OIG |

New CMS LTC Staffing Requirements Likely To Increase Workforce Competition, Costs Industry-Wide

May 12, 2024

Nursing homes and other health care facilities competing for staffing with these facilities should begin preparing to cope with expected wage costs and other pressures expected to result from new staffing and other changes to staffing requirements for Meficare and Medicaid participating long-term care favorites released by the Department of Health and Human Services Centers for Medicare & Medicaid Services (“”CMS”) on April 22, 2024.

The Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting final rule (“Final Rule”) will require long-term care facilities participating in federal programs such as Medicare and Medicaid are to have a licensed registered nurse (“RN”) on site at all times and to meet minimum nurse staffing (“TNS”) requirements imposed under the Final Rule. The Final Rule also will face enhanced facility assessment requirements under the Final Rule.

The mandates of the Final Rule and resulting increases in compensation and competition will impact both participating LTCs and other health care providers competing for staffing.

Total Nurse Staffing

CMS says its new minimum nurse staffing standards “will set a national and broadly applicable baseline that will significantly reduce the risk of unsafe and low-quality care for residents across all LTC facilities.”

Subject to certain limited temporary exceptions, the TNS requirements for long-term care (“LTC”) facilities aim to significantly reduce the risk of residents receiving unsafe and low-quality care within LTC facilities by specifying required minimum nurse staffing.

The Final Rule generally will require LTC facilities to meet a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. LTCs may use any combination of registered nurse (“RN”), licensed practical nurse (“LPN”), licensed vocational nurse (“LBN”), or nurse aide) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard.

In addition, the Final Rule will require LTCs to have at least one RN on site 24 hours a day, 7 days a week to provide skilled nursing care.

Some “limited temporary exceptions” may apply to all the requirements for qualifying LTCs in areas with workforce shortages that meet other criteria. While an estimated 25% of nursing homes would be eligible for exceptions, these are “limited, temporary exceptions,” LTC must be in a workforce shortage area and report the amount of their income spent on wage and other information to prove their “good faith” efforts to hire by paying competitive wages.”

While these are minimum staffing standards, CMS expects LTC facilities to use the updated and newly strengthened facility assessment to determine whether their staffing needs to be set above these minimums, based on resident acuity and individual care needs. CMS is committed to continued examination of staffing thresholds, including work to review quality and safety data resulting from initial implementation of these finalized policies, as well as robust public engagement.

Additionally, to increase transparency related to compensation for workers, CMS will also require states to collect and report on the percent of Medicaid payments that are spent on compensation for direct care workers, and support staff, delivering care in nursing facilities and intermediate care facilities, for individuals with intellectual disabilities.

CMS Tightening LTC Assessments

LTC facilities are already required to conduct, document, and review, annually and as necessary, a facility-wide assessment to determine what resources are necessary to care for residents competently during both day-to-day operations and emergencies. ensure that facilities are utilizing the assessment as intended by making thoughtful, person-centered staffing plans, and decisions focused on meeting resident needs, including staffing at levels above the finalized minimums as indicated by resident acuity, the Final Rule raises the assessment requirements as follows:

Facilities must use evidence-based methods when care planning for their residents, including consideration for those residents with behavioral health needs.
Facilities must use the facility assessment to assess the specific needs of each resident in the facility and to adjust as necessary based on any significant changes in the resident population.
Facilities must include the input of the nursing home leadership, including but not limited to, a member of the governing body and the medical director; management, including but not limited to, an administrator and the director of nursing; and direct care staff, including but not limited to, RNs, LPNs/LVNs, and NAs, and representatives of direct care staff as applicable. The LTC facility must also solicit and consider input received from residents, resident representatives, and family members.
Facilities are required to develop a staffing plan to maximize recruitment and retention of staff consistent with what was described in the President’s April Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers.

Temporary Limited Exceptions

LTC facilities may qualify for a temporary hardship exemption from the minimum nurse staffing HPRD standards and the 24/7 RN requirement only if they meet the following criterion for geographic staffing unavailability, financial commitment to staffing, and good faith efforts to hire:

The facility is located in an area where the supply of RN, NA, or total nurse staff is not sufficient to meet area needs as evidenced by the applicable provider-to-population ratio for nursing workforce (RN, NA, or combined licensed nurse and nurse aide), which is a minimum of 20% below the national average, as calculated by CMS using data from the U.S. Bureau of Labor Statistics and the U.S. Census Bureau.
- The facility may receive an exemption from the total nurse staffing requirement of 3.48 HPRD if the combined licensed nurse and nurse aide to population ratio in its area is a minimum of 20% below the national average.
- The facility may receive an exemption from the 0.55 RN HPRD requirement, and an exemption of eight hours a day from the RN on-site 24 hours per day for seven days a week requirement, if the RN to population ratio in its area is a minimum of 20% below the national average.
- The facility may receive an exemption from the 2.45 NA HPRD requirement if the NA to population ratio in its area is a minimum of 20% below the national average.

Eligible LTC facilities that meet the criteria will receive a temporary hardship exemption by completing the following:

The facility provides documentation of good faith efforts to hire and retain staff, such as through job postings, the number and duration of vacancies, job offers made, and competitive wage offerings.
The facility provides documentation of the facility’s financial commitment to staffing, including the amount the facility expends on nurse staffing relative to revenue.

Before being considered, the LTC facility must be surveyed for compliance with the LTC participation requirements. CMS will coordinate with state survey agencies to determine if the facility meets the criteria for a hardship exemption noted above.

Facilities granted an exemption will be required to: 1) post a notice of its exemption status in a prominent and publicly viewable location in each resident facility; 2) provide notice of its exemption status, and the degree to which it is not in compliance with the HPRD requirements, to each current and prospective resident; and 3) send a copy of the notice to a representative of the Office of the State Long-Term Care Ombudsman.

CMS will indicate if a facility has obtained an exemption on the Medicare.gov Care Comparewebsite.

Facilities are not eligible for an exemption if any one of the following is true:

They have failed to submit their data to the Payroll Based Journal System.
They have been identified as a special focus facility (SFF).
They have been identified within the preceding 12 months as having: widespread, or a pattern of, insufficient staffing that resulted in actual harm to a resident; or an incident of insufficient staffing that caused or is likely to cause serious harm or death to a resident.

Facilities that meet the hardship exemption criteria are eligible from the time at which the exemption is granted until the next standard recertification survey, unless the facility meets any of the above-mentioned criteria for not being eligible for the exemption during that time. The hardship exemption may be extended on each standard recertification survey, after the initial period, if the facility continues to meet the exemption criteria.

Implementation Deadlines

The Final Rule has staggered implementation timeframe for its minimum nurse staffing standards and 24/7 RN requirement based on geographic location as well as possible exemptions for qualifying facilities for some parts of these requirements based on workforce unavailability and other factors.

CMS is implementing the minimum nurse staffing requirements to occur in three phases over a three-year period for all non-rural facilities. The following deadlines apply for non-rural facilities:

Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within two years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within three years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.

The Final Rule sets later deadlines for rural facilities in acknowledgment of the unique challenges that rural LTC facilities may face in staffing as follows:

Phase 1 — Within 90 days of the final rule publication, facilities must meet the facility assessment requirements.
Phase 2 — Within three years of the final rule publication, facilities must meet the 3.48 HPRD total nurse staffing requirement and the 24/7 RN requirement.
Phase 3 — Within five years of the final rule publication, facilities must meet the 0.55 RN and 2.45 NA HPRD requirements.

Qualification as a rural facility is determined by the Office of Management and Budget.

CMS Nursing Home Staffing Campaign

CMS continues efforts to encourage the availability to increase the number of nurses in nursing homes. As part of these efforts, CMS plans to promote awareness of the many career pathways in the nursing field that are available to help recruit all types of individuals, from NAs to LPNs/LVNs and RNs. It also plans to offer financial incentives like tuition assistance for nurses to work in the nursing home environment in qualifying facilities or state oversight roles and to make it easier for individuals to become nurse aides by streamlining the process for enrolling in training programs and finding placement in a nursing home.

Additionally, CMS plans to partner with states to bolster nurse recruitment.

CMS says more announcements are expected later this year and it anticipates beginning distribution of financial incentives in 2025.

Begin Preparing Now

All nursing homes and other health care facilities competing for staffing should begin preparing for these changes immediately. Obviously, LTC is participating in Medicare, Medicaid or other covered programs will face the most immediate and direct impact from these rules. Facility should begin documented efforts to meet the staffing requirements and where applicable, evidence and other materials needed to prepare for required surveys and to establish, other criteria necessary to qualify for exemption if needed.

It is not just the facilities directly covered by the rules that the new staffing requirements will impact.

While the new requirements technically apply only to LTCs participating in Medicare, Medicaid or other CMS regulated programs, their applicability likely will impact non-participating programs as well. the new minimum requirements will affect standards of care for negligence and other purposes.

Likewise, increases in compensation and other terms and conditions of employment at covered facilities will affect other types of providers. Non-participating nursing homes, home health, hospice, rehabilitation, hospitals, rehabilitation, facilities, assisted living facilities and other providers should expect greater scrutiny of their staffing and greater pressure to pay better wages and improve other work conditions and benefits in response to greater competition for workers.

Facilities that have used noncompetition agreements or other restraints on post employment eligibility to work are cautioned that these types of restraints could run afoul of the federal trade commissions new Non-Competition Clause Final Rule slated to take affect in September, 2024 if the current judicial stay against it is lifted by that time.

Likewise, long-term care another healthcare employers planning to increase wages, or other terms of employment are cautioned to use care to comply with any applicable duties to bargain or other requirements if subject to union organization or contracts.

Given the complicated maze of employment, benefits, and healthcare regulations that facilities working to deal with these new requirements must negotiate, healthcare providers working with these and other recruitment rules are encouraged to consult with qualified legal counsel with experience in both the healthcare and employment issues involved.

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 workforce, risk management, compliance, regulatory and government affairs and other work with health care, employee benefit, managed care and other insurance, education, workforce and other performance and data dependent organizations, 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 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 government and private health care and managed care, life sciences, health and other employee benefit plan, insurance and financial services, education 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, her experience includes extensive involvement throughout her career advising and representing health care and life sciences and other clients about preventing, investigating and defending HHS CMS, OIG, CIICO, OCR; , DOL WHD, EEOC, EBSA, OSHA; DOJ, OFCCP; NLRB; DOE; ICE; state attorney general licensing, Department of Health, Aging, Disability, Insurance, and other federal and state, JCHO and other accreditation and quality, peer review, employment and other workforce, contract and other investigations, audits, and other enforcement actions as well as advocacy before Congress and regulators regarding federal and state 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.

Leave a Comment » | Academic medicine, Accreditation, Ambulatory care, compensation, Conditions of Participation, Doctor, Emergency Care, Employee Benefits, Employer, Employment law, ERISA, FLSA, FTC, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, Health Plan, Health Plans, healthcare, HHS, Home Health, Hospice, Hospital, hospitals, Immigration, Indian Health, Labor Law, Medicaid, Medicaid Advantage, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, nursing home, OIG, Patients, Peer Review, Reimbursement, Rural Health Care, Skilled Nursing Facility | Tagged: Health Care, Health Care Provider, nursing home, Skilled Nursing | Permalink
Posted by Cynthia Marcotte Stamer

Accommodating Patient Preferences No Defense To Prohibited Employment Discrimination

July 31, 2023

A new federal Equal Employment Opportunity Commission (“EEOC”) lawsuit reminds health industry and other employers that patient or other customer preferences do not justify or excuse an employer’s discrimination against employees in violation of the Civil Rights Act or other federal employment discrimination laws.

Brooklyn-based home health company ACARE HHC Inc., doing business as Four Seasons Licensed Home Health Care Agency (“Four Seasons”) faces a race discrimination suit for allegedly removing home health aides from their work assignments due to their race and national origin to accommodate client preferences.

According to a lawsuit (EEOC v. ACARE HHC d/b/a Four Seasons Licensed Home Health Care, 23-cv-5760), filed by the EEOC in the U.S. District Court for Eastern District of New York on July 31, 2023, Four Seasons violated the Title VII of the Civil Rights Act of 1964 (“Civil Rights Act”) by routinely acceding to racial preferences of patients in making home health aide assignments. The EEOC claims Four Seasons routinely removed Black and Hispanic home health aides based on clients’ race and national origin-based requests. Four Seasons would transfer aides to a new assignment or, if no other assignment was available, the aides lost their employment completely. The EEOC charges this alleged conduct violates the Civil Rights Act, which among other things prohibits employers from discriminating against employees on the basis of race and national origin. The EEOC seeks compensatory damages and punitive damages for the affected employees, and injunctive relief to remedy and prevent future discrimination based on employees’ race and national origin.

