The Centers for Medicare & Medicaid Services (CMS) issued this week a proposed rule regarding the expansion of Open Payments reporting requirements (Proposed Rule). As we discussed here, the 2018 SUPPORT Act expanded the definition of “covered recipients” to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. The Proposed Rule seeks to implement these changes beginning with data collected in calendar year 2021 and reported to CMS in March 2022.

The Proposed Rule also seeks to update and expand the “nature” payment categories available for reporting by (i) combining the current categories for payments to faculty at accredited and unaccredited medical education programs to a single medical education program category; and (ii) adding three new categories for debt forgiveness, long-term medical supply or device loan, and acquisitions. The Proposed Rules further seeks to standardize reported data by (i) requiring medical device manufacturers to include on the report the unique device identifier (UDI), if applicable; and (ii) reiterate that national drug codes (NDCs) for drugs and biologics are required for both research and non-research payments.

Comments to the Proposed Rule are due by September 27, 2019. Pharmaceutical, biotechnology and medical device manufacturers and covered recipients should carefully review the Proposed Rule and consider providing comments to CMS. Manufacturers also should consider potential system enhancements and other changes that will be necessary to implement these updates if the Proposed Rule is finalized by CMS.

Posted by Sarah K. diFrancesca