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Sunshine Act: Increasing Transparency
On February 1st, 2013, the Centers for Medicare & Medicaid Services (“CMS”) within the Department of Health and Human Services (HHS) announced the release of the final rule implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act (“ACA”), commonly referred to as the “Sunshine Act.”
Companies were required to begin data capturing on August 1, 2013, and submitted their first federal reports on March 31, 2014.
The Sunshine Act requires all U.S. drug and medical device manufacturers to report any gifts and payments made to physicians and teaching hospitals with a value totaling $100 annually or greater, as part of the Patient Protection and Affordable Car Act of 2009 (H.R. 3590, section 6002). Failure to stay in compliance may result in fines ranging from $10,000 to $1,000,000 annually.
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