AAFP Fights to Block Undue 'Sunshine' Reporting Requirements

Academy Supports Bill to Clarify CME Exemptions

July 12, 2016 10:13 am News Staff

The AAFP recently joined more than a hundred other national and state physician organizations in the medical community's latest attempt to rectify an overreach CMS made back in 2013. By throwing its support behind legislation that is intended to clarify what is and isn't reportable under the Physician Payments Sunshine Act, the Academy seeks to safeguard physicians' unfettered access to high-quality educational resources and independent certified and/or accredited CME.

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In a June 29 letter(4 page PDF) to Sen. John Barrasso, M.D., R-Wyo., the groups expressed their "strong support" for the Protect Physician Continuing Education and Patient Care Act,(www.congress.gov) which Barrasso introduced in May in an effort to "protect the dissemination of peer- and independent third party-reviewed services and products that improve patient care."

Designed to promote transparency regarding payments and other financial transfers of value between physicians and the medical product industry and, thus, reduce potential conflicts of interest that could arise from such relationships, the so-called Sunshine Act requires drug and device manufacturers to report these transfers of value to CMS. Those reports are made to the agency's Open Payments transparency program, which, in turn, makes the data publicly available.

In its final rule(www.gpo.gov) implementing the act, however, CMS has imposed "onerous and burdensome reporting obligations" that clearly diverge from Congress' intent in passing the legislation, the groups argue.

At issue is the agency's interpretation of the statute, say the signatories. Whereas Congress outlined 12 specific exclusions from the reporting requirement, including educational materials "that directly benefit patients or are intended for patient use," the agency concluded that medical textbooks, reprints of peer-reviewed clinical journal articles and abstracts of these articles "are not directly beneficial to patients, nor are they intended for patient use."

Nothing could be further from the truth, the groups contend.

"The importance of up-to-date, peer-reviewed scientific medical information as the foundation for good medical care is well documented," they write. "Scientific peer-reviewed journal reprints, supplements and medical textbooks have long been considered essential tools for physicians to remain informed about the latest in medical practice and patient care."

Such resources, in fact, "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, say the groups, Barrasso's bill also clarifies that CME that meets standards for independence "must be exempt from Sunshine Act reporting." Contradictory direction from the agency on this issue has "required several revisions to subregulatory guidance," they point out.

To make matters worse, a March 10 New England Journal of Medicine article(www.nejm.org) that was co-authored by current and former CMS staff stated 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 organizations claim.

Overall, say the groups, indications are that CMS' misinterpretation of Congress' intent has "already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals," and the signatories now seek "to avert a similar negative impact on access to independent certified and/or accredited continuing medical education."

"The Sunshine Act was not passed to limit or construct additional barriers to the dissemination of new medical knowledge that improves patient health outcomes," the groups conclude. "This bill is needed to ensure patients benefit from the most up-to-date and relevant medical knowledge."

Related AAFP News Coverage
AAFP Throws Support Behind Bill That Would Safeguard CME
Measure Affirms 'Sunshine' Reporting Exclusion for Educational Materials


AAFP Supports Bill Providing 'Sunshine' Exemption for Educational Materials

Physician Organizations Call Out CMS for Overreach in Sunshine Act Regulation

Final Rule on Physician Sunshine Act Released
Manufacturers, GPOs Required to Report Certain Payments, Gifts to Physicians


Additional Resource
CMS: Open Payments(www.cms.gov)