The “National Physician Payment Transparency Program: Open Payments” requires certain manufacturers of drugs, devices and certain other products to disclose annually to the Centers for Medicare and Medicaid Services (CMS) payments or other transfers of value made to physicians or teaching hospitals. It also requires certain manufacturers and group purchasing organizations (GPOs) to disclose physician ownership or investment interests held in those entities, as well as provide information on payments or other transfers of value made to such owners or investors. The Open Payments program was designed to increase transparency and public awareness of the financial relationships between manufacturers and healthcare providers. Reports are required to be submitted annually.
On August 14, 2019, CMS issued a proposed rule to expand Open Payments reporting requirements to transfers of value or payments made to a broader range of healthcare professionals (the current framework only included transfers of value or payments to physicians or teaching hospitals). The proposal was finalized on November 15, 2019, with the publication of the CY 2020 Physician Fee Schedule Final Rule (PFS Final Rule).
The expanded reporting requirements implement the 2018 SUPPORT Act, which included in the definition of “covered recipients” for purposes of Open Payments reporting the following categories of healthcare professionals: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. The PFS Final Rule codified this expanded definition, requiring that data collected in calendar year 2021 include payments or other transfers of value to these additional categories of healthcare professionals (in addition to physicians and teaching hospitals).
CMS also modified some of the payment categories under the Open Payments Program. CMS created one combined category called “medical education programs” to represent what previously was collected under two separate payment categories—accredited/certified and unaccredited/non-certified continuing education programs. CMS also added new payment categories for the following: debt forgiveness, long-term medical supply or device loan, and acquisitions.
The PFS Final Rule also included requirements for manufacturers to include certain standardized data on reported products and made it clear that national drug codes (NDCs) are required for research and non-research payments. The change to the NDC reporting requirements for drugs and biologicals will be effective 60 days following the publication of the final rule.
Manufacturers should be aware of these changes and take measures to ensure that all required payments are tracked and reported in accordance with the PFS Final Rule.
