Last week, the House voted overwhelmingly (392 to 26) to pass the 21st Century Cures Act (H.R. 34), a major piece of legislation whose primary intent is to develop and fund research on significant health and medical policy objectives. It includes $1 billion to address the opioid epidemic over two years as well as $4.8 billion in funding for the National Institutes of Health. At 996 pages, the bill includes a number of ancillary, but not insignificant, provisions. Leading Democrats in the Senate have cautioned against some provisions of the bill, specifically one that directs the FDA to consider "real world" evidence in addition to clinical trials, an expedited review process for medical devices, and permitting drug companies to share "off label" benefits of their products with insurance companies. The bill also folds in several provisions from the Mental Health Reform Act, a bill championed by Sen. Chris Murphy (D-CT). The CHIME Public Policy Group, a trade association for CIOs and senior IT leaders in healthcare related organizations, created a comparison chart and summary of major provisions in the legislation.
The 21st Century Cures Act includes a pay-for that had previously been introduced in a major mental health bill as well as the Disability Community Act (DCA), which would reduce the federal match given to states that fail to implement electronic visit verification (EVV) as required over several years starting in 2019. Although there has been concern raised over the mandatory implementation of EVV, ANCOR approved of the language contained in this pay-for in the DCA, recognizing that there is increasing legislative pressure to mandate EVV. As written, this section would require stakeholder involvement at the state level, be minimally burdensome, and not require that services be provided solely in home, among other requirements.
The bill is expected to pass the Senate when it comes up for a vote on Wednesday.