Biden-Harris Administration to Expand Vaccination Requirements for Health Care and Many Other Employers

September 9, 2021

All Medicare and Medicaid certified health care facilities, and a broad range of other employers must prepare to meet impending new federal COVID-19 vaccine mandates announced by the Biden-Harris Administration today.

According to today’s announcements all healthcare facilities participating in Medicare or Medicaid or employing 100 or more employees will be required to ensure all staff are vaccinated against COVID-19.

The Biden-Harris Administration says the new health industry COVID-19 vaccine mandates will be implemented through emergency regulations to be issued in October.

According to today’s announcement, the Centers for Medicare & Medicaid Service (“CMS”) in collaboration with the Centers for Disease Control (“CDC”) is developing an Interim Final Rule with Comment Period that will be issued in October that will extend vaccine mandates originally announced last month for all Medicare and Medicaid participating nursing home workers to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. See .

The announcement of the vaccine mandates for healthcare workers coincides with the Biden-Harris Administration’s announcement of sweeping new vaccine mandates for all government workers, government contractors and employers employing more than 100 employees.

The two mandates will force most health care facilities to impose mask mandates for all staff in order to meet the requirement all staff be vaccinated.

CMS and CDC say the decision was based on the continued and growing spread of the virus in health care settings, especially in parts of the U.S. with higher incidence of COVID-19. They claim the action will protect patients of the 50,000 providers and over 17 million health care workers in Medicare and Medicaid certified facilities.

According to the CDC, nursing homes with an overall staff vaccination rate of 75% or lower experience higher rates of preventable COVID infection. In CMS’s review of available data, the agency is seeing lower staff vaccination rates among hospital and End Stage Renal Disease (ESRD) facilities. To combat this issue, CMS is using its authority to establish vaccine requirements for all providers and suppliers that participate in the Medicare and Medicaid programs. Vaccinations have proven to reduce the risk of severe illness and death from COVID-19 and are effective against the Delta variant.

In it’s announcement of the impending vaccination requirements, CDC urged health care facilities to prepare now to meet the new mandate in October. CMS expects certified Medicare and Medicaid facilities to act in the best interest of patients and staff by complying with new COVID-19 vaccination requirements.

CDC also urged any health care workers employed in these facilities who are not currently vaccinated are urged to begin the process immediately and facilities to use all available resources to support employee vaccinations, including employee education and clinics, as they work to meet new federal requirements.

While legal challenges to the mandate requirements are likely, most facilities that have not already adopted vaccine mandates are expected to adopt these mandates rather than risk losing eligibility for Medicare and Medicaid reimbursement and other sanctions.

Beyondprogram disqualification and attendant financial pressures, announcement of the new vaccine mandates adds vaccination to the list of safety safeguards that healthcare facilities as employers can expect to be required to enforce as part of the occupational safety rules of the Occupational Safety and Health Administration (”OSHA”).

OSHA already is sanctioning employers for violating COVID-19 related OSHA requirements. For instance, OSHA nailed Lakewood Resource and Referral Center Inc., dba Center for Education Medicine and Dentistry (CHEMED) with heavy fines for allegedly violating applicable COVID-19 safety guidelines in January, 2021.

In a July 23, 2021 citation letter, OSH proposes to fine CHEMED $273,064.00 for willfully violating OSHA by not providing a medical evaluation to determine each employee’s ability to use a N95 respirator, before the employee was fit tested or required to use the respirator in the workplace to protect against SARS-CoV-2 virus while testing suspected COVID-19 individuals.

In addition to the proposed fine, the citation also orders CHEMED to take a series of corrective actions and to post notices in the workplace informing workers of the violation. 

Along with the CHEMED citation, OSH also cited a staffing agency contracted to provide nursing staffing to CHEMED, Homecare Therapies for also failing to conduct medical evaluations and fit tests. It received two violations and a proposed fine of $13,653.

In the face of these potential consequences, most covered health care facilities and other employers impacted by the mandate are likely to implement mandates unless and until these requirements are struct down by the courts or withdrawn.

Assuming the Administration follows appropriate procedures to adopt the rules, most legal commentators do not expect the legal challenges opposing the mandate orders to be successful in the courts particularly after the Supreme Court refused to overturn or hear arguments for overturning a unanimous decision of a three-judge panel of the United States Court of Appeals for the Seventh Circuit in Klassen v. Trustees of Indiana University that refused to enjoin a vaccine mandate imposed by Indiana University as a condition of student or staff in person participation in classes or other activities.

While most healthcare and other covered businesses are not expected to challenge the rules, compliance us likely to trigger backlash from some unvaccinated workers strongly opposed to becoming vaccinated. Employers may find that some employees will resign their employment or take other tactics to avoid becoming vaccinated. Even those who elect to become vaccinated to retain their employment are likely to express opposition and dissatisfaction that could create liability exposures for the employers if it becomes a basis for retaliation claim.

Employers in Texas and certain other states that have adopted rules restricting or prohibiting vaccine, mask or other mandates also may face challenges based on the state rules.

In light of these and other uncertainties and challenges, Healthcare and Other or Employers generally should seek legal advice and assistance from legal counsel experienced with the relevant health care, labor and employment, privacy and other concerns.

More Information

This article is republished by permission of the author, Cynthia Marcotte Stamer.  To review the original work, see here.

Solutions Law Press, Inc. invites you to receive future updates by registering here and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here. For specific information about the these or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years working as an on demand, special project, consulting, general counsel or other basis with domestic and international business, charitable, community and government organizations of all types, sizes and industries and their leaders on labor and employment and other workforce compliance, performance management, internal controls and governance, compensation and benefits, regulatory compliance, investigations and audits, change management and restructuring, disaster preparedness and response and other operational, risk management and tactical concerns.

Most widely recognized for her work with health care, life sciences, insurance and data and technology organizations, she also has worked extensively with health plan and insurance, employee benefits, financial, transportation, manufacturing, energy, real estate, accounting and other services, public and private academic and other education, hospitality, charitable, civic and other business, government and community organizations. and their leaders.

Ms. Stamer has extensive experience advising, representing, defending, and training domestic and international public and private business, charitable, community and governmental organizations and their leaders, employers, employee benefit plans, their fiduciaries and service providers, insurers, and others has published and spoken extensively on these concerns. As part of these involvements, she has worked, published and spoken extensively on these and other human resources, employee benefits, compensation, worker classification and other workforce and other services; insurance; health care; workers’ compensation and occupational disease; business reengineering, disaster and distress; and many other performance, risk management, compliance, public policy and regulatory affairs, and other operational concerns. 

A former lead advisor to the Government of Bolivia on its pension  project, Ms. Stamer also has worked internationally and domestically as an advisor to business, community and government leaders on these and other legislative, regulatory and other legislative and regulatory design, drafting, interpretation and enforcement, as well as regularly advises and represents organizations on the design, administration and defense of workforce, employee benefit and compensation, safety, discipline, reengineering, regulatory and operational compliance and other management practices and actions.

Ms. Stamer also serves in leadership of a broad range of professional and civic organizations and provides insights and thought leadership through her extensive publications, public speaking and volunteer service with a diverse range of organizations including as Chair of the American Bar Association (“ABA”) Intellectual Property Section Law Practice Management Committee, Vice Chair of the International Section Life Sciences and Health Committee, Past ABA RPTE Employee Benefits & Other Compensation Group Chair and Council Representative and current Welfare Benefit Committee Co-Chair, Past Chair of the ABA Managed Care & Insurance Interest Group, past Region IV Chair and national Society of Human Resources Management Consultant Forum Board Member,  past Texas Association of Business BACPAC Chair, Regional Chair and Dallas Chapter Chair, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation and many others.

For more information about these concerns or Ms. Stamer’s work, experience, involvements, other publications, or programs, see www.cynthiastamer.com,  on  Facebook, on LinkedIn or Twitter or e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns.

©2021 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™


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.

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 GroupHR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.  As a part of this work, she has continuously and extensively worked with domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EMR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.

Ms. Stamer is most widely recognized for her decades-long leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns.  This  involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve fraud, substandard quality, safety, unprofessional conduct, sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement;  and other strategic and operational concerns.

Author of leading works on HIPAA and a multitude of other health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources available here such as:

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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.

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©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.


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

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer’s legal, management, governmental affairs work and speaking and publications have focused on helping health industry, health benefit and other organizations and their management use the law, performance and risk management tools and process to manage people, performance, quality, compliance, operations and risk.

Highly valued for her rare ability to find pragmatic client-centric solutions by combining her detailed legal and operational knowledge and experience with her talent for creative problem-solving, Ms. Stamer supports these organizations and their leaders on both a real-time, “on demand” basis as well as outsourced operations or special counsel on an interim, special project, or ongoing basis with strategic planning and product and services development and innovation; workforce and operations management, crisis preparedness and response as well as to prevent, stabilize and cleanup legal and operational crises large and small that arise in the course of operations.

As core components of this work, Ms. Stamer helps health industry, health plans and insurers, health IT, life sciences and other health industry clients manage regulatory, contractual and other compliance; vendors and suppliers; Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other private payer and other terms of participation, medical billing, reimbursement, claims administration and coordination, and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EMR, HIPAA and other technology,  data security and breach and other health IT and data; STARK, antikickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care;  internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; 1557 and other Civil Rights; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns.

Her clients include public and private, domestic and international hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, insurers, self-insured health plans and other payers; and other health industry clients to establish and administer compliance and risk management policies; comply with requirements, investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry investigation, enforcement including insurance or other liability management and allocation; process and product development, contracting, deployment and defense; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; enforcement, and a host of other related concerns for public and private health care providers, health insurers, health plans, technology and other vendors, employers, and others.and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Author of leading works on a multitude of health care, health plan and other health industry matters, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting, former Vice President of the North Texas Health Care Compliance Professionals Association, past Chair of the ABA Health Law Section Managed Care & Insurance Section, past ABA JCEB Council Representative and CLE and Marketing Committee Chair, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer’s health industry clients include public health organizations; public and private hospitals, healthcare systems, clinics and other health care facilities; physicians, physician practices, medical staff, and other provider organizations; skilled nursing, long term care, assisted living, home health, ambulatory surgery, dialysis, telemedicine, DME, Pharma, clinics, and other health care providers; billing, management and other administrative services organizations; insured, self-insured, association and other health plans; PPOs, HMOs and other managed care organizations, insurance, claims administration, utilization management, and other health care payers; public and private peer review, quality assurance, accreditation and licensing; technology and other outsourcing; healthcare clearinghouse and other data; research; public and private social and community organizations; real estate, technology, clinical pathways, and other developers; investors, banks and financial institutions; audit, accounting, law firm; consulting; document management and recordkeeping, business associates, vendors, and service providers and other professional and other health industry organizations; academic medicine; trade associations; legislative and other law making bodies and others.

Past Chair of the ABA Managed Care & Insurance Interest Group and, a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also has extensive health care reimbursement and insurance experience advising and defending health care providers, payers, and others about Medicare, Medicaid, Medicare and Medicaid Advantage, Tri-Care, self-insured group, association, individual and group and other health benefit programs and coverages including but not limited to advising public and private payers about coverage and program design and documentation, advising and defending providers, payers and systems and billing services entities about systems and process design, audits, and other processes; provider credentialing, and contracting; providers and payer billing, reimbursement, claims audits, denials and appeals, coverage coordination, reporting, direct contracting, False Claims Act, Medicare & Medicaid, ERISA, state Prompt Pay, out-of-network and other nonpar insured, and other health care claims, prepayment, post-payment and other coverage, claims denials, appeals, billing and fraud investigations and actions and other reimbursement and payment related investigation, enforcement, litigation and actions.

Heavily involved in health care and health information technology, data and related process and systems development, policy and operations innovation and a Scribe for ABA JCEB annual agency meeting with OCR for many years who has authored numerous highly-regarded works and training programs on HIPAA and other data security, privacy and use, Ms. Stamer also is widely recognized for her extensive work and leadership on leading edge health care and benefit policy and operational issues including meaningful use and EMR, billing and reimbursement, quality measurement and reimbursement, HIPAA, FACTA, PCI, trade secret, physician and other medical confidentiality and privacy, federal and state data security and data breach and other information privacy and data security rules and many other concerns. Her work includes both regulatory and public policy advocacy and thought leadership, as well as advising and representing a broad range of health industry and other clients about policy design, drafting, administration, business associate and other contracting, risk assessments, audits and other risk prevention and mitigation, investigation, reporting, mitigation and resolution of known or suspected violations or other incidents and responding to and defending investigations or other actions by plaintiffs, DOJ, OCR, FTC, state attorneys’ general and other federal or state agencies, other business partners, patients and others.

Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2018 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved

May 8, 2018

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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

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management, disaster and other crisis preparedness and response, and other performance and operations management and compliance. Her experienced includes career long involvement in advising and defending health industry and other organizations about disaster and other crisis preparation, response and mitigation arising from natural and man-made disasters, government enforcement, financial distress, workplace emergencies and accidents, data breach and other cybersecurity and other events.  For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and publisher disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

Circular 230 Compliance. The following disclaimer is included to ensure that we comply with U.S. Treasury Department Regulations. Any statements contained herein are not intended or written by the writer to be used, and nothing contained herein can be used by you or any other person, for the purpose of (1) avoiding penalties that may be imposed under federal tax law, or (2) promoting, marketing or recommending to another party any tax-related transaction or matter addressed herein.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


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.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical  staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press Inc.™

Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns.

If you found these updates of interest, you may be interested in other recent Solutions Law Press, Inc. updates, 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.

©2017 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.


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.


Medical Clinic HIPAA Resolution Agreement Shows Need For Current Business Associate Agreements

April 24, 2017

Health care providers, health plans, health care clearinghouses and business associates must get and keep their business associate (BA) agreements (BAAs) in place, up- to-date, and readily available for inspection in accordance with the Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule, 45 C.F.R. Part 160 and Subparts A and E of Part 164 (Privacy Rule).  That’s the clear message physician practices and other health care providers, health plans, health care clearinghouses (“covered entities”) and their business associates should learn about Privacy Rule compliance from an April 17, 2017 HIPAA Resolution Agreement just announced by the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) with the Center for Children’s Digestive Health (CCDH).

While the Resolution Agreement relates to breaches of the BAA requirements of a small pediatric practice, the  Center for Children’s Digestive Health (CCDH), all health plans, health care providers and other covered entities and business associates should focus on the adequacy of their BAAs  and their BAA recordkeeping.  HIPAA compliance surveys reflect deficiencies with the BAA rules are common throughout the industry.  These findings and the involvement of BAs in data breaches or other OCR enforcement activities suggest a high probability that many other covered entities and business associates may be sitting ducks for similar sanctions.  See e.g., HIPAA Compliance Survey Churns Up Many Business Associate Problems (January 3, 2017).

The HIPAA Business Associate Agreement Requirements

OCR’s announcement of the CCDH Resolution Agreement is the latest in a growing series of HIPAA enforcement actions showing the growing risk covered entities and their business associates face for failing to take appropriate steps to comply with the BAA and other Privacy Rule requirements of HIPAA.

As compliance audits and surveys of covered entities and business associates suggest a high level of noncompliance with the business associate agreement requirements among covered entities and business associates, While the ever-growing list of Resolution Agreements and Civil Monetary Penalties announced by OCR cover a variety of categories of HIPAA violations, the CCDH Resolution Agreement highlights the importance of covered entities and their business associates ensuring that before the BA creates, accesses, receives, discloses, retains or destroys any PHI for the covered entity,  a BAA meeting the Privacy Rule requirements is signed and retained for at least the six year period the Privacy Rule requires in a manner easily producible when and if OCR or another agency asks for a copy as part of an investigation or other compliance audit.  See Privacy Rule §§ 164.502(e), 164.504(e), 164.532(d) and (e).

The Privacy Rule requires that covered entities and business associates enter into a written and signed business associate agreement that contains the elements specified in Privacy Rule § 164.504(e) before the business associate creates, uses, accesses or discloses PHI of the covered entity. Meanwhile, the Privacy Rule recordkeeping requirements require that covered entities and BAs maintain copies of these BAAs for a minimum of six years.

Violations of the Privacy Rule can carry stiff civil or even criminal penalties  Pursuant to amendments to HIPAA enacted as part of the HITECH Act, civil penalties typically do not apply to violations punished under the criminal penalty rules of HIPAA set forth in Social Security Act , 42 U.S.C § 1320d-6 (Section 1177).

Under Section 1177, the criminal enforcement provisions of HIPAA authorize the Justice Department to prosecute a person who knowingly in violation of the Privacy Rule (1) uses or causes to be used a unique health identifier; (2) obtains individually identifiable health information relating to an individual; or (3) discloses individually identifiable health information to another person, punishable by the following criminal sanctions and penalties:

  • A fine of up to $50,000, imprisoned not more than 1 year, or both;
  • If the offense is committed under false pretenses, a fine of up to $100,000, imprisonment of not more than 5 years, or both; and
  • If the offense is committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, a fine of up to $250,000, imprisoned not more than 10 years, or both.

In contrast, as amended by the HITECH Act, the civil enforcement provisions of HIPAA empower OCR to impose Civil Monetary Penalties on both covered entities and BAs for violations of any of the requirements of the Privacy or Security Rules.  The penalty ranges for civil violations depends upon the circumstances associated with the violations and are subject to upward adjustment for inflation.  As most recently adjusted here effective September 6, 2016,  the following currently are the progressively increasing Civil Monetary Penalty tiers:

  • A minimum penalty of $100 and a maximum penalty of $50,000 per violation, for violations which the CE or BA “did not know, and by exercising reasonable diligence would not have known” about using “the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances;”
  • A minimum penalty of $1,000 and a maximum penalty of $50,000 per violation, for violations for “reasonable cause” which do not rise to the level of “willful neglect” where “reasonable cause” means the “circumstances that would make it unreasonable for the covered entity, despite the exercise of ordinary business care and prudence, to comply with the violated Privacy Rule requirement;”
  • A minimum penalty of $10,000 and a maximum penalty of $50,000 per violation, for violations attributed to “willful neglect,” defined as “the conscious, intentional failure or reckless indifference to the obligation to comply” with the requirement or prohibition; and
  • A minimum penalty of $50,000 and a maximum penalty of $1.5 million per violation, for violations attributed to “willful neglect” not remedied within 30 days of the date that the covered entity or BA knew or should have known of the violation.

For continuing violations such as failing to implement a required BAA, OCR can treat each day  of noncompliance as a separate violation.  However, sanctions under each of these tiers generally are subject to a maximum penalty of $1,500,000 for violations of identical requirements or prohibitions during a calendar year.  For violations such as the failure to implement and maintain a required BAA where more than one covered entity bears responsibility for the violation, OCR an impose Civil Monetary Penalties against each culpable party. OCR considers a variety of mitigating and aggravating facts and circumstances when arriving at the amount of the penalty within each of these applicable tiers to impose.

While criminal enforcement of HIPAA remains relatively rare, a review of the OCR enforcement record in recent years makes clear that civil enforcement of HIPAA and the sanctions imposed is growing. See e.g.,  $400K HIPAA Settlement Shows Need To Conduct Timely & Appropriate Risk Assessments$5.5M Memorial HIPAA Resolution Agreement Shows Need To Audit.  For more examples, also see here.

CCDH Sanctions For Violation Of HIPAA Business Associate Agreement Rules

The CCDH Resolution Agreement arises from violations of this requirement that OCR says it discovered as a result of a compliance review conducted in response to an OCR investigation of a CCDH business associate, FileFax, Inc.  According to OCR, OCR found from the compliance review of CCDH triggered by OCR’s investigation of FileFax that while CCDH began disclosing PHI to Filefax in 2003 and that Filefax stored records containing protected health information (PHI) for CCDH, neither CCDH nor Filefax could produce a signed Business Associate Agreement (BAA) covering their relationship for any period before October 12, 2015.

Based on the resulting investigation,  OCR concluded:

  • CCDH failed to obtain a BAA providing written assurances from Filefax that it would appropriately safeguard the PHI in Filefax’s possession or control satisfactory assurances as required by Privacy Rule §164.502(e); and
  • Because CCDH failed to secure the required BAA, it violated the Privacy Rule by impermissibly disclosing the PHI of at least 10,728 individuals to Filefax when CCDH transferred the PHI to Filefax without obtaining the requisite BAA from Filefax (Covered Conduct).

In the Resolution Agreement, CCDH agrees to pay HHS $31,000.00 (Resolution Amount) and enter into and comply with a Corrective Action Plan (CAP) in return for OCR’s release of CCDH from liability for “any actions it may have against CCDH under the HIPAA Rules” for the Covered Conduct.  The Resolution Agreement only settles the civil monetary penalty and other OCR enforcement liabilities of CCDH with respect to the Covered Conduct.  Its provisions expressly state the Resolution Agreement does not affect any exposures of CCDH to CCDH to OCR civil monetary penalties or other enforcement for any HIPAA violations other than the Covered Conduct.

Perhaps even more noteworthy given the HITECH Act’s provisions coordinating the civil and criminal sanctions of HIPAA, while  the Resolution Agreement provides no clear indication that the Justice Department might be considering criminally prosecuting CCDH or any other party in relation to the Covered Conduct, the Resolution Agreement also expressly states that its provisions do not affect CCDH’s potential exposure, if any, to criminal prosecution by the Justice Department for a criminal violation of the Privacy Rules under Section 1177 of the Social Security Act.

Implications For Covered Entities & Business Associates

Covered entities and their business associates should heed the CCDH Resolution Agreement as a strong message from OCR to ensure their organizations are complying with HIPAA’s BAA and other requirements.  The Resolution Agreement makes clear that the starting point of this compliance effort must be obtaining and maintaining the requisite BAAs for each BA relationship.

To position their organizations to withstand potential investigation by OCR, covered entities and BAs should start by conducting a well-documented audit within the scope of attorney-client privilege both to verify that an appropriate, signed BAA is in place for each BA relationship as well as adequacy of processes for identifying business associate relationships, ensuring that signed BAAs are in effect before BAs access any PHI, and for investigating, reporting and resolving any breaches of the HIPAA Privacy or Security Rules that may arise in the course of operations.

