Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision

Aug. 6, 2014 – More than 100 medical associations and medical specialty societies have asked the Centers for Medicare & Medicaid Services (CMS) to consider its “serious concerns with implementation of the Physician Payments Sunshine Act,” which include revising CMS’ recently proposed elimination of the continuing medical education (CME) exemption and reversing the agency’s position that medical textbooks and reprints of peer-reviewed journal articles should not be excluded from Sunshine Act reporting requirements.

In a letter dated Aug. 5, these groups also ask the agency to extend the time frame for physician registration on the CMS Open Payments site by six months and to allow physicians to review and dispute reports in a reasonable manner.

“When virtually all of organized medicine expresses grave concerns over the policy and process errors in implementing the Sunshine Act, CMS must respond,” said Coalition for Healthcare Communication Executive Director John Kamp. “All of the requests are appropriate — including the need to consider journal articles and reference texts as exceptions to reporting — and CMS simply must postpone the initial reporting date, both to enable doctors to protest errors and to ensure that CMS can provide proper context to the payments,” he said.

Specifically, the medical organizations object to CMS’ proposal to revoke the CME exemption under the Sunshine Act and allow exemptions through third-party transfers only where an industry donor is unaware of the recipients/beneficiaries before and after the funds are transferred. “Our organizations believe that this raises concerns as industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications” or through other means, the letter states. “Our organizations are concerned that this would have a significant, chilling impact on [continuing education], which runs contrary to the public interest.”

The groups “strongly recommend” that CMS slightly modify the proposal to add the language that the exemption applies when “an applicable manufacturer provides funding to a CE provider, but does not select or pay the covered recipient speaker/faculty directly, or provide the CE speaker with a distinct, identifiable set of covered recipients to be considered as speakers/faculty for the CE program.”

The letter also states that CMS can include guidance stipulating that industry donors must be unaware of the speakers/faculty/participants before committing to fund the activity. “This accomplishes CMS’ goal while eliminating the potential for negatively impacting CE,” the groups assert.

Further, these organizations contend that CMS failing to exclude textbooks and reprints from Sunshine Act reporting is an “overbroad interpretation of the statute.”  The letter states that “the importance of up-to-date, peer-reviewed scientific medical information as the foundation for good medical care is well documented,” and that 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.” Accordingly, the letter signatories “urge the Agency to reconsider its decision.”

This letter to CMS follows a July 28 letter to the agency signed by 26 physician and industry groups, which calls on CMS to provide physicians and industry stakeholders with information “describing how context will be provided to the general public when Sunshine Act data is made available in September.”

For additional coverage of the Aug. 5 letter, go to: