Federal Open Payments (Sunshine Act)

Overview

In an effort to provide greater transparency into the financial relationships between physicians and medical product manufacturers, the Sunshine Act was enacted as Section 6002 of the Affordable Care Act (ACA) in 2010 (officially entitled “Transparency Reports and Reporting of Physician Ownership or Investment Interests Regulations”). Starting on March 31, 2014 and subsequently on the 90th day of each calendar year thereafter, it mandates that 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)) 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).

To facilitate the collection of this data, CMS developed the Open Payments program. Open Payments provides the means through which AMs and GPOs submit information about the payments they make to covered recipients. AMs and GPOs must report on payments made to covered recipients for travel, research, gifts, speaking engagements, meals, entertainment, education and other purposes. Additionally, ownership interests in these companies held by physicians or their immediate family members are also reportable. For transparency purposes, much of this data is then made available to the public annually. AMs and GPOs must register with Open Payments, collect data for the entire calendar year related to these expenditures, format the data according to CMS requirements and submit the report the following March to ensure Federal Open Payments (Sunshine Act) compliance.

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) that amended the definition of a “covered recipient” in Open Payments to include the following additional, non-physician practitioner (NPP) types:

In November 2019, CMS issued its final rule requiring applicable manufacturers to begin NPP data capture for the 2021 calendar year and submission in 2022. For more information on Federal Open Payments (Sunshine Act) reporting requirements, visit the CMS Open Payments website.