Conducting this audit as soon as possible is particularly important in light of reported findings of widespread compliance concerns. See HIPAA Compliance Survey Churns Up Many Business Associate Problems (January 3, 2017).  As the audit process could identify potential violations or other legally sensitive concerns,  covered entities and business associates generally will want to arrange for this audit and evaluation to be conducted under the supervision of legal counsel experienced with HIPAA within or pursuant to processes structured with the assistance of legal counsel within the scope of attorney-client privilege.

Beyond confirming all necessary BAAs are in place, covered entities and business associates also generally will want to evaluate the adequacy of BAs’ processes and procedures for maintaining compliance with the Privacy and Security Rules as well as processes and procedures for responding to audits, investigations and complaints, reporting and addressing breaches of electronic and other PHI and other possible compliance concerns under HIPAA and other related laws.  In many instances, parties may n wish to revise and strengthen existing BAAs to more specifically define these policies and procedures more specifically as well as indemnification, cyber or other liability coverage requirements and other contractual provisions for allocating potential costs and liabilities arising from breaches, audits, investigations and other expenses associated with the administration of these provisions.

About The Author

Recognized by LexisNexis® Martindale-Hubbell® as a “AV-Preeminent” (Top 1%/ the highest) and “Top Rated Lawyer,” with special recognition 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 “Health Care,” “Labor & Employment,” “Tax: Erisa & Employee Benefits” and “Business and Commercial Law” by D Magazine, the author of this update is widely known for her 29 plus years’ of work in health care, health benefit, health policy and regulatory affairs and other health industry concerns as a practicing attorney and management consultant, thought leader, author, public policy advocate and lecturer.

Throughout her adult life and nearly 30-year legal career, Ms. Stamer’s legal, management and governmental affairs work has 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 a core component of her work, Ms. Stamer has worked extensively throughout her career with health care providers, health plans and insurers, managed care organizations, health care clearinghouses, their business associates, employers, banks and other financial institutions, management services organizations, professional associations, medical staffs, accreditation agencies, auditors, technology and other vendors and service providers, and others on legal and operational compliance, risk management and compliance, public policies and regulatory affairs, contracting, payer-provider, provider-provider, vendor, patient, governmental and community relations and matters including extensive involvement advising, representing and defending public and private hospitals and health care systems; physicians, physician organizations and medical staffs; specialty clinics and pharmacies; skilled nursing, home health, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing and management services 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 manage and defend compliance, public policy, regulatory, staffing and other operations and risk management concerns. A core focus of this work includes work 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; dealings with JCHO and other accreditation and quality organizations; investigation and defense of private litigation and other federal and state health care industry investigations and enforcement; insurance or other liability management and allocation; process and product development; managed care, physician and other staffing, business associate and other contracting; evaluation, commenting or seeking modification of regulatory guidance, and other regulatory and public policy advocacy; training and discipline; 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.

In the course of this work, Ms. Stamer has accumulated extensive experience helping health industry clients manage workforce, medical staff, vendors and suppliers, medical billing, reimbursement, claims and other provider-payer relations, business partners, and their recruitment, performance, discipline, compliance, safety, compensation, benefits, and training, board, medical staff and other governance; compliance and internal controls; strategic planning, process and quality improvement; change management; assess, deter, investigate and address staffing, quality, compliance and other performance; meaningful use, EMR, HIPAA and other data security and breach and other health IT and data; crisis preparedness and response; internal, government and third-party reporting, audits, investigations and enforcement; government affairs and public policy; and other compliance and risk management, government and regulatory affairs and operations concerns.

Author of leading works on HIPAA and other privacy and data security works and the scribe leading the American Bar Association Joint Committee on Employee Benefits Annual Agency Meeting with OCR, her experience includes extensive compliance, risk management and data breach and other crisis event investigation, response and remediation under HIPAA and other laws.

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, 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 has worked closely with a diverse range of physicians, hospitals and healthcare systems, DME, Pharma, clinics, health care providers, managed care, insurance and other health care payers, quality assurance, credentialing, technical, research, public and private social and community organizations, and other health industry organizations and their management deal with governance; credentialing, patient relations and care; staffing, peer review, human resources and workforce performance management; outsourcing; internal controls and regulatory compliance; billing and reimbursement; physician, employment, vendor, managed care, government and other contracting; business transactions; grants; tax-exemption and not-for-profit; licensure and accreditation; vendor selection and management; privacy and data security; training; risk and change management; regulatory affairs and public policy and other concerns.

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.

In connection with this work, 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.

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.

In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, MGMA, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A former lead consultant to the Government of Bolivia on its Pension Privatization Project with extensive domestic and international public policy concerns in Pensions, healthcare, workforce, immigration, tax, education and other areas.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, privacy and data security, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her thought leadership, experience and advocacy on these and other related concerns by her service in the leadership of the Solutions Law Press, Inc. Coalition for Responsible Health Policy, its PROJECT COPE: Coalition on Patient Empowerment, and a broad range of other professional and civic organizations including North Texas Healthcare Compliance Association, a founding Board Member and past President of the Alliance for Healthcare Excellence, past Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; former Board President of the early childhood development intervention agency, The Richardson Development Center for Children (now Warren Center For Children); current Vice Chair of the ABA Tort & Insurance Practice Section Employee Benefits Committee, current Vice Chair of Policy for the Life Sciences Committee of the ABA International Section, Past Chair of the ABA Health Law Section Managed Care & Insurance Section, a current Defined Contribution Plan Committee Co-Chair, former Group Chair and Co-Chair of the ABA RPTE Section Employee Benefits Group, past Representative and chair of various committees of ABA Joint Committee on Employee Benefits; a ABA Health Law Coordinating Council representative, former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division, past Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee, a former member of the Board of Directors of the Southwest Benefits Association and others.

Ms. Stamer also is a highly popular lecturer, symposium and chair, faculty member and author, who publishes and speaks extensively on health and managed care industry, human resources, employment and other privacy, data security and other technology, regulatory and operational risk management. Examples of her many highly regarded publications on these matters include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security: Beyond HIPAA,” as well as thousands of other publications, programs and workshops these and other concerns for the American Bar Association, ALI-ABA, American Health Lawyers, Society of Human Resources Professionals, the Southwest Benefits Association, the Society of Employee Benefits Administrators, the American Law Institute, Lexis-Nexis, Atlantic Information Services, The Bureau of National Affairs (BNA), InsuranceThoughtLeaders.com, Benefits Magazine, Employee Benefit News, Texas CEO Magazine, HealthLeaders, the HCCA, ISSA, HIMSS, Modern Healthcare, Managed Healthcare, Institute of Internal Auditors, Society of CPAs, Business Insurance, Employee Benefits News, World At Work, Benefits Magazine, the Wall Street Journal, the Dallas Morning News, the Dallas Business Journal, the Houston Business Journal, and many other symposia and publications. She also has served as an Editorial Advisory Board Member for human resources, employee benefit and other management focused publications of BNA, HR.com, Employee Benefit News, Insurance Thought Leadership and many other prominent publications and speaks and conducts training for a broad range of professional organizations.

For more information about Ms. Stamer or her health industry and other experience and involvements, see here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ All other rights reserved. For information about republication or other use, please contact Ms. Stamer here.


All Covered Entities Should Learn Lessons From Mississippi Medical Center’s $2.75 Million HIPAA Resolution Agreement

July 27, 2016

Health care providers, health plans, healthcare clearinghouses (covered entities) and their business associates should reevaluate the adequacy of their practices and procedures for the protection of electronic protected health information (ePHI) on or accessible through laptops or other mobile devices in light of the $2.75 million penalty and other schooling the Department of Health and Human Services Office for Civil Rights (OCR) just gave the University of Mississippi (UM) Medical Center (UMMC) documented in a July 7, 2016 Resolution Agreement and Corrective Action Plan (Resolution Agreement) resolving OCR charges of multiple violations of the privacy, security and breach notification requirements of the Health Insurance Portability and Accountability Act (HIPAA) OCR says it uncovered while investigating UMMC’s breach notification report to OCR of the loss a laptop containing 328 files containing the ePHI of an estimated 10,000 patients.

UMMC Report of Missing Laptop Leads To Multiple Charges & Resolution Agreement

Mississippi’s sole public academic health science center, UMMC provides patient care in four specialized hospitals on the Jackson campus and at clinics throughout Jackson and the State as well as conducts medical education and research functions.  Its designated health care component, UMMC, includes University Hospital, the site of the breach in this case, located on the main UMMC campus in Jackson.

The settlement agreed to by UMMC stems from charges resulting from an OCR investigation of UMMC triggered by a breach of unsecured electronic protected health information (“ePHI”) affecting approximately 10,000 individuals.

Like many prior resolution agreements previously announced by OCR, UMMC’s HIPAA woes came to light after a laptop went missing.  OCR learned of the breach and opened its investigation in response to a March 21, 2013 notification UMMC filed with OCR.  UMMC made the breach notification to comply with HIPAA’s Breach Notification Rule requirement that health care providers, health plans and healthcare clearinghouses (Covered Entities) timely notify affected individuals, OCR and others of breaches of unsecured ePHI.

UMMC’s breach notification disclosed that UMMC’s privacy officer had discovered a password-protected laptop containing ePHI of thousands of UMMC patients missing from UMMC’s Medical Intensive Care Unit (MICU). UMMC additionally reported that based on its investigation, UMMC believed that the missing laptop likely was stolen by a visitor to the MICU who had inquired about borrowing one of the laptops.

After discovering the loss, UMMC disclosed the breach to local media and on its website and notified OCR of the breach but apparently did not individually notify the subjects of the missing ePHI.

In keeping with its announced policy of investigating all breach reports impacting 500 or more individuals, OCR opened an investigation into UMMC’s breach report.  Based on this investigation, OCR concluded that while the laptop apparently was password protected, UMMC had breached the Security Rules because ePHI stored on a UMMC network drive was vulnerable to unauthorized access via UMMC’s wireless network because users could use a generic username and password to access an active directory containing 67,000 files including 328 files containing the ePHI of an estimated 10,000 patients.

While OCR’s investigation confirmed that UMMC had implemented policies and procedures pursuant to the HIPAA Rules, OCR’s additionally found that the theft of the laptop that prompted UMMC’s breach report resulted from broad deficiencies in UMMC’s implementation and administration of these policies and its practices.

Based on these findings, OCR charged UMMC with the following HIPAA violations:

  • From the compliance date of the Security Rule, April 20, 2005, through the settlement date, UMMC violated 45 C.F.R. §164.308(a)(1)(i) by failing to implement policies and procedures to prevent, detect, contain, and correct security violations, including conducting an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of the ePHI it holds, and implementing security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level;
  • From January 19, 2013, until March 1, 2014, UMMC violated 45 C.F.R. §164.310(c) by failing to implement physical safeguards for all workstations that access ePHI to restrict access to authorized users;
  • From the compliance date of the Security Rule, April 20, 2005, to March 14, 2013, UM violated 45 C.F.R. § 164.312 (a)(2)(i) by failing to assign a unique user name and/or number for identifying and tracking user identity in information systems containing ePHI including, for example, allowing workforce members to access ePHI on a shared department network drive through a generic account, preventing UMMC from tracking which specific users were accessing ePHI; and
  • While UMMC provided notification on UMMC’s website and in local media outlets following the discovery of the reported breach of unsecured ePHI,, UMMC violated the Breach Notification Rule by failing to notify each individual whose unsecured ePHI was reasonably believed to have been accessed, acquired, used, or disclosed as a result of the breach.

Finally, OCR determined that UMMC was aware of risks and vulnerabilities to its systems as far back as April 2005, yet took no significant risk management activity until after the breach, due largely to organizational deficiencies and insufficient institutional oversight.

To resolve these charges, UMMC agrees in the Resolution Agreement to pay OCR $2.75 million and implement a comprehensive compliance plan which among other things, requires UMMC to conduct a sweeping review and correct its HIPAA privacy, security and breach notification policies and their implementation and administration to comply with HIPAA as well as implement and administer detailed management and OCR oversight and reporting processes over the implementation and administration of these procedures.

Lessons For Other Covered Entities From UMMC Resolution Agreement

The UMMC charges and Resolution Agreement contains several key lessons for other covered entities and their business associates, which OCR’s July 21, 2016 announcement warns other covered entities and business associates to heed..

Certainly, the $2.75 million settlement amount reaffirms that covered entities and their business associates risk substantial liability for failing to properly assess and protect the security of ePHI in accordance with HIPAA’s Privacy and Security Rule.

Furthermore, the charges and Resolution Agreement also adds a new twist to OCR’s now well established to stiffly sanction covered entities and their business associates that fail appropriately assess and address risks to the security of their ePHI on or accessible from laptops or other mobile devices. Through previous resolution agreements and guidance, OCR has made clear that it interprets the HIPAA Security Rule as generally requiring that covered entities and business associates encrypt all laptops or other mobile devices containing ePHI.  The UMMC charges and Resolution Agreement makes clear that the responsibility to protect ePHI on or accessible through laptops or other mobile devices does not end with encryption.  Rather, the Resolution Agreement makes clear that covered entities and their business associates also must take appropriate, well-documented steps to monitor, assess, identify, and timely and effectively address other potential risks to the security of the ePHI.

The Resolution Agreement makes clear that these additional responsibilities include, but are not necessarily limited to ensuring that proper safeguards are implemented and enforced to secure access not only to the ePHI contained on the laptop as well as other data bases and systems containing ePHI accessible through the laptop.  In this respect, the Resolution Agreement particularly highlights the need for covered entities and their business associates to assess risks and take appropriate steps:

  • To safeguard the physical security of laptops and other mobile devices;
  • To prevent the use of generic or other unsecure passwords to access ePHI on or accessible through the laptop or other mobile device;
  • To establish and administer appropriate, well-documented processes for assessing and addressing the adequacy of safeguards for and potential threats to the security of ePHI both initially and on an ongoing basis in a manner that meaningfully assesses the actual risks and effectiveness of safeguards against these risks, including those resulting from nonadherence to required safeguards and practices such as the sharing of passwords, changing systems or circumstances, and other developments that potentially threaten the adequacy of ePHI security.

Furthermore, OCR’s July 21, 2016 press release concerning the Resolution Agreement also sends a clear message to all covered entities and business associates that OCR views HIPAA as requiring organizations not only to adopt written policies and procedures that comply on paper or in theory with HIPAA, but also to take steps to monitor and maintain the effectiveness of their safeguard by continuously assessing and monitoring their HIPAA risks and acting as necessary to ensure that required safeguards of protected health information and ePHI and other HIPAA requirements are effectively implemented and administered in operation as well as form.

In OCR’s Press Release announcing the Resolution Agreement, OCR Director Jocelyn Samuels. Stated, “We at OCR remain particularly concerned with unaddressed risks that may lead to impermissible access to ePHI.”  She also warned “In addition to identifying risks and vulnerabilities to their ePHI, entities must also implement reasonable and appropriate safeguards to address them within an appropriate time frame.”

Additionally, the Resolution Agreement also illustrates need for covered entities and business associates to timely provide all individual and other notifications and otherwise fully comply with all requirements of the Breach Notification Rules.

Since the risk of a breach is ever-present even for Covered Entities and business associates exercising the highest degree of care to safeguard PHI and maintain compliance with HIPAA, Covered Entities and business associates are wise to take steps to position themselves to be able to demonstrate the adequacy of both their written policies and procedures and the effectiveness of their implementation and enforcement including ongoing documented practices for assessing, monitoring and addressing security risks and other compliance concerns as well as prepare to comply with the breach notification requirements in the event they experience their own breach of unsecured ePHI.

About The Author

A Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, current American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, former scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and JCEB Council Representative, former Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section,  the former Board President and Treasurer of the Richardson Development Center for Children Early Childhood Intervention Agency, and past  Board Compliance Chair of the National Kidney Foundation of North Texas, and Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization, the author of this update, attorney Cynthia Marcotte Stamer, is AV-Preeminent (the highest) rated attorney repeatedly recognized for her nearly 30 years of experience and knowledge representing and advising healthcare, health plan and other health industry and others on these and other regulatory, workforce, risk management, technology, public policy and operations matters as a Martindale-Hubble as a “LEGAL LEADER™” and “Texas Top Rated Lawyer” in Health Care Law, Labor and Employment Law, and Business & Commercial Law and among the “Best Lawyers In Dallas” by D Magazine.

Ms. Stamer’s health industry experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Ms. Stamer also is known for her experience in HIPAA and other privacy and data security and breach concerns.  The scribe for ABA JCEB annual agency meeting with OCR for many years, Ms. Stamer has worked extensively with health care providers, health plans, health care clearinghouses, their business associates, employers and other plan sponsors, banks and other financial institutions, and others on risk management and compliance with HIPAA, FACTA, trade secret and other information privacy and data security rules, including the establishment, documentation, implementation, audit and enforcement of policies, procedures, systems and safeguards, investigating and responding to known or suspected breaches, defending investigations or other actions by plaintiffs, OCR and other federal or state agencies, reporting known or suspected violations, business associate and other contracting, commenting or obtaining other clarification of guidance, training and enforcement, and a host of other related concerns. Her clients include public and private health care providers, health insurers, health plans, technology and other vendors, and others. In addition to representing and advising these organizations, she also has conducted training on Privacy & The Pandemic for the Association of State & Territorial Health Plans, as well as HIPAA, FACTA, PCI, medical confidentiality, insurance confidentiality and other privacy and data security compliance and risk management for Los Angeles County Health Department, ISSA, HIMMS, the ABA, SHRM, schools, medical societies, government and private health care and health plan organizations, their business associates, trade associations and others.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical  staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.

You can get more information about her health industry experience here or contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

 

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For important information concerning this communication see here. THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2016 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc. All other rights reserved.

 


Use Free Cyber Security Awareness Month Resources To Boost HIPAA & Other Cyber Security Training & Skills

October 25, 2015

Halloween’s annual celebration of spooks and goblins peak is a perfect time to promote awareness and help American businesses and citizens build their skills to guard against the real and growing menace of identity thieves and other cybercriminals by getting involved with the 12th annual National Cyber Security Awareness Month (NCSAM) in October, begin preparing to participate in the next annual “Data Privacy Day” on January 28, 2016 and joining in other activities highlighted through NCSAM and Data Privacy Day to help deter Cybercrime and identity theft threats. Even if your organization or family choose not to participate in any official or public way, checking out and using the many free resources provides an invaluable, free opportunity to raise your defenses against this rising menace.

Health care providers and organizations, health plans, and their business associates face special legal and ethical mandates to safeguard “protected health information” and other sensitive patient information under the Privacy & Security Rules of the Health Insurance Portability & Accountability Act (HIPAA), state health care, insurance, medical ethics and licensure, identity theft and other laws.   Most health care organizations and providers are sensitive to the need to comply with these requirements as a result of the stiff civil and criminal sanctions associated with violation of these medical privacy and data security requirements and notoriety surrounding stiff sanctions imposed as part of their enforcement, effective operationalization and maintenance of compliance with these rules remains a continuous challenge and only covers a small part of any health care organization’s legal responsibilities and risks.   Health care organizations not only must manage their health care specific  obligations, but also a host of other concerns like those that apply to other organizations.  Getting workforce members, vendors, patients and others to understand and practice good Cyber Security in all aspects of their personal and private lives is key to effective management of all of these risks and responsibilities.

With virtually every American business and citizen now connected to and using the Internet to conduct key personal and business transactions and the constant drive by government and business to digitize regular business transactions, no one agency, business or individual alone can truly know where and who has their sensitive data, much less reliably can defend this data against the identity and other theft and other cybercriminals lurking in the digital world’s virtual streets waiting to strike, then disappear in “Jack The Ripper” style into the darkness of the Internet.  That’s why every American and American business in general – and health industry organizations and providers particularly – should take time to participate and urge others to Get Involved in the 12th Annual NCSAM activities this month and use the supportive resources offered through that involvement throughout the year.

Celebrated annually in October, NCSAM was created to provide resources to help Americans stay safer and more secure online through public-private collaboration between the U.S. Department of Homeland Security and industry led by the National Cyber Security Alliance (NCSA). NCSAM and its associated activities outreach to consumers, small and medium-sized businesses, corporations, educational institutions and young people across the nation.  NCSAM 2015 particularly focuses on the consumer and his/her needs regarding cybersecurity and safety continuing the overall message of STOP. THINK. CONNECT. Campaign founded in 2010 and its capstone concepts: “Keep a Clean Machine,” “Protect Your Personal Information,” “Connect with Care,” “Be Web Wise” and “Be a Good Online Citizen.” NCSAM seeks to remind Americans to incorporate “STOP. THINK. CONNECT.” into their online routines and offers resources to help individuals understand and put these principles into practice into their online routine at the home, the office and elsewhere.

Designed to be accessible and understandable by consumers, many business and government organizations may want to support and promote their Cyber Security employee and customer training and awareness efforts by participating annually in NCSAM in October, signing up your organization to Data Privacy Day Champion and/or participating in Data Privacy Day on January 28, 2016, or otherwise using and sharing tips, tools and other resources in the Privacy Library such as:

General Privacy & Cyber Security Awareness

Keep a Clean Machine/Cookies & Behavioral Tracking

  • Malware & Botnets
  • A video about cookies and why they matter created by the Wall Street Journal.
  • Information about the Network Advertising Initiative (NAI) offering opt-out of online behavior advertising and provides factual information about online behavioral advertising, privacy, cookies.

Health Privacy

Identity Theft Prevention & Clean Up

Mobile App Privacy & Security

Student & Educational Privacy & Security

  • I want to each online safety for Grades K-2,  Grades 3-5  Middle and High School Higher Education and CSave Volunteer Lesson Plans & Materials
  • The Protecting Privacy in Connected Learning toolkit is an in-depth, step-by-step guide to navigating the Family Education Rights and Privacy Act (FERPA), the Children’s Online Privacy Protection Act (COPPA) and related privacy issues.
  • Securing Your Home Network
  • The Family Educational Rights and Privacy Act, or FERPA, is the main federal law that deals with education privacy, but there are a host of other laws, best practices, and guidelines that are essential to understanding education privacy. FERPA|SHERPA aims to provide service providers, parents, school officials, and policymakers with easy access to those materials to help guide responsible uses of student’s data.
  • General guidance for parents provided by the department of education Family Educational Rights and Privacy Act (FERPA)
  • Student Privacy 101: FERPA for parents and students – Ever have questions about your rights regarding education records? This short video highlights the key points of the family education rights and privacy act (FERPA).