The lawsuit, warns employers against resigning or assigning workers to accommodate racial or other prohibited discriminatory preferences of customers, or business partners. “Making work assignment decisions based on an employee’s race or national origin is against the law, including when these decisions are grounded in preferences of the employer’s clients,” said Jeffrey Burstein, regional attorney for the EEOC’s New York District Office.

The lawsuit is one of a plethora of enforcement Civil Rights and other federal discrimination law actions by EEOC, the Department of Health and Human Services Office of Civil Rights, and other federal agencies under the Biden Administration’s prioritization of expansion and enforcement of discrimination and other discrimination and equal opportunity laws.

In light of these efforts, employers should take immediate steps to update policies, postings, training, and practices to ensure their ability to defend their compliance with race and other federal nondiscrimination laws.

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.

About the Author

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Abortion, Academic medicine, air ambulance, Child Care, Childcare, Childrens Health Insurance Program, Civil Rights, Conditions of Participation, Corporate Compliance, Direct Primary Care, Discrimination, DME, Doctor, drug treatment, early childhood education, Emergency Care, Employer, exchange plans, Federal Health Center, Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Insurance, Health Plan, HHS, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Life Sciences, long-term care, Medicare Prescription Drug Program, Mental Health, Nonprofits, nursing home, OCR, OIG, Physician, Prescription Drugs, Provider contracting, Rehabilitation Act, Reproductive Rights, Section 1557, Sexual Abuse, Sexual Assault, Sexual Harassment | Permalink
Posted by Cynthia Marcotte Stamer

HHS Recommits To LGBTQ Nondiscrimination Protections In Newly Proposed Rules; Religious Exemption Likely Limited By Pending HHS Changes In Religious Freedom Protections

July 11, 2023

Health care providers, health insurance issuers, health care professional associations, state and local government entities and other organizations and providers participating or receiving funds from the Department of Health and Human Services (“HHS”) funded programs should evaluate their likely responsibilities and exposures for preventing discrimination on the basis of sexual orientation and gender under the Notice of Proposed Rule Making (“NPRM”) to the Health and Human Services Grants Regulation (the “Proposed HHS Grants Rule”) the HHS Office for Civil Rights (“OCR”) and the Assistant Secretary for Financial Resources (“ASFR”) released to the public today (July 11, 2023) and scheduled for joint publication the Federal Register on July 13, 2023.

Proposed HHS Grants Rule Overview

The NPRM builds on HHS’ efforts to ensure access to health and human services for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex (“LGBTQI”) individuals in furtherance of President Biden’s Executive Orders on Preventing and Combating Discrimination on the Basis of Gender Identity and Sexual Orientation and Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals by reaffirming the prohibition against discrimination on the basis of sexual orientation and gender identity in federal statutes administered by HHS while defining procedures through which HHS would permit organization with religious objections to seek an exemption from or modification of the otherwise applicable requirements.

The Proposed HHS Grants Rule clarifies and reaffirms HHS’ prohibition against LGBTQI discrimination by stating, “In statutes that HHS administers which prohibit discrimination on the basis of sex, the Department interprets those provisions to include a prohibition against discrimination on the basis of sexual orientation and gender identity, consistent with the Supreme Court’s decision in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and other federal court precedent applying Bostock’s reasoning that sex discrimination includes discrimination based on sexual orientation and gender identity.”

The Proposed HHS Grants Rule represents the latest effort of HHS to finalize and implement prohibition against LGBTQI individuals in HHS first undertaken in 2016. Since HHS originally adding the prohibition against LGBTQI discrimination to its HHS Grants Rule, HHS faced various court challenges to its LGBTQI nondiscrimination provisions. These challenges included lawsuits challenging HHS’ interpretation of the sex discrimination prohibitions of Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e-2(a)(1) (“Title VII”) as prohibiting discrimination based on sexual orientation and identity, First Amendment religious freedom challenges and challenges based on alleged violations of the Administrative Procedures Act.

In the intervening years, HHS originally granted various waivers, then subsequently adopted a blanket non-enforcement policy to address First Amendment religious freedom concerns about the LGBTQI discrimination prohibition and attempted to resolve Administrative Procedures Act challenges in subsequently published versions of the rules. Meanwhile, the U.S. Supreme Court resolved objections to HHS’ expansive interpretation of Title VII as extending to LGBTQI when it affirmed Title VII’s prohibition against discrimination on the basis of sex includes discrimination based on sexual orientation and gender identity in Bostock v. Clayton County, 140 S. Ct. 1731 (2020).

As currently proposed, the HHS Grants Rule has a sweeping reach. In the Proposed HHS Grant Rule, HHS reaffirms that discrimination against LGBTQI individuals is prohibited in virtually all HHS-funded and administered programs while revising the existing HHS Grants Rule to address when and how a provider with faith-based objections to the rules can seek exemption or other religious accommodations from HHS.

As currently proposed the Proposed HHS Grants Rule would treat LGBTQI discrimination as prohibited discrimination on the basis of sex in most HHS regulated or funded programs. The LGBTQI discrimination prohibition would apply to authorizations for domestic resettlement of and assistance to refugees; assistance in transition from homelessness; Children with Serious Emotional Disturbances; Title VII Health Workforce Programs; Nursing Workforce Development; Preventive Health Services Block Grant; Substance Abuse Treatment and Prevention Block Grant; Community Mental Health Services Block Grant; Maternal and Child Health Block Grant; Disaster relief; Low-Income Home Energy Assistance Program; Head Start; Community Services Block Grant Program; and Family Violence Prevention and Services programs.

HHS’ announcement of its plans to reaffirm its LGBTQI equal protection requirements in the HHS Grants Rule likely will prompt new attention and scrutiny from organizations and individuals with faith-based objections to its mandates, particularly given HHS’ release of the rule comes less than two weeks after the Supreme Court’s June 30, 2023 landmark ruling in 303 Creative LLC . v. Elenis, 600 U. S. ____ (2023), upholding the right of a website designer, who believes same-sex marriage contravenes her faith, to exemption from enforcement of a state law that prohibited a public business from communicating to patrons that service would be refused based on sexual orientation.

The Proposed HHS Grants Rule includes provisions requiring HHS to accommodate the religious rights of organizations or individuals with faith-based objections protected by the Religious Freedom Restoration Act (“RFRA”) or the First Amendment when administering and enforcing its provisions without specifically detailing the procedures for raising such objections or the standards HHS will apply to decide whether to approve a request for religious exemption or accommodation.

In this respect, the Proposed HHS Grants Rule provides that a recipient at any time may notify the HHS awarding agency, ASFR, or the Office for Civil Rights (OCR) of the recipient’s view that it is exempt from, or requires modified application of, certain provisions of the Rule due to the RFRA, the First Amendment or another religious freedom law. The Proposed HHS Grants Rule also directs that once the awarding agency receives notice of religious objection from a particular recipient, “any relevant ongoing compliance activity regarding the recipient shall be held in abeyance” until the applicable agencies in legal consultation with the HHS Office of the General Counsel determine whether the recipient is exempt from the application of certain provisions or entitled to modified application of the rules based on a federal religious freedom law.

While the Proposed HHS Grants Rule does not detail the procedures for requesting religious accommodation or the standards HHS will use to decide whether to approve requests, HHS does address those standards and procedures in other guidance, the current provision of which are highlighted on the HHS Conscience and Religious Freedom Webpage. It bears noting, however, that along with the Proposed HHS Grants Rule, HHS also currently is considering a separate proposal to narrow the availability of religious and conscience objections to its rules it announced in a January 5, 2023 Notice of Proposed Rule Making titled “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (“Proposed Religion Rule”). While the official comment period for the Proposed Religion Rule closed on March 6, 2023, its provisions, if adopted as proposed, could materially affect the interpretation and enforcement of the HHS Grants Rule. Accordingly, organizations and other parties concerned about the likely interpretation and enforcement of the HHS Grants Rule with respect to parties claiming religious freedom objections should consider the likely implications of the Proposed Religion Rule in their evaluation of the HHS Grants Rule.

In response to the HHS Grants Rule, all health care providers, health plans and others expected to be impacted by the Proposed HHS Grants Rule should both begin preparing to adjust their existing policies and practices in anticipation of the finalization of the Proposed HHS Grants Rule as well as submit relevant concerns and other feedback on the Proposed Rule by the September 11, 2023 comment deadline established in the NPRM. Providers and other stakeholders with potential faith-based concerns about any of the requirements of the Proposed HHS Grants Rule should take particular note of the Rule’s proposed provisions regarding religious accommodation, taking into account the Proposed Religion Rule purposes of this planning as well as their timely submission of any comments by the applicable September 11, 2023 comment deadline.

For More Information

About the Author

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Sibley Hospital & Johns Hopkins Health System Pay $5 Million To Settle Stark Violations

April 19, 2023

Sibley Hospital (“Sibley”) and its parent company, Johns Hopkins Health System (“Johns Hopkins”) will pay the United States $5 million to resolve Physician Self-Referral Law, (commonly known as the “Stark Law”) allegations arising from claims that Sibley submitted to the Medicare Program, the Justice Department announced today.

The Stark Law prohibits a hospital from billing Medicare for certain services referred by physicians with whom the hospital has a financial relationship, unless that relationship satisfies one of the law’s statutory or regulatory exceptions. It is intended to ensure that medical decision-making is not influenced by improper financial incentives and instead is based on the best interests of the patient.

The new settlement resolves allegations that, from 2008 through 2011, Sibley violated the Stark Law by billing Medicare for services referred by ten cardiologists to whom Sibley was paying compensation that exceeded the fair market value of the services provided. These allegations arose out of conduct that Sibley and Johns Hopkins self-disclosed to the United States.

“Improper financial arrangements between hospitals and physicians can influence the type and amount of health care that is provided,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department is committed to holding accountable those who violate prohibitions designed to protect the integrity of physician decision-making.”

The high dollar settlement reminds other health care providers to ensure their own relationships with other health care providers comply with Stark, anti-kickback and other federal and state health care fraud laws.

More Information

About the Author

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, billing, Child Care, Childcare, Childrens Health Insurance Program, Conditions of Participation, Corporate Compliance, DME, Doctor, E-Prescribing, false claims act, Grants, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Hospital, Laws, Life Sciences, Medicaid, Medicare, Medicare Advantage, OIG, pharmaceutical, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

4/21 Deadline For Comments On Proposed HIPAA Administrative Simplification Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification To Referral Certification and Authorization Transaction Standard

April 19, 2023

April 21 is the deadline to comment on the Centers for Medicare & Medicaid Services (CMS) National Standards Group (NSG) proposed rule that, if finalized, would adopt standards for “health care attachments” transactions, a standard for electronic signatures to be used in conjunction with health care attachments transactions, and a modification to the standard for the referral certification and authorization transaction (X12 278) published last December.

The April 21, 2023 deadline reflects a 30-day extension from the original deadline date of March 21, 2023. Comments must be received no later than 5 p.m. on April 21.

More Information

About the Author

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

FY 2022 Medicaid Fraud Conviction Increase, Other Data Shows Continued Robustness of Federal Medicaid Enforcement

March 10, 2023

Department of Health & Human Services Office of Inspector General (“OIG”) data showing a rise in Medicaid criminal convictions arising from fraud and patient abuse or neglect investigations and prosecutions during the 2022 fiscal year (“FY”) confirms the continued robustness of its Medicaid Fraud Control Units (MFCUs).

According to the just-released Medicaid Fraud Control Units Fiscal Year 2022 Annual Report convictions both for fraud and for patient abuse or neglect increased since FY 2020. In FY 2022, MFCUs achieved:

1,327 criminal convictions, an increase over the previous 2 years, but resulted in criminal recoveries of only $416 million; and
553 civil settlements and judgments resulting in civil recoveries of $641 million.

A Statistical Chart included in the Report provides a breakdown by state of the civil and criminal convictions and recoveries by nature of the offense.

While the Report reveals that civil and criminal recoveries from Medicaid criminal and civil enforcement dropped in FY 2022, the increase in convictions and other data sends a clear warning to health care providers and others that Medicaid fraud investigation and enforcement remains a key priority of the OIG and federal prosecutors.

