL, Gampel and Modern Vascular Corporate further required the physician-investors to make referrals to Modern Vascular OBLs as a condition for remaining as a physician-investor. The complaint also alleges that Gampel pressured vascular surgeons and interventional radiologists employed at the Modern Vascular office-based labs to increase the number of invasive surgical procedures performed by tracking procedures and setting aggressive weekly and monthly goals for such procedures. In particular, Gampel and Modern Vascular Corporate provided remuneration to physician investors in Modern Vascular OBLs to induce those investors to refer patients to the Modern Vascular OBL.
The Justice Department charges that using this scheme, Defendants between January 1, 2018 and June 30, 2022 submitted, and caused to be submitted, tens of millions of dollars in false or fraudulent claims to Medicare, TRICARE and other federal health care programs by offering and providing illegal remuneration to health care providers to induce referrals to the Modern Vascular OBLs in violation of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b. To induce referrals, Gampel and Modern Vascular Corporate provided remuneration to physician-investors in the form of equity ownership interests in an OBL, which also included distributions, the prospect of future distributions, and/or the prospect of a cash-out of the equity ownership amounts when
the Modern Vascular OBLs were sold. During the relevant time period, the Justice Department also claims Modern Vascular
OBLs received over $50 million from Medicare Part B alone for claims submitted for patients referred by physician-investors in violation of the FCA.
Warning To Other Heath Care Providers & Suppliers
In announcing its filing of the Gambrel FCA lawsuit, the Justice Department warned other federal health program providers and suppliers and their business partners, investors, employees and agents from violating the AKS, FCA or both in the provision of or billing of health care services or supplies. “As part of our mission to protect the American people, the FBI remains committed to safeguarding patients who rely on our healthcare systems,” said Deputy Assistant Director Aaron Tapp of the FBI’s Criminal Investigative Division. “The FBI and our law enforcement partners will continue to investigate those who abuse our healthcare systems, place patients at risk, and waste taxpayer dollars.”
This warning, along with the ever-lengthening list of federal criminal and civil prosecutions, convictions and settlements by the Justice Department, the Department of Health & Human Services Office of Inspector General and other agencies provide a strong warning to health care providers, suppliers and others involved in creating or administering transactions and other arrangements for the delivery and billing for health are to be billed to Medicare, Medicaid, TRICARE and other health care arrangements covered by the AKS, the FCA or other federal or state health care fraud laws to take well documented care to ensure the care delivery arrangement does not involve transactions prohibited under the AKS or other federal or state health care fraud transactions and the care billed qualifies for reimbursement before submitting the claim. Parties who know or suspect that they may have participated in an arrangement prohibited under these laws or submitted prohibited claims should contact experienced legal counsel within the scope of attorney-client privilege for assistance in reviewing those concerns and exploring options for correction or mitigation.
For More Information
If your organization would like to learn more about the concerns discussed in this update or seeks assistance auditing, updating, administering or defending its human resources, compensation, benefits, corporate ethics and compliance practices, or other performance related concerns, contact management attorney and consultant Cynthia Marcotte Stamer.
An attorney Board Certified in Labor & Employment Law by Texas Board of Legal Specialization, Ms. Stamer is recognized for work helping organizations management people, operations and risk as a Fellow in the American College of Employee Benefit Counsel, a “Top Woman Lawyer,” “Top Rated Lawyer,” and “LEGAL LEADER™” in Labor and Employment Law and Health Care Law; a “Best Lawyers” in “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law.”
For 35 years, Ms. Stamer’s work has focused on advising and assisting businesses and business leaders with these and other employment and other staffing, employee benefit, compensation, risk, performance and compliance management and other operational solutions and concerns. Her experience includes helping management both manage performance and manage legal risk and compliance. While helping businesses define and manage the conduct and performance of their employees, contractors and vendors, she also assists employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, leave, and other labor and employment laws, advises and defends businesses against labor and employment, employee benefit, compensation, fraud and other regulatory compliance and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor, Department of Justice, SEC, Federal Trade Commission, HUD, HHS, DOD, Departments of Insurance, and other federal and state regulators. Ms. Stamer also speaks, coaches management and publishes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see hereor contact Ms. Stamer directly.
Other Helpful Resources & Information
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NOTICE: Terms. These materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice, a substitute for legal advice, an offer or commitment to provide legal advice or an admission. The information and statements in these materials may not address all relevant issues or apply to any situation or circumstances. The author reserves the right to qualify or retract any of these statements at any time. and does not necessarily address all relevant issues. Because the law evolves and in ways that subsequent developments could impact the currency and completeness of this discussion. The author disclaims and has no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers are urged to engage competent legal counsel for consultation and representation considering the specific facts and circumstances presented in their unique circumstance at any time. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication. Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein. ©2022 Cynthia Marcotte Stamer. Nonexclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.
Leave a Comment » | Academic medicine, Anti-KickBack, ASC, billing, compensation, Conditions of Participation, Corporate Compliance, DME, Doctor, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, Health IT, Home Health, Hospice, Hospital, Hospital, Indian Health, Inpatient Rehabilitation Facility, Laboratory tests, Laws, long-term care, Medicaid, Medicaid Advantage, Medicare, Mergers and Acquisitions, nursing home, Outpatient, pain management, Pharmaceudical, Physician, Physician Licensing, Prescription Drugs, Reimbursement | Tagged: Anti-Kickback, Health Care Fraud, Health Care Reimbursement, Medicaid, Medicare, Office-based labs | Permalink
Posted by Cynthia Marcotte Stamer
November 11, 2022
Fuve former Methodist Hospital Employees face criminal charges for conspiring with Roderick Harvey, to unlawfully disclose patient information in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) under indictments announced by the Justice Department today.
HIPAA was enacted by Congress in 1996 to create national standards to protect sensitive patient information from being disclosed without a patient’s knowledge or consent. HIPAA’s provisions make it a crime to disclose patient information, or to obtain patient information with the intent to sell, transfer or use such information for personal gain.
According to the indictment, between November 2017 and December 2020, Harvey paid defendants Kirby Dandridge, Sylvia Taylor, Kara Thompson, Melanie Russell and Adrianna Taber, to provide him with names and phone numbers of Methodist patients who had been involved in motor vehicle accidents. After obtaining the information, Harvey sold the information to third persons including personal injury attorneys and chiropractors.
However, if convicted, the conspiracy charge carries a maximum penalty of five years imprisonment, a fine of $250,000 and three-year period of supervised release.
Harvey was also charged with seven counts of obtaining patient information with the intent to sell it for financial gain on various dates between November 12, 2017, and September 7, 2019. Each of those charges carries a maximum penalty of 10 years’ imprisonment, a fine of $250,000 and three years’ of supervised release.
Dandridge, Taylor, Thompson, Russell, and Taber were each charged with separate violations of disclosing the information to Harvey in violation of HIPAA. That charge carries a maximum penalty of one year imprisonment, a $50,000 fine and a one-year period of supervised release.
The Justice Department announcement reminds that charges and allegations in the indictment are merely accusations, and the defendants are presumed innocent unless and until proven guilty.
The. Indictments demonstrate the criminal liability that health care providers and others can face for willfully misappropriation or other misuse of medical records or other information in violation of HIPAA. Because these violations are federal felonies, Employing organizations like Methodist could face liability under the federal sentencing guidelines unless they have implemented and administered appropriate preventing procedures and taken timely and appropriate corrective action to mitigate that liability under federal criminal law. When the organization investigates in response promptly and has taken appropriate reasonable steps, the Justice Department generally does not pursue criminal charges against the organization. Rather, the organizations liability typically is handled by the Department of Health and Human Services Office of Civil Rights (“OCR”). If it determines that the organization’s deficiencies in compliance with HIPAA contributed to or failed timely to remediate the violations, OCR can pursue civil monetary penalties. In most cases, however, OCR charges are resolved through resolution agreement settlement processes.
The indictments and associated investigations remind other healthcare providers, health plans, healthcare clearinghouse as a business associates of the importance of ensuring that they maintain and administer appropriate processes to prevent breaches of their data by internal personnel and others as well as comply with post breach investigation over mediation and reporting obligations.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2022 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Health Care | Tagged: Health Care Fraud, HIPAA | Permalink
Posted by Cynthia Marcotte Stamer
October 14, 2022
The $6.8 million settlement paid by four pharmacies to settle False Claims Act civil claims warns other pharmacies and other health care providers against improper copayment or other cost sharing waiver, billing and referral practices.
The Department of Justice announced October 12, 2022 that DermaTran Health Solutions, LLC (“DermaTran”); Pharmacy Insurance Administrators, LLC; Legends Pharmacy; TriadRx; and the former owners of Lake Side Pharmacy and related entities, agreed to pay $6,876,564 to resolve allegations that they violated the False Claims Act by waiving copays, charging the government higher prices than permitted, and trading federal healthcare business with other pharmacies.
The government alleged that in 2012, pharmacy DermaTran opened in Rome, Georgia, for the purpose of making and selling custom “compound” pain creams. DermaTran’s owners during the relevant time include DIII Consulting, LLC; SRM Holdings, LLC; Gussenhoven Holdings, LLC; Sam Moss; and Robert Gussenhoven. At the same time, another company named Pharmacy Insurance Administrators, LLC (“PIA”), was created to handle the billing for DermaTran. During the relevant time, PIA was a subsidiary of Insurance Administrative Solutions, LLC; which was a subsidiary of Gulfcoast Administrators, LLC; which was majority-owned by Life & Health Holdings, Inc.; which was a subsidiary of State Mutual Insurance Company.
Compound pain creams were very lucrative. Government-backed health insurance programs such as TRICARE (for the military) and the Federal Employees Health Benefits Program (for federal workers) would reimburse hundreds of dollars for these prescriptions. But the government programs imposed certain restrictions to limit spending. For example, patients were required to contribute to the cost of the prescription in the form of copays. The government programs also limited payments to the “usual and customary price”—the price charged to a cash-paying, uninsured patient.
The Government alleged that DermaTran and PIA found ways to avoid these restrictions. DermaTran and PIA created a copay-waiver program where patients would have their copays waived based on a brief, unverified statement of economic need. DermaTran and PIA also misled the government programs about the price being charged to uninsured, cash-paying patients by falsely stating that that price was high when, in fact, it was only $30. As a result, there were days that veterans were charged $600+ for pain creams, while uninsured patients were charged only $30.
Eventually, various auditors uncovered these problems and began to terminate DermaTran from their networks. The Government alleged that DermaTran, looking for a way to continue to earn money, began selling its out-of-network prescriptions to other pharmacies. The other pharmacies could fill the prescriptions because they were still in network. After filling the lucrative prescriptions, the other pharmacies remitted a portion of the proceeds to DermaTran and PIA. The government alleged that this arrangement constituted an illegal kickback. The other pharmacies that participated in this prescriptions-for-money scheme included Legends Pharmacy (in Texas), Lake Side Pharmacy (in Alabama), and TriadRx (in Alabama).
This settlement resulted from a joint investigation by the U.S. Attorney’s Office for the Northern District of Georgia, the FBI, the Defense Criminal Investigative Service, the US Office of Personnel Management – Office of the Inspector General, the U.S. Postal Service – Office of Inspector General, and the Health and Human Services – Office of Inspector General.
This civil settlement resolves a lawsuit filed in the U.S. District Court for the Northern District of Georgia by a former accountant for DermaTran, under the qui tam, or whistleblower provisions, of the False Claims Act. United States ex rel. Doe v. DermaTran Health Solutions, LLC, et al., Civil Action No. 1:17-CV-1765. Under the False Claims Act, private citizens may bring suit for false claims on behalf of the United States and share in any recovery obtained by the government.
Under the settlement, PIA will contribute $6.5 million to the settlement. DermaTran is no longer operating and was sold in an arm’s-length transaction to a third-party buyer last year for the price of $40,000. That amount will be turned over to the government as part of the settlement. MLDP of Texas, LP (a/k/a “Legends Pharmacy”) will pay $59,293. TRIAD Rx, Inc. will pay $166,547. Lake Side Pharmacy is no longer in business, but former owners of Lake Side Pharmacy will pay $110,724. The former owners include Titan Medical Marketing, LLC; Donald Wayne Bogue; George Takashi Elkins; James Bernard Bogue, Jr.; Robert Joseph Puckett, Jr.; Robert Joseph Puckett, Sr.; Stephen Weston Wilson; and Charles Franklin Taylor, Jr. The whistleblower will receive $1,434,775 from the settlements. PIA will also pay her attorney’s fees.
The settlement documents the commitment of the Justice Department, the Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) and other federal agencies to enforce the False Claims Act to recover government payments that result from improper waiver of copays, charging the government higher prices and other improper practices in violation of the False Claims Act. The agencies made a point of including their respective warnings in their announcement of the settlement.
“Health care fraud abuse like this case erodes the trust patients have in the health care system,” said Keri Farley, Special Agent in Charge of FBI Atlanta. “The FBI will not stand by when there are allegations of companies operating corporate wide schemes to illegally line their pockets.”
“Fraud through compounding pharmacies bilked billions out of TRICARE and undermined the integrity of our healthcare system designed to care for our service members and their families,” stated Cynthia Bruce, Special Agent in Charge of the Department of Defense, Office of Inspector General, Defense Criminal Investigative Service (DCIS). “I appreciate the partnership among involved law enforcement agencies and the U.S. Attorney’s Office to bring this matter to justice.”
“The OPM OIG has no tolerance for businesses that knowingly take advantage of FEHBP, violating the rules to make a profit,” said Amy K. Parker, Special Agent in Charge, OPM OIG. “I am extremely proud of the hard work of our investigators, analysts, and other law enforcement partners because overcharging the government is not a victimless crime – it contributes to higher premium prices and harms the financial integrity of the FEHBP.”
“The U.S. Postal Service, Office of Inspector General, will continue to tirelessly investigate those who commit frauds against federal benefit programs and the U.S. Postal Service. This settlement is a clear message that the USPS OIG is dedicated to rooting out corruption and bringing to justice those responsible for these crimes, said Special Agent in Charge Matthew Modafferi of the U.S. Postal Service, Office of Inspector General Northeast Area Field Office. The USPS OIG would like to thank our law enforcement partners and the Department of Justice for their efforts in this investigation”.
“Health care providers that try to boost their profits by submitting fraudulent claims to Federal health care programs threaten the integrity of those programs and drive up prices for everyone,” said Tamala E. Miles, Special Agent in Charge with the U.S. Department of Health and Human Services Office of Inspector General. “We work tirelessly alongside our law enforcement partners to protect the integrity of Federal health care programs and to ensure the appropriate use of taxpayer dollars.”
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
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NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2022 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Health Care | Tagged: CMS, controlled substance, DEA, drugs, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Health Plans, Hospital, Medicaid, Medicare, Medicare Part B, OIG, pain management, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
October 13, 2022
Criminal inditements unsealed October 12, 2022 against a Brooklyn area doctor, three pharmacies and four employees illustrate federal authorities’ continuing war against providers for wrongfully distributing oxycodone or other controlled substances.
The 10-count indictment unsealed charges Dr. Somsri Ratanaprasatporn, her office manager Leticia Smith, pharmacists Bassam Amin, Omar Elsayed, and Yousef Ennab, Michael Kent, Anthony Mathis, and Raymond Walker with conspiracy to distribute and possess with intent to distribute oxycodone and related crimes. Smith and Kent are also charged with money laundering in connection with their alleged efforts to hide the proceeds of their illegal oxycodone distribution operation. All eight defendants were arrested this morning and are scheduled to be arraigned this afternoon before United States Magistrate Judge Robert M. Levy.
As set forth in the indictment and publicly filed documents, between December 2018 and October 2022, the defendants operated a drug distribution ring out of a medical practice on Linden Boulevard in East New York, Brooklyn. Together, they unlawfully distributed more than 11,000 prescriptions for oxycodone.
According to the unsealed inditements, the structured drug trafficking ring’s operations started in a doctor’s office and ended with more than 1.2 million dangerously addictive opioids worth $24 million supplied to the streets of New York City,. Ratanaprasatporn, a pediatrician and general practitioner, and Smith, issued the prescriptions; Amin, Ennab and Elsayed filled the prescriptions at pharmacies in Brooklyn and Staten Island, and Kent, Mathis, and Walker oversaw “crews” of sham patients who received medically unnecessary prescriptions. Together, the defendants made millions of dollars from the scheme. During the execution of a search warrant this morning, members of law enforcement recovered several hundred thousand dollars in U.S. currency from Smith’s residence. Law enforcement also recovered two handguns that Kent was observed tossing from a rear door of his residence.
The charges in the indictment are allegations, and the defendants are presumed innocent unless and until proven guilty. If convicted of the drug charges, the defendants face up to 20 years’ imprisonment. If convicted of the money laundering charges, Smith and Kent face up to 20 years’ imprisonment for each count.
Oxycodone is a highly addictive opioid used to treat severe and chronic pain conditions. Addition and other abuse often starts from medications prescribed by or otherwise made available by health care providers.
Every year, millions of Americans abuse oxycodone. Misuse of painkillers like oxycodone leads to hundreds of thousands of annual emergency room visits. More than 16,000 Americans died from prescription opioid overdoses in 2020. Oxycodone prescriptions have enormous cash value to drug dealers. For example, one oxycodone 30 mg tablet, which was the dosage prescribed in this case, can be sold by dealers on the street for between $20 and $30 in New York City.
The growing epidemic of abuse of oxycodone and other prescription pain medications have prompted federal and state authorities to partner in their fight against pain medication abuse.
The charges are the result of an ongoing Organized Crime Drug Enforcement Task Forces (OCDETF) investigation led by the United States Attorney’s Office for the Eastern District of New York and the DEA. The principal mission of the OCDETF program is to identify, disrupt, and dismantle the most serious drug trafficking, weapons trafficking, and money laundering organizations, and those primarily responsible for the nation’s illegal drug supply. OCDETF uses a prosecutor-led, intelligence-driven, multi-agency approach that leverages the strengths of federal, state, and local law enforcement agencies against criminal networks.
Like many other recent prosecutions, these inditements target health care providers profiting off of the illegal prescription or other distribution of oxycodine or other controlled substances.
In announcing the inditements, representatives of each participating agency reintegrated their agencies commitment to continue investigation and prosecuting health care providers improperly distributing controlled substances.
“Doctors and medical professionals have a professional obligation to do no harm, but, as alleged, the defendants callously supplied more than one million pills to traffickers for distribution, resulting in dangerous opioids flooding the streets of this district,” stated United States Attorney Peace. “Today’s charges demonstrate this Office’s continued commitment to stemming the availability of illegal drugs and holding to account those who contribute to the epic tragedy that is the opioid epidemic.”
DEA Special Agent-in-Charge Tarentino warned the “DEA and our law enforcement partners will continue to hold DEA Registrants and other medical professionals to the highest possible standards and also hold them accountable when they knowingly endanger members of the community.”
“With this multi-million-dollar criminal scheme, it’s alleged the defendants made their profits off the vulnerabilities and addictions of their customers throughout New York City. Law enforcement partnerships like those seen here today have been and continue to be an integral part of stopping the flow of highly addictive narcotics into our communities,” stated IRS-CI Special Agent-in-Charge Fattorusso.
“Today’s charges show how diverted prescription drugs still fuel the opioid epidemic in New York. The Bureau of Narcotic Enforcement remains resolute in its commitment to work together with our federal and local law enforcement partners to disrupt and dismantle the criminal organizations that abuse the public’s trust in health care practitioners to move these dangerous and addictive pills from pharmacies to our neighborhoods,” stated BNE Director Vinciguerra.
Along with vigorous investigation and enforcement of providers and others involved in illegal distribution, federal and state authorities also have worked to tighten rules, standards and records keeping requirements for the legal prescription of opioids and other narcotics by physicians and other prescribers and stepped up disciplinary investigation and enforcement of these requirements. Billing for prescriptions of opioids beyond the parameters of tightened parameters also can trigger overprescribing and other allegations. Physician and other prescribers, pharmacists and pharmacies and other health industry participants should use care to establish and ensure they and their staff meticulously follow appropriate protocols and procedures to ensure their ability to defend their handling of opioid and other narcotic painkillers.
More Information
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
A Fellow in the American College of Employee Benefit Counsel, Vice Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and managed care industry legal, public policy and operational concerns.
Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.
For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here.
IMPORTANT NOTICE ABOUT THIS COMMUNICATION
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2022 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™
Leave a Comment » | Health Care | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Hospital, Medical Board, Medicare, pain management, pharmacist, pharmacy, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
September 9, 2021
All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.
According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.
The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.
According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See CMS/CDC Mandating COVID Vaccination For All Nursing Home Staff.
The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.
The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.
CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.
According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.
In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.
CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.
While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.
Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).
OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.
In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.
In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation.
Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.
In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.
Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.
While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.
Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.
In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.
More Information
This article is republished by permission of the author, Cynthia Marcotte Stamer. To review the original work, see here.
Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending, and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employers, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and other human resources, employee benefits, compensation, worker classification and other workforce and other services; insurance; health care; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other performance, risk management, compliance, public policy and regulatory affairs, and other operational concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com, on Facebook, on LinkedIn or Twitter or e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns.
©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™
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Posted by Cynthia Marcotte Stamer
July 8, 2021
Providers that received COVID-19 accelerated and advance payments should read the Centers for Medicare and Medicaid Services (“CMS”) updated FAQs (PDF) about repayment of COVID-19 accelerated and advance payments to learn how recoupment works and how it affects the provider’s Medicare claims payment amounts.
The new FAQ updates the Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021 (PDF) guidance.
For more information and to follow future updates, see the COVID-19 Accelerated and Advance Payments webpage or contact the author of this update.
More Information
If you are interested in a more detailed description of this or other developments discussed in this article, see here.
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About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.
Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.
Ms. Stamer has extensive experience advising, representing, defending and training domestic and international public and private health care and life sciences, charitable, community and governmental, and other business organizations and their leaders, employee benefit plans, their fiduciaries and service providers, insurers, and others. A widely published author and popular speaker, Ms. Stamer also has published and spoken extensively on wage and other and other health care, human resources, employee benefits and other workforce and services; insurance; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other compliance, governance, risk management, operational and public and regulatory affairs concerns.
A former lead advisor to the Government of Bolivia on its pension project, Ms. Stamer also has worked internationally and domestically as an advisor to health, managed care, insurance, and other business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.
Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member, past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. ©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™
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Posted by Cynthia Marcotte Stamer
December 17, 2019
The Department of Justice today sued the nation’s largest long term care pharmacy provider, Omnicare, and its parent company, CVS Healthcare Corporation seeking seeks damages and civil penalties under the False Claims Act for fraudulently billing federal healthcare programs for hundreds of thousands of non-controlled prescription drugs DOJ says Omnicare illegally dispensed to elderly and disabled individuals in assisted living facilities, group homes, independent living communities, and other non-skilled residential long-term care facilities (“LTC facilities”).
In the civil health care fraud complaint the DOJ filed a New York Federal District Court, the Omnicare illegally dispensed and billed the federal government and patients for antipsychotics, anticonvulsants, and antidepressants to elderly and disabled residents in LTC facilities without proper prescriptions. DOJ’s lawsuit alleges that instead of obtaining new prescriptions from patients’ doctors after the old ones had expired or run out of refills, Omnicare just assigned a new number to the old prescription and kept on dispensing drugs for months, and sometimes years, after the prescriptions expired. DOJ’s complaint alleges that Omnicare internally referred to these renumbered expired prescriptions as “rollover” prescriptions. The DOJ complaint also charges that Omnicare also submitted, or caused to be submitted false claims for payment for medications dispensed based on invalid prescriptions it internally referred to as “rollover” prescriptions” to Medicare, Medicaid, and TRICARE in violation of the False Claims Act.
Omnicare is the country’s largest provider of pharmacy services to LTC facilities. It currently operates approximately 160 pharmacies in 47 states across the United States, which dispense tens of millions of prescription drugs to LTC facilities that serve elderly and disabled individuals. CVS acquired Omnicare in May 2015, and shortly thereafter assumed an active role in overseeing Omnicare’s operations, including pharmacy dispensing practices and systems.
According to the DOJ complaint failed today, from 2010 until 2018, Omnicare and CVS allowed Omnicare pharmacies to dispense non-controlled prescription drugs to tens of thousands of elderly and disabled individuals living in LTC facilities based on prescriptions that had expired, were out of refills, or were otherwise invalid. Omnicare repeatedly disregarded prescription refill limitations and expiration dates that required doctor visits to reevaluate whether the drug should be renewed. Instead of requesting new prescriptions when old ones expired, Omnicare allowed prescriptions to “roll over.” At Omnicare, “rolling over” a prescription meant that when a prescription expired, Omnicare’s computer systems would assign the old prescription a new number and the pharmacy would continue to dispense the drug indefinitely without the need for a prescription renewal. Depending on the computer system used, Omnicare also sometimes assigned a fake number of authorized refills to a prescription – usually 99 allowable refills for Medicare patients – to allow for continuous refilling. DOJ claims that Omnicare pharmacies “rolled over” prescriptions for elderly and disabled individuals living in more than 3,000 residential long-term care facilities, including assisted living facilities operated by the largest long-term care providers in the country, such as Brookdale Senior Living, Atria Senior Living, Sunrise Senior Living Services, and Five Star Senior Living. DOJ also claims Omnicare managers exerted pressure on overwhelmed pharmacy staff to fill prescriptions quickly so that Omnicare could submit claims and collect payments.
According to the DOJ, Senior management at Omnicare and CVS knew of the practices. The DOJ complaint charges among other things that the Omnicare’s Compliance Department succinctly acknowledged the problem in an internal April 2015 email in which one Regional Compliance Officer stated: “An issue that I am running into more and more in multiple states concerns the ability of our systems to allow prescriptions to continue to roll after a year to a new prescription number without any documentation or pharmacist intervention.” A compliance officer then forwarded the email to the head of Omnicare’s Third Party Audit group, who responded that she had a “potential solution (programmed last year) but no one is rolling it out now.”
DOJ says Omnicare’s practice of illegally dispensing drugs to elderly and disabled individuals living in LTC facilities exposed these vulnerable individuals to a significant risk of harm. In contrast to traditional skilled nursing homes, where residents have access to 24-hour medical care supervised by doctors, assisted living and other non-skilled residential facilities offer more limited medical care, or none at all. In particular, these LTC facilities generally do not have doctors on staff to oversee and monitor residents’ drug therapy.
Many of the prescription drugs dispensed by Omnicare without valid prescriptions treat serious, chronic conditions, such as dementia, depression, and heart disease. They include antipsychotics, anticonvulsants, cardiovascular medications, anti-depressants, and other drugs that can have dangerous side effects and need to be closely monitored by doctors, particularly when taken in combination with other drugs by elderly patients. By repeatedly dispensing potent drugs without current and valid prescriptions, Omnicare jeopardized the health and safety of tens of thousands of individuals who continued to take the same drugs for months, and sometimes years, without consulting their doctors to determine whether the medications were still clinically appropriate.
