In response to the current opioid crisis sweeping across the country, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (commonly referred to as the SUPPORT Act). President Trump signed the Act on October 24, 2018, which will take full effect on January 1, 2022.
The Act included over 120 provisions. One of these provisions, Section 6111 (“Fighting the Opioid Epidemic with Sunshine”), expands the reporting obligations that are required as part of the Physician Payments Sunshine Act. The Sunshine Act, which the Center for Medicare and Medicaid Services (CMS) refers to as the Open Payments Program, was passed in 2010 as part of the Patient Protection and Affordable Care Act. This made it mandatory for pharmaceutical and medical device manufacturers to disclose to CMS any payments or other transfers of value, such as consulting fees or research grants, made to physicians or teaching hospitals. This payment information is then made publicly available in a searchable online database.
The SUPPORT Act extends the Sunshine Act to now include additional health professional affiliates – physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, and certified registered nurse anesthetists. In addition, CMS is now authorized to post National Provider Identifier numbers (NPIs) on the public database, something that was previously barred by the Sunshine Act.
These changes will go into effect for “information required to be submitted…on or after January 1, 2022.” Therefore, beginning January 1, 2021, affected manufacturers and health professionals will need to begin tracking payments and other transfers of value for the March 2022 report.
Consistent with the history of the Sunshine Act and its implementing regulations/guidance, HLP anticipates that there will be revisions, clarifications, and potentially delays related to extending reporting to additional health care professionals. These professionals, previously not covered, will need to be educated regarding the what, why, and consequences of the Sunshine Act. Further, as with the original Sunshine Act, it is anticipated that pharmaceutical and medical device companies will re-evaluate their marketing spend/efforts, and struggle (initially) with implementation. Stay tuned.