President Trump is expected to sign into law a bill which will – among other things – expand the scope of the Open Payments reporting requirements mandated by Section 6002 of the Patient Protection and Affordable Care Act (often referred to as the Sunshine Act).

Existing law already requires drug manufacturers and medical device companies to report certain payments and transfers of value provided to physicians and teaching hospitals; the new law would expand the reporting requirement to include payments and transfers of value provided to physician assistants, nurse practitioners, and other practitioners.

Current Sunshine Act Requirements

The Sunshine Act currently requires manufacturers of drugs, biologicals, devices, or medical supplies covered under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) to track and report annually to the Centers for Medicare & Medicaid Services (CMS) certain payments or other transfers of value made to physicians and teaching hospitals. CMS publishes this data in a searchable database online, which has led to concern from hospitals and physicians about the accuracy of the data and that legitimate payments for research and consulting could be misconstrued by patients as suspect. The Arent Fox Health Care Team previously summarized the Sunshine Act’s implementing regulations in a February 13, 2013 Alert.

The SUPPORT Act

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT Act”), which is still in the reconciliation phase, primarily focuses on bipartisan efforts to combat the nationwide opioid epidemic. As part of this, the SUPPORT Act includes changes to the Sunshine Act which will impact drug manufacturers, medical device companies, hospitals, physicians, and the new types of practitioners impacted by the law. (Because the SUPPORT Act is still in the reconciliation phase, additional changes could be made.)

If signed into law, the SUPPORT Act will expand the scope of the Sunshine Act to include payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwifes. In addition, the SUPPORT Act would allow CMS to publicly post providers’ National Provider Identifiers (NPIs) on the online database. Currently, the Sunshine Act prohibits CMS from posting NPIs on the database.

These changes would go into effect for “information required to be submitted … on or after January 1, 2022,” which would impact the March 2022 report on payments made during calendar year 2021. Applicable manufacturers will need to track payments and transfers of value made to these additional practitioner types during calendar year 2021. Manufacturers and other stakeholders should keep an eye out for further clarification from CMS, which will likely amend its implementing regulations through a notice and comment rulemaking.