Blog: CMS Exempts CME and Makes Other Sunshine Reporting Changes

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Late last week, the Centers for Medicare and Medicaid Services (CMS) issued the 2015 physician payment fee schedule, which includes changes to the Final Rule implementing the federal Sunshine law.  Most significantly, CMS announced that it had exempted payments to speakers at all continuing medical education (CME) events under §403.904(i)(1) if the applicable manufacturer “provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.”  According to CMS, this change “will create a more consistent reporting requirement, and will also be more consistent for consumers who will ultimately have access to the reported data.”  However, grants influenced by a company, and speakers paid directly by an applicable manufacturer, will continue to be subject to reporting.

Additionally, applicable manufacturers and group purchasing organizations (GPOs) will be required to report the marketed name for all drugs, biologicals, devices and medical supplies, as well as a product category or therapeutic area.  Further, reporting of stock, stock options, and other ownership interests will be reported as distinct categories.  Both of these changes will require applicable manufacturers and GPOs to update current aggregate spend processes and systems.

All changes will be implemented as of January 1, 2016 and be part of the 2017 reporting period.

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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