Medical Communication Transparency Reporting: CME Exemptions & Indirect Payments
1 Hour and 5 Minute Video | Brian A. Bohnenkamp, King & Spalding LLP
Under the final rule of the Sunshine Act, life science manufacturers are required to report on a wide variety of payments made directly or indirectly to physicians and teaching hospitals, with some exceptions. One exception included payments made indirectly to physicians for speaking at accredited continuing medical education (CME) programs. In a surprising reversal of policy, CMS recently removed that exception as part of a host of revisions to the Sunshine requirements. The agency’s statements accompanying the exception’s removal, however, have created confusion as to what will be the practical impact of the change.
- Analysis of the removal of the CME exception, CMS’s related guidance, and the practical implications
- Trends in CME and physician involvement
- Comparison of key stakeholder perspectives
Participants that will find this webinar most beneficial will be those involved in medical device, pharmaceutical, biotechnology, and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Medical Communications
- Regulatory Affairs
- Legal Counsel
Brian Bohnenkamp is an associate in King & Spalding’s Washington, D.C., office and a member of the FDA & Life Sciences Practice Group. He has assessed a variety of regulatory compliance issues for manufacturers of drugs and medical devices. Specifically, he has assisted in advising companies on state law compliance issues, development and implementation of comprehensive compliance programs, fraud and abuse issues, and advertising and promotion practices. Mr. Bohnenkamp provides counsel to the Ad Hoc State Law Compliance Group (a coalition of pharmaceutical, biotechnology, and medical device manufacturers) on a variety of laws and regulations, including state marketing code of conduct laws, gift prohibition laws, marketing costs disclosure laws, and prescriber data privacy laws, as well as the federal Physician Payment Sunshine provisions.