A large percentage of the long-term care residents served by Omnicare are beneficiaries of federal healthcare programs. By dispensing drugs without valid prescriptions, Omnicare presented, or caused to be presented, hundreds of thousands of false claims to Medicare, Medicaid, and TRICARE. These claims were ineligible for payment. In addition, Omnicare knowingly transmitted false information to these federal healthcare programs that made it appear that drug dispensations were supported by current, valid prescriptions from physicians when in fact they were not.
The DOJ lawsuit resulted from the DOJ’s intervention in whistleblower lawsuits filed by former employees.
In today’s announcement of the lawsuit, Manhattan U.S. Attorney Geoffrey S. Berman said: “As alleged, Omnicare put at risk the health of tens of thousands of elderly and disabled individuals living in assisted living and other residential long-term care facilities by dispensing drugs for months, and sometimes years, without obtaining current, valid prescriptions from doctors. A pharmacy’s fundamental obligation is to ensure that drugs are dispensed only under the supervision of treating doctors who monitor patients’ drug therapies. Omnicare blatantly ignored this obligation in favor of pushing drugs out the door as quickly as possible to make more money. This Office will continue to hold accountable those who put at risk people’s health and safety just to turn a profit.”
Meanwhile, HHS-OIG Special Agent in Charge Scott J. Lampert said: “Failing to consult doctors as to whether prescriptions should be refilled places patients’ health and medical care at serious risk. These automatic rollover refills could have significant consequences for vulnerable people in long term-care facilities. We will continue working with law enforcement partners to protect people depending on these taxpayer-funded government health programs.”
More information is expected to be forthcoming.
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We hope this update is helpful. For more information about this or other labor and employment developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
Solutions Law Press, Inc. invites you receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
Ms. Stamer is most widely recognized for her decades-long leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve fraud, substandard quality, safety, unprofessional conduct, sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:
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Posted by Cynthia Marcotte Stamer
May 8, 2018
Three physicians are paying a total of $700,000 to settle Justice Department (DOJ) charges stemming from financial relationships with a drug testing lab. The settlement highlights the continuing need for providers to exercise care to avoid entering into financial arrangements with laboratories that DOJ, the Department of Health & Human Services Office of Inspector General (OIG) considers improper under federal health care fraud laws.
Dr. Robert Fetchero, D.O., Dr. Sridhar Pinnamaneni, M.D., and Dr. Thelma Green-Mack, M.D., separately agreed to settle allegations that they each received improper payments for referrals from Greensburg, Pennsylvania drug testing lab Universal Oral Fluid Laboratories, and caused false claims to be submitted to Medicare for drug testing services, United States Attorney Scott W. Brady announced yesterday.
The settlements announced resolve allegations that the settling physicians referred Medicare patients to Universal Oral Fluid Laboratories (“UOFL”) for drug testing services while engaged in a financial relationship with the lab. Specifically, UOFL paid the settling physicians to refer their patients to the lab for drug tests; UOFL then submitted claims to Medicare for the drug testing services from 2011 to 2014.
The settlements follow the earlier guilty plea on related charges of UOFL’s former medical director, Dr. John H. Johnson.
UOFL was owned and operated by William Hughes. The United States alleged that the financial arrangement between the settling physicians and UOFL violated the physician self-referral law, commonly known as the “Stark Law,” and the Anti-Kickback Statute, giving rise to liability under the False Claims Act. Pursuant to separately executed settlement agreements, Dr. Fetchero agreed to pay $200,000; Dr. Pinnamaneni agreed to pay $370,000; and Dr. Green-Mack agreed to pay $130,000.
The Stark Law forbids physicians from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless an exception applies. The Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of services covered by federal health care programs, such as Medicare. Violations of the Stark Law or Anti-Kickback Statute may give rise to civil liability for treble damages and penalties under the False Claims Act.
The settlements and underlying charges the resolve illustrate the risks that physicians and other providers run for participating in financial arrangements not structured to clearly meet applicable federal anti-kickback and STARK rules.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.
Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.
As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.
Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.
Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.
Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.
Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.
For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved
May 8, 2018
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Posted by Cynthia Marcotte Stamer
February 2, 2018
Fresenius Medical Care North America (FMCNA) is paying $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopting a comprehensive corrective action plan, under a voluntary resolution agreement that settles FMCNA exposures to OCR for violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules OCR asserts it found from an investigation it conducted into five separate HIPAA breach reports FMCNA filed in January 21, 2017.
Widespread publicity and fallout from data breaches involving Equifax, Blue Cross, the Internal Revenue Service and many other giant organizations have ramped up public awareness and government concern about health care and other data security. The resulting pressure is adding additional fuel to the already substantial concern of OCR and other agencies about compliance with HIPAA and other data security and breach laws. Like the $2.3 million HIPAA resolution agreement OCR announced with now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO) earlier this year, see, e.g., $23M Penalty Small Part of 21st Century’s Data Breach Fallout; Offers Data Breach Lessons For Other Businesses, the growing list of OCR resolution agreements and other enforcement actions against FMCNA, 21CO and other covered entities and other legal and market fallout that covered entities and other organizations experience following the announcement of breaches or other security deficiencies make the case for why HIPAA-covered health care providers, health plans, health care clearinghouses and their business associates (covered entities) must prioritize HIPAA compliance and other medical and other data security protection, privacy and risk management a top priority in 2018.
HIPAA Privacy, Security & Breach Notification Rule Responsibilities & Risks
The Privacy Rule requires that health plans, health care providers, health care clearinghouses (covered entities) and their vendors that qualify as “business associates” under HIPAA comply with detailed requirements concerning the protection, use, access, destruction and disclosure of protected health information. As part of these requirements, covered entities and their business associates must adopt, administer and enforce detailed policies and practices, assess, monitor and maintain the security of electronic protected health information (ePHI) and other protected health information, provide notices of privacy practices and breaches of “unsecured” ePHI, afford individuals that are the subject of protected health information certain rights and comply with other requirements as specified by the Privacy, Security and Breach Notification Rules. In addition, covered entities and business associates also must enter into a written and signed business associate agreement that contains the elements specified in Privacy Rule § 164.504(e) before the business associate creates, uses, accesses or discloses PHI of the covered entity. Furthermore, the Privacy Rule includes extensive documentation and keeping requirements require that covered entities and BAs maintain copies of these BAAs for a minimum of six years and to provide that documentation to OCR upon demand.
Violations of the Privacy Rule can carry stiff civil or even criminal penalties. Pursuant to amendments to HIPAA enacted as part of the HITECH Act, civil penalties typically do not apply to violations punished under the criminal penalty rules of HIPAA set forth in Social Security Act , 42 U.S.C § 1320d-6 (Section 1177).
Resolution Agreements like the $3.2 million FMCNA resolution agreement allow covered entities and business associates to resolve potentially substantially larger civil monetary penalty liabilities that OCR can impose under the civil enforcement provisions of HIPAA. As amended by the HITECH Act, the civil enforcement provisions of HIPAA empower OCR to impose Civil Monetary Penalties on both covered entities and BAs for violations of any of the requirements of the Privacy or Security Rules. The penalty ranges for civil violations depends upon the circumstances associated with the violations and are subject to upward adjustment for inflation. As most recently adjusted here effective September 6, 2016, the following currently are the progressively increasing Civil Monetary Penalty tiers:
- A minimum penalty of $100 and a maximum penalty of $50,000 per violation, for violations which the CE or BA “did not know, and by exercising reasonable diligence would not have known” about using “the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances;”
- A minimum penalty of $1,000 and a maximum penalty of $50,000 per violation, for violations for “reasonable cause” which do not rise to the level of “willful neglect” where “reasonable cause” means the “circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the violated Privacy Rule requirement;”
- A minimum penalty of $10,000 and a maximum penalty of $50,000 per violation, for violations attributed to “willful neglect,” defined as “the conscious, intentional failure or reckless indifference to the obligation to comply” with the requirement or prohibition; and
- A minimum penalty of $50,000 and a maximum penalty of $1.5 million per violation, for violations attributed to “willful neglect” not remedied within 30 days of the date that the covered entity or BA knew or should have known of the violation.
For continuing violations such as failing to implement a required BAA, OCR can treat each day of noncompliance as a separate violation. However, sanctions under each of these tiers generally are subject to a maximum penalty of $1,500,000 for violations of identical requirements or prohibitions during a calendar year. For violations such as the failure to implement and maintain a required BAA where more than one covered entity bears responsibility for the violation, OCR an impose Civil Monetary Penalties against each culpable party. OCR considers a variety of mitigating and aggravating facts and circumstances when arriving at the amount of the penalty within each of these applicable tiers to impose.
In addition to these potential civil liability exposures, however, covered entities, their business associates and other individuals or organizations that wrongfully use, access or disclose electronic or other protected health information also can face civil liability under various circumstances. The criminal enforcement provisions of HIPAA authorize the Justice Department to prosecute a person who knowingly in violation of the Privacy Rule (1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person, punishable by the following criminal sanctions and penalties:
- A fine of up to $50,000, imprisoned not more than 1 year, or both;
- If the offense is committed under false pretenses, a fine of up to $100,000, imprisonment of not more than 5 years, or both; and
- If the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, a fine of up to $250,000, imprisoned not more than 10 years, or both.
Because HIPAA Privacy Rule criminal violations are Class A Misdemeanors or felonies, Covered Entities and business associates should include HIPAA compliance in their Federal Sentencing Guideline Compliance Programs and practices and need to be concerned both about criminal exposure for their own direct violations, as well as imputed organizational liability for violations committed by their employees or agents under the Federal Sentencing Guidelines, particularly where their failure to implement or administer these required compliance policies and practices or failure to properly investigate or redress potential violations enables, perpetuates or covers up the criminal breach.
Fresenius Breach, Charges & Settlement Agreement Illustrate Civil Exposures
The FMCNA resolution agreement is another example of a growing list of resolution agreements various HIPAA covered entities have entered into to resolve their exposure to potentially greater liability should OCR assess civil monetary penalties under HIPAA’s civil sanction scheme.
The breach reports filed on January 21, 2017 reported five separate breach incidents occurring between February 23, 2012 and July 18, 2012 implicating the electronic protected health information (ePHI) of five separate FMCNA owned covered entities (FMCNA covered entities): Bio-Medical Applications of Florida, Inc. d/b/a Fresenius Medical Care Duval Facility in Jacksonville, Florida (FMC Duval Facility); Bio-Medical Applications of Alabama, Inc. d/b/a Fresenius Medical Care Magnolia Grove in Semmes, Alabama (FMC Magnolia Grove Facility); Renal Dimensions, LLC d/b/a Fresenius Medical Care Ak-Chin in Maricopa, Arizona (FMC Ak-Chin Facility); Fresenius Vascular Care Augusta, LLC (FVC Augusta); and WSKC Dialysis Services, Inc. d/b/a Fresenius Medical Care Blue Island Dialysis (FMC Blue Island Facility).
OCR concluded its investigation showed the breaches resulted because FMCNA failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its ePHI. OCR also concluded:
- The FMCNA covered entities impermissibly disclosed the ePHI of patients by providing unauthorized access for a purpose not permitted by the Privacy Rule.
- FMC Ak-Chin failed to implement policies and procedures to address security incidents.
- FMC Magnolia Grove failed to implement policies and procedures that govern the receipt and removal of hardware and electronic media that contain ePHI into and out of a facility; and the movement of these items within the facility.
- FMC Duval and FMC Blue Island failed to implement policies and procedures to safeguard their facilities and equipment therein from unauthorized access, tampering, and theft, when it was reasonable and appropriate to do so under the circumstances.
- FMC Magnolia Grove and FVC Augusta failed to implement a mechanism to encrypt and decrypt ePHI, when it was reasonable and appropriate to do so under the circumstances.
In addition to a $3.5 million monetary settlement, a corrective action plan requires the FMCNA covered entities to complete a risk analysis and risk management plan, revise policies and procedures on device and media controls as well as facility access controls, develop an encryption report, and educate its workforce on policies and procedures.
HIPAA Enforcement A Growing Risk
Covered entities, their business associates and members of their workforce need to recognize that the FMCNA and other resolution agreements are part of a growing trend, rather than isolated incidents of enforcement.
While civil monetary penalty enforcement remains much more common than criminal prosecution, covered entities, their business associates and members of their workforce must understand that HIPAA enforcement and resulting liability is growing.
While Department of Justice federal criminal prosecutions and convictions under HIPAA remain relatively rare, they occur and are growing. See e.g., Former Hospital Employee Sentenced for HIPAA Violations (Texas man sentenced to 18 months in federal prison for obtaining protected health information with the intent to use it for personal gain); Three Life Sentences Imposed On Man Following Convictions For Drug Trafficking, Kidnapping, Using Firearms and HIPAA Violations (drug king pin gets multiple 10 year consecutive prison terms for unauthorized access to private health information in violation of HIPAA; his health care worker friend sentenced for accessing electronic medical files and reporting information to him); Former Therapist Charged In HIPAA Case; Hefty Prison Sentence in ID Theft Case (former assisted living facility worker gets 37 months in prison after pleading guilty to wrongful disclosure of HIPAA protected information and other charges); Hefty Prison Sentence in ID Theft Case (former medical supply company owner sentenced to 12 years for HIPAA violations and fraud). While the harshest sentences tend to be associated with health care fraud or other criminal conduct, lighter criminal sentences are imposed against defendants in other cases as well. See e.g., Sentencing In S.C. Medicaid Breach Case (former South Carolina state employee sentenced to three years’ probation, plus community service, for sending personal information about more than 228,000 Medicaid recipients to his personal e-mail account.); HIPAA Violation Leads To Prison Term (former UCLA Healthcare System surgeon gets four months in prison after admitting he illegally read private electronic medical records of celebrities and others.)
While criminal enforcement of HIPAA remains relatively rare and OCR to date only actually has assessed HIPAA civil monetary penalties against certain Covered Entities for violating HIPAA in a couple isolated instances, the growing list of multi-million dollar resolution payments that FMCNA and other covered entities caught violating HIPAA make clear that HIPAA enforcement is both meaningful and growing. See e.g., Learn From Children’s New $3.2M+ HIPAA CMP For “Knowing” Violation of HIPAA Security Rules ($3.2 million Children’s Medical Center HIPAA Civil Monetary Penalty); 1st HIPAA Privacy Civil Penalty of $4.3 Million Signals CMS Serious About HIPAA Enforcement; $400K HIPAA Settlement Shows Need To Conduct Timely & Appropriate Risk Assessments; $5.5M Memorial HIPAA Resolution Agreement Shows Need To Audit. For more examples, also see here.
Coming on the heels of an already lengthy and growing list of OCR high dollar HIPAA enforcement actions, the FMCNA and other resolution agreements and civil monetary penalties these and other announced enforcement actions clearly reflect that OCR takes HIPAA compliance seriously and stands ready to impose substantial penalties when it finds violations in connection with breach notice investigations. Viewed in the context of these and other enforcement actions, the FMCNA Resolution Agreement and others clearly reflect the time for complacency in HIPAA compliance and leniency in HIPAA HIPAA enforcement are passed. Rather, these and other enforcement actions make clear why health care providers, health plans, healthcare clearinghouses and their business associates must make HIPAA compliance a priority now.
Covered entities and business associates also should recognize their potential responsibilities and risks for breaches or other improper conduct concerning patient or other sensitive personal financial information, trade secrets or other data under a wide range of laws beyond HIPAA and its state law equivalents. As documented by the media coverage of the legal and business woes of Alteryx, eBay, Paypal owner TIO Networks, Uber, Equifax and a long list of other previously trusted prominent businesses have and continue to incur from data breaches within their organizations, health care or other covered entities experiencing breaches often also face FTC or other government investigations and enforcement under the Fair and Accurate Credit Transactions Act (FACTA) and other federal or state identity theft, data privacy and security, electronic crimes and other rules as well as business losses and disruptions; civil litigation from breach victims, shareholders and investors, and business partners as well as OCR, FTC, and state data security regulation enforcement. Amid this growing concern, OCR has indicated that it intends to continue to diligently both seek to support and encourage voluntary compliance by covered entities and their business associates and investigate and enforce HIPAA against HIPAA covered entities and their business associates that fail to adequately safeguard PHI and ePHI in accordance with HIPAA. In the face of these growing risks and liabilities, covered entities and their business leaders face a strong imperative to clean up and maintain their HIPAA compliance and other data security to minimize their exposure to similar consequences.
In light of these rises, leaders, investors, insurers, lenders and others involved with covered entities and their business associates should take steps to verify that the covered entities and their business associates not only maintain compliance with HIPAA, but also comply with data security, privacy and other information protection requirements arising under other laws, regulations, and contracts, as well as the practical business risks that typically follow the announcement of a breach. Considering these risks, covered entities and their business associates must recognize and take meaningful, documented action to verify their existing compliance and ongoing oversight to ensure their organizations can demonstrate appropriate action to maintain appropriate practices, insurance and other safeguards to prevent, respond to and mitigate exposures in the event of a breach of protected health information or other sensitive data.
In response to these growing risks and concerns, covered entities and their business associates should ensure that they have conducted, and maintain and are ready to produce appropriate policies and procedures backed up by a well documented, up-to-date industry wide risk assessment of their organization’s susceptibility to breaches or other misuse of electronic or other protected health information. The starting point of these efforts should be to adopt and enforce updated written policies, procedures, technical and physical safeguards, processes and training to prevent the improper use, access, destruction or disclosure of patient PHI. Processes also should create, retain and be designed to cost effectively track, capture, and retain both all protected health information, its use, access, protection, destruction and disclosure, and the requisite supportive documentation supporting the appropriateness of those action to position the organization cost-effectively and quickly to fulfill required accounting, reporting and other needs in the event of a data breach, audit, participant inquiry or other event.
As part of this process, covered entities and business associates should start by reviewing and updating their policies, HIPAA audits and assessments and other documentation and processes. In doing so, they must use care to look outside the four corners of their Privacy Policies and core operating systems to ensure that their policies, practices, oversight and training address all protected health information within their operations on an entity wide basis. This entity-wide assessment should include both communications and requests for information normally addressed to the Privacy Officer as well as requests and communications that could arise in the course of media or other public relations, practice transition, workforce communication and other operations not typically under the direct oversight and management of the Privacy Officer.
In connection with these efforts, the enforcement actions make clear that Covered Entities and business associates should adopt, implement and monitor PHI privacy, and security on an entity wide basis. These efforts should include both general policies, practices and procedures as well as specifically tailored policies, processes and training to protect PHI and preserve HIPAA compliance throughout their organization as well as the business associate agreements and other processes to provide for HIPAA compliance with respect to protected health information created, used, accessed or disclosed to business associates or others not part of their direct workforce or operating outside the core boundaries of their facilities.
Covered entities and their business associates also must recognize and design their compliance efforts and documentation recognizing that HIPAA compliance is a living process, which require both constant diligence about changes in systems or other events that may require reevaluation or adjustments, whether from changes in software, systems or processes or external threats.
Because the cost of responding to and investigating breaches or other compliance concern can be quite burdensome, covered entities and their business associates also generally will want to pursue options to plan for and minimize potential expenses in the design and administration of their programs as well as to minimize and cover the potentially extraordinary costs of breach or other compliance investigation and results that commonly arise following a breach or other compliance event. As a part of this planning, covered entities and their business associates also generally will want to add consideration of changes to federal tax rules on the deductibility of compliance penalty and other related compliance expenditures.
While the Internal Revenue Code traditionally has prohibited businesses and individuals from deducting penalties, fines and other expenditures arising from violations of federal or state laws under Section 162(f) of the Internal Revenue Code, Section 13306 of the Tax Cuts and Jobs Creation Act creates a new exception for amounts (other than amounts paid or incurred any amount paid or incurred as reimbursement to the government or entity for the costs of any investigation or litigation) that a taxpayer establishes meet the following requirements:
- Constitute restitution (including remediation of property) for damage or harm which was or may be caused by the violation of any law or the potential violation of any law, or
- Are paid to come into compliance with any law which was violated or otherwise involved in the investigation or inquiry into a violation or potential violation of any law;
- Are identified as restitution or as an amount paid to come into compliance with such law, as the case may be, in the court order or settlement agreement, and
- In the case of any amount of restitution for failure to pay any tax imposed under this title in the same manner as if such amount were such tax, would have been allowed as a deduction under this chapter if it had been timely paid.
Because the true effect of these modifications will be impacted by implementing regulations and a number of other special conditions and rules may impact the deductibility of these payments and the reporting obligations attached to their payment, covered entities will want to consult with legal counsel about these rules and monitor their implementation to understand their potential implications on compliance expenditures and penalties.
About The Author
Repeatedly recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career. Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.
Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers. Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
December 29, 2017
The just-announced agreement $2.3 million (Resolution Amount) settlement by now bankrupt radiation oncology and cancer care provider 21st Century Oncology, Inc. (21CO) is paying to settle Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules violation charges and other continuing post-breach fallout that helped push 21CO to file for Chapter 11 bankruptcy protection demonstrates again why HIPAA-covered health care providers, health plans, health care clearinghouses and their business associates (covered entities) must make HIPAA compliance and risk management a high priority in 2018.
Distinctive as the first HIPAA resolution agreement requiring bankruptcy court approval and for the bankruptcy court’s order including a direction to the covered entity’s cyber liability insurer to pay the Resolution Payment and other investigation defense expenses, the 21CO resolution agreement resolves potential civil monetary penalty exposures the Fort Myers, Florida based provider of cancer care services and radiation oncology could have faced from the Department of Health & Human Services Office of Civil Rights (OCR) charges it violated HIPAA’s Privacy and Security Rules arising from the hacking and misappropriation of records containing sensitive electronic protected health information (ePHI) of up to 2,213597 individuals.
When their own 2018 HIPAA or other compliance investigation activities or planning HIPAA compliance and risk management activities, covered entities and their business associates and their leaders should use 21CO’s painful post-breach lessons experience to minimize their own HIPAA breach exposures, as well as consider how amendments to Internal Revenue Code Section 162(f) might impact the tax deductibility of certain compliance expenditures.
21CO HIPAA Breaches & Fallout
The OCR charges against 21CO arose from an OCR investigation commenced after the Federal Bureau of Investigation (FBI) notified 21CO on November 13, 2015 and a second time on December 13, 2015 than unauthorized third-party illegally obtained 21CO sensitive patient information and produced 21CO patient files purchased by a FBI informant. As part of its internal investigation, 21CO hired a third party forensic auditing firm in November 2015. 21CO determined that the attacker may have accessed 21CO’s network SQL database as early as October 3, 2015, through Remote Desktop Protocol from an Exchange Server within 21CO’s network. 21CO determined that it is possible that 2,213,597 individuals may have been affected by the impermissible access to their names, social security numbers, physicians’ names, diagnoses, treatment and insurance information.
Although it knew of the breaches in November and December, 2015, 21CO delayed notifying patients of the data breach for more than three months after the FBI notified it of the breaches before it sent HIPAA or other breach notifications about the data breach to patients or notified investors in March, 2016. Its March 4, 2016 Securities and Exchange Commission 8-K on Data Security Incident (Breach 8-K) states 21CO delayed notification at the request of the FBI to avoid interfering in the criminal investigation of the breach.
When announcing the breach, 21CO provided all individuals affected by the breach with a free one-year subscription to the Experian ProtectMyID fraud protection service. At that time, 21CO said it had no evidence that any patient information actually had been misused. However victims of the breach subsequently are claiming being victimized by a variety of scams since the breach in news reports and lawsuits about the breach.
At the time of the breach and its March 4, 2016 announcement of the breach, 21CO already was working to resolve other compliance issues. On December 16, 2015, 21CO announced that a 21CO subsidiary had agreed to pay $19.75 million to the United States and $528,000 in attorneys’ fees and costs and comply with a corporate integrity agreement related to a qui tam action in which it was accused of making false claims to Medicare and other federal health programs. See 21CO 8-K Re: Entry into a Material Definitive Agreement (December 22, 2015). Among other things, the corporate integrity agreement required by that settlement required 21CO to appoint a compliance officer and take other steps to maintain compliance with federal health care laws. In addition, five days after releasing the March 4, 2017 Breach 8-K, 21CO notified investors that its subsidiary, 21st Century Oncology, Inc. (“21C”), had agreed to pay $37.4 million to settle health care fraud law charges relating to billing and other protocols of certain staff in the utilization of state-of-the-art radiation dose calculation system used by radiation oncologists called GAMMA. See 21CO 8-K Re: GAMMA Settlement March 9, 2016 ; See also United States Settles False Claims Act Allegations Against 21st Century Oncology for $34.7 Million.
As the breeches impacted more than 500 individuals, 21CO’s HIPAA breaches were considered large breaches for purposes of the Breach Notification Rules. It is the policy of OCR to investigate all large breach notifications filed under the HIPAA Breach Notification Rules.
Based on OCR’s subsequent investigation into these breaches, OCR found:
- 21CO impermissibly disclosed certain PHI of 2,213,597 of its patients in violation of 45 C.F.R. § 164.502(a);
- 21CO failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the electronic protected health information (ePHI) held by 21CO in violation of 45 C.F.R. § 164.308(a)(1)(ii)(A);
- 21CO failed to implement certain security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with 45 C.F.R. § 164.306(A) in violation of 45 C.F.R. § 164.308(a)(1)(ii)(B);
- 21CO failed to implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports as required by 45 C.F.R. §164.308(a)(1)(ii)(D);
- 21CO disclosed protected health information to a third-party vendors, acting as its business associates, without obtaining satisfactory assurances in the form of a written business associate agreement in violation of HIPAA’s business associate rule requirements under 45 C.F.R. §§ 164.502(e) and 164.308(b)(3).
The Resolution Agreement settles potential charges and exposures to potentially much higher civil monetary penalties that 21CO could have faced had OCR successfully prosecuted charges against 21CO for the breaches. In return for OCR’s agreement not to further pursue charges or penalties relating to the breach investigation, the Resolution Agreement requires that 21CO pay OCR a $2.3 million Resolution Amount and implement to OCR’s satisfaction a corrective action plan that among other things requires that 21CO complete the following corrective actions to the satisfaction of OCR:
- To complete a risk analysis and risk management plan;
- To revise its HIPAA policies and procedures regarding information system activity review to require the regular review of audit logs, access reports, and security incident tracking reports pursuant to 45 C.F.R. § 164.308(a)(1)(ii)(D);
- To revise its policies and procedures regarding access establishment and modification and termination pursuant to 45 C.F.R. § 164.308(a)(4)(ii)(C) and 45 C.F.R. § 164.308(a)(3)(ii)(C) to include protocols for access to 21CO’s e-PHI by affiliated physicians, their practices, and their employees.
- To distribute its policies to and educate its workforce on the updated and other HIPAA policies and procedures;
- To provide OCR with an accounting of 21CO’s business associates that includes names of business associates, a description of services provided, a description of the business associate’s handling of 21CO’s PHI, the date services began and copies of the actual business associate agreement with each business associate; and
- Submit an internal monitoring plan to OCR.
