Today, Inside Health Policy reported on a letter sent by the American Medial Association (AMA) and other medical groups urging passage of Sen. John Barrasso's (R-WY) legislation (S. 2978) that would exempt continuing medical education (CME) activities from Sunshine Act reporting requirements. As the article notes, a Centers for Medicare and Medicaid Services (CMS) interpretation of the Physician Payments Sunshine Act has deemed that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of those articles are not directly beneficial to patients - and are therefore subject to reporting requirements. The physician groups note that the interpretation is "inconsistent with the reality of clinical practice" and that Sen. Barrasso's legislation would "ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge."
The CME Coalition has also spoken out against the CMS interpretation, and conducted research showing that 98 percent of public comments on the proposal support maintaining the exclusion or expanding it.
The full article can be found below.
The full article can be found below.
Physician Groups Push Senate Bill Waiving CME From Sunshine Reporting
The American Medical Association, joined by dozens of specialty groups and state medical societies, has thrown its support behind a Senate bill that would exempt certain continuing medical education from Sunshine Act reporting requirements. The groups say passage of the bill is urgently needed 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 groups recently wrote to bill sponsor Sen. John Barrasso (R-WY) saying his measure "would protect the dissemination of peer and independent third-party reviewed services and products that improve patient care." The legislation is important, the groups say, 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.
They say the bill's clarification that CME meeting the standard for independence must be exempt from Sunshine Act reporting has become necessary due to contradictory guidance from CMS that required several revisions to subregulatory guidance. "Adding 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," AMA and the other physician groups write to Barrasso.
Congress, when it first took the Physician Payments Sunshine Act, specifically intended to exclude independent sources of clinical information from sunshine reporting requirements, according to AMA and the specialty groups. The Sunshine law was created to promote transparency about payments and other financial transfers of value between physicians and the medical product industry. Congress wrote into the law 12 exclusions from the reporting requirements, including for "[e]ducational materials that directly benefit patients or are intended for patient use," according to the groups.
But CMS has interpreted 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 supposed to be for patient use.
"This 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 physician groups tell Barrasso.
The agency defended its policy in a proposed Sunshine rule, saying the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturers are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made. In 2014, the CME Coalition, which opposes CMS' proposal to do away with the continuing medical education exclusion as part of the Open Payments Act, said the overwhelming majority of comments to the agency ask the agency to keep or expand the CME exemption. The CME Coalition says it went over the more than 800 comments submitted on CMS' proposal in the 2015 Physician Fee Schedule and found that 820 -- or 98 percent -- of the comments support keeping the exclusion or expanding it, while "approximately 20" comments support the agency's proposal.
The physician groups say Barrasso's bill, the "Protect Continuing Physician Education and Patient Care Act" (S. 2978), would protect the circulation of peer and independent third-party reviewed services and products.
"This legislation 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 groups say.
They add: "Scientific 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 note that 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," shows the "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."
CMS released 2015 Open Payments data last Thursday (June 30), but the AMA said because of data errors and registration challenges during the past two years, physicians have shied away from participating in the review and validation process.