According to a recent article from Inside Health Policy, "the overwhelming majority of comments to the agency ask the agency to keep or expand the... continuing medical education exclusion exclusion as part of the Open Payments Act." Citing recent analysis from the CME Coalition, the author notes that 98 percent of comments submitted to the Centers for Medicare and Medicaid Services (CMS) encourage the agency to maintain or expand the exemption for accredited CME. The article goes on to explain the rationale laid out by the CME Coalition and other stakeholders, who take issue with CMS' assertion that "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." Indeed, the author points out that "it is virtually impossible for manufacturers to remain in the dark that long as to who speakers and presenters at a CME event were, which means those indirect payments will have to be reported on the Open Payments website."
CME Coalition: Most Commenters Back Sunshine Law's CME Exclusion
The CME Coalition, which opposes CMS' proposal to do away with the continuing medical education exclusion as part of the Open Payments Act, says the overwhelming majority of comments to the agency ask the agency to keep or expand the 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 sunshine law requires drug, medical device and group purchasing organizations to report payments to physicians, which are then posted on the Open Payments website for the public to see. Funding for continuing medical education events currently 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.
CMS said some stakeholders argued the exclusion amounted to an endorsement of five CME accreditation organizations -- Accreditation Council for Continuing Medical Education; American Academy of Family Physicians; American Dental Association's Continuing Education Recognition Program; American Medical Association; and 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 its entirety.
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 manufacturers are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made.
Stakeholders, like the CME Coalition, have argued that it is virtually impossible for manufacturers to remain in the dark that long as to who speakers and presenters at a CME event were, which means those indirect payments will have to be reported on the Open Payments website.
An industry lawyer made a similar argument to Inside Health Policy about CMS' proposal before stakeholders began speaking out.
The CME Coalition says that, according to its survey, more than 200 leading medical societies -- including American Medical Association, American Academy of Family Physicians, Council of Medical Specialty Societies and Accreditation Council for Continuing Medical Education -- have commented on or signed onto comments and hundreds of individual practitioners have submitted comments asking that CMS keep or expand the CME exclusion.
“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 their physician-employees' participation in CE [continuing education] activities… Our organizations are concerned that this would have a significant, chilling impact on CE, which runs contrary to the public interest,” the AMA writes in its comments to CMS.
The CME Coalition suggests in its comments that if CMS really wants to keep indirect payments from drug and device manufacturers for CME events as exempt from reporting it should rewrite the CME exclusion rather than dumping it. The organization submitted language to CMS that would offer a definition of an acceptable accrediting organization rather than listing out specific organizations as a remedy to what the agency said was the appearance of specific endorsement.
"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 in its comments to CMS.
Contrary to the CME Coalition and other stakeholders' positions, the Pew Charitable Trusts has endorsed CMS' proposal saying that manufacturers' payments for CME events should be treated like any other indirect payment and should fall under reporting requirements. Pew does offer a caveat, saying that it should be made clear on the Open Payments website that these are indeed indirect payments for CME, so that providers aren't penalized.
"We therefore encourage CMS to allow the reporting of these payments so that indirect CME payments can be clearly distinguished from direct payments for promotional speaking," Pew writes.