The Sunshine Act and New legislation in Congress
Background
Under the Sunshine Act, CMS has provided varied and inconsistent guidance concerning the treatment (“reportability”) of commercial support payments in furtherance of CME, impacting a number of areas including: (1) honoraria, speaking fees and travel expenses, (2) attendee subsidies, and (3) meals.
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.
Legislative Fix
Legislation ensuring that CME is not unduly endangered by Sunshine Act requirements has been considered in both chambers of Congress. In the House, Section 3041 of the House-passed 21st Century Cures Act would have codified 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).
In the Senate, Sen. John Barrasso (R-WY) introduced a bill in the 114th COngress (S. 2978) mirroring the House effort to exempt CME and certain educational materials from the Sunshine Act reporting requirements. The Senate legislation may eventually be included as a part of the the Senate's 'Innovation' Initiative, which was advanced by the Health, Education, Labor, and Pensions (HELP) Committee earlier this year. An informational bulletin detailing the Senate bill is provided further below.
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…”
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.
Under the Sunshine Act, CMS has provided varied and inconsistent guidance concerning the treatment (“reportability”) of commercial support payments in furtherance of CME, impacting a number of areas including: (1) honoraria, speaking fees and travel expenses, (2) attendee subsidies, and (3) meals.
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.
Legislative Fix
Legislation ensuring that CME is not unduly endangered by Sunshine Act requirements has been considered in both chambers of Congress. In the House, Section 3041 of the House-passed 21st Century Cures Act would have codified 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).
In the Senate, Sen. John Barrasso (R-WY) introduced a bill in the 114th COngress (S. 2978) mirroring the House effort to exempt CME and certain educational materials from the Sunshine Act reporting requirements. The Senate legislation may eventually be included as a part of the the Senate's 'Innovation' Initiative, which was advanced by the Health, Education, Labor, and Pensions (HELP) Committee earlier this year. An informational bulletin detailing the Senate bill is provided further below.
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…”
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.
| CME Coalition 21st Century Cures Provision Summary |
| CME Coalition - S. 2978 The Protect Continuing Physician Education and Patient Care Act |
