The Sunshine Act and CME

On February 1, the Centers for Medicare & Medicaid Services (CMS) issued its final ruling on the Physician Payment Sunshine Act, Section 6002 of the Affordable Care Act (ACA). The Sunshine Act requires manufacturers of drugs, medical devices, and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. UNT Health Science Center was one of about 350 organizations nationwide who provided comments to CMS during deliberation.

The final rule correctly excludes accredited CME activities that meet the definition of “indirect payments” from the purview of this law. The three criteria which must be met in order to comply with the exclusion include:

• the program meets the accreditation or certification requirements for continuing education of one of five specifically listed organizations (e.g., the AOA or ACCME);
• the applicable manufacturer does not select the covered recipient speaker or even provide a distinct list of potential speakers to be considered by the CME provider; and
• the applicable manufacturer does not pay the covered recipient directly.

Each of UNTHSC’s activities planned by the Office of Professional and Continuing Education (PACE) is a certified CME activity. By definition, that ensure criteria 2 and 3 are satisfied. Consequently, our CME activities are not subject to Sunshine Act reporting.

PACE strives to ensure the highest level of integrity and quality in its CME activities. The Sunshine Act final rule underscores the importance of its efforts.

The Sunshine act has significant implications for non-certified education, meals that pharmaceutical or device companies bring to clinics or events and research.  More on the final regulation can be found at
https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-02572.pdf.