In addition to the OCR investigation that lead to the new HIPAA resolution agreement announced by OCR on December 28, 2017, 21CO experienced other fallout following its March 4, 2016 public disclosure of the breach. Not surprisingly, the breach notification led to a multitude of class-action civil lawsuits by breach victims and shareholders. See, e.g., 16 Data Breach Class Action Lawsuits Filed Against 21st Century Oncology Consolidated; 21st Century Oncology data breach prompts multiple lawsuits. Reports of spoofing and other misleading contacts made to 21CO patients following the breach prompted the Federal Trade Commission (FTC) to issue a specific notice alerting victims about potential false breach notifications and other misleading contacts. See April 4, 2016 FTC Announcement Re: 21st Century Oncology breach exposes patients’ info.
These and other developments also had significant consequences on 21CO’s financial status and leadership. By March 31, 2015, 21CO notified the SEC and investors that it needed added time to complete its financial statements. Subsequent SEC filings document its restatement of financial statements, the departure of board members and other leaders, default on credit terms, and ultimately its filing for Chapter 11 bankruptcy protection in the United States Bankruptcy Court for the Southern District of New York on May 25, 2017.
Insurer Funding $2.3 Million Settlement Payment For Bankrupt 21CO
The 21CO resolution agreement required bankruptcy court approval, Funds for payment of the required $2.3 million resolution payment and other charges associated with the investigation apparently are being provided in part from breach liability insurance coverage provided under a policy issued by Beazley Insurance, as the Bankruptcy Court order directs Beazley Breach Response Policy No. W140E2150301 to make immediate payment to the OCR of the resolution amount and the payment of fees incurred by 21CO in connection with regulatory defense issues.
Settlements Highlight Growing Risks Of Noncompliance, Lack Data Security
One of a growing multitude of multimillion dollar HIPAA resolution agreements to avoid HIPAA civil monetary sanctions that OCR already has announced, the 21CO resolution agreement announcement also comes when a steady stream of reports of massive data breaches at Alteryx, eBay, Paypal owner TIO Networks, Uber, Equifax and a long list of other previously trusted prominent businesses are stoking government and public awareness and concern over health care and other data privacy and cybersecurity. Beyond their potential HIPAA enforcement exposures, health care or other covered entities experiencing breaches often also face FTC or other government investigations and enforcement under the Fair and Accurate Credit Transactions Act (FACTA) and other federal or state identity theft, data privacy and security, electronic crimes and other rules as well as business losses and disruptions; civil litigation from breach victims, shareholders and investors, and business partners as well as OCR, FTC, and state data security regulation enforcement. Amid this growing concern, OCR has indicated that it intends to continue to diligently both seek to support and encourage voluntary compliance by covered entities and their business associates and investigate and enforce HIPAA against HIPAA covered entities and their business associates that fail to adequately safeguard PHI and ePHI in accordance with HIPAA. In the face of these growing risks and liabilities, covered entities and their business leaders face a strong imperative to clean up and maintain their HIPAA compliance and other data security to minimize their exposure to similar consequences.
In light of these rises, leaders, investors, insurers, lenders and others involved with covered entities and their business associates should take steps to verify that the covered entities and their business associates not only maintain compliance with HIPAA, but also maintain appropriate practices, insurance and other safeguards to prevent, respond to and mitigate exposures in the event of a breach of protected health information or other sensitive data.
As a part of this planning, covered entities and their business associates also generally will want to add consideration of changes to federal tax rules on the deductibility of compliance penalty and other related compliance expenditures. While the Internal Revenue Code traditionally has prohibited businesses and individuals from deducting penalties, fines and other expenditures arising from violations of federal or state laws under Section 162(f) of the Internal Revenue Code, Section 13306 of the Tax Cuts and Jobs Creation Act creates a new exception for amounts (other than amounts paid or incurred any amount paid or incurred as reimbursement to the government or entity for the costs of any investigation or litigation) that a taxpayer establishes meet the following requirements:
- Constitute restitution (including remediation of property) for damage or harm which was or may be caused by the violation of any law or the potential violation of any law, or
- Are paid to come into compliance with any law which was violated or otherwise involved in the investigation or inquiry into a violation or potential violation of any law;
- Are identified as restitution or as an amount paid to come into compliance with such law, as the case may be, in the court order or settlement agreement, and
- In the case of any amount of restitution for failure to pay any tax imposed under this title in the same manner as if such amount were such tax, would have been allowed as a deduction under this chapter if it had been timely paid.
Because the true effect of these modifications will be impacted by implementing regulations and a number of other special conditions and rules may impact the deductibility of these payments and the reporting obligations attached to their payment, covered entities will want to consult with legal counsel about these rules and monitor their implementation to understand their potential implications on compliance expenditures and penalties.
About The Author
Repeatedly recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, a Fellow in the American College of Employee Benefit Council, the American Bar Foundation and the Texas Bar Foundation and board certified in labor and employment law by the Texas Board of Legal Specialization, Cynthia Marcotte Stamer is a practicing attorney, management consultant, author, public policy advocate and lecturer widely known for health and managed care, employee benefits, insurance and financial services, data and technology and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Nationally recognized for her work, experience, leadership and publications on HIPAA and other medical privacy and data use and security, FACTA, GLB, trade secrets and other privacy and data security concerns, Ms. Stamer has worked extensively with clients and the government on cybersecurity, technology and processes and other issues involved in the use and management of medical, insurance and other financial, workforce, trade secrets and other sensitive data and information throughout her career. Scribe or co-scribe of the ABA Joint Committee on Employee Benefits Agency meeting with OCR since 2011 and author of a multitude of highly regarded publications on HIPAA and other health care, insurance, financial and other privacy and data security, Ms. Stamer is widely known for her extensive and leading edge experience, advising, representing, training and coaching health care providers, health plans, healthcare clearinghouses, business associates, their information technology and other solutions providers and vendors, and others on HIPAA and other privacy, data security and cybersecurity design, documentation, administration, audit and oversight, business associate and other data and technology contracting, breach investigation and response, and other related concerns including extensive involvement representing clients in dealings with OCR and other Health & Human Services, Federal Trade Commission, Department of Labor, Department of Treasury, state health, insurance and attorneys’ general, Congress and state legislators and other federal officials.
Ms. Stamer also has an extensive contributes her leadership and insights with other professionals, industry leaders and lawmakers. Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
November 14, 2017
Physician Abdul Haq faces sentencing on May 29, 2018 after pleading guilty to one count of conspiracy to commit health care fraud on October 3 for his role in an approximately $19 million Medicare fraud scheme involving billing Medicare for providing medically unnecessary controlled substances, including Oxycodone, Hydrocodone and Opana, to narcotic addicted Medicare beneficiaries. See Doctor Pleads Guilty to Health Care Fraud Conspiracy for Role in $19 Million Detroit Area Medicare Fraud Scheme. Haq’s prosecution and guilty plea is one of a growing federal prosecutions of health care providers involving billing of Medicare or other health payers for prescribing medically unnecessary controlled substances to Medicare or other health plan beneficiaries.
According to court documents, Haq admitted he participated in a schedule where he and his co-conspirators prescribed and billed Medicare for medically unnecessary controlled substances, including Oxycodone, Hydrocodone and Opana, to Medicare beneficiaries, many of whom were addicted to narcotics. Haq also admitted in court that he and his co-conspirators required some Medicare beneficiaries to undergo and billed Medicare for medically unnecessary facet joint injections if the beneficiary wished to obtain prescriptions for controlled substances.
According to the Justice Department, in furtherance of the conspiracy, Haq and others referred Medicare beneficiaries to specific third party home health agencies, laboratories and diagnostic providers even though those referrals were medically unnecessary. Haq also admitted to serving as the straw owner of various pain clinics owned and/or controlled by Rashid, and submitted false and fraudulent enrollment materials to Medicare that failed to disclose the ownership interest of Rashid, as it was illegal for Rashid – a non-physician – to own medical clinics under Michigan law. In total, Haq admitted that he submitted or caused the submission of approximately $19,322,846.60 in false and fraudulent claims to Medicare.
Haq was charged along with Michigan residents Mashiyat Rashid, Joseph Betro, Tariq Omar and Mohammed Zahoor and Ohio resident Yasser Mozeb, Ohio under inditements unsealed on July 6. Haq is scheduled to be sentenced for his guilty plea on May 29, 2018. Rashid, Mozeb, Pappas, Betro, Omar and Zahoor are awaiting trial.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.
Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.
As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.
Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.
Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.
Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.
Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.
For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including updates like the following:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved
Leave a Comment » | Anethesiology, Controlled Substances, drug treatment, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Money Laundering, pain management, Sober Homes, Uncategorized | Tagged: Chatman, drug treatment, Health Care Fraud, Reflections Treatment Centers, Sober Homes | Permalink
Posted by Cynthia Marcotte Stamer
November 14, 2017
A recently announced health care fraud settlement involving New York Anesthesiology Medical Specialties, P.C. reminds anesthesiology practices and their billing and management companies to double check the defensibly their practices for billing for moderate sedation procedures.
On October 3, 2017; for instance, Acting United States Attorney for the Northern District of New York Grant C. Jaquith and New York State Attorney General Eric T. Schneiderman announced that New York Anesthesiology Medical Specialties, P.C. d/b/a New York Spine and Wellness Center (New York Spine & Wellness) would pay $1,941,850.29 to resolve claims that it improperly billed for moderate sedation services by routinely billing for moderate sedation services when its physicians spent less than the required 16 minutes with the patient.
The fraud charges stemmed from an investigation started after a private insurance company rejected two of New York Spine & Wellness’s claims for moderate sedation services in January, 2015 because, as described by New York Spine & Wellness’s billing company, the “Medicare 16 minute span rule to bill [the] code” was not satisfied. In mid-June 2015, the same private insurance company performed an audit and rejected New York Spine & Wellness’s claims for moderate sedation services where the documentation did not support that the procedure lasted more than 16 minutes.
Under 2011 American Medical Association guidance on the billing requirements for moderate sedation services adopted and enforced by Medicare billing intermediaries and many private payers, moderate sedation services are billable only when the physician spends at least 16 minutes face-to-face with the patient. The billing company advised New York Spine & Wellness to review the audit findings concerning moderate sedation services. New York Spine & Wellness continued to bill for moderate sedation services after mid-June 2015 without the required 16 minutes of face-to-face time. The improper billing stopped after New York Spine & Wellness was contacted by the United States Attorney’s Office for the Northern District of New York in connection with this investigation. See Syracuse Area Medical Practice to Pay Nearly $2 Million to Resolve False Claims Act Exposure.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.
Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.
As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.
Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.
Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.
Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.
Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.
For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including updates like the following:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved
Leave a Comment » | Anethesiology, drug treatment, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Money Laundering, pain management, Sober Homes, Uncategorized | Tagged: Chatman, drug treatment, Health Care Fraud, Reflections Treatment Centers, Sober Homes | Permalink
Posted by Cynthia Marcotte Stamer
November 14, 2017
Florida physician Joaquin Mendez was sentenced to serve 48 months in prison, followed by one year of supervised release and pay $2,198,520.37 in restitution for participating in a now notorious multi-million dollar health care fraud and money laundering scheme under which Mendez, along with co-defendants Kenneth Chatman, Fransesia Davis, and Michael Bonds defrauded public and private payers by giving free or reduced rent and other benefits as kickbacks and bribes to individuals with insurance who agreed to reside at Reflections Treatment Center sober homes, attend drug treatment, and submit to regular drug testing that members of the conspiracy could bill to the residents’ insurance plans. A Southern District of Florida Judge on Thursday, November 9, 2017 imposed the sentence as punishment for Mendez’s previously entered guilty plea to one count of conspiracy to commit health care fraud, in violation of Title 18, United States Code, Section 1347; all in violation of Title 18, United States Code, Section 1349.
The case is notable not only for its colorful facts, but also broad reaching participation and collaboration of federal and state law enforcement and other agencies that collaborated in the investigations and prosecutions that lead to the prosecution and conviction of Mendez and his co-defendants.
Mendez’s sentencing wraps up the last prosecutions arising from a now notorious federal health care fraud scheme under which federal prosecutors charged Mendez and the other co-defendants referred the sober homes’ residents who had insurance to Reflections Treatment Centers that purportedly offered clinical treatment services for persons suffering from alcohol and drug addiction while continuing to allow residents to use drugs and in some cases forcing female patients into prostitution.
According to prosecutors, Reflections Treatment Centers owner defendant Chatman hired defendant Mendez and other doctors to serve as medical directors of his treatment centers. As medical director, Mendez was purportedly responsible for evaluating patients and prescribing medically necessary treatment and testing. Instead of Mendez using his medical expertise and his individual assessments of patients to decide what type of laboratory testing was needed by each patient, co-defendant Chatman dictated the type and frequency of different types of lab testing that would be performed based upon the kickbacks and bribes that he was receiving from different clinical laboratories. Mendez facilitated this testing by signing doctor’s orders for urine drug tests and certificates of medical necessity for saliva drug tests, although Mendez had never seen some of the patients. Prosecutors also charged Mendez signed off on hundreds of “certificates of medical necessity” for urine and saliva tests after the testing had already been done including some tests ordered after the patients already had been discharged from Reflections Treatment Centers. When he examined treatment center patients, Mendez billed those patients’ insurance plans using procedure codes that reflected more complex and lengthier examinations than Mendez actually performed. Prosecutors charge that Mendez knew that insurance claims for the medically unnecessary tests that he prescribed would be submitted to the patients’ insurance companies.
Beyond fraudulently billing public and private health plans for health care services, federal prosecutors also charged that Mendez’s failure to properly evaluate and supervise patients facilitated Chatman’s commission of other crimes besides health care fraud through his operation of the Reflections Treatment Centers. According to federal prosecutors, had Mendez properly supervised the drug test results for the tests that he ordered, he would have noticed that drug use was rampant among patients in residence at the facilities. Federal prosecutors charge that 90 percent of the people in residence at Reflections Treatment Centers continued to actively use drugs during their stay. According to federal prosecutors, at least four people died of overdoses while Reflections Treatment Centers residents.
Aside from his fraudulent billing scheme, Federal prosecutors also charged that Chatman restrained some female patients and forced them into prostitution.
Mendenz’s sentencing wraps up the final prosecution of defendants arising from the Reflections Treatment Centers sting. Chatman previously was sentenced to 27½ years in prison in May. All of the other defendants also took plea deals, including another doctor and Chatman’s wife.
The prosecution of Mendez and his co-defendants resulted from an investigation conducted by the Greater Palm Beach Health Care Fraud Task Force. Agencies of the task force include the FBI, IRS-CI, the Palm Beach County State Attorney’s Office Sober Homes Task Force, Florida Division of Investigative and Forensic Services, Martin County Sheriff’s Office, Amtrak-Office of Inspector General, the Department of Labor Inspector General and Employee Benefit Security Administration, the National Insurance Crime Bureau, the Palm Beach County Sheriff’s Office, the West Palm Beach Police Department, the Delray Beach Police Department, the Florida Attorney General Office of Statewide Prosecution, and the Office of Personnel Management Office of Inspector General.
The cases against Mendez and his co-defendants were prosecuted by Assistant United States Attorney A. Marie Villafaña; Benjamin G. Greenberg, Acting United States Attorney for the Southern District of Florida; Robert F. Lasky, Special Agent in Charge, Federal Bureau of Investigation (FBI), Miami Field Office; Kelly R. Jackson, Special Agent in Charge, Internal Revenue Service, Criminal Investigation (IRS-CI); Dave Aronberg, State Attorney, Palm Beach County State Attorney’s Office; Jimmy Patronis, Florida Chief Financial Officer; William D. Snyder, Sheriff, Martin County Sheriff’s Office; George L. Dorsett, Assistant Inspector General for Investigations, Amtrak Office of Inspector General; Rafiq Ahmad, Special Agent in Charge, United States Department of Labor, Office of Inspector General ; Isabel Colon, Regional Director, United States Department of Labor, Employee Benefits Security Administration; Dennis Russo, Director of Operations, National Insurance Crime Bureau; Ric Bradshaw, Sheriff, Palm Beach County Sheriff’s Office; Sarah J. Mooney, Chief, West Palm Beach Police Department; Jeffrey S. Goldman, Chief, Delray Beach Police Department; Pam Bondi, Florida Attorney General; and Scott Rezendes, Special Agent in Charge, Office of Personnel Management, Office of Inspector General.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.
Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.
As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology, data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.
Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.
Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.
Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.
Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.
For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here including updates like the following:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved
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Posted by Cynthia Marcotte Stamer
October 11, 2017
President Trump has appointed Eric D. Hargan Acting Secretary of the U.S. Department of Health and Human Services (HHS).
Hargan, who was just sworn into office as Deputy Secretary of HHS on Oct. 6, 2017, takes over the duties of former Secretary Dr. Tom Price, who recently resigned in response to criticism about his expenditures for charter flights.
Before joining HHS, Mr. Hargan was an attorney, most recently a shareholder in Greenberg Traurig’s Chicago office in the Health and FDA Business department, where he focused his practice on transactions, healthcare regulations and government relations. He represented investors, companies, and individuals in healthcare investments and issues across the entire sector.
From 2003 to 2007, Mr. Hargan served at HHS in a variety of capacities, ultimately holding the position of Acting Deputy Secretary. During his tenure at HHS, Mr. Hargan also served as the Department’s Regulatory Policy Officer, overseeing the development and approval of all HHS, CMS, and FDA regulations and significant guidances.
Prior to this role, he served HHS as Deputy General Counsel. More recently, he was tapped by Governor Bruce Rauner to serve during transition as lead co-chair for Gov. Rauner’s Healthcare and Human Services committee.
During his time in Illinois, Mr. Hargan taught at Loyola Law School in Chicago, focusing on administrative law and healthcare regulations. He was a member of the U.S. government team at the inaugural U.S.-China Strategic Economic Dialogue in Beijing in 2006-2007, worked with the State Department’s Bureau of Arms Control to advance biosecurity in developing nations, and initiated and led the HHS team that developed the first responses to international food safety and importation issues in 2007.
He received his B.A. cum laude from Harvard University, and his J.D. from Columbia University Law School, where he was Senior Editor of the Columbia Law Review. Mr. Hargan also received a Certificate in International Law from the Parker School of Foreign and Comparative Law at Columbia University.
Before returning to Washington, D.C., Mr. Hargan lived in the suburbs of Chicago with his wife, Emily, and their two sons.
About The Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.
Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management, disaster and other crisis preparedness and response, and other performance and operations management and compliance. Her experienced includes career long involvement in advising and defending health industry and other organizations about disaster and other crisis preparation, response and mitigation arising from natural and man-made disasters, government enforcement, financial distress, workplace emergencies and accidents, data breach and other cybersecurity and other events. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and publisher disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
September 11, 2017
CHRISTUS St. Vincent Regional Medical Center (St. Vincent) and its partner, CHRISTUS Health (CHRISTUS), have agreed to pay $12.24 million, plus interest to resolve charges by the U.S. Department of Justice (DOJ) and U.S Department of Health and Human Services Office of Inspector General (OIG) they violated the False Claims Act by making illegal donations to county governments that the counties used to fund the state share of Medicaid payments to the hospital. The settlement announced September 1, 2017 highlights the needs for States and private healthcare providers to use care to ensure that creative partnerships don’t violate federal Medicare or other program requirements as well as the risk that the False Claims Act or other whistleblower rules will incentivize disgruntled employees or other service providers to bring aggressive conduct to the attention of federal officials.
The settlement resolves allegations made in U.S. ex rel. Stepan v. Christus St. Vincent Regional Medical Center Corp. et al., Civil Action No. 11-cv-572 (D.N.M.) that St. Vincent and CHRISTUS allegedly caused the State of New Mexico to present false Medicaid claims in violation of the False Claims Act by making non-bona fide donations to the State of New Mexico that New Mexico improperly used to fulfill the requirement that the State pay 25% “matching” share to fund the New Mexico Sole Community Provider Program (SCP) between 2001 and 2009.
Under the now defunct SCP Program, federal law required that New Mexico fund 25% of the costs of the SCP program to qualify for reimbursement from the federal government for approximately 75 percent of its health care expenditures under the SCP program. Under federal law, New Mexico’s 25 percent “matching” share of SCP program payments had to consist of state or county funds, and not impermissible “donations” from private hospitals. Congress enacted this restriction on the use of private hospital funds to satisfy state Medicaid obligations to curb possible abuses and ensure that states have sufficient incentive to curb rising Medicaid costs.
The charges resolved by the settlement originally were brought in a qui tam lawsuit filed by a former Los Alamos County, New Mexico Indigent Healthcare Administrator . The whistleblower will receive $2.249 million as her share of the recovery in this case.
The prosecution and its settlement drive home both the importance for States receiving Medicaid funds and private health care partners providing services to patients reimbursed by these funds to use care to comply with all applicable program requirements, as well as the continuing risk of exposure and resulting liability from whistleblower claims brought by unhappy employees or others looking to use their knowledge of questionable conduct to realize profitable recoveries.
About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.
About Solutions Law Press, Inc.™
Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.
NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.
Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.
©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
August 15, 2017
A Centers for Medicare and Medicaid Services (CMS) proposed rule scheduled for publication in the August 18, 2017 Federal Register will propose to reduce the number of mandatory geographic areas for the joint bundled payment program and cancel the cardiac bundled payment program model for determining reimbursement of providers for care under Medicare as well as make other refinements to the bundled payment program scheduled to take effect in January.
Widely criticized by many providers including department of Health and Human Services Secretary Dr. Tom Price, the mandatory bundled payment program presently is scheduled to take effect in January, 2018 after multiple delays.
According to the advanced copy of the proposed rule released by CMS on August 15, 2017, the proposed rule will propose among other things the following changes to the bundled payment program:
- Cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model and rescind the regulations governing these models;
- Revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model, including: giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model;
- Make technical refinements and clarifications for certain payment, reconciliation and quality provisions; and
- Increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (APM) track.
Healthcare providers and others interested in the proposed changes should carefully review the proposed changes and provide feedback as soon as possible and no later than the October 17, 2017 deadline the proposed regulation sets for submitting comments.
About The Author
The author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.
An American Bar Foundation, American College of Employee Benefits Counsel, and Texas Bar Foundation Fellow, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management and a broad range of other legal and operational concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.
You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
About Solutions Law Press Inc.™
Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
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For important information concerning this communication see here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2017 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.
Leave a Comment » | Anti-KickBack, billing, Clinical pathway, Conditions of Participation, Consumer Driven Health Care, Corporate Compliance, Doctor, Electronic Medical Records, Evidence Based Medicine, false claims act, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Plan, Health Plans, healthcare, Hospital, Inpatient Rehabilitation Facility, Medicare, Medicare Fee Schedule, OIG, Physician, Prospective Payment, Reimbursement, Uncategorized | Tagged: Affordable Care Act, bundled payment program, CMS, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, HHS, Hospital, Hospitals, Medicaid, Medicare, OIG, physical therapy, Physician, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
August 4, 2017
The Quality Payment Program Hardship Exception Application for the 2017 transition year now is available on the Quality Payment Program website.
MIPS eligible clinicians and groups may qualify for a reweighting of their Advancing Care Information performance category score to 0% of the final score, and can submit a hardship exception application, for one of the following specified reasons:
- Insufficient internet connectivity
- Extreme and uncontrollable circumstances
- Lack of control over the availability of Certified EHR Technology (CEHRT).
Some MIPS eligible clinicians who are considered Special Status, will be automatically reweighted (or, exempted in the case of MIPS eligible clinicians participating in a MIPS APM), do not need to submit a Quality Payment Program Hardship Exception Application.
In addition to submitting an application via the Quality Payment Program website, clinicians also may contact the Quality Payment Program Service Center and work with a representative to verbally submit an application.
To submit an application, a physician or other applying clinician will need:
- The Taxpayer Identification Number (TIN) for group applications or National Provider Identifier (NPI) for individual applications;
- Contact information for the person working on behalf of the individual clinician or group, including first and last name, e-mail address, and telephone number; and
- Selection of hardship exception category (listed above) and supplemental information.
Applicants for a hardship exception based on the Extreme and Uncontrollable Circumstance category, also must select one of the following and provide a start and end date of when the circumstance occurred:
- Disaster (e.g., a natural disaster in which the CEHRT was damaged or destroyed);
- Practice or hospital closure;
- Severe financial distress (bankruptcy or debt restructuring);
- EHR certification/vendor issues (CEHRT issues)
Once an application is submitted, CMS will send the applicant a confirmation email acknowledging receipt of the application and when it is pending, approved, or dismissed. Applications will be processed on a rolling basis.
Physician and other clinicians or practices interested in pursuing an exemption should act promptly.
About The Author
Cynthia Marcotte Stamer is a Martindale-Hubble “AV-Preeminent (Top 1%) rated practicing attorney and management consultant, health industry public policy advocate, widely published author and lecturer, recognized for her nearly 30 years’ of work on health industry and other privacy and data security and other health care, health benefit, health policy and regulatory affairs and other health industry legal and operational as a LexisNexis® Martindale-Hubbell® “LEGAL LEADER™ and “Top Rated Lawyer,” in Health Care Law and Labor and Employment Law; a D Magazine “Best Lawyers In Dallas” in the fields of “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law,” a Fellow in the American Bar Foundation, the Texas Bar Foundation and the American College of Employee Benefit Counsel.
Technical advisor to the National Physicians Council for Healthcare Policy, Vice President of the North Texas Healthcare Professionals Association, American Bar Association (ABA) International Life Sciences Committee Vice Chair, Policy; Scribe for ABA JCEB annual agency meeting with OCR, Ms. Stamer is well-known for her extensive work and leadership throughout her career on healthcare and health policy, regulatory, operations and other industry topics. Her clients include public and private healthcare systems, hospitals and other healthcare facilities, health care providers, health insurers, health plans, employers, health and other technology and other vendors, communities and others.
In addition to representing and advising these organizations, she also speaks extensively and conducts training on health care and other privacy and data security and many other matters.
Beyond these involvements, Ms. Stamer also is active in the leadership of a broad range of other health care and other professional and civic organizations. Through these and other involvements, she helps develop and build solutions, build consensus, garner funding and other resources, manage compliance and other operations, and take other actions to identify promote tangible improvements in health care and other policy and operational areas.
For additional information about Ms. Stamer, see here or contact Ms. Stamer directly by e-mail here or by telephone at (469) 767-8872. ©2017 Cynthia Marcotte Stamer. Limited, non-exclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.
Leave a Comment » | Academic medicine, Affordable Care Act, Conditions of Participation, E-Prescribing, Evidence Based Medicine, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, healthcare, Home Health, Hospice, Hospital, hospitals, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Meaningful Use, Medical Records, Medicare, Medicare Fee Schedule, OIG, Outcomes Data, Peer Review, quality reporting, Reimbursement, Rural Health Care, Skilled Nursing Facility, Uncategorized | Tagged: Affordable Care Act, CMS, Doctor, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Policy, Health Care Provider, Health Care Reform, Health Care Reimbursement, HEAT, HHS, Hospital, Medical Board, Medicare, Medicare Part B, physical therapy, Physician, Physicians, PQRS, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
October 17, 2016
Owners, operators, and leaders of health care organizations face an ever-growing imperative to lock down compliance by the organization and its employees and agents both to protect their organizations and its investors and themselves personally against the criminal, civil and administrative sanctions that result when health care organizations or their people break the rules.
