Drug and medical device companies would have to report most payments to doctors above $10, under a version of the Physician Payments Sunshine Act included in the Senate health reform bill introduced this morning.
The Chairman’s Mark, the health reform bill language released by Senate Finance Committee Chairman Max Baucus today, applies to all U.S. drug, device, biologics, and medical supply manufacturers. It requires those companies to report payments over $10 made to physicians, physician practices, hospitals and academic medical centers. If an individual receives a total of more than $100 per year, then all payments would have to be reported (i.e., even those smaller than $10). The data will be publicly available on a website to be created by the Department of Health and Human Services (up and running by 2012, according to the Mark).
Certain gifts and payments would not be reported, including the provision of patient education materials and drug samples for use by patients. However, a separate provision of the Mark requires companies to provide information on samples to HHS. Delayed reporting is permitted for payments related to product development, in order to protect commercial sensitivities.
The bill would create a uniform national disclosure database across all states, but it would not pre-empt aspects of state laws or regulations (such as those in Vermont, Minnesota and Massachusetts) that go beyond its provisions—such as payments to non-physician providers, other types of payments or prohibitions on some payments.
Companies that knowingly fail to report could be fined up to $1 million.
The Senate Finance provisions are broadly similar to Sunshine provisions included in health reform legislation passed by the House Energy and Commerce Committee in July.
Today’s bill establishes physician-industry transparency as a bicameral priority within health reform. A national disclosure law has the support of major consumer, physician and industry groups – and of legislators from both parties. Today’s Senate provisions are thorough and comprehensive, and we strongly endorse them.
For more, visit the Pew Prescription Project’s Sunshine Act Guide.
-Marcia Hams, Director of Prescription Access and Quality,