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CMS Removes Continuing Education Reporting Exclusion from Sunshine Act

Posted in Affordable Care Act, Hospitals and Institutions, Legislation and Public Policy, Life Sciences, Medical Devices, Medicare and Medicaid, Pharmaceuticals, Reimbursement Matters

On October 31, the Centers for Medicare and Medicaid Services (CMS) issued a rule updating payment policies and payment rates in the Medicare Physician Fee Schedule for outpatient services furnished by hospitals and ambulatory surgical centers. This rule also includes several changes to the “Transparency Reports and Reporting of Physician Ownership Investment Interests” (the “Final Rule”) promulgated by CMS in February 2013 to implement the requirements of the Physician Payment Sunshine Act (the “Sunshine Act”). Most notably, the CMS rule completely deletes the exclusion for payments or other transfers of value to speakers of certain continuing education events.

The Sunshine Act generally requires manufacturers of certain drugs, devices, biologics, and medical supplies to report to CMS certain payments and other transfers of value made, directly or indirectly, to physicians and teaching hospitals (collectively, “Covered Recipients”) during a calendar year. The Final Rule defined specific reportable payments and transfers of value and identified certain reporting exclusions. One such reporting exclusion was for payments or other transfers of value provided as compensation for speaking at a continuing education program, provided that certain conditions were met. These conditions include:

• The continuing education event must meet certain accreditation or certification standards of the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, or the American Osteopathic Association;
• The manufacturer must not pay the Covered Recipient speaker directly; and
• The manufacturer must not select the speaker or provide a list of individuals to be considered as a speaker.

CMS explained that it deleted the continuing education reporting exclusion because of the implication that CMS endorsed the five named organizations over other continuing education providers, and due to the redundancy of the exclusion with the exclusion for indirect payments or other transfers of value in which the manufacturer is “unaware” of the identity of the recipient.

The deletion of the continuing education reporting exclusion will take effect on January 1, 2016. The CMS rule is scheduled to be published in the Federal Register on November 13, 2014.

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