Criminal Convictions

Total convictions resulting from MFCU cases continued to increase from the FY 2020 level but remained lower than in FY 2019. In FY 2022, MFCU cases resulted in 946 convictions for fraud and 381 convictions for patient abuse or neglect.
Exhibit 2 shows the total number of convictions during FYs 2018 through 2022. Although the proportion of patient abuse or neglect convictions to fraud convictions was similar to that in previous years, the total number of patient abuse or neglect
convictions also continued to increase from the FY 2020 level.

As in previous years, significantly more convictions for fraud involved Personal Care Services (PCS) attendants than any other provider type with fraud convictions of PCS attendants, accounting for 44 percent of the fraud convictions.

MFCU convictions related to the fraudulent billing of Medicaid, fraudulent activities of Medicaid providers involving drugs diverted from legal and medically necessary uses, regardless of whether Medicaid itself was billed and other “drug diversion” cases continued to increase from the FY 2020 level. Associated criminal recoveries from drug diversion cases totaled $18 million in FY 2022. Two States, Pennsylvania and Kentucky, accounted for 79 percent of the total convictions.

In FY 2022, convictions of nurse’s aides and of nurses or physician assistants accounted for 39 percent of the total 381 convictions for patient abuse or neglect.

Criminal and Civil Recoveries

While convictions rose, criminal recoveries decreased from $857 million in FY 2021 to $416 million in FY 2022. The Report attributes the drop in atypically large criminal recovery amounts realized in FY 2021 that resulted primarily from cases prosecuted by MFCUs in Virginia and Texas that produced a combined $714 million in criminal recoveries, 83 percent of the total reported criminal recoveries in FY 2021.

The Report points out that a single Texas criminal prosecution also significantly contributed to the total criminal recoveries in FY 2022. According to the Report, $82 million of the FY 2022 criminal recoveries resulted from the prosecution and conviction of the former head of Novus and Optimum Health Services, Bradley J. Harris and other defendants by the U.S. Attorney’s Office for the Northern District of Texas for defrauding the Medicare and Medicaid programs by among other actions:

Billing Medicare and Medicaid for hospice services that were (1) not provided, (2) not directed by a medical professional, and (3) provided to patients not eligible for hospice care; and
Using blank, pre-signed controlled substance prescriptions to distribute drugs without
physician input.

Recoveries from civil settlements and judgments also decreased in FY 2022, as did the total number of civil settlements and judgments associated with pharmaceutical manufacturers. In FY 2022, $395 million (62 percent) of the $641 million in civil recoveries derived from nonglobal cases. The remaining $246 million derived from global cases.

Appendixes to the report include a list of “beneficial” practices implemented by the MFCUs to prevent and discover these and other Medicaid abuses in various regions. Reviewing the granular statistics and these findings set forth in the Report provide valuable insights for health care providers, their leaders and advisors about these and other enforcement priorities and practices.

More Information

About the Author

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.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Anti-KickBack, ASC, Health Care, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, home health, Hospital, Medicaid, Medical Licensure, OIG | Permalink
Posted by Cynthia Marcotte Stamer

Criminal IV Tampering Charges Against Anesthesiologist Highlight Exposures Providers And Their Facilities Can Face From Team Members Retaliatory or Other Misdeeds

September 15, 2022

The arrest and criminal charges against Dallas anesthesiologist Raynaldo Rivera Ortiz Jr. (“Dr. Ortiz”) announced September 15, 2022 highlight the advisability of health care facilities and providers to use care to use appropriate monitoring and other safeguards to protect patients and other critical operations against potential retaliatory misconduct during professional peer review or other investigation or discipline of health care professionals or other members of their workforces.

Dr. Ortiz was arrested in Plano, Texas on Wednesday, September 14, 2022 and is scheduled to make his initial court appearance on Friday, September 16, 2022 on federal felony criminal charges that he caused the death of a patient and surgical emergencies of other patients by intentionally tampering with a consumer product and intentional drug alteration.

According to the by Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, and U.S. Attorney for the Northern District of Texas Chad E. Meacham, Dr. Ortiz was arrested and charged via criminal complaint with tampering with a consumer product causing death and intentional drug adulteration.

According the criminal complaint, on June 21, 2022, a 55-year-old female coworker of Dr. Ortiz, experienced a medical emergency and died immediately after treating herself for dehydration using an IV bag of saline taken from a Baylor Scott & White operated surgical center. An autopsy report revealed that she died from a lethal dose of bupivacaine, a nerve blocking agent that is rarely abused but is often used during the administration of anesthesia.

Two months later, on August 24, 2022, an 18-year-old male patient experienced a cardiac emergency during a routine sinus surgery. The teen was intubated and transferred to a local ICU. Chemical analysis of the fluid from a saline bag used during his surgery revealed the presence of bupivacaine, epinephrine (a stimulant), and lidocaine, drugs that could have caused the patient’s sudden symptoms.

According to the complaint, surgical center personnel concluded that the incidents involving both patients suggested a pattern of intentional adulteration of IV bags used at the surgical center.

The surgical center personnel also identified 10 additional unexpected cardiac emergencies that occurred during otherwise unremarkable surgeries between May and August 2022, which the criminal complaint alleges is an exceptionally high rate of complications over such a short period of time. According to the criminal complaint, medical personnel in each of those additional 10 cases only were able to stabilize the patient through use of emergency measures. Most of the incidents occurred during longer surgeries that used more than one IV bag, including one or more bags retrieved mid-surgery from a stainless steel bag warmer.

Surveillance video from the center’s operating room hallway allegedly also shows Dr. Ortiz placing IV bags into the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies. The complaint alleges that in one instance captured in the surveillance video, agents observed Dr. Ortiz walk quickly from an operating room to the bag warmer, place a single IV bag inside, visually scan the empty hallway, and quickly walk away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. The complaint also states that in another instance, agents observed Dr. Ortiz exit his operating room carrying an IV bag concealed in what appeared to be a paper folder, swap the bag with another bag from the warmer, and walk away. Roughly half an hour later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.

According to the complaint, none of the cardiac incidents occurred during Dr. Ortiz’s surgeries, and that the series of emergencies began just two days after Dr. Oritz was notified of a disciplinary inquiry stemming from an incident during which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency. The complaint alleges that all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while Dr. Ortiz was on vacation.

The complaint further alleges that Dr. Ortiz, who had a history of disciplinary actions against him, expressed concern to other physicians over the disciplinary action at the facility and complained the center was trying to “crucify” him. A nurse who worked on one of Dr. Ortiz’s surgeries allegedly told law enforcement that Dr. Ortiz refused to use an IV bag she retrieved from the warmer, physically waving the bag off.

“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic oath,” said U.S. Attorney Chad E. Meacham in the Department of Justice announcement of the charges. The criminal charges stemmed from these findings.

The Justice Department announcement reminds readers that a criminal complaint is merely an allegation of criminal conduct, not evidence. Dr. Ortiz is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law. If convicted, however, Dr. Ortiz faces a maximum penalty of life in prison.

Both Dr. Ortiz and the surgical facility are exposed to potential liability as a result of the alleged charges. Aside from the pending criminal charges, Dr. Ortiz also almost certainly could face potential peer review and licensing board disciplinary investigation, as well as civil lawsuits.

In addition to these liability exposures for Dr. Ortiz, the surgical facility and other providers also could face civil or potentially even criminal liability.

It seems almost inevitable that the facility and potentially some other providers might be drawn into civil lawsuits brought by affected patients and their families allegedly injured or place at risk by the alleged actions by Dr. Ortiz, as well as licensing and/or accreditation investigation arising from the alleged events.

Because Dr. Ortez’s alleged Actions constitute federal felonies, the Federal Sentencing Guidelines sentencing and organizational liability rules apply. The Sentencing Guidelines will apply to determine the sentence imposed if Dr. Ortez ultimately is convicted. In addition, the Sentencing Guidelines organizational liability provisions also raise a risk of criminal charges against the facility or other parties with knowledge or other imputed responsibility. Under the organizational guidelines, organizations can have imputedliability for the criminal acts committed by the members of their workforce. However whether criminal charges will be pursued against the organization and the level of culpability and resulting liability is determined based upon both whether the organization took appropriate steps to prevent the misconduct before it happened and the extent to which the organization acted promptly in its investigation and redress of the conduct. The apparent actions of the surgical center and its leader ship to investigate, report, and cooperate in the investigation with federal officials are likely to mitigate if not resolve their criminal exposure.

Organizations and their leaders should treat the charges against Dr. Ortiz as a reminder, at minimum carefully to credential and monitor team members including doctors or other non-employer actors working in or with their facilities, to establish appropriate safeguards to prevent and identify quickly mistakes or intentional conduct, to monitor and enforce those safeguards, and to take appropriate prompt action to investigate concerns and redress and if necessary report misconduct with the advice of counsel.

When dealing with position performance and discipline concerns, facilities typically must carefully negotiate applicable contractual and workforce issues as well as the procedural and due process requirements of applicable medical staff bylaws and federal and state peer review and discipline statutes and regulations and medical staff discipline rules.

When a medical staff member protected by peer review or other procedural safeguards commits behaviors that raise a material and continuing threat to the health and safety of patients or the public, summary suspension may be necessary. When considering or taking an action to summarily suspend a healthcare provider, however, facilities and their medical staff leaders should document both the grounds for the patient safety concerns and need for immediate action and scrupulously follow the summary suspension procedures.

Along with seeking to prevent and mitigate these legal risks, Facilities and other providers also need to consider white reporting obligations they may bear under applicable statutes, regulations and contracts.

While managing these legal risks, facilities and other involved parties also need to anticipate media and public concern about the occurrences. Facilities and their leaders should anticipate and be prepared to work in conjunction with qualified legal counsel and experienced qualified public relations experts to decide when, what, and how to communicate with the public in the media about these types of events to avoid is there a bold minefield of traps created by privacy laws, evidentiary and other legal risk management concerns, and the management of relationships with other members of the medical staff and workforce, business partners, insurance, and the public.

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

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 35 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. In the course of this work, she has worked extensively on workforce and medical staff credentialing, management, investigation, peer review and discipline, and reporting and remediation of criminal or other activity to regulatory officials.

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

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.

Leave a Comment » | Academic medicine, Ambulatory care, Anethesiology, Conditions of Participation, Corporate Compliance, Credentialing, Doctor, Employer, Employment law, FDA, Federal Sentencing Guidelines, Fiduciary Responsibility, Health Care, Health Care Provider, Health Care Quality, Home Health, home health, Hospice, Hospital, hospitals, nursing home, OIG, Physician, Physician Licensing, physician licensure, Prescription Drugs, quality repoting, retaliation, Skilled Nursing Facility, Whistleblower | Tagged: ortiz | Permalink
Posted by Cynthia Marcotte Stamer

6 Texas Physicians Face Federal Health Care Fraud Charges For Alleged Improper Kickbacks & Lab Testing Claims

May 29, 2022

The Department of Justice sent another strong warning to physicians and other health care provides not to violate the False Claims Act by making improper patient referrals in violation of the Anti-Kickback Statute and the Stark Law, billing federal health care programs for medically unnecessary laboratory testing or other services or both when charged six Texas physicians with federal health care fraud this week. The prosecution of the physicians for laboratory tests arranged and billed through management services organizations also reminds physicians and other providers that reliance upon management services or other third-party service providers generally does not protect a physician participating in prohibited laboratory or other testing, durable medical equipment, facility, physical therapy or other health care billing or referral arrangements from liability.

Charges Against Texas Physicians

This week, the Justice Department added the following six physicians as defendants to criminal charges filed in a False Claims Act complaint filed in January 2022 against former True Health Diagnostics LLC (THD) CEO Christopher Grottenthaler, former Boston Heart Diagnostics Corporation (BHD) CEO Susan Hertzberg, former LRH CEO Jeffrey Madison, and others:

Doyce Cartrett, Jr., M.D., of Silsbee, Texas, allegedly received over $320,000 from LRH and two management services organizations or “MSOs,” Ascend MSO of TX LLC (Ascend) and Eridanus MG LLC (Eridanus), in return for his referrals.
Elizabeth Seymour, M.D., of Corinth, Texas, allegedly received over $280,000 from two MSOs, Ascend and Eridanus, in return for her referrals.
Emanuel Paul “E.P.” Descant, II, M.D., of Spring, Texas, allegedly received over $125,000 from two MSOs, North Houston MSO and Tomball Medical Management Inc., in return for his referrals.
Frederick Brown, M.D., of Missouri City, Texas, allegedly received over $190,000 from two MSOs, Ascend and Indus MG LLC (Indus), in return for his referrals.
Heriberto Salinas, M.D., of Cleburne, Texas, allegedly received over $75,000 from two MSOs, Ascend and Herculis MG LLC (Herculis), in return for his referrals.
Hong Davis, M.D., of Lewisville, Texas, allegedly received over $70,000 from two MSOs, Ascend and Herculis, in return for her referrals.

