Inside Health Policy recently led with a story about the legislation that Chairman Burgess (R-TX) and Rep. Schwartz (D-PA) have introduced regarding the CME exemption within the PPSA. Author Todd Allen Wilson writes that the bill was spurred by the letter from the Chairman and Ranking member Pallone (NJ) and their bipartisan concern for the Agency's attempt to stigmatize continuing medical education. The article goes on to state that stakeholders have contributed an "overwhelming chorus" of support for the exemption. It also directly notes the efforts of the Coalition to provide an alternative to the Agency's proposed rule. "The CME Coalition proposed that rather than dumping the CME exclusion CMS should rewrite the rule so that instead of listing the five above mentioned CME accreditation organizations the agency provides a clear and detailed definition of what qualifies as an accredited provider."
Reps. Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation Friday (Sept. 19) that would exempt indirect payments that drug and device manufacturers offer to continuing medical education providers from sunshine reporting requirements, legislation that if enacted would reverse CMS' plan to do away with the exemption.
The legislation comes on the heels of a letter sent to CMS Thursday (Sept.18) by Burgess and Rep. Frank Pallone Jr. (D-NJ) expressing their concern over the agency's plan to do away with the CME exemption in the physician sunshine law's Open Payments program. Burgess and Pallone, who sit on the House Energy and Commerce Committee health subcommittee, say in the letter to CMS Administrator Marilyn Tavenner that the proposal to do away with the CME-specific exemption in favor of another provision of the Open Payments program would cause confusion for CME providers and have a negative impact on continuing medical education and the medical community as a whole.
The lawmakers join an overwhelming chorus of CME stakeholders asking CMS to rethink its proposal. The CME Coalition, itself opposed to the agency's plan, found in its tally of the comments submitted to CMS on the issue earlier this month that 98 percent of the more than 800 comments favored keeping the exclusion in place.
Burgess and Pallone said that the importance of CME “in our healthcare system by improving patient outcomes, facilitating medical innovations, and keeping our nation's medical professionals up-to-date with the rapid pace of scientific discovery” is why CMS excluded indirect payments from drug and device manufacturers to CME providers from having to report under the Open Payments program.
“As you consider public comment and finalize your proposal in the coming weeks, we ask that you take into account our concerns for the proposed policy's potential negative impact on CME and the medical community,” Burgess and Pallone write.
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. Funding for CME 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 proposed that rather than dumping the CME exclusion CMS should rewrite the rule so that instead of listing the five above mentioned CME accreditation organizations the agency provides a clear and detailed definition of what qualifies as an accredited provider.
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 compromise, saying it should be made clear on the Open Payments website that these are indeed indirect payments for CME, so that providers aren't penalized.
The CME Coalition estimates that requiring reporting of indirect payments from manufacturers would cost CME providers nearly $200 million over three years in administrative costs
