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  • Washington Highlights

    Senate HELP Panel Passes First Pieces of Biomedical Innovation Agenda

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

    The Senate Health, Education, Labor, and Pensions (HELP) Committee Feb. 9 approved seven bipartisan bills as the first step in its effort to produce companion legislation to the House-passed 21st Century Cures Act (H.R. 6).

    The committee voted 22-0 to pass the Improving Health Information Technology Act (S. 2511), introduced by committee chair Lamar Alexander (R-Tenn.) and ranking member Patty Murray (D-Wash.).

    S. 2511 would:

    • Reduce documentation burdens on providers by convening public and private stakeholders to develop a strategy and recommendations to minimize the documentation burden on providers while maintaining quality.
    • Establish an unbiased rating system for health information technology (HIT) products to help providers better choose HIT products.
    • Give the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information.
    • Convene existing data sharing networks to develop a voluntary model framework and common agreement for the secure exchange of health information across existing networks.
    • Require that certified HIT exchange data with registries that are certified to use standards endorsed by the Office of the National Coordinator (ONC).
    • Support the certification and development of patient-centered health record technology.
    • Direct the Governmental Accountability Office (GAO) to study methods for securely matching patient records to the correct patient.

    The committee also approved by voice vote the AAMC-endorsed bipartisan Next Generation (NextGen) Researchers Act (S.2014), sponsored by Senators Tammy Baldwin (D-Wis.) and Susan Collins (R-Maine).

    The legislation would create the “Next Generation Researchers Initiative” within the National Institutes of Health (NIH) Office of the Director to coordinate all current and new NIH policies aimed at promoting opportunities for new researchers and earlier research independence. In addition, the legislation directs the NIH to consider recommendations from a National Academy of Sciences (NAS) comprehensive study and report on fostering the next generation of researchers that Senators Baldwin and Collins included in the recently passed Consolidated Appropriations Act. The bill also would increase the amount of loans that can be forgiven through the NIH’s loan repayment program, as recommended by the NIH’s Physician-Scientist Working Group.

    Committee Democrats continue to push for the addition of mandatory funding streams for the NIH and the Food and Drug Administration (FDA). During the markup, Senator Murray said, “The path to a bipartisan bill on medical innovation must include mandatory investments in the NIH and the FDA.”

    The committee also approved:

    • The FDA Device Accountability Act of 2015 (S.1622), sponsored by Senators Richard Burr (R-N.C.) and Al Franken (D-Minn.);
    • The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030), sponsored by Senators Michael Bennet (D-Colo.), Burr, Elizabeth Warren (D-Mass.), and Orrin Hatch (R-Utah);
    • The Advancing Research for Neurological Diseases Act of 2015 (S.849), sponsored by Senators Johnny Isakson (R-Ga.) and Christopher Murphy (D-Conn.); and
    • The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800), sponsored by Senators Mark Kirk (D-Ill.), Bennet, Hatch, Lisa Murkowski (R-Alaska), Isakson, and Collins.

    The session marked the first of three scheduled meetings to mark up biomedical innovation legislation. The committee will consider five additional bipartisan proposals March 9, and additional bills may be added.