In a discreet "holiday news dump" just hours before the Fourth of July holiday, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would reverse a narrow, but vitally important exemption from the Physician Sunshine Act for the reporting of payments related to certain accredited CME programs. This proposal, first reported by Modern Healthcare, inexplicably reverses a decision that CMS had previously reached after reviewing hundreds of stakeholder comments in a comprehensive rulemaking process.
According to the article, CME organizations and industry sponsors were blindsided by the recent proposal. Andy Rosenberg, Senior Advisor to the CME Coalition, stated, “If it is allowed to stand, this policy change will be massively 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.” Extending the disclosure to CME, he added, would “discourage physicians from learning new medical science by creating a false stigma.” Indeed, if finalized, this decision would completely disrupt the practice of CME and the confidence of doctors, educators and commercial supporters who have spent over a year planning for implementation of the current rule that protected CME from the burdensome reporting requirements of the Sunshine Act.
The CMS intends to eliminate the exclusion for continuing medical education in the Open Payments program, more commonly known as the Sunshine Act, which requires drug and device companies to disclose payments to physicians. The reversal was included in the proposed Physician Fee Schedule for 2015, which also would make changes that would benefit primary-care medicine at the expense of payments to specialties.
Sponsorships for CME were initially given a pass in the Open Payments program because the CMS believed adequate safeguards were already in place. Many experts, however, argued that the exclusion would allow drug and device companies to avoid disclosure by shifting marketing dollars to CME from direct promotional programs. In the proposed rule, the CMS said “an unintended consequence” of the policy was the appearance the agency was tacitly endorsing corporate sponsorships of continuing education events. The Open Payments program stems from a provision of the Patient Protection and Affordable Care Act known as the Sunshine Act.
CME organizations and manufacturers that fund education events were blindsided by the move, said Andrew Rosenberg, senior adviser for the CME Coalition, a trade group. “If it is allowed to stand, this policy change will be massively 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,” Rosenberg wrote in an e-mail to Modern Healthcare late Friday. Extending the disclosure to CME, he added, would “discourage physicians from learning new medical science by creating a false stigma.”