The commercial sponsorship of continuing medical education (CME) poses a potential conflict of interest between patient welfare and the commercial interests of sponsors, according to the testimony of the Office of Inspector General (OIG) Chief Counsel, Lewis Morris. Sponsors that provide funding to CME providers are frequently manufacturers of drugs, biologics, or medical devices related to the topic of the CME program. Commercially-sponsored CME programs consequently tend to focus more on sponsors' products than do programs that are not commercially-sponsored. One study on pharmaceutical promotional strategies revealed that spending $1 on physician events generated an average of $3.56 in increased revenue.
ACCME authority. The Accreditation Council for Continuing Medical Education (ACCME) is the principal CME accrediting authority in the U.S. Its responsibilities include determining whether providers qualify to offer accredited CME programs, and overseeing the CME industry. Once a CME provider is accredited by ACCME, the provider can offer accredited CME programs without further review on the program's content. ACCME has enacted measures to mitigate commercial bias, such as prohibiting CME content from promoting a specific proprietary interest.
Limited oversight. However, the impact of ACCME's measures is limited. ACCME neither pre-approves content nor routinely monitors CME programs. Its oversight is complaint-driven, and in practice, several years may lapse before a noncompliant CME provider's accreditation is revoked. Under the current system, CME providers can seek commercial financial support by developing CME content to favor funders' economic interests. Some manufacturers publicize general topics they are willing to fund to solicit grant applications from CME providers that propose programs on those topics. As a result of these and other activities, industry-supported CME usually covers topics related to commercial products, rather than patient care.
Legal implications. Commercially-sponsored CME may implicate the Federal Food, Drug, and Cosmetic Act (FDCA). On at least two occasions, a pharmaceutical company was required to pay millions of dollars to resolve charges arising out of CME programs that allegedly promoted the off-label uses of its product in violation of the FDCA. The False Claims Act may be similarly implicated if a manufacturer knowingly collaborates with a CME provider to promote an off-label use and submit claims for that drug to federal health care programs. Industry-supported education may also implicate the criminal anti-kickback statute; for example if a pharmaceutical manufacturer rewards a high-prescribing physician by directing a CME provider to pay that physician to be CME faculty, that payment may be a kickback.
Measures to preserve the integrity of CME. According to the OIG, the “surest way to eliminate commercial bias in CME is to eliminate industry sponsorship by funders who have a significant financial interest in physicians' clinical decisions.” CME providers should accept funds only from sources that have no commercial interest in the CME. A consequence, however, is that CME providers would have to find alternative funding. Toward that end, companies should take the following interim measures to permit industry funding but limit commercial bias in CME: (1) grant-making functions should be separated from sales and marketing to ensure that grant funding is not influenced by marketing motivations; (2) objective criteria for making educational grants should be established to ensure that funded activities are for legitimate educational purposes; and (3) company control over speakers or content of CME should be eliminated to reduce the risk that payments are for speaker's referrals or promotion of “off-label” uses.
Another measure that may limit commercial bias is the creation of independent CME grant organizations that would accept donations from the industry and distribute the funds to CME providers. Broad educational categories could also be established to allocate industry donations to ensure that grants are awarded for general topics such as “oncology,”; rather than specific, commercially motivated topics such as “injectable therapies for osteoarthritis of the knee.”
Visit our News Library to read more news stories.