The complaint in United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.) charges that small Texas hospitals including Rockdale Hospital dba Little River Healthcare (LRH), THD, BHD, the six physicians and others conspired to pay physicians to induce referrals to the hospitals for laboratory testing performed by THD or BHD. The charges stem from allegations made under the qui tam or whistleblower provisions of the False Claims Act by STF LLC by Felice Gersh, M.D. and Chris Riedel. The United States intervened in the qui tam action in December 2021.

The complaint alleges the charged hospitals paid a portion of their laboratory profits to recruiters, who in turn kicked back those funds to the referring physicians through MSOs allegedly set up by the recruiters to make payments to referring physicians. The Justice Department charges the alleged kickbacks were disguised as investment returns but actually were based on, and offered in exchange for, the physicians’ referrals. The complaint alleges that laboratory tests resulting from this referral scheme were billed to various federal health care programs, and that the claims not only were tainted by improper inducements but, in many cases, also involved tests that were not reasonable and necessary.

The Justice Department reports that before adding charges against the six physicians to the complaint this week, the Justice Department recovered more than $31 million relating to conduct involving BHD, THD and LRH, including False Claims Act settlements with 29 physicians, two health care executives and a laboratory company.

Health Care Fraud Liability Under False Claims Act, Anti-Kickback Statute, Stark Law

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. The Stark Law forbids a hospital or laboratory from billing Medicare for certain services referred by physicians that have a financial relationship with the hospital or laboratory. The Anti-Kickback Statute and the Stark Law seek to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.

The False Claims Act prohibits health care providers from billing federal health care programs for services resulting from referrals prohibited by the Anti-Kickback Statute or the Stark law.

Under the False Claims Act, a private party can file an action on behalf of the United States and receive a portion of the recovery. The False Claims Act also allows the Justice Department to intervene in such lawsuits and add claims and defendants, as happened in this litigation. The qui tam case is captioned United States, et al. ex rel. STF, LLC v. True Health Diagnostics, LLC, et al., No. 4:16-cv-547 (E.D. Tex.). If a defendant is found liable for violating the act, the United States may recover three times the amount of its losses plus applicable penalties.

The United States’ pursuit of this lawsuit illustrates the government’s emphasis on combating health care fraud generally with a special emphasis on physicians. For instance, U.S. Attorney Brit Featherston is quoted as saying, “Schemes that funnel health care referrals do not work without the participation of physicians. … They are not merely passive players in these elaborate schemes, but an integral part, without which the scheme could not exist. Our office is committed to rooting out health care fraud by pursuing all players involved the scheme, from the laboratories and their leaders to the marketers and the physicians who make it all possible. Naming these physicians in the complaint is evidence of that commitment.”

Given this clear warning, physicians and other prescribers, as well as recruiting, billing and management services organizations, laboratories and others involved in recruiting and marketing, providing or billing for laboratory or other services to double check the appropriateness of their referral and other practices keeping in mind that the Anti-Kickback Statute and Stark Law prohibitions against direct and indirect compensation can reach to a wide range of subtle value and benefits in addition to the obvious payment of cash or gifts delivered in a multitude of ways. The prosecution of these physicians for referrals made and compensation delivered under management services contracts also clearly warns physicians and other providers against expecting their reliance upon billing, management services or other staff or management service providers to shield them from liability if an improper referral or payment happens.

More Information

About the Author

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

Leave a Comment » | Anti-KickBack, billing, Centers For Disease Control, Conditions of Participation, DME, Doctor, Durable Medical Equipment, E-Prescribing, false claims act, Federal Sentencing Guidelines, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, healthcare, HHS, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Laboratory tests, Licensing, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Money Laundering, nursing home, OIG, Opiates, Pharmaceudical, Physician, Physician Licensing, Reimbursement, Stark, Substance Abuse | Tagged: Federal Sentencing Guidelines, Opiate, pain management, Physician | Permalink
Posted by Cynthia Marcotte Stamer

SCOTUS: Emotional Injury Damages Not Recoverable In Patient’s Private Rehab Act and ACA Disability Discrimination Lawsuit But Other Significant Liability Risks Remain

May 2, 2022

Today’s Supreme Court ruling that emotional distress damages are not recoverable in a private action to enforce the disability discrimination and accommodation requirements of either the Rehabilitation Act of 1973 (“Rehab Act”) or the Patient Protection and Affordable Care Act (“ACA”) prevents health care and other businesses subject to these requirements against the risk of large emotional injury awards in private actions for discrimination based on these laws. However, health care providers and other organizations subject to these requirements should use care to maintain compliance to avoid large actual damage awards to plaintiffs bringing private lawsuits, program exclusion, penalties or other governmental sanctions or both.

Cummings Supreme Court Ruling

The May 1, 2022 United States Supreme Court ruling in Cummings v. Premier Rehab Keller authored by Supreme Court Justice John Roberts resulted from a suit that sought emotional distress damages brought by filed by a deaf and legally blind woman, Jane Cummings against Premier Rehab Keller after it denied her request that it provide an American Sign Language interpreter at her physical therapy sessions. Premier Rehab told Cummings the therapist could communicate with her through other means, Claiming Premier Rehab’s failure to provide an ASL interpreter constituted discrimination on the basis of disability in violation of the Rehab Act and Section 1557 of the ACA, Cummings sued Premier Rehab seeking various damages and other relief, including emotional distress damages.

The Supreme Court took notice that Premier Rehab was subject to these laws because its receipt of Medicare and Medicaid payments qualified as federal financial assistance triggering their applicability.

The Supreme Court affirmed the previous District Court and Fifth Circuit Court of Appeals’ rulings that emotional distress damages are not recoverable in a private action to enforce either the Rehab Act or the ACA.

The Supreme Court Majority based its decision on its finding that the Rehab Act and Act both are spending statutes that condition their offer of federal funding on a promise by the recipient not to discriminate creating what amounts essentially to a contract between the Government and the recipient of funds. Following previously established Supreme Court precedent for “private spending clause actions,” the Court ruled the emotional distress or other remedy is not available unless “the funding recipient is on notice that by accepting federal funding, it exposes itself to liability of that nature.”

To decide whether emotional distress damages are available under the Spending Clause statutes in this case, the Court therefore asked if a prospective funding recipient deciding whether to accept
federal funds would have had “clear notice” regarding that liability. Because the two statutes are silent on the availability of emotional injury damages, the Supreme Court followed prior precedent by looking to whether the emotional damages sought by Cummings were the type of damages traditionally available in suits for breach of contract so as to put Premier Rehab and other defendants on notice of their exposure to such damages from actions under the Rehab Act or ACA. While acknowledging some exceptional circumstances where punitive damages may be recovered where “the conduct constituting the breach is also a tort for which punitive damages are recoverable,” the Court found such damages “are generally not available for breach of contract.” Concluding that the recognized exception to the general rule was insufficient to give funding recipients the requisite notice that they could face such damages. the Supreme Court ruled that funding recipients under the Rehab Act and the ACA “have not, merely by accepting funds, implicitly consented to liability for punitive damages.”

To read the full Majority opinion and related consenting and dissenting opinions, see here.

Liability Risks Remain Substantial Despite Cummings Ruling

While the Supreme Court’s ruling means private litigants cannot recover emotional injury damages in discrimination actions brought to enforce the Rehabilitation Act or the ACA, health industry and other organizations remain subject to other substantial liability risks for improper discrimination in violation of those laws. Beyond recoveries for actual damages, attorneys’ fees and costs recoverable by private litigants, covered organizations also can face substantial civil monetary penalties, program disqualification, in some instances even False Claims Act liability for billing in violation of program conditions of participation and other risks. As federal agencies continue to make enforcement of these sanctions a priority, organization covered by either of these laws should use care to maintain appropriate compliance and risk management to ensure their ability to defend against any potential charges.

For instance, HHS recently reaffirmed its continued commitment and prioritization of protecting disabled individuals against disability discrimination by its publication of its February 4, 2022 FAQs for Healthcare Providers during the COVID-19 Public Health Emergency: Federal Civil Rights Protections for Individuals with Disabilities under Section 504 and Section 1557. Published to remind health care providers of their obligations under law and provide examples of applicability, HHS clarifies in that guidance that federal civil rights laws apply to health care providers, including those administering COVID-19 testing, medical supplies, and medication. These rules also apply to entities providing hospitalization, long-term care, intensive treatments, and critical care, such as oxygen therapy and mechanical ventilators. HHS also confirm that federal civil rights laws apply to state Crisis Standard of Care plans, procedures, and related standards for triaging scarce resources that hospitals are required to follow. HHS Issues New Guidance for Health Care Providers on Civil Rights Protections for People with Disabilities. See also New Guidance to Boost Accessibility and Equity in COVID-19 Vaccine Programs (December 22, 2021); HHS Takes Action to Prevent Discrimination and Strengthen Civil Rights (November 18, 2021); HHS and DOJ Issue Guidance on “Long COVID” and Disability Rights Under the ADA, Section 504, and Section 1557 (July 26, 2021); OCR Provides Technical Assistance to the State of Arizona to Ensure Crisis Standards of Care Protect Against Age and Disability Discrimination (May 25, 2021); HHS Announces Prohibition on Sex Discrimination Includes Discrimination on the Basis of Sexual Orientation and Gender Identity (May 10, 2021); New Legal Guidance and Resources to Ensure — and Expand — Access to COVID-19 Vaccines for People with Disabilities and Older Adults (April 13, 2021).

HHS’ guidance announcements all include a warning like the one from OCR Director Lisa J. Pino in the February 4, 2022 announcment that “OCR will continue our robust enforcement of federal civil rights laws that protect people with disabilities from discrimination, including when Crisis Standards of Care are in effect.”

The current and historical enforcement record of HHS demonstrates the teeth behind this commitment. OCR has a long and continuing history of extracting substantial settlements or civil monetary penalties from health care or other organizations receiving Medicare, Medicaid or other federal funds administered by HSS for engaging in conduct OCR finds inconsistent with the ACA or Rehabilitation Act discrimination requirements. See, e.g., Settlement Agreement Reached with Rhode Island Department of Children, Youth and Families to Address Discrimination Against Parents with Disabilities (March 30, 2022); Massachusetts Healthcare Provider Resolves Allegations of Discriminatory Practices Regarding Patients Needing Opioid Use Disorder Treatment (December 22, 2021); HHS Office for Civil Rights and U.S. Attorney’s Office for the District of Massachusetts Settle Disability Discrimination Case with Baystate Medical Center (November 17, 2021); HHS Office for Civil Rights and U.S. Attorney’s Office Settle Disability Discrimination Case with Backus Hospital (October 5, 2021); Rhode Island, Massachusetts Healthcare Provider Resolves Allegations of Discriminatory Practices Regarding Patients Needing Opioid Use Disorder Treatment (August 9, 2021).

These OCR guidance and enforcement actions and similar activities by other federal agencies send a strong message that OCR and other federal agencies will continue and expand their zealous investigation and enforcement of disability and other violations by health care providers and other public and private organizations covered by the Rehabilitation Act, the ACA or other federal discrimination and civil rights laws. Health care providers and others regulated by these federal discrimination laws should consider auditing the adequacy of existing practices, reaffirming their own and their business partners’ compliance, retraining workforce and taking other appropriate steps to help prevent illegal discrimination within their organization and to position their organization to respond and defend against potential discrimination investigations or charges.

For Additional Information Or Assistance

If you need have questions or need assistance with health, health or other insurance, employee benefit, payroll, investment or other data, systems or other privacy or security related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help. Longtime scribe for the American Bar Association Joint Committee on Employee Benefits agency meeting with OCR and author of leading publications on HIPAA and other privacy and data security concerns, Ms. Stamer regularly assists clients and provides input to Congress, OCR and other agencies, publishes and speaks extensively on medical and other privacy and cybersecurity, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

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.

