Long-awaited and controversial, the final Sunshine Act rule has been released. Here is a quick recap of what has changed, and what you need to know going forward:
Where did the Sunshine Act rule come from?
A part of the Affordable Care Act, the Sunshine rule was released by the Centers for Medicare and Medicaid Services to establish guidelines for the ways data is gathered and published in regards to finances among physicians, teaching hospitals, group purchasing organizations and drug and device makers. The Sunshine rule is the response to concerns that medical practice and research may be inappropriately influenced by the financial relationships between these groups.
What will change under this new rule?
A notable difference under this law is the change in reporting payments in relation to continuing medical education (CME) events. As long as drugmakers don’t select the speakers of the event, or directly pay them, they will not be required to report any payments made to the speaker. Specifically the law states that the drugmaker “does not select the speaker or give the CME provider a distinct, identifiable set of individuals to be considered as speakers, and the drugmaker does not directly pay the speaker.”
The new rule also states, “When (drugmakers) do not suggest speakers, they are allowing the continuing education provider full discretion over the CME programming, so the payment or other transfer of value will not be considered an indirect payment for purpose of these reporting requirements.”
Going forward under the Sunshine Act rule
Both sides have weighed in on the practice of drugmakers choosing speakers and providing material for their speaking events. On one side, this decision seemed to be expected and met with relief. It has been called “common sense” and allows for the CME programmer to have ultimate control over their event. However, on the other side, industry funding will continue to be the main source of paying for speakers. So going forward, choosing someone favorable may continue to be a tempting practice.
Do you think the right decision was made?
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