Other Resources 

About the Author

Cynthia Marcotte Stamer is a practicing attorney and Managing Shareholder of Cynthia Marcotte Stamer, P.C., a member of Stamer│Chadwick │Soefje PLLC, author, pubic speaker, management policy advocate and industry thought leader with more than years’ experience helping business and government organizations and their leaders manage. Ms. Stamer’s legal and management consulting work throughout her 28 plus year career has focused on helping organizations and their management understand and use the law and process to manage people, process, compliance, operations and risk including significant work in the prevention, investigation and remediation of data breach and other Cybercrime events.

Scribe responsible for leading the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) annual agency meeting with the Department of Health & Human Services Office of Civil Rights,Scribe responsible for leading the American Bar Association (ABA) Joint Committee on Employee Benefits (JCEB) annual agency meeting with the Department of Health & Human Services Cynthia Marcotte Stamer’s practice has focused on advising and representing government and private technology, security, health care providers, health plans, health, schools and other educational organizations, insurance, banking and financial services, retail, employer and other organizations about privacy and data security compliance and risk management, breach and other investigations and enforcement, workforce and performance management and other risk management, compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

With data and technology use, protection and management imbedded in virtually every aspect of her client’s operations, data and other confidential information and systems use, protection, breach or other abuse investigation and response, enforcement and liability mitigation and defense and other Cybercrime and Cyber Security challenges are a continuous component of Ms. Stamer’s management work.  Ms. Stamer helps public and private, domestic and international businesses, governments, and other organizations and their leaders manage their employees, vendors and suppliers, and other workforce members, customers and other’ performance, compliance, compensation and benefits, operations, risks and liabilities, as well as to prevent, stabilize and cleanup workforce, data breach and Cybercrime, and other legal and operational crises large and small that arise in the course of operations.  Ms. Stamer regularly helps clients design, administer and defend HIPAA, FACTA, data breach, identity theft and other risk management, compliance and other privacy, data security, confidential information and other data security, technology and management policies and practices affecting their operations.   She also helps clients prevent, investigate and mitigate HIPAA, FACTA, PHI and other data breach hacking, identity theft, data breach, data loss or destruction, theft of trade secrets or other sensitive data, spoofing, industrial espionage, insider and other parties misuse of data or technology and other cybercrime and technology use concerns.  Best-known for her extensive work helping health care, insurance and other highly regulated entities manage both general employment and management concerns and their highly complicated, industry specific corporate compliance, internal controls and risk management requirements, Ms. Stamer’s clients and experience also includes a broad range of other businesses.  Her clients range from highly regulated entities like employers, contractors and their employee benefit plans, their sponsors, management, administrators, insurers, fiduciaries and advisors, technology and data service providers, health care, managed care and insurance, financial services, government contractors and government entities, as well as retail, manufacturing, construction, consulting and a host of other domestic and international businesses of all types and sizes.  Common engagements include internal and external privacy and data security compliance, risk management, investigation and remediation, workforce hiring, management, training, performance management, compliance and administration, discipline and termination, and other aspects of workforce management including employment and outsourced services contracting and enforcement, sentencing guidelines and other compliance plan, policy and program development, administration, and defense, performance management, wage and hour and other compensation and benefits, reengineering and other change management, internal controls, compliance and risk management, communications and training, worker classification, tax and payroll, investigations, crisis preparedness and response, government relations, safety, government contracting and audits, litigation and other enforcement, and other legal and operational compliance, risk management, disaster preparedness and response, and liability defense and mitigation concerns arising out of organization’s operations.

Cindy also is widely recognized for her regulatory and public policy advocacy, publications, and public speaking on privacy and other compliance, risk management concerns. Among others, she is the author of “Privacy & Securities Standards-A Brief Nutshell,” “Privacy Invasions of Medical Care-An Emerging Perspective,” the E-Health Business and Transactional Law Chapter on Other Liability-Tort and Regulatory;” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA;” “Personal Identity Management Legal Demands and Technology Solutions;” “Tailoring A Records Management Plan And Process To Meet Your Legal And Operational Needs;” “Brokers & Insurers Identity Theft and Privacy Perils;” “HR’s Role In Personal Identity Theft & Cyber Crime Prevention;” “Protecting & Using Patient Data In Disease Management Opportunities, Liabilities And Prescriptions;” “Why Your Business Needs A Cybercrime Prevention and Compliance Program;” “Leveraging Your Enterprise Digital Identity Management Investments and Breaking though the Identity Management Buzz;” “When Your Employee’s Private Life Becomes Your Business;” “Healthcare Breaches: How to Respond” and hundreds of other works. Her insights on privacy, data security, and other matters have appeared in The Wall Street Journal, Business Insurance, the Dallas Morning News, Spencer Publications, and a host of other publications. She speaks and has conducted privacy training 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.

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 works with businesses and government organizations and their management, employee benefit plans, schools, financial institutions, retail, hospitality, and other organizations deal with all aspects of these and other operations performance and compliance management.  She supports her clients both on a real time, “on demand” basis and with longer term basis to deal with daily performance management and operations, emerging crises, strategic planning, process improvement and change management, investigations, defending litigation, audits, investigations or other enforcement challenges, government affairs and public policy.

Ms. Stamer also is active in the leadership of a broad range of other professional and civic organizations. For instance, Ms. Stamer serves on the steering committee and as a faculty member of the Southern California ISSA-HIMMS Annual Security Summit and Chaired its 2015 3rd Annual Health Care Privacy Summit.  Ms. Stamer presently serves on an American Bar Association (ABA) Joint Committee on Employee Benefits Council representative; Vice President of the North Texas Healthcare Compliance Professionals Association; Immediate Past Chair of the ABA RPTE Employee Benefits & Other Compensation Committee, its current Welfare Benefit Plans Committee Co-Chair, on its Substantive Groups & Committee and its incoming Defined Contribution Plan Committee Chair and Practice Management Vice Chair; Past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and a current member of its Healthcare Coordinating Council; current Vice Chair of the ABA TIPS Employee Benefit Committee; the former Coordinator and a Vice-Chair of the Gulf Coast TEGE Council TE Division; on the Advisory Boards of InsuranceThoughtLeadership.com, HR.com, Employee Benefit News, and many other publications.  She also previously served as a founding Board Member and President of the Alliance for Healthcare Excellence, as a Board Member and Board Compliance Committee Chair for the National Kidney Foundation of North Texas; the Board President of the early childhood development intervention agency, The Richardson Development Center for Children; Chair of the Dallas Bar Association Employee Benefits & Executive Compensation Committee; a member of the Board of Directors of the Southwest Benefits Association. For additional information about Ms. Stamer, see here, or the Stamer Chadwick Soefje PLLC website here.  To contact Ms. Stamer, e-mail her at here or telephone (469) 767-8872.

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 Ms. Stamer’s publications our other Solutions Law Press, Inc.™ resources such as:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating or updating your profile here.

©2015 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.. All other rights reserved.


Doc Caught Submitting Conflicting Patient Records to Private Payer Versus Medicare Criminally Sentence, Pays Civil Settlement

July 23, 2013

The  recent criminal sentencing and civil settlement of Illinois physician Dr. Mahmoud Yassin highlights the growing- but too often appreciated exposure of physicians and other health care providers and their billing or other management who submit conflicting claims data to private and government claims or otherwise permit in false  falsely bill or participate in the cover-up of fraudulent or other improper billings to payers.  The Yassin sentencing is notable both because Yassin incurred criminal liability for obstruction based on his presentation of altered patient records to a private payer and and civil liability for  making false claims to Medicare and others.

Yassin was sentenced July 22, 2013 to serve 30 days in prison and 3 years of probation and to pay  a fine of $10,000, a special assessment of $100, and restitution to Blue Cross Blue Shield of Illinois in the amount of $19,615.17 in federal district court in Benton, Illinois for Obstructing a Criminal Health Care Fraud Investigator.  The felony obstruction conviction stemmed from charges that on March 2, 2012, when a FBI agent, having served a subpoena for patient records on Dr. Yassin, gave an altered patient progress note  that showed an in-office examination previously claimed to an insurance carrier, but which had not taken place.

In a separate civil settlement with the United States Attorney’s Office regarding false claims to Medicare, Dr. Yassin also previously has paid double damages for $87,348.64. The restitution and civil false claims settlement were based on claims for in person office visits in which the patient either failed to show up for an appointment or only was spoken to by telephone.

The Yassin prosecution demonstrates the importance of providers getting their records and billings straight when billing both private payers and government payers.  While most  health care providers recognize  the significant exposure they incur from overbilling Medicare or other federal programs as a result of the highly publicized, heavy-handed audit and enforcement activities of the Centers for Medicare & Medicaid Services (CMS), the Department of Health & Human Services Office of Inspector General (OIG) and Department of Justice (DOJ), many  don’t recognize their exposure from private payer billings or the potential interaction between private and government claims investigations  Amendments enacted as part of the anti-fraud provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added private health plans to the list of plans protected by federal prohibitions against fraudulent billing by providers.  Furthermore, federal fraud investigators and private payers increasingly are working together on the investigation and redress of false billing and other aggressive practices.  These and other risks mean that providers cannot afford to be unprepared when asked to respond to investigations like one that lead to the Yassin conviction, recoupment or other audit and enforcement actions  See,  Secondary Payers Hit Physician Group With Recoupment After Medicare Audit Findings.   Rather, physicians and other health care clinics must be ready to prove and defend their billings to public and private payers.  In both cases, these preparations should ensure that records accurately and completely document the care provided, that the coding and billing applied is reflective of actual care and consistent with existing reimbursement, and otherwise defensible.  As demonstrated by Yassin, inconsistencies between records presented to different payers should be avoided.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include a wide range of compliance, risk management and other workshops, programs and publications.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see  here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Improper Billing Of Private Payers Increasing Source Of Liability & Risk For Providers

July 8, 2013

Physicians or other health care providers now have even more to worry about when a Medicare or other federal program audit reveals overpayments – repayment demands from commercial insurers and self-insured health plans, who are secondary payers.  Federal officials and private payers alike increasingly are coming after providers to recover overpayments or other inappropriate billings identified through audits or other investigations.  In the face of these actions, providers should use care to ensure that their billing and compliance programs appropriately manage and monitor the defensibility of claims billed to private payers as well as those to Medicare or other government programs.

Most  health care providers recognize  the significant exposure they incur from overbilling Medicare or other federal programs as a result of the highly publicized, heavy-handed audit and enforcement activities of the Centers for Medicare & Medicaid Services (CMS), the Department of Health & Human Services Office of Inspector General (OIG) and Department of Justice (DOJ).

Unfortunately, many health care providers don’t recognize that overbilling private payers can carry similar risks and liabilities.  Amendments enacted as part of the anti-fraud provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added private health plans to the list of plans protected by federal prohibitions against fraudulent billing by providers.

While CMS, OIG and DOJ tend to emphasize Medicare and other federal program recoveries in media releases about their overbilling and health care fraud enforcement efforts, careful review of these actions increasingly shows that these enforcement actions often also cover overbilling of private health plans uncovered in connection with the underlying  Medicare or other federal program overpayment audit or investigation.   For instance, upcoding and other false billing of claims was the basis of the federal criminal health care fraud prosecution of the Chief Executive Officer of a small, rural Texas health care clinic.  Texas Clinic CEO Sentence Highlights Risks Of Upcoding. See, also Pharmas Face New Pressure To Put Patients Before Profits After GlaxoSmithKline Record $3 Billion Health Care Fraud & FDCA Settlement.

Unfortunately, many providers have failed to recognize and adequately respond to these and other clear indicators of their exposure to fraud, recoupment and other enforcement actions from sloppy or otherwise improper billings to private insurers and self insured plans.  With health care reform increasingly focusing on reducing health care expenditures in the private as well as public arena, already existing federal and state enforcement against providers for improper billing of private payers will inevitably grown.

Taking into account these and other trends toward stepped up enforcement against aggressive billing by providers of private insurance or self-insured plans, physicians and other providers should not be surprised or unprepared to respond to recoupment or other audit and enforcement actions like that recently reported by Nina Youngstrom in AIS Health about the recoupment demands by commercial insurers against a Kansas health care clinic based on the Medicare audit findings of overpayments. See,  Secondary Payers Hit Physician Group With Recoupment After Medicare Audit Findings.   Rather, physicians and other health care clinics must be ready to prove and defend their billings to private payers as well as Medicare and other government payers.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include a wide range of compliance, risk management and other workshops, programs and publications.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see  here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


7 Arrested, Charged In Detroit-Area Home Health Care Fraud Takedown

January 18, 2013

January 17, 2013; U.S. Department of Justice

Seven Arrested, Charged with $22 Million Detroit-area Home Health Care Fraud Scheme

Six Detroit-area residents and one Chicago-area resident were arrested on January 17, 2012 by federal agents on charges arising from the ongoing investigation into an alleged $22 million home health care fraud scheme that the indictment charges operated out of four Oakland County, Michigan home health agencies claiming to provide in-home health service, Royal Home Health Care Inc., Prestige Home Health Services Inc., Platinum Home Health Services Inc. and Empirical Home Health Care Inc. (the “Agencies”).  The defendants arrested are Detroit-area residents Muhammad Aamir, Usman Butt, Hemal Bhagat, Syed Shah, Tariq Tahir, and Raquel Ellington, and Chicago-area resident Tayyab Aziz (the “Defendants”).

According to the Justice Department, the arrests and Medicare payment suspensions stem from charges brought in an 18-count indictment returned January 15, 2013, which alleges that the Defendants participated in a Medicare fraud scheme operating out of the Agencies. The indictment alleges Medicare paid the agencies approximately $22 million for fraudulently reported services since August 2008. See Aamir, Muhammed et al. (Prestige) Indictment.  In addition to the arrests, law enforcement agents suspended Medicare payments to the Agencies associated with the alleged scheme.

According to the indictment, Aamir and Butt owned and operated Prestige; Butt, Bhagat and Shah owned and operated Royal; and Aamir owned and operated Platinum and Empirical.  The indictment alleges that of the Agencies allegedly claimed to provide home health therapy services to Medicare beneficiaries that were unnecessary and/or were never performed.  The indictment also alleges that Tahir and Ellington recruited Medicare beneficiaries, paying them kickbacks for their Medicare information and signatures on documents that detailed physical therapy and/or skilled nursing services that were either never rendered or not medically necessary.  The indictment also charges Aamir, Butt, Bhagat, Shah, Tahir and Ellington with conspiring to pay kickbacks to Tahir and Ellington for their recruiting work and Butt, Bhagat, Shah and Aziz with allegedly conspiring to launder the proceeds of the scheme.

Based on the alleged conduct, the indictment charges each of the Defendants with conspiracy to commit health care fraud.  All but Aziz are also charged with health care fraud and with conspiracy to violate the Anti-Kickback Statute.  Butt, Bhagat, Shah and Aziz are additionally charged with conspiracy to commit money laundering.

A conviction on the charges is likely to carry heavy penalities.  The charges of health care fraud conspiracy and health care fraud each carry a maximum potential penalty of 10 years in prison and a $250,000 fine.  The charge of conspiracy to violate the Anti-Kickback Statute carries a maximum potential penalty of five years in prison and a $25,000 fine.  The charge of conspiracy to commit money laundering carries a maximum potential penalty of 20 years in prison and a $500,000 fine.
 
The arrests and indictments reflect the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by health care providers in the federal war on what officials view as health care fraud.  The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

Since their inception in March 2007, the the HEAT health care fraud task force operations in nine locations have lead to charges against more than 1,480 defendants who Federal officals claim collectively have falsely billed the Medicare program for more than $4.8 billion.  In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to exclude and impose other remedies against health care providers that it perceives engage in fraud or other aggressive billing or other practices.These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA or other health industry, 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.

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. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, 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 help 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.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: 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. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

November 29, 2012

The Department of Health & Human Services Office of Inspector General is recommending the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) act to improve the effectiveness of its oversight and management of the Medicare electronic health record (EHR) incentive program.  The recommendations are likely to impact on the requirements that hospitals and other professionals will be required to meet to get and keep EHR program incentive payments.  Consequently, hospitals, physicians and other providers and their technology and other systems advisors and vendors should carefully watch and respond to changes that these two agencies implement in response to the OIG feedback.

According to an OIG study reported here, the CMS estimates that it will pay $6.6 billion in EHR incentive payments to providers under the program between 2011 and 2016.  Many hospitals, physician organizations and other providers are making substantial investments in EHR and related technologies in reliance of expectation of receiving program incentive payments.  Accordingly, parties hoping to qualify for incentive programs need to watch closely the actions that the agencies take in response to this OIG input or otherwise that impacts on qualification and audits.

OIG Study & Findings

OIG’s early assessment of CMS’s oversight of the Program found that because professionals and hospitals self-report data to prove fulfillment of program requirements, CMS’s efforts to verify these data will help make sure the integrity of Medicare EHR incentive payments.

The recommendation comes from an OIG study reviewing CMS’s oversight of professionals’ and hospitals’ self-reported meaningful use of certified EHR technology in 2011, the first year of the program.  OIG evaluated self-reported information against program requirements.  It also looked at CMS’s audit planning documents, regulations and guidance for the program and conducted structured interviews with CMS staff on CMS’s oversight.

Based on this evaluation, OIG foundCMS faces obstacles to overseeing the Medicare EHR incentive program that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements.  OIG says CMS has not yet implemented strong prepayment safeguards, and has limited ability to safeguard incentive payments postpayment. OIG also reports that the ONC requirements for EHR reports may contribute to CMS’s oversight obstacles.

OIG Recommended Corrective Action

Based on its study, OIG is recommending that CMS take the following actions.

  • Obtain and review supporting documentation from selected professionals and hospitals prior to payment to verify the accuracy of their self‑reported information and
  • Issue guidance with specific examples of documentation that professionals and hospitals should maintain to support their compliance. 

CMS did not agree with our first recommendation, stating that prepayment reviews would increase the burden on practitioners and hospitals and could delay incentive payments.  Despite this CMS feedback, OIG nevertheless is continuing to recommend that CMS conduct prepayment reviews to improve program oversight. CMS concurred with our second recommendation.

OIG also recommended that ONC take the following actions: 

  • Require that certified EHR technology be capable of producing reports for yes/no meaningful use measures where possible and
  • Improve the certification process for EHR technology to make sure applicants provide accurate EHR reports. 

ONC concurred with both recommendations.

Recommended Provider Action

Hospitals and providers looking to take advantage of the HER incentive payments should carefully monitor the developments resulting from these recommendations and take proper actions to stay compliant with evolving requirements as they move forward.

Along with monitoring these responses, providers participating in the incentive program also need to stay abreast of other developments.  For instance, last month, ONC announced the release of the Wave 7 2014 Edition Draft Test Methods (test procedures, tools, and applicable test data and files).  See 2014 Edition Draft Test Procedures webpage. Additional waves of test methods are impending.  ONC says it expects the final set of Test Methods to be available for use in early 2013. 

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, can 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, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, 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 experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

ONC Changes Start Time, Releases Agenda For 11/13 Virtual Workshop On Health IT Test Standards

November 9, 2012

The Office of the National Coordinator for Health IT (ONC) today (November 9, 2012) announced a preliminary agenda of topics and  the procedures that health care providers and other interested parties wishing to participate in  a public virtual workshop on the ONC Health Information Technology (IT) Certification Program and 2014 Edition Test Methods that ONC plans to host on Tuesday, November 13, 2012 from 8:15 AM-4:30PM EST.   

The announced commencement time is 45 minutes earlier than the originally announced 9:00 AM start time that ONC had announced as the start time for the workshop in November 8 announcements.

To review the preliminary agenda for the workshop, see http://www.healthit.gov/policy-researchers-implementers/2014-edition-draft-test-methods.

According to today’s  ONC announcement, parties wishing to participate in the virtual workshop should  register for ONC Certification Technical Workshop on Nov 13, 2012 8:15 AM EST at https://attendee.gotowebinar.com/register/2114316126469925632 .  ONC says that successful registrants will receive a confirmation email containing information about joining the webinar. 

The planned workshop follows ONC’s anno0uncement of the release for review of the latest in a series of electronic medical records Test Standards that ONC has issued recently in its march to implement its mandate.    ONC says all Test Methods will undergo public review and comment before being finalized and approved by ONC for use in testing and certification.   ONC  typically allows  a two week period of public review and comment from the date posted for public review and comment on each Wave.  

In keeping with this process, ONC is inviting interested persons to  submit comments and suggestions to ONC.Certification@hhs.gov. All submissions should include “2014 Test Methods” in the subject line. ONC asks that parties submitting input to be as specific as possible in their comment submissions.

ONC says it expects the final set of Test Methods to be available for use in early 2013. 

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  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 Among others, she has conducted privacy training 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.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

November 8, 2012

The Office of the National Coordinator for Health IT (ONC) today (November 8, 2012) announced the release of the Wave 7 2014 Edition Draft Test Methods (test procedures, tools, and applicable test data and files). To review the 2014 Edition draft Test Methods, visit the 2014 Edition Draft Test Procedures webpage.   As a follow up to this announcement, ONC is inviting interested parties to participate in a public workshop on the ONC HIT Certification Program and 2014 Edition Test Methods on Tuesday, November 13th, 9AM-4:30PM EST.

The Test Procedures announced today are the latest in a series ONC has issued recently.    ONC says all Test Methods will undergo public review and comment before being finalized and approved by ONC for use in testing and certification.   ONC  typically allows  a two week period of public review and comment from the date posted for public review and comment on each Wave.  

In keeping with this process, ONC is inviting interested persons to  submit comments and suggestions to ONC.Certification@hhs.gov. All submissions should include “2014 Test Methods” in the subject line. ONC asks that parties submitting input to be as specific as possible in their comment submissions.

ONC says it expects the final set of Test Methods to be available for use in early 2013. 

To help interested parties stay informed about the Test Messages, ONC also announced today it will host a virtual public workshop on the ONC HIT Certification Program and 2014 Edition Test Methods on Tuesday, November 13th, 9AM-4:30PM EST.  According to ONC, the topics to be covered include 2014 Test Procedures, Test Tools, Test Data, ONC Timeline, and the Certified Health IT Product List (CHPL).   ONC says additional details regarding access and agenda will be forthcoming.  Watch the ONC website.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding 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, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  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 Among others, she has conducted privacy training 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.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

September 17, 2012

Stamer Speaks on “PCI In the Hospital/Healthcare Setting” on 11/1 in LA

Cynthia Marcotte Stamer will speak on “PCI In The Hospital/Healthcare Setting” at the Privacy and Security Forum in Los Angeles, CA on Thursday, November 1.