Her publications and insights 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. Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications. She also is a highly-sought out speaker on privacy and data security who serves on the planning faculty and speaks for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, 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. 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, e-mail Ms. Stamer or call (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 available here.

Important Information About This Communication

Leave a Comment » | 1335 Waiver, Academic medicine, ADA, air ambulance, Ambulatory care, Childrens Health Insurance Program, Civil Rights, Conditions of Participation, Corporate Compliance, Covid, Disability Discrimination, Discrimination, DME, early childhood education, Emergency Care, Employee Benefits, Employment, false claims act, Health Care, Health Care Fraud, Health Care Provider, health care reimbursement, Health Plan, Health Plans, healthcare, HHS, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Labor Law, Laws, Life Sciences, Medicaid, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, nursing home, occupational health, OCR, OIG, Opiates, Outpatient, Pharmaceudical, Pharmacy, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Section 1557 | Permalink
Posted by Cynthia Marcotte Stamer

Federal Convictions Of Physicians Highlight Need For Care In Opiate & Other Pain Management Prescribing & Billing

March 4, 2022

Physicians and other health care prescribers must remain hyper vigilant when prescribing, documenting, billing and managing opiate and other pain management prescriptions and patients. That’s the clear message sent by the ever-growing wave of federal prosecutions and convictions like the March 2, 2022 federal conviction of Tennessee physician Mark Murphy and his wife, Jennifer Murphy and his wife for unlawfully distributing opioids, providing unnecessary services and defrauding insurers from their now-shuttered North Alabama Pain Services clinics (“NAPS”) and March 1, 2022 sentencing of former physician Patrick Titus to 20 years in prison for his conviction of unlawful distribution of opioid drug outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice.

Tennessee Doctor & Wife Convicted of Pain Management Related Unlawful Opioid Distribution, Health Care Fraud & Other Criminal Charges

The March 2 federal jury conviction of Dr. and Ms. Murphy stemmed from their ownership and operation of their now-defunct pain management clinics resulted from evidence gathered through a joint investigation by the Federal Bureau of Investigation, the Department of Health & Human Services Office of Inspector General, the Internal Revenue Service, and the Drug Enforcement Agency.

During the resulting jury trial, federal prosecutors presented evidence that during the five-year period leading up to the clinic closing its Alabama locations in 2017, Dr. Murphy and Ms. Murphy, who was the office manager, caused over $50 million in fraudulent or unnecessary medical services to be charged to Medicare, TRICARE, Blue Cross Blue Shield of Alabama and others. Evidence at trial showed that NAPS provided pre-signed prescriptions to thousands of patients a month, including prescriptions written outside the usual course of professional practice without a legitimate medical purpose. Federal prosecutors also introduced evidence that the Murphys also solicited and received unlawful payments for referring fraudulent or unnecessary services to patients.

Based on the evidence, the jury found both Dr. and Ms. Murphy guilty on numerous criminal charges including:

Conspiracy to unlawfully distribute and unlawful distribution of controlled substances;
Conspiracy to commit and commission of health care fraud;
Conspiracy to defraud the United States; and
Receiving illegal kickbacks in violation of the Anti-Kickback Statute.

Ms. Murphy also was convicted of tax-related charges for underreporting clinic income.

Currently scheduled for sentencing in June, the Murphys each face a maximum of 20 years in prison for the drug charges and a maximum of 10 years in prison for the health care fraud charges. Both defendants also face a maximum of five years in prison for charges stemming from violations of the Anti-Kickback Statute, and Ms. Murphy faces up to three years in prison for the tax charges.

Former Delaware Doctor Sentenced to 20 Years in Prison for Unlawful Opioid Distribution

The Murphy’s jury conviction came one day after the sentencing of former to 20 years in prison for his July 2021 federal jury conviction on 13 counts of unlawfully distributing and dispensing controlled substances and one count of maintaining a drug-involved premises.

Federal prosecutors presented evidence in court documents and trial that Dr. Titus unlawfully distributed or dispensed opioid drugs including fentanyl, morphine, methadone, OxyContin and oxycodone outside the usual scope of professional practice and not for legitimate medical purposes as part of the his internal medicine practice. The Justice Department charged Dr. Titus frequently prescribed these dangerous controlled substances in high dosages, sometimes in combination with each other or in other dangerous combinations, mostly in exchange for cash. Evidence at trial showed he distributed over 1 million opioid pills without providing any meaningful medical care and to patients he knew were suffering from substance use disorder and/or who demonstrated clear signs that the prescribed drugs were being abused, diverted or sold on the street.

Health Care Fraud Task Force Targeting Opioid Distribution, Billing, & Related Misconduct

Both the Murphy and Titus prosecutions and convictions are two of a growing series of convictions resulted from investigations into opioid and other pain management prescribing conducted as part of efforts targeting physicians and other health care providers involved in prohibited the federal Health Care Fraud Strike Force Program. See e.g., Medical Director Convicted in $110 Million Addiction Treatment Fraud Scheme.

The Federal agencies made a point of warning to other physicians not to overprescribe, bill or engage in other prohibited dealings involving opioids or other controlled substances when announcing the Titus sentencing.

“As we continue the fight against the opioid crisis, this case serves as an important reminder that health care professionals have a duty to prescribe medication responsibly to ensure the well-being of individuals under their care. Failing to do so can endanger patients and undermines critical, ongoing public health measures,” said Special Agent in Charge Maureen Dixon of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG will continue to work with our law enforcement partners to hold bad actors accountable.”

“This sentence is a reminder that the Department of Justice will hold accountable those doctors who are illegitimately prescribing opioids and fueling the country’s opioid crisis,” said Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division. “Doctors who commit these unlawful acts exploit their roles as stewards of their patients’ care for their own profit.”

“DEA-registered medical practitioners have an important role in our communities to treat patients compassionately and responsibly,” said DEA Administrator Anne Milgram. “Today’s sentencing makes clear that medical professionals who recklessly prescribe opioids and endanger the safety and health of patients will be held accountable.”

More Information

About the Author

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

Leave a Comment » | billing, Centers For Disease Control, Conditions of Participation, Controlled Substances, Corporate Compliance, DEA, Doctor, drug treatment, E-Prescribing, Evidence Based Medicine, false claims act, FDA, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, Health Plan, Health Plans, healthcare, hemp, HHS, Home Health, home health, Hospice, Hospital, Hospital, hospitals, Licensing, managed care, marijuana, Medical Licensure, Medical Malpractice, Medical Records, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, Monopoly, OIG, Opiates, pain management, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Substance Abuse | Tagged: Federal Sentencing Guidelines, Opiate, pain management, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Justice Department COVID & Other Health Care Fraud Enforcement Thriving Despite Pandemic Emergency

November 23, 2021

Federal health care fraud prosecution continues to thrive despite the ongoing COVID-19 health care emergency.

Recently announced prosecutions and other enforcement actions include Fraud & Abuse, False Claims Act and other health care fraud prosecutions commonly pursued by the Justice Department in recent decades as well as a host of new prosecutions of abuses of Covid-19 relief programs. Examples include:

These and other actions send a clear message to health care and life science organizations to continue vigorous health care fraud compliance and risk management activities as well as stay vigilant for signs of new audit and enforcement activities.

More Information

About the Author

Past Board President of the Richardson Development Program for Children ECE and Scribe for the ABA JCEB Annual Agency Meeting with HHS-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 is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health industry legal, public policy and operational concerns.

As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; 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; EHR, 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.

This involvement encompasses helping health care systems and organizations, schools, ECEs, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve 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, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, 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 a multitude of health industry and other highly regarded publications and presentations, 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.

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Leave a Comment » | Academic medicine, American Rescue Plan Act of 2021, Anti-KickBack, ASC, Centers For Disease Control, Conditions of Participation, Coronavirus, Corporate Compliance, Covid, COVID-19, Electronic Health Records, Employer, false claims act, Health Care, Health care coding, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, healthcare, HHS, Home Health, home health, Hospice, Hospital, hospitals, Life Sciences, long-term care, Medicaid, Medicaid Advantage, Medicare, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pandemic, Pharmacy, Physician, physician licensure, Reimbursement, retaliation, Skilled Nursing Facility, Stark, substance abuse treatment | Permalink
Posted by Cynthia Marcotte Stamer

CMS Updates COVID-19 Accelerated and Advance Payments FAQs

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.

If you 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 or counsel about the these or other legal, management or public policy developments, Ms. Stamer’s work, experience, involvements, other publications, or programs, contact Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297, follow her on Facebook, LinkedIn or Twitter or see Cynthia Marcotte Stamer, P.C. Website.

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:

Leave a Comment » | Academic medicine, American Rescue Plan Act of 2021, Anti-KickBack, billing, Centers For Disease Control, compensation, Conditions of Participation, Coronavirus, Corporate Compliance, COVID-19, Doctor, E-Prescribing, Emergency Care, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Insurance, Health Plan, Health Plans, healthcare, HHS, Home Health, home health, Hospital, hospitals, Indian Health, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, OIG, Pandemic, Physician, public health, Reimbursement, Uncategorized | Tagged: COVID-19, Health Care, Health Care Fraud, Medicare, Physician, recoupment, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

Omnicare & CVS Accused Of Health Care Fraud In Long Term Care Pharmacies

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.

For More Information

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.

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:

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 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.

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.

©2019 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 » | Conditions of Participation, Controlled Substances, Corporate Compliance, DEA, Doctor, drug treatment, E-Prescribing, false claims act, FDA, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, health care reimbursement, Health Insurance, Health Plan, Health Plans, healthcare, HHS, Hospice, long-term care, Medicare Prescription Drug Program, OIG, Patient Empowerment, Pharmaceudical, Pharmacy, Prescription Drugs, Reimbursement, Uncategorized, Veterans Health, Veterans Health Administration, Veterans Health Care | Tagged: controlled substance, cvs, DEA, drugs, false claims act, Health Care, Health Care Fraud, Health Care Provider, HEAT, Medicaid, omnicare, pharmacist, pharmacy | Permalink
Posted by Cynthia Marcotte Stamer

Physicians Pay $700,000 to Settle False Claims Act Violation Charges Arising from Financial Relationship with Drug Testing Lab

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

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 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.

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.

May 8, 2018

CMS Publishes 2018 Physician Fee Schedule Rule

November 2, 2017

On November 2, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that includes updates to payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after January 1, 2018.

The overall update to payments under the PFS based on the finalized CY 2018 rates will be +0.41 percent. This update reflects the +0.50 percent update established under the Medicare Access and CHIP Reauthorization Act of 2015, reduced by 0.09 percent, due to the misvalued code target recapture amount, required under the Achieving a Better Life Experience Act of 2014. After applying these adjustments, and the budget neutrality adjustment to account for changes in Relative Value Units, all required by law, the final 2018 PFS conversion factor is $35.99, an increase to the 2017 PFS conversion factor of $35.89.

The Final Rule Includes:

Patients over Paperwork Initiative
Changes in valuation for specific services
Payment rates for nonexcepted off-campus provider-based hospital departments
Medicare telehealth services
Malpractice relative value units
Care management services
Improvement of payment rates for office-based behavioral health services
Evaluation and management comment solicitation
Emergency department visits comment solicitation
Solicitation of public comments on initial data collection and reporting periods for Clinical Laboratory Fee Schedule
Part B drugs: Payment for biosimilar biological products
Part B drug payment: Infusion drugs furnished through an item of durable medical equipment
New care coordination services and payment for rural health clinics and federally-qualified health centers
Appropriate use criteria for advanced diagnostic imaging
Medicare Diabetes Prevention Program expanded model
Physician Quality Reporting System
Patient relationship codes
Medicare Shared Savings Program
2018 Value Modifier.

Physicians and other healthcare organizations should review this new guidance as soon as possible and begin preparing for these changes which take affect at the first of the year.

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.

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.

©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 » | Conditions of Participation, Corporate Compliance, Doctor, Electronic Health Records, Health Care, Health care coding, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health IT, Hospital, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Money Laundering, OIG, Outpatient, Physician, Prospective Payment, quality reporting, Reimbursement, Rural Health Care, Stark, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

Check Your Medicare/Medicaid Compliance Against Against Quarterly Guidance Changes List

October 27, 2017

Healthcare providers, Medicare/Medicaid Advantage Plans, beneficiaries, and suppliers should use the Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2017 published today to help confirm compliance and other practices take into account potentially relevant new key Medicare and Medicaid guidance issued during the period from July 1 to September 30, 2017.

