As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion in the Legislation is draft language that would exclude from federal Sunshine law reporting:
- “peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks”;
- indirect payments or transfers of value provided to covered recipients “for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply”; and
- payments or transfers of value made for the “sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.’’
This language is significant due to the ongoing debate between industry and the Centers for Medicare & Medicaid Services (CMS) regarding the significant burdens of tracking and reporting educational items, such as medical reprints. There also is continued confusion regarding CMS direction on whether indirect payments to speakers for independent medical education events are reportable beginning January 1, 2016. This is because CMS released guidance in late 2014 suggesting that these payments were not reportable, and then appeared to change course a few weeks later.
We will continue to monitor this Legislation.