The Departmnet of Health and Human Services Office of Inspector General (OIG) and the Department of Justice (DOJ) increasingly are going after owners, operators and other leaders of healthcare organizations for participating in, failing to act to prevent or inadequately investigating and redressing fraud or other illegal conduct in their organizations or by members of their organization’s team. Leaders and owners need to learn the rules and what to do to manage their risk. Owners and leaders must get informed about their expectations and exposures and learn and take the right steps to adopt compliance plans, monitor and enforce compliance, investigate and redress concerns and deal with these responsibilities and risk
The latest slew of federal health care fraud prosecutions reported by DOJ and OIG during the first two weeks of October illustrate some of the risks owners and executives face when they, their organization or employees or agents violate these rules. DOJ and federal regulators like OIG have made clear that they construe these rules to require leaders both to abstain from violating these laws and to adopt and administer effective compliance plans, oversight and other actions to train and prevent their employees and agents from violating these rules. See, e.g., Practical Guidance for Health Care Governing Boards on Compliance Oversight.
Of course, owners and management leaders inevitably face significant financial loss and other fallout if their organizations or members of their teams are found to have violated federal or state health care fraud laws. Over the past decade, however, owners and leaders increasingly also face growing risks of personal prosecution when their organization or someone on their team breaks the rules.
Owners, executives or other leaders who may be tempted to underesktimate the significance of these warnings should note DOJ’s increasingly aggressive and heavy handed prosecution of owners, executives and other leaders who either directly participate in, or by failing to adopt or administer meaningful compliance and investigation practices, are perceived to have allowed, encouraged or facilitated employees or agents to engage in actions hat DOJ, OIG or other federal regulators consider fraudulent.
DOJ’s growing emphasis on holding health care executives accountable for health care fraud or other violations of federal health care and other laws is clearly reflected in the prosecutions and convictions it announced during the first two weeks of October clearly demonstrate the critical need for health care organization owners, officers and other leaders (executives) to safeguard themselves personally, as well as their organizations against becoming targeted or convicted of health care fraud or other violations of federal health care laws by ensuring their organization adopts and administers effective compliance programs and taking other meaningful, well-documented steps , efforts to ensure the effectiveness of these compliance efforts.
Federal criminal and civil health care fraud laws both prohibit owners, operators and executives from participating in or conspiring to violate federal anti-kickback, anti-referral, false claims and other health care fraud laws, as well as provide various mechanisms that impose liability against owners and executives that fail to adopt and administer appropriate compliance, audit and other oversight and enforcement processes and procedures. Since October 1, 2016, for instance, DOJ has announced the following healthcare charges, convictions and settlements involving owners and executives.
- On October 4, 2016, a federal judge sentenced Bassem Kuran, the President and owner of Pennsylvania based a VIP Ambulance, Inc 10 months imprisonment followed by three years of supervised release, plus ordered him to pay $66,901.93 in restitution for making false statements to Medicare. See Ambulance Company Owner Sentenced To 10 Months In Prison;
- On October 5, 2016, DOJ four California residents that operated Louisiana based Care Concepts, LLC, and California based Choice Home Medical Equipment and Supplies (Choice), Geoffrey and Marla Ricketts and Samuel and Sunyup Kim, are awaiting sentences of up to 10 years in prison, $250,000 fines, restitution liabilities, and three years’ supervised release for their health care fraud convictions relating to a $38 million fraud scheme centering around the distribution of “talking glucose meters” not medically needed and often not even requested. Four Californians Plead Guilty to Conspiracy to Commit Health Care Fraud;
- On October 6, 2016, the owner of a medical supply company was sentenced to 60 months in prison for his role in a scheme that fraudulently billed more than $4 million to Medicare. Owner of Los Angeles Medical Supply Company Sentenced to 60 Months in Prison for Multimillion-Dollar Medicare Fraud Scheme;
- On October 6, 2016. United States Attorney for the Western District of Missouri Tammy Dickinson and Missouri Attorney General Chris Koster announced the sentencing for federal health care fraud of a Springfield, Mo. man who operated four Family Medical Center clinics in southern Missouri. See Springfield Man Sentenced for Fraud Scheme to Overcharge Medicaid, Medicare at Four Clinics;
- On October 6, 2016, DOJ announced the sentencing in federal court of the Los Angeles owner of a medical supply company to 5 years in prison for his role in a scheme that fraudulently billed more than $4 million to Medicare. See Owner of Los Angeles Medical Supply Company Sentenced to 60 Months in Prison for Multimillion-Dollar Medicare Fraud Scheme;
- On October 7, 2016, a Tampa, Florida home health agency owner was convicted by a federal jury for her participation in a multimillion-dollar health care fraud and money laundering scheme. Owner of Florida Home Health Agency Convicted in Multimillion-Dollar Health Care Fraud Scheme;
- On October 12, 2016, U.S. Attorney Josh J. Minkler announced the indictment of former Chief Executive Officer James Burkhart, former Indiana nursing home chain American Senior Communities (ASC) Chief Operating Officer Daniel Benson, for their alleged roles in a vast fraud, kickback, and money laundering scheme involving ASC. Former American Senior Communities executives indicted;
- On October 13, 2016, the U.S. Attorney in Massachusetts announced the agreement of Haverhill-based skilled nursing facility operator Whittier Health Network, Inc., and its Director of Long Term Care, Leo Curtin, to pay $2.5 million to resolve allegations concerning inflated Medicare claims. See Nursing Home Operator and Director of Long Term Care to Pay $2.5 Million to Settle False Claims for Rehabilitation Therapy. See Nursing Home Operator and Director of Long Term Care to Pay $2.5 Million to Settle False Claims for Rehabilitation Therapy; and
- On October 14, 2016, a federal district judge in the Northern District of Alabama sentenced the former chief executive of two non-profit health clinics for the poor and homeless to 18 years in prison for funneling millions in federal grant money to private companies he formed to contract with the clinics. See Former Non-Profit Health Clinics CEO Sentenced to 18 Years for Funneling Millions in Grant Money to Private Companies.
Of course, the costs and liabilities of federal criminal or civil investigations and prosecutions are only part of the challenges an organization and its leaders generally face when their healthcare organization or its actions are questioned under federal health care fraud or other laws. Whistleblower or other claims of employees and agents claiming to have been penalized for questioning practices, shareholder or other investor lawsuits, federal program disqualification, loss of position or reputation, the financial and other burdens of responding to and defending investigations and charges and a parade of other horribles that typically attend investigations and prosecutions also often exact a heavy toll on health care organization owners and leaders caught up in federal fraud investigations or prosecutions.
In the face of these growing risks, healthcare owners, executives and other leaders need a clear and up to date understanding of health care fraud laws and the obligations and expectations that these rules create not only for their organizations, but also increasingly them personally. Owners and other leaders need to understand the health care fraud rules, the ways that liability can attach not only to their organization but also themselves and their leaders under these rules, the burdens of proof and assumptions that create special challenges in responding to challenges or defending charges and actions and strategies they should take before, during, and after compliance issue or prosecution arises to strengthen their ability to defend or mitigate their and their organization’s liability exposures. As part of these efforts, owners and leaders not only should ensure that their organization adopt, train staff and others on and meaningfully administer up-to-date compliance programs in a manner that clearly documents the commitment of their organization and its leaders to compliance. Owners, executives and leaders also should become educated about the expectations of DOJ, HHS and other agencies and whistleblowers are likely to expect concerning their role and actions as owners and leaders both in establishing a clear expectation of compliance, as well as adopting, overseeing and enforcing practices and policies to maintain compliance, investigate and redress potential wrongdoing and otherwise maintain the compliance and culture expected and required under federal law. Owners and leaders should ensure that they and others in their organization are trained to recognize potential compliance issues, understand the steps they and their organization need to take when a potential compliance concern arises, and how to conduct and document investigations and other actions to strengthen their and their organization’s ability to defend against potential charges or other claims..
Owners, executives and other leaders also should anticipate, and prepare in advance for the likelihood that they and their organizations will need to respond investigations, suspected violations, whistleblower claims and other events that could create substantial exposure for their organizations and themselves personally. Leaders need to understand that the nature and risks associated with these potential health care fraud liabilities may make ill-advised commonly used settlement or other practices for resolving quickly disputes or other concerns. Owners and leaders bearing these responsibilities should seek specific advice and training about their responsibilities, as well as recommended strategies for investigating and responding to concerns that may carry or give rise to these risks. Most leaders also will want to ensure that their employment, shareholder and other agreements include sufficient flexibility and protections to protect the executive or other leader for termination, retaliation or other loss or injury for taking appropriate steps to investigate and respond to a compliance concern as well as plan in advance by arranging for their organization to provide indemnification, insurance or other coverage, and/or securing personally coverage to provide coverage needed to fund what often may be substantial legal fees arising out of investigation and defense of investigations, charges, or other actions and the corporate, employment and other fallout that often accompanies such events.
About The Author
A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.
Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
Ms. Stamer also is known for her experience in HIPAA and other privacy and data security and breach concerns. The scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.
You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
About Solutions Law Press Inc.™
Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates like the following:
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For important information concerning this communication see here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2016 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.
Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Clinical pathway, Conditions of Participation, Controlled Substances, Corporate Compliance, data breach, Disease Management, DME, Doctor, E-Prescribing, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Policy, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, hospitals, managed care, Medicaid, Medical Records, Medicare, Medicare Advantage, Medicare Fee Schedule, Money Laundering, Pharmaceudical, Pharmacy, Prospective Payment, Psychiatric, Public Policy, substance abuse treatment, Tax, Uncategorized | Tagged: Board Governance, Compliance, Directors and Officers, false claims act, Federal Sentencing Guidelines, Health Care Fraud, internal controls, Risk Management, STARK | Permalink
Posted by Cynthia Marcotte Stamer
January 4, 2016
Healthcare providers interested in or offering financial assistance with co-pays or other out-of-pocket charges to Medicare or Medicaid patients should review carefully two new and one modified opinion just published by the Department of Health and Human Services Office of Inspector General (OIG).
OIG generally interprets federal healthcare fraud laws as prohibiting healthcare providers from paying for or providing financial assistance with co-pay or other out-of-pocket costs for Medicare or Medicaid beneficiaries unless the arrangement Falls then an exemption approved by OIG.
In recent years the OIG increasingly has approved certain nearly defined co-pay or other financial assistance for him arrangements in a series of specific opinion letters. The three Advisory Opinions released today are the latest of these opinions. See Advisory Opinion 15-17 at http://go.usa.gov/c5ekz; Advisory Opinion 15-16 at http://go.usa.gov/c5e8C; and Modification of Advisory Opinion 06-04 http://go.usa.gov/c5e8W.
Healthcare providers reading these opinions must keep in mind the opinions only protect the parties who receive that opinion; other parties interested in offering financial assistance to Medicare or Medicaid beneficiaries with copayments or other out-of-pocket costs must get the OIG to issue them an opinion specifically blessing their proposed arrangement before moving forward to avoid risking triggering fraud enforcement.
While non parties cannot rely n opinions issued to others, health care providers offering or considering offering financial assistance carefully should review the guidance published in these opinions as a roadmap for designing and operating their own arrangements. Guidance in these opinions helps identify key criteria for qualification and enforcement.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years of experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
Leave a Comment » | Anti-KickBack, DME, Doctor, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, health care reimbursement, Home Health, Hospice, Hospital, Hospital, hospitals, Medicaid, Medicare, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, Money Laundering, Nonprofits, OIG, Outpatient, Pharmacy, Physician, Prescription Drugs, Stark, Uncategorized | Tagged: Fianancial Assistance, Fraud & Abuse, Health Care Fraud, OIG, Rebate, STARK | Permalink
Posted by Cynthia Marcotte Stamer
November 17, 2015
The November 12, 2015 jury verdict followed a more than four week trial in the U.S. District Court for the District of Columbia during which Federal prosecutors charged Mr. & Mrs. Bikundi raided the Medicaid program of $80 million through massive and systematic fraud of a four year period and used the proceeds of this fraud to finance a lavish lifestyle, including a million-dollar home, a $140,000 Land Rover, a $120,000 Porsche, and a $75,000 Mercedes Benz.
According to evidence presented at trial, Ms. Bikundi, a former nurse, and her husband owned Global Healthcare, Inc. According to the government’s evidence, Ms. Bikundi not entitled to take part in the Medicaid program under her maiden name of Florence Igwacho but concealed that exclusion and fraudulently got approval as a provider by using her married name to apply for participation. Then, the government’s evidence showed, she and her husband led a scheme to bill Medicaid for services that never were provided – recruiting others, including family members, into the scam, and creating fraudulent paperwork to hide the illegal activity.
The D.C. Medicaid program is funded jointly by District of Columbia tax dollars and federal tax dollars. Medicaid provides for home care services to be performed by personal care aides, working for eligible home care agencies. Doctors or advanced practice registered nurses must examine beneficiaries and authorize them to receive these services. The aides are to follow a plan of care and assist Medicaid beneficiaries in performing activities of daily living, such as getting in and out of bed, bathing, dressing, keeping track of medication, and so forth.
In 1999, Ms. Bikundi went by her maiden name of Florence Igwacho. In August 1999, the Virginia Board of Nursing revoked the nursing license of Florence Igwacho. In March 2000, the U.S. Department of Health and Human Services, Office of Inspector General notified Florence Igwacho in writing that she was excluded from participation in Medicare, Medicaid, and all federal health care programs due to the revocation.
Florence Bikundi subsequently concealed her past – namely, the Medicaid exclusion and the revocation of her nursing license – when she applied for a Medicaid provider number for Global Healthcare in June 2009 using the name of Florence Bikundi. She also used three forged signatures on her Medicaid provider application. Florence Bikundi married Michael Bikundi in September 2009.
From August 2009 through February 2014, Florence and Michael Bikundi used Global HealthCare to carry out a massive fraud, the government’s evidence showed. Year after year, the D.C. Medicaid program was billed for personal home health aide services that were not provided to Medicaid beneficiaries. Phony time sheets, patient files and employment files were created. Global Healthcare generated increasing amounts of payments as the years continued, going from roughly $1.35 million in 2009 to $14.27 million in 2011 to $27.16 million in 2013.
According to the government’s evidence, the Bikundis used the proceeds to finance a lavish lifestyle. In just over three years, they spent $1.3 million to purchase and renovate a newly built home. They also used the proceeds for a $140,000 Land Rover, a $120,000 Porsche, a $75,000 Mercedes Benz, a $70,000 Cadillac and a $36,000 BMW.
The Bikundis were among 25 people charged in February 2014 after a wide-ranging investigation conducted by the FBI’s Washington Field Office; the U.S. Department of Health and Human Services, Office of Inspector General; the U.S. Secret Service; the Medicaid Fraud Control Unit of the District of Columbia’s Office of the Inspector General; the Internal Revenue Service-Criminal Investigation; the U.S. Immigration and Customs Enforcement (ICE) Office of Homeland Security Investigations (HSI); the Office of Labor Racketeering and Fraud Investigations, Office of Inspector General, Department of Labor; the Social Security Administration, Office of Inspector General, and the Medicaid Fraud Control Unit of the Maryland Attorney General’s Office with the assistance of the District of Columbia’s Department of Health Care Finance and other agencies uncovered what the Justice Department describes as “numerous, separate schemes involving fraud, kickbacks, and false billings in the growing field of home care services for D.C. Medicaid beneficiaries.” So far, 23 defendants including Florence Bikundi’s son, and Florence Bikundi’s two sisters as well as others who worked as personal care aides in the home care industry, patient recruiters who demanded money for access to Medicaid beneficiaries or in other capacities have either pled guilty or been found guilty of charges.
With health care fraud enforcement a key component of the federal government’s efforts to bring down health care costs and the continuing success of federal and state health care fraud investigation and enforcement efforts like those already achieved by the Justice Department against the 12 defendants that already pleaded guilty, health care providers providing substance abuse or other treatments reimbursed by federal or state programs should must ensure that their care and billings are appropriately delivered and documented to withstand almost inevitable government scrutiny of their operations and activities.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years of experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
Leave a Comment » | Health Care Finance, Health Care Provider, health care reimbursement, Medicaid, Medicare, Uncategorized | Tagged: excluded provider, Health Care Fraud, Medicaid | Permalink
Posted by Cynthia Marcotte Stamer
September 9, 2015
Solutions Law Press, Inc. is happy to share information about this upcoming free health industry study group meeting on 9/15/2015 in Irving, Texas.
NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONALS ASSOCIATION
Invites Members and Guests to Our Next Group Luncheon
Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act
Featuring
Kristi Gotcher
U.S. Department of Labor Employee Benefit Security Administration Investigator
Tuesday, September 15, 2015
11:30 a.m. to 1:30 p.m.
DFW Hospital Council Offices
250 Decker Drive
Irving, Texas
RSVP here by Noon on September 14, 2015
Space Limited! Register Early To Reserve Your Spot To Participate!
Please share this invitation with others who might be interested in this topic or other NTHCPA events!
The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals to join us on Tuesday, September 15, 2015 from 11:30 a.m. to 1:30 p.m. for our Study Group Luncheon featuring a program on “Employee Benefit Security Administration Insights On Healthcare Organization’s Health & Other Employee Benefit Plan Rights & Responsibilities Under Employee Retirement Income Security Act” from U.S. Department of Labor Employee Benefit Security Administration (EBSA) Investigator Kristi Gotcher.
The health and other employee benefit plan rules of the Employee Retirement Income Security Act (ERISA) generally offer important protections and create significant compliance challenges for health care organizations and providers. On one hand, health care providers generally rely heavily on their or their patient’s ability to obtain health benefits promised under employer or union-sponsored health plans covering their patients to help reimbursement provider charges. Meanwhile, health care providers and their leaders also can incur significant liability for failing to comply with ERISA’s rules when establishing and maintaining health or other employee benefit programs for their own employees. Drawing on her involvement as investigator with the Department of Labor agency primarily responsible for both interpreting and enforcing ERISA’s rules, EBSA Ms. Gotcher will share key updates and insights on both how ERISA and the EBSA can help patients and providers enforce benefit rights under ERISA-covered health plans and key health and highlight employee benefit compliance responsibilities that health care organizations and their leaders need to ensure that their own health and other employee benefit programs meet to avoid violating ERISA.
About the Speaker
Kristi A. Gotcher is an Investigator with the United States Department of Labor, Employee Benefits Security Administration (EBSA) in the Dallas Regional Office. Kristi began working for EBSA in the Dallas Regional Office in November 2007 as a Benefits Advisor. She earned her Bachelor of Arts in Social Political Relations from St. Edwards University and a J.D. from Texas Wesleyan University School of Law (now Texas A&M University School of Law). Ms. Gotcher is licensed to practice law in the State of Texas.
Registration & Meeting Details
The meeting scheduled from 11:30 a.m. to 1:30 p.m. on Tuesday, September 15, 2015 at the DFW Hospital Council Offices located at 250 Decker Drive, Irving Texas. Participants who timely R.S.V.P. will enjoy a complimentary luncheon. Networking and lunch service will begin at 11:30. Our program will begin at Noon.
NTHCPA encourages members and other interested health care compliance professionals to register early to reserve their spot to participate and to share this invitation with others in the industry who might benefit from participation.
There is no charge to participate in the meeting. However space is limited and available only on a first come, first serve basis. To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on September 14, 2015. Walk in guests will be accommodated on a space-available basis only.
Thanks To Meeting Underwriter Stamer ׀ Chadwick ׀ Soefje, PLLC
NTHCPA and its members extend our thanks to Cynthia Marcotte Stamer, P.C. and the other members of Stamer ׀ Chadwick ׀ Soefje PLLC for underwriting this month’s study group luncheon and other support of NTHCPA.
A boutique firm of exceptionally experienced and skilled “big-firm” lawyers committed to changing the way law firms serve their clients, Stamer │Chadwick │Soefje, PLLC delivers sophisticated legal advice and innovative solutions to the most challenging and complex problems. Simply put, Stamer │Chadwick │Soefje, PLLC attorneys are “Solutions Lawyers™.”
Stamer │Chadwick │Soefje, PLLC attorneys deliver sophisticated legal advice and innovative solutions to the most challenging and complex problems. Stamer │Chadwick │Soefje, PLLC attorneys possess the breadth of experience to respond to the unique legal and operational challenges health industry and other clients face and help guide them toward pragmatic resolutions that make sense for them. “Solutions Lawyers™ possess the breadth of experience to respond to the unique challenges our corporate and individual clients face and help guide them toward pragmatic resolutions that make sense for them.
Founded by nationally-known, healthcare and labor & employment attorney Cynthia Marcotte Stamer; labor & employment attorney Robert G. Chadwick; and professional liability and civil litigation attorney Timothy B. Soefje, Stamer │Chadwick │Soefje, PLLC focuses on advising and representing businesses and professionals nationally in the areas of healthcare, cyber liability, ERISA, employee benefits, labor & employment, corporate and commercial litigation, professional liability, construction litigation, and insurance defense. All three attorneys are rated AV® Preeminent™ by Martindale-Hubbell® Peer Review Ratings™ Ms. Stamer and Mr. Chadwick are both Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, are Fellows in the American Bar Foundation, and recognized as “Top Lawyers” in Labor and Employment Law. Ms. Stamer also has received recognition as a “Top” attorney in health care and employee benefits law and is a Fellow in the American College of Employee Benefit Council.
Ms. Stamer more than 28 years’ experience advising and representing health industry and employee benefit clients on a wide range of legal, public policy, management and operational concerns as well as extensive leadership and management experience serving in on the board of health industry nonprofit organizations. Nationally recognized for her legal work, advocacy, publications, writings and presentations on health industry concerns, Ms. Stamer provides legal and management advice, training and coaching, defense, public policy and regulatory advocacy to health industry and other clients on health and other regulatory and operational compliance, federal and state public policy and enforcement, managed care and other contracting, reimbursement, fraud, quality, employment, staffing and other workforce, benefits, licensing, credentialing and peer review, safety, disaster preparedness and response, HIPAA and other privacy and data security, corporate governance, investigations and internal controls, and a host of other health industry compliance and risk management and other legal and operational concerns. In addition to her legal experience, Ms. Stamer also contributes her experience and talents to serving in a number of health industry and other civil and professional groups. Among other things, Ms. Stamer serves as Vice President of the NTHCPA, the RPTE representative to the American Bar Association (ABA) Joint Committee on Employee Benefits Council and scrivener for its annual agency meeting with the Office of Civil Rights, the ABA International Section Life Sciences and Health Law Committee Vice President of Policy, RPTE Liaison to the ABA Health Care Coordinating Counsel, TIPS Employee Benefit Committee Vice Chair, Founder and Executive Director of the Project COPE: The Coalition on Patient Empowerment, and National Physicians Council for Healthcare Policy. She also previously served as President and Founding Board Member of the Alliance for Health Care Excellence and its Health Care Heroes and Patient Empowerment Programs, as RPTE Employee Benefits & Other Compensation Group Chair and Welfare Benefit Committee Vice Chair, Exempt Organizations Coordinator of the Gulf States Area TEGE Council, Board President and Audit Committee Chair of the Richardson Development Center for Children ECI Agency, National Kidney Foundation of North Texas Board Audit Committee Chair, the United Way of North Texas Long Range Planning Committee. She also has and continues to serve in the leadership of many other civic and professional boards, seminar faculties, editorial advisory boards and publishes and speaks extensively on health industry and employee benefit related concerns.
Mr. Chadwick has extensive experience advising and defending health industry and other clients on OSHA and other occupational health and safety, employee benefits, compensation and other labor and employment concerns as well as defending boards and other management leaders against management liability claims.
Mr. Soefje has extensive experience advising and representing health industry clients and professionals on medical malpractice, officers and directors liability and other professional liability, errors and omissions, construction defect and other litigation and disputes.
For additional information, contact Ms. Stamer cstamer@solutionslawyer.net
About the NTHCPA
NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
Leave a Comment » | Uncategorized | Tagged: Affordable Care Act, billing, Compliance, Corporate Compliance, employee benefits, ERISA, Health Care Fraud, Health Plans, healthcare, heatlth insurance, Hospital, Physicians, Reimbursement, Risk Management | Permalink
Posted by Cynthia Marcotte Stamer
September 3, 2015
Federal prosecutors secured indictments against 8 more former employees of Long Beach, California based Atlantic Health Services, formerly known as Atlantic Recovery Services (ARS) for health care fraud and aggravated identity theft for their alleged participation in a scheme that prosecutors claim resulted in the submission of more than $50 million in fraudulent bills to a California state program for alcohol and drug treatment services for high school and middle school students that in many instances, were not provided or were provided to students who did not have substance abuse problems. Download Drug Counseling Scam Indictment.
The latest in the ongoing series of charges brought by federal officials resulting from investigations into charges made by ARS, the indictments accuse ARS and its employees of engaging in a long-running fraud scheme to steal tens of millions of dollars from a program with limited resources that was designed to help underprivileged youth in recovery. In the process, prosecutors claim the defendants and ARS branded many innocent young people as substance abusers and addicts in order to boost enrollment numbers and billings.
Prosecutors claim ARS received more than $46 million from California’s Drug Medi-Cal program after ARS submitted false and fraudulent claims for group and individual substance abuse counseling services. All 8 defendants are former employees of ARS, which received contracts to provide substance abuse treatment services through the Drug Medi-Cal program to students in schools in Los Angeles County. The schools included various sites operated by Soledad Enrichment Action and public schools in Montebello, California, Bell Gardens, Californina, Lakewood, and the Antelope Valley.
According to the indictment unsealed this morning, the claims submitted by ARS to the Drug Medi-Cal program were false and fraudulent for a number of reasons, including:
- ARS billed for services provided to students who did not have substance abuse disorders or addictions and therefore did not qualify to receive Drug Medi-Cal services;
- ARS billed for counseling sessions that were not conducted at all;
- ARS billed for counseling services that were not conducted in accordance with Drug Medi-Cal regulations regarding length, number of students, content and setting;
- ARS personnel falsified documents, including treatment plans, group counseling sign-in sheets, progress notes and update logs (which listed the dates and times of counseling sessions); and
- ARS personnel forged student signatures on documents.
