In November 2013, several members of Congress submitted a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS), urging that the distribution of textbooks and scientific peer-reviewed medical journal materials be excluded from the reporting requirements under the Sunshine Act. According to the preamble of the final regulations implementing the Sunshine Act, educational materials (including medical textbooks) provided to covered recipient physicians for their own education, but that do not directly benefit patients, are subject to reporting. CMS notes in the preamble 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. Therefore, according to CMS, these items are reportable under the Sunshine Act.
Administrator Tavenner responded to this letter, and denied the request to exclude the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirement under the Sunshine Act. In her response Administrator Tavenner noted CMS’ agreement that “scientific peer-reviewed journal reprints, supplements, and medical textbooks are educational to physicians.” CMS does not believe, however, that these materials fall within the statutory exclusion, as they do not directly benefit the patient.
On September 18, 2014, the United States House of Representatives introduced House Bill 5539 (H.R. 5539), which would amend the Sunshine Act by excluding from the reporting requirement "peer-reviewed journals, journal reprints, journal supplements, and medical textbooks." Additionally, H.R. 5539 would add to the current list of exclusions "[a] transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician."