Member Article

The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes. These changes were implemented by the Centers for Medicare & Medicaid Services (“CMS”) in its CY 2020 Physician Fee Schedule Final Rule.[4]

Specifically, pharmaceutical, biotechnology, and medical device manufacturers subject to the Sunshine Act must track and report applicable payments and transfers of value to teaching hospitals and physicians, which include medical doctors and doctors of osteopathy, optometry, dental surgery, dental medicine, podiatry, and chiropractic medicine.[5] The Support Act expanded this obligation to include physician assistants, nurse practitioners, certified registered nurse anesthetists, clinical nurse specialists, and certified nurse midwives, effective for all reporting submitted on or after January 1, 2022. This means manufacturers must ensure that their processes and systems are updated to capture relevant information as of January 1, 2021.

While CMS acknowledged that “accurately identifying mid-level practitioners will entail additional challenges,” it declined to delay this revised reporting requirement.[6] It is critical for drug, device, and biologics manufacturers to carefully consider these updates and to implement revisions to policies, procedures, processes, and systems used to track and report payments to ensure complete and accurate reporting to CMS.

Further, health care professionals who will now have data reported about them should consider becoming familiar with the Sunshine Act and the CMS Open Payments system. This would include reviewing the CMS Open Payments resources for covered recipients and registering with CMS to review data reported about you.[7]

[1] Public Law No. 115-271, https://www.congress.gov/bill/115th-congress/house-bill/6.

[2] 42 C.F.R. § 403.900 et seq.

[3] 42 C.F.R. § 403.902.

[4] 84 Fed. Reg. 62,568 (Nov. 15, 2019) (“PFS Final Rule”).

[5] 42 C.F.R. § 403.902; 42 U.S. Code §?1395x(r).

[6] PFS Final Rule, supra note 4 at 62,916.

[7] See https://www.cms.gov/OpenPayments/Program-Participants/Physicians-and-Teaching-Hospitals/Physicians-and-Teaching-Hospitals.