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Understanding the Sunshine Act: Dispersing the Clouds of Confusion

March 19, 2012

"On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act. Section 6002 of the Act, entitled “Transparency Reports and Reporting of Physician Ownership or Investment Interests,” is commonly known as the “Sunshine Act.” Pursuant to the Sunshine Act, certain pharmaceutical, medical device, biological product, and medical supply companies are required to disclose annually gifts and payments provided to covered recipients, and ownership and investment interests in the company that are held by covered recipients.

On December 19, 2011, the Department of Health and Human Services published in the Federal Register the much-anticipated draft regulations for the Sunshine Act. The draft regulations propose various definitions, clarifications and requirements for implementing the law, and will be followed by final regulations before they become effective. In the draft regulations, the Centers for Medicare & Medicaid Services (“CMS”) requested that the public submit comments on many of the proposed requirements, definitions, and methods suggested for implementing the law. The public comment period for the draft regulations closed on February 17, 2012. To date, the final regulations have not been published."

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