The Centers for Medicare and Medicaid Services (CMS) has denied requests to exclude the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirements under the Sunshine Act. According to the preamble of the final regulations, 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 under the Sunshine Act. 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.
Over the past few months, CMS has received requests to change its position regarding textbooks and scientific peer-reviewed medical journal reprints, supplements, and abstracts. Specifically, on October 28, 2013, seventy-four (74) physician organizations submitted a letter to Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services , requesting the reversal of CMS’ position regarding these materials. The physician organizations noted that “[s]cientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care.” The organizations further noted that the Sunshine Act excludes items that directly benefit patients, including reference materials that are often used side-by-side with a patient as a first resource when a patient brings an unfamiliar medical issue to a clinician. The organizations asserted that because many medical textbooks and scientific medical journal supplements and reprints are used in this way by physicians, then these items should also be excluded from the reporting requirement. They also referenced a 2009 Food and Drug Administration guidance providing that “medical reprints should be distributed separately from information that is promotional in nature, specifically because the reprints are designed to promote the science of medicine, are educational, and intended to benefit patients.”
On November 22, 2013, several members of Congress submitted a letter to Marilyn Tavenner, Administrator of CMS, making the same request. In their letter, the members of Congress note that “independent, peer-reviewed medical textbooks and journal article reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients.” The reporting requirement, however, “presents a clear disincentive for clinicians to accept high quality, independent educational materials.” The members of Congress believe that this outcome, resulting from the reporting requirement, is “inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge.”
Administrator Tavenner recently responded to the Congress members’ letter, and denied the request to exclude the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirements 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.
In what appears to be a response to the Congress members’ concern that the reporting requirement creates a disincentive for clinicians to accept independent educational materials, Administrator Tavenner indicated that the “mere existence of a financial relationship between the industry and physicians does not necessarily signify an inappropriate relationship,” and that “[d]isclosure alone is not sufficient to differentiate beneficial financial relationships from those that potentially create conflicts of interest.” Administrator Tavenner further emphasizes that the purpose of the Open Payments program is to report information in a “neutral and non-judgmental way for the use of physicians, patients, researchers, or any other member of the public.”
For more information regarding Sunshine Act reporting, please see CMS' Open Payments website.