A long list of over one hundred specialty groups and state medical societies penned a joint letter to Senator John Barrasso expressing their “strong support” for S. 2978, the Senate bill that would exempt certain continuing medical education (CME) from Sunshine Act reporting requirements. Among the lengthy list of groups signing the letter were groups such as the: American Medical Association, American College of Cardiology, American Academy of Family Physicians, and Medical Society of the District of Columbia.
The groups note that the enactment of the senate bill would “protect the dissemination of peer and independent third-party reviewed services and products that improve patient care.” Such legislation is important because evidence-based medicine is facilitated by a practicing physician’s ability to look at independent peer-reviewed journals, medical textbooks, and independent continuing medical education.
In the letter, the groups urge Congress to pass the bill because CMS has already “chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals” and appears ready to also stifle access to independent certified and/or accredited CME. The letter also mentions the fact that the bill attempts to clarify that CME which meets the standard for independence must be exempt from Sunshine Act reporting. Such a requirement has become necessary due to contradictory guidance from CMS that required several revisions to subregulatory guidance.
The letter continues on, stating, “[a]dding to the concern, a recent New England Journal of Medicine article, which was co-authored by current and former CMS staff, says that ‘payments related to all accredited CME activities must be reported beginning in 2017.’ This statement only adds to the confusion surrounding the status of independent CME as it relates to Open Payments reporting.”
The groups believe that when Congress first enacted the Physician Payments Sunshine Act, it specifically intended to exclude independent sources of clinical information from sunshine reporting requirements. Congress wrote into the law twelve exclusions from the reporting requirements, including an exclusion for “[e]ducational materials that directly benefit patients or are intended for patient use.”
However, CMS has decided to interpret the statute to mean 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 meant to be used by patients. According to the letter, “[t]his conclusion is inconsistent with the reality of clinical practice where patients benefit directly from improved physician medical knowledge and is not supported by the statutory language on its face or congressional intent.”
The letter continues, stating, “[s]cientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for physicians to remain informed about the latest in medical practice and patient care. 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.”
The groups also make mention of the 2009 FDA guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” stating that the guidance shows that the FDA understands the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.”
As one of the participating organizations, the American Academy of Family Physicians issued a statement on the letter, noting that the Academy “seeks to safeguard physicians’ unfettered access to high-quality educational resources and independent certified and/or accredited CME.