POLICY BRIEFINGS

COVID-19 Antiviral Up for EUA

The Food and Drug Administration (FDA) has announced a forthcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss an emergency use authorization (EUA) request from Merck and Ridgeback for their investigational antiviral drug molnupiravir for the oral treatment of COVID-19. The panel will meet on November 30 to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19 in adults who have tested positive for coronavirus and who are at high risk for progression to severe COVID-19, including hospitalization or death. The committee will hear presentations from the company regarding the data for the antiviral drug, and the FDA will present its perspective regarding the sponsor’s data. The meeting will be livestreamed on the FDA’s YouTube page and webcast from the FDA’s website.

PHE Declaration Extended

As a result of the continued COVID-19 pandemic, the U.S. Department of Health and Human Services (HHS) has renewed the public health emergency (PHE) declaration effective October 18. The renewal lasts for 90 days and may be extended again by the HHS Secretary. Previously, President Bident has told state officials that he plans to extend the PHE through 2021 and provide a 60-day notice to states when he plans not to renew the PHE. The nationwide PHE was first declared on January 27, 2020.

Upcoming Congressional Hearings and Markups

Senate Finance Committee hearing “Health Insurance Coverage in America: Current and Future Role of Federal Programs;” 10:00 a.m.; October 20

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Global Supply Chains and Small Business Trade Challenges;” 10:00 a.m.; October 20

House Energy and Commerce Subcommittee on Health legislative hearing “Enhancing Public Health: Legislation to Protect Children and Families;” 10:30 a.m.; October 20

Senate Banking, Housing, and Urban Affairs Subcommittee on Economic Policy hearing “Protecting Companies and Communities from Private Equity Abuse;” 2:00 p.m.; October 20

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies hearing “Update on VA’s Electronic Health Record Modernization Implementation;” witness: VA Deputy Secretary; 10:00 a.m.; October 21

Senate Judiciary Committee hearing “Oversight of the Department of Homeland Security;” witness: DHS Secretary; 10:00 a.m.; October 21

Recently Introduced Health Legislation

H.R.5549 — To amend the Indian Health Care Improvement Act to authorize advance appropriations for the Indian Health Service by providing 2-fiscal-year budget authority, and for other purposes. Sponsor: Rep. Young, Don [R-AK-At Large]; Committees: House - Natural Resources; Energy and Commerce; Budget

H.R.5548 — To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to establish a patient outreach system relating to mental health care, and for other purposes. Sponsor: Rep. Wittman, Robert J. [R-VA-1]; Committees: House - Veterans’ Affairs

H.R.5546 — To amend the Public Health Service Act to provide for a Reducing Youth Use of E-Cigarettes Initiative. Sponsor: Rep. Wasserman Schultz, Debbie [D-FL-23]; Committees: House - Energy and Commerce

H.R.5542 — To direct the Secretary of Health and Human Services to establish a grant program to facilitate the distribution of funding for travel related expenses paid by individuals impacted by restrictions to the provision of abortion services, and for other purposes. Sponsor: Rep. Sherman, Brad [D-CA-30]; Committees: House - Energy and Commerce; Judiciary

H.R.5541 — To amend the Internal Revenue Code of 1986 to extend the exemption for telehealth services from certain high deductible health plan rules, and for other purposes. Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House - Ways and Means

H.R.5540 —To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to cosmetic safety, with an emphasis on communities of color and professional salon workers, and for other purposes. Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]; Committees: House - Energy and Commerce; Education and Labor

H.R.5539 — To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cosmetics, and for other purposes. Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]; Committees: House - Energy and Commerce

H.R.5538 — To amend title VI of the Federal Food, Drug, and Cosmetic Act to provide for greater transparency with respect to fragrance and flavor ingredients in cosmetics, and for other purposes. Sponsor: Rep. Schakowsky, Janice D. [D- IL-9]; Committees: House - Energy and Commerce

H.R.5537 — To amend the Federal Food, Drug, and Cosmetic Act to ban certain substances in cosmetic products, and for other purposes. Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]; Committees: House - Energy and Commerce

H.R.5536 — To amend title XVIII of the Social Security Act to revise certain payment rules for outpatient physical therapy and outpatient occupational therapy furnished in rural areas and medically underserved areas, and for other purposes. Sponsor: Rep. Rush, Bobby L. [D-IL-1]; Committees: House - Energy and Commerce; Ways and Means

H.R.5530 — To authorize appropriations for the substance abuse youth initiative, and for other purposes. Sponsor: Rep. Neguse, Joe [D-CO-2]; Committees: House - Education and Labor

H.R.5527 — To prohibit the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health from conducting or supporting research on animals in certain foreign countries, and for other purposes. Sponsor: Rep. McClain, Lisa C. [R-MI-10]; Committees: House - Energy and Commerce

H.R.5526 — To amend the Richard B. Russell School Lunch Act to increase access to mental health resources, and for other purposes. Sponsor: Rep. Manning, Kathy E. [D-NC-6]; Committees: House - Education and Labor