Staying up-to-date with the latest Program is critical maintain qualification for benefits and rights and avoid getting nailed for harsh civil or even criminal penalties that violations can trigger. However keeping up with the constantly evolving guidance can be daunting.

The quarterly notice lists updates that happened in the 3-month period along with a hyperlink to the full listing that is available on the CMS Web site or the appropriate data registries that are used as Center for Medicare and Medicaid Services resources. for beneficiaries, providers, and suppliers.

The resource provides a convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ‘‘real time’’ accessibility. In addition, many of the Web sites have listservs; that the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur.

This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. Interested persons should use the Quarterly Notice in concert with previously published notices.

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.

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.

Leave a Comment » | Academic medicine, Affordable Care Act, ASC, Border Health, Centers For Disease Control, Childrens Health Insurance Program, Conditions of Participation, Consumer Driven Health Care, Controlled Substances, Corporate Compliance, Cultural diversity, data breach, data security, Disability Discrimination, Disease Management, DME, Doctor, drug treatment, Durable Medical Equipment, E-Prescribing, Electronic Health Records, Electronic Medical Records, EMTALA, Evidence Based Medicine, false claims act, FDA, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, health care reimbursement, Health Insurance Exchange, Health IT, healthcare, HIPAA, Home Health, Hospice, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Meaningful Use, Medicaid, Medical Licensure, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, Money Laundering, NIOSH, OCR, OIG, Outcomes Data, Pharmaceudical, Pharmacy, Physician, Physician Licensing, Prescription Drugs, Psychiatric, quality reporting, Reimbursement, Rural Health Care, Stark, Substance Abuse, Telemarketing, Uncategorized, Veterans Health, Veterans Health Care | Permalink
Posted by Cynthia Marcotte Stamer

HHS Picks Hargan As Acting HHS Secretary

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

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.

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.

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Centers For Disease Control, Childrens Health Insurance Program, Conditions of Participation, data breach, data security, DEA, Doctor, Electronic Medical Records, EMTALA, FDA, 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 Insurance Exchange, Health IT, Health Plan, Health Plans, healthcare, HHS, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, managed care, Meaningful Use, Medicaid, Medical Privacy, Medical Records, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Health, Mental Heatlh, OCR, OIG, Outcomes Data, Outpatient, Peer Review, Pharmaceudical, Pharmacy, Physician, Preexisting Condition Insurance Plan, Prescription Drugs, Privacy, Prospective Payment, Psychiatric, public health, Public Policy, quality reporting, Reimbursement, Reproductive Rights, Rural Health Care, Skilled Nursing Facility, Stark, Substance Abuse, substance abuse treatment, Telemarketing, Telemedicine, Uncategorized, Wellness | Tagged: Affordable Care Act, controlled substance, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, Health Care Provider, Health Care Reimbursement, Health Plans, HEAT, HHS, HIPAA, Hospital, Medicaid, Medicare, OCR, pain management, pharmacist, pharmacy, Physician, Physicians, Privacy, Reimbursement | Permalink
Posted by Cynthia Marcotte Stamer

CMS Proposes Cutbacks To Medicare Bundled Payment Program

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.

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, publications, training program, advocacy and other initiatives available here.

Go here to register to receive other Solutions Law Press, Inc. updates and announcements about other upcoming briefings, training or other programs, products, services, and activities or to learn more about Solutions Law Press, Inc., its publications, programs and training, PROJECT COPE: Coalition on Patient Empowerment community service and education projects, event management and other resources and services.

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.

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

CMS Releases 2017 Provider Payment Program Hardship Exception Application

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

Stamer Speaks, Moderates On Medical Cyber Security At LA Medical Privacy Summit

May 12, 2017

Solutions Law Press, Inc. editor and attorney Cynthia Marcotte Stamer will speak and moderate two key panel programs on health care privacy and data security scheduled at the Healthcare Privacy & Security Form hosted on May 19, 2017 by the Information Security Systems Association of Los Angeles County (ISSA-LA) as a component of its 9th Annual ISSA-LA Information Security Summit. The presentations of Ms. Stamer and others at the conference are particularly timely coming on the heels of the May 12 Cyber alerts to U.S. health industry and other businesses about the urgent need to defend against the spread of an epidemic international malware threat targeting U.S. healthcare and other businesses. See Health Care, Health Plan & Other Health IT Systems Warned of E-Mail Cyber Attack; Urgent WannaCry Ransomware Cyber Warning Issued; Alert: Guard Health E-Mail, Other IT Against WannaCry Malware Attack.

The Medical Privacy & Security Summit is part of the 9th Annual ISSA-LA Information Security Summit scheduled for May 18-19, 2017 at the Universal City Hilton in Los Angeles. Recognized as a premier information security education and networking event, the Summit is expected to bring together 1000 or more health industry and other IT and InfoSec executives, leaders, analysts, and practitioners to learn from the experts, exchange ideas with their peers, and enjoy conversations with the community.

The Healthcare Privacy & Security Forum offered for the 5^th year as a component of the annual Summit on May 19 specifically focuses on leading challenges, issues and opportunities confronted by health industry privacy and security professionals and their organizations. Ms. Stamer has served on the steering committee, moderator and popular faculty member for the 2017 Forum for the 5^th consecutive year. During the 2017 Forum, she will moderate and speak on two panels:

“Finding & Negotiating The Mine Fields: CISO, CIO & Privacy Officer’s Playbook for Promoting Compliance & Security Without Getting Fired,” a luncheon interactive panel discussion with the audience exploring the challenging mission CISOs, CIOs and Privacy Officers face to ensure their healthcare, financial and other critical information, data and systems continue to support the patient care and operating functions of their organizations, while at the same time defending these systems, operations and their sensitive, but mission critical data against malicious or innocent misappropriation, use, access or destruction; and
The closing panel on “What Initiatives Are on the Horizon in Healthcare, and How Can We Secure Them?”, which will explore likely future emerging privacy and security threats and technologies, regulatory challenges and enforcement, and other trends that Privacy and Security professionals are likely to face and tips and strategies for preparing to leverage these likely new opportunities and manage new challenges.

Register or get the full schedule of programs and other events scheduled at the Healthcare Privacy & Security Forum specifically along with the overall Information Security Summit here.

About Ms. Stamer

Scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer is well-known for her extensive work and leadership throughout her career on HIPAA, FACTA, PCI, IRC and other tax, Social Security, GLB, 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 concerns. Ms. Stamer has worked extensively throughout her career with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks, insurers and other financial institutions, and others on trade secret confidentiality, privacy, data security and other risk management and compliance including design, establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, drafting and negotiation of business associate, chain of custody, confidentiality, and other contracting; risk assessments, audits and other risk prevention and mitigation; investigation, reporting, mitigation and resolution of known or suspected breaches, violations or other incidents; and defending investigations or other actions by plaintiffs, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others; reporting known or suspected violations; commenting or obtaining other clarification of guidance and other regulatory affairs, training and enforcement, and a host of other related concerns.

Her clients include public and private health care providers, health insurers, health plans, employers, payroll, staffing, recruitment, insurance and financial services, health and other technology and other vendors, and others.

Author of a multitude of highly-regarded works and training programs on HIPAA and other data security, privacy and use published by BNA, the ABA and other premier legal industry publishers 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 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.

Beyond these involvements, Ms. Stamer also is active in the leadership of a broad range of 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.

Leave a Comment » | Corporate Compliance, Cyber crime, data breach, data security, Disease Management, DME, Doctor, drug treatment, Durable Medical Equipment, E-Prescribing, Electronic Health Records, Electronic Medical Records, Employer, ERISA, FDA, Federal Health Center, Federal Sentencing Guidelines, Fiduciary Responsibility, Genetic Information, GINA, Health Care, Health Care Finance, Health Care Provider, Health Care Quality, Health Insurance Exchange, Health IT, Health Plan, Health Plans, healthcare, HIPAA, HIPAA Cyber Crime, HITECH Act, Home Health, Hospice, Hospital, Hospital, hospitals, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, managed care, Meaningful Use, Medical Malpractice, Medical Privacy, Medical Records, Medicare, Medicare Advantage, Mental Heatlh, OCR, OIG, Pharmaceudical, Pharmacy, Physician, Prescription Drugs, Privacy, Psychiatric, quality reporting, Rural Health Care, Skilled Nursing Facility, substance abuse treatment, Technology, Telemarketing, Telemedicine, Uncategorized | Tagged: Cyber Security, Cybercrime, HIPAA, Malware, Medical Privacy, Medical Security, Technology, WannaCry | Permalink
Posted by Cynthia Marcotte Stamer

HHS OIG Says Texas Paid $6 Million Of Unallowable Medicaid Managed Care Payments

April 13, 2017

The Texas Health and Human Services Commission did not always claim Federal Medicaid reimbursement for managed care payments in compliance with Federal requirements, according to a Department of Health & Human Services Office of Inspector General (OIG) report.

Sections 2(f)(2)(A) and (B) of the Improper Payments Elimination and Recovery Act of 2010 defined an improper payment as any payment that should not have been made, including any duplicate payment. OIG audited the Texas Medicaid Managed Care payments to determine if the State of Texas received excessive payments in violation of the Act.

OIG Report A-06-15-00024 states that the OIG audit found of the 3,170 beneficiary matches reviewed by OIG, 3,045 were assigned more than 1 Medicaid identification number. As a result, OIG found the Texas agency made duplicate managed care payments totaling $3,005,5737 to MCOs for the same beneficiary under different Medicaid identification numbers for the same month.

In addition, the Report also states the Texas agency paid MCOs $3,509,450 for beneficiaries under an inactive Medicaid identification number rather than the beneficiaries’ active numbers.

In total, the OIG Report concludes that the Texas agency improperly claimed $6,515,023 ($3,843,339 Federal share) for managed care payments that did not comply with Federal requirements because the State agency did not ensure that beneficiaries were assigned only one Medicaid identification number. Specifically, OIG reported the Texas agency stated that its eligibility staff failed to appropriately research potential beneficiary matches identified during the application process before assigning a Medicaid identification number. In other instances, the State agency explained that it did not identify potential beneficiary matches because insufficient applicant information was available during the application process or that the applicant provided incorrect information. In addition, the State agency stated that eligibility staff made data entry errors that prevented potential beneficiary matches from being identified.

Based on its findings, OIG recommended that the Texas Medicaid Agency

Refund $3,843,339 to the Federal Government,
Identify additional unallowable monthly Medicaid managed care payments made before and after our audit period for the 3,045 beneficiary matches,
Identify any other beneficiaries who are assigned more than one Medicaid identification number and refund any unallowable payments associated with those beneficiaries, and
Strengthen its procedures to determine whether applicants are enrolled in any medical or public assistance benefits throughout the State and ensure that no beneficiary is issued more than one Medicaid identification number.

In its written comments on the draft report regarding the first and second recommendations, the Report states that the Texas Medicaid agency stated that it would research OIG’s findings and refund any unallowable payments. Regarding OIG’s third recommendation, the State agency said that it would identify any additional beneficiaries assigned more than one Medicaid identification number and refund any unallowable payments associated with those beneficiaries. Regarding OIG’s last recommendation, the Texas Medicaid agency stated that it had implemented several strategies to mitigate the creation of more than one Medicaid identification number for a beneficiary, including improved automation and training. In addition, the State agency explained that it has established an eligibility and enrollment workgroup actively engaged in addressing eligibility and enrollment issues, including the proactive analysis and resolution of payment discrepancies stemming from the assignment of more than one Medicaid identification number to a beneficiary.

Leave a Comment » | Health Care, managed care, Medicaid, OIG, Uncategorized | Permalink
Posted by Cynthia Marcotte Stamer

OIG Modifies Past Ruling, Blesses Two New Medicare Co-Pay Financial Programs

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

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.

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

Health Care Providers, Provide ACO, Reimbursement Reform Input To HHS

March 2, 2015

Physicians, nurses, hospitals and other health care providers, patients and others concerned about health care reimbursement and other health care reforms in the United States should sign up and participate in the new Health Care Payment Learning and Action Network (“Network”) the Department of Health and Human Services (HHS) is creating to help shape ongoing reform of the US health care delivery system to promote better care, smarter spending, and healthier people through the expansion of new health care payment models and other reforms. HHS is inviting private payers, employers, providers, patients, states, consumer groups, consumers, and other partners within the health care community to register here to participate in the Network activities including kickoff event scheduled for Wednesday, March 25, 2015.

