October 31, 2014
The California Medical Association (CMA) has joined the American Medical Association (AMA) and 70 other medical associations in support of H.R. 5539, which would exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements.
In a joint letter the organizations said that “passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by the Centers for Medicare and Medicaid Services (CMS) that have already chilled the dissemination of medical textbooks, peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent certified and/or accredited continuing medical education (CME).”
H.R. 5539 would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive.
The Sunshine Act was designed to promote transparency with regard to payments and other financial transfers of value between physicians and the pharmaceutical and medical product industries. 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.
AMA and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for quality 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." H.R. 5539 would clarify that the Sunshine Act was designed to support the dissemination of this type of educational material.
The letter also addresses CMS’ proposal to eliminate the CME exemption from the Act. This proposal will “erode support of independent medical education," the letter states. "There is widespread consensus that [this] 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."