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  • Washington Highlights

    House Overwhelmingly Approves 21st Century Cures Package

    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach

    The House of Representatives Nov. 30 approved, by a vote of 392-26, the 21st Century Cures Act (H.R. 34), which includes new funding for the National Institutes of Health (NIH) and Food and Drug Administration (FDA), as well as mental health provisions and other hospital and health care provisions.

    AAMC President and CEO Darrell Kirch, MD, sent a letter of support to House leaders and released a statement following the passage of the bill, urging the “Senate to pass this critical legislation.” Dr. Kirch also noted that the “bill recognizes the importance of more funding for the National Institutes of Health (NIH), reducing the administrative burden for medical researchers, and the role of socioeconomic status—SES—in the Medicare hospital readmissions reduction program,” adding that the new funding for NIH is meant to “supplement—not supplant—increases to the base NIH budget.”

    The bill establishes an “Innovation Account” for specific initiatives at the NIH and the FDA. The bill provides $500 million for initiatives at the FDA. For NIH, the bill provides $4.796 billion, including:

    • $1.455 billion for the Precision Medicine Initiative;
    • $1.511 billion for the Brain Research through Advancing Innovative Neuroethologies  (BRAIN) Initiative;
    • $1.8 billion for the Cancer Moonshot Initiative; and
    • $30 million for clinical research to advance regenerative medicine using adult stem cells.

    In addition to the new funding for NIH and FDA, the bill includes provisions to address health disparities, data collection, and young researchers. This bill also would implement many of the recommendations of the National Academies of Sciences, Engineering, and Medicine report Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1, which would reduce the administrative burden on researchers.

    The bill also incorporates socioeconomic status (SES) into the Medicare Hospital Readmissions Reduction Program (HRRP). Further, the bill exempts off-campus teaching hospital outpatient departments (HOPDs) that either attested that the regulatory requirements were met prior to Dec. 2, 2015, or were “mid-build” upon passage of the Bipartisan Budget Act of 2015 (P.L. 114-74) from so-called “site-neutral” payment policies. It also provides $1 billion for states to support opioid abuse prevention and response efforts.

    House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Ranking Member Diana DeGette (D-Colo.) noted that “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need.” Speaker of the House Paul Ryan (R-Wis.) added, “With this bill, we are laying the groundwork for medical breakthroughs that will help countless Americans suffering from what today are considered incurable diseases.” The White House Nov. 29 issued a Statement of Administration Policy, noting that the administration “strongly supports” the package.

    The AAMC-led Ad Hoc Group for Medical Research Nov. 29 issued a statement, noting that the bill “provides a meaningful injection of funds for lifesaving biomedical research.”

    The Senate is expected to consider and approve the bill early next week.