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.
Despite CMS’ stated intentions, we believe that removing the explicit CME exemption that exists in the current Final Rule could have the disastrous effect of expanding the reporting requirements for accredited CME. As detailed further in the document below, the CME Coalition has drafted specific language for CMS to adopt in place of their proposal.
Thus, our proposal not only provides continuity from the current Final Rule, in (a) and (b), but also adds (c), an additional firewall, which states that a manufacturer may not influence attendees. So, in total, there are four explicit firewalls in our proposed revision to be spelled out in the Final Rule, namely, the CME program: (1) must meet the definition of “accredited or certified”, (2) manufacturers must not pay physicians directly, (3) manufacturers must not send speaker lists or suggest speakers, and (4) manufacturers must not influence, invite, or select physician attendees. Our proposal also specifies that the “awareness” standard for indirect payments does not apply to accredited or certified CME.
- First, we are proposing that CMS maintain an explicit definition in the Final Rule of "accredited or certified CME" in the definition section of the Final Rule itself.
- Second, on top of this revised definition, we would propose the following response to the CMS request for comment.
Thus, our proposal not only provides continuity from the current Final Rule, in (a) and (b), but also adds (c), an additional firewall, which states that a manufacturer may not influence attendees. So, in total, there are four explicit firewalls in our proposed revision to be spelled out in the Final Rule, namely, the CME program: (1) must meet the definition of “accredited or certified”, (2) manufacturers must not pay physicians directly, (3) manufacturers must not send speaker lists or suggest speakers, and (4) manufacturers must not influence, invite, or select physician attendees. Our proposal also specifies that the “awareness” standard for indirect payments does not apply to accredited or certified CME.
| CMS Proposed Comments to CMS -- Sunshine Act |
