Proposed revisions to The Sunshine Act

The Sunshine Act is a law that requires Pharmaceutical and Medical Device companies to disclose all payments and transfers of value made to any physician or teaching hospital via an annual report. Right now, the law provides an exception for payments to speakers at qualified Continuing Medical Education (or CME) programs (42 CFR § 403.904). This exception is intended to encourage physician involvement in genuine CME programs—or to at least avoid discouraging them from participating.

Things may not stay that way.

On July 11, 2014, CMS announced that it wishes to repeal the CME exception. CMS explained its reasoning in the Federal Register, essentially stating that it wanted to create consistency across reporting for all CME payments, rather than just excluding the programs approved by one of five accrediting bodies. That may be simpler for them, but it could come at a dire cost for CMEs.

If the exception is repealed, CME payments will be included in the annual tally with all other payments. Knowing that every CME payment will be reported and not distinguished from gifts or other transfers of value could discourage physicians from speaking at CME programs.

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Kesha Boykin-McLean

About the Author
Kesha Boykin-McLean

As Chief Compliance Officer, Kesha Boykin-Mclean brings over 20 years of experience in healthcare. Prior to joining VCS, Boykin-Mclean held a number of senior-level compliance roles, including managing and developing the compliance program for St. Francis Hospital in Connecticut. She was also the Division Ethics and Compliance Officer for the Hospital Corporation of America’s Gulf Coast Division where she was responsible for oversight of compliance programs for all hospitals within the division. Most recently, she served as an independent healthcare consultant, assisting hospitals with the planning and implementation of compliance programs.

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