In response to questions about the Sunshine Act 'reportability' for transfers of value related to the provision of accredited CME events, the CME Coalition has developed ‘template’ grant language for use in CME agreements between commercial supporters and providers. The template included below, drafted with expert legal counsel from Arnold and Porter, includes language that tracks directly with CMS’ guidance indicating that supporters have not “directed, instructed or caused” the CME provider to pay specific covered recipients.
In a letter to House Energy and Commerce Chairman Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ), the CME Coalition "wholeheartedly endorses" the Committee's passage of the 21st Century Cures Act (H.R. 6), along with the inclusion of a provision to exempt CME and certain educational materials from the reporting requirements of the Physician Payment Sunshine Act. As an organization that represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in our health care system, the CME Coalition recognizes the importance of ensuring that physicians are encouraged to continue in their professional development. That's why the Coalition has come out in strong support of the provision to ensure providers that continuing medical education events will continue to be exempt from the Sunshine Act's reporting requirements.
Today, the Centers for Medicare and Medicaid Services (CMS) has issued updated guidance that further clarifies the Sunshine Act exemption for continuing medical education (CME). Specifically, in updated Frequently Asked Questions (FAQs) addressing the reporting of indirect payments related to CME (see here for the underlying Final Rule), the agency has clarified that applicable manufacturers subject to Sunshine Act reporting are only required to report CME-related payments to covered recipients if the reporting entity: (1) determines the payment or transfer of value meets the definition of an indirect payment at 42 C.F.R. § 403.902; and (2) if it does meet the definition, must report the payment if the applicable manufacturer knows or has the ability to determine the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.
Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (section-by-section summary here), which includes an important provision that would codify the Sunshine Act exemption for continuing medical education (CME). Specifically, the provision excludes from the reporting requirements any transfer of value "that serves the sole purpose of providing the covered recipient with medical education."
Today, the CME Coalition submitted comments to the Senate HELP Committee regarding their new legislative initiative to prioritize drug and device discovery and development. The Senate endeavor is analogous to the ‘21st Century Cures’ initiative being pursued by the House Energy and Commerce Committee, although the Senate has yet to release a legislative discussion draft presenting specific policies for consideration.
As you may recall, the ‘21st Century Cures’ discussion draft released earlier this month included the bill introduced by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR) to exempt CME and educational texts from the reporting requirements of the Sunshine Act. In the Coalition's comments to the Senate, we encourage them to take a similar approach, highlighting the role of CME in educating physicians on the latest innovations in medicine.