The Open Payments Program reveals critical compliance issues in healthcare, highlighting recent legal cases and the importance of accurate financial reporting.
© ipuwadol - stock.adobe.com
Initially implemented as part of Section 6002 of the Affordable Care Act (ACA) as the Physician Sunshine Act, on November 13, 2014, the Centers for Medicare & Medicaid (CMS) issued a final rule in 79 Fed. Reg. 67548, which changed the name to the Open Payments Program. Its primary purpose is to establish “establishes a system for annually reporting and increasing public awareness of financial relationships between drug and device manufacturers and certain health care providers.”
Over a decade ago, I wrote an article for Physicians Practice on the Sunshine Act and the intersection with the Anti-Kickback Statute (AKS) and Stark Law, as well as compliance steps espoused by the American Medical Association. After the 2014 article, two (2) cases involving the False Claims Act (FCA) brought by whistleblowers, AKS and Open Payments Program settled.
This brings us to May 19, 2025. The Chief Executive Officer of Spine Frontier, Inc. pled guilty to submitting false statements to CMS through the Open Payments website. The Key items are as follows:
In sum, violations of the Open Payments Systems are material to the Government. Persons should be vigilant about addressing these requirements, along with fraud, waste and abuse laws in compliance programs.
Rachel V. Rose, JD, MBA, advises clients on compliance, transactions, government administrative actions, and litigation involving healthcare, cybersecurity, corporate and securities law, as well as False Claims Act and Dodd-Frank whistleblower cases. She also teaches bioethics at Baylor College of Medicine in Houston. Rachel can be reached through her website, www.rvrose.com.