As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, and other issues.
This blog post focuses on the bill’s proposed Sunshine Act (aka Open Payments) changes, which would broaden exclusions related to the provision of education-related payments or transfers of value.
First, the bill would expand the types of educational materials that would be excluded from reporting because they “directly benefit patients or are intended for patient use.” The bill specifies that educational materials such as peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks would all be excluded from reporting if such materials directly benefit patients or are intended for patient use. CMS has previously made clear that such items are not excluded from reporting pursuant to the law as it currently exists.
Next, and also significantly, the bill would add a new category of payments or transfers of value that are excluded from the reporting requirement relating to the education of physicians. Specifically, the new exclusion category would exclude from reporting indirect payments or transfers of value provided to physicians 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. The new exclusion would also exclude from reporting payments that serve the sole purpose of providing a physician 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.
The addition of the new exclusion category described above would be significant given the current ambiguity with respect to the reporting of payments related to continuing medical education programs. As we reported in November 2014, as part of its final 2015 Medicare physician fee schedule rule, CMS deleted the reporting exclusion for payments made to speakers at accredited continuing medical education events. While CMS noted that such payments may still be excluded from reporting if they do not meet the definition of an indirect payment, industry expressed frustration after CMS released website guidance suggesting that indirect payments to speakers for independent medical education events are reportable.
The bill now moves to a full House vote.