In accordance with the Physician Payments Sunshine Act, when physicians receive a transfer of value from a drug or device manufacturer, the transaction is reported to CMS' Open Payments transparency program. However, there has been some confusion about whether the act applies to certain educational materials.
For example, the act specifies an exemption from reporting for educational materials physicians receive that offer a direct benefit to patient care. However, CMS has interpreted the law to mean that medical textbooks and reprints of journal articles do not confer any direct patient benefit and, thus, should not be exempt from reporting requirements.
In response, Rep. Michael Burgess, R-Texas, introduced legislation that would provide a clear exemption from reporting requirements for educational materials such as peer-reviewed textbooks and journal article reprints that physicians obtain when they attend educational seminars or similar professional events.
Late last month, the AAFP and several dozen medical specialty organizations and state medical associations signed a letter of support(4 page PDF) for the legislation Burgess introduced.
"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," say the groups in their letter to Burgess.
The letter goes on to cite industry guidance from the FDA that "underscores the importance of this scientific peer-reviewed information."
"The FDA noted the 'important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications,'" says the letter.
The groups also point out that CMS is proposing to eliminate an exemption for "certified and accredited CME that meets certain criteria demonstrating independence."
"The proposal is inconsistent with the legislative history of the Sunshine Act and will further erode support of independent medical education," say the signatories. "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."
In short, the letter concludes, "The Sunshine Act was not passed to limit or construct additional barriers to the dissemination of new medical knowledge that improves patient health outcomes," and passage of Burgess' bill would "ensure patients benefit from the most up-to-date and relevant medical knowledge."
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