On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new treatments and therapies. Over the next several weeks, Arnall Golden Gregory will publish a series of articles analyzing provisions in the 21st Century Cures Act that address: (1) funding for the National Institutes of Health (NIH); (2) new drug development; (3) new device development; (4) interoperability; and (5) Medicare and Medicaid coverage and payment issues.
In general, the 21st Century Cures Act would make significant changes to the processes at the Food and Drug Administration (FDA) and NIH. The bill provides $1.75 billion annually from FY 2016 through FY 2020 for NIH and $110 million annually from FY 2016 through FY 2020 for the FDA. The regular appropriations process would be used to direct the money to NIH and FDA and the funding would sunset after five years. In addition, the bill would require certain health information technology to be interoperable, and would modify certain Medicare and Medicaid coverage and reimbursement requirements.
The cost of the bill is offset by several provisions, including: (1) requiring the Department of Energy to drawn down and sell crude oil from the Strategic Petroleum Reserve; (2) extending and expanding prior authorization for power mobility devices and accessories; (3) setting payment amounts for Part B drugs infused through durable medical equipment (DME) items at average sales price (ASP) plus 6 percent; (4) excluding authorized generics from the calculation of average manufacturer price (AMP); (5) creating payment incentives to transition from traditional x-ray imaging to digital radiography; and (6) limiting federal Medicaid reimbursement to states for durable medical equipment to Medicare payment rates.
Next, the bill will be considered by the Senate. Although Senate committees have held several hearings related to issues that were addressed in the 21st Century Cures Act, the Senate leadership does not expect to bring a bill to the floor until later in the year.