Senate Pushes Sunshine in Dealings with Doctors
20 November 2012
Companies involved in the manufacture of drug, device, biologic and medical supplies may soon face stringent requirements to report their dealings with physicians in the United States, according to Michael J Werner, a partner at Holland & Knight in Washington, writing in the firm’s Health Law & Life Sciences newsletter.
The Physician Payments Sunshine Act of 2009 is, according to its supporters, designed to provide greater "transparency" to the relationships between companies and physicians. In his statement in the Congressional Record upon introduction of the legislation, Senator Charles Grassley (R-Iowa) said transparency is necessary because there are “significant undisclosed financial ties between physicians and industry” that could influence patient care and medical research.
“The Act requires drug, biologic, device and medical supply manufacturers (defined as any entity engaged in the ‘production, preparation, propagation, compounding, conversion, processing, marketing, or distribution’ of the product) receiving funds under Medicare, Medicaid, or SCHIP to annually report to the Secretary of DHHS all payments or other transfers of value to physicians and medical practices that are greater than US$100 during the previous calendar year,” said Werner.
The first reports will be made electronically on March 31, 2011, and are to be made on the 90th day of each subsequent calendar year. The Act provides for civil monetary penalties for non-compliance of up to US$10,000 for each payment not reported.
