1. WHAT STAKEHOLDERS NEED TO KNOW ABOUT THE CME/SUNSHINE ACT PROVISION OF THE ‘21 ST CENTURY CURES ACT’ JULY 14, 2015 1

2. The Issue 2 Under the Sunshine Act, CMS has provided varied and inconsistent guidance concerning the treatment (“reportability”) of commercial support payments in furtherance of CME.  Honoraria, speaking fees and travel expenses  Attendee subsidies  Meals

3. Current Law 3 Under its most recent guidance (April 2015), CMS declared that applicable manufacturers can reasonably exclude from Sunshine Act reporting payments or transfers of value to physician speakers, faculty, or attendees at CME programs when the applicable manufacturer does not “require, instruct, direct, or otherwise cause” payment or transfer of value to be made to particular or specific covered recipient.  In simple terms, if a manufacturer does not condition its financial support of a CME program on the participation of particular physician speakers or faculty, and does not otherwise pay such physicians directly, these payments are excluded from reporting under the indirect payment rules.  This mirrors the prohibitions under the rules of accreditation.

4. 21 st Century Cures Language 4 Section 3041 of the House-passed 21 st Century Cures Act would codify Congressional intent by exempting bona fide CME and medical texts from the reporting requirements of the Physician Payment Sunshine Act.  The provision is based on separate legislation (H.R. 293) introduced by Rep. Peter DeFazio (D-OR) – one of the original authors of the Sunshine Act – and Rep. Michael Burgess (R- TX).H.R. 293 Specifically, the legislation would exempt from reporting any indirect payment “for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply,” or “that serves the sole purpose of providing the covered recipient with medical education… such as… tuition… or with materials…”

5. Why it Matters 5 If enacted, the bill language would eliminate the ability of CMS to issue future guidance requiring Sunshine reporting of CME-related payments. To the degree that several iterations of conflicting CMS guidance has proven confusing for some stakeholders, the bill language would bring clarity and finality to the question of reportability.