- The defendants named in the indictment are:
- Lori Renee Miller, 54, of Lakewood, California, the program manager at ARS who supervised substance abuse recovery managers and counselors;
- Nguyet Galaz, 41, of Montclair, California, who oversaw services provided at approximately 11 schools in Los Angeles County;
- Angela Frances Micklo, 56, of Palmdale, California, who managed counselors at approximately nine schools in Los Angeles County, including several in the Antelope Valley;
- Maribel Navarro, 48, of Pico Rivera, California, who managed counselors at approximately ten schools in Los Angeles County;
- Carrenda Jeffery, 64, of the Mid-City District of Los Angeles, who managed counselors at approximately three schools;
- LaLonnie Egans, 57, of Bellflower, California, who managed counselors at three schools;
- Tina Lynn St. Julian, 51, of Compton, California, who worked as a counselor at two schools; and
- Shyrie Womack, 33, Egans’ daughter, also of Bellflower, who worked as a counselor at three schools.The indictments announced today raise the total former ARS employees charged as a result of an investigation by the Office of Inspector General of the Department of Health and Human Services; the California Department of Justice, Bureau of Medi-Cal Fraud and Elder Abuse; and IRS – Criminal Investigation of ARS to 20. Previously, 11 other defendants pleaded guilty to health care fraud charges stemming from the ARS scheme. Those defendants are former ARS managers Cathy Fernandez, 53, of Downey, California; Erin Hoover, 37, of Long Beach, California; Elizabeth Black, 51, of Long Beach; Helsa Casillas, 44, of El Sereno, California; and Sandra Lopez, 41, of Huntington Park, California; and former ARS counselors Tamara Diaz, 45 of East Los Angeles, California; Margarita Lopez, 40, of Paramount, California; Irma Talavera, 27, of Paramount; Laura Vasquez, 52, of Pico Rivera; Cindy Leticia Ortiz, 29, of Norwalk, California; and Arthur Dominguez, 63, of Glendale, California. Another defendant, Dr. Leland Whitson, 75, of Redondo Beach, California, the former Medical/Clinical Director of ARS, previously pleaded guilty to making a false statement affecting a health care program. The dozen defendants who already pleaded guilty are pending sentencing by U.S. District Judge Philip S. Gutierrez.
- Each of the eight defendants named in the August 26 indictment unsealed today potentially faces decades in federal prison if convicted. For example, if convicted, Miller faces a statutory maximum sentence of 324 years in federal prison. Federal officials arrested six of the defendants today. The Justice Department says it expects Galaz and Micklo self-surrender in the coming weeks.
With health care fraud enforcement a key component of the federal government’s efforts to bring down health care costs and the continuing success of federal and state health care fraud investigation and enforcement efforts like those already achieved by the Justice Department against the 12 defendants that already pleaded guilty, health care providers providing substance abuse or other treatments reimbursed by federal or state programs should must ensure that their care and billings are appropriately delivered and documented to withstand almost inevitable government scrutiny of their operations and activities.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | drug treatment, Health Care, Health Care Fraud, health care reimbursement, substance abuse treatment | Tagged: clinics, drug treatment, Health Care Fraud, Health Care Reimbursement, medi-Cal, Medicaid, Medicare, mental health care chemical dependency, school health care, substance abuse, substance abuse counseling, treatment facilities | Permalink
Posted by Cynthia Marcotte Stamer
July 31, 2015
Austin, Texas physician Dennis B. Barson Jr. and his medical clinic administrator are headed to prison. The 10 year prison sentence imposed against Barson on July 27, 2014, like an $8 million plus health care fraud civil settlement announced by the Justice Department on July 24, 2014 illustrate the significant legal risks that physicians and other health care providers face when physician charges are improperly billed to Medicare, Medicaid, Tricare or other federal or state health care programs for services actually provided by non-physician staff. Physicians and others should heed the lessons from these and other similar federal and state health care fraud enforcement actions when deciding how and when it is appropriate to delegate to and bill federal health care programs for physician services where physicians assistants, nurse practitioners or other nursing staff or other non-physicians perform part or all of the procedures billed.
Dr. Barson Prison Sentence Highlights Criminal Risks
On Monday, July 27, 2015, U.S. District Court Judge Melinda Harmon ordered Barson to serve 120 months in prison, followed by three years of supervised release and pay restitution of approximately $1.2 million in punishment for his November 5, 2014 on all 20 counts of conspiracy to defraud Medicare of $2.1 million. See, Austin Doctor Heads to Prison for Health Care Fraud.
With Judge Harmon presiding, a Houston jury found Barson and his medical clinic administrator, Dario Juarez, 55 guilty on the Medicare fraud charges last November. Another co-defendant Edgar Shakbazyan entered a guilty plea to the 21-count original indictment on October 27, 2014. Shakbazyan, of Glendale, California, was sentenced to 97 months in prison, while Juarez, of Beeville, Texas received 130 months. Both will also serve three years of supervised release. The jury convictions of Barson and Juarez followed a trial where Department of Justice prosecutors proved the health care fraud charges based on evidence that Barson, Juarez and Shakbazyan fraudulently billed Medicare for rectal sensation tests and electromyogram (EMG) studies of the anal or urethral sphincter never performed. Shakbazyan was additionally charged and plead guilty to conspiracy to pay kickbacks for payments made to recruiters and beneficiaries. According to the testimony at trial, Barson was the only doctor affiliated with the medical clinic located at 8470 Gulf Freeway in Houston. However, Juarez represented himself to be a doctor and was the one who actually saw patients at the clinic. Barson, Juarez and Shakbazyan caused Medicare to be billed for procedures on 429 patients in just two months. The three men also billed Medicare for seeing more than 100 patients on 13 different days, including a high of 156 patients on July 13, 2009.
Barson’s defense attempted to convince the jury that he was a victim of identity theft and was not the perpetrator of the crimes. The jury conviction shows the jurors not believe his story. The criminal charges are the result of a joint investigation conducted by agents of the FBI, Department of Health and Human Services-Office of Inspector General and the Medicaid Fraud Control Unit of the Texas Attorney General’s Office.
Margossian Settlement Shows Even More Common Civil Penalty Risks
Barson’s sentencing is one of a growing series of criminal convictions and sentencing of physicians and other health care providers for health care fraud by participating in arrangements where Medicare, Medicaid or other federal health care programs are billed for services not provided or not provided as required to qualify for reimbursement. On July 24, 2015, for instance, the U.S. Attorney for the Eastern District of New York and the State of New York announced that that Brooklyn, New York OB/GYN Haroutyoun Margossian, will pay $8, 047, 291.05 as part of a civil settlement with the United States and the State of New York that resolves charges brought under the federal False Claims Act and the New York False Claims Act that Margossian wrongfully billed Medicare and Medicaid for physician services for treatments of women suffering from urinary incontinence that unlicensed and often unsupervised staff, rather than Margossian or another physician, actually administered. Under the terms of the civil settlement agreement, Margossian will pay a total of $8,047,291.06. Contemporaneously with the execution of the civil settlement agreement, the government filed a criminal charge against Margossian for making false statements to Medicare and entered into a deferred prosecution agreement with him. See, Board Certified Obstetrician And Gynecologist Agrees To Civil Fraud Settlement In Conjunction With Deferred Prosecution In Medicare And Medicaid Fraud Investigation.
Health Care Fraud Investigations Raise Other Licensing & Practice Risks
The Barson and Margossian actions are just two, of the already long, and ever-growing criminal convictions, civil sanctions and civil settlements that Federal and state health care fraud fighters already can count as notches of success in their war against health care fraud by physicians and other health care providers. With these successes fueling more investigations, physicians and others considering engaging in billing or other practices in violation of the False Claims Act or other health care fraud laws clearly should be prepared to “do time” for improperly billing physician fees to federal health care programs for services not provided by the billing physician or engage in other inappropriate billing practices. While successfully defending criminal and civil investigations is critical for physicians and others under investigation, targets of audits and investigations also must prepare to deal with a host of other threats to their practices which almost inevitably arise regardless of whether the government investigation leads to a conviction, civil sanctions or a settlement.
As demonstrated by the Margossian settlement, even if physicians, practice management and others swept up into these investigations escape being criminally charged, subjected to civil sanctions or penalties or suspended or excluded from Medicare or other federal health care programs, health care fraud investigations or charges still will carry a heavy cost. Alongside of the growing success of federal and state prosecutors in criminally prosecuting physicians and others for health care fraud, health care fraud warriors are realizing even greater success in securing civil sanctions and settlements, federal program exclusions and other civil and administrative punishments against physicians and other health care providers that the government accuses of violating the False Claims Act or other federal health care fraud rules.
Of course, whether or not health care fraud civil or criminal investigations, ultimately result in any civil or criminal prosecution, conviction or settlement, physicians and other licensed health care providers under suspicion, audit, investigation, charges or other scrutiny for alleged false claims or other health care fraud inevitably must deal with a broad range of other professional fallout as these activities almost always trigger scrutiny or other actions by their employers and medical practices, peer review notifications and investigations by hospitals, managed care organizations and other health care organizations and plans where they have privileges or contracts, and licensing board or other professional disciplinary investigations if not actual discipline.
Act To Strengthen Your Defenses
In the face of these and other enforcement actions, physicians and others should take steps to minimize the risk of an investigation or audit leading to criminal, civil or other charges as well as take steps to help ensure sufficient resources to defend themselves if the government comes knocking.
Of course, the first step of the process should be to take proper, well documented efforts to properly comply with the rules and be prepared to prove it. Physicians and the clinics, hospitals and management working with them should use care to critically evaluate when and what can be defensibly billed as physician services to Medicare or another federal healthcare program taking keeping in mind that the billing party, not the government, generally bears the burden of proving that the amount bill qualifies for coverage. For this reason, physicians and others involved in the process must carefully consider the adequacy of the physician’s involvement in prescribing and delivering services intended to be billed as physician services to Medicare, Medicaid or other federal health care programs to ensure that they deliver and document the services appropriately and that these service billed under the physician’s number as physician services meet all other requirements to qualify for reimbursement as billed. In areas where questions could be raised, physicians and their organizations are strongly urged to take extra care to conduct and retain documentation of their analysis and efforts to verify the compliance of their actions before proceeding, including consulting legal counsel for advice within the scope of attorney-client privilege. Beyond exercising great care to accurately document and properly bill for all services, physicians and others working with them also should familiarize themselves with their obligations and rights under employment agreements, shareholder or partnership agreements, medical staff bylaws, managed care contracts, medical licensing board rules and the Health Care Quality And Improvement Act. In many cases, these arrangements will compel a physician to provide notice of an investigation, audit, allegation or charge, trigger separate investigatory or disciplinary action against the physician, or both. These notice and other obligations may arise and often trigger employment, peer review, licensing board or other investigations before or concurrent with the investigation or prosecution by the government.
Along with the stiff civil sanctions or settlements imposed, physicians and others investigated or charged with health care fraud often incur significant legal and other costs responding to and defending years of government audits and investigations, as well as well as employment, peer review, licensing board and other investigations and disciplinary actions that almost always result from when a physician is accused or investigated for health care fraud even if the government investigation ultimately does not lead to the government filing criminal or civil charges against the physician or other licensed healthcare provider. Since a physician faces a substantial likelihood of being required to respond to and defend him or herself against peer review, licensing board, employment or other nongovernmental investigations or charges as well as the government action, physicians and others also should consider if they can expect to have sufficient funds to pay the legal and other costs of their defense in the event they come under scrutiny taking into account their existing malpractice or other liability insurance coverages, commitments to defend and indemnify under employment, shareholder or partnership, or other agreements, and other resources. Physicians and their organizations concerned about the adequacy of these resources may wish to explore, where available, raising their malpractice policy coverage limits, purchasing other supplemental coverage, and other similar steps to better position themselves to have funds to support and conduct their defense. As part of this process, physicians generally will want to review the adequacy and limits of the coverages that their practices provides, as well as consider the reliability of that coverage in the event that the physician is terminates or leaves the practice as a result of the investigation or otherwise.
When considering the sufficiency of their existing professional liability insurance coverages, physicians generally will want to consider the adequacy of the coverage if the physician remains with the practice as well as if the physician leaves it. The 10 year statute of limitations applicable to False Claims Act claims, physicians billings can come back to haunt a physician 10 years after their submission. With this tremendously long liability period, even in the absence of government investigation, a significant risk exists that a physician may experience a practice relocation or other change that would affect his coverage during this period. When an investigation happens, the possibility that the physician will relocate his practice skyrockets as physicians often experience suspensions of privileges, involuntary employment terminations and other disruptions to their practice in direct response to the investigation or prosecution. Consequently, physicians should consider purchasing tail coverage, maintaining separate, portable professional liability coverage or both to mitigate these risks.
Beyond the availability of the professional liability coverage, physicians and their practices also should consider the adequacy of the coverage provided by their professional liability or other policies. When reviewing these coverages, physicians and practices should consider what coverage, if any, the policies provide for defense of the physician in relation to peer review, licensing, or other disciplinary actions, government investigations or prosecutions, or both. If the policy provides no or limited coverage for costs of defending against these events, both the physician and his associated organization or practice may want to explore purchasing additional riders on the existing policy, purchasing separate coverage or both as well as to raise the limits on the coverages provided in light of the predictable high expenses of defending these events.
While physicians definitely need evaluate their coverages in anticipation of a potential investigation or prosecution, practice leaders, hospitals and other organizations that would be swept up into these investigations generally share an interest in ensuring that the physician possesses adequate resources to defend against a government investigation or prosecution, as their organization and its billings are likely to be adversely impacted if the physician is unable to defend the billings.
For More Advice, Assistance Or More Information
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Ms. Stamer is a highly regarded practicing attorney with extensive health industry legal and policy experience, also recognized as a knowledgeable and highly popular health industry thought and policy leader, who writes and publishes extensively on health industry concerns. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, recognized as a “Top” lawyer in Health Care, Labor and Employment and Employee Benefits Law, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 27 years experience advising health industry clients about these and other matters. Her experience includes advising and defending hospitals, nursing home, home health, physicians and other health care professionals, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies and programs in response under CMS, OCR, HHS, FDA, IRS, DOJ, DEA, NIH, licensing, and other regulations; prevent, conduct and investigate, and respond to Board of Medicine, OIG, DOJ, DEA, DOD, DOL, Department of Health, Department of Aging & Disability, IRS, Department of Insurance, and other federal and state regulators; ERISA and private insurance, prompt pay and other reimbursement and contracting; peer review and other quality concerns; and other health care industry investigation, and enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. This experience includes extensive work advising and defending physicians, practices, hospitals and other health care organizations and others about Medicare and other health care billing and reimbursement practices, as well as advising and defending providers against Medicare, Medicaid, Tricare and other audits, prepayment suspensions, provider exclusions and provider number revocation, and counseling and defending providers, medical staff and peer review committees, hospitals, medical practices and other health care organizations and others in relation to the conduct of audits and investigations, peer review investigations and discipline, employment, licensing board and other associated events.
The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others. Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. ©2015 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc. All other rights reserved.
Leave a Comment » | Uncategorized | Tagged: civil monetary penalty, false claims act, Health Care Fraud, Medicare, physicians services, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
April 21, 2015
Physicians and other practitioners and others with concerns or other input on a plan by the Centers for Medicare & Medicaid Services (CMS) to implement a voluntary electronic clinical template and a voluntary home health paper clinical template available for review here will have one final chance share their concerns by submitting feedback and questions on the templates via email here, participating in the final Open Forum telephone conference call about the proposed templates that CMS has scheduled for Tuesday, April 28, 2015 from 1:30-2:30 pm Eastern Time, or both.
Physicians and others who prescribe or bill for home health services should use these or other opportunities to learn about the proposed templates and the CMS plans to implement them for “voluntary” use by home health care subscribers. At minimum, physicians and other health care providers prescribing or billing for these services will want to take the voluntary guidelines, if implemented, into account when ordering, providing or billing for this care to minimize potential problems in billing of Medicare for these services. Even if never implemented in final form, however, reviewing the proposed template provides valuable insights into CMS’ perspectives on the requirements that home health care must meet to qualify for Medicare benefit coverage and CMS’ expectations about how physicians and others should order and bill services intended to qualify for reimbursement by Medicare..
CMS developed the proposed templates over the past year in response to reported findings of extraordinarily high error rates in Medicare home health care claims submissions and payments. According to CMS, analysis performed under the Comprehensive Error Rate Testing (CERT) program raised concerns about the accuracy and appropriateness of Medicare home health claims submissions and payment. CMS reports that in fiscal year 2014, the CERT program analysis revealed that more than half (51.4 percent) of the home health claims were paid improperly and that approximately 90 percent of the 1308 CERT-reviewed claim lines in error were found to have insufficient documentation errors.
According to an Apri1 21, 2015 announcement, CMS now plans to deploy the proposed voluntary home health electronic and paper clinical templates developed by CMS over the past year to help physicians and other practitioners better meet CMS’ requirements for accurately documenting patient eligibility for the Medicare home health benefit. CMS believes the use of clinical templates may reduce burden on the physicians and practitioners who order home health services to code and bill care in accordance with CMS expectations.
As part of the developmental process, CMS has hosted a series of Special Open Door Forum calls inviting physicians and other practitioners, home health agencies and other interested parties to provide feedback on the draft templates. The next and final Open Door Forum to discuss the draft templates is scheduled to take place on Tuesday, April 28, 2015 at 1:30p.m. Eastern Standard Time.
Interested persons can use the following information to join the April 28, 2015 Open Door Forum conference call: Participant Dial-In Number: 1-800-603-1774, Conference ID#: 78964234. Questions or feedback on the templates can be emailed here.
We value all of the comments submitted and consider each one, but we cannot guarantee all questions will be addressed during the Open Door Forum Call. We will try to address the most common issues/concerns received. CMS will continue to accept comments sent to the email address even after the call. Stakeholders are encouraged to submit questions or comments as quickly as possible.
Physicians and other practitioners with questions, concerns or other input about the proposed templates or their use should consider participating in the telephone conference, submitting questions or other input to the designated email, or both.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can t access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | billing, Clinical pathway, Health Care, Health care coding, Health Care Fraud, Home Health, Physician, Reimbursement, templates | Tagged: Health Care Compliance, Health Care Fraud, home health, Medicare, Physicians, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer
March 5, 2015
A former National Quality Forum Committee Safe Practices Co-Chair landed in hot water under the False Claims Act for receiving compensation to use his influence and position to influence safety practices standards. Patient safety consultant Dr. Charles Denham, will pay $1 million to settle Justice Department allegations that he violated the False Claims Act by soliciting and accepting kickbacks while he co-chaired the Safe Practices Committee 2009 and 2010, according to a Justice Department announcement. The consulting company Health Care Concepts Inc. and the research organization Texas Medical Institute of Technology, operated by Denham both also are parties to the settlement.
With physicians and other health care organizations increasingly stepping up involvement in credentialing organizations and government advisory and other task forces, the enforcement action highlights another area where health care organizations and their people need to be careful to avoid violations of the False Claims Act or other laws. The settlement illustrates both the need for health care providers participating in HHS or other government advisory or other consulting roles to carefully evaluate their compensation and other arrangements for illegal remuneration or other prohibited elements in light of the continuing emphasis on and success of the Departments of Health & Human Services (HHS) and Justice in investigating and prosecuting arrangements they view as health care fraud under the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative announced in 2009.
The charges against Denham resolved by the settlement stem from payments he and his companies received while he co-chaired the Safe Practices Committee. The Safe Practices Committee reviews, endorses and recommends standardized healthcare performance measures and practices. The settlement resolves allegations that, under agreements entered into in 2008, Denham received monthly payments from CareFusion Corporation while serving as the co-chair of the Safe Practices Committee. The Justice Department charged that Denham did not disclose to the committee, or any other individual or component of the National Quality Forum, that he was receiving payments from CareFusion while co-chairing the Committee and that Denham solicited and received these payments in exchange for influencing the recommendations of the National Quality Forum and for recommending, promoting and/or arranging for the purchase of CareFusion’s product, ChloraPrep, in violation of the Federal Anti-Kickback Statute. The United States alleged that this conduct caused the submission of false or fraudulent claims for ChloraPrep to federal health care programs.
In addition to paying $1 million to the United States, Dr. Denham and his two businesses will be excluded from Medicare, Medicaid and all federal health programs as part of the settlement.
The settlement highlights another example of the widespread success HHS, the Justice Department and other agencies participating in the HEAT initiative in using the False Claims Act against doctors, hospitals and other health care providers and organizations. Since January 2009, the Justice Department reports recovery of more than $23.8 billion through False Claims Act cases, with more than $15.2 billion of that amount recovered in cases involving fraud against federal health care programs. With HHS and the Justice Department claiming it recovers an average return of $8 for each $1 invested in health care fraud enforcement, the enforcement initiative is a key player in Federal efforts to control and reduce federal health care expenditures. The Obama Administration tout the success of these efforts to fuel Congressional and public support for continuation and expansion of these and other health care fraud enforcement efforts by HHS, the Justice Department and other agencies.
“Kickback schemes undermine the integrity of medical decisions, subvert the health marketplace and waste taxpayer dollars,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division. “Doctors and other health care professionals who accept illegal inducements undermine the public’s trust in federal health care programs and will continue to be the focus of our enforcement efforts
Given the success of the programs and the HEAT agencies commitment to continuing their heavy-handed enforcement efforts, physicians, hospitals, skilled nursing, home health, durable medical equipment, and other health care providers and their leaders should stay ever diligent in their efforts to maintain compliance and other necessary defenses in anticipation of government scrutiny of their operations and activities. As part of these efforts, health care providers and organizations serving on advisory task forces or committees to government agencies or to credentialing or standard settling organizations that provide input on regulatory, standard setting or other activities need to use special care to ensure that any potential conflicts of interest are properly identified and disclosed and that the arrangements otherwise are structured and conducted to avoid violations of both the Anti-Kickback and other health care fraud laws and lobbying, conflict of interest and other laws, regulations and policies applicable to those activities.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Board Certified in Labor & Employment Law, and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.
Other Helpful Resources & Other Information
We hope that this information is useful to you. If you found these updates of interest, you also be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here, our electronic Solutions Law Press Health Care Update publication available here, or our HR & Benefits Update electronic publication available here. You also can get access to information about how you can arrange for training on “Building Your Family’s Health Care Toolkit,” using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail by creating or updating your profile here. You can reach other recent updates and other informative publications and resources.
Examples of some of these recent health care related publications include:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
February 9, 2015
On February 2, 2015, U.S. District Judge Michael Schneider sentenced former Ivy Health Care Supply owner Vivian Yusuf to 7 years and 3 months in jail and ordered her to pay $1.6 million in restitution for her September 17, 2014 guilty plea to conspiracy to commit health care fraud.
In March 2011, Yusuf was indicted on charges of conspiracy to commit health care fraud, health care fraud, and aggravated identity theft. Investigators believe that Yusuf and her co-conspirators billed Medicare for more than $3.4 million for durable medical equipment (DME) that was neither medically necessary nor prescribed by a physician.
The guilty plea stemmed from Yusuf’s January 12, 2012 indictment for conspiracy to commit health care fraud, health care fraud, and aggravated identity theft for acts committed when she owned and operated Ivy Health Care Supply, a Houston-area durable medical equipment (DME) company based in Stafford, Texas.
According to information presented in court, from June 2007 to May 2009, Yusuf and Aghaegbuna “Ike” Odelugo, James Reese, and others unlawfully submitted false and fraudulent claims to Medicare of more than $3.4 million and defrauded Medicare of more than $1.6 million by marketing of power wheelchairs and accessories, as well as “ortho kits,” which primarily consisted of a bag of orthotic items, including braces, wraps, and supports, and a heat lamp or heat pad. As part of the scheme, the defendant and her co-conspirators illegally obtained protected health information, including names, dates of birth, and Medicare numbers from elderly individuals. Yusuf and her co-conspirators supplied approximately 790 beneficiaries located primarily in Texas and Louisiana with kits and power wheelchairs that the beneficiaries did not want and not prescribed or otherwise authorized by a physician. In some instances, physicians’ signatures were forged and false claims were submitted to Medicare in the names of Medicare beneficiaries who were deceased.
A fugitive for several years before her arrest June 3, 2014 at George Bush Intercontinental Airport in Houston, the Department of Health & Human Services Office of Inspector General (OIG) once listed her on its “Most Wanted List.”
According to OIG, Odelugo and Reese were indicted for their involvement in similar health care fraud schemes. Odelugo pleaded guilty to conspiracy to commit health care fraud, health care fraud, and money laundering and was sentenced to 72 months in federal prison. The loss to Medicare as a result of Odelugo’s scheme was approximately $9.9 million. Reese pleaded guilty to health care fraud and tax evasion and was sentenced to 180 months in federal prison. The loss to Medicare as a result of Reese’s scheme was approximately $8.6 million.
In the face of these continuing investigations and prosecutions, health care providers should continue to diligently work to comply with the False Claims Act and other federal and state health care fraud laws by tightening their internal controls and other compliance programs. As a key element of these efforts, health care providers should ensure that their human resources and other management carefully monitor employee, contractor and vendor complaints, concerns and other communications for potential signs of compliance concerns, retaliation or other indicators of the need to intervene to correct potential violations or other risks.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
Leave a Comment » | Durable Medical Equipment, false claims act, Federal Health Center, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Money Laundering, Uncategorized | Tagged: false claims act, Health Care Fraud, OIG | Permalink
Posted by Cynthia Marcotte Stamer
February 3, 2015
Franklin, Tennessee based Community Health Systems Professional Services Corporation (CHSPSC) and three of its New Mexico affiliate hospitals- Eastern New Mexico Medical Center in Chaves County, Mimbres Memorial Hospital and Nursing Home in Luna County and Alta Vista Regional Medical Center in San Miguel County (collectively CHS) will pay the United States $75 million to settle Justice Department allegations that CHS violated the False Claims Act by illegally donating funds to county governments to use to fund the 25 percent “matching share” of the now discontinued New Mexico Sole Community Provider (SCP) program. The Justice Department action and resulting settlement highlight both the rising role of whistleblowers in helping Federal and state officials uncover potential False Claims Act or other health care fraud allegations and the Federal government’s continuing commitment to investigate and prosecute health care fraud charges against hospitals and other health care providers.
The Justice Department announced on February 3, 2015 that CHS had agreed to settle charges made by the Justice Department in United States ex rel. Baker v. Community Health Systems Professional Services Corporation, et al., Civ. Action No. 05-279 (D. N.M.). , that CHS violated the False Claims Act by providing illegal donations to New Mexico to use to pay its required portion of the SCP funding.
The New Mexico SCP program provided supplemental Medicaid funds to hospitals in mostly rural communities using a mix of federal and state funding. Under the program, the federal government reimbursed the state of New Mexico for approximately 75 percent of its health care expenditures under the SCP program provided that New Mexico provide state or county funds, and not impermissible “donations” from private hospitals, to fund the remaining 25 percent “matching” share of SCP program payments. Congress enacted the prohibition against the use of private hospital funds to fund the state’s required matching share of SCP program payments to curb possible abuses and ensure that states have sufficient incentive to curb rising Medicaid costs.
According to the Justice Department, CHS violated the False Claims Act from August 1, 2000 to December 31, 2010, by knowingly causing the state of New Mexico to present false claims to the United States for payments made to CHS under the SCP program by making improper donations to Chaves, Luna and San Miguel counties, which were then used by the counties, and later the state, to obtain federal matching payments. The government alleged that CHS concealed the true nature of these donations to avoid detection by federal and state authorities. The Justice Department additionally claimed that as a result of its scheme, CHS received SCP payments which were funded by the United States in the amount of three times CHS’ “donations.”
