The Sunshine Act also requires applicable manufacturers and GPOs to report certain “indirect payments” or payments made to third parties or entities. Specifically, CMS indicated in the final rule several “nature of payment” categories that applicable manufacturers must select to describe and explain the nature of the payment and relationship they have with a physician or teaching hospital for a particular transaction. In the final rule, CMS created an exception and new rules for payments related to accredited or certified continuing medical education.

Payments to speakers or faculty of certain accredited CME programs are exempt or excluded from reporting if three conditions are met.

1. The CME activity or “event” for which a physician is a speaker or faculty must “meet the accreditation or certification requirements and standards for continuing education” of an accreditation body (Final Rule 9524). In the final rule, CMS listed only five accrediting bodies: the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, and the American Osteopathic Association.

2. An applicable manufacturer providing commercial support for a CME program may not pay the physician speaker or faculty directly.

3. The applicable manufacturer may not select the physician speaker or faculty or provide a third party or CME provider with a distinct, identifiable set of individuals to be considered as speakers for the CME program.

The latter two conditions are noncontroversial for ACCME-accredited providers because the ACCME Standards for Commercial Support explicitly prohibit direct payment or any control or input by a commercial supporter over any content or speakers and faculty. This is particularly important because the AAFP, AOA, and AMA have all formally adopted the ACCME SCS.

Consequently, if all three of these conditions are met, the payment from the applicable manufacturer to the CME provider (and thus indirectly to the physician-speaker or faculty member) is excluded from reporting—meaning the transaction achieves the so-called “Sunshine-exempt” CME status. While these conditions appear somewhat straightforward, the CME Coalition, a Washington, D.C.–based advocacy organization for CME providers and supporters, along with other stakeholders, have raised concerns about several areas in need of further clarification. Despite these areas of uncertainty, the CME Coalition formulated a set of guidelines for CME providers and stakeholders to follow to ensure compliance with the final Sunshine Act regulations. The guidelines are based largely upon a legal memorandum commissioned by the Coalition by the national law firm of Alston & Bird LLP.