On Wednesday, October 24, President Donald Trump signed into law a bipartisan opioid response bill that includes an expansion of pharmaceutical and medical device manufacturer reporting obligations under the federal Physician Payment Sunshine Act (Sunshine Act). The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) includes a number of provisions aimed at addressing the national opioid abuse epidemic.
One such provision, entitled “Fighting the Opioid Epidemic with Sunshine,” expands the scope of the Sunshine Act to require drug and medical device manufacturers to publicly disclose payments and other transfers of value they make to certain nonphysician practitioners.
Enacted in 2010 as part of the Patient Protection and Affordable Care Act, the Sunshine Act aims to promote financial transparency with respect to manufacturer-healthcare provider relationships by requiring manufacturers of covered drugs, devices, biologicals and medical supplies to track and report to the Centers for Medicare and Medicaid Services (CMS) certain payments or other transfers of value they make to “covered recipients.” Prior to passage of the SUPPORT Act, the Sunshine Act defined “covered recipient” to include only U.S.-licensed physicians and teaching hospitals.
The SUPPORT Act expands manufacturer tracking and reporting obligations under the Sunshine Act to include additional covered recipients in a position to prescribe or order covered drugs, devices, biologicals or medical supplies. For transparency reports submitted to CMS on or after January 1, 2022, manufacturers must also include payments or other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists and certified nurse-midwives.CMS will likely implement these changes through rulemaking.
The SUPPORT Act also sunsets the prior exclusion of covered recipient National Provider Identifiers (NPIs) in the publicly available information in CMS’s Open Payments database. Effective for information first included in the Open Payments database on or after January 1, 2022, CMS will include covered recipients’ NPIs along with providers’ other existing information.
Drug and device manufacturers should prepare for the impact that expanded Sunshine Act reporting may have on their data collection, compliance and contracting policies and practices. In advance of the effective date of the SUPPORT Act amendments, manufacturers should consider (i) implementing or modifying policies, procedures and reporting systems to accurately track covered payments to the expanded scope of covered recipients; (ii) amending existing agreements, as appropriate, to clarify reporting obligations; and (iii) ensuring that future agreements adequately address these legislative changes.