HHS hopes cooperation through the Network will help the entire U.S. health care system match and exceed the following HHS goals for Medicare:

Tying 30 percent of payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and
Tying 50 percent of payments to alternative payment models by the end of 2018. The Network will also support the broader goal of tying the vast majority of payments in the health care system to quality or value.

As HHS moves forward to promote ACOs and other reforms, it is particularly important that providers and patients provide feedback and input about the goals and ideas HHS is promoting as solutions for “improving” health care. While HHS often touts consolidation of care into ACOs and other reimbursement strategies using government generated standards of quality as the best means of improving quality and cost-effectiveness, many patients, providers and others worry that HHS ACO and other reimbursement reforms as presently implemented or contemplated by HHS cut costs at the expense of patients by denying reimbursement or other access for effective care options based on cost or ignore other patient needs in the name of cost savings. Active, consistent participation in these and other opportunities for input is critical for those concerned about these and other issues to question and shape the goals, assumptions and actions HHS, Congress and others take to change the U.S. health care system.

HHS says most Network meetings will occur virtually by teleconference or webinar. In-person meetings will occur in the Washington D.C. area. HHS plans to hold the first live streaming of the kickoff event on Wednesday, March 25, 2015. HHS will share details through e-mails to those registered online to participate in the network. Individuals and organizations concerned about ACO and other HHS-lead health care reforms are urged to register and participate in the Network as one of the ways to help monitor and shape health care reform as lead by HHS.

About Project COPE: The Coalition On Patient Empowerment & Coalition on Responsible Health Policy

Do you have feedback or other experiences to share about medical debit, ACA or other health care challenges? Have ideas for helping improve our system, helping Americans cope with these and other health care challenges or other health care matters? Know other helpful resources or experiences that you are willing to share? Are you concerned about health care coverage or other health care and disability issues or policy concerns? Join the discussion and share your input by joining Project COPE: Coalition for Patient Empowerment here.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these needs is the purpose of

The Coalition and its Project COPE are founded and operate based on the belief that health care reform and policy must be patient focused, patient centric and patient empowering. The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up: Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can. Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process. Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist. The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye. Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families. While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining Project COPE: Coalition for Patient Empowerment here by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

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:

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.

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

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 » | Academic medicine, Affordable Care Act, Ambulatory care, Anti-KickBack, ASC, Border Health, Centers For Disease Control, Conditions of Participation, Consumer Driven Health Care, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Medical Records, Employer, Evidence Based Medicine, false claims act, FDA, Federal Health Center, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Insurance Exchange, Health IT, Health Plan, Health Policy, Home Health, Hospital, Hospital, Indian Health, Inpatient Rehabilitation, Inpatient Rehabilitation Facility, Meaningful Use, Medicaid, Medical Licensure, Medical Malpractice, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Fee Schedule, Medicare Prescription Drug Program, OIG, Outcomes Data, Patient Empowerment, Pharmacy, Physician, Prospective Payment, Public Policy, Rural Health Care, Stark, Telemedicine | Permalink
Posted by Cynthia Marcotte Stamer

Use New State Ebola Protocol Table In Ebola Prevention & Management Planning

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.

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:

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 » | 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

Unpatched and Unsupported Software Triggers Latest HIPAA Security Breach Resolution Agreement

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.

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

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

Congress Sends Bill To Fast Track FDA Ebola Treatment Review & HHS Declaration Gives Ebola Treatment Manufacturers Special Immunity

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 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

Former Center Texas Medical Center CFO Faces 5 Years After Guilty Plea To EHR Incentive Fraud Reminder To Manage Incentive Compliance

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 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

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

Preparing Privacy Compliance For Emergencies-Ebola Crisis Prompts HHS OCR To Share Guidance On HIPAA Privacy in Emergency Situations

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:

Treatment.

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.

Imminent Danger

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.

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

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

IRS Issues Ebola-Related Tax Relief

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

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

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

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

Columbia to Pay $9 Million Plus To Settle DOJ/HHS False Claims Charges For Submitting Inaccurate Cost Reports and Mischarging Federal Grants

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.

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 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

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

OIG Warns Pharma Manufacturers to Prevent Copayment Coupon Use for Part D Drug Purchases

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 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

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, 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

Whistleblower To Get $17M+ of Omnicare $124M False Claims Settlement

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 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

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

CMS Proposes Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pre-Authorization Rule

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 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

1 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

Medicare Fraud Strike Force Nails 90 Individuals For Almost $260 Million In False Billing Including 16 Doctors

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.”

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

For More Information Or Assistance

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

Small Smiles Dental Centers Excluded As Federal Health Program Provider For 5 Years

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

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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Federal Health Program Exclusion, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Latest OCR Resolution Agreement Hits Public Health Department, Shows Needs To Stay Up-To-Date

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

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

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

OCR Assigns More HIPAA Compliance Work To Health Care Providers

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:

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 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

Federal Health Care Fraud Enforcement Recouped Record $4.3 Billion in FY 2013

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

For More Information Or Assistance

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

CMS Publishes Tools To Help Providers Understand E-Health Administrative Simplification Tools & Processes

March 4, 2014

The Centers for Medicare & Medicaid Services (CMS) is offering training resources to help providers learn about the electronic administrative simplification tools available through the CMS eHealth programs implemented as part of the Health Insurance Portability & Accountability Act (HIPAA) Administrative Simplification rules.

CMS recently launched eHealth University, a new education portal designed to give providers information vital for understanding, implementing, and successfully participating in a range of . The curriculum offers resources organized by level, from beginner to advanced, in a variety of formats, including　fact sheets, guides, videos, checklists, webinar recordings, and more.

As part of eHealth University, CMS is offering tools and resources to help providers understand Administrative Simplification initiatives such as claims and eligibility operating rules, electronic funds transfer and remittance advice operating rules and standards, and the health plan identifier. These resources include:

What Administrative Simplification Does For You – This fact sheet explains the basics behind how Administrative Simplification will help improve health care efficiency and lower costs.
Introduction to Administrative Simplification – This guide gives an overview of Administrative Simplification initiatives and their purposes.
Introduction to Administrative Simplification: Operating Rules – A short video with information on Administrative Simplification operating rules.

Once providers or others have an understanding of the basics of Administrative Simplification through these beginner-level resources, the user can use the intermediate and advanced resources also available on the eHealth University website.

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 and Employment Law by the Texas Board of Legal Specialization, 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 on how to establish, administer and defend workforce, staffing, management, compliance and risk management policies and practices; prevent, conduct and investigate, and respond to employment, staffing, peer review and other quality, compliance and enforcement concerns; and to respond to OSHA and other Department of Labor, IRS, 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.

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.

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

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: ADministrative Simplification, eHealth, health plan issuer, HIPAA health-care, Hospital, insurer, OSHA, Physician, Safety | Permalink
Posted by Cynthia Marcotte Stamer

OSHA Hospital Tool Signals OSHA Enforcement Risk

January 20, 2014

Health industry employers brace for heightened worker health and safety exposures. The U.S. Department of Labor’s Occupational Safety and Health Administration (OHSA) is getting serious about health care worker safety.

On January 15, 2014, OSHA launched a new educational Web-based OSHA Hospital Resource with extensive materials it intends to help hospitals prevent worker injuries, assess workplace safety needs, enhance safe patient handling programs, and implement safety and health management systems. The materials include fact books, self-assessments and best practice guides.

In announcing the new resource, OSHA noted that hospital workers face serious hazards, including: lifting and moving patients, workplace violence, slips and falls, exposure to chemicals and hazardous drugs, exposures to infectious diseases and needlesticks.

According to OSHA, U.S. hospitals recorded 250,000 work-related injuries and illnesses, almost 60,000 of which caused employees to miss work in 2012. Nationwide, workers’ compensation losses result in a total annual expense of $2 billion for hospitals.

According to OSHA, the website’s materials on safe patient handling are designed to address the most common type of injuries hospital workers face, and hospitals can use these resources to protect their workers, improve patient safety and reduce costs.

While presented as helpful tools for industry employers, health care employers should not overlook the potential legal exposures risked by failing to properly manage employee health and safety risks.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. Viewed from this perspective, health industry employers generally will want to use the tool within the scope of attorney-client privilege to evaluate their potential risks and exposures in the event of a workplace injury or death, OSHA audit or both, and take appropriate steps to mitigate those risks promptly.

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 and Employment Law by the Texas Board of Legal Specialization, 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 on how to establish, administer and defend workforce, staffing, management, compliance and risk management policies and practices; prevent, conduct and investigate, and respond to employment, staffing, peer review and other quality, compliance and enforcement concerns; and to respond to OSHA and other Department of Labor, IRS, 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.

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

Health Insurance Provider Fee Reporting Rules Published

January 20, 2014

Notice 2013-76 provides guidance on the health insurance providers fee related to (1) the time and manner for submitting Form 8963, “Report of Health Insurance Provider Information,” (2) the time and manner for notifying covered entities of their preliminary fee calculation, (3) the time and manner for submitting a corrected Form 8963 for the error correction process, and (4) the time for notifying covered entities of their final fee calculation. The Notice was published in the Internal Revenue Bulletin on December 16, 2013.

For More Information Or Assistance

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

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: EHR, electronic health record, Health Care, Health Care Reform, health insurance provider, health plan issuer, insurer, Physician, Safety | Permalink
Posted by Cynthia Marcotte Stamer

HHS “Safer Guides” Tool For Safe EHR Implementation Published

January 20, 2014

The Office of the National Coordinator for Health Information Technology (ONC) recently published guidance intended to help health care providers safely use electronic health record (EHR) technology. The Safety Assurance Factors for EHR Resilience (SAFER) Guides published here January 15, 2014 as part of the U.S. Department of Health and Human Services’ (HHS’) Health IT Patient Safety Action and Surveillance Plan are intended to serve as a tool health care providers can use to help identify and mitigate potential hazards of EHR technology.
According to HHS, HHS does not intend for the SAFER Guides to replace or revise the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules, the Centers for Medicare & Medicaid Services EHR Incentive Program (Meaningful Use) Rules or other federal rules. Rather, HHS intends for health care providers to use the Guides to start a process that identifies electronic health record (EHR) EHR-related safety concerns and encourages mitigation of the high-priority risks of the EHR.
HHS has published each SAFER Guide in an interactive PDF format designed to help guide providers in self-assessing and documenting their assessments in the following areas associated with EHR implementation:

High Priority Practices;
Organizational Responsibilities;
Patient Identification;
Computerized Physician Order Entry with Decision Support;
Test Results Review and Follow-Up;
Clinician Communication;
Contingency Planning;
System Interfaces; and
System Configuration

A checklist of recommended practices in each SAFER Guide may help providers show and assess EHR safety practices adopted at their organization.

For More Information Or Assistance

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

2/28/14 Deadline To Submit Quality Data for 2013 PQRS-Medicare EHR Incentive Pilot

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 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

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

Final CMS Rule To Expand Medicaid Support For Community & Home-Based Care

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 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

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

Abbott Labs, Sisters of Charity Paying More Than $9M In Two Anti-Kickback Settlements

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

For More Information Or Assistance

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

APDerm To Pay $150k To Settle 1st HIPAA Breach Rule Charges

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

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:

About Solutions Law Press

[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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: Breach Notification, DOJ, Health Care, Health Care Fraud, HIPAA, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Reminder To Follow Confidentiality, Due Process When Conducting Peer Revew & Credentialing

December 16, 2013

Hospitals, physicians, health plans and others participating in credentialing and peer review activities need to use care to ensure that they and others involved in these matters understand and comply with the confidentiality requirements of the Health Care Quality Improvement Act and similar state laws.

Hospitals and their medical staffs, physician and other practice groups and other health care organizations commonly require or query the National Practitioner Data Bank (NPDB) established under HCQIA and other sensitive professional and personal when checking the backgrounds and credentials of physicians seeking admission to the medical staff, employment, staff privileges, participation in provider panels or other positions. These health care organizations and providers also frequently may receive inquiries from other health care providers or organizations seeking information about a provider who is applying for admission, employment or other status. Finally, medical staffs, practices and other health care organizations from time to time may conduct credentialing, peer review or other disciplinary activities, or quality assurance reviews that may involve the discussion of information about the conduct, quality, discipline or other credentials and qualifications of current or former physicians at their own or another health care organization.