The prosecution leading to the settlement provides yet another example of the role of whistleblowers in helping the governing identify and prosecute fraud. The False Claims Act qui tam rules allow individuals to bring a lawsuit on behalf of the government and to share in the proceeds of the suit. The act also permits the government to intervene in and take over the lawsuit, as it did in this case as to some of Baker’s allegations. The United States did not intervene in Baker’s allegations as to SCP payments made to two other affiliated New Mexico hospitals, Carlsbad Medical Center and Lea Regional Medical Center. Today’s settlement also resolves these other allegations. Baker will receive $18,671,561 as his share of the government’s recovery.
In addition, the action and its settlement also affirms the Federal government’s continuing commitment to find and prosecute health care providers that it perceives violate the False Claims Act or other Federal health care fraud laws.
“Congress expressly intended that states and counties use their own money when seeking federal matching funds in order to encourage them to join the federal government in ensuring that Medicaid funds are spent on the needs of beneficiaries,” said Acting Assistant Attorney General for the Justice Department’s Civil Division Joyce R. Branda. “When private hospitals violate the rules against hospital donations funding the state share, that important protection of the Medicaid program is destroyed.”
“Hospitals that make provider donations with the expectation that they will receive a windfall from the Medicaid program threaten the integrity of the Medicaid program and will be held accountable,” said Special Agent in Charge Mike Fields for the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) Dallas region.
In the face of these continuing investigations and prosecutions, health care providers should continue to diligently work to comply with the False Claims Act and other federal and state health care fraud laws by tightening their internal controls and other compliance programs. As a key element of these efforts, health care providers should ensure that their human resources and other management carefully monitor employee, contractor and vendor complaints, concerns and other communications for potential signs of compliance concerns, retaliation or other indicators of the need to intervene to correct potential violations or other risks.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
- Use New State Ebola Protocol Table In Ebola Prevention & Management Planning
- Unpatched and Unsupported Software Triggers Latest HIPAA Security Breach Resolution Agreement
- Congress Sends Bill To Fast Track FDA Ebola Treatment Review & HHS Declaration Gives Ebola Treatment Manufacturers Special Immunity
- Former Center Texas Medical Center CFO Faces 5 Years After Guilty Plea To EHR Incentive Fraud Reminder To Manage Incentive Compliance
- Preparing Privacy Compliance For Emergencies-Ebola Crisis Prompts HHS OCR To Share Guidance On HIPAA Privacy in Emergency Situations
- IRS Issues Ebola-Related Tax Relief
- Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants
- OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases
- 10/10 Kidney Foundation Professional Symposium Offers 7.5 Hours CME/CEUs
- Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle
- Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement
- Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts
- CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule
- Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors
- Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants
- OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases
- Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle
- Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement
- Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts
- CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule
- Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements
- Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years
- Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date
- NLRB Helps Union Force Another Health Care Employer To Recognize & Bargain With Union
- Federal Health Care Fraud Enforcement Recouped Record $4.3 Billion in FY 2013
- Former Houston Texas Physician Gets 70 Month Prison Sentence For Fraud Conviction
- Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims
- Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action
- Medical Identity Theft/Fraud Convictions Highlight Need For Health Care Providers To Safeguard Health Information, Guard Against Fraud Schemes
- Detroit-Area Foot Doctor Pleads Guilty to Medicare Fraud Scheme
- Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges
- Texas Physicians Get New Option For Resolving Some Medical Board Complaint
- Broad-Reaching Prosecution Of Individuals Participating In Operations Of Companies Convicted Of Fraud Shows Risks Of Participation
- Hospitals Can Expect CMS To Add Hospital Incident Reporting To Surveys In Response To OIG Report
- Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians
- DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing Functions, Urges Adoption of Written Policies & Agreements
- If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Anti-KickBack, false claims act, Federal Health Center, Health Care Finance, Health Care Provider, Uncategorized | Tagged: false claims act, Health Care Fraud, OIG | Permalink
Posted by Cynthia Marcotte Stamer
January 10, 2015
Health care providers, public health, school, and other community organizations, employers and other business leaders and others concerned about continuing Ebola and other pandemic prevention and containment should check out the new table of State Ebola Protocols Table compiled by the Centers for Disease Control (CDC) to help law and policy makers prepare for and respond to Ebola-related situations As part of continuing Federal efforts to make up for lost time on helping U.S. health care providers and communities prepare to prevent and respond to Ebola outbreak risks since the death of Liberian Ebola patient Thomas Eric Duncan at a in Dallas hospital last year alerted Americans to the risks and need for tighter preparations.
While the Dallas hospital that treated Mr. Duncan paid a settlement to his family and faced other widespread criticism and negative publicity, it then has become clear that misinformation provided by the patient, the original presentation of the patient with flu-like symptoms, the Obama Administration’s reluctance to adopt policies or communications that might interfere with its pro-immigration political agenda, the CDC’s failure to maintain and communicate the most current health care information to health care providers and communities, the CDC’s academic rather than operational emphasis, EMTALA mandates that forced the hospital to triage the patient, Medicaid and other insurance payment protocols that would have as medically unnecessary screening tests in the absence of more clear risk factors, federal licensing restrictions on the use of testing and a host of other limits and deficiencies in the Federal government’s preparations and response to Ebola and other communication risks, left Texas Health Resources and other U.S. health care providers, as well as U.S schools, public service agencies, employers and others at a great disadvantage in their efforts to deal with the outbreak. After denying the seriousness of Ebola risk concerns for several weeks, the diagnosis with Ebola of health care providers that treated Mr. Duncan and subsequent death and diagnosis resulted in the CDC and other federal and state agencies stepping up their Ebola preparation and guidelines. In keeping with this ongoing commitment, CDC says the CDC now will continue to update the State guidelines table as states continue to modify their Ebola response protocols.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related developments or other risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
December 11, 2014
Health care providers, health plans, health care clearinghouses (covered entities) and their business associates need to watch for and protect protected health information (PHI) against security exposures from unpatched or unsupported software and other weaknesses in their data security protections as part of their compliance obligations under the Security Rules of the Health Insurance Portability & Accountability Act (HIPAA).
The need to monitor and address data security threats associated with unpatched or unsupported software is demonstrated by the December 9, 2014 announcement by the U.S. Department of Health & Human Services (HHS) Office of Civil Rights (OCR) that Anchorage Community Mental Health Services (ACMHS) will pay $150,000 and adopt a corrective action plan to correct deficiencies in its HIPAA compliance program resulting from unpatched and unsupported software.
OCR opened an investigation against the five-facility, nonprofit provider of behavioral health care services to children, adults, and families in Anchorage, Alaska after receiving notification from ACMHS of a breach of unsecured electronic protected health information (ePHI) affecting 2,743 individuals due to malware compromising the security of its information technology resources.
According to the OCR announcement of the ACMHS Resolution Agreement with OCR, OCR’s investigation revealed that ACMHS had adopted sample Security Rule policies and procedures in 2005, but failed to follow these procedures. Moreover, OCR found that the reported security incident directly resulted of ACMHS failing to identify and address basic risks, such as not regularly updating their IT resources with available patches and running outdated, unsupported software.
“Successful HIPAA compliance requires a common sense approach to assessing and addressing the risks to ePHI on a regular basis,” said OCR Director Jocelyn Samuels. “This includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”
In an effort to promote awareness of the need to assess and monitor the security of ePHI by covered entities and business associates, OCR continues to encourage covered entities and business associates to conduct regular documented evaluations of the adequacy of their ePHI safeguards and systems. To aid in this process, OCR and the Office of the National Coordinator for Health Information Technology have created a Security Rule Risk Assessment Tool available here to assist organizations that handle PHI in conducting a regular review of the administrative, physical and technical safeguards they have in place to protect the security of the information. Since OCR points to the Tool as a resource, covered entities and business associates should anticipate that their failure to identify and address any deficiencies in the areas identified by the tools as a potentially serious compliance issue. As a result, covered entities and business associates likely will want to take steps to ensure that their records include documented review of the adequacy of the security safeguards identified in the Tool. At the same time, covered entities and their business associates should not assume that the Tool adequately covers all potential HIPAA Security Rule exposures. OCR has made clear in this and other Resolution Agreements that HIPAA’s Security Rule requires ongoing monitoring and assessment of the adequacy of security in response to changes in software or system, emerging threats and other developments.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Centers For Disease Control, Childrens Health Insurance Program, Disability Discrimination, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, FDA, Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Medical Licensure, Medical Malpractice, OIG, Pandemic, Patient Empowerment, Pharmacy, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, Health Plans, HEAT, HIPAA, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
December 11, 2014
As part of Washington’s late response to the Ebola outbreak crisis, the House and Senate in the past week have passed legislation that if signed by the President as expected will add Ebola and other filoviruses to the list of diseases eligible for fast track review by the Food and Drug Administration (FDA) under the FDA Priority Review Voucher Program (Program).
The FDA Program awards vouchers to sponsors of human drug applications that are approved to prevent or treat designated tropical diseases. A voucher entitles the holder to have a future human drug application acted upon by the FDA within six months.
The House on December 3, 2014 and the Senate on December 10, 2014 respectively passed the “FDA Priority Review Voucher Program Act,” (S.B. 2917/H.B. 5729) (the “Bill”) that will amend the Federal Food, Drug, and Cosmetic Act to add Ebola and other filoviruses to the list of diseases covered by the Program. The Bill also seeks to expedite FDA approval of Ebola and other designated disease treatments by:
- Changing the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).
- Allowing priority review vouchers to be transferred between sponsors of human drug applications any number of times.
- Reducing from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.
Congress sent the Bill to the President just one day after Department of Health & Human Services (HHS) Secretary Sylvia M. Burwell today announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act HHS says it hopes will “facilitate the development and availability of experimental Ebola vaccines in hopes of helping combat the current epidemic in West Africa and help prevent future outbreaks there.”
Fighting the disease in Africa has been the primary focus of the Obama Administration’s Ebola response. The December 9, 2014 HHS declaration provides immunity under United States law against legal claims related to the manufacturing, testing, development, distribution, and administration of three vaccines for Ebola virus disease. It does not, generally, provide immunity for a claim brought in a court outside the United States.
For many years, the U.S. has encouraged vaccine development by managing liability and compensation, starting with the National Childhood Vaccine Injury Act of 1986. The PREP Act was designed to facilitate the development of medical countermeasures to respond to urgent public health needs, including the development of critical vaccines like those to prevent the spread of Ebola. This U.S. declaration under the PREP act is part of a global dialogue to address these issues in the U.S., and other countries where the vaccine is being developed, manufactured and potentially used.
“My strong hope in issuing this PREP Act declaration in the United States is that other nations will also enact appropriate liability protection and compensation legislation,” said Secretary Burwell. “As a global community, we must ensure that legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine, an essential strategy in our global response to the Ebola epidemic in West Africa.”
HHS hopes the PREP Act declaration will strengthen the incentive to conduct research and spur development, manufacturing, and the potential use of the vaccines in large scale vaccination campaigns in West Africa. The PREP Act declaration provides legal protection under U.S. law for three vaccine candidates:
- the GlaxoSmithKline’s Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine known as ChAd3-EBO-Z;
- the BPSC1001 vaccine, known as rVSV-ZEBOV-GP, made by BioProtection Services Corporation, a subsidiary of Newlink Genetics; and
- the Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corporation, subsidiary of Johnson & Johnson/Bavarian Nordic.
Similar PREP Act declarations have been issued, revised or renewed 14 times since the Act was signed in 2005. Past declarations have covered vaccines used in H5N1 pandemic influenza clinical trials in 2008, products related to the H1N1 influenza pandemic in 2009, and the development and manufacturing of antitoxins to treat botulism in 2008. For more information about the PREP Act, see here .
The Bill and the HHS PREP Act declaration are the latest efforts to provide what many health care providers see as a long overdue response to the Ebola outbreak in the wake of the diagnosis and subsequent death of an Ebola patient in Dallas lead to his death and the infection of nurses involved in his treatment, and a small number of other Ebola victims in the United States raised national awareness and concern.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related developments or other risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Centers For Disease Control, Childrens Health Insurance Program, Disability Discrimination, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, FDA, Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Medical Licensure, Medical Malpractice, OIG, Pandemic, Patient Empowerment, Pharmacy, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, Health Plans, HEAT, HIPAA, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
November 18, 2014
The prosecution and resulting November 12, 2014 guilty plea of former Shelby Regional Medical Center Chief Financial Officer Joe White to making false statements when applying for electronic health record (EHR) incentives highlights another growing fraud exposure risk that health care organizations and their leaders need to manage arising from applications or other claims made in seeking EHR or other incentives or grants.
White presently faces sentencing to up to five years in prison after pleading guilty to making a false statement in an application for EHR incentives he signed on behalf of Center, Texas-based Shelby Regional Medical Center. White plead guilty to the charge before U.S. Magistrate Judge John D. Love on November 12, 2014.
The charges against White stemmed from an application he made on behalf of the medical center for EHR incentives. According to information presented by the U.S. Department of Justice in court, White was the Chief Financial Officer for the medical center owned and operated by Dr. Taqriq Mahmood. White oversaw the implementation of EHRs for the hospital and was responsible for attesting to the meaningful use of electronic health records in order to qualify to receive incentive payments under Medicare’s Electronic Health Record (EHR) Incentive Program. The Justice Department charged that on November 20, 2012, White knowingly made a false statement to Medicare falsely representing that the hospital was a meaningful user of electronic health records, when the hospital did not meet the meaningful use requirements. As a result, the medical center received $785,655.00 in EHR incentives from Medicare. A federal grand jury indicted White on February 6, 2014. He faces up to five years in prison when sentenced. The sentencing date is not set yet.
White’s prosecution and guilty plea is one of several actions that highlight the growing exposure that health care organizations and their leaders face to criminal and civil prosecution for fraud or other misconduct in seeking or collecting federal incentives or grants.
Federal and state officials responsible for administering the massive influx of grants and incentives to health care providers and others authorized under the Patient Protection and Affordable Care Act, the Stimulus Bill and other legislation now are auditing and investigating fraud or other compliance concerns and acting aggressively to prosecute organizations and individuals criminally, civilly or both for fraudulent or other abuse of the rules. The White criminal conviction, for instance, follows the October, 2014 civil complaint and simultaneous settlement of theFalse Claims Act civil suit, US ex rel. v. Columbia U. and ICAP complaint-in-intervention and its resolution through the simultaneously filed US ex rel. v. Columbia U. and ICAP stipulation and order (“Settlement”) involving the Trustees Of Columbia University In The City Of New York (“Columbia University”), and ICAP (formerly known as the International Center For Aids Care And Treatment Programs) (collectively, “Columbia”). In that suit, federal officials charged Columbia University with improperly defrauding the federal government in violation of the False Claims Act in federal grants that Columbia University obtained to fund ICAP’s AIDS- and HIV-related work. The United States’ Complaint-in-Intervention (the “Complaint”) alleged that Columbia University, as the grant administrator on behalf of ICAP, received millions of dollars in federal grants and, pursuant to the rules applicable to such grants, was required for nearly 200 of ICAP’s employees located in New York City to use a suitable means of verifying that the employees had actually performed the work charged to a particular grant. The Complaint alleges that Columbia was well aware that this was not being done, yet continued wrongly to charge many federal grants for work that was not devoted to the projects they funded. According to the Justice Department, Colombia failed to ensure that these reports were created or verified by the more than 200 individuals for which grant monies were sought. Instead, Columbia’s Finance Department provided information for these reports even though the employees of that department had limited or no knowledge of which grants the individuals actually worked on. In addition, the lawsuit charged that the effort reports were certified as correct by the principal investigators on the grants without using suitable means to verify the accuracy of the reports. Instead of taking the appropriate steps to determine whether the reports were accurate, the principal investigators would certify large batches of the reports, without making any inquiry into whether the allocation of work among the grants was accurate. Moreover, ICAP’s management was well aware of the inaccuracies of the effort reporting system. According to the complaint, these omissions resulted in Columbia charging grants for work that was not performed on the project being funded by that grant. For instance, an ICAP Finance Analyst stated that he spent approximately 15-20% of his time on MCAP in fiscal year 2010, but his effort report falsely listed his MCAP effort, and related salary charges, as 85%. Likewise, in fiscal year 2010, an ICAP Subcontracts Manager’s effort report listed her effort as 100% MCAP, but the Subcontracts Manager actually worked on three other grants, in addition to MCAP, that year. The time submitted for many other employees was similarly mischarged. The complaint also charged that ICAP also charged federal grants for time spent on activities that are not chargeable to any federal grants, such as competitive grant proposal writing. For example, an ICAP Grants Manager spent a significant amount of her time writing competitive grant proposals, but her effort report showed that all of her time was charged to grants, with as much as 92% of her time charged to MCAP in some years.
In the Settlement, Columbia admitted failing to use a suitable means of verifying whether the salary and wage charges that ICAP applied to specific federal grants were based on an employee’s actual effort for that grant. Columbia also admitted that as a result, certain effort reports contained inaccurate information, and for a number of years ICAP mischarged certain federal grants for work that was not allocable to those agreements. Columbia also agreed to pay $9,020,073 to resolve the Government’s claims.
The White criminal prosecution and conviction and the Colombia civil prosecution and settlement are two of a growing list of reminders to health care, educational and other organizations receiving Department of Health & Human Services or other federal grants or incentives as a critical reminder to review and tighten as necessary their federal grant and other incentive program compliance and documentation to ensure that it can withstand an audit or other scrutiny by federal officials.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | DME, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, EHR, Electronic Health Records, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
November 11, 2014
The recent US Ebola scare provided an important reminder to health care providers, health insurers and health plans, health care clearinghouses, employers and others of the importance of understanding and preparing to deal with health care privacy and other challenges arising from epidemics and other emergencies. In response to the recent Ebola and other contagious disease outbreaks and just as U.S. health care and other business leaders are working to prepare for the biggest contagious disease time of the year, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is reminding health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates that the privacy rules of the Health Insurance Portability & Accountability Act (HIPAA) requiring Covered Entities and their business associates to limit the use, access and disclosure of patient’s protected health information (PHI) continue to apply during emergency situations and help them understand when HIPAA allows them to share PHI in emergency situations in a new notice titled “HIPAA Privacy in Emergency Situations” (Guidance) published November 10, 2014. A business associate of a covered entity (including a business associate that is a subcontractor) also must continue to comply with HIPAA and may only make disclosures permitted by the Privacy Rule on behalf of a Covered Entity or another business associate to the extent authorized by its business associate agreement and consistent with HIPAA’s requirements.
Sharing Patient Information
The Guidance begins by reminding Covered Entities and their business associates that HIPAA’s Privacy Rule continues to apply in emergency situations and requires Covered Entities protect and prohibits their use, access or disclosure of patient’s protected health information except as allowed by HIPAA unless the patient authorizes the Covered Entity to disclose the PHI in accordance with HIPAA’s requirements for authorization set forth in 45 CFR 164.508.
The Guidance then goes on to discuss the following circumstances that the HIPAA Privacy Rule might allow Covered Entities to share PHI without getting patient authorization, subject to the reminder that in many cases, HIPAA will require that the Covered Entity limit the disclosure to the minimum necessary disclosure necessary for the allowable purpose and require other conditions to be fulfilled:
Under the Privacy Rule, covered entities may disclose, without a patient’s authorization, protected health information about the patient as necessary to treat the patient or to treat a different patient. Treatment includes the coordination or management of health care and related services by one or more health care providers and others, consultation between providers, and the referral of patients for treatment. See 45 CFR §§ 164.502(a)(1)(ii), 164.506(c), and the definition of “treatment” at 164.501.
- Public Health Activities.
The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and others responsible for ensuring public health and safety to have access to protected health information that is necessary to carry out their public health mission. Therefore, the Privacy Rule permits covered entities to disclose needed protected health information without individual authorization:
- To Or At The Direction Of A Public Health Authority.
The HIPAA Privacy Rule allows Covered Entities to share protected health information with Public Health Authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury or disability like the Centers for Disease Control and Prevention (CDC) or a state or local health department. This would include, for example, the reporting of disease or injury; reporting vital events, such as births or deaths; and conducting public health surveillance, investigations, or interventions. A “public health authority” is an agency or authority of the United States government, a State, a territory, a political subdivision of a State or territory, or Indian tribe that is responsible for public health matters as part of its official mandate, as well as a person or entity acting under a grant of authority from, or under a contract with, a public health agency. See 45 CFR §§ 164.501 and 164.512(b)(1)(i). For example, a covered entity may disclose to the CDC protected health information on an ongoing basis as needed to report all prior and prospective cases of patients exposed to or suspected or confirmed to have Ebola virus disease.
The HIPAA Privacy Rule also allows Covered Entities to share information at the direction of a public health authority:
- To a foreign government agency that is acting in collaboration with the public health authority. See 45 CFR 164.512(b)(1)(i); and
- To persons at risk of contracting or spreading a disease or condition if other law, such as state law, authorizes the covered entity to notify such persons as necessary to prevent or control the spread of the disease or otherwise to carry out public health interventions or investigations. See 45 CFR 164.512(b)(1)(iv)
- Disclosures to Family, Friends, and Others Involved in an Individual’s Care and for Notification.
The HIPAA Privacy Rule allows a Covered Entity to share protected health information:
- With a patient’s family members, relatives, friends, or other persons identified by the patient as involved in the patient’s care;
- About a patient as necessary to identify, locate, and notify family members, guardians, or anyone else responsible for the patient’s care, of the patient’s location, general condition, or death including where necessary to notify family members and others, the police, the press, or the public at large. See 45 CFR 164.510(b).
The Guidance reminds Covered Entities, however, that the Privacy Rule requires the Covered Entity to get verbal permission from individuals or otherwise be able to reasonably infer that the patient does not object, when possible. If the individual is incapacitated or not available, the Guidance states Covered Entities may share information for these purposes if, in their professional judgment, doing so is in the patient’s best interest.
The Guidance also confirms that Covered Entities may share protected health information with disaster relief organizations authorized by law or by their charters to assist in disaster relief efforts like the American Red Cross for the purpose of coordinating the notification of family members or other persons involved in the patient’s care, of the patient’s location, general condition, or death. It is unnecessary to obtain a patient’s permission to share the information in this situation if doing so would interfere with the organization’s ability to respond to the emergency.
The Guidance also states that Covered Entities that are health care providers may share patient information with anyone as necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public – consistent with applicable law (such as state statutes, regulations, or case law) and the provider’s standards of ethical conduct. See 45 CFR 164.512(j).
- Disclosures to the Media & Others Not Involved in the Care of the Patient/Notification
The Guidance also reminds Covered Entities of the importance of closely adhering to HIPAA’s rules when responding to information requests from the medial or others not involved in the care of a patient. The Guidance states that when the media or other other party not involved un the patient’s care asks the Covered Entity for information about a particular patient by name, a hospital or other health care facility may release limited facility directory information to acknowledge an individual is a patient at the facility and provide basic information about the patient’s condition in general terms (e.g., critical or stable, deceased, or treated and released) if the patient has not objected to or restricted the release of such information or, if the patient is incapacitated, if the disclosure is believed to be in the best interest of the patient and is consistent with any prior expressed preferences of the patient. See 45 CFR 164.510(a). In general, except in the limited circumstances authorized in the HIPAA Privacy Rule, affirmative reporting to the media or the public at large about an identifiable patient, or the disclosure to the public or media of specific information about treatment of an identifiable patient, such as specific tests, test results or details of a patient’s illness, may not be done without the patient’s written authorization (or the written authorization of a personal representative who is a person legally authorized to make health care decisions for the patient).
- Minimum Necessary Restriction Requirement
The Guidance cautions Covered Entities and their business associates that for most disclosures, a Covered Entity generally must make reasonable efforts to limit the information disclosed to that which is the “minimum necessary” to accomplish the purpose. However, this minimum necessary requirement does not apply to disclosures to health care providers for treatment purposes.
Covered Entities may rely on representations from a public health authority or other public official that the requested information is the minimum necessary when making disclosures in response to request from those parties. For example, a covered entity may rely on representations from the CDC that the protected health information requested by the CDC about all patients exposed to or suspected or confirmed to have Ebola virus disease is the minimum necessary for the public health purpose.
- Required Internal Restrictions On Use, Access & Disclosure
Internally, covered entities should continue to apply their role-based access policies to limit access to protected health information to only those workforce members who need it to carry out their duties. See 45 CFR §§ 164.502(b), 164.514(d).
Safeguarding Patient Information
Beyond limiting the use, access and disclosure of PHI, the Guidance also reminds Covered Entities and their business associates that even in emergency situations, HIPAA continues to require them to implement reasonable safeguards to protect patient information against intentional or unintentional impermissible uses and disclosures as well as to apply the administrative, physical, and technical safeguards of the HIPAA Security Rule to electronic PHI.
Limited Waiver
Although HHS has yet to take steps to trigger a limited waiver, the Guidance also reminds Covered Entities and their business associates that HHS has the power to do so, the effect of a limited waiver and the circumstances under which HHS could elect to apply a limited waiver to waive sanctions against a hospital for certain specific types of HIPAA violations while the waiver is in effect.
As the Guidance notes, the HIPAA Privacy Rule is not suspended during a public health or other emergency. Rather, the limited waiver rules only operates to permit the Secretary of HHS to waive certain provisions of the Privacy Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act. The limited waiver only applies when the President declares an emergency or disaster and HHS declares a public health emergency. When and if these requirements are met, HHS may waive sanctions and penalties against a Covered Entity that is a hospital for failing to comply with the following HIPAA Privacy Rule provisions:
- The requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
- The requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
- The requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
- The patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
- The patient’s right to request confidential communications. See 45 CFR 164.522(b).
If the Secretary issues such a waiver, Covered Entities and their business associates should keep in mind the waiver only applies to the list violations and only applies:
- For so long as the waiver remains in effect;
- In the emergency area and for the emergency period identified in the public health emergency declaration
- To hospitals that have instituted a disaster protocol; and
- For up to 72 hours from the time the hospital implements its disaster protocol.
When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.
Not Necessarily Just About HIPAA
HIPAA is not necessarily the only law that Covered Entities, business associates or others need to consider when deciding what to disclose during an emergency or otherwise. The HIPAA Privacy Rule applies to disclosures made by and Covered Entities, business associates employees, volunteers, and other members of a Covered Entity’s or Business Associate’s workforce. The Privacy Rule does not apply to disclosures made by entities or other persons who are not Covered Entities.
Beyond HIPAA, Covered Entities, their business associates or members of their workforce, employers, and other organizations also need to consider whether other federal or state laws, ethical rules, contracts or policies may restrict use or disclosure, safeguard, or take other steps to protect PHI or other information. For instance, other federal laws, state law, professional ethical rules, contracts, facility policies or procedures, or other restrictions often apply to health care provides, insurers, brokers, employers or others. Employers, health care organizations, insurers and others also need to be concerned about potential discrimination, common law and statutory privacy, retaliation, defamation and other exposures.