H.R.5520 — To amend the Public Health Service Act to increase due process and transparency at the National Library of Medicine in listing and delisting journals in MEDLINE (or any other current or successor databases or indices), and for other purposes. Sponsor: Rep. Jacobs, Chris [R-NY-27]; Committees: House - Energy and Commerce

H.R.5515 — To direct the Secretary of Health and Human Services to ensure that certain biomedical research is conducted in a manner that considers national security risks, and for other purposes. Sponsor: Rep. Dunn, Neal P. [R-FL-2]; Committees: House - Energy and Commerce

H.R.5514 — To amend title XVIII of the Social Security Act to improve extended care services by providing Medicare beneficiaries with an option for cost effective home-based extended care under the Medicare program, and for other purposes. Sponsor: Rep. Cuellar, Henry [D-TX-28]; Committees: House - Ways and Means; Energy and Commerce

H.R.5510 — To ensure that patients receive accurate health care information by prohibiting misleading and deceptive advertising or representation in the provision of health care services, to require the identification of the license of health care professionals, and for other purposes. Sponsor: Rep. Bucshon, Larry [R-IN-8]; Committees: House - Energy and Commerce

H.R.5509 — To amend title 38, United States Code, the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020, and the Student Veteran Coronavirus Response Act of 2020 to make certain improvements to the educational assistance programs of the Department of Veterans Affairs, and for other purposes. Sponsor: Rep. Bost, Mike [R-IL-12]; Committees: House - Veterans’ Affairs

H.R.5506 — To establish a Rural Telehealth Access Task Force to determine how to address barriers to the adoption of telehealth technology and access to broadband internet access service in rural areas, and for other purposes. Sponsor: Rep. Pence, Greg [R-IN-6]; Committees: House - Energy and Commerce; Agriculture

H.Res.718 — Expressing support for the designation of October 17, 2021, as “National Vitiligo Awareness Day”; Sponsor: Rep. Johnson, Henry C. “Hank,” Jr. [D-GA-4]; Committees: House - Energy and Commerce

H.Res.719 — Thanking and promoting the professions of perinatal nurses by encouraging participation in “National Perinatal Nurses Week”; Sponsor: Rep. Roybal-Allard, Lucille [D-CA-40]; Committees: House - Energy and Commerce

H.R.5551 — To amend title III of the Public Health Service Act to reauthorize the National Center on Birth Defects and Developmental Disabilities, and for other purposes; Sponsor: Rep. Carter, Earl L. “Buddy” [R-GA-1]; Committees: House - Energy and Commerce

H.R.5552 — To amend title III of the Public Health Service Act to reauthorize certain programs with respect to lead poisoning, and for other purposes; Sponsor: Rep. Walberg, Tim [R-MI-7]; Committees: House - Energy and Commerce

H.R.5553 — To prohibit the Secretary of Veterans Affairs from providing or paying for surgical treatment related to gender transition; Sponsor: Rep. Bergman, Jack [R-MI-1]; Committees: House - Veterans’ Affairs

H.R.5555 — To establish a manufacturing cluster program, and for other purposes; Sponsor: Rep. Delgado, Antonio [D- NY-19]; Committees: House - Energy and Commerce; Science, Space, and Technology; Armed Services

H.R.5558 — To amend the Public Health Service Act to reauthorize preventive health measures with respect to prostate cancer, and for other purposes; Sponsor: Rep. Dunn, Neal P. [R-FL-2]; Committees: House - Energy and Commerce

H.R.5561 — To reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children, and for other purposes; Sponsor: Rep. Guthrie, Brett [R-KY-2]; Committees: House - Energy and Commerce

H.R.5562 — To amend title 38, United States Code, to expand eligibility for hospital care, medical services, and nursing home care from the Department of Veterans Affairs to include veterans of World War II; Sponsor: Rep. Harder, Josh [D- CA-10]; Committees: House - Veterans’ Affairs

H.R.5563 — To amend the Internal Revenue Code of 1986 to allow individuals only enrolled in Medicare Part A to contribute to health savings accounts; Sponsor: Rep. Latta, Robert E. [R-OH-5]; Committees: House - Ways and Means

H.R.5566 — To support fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes; Sponsor: Rep. McCarthy, Kevin [R-CA-23]; Committees: House - Energy and Commerce

H.R.5575 — To amend title 38, United States Code, to increase the rate of pay for certain nurses and other medical positions of the Department of Veterans Affairs, and for other purposes; Sponsor: Rep. Underwood, Lauren [D-IL-14]; Committees: House - Veterans’ Affairs

H.R.5576 — To amend titles XIX and XXI of the Social Security Act to give States the option to extend the Medicaid drug rebate program to the Children’s Health Insurance Program, and for other purposes; Sponsor: Rep. Wild, Susan [D-PA-7]; Committees: House - Energy and Commerce

October 18, 2021: | Page 1 Page 2