The House Energy and Commerce Committee May 21 unanimously approved the 21st Century Cures Act (H.R. 6) after delaying the mark-up for a day as committee members worked out how to pay for the bill.
In a May 21 statement, AAMC President and CEO Darrell Kirch, M.D., commended the committee for “working in a bipartisan and transparent manner to advance this groundbreaking piece of legislation.” Dr. Kirch thanked the committee for including language that would reauthorize the National Institutes of Health (NIH) for three years and for proposing a five-year, $10 billion NIH Innovation Fund.
Final passage occurred after the committee adopted by voice vote a manager’s amendment offered by committee chair Fred Upton (R-Mich.) that included offsets to pay for the estimated $13 billion cost of the legislation, including drawing down and sell crude oil from the Strategic Petroleum Reserve to generate $5.2 billion for fiscal years (FYs) 2018 through 2025.
In addition, the amendment would delay the timing of pre-payments to Medicare Advantage Part D prescription drug sponsors, a move that would save an estimated $5 billion to $7 billion.
The amendment also would limit federal Medicaid reimbursement rates for durable medical equipment to levels paid by Medicare to provide another $2.8 billion and would limit Medicare payments for traditional x-ray imaging services to incentivize the transition towards digital imaging for $200 million in savings.
The manager’s amendment:
- Mandates the NIH Director ensure that “the participation by scientists from groups traditionally underrepresented in the scientific workforce” remains a priority in the agency’s strategic plan;
- Includes a “sense of Congress” that the National Institute on Minority Health and Health Disparities (NIMHD) should include in its strategic plan ways to increase representation of underrepresented communities in clinical trials;
- Mandates the Secretary of Health and Human Services (HHS) to finalize within a year draft NIH policy on the use of a single institutional review board for multi-site research;
- Creates a Cures Innovation Fund for the Food and Drug Administration (FDA), supported by a mandatory appropriation of $110 million a year for FYs 2016 through 2020;
- Provides additional hiring authority to FDA for scientific, technical, and professional personnel;
- Exempts certain FDA user fees from sequestration; and
- Includes a House-passed measure from last year encouraging Lyme disease research.
Several committee members offered and withdrew amendments on a number of issues, including prescription drug price transparency, negotiation of Medicare Part D prescription drug prices, inclusion of underrepresented minorities in clinical trials and the biomedical research workforce, and research on the medical efficacy of marijuana. Chairman Upton pledged to work with committee members to attempt to address their concerns before the bill goes to the House floor, which is expected in June.
Despite rumors earlier in the week that the package would include language modifying the Health Resources and Services Administration (HRSA)’s 340B Drug Pricing Program, the legislation does not include the text.