Over 800 comments have been submitted to CMS telling the agency to keep or expand the Sunshine Act exemption for CME, according to a recent article in MeetingsNet. Citing analysis from the CME Coalition, the author notes that 98 percent of the total comments received by CMS reflect the position that the CME exemption is necessary to protect speakers and attendees from being reported as being supported by industry in the Open Payments database. The article notes that the CME Coalition and other stakeholders effectively worked to secure the initial exemption, and "CMS did explicitly exempt speaker compensation and expenses at accredited CME activities from the Open Payments reporting requirements, as long as the CME providers met certain conditions." But in a proposed rule released earlier this summer, "CME reversed itself and proposed eliminating the exemption."
820 Commenters Tell CMS to Keep CME Exemption
Those who submitted comments to the Centers for Medicare and Medicaid Services’ proposal to drop its exclusion of continuing medical education from Open Payments physician spend-tracking and reporting requirements overwhelmingly favor either maintaining or expanding the exemption, according to analysis of results by the CME Coalition, a Washington, D.C., lobbying group. Here are the numbers: 820 in favor of keeping CME out of the act’s requirements—98 percent of the total comments received—and approximately 20 who think the current exemption should go.
When it was first released, the act, then called the Sunshine Act, did not explicitly address CME. Stakeholders worried that this would cause confusion over whether speaker compensation and expenses at accredited events would be reportable or not. The CME Coalition and others lobbied to have accredited CME exempted, and CMS did explicitly exempt speaker compensation and expenses at accredited CME activities from the Open Payments reporting requirements, as long as the CME providers met certain conditions. Then, earlier this summer, CME reversed itself and proposed eliminating the exemption. Without an exemption, says the Coaliton,
“A manufacturer who makes an independent grant to a CME provider would make what is defined as an ‘indirect payment’ whenever the provider uses the manufacturer’s funds to cover physician speaker fees, travel costs, and lodging expenses. These payments become reportable should the manufacturer learn of the identity of the recipient of the value transfer up to 18 months after the grant is executed. Despite CMS’ stated intention to maintain the current reporting exemption, hundreds of CME stakeholders have expressed concern that [the] CMS proposal to remove the explicit CME exemption that exists in the current rule could have the disastrous effect of expanding the reporting requirements for accredited CME.”
Hundreds of CME stakeholders, from the Accreditation Council for CME to the American Medical Association, responded to the CMS call for comments, which closed September 2. A full list of organizations that submitted comments and excerpts from selected comments are available on the Coalition’s Web site.