About The Program

The Forum co-sponsored by the HIMSS SoCal Chapter, along with the ISSA-LA, ISACA-LA, ISC2-LA, & OWASP will be held at the to be held at the Center For Healthy Community in Los Angeles, CA on November 1, 2012 from 7:30AM – 1:30PM.

Ms. Stamer’s and her co-panelist, John B. Sapp Jr., CISSP, CRISC, HISP, CGEIT, Senior Director, Information Security Product Management & Innovation at McKesson Corporation, will discuss the diverse risks, responsibilities and challenges that health care providers, retailers and vendors and consumers face in handling, using and protecting payment card data and information (PCI) used or disclosed in hospital and other health care settings. This includes both personal consumer information that qualifies as protected health information or personal financial information obtained in connection with reimbursement or other core health care operations, as well as PCI from retail, hospitality, parking or other related operations.

About Ms. Stamer

Ms. Stamer has more than 25 years experience advising and assisting health care providers, health plans, health care technology, their business associates and other health industry clients about privacy and data security, investigations and enforcement, and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Recognized in the International Who’s Who of Professionals for her work as an attorney, consultant and author to a wide range of health care, technology, financial services, insurance and other business and governmental organizations, Ms. Stamer helps health industry and other clients to develop and use legal and other strategies to manage legal, operational and other risks, to enhance business and operational effectiveness, to reengineer people, processes and culture, and meet other goals.   As a key component of this involvement, Ms. Stamer has worked extensively on the design, development, operation and defense health, financial services and other information systems, technology and other systems and processes.  She regularly advises businesses and their leaders about the risks and responsibilities under federal and state civil and criminal laws affecting their operations and the development and administration of technology and other strategies for managing these risks and mitigation of data and privacy breaches.  She advises health care organizations, technology companies, outsourcers and others to design processes and technology to manage compliance and risks or promote other operational objectives. 

Vice President of the North Texas Health Care Compliance Professionals Association, founder and Executive Director of the Coalition for Responsible Health Policy and Project COPE; The Coalition on Patient Empowerment, 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, as a continuous part of this work, she helps clients design, administer and defend HIPAA, FACTA, data breach, identity theft and other risk management, compliance and other privacy, data security, confidential information and other data security and technology policies and practices affecting their operations. She has assisted a multitude of health industry, health and other employee benefits, insurance and financial services, technology and other businesses to design and administer privacy, data security and other policies, processes and technology.  She workers with these and other clients to investigate and redress legal and business liabilities and other concerns resulting from HIPAA PHI and other personal information breaches and use, hacking, identity theft, data breach, theft of trade secrets, spoofing, industrial espionage, insider and other parties misuse of data or technology and other cybercrime and technology use concerns under HIPAA, FACTA and other FTC, and other federal and state data breach, privacy, cybercrime, tort, trade secret and other intellectual property, contract and other laws.  She assists these and other clients to design and administer compliance and risk management programs to protect and defend their use and collection of sensitive data. She drafts and advises clients about privacy, security, confidentiality and data security, credit and other background checks, workplace and other investigations and surveillance, and other tools and practices to assist businesses to mitigate risks arising out of technology and data use and monitoring.  Ms. Stamer regularly works with health care, health and other insurance and financial services, and other businesses, the Office of Civil Rights (OCR), Federal Trade Commission, Department of Justice, US Secret Service, Federal Bureau of Investigations, state attorneys general and other agencies on HIPAA, FACTA and other privacy, data security, cybercrime, trade secret and related concerns.

Ms. Stamer also is widely recognized for her regulatory and public policy advocacy, publications, and public speaking on privacy and other compliance, risk management concerns.  For the past two years, Ms. Stamer has serve as the appointed scribe for the ABA Joint Committee on Employee Benefits annual agency meeting with OCR and has lead numerous programs for the ABA and others on this topic.  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 Among others, she has conducted privacy training 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.

A highly popular lecturer and widely published author on privacy, data security, and other matters, Ms. Stamer’s insights have been quoted in The Wall Street Journal, Business Insurance, the Dallas Morning News, Spencer Publications, and a host of other publications.  Her “Personal Identity Theft Training Online Training Program For CIOs” has been included as part of the curriculum of the University of Dallas Information Management Graduate Program.  Cindy also regularly publishes and speaks for a wide range of organizations including the American Bar Association, the Bureau of National Affairs (BNA), Aspen Publishers, Spencer Publications, ISSA, HIMSS, the American Electronics Association (AEA), the Institute of Internal Auditors, Business Institutes and a multitude of others.  She is the author of hundreds of other publications and workshops including “Privacy & Securities Standards-A Brief Nutshell,” “Privacy Invasions of Medical Care-An Emerging Perspective,” the E-Health Business and Transactional Law Chapter on Other Liability-Tort and Regulatory;” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA;” “Personal Identity Management Legal Demands and Technology Solutions;” “Tailoring A Records Management Plan And Process To Meet Your Legal And Operational Needs;” “Brokers & Insurers Identity Theft and Privacy Perils;” “HR’s Role In Personal Identity Theft & Cyber Crime Prevention;” “Protecting & Using Patient Data In Disease Management Opportunities, Liabilities And Prescriptions;” “Why Your Business Needs A Cybercrime Prevention and Compliance Program;” “Leveraging Your Enterprise Digital Identity Management Investments and Breaking though the Identity Management Buzz;” “When Your Employee’s Private Life Becomes Your Business;” “and hundreds of other works.

Cindy also applies her experience as a leader in numerous professional and civic organizations. She currently and previously has served as an advisory board member to a wide range of health information technology and data security incubators, and in a host of other leadership roles in various other professional, charitable and civil organizations.  Cindy also has served as an Adjunct Faculty Member of the University of Dallas Graduate School of Management, on the editorial advisory boards of The Bureau of National Affairs, Inc. (BNA), and a host of other editorial advisory boards and seminar faculties.

For more information about Cindy as your Solutions Lawyer, to conduct training for your organization, or for other information, you may call her at 469.767.8872 or see http://www.Cynthiastamer.com.

 


ONC Releases First Wave of EHR Test Procedures; More To Come

September 14, 2012

On September 7th the ONC published the first wave of draft Test Procedures and applicable test data files for the 2014 Edition Elelctronic Health Record (EHR) certification criteria for public review and comment. ONC will release additional Test Procedures in waves on a weekly or bi-weekly basis. Each set of draft test procedures will undergo a two week period of public review and comment from the date posted. You can now provide input on Wave One 2014 draft Test Procedures. Visit the site for detailed information on the 2014 Test Procedure development process at http://www.healthit.gov/policy-researchers-implementers/2014-edition-draft-test-procedures.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help monitoring federal health reform, 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, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  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 Among others, she has conducted privacy training 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.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks

November 9, 2011

The kickoff of a new compliance audit pilot program provides another reason for health care providers, health plans, healthcare clearinghouses and their business associates to get serious about compliance with the privacy, security and data breach requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

OCR Pilot Audit Program Begins

On November 8, 2011, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) announced that it will begin auditing HIPAA compliance this month under a new pilot program.

As amended by the American Recovery and Reinvestment Act of 2009 in Section 13411 of the HITECH Act, requires HHS to provide for periodic audits to make sure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards.  To carry out this mandate, OCR is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance between November 2011 and December 2012.

The commencement of OCR HIPAA compliance audits is yet another sign that covered entities and their business associates should get serious about HIPAA compliance. The audit program serves as a new part of OCR’s health information privacy and security compliance program.  While OCR says that it presently views the pilot audits as primarily a compliance improvement tool, this does not mean violators should expect a free walk.

Even before the impending audits, HIPAA Privacy exposures of covered entities for failing to comply with HIPAA already had risen significantly.  Earlier this year, OCR imposed a $4.3 Million Civil Money Penalty (CMP) against Cignet Health of Prince George’s County (Cignet) for violating HIPAA.  Meanwhile, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. Under amendments made by the HITECH Act, state attorneys general also now are empowered to bring civil lawsuits against covered entities and business associates that commit HIPAA violations that injure citizens in their state under certain circumstances. Eventually, individuals injured by HIPAA violations also will get the right to share in a portion of certain HIPAA recoveries.

These and other audit and enforcement activities send a strong message that covered entities and their business associates need to get serious about HIPAA compliance. As stated by OCR Director Georgina Verdugo when announcing the Mass General Resolution Agreement, “To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” Verdugo added, “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.” Learn more here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, 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, can help.

Vice President of the North Texas Health Care Compliance Professionals Association, a member of the American College of Employee Benefit Counsel, Past Chair of the ABA RPTE Employee Benefits & Other Compensation Arrangements Group, 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 extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies.  Ms. Stamer also regularly helps clients deal with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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 the required “culture of compliance” with HIPAA are frequently included in medical privacy related publications of the Atlantic Information Service, Modern Health Care, HealthLeaders and many others. Among others, she has conducted privacy training 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, employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here or may contact her at (469) 767-8872 or via e-mail here.

You can review other selected publications and resources and additional information about the employment, employee benefits and other experience of Ms. Stamer 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 available at www.solutionslawpress.com

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

 


UCLA Health Systems Payment of $865,500 To Settle HIPAA Charges Shows Rising HIPAA Risk

September 15, 2011

Health care providers, health plans, health care clearinghouses and their business associates got another wake up call about the growing importance of strengthening their policies, practices and safeguards of medical information and records that are “protected health information” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules with the announcement on July 7 that the University of California at Los Angeles Health System (UCLAHS) has reached an agreement with the U.S. Department of Health & Human Services Office of Civil Rights (OCR) to pay $865,500 and act to strengthen its health information privacy and security practices to settle charges of HIPAA violations.

The latest in a series of recently announced high-dollar Resolution Agreements, the UCLAHS Resolution Agreement highlights the growing risks that covered entities and their business associates run by failing to adequately adopt and administer the policies, systems and other management controls and training necessary to ensure that their organizations and their employees and other members of their workforce actually operationally comply with HIPAA.

Increased penalties, tighter rules and recent enforcement actions by OCR make it more important than ever that covered entities tighten their compliance and risk management policies and procedures.

As a result of amendments enacted as part of the HITECH Act, Congress modified and expanded the HIPAA audit and enforcement obligations of OCR, amended and expanded the potential penalties, made business associates liable for violation of the privacy rules like covered entities, added an obligation for covered entities and business associates to provide notification of breaches of unsecured PHI and tightened other HIPAA obligations. The HITECH Act also gave state attorneys general to bring civil lawsuits against covered entities and business associates that commit HIPAA violations that injure citizens in their state under certain circumstances. Eventually, individuals injured by HIPAA violations will get the right to share in a portion of certain HIPAA recoveries. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

OCR enforcement actions and statistics make clear that OCR is serious about investigation and enforcement of HIPAA violations. This Spring, OCR assessed its first civil monetary penalty (CMP) under HIPAA – a $4.3 million against Cignet Health of Prince George’s County, Md. (Cignet) and entered into a series of Resolution Agreements under which CVS Pharmacy, Inc., General Hospital Corporation and Massachusetts General Physicians Organization Inc., Rite Aid and others paid a million or more dollars as part of the required terms of settlement. See e.g., Rite Aid Pays $1 Million HIPAA Privacy Settlement As OCR Tightens HIPAA Regulations; HIPAA Risks Soar As CVS Agrees To Pay $2.25 Million To Resolve HIPAA Charges & Stimulus Bill Amends HIPAA; Providence To Pay $100,000 & Implement Other Safeguards To Settle HIPAA Penalty Exposures Under HIPAA. Meanwhile, as of January 1, 2011, OCR reported that it had referred more than 484 Privacy Rule breach investigations to the Department of Justice for consideration for potential criminal prosecution and required changes in privacy practices and other corrective actions as part of the requirements for resolution of an additional 12,781 of cases investigated. In addition to these civil enforcement actions by OCR, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. OCR data confirms that the covered entities involved in these actions included health care providers, health plans, and others. See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health Information

Lax HIPAA and other practices for protection of medical and other confidential personal information also increasingly exposes covered entities and other organizations to liability under state laws. State courts allow individual plaintiffs to rely on violations of HIPAA as the basis for bringing state privacy, retaliation or other actions. See, e.g. Sorensen v. Barbuto, 143 P.3d 295 (Utah Ct. App. 2006), Acosta v. Byrum, 638 S.E. 2d 246 (N.C. Ct. App. 2006). Private plaintiffs employed by covered entities also claim HIPAA related misconduct as the basis for their retaliation claims. See, e.g.,  Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim.

HIPAA-specific exposures, wrongful use, access or disclosure of medical information also can expose covered entities, members of their workforce and others improperly using, accessing or disclosing protected health information to liability under other federal or state laws. See, Cybercrime & Identity Theft: Health Information Security Beyond HIPAA; NY AG Cuomo Announcement of 1st Settlement For Violation of NY Security Breach Notification Law; Woman Who Revealed AIDs Info Gets A Year.

These and other developments make clear that covered entities and their business associates must get serious about HIPAA compliance and risk management. These organizations should review and tighten privacy policies, breach and other monitoring, training and other practices to mitigate against exposures in light of recently tightened requirements and new enforcement risks.

For More Details Or Help With HIPAA & Other Risk Management & Compliance Needs

To learn more about the UCLAHS Resolution Agreement and other risk management tips, see UCLA Health Systems Payment of $865,000 To Settle HIPAA Charges Shows Rising HIPAA Risk.

If you need assistance monitoring federal health reform, 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, can 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 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 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.  For instance, On May 3, 2011, Ms. Stamer served as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR and will moderate a teleconference featuring comments by OCR’s Susan McAndrew for the Joint Committee on Employee Benefits scheduled for May 16. Her insights on the required “culture of compliance” with HIPAA also recently were quoted in medical privacy related publications of the Atlantic Information Service. Among others, she has conducted privacy training 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, employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. To ask for legal help with these or other compliance concerns, inquire about arranging for compliance audit or training, or matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here. You can review other publications and resources and additional information about the employment, employee benefits and other experience of Ms. Stamer here and register to receive future updates about developments on these and other concerns from Ms. Stamer here. For important information concerning this communication click here.Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources available at www.solutionslawpress.com.

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS. ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

 

©2011 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press. All other rights reserved.


4th Circuit Rejects Affordable Care Act Constitutional Challenges In 2 Suits

September 8, 2011

The Fourth Circuit this morning (September 8, 2011) published decisions ruled rejecting two lawsuits challenging the constitutionality of the Patient Protection and Affordable Care Act on jurisdictional grounds in Liberty University v. Geithner and Commonwealth of Virgina v. Sebelius.

These decisions add to the growing differences of opinions about the Constitutionality of the Affordable Care Act among the various trial and appeals courts.    These disparities make it increasingly likely that the Supreme Court eventually will decide the issue.  Absent unforsee circumstances, however, any Supreme Court resolution is unlikely to come before the next round of health plan and exchange deadlines start taking effect in 2012 and the lack of agreement among the courts means that most health care providers and others impacted by the Affordable Care Act must continue to plan and comply absent new rulings or other guidance to the contrary. 

If you have about the decisions or other questions about Affordable Care Act or other health care, health plan or related matters, please contact the author, Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or (469) 767-8872.


Health Care Reform’s 1st Birthday: Share What You Think!

March 23, 2011

On the 1st anniversary of the passage of Health Care Reform,  let’s celebrate by accepting the invitation from Joe Biden to “discuss how health care reform is already working.”

Below is the text of an e-mail I (and millions of other Americans, I suspect, received an e-mail from Joe Biden, in which he touts health care reform  as already saving patients like a young man from Minnesota.  In the e-mail, Biden says:  “On the one-year anniversary of the Affordable Care Act, I think we have a duty to discuss how reform is already working.”  OK, tell me what you think?

Unquestionably, health care reform produces some winners and loosers.  Although few of the reforms enacted are actually in effect yet, Biden says heath care reform is working and credits the law for saving the life of the young man and millions of others.   On the other hands, many patients and doctors treating patients with cancer and other life threatening illnesses complain and report fears that in the future increasing Medicare, Medicaid or other government regulations and market distruptions.    Some folks think it’s all good.  Other’s think it’s all bad.  Many American’s think it’s a little bit of both and many just don’t know.

Where does the truth lie?  On the 1st anniversary of the passage of health are reform, one thing is certain.  The American health care system and it’s impact on our employees, families, friends, communities and goverment and personal budget’s is too great to be complacent.  So, as Health Care Reform turns one, let’s accept the invitation of Vice President Biden and share our experiences and thoughts with our elected representatives, regulators,  with others on with others on the Coalition for Responsible Health Care Policy linkedin a the following link and keep the discussion going until we get it right:   

Coalition for Responsible Health Care Policy 

Here’s the e-mail from “Joe Biden [info@barackobama.com]”

Cynthia –I want to tell you about a family in Minnesota.

Justin and Kari live in Brooklyn Park, right outside of Minneapolis. They’re parents to three children. Their three-year-old, William, was born with a genetic disorder called tuberous sclerosis complex.

For the rest of his life, William will wrestle with tumors in his brain, his heart, his kidneys, his skin, and possibly other major organs. He must take medication to control seizures and faces the threat of kidney disease.

What Justin and Kari want for William is a future. And because of health reform, that’s what he’ll have.

Today, insurance companies are no longer able to discriminate against William because of the condition he’s dealt with since birth. Now, Justin and Kari know they’ll be able to get the kind of care that William needs — today and into the future.

Their story isn’t unique, but it’s one of many that need to be told. We all know people whose lives have been changed because of the Affordable Care Act, even if we don’t realize it. So we’ve found a way to show exactly how reform is working for all of us — for our parents, our siblings, our kids, ourselves.

Will you take a minute to take our Health Reform Checkup and let the people you love know how reform is working for them?

Before the Affordable Care Act, Justin and Kari weren’t sure about the future. They worried that they’d never be able to find coverage for William again if Justin lost his job. They worried about the life that William would lead — whether he’d ever be able to work or support a family.

Not anymore. William’s condition isn’t going away, but he’ll always be able to get care. The Affordable Care Act is one year old today, and it has already changed William’s life — and this country — for good.

Today, there are families who feel better about the future than they did a year ago. They’ve found some security, some relief. And these are people we know. They’re our neighbors, our colleagues, our friends, our families — the people next to us every day.

On the one-year anniversary of the Affordable Care Act, I think we have a duty to discuss how reform is already working.

Watch Justin and Kari tell their story, and take a moment to learn how health reform is changing the lives of those you know:

 

 

A year ago, I stood next to the President as he signed health reform into law — and we have you to thank for making that possible.

 

  

Yours,

 

  

Joe

Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.

Paid for by Organizing for America, a project of the Democratic National Committee — 430 South Capitol Street SE, Washington, D.C. 20003. This communication is not authorized by any candidate or candidate’s committee.

 


States Get More Info On Affordable Care Act Medicaid Eligibility Maintenance Of Effort; Payers & Providers Must Monitor

March 7, 2011

On February 27, 2011, Department of Health and Human Services Secretary Kathleen Sebelius issued a new letter and a frequently asked questions (FAQ) document that explain Medicaid and Children’s Health Insurance Program (CHIP) provisions in the Affordable Care Act in ways that afford greater flexibility to States.  The new guidance clarifies aspects of the maintenance of effort (MOE) rules for Medicaid and CHIP.  According to HHS, added guidance will follow.  In these turbulent financial times, states are likely to welcome guidance that allows them more flexibility.  While HHS and the states work out the detaails of these rules, health care providers and health plans also must keep a close eye out for developments that may require changes in enrollment or coverage coordination procedures to ensure their ability to comply with these evolving requirements.

The Medicaid MOE provision in the Affordable Care Act generally ensures that States’ eligibility rules for adults under the Medicaid program remain in place pending implementation of eligibility rules changes that become effective in January 2014.  The MOE provision for children extends to 2019.

The letter and supporting FAQ document released February 27, 2011 address three aspects of the MOE provisions:

  • The MOE exemption for higher-income adult populations in States that are experiencing budget deficits.  Under the Affordable Care Act, if a State has or projects a budget deficit, the MOE provision does not apply to adults who are not eligible for coverage on the basis of pregnancy or disability and whose incomes are above 133 percent of the Federal poverty level.  The FAQ document explains State options and how States can seek this exemption.
  • The implication of the MOE provision on Section 1115 demonstration projects.  Some States cover groups of people under Medicaid through a Section 1115 demonstration.  As explained in the FAQ document, the MOE provision generally applies to these waivers and demonstrations.  However, waivers and demonstration are, by their terms, time limited.  The guidance clarifies that the MOE provision does not require States to seek a new or renewed waiver after the expiration of their waiver or demonstration.
  • How premiums are treated under the MOE requirements.  Because premiums and premium increases have an impact on eligibility, previous guidance under the Recovery Act explained that new or increased premiums were considered to be a violation of the Recovery Act MOE requirement.  Because the period during which the Affordable Care Act MOE provisions apply is considerably longer than the MOE period under the Recovery Act, this new guidance offers States additional flexibility relating to premiums and the MOE requirements under the Affordable Care Act.  This will help a number of States that have been requesting the ability to adjust premiums for populations such as children in CHIP with family incomes above 150 percent of the Federal poverty line.

For Help With Compliance, Investigations Or Other Needs

If you need assistance responding to or monitoring changes in Medicaid, CHIP or other federal or state health program eligibility rules or dealing with 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 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies and to respond to OCR, FTC, medical board and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on Medicare quality and other compliance concerns.  Her publications and insights on HIPAA 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.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Office of Civil Rights Proposes Changes To HIPAA Privacy, Security & Civil Sanctions Rules

July 9, 2010

Stay Tuned To Solutions Law Press For More Details

Get ready for even tighter privacy and security rules and more enforcement!  The U.S. Department of Health & Human Services Office for Civil Rights (OCR) on July 8, 2010 proposed changes to its existing Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Enforcement Rules in response to amendments enacted under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Because of the lead time required to implement needed changes in policies, technology and training, health care providers, health plans, healthcare clearinghouses and their business associates should evaluate and begin preparations to adjust their health information privacy and data security policies and practices in anticipation of the finalization and implementation of these rules. 

