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On October 24, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). Designed to increase the federal government’s ability to respond to the opioid epidemic, the SUPPORT Act includes a provision to expand pharmaceutical and medical device manufacturers’ reporting obligations under the federal Physician Payments Sunshine Act to include nonphysician medical professionals for the first time.
The Sunshine Act was passed in 2010 as part of the Affordable Care Act. Under the Sunshine Act, pharmaceutical and medical device manufacturers must disclose to the Centers for Medicare and Medicaid Services (CMS) any payments or other transfers of value made to physicians or teaching hospitals. Transfers of value include items such as consulting fees, honoraria for speaking events and research grants.
The SUPPORT Act expands Sunshine Act reporting to include data for physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwifes. Congress’s decision to expand Sunshine Act reporting requirements as part of broad-based legislation to combat the growing opioid crisis reflects the concern that nonphysicians are among the prescribers of opioids. There were no changes to the Sunshine Act’s definitions of “applicable manufacturers” or “reportable payments.”
The amendment applies to reports submitted to CMS on or after January 1, 2022. Therefore, federal Sunshine Act submissions in March 2022 (which would contain information for the calendar year 2021) will be the first to include the expanded reporting.
The federal Sunshine Act preempts state requirements to the extent that they impose duplicative reporting obligations, but it does not prohibit states from requiring manufacturers to report information that is “not of the type required to be disclosed or reported” under the federal law. Several states have passed their own sunshine laws, some of which require disclosure of payment information to nonphysician prescribers. The SUPPORT Act’s broadening of Sunshine Act reportable prescribers will have the effect of preempting some of the existing state reporting requirements.
Companies will need to conform policies to be prepared for this broader federal reporting requirement and may wish to reexamine their state disclosure policies.
Ronni Fuchs is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Michael Vives is an associate in the Health Sciences Department. Mr. Vives is admitted to practice in Pennsylvania, New Jersey and the District of Columbia (he is not admitted in New York).
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.