Life Science Compliance Update

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January 16, 2014

Physician Payment Sunshine Act: Members of Congress Pursue Repeal of Sunshine Reporting Requirement for Medical Journals and Textbooks

Congressional lawmakers will work to eliminate the Physician Payment Sunshine Act (Open Payments) requirement that applicable manufacturers (pharmaceutical, device and biologic) disclose gifts of medical journals and textbooks to physicians.

We reported that the Centers for Medicare & Medicaid Services (CMS) recently rejected a letter from a bipartisan group of 23 members of the House of Representatives, which argued that Congress explicitly excluded the reporting of "educational materials" in the law, and medical journals and textbooks fit neatly into that category. CMS Administrator, Marilyn Tavenner, responded that although these items are important for physicians and may have "downstream benefits" for patients, they are not directly beneficial to patients and are not intended for patient use as the text requires. Therefore, according to CMS, these items are reportable under the Sunshine Act.

Members of Congress are not sold on this interpretation.

According to FDANEWS, an aide to Rep. Andrew Harris (R-Md.) stated that the lawmaker will add language to a future appropriations bill to halt CMS' enforcement of the textbook/reprint reporting requirement. Furthermore, Greg Vadala, a spokesperson for Rep. Allyson Schwartz (D-Penn.), said the congresswoman is also exploring options to address the issue and will work with other lawmakers who share her concern the requirement could impede patient care.

Critics of CMS's interpretation believe that doctors depend on scientific peer-reviewed medical textbooks and journals to stay up-to-date on the latest medical knowledge to give their patients the best care possible. Members of Congress argue that they explicitly excluded education materials from the Sunshine requirements so as not to prevent timely distribution of the information to clinicians.

Policy and Medicine has followed the Sunshine Act closely, and will continue to report on any legislative activity surrounding the Act.

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