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.
In comments submitted today to House Energy and Commerce Committee Chairman Fred Upton (R-MI), the CME Coalition applauded the Committee’s 21st Century Cures Initiative, and championed the Committee’s efforts to streamline the implementation of new medical treatments. The CME Coalition understand that unless doctors are given the tools and education they need to implement the newest innovations in medicine, the promise of 21st Century Cures won’t make it to the bedside – and so, we applaud the Committee for including an important provision in their discussion draft (summary here) to ensure that access to continuing medical education (CME) will not be an unintended casualty of unnecessary regulation.
In response to an overwhelming outpouring of stakeholder comments, CMS published a Final Rule (pg. 595-596) redefining its Open Payment reporting rules to specifically exclude the vast majority of CME payments, including speaker-related payments and tuition support for attendees, so long as they follow CME guidelines and are, therefore, not directed by a commercial supporter. Although CMS deleted the section of a previous rule that defined a limited CME reporting exclusion for CME payments for certain accredited programs, the new rule sets reasonable criteria for determining which CME-related payments need not be reported.
Reps. Burgess, Schwarts Introduce Bipartisan Bill to Exempt CME Payments and Medical Texts from Sunshine Act
Today, Representatives Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. The Sunshine Act lists as one of its exclusions "educational materials that directly benefit patients or are intended for patient use," which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have "downstream benefits" for patients as compared to "wall models and anatomical models," which are intended to be used with the patient and are excluded from reporting requirements.
In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX) and Frank Pallone (D-NJ), Vice Chairman and Ranking Member of the House Energy and Commerce Subcommittee on Health, came together to encourage the Centers for Medicare and Medicaid Services (CMS) to exempt from Sunshine Act reporting requirements payments related to the support of certified continuing medical education (CME). The lawmakers stated that this would “ensure robust physician participation in this important activity without concern for Sunshine Act reporting rules.”
The CME Coalition has submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposed change to the Sunshine Act’s current exemption for reporting transfers of value that are affiliated with accredited CME provider organizations to the Open Payments Database. In its submission, the Coalition embraces the preamble of CMS’s proposed rule, that the criteria for determining Sunshine-exempt continuing education should be expanded. However, the Coalition’s analysis of the proposed rule’s actual language suggests that rather than expanding the exemption beyond the originally designated “five accrediting bodies,” the proposal could instead require additional reporting for both speakers and attendees at CME events. The resulting elimination of the CME exemption could be devastating for the practice of CME.
The CME Coalition has published a new proposal to ameliorate concerns raised by a litany of stakeholders regarding the Centers for Medicare and Medicaid Services' (CMS) proposal to eliminate the “CME exemption” under the Sunshine Act. Under current law, the Sunshine Act exclusion for CME explicitly exempts speaker compensation at certain accredited events from the Open Payments reporting requirements. Without an exemption, a manufacturer who contributes a 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. 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.
CMS Proposal to Eliminate Section §403.904(g) of the Final Rule on the Physician Payments Sunshine Act
On July 3, presumably in response to concerns that were put forward by the CME Coalition and others about the need to expand the list of accrediting bodies that counted towards determining CME Sunshine exemption, CMS proposed eliminating the section of the current Final Rule that requires events to be accredited by one of five enumerated accredited bodies in order to be “sunshine exempt” (the Accreditation Council for Continuing Medical Education ("ACCME"), the American Academy of Family Physicians ("AAFP"), the American Dental Association's Continuing Education Recognition Program ("ADA CERP"), the American Medical Association ("AMA"), or the American Osteopathic Association ("AOA").
Please join the CME Coalition for a FREE CONFERENCE CALL on Wednesday, July 16 @ 2:00 pm ET to discuss the Centers for Medicare and Medicaid Services’ (CMS) recent proposal regarding the Physician Payment Sunshine Act. On July 3rd, CMS issued a proposal that would revise an earlier Final Rule on the Sunshine Act – one that created a narrow, but vitally important exemption for the reporting of payments related to certain accredited CME programs.