Prepare For Compliance Now
The recent experiences of various health care organizations intimately involved in caring for the Ebola patients highlights the importance of anticipating, preparing and conducting training, and having your workforce practice to prepare to deal with the special challenges of dealing with HIPAA and other legal responsibilities in advance of emergency events. When preparing for these events, Covered Entities and business associates need to take into account the need to comply operationally as well as to document and retain records of compliance. They should both should anticipate and prepare to respond to both typical inquiries as well as those from the media, public and others. They also should consider how various types of emergencies could create new privacy or security risks. For instance, in certain emergency situations, recordkeeping or other systems could be disrupted, impacting the ability retain and subsequently produce required documentation. Furthermore, Covered Entities also should prepare to manage the patient and public relations aspects of these events including adverse impressions that often arise when the media or others are disappointed at being denied information because of compliance obligations, from breaches or perceived breaches, or other similar events.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 26 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. The scribe for the American Bar Association (ABA) Joint Committee on Employee Benefits annual agency meeting with the Department of Health & Human Services Office of Civil Rights, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers, banks and other financial institutions, and others on risk management and compliance with HIPAA and other information privacy and data security rules, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Centers For Disease Control, Childrens Health Insurance Program, Disability Discrimination, DME, Doctor, Durable Medical Equipment, E-Prescribing, Employee Benefits, FDA, Health Care, Health Care Fraud, Health Care Provider, Health Care Quality, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Licensing, Medical Licensure, Medical Malpractice, OIG, Pandemic, Patient Empowerment, Pharmacy, Prescription Drugs, Privacy, Prospective Payment, Public Policy, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, Health Plans, HEAT, HIPAA, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
October 29, 2014
The Internal Revenue Service (IRS) has published the following tax rule relief under the Internal Revenue Code (Code)
Notice 2014-65 designates the Ebola virus outbreak occurring in the West African countries of Guinea, Liberia, and Sierra Leone as a qualified disaster for purposes of section 139 of the Code. As a result of the designation of the EVD outbreak as a qualified disaster for purposes of § 139, payments of qualified disaster relief to assist victims affected by the EVD outbreak in the three countries (Guinea, Liberia, and Sierra Leone) are excludable from the recipients’ gross income.
Notice 2014-68 provides guidance on the treatment of leave-based donation programs to aid victims of the Ebola virus outbreak occurring in the West African countries of Guinea, Liberia, and Sierra Leone for income and employment tax purposes where an employer allows employees to elect to forgo vacation, sick, or personal leave in exchange for cash payments an employer makes to organizations described in § 170(c) of the Code for the relief of victims of the EVD outbreak in Guinea, Liberia, and Sierra Leone. This notice provides guidance on the treatment of these payments for income and employment tax purposes.
Notice 2014-65 and Notice 2014-68 will be published in Internal Revenue Bulletin 2014-47 on Nov. 17.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years’ experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
Parkview Hospital To Pay $800K To Settle HIPAA Charges After Retiring Physician Blows The Whistle
Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement
Health Care & Other HIPAA Covered Entities Should Review New Reports As Part of HIPAA Risk Management Efforts
CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule
Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors
Encrypt Mobile Devices & Clean Up Management Documentation Key HIPAA Compliance Messages In New HIPAA Settlements
Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years
Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date
Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims
Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | DME, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, DOJ, Drug Testing, drugs, false claims act, Grants, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
October 29, 2014
The US ex rel. v. Columbia U. and ICAP complaint-in-intervention civil False Claims Act lawsuit (lawsuit) and its resolution through the simultaneously filed US ex rel. v. Columbia U. and ICAP stipulation and order (“Settlement”) entered against the Trustees Of Columbia University In The City Of New York (“Columbia University”), and ICAP (formerly known as the International Center For Aids Care And Treatment Programs) (collectively, “Columbia”) that U.S. Department of Justice (DOJ) announced October 28, 2014 reminds health care, education and other organizations receiving federal grant monies that their False Claims Act and other compliance programs must provide for appropriate management and recordkeeping of any federal grant programs participated in by their organizations. The lawsuit and settlement highlight the importance for health care, education and other organizations receiving or managing federal grants to establish appropriate controls to ensure that they can demonstrate the requisite compliance with grant requirements and other terms and conditions.
The settlement resolves a civil lawsuit jointly brought and simultaneously settled by DOJ and the Department of Health & Human Service against Colombia that charged Columbia with submitting false claims in connection with federal grants that Columbia University obtained to fund ICAP’s AIDS- and HIV-related work. The United States’ Complaint-in-Intervention (the “Complaint”) alleged that Columbia University, as the grant administrator on behalf of ICAP, received millions of dollars in federal grants and, pursuant to the rules applicable to such grants, was required for nearly 200 of ICAP’s employees located in New York City to use a suitable means of verifying that the employees had actually performed the work charged to a particular grant. The Complaint alleges that Columbia was well aware that this was not being done, yet continued wrongly to charge many federal grants for work that was not devoted to the projects they funded. The lawsuit seeks damages and penalties under the False Claims Act.
According to DOJ, the Colombia lawsuit and Settlement arose from Columbia’s participation in the President’s Emergency Plan for AIDS Relief (“PEPFAR program”), a global HIV/AIDS program, targeting billions of dollars in new funding for prevention, treatment, and care services in the most affected countries of the world. Columbia received $125 million in PEPFAR funding through the Multi-Country Columbia Antiretroviral Program (“MCAP”) grant, and over the years obtained over 75 grants and many millions more from the federal government for HIV- and AIDs-related work performed by ICAP.
The grant rules among other things, required that grantees track the work performed by the recipient’s employees and, with limited exceptions, charge grants only for work actually performed as a part of that grant. Columbia claimed to accomplish this by producing effort reports for ICAP’s New York City-based employees purportedly detailing the employees’ distribution of work across federal, state, and private grants, as well as Columbia-sponsored projects. These reports were used to determine how much a given grant was charged for work performed by individual employees.
For nearly 200 individuals, however, DOJ and the Justice Department charged Colombia failed to ensure that these reports were created or verified by the individuals to whom they applied. Instead, Columbia’s Finance Department provided information for these reports even though the employees of that department had limited or no knowledge of which grants the individuals actually worked on. In addition, the lawsuit charged that the effort reports were certified as correct by the principal investigators on the grants without using suitable means to verify the accuracy of the reports. Instead of taking the appropriate steps to determine whether the reports were accurate, the principal investigators would certify large batches of the reports, without making any inquiry into whether the allocation of work among the grants was accurate. Moreover, ICAP’s management was well aware of the inaccuracies of the effort reporting system.
According to the complaint, these omissions resulted in Columbia charging grants for work that was not performed on the project being funded by that grant. For instance, an ICAP Finance Analyst stated that he spent approximately 15-20% of his time on MCAP in fiscal year 2010, but his effort report falsely listed his MCAP effort, and related salary charges, as 85%. Likewise, in fiscal year 2010, an ICAP Subcontracts Manager’s effort report listed her effort as 100% MCAP, but the Subcontracts Manager actually worked on three other grants, in addition to MCAP, that year. The time submitted for many other employees was similarly mischarged.
The complaint also charged that ICAP also charged federal grants for time spent on activities that are not chargeable to any federal grants, such as competitive grant proposal writing. For example, an ICAP Grants Manager spent a significant amount of her time writing competitive grant proposals, but her effort report showed that all of her time was charged to grants, with as much as 92% of her time charged to MCAP in some years.
In the Settlement, Columbia admitted failing to use a suitable means of verifying whether the salary and wage charges that ICAP applied to specific federal grants were based on an employee’s actual effort for that grant. Columbia also admitted that as a result, certain effort reports contained inaccurate information, and for a number of years ICAP mischarged certain federal grants for work that was not allocable to those agreements. Columbia also agreed to pay $9,020,073 to resolve the Government’s claims.
Health care, educational and other organizations receiving HHS or other federal grants should heed the lawsuit and settlement as a reminder to review and tighten as necessary their federal grant program compliance and documentation to ensure that it can withstand an audit or other scrutiny by federal officials.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
September 19, 2014
Pharmaceutical manufacturers risk sanctions unless they take appropriate steps to ensure that their copayment coupons intended to reduce patient out-of-pocket costs for purchase for specific brand name drugs do not induce improperly the purchase drugs paid for by Medicare Part D or other Federal health care programs items or services.
The warning from the Department of Health & Human Services Office of Inspector General (OIG) appears in OEI-05-12-00540 Study Results and accompanying Special Advisory Bulletin published warns pharmaceutical manufacturers they may be liable under the anti-kickback statute if they offer coupons to induce the purchase of drugs paid for by Federal health care programs, including Medicare Part D.
Pharmaceutical manufacturers often offer copayment coupons to reduce or eliminate the cost of patients’ out of pocket copayments for specific brand name drugs.
The anti-kickback statute prohibits the knowing and willful offer or payment of remuneration to a person to induce the purchase of any item or service for which payment may be made by a Federal health care program.
According to OIG, the use of coupons by Medicare beneficiaries could impose significant costs on the Part D program because many coupons encourage beneficiaries to choose more expensive brand name drugs over less expensive alternative drugs.
OIG’s warning comes in conjunction with its announcement of findings an OIG study about the safeguards pharmaceutical manufacturers employ to prevent their copayment coupons from being used for drugs paid for by Part D and to identify vulnerabilities in those safeguards which OIG reports revealed that pharmaceutical manufacturers’ current safeguards may not prevent all copayment coupons from being used for drugs paid for by Part D.
According to the OIG, all surveyed manufacturers provide notices directed to beneficiaries and pharmacists that coupons may not be used in Federal health care programs. Most surveyed manufacturers use pharmacy claims edits to prevent coupons from being processed for drugs covered by Part D. Despite these actions, OIG reports most of these edits may not prevent all coupons from being processed for Part D covered drugs. Finally, Part D plans and other entities cannot identify coupons within pharmacy claims.
In light of these findings, OIG’s Special Advisory Bulletin affirms that pharmaceutical manufacturers should act to ensure that their copayment coupons do not induce the purchase of Federal health care programs items or services, including drugs paid for by Medicare Part D. The guidance makes clear that OIG does not view the current practices of many manufacturers as sufficient controls.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
June 26, 2014
Former employee turned whistleblower Donald Gale will receive $17.24 million of the $124.24 million that the U.S.’ largest provider of pharmaceuticals and pharmacy services to nursing homes, Omnicare, Inc. has agreed to pay to settle charges that Omnicare violated the Anti-Kickback Statute by offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to provide pharmaceuticals and pharmacy services to their residents. The settlement announced June 25, 2014 by the Department of Justice (DOJ) highlights the growing risks that health care organizations using aggressive marketing incentive programs face to whistleblower, Department of Justice and other investigations.
According to DOJ, the Omnicare settlement resolves allegations that “Omnicare provided improper discounts in return for the opportunity to provide medication to Medicare and Medicaid beneficiaries” in violation of the Anti-Kickback Statute. The settlement resolves allegations initially brought by two whistleblowers that Omnicare submitted false claims by entering into below-cost contracts to supply prescription medication and other pharmaceutical drugs to skilled nursing facilities and their resident patients to induce the facilities to select Omnicare as their pharmacy provider. The facilities were participating providers under agreements with Medicare and Medicaid. In addition to the facilities’ own claims for reimbursement from Medicare for short-term rehabilitation treatment rendered to patients, Omnicare submitted additional claims for reimbursement to Medicare and Medicaid for drugs Omnicare supplied.
The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally funded programs as a means of helping to ensure that the selection of health care providers and suppliers is not compromised by improper financial incentives and is instead based on the best interests of the patient. This settlement illustrates both the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative and the critical role that current or former employees or other whistleblowers often play in the successful investigation and prosecution of these cases.
The HEAT initiative announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius makes heavy use of whistleblowers to uncover potential violations and then uses the False Claims Act and other expanded investigatory and enforcement tools granted by Congress to nail providers.
In conducting its war against health care fraud, Federal officials credited new tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) with aiding their health care fraud investigation and enforcement efforts. Legal reforms and new resources granted under the Affordable Care Act and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors. Examples of these new tools include:
- Tough new rules and sentences for criminals
- Enhanced screening and other enrollment requirements
- Increased coordination of fraud prevention efforts
- Health Care Fraud Prevention and Enforcement Action Team (HEAT)
- New focus on compliance and prevention
- Expanded overpayment recovery efforts
- New durable medical equipment (DME) requirements
- An additional $350 million over 10 years to ramp up anti-fraud efforts
- Greater oversight of private insurance abuses
- Senior Medicare Patrols
The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. Since January 2009, the Justice Department has recovered a total of more than $19.5 billion through False Claims Act cases, with more than $13.9 billion of that amount recovered in cases involving fraud against federal health care programs. In announcing the settlement, Justice Department officials sent strong warnings to other health care providers and suppliers about the dangers of providing or accepting improper discounts or other improper incentives as part of their business marketing strategies. “Health care providers who seek to profit from providing illegal financial benefits will be held accountable,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Schemes such as this one undermine the health care system and take advantage of elderly nursing home residents.” Meanwhile, Steven M. Dettelbach, United States Attorney for the Northern District of Ohio, said “Nursing homes should select their pharmacy provider based on the best quality, service and cost to the residents, not based on improper discounts to the nursing facility.”
Any quick look at the DOJ’s enforcement record shows its acting on these promises. For instance, in addition to the Omnicare settlement, DOJ also announced on June 25 the guilty plea of a physician and the sentencing on an ambulance company owner on health care fraud charges. See Huntersville Physician Pleads Guilty To Health Care Fraud and Tax Fraud and Agrees To Pay $6.2 Million to Settle Civil Fraud Claims; Ambulance Company Co-Owner Sentenced To 13 1/2 Years for Health Care Fraud Scheme.
Health Care Providers Must Act To Manage Risks
In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
May 28, 2014
July 28, 2014 is the deadline for concerned persons to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule requiring prior authorization for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The proposed rule available for review at http://www.gpo.gov/fdsys/pkg/FR-2014-05-28/pdf/2014-12245.pdf would establish a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization and would add a contractor’s decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
May 13, 2014
27 Medical Professionals Charged with Health Care Fraud
A nationwide takedown by Medicare Fraud Strike Force operations in six cities today (May 13, 2014) resulted in charges against 90 individuals, including 27 doctors, nurses and other medical professionals, for alleged participation in Medicare fraud schemes involving approximately $260 million in false billings, according to U.S. Attorney General Eric Holder and Department of Health and Human Services (HHS) Secretary Kathleen Sebelius. The announcement reminds U.S. health care providers that the Obama Administration continues to target health care providers in its campaign against health care fraud.
The seventh coordinated national Medicare fraud takedown by the Medicare Fraud Strike Force operations team of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), Federal officials filed charges that accuse the defendants of various health care fraud-related crimes, including conspiracy to commit health care fraud, violations of the anti-kickback statutes and money laundering. The charges are based on a variety of alleged fraud schemes involving various medical treatments and services, including home health care, mental health services, psychotherapy, physical and occupational therapy, durable medical equipment and pharmacy fraud.
Among the defendants charged were 27 medical professionals, including 16 doctors, who Federal officials charge included doctors billing for services that were never rendered, supply companies providing motorized wheelchairs that were never needed, and recruiters paying kickbacks to get Medicare billing numbers of patients. According to court documents, the defendants allegedly participated in schemes to submit claims to Medicare for treatments that were medically unnecessary and often never provided. In many cases, court documents allege that patient recruiters, Medicare beneficiaries and other co-conspirators were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could then submit fraudulent bills to Medicare for services that were medically unnecessary or never performed. Collectively, the doctors, nurses, licensed medical professionals, health care company owners and others charged are accused of conspiring to submit approximately $260 million in fraudulent billings.
In Miami, a total of 50 defendants were charged today and yesterday for their alleged participation in various fraud schemes involving approximately $65.5 million in false billings for home health care and mental health services, and pharmacy fraud. In one case, two defendants were charged in connection with a $23 million pharmacy kickback and laundering scheme. Court documents allege that the defendants solicited kickbacks from a pharmacy owner for Medicare beneficiary information, which was used to bill for drugs that were never dispensed. The kickbacks were concealed as bi-weekly payments under a sham services contract and were laundered through shell entities owned by the defendants.
Eleven individuals were charged by the Houston Medicare Strike Force. Five Houston-area physicians were charged with conspiring to bill Medicare for medically unnecessary home health services. According to court documents, the defendant doctors were paid by two co-conspirators to sign off on home health care services that were not necessary and often never provided.
Eight defendants were charged in Los Angeles for their roles in schemes to defraud Medicare of approximately $32 million. In one case, a doctor was charged for causing almost $24 million in losses to Medicare through his own fraudulent billing and referrals for durable medical equipment, including over 1,000 expensive power wheelchairs, and home health services that were not medically necessary and often not provided.
In Detroit, seven defendants were charged for their roles in fraud schemes involving approximately $30 million in false claims for medically unnecessary services, including home health services, psychotherapy and infusion therapy. In one case, four individuals, including a doctor, were charged in a sophisticated $28 million fraud scheme, where the physician billed for expensive tests, physical therapy and injections that were not necessary and not provided. Court documents allege that when the physician’s billings raised red flags, he was put on payment review by Medicare. He was allegedly able to continue his scheme and evade detection by continuing to bill using the billing information of other Medicare providers, sometimes without their knowledge.
In Tampa, Florida, seven individuals were charged in a variety of schemes, ranging from fraudulent physical therapy billings to a scheme involving millions of dollars in physician services and tests that never occurred. In one case, five individuals were charged for their alleged roles in a $12 million health care fraud and money laundering scheme that involved billing Medicare using names of beneficiaries from Miami-Dade County for services purportedly provided in Tampa area clinics, 280 miles away. The defendants then allegedly laundered the proceeds through a number of transactions involving several shell entities.
In Brooklyn, New York, the Strike Force announced an indictment against Syed Imran Ahmed, M.D., in connection with his alleged $85 million scheme involving billings for surgeries that never occurred; Dr. Ahmed had been arrested last month and charged by complaint. Dr. Ahmed has charged with health care fraud and making false statements. In addition, the Brooklyn Strike Force charged six other individuals, including a physician and two billers who allegedly concocted a $14.4 million scheme in which they recruited elderly Medicare beneficiaries and billed Medicare for medically unnecessary vitamin infusions, diagnostic tests and physical and occupational therapy supposedly provided to these patients.
The cases announced today are being prosecuted and investigated by Medicare Fraud Strike Force teams comprised of attorneys from the Fraud Section of the Justice Department’s Criminal Division and from the U.S. Attorney’s Offices for the Southern District of Florida, the Eastern District of Michigan, the Eastern District of New York, the Southern District of Texas, the Central District of California, the Middle District of Louisiana, the Northern District of Illinois and the Middle District of Florida; and agents from the FBI, HHS-OIG and state Medicaid Fraud Control Units.
The HEAT Strike Force is a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice and HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Almost 400 law enforcement agents from the FBI, HHS-OIG, multiple Medicaid Fraud Control Units and other federal, state and local law enforcement agencies participated in today’s takedown.
Since their inception in March 2007, Strike Force operations in nine locations have charged almost 1,900 defendants who collectively have falsely billed the Medicare program for almost $6 billion. Overall, since its inception, the Department of Justice’s Medicare Fraud Strike Force has charged nearly 1,900 individuals involved in approximately $6 billion of fraud. We are committed to using every tool at our disposal to prevent, deter, and prosecute health care fraud. In addition, CMS, working in conjunction with HHS-OIG, has suspended enrollments of high-risk providers in five Strike force locations and has removed over 17,000 providers from the Medicare program since 2011.
“Medicare is a sacred compact with our nation’s seniors, and to protect it, we must remain aggressive in combating fraud,” said Attorney General Holder. “This nationwide Medicare Strike Force takedown represents another important step forward in our ongoing fight to safeguard taxpayer resources and to ensure the integrity of essential health care programs. Department of Justice will not tolerate these activities. And we will continue working alongside the Department of Health and Human Services – as well as federal, state, and local partners – to use every appropriate tool and available resource to find, stop, and punish those who seek to take advantage of their fellow citizens.”
In conducting its war against health care fraud, Federal officials credited new tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) with aiding their health care fraud investigation and enforcement efforts. Legal reforms and new resources granted under the Affordable Care Act and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors. Examples of these new tools include:
- Tough new rules and sentences for criminals
- Enhanced screening and other enrollment requirements
- Increased coordination of fraud prevention efforts
- Health Care Fraud Prevention and Enforcement Action Team (HEAT)
- New focus on compliance and prevention
- Expanded overpayment recovery efforts
- New durable medical equipment (DME) requirements
- An additional $350 million over 10 years to ramp up anti-fraud efforts
- Greater oversight of private insurance abuses
- Senior Medicare Patrols
“The Affordable Care Act has given us additional tools to preserve Medicare and protect the tens of millions of Americans who rely on it each day,” said Secretary Sebelius. “By expanding our authority to suspend Medicare payments and reimbursements when fraud is suspected, the law allows us to better preserve the system and save taxpayer dollars. Today we’re sending a strong, clear message to anyone seeking to defraud Medicare: You will get caught and you will pay the price. We will protect a sacred trust and an earned guarantee.”
The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to demonstrate the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.
Health Care Providers Must Act To Manage Risks
In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
April 4, 2014
Yesterday’s announcement of the exclusion of the operator and manager of the national dental chain, Small Smiles Dental Centers, from exclusion in Medicaid, Medicare and other federal health programs highlights the risks health care providers run by failing to comply with a Corporate Integrity Agreement.
Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services, announced April 3, 2014 that the operator and manager of the Small Smiles Dental Centers, CSHM, LLC (formerly known as FORBA Holdings and Church Street Health Management (CSHM), has signed an Exclusion Agreement that bars CSHM from participating in Medicare, Medicaid, and all other Federal health care programs for 5 years. Small Smiles Dental Centers provides services primarily to children on Medicaid.
Mr. Levinson said that this exclusion “makes clear to the provider community that OIG closely monitors our CIAs, critically evaluates providers’ representations and certifications, and will pursue exclusion actions against providers that fail to abide by their integrity agreement obligations.”
According to the announcement, the exclusion is based on CSHM’s alleged material breaches of its Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG).
CSHM’s corporate predecessor entered into the CIA in 2010, as part of the resolution of a False Claims Act case involving allegations that the company had provided dental services to children on Medicaid that were medically unnecessary or failed to meet professionally recognized standards of care.
On March 7, 2014, OIG issued a Notice of Exclusion to CSHM based upon numerous material breaches of its obligations under the CIA. CSHM failed to report serious quality-of-care reportable events, take corrective action, or make appropriate notifications of those events to the State dental boards as required by the CIA, OIG found. CSHM also failed to implement and maintain key quality-related policies and procedures, comply with internal quality and compliance review requirements, properly maintain a log of compliance disclosures, and perform training as required by the CIA. Finally, CSHM submitted a false certification from its Compliance Officer regarding its compliance with CIA obligations.
This exclusion marks the culmination of a series of alleged failures by CSHM and its corporate predecessors to comply with its CIA. Under the CIA, an independent quality monitor conducted more than 90 site visits and reviews to monitor CSHM’s compliance. Since the 2010 settlement, OIG repeatedly cited CSHM and took actions to address those violations, promote improved compliance, and maintain access to care for an underserved population. These actions included imposing financial penalties and forcing the divestiture of one of the company’s clinics.
Despite these actions, CSHM remained in material breach of its CIA and OIG issued Notices of Intent to Exclude to the company in December 2013 and January 2014. In such cases, providers get the chance to show OIG that they have cured, or are in the process of curing, the material breaches. CSHM represented to OIG that it would cure the material breaches. However, through meetings with CSHM and its Board of Directors and review of its written submissions, OIG determined that CSHM had failed to cure the material breaches and proceeded with the exclusion.
CSHM disputed OIG’s determination that it was in material breach of the CIA. However, under the Exclusion Agreement, CSHM now has waived its objections to these findings.
To minimize immediate disruption of care to the hundreds of thousands of children treated at CSHM clinics and to enable an orderly, controlled shutdown of the company or divestiture of its assets, the exclusion takes effect September 30, 2014. CSHM waived its right to appeal this exclusion in any judicial forum.
Until the exclusion goes into effect on September 30, 2014, an independent monitor will continue to monitor the quality of care being provided to patients at CSHM clinics. CSHM is required to inform patients at least 30 days before closing a clinic. CSHM is also required to keep State Medicaid agencies abreast of developments and provide monthly status reports to OIG. Any divestiture of assets by CSHM must be through bona fide, arms-length transactions to an entity that is not related to or affiliated with CSHM.
Beyond the implications for Small Smiles Dental Centers, the announced exclusion carries important implications for other health care providers. First, of course, the exclusion means that Small Smiles Dental Centers and CSHM as excluded providers are ineligible for hiring by other providers participating in Medicare or other Federal Health Programs. Second, the exclusion also highlights the advisability for other providers covered by CIAs not only to see to comply with their CIA and in the event the OIG questions of the adequacy of that compliance to look for opportunities to work with OIG to rectify alleged concerns as cooperatively as possible unless a high degree of certainty that the provider can prove that OIG’s concerns are unfounded.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help.
Board Certified in Labor & Employment Law, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters.
Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.
Other Resources
If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources available at www.solutionslawpress.com.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
March 16, 2014
Health Department HIPAA Violations Cost County $250,000, Requires Sweeping HIPAA Reforms
Hear Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting –
RSVP here by Noon on March 17, 2014
Skagit County, Washington will pay a $215,000 monetary settlement and work closely with the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) to correct deficiencies in its HIPAA compliance program to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules by the Skagit County Public Health Department (Health Department) under a Resolution Agreement announced by OCR on March 7, 2014. The Resolution Agreement makes clear the need for health care providers, health plans, health care clearinghouses and their business associates to update and maintain their policies and practices in compliance with the constantly evolving OCR guidance and resolution agreements, as well as to timely investigate and report breaches. Interested persons are invited to hear a briefing on a series of new developments including this latest Resolution Agreement at the March 18, 2014 North Texas Healthcare Professionals Association Meeting.
OCR investigated the Health Department after receiving a breach report that unknown parties accessed money receipts with electronic protected health information (ePHI) of seven individuals after the ePHI had been inadvertently moved to a publicly accessible server maintained by the County.
OCR reports its investigation revealed a broader exposure of protected health information involved in the incident, which included the ePHI of 1,581 individuals. Many of the accessible files involved sensitive information, including protected health information about the testing and treatment of infectious diseases.
OCR’s investigation further uncovered general and widespread non-compliance by Skagit County with the HIPAA Privacy, Security, and Breach Notification Rules.
Specifically, the Resolution Agreement between OCR and the Health Department states that OCR found the following conduct occurred (“Covered Conduct”).
