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Sunshine Act Implementation Delayed Until 2013

With little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013.  Pharmaceutical and medical device manufacturers and group purchasing organizations covered by the Sunshine Act thus will not have to begin collecting data before January 1, 2013.  In its announcement, CMS said that the delay is designed to "provide time for organizations to prepare for data submission and to sufficiently address the important input we received during the rulemaking process."

CMS intends to issue final regulations implementing the Sunshine Act later this year, but was not clear when it plans to do so.  CMS stated that the additional time will permit it "to address operational and implementation issues in a thoughtful manner, and the ability to ensure the accuracy of the data that is collected."  We will continue to monitor developments in this area.

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Brian P. Dunphy is a member of the Health Care Enforcement & Investigations Group at Mintz. He defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act. Brian also handles commercial health care litigation.