In a January 5, 2015, Law360 article, Shook, Hardy & Bacon Senior Associate Tim Moore addresses changes to physician-payment Sunshine Act regulations that may require applicable manufacturers reimbursed under Medicaid, Medicare or the Children's Health Insurance Program to disclose indirect payments to accredited or certified continuing education (CE) programs. Under an exclusion slated to expire in 2016, pharmaceutical and medial device companies do not need to report indirect speaker payments that meet specific standards laid out in regulations issued by the Centers for Medicare and Medicaid Services (CMS).
"Before committing to fund a CE event after 2015, pharmaceutical and medical device companies should consider whether CMS' change affects their Sunshine Act reporting burden and whether to adjust their CE-funding practices," writes Moore. "If a company’s current funding terms for CE support may be characterized as 'unrestricted,' CMS' deletion of the indirect CE speaker payments exclusion is of no consequence. Thus, companies should consider whether their business rationale for supporting CE justifies using funding terms consistent with unrestricted payments to CE providers. Providing support that is not unrestricted may lead to greater obligations under the Sunshine Act, with all the attendant consequences."