The Centers for Medicare & Medicaid Services (CMS) recently released the CY 2020 Physician Fee Schedule Final Rule (PFS Final Rule) which is expected to be published this week in the Federal Register. CMS previously solicited comments to these changes. Among other things, the PFS Final Rule implements the following important changes to the Open Payments program:

Implements changes to definition of “covered recipient”: The PFS Final Rule codifies the Open Payments provisions from the SUPPORT Act, which expanded the definition of “covered recipients” from physicians and teaching hospitals to include physician assistants (PAs), nurse practitioners (NPs), certified registered nurse anesthetist (CRNAs), clinical nurse specialist (CNSs) and certified nurse midwives (CNMs). The SUPPORT Act requires these changes to be in effect as of January 1, 2021 for all reporting submitted on or after January 1, 2022. Although CMS acknowledges in the Final Rule that “accurately identifying mid-level practitioners will entail additional challenges”, it declines to delay this important reporting change.

Updates the nature of payment categories: Consistent with public comments received from the CY 2017 Physician Fee Schedule proposed rule, CMS simplifies the reporting process by combining the two current payment categories for
accredited/certified and unaccredited/non-certified continuing education programs into a single “medical education programs” category. Additionally, CMS adds new payment categories for debt forgiveness; long-term medical supply or device loan, defined a“the loan of supplies or a device for 91 days or longer; and acquisitions.

Standardizes data on reported products: CMS finalizes its proposal to require the reporting of a medical device identifier (DI), which is the mandatory fixed portion of the unique device identifier (UDI). CMS also proposes to correct an error from the CY 2015 Physician Fee Schedule Final Rule to make it clear that national drug codes (NDCs) are required for both research and non-research payments reported by drug and biologics manufacturers. This change will be effective 60 days following the publication of the final rule.

Drug, device and biologics manufacturers should carefully consider these updates to the Open Payments program finalized in the PFS Final Rule. Revisions to policies, procedures, processes and systems used to track and report payments will be necessary to ensure complete and accurate reporting to CMS.