Pharm Exec Blog, an industry publication that follows business and policy for biopharma companies, quoted the CME Coalition and two members as it explained the Centers for Medicare and Medicaid's (CMS) recent regulation regarding Sunshine Reporting for CME events. "This legal language brought a sigh of relief from CME supporters, such as the CME Coalition and the Coalition for Healthcare Communication. Under pressure from industry critics, CMS had proposed in July to remove the CME exemption, as explained in more detail by Tom Sullivan’s Policy & Medicine blog." The blog post goes on to mention that bi-partisan support exists for legislation to that makes indirect CME funding permanently exempt from Sunshine reporting requirements (HR 5539 sponsored by Rep. Michael Burgess, R-TX.)
A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of value from manufacturers to prescribers.
It’s confusing because CMS technically revoked its policy that excludes reporting for accredited CME where commercial supporters have no control over program content or how funds are spent. But the final rule for implementing the Physician Payments Sunshine Act specifies that manufacturers don’t have to report CME funding as payments to specific doctors or teaching hospitals, so long as the firm does not direct funding to any specific covered recipient — which is already the case for accredited independent CME activities.
This legal language brought a sigh of relief from CME supporters, such as the CME Coalition and the Coalition for Healthcare Communication. Under pressure from industry critics, CMS had proposed in July to remove the CME exemption, as explained in more detail by Tom Sullivan’s Policy & Medicine blog [www.policymed.com, Nov. 3, 2014]. The July notice generated hundreds of comments on the confusing nature of the CMS proposal.
In response, CMS now clarifies that most grants for accredited or certified CME programs are not “indirect payments” to prescribers and don’t have to be reported. The final language was issued as part of a rule finalizing Medicare physician payments for 2015 and is posted on the Open Payments website at www.cms.gov/openpayments (click on “Law & Policy” under “About”). The website also advises manufacturers on accessing and correcting 2013 records found to have “errors” and omissions when the program went live September 30.
CME supporters still would like Congress to codify that indirect CME funding is exempt from Sunshine reporting, and extend that policy to reporting on the value of educational materials, such as textbooks, which CMS continues to consider payments to physicians. There’s bi-partisan support for legislation on the topic (HR 5539 sponsored by Rep. Michael Burgess, R-Tx), but it’s not likely to move through Congress any time soon.