The more than 220 page Notice of Proposed Rulemaking (NPRM) proposes to revise the existing Standards for Privacy of Individually Identifiable Health Information (Privacy Rule); the Security Standards for the Protection of Electronic Protected Health Information (Security Rule); and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

Solutions Law Press is finalizing arrangements to host a briefing on the proposed changes in August and planning more detailed updates on these developments.  Stay tuned to Solutions Law Press for additional updates and details about a future briefing on these proposed HIPAA changes and other developments affecting HIPAA and other health plan and human resources matters.   In the meanwhile, you may want to check out other existing Solutions Law Press updates and resources about HITECH Act and other HIPAA developments such as HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with HIPAA and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

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. A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about health industry and other related 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 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. For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here. To unsubscribe, e-mail here.

©2010 Solutions Law Press. All rights reserved.


OIG Touts Expanding Health Care Fraud Enforcement Success & Launches New Health Care Fraud Hotline

May 20, 2010

Continuing expansion of health care fraud enforcement initiatives, the Office of Inspector General (OIG) recently released its Health Care Fraud and Abuse Control Program Report and launched a new online Fraud Hotline Website to allow individuals the option of reporting federal health care fraud suspicions to OIG online.

The May 12 launch of the Fraud Hotline Website means whistleblowers now can report suspected federal health care fraud to OIG over the Internet, by telephone or by mail. CMS hopes the addition of online fraud reporting capability will lead to more investigations, audits and/or monetary recoveries. 

OIG followed up May 13, by releasing its latest Health Care Fraud and Abuse Control Program Report, In addition to detailing 2009 healthcare fraud enforcement activities and accomplishments, the Report also highlights the continuing success of its HEAT initiative as well as new enforcement tools created by the recent health care reform legislation, the “Fraud Enforcement and Recovery Act of 2009”(FERA) and other recent developments that facilitate the ability of OIG and the Justice Department to prosecute and secure larger fines and penalties from healthcare providers engaging in health care fraud.  For more information, read the OIG Press Release here.

The heightened emphasis by federal officials on enforcement of federal health care fraud laws and the implementation of tools like the new Fraud Hotline Website increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.  These and other activities are part of a significant ramp up in federal emphasis on the detection and prosecution of violations of federal health care fraud laws by both the Administration and Congress.  Many state agencies also are stepping up their health care fraud investigations and enforcement. In light of this new emphasis upon health care fraud detection and enforcement, health care providers now more than ever need to prepare to demonstrate the appropriateness and defensibility of their health care billing and other compliance efforts.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. 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 Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

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 22 years experience advising health industry clients about these and other matters.  A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about these and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, 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, 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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here. To unsubscribe, e-mail here.

©2010 Solutions Law Press.  All rights reserved.


CMS Proposes FY 2011 Acute Care & Long-Term Care Inpatient Policy & Payment Rate Changes

April 20, 2010

June 18, 2010 is the deadline for health care providers and other concerned parties to comment on proposed Medicare inpatient acute care and long-term are hospital stay policy and payment rate changes announced by the Centers for Medicare & Medicaid Services (CMS) on Monday, April 19 2010.  CMS intends to publish a final rule by August 1, 2010.

CMS issued the proposed fiscal year (FY) 2011 policies and payment rates for inpatient services furnished to people with Medicare by both acute care hospitals and long-term care hospitals on Monday.  The proposed rule does not address inpatient hospital related provisions of the recently enacted Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively the “Affordable Care Act”).  

In the proposed Medicare payment rates announced April 19, CMS proposes update acute care hospital rates by a slight 2.4 percent for inflation and to apply an adjustment of -2.9 percentage points to recoup one-half of the estimated excess spending in FY 2008 and 2009 aggregate payments, due to changes in hospital coding practices that CMS says did not reflect increases in patients severity of illness.  Legislation passed in 2007 requires CMS to recoup the entire amount of FY 2008 and 2009 excess spending from changes in hospital coding practices by FY 2012.  CMS estimates that payments to general acute care hospitals under the proposed rule for operating expenses in FY 2011 will decline by 0.1 percent, or $142 million, compared with FY 2010, and taking into account all factors that would affect spending.

CMS concurrently is similarly proposing to update long-term care hospital (LTCH) rates by 2.4 percent for inflation and apply an adjustment of -2.5 percentage points for the estimated increase in spending in FYs 2008 and 2009 due to documentation and coding that did not reflect increases in patients’ severity of illness.  Based on these two proposed provisions and other proposed changes, CMS estimates that payments to LTCHs would increase by 0.8 percent or $41 million. 

Interested parties may review the proposed regulation here. More information about the proposed rule, including the documentation and coding adjustment and the RHQDAPU changes and HACs discussion, can be found in Fact Sheets on the CMS Website here. CMS warns that the projected inflation updates for both types of hospitals may be revised in the final rule based on more recent data.

The proposed rule would apply to approximately 3,500 acute care hospitals paid under the Inpatient Prospective Payment System (IPPS), and approximately 420 long-term care hospitals paid under the Long-Term Care Hospital Prospective Payment System (LTCH PPS), beginning with discharges occurring on or after October 1, 2010.  Proposed payment rates are based on the most recently available data and may be revised in the final rule to reflect more current data.

Under current law, hospitals that successfully report quality measures included in the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program will receive the full update for 2011.  Hospitals that do not participate in the quality reporting program will get the update less two percentage points.  Based on the required reporting in 2009, 96 percent of participating hospitals are receiving the full update this year. 

CMS is proposing to add 45 measures to the RHQDAPU set for reporting in 2011.  However, only 10 of the proposed measures, including rates of occurrence for eight of 10 categories of conditions that are subject to the hospital-acquired conditions (HACs) policy, will be considered in determining a hospital’s FY 2012 update.  The remaining 35 measures would be considered in determining the hospital’s FY 2013 update, and hospitals would not be required to report all of the proposed registry-based measures.  The proposed use of registries would prevent hospitals from having to report the same data twice.  In addition, CMS is proposing to retire one existing measure for reporting mortality for selected surgical procedures.

For Assistance With Health Industry Concerns

If your organization needs advice or help with the proposed regulation, preparing or submitting comments on the regulation or with other health care matters, contact Cynthia Marcotte Stamer at (469) 767-8872 or via e-mail here

Vice President of the North Texas Health Care Compliance Professionals Association, Exempt Organization Vice-Coordinator of the Southern States IRS TEGE Council, Chair of the American Bar Association (ABA) Real Property, Probate & Trust Section Employee Benefits & Other Compensation Arrangements Group, a Council Member of the ABA Joint Committee On Employee Benefits Council, 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 22 years experience advising health industry clients about these and other matters.    A popular lecturer and widely published author on health industry matters, Ms. Stamer advises hospitals and other health industry clients about responding to and using these and other quality measures and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns.  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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact Cynthia Marcotte Stamer, at (469) 767-8872 or to cstamer@solutionslawyer.net.. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information to 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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


TSHHRAE Provides Health Industry Managers Employment Law Update & Other Timely Management Training At April Barnstorm 2010: Creating Effective Leaders Programs

March 23, 2010

Get Details & Registration Information here!

A Legal Update on Employment Law presentation by Attorney Cynthia Marcotte Stamer is among 5 hours of “Barnstorm 2010: Creating an Effective Leaders-Tools of the Trade” management training that the Texas Society for Healthcare Human Resources Administration and Education (TSHHRAE) will be hosting for health industry human resources and other managers in five Texas cities between April 26 and April 30, 2010. 

Interested health industry human resources and other managers can elect to participate in TSHHRAE’s Barnstorm 2010 management training at the following dates and locations:  

  • April 26 – Weslaco, Knapp Medical Center
  • April 28 – Sweetwater, Rolling Plains Memorial Hospital
  • April 28 – Brenham, Trinity Medical Center
  • April 29 – Lubbock, University Medical Center
  • April 30 – Odessa, Medical Center Hospital

Update on Employment Law Program Highlights

Ms. Stamer’s Legal Update on Employment Law Program will address:

  • Recent changes in FMLA, Military Leave, wage and hour, ADA & other disability, COBRA, GINA, HIPAA and other selected federal & Texas employment laws and regulations;
  • Rising government enforcement of EEOC, HIPAA, wage & hour, worker classification, and other laws and regulations;
  • Recent developments and increases in retaliation claims;
  • Recent cases related to supervision; and
  • Other selected developments impacting health industry human resources management.

Other Barnstorm 2010 Program Highlights and Details

In addition to the Legal Update on Employment Law that Ms. Stamer is scheduled to present, the Barnstorm Program also will feature presentations on:

  • Leadership in 2010
  • Dealing with Poor Performers; and
  • Cultivating a Superstar

For registration and other information about the Barnstorm Program, see here.

About Ms. Stamer

Nationally and internationally recognized for more than 22 years of work with health industry and other organizations, publications, workshops and presentations and leadership on health industry and other labor and employment, staffing and credentialing, employee benefits, performance management and discipline, regulatory compliance and internal controls, risk management, and public policy matters, Ms. Stamer is Chair of the Curran Tomko Tarski Labor & Employment & Health Care Practice Groups, Vice President of the North Texas Health Care Compliance Professionals Association, Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, Chair of the American Bar Association (ABA) RPTE Employee Benefits & Other Compensation Committee, a Council Representative on the ABA Joint Committee on Employee Benefits and past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group, Ms. Stamer is.  The publisher of Solutions Law Press HR & Benefits Update, the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update and a former legal columnist for MD News, Ms. Stamer also is a popular speaker and author of these topics.  She regularly speaks and conducts training for the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, Harris County Medical Society, the Medical Group Management Association, SHRM, Southwest Benefits Association and many other organizations.  Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others.  You can review other highlights of Ms. Stamer’s health care experience here, and employment experience hereHer insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@cttlegal.com or 214.270.2402. 

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More Information

We hope that this information is useful to you.  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 at here or e-mailing this information here. To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


House Could Vote On Health Care Reform As Early As Sunday

March 19, 2010

By Cynthia Marcotte Stamer

The stage now appears to be set for the House of Representatives to vote as early as Sunday on the latest version of health care reform backed by President Obama, Speaker Nancy Pelosi and other key Congressional Democrats, the Reconciliation Act of 2010 (H.R. 4872).  The impending deadline means that health industry providers and other Americans concerned about the potential outcome of the impending vote need to act quickly if they wish to attempt to influence the decision. For tips about sharing your input with Congress effectively, see Getting Your Health Care Reform Message Heard By Key Congressional Leaders.

Developments Today Start Clock Running For Vote

On Thursday, March 18, 2010, two key developments set the stage for a vote on H.R. 4871 as early as Sunday:

  • The House Rules Committee posted the text of H.R. 4872 on its website; and
  • The Congressional Budget Office (CBO) delivered its scoring of H.R 4872 to House Speaker Nancy Pelosi.

The delivery of CBO scoring started the clock running on the 72 hour mandatory period between the release of the CBO scoring and any final vote on the bill. This means the House could vote on H.R. 4872 as early as Sunday, March 21. 

If passed by the House, H.R. 4872 would make sweeping changes to the U.S. health care system impacting virtually every American patient, health care provider, employer and taxpayer.  To learn the facts about these proposed changes, read the full text of H.R. 4872 here.  

According to the CBO, H.R. 4872 will cost $940 billion over 10 years to extend coverage to 32 million uninsured people.  To learn more specifics about these cost and other determinations, review the CBO scoring here.

This Is Only The Beginning: Stay Involved

The outcome of this latest health care reform push is only a small part of a continuing process.  Whether or not the President’s proposal or some other version of health care reform passes this week, Congress already has and will continue to consider other legislation impacting health care reform.  This reality is demonstrated by Congressional actions recently taken on the COBRA premium subsidy extension, Medical reimbursement for physicians, continuing federal efforts to develop and implement federal health care quality and technology standards, and other legislative, regulatory and enforcement actions taken while public attention has been focused largely only on the broader health care reform debate.

Upcoming mid-term elections will significantly impact the nature and scope of these upcoming efforts.  Perhaps even more significantly, the enactment of legislation is only a beginning point.  The real meaning of these or other health care reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye.  Monitoring and staying active in these ongoing processes provides a critical opportunity to continue to monitor your issues and provide input to shape how they are addressed.

Individuals concerned about these and other health care reform proposals and concerns are invited to stay involved in the discussion by sharing their input with Congress, regulators.  Concerned individuals also are invited to stay involved in the discussion by joining the Coalition for Responsible Health Care Reform Group on Linkedin and registering to receive these updates here. The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health industry clients and others about a diverse range of health care policy, regulatory, compliance, risk management and operational concerns.  You can get more information about her health industry experience here.  

Help Monitoring & Responding To Developments

If you need assistance evaluating or formulating comments on the proposed reforms contained in the House Bill or on other health industry matters please contact Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com or 214.270.2402. 

From her extensive involvement with federal and state legislative and regulatory licensing, telemedicine, managed care, privacy and other health, pension and other reforms in the U.S. to her involvement as a lead advisor to the Government of Bolivia on its pension privatization legislation, Ms. Stamer’s experience includes significant experience working with clients domestically on key health care and other public policy matters.  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 Chairman of the Board of Richardson Development Center for Children and past Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer couples her policy experience with her extensive experience working with health industry clients on regulatory, staffing, reimbursement, risk management and compliance and other operational matters.  She has more than 22 years experience advising health industry clients about these and other matters.    A popular lecturer and widely published author on health industry matters, Ms. Stamer advises hospitals and other health industry clients about responding to and using these and other quality measures and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns.  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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information to cstamer@cttlegal.com.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


Medicare Ends Fox Insurance Company Drug Plan Contract As CMS Turns Up Heat on Medicare Advantage & Part D Plan Enforcement & Oversight

March 16, 2010

By Cynthia Marcotte Stamer

The Centers for Medicare & Medicaid Services (CMS) terminated its Medicare Part D prescription drug coverage contract with Fox Insurance Company (Fox) on March 9, 2010.    The action highlights CMS’s growing scrutiny and enforcement of Medicare requirements against Medicare Part D, Medicare Advantage Plans and other federal health care program contractors.

CMS terminated the Fox contract after CMS found the failure by Fox’s plan and services to meet Medicare’s requirements to provide enrollees with prescription drugs according to recognized standards of care jeopardized the health and safety of Fox enrollees.   When announcing the contract termination, CMS reported that an on-sight review by CMS showed that Fox committed a series of violations, including improperly denying its enrollees coverage of critical HIV, cancer, and seizure medications. CMS issued an enrollment and marketing sanction to Fox on Feb. 26, 2010, because the organization was not following Medicare’s rules for providing prescription drug coverage to its enrollees.   According to CMS, an onsite audit conducted between March 2 and March 4 showed that Fox’s problems persisted and that Fox continued to subject its enrollees to obstacles in getting sustaining medicines or other needed medications.  Among other things, CMS found Fox:

  • Failed to provide access to Medicare prescription drugs benefits by imposing unapproved prior authorization and step therapy criteria that made it more difficult for beneficiaries to get drugs that are protected by law;
  • Failed to meet the plan’s appeals deadlines; and
  • Did not comply with Medicare regulations requiring enrollees to be transitioned to new drugs at the beginning of the new plan year.
  • Failed to notify enrollees about prior authorization and step therapy determinations as required by Medicare.

CMS also found that many of the obstacles were in place to limit access to high-cost drugs, which could have led to enrollees’ clinical needs not being met.

In many cases, CMS reported that Fox required enrollees to have unnecessary and invasive medical procedures before they were able to obtain drugs. Finding that Fox was unable to satisfactorily address these compliance concerns and furnish medicines to its Medicare enrollees, CMS immediately terminated the Fox contract.

At the time of the termination, more than 123,000 Medicare beneficiaries were enrolled in Fox plans. Beginning March 10, 2010, CMS indicated that LI-NET, a Medicare run program administered by Humana, would replace the Medicare Part D coverage of  enrollees affected by the Fox contract termination on an interim basis. Fox enrollees will be able to choose a new Medicare prescription drug plan through May 1, 2010. Current enrollees who do not choose a plan will be enrolled into a new plan by Medicare. CMS is sending letters explaining the actions taken by CMS to enrollees and has established a 1-800 number to receive questions.

The action against Fox is part of an ongoing series of oversight, disciplinary and enforcement actions by CMS against Medicare Advantage and other federal health care program participants.  These programs and CMS’ oversight and enforcement of federal programs are drawing increasing Congressional scrutiny in connection with Congressional health care reform efforts. Amid this heightened scrutiny, Medicare Part D and Medicare Advantage Plans; health care providers, administrative services providers and others contracting with these plans and others involved with this programs should take appropriate action to maintain compliance, tighten their contracts with and oversight of actions of partners and vendors performing critical functions; review complaint reporting, investigation and response processes and procedures; and strengthen other practices to minimize exposures to audit or other enforcement actions.

For Assistance With Medicare Managed Care or Other Matters

If your organization needs advice or assistance about Medicare Part D or other Medicare Advantage contracting or other requirements or about other health plan or health care matters, consider contacting the author of this article, Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail here

Past Chair of the ABA Health Law Section Managed Care & Insurance Section, Chair of the American Bar Association RPTE Employee Benefits & Compensation Committee and an ABA Joint Committee on Employee Benefits Council member,  Ms. Stamer has more than 22 years experience advising health plans, health care providers, and other health industry and insurance clients.  Her experience includes specific experience assisting Medicare, Medicaid and other health plan sponsors, administrators,  or administrative services providers about contracting, compliance, coverage and other matters.    A popular lecturer and widely published author on health industry matters, Ms. Stamer also conducts compliance and other training on Medicare Advantage and other contract and compliance matters, as well as a broad range of other health industry related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns.  Her insights on health industry 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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent updates available online by clicking on the article title:

You can review other recent health plan, health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here; e-mailing this information to cstamer@cttlegal.com; or registering to participate in the distribution of these and other Solutions Law Press updates here. For important information concerning this communication click here.   

To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


Southern States Collect Largest Share of $162 Million AARA Fund Meaningful Use Development Grants

March 16, 2010

By Cynthia Marcotte Stamer

Southern states are the big winners among the 16 states and qualified state designated entities (SDEs) to share in the approximately $162 Million in American Recovery and Reinvestment Act of 2009 (ARRA) fund grants to facilitate the development of health information exchange and advance health information technology (health IT) announced by the U.S. Department of Health and Human Services HHS today (March 15, 2010).

Drawn from the $2 billion in funding set aside in ARRA to promote widespread meaningful use of health IT and use of an electronic health record, the following  health information exchange awards seek to facilitate to facilitate non-proprietary health information exchange that adheres to national standards widely perceived as critical to enabling care coordination and improving the quality and efficiency of health care.

The recipients and award amounts of the grants announced today are:

  • Texas Health and Human Services Commission, $28,810,208
  • Florida Agency of Health Care Administration, $20,738,582
  • New Jersey Health Care Facilities Financing Authority, $11,408,594
  • Louisiana Health Care Quality Forum, $10,583,000
  • State of Mississippi, $10,387,000
  • Indiana Health Information Technology, Inc., $10,300,000
  • The Maryland Department of Health and Mental Hygiene, $9,313,924
  • South Carolina Department of Health & Human Services, $9,576,408
  • Iowa Department of Public Health, $8,375,000
  • State of Connecticut Department of Public Health, $7,297,930
  • Nebraska Department of Administrative Services, $6,837,180
  • South Dakota Department of Health, $6,081,750
  • Idaho Health Data Exchange, $5,940,500
  • State of North Dakota, Information Technology Department,  $5,343,733
  • State of Alaska, $4,963,063

Additional information about the state HIE program may be found here.  Other information about other health IT programs funded through ARRA generally can be found at here.

For Assistance With This Opportunity Or Other Health Industry Concerns

If your organization needs advice or assistance with commenting on the AHRO proposal or to respond to other health care quality or other health care matters, consider contacting the author of this article, Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail here

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 22 years experience advising health industry clients about these and other matters.    A popular lecturer and widely published author on health industry matters, Ms. Stamer advises hospitals and other health industry clients about responding to and using these and other quality measures and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry quality, regulatory, reimbursement, and other operations, risk management and public policy concerns.  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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

Other Recent Developments & Resources

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

We hope that this information is useful to you.  If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information to cstamer@cttlegal.com.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2010 Cynthia Marcotte Stamer.  All rights reserved.


HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website

February 25, 2010

By Cynthia Marcotte Stamer

The Department of Health and Human Services Office of Civil Rights (OCR) has begun posting on its website the names and certain information about health care providers, health insurers,  employer and other health plans, health care clearinghouses and their business associates (Covered Entities) reporting to OCR “breaches” of “unsecured protected health information” (UPHI) under new breach notice rules added by the Health Information Technology for Economic and Clinical Health Act (HITECH Act).

Covered Entities should anticipate the posting of the breach information and other HITECH Act breach notices coupled with amendments to the medical privacy and security requirements of the Health Insurance Portability & Accountability Act (HIPAA) effective since February 17, 2010, will heighten enforcement risks and public sensitivities about medical information privacy safeguards.  As failing to comply with the amended rules effective February 17, 2010 can trigger obligations under the Breach Regulations and other significant liability exposures, Covered Entities should act quickly to manage these emerging risks.

Covered Entity Breach Notification Requirements

The initial list of Covered Entities reporting  breaches of UPHI affecting 500 or more individuals posted by OCR on February 22, 2010 discloses the Covered Entity’s name and State, the approximate number of individuals affected, the date and type of breach and the location of the breached information. OCR’s posting of this information is required under the HITECH Act breach notification requirements as part of its implementation and enforcement of new breach notification requirements added to HIPAA by Section 13402(e)(3) of the HITECH Act.

The HITECH Act amended HIPAA to require Covered Entities to require Covered Entities provide notification to individuals, OCR and others when certain breaches of UPHI happen.  The implementing interim “Breach Notification For Unsecured Protected Health Information” regulations (Breach Regulation) published by OCR here require Covered Entities subject to HIPAA to notify affected individuals, OCR and in some cases the media within specified periods following a “breach” of UPHI occurring on or after September 23, 2009 unless the Covered Entity can demonstrate that the breach qualified as exempt from the breach notification obligation under the Breach Regulations.

