On May 21, 2015, the House Energy and Commerce Committee unanimously approved the 21st Century Cures Act (H.R. 6). The bill aims to expand patients’ access to treatments, promote drug and device development, support research, and encourage biomedical innovation. It makes significant changes to processes at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), and provides increased funding for both the FDA and the NIH.
The bill requires the FDA to establish a framework to incorporate patient experience data into the regulatory decision-making process and to develop a streamlined data review program that would enable clinical data summaries to be used to support the approval or licensure of new indications of drugs and biologics. Additionally, it requires the FDA to issue guidances related to the development of biomarkers and precision drugs and biological products, and to finalize guidance on how it interprets and uses adverse drug event data resulting from drug use under the expanded access programs.
In addition to revising processes at the FDA and NIH, the bill includes several provisions that address different aspects of health care delivery, such as: the interoperability of health technology; telehealth; disposable medical technologies; changes to the Medicare local coverage determination (LCD) process; and establishing a Medicare Pharmaceutical and Technology Ombudsman.
The bill includes the following four provisions to offset $13.2 billion in costs: (1) selling 8 million barrels of crude oil from the nation’s strategic petroleum reserve during each of fiscal years 2018 through 2025; (2) modifying the timing of pre-payments on Medicare Part D; (3) reducing payments for x-rays taken using film or computed radiography technology; and (4) limiting federal Medicaid spending for durable medical equipment to Medicare rates. It also makes additional funds available to the FDA by exempting certain user fees from sequestration.
The bill will be considered by the House Ways and Means Committee, as well as the Appropriations, Budget and Rules committees before it reaches the floor of the House of Representatives. Rep. Fred Upton, Chair of the House Energy and Commerce Committee hopes for the full House of Representatives to vote on the bill by the end of June. If the House of Representatives approves the bill, it will go to the Senate for its consideration. The Senate is working under a longer timeline than the House of Representatives, and hopes to bring a bill to the President by the beginning of 2016.