This article was originally published by the Physicians Organizations Practice Group of the American Health Lawyers Association.
On December 14, 2011, CMS released the much-anticipated proposed rule implementing the “sunshine” provisions of Section 6002 of the Affordable Care Act (ACA). The proposed sunshine regulation requires certain manufactures of drugs, devices, and biologics to report to CMS information regarding payments and other transfers of value to covered physicians and teaching hospital. Transfers of value include gifts, consulting fees, research activities, speaking fees, meals and travel. In addition, the proposed regulation also would require certain manufactures and group purchasing organizations (GPOs) to report ownership interests in such organizations held by physicians. CMS would make the reported information available on a searchable, public website.
The proposed regulation seeks comments about a number of aspects of the reporting requirements. Comments must be submitted by February 17, 2012. CMS anticipates publishing the final rule in 2012...
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