Covered Entities generally should consider the need to provide breach notification under the Breach Regulation whenever electronic or non-electronic protected health  information which is not adequately encrypted or destroyed to qualify as “secured” under the breach rules is used, accessed or disclosed in violation of HIPAA.  

Since the potential need to provide breach notification is triggered by an impermissible use, access or disclosure of UPHI, up-to-date maintenance, monitoring and enforcement is at the heart of compliance with the Breach Regulation as well as HIPAA generally.

You can review the currently posted list of Covered Entities that have reported breaches on the OCR website here.  Learn more about the Breach Regulation requirements here

Broader & Stricter Medical Privacy Mandates Effective 2/17/210

The new breach notification requirements are part of a series of changes made to HIPAA under the HITECH Act that are increasing the responsibilities and liability exposures of Covered Entities. On February 17, 2010, Covered Entities and their business associates also became subject to tighter federal requirements for the use, access, protection and disclosure of protected health information under amendments to HIPAA’s Privacy & Security Standards enacted in the HITECH Act. When the HITECH Act was signed into law on February 17, 2009, Covered Entities also became subject to expanded sanctions and remedies for HIPAA violations.

To comply with the HITECH Act changes to HIPAA effective on February 17, 2010, most Covered Entities and their business associates generally will need to update their written policies, operational procedures, technical safeguards, privacy notices, vendor and other agreements, training, and other management procedures in several respects. For more details, see here.

While the HITECH Act gave Covered Entities and business associates a year to complete the necessary arrangements to comply with these HITECH Act changes, many Covered Entities and business associates have not adequately implemented the necessary arrangements. To mitigate these exposures, Covered Entities and their business associates should act quickly to review and update their policies, procedures, training, business associate and other services agreements, and other practices and procedures, as well as to implement the training, oversight, and other management necessary to comply with the HITECH Act changes and to mitigate other HIPAA risks.

Exposures Significant & Growing

HIPAA-associated exposures for Covered Entities are significant and growing. Timely action to comply with the amended HIPAA requirements and Breach Regulations is important to avoid triggering the breach notification requirements; to prevent loss of public trust and reputation;  and to minimize exposures to legal actions, administrative complaints and sanctions and the  investigation, defense and correction costs likely to result when a Covered Entity violates or is accused of violating HIPAA or otherwise mishandling medical or other personal information. 

Even before the HITECH Act changes became effective, federal regulators were stepping up HIPAA enforcement. The HITECH Act amendments further increase the risk that Covered Entities violating HIPAA face investigation and sanction. The HITECH Act amendments increase the likelihood that Covered Entities violating HIPAA will get caught and will face some form of damage or penalty assessment.  Heightened awareness of UPHI breaches resulting from HITECH Act mandated breach notifications are likely to fuel new HIPAA-related complaints, charges and demands.  Covered Entities, workforce members who wrongfully access protected health information now face potential civil penalties,  criminal prosecution, civil lawsuits and other actions. Allowing state attorneys general to bring suit adds more manpower to the enforcement team.   Furthermore, the wrongful use, access or disclosure of protected health information or other confidential information also increasingly is the basis of civil or criminal actions brought under a variety of other federal and state laws.

New Risks Created By HITECH Act Amendments

Heightened HIPAA exposures stem in part from the HITECH Act’s amendments to HIPAA’s remedy provisions.  Among other things, the HITECH Act amended HIPAA to:

  • Allow a State Attorney General to sue Covered Entities that commit HIPAA violations after February 16, 2009 for damages caused to state citizens;
  • Expand the mandate by OCR to investigate violations and audit compliance with HIPAA;
  • Require OCR to impose civil sanctions against Covered Entities and business associates involved in violations of HIPAA in accordance with tightened standards added to HIPAA by the HITECH Act;
  • Revise the criminal sanctions that the Department of Justice can seek against Covered Entities and others for violations of HIPAA; and
  • Amend HIPAA to make clear that workforce members and others improperly using, accessing or disclosing protected health information in violation of HIPAA can face criminal prosecution.

State Attorney General Lawsuit Exposures

Covered Entities must be concerned about the potential that a state Attorney General may bring civil suit to remedy damages caused to state citizens by a breach of HIPAA.  In certain situations, the HITECH Act empowers a state attorney general to sue Covered Entities for damages if their HIPAA violations harm state citizens. Statutory damages equal to the sum of the number of violations multiplied by 100 up to a maximum of $25,000 per calendar year plus attorneys fees and costs are authorized.

A HIPAA civil lawsuit demonstrates the willingness of at least some states to exercise the new authority to sue Covered Entities. On January 13, 2010 Connecticut Attorney General Richard Blumenthal sued Health Net of Connecticut, Inc. (Health Net) for failing to secure private patient medical records and financial information involving 446,000 Connecticut enrollees and promptly notify consumers endangered by the security breach.   The first attorney general enforcement action brought based on amendments made to HIPAA under the HITECH Act, Connecticut charges that Health Net violated HIPAA by failing to safeguard protected medical records and financial information on almost a half million Health Net enrollees in Connecticut then allowing this information to remain exposed for at least six months before notifying authorities and consumers. The suit also names UnitedHealth Group Inc. and Oxford Health Plans LLC, who have acquired Health Net. 

Stepped Up Federal Enforcement

Even before the HITECH Act amendments, OCR and Department of Justice increased HIPAA investigation and enforcement.  The Department of Justice has obtained a variety of criminal convictions against violators of HIPAA.  See, e.g., 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health InformationMeanwhile, OCR also is emphasizing HIPAA enforcement.  In February, 2009, OCR announced that CVS Pharmacies, Inc. would pay $2.25 million to resolve HIPAA charges.  This announcement followed OCR’s announcement in July, 2008 that Providence Health Care would pay $100,000 to resolve HIPAA violation charges.  OCR also has taken HIPAA enforcement actions against a broad range of other Covered Entities. See more details hereWhile not resulting in the significant payments involved in CVS or Providence, all Covered Entities involved in these and other enforcement actions or investigations have incurred significant legal and other defense costs, loss of community trust, or both.

In addition to these HIPAA-specific exposures, wrongful use, access or disclosure of medical information also can expose Covered Entities, members of their workforce and others improperly using, accessing or disclosing protected health information to liability under other federal or state laws.  Federal and state prosecutors may and increasingly do bring criminal or civil actions against organizations or individuals for improperly accessing or using medical or other personal information under a variety of other federal or state laws .  See e.g., Cybercrime & Identity Theft: Health Information Security Beyond HIPAA; NY AG Cuomo Announcement of 1st Settlement For Violation of NY Security Breach Notification Law; Woman Who Revealed AIDs Info Gets A Year

State Civil Lawsuits

Covered Entities also need to prepare to defend HIPAA-related conduct in state civil actions.  Individual plaintiffs increasingly used alleged HIPAA violations in state privacy, negligence, retaliation, wrongful discharge or other lawsuits.  State courts have allowed private plaintiffs to use the obligations imposed by HIPAA as the basis of a Covered Entity’s duty for purposes of certain state law lawsuits.  In  Sorensen v. Barbuto, 143 P.3d 295 (Utah Ct. App. 2006), for example, a Utah appeals court ruled a private plaintiff could use HIPAA standards to establish that a physician owed a duty of confidentiality to his patients for purposes of maintaining a state law damages claim.  Similarly, the Court in Acosta v. Byrum, 638 S.E. 2d 246 (N.C. Ct. App. 2006) ruled that a plaintiff could use HIPAA to establish the “standard of care” in a negligence lawsuit. Meanwhile, disgruntled employees or other business partners performing services for  Covered Entities also increasingly are pointing to HIPAA as the basis for their retaliation or wrongful discharge claims. See, e.g.,  Retaliation For Filing HIPAA Complaint Recognized As Basis For State Retaliatory Discharge Claim. Read more here

Coupled with the HITECH Act changes, these and other enforcement actions signal growing potential hazards for Covered Entities that  fail to properly manage their HIPAA compliance obligations and risks. To help guard against these exposures, Covered Entities should act quickly to strengthen their HIPAA defenses by updating policies, contracts, practices, security, training, oversight, documentation and management.

Covered Entities & Business Associates Urged To Act Promptly To Manage Mitigating Expanded HIPAA Risks & Obligations

Faced with these expanding obligations and exposures, Covered Entities should prepare for the need to defend the adequacy of their HIPAA compliance efforts on paper and in operation. As part of these efforts, Covered Entities should consider:

  • Reviewing the adequacy of the practices, policies and procedures of the Covered Entities, business associates, and others that may come into contact with protected health information within the scope of attorney-client privilege taking into consideration the Corrective Action Plan, published OCR noncompliance and enforcement statistics, their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable;
  • Updating policies, privacy and other notices, practices, procedures, training and other practices as needed to promote compliance and defensibility;
  • Renegotiating and enhancing service provider agreements to detail the specific compliance obligations of each party; to clarify the respective rights, procedures and responsibilities of each party in regards to compliance audits, investigation, breach reporting, and mitigation; to clarify rights of indemnification; and other related relevant matters;
  • Improving technological and other tracking, documentation and safeguards and controls to the use, access and disclosure of protected health information;
  • Conducting well-documented training as necessary to ensure that members of the Covered Entity’s workforce understand and are prepared to comply with the expanded requirements of HIPAA, can detect potential breaches or other compliance concerns, and understand and are prepared to follow appropriate procedures for reporting and responding to suspected violations;
  • Tracking actual and near miss violations and making adjustments to policies, practices, training, safeguards and other compliance components as necessary to deter future concern
  • Establishing and providing well-documented monitoring of compliance;
  • Establishing and providing well-documented timely investigation and redress of reported violations or other compliance concerns;
  • Establishing contingency plans for responding in the event of a breach;
  • Establishing a well-documented process for monitoring and updating policies, practices and other efforts in response to changes in risks, practices and  requirements;
  • Preparing and maintaining a well-documented record of compliance activities; and
  • Pursuing other appropriate strategies to enhance the Covered Entity’s ability to demonstrate its compliance commitment both on paper and in operation.

For Assistance With Compliance Or Other Concerns

The author of this article,  Ms. Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. 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 the author of this article, Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or another Curran Tomko Tarski LLP attorney of your choice.  You can get more information about the CTT Health Care Practice  and more specifics about Ms. Stamer’s health industry experience here.

Ms. Stamer is nationally known for her work, training and presentations, and publications on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts. 

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 22 years experience advising clients, conducting workshops and other training, and providing policy advice about health care, privacy, data security, and other matters. She advises health care providers, health insurers and administrators, employer and other health plan sponsors, employee benefit plan fiduciaries, schools, financial services providers, governments and others about privacy and data security, health care, insurance, human resources, ERISA, technology, and other legal and operational concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters. A widely published author on privacy, data security, health care and other related matters, Ms. Stamer is the author of “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of other highly regarded publications. Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

Other Helpful Resources & Other Information

If you found these updates of interest, you also be interested in one or more of the following other recent articles:

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 at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2010 Cynthia Marcotte Stamer.  All rights reserved. 


Federal HEAT & Other Federal Health Care Fraud Efforts Score More Than 15 Successes As OIG Claims $20.97 Billion Saved From Enforcement Activities In December

December 30, 2009

As the interagency Medicare Fraud Strike Force targeting Medicare Fraud scored another series of more than 15 successful criminal enforcement actions across the national during December, 2009, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) credited the Medicare Fraud Strike Force and other stepped up oversight and enforcement activities as helping it achieve $20.97 Billion in Medicare and other federal health care program savings during Fiscal Year 2009 in its Semiannual Report to Congress

The Detroit convictions were among three of more than 15 other criminal enforcement successes reported by the Department of Justice during December.  These and other reports document the rising prosecution and enforcement risks that health care providers face for failing to tailor their billing and other practices to comply with federal health care fraud laws.  In light of the growing enforcement and emphasis of federal prosecutors and regulations on the detection and prosecution of organizations and individuals participating in billing or other activities that violate federal health care fraud laws, health care organizations, their officers, directors, employees, consultants and other business partners should tighten practices and step up oversight to minimize the likelihood that they or their organizations will engage in activities that federal regulators view as federal health care fraud.

December 13 Detroit Criminal Convictions

The U.S. Department of Justice Criminal Division (Justice Department), Federal Bureau of Investigation (FBI) and Inspector General for the U.S. Department of Health and Human Services (HHS) jointly announced Friday (December 11, 2009) that Baskaran Thangarasan, Sandeep Aggarwal and Wayne Smith had plead guilty for their roles in connection with several Detroit-area health care fraud scheme.

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud and Aggarwal plead guilty to one count of conspiracy to launder money. On December 11, 2009, Smith plead guilty to one count of conspiracy to commit health care fraud.

  • Thangarasan Guilty Plea To Conspiracy To Commit Health Care Fraud

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud. And Aggarwal plead guilty to one count of conspiracy to launder money. He faces a maximum sentence of 10 years in prison and a $250,000 fine at sentencing.

According to information contained in plea documents, Thangarasan, a licensed physical therapist, admitted that he began working in approximately September 2003 as a contract therapist for a co-conspirator. This co-conspirator owned and controlled several companies operating in the Detroit area that purported to provide physical and occupational therapy services to Medicare beneficiaries. Thangarasan admitted that he, the co-conspirator and others created fictitious therapy files appearing to document physical therapy services provided to Medicare beneficiaries, when in fact no such services had been provided. According to court documents, the fictitious services reflected in the files were billed to Medicare through sham Medicare providers controlled by Thangarasan’s co-conspirators.

Thangarasan admitted that his role in creating the fictitious therapy files was to sign documents and progress notes indicating he had provided physical therapy services to particular Medicare beneficiaries, when in fact he had not. Thangarasan was paid approximately $50 by co-conspirators per file that he falsified in this manner. Thangarasan also admitted that in the course of the scheme charged in the indictment, he signed approximately 1,011 fictitious physical therapy files, falsely indicating he had provided physical therapy services to Medicare beneficiaries. Thangarasan admitted he knew that the files he helped falsify were used to justify fraudulent billings to Medicare.

In addition, Thangarasan admitted that between approximately September 2003 and May 2006, his co-conspirators submitted claims to the Medicare program totaling approximately $5,055,000 for files that were falsified by Thangarasan. Medicare actually paid approximately $2,325,000 on those claims. Thangarasan admitted that throughout the conspiracy, he was fully aware that Medicare was being billed for occupational therapy services he had falsely indicated he had performed.

  • Aggarwal Guilty Plea to Money Laundering

Aggarwal faces a maximum sentence of 20 years in prison and a $500,000 fine after admitting in the same case to assisting co-conspirator Suresh Chand in laundering the proceeds of Chand’s Medicare fraud scheme. Chand, who pleaded guilty in September 2009 to conspiracy to commit health care fraud and conspiracy to launder money, admitted to conspiring to submit approximately $18 million in fraudulent physical and occupational therapy claims to the Medicare program. Aggarwal, who admitted working at Chand’s office, acknowledged that his role in the scheme was to set up sham entities at Chand’s direction, with the purpose of using those entities to distribute the proceeds of the fraud to the various co-conspirators. According to plea documents, one such entity was called Global Health Care Management Services. Aggarwal admitted that Global Health Care Management Services, which he helped create, provided no health or management services of any type, but existed solely as a mechanism to conceal the location of fraudulently obtained Medicare proceeds. Aggarwal admitted in his plea that he and Chand laundered approximately $393,000 through this sham entity.

  • Smith Guilty Plea To Conspiracy To Commit Health Care Fraud

At sentencing, Smith face a maximum sentence of 10 years in prison and a $250,000 fine for his participation in a scheme to falsely bill Medicare.  His indictment charged that he transported and paid Medicare beneficiaries to attend Sacred Hope Center, a Southfield, Mich.-infusion clinic. According to the indictment, the Medicare beneficiaries he paid and transported were paid to sign paperwork indicating that they had received infusions and injections of specialty medications that they did not in fact receive.

According to the indictment, Sacred Hope Center routinely billed the Medicare program for services that were medically unnecessary and/or never provided. The primary owners and operators of Sacred Hope Center have pleaded guilty and admitted purchasing only a small fraction of the medications that the clinic billed the Medicare program for providing. These co-conspirators have also stated that patients were prescribed medications at the clinic based not on medical need, but instead based on which medications were likely to generate Medicare reimbursements.

Other Criminal Enforcement Actions During December

The Detroit convictions are three of nearly 20 successful criminal enforcement activities that DOJ announced during December, 2009.  During the same month, DOJ also announced:

  • On December 20, 2009, sentencing of an Audiologist to six months in prison for Medicare Fraud in California  here
  • On December 17, 2009 , the guilty plea and sentencing of a Houston physician for operating an illegal pill mill here
  • On December 16, 2009, the sentencing in Michigan of the owner of health care agency to 18 months prison in Medicare kickback scheme here
  • On December 15, 2009, the sentencing of a Lexington. South Carolina doctor to perform community service in a health care fraud case  here
  • On December 15, 2009, the guilty plea of a Plymouth, Minnesota man to defrauding Medicaid out of $74,000  here
  • On December 14, 2009, the sentencing of a Miami, Georgia man to more than a decade in Federal prison for million dollar Medicaid fraud here
  • On December 11, 2009, the charging of a durable medical equipment company and six other defendants in Pennsylvania in a Medicare Fraud And Kickback Scheme here
  • On December 11, 2009, the guilty plea of an Aulander, North Carolina woman to $650,000 Health Care Fraud  here
  • On December 7, 2009, the guilty plea of a corporation various health care fraud schemes here
  • On December 6, 2009, the guilty plea of a Dallas, Texas durable medical equipment business owner to aggravated id theft in a Medicare Fraud scheme  here
  • On December 3, 2009, the arrest of the owner of a Florida home health care provider and his alleged accomplice for a scheme to bribe a government contractor  here
  • On December 3, 2009, the conviction of two defendants for Health Care Fraud in Idaho here
  • On December 2, 2009, the entry of an order requiring a Sioux City, Iowa hospital to pay $400,000 to resolve false claims allegations  here
  • On December 1, 2009, the admission by a Maryland man to health care fraud on a hospital in the District of Columbia  here
  • On December 1, 2009, the arrest of a Miami, Florida man for obstructing a Health Care Fraud Investigation here
  • On December 1, 2009, the $125,000  fine of a Michigan chiropractor for Falsifying Records here

HEAT Operations Continued & Expanded

The Detroit and many of these other criminal successes resulted from joint investigations by the FBI and the OIG as part of the Medicare Fraud Strike Force as part of various interagency Medicare Fraud “Strike Forces” operating in several regions of the U.S. as part of the continuing Health Care Fraud Prevention and Enforcement Action Team (HEAT) operations of the FBI, HHS and the Justice Department which DOJ credits with producing more than 250 criminal convictions since their inception,  Based on initial successes of Strike Force operations in Miami (Phase One) and  Los Angeles (Phase Two), the Justice Department and HHS on May 20, 2009 expanded the scope of these operations to include Detroit and Houston Strike Force teams. Recently, DOJ and HHS announced the expansion of its HEAT operations to include Strike Force teams also targeting health care fraud in Brooklyn, New York; Tampa, Florida and Baton Rouge, Louisiana.

The heightened emphasis on enforcement of federal health care fraud laws reflected in the HEAT program the enactment of recent amendments to the False Claims Act, 31 U.S.C. § 3729 (FCA)  under the “Fraud Enforcement and Recovery Act of 2009”(FERA).  The FERA amendments increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.

The FERA amendments and the HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws by both the Administration and Congress.  President Obama’s proposed Fiscal Year 2010 budget seeks to further increase funding for fraud prevention and enforcement by investing $311 million — a 50 percent increase from 2009 funding — to strengthen program integrity activities within the Medicare and Medicaid programs.  The Obama Administration anticipates that all combined, the anti-fraud efforts in the President’s budget could save $2.7 billion over five years by improving oversight and stopping fraud in the Medicare and Medicaid programs, including the Medicare Advantage and Medicare prescription drug programs.  Many state agencies also are stepping up their health care fraud investigations and enforcement.

Health Care Providers Must Step Up Compliance & Risk Management

In light of this new emphasis upon health care fraud detection and enforcement, health care providers now more than ever need to prepare to demonstrate the appropriateness and defensibility of their health care billing and other compliance efforts.

Solutions Law Press author and Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. You can get more information about the CTT Health Care Practice  and more specifics about Ms. Stamer’s health industry experience here on the CTT Website.

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 Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402, CTT White Collar Defense Litigation Practice Chair Edwin J. Tomko at etomko@cttlegal.com, or  214.270.1405 or another Curran Tomko Tarski LLP attorney of your choice.. 

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 other updates on HEAT activities such as the following:

Other recent updates that also may be of interested published on our electronic Solutions Law Press Health Care Update publication include:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject here.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


HEAT Initiative Snares Health Fraud Related Guilty Pleas of Physical Therapist, Money Launderer and Patient Recruiter In Detroit

December 14, 2009

By Cynthia Marcotte Stamer

The interagency Medicare Fraud Strike Force targeting Medicare Fraud in the Detroit area scored another series of criminal convictions last week. 

The U.S. Department of Justice Criminal Division (Justice Department), Federal Bureau of Investigation (FBI) and Inspector General for the U.S. Department of Health and Human Services (HHS) jointly announced Friday (December 11, 2009) that Baskaran Thangarasan, Sandeep Aggarwal and Wayne Smith had plead guilty for their roles in connection with several Detroit-area health care fraud scheme.

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud and Aggarwal plead guilty to one count of conspiracy to launder money. On December 11, 2009, Smith plead guilty to one count of conspiracy to commit health care fraud.

Thangarasan Guilty Plea To Conspiracy To Commit Health Care Fraud

On December 9, 2009, Thangarasan plead guilty to one count of conspiracy to commit health care fraud. And Aggarwal plead guilty to one count of conspiracy to launder money. He faces a maximum sentence of 10 years in prison and a $250,000 fine at sentencing.

According to information contained in plea documents, Thangarasan, a licensed physical therapist, admitted that he began working in approximately September 2003 as a contract therapist for a co-conspirator. This co-conspirator owned and controlled several companies operating in the Detroit area that purported to provide physical and occupational therapy services to Medicare beneficiaries. Thangarasan admitted that he, the co-conspirator and others created fictitious therapy files appearing to document physical therapy services provided to Medicare beneficiaries, when in fact no such services had been provided. According to court documents, the fictitious services reflected in the files were billed to Medicare through sham Medicare providers controlled by Thangarasan’s co-conspirators.

