Overview
To enhance transparency regarding financial relationships between healthcare providers (physicians) and medical product manufacturers, the Sunshine Act was enacted as Section 6002 of the Affordable Care Act (ACA) in 2010. Officially titled “Transparency Reports and Reporting of Physician Ownership or Investment Interests Regulations,” this legislation requires manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare or Medicaid (referred to as “applicable manufacturers” (AMs) and “applicable group purchasing organizations” (GPOs)) to annually report certain payments or transfers of value provided to physicians or teaching hospitals (referred to as “covered recipients”) to the Centers for Medicare and Medicaid Services (CMS). Starting on March 31st, 2014, and subsequently on the 90th day of each calendar year thereafter, manufacturers are required to report. Compliance with Sunshine Law requirements is essential for these entities.
To facilitate data collection, CMS established the Open Payments program, enabling AMs and GPOs to submit detailed reports on payments made to covered recipients. These payments include those related to travel, research, gifts, speaking engagements, meals, entertainment, education, and more. Additionally, ownership interests in these companies held by physicians or their immediate family members must also be reported. For transparency reporting purposes, much of this data is made publicly available each year. To comply with US Sunshine Reporting, AMs and GPOs must register with Open Payments, collect data for the entire calendar year, format the data per CMS guidelines, and submit the report by the following March.
2021 Open Payments Expansion
In October 2018, Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which expanded the definition of “covered recipients” under Open Payments to include additional non-physician practitioners (NPPs) such as:
- Physician Assistants (PA)
- Nurse Practitioners (NP)
- Clinical Nurse Specialists (CNS)
- Certified Registered Nurse Anesthetists (CRNA)
- Certified Nurse Midwives (CNM)
- Anesthesiologist Assistants (AA)
In November 2019, CMS issued a final rule mandating that applicable manufacturers begin capturing data for these NPPs starting in the 2021 calendar year, with the first submission occurring in 2022.
For more details on Federal Open Payments (Sunshine Act) reporting requirements, visit the CMS website: www.cms.gov/openpayments.
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