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CME Coalition Proposes Expanded Sunshine Act Exemption for CME

8/4/2014

 
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.

  • 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.
We believe that, given the structure of the Rule, we must have a definition for what a “Sunshine Exempt event” looks like. We believe that CMS is never going to exempt all “indirect payments” from reporting, so there is a need to create a category of events where speaker and attendee value is exempt from reporting. Our proposal expands the current CME exemption beyond the currently enumerated five accrediting bodies to include all bona fide accreditors.

  • Second, on top of this revised definition, we would propose the following response to the CMS request for comment.
We recommend incorporating the definition of “accredited or certified continuing education” in section (g) to specifically exempt payments to speakers, faculty, and attendees at events that meet the previously described exemption definition. Additionally, our revision to (g) includes three more safeguards (which all accredited and certified CME providers already have in place) to provide addition assurance to CMS. 

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
File Size: 153 kb
File Type: pdf
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