Thangarasan admitted that his role in creating the fictitious therapy files was to sign documents and progress notes indicating he had provided physical therapy services to particular Medicare beneficiaries, when in fact he had not. Thangarasan was paid approximately $50 by co-conspirators per file that he falsified in this manner. Thangarasan also admitted that in the course of the scheme charged in the indictment, he signed approximately 1,011 fictitious physical therapy files, falsely indicating he had provided physical therapy services to Medicare beneficiaries. Thangarasan admitted he knew that the files he helped falsify were used to justify fraudulent billings to Medicare.

In addition, Thangarasan admitted that between approximately September 2003 and May 2006, his co-conspirators submitted claims to the Medicare program totaling approximately $5,055,000 for files that were falsified by Thangarasan. Medicare actually paid approximately $2,325,000 on those claims. Thangarasan admitted that throughout the conspiracy, he was fully aware that Medicare was being billed for occupational therapy services he had falsely indicated he had performed.

Aggarwal Guilty Plea to Money Laundering

Aggarwal faces a maximum sentence of 20 years in prison and a $500,000 fine after admitting in the same case to assisting co-conspirator Suresh Chand in laundering the proceeds of Chand’s Medicare fraud scheme. Chand, who pleaded guilty in September 2009 to conspiracy to commit health care fraud and conspiracy to launder money, admitted to conspiring to submit approximately $18 million in fraudulent physical and occupational therapy claims to the Medicare program. Aggarwal, who admitted working at Chand’s office, acknowledged that his role in the scheme was to set up sham entities at Chand’s direction, with the purpose of using those entities to distribute the proceeds of the fraud to the various co-conspirators. According to plea documents, one such entity was called Global Health Care Management Services. Aggarwal admitted that Global Health Care Management Services, which he helped create, provided no health or management services of any type, but existed solely as a mechanism to conceal the location of fraudulently obtained Medicare proceeds. Aggarwal admitted in his plea that he and Chand laundered approximately $393,000 through this sham entity.

Smith Guilty Plea To Conspiracy To Commit Health Care Fraud

At sentencing, Smith face a maximum sentence of 10 years in prison and a $250,000 fine for his participation in a scheme to falsely bill Medicare.  . 

Smith pleaded guilty to an indictment that charged he transported and paid Medicare beneficiaries to attend Sacred Hope Center, a Southfield, Mich.-infusion clinic. According to the indictment, the Medicare beneficiaries he paid and transported were paid to sign paperwork indicating that they had received infusions and injections of specialty medications that they did not in fact receive.

According to the indictment, Sacred Hope Center routinely billed the Medicare program for services that were medically unnecessary and/or never provided. The primary owners and operators of Sacred Hope Center have pleaded guilty and admitted purchasing only a small fraction of the medications that the clinic billed the Medicare program for providing. These co-conspirators have also stated that patients were prescribed medications at the clinic based not on medical need, but instead based on which medications were likely to generate Medicare reimbursements.

HEAT Operations Continuing

The cases are being investigated by the FBI and the HHS Office of the Inspector General. Theses cases were brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and U.S. Attorney’s Office for the Eastern District of Michigan.

The investigation resulting in these guilty pleas were conducted as part of a series of interagency Medicare Fraud “Strike Forces” operating in several regions of the U.S. as part of the continuing Health Care Fraud Prevention and Enforcement Action Team (HEAT) operations of HHS and the Justice Department.  Based on initial successes of Strike Force operations in Miami (Phase One) and  Los Angeles (Phase Two), the Justice Department and HHS on May 20, 2009 expanded the scope of these operations to include Detroit and Houston Strike Force teams.

The heightened emphasis on enforcement of federal health care fraud laws reflected in the HEAT program the enactment of recent amendments to the False Claims Act, 31 U.S.C. § 3729 (FCA)  under the “Fraud Enforcement and Recovery Act of 2009”(FERA).  The FERA amendments increase the likelihood both that whistleblowers will turn in health care providers and other individuals and organizations that file false claims in violation of the FCA and the liability that violators may incur for that misconduct.

The FERA amendments and the HEAT Team and Strike Force activities are part of a broader emphasis in the enforcement of federal health care fraud laws by both the Administration and Congress.  President Obama’s proposed Fiscal Year 2010 budget seeks to further increase funding for fraud prevention and enforcement by investing $311 million — a 50 percent increase from 2009 funding — to strengthen program integrity activities within the Medicare and Medicaid programs.  The Obama Administration anticipates that all combined, the anti-fraud efforts in the President’s budget could save $2.7 billion over five years by improving oversight and stopping fraud in the Medicare and Medicaid programs, including the Medicare Advantage and Medicare prescription drug programs.  Many state agencies also are stepping up their health care fraud investigations and enforcement.

In light of this new emphasis upon health care fraud detection and enforcement, health care providers now more than ever need to prepare to demonstrate the appropriateness and defensibility of their health care billing and other compliance efforts.

Solutions Law Press author and Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care practitioners and other businesses and business leaders to establish, administer, investigate and defend health care fraud and other compliance and internal control policies and practices to reduce risk under federal and state health care and other laws. 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 Cynthia Marcotte Stamer, CTT Health Care Practice Group Chair, at cstamer@cttlegal.com, 214.270.2402 or your other favorite Curran Tomko Tarski LLP attorney. 

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 other updates on HEAT activities such as the following:

Other recent updates that also may be of interested published on our electronic Solutions Law Press Health Care Update publication include:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject here.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


HIT Policy Committee’s Nationwide Health Information Network Workgroup Meets December 16, 2009

December 1, 2009

The Office of the National Coordinator for Health Information Technology (ONC) HIT Policy Committee’s Nationwide Health Information Network Workgroup will hold a public meeting on December 16, 2009.  The meeting is scheduled from 10 a.m. to 5 p.m./Eastern Time at the OMNI Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC. Members of the public care invited to participate live, via telephone, or Webcast.  For details about options for participation, instructions to present input, and other details, see here.

For More Information

We hope that this information is useful to you.  If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters.  You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


HIT Committee To Meet October 14 In Washington, D.C.

September 29, 2009

The next meeting of the HIT Standards Committee of the Office of the National Coordinator for Health Information Technology (ONC) will be held on October 14, 2009, from 9 a.m. to 3 p.m./Eastern Time at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC. The hotel telephone number is 202-234-0700. Interested members of the public are invited to attend. 

Created under the American Recovery and Reinvestment Act of 2009 (ARRA), the HIT Standards Committee is charged with making recommendations to the Office of National Coordinator for Health Information Technology (ONC) on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee.   Even as Congress debates further reforms, the activities of the HIT Committee and other components of the ONC are key actors in the continuing efforts of the Obama Administration to promote health care efficiency by reengineering health care technology.

During a previous meeting on August 20, 2009, the HIT Committee finalized certain recommendations concerning meaningful use of electronic medical records, clinical quality, and privacy and security of protected health information, which are available for review here.

According to the ONC announcement regarding the upcoming meeting in today’s (September 29, 2009) Federal Register available here, the Committee plans during the meeting to:

  • Discuss reports from its Clinical Operations, Clinical Quality, and Privacy and Security Workgroups
  • Take testimony from invited experts in the field of security as it relates to health information technology

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 6, 2009. Oral comments from the public will be scheduled between approximately 2:30 p.m. to 3 p.m. Time allotted for each presentation may be limited. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business.

ONC hopes to make background material available to the public at least two (2) business days prior to the meeting. However, if ONC is unable to post the background material on its Web site before the meeting, it will make that material publicly available at the location of the advisory committee meeting, and post the background material on ONC’s web site after the meeting here.

The designated person to contact for additional information is Jonathan Ishee, Office of the National Coordinator, HHS, 200 Independence Ave, SW., Room 729-G, Washington, DC 20201, 202-205-8493, Fax: 202-690-6079, e-mail: jonathan.ishee@hhs.gov.

If you need assistance preparing or presenting comments to the HIT Standards Committee or with monitoring or responding to other health care IT, privacy and data security, regulatory, operational, public policy or other health care concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Chair and Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Updates available online by clicking on the applicable article title below:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here, registering to receive updates in blog form here or e-mailing this information to support@solutionslawyer.net.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


Baucus Health Care Reform Proposal Calls For Significant Tightening In Tax-Exemption Rules

September 22, 2009

Senate Finance Set To Begin Markup Sessions Today – Repeal of Rebuttable Presumption Rule In Reasonable Compensation Rules, Other Tightening of Requirements Threatened

With Senate Finance Committee meetings to mark up Chairman Max Baucus’ health care reform proposal as outlined in his 220-page “Chairman’s Mark of America’s Healthy Future Act of 2009” (the “Baucus Proposal”) scheduled to begin today (September 22, 2009), tax-exempt health care and other non-profit organizations should evaluate carefully proposed amendments that could impact their tax-exempt status or related obligations.  The proposed amendments have serious implications for non-profits within and beyond the health care industry.

Markup Scheduled To Begin Tuesday

The Senate Committee on Finance began meeting today (September 22, 2009) to negotiate how to convert into proposed legislation the Baucus Proposal introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

Since no text of the proposed legislation itself has been released yet, it is impossible to fully evaluate the specific nature and implications of the Baucus Proposal.  While this week’s planned Senate Finance Committee mark up will further clarify these matters, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals nevertheless provides significant insight of what health care organizations can expect to be discussed and, in all likelihood incorporated into the draft legislation ultimately proposed in some form.  Accordingly, tax-exempt health care organizations should carefully evaluate and act promptly to share their input with members of the Senate Finance Committee and other members of Congress about a series of proposed amendments that would impact their tax-treatment and other responsibilities.

All Tax-Exempts Should Monitor Proposals To Shift Burden Of Proof On Compensation Reasonability & Expanded IRS Powers

Among a multitude of proposed tax amendments, tax-exempt organizations inside and outside the health care industry will want to keep a a close eye on discussions and proposals to amend the Baucus Proposal to further modify the tax-exemption requirements for tax-exempt hospitals and other tax-exempt organizations.  Late last week, Ranking Member Senator Chuck Grassley submitted a proposal to amend the Baucus Proposal to further tighten tax-exemption requirements in two material respects likely to generally concern tax-exempt organizations:

  • For the stated purpose of avoiding wasteful legal challenges to the management and governance questions on the revised Form 990, to specifically grant statutory authority to the Internal Revenue Service to ask management and governance questions on the Form 990; and
  • To make it easier for the Internal Revenue Service to challenge as unreasonable compensation payments made by tax-exempt entities by shifting the burden to the taxpayer of proving the reasonability of compensation and removing the burden currently borne by the Internal Revenue Service of going forward with the evidence on comparability.  This would be accomplished by overruling the rebuttable presumption of reasonableness currently set forth in Treasury Regulation § 53.4958-6 of the intermediate sanctions rules and replacing it with a requirement that public charities due diligence demonstrate that their compensation payments meet the 3 current elements of the presumption:
    • Review by an authorized body made of members without a conflict of interest
    • Use of appropriate data as to comparability and
    • Adequate and contemporaneous documentation. This amendment is expected to raise revenue, according to the summary.

Given the potential implications of these proposed amendments, tax-exempt health care and other organizations should keep a close eye on proposed tax provisions of the Baucus Proposal and other related proposals.

Proposal To Tighten Other Tax-Exemption & Reporting Requirements For Tax-Exempt Hospitals

While the Senate Finance Committee as of yet has not released text of the proposed legislation itself, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals and other subsequently proposed amendments to the Baucus Proposal reveal other plans to materially change the tax-exemption qualification, governance and reporting requirements for tax-exempt hospitals beyond the proposal to create CO-OPs.  Among other things, the Baucus Proposal calls for the Internal Revenue Code § 501(c)(3) and its related provisions to be amended to require tax-exempt hospitals:

  • To conduct or participate in and share with the public a community-needs analysis with input from a broad cross section of the community at least once every 3 years and thereafter to report on its implementation, including explaining where applicable why identified needs were unaddressed.  These additional requirements would supplement rather than replace existing community benefit standards already generally applicable to charitable entities
  • To provide non-discriminatory emergency care
  • To have, implement and widely disseminate a written financial assistance policy  defining among other things:
    • The rules for determining who qualifies for financial assistance
    • How the hospital determines amounts to be billed to patients in manner that provides for patient discounts to be based on Medicare rates, “best” commercial rates or other approved statutory measures rather than “chargemaster rates”
    • Require hospital to notify patients of the financial assistance policy on admission, on bills and in telephone calls of its financial assistance policy before initiating various collection actions or reporting the account to a credit rating agency
  • To make its audited financial statements (and where applicable, the consolidated financial report of any entity of which it is a part) available widely
  • The Internal Revenue Service (IRS) to conduct a SEC-type review of each 501(c)(3) hospital’s community benefit activities at least once every three years based on data reported on Schedule H of the Form 990
  • The IRS and the Department of Health and Human Services (HHS)  to report annually to Congress on community benefit activities of non-governmental tax-exempt hospitals, charity care, bad debt, and unreimbursed costs of government programs (means-tested and non-means-tested) incurred by tax-exempt, taxable, and governmental hospitals.

CO-Ops As Health Coverage Alternative

Much more widely discussed is the Chairman’s CO-OP proposal.  The Baucus Proposal calls for the creation of a new vehicle to provide an alternative source of health care coverage called “CO-Ops.”  As contemplated by the Baucus Proposal, CO-Ops would be associations controlled by a beneficiary board unrelated to existing organizations providing health insurance as of July 16, 2009.  Subject to their meeting non-inurement and other common existing requirements for charitable status as well as other conditions, CO-Ops would be able to apply for tax-exempt status as well as federal funding.

New Taxes and Fees On Insurers & Others

The Baucus Proposal proposes to finance its health care reforms through a variety of mechanisms including, excise taxes and penalties on employers and individuals that fail to purchase the government specified health care package, taxes on premiums paid for health insurance coverage in excess of certain specified annual limits, the imposition of certain premium taxes and “sector fees” on healthcare insurers (with some exceptions possible under certain circumstances for certain 501(c)(3) and (c)(4) HMOs not providing commercial-type insurance within the meaning of Section 501(m)).

Other Baucus Proposal Highlights

In its current summary form, the 220-page Baucus Proposal includes a host of other sweeping reforms, which are certain to be further expanded and refined during this week’s scheduled Senate Finance Committee markup session.  Many of these other proposed reforms were highlighted in an overview of the Baucus Proposal published hereYou can join the discussion of these and other proposed health care forms and exchange updates and other resources about health care reform and related concerns by registering to participate in the Coalition For Responsible Health Care Policy Group on Linkedin.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Health Care Updates available online by clicking on the article title below:

 

For More Information

We hope that this information is useful to you.  If you need assistance with health care compliance, risk management, reimbursement, staffing, credentialing, transactional, operational or public policy concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.  Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and related matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here, by e-mailing this information to support@cttlegal.com or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

©2009 Curran Tomko Tarski LLP.  All rights reserved.


Baucus’ America’s Healthy Future Act of 2009 Calls For Significant Tightening of Tax Exemption Rules

September 21, 2009

Senate Finance Set To Begin Markup Session Proposal September 22 – Repeal of Rebuttable Presumption Rule In Reasonable Compensation Rules, Other Tightening of Requirements Threatened

With Senate Finance Committee meetings to mark up Chairman Max Baucus’ health care reform proposal as outlined in his 220-page “Chairman’s Mark of America’s Healthy Future Act of 2009” (the “Baucus Proposal”) scheduled to begin tomorrow (September 22, 2009), tax-exempt health care and other non-profit organizations should evaluate carefully proposed amendments that could impact their tax-exempt status or related obligations in addition to the widely-discussed proposal to create “Consumer Operated and Oriented Plans (CO-OPs).

Markup Scheduled To Begin Tuesday

The Senate Committee on Finance plans on Tuesday, September 22, 2009 to hash out how to convert into proposed legislation the health care reform proposal outlined in the “Chairman’s Mark America’s Healthy Future Act of 2009” introduced by Committee Chairman Max Baucus on September 16, 2009, the text of which may be reviewed here.

Since no text of the proposed legislation itself has been released yet, it is impossible to fully evaluate the specific nature and implications of the Baucus Proposal.  While this week’s planned Senate Finance Committee mark up will further clarify these matters, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals nevertheless provides significant insight of what health care organizations can expect to be discussed and, in all likelihood incorporated into the draft legislation ultimately proposed.  Accordingly, tax-exempt health care organizations should carefully evaluate and act promptly to share their input with members of the Senate Finance Committee and other members of Congress about a series of proposed amendments that would impact their tax-treatment and other responsibilities.

Proposal To Tighten Tax-Exemption & Reporting

Requirements For Tax-Exempt Hospitals

While the Senate Finance Committee as of yet has not released text of the proposed legislation itself, a review of the description of changes proposed by Chairman Baucus in the Baucus Proposals and other subsequently proposed amendments to the Baucus Proposal reveal plans to materially change the tax-exemption qualification, governance and reporting requirements for tax-exempt hospitals beyond the proposal to create CO-OPs.  Among other things, the Baucus Proposal calls for the Internal Revenue Code § 50!(c)(3) and its related provisions to be amended to require:

  • The hospital to conduct or participate in and share with the public a community-needs analysis with input from a broad cross section of the community at least once every 3 years and thereafter to report on its implementation, including explaining where applicable why identified needs were unaddressed.  These additional requirements would supplement rather than replace existing community benefit standards already generally applicable to charitable entities
  • The hospital to provide non-discriminatory emergency care
  • The hospital to have, implement and widely disseminate a written financial assistance policy  defining among other things:
    • The rules for determining who qualifies for financial assistance
    • How the hospital determines amounts to be billed to patients in manner that provides for patient discounts to be based on Medicare rates, “best” commercial rates or other approved statutory measures rather than “chargemaster rates”
    • Require hospital to notify patients of the financial assistance policy on admission, on bills and in telephone calls of its financial assistance policy before initiating various collection actions or reporting the account to a credit rating agency
  • The hospital make its audited financial statements (and where applicable, the consolidated financial report of any entity of which it is a part) available widely
  • The Internal Revenue Service (IRS) to conduct a SEC-type review of each 501(c)(3) hospital’s community benefit activities at least once every three years based on data reported on Schedule H of the Form 990
  • The IRS and the Department of Health and Human Services (HHS)  to report annually to Congress on community benefit activities of non-governmental tax-exempt hospitals, charity care, bad debt, and unreimbursed costs of government programs (means-tested and non-means-tested) incurred by tax-exempt, taxable, and governmental hospitals.

In addition to the proposed amendments included in the Baucus Proposal as originally introduced, health care organizations also will need a close eye on discussions and proposals to amend the Baucus Proposal to further modify the tax-exemption requirements for tax-exempt hospitals and other health care organizations.  For instance, late last week, Ranking Member Senator Chuck Grassley submitted a proposal to amend the Baucus Proposal to further tighten requirements for tax-exempt health care organizations:

  • For the stated purpose of avoiding wasteful legal challenges to the management and governance questions on the revised Form 990, to specifically grant statutory authority to the Internal Revenue Service to ask management and governance questions on the Form 990; and
  • To make it easier for the Internal Revenue Service to challenge as unreasonable compensation payments made by tax-exempt entities by shifting the burden to the taxpayer of proving the reasonability of compensation and removing the burden currently borne by the Internal Revenue Service of going forward with the evidence on comparability.  This would be accomplished by overruling the rebuttable presumption of reasonableness currently set forth in Treasury Regulation § 53.4958-6 of the intermediate sanctions rules and replacing it with a requirement that public charities due diligence demonstrate that their compensation payments meet the 3 current elements of the presumption:
    • Review by an authorized body made of members without a conflict of interest
    • Use of appropriate data as to comparability and
    • Adequate and contemporaneous documentation. This amendment is expected to raise revenue, according to the summary.

With these provisions already targeting their tax-exempt status, tax-exempt hospitals and other non-profits and others likely to surface as the legislative discussion proceeds, tax-exempt health care and other organizations should keep a close eye on proposed tax provisions of the Baucus Proposal and other related proposals.

CO-Ops As Health Coverage Alternative

Much more widely discussed is the Chairman’s CO-OP proposal.  The Baucus Proposal calls for the creation of a new vehicle to provide an alternative source of health care coverage called  “CO-Ops.”  As contemplated by the Baucus Proposal, CO-Ops would be associations controlled by a beneficiary board unrelated to existing organizations providing health insurance as of July 16, 2009.  Subject to their meeting non-inurement and other common existing requirements for charitable status as well as other conditions, CO-Ops would be able to apply for tax-exempt status as well as federal funding.

New Taxes and Fees On Insurers & Others

The Baucus Proposal proposes to finance its health care reforms through a variety of mechanisms including, excise taxes and penalties on employers and individuals that fail to purchase the government specified health care package, taxes on premiums paid for health insurance coverage in excess of certain specified annual limits, the imposition of certain premium taxes and “sector fees” on healthcare insurers (with some exceptions possible under certain circumstances for certain 501(c)(3) and (c)(4) HMOs not providing commercial-type insurance within the meaning of Section 501(m)).

Other Baucus Proposal Highlights

In its current summary form, the 220-page Baucus Proposal includes a host of other sweeping reforms, which are certain to be further expanded and refined during this week’s scheduled Senate Finance Committee markup session.  Many of these other proposed reforms were highlighted in an overview of the Baucus Proposal published hereYou can join the discussion of these and other proposed health care forms and exchange updates and other resources about health care reform and related concerns by registering to participate in the Coalition For Responsible Health Care Policy Group on Linkedin.

 

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Solution Law Press Health Care Updates available online by clicking on the article title below:

For More Information

We hope that this information is useful to you.  If you need assistance with these or other health care public policy, regulatory, compliance, risk management, workforce and other staffing, transactional or operational concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other reimbursement, operations, internal controls and risk management matters. 

