An article published in Inside Health Policy highlights the CME Coalition's disapproval - and suggested remedy - to CMS' recent proposed rule on the Sunshine Act reporting exemption for certain CME payments. While the proposed rule argues that the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals, the article notes that "industry and CME organizations complain that the exemption is not redundant because it's impossible for drug and device companies to remain ignorant of speakers' identities that are publicly available on conference agendas and elsewhere, such as trade press accounts of speaker presentations." The article goes on to outline the CME Coalition's proposed policy fix, which includes allowing CMS to audit manufacturers for compliance and avoids endorsement of CME accrediting organizations.
Inside Health Policy: CME Coalition Advises Rewriting Sunshine Exemption, Instead Of Axing It
The CME Coalition is proposing that, rather than scrap the exclusion for continuing medical education funding on the Open Payments website, CMS should rewrite the exemption to include all CME accrediting organizations. The coalition, which helped get CME funding excluded from being reporting, says tossing the exclusion would cost CME providers nearly $200 million over three years.
"(T)he Coalition's analysis of the proposed rule's actual language suggests that rather than expanding the exemption beyond the originally designated 'five accrediting bodies,' the proposal could instead require additional reporting for both speakers and attendees at CME events. The resulting elimination of the CME exemption could be devastating for the practice of CME," the CME Coalition writes in a press release accompanying its formal comments on the issue to CMS administrator Marilyn Tavenner.
The physician sunshine law requires drug, medical device and group purchasing organizations to report payments to physicians, which is then posted on the Open Payments website for the public to see. Funding for continuing medical education events does not have to be reported if companies do not set the agenda, choose speakers, or pay them directly, but CMS proposed including that funding in indirect payments.
Stakeholders told CMS the exclusion amounted to an endorsement of five CME accreditation organizations -- the Accreditation Council for Continuing Medical Education; the American Academy of Family Physicians; the American Dental Association's Continuing Education Recognition Program; The American Medical Association; and the American Osteopathic Association -- because the agency excluded others that use the same or similar accreditation standards.
The proposed rule states that CMS didn't intend to endorse those organizations, and it used this criticism to justify getting rid of the exclusion.
In the proposed rule, CMS said the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturer are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made.
Industry and CME organizations complain that the exemption is not redundant because it's impossible for drug and device companies to remain ignorant of speakers' identities that are publicly available on conference agendas and elsewhere, such as trade press accounts of speaker presentations.
"You can't keep [the manufacturers] in the dark for the amount of time required," an industry lawyer told Inside Health Policy. "As a lawyer, that's what I'd argue."
To remedy this the CME coalition is proposing that CMS should rewrite the CME exclusion by replacing the list of five accreditation organization with a formal definition of what qualifies as an accredited provider.
Under CME Coalition's proposal the accrediting body would be required to:
· Have standards regarding the acceptance and use of payments or other transfers of value from applicable manufacturers.
· Enforce compliance with these standards through audit, inspection, complaints, or otherwise.
· Have the authority to impose penalties for non-compliance with such standards, including loss of status or ability to offer credits to physicians.
· Require the third-party organization to certify compliance with such standards on a regularly scheduled basis.
· Not be owned or controlled, in whole or in part, by an applicable manufacturer.
The CME Coalition says its proposal would allow CMS to audit manufacturers for compliance and avoids endorsement of CME accrediting organizations.
"This voluntary system would remove CMS from the 'approver' role and allow the agency to rely on established CME stakeholders to self-regulate CME providers with respect to commercial support from applicable manufacturers," the CME coalition writes.
Manufacturers would be the entities required to report the indirect payments to physicians to CMS, but CME providers would have to itemize CME funding so companies could attribute indirect payments to physicians, such as honoraria, travel costs and educational materials.
The CME Coalition contends that the reporting requirements would be overly burdensome for CME providers and manufacturers, and it estimates the requirements could cost providers $197,586,521 over three years -- or 10.6 percent of what the CME providers receive in sponsorships from drug and device manufacturers.