Applicable manufacturers will need to update their methods of documenting payments and transfers of value to include the newly expanded list of providers.
A bill recently signed into law expands the reporting requirements under the Physician Payments Sunshine Act ("Sunshine Act"). Applicable manufacturers will now be required to report payments and other transfers of value to physician assistants and advance practice nurses, in addition to physicians and teaching hospitals.
Currently, applicable manufacturers are required to report payments and other transfers of value to "covered recipients," defined as physicians and teaching hospitals. The bill expands the definition of "covered recipients" to include physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives, recognizing that these providers have prescriptive authority under most states' laws. These changes apply to data submitted on or after January 1, 2022, which will have been collected in 2021. Applicable manufacturers will need to update their policies and systems for capturing and tracking payments and transfers of value to this expanded list of providers and should consider providing additional training.
The bill, titled the "SUPPORT for Patients and Communities Act," includes a variety of health reforms aimed at combatting the opioid crisis. It incorporates a bipartisan bill introduced earlier in the year by Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) to shine a light on the relationship between drug companies and prescriptions for opioids. These changes apply beyond opioids, however, to all covered products, reflecting Senators Grassley's and Blumenthal's earlier attempts to expand the reach of the Sunshine Act to anyone with prescriptive authority.
The bill also sunsets a provision that currently excludes a provider's National Provider Identifier ("NPI") from the data that is made public by the Centers for Medicare and Medicaid Services ("CMS") through the Open Payments program. Applicable manufacturers are required to report a covered recipient's NPI, but the NPI is not published by CMS. However, data made publicly available after January 1, 2022, will include the NPIs for covered recipients.