Ms. Stamer has extensive experience in these and other health industry related representation.  You can review other recent health care and related resources and additional information about the health industry and other experience of Ms. Stamer 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 at here, or e-mailing this information to cstamer@cttlegal.com, and/or by participating in the SLP Health Care Risk Management & Operations Group on LinkedIn.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


Two Recent Criminal Prosecutions For HIPAA Privacy Rule Violations Signal Rising Criminal Enforcement Risks

September 8, 2009

Register here  To Participate In September 9 or September 17 Briefings on New HIPAA Data Breach Rules

September 8, 2009

Two recent separate criminal actions against hospital workers for wrongfully accessed medical records in violation of the medical privacy provisions of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA) are the latest reminders to health care providers, health plans, health care clearinghouses, their business associates and members of their workforce that the criminal provisions of the HIPAA Privacy Rules have teeth. 

Palmetto General Hospital Employee And Accomplice Indicted For Stealing Patient Records As Part Of Fraud

 In Miami-Dade County, federal felony charges are pending against Jacquettia L. Brown, 29, and Tear Renee Barbary, 25, prosecution on for offenses relating to the theft of patient profile records from Palmetto General Hospital to further a fraud scheme.

A seven-count Indictment announced by the Department of Justice on May 26, 2009 charges Brown and Barbary with conspiracy to commit access device fraud in violation of Title 18, United States Code, Section 1029(b)(2), and criminal violations of HIPAA. In addition, Brown is charged with aggravated identity theft, in violation of Title 18, United States Code, Section 1028A(a)(1).  If convicted, the defendants face a statutory maximum of five (5) years’ imprisonment on Count 1, and a statutory maximum of ten (10) years’ imprisonment as to each of Counts 2, 3, and 7. As to Counts 4-6, Brown faces a two (2) year mandatory prison sentence per count. 

According to the Indictment, Brown, a medical records employee of Palmetto General Hospital, took records containing personal profile information of Palmetto General Hospital patients. Defendant Brown and Barbary then used the stolen personal information to further a credit card fraud conspiracy. The patient profile records that Brown stole included personal identifying information, such as patients’ names, birthdates, Social Security numbers, addresses, driver’s license numbers, and next of kin contacts. Brown used the stolen identifying information to obtain patients’ credit card account numbers. She gave patient profile records and credit card account numbers to Barbary, who used the information to make unauthorized credit card purchases. When law enforcement officials disrupted the scheme, Brown was in possession of 41 patient profile records and Barbary was in possession of six patient profile records.

Curiosity Check of Medical Records Results In Arkansas Doctor, 2 Former Hospital Employees Guilty Plea To HIPAA Violation

Three Arkansas health care workers could be sentenced to up to 1 year in prison, a fine of not more than $50,000, or both after pleading guilty in July, 2009 to misdemeanor violations of the health information privacy provisions of HIPAA for accessing a patient’s record without any legitimate purpose.

United States Magistrate Judge Henry L. Jones, Jr. accepted the guilty pleas of Dr. Jay Holland, age 56, of Little Rock, Arkansas; Sarah Elizabeth Miller, age 28, of England Arkansas; and Candida Griffin, age 34 of Little Rock, Arkansas after each admitted to accessing patient records to satisfy their own curiosity.

Dr. Holland, Medical Director of Select Specialty Hospital, located on the 6 floor of the St. Vincent Infirmary Medical Center (SVIMC), admitted that after watching news reports on television, he logged on to the SVIMC patient records from his computer at home and accessed a patient’s files to determine if the news reports were accurate. He admitted he accessed the file because he was curious even though he had had HIPAA training and understood he was violating HIPAA when he accessed the file. SVIMC suspended Dr. Holland’s privileges for two weeks and required him to complete on-line HIPAA training.

Sarah Elizabeth Miller, formerly an account representative at SVIMC, Sherwood Campus, was responsible for checking patients in and out of the clinic and for processing patient billing. In order to perform her duties, she had access to the SVIMC patient records program which includes all locations, not just that of the Sherwood clinic. Miller admitted that on October 20 and 21, 2008, she accessed a patient’s files approximately 12 times out of curiosity. She admitted that she accessed the records without any legitimate purpose. Records show that Miller was trained on HIPAA privacy laws by SVIMC. SVIMC fired Miller from her position.

Candida Griffin was the emergency room unit coordinator at SVIMC. Her responsibilities were to order patient tests, perform data entry into electronic patient files for patients and perform other secretarial functions in the emergency room. Griffin admitted that on October 20, 2008, she was told by the charge nurse to set-up an alias for a particular patient admitted to the emergency room. On October 21, 2008, after the patient had been moved to ICU, Griffin admitted that she became curious about the patient’s status and accessed the medical chart to find out if the patient was still living. Although Griffin did not inform anyone about accessing the chart, hospital records show that the patient’s records were accessed three times that day by Ms. Griffin. SVIMC records show that Griffin was trained on HIPAA privacy laws. SVIMC fired Griffin from her position.

Pursuant to plea agreements with the United States, Holland, Miller and Griffin pleaded guilty to a misdemeanor a violation of the health information privacy provisions of HIPAA based on their accessing a patient’s record without any legitimate purpose. Each faces a maximum penalty of 1 year imprisonment, a fine of not more than $50,000, or both. A sentencing date has not yet been set, but is expected within the next few weeks.

Criminal Referral and Enforcement Continues

Together with the HIPAA-related criminal convictions of in 2008 of David Gibson, Ferando Ferrer, Jr. and Andrea Smith discussed here, these new Arkansas and Florida criminal actions document the willingness of Justice Department attorneys to investigate and prosecute certain criminal violations.  Because they involved the theft of health information for use in furtherance of other health care fraud schemes, many have viewed as predictable and understandable the prosecution of Gibson, Ferrer, Brown and Barbary.  In contrast, the willingness of Jane W. Duke, United States Attorney for the Eastern District of Arkansas, to prosecute criminally the wrongful access by the SVIMC health care workers and Andrea Smith in the absence of other health care fraud motives challenges the perception widely held among certain segments of the health care and health plan industry that the criminal provisions of HIPAA have little teeth.  Since U.S. Attorney Duke pursued both the SVIMC and Smith prosecutions, it remains to be seen whether other U.S. Attorneys will be equally willing to pursue prosecution of HIPAA violations in the absence of evidence of other federal health care crimes.  

Less speculative is the growing readiness of the Department of Health & Human Services Office of Civil Rights to pursue civil remedies for HIPAA violations.  On February 18, 2009, for instance, OCR and the Federal Trade Commission (“FTC”) issued a joint announcement (the “Announcement”) ordering CVS Pharmacy, Inc., the nation’s largest retail pharmacy chain, to pay the U.S. government a $2.25 million settlement and to take other corrective action to ensure that it does not violate the privacy rights patients under HIPAA when disposing of patient information such as identifying information on pill bottle labels.  In a coordinated action, CVS Caremark Corp., the parent company of the pharmacy chain, also signed a consent order and agreed to a settlement with the FTC to settle potential violations of the FTC Act.  The investigation resulting in the settlement marks the first instance where the OCR formally coordinated on investigation and resolution of a case with the FTC. 

Coming as new data breach notification requirements for HIPAA-covered entities are set to take effect on September 23, 2009, these and other stepped up oversight and enforcement activities make it critical that all health care providers, health plans, health care clearinghouses and their business associates need to update their policies and practices, tighten their compliance and data breach monitoring processes, and strengthen their internal controls, compliance in preparation for defending their actions under the newly strengthened Privacy Rules.  Covered entities and their business associates more than ever must ensure their ability to demonstrate to federal regulators the effectiveness of their HIPAA compliance efforts by both adopting the written policies and procedures required by HIPAA and continuously monitoring and administering these safeguards.  Covered entities should consider reviewing the adequacy of their current HIPAA Privacy and Security compliance practices taking into consideration the Corrective Action Plan, published OCR noncompliance and enforcement statistics, their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable.

If you need assistance with auditing, updating or defending your organizations HIPAA and other privacy and data security practices, please contact Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer at (214) 270-2402 or via e-mail at CStamer@CTTLegal.com.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

  • HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP 
  • How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
  • Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Curran Tomko Tarski LLP Latest in Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending these or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information to cstamer@cttlegal.com.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


North Texas Healthcare Compliance Professional Association September 8 Meeting Covers Provider Outreach Activities, New Data Breach Rules.

September 4, 2009

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONAL ASSOCIATION

September 8, 2009 Meeting Reminder

North Texas Health Care Compliance Professional Association’s September, 2009 Meeting will feature a discussion by Adele Culpepper, Health Integrity, on Provider Outreach Activities, followed by a discussion of the new HIPAA Data Breach Regulations scheduled to take effect this month.

Date:  Tuesday, September 8, 2009,  2:00 – 4:00 p.m.

Location:          Offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas TX  76011.  Click here for a map and driving directions.

For additional information, please contact Cynthia Stamer at (214) 270-2402 or by e-mail at cstamer@solutionslawyer.net.  We look forward to seeing you there!

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles. The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

To register or update your registration or to receive notice of future meetings, e-mail here .  There is no charge to participate.

This communication may be considered a marketing communication for certain purposes.  If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading to here.


Pfizer To Pay $2.3 Billion For Fraudulent Marketing In Largest DOJ Health Care Fraud Settlement

September 2, 2009

Announcement Highlights Growing Fraud Prosecution Risks of Health Industry Businesses

Today’s announcement that Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (collectively “Pfizer”) will pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability for alleged illegal promotion of certain pharmaceutical products and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

The pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the alleged illegal promotion of certain pharmaceutical products, the Justice Department (DOJ) announced today (September 2, 2009).

According to DOJ, Pharmacia & Upjohn Company agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead.  Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. 

The Food, Drug and Cosmetic Act requires that a company specify the intended uses of a product in its new drug application to FDA.  Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA.  DOJ charged Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.  Under the announced settlement, Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter.  Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs.  The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs.  The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170.  This is the largest civil fraud settlement in history against a pharmaceutical company.

As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.  That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation.  As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.

Today’s announcement of this historic settlement emphasizes the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by pharmaceutical industry and other health care providers.  The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

The enhanced coordination among agencies central to this strategy is reflected in the collaboration among the many agencies involved in the investigation leading to these charges. The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases.  The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra.  The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.

These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

  • HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP 
  • How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
  • Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Curran Tomko Tarski LLP Latest in Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information to cstamer@cttlegal.com.

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 at here or e-mailing this information here.  To unsubscribe, e-mail here.

©2009 Cynthia Marcotte Stamer.  All rights reserved.


Health Care Providers & Other HIPAA-Covered Entities & Their Business Associates Must Comply With New HHS Health Information Data Breach Rules By September 24

August 24, 2009

Register Now To Participate in September 9  “HITECH Act Health Data Security & Breach Update”

Health care providers, health clearinghouses, health plans and their business associates generally must start complying with new federal data breach notification rules on September 24, 2009. 

The new “Breach Notification For Unsecured Protected Health Information” regulation (Breach Regulation) published here in today’s Federal Register requires health care providers, health plans, health care clearinghouses and their business associates (Covered Entities) covered under the personal health information privacy and security rules of the Health Insurance Portability & Accountability Act (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. The Breach Regulation is part of a series of guidance that HHS is issuing to implement new and stricter personal health information privacy and data security requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA).

You are invited to catch up on what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time.

HITECH Act Data Breach and Unsecured PHI Rules

Scheduled for publication in the Federal Register on August 24, 2009, the new Breach Regulation implements the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, when a breach of “unsecured protected health information” happens and the form, manner, and timing of that notification. Covered Entities must begin complying with the new Breach Regulation on September 24, 2009. 

Part of a series of new HHS rules implementing recent changes to HIPAA enacted under the HITECH Act to strengthen existing federally mandates requiring Covered Entities to safeguard protected health information, the Breach Regulation will obligate Covered Entities and business associates to provide certain notifications following a breach of “protected health information” that not secured at the time of the breach through the use of a technology or methodology meeting minimum standards issued by HHS pursuant to other provisions of the HITECH Act.

Under the HITECH Act, the breach notification obligations contained in the Breach Notification only apply to a breach of “unsecured protected health information.” The Breach Regulation exempts breaches of protected health information that qualify as “secured” under separately issued HHS and Federal Trade Commission (FTC) standards for encryption and destruction of protected health information from its breach notification requirements.  

For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the Covered Entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act.  Earlier this year, HHS and the FTC issued interim rules defining the minimum encryption and destruction technologies and methodologies that Covered Entities must use to render protected health information unusable, unreadable, or indecipherable to unauthorized individuals for purposes of determining when protected health information is “unsecured” for purposes of the HITECH Act.  Concurrent with its publication of the Breach Regulation, HHS also released guidance updating and clarifying this previously issued guidance. 

Read the Breach Regulation here.  To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

September 9 “HITECH Act Health Data Security & Breach Update” Briefing

Interested persons are invited to register here now  to learn what these new rules mean for your organization and how it must respond by participating in the “HITECH Act Health Data Security & Breach Update” on Wednesday, September 9, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201.  For information about registering for this program or other questions here 

Conducted by Curran Tomko and Tarski LLP Partner Cynthia Marcotte Stamer, the briefing will cover:

  • Who must comply
  • What your organization must do
  • How to qualify protected health information as exempt from the breach regulations as “secure” protected health information
  • What is considered a breach of unsecured protected health information
  • What steps must a covered entity take if a breach of unsecured protected information happens
  • What liabilities do covered entities face for non-compliance
  • What new contractual requirements, policies and procedures Covered Entities and Business Associates will need
  • How the Breach Regulation, the Privacy Regulation, impending FTC red flag rules and state data breach and privacy rules interrelate
  •  Other recent developments
  • Practical tips for assessing, planning, moving to and defending compliance
  • Participant questions
  • More 

About The Presenter

 The program will be presented by Curran Tomko Tarski LLP Partner Cynthia Marcotte Stamer.  Ms. Stamer is nationally known for her work, publications and presentations on privacy and security of health and other sensitive information in health and managed care, employment, employee benefits, financial services, education and other contexts. 

Vice President of the North Texas Health Care Compliance Professionals Association  and Past Chair of the ABA Health Law Section Managed Care & Insurance Section, and Former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 20 years experience advising clients about health and other privacy and security matters.  A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer is the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010, as well as the author of “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of other highly regarded publications. She has continuously advises employers, health care providers, health insurers and administrators, health plan sponsors, employee benefit plan fiduciaries, schools, financial services providers, governments and others about privacy and data security, health care, insurance, human resources, technology, and other legal and operational concerns. Ms. Stamer also publishes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters.  Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a many other national and local publications.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

We hope that this information is useful to you.  If you need assistance monitoring, evaluating or responding to these or other compliance, risk management, transaction or operation concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or another Curran Tomko Tarski LLP Partner of your choice.

Other Helpful Resources & Other Information

If you found these updates of interest, you also be interested in one or more of the following other recent articles published on our electronic Curran Tomko Tarski LLP publications available for review 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 at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@cttlegal.net.

©2009 Cynthia Marcotte Stamer.   All rights reserved. 

 


HHS Issues Interim Final Requiring Health Care Provider, Health Plans & Other Covered Entities To Give Breach Notifications When Certain Personal Health Information Breached Beginning In September; Register to Participate In September 10th Briefing on New Rules In Person or Via Telephone

August 20, 2009

The U.S. Department of Health and Human Services (HHS) yesterday (August 19, 2009) issued “breach notification” regulations requiring health care providers, health plans and other covered entities (Covered Entities) under the personal health information privacy and security rules of the Health Insurance Portability & Accountability  (HIPAA) to notify affected individuals following a “breach” of “unsecured” protected health information. Scheduled for publication in the Federal Register on August 24, 2009, the new breach notification regulations are part of a series of new rules that implement new electronic personal health information data security and data breach notification requirements for Covered Entities added to HIPAA under the Health Information Technology for Economic and Clinical Health (HITECH) Act signed into law on February 17, 2009 as part of American Recovery and Reinvestment Act of 2009 (ARRA).  Covered entities must begin complying with the new rules no later than September 24, 2009.

Curran Tomko Tarski, LLP Health Practice leader Cynthia Marcotte Stamer will conduct a briefing on these new protected health information data security and data breach rules on Thursday, September 10, 2009 from Noon to 1:30 P.M. Central Time. For a registration fee of $45.00, registrants will have the option to participate via teleconference or in person at the offices of Curran Tomko Tarski LLP, 2001 Bryan Street, Suite 2050, Dallas Texas 75201.  For more information, e-mail here.

 HITECH Act Data Breach and Unsecured PHI Rules

The new data breach notification rules are part of a series of recent HIPAA enacted under the HITECH Act to strengthen the federal rules requiring HIPAA covered entities to safeguard electronic and certain other protected health information. Enhanced data security and data breach rules added as part of these HITECH Act amendments obligate  covered entities and business associates to provide certain notifications following a breach of “unsecured”  “protected health information” within the meaning of HIPAA, as amended.  “Unsecured protected health information” is defined as protected health information that is not secured through the use of a technology or methodology specified by the HHS Secretary.

The new data breach regulations implement the HITECH Act requirement that Covered Entities and their business associates notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach and the form, manner, and timing of that notification.  For purposes of the HITECH Act, electronic protected health information is considered “unsecured” unless the covered entity has satisfied certain minimum standards for the protection of that data established pursuant to the HITECH Act.  HHS and the Federal Trade Commission previously issued certain initial guidance concerning the HITECH Act standards for determining when electronic personal health information qualifies as secure.  To help further define when electronic health information is treated as “unsecured” and therefore subject to the breach notification requirements, the data breach rules also update and clarify the previously issued existing HHS guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals published earlier this year by HHS to for purposes of determining when protected health information will be considered “unsecured” for purposes of the HITECH Act data breach rules.  Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information.  

The HHS interim final regulations are effective September 24, 2009, which is the date 30 days after the date they will be published on the Federal Register and include a 60-day public comment period. To review the interim final data breach regulations, see here.  To review the HITECH Act Breach Notification Guidance and Request for Information, see here.

For More Information

The author of this article, Curran Tomko and Tarski LLP Health Care Practice Chair Cynthia Marcotte Stamer has extensive experience advising and assisting health care providers, payors and their business associates about HIPAA and other privacy and data security matters, as well as a diverse range of health care policy, regulatory, compliance, risk management and operational concerns. 

Past chair of the American Bar Association Health Law Section Managed Care & Insurance Section, Martindale Hubble AV-rated and recognized in International Who’s Who of Professionals, Ms. Stamer continuously advises health care providers, health care payers and administrators, employers, governments and others about health care, insurance, human resources, privacy and data security, technology, and other legal and operational concerns.  A popular lecturer and widely published author on privacy and data security and other related health care and health plan matters, Ms. Stamer also writes and speaks extensively on health and managed care industry privacy, data security and other technology, regulatory and operational risk management matters.  She currently serves as the Editor in Chief of the forthcoming 2010 edition of the Information Security Guide to be published by the American Bar Association Information Security Committee in 2010.  Examples of her other works include “Protecting & Using Patient Data In Disease Management: Opportunities, Liabilities And Prescriptions,” “Privacy Invasions of Medical Care-An Emerging Perspective,” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA,” and a host of others.  Her insights on health care, health insurance, human resources and related matters appear in the Atlantic Information Service Privacy Report, The Wall Street Journal, Business Insurance, the Dallas Morning News, Managed Healthcare, Health Leaders, and a various other national and local publications.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

We hope that this information is useful to you.  If you need assistance monitoring, evaluating or responding to these or other proposed health care or other regulatory reforms or with other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270-2402, cstamer@cttlegal.com or your other favorite Curran Tomko Tarski LLP Partner.

We also encourage you and others to join the discussion about these and other health care reform proposals and concerns by joining the Coalition for Responsible Health Care Reform Group on Linkedin, registering to receive these updates here.

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 our electronic Solutions Law Press Health Care Update publication available here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please register to receive this Solutions Law Press Health Care Update here and be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here. You can access other recent updates and other informative publications and resources provided by Curran Tomko Tarski LLP attorneys and get information about its attorneys’ experience, briefings, speeches and other credentials here.

For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

©2009 Cynthia Marcotte Stamer.  All rights reserved. 


CMS Publishes Updated FY 2010 Inpatient Rehabilitation Facility Prospective Payment System Final Rule

August 7, 2009

On August 6, 2009, the Center for Medicare & Medicaid Services (CMS) published its updated final rule governing the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2010.  The provisions of the final rule generally are effective October 1, 2009 and will apply to IRF discharges occurring on or after October 1, 2009 and on or before September 30, 2010 (FY 2010).  However, amendments to Sections 412.23, 412.29, and 412.622 don’t take effect until January 1, 2010.

Among other things, the final rule:

  • Updates the FY 2010 IRF PPS relative weights and average length of stay values using the most current and complete Medicare claims and cost report data in a budget neutral manner;
  • Updates the FY 2010 IRF facility level adjustments (rural, LIP, and teaching status adjustments) using the most current and complete Medicare claims and cost report data in a budget neutral manner;
  • Updates the FY 2010 IRF PPS payment rates by the proposed market basket;
  • Updates the FY 2010 IRF PPS payment rates by the wage index and labor-related share in a budget neutral manner;
  • Updates the outlier threshold amount for FY 2010;
  • Updates the cost-to-charge ratio ceiling and the national average urban and rural cost-to-charge ratios for purposes of determining the outlier payments under the IRF PPS for FY 2010;
  • Removes the words “or assessment” from Sections 412.23(b)(3) and 412.29(b) to indicate that CMS is no longer providing for a 3 to 10 day inpatient assessment period after admission to an IRF to assess the appropriateness of the IRF admission;
  • Amends paragraphs Section  412.23(b)(4) and Section 412.29(c) to require that IRFs “furnish, through the use of qualified personnel, rehabilitation nursing, physical therapy, and occupational therapy, plus, as needed, speech-language pathology, social services, psychological services (including neuropsychological services), and orthotic and prosthetic services;”
  • Replaces the word “multidisciplinary” with the word “interdisciplinary” in Section 412.23(b)(7) and Section  412.29(e) to make the terminology consistent with the new IRF coverage criteria in Section 412.622(a);
  • Requires in both Section  412.23(b)(7) and Section 412.29(e) that the interdisciplinary team meetings occur at least once per week (rather than once every two weeks) to be consistent with the new IRF coverage criteria in Section  412.622(a);
  • Adds new paragraphs (3), (4), and (5) to Section 412.622(a) to implement new IRF coverage requirements;
  • With respect to Sections  412.604, 412.606, 412.610, 412.614 and 412.618, removes from Section  412.614(a) current subparagraph (3); and
  • In Section  412.614(d), makes a technical correction to the paragraph formerly designated as paragraph and