At a packed meeting held after-hours at the Alliance for Continuing Education in the Health Professions annual conference on January 23, the Continuing Medical Education Coalition, a lobbying group formed in 2011 to represent the interests of the CME community on Capitol Hill, called on CME providers, medical societies, patient advocacy groups, and other nonprofit organizations to voice their objections to a proposed rule that would make them responsible for reporting what they spend on faculty and other healthcare professionals whose fees are paid for by educational grants from pharmaceutical companies.

The Physician Payment Sunshine Act as originally written in the Affordable Care Act of 2010 had excluded these third parties from having to disclose indirect payments to “covered recipients” (physicians or other healthcare professionals) by “applicable manufacturers” (drug and device companies). Payments to faculty of CME supported by industry fell under this exclusion.

In December, the Department of Health and Human Services issued a proposed rule that would require indirect payments to also be reported, something the Coalition called “neither good public policy nor consistent with the intent of Congress.” The proposed rule, which would require companies to report any commercial support money that they become aware of having indirectly benefitted faculty or attendees, puts the burden on CME providers to track who is the recipient of every dollar of the commercial support spent on each activity, says the Coalition. The CME providers then would have to provide that information back to the commercial supporter to include in its public healthcare provider payment disclosures.

This level of spend tracking would be too difficult, if not impossible, to implement, said Coalition representatives. In addition, the proposed rule does not differentiate between accredited CME—which already is regulated by the Accreditation Council for CME, Food and Drug Administration, Office of the Inspector General, and the American Medical Association, along with industry voluntary codes, to safeguard against bias and conflict of interest—and promotional programs.

While payments to third parties would still be excluded as long as the supporting company doesn’t know the recipient’s identity, that's a moot point, they said, as providers are required to disclose their faculty by ACCME rules. The proposed rule, said the Coalition representatives, would put an undue burden on CME providers who would have to track all payments and other “transfers of value,” and could ultimately make top-tier faculty wary of participating in a program when their payments would be made public. It would also be a burden on commercial supporters to have to wade through additional paperwork from CME providers.

However, the proposed rule does let organizers off the hook for having to track what they spend on each physician who partakes of coffee, snacks, or buffets offered in their exhibit halls, saying it would be too difficult to figure out who ate what, exactly. There is another exception for educational materials that are intended for patient use, though the Coalition also said questions remain about this exception, including whether it implies that other educational materials that do not fall under other exceptions must be reported, and how to interpret exactly what constitutes “educational materials intended for patient use”—e.g., does a medical textbook count?

While the CME Coalition was solidly against this piece of the proposed rule—Andrew Rosenberg, the Coalition’s senior strategist, said, “In the name of protecting patients, this will end up hurting patients”—others are hailing it as long-needed closure of a loophole. As vocal commercial support critic, psychiatrist, writer, and publisher Daniel Carlat, MD, said in a blog post recently, “Those of us in favor of transparency were able to breathe a sigh of relief when CMS recently unveiled its proposed regulations. Drug companies will, in fact, be required to report payments that flow through third-party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor. And how could they not be aware? ACCME requires all CME programs to publicly disclose the identities of both the industry supporter and the faculty—meaning that companies will eventually always know which doctors end up partaking of their ‘educational grants.’”

The HHS is collecting comments on the proposed rule until February 17, 2012. The final rules will be implemented beginning in 2013. Comments can be submitted here.

The CME Coalition is planning to post a sample letter of protest to its Web site before the deadline for those who would like an example on which to base their own letters to the Centers for Medicare and Medicaid Services and/or legislative representatives. (Update: A copy of the Coalition's response, along with sample letters, can be found here.)

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