Overview clarifies CME reporting under the Sunshine Act

The Physician Payments 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. The Centers for Medicare & Medicaid Services (CMS) has been charged with implementing the Sunshine Act and has called it the “Open Payments Program.” A subset of drug, biological and device manufacturers have raised questions concerning the Open Payments Program’s reporting requirements and participation in commercially supported, accredited and certified continuing medical education (CME) programs in 2016. To respond to these concerns, the AMA has provided an overview of the relevant statutory, regulatory and sub-regulatory guidance issued by CMS through Feb. 1, which exempts compliant certified and accredited independent CME from reporting in the Open Payments Program. Under the AMA CME credit system standards, AMA Code of Medical Ethics and Accreditation Council for Continuing Medical Education (ACCME) accreditation standards, commercial supporters are prohibited from having any direct or indirect influence or control with respect to the content, faculty, speakers or attendees of an educational program or activity. Therefore, educational grants given to AMA-certified and ACCME-accredited programs (including online or enduring educational programs) that comply with those standards do not meet the definition of an “indir...
Source: AMA Wire - Category: Journals (General) Authors: Source Type: news