Last month we wrote about a bipartisan effort in Congress to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. Click here for the text of H.R. 5539. Now, dozens of physician organizations representing both national specialty societies and state medical societies have expressed their support of the bill. "H.R. is needed to ensure patients benefit from the most up-to-date and relevant medical knowledge," the letter states.
View the medical societies' letter to Representative Michael Burgess (R-TX), who introduced the bill. Allyson Schwartz (D-PA) co-sponsored.
Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. "This conclusion 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," states the letter.
The American Medical Association and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for patient care. "Scientific 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 letter states. "Independent, peer reviewed medical textbooks and journal article supplements and 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."
Furthermore, the letter states that FDA's reprint guidance underscores the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” H.R. 5539 clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material.
The letter also addresses the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Act. "[This] proposal is inconsistent with the legislative history of the Sunshine Act and will further erode support of independent medical education," the societies note. "There is widespread consensus that the agency’s proposal will harm the dissemination of clinically relevant and critical medical knowledge that improves and enhances patient care. We strongly support the provisions in H.R. 5539 which would clarify that CME that meets the standard for independence must be exempt from Sunshine Act reporting."
Click here for our article on the outpouring of support in favor of keeping the CME exemption.
H.R. 5539 revises the Sunshine Act in the following way:
Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]
(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:
(iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
(xiii) 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.