Last Wednesday, October 3, a wide-ranging opioid bill cleared its last legislative hurdle by passing the Senate, and is expected to be signed by the President in the near future. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act, makes sweeping changes intended to combat the ongoing opioid abuse crisis. We will be blogging on several SUPPORT provisions in the upcoming days.
Buried in the 250-page bill is Section 6111, entitled “Fighting the Opioid Epidemic with Sunshine,” which expands reporting requirements under the Physician Payments Sunshine Act (“Sunshine Act”) to include additional types of healthcare practitioners. This expansion in scope is only tangentially related to the Opioid epidemic, as it applies to applicable manufacturers of all types of drugs – not just opioids – as well as biologics and devices.
The Sunshine Act, which was originally enacted as Section 6002 of the Affordable Care Act in 2010, requires applicable manufacturers of certain drugs, medical devices, and biologics that are paid for by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.” 42 U.S.C. § 1320a–7h(a). (As a refresher, our blog post on the implementing CMS regulations is available here.) Under the Sunshine Act, the definition of a “covered recipient” was limited to physicians and teaching hospitals. Id. § 1320a–7h(e)(6). SUPPORT expands the definition of covered recipient to include:
- A physician assistant, nurse practitioner, or clinical nurse specialist
- A certified registered nurse anesthetist
- A certified nurse-midwife
The new provisions will apply “with respect to information required to be submitted under section 1128G of the Social Security Act [the Sunshine Act] on or after January 1, 2022.” The phrase “information required to be submitted” most likely refers to the report that is to be submitted after the specified date. The first report due after January 1, 2022 will be the March 2022 report on calendar year 2021, which means that the reported 2021 data must include payments to the new covered recipient categories. However, the issue is not entirely free from doubt: some might argue that the January 1, 2022 effective date applies to payments and other transfers of value made after that date, so that data on the new categories of covered recipients would begin to be collected in calendar year 2022 and would not be reportable until March 2023. CMS will undoubtedly amend its implementing regulations (42 C.F.R. § 403.900 et seq.) through a notice and comment rulemaking, in which we can expect CMS to articulate its position on the effective date.