Oct 2014

Authors:
Mark Gardner, MBA, JD, Associate, DuVal & Associates, PA
Suzanne Sullivan, RN, CCRA, Manager, Clinical Research Services, NAMSA

Abstract:

The Sunshine Act requires that research payments made to physicians and teaching hospitals be reported to CMS. This includes payments and grants in support of basic and applied research and product development. CMS began publically displaying the payment information starting in the fall of 2014. In certain situations, such payments can be reported in aggregate as a single research payment. Under special circumstances, companies may delay reporting payment information relating to product research or development agreements and clinical investigations for up to 4 years. Practically speaking, manufacturers should invest the time in understanding this new and complex regulation. Failure to do so may result not only in fines and bad publicity but also in harm to relationships with customers.