Pharmaceutical Executive March 1, 2024
New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.
After more than a decade of relative inactivity, the Centers for Medicare & Medicaid Services (CMS) has signaled that it may soon commence audits of reporting entities under the Sunshine Act.
Limited Audit and Enforcement Activity To-Date
The Sunshine Act, formally known as the federal Physician Payments Sunshine Act, requires group purchasing organizations (GPOs) and manufacturers of certain drugs and devices that are reimbursed by certain federal healthcare programs to annually report to CMS payments or other transfers of value they make to US-licensed physicians, teaching hospitals, and certain other US-licensed healthcare professionals, referred to as “covered recipients,”...
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