The investigation or discipline of a physician and certain other information regarding potential performance or credentialing concerns about a physician or other health care worker often by necessity involves the receipt, sharing, or use of sensitive professional or personal information with credentialing, management, medical staff leadership or others involved in the investigation, review or process. When participating in any of these activities, all parties involved in the activities or providing input or participation in their conduct need to understand and be required to comply fully with all applicable confidentiality and privacy requirements. While participants in these processes often may feel great temptation to circumvent formal processes in the name of expediency, to share sensitive insight with special relationships or other inducements to cut corners on confidentiality, the participants in these activities and the organizations conducting the activities should take all necessary steps to ensure that the participants carefully comply with the confidentiality and privacy requirements and only obtain and share information as allowed by and in accordance with the procedures established by these rules.

The background check rules of the Fair Credit Reporting Act (FCRA) generally require that health care organizations, as well as other businesses, conducting background check or other investigations using third party data or investigators comply with the notice, consent and disclosures of the FCRA. Parties requesting or providing information as part of a credentialing, peer review or other investigation should ensure that the necessary disclosures, notices and consents have been obtained before requesting or sharing information. The fulfillment of these requirements should not be assumed as experience demonstrates that these requirements are commonly overlooked by many health care and other organizations engaged in these activities.

In addition to meeting the FCRA, HCQIA, most state peer review, and medical staff bylaws generally require that credentialing, peer review, quality assurance, and other performance and discipline activities be conducted in accordance with carefully prescribed rules, including specific requirements concerning the protection of the confidentiality of information about a provider. While relatively rare, violation of HCQIA’s confidentiality rules can create significant liability. For instance, after it self-disclosed conduct to the Department of Health & Human Services Office of Inspector General (OIG), The Queen’s Medical Center (QMC), Hawaii, agreed to pay $150,500 in civil money penalties for allegedly violating the NPDB in 2009.

Beyond the rare sanctions under HCQIA, failing to following the rules of HCQIA and state laws can undermine the defensibility of peer review and credentialing decisions by undermining the ability of participants in the process to rely upon the peer review privilege to protect deliberations and discussions conducted in connection with the peer review and credentialing process from discovery, as well as by providing evidence of bad faith, malice or other bad motivation or acts corrupted the process and determination. Beyond hurting the defensibility of the credentialing and peer review process, violations of confidentiality or other procedures often also give rise to antitrust, defamation, invasion of privacy, tortious interferences, and other damage claims by physicians who feel their ability to practice and reputations have been injured by alleged improper conduct in connection with a peer review, credentialing or quality assurance process.

Beyond avoiding giving rise to claims by the targeted physician or other health care provider, all participants in these processes also need to use care to properly protect any individually identifiable patient information. Records and information about a patient, his medical condition, payment history and other related patient data and information often involved in these activities typically qualifies as personal health information, the use, access, and disclosure of which is restricted by the Privacy Rules of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and state common law, HIPAA and other medical records privacy and confidentiality laws. In addition to the specific requirements of HIPAA and other medical information privacy laws, patient financial information and certain other sensitive information also may be protected by a broad range of federal and state laws protecting personal financial and other sensitive personal information, contractual rights created by privacy policies of the organizations involved or other laws.

Conducting proper credentialing, peer review and quality assurance activities is a critical aspect of the hiring and oversight of physicians and others providing care. As important as these requirements are, health care providers and organizations participating in these activities need to remember that the physicians who are subjected to these requirements also enjoy confidentiality, due process and other legal protections, which can create significant liability when violated. Consequently, health care organizations, physicians and members of management, and other staff and participants should use care to follow the proper procedures to ensure that physician rights to confidentiality, due process and other protections are honored as these activities are conducted.

Using care when discussing these concerns is equally important for a physician or other health care provider who is the subject of an investigation, credentialing, peer review, quality assurance or other activity. While a physician whose personal or professional conduct or credentials are questioned understandably feels a strong urge to defend him or herself through a campaign of communication or other actions, physicians on the receiving end also need to follow the process and restrict their discussions.

Cynthia Marcotte Stamer, for additional information or representation.

For More Information Or Assistance

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:

About Solutions Law Press

[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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: CMS, compensation, DOJ, E-Prescribing, Fee Schedule, Health Care, Health Care Fraud, Home Care, home health, medical expense, Medicare, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Physician Fee Schedule, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

CMS Gives Providers Facing Fee Schedule Reduction For Unsuccessful EPrescribing Can Request Review Until 2/28

December 16, 2013

Physicians and other eligible professionals and group practices (who self-nominated for the 2012 and/or 2013 Electronic Prescribing (eRx) group practice reporting option) who were unsuccessful electronic prescribers under the 2012 or 2013 eRx Incentive Program can expect to receive notification from the Centers for Medicare & Medicaid Services (CMS) plans that CMS will have their 2014 eRx payment adjusted to 98.0% of his or her otherwise applicable Medicare Part B physician fee schedule (PFS) allowed charges amount for the specified services for all charges with dates of service from January 1–December 31, 2014.

Providers receiving these notices may wish to request a review of this planned adjustment under an informal review process for the 2014 eRx payment adjustment implemented by CMS. An informal review may be requested if the eligible professional or group practice receives notification from CMS confirming they will be subject to the 2014 eRx payment adjustment or they did not meet the requirements to avoid the 2014 eRx payment adjustment. CMS will accept nformal review requests through February 28, 2014.

Eligible professionals and group practices should submit their eRx informal review request via email to the informal review mailbox at eRxInformalReview@cms.hhs.gov.

Complete instructions on how to request an informal review are available in the 2014 eRx Payment Adjustment Informal Review Made Simple educational document.

Physicians or other health care providers who have questions about these or other e-prescribing or reimbursement concerns may contact the author of this update, Cynthia Marcotte Stamer, for additional information or representation.

For More Information Or Assistance

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:

About Solutions Law Press

[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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: CMS, compensation, DOJ, E-Prescribing, Fee Schedule, Health Care, Health Care Fraud, Home Care, home health, medical expense, Medicare, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Physician Fee Schedule, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Update Mileage Reimbursement Policies, Communications For IRS 2014 Mileage Rates

December 10, 2013

Health care organizations should review the updated optional standard mileage rates and maximum standard automobile costs for purposes of claiming certain automobile allowances during 2014 recently released by the Internal Revenue Service (IRS) to determine and make the necessary arrangements to communicate and implement any changes in the rates that their business plans to use to reimburse employees and others for mileage. In addition, health care organizations also may want to consider sharing information about the updates to medical expense mileage reimbursement rates and other aspects of those rules in newsletters or other marketing communications to help empower those patients and their families to understand and use the new rates and rules to properly claim deductions that their families qualify for on their 2014 tax return for mileage incurred traveling for medical care.

Notice 2013-80, which is scheduled for official publication in Internal Revenue Bulletin 2013-52 on December 23, 2013, provides the optional 2014 standard mileage rates for taxpayers to use in computing the deductible costs of operating an automobile for business, charitable, medical or moving expense purposes. This notice also provides the amount taxpayers must use in calculating reductions to basis for depreciation taken under the business standard mileage rate, and the maximum standard automobile cost that may be used in computing the allowance under a fixed and variable rate (FAVR) plan. The IRS released an advanced copy of the Notice on December 6, 2013.

Many health care organizations reimburse doctors, management, home health, sales and marketing or other employees and other service providers for mileage and other automobile expenses under policies that use these IRS standard rates to calculate the reimbursement amounts. Reimbursement of employees based on these rate is not required. Because reimbursements in excess of the standard rates can create income tax recordkeeping and reporting challenges for the employer, the employee or both, however, most businesses use standard mileage reimbursement rates set at or below the IRS optional standard rates. Businesses facing financial or other challenges may want to reevaluate whether to continue to reimburse mileage and if so, the rate of reimbursement to use to do so.

When communicating with employees about the businesses’ policies for reimbursing business and moving expense mileage, businesses should take care to ensure that employees understand differences in the mileage reimbursement rates that apply to different categories of expenses. As an added service to employees, many human resources departments also may want to consider alerting employees to consult their tax advisor or take other steps to properly understand and retain documentation of mileage not only for business expense reimbursement, but also medical and moving purposes. The availability of this information can be helpful to empower workers and their families to understand and take proper advantage of rules for deducting these expenses even when the employer or its health plan does not reimburse the employee for the expenses.

In addition to reimbursements for workers, businesses also should consider the potential effects of the adjustments in the IRS optional standard mileage rates on the amounts they may bill their customers for mileage expenses as well as the amount that they should expect that their vendors and service providers may bill the business for mileage expenses under contracts that provide for reimbursement of those expenses. Businesses whose contracts with vendors or customers provide for reimbursement of mileage expenses using rates based on the IRS’ optional standard mileage rates should evaluate the effect of the announced adjustments on those mileage obligations to ensure that mileage expenses are properly anticipated, billed and paid.

Beyond dealing with their own policies for reimbursement and billing for mileage, many health care organizations may want to consider sharing information about the 2014 medical mileage reimbursement rates announced by the IRS with patients and their families. Many patients and their families may qualify to claim deductions for mileage for medical travel under IRS rules, but may not be aware of the adjusted rates or the proper procedures for identifying and documenting their medical mileage. While often negligible for families who are not suffering major illness requiring extensive commuting or travel, patients with chronic or serious medical conditions often can benefit from claiming these deductions properly. Communicating the new rates and other tips for keeping records and claiming the mileage deduction could be a significant and valued service to aid these families.

For More Information Or Assistance

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:

About Solutions Law Press

[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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: compensation, DOJ, Health Care, Health Care Fraud, Home Care, home health, Hospital, medical expense, Medicare Fraud, mileage reimbursement, Minimum Wage, nurses, OIG, Overtime, Physician, physician compensation, Provider, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Doc Sentenced to 15 Years for Health Care Fraud

November 16, 2013

Dr. Anthony Stevens Chase faces a 15 month sentence and must pay $360,293 in restitution after pleading guilty to two health care fraud counts.

On October 21, 2011, Jase pled guilty to two counts of health care fraud before Judge James J. Brady, for involvement in two nearly identical schemes to defraud Medicare.

The first conviction arose from Jase’s association Baton Rouge-based company Lobdale Medical Services, which was owned by Beatrice and Young Anyanwu. As part of the scheme to defraud, Sandra Parkman Thompson and others procured the names and personal information of Medicare beneficiaries in and around the New Orleans area and delivered these names to Jase, who then signed false and fraudulent prescriptions for power wheelchairs and other durable medical equipment for which the Medicare beneficiaries had no medical need. Thompson later delivered the fraudulent prescriptions to the Anyanwus, who submitted claims to Medicare through Lobdale Medical Services for the medically unnecessary equipment. The total billings to Medicare by Lobdale Medicare Services exceeded $1,000,000.

The second conviction arose from JASE’s involvement with a New Orleans-based durable medical equipment company known as Psalms 23-DME, which also paid Thompson to deliver prescriptions for wheelchairs and other durable medical equipment. Jase wrote prescriptions for beneficiaries whom he had never seen and who had no need for the equipment prescribed them. As a result, Psalms 23-DME billed Medicare for claims totaling $230,963 using JASE’s provider number.

Beatrice and Young Anyanwu pled guilty to the health care fraud scheme to defraud Medicare as well as the illegal remuneration conspiracy on August 14, 2012. Theywere sentenced February 1, 2013. Sandra Parkman Thompson was convicted after a jury trial on August 20, 2012. She was sentenced on March 14, 2013.

The investigation of Jase was conducted by the Department of Health and Human Services, Office of Inspector General, the Federal Bureau of Investigation, and the Louisiana Department of Justice. Announcing the sentence, acting U.S. Attorney Walt Green stated, “This case is a great example of how federal and state law enforcement work together on a daily basis to stamp out health care fraud by doctors and others who abuse our health care system in our state.”

For More Information Or Assistance

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:

About Solutions Law Press

[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

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

Total Nurse Staffing

CMS Tightening LTC Assessments

Temporary Limited Exceptions

Implementation Deadlines

CMS Nursing Home Staffing Campaign

Begin Preparing Now

For Additional Information

About the Author

About Solutions Laws Press, Inc.™

IMPORTANT NOTICE

Share this:

For More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

Proposed HHS Grants Rule Overview

For More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

Criminal Convictions

Criminal and Civil Recoveries

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

About Solutions Law Press, Inc.™

Important Information About This Communication

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

More Information

About the Author

About Solutions Law Press, Inc.™

IMPORTANT NOTICE ABOUT THIS COMMUNICATION

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this:

Share this: