Should drug and device manufacturers be required to report payments to physicians who speak at CME (continuing medical education) programs?

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act.  The Sunshine Act generally requires a manufacturer to report all payments and benefits it provides to physicians.  The theory is that patients have a right to know when a physician who uses or prescribes a particular drug or device might be financially beholden to the manufacturer.

But the act has always had an exemption for payments to speakers at CME programs.  That exemption will disappear, or at least be severely narrowed, under regulations to be published       July 11 as part of the 2015 Medicare physician fee schedule.

The reasoning behind the change?  Critics say the exemption provides manufacturers with an easy loophole.  They simply shift marketing payments from direct promotional programs to CME events.

Under the new rule the exemption would be unavailable if a manufacturer pays the CME speaker directly or requires the program to use a specific speaker or to choose the speaker from a list provided by the manufacturer.

Needless to say, CME organizations and program providers are distraught over the change.  Andrew Rosenberg, a senior advisor for the CME Coalition calls the change “massively destructive to every stakeholder in the CME ecosystem.”


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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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