Now under Section 6111 of the SUPPORT Act, additional practitioners beyond U.S. physicians and teaching hospitals will be considered covered recipients.
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
As previously discussed in an earlier Alert, the Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act) requires certain drug and device manufacturers and group purchasing organizations (GPOs) to report direct and indirect payments and other transfers of value made to "covered recipients," defined as U.S. physicians and teaching hospitals. Since March 31, 2014, applicable manufacturers and GPOs have been required to report such payments to the Centers for Medicare & Medicaid Services (CMS), and the disclosures have been made public through its Open Payments system.
Now under Section 6111 (Fighting the Opioid Epidemic with Sunshine) of the SUPPORT Act, additional practitioners beyond U.S. physicians and teaching hospitals will be considered covered recipients. As a result, the newly signed law will require applicable manufacturers and GPOs to track and report payments made to those additional recipients. Once the law is effective, the disclosures must also include payments made to:
- Physician assistants,
- Nurse practitioners,
- Clinical nurse specialists,
- Certified registered nurse anesthetists, and
- Certified nurse-midwives.
However, this requirement is not effective until at least January 1, 2022. In the meantime, CMS will likely promulgate regulations to implement further details about the disclosures.
Further, Section 6111 ends the provision of the Sunshine Act that excludes the U.S. physician or teaching hospital's National Provider Identifier (NPI) from the publicly available information published on the CMS website, applicable beginning January 1, 2022, as well.
For Further Information
If you have any questions about this Alert or would like more information, please contact Frederick R. Ball; Erin M. Duffy; Lauren G. Perry; any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food Industry Group; any of the attorneys in our Health Law Practice Group; or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.