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The Sunshine Act provisions of the Affordable Care Act are here to stay. A compliance expert opened the 2013 Pharma Forum in Orlando with a detailed look at what meeting professionals at pharmaceutical and other life sciences and medical device manufacturers need to know to keep their programs complaint.
Daniel Garen, senior vice president and chief compliance office, Wright Medical Technology, Inc.
“It’s like we’re flying a plane at 40,000 feet and just now are opening up the book to see how we’ll land,” said Daniel Garen, senior vice president and chief compliance officer with Wright Medical Technology, who opened the 2013 Pharma Forum at the Marriott World Center in Orlando by detailing what today's life sciences meeting managers need to know about the Sunshine Act. The Forum is co-organized by and The Center for Business Intelligence.
Final rules for the Physician Payment Sunshine Act, a provision of the Patient Protection and Affordable Care Act, require that manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, and the Children’s Health Insurance Program report all transfers of value—including payments, gifts, research and consulting fees, speaking fees, meals, and travel—to physicians and teaching hospitals.
To continue Garen’s analogy, the plane pushed back from the gate in 2004, when states first began passing their own transparency laws. Then it got off the ground when the Affordable Care Act got under way in 2009, and reached cruising altitude in 2010 when PPACA was passed into law. We’ve been in a holding pattern since 2011, however: While the Centers for Medicare and Medicaid promised to issue guidance on how to implement Sunshine, that didn’t happen until February of this year.