The CME Coalition, which launched last June to provide a voice on Capitol Hill for those who believe continuing medical education can and does improve patient care, has released a voluntary Code of Conduct.
The idea behind the new Code, says the CME Coalition’s Senior Advisor Andrew Rosenberg, was not to break any new ground or impose any more stringent limitations than are already required by the various CME accrediting bodies. Instead, he says, the code is designed to pull all the disparate regulations surrounding CME and, specifically pharmaceutical and medical device/CME /provider relationships, into one “10 Commandments” type of document.
The hope, he says, is that it will make clear to the CME community and, perhaps more to the point, those on Capitol Hill, the rigorous requirements that are already in place to deal with potential conflicts of interest that could arise when industry commercially supports healthcare provider education. CME Coalition members are asked to formally and publicly agree to the 10 principles to demonstrate their support for transparency, adherence to established guidelines regarding conflicts of interest, and scientific rigor as the basis for their curricula.
According to the Coalition, the Code also calls for the CME community to further “the appropriate advancement and adoption of innovative technologies, treatments, and procedures through state-of-the-art educational programming.” It asks both CME providers and commercial supporters to commit to “educating the public as to the vital role of continuing medical education to our health care system.”
Rosenberg says that, once everyone realizes the stringency of the rules under which CME is conducted, they also should realize that “they shouldn’t be discouraging private sector support for CME—they should be encouraging it. We should all applaud companies that want to participate and experts who want to engage in CME, not stigmatize them or putting unreasonable limitations on their engagement.”
Coalition Endorses Medical Device Regulatory Improvement Act
[This article has been updated since its original publication to include the following section.] The Coalition also has endorsed S.1700, the Medical Device Regulatory Improvement Act, a bipartisan bill introduced jointly by Senators Amy Klobuchar (D-Minn.), Michael Bennet (D-Colo.) and Richard Burr (R-N.C.).
According to a Coalition press release, the group sees the bill as a sign that its sponsors believe the strictness of the current FDA conflict of interest restrictions make it "unnecessarily difficult for the agency to find qualified experts to serve on advisory committees, which can contribute to unnecessary delays in access to treatment for patients." The Coalition supports S.1700 for "restoring the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government under the Federal Advisory Committee." The group notes that the problems caused by the FDA rules' stringency parallels those experienced by other institutions that are prohibiting experts with financial ties to industry from participating in CME, rather than finding ways to effectively disclose and manage those potential conflicts of interest.
Briefings on Both Sides of the Aisle
Borne out of a concern that there’s no one pleading the CME community’s case when the heat is turned up in Washington on industry/provider relationships, the CME Coalition also held two briefings on Capitol Hill this fall. Rosenberg stresses that they were informational in nature, not in response to a specific issue. “The broader goal of the CME Coalition isn’t to lobby for any specific piece of legislation or to oppose or support any specific member of Congress,” Rosenberg says. “It’s to educate policymakers on Capitol Hill about what CME is, the rules that are in place to govern its practice and guarantee its scientific integrity, and to tell the story of how CME is changing the face of medicine and maximizing the benefits of innovation for patients.” It also supports private sector commercial support for CME as a vital source of funding, without which, he says, “You are never going to maximize the uptake of innovation, you’re never going to improve physician awareness and education, and ultimately you’re never going to improve patient outcomes.”
The two briefings, held back-to-back in late September, rolled out the organization to Capitol Hill staffers and began its ongoing effort to get its message across. The first was held on the House side.(“It’s difficult to get House staff to travel to the Senate side and vice versa, so we held one on each side to maximize attendance,” says Rosenberg.) It was designed to educate House healthcare staff about both CME and the specific benefits that can result from CME about breast. The briefing included Jonathan Sackier, MD, professor of surgery, University of Virginia, who served as the moderator; Charles M. Balch, MD, FACS, professor of surgery, division of surgical oncology, department of surgery, University of Texas Southwestern Medical Center; and Dana Simpler, MD, family doctor and internist, Mercy Medical Center, Baltimore, who spoke about how the CME activities she has participated in have improved the way she treats her primary care patients.
The briefing before the Senate healthcare staffers, also moderated by Sackier, featured a similar program, this time focusing more on HIV/AIDS. It included presentations by John Bartlett, MD, professor and chief of the division of infectious diseases at Johns Hopkins; and Alan Wasserman, MD, The Eugene Meyer Professor of Medicine and the chairman of the department of medicine at The George Washington University School of Medicine and Health Sciences.
According to Rosenberg, both House and Senate briefings including robust question-and-answer sessions. For example, on the House side, staff from the office of Rep. Michael Burgess (R-Texas) were interested in speaking at length with the CME Coalition to address COI-related policies in the CME world. On the Senate side, a senior staff member from the office of Sen. Herb Kohl (D-Wis.), who has traditionally has been skeptical about industry/CME relationships, got into an interesting conversation with the presenters about how to minimize industry bias while allowing what’s best in CME to grow, says Rosenberg.
While membership in the coalition remains small—just six organizations, five of which are medical education companies—at this point, Rosenberg says the group is still in its early growth stages and all CME stakeholders are welcome. To spread the word about its mission, focus, and activities, the Coalition held an informational breakfast meeting at the American Medical Association CME Provider/Industry Task Force conference in September. It intends to hold another meeting at the upcoming Alliance for CME meeting in January in Orlando.
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