- From approximately September 14, 2011 until September 28, 2011, Skagit County disclosed the ePHI of 1,581 individuals in violation of the Privacy Rule by providing access to ePHI on its public web server;
- From November 28, 2011 until present, Skagit County failed to provide notification as required by the Breach Notification Rule to all of the individuals for whom it knew or should have known that the privacy or security of the individual’s ePHI had been compromised as a result of the breach incident;
- From April 20, 2005 until present, Skagit County failed to implement sufficient policies and procedures to prevent, detect, contain, and correct security violations;
- From April 20, 2005 until June 1, 2012, Skagit County failed to implement and maintain in written or electronic form policies and procedures reasonably designed to ensure compliance with the Security Rule; and
- From April 20, 2005 until present, Skagit County failed to provide security awareness and training to all workforce members, including its Information Security staff members, as necessary and appropriate for the workforce members to carry out their functions within Skagit County.
To resolve OCR’s allegations of these breaches, Skagit County agrees under the Resolution Agreement to pay HHS $215,000.00 and to ensure that the Health Department implements a series of corrective actions. Among other things, the Resolution Agreement requires that the Health Department:
- Provide substitute Breach Notification to individuals not previously notified of the breach of their ePHI in accordance with the Resolution Agreement
- Revise to the satisfaction of OCR and adopt revised accounting for disclosure, hybrid entity designations, policies on safeguarding PHI, including its sample business associate agreements;
- Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by the covered health care components of Skagit County as identified in its hybrid entity documentation approved by HHS and implement security measures sufficient to reduce the risks and vulnerabilities identified in the risk analysis to a reasonable and appropriate level.
- Create and revise, as necessary, written policies and procedures for its covered health care components to comply with the Federal standards that govern the privacy, security, and breach notification of individually identifiable health information;
- Comply with strict workforce training requirements;
- Notify and OCR of the occurrence of some reported breaches, its investigation and corrective actions;
- Provide a summary of the reported events and the status of any corrective and preventative action relating to all such Reportable Events; and
- Provide OCR with an attestation signed by an officer of Skagit County attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.
In addition to bringing its policies and practices up to date with OCR regulations in effect at the time of the breach that resulted in the Resolution Agreement, the Health Department also will have to update its polic9ies and practices to meet changes to OCR’s HIPAA rules that have taken effect since the breach under the revised rules published by OCR in its Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Final Rule) OCR published January 25, 2013 as well as a series of recently issued OCR rules such as the following:
With OCR stepping up both audits and enforcement and penalties for violations higher than ever since the HITECH Act amended HIPAA, Covered Entities and business associates should act quickly to review and update their policies, practices and training to implement any adjustments needed to maintain compliance and manage other risks under these ever-evolving HIPAA standards.
Covered Entities & Business Associates Should Review & Tighten Practices in Response To Resolution Agreement & Other New Guidance
Other covered entities and their business associates should carefully evaluate and tighten their existing practices in response to the Resolution Agreement and other recent guidance. In the past, OCR officials have stated it expects that other health care providers, health plans, health care clearinghouses and their business associates will review resolution agreements like this one along with other emerging OCR guidance and update their practices as necessary to address concerns within their own organization that might be similar to those reflected in the applicable resolution agreement. The Resolution Agreement documents this expectation by specifically incorporating this requirement as part of its terms.
When conducting these efforts, Covered Entities and business associates not only carefully watch for and react promptly to new OCR guidance and enforcement actions, but also document their commitment and ongoing compliance and risk management activities to help support their ability to show their organization maintains the necessary “culture of compliance” commitment needed to mitigate risks in the event of a breach or other HIPAA violation and take well-documented, reasonable steps to encourage their business associates to do the same. When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent.
Hear Stamer’s Update On Resolution Agreement & Other New HIPAA Developments At 3/18 North Texas Healthcare Professionals Association Meeting
Scribe for the American Bar Association Annual Agency Meeting with OCR for the fourth year, attorney Cynthia Marcotte Stamer will overview these and other HIPAA developments when she presents “Tutoring On OCR’s Latest HIPAA Homework” at the North Texas Healthcare Professionals Association Study Group Luncheon on Tuesday, March 18, 2014 from 11:30 p.m. to 1:00 p.m. at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706. A complimentary luncheon will be served to guests to who register in advance. There is no charge to particulate but space is limited. RSVP here by Noon on March 17, 2014.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include a wide range of other workshops, programs and publications on fraud and other compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, GINA, Health Care, Health Care Provider, Health IT, HIPAA, HITECH Act, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: Business Associates, Compliance, controlled substance, Covered Entities, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, HIPAA, licensure, Medicaid, Medical Board, Medical Privacy, pain management, pharmacist, pharmacy, PHI, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
March 5, 2014
Think your health care organization or health plan has health care privacy covered? Think again.
A series of supplemental guidance issued by the Department of Health & Human Services Office of Civil Rights (OCR) in recent weeks is giving health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates even more to do in reviewing and updating their policies, practices and training for handing protected health information (PHI) beyond bringing their policies and practices into line with OCR’s restatement and update to the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Final Rule) OCR published January 25, 2013.
Covered Entities generally have been required to comply with most requirements the Omnibus Final Rule’s restated regulations restating OCR’s regulations implementing the Health Insurance Portability & Accountability Act (HIPAA) Privacy, Security and Breach Notification Rules to reflect HIPAA amendments enacted by the Health Information Technology for Economic and Clinical Health (HITECH) Act since the Omnibus Final Rule took effect on March 26, 2013 and to have updated business associate agreements in place since September 23, 2013. Meanwhile, the Omnibus Final Rule generally has required business associates have updated business associate agreements in place and otherwise to have come into compliance with all of the applicable requirements of the Omnibus Final Rule since September 23, 2013. Although these deadlines are long past, many Covered Entities and business associates have yet to complete the policy, process and training updates required to comply with the modifications implemented in the Omnibus Final Rule.
Even if a Covered Entity or business associate completed the updates required to comply with the Omnibus Final Rule, however, recent supplemental guidance published by OCR means that most organizations now have even more work to do on HIPAA compliance. This includes the following supplemental guidance concerning its interpretation and enforcement of HIPAA against Covered Entities and business associates published by OCR since January 1, 2014 alone:
Beyond this 2014 guidance, Covered Entities and their business associates also should look at enforcement actions and data as well as other guidance OCR issued during 2013 after publishing the Omnibus Final Rule such as:
With OCR stepping up both audits and enforcement and penalties for violations higher than ever since the HITECH Act amended HIPAA, Covered Entities and business associates should act quickly to review and update their policies, practices and training to implement any adjustments needed to maintain compliance and manage other risks under these ever-evolving HIPAA standards.
When conducting these efforts, Covered Entities and business associates not only carefully watch for and react promptly to new OCR guidance and enforcement actions, but also document their commitment and ongoing compliance and risk management activities to help support their ability to demonstrate their organization maintains the necessary “culture of compliance” commitment needed to mitigate risks in the event of a breach or other HIPAA violation and take well-documented, reasonable steps to encourage their business associates to do the same. When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include a wide range of other workshops, programs and publications on fraud and other compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
March 4, 2014
Health care providers got another reminder last week of their ever-growing exposure to federal health care fraud detection and enforcement efforts. The joint federal health care fraud enforcement efforts of the Departments of Justice (DOJ) and Health and Human Services (HHS) set new records for recoveries in Fiscal Year (FY) 2013, according to the newly released annual Health Care Fraud and Abuse (HCFAC) Program Report (the “Fraud Report”).
Record Breaking Fraud Recoveries In FY 2013 Highlight Health Care Fraud Enforcement Risk
According to the Fraud Report, the government’s health care fraud prevention and enforcement efforts recovered a record-breaking $4.3 billion in taxpayer dollars in Fiscal Year (FY) 2013, up from $4.2 billion in FY 2012, from individuals and companies who attempted to defraud federal health programs serving seniors or who sought payments from taxpayers to which they were not entitled. Over the last five years, the Fraud Report says administration’s enforcement efforts have recovered $19.2 billion, up from $9.4 billion over the prior five-year period. Since the inception of the program in1997, the HCFAC Program has returned more than $25.9 billion to the Medicare Trust Funds and treasury.
These reported recoveries show the commitment and growing success of federal health care fraud detection, investigation and enforcement efforts targeting providers and others in health care. This is the fifth consecutive year that the program has increased recoveries over the past year, climbing from $2 billion in FY 2008 to over $4 billion every year since FY 2011.
Recoveries Show Providers Big & Growing
The DOJ and HHS credit the success of these efforts largely to the joint Health Care Fraud Prevention and Enforcement Action Team (HEAT) program DOJ and HHS created in 2009 to target health care fraud and reforms passed as part of the Patient Protection and Affordable Care Act (ACA) that aid government investigation and enforcement efforts.
DOJ and HHS have used HEAT and expanded powers in ACA to strengthen and grow their join fraud detection and enforcement efforts. ACA reforms have strengthened these efforts by giving the agencies new tools.
Among other things, ACA empowered HHS to:
- Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
- Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
- Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
- Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
- Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.
These tools make it easier for HHS to detect and prevent potential questionable activities, as well as aid DOJ and HHS in investigating and prosecuting suspected fraud or other misconduct. The agencies tout their use of these tools along with their heightened enforcement and coordination for the growing success of their health care fraud detection and prosecution efforts.
“With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder. “Thanks to initiatives like HEAT, our work to combat fraud has never been more cooperative or more effective. And our unprecedented commitment to holding criminals accountable, and securing remarkable results for American taxpayers, is paying dividends.”
“These impressive recoveries for the American taxpayer are just one aspect of the comprehensive anti-fraud strategy we have implemented since the passage of the Affordable Care Act,” said HHS Secretary Sebelius. “We’ve cracked down on tens of thousands health care providers suspected of Medicare fraud. New enrollment screening techniques are proving effective in preventing high risk providers from getting into the system, and the new computer analytics system that detects and stops fraudulent billing before money ever goes out the door is accomplishing positive results – all of which are adding to savings for the Medicare Trust Fund.”
Federal officials also give credit to new new authorities given to them by the Affordable Care Act that help HHS and the Centers for Medicare & Medicaid Services (CMS) to detect and target heatlh care fraud.
In FY 2013, CMS announced the first use of its temporary moratoria authority granted by the Affordable Care Act. The action stopped enrollment of new home health or ambulance enrollments in three fraud hot spots around the country, allowing CMS and its law enforcement partners to remove bad actors from the program while blocking provider entry or re-entry into these already over-supplied markets.
The Justice Department and HHS have improved their coordination through HEAT and are currently operating Medicare Fraud Strike Force teams in nine areas across the country. The strike force teams use advanced data analysis techniques to identify high-billing levels in health care fraud hot spots so that interagency teams can target emerging or migrating schemes as well as chronic fraud by criminals masquerading as health care providers or suppliers. The Justice Department’s enforcement of the civil False Claims Act and the Federal Food, Drug and Cosmetic Act has produced similar record-breaking results. These combined efforts coordinated under HEAT have expanded local partnerships and helped educate Medicare beneficiaries about how to protect themselves against fraud.
In Fiscal Year 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (46). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In FY 2013, the Justice Department opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants, and a total of 718 defendants were convicted of health care fraud-related crimes during the year. The department also opened 1,083 new civil health care fraud investigations.
The strike force coordinated a takedown in May 2013 that resulted in charges by eight strike force cities against 89 individuals, including doctors, nurses and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $223 million in false billings. As a part of the May 2013 takedown, HHS also suspended or took other administrative action against 18 providers using authority under the health care law to suspend payments until an investigation is complete.
In FY 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (48). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In March 2011, CMS began an ambitious project to revalidate all 1.5 million Medicare enrolled providers and suppliers under the Affordable Care Act screening requirements. As of September 2013, more than 535,000 providers were subject to the new screening requirements and over 225,000 lost the ability to bill Medicare due to the Affordable Care Act requirements and other proactive initiatives. Since the Affordable Care Act, CMS has also revoked 14,663 providers and suppliers’ ability to bill the Medicare program. These providers were removed from the program because they had felony convictions, were not operational at the address CMS had on file, or were not in compliance with CMS rules.
HHS and the Justice Department are leading historic efforts with the private sector to bring innovation to the fight against health care fraud. In addition to real-time data and information exchanges with the private sector, CMS’ Program Integrity Command Center worked with the HHS Office of the Inspector General and the FBI to conduct 93 missions to detect, investigate, and reduce improper payments in FY 2013.
From May 2013 through August 2013, CMS led an outreach and education campaign targeted to specific communities where Medicare fraud is more prevalent. This multimedia campaign included national television, radio, and print outreach and resulted in an increased awareness of how to detect and report Medicare fraud.
These and other activities make it more important than ever that hospitals, physicians and other health care providers participating in Medicare, Medicaid or other federal health care programs tighten their compliance and risk management practices and processes to manage their exposures.
Providers Urged To Act To Manage Risks
In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include a wide range of other workshops, programs and publications on fraud and other compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
January 17, 2014
February 28, 2014 is the deadline for any eligible professional participating or wishes to participate in the 2013 PQRS-Medicare EHR Incentive Pilot to submit its quality data. Eligible providers wishing to participate in the pilot must submit 12 months of CQM data by February 28, 2014 at 11:59 pm ET. The system is currently open to accept this data so eligible professionals wishing to participate should complete the collection and submission of this data as soon as possible.
Steps to Successfully Participate
To successfully participate in the pilot, you must do the following by February 28, 2014:
- Register for an IACS account (for EHR submission only)
- Indicate intent to report CQMs using pilot in EHR Registration & Attestation System
- Generate required reporting files
- Test data submission
- Submit quality data
Eligible professionals that cannot submit their CQM data for 12 months electronically through PQRS must return to the EHR Attestation System and deselect the electronic reporting option. Please note: if a provider does not submit its 2013 quality data or deselect the electronic reporting option in the EHR Attestation System, CMS says the provider will not receive an EHR incentive payment.
For More Information
For further guidance on the 2013 PQRS-Medicare EHR Incentive Pilot, eligible providers should read the Participation Guide and Quick-Reference Guide.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: aging in place, community-based care, controlled substance, DEA, Disability, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, long-term care, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
January 12, 2014
New Rule Expands Medicaid Coverage For Community Living For Disabled Aging Adults
Caregivers and service providers caring the Medicaid-eligible aging or disabled individuals will want to check out the new final rule on Home and Community-Based Services published by the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) on Friday, January 10. See Final Rule: Home and Community-Based Services (“Final Rule”).
HHS views the Final Rule as supporting its Community Living Initiative, which seeks to expand and improve community services in order to allow aging and disabled people to live, work, and participate in the greater community. The Initiative reflects the growing community support for helping aging and disabled individuals to avoid institutionalization and instead “age in place” by offering broader care options, developing community services that extend options for disabled and aging persons to live independently, and other actions that support the ability of individuals to live safely within community rather than institutional settings. In announcing the Final Rule, HHS Secretary Kathleen Sebelius. “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.”
The Final Rule expands the conditions under which Medicaid provides coverage for home and community-based services as an alternative to institutional care for older.. adults covered by Medicaid. Among other things, the Final Rule defines home and community-based settings and implements new flexibility authorized by the Patient Protection and Affordable Care Act (ACA) that gives states additional options as part of their State Plan Option to expand home and community-based services and to target services to specific populations under the provisions of Section 1915(i) on home and community-based services. It also amends the 1915(c) home and community-based services waiver program to add new person-centered planning requirements, allow states to combine multiple target populations in one waiver, and streamlines waiver administration. The final rule also includes a transitional period for states to adjust their programs to meet the new home and community-based services settings requirements. CMS says technical assistance will also be available for states.
Service providers and community agencies caring for Medicaid-eligible populations will want to check out these new rules for insights on helping the aging and disabled covered by Medicaid and their families to adapt care plans in response to the new options that the Final Rule may afford.
For more information about Home and Community-Based Services available under Medicaid, see here. For information about the HHS Community Living Initiative, see here. For additional resources, persons interested in these and other aging in place trends and resources may want to contact the author of this update, Cynthia Marcotte Stamer, who regularly speaks and writes on these concerns.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: aging in place, community-based care, controlled substance, DEA, Disability, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, long-term care, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer
January 2, 2014
The Justice Department’s recovery of more than $9 million in two physician kickback settlements during the last week of December, 2013 sends another strong warning to health care providers and physicians of the risks of structuring physician compensation or other arrangements that run afoul of the federal Anti-kickback Statute, STARK Law or False Claims Act Health care providers and physicians or others who may be receiving or seeking compensation or other benefits prohibited by these and other federal or state health care fraud laws should seek advice and assistance from experienced qualified legal counsel to structure or review any proposed or existing transactions that could create these risks.
The two settlements both stem from alleged payments of kickbacks to physicians to induce referrals in contravention of federal health care fraud laws.
On December 31, 2013, DOJ announced that Butte, Montana based St. James Healthcare (St. James) and its Denver-based parent company, Sisters of Charity of Leavenworth Health System (Sisters of Charity), have agreed to pay $3.85 million to resolve allegations that they violated the Anti-Kickback Statute, the Stark Law and the False Claims Act by improperly providing financial benefits to physicians and physician groups that made referrals to the hospital. Colorado Health Care Organization and One of Its Montana Hospitals to Pay $3.85 Million for Allegedly Providing Financial Benefits to Referring Physicians and Physician Groups.
The St. James settlement announcement follows DOJ’s December 27, 2013 announcement that pharmaceutical giant Abbot Laboratories has agreed to pay the United States $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products. U.S. Department of Justice. Abbott Laboratories Pays U.S. $5.475 Million to Settle Claims That Company Paid Kickbacks to Physicians.
St. James/Sisters of Charity Settlement
The settlement with St. James and Sisters of Charity resolves DOJ charges that they provided various improper financial incentives to physicians and physician groups involved in a joint venture with St. James to own and run a medical office building on the St. James campus. These incentives included a payment to the joint venture that increased the share values for the physicians and physician groups in the joint venture and resulted in below fair market value lease rates for the physicians renting space in the medical office building. Additional incentives provided by St. James and Sisters of Charity included below fair market value lease rates for the land upon which the medical office building was constructed and other below fair market value arrangements related to shared facilities, use and maintenance. These issues were disclosed by St. James and Sisters of Charity to the government. To resolve their liability, St. James and the Sisters of Charity will pay $3.85 millions to the U.S. Government.
In announcing the settlement, U.S. Attorney for the District of Montana Michael W. Cotter cautioned other heath care providers to review their own transactions and to take the rules seriously, stating. “We are encouraged that hospitals like St. James Healthcare are taking these issues seriously by reviewing their operations and making disclosures to the government where necessary.”
Abbott Laboratories Settlement
The Abbott Laboratories settlement requires it to pay the U.S. $5.475 million to resolve allegations that Abbott Laboratories knowingly paid prominent physicians for teaching assignments, speaking engagements and conferences with the expectation that these physicians would arrange for the hospitals with which they were affiliated to purchase Abbott’s carotid, biliary and peripheral vascular products in violation of the Anti-Kickback Act and caused the submission of false claims to Medicare for the procedures using these Abbott products .
The settlement resolves allegations originally brought in a lawsuit filed by Steven Peters and Douglas Gray, former Abbott employees, under the qui tam provision of the False Claims Act. See United States ex rel. Peters et al. v. Abbott Laboratories, Inc., Civil Action No. 3:09-CV-430 (E.D. Tenn.). The False Claims Act allows whistleblowers to file suit on behalf of the United States for false claims and share in any recovery Whistleblower claims are a major tool in the enforcement efforts and success of the DOJ in its campaign to find and prosecute health care fraud. As part of the Abbott Laboratory’s settlement, the two whistleblowers will receive a total payment of more than $1 million.
Settlements Reflect Heightened Enforcement Risks For Health Care Providers Participating In Kickback Arrangements
Health care providers offering or providing illegal or otherwise aggressive inducements to physicians or others for referrals of health care services covered by Medicare, Medicaid or other federal health care programs should heed the settlements as a warning. The two settlements illustrate the growing emphasis on the investigation and enforcement of Anti-Kickback, STARK and False Claims Act laws against health care providers by the DOJ and Department of Health & Human Services (HHS). The Anti-Kickback Statute prohibits the provision of remuneration with the intent to induce referrals of government health care program business unless the transaction falls within one of the safe harbors or otherwise qualifies as exempt from the prohibition. The Stark Law restricts financial relationships that hospitals or other designated health care providers may enter into with physicians who refer patients to them unless the arrangement meets the criteria to qualify as exempt from the prohibition. When either of these two prohibitions is violated, billing for services for care rendered creates additional fraud law exposures. Federal law prohibits payment by federal health care programs of medical claims that result from arrangements that violate the Anti-Kickback Statute or the Stark Law. The settlements announced this week both stemmed from civil prosecutions by the Justice Department. However, violations of these health care fraud laws also may result in criminal prosecutions.
DOJ, HHS and other federal and state agencies acting through the Medicare Fraud Strike Force activities conducted as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), federal RAC audits and other actions hunting for, and increasingly finding an prosecuting health care providers and others who participate in transactions that violate these and other federal health care fraud laws as part of efforts to control health care costs and expenditures. HEAT is a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The joint Department of Justice-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since its announcement, the Strike Force has used the combined resources of agents from the FBI, HHS-Office of Inspector General (HHS-OIG), multiple Medicaid Fraud Control Units, and other state and local law enforcement agencies to investigate and prosecute a rising number of organizations and individuals throughout the industry for alleged violations of Federal health care fraud prohibitions.
The effectiveness of these Federal efforts to deter, find and prosecute false claims and other perceived abuses of Federal health care law has been significantly strengthened since Congress passed the Patient Protection & Affordable Care Act (Affordable Care Act). Among other things, ACA empowered HHS to:
- Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
- Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
- Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
- Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
- Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.
In its Abbott Laboratories settlement announcement, DOJ touted the HEAT efforts with resulting in the recovery of a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.
Act To Manage Risks
In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2014 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
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Posted by Cynthia Marcotte Stamer
December 27, 2013
A new settlement agreement announced by the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) shows health plans, health care providers, health care clearinghouses and their business associates the perils of failing to properly implement the necessary policies and procedures to comply with the breach notification requirements added to the Health Insurance Portability & Accountability Act of 1996 (HIPAA) added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed as part of American Recovery and Reinvestment Act of 2009 (ARRA).
APDerm Settlement Overview
Private dermatology practice, Adult & Pediatric Dermatology, P.C., (APDerm) has agreed to pay $150,000 and implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules. The APDerm Settlement marks the first settlement with a covered entity for not having policies and procedures in place to address the breach notification provisions of the HITECH Act.
According to its December 26, 2013 announcement of the settlement, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) opened an investigation of APDerm upon receiving a report that an unencrypted thumb drive containing the electronic protected health information (ePHI) of approximately 2,200 individuals was stolen from a vehicle of one its staff members. The thumb drive was never recovered. The investigation revealed that APDerm had not conducted an accurate and thorough analysis of the potential risks and vulnerabilities to the confidentiality of ePHI as part of its security management process. Further, APDerm did not fully comply with requirements of the Breach Notification Rule to have in place written policies and procedures and train workforce members.
Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities
The APDerm settlement provides more evidence of the growing exposures that health care providers, health plans, health care clearinghouses and their business associates need to carefully and appropriately manage their HIPAA responsibilities. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website. It joins the growing list of settlement or resolution agreements under HIPAA announced by OCR.
The APDerm also is notable both as it settles the first ever charges against a covered entity for failing to adopt required Breach Notification policies and procedures and the relatively most settlement payment required in comparison to other announced settlement. Other settlements have been significantly higher. For instance, OCR required that Blue Cross Blue Shield of Tennessee (BCBST) to pay $1.5 million to resolve HIPAA violations charges.
In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s audit, investigation and enforcement actions, emerging litigation and other enforcement data, their own and reports of other security and privacy breaches and near misses, evolving rules and technology, and other developments to determine if additional steps are necessary or advisable. For tips, see
here.
For Representation, Training & Other Resources
If you need assistance monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.
For More Information Or Assistance
If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help.
Board Certified in Labor & Employment Law, Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters.
Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.
Other Resources
If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:
- DFW Hospital Council Foundation Among 26 Organizations Selected To Lead Quality Effort
- Former Houston Texas Physician Gets 70 Month Prison Sentence For Fraud Conviction
- Euless Healthcare Corporation Owner, Associates Face Conspiracy And Health Care Fraud Charges For Alleged Submission Of $700,000+ In Fraudulent Health Care Claims
- Former Manager 9th Employee Sentenced For Involvement In Maxim Medicare False Claims Action
- Medical Identity Theft/Fraud Convictions Highlight Need For Health Care Providers To Safeguard Health Information, Guard Against Fraud Schemes
- Detroit-Area Foot Doctor Pleads Guilty to Medicare Fraud Scheme
- Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges
- Texas Medical Board Suspends Child Psychiatrist For Sexual Misconduct
- 100,000+ Primary Care Providers Signed Up To Get EHRs Regional Extension Centers
- IRS Urges Preparers to Renew PTINs for 2012
- OFCCP Proposed Increased Disability Hiring Targets, Other Tougher Government Contractor Rules another Sign Of Rising Employment Discrimination Risks
- New Guidance On Fiduciary Duties In Handling ACA Group Health Plan Premium Rebates Highlight Advisability Of Tightening Funding Terms & Fund Handling Practices To Manage Fiduciary Risks
- Mental Health Parity Guidance On Mental Health & Substance Abuse Copays, Utilization Management Limits Released
- Mental Health Parity Guidance On Mental Health & Substance Abuse Copays, Utilization Management Limits Released
- Group Health Plans & Insurer To Get More Time To Meet Affordable Care Act Summary of Benefits and Coverage Requirements
- CMS Final Medicare Rule Imposes Many Conditions On Access To Medicare Claims Data To Evaluate Providers & Suppliers
- OSHA Updates Safety Resources To Prevent Construction, Other “Top 10″ Exposures
- OSHA Silo Safety Citations Heads Up To Grain Operators To Manage Safety
- OSHA Updates Safety Resources To Prevent Construction, Other “Top 10″ Exposures
- EBSA Releases Collection of New M-1 and Other Guidance Impacting Multiple Employer Welfare Plans
- New Obama Administration Affirmative Action Guidance Highlights Organization’s Need To Tighten Nondiscrimination Practices
- Incentives To Get Employee Into Wellness Education Requires Legal Risk Management
- HR Key Player In Managing Rising Risk of Disability, Other Discrimination Suits Under Obama Administration Justice Department
- HHS Chides Insurer For “Excessive” Premium Increases After Affordable Care Act Rate Audit
- IRS U-Tube Video Discusses 2012 Flexible Benefit Plan Rule Change
- Big Penalty for Lender Shows Risks of Violating Military Service or Vets Rights
- OCR 1st HIPAA Privacy, Security & Breach Notification Compliance Audits Begin
- Employers Face New Labor-Management Exposures Under Activist National Labor Relations Board
- Unions Gaining New Power From National Labor Relations Board’s New Activism
- IRS Exempts Enrolled Retirement Plan Agents From PTIN Requirement
About Solutions Law Press
Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources available at www.solutionslawpress.com.
THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.
©2011 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.
[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register
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Posted by Cynthia Marcotte Stamer
slphealthcareupdate.com 