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CMS Finalizes Changes Expanding the Scope of the Open Payments Program

On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule.  The Open Payments reporting requirements, also known as the Sunshine Act, require manufacturers of drugs, biologicals, devices, or medical supplies covered by Medicare, Medicaid, or CHIP to track and report annually to CMS certain payments or transfers of value made to physicians and teaching hospitals (“Covered Recipients”).  Manufacturers and group purchasing organizations also must report ownership or investment interests held by physicians or their immediate family members.  CMS publishes this data in a searchable online database accessible by the general public.  The final rule adopts all of the changes CMS proposed in August, which we previously reported on in an August 12, 2019 blog post

Perhaps most importantly, CMS broadened the list of Covered Recipients.  Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.   CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions.  CMS consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs.  Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.

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About this Author

Brian P. Dunphy, Pharmaceutical Attorney, Mintz Levin, Anti-Kickback Lawyer,Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Complex Commercial Litigation
Member

Brian has handled a wide range of health care litigation matters, government investigations, and voluntary disclosures for an array of health care providers, life sciences companies, and private equity funds and their portfolio companies. He defends clients against allegations of false claims for payment to the government, in SEC investigations and enforcement proceedings, and represents clients in complex business disputes. Brian also counsels clients on health care regulatory issues, including telemedicine laws, compliance with the federal Physician Payments Sunshine Act and analogous...

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Rachel Yount Healthcare Attorney Mintz Levin
Associate

Rachel focuses her practice on health care industry transactions.  

Prior to joining Mintz, Rachel was a health care associate in the Washington, DC office of an Am Law 200 law firm, where she represented long-term care clients in complex multistate transactions; helped health systems structure financial arrangements with referral sources; advised pharmaceutical manufacturers and pharmacy benefit managers on state laws affecting drug pricing transparency; and counseled clients on compliance with the Anti-Kickback Statute, Stark Law, False Claims Act, Medicare billing and reimbursement regulations, beneficiary inducement prohibitions, civil monetary penalties, and the Health Insurance Portability and Accountability Act (HIPAA). Rachel also represented providers under investigation by the Department of Justice (DOJ), assisted providers with designing and implementing effective compliance programs, and provided representation in significant reimbursement and coverage disputes.
 
Earlier Rachel was a compliance attorney with Sentara Healthcare, a health care system with 12 acute care hospitals and more than 300 sites of care in Virginia and North Carolina. Focusing on the physician contracting process, Rachel developed strategic solutions to operational problems and provided legal support for compliance issues across the system.

Rachel also worked as a legal fellow at Bon Secours Richmond Health System, where she focused on risk management and regulatory compliance. 

An active member of the American Bar Association’s Health Law Section, Rachel assisted in drafting several revisions to the group’s reference guide, Health Care Fraud and Abuse: Practical Perspectives, and organized and moderated a panel of senior government attorneys for an ABA networking event. She is frequently invited to speak on health care compliance and other health law matters.  

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