The top CME-industry blog, MeetingsNet, recently highlighted how the new proposal from CMS to withdraw the Sunshine Act’s CME exemption “has stunned the continuing medical education community.” In the article, the author notes that the agency’s decision—which was “buried at the bottom of a fact sheet”—was a surprising reversal of policy that onlookers say would be “highly disruptive to every stakeholder in the CME ecosystem.”
The article goes on to outline the initial rationale for the current exemption, citing the important distinction “between accredited CME—which is already subject to strict rules designed to safeguard against bias and conflict of interest under the Accreditation Council for CME and other accreditors, the Food and Drug Administration, the Office of the Inspector General, and the American Medical Association—and non-accredited CME and promotional programs.” Andrew Rosenberg, Senior Advisor to the CME Coalition, added that “CMS got it right the first time when it recognized that encouraging the practice of accredited CME is vitally important for doctors and patients, and that extending the Sunshine Act's reporting requirements for direct payments between doctors and manufacturers to participants in bona fide, accredited CME would actually discourage physicians from learning new medical science by creating a false stigma of public disclosure.
Rosenberg believes that the reversal, if it is allowed to stand, would be “highly disruptive to every stakeholder in the CME ecosystem—doctors, educators and commercial supporters—who have spent over a year preparing for the implementation of the current rules.
“CMS got it right the first time when it recognized that encouraging the practice of accredited CME is vitally important for doctors and patients, and that extending the Sunshine Act's reporting requirements for direct payments between doctors and manufacturers to participants in bona fide, accredited CME would actually discourage physicians from learning new medical science by creating a false stigma of public disclosure. We will fight this proposal alongside patients, doctors, and others in order to protect CME from being treated no differently from promotional, marketing or other reportable payment categories under the Sunshine Act.”
But not everyone agrees. An article in Modern Healthcare that was published prior to this CMS announcement found there is “increasing concern…that industry payments for CME bias these programs.” Daniel Carlat, director of the Prescription Project at Pew Charitable Trusts and an outspoken critic of the current requirements’ ability to rein in bias and conflict of interest in commercially supported CME, added that these compromised CME activities could sway docs to prescribe drugs that are more in the interest of the drug companies than the patients.
