CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013.

The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal Register on February 8, 2013 provides key definitions and terms, broad reporting requirements, important exemptions and limitations, and additional reporting guidance.

The Sunshine Act requires manufacturers of drugs, devices, biologics, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (‘‘CHIP’’) (each a ‘‘Covered Product’’) to report payments and other transfers of value to physicians and teaching hospitals (‘‘covered recipients’’). The Sunshine Act also requires such manufacturers (collectively, ‘‘Manufacturers’’) and Group Purchasing Organizations (‘‘GPOs’’) to disclose ownership or investment interests held by physicians or their immediate family members.

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