Physician Payment Sunshine Act: CMS Announces Final Rule
On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services ("CMS") announced its long-awaited final rule on the "National Physician Payment Transparency Program: Open Payments," better known as the Physician Payment Sunshine Act. This was part of the Patient Protection and Affordable Care Act ("PPACA") that Congress passed in March of 2010 and upheld by the US Supreme Court in June of 2012. The purpose of the Act is to prevent fraud abuse and waste in the health care system by making the public aware of payments made to applicable health care providers.
The finalized rule requires all manufacturers of "covered" drugs, biologicals, devices and medical supplies to report all payments to or on behalf of physicians and teaching hospitals to the CMS. The definition of teaching hospital is any hospital that receives direct or indirect graduate medical education payments from CMS. CMS will annually publish a list of such hospitals. The finalized rule would only apply to medical device products requiring a premarket approval by or premarket notification to the Food and Drug Administration ("FDA"); this excludes most Class I medical devices.
Click here to view the final rule (Note: information pertaining to Class I medical devices can be found on pages 29-30).
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