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."
This provision, based on legislation (H.R. 293) introduced by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR), would appropriately exempt CME and certain educational materials from the reporting requirements of the Physician Payment Sunshine Act. While the Sunshine Act intended to make payments to physicians more transparent, the Centers for Medicare and Medicaid Services’ (CMS) has ostensibly defied Congressional intent, providing a smattering of regulatory interpretations that have called into question whether continuing medical education events could be subject to the law’s reporting requirements, making them less accessible to physicians. The bipartisan provision included in the Committee’s discussion draft was authored in response to these unintended consequences, and would ensure that physicians will have necessary access to the innovations in medicine that the 21st Century Cures initiative is intended to stimulate.
Unlike January’s release of the draft, which Democrats did not formally endorse, today's document is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).
The text included in the draft legislation is below, with updates to the Sunshine Act reporting requirements included in red:
Subtitle C—Encouraging Continuing Medical Education for Physicians: Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]
(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:
Unlike January’s release of the draft, which Democrats did not formally endorse, today's document is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).
The text included in the draft legislation is below, with updates to the Sunshine Act reporting requirements included in red:
Subtitle C—Encouraging Continuing Medical Education for Physicians: Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]
(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:
- (iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
- (xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient
- (I) 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
- (II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.
