POLICY BRIEFINGS

---

FDA, CDC Update COVID Booster Policies

The Food and Drug Administration (FDA) announced last week that it is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:

• The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals:
  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
• The use of a single booster dose of the Janssen COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
• The use of each of the available COVID-19 vaccines as a heterologous booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
• To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

The Centers for Disease Control and Prevention (CDC) also announced its endorsement of the Advisory Committee on Immunization Practices’ (ACIP) recommendations for the Moderna and Johnson & Johnson COVID-19 boosters. The CDC’s recommendations cover all three available vaccines and allow for mix and match dosing of booster shots. The panel signed off on boosters for all adults who received the J&J vaccine at least two months post-immunization, and for those who received the Moderna vaccine who are 65 years and older, live in long-term care settings, have underlying medical conditions, or who work or live in high-risk settings.

FDA Approves New Interchangeable Biosimilar

The Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo, whose reference product is Humira, is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Cyltezo is approved for the following indications in adult patients:

• moderately to severely active rheumatoid arthritis;
• active psoriatic arthritis;
• active ankylosing spondylitis;
• moderately to severely active Crohn’s disease;
• moderately to severely active ulcerative colitis; and
• moderate to severe chronic plaque psoriasis.

NC, PA Representatives Announce Plans to Retire

Rep. David Price (D-N.C.) has announced plans to retire after next year’s midterm elections. Price was first elected to the House of Representatives in 1986. He is a senior member of the House Appropriations Committee and serves on the House Budget Committee. Rep. Mike Doyle (D-Penn.) also announced last week that he will not be running for reelection to seek a 15th term in Congress. Doyle was first elected in 1994 and currently serves on the Energy and Commerce Committee.

DHS Secretary Tests Positive for COVID

Secretary of Homeland Security Alejandro Mayorkas has tested positive for COVID-19. He is fully vaccinated. Mayorkas stated that he is experiencing mild congestion and will continue working from home in keeping with guidance from the Centers for Disease Control and Prevention (CDC).

Upcoming Congressional Hearings and Markups

House Education & Labor Joint Subcommittee hearing “Protecting Lives and Livelihoods: Vaccine Requirements and Employee Accommodations;” 10:15 a.m.; October 26

House Energy and Commerce Subcommittee on Health legislative hearing “Caring for America: Legislation to Support Patients, Caregivers, and Providers;” 10:30 a.m.; October 26

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program;” 2:00 p.m.; October 26

House Veterans’ Affairs Subcommittee on Health hearing “Lessons Learned? Building a Culture of Patient Safety Within the Veterans Health Administration;” 10:00 a.m.; October 27

House Appropriations Subcommittee on State, Foreign Operations, and Related Programs hearing “United States Global COVID-19 Response: Actions Taken & Future Needs;” 10:00 a.m.; October 27

House Energy and Commerce Subcommittee on Environment and Climate Change hearing “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act;” 10:30 a.m.; October 27

Senate Judiciary Committee Executive Session including markup of S. 2428, False Claims Amendments Act; 9:00 a.m.; October 28

Recently Introduced Health Legislation

H.R.5583 — To amend the Public Health Service Act to reauthorize certain programs to strengthen the health care workforce, and for other purposes; Sponsor: Rep. Curtis, John R. [R-UT-3]; Committees: House - Energy and Commerce

H.R.5585 — To establish the Advanced Research Projects Agency–Health, and for other purposes; Sponsor: Rep. Eshoo, Anna G. [D-CA-18]; Committees: House - Energy and Commerce

H.R.5590 — To require Federal agencies to acknowledge, accept, and agree to truthfully present, natural immunity pertaining to COVID–19 pursuant to promulgating certain regulations; Sponsor: Rep. Harshbarger, Diana [R-TN-1]; Committees: House - Oversight and Reform

H.R.5594 — To amend the Public Health Service Act to reauthorize grants to promote positive health behaviors and outcomes for populations in medically underserved communities, and for other purposes; Sponsor: Rep. Joyce, John [R- PA-13]; Committees: House - Energy and Commerce

H.R.5602 — To amend the Public Health Service Act to establish a Bio-Preparedness and Infectious Diseases Workforce Loan Repayment Program; Sponsor: Rep. Trahan, Lori [D-MA-3]; Committees: House - Energy and Commerce

H.R.5604 — To direct the Patient Center Outcome Research Institute to prepare and release a report on home cardiorespiratory monitors for infants, and for other purposes; Sponsor: Rep. Walorski, Jackie [R-IN-2]; Committees: House - Energy and Commerce; Ways and Means

H.R.5605 — To establish a grant program that provides grants to States, Indian Tribal governments, Federally qualified health centers, rural health clinics, local governments, and community-based organizations to establish and support PrEP programs, and for other purposes; Sponsor: Rep. Watson Coleman, Bonnie [D-NJ-12]; Committees: House - Energy and Commerce

S.2988 — To require any COVID–19 vaccine mandate issued by Congress or an Executive agency to include informed parental consent for the administration of a COVID–19 vaccine to a minor, and for other purposes; Sponsor: Sen. Lee, Mike [R-UT]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.5642 — To make any individual who is demonstrated to have antibodies to the virus that causes COVID-19 exempt from any Federal mandate for vaccination against COVID-19; Sponsor: Rep. Issa, Darrell E. [R-CA-50]; Committees: House - Energy and Commerce

H.R.5645 — To require the evaluation and standardization of suicide prevention efforts by the Department of Defense, and for other purposes; Sponsor: Rep. Miller-Meeks, Mariannette [R-IA-2]; Committees: House - Armed Services

H.R.5649 — To amend the Internal Revenue Code of 1986 to provide incentives for relocating manufacturing to the United States, permanent full expensing for qualified property, and for other purposes; Sponsor: Rep. Roy, Chip [R-TX-21]; Committees: House - Ways and Means

H.R.5632 — To codify a statutory definition for long-term care pharmacies. Sponsor: Rep. Schrader, Kurt [D-OR-5]; Committees: House - Energy and Commerce; Ways and Means

H.R.5627 — To amend titles XVIII and XIX of the Social Security Act to prohibit certain vaccine mandates as conditions of participation under the Medicare and Medicaid programs. Sponsor: Rep. Latta, Robert E. [R-OH-5]; Committees: House - Energy and Commerce; Ways and Means

H.R.5626 — To amend title IV of the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to consult with certain heads of Federal agencies with respect to biomedical research that may affect national security, and for other purposes. Sponsor: Rep. Joyce, John [R-PA- 13]; Committees: House - Energy and Commerce

H.R.5625 — To direct the Secretary of Health and Human Services to revise the requirement that a recipient of a grant under the High Obesity Program be located in a county with an adult obesity rate of more than 40 percent, and for other purposes. Sponsor: Rep. Jeffries, Hakeem S. [D-NY-8]; Committees: House - Energy and Commerce

H.R.5623 — To amend title XVIII of the Social Security Act to prohibit price concessions with respect to insulin drugs and exceptions under part D of Medicare, and for other purposes. Sponsor: Rep. Grothman, Glenn [R-WI-6]; Committees: House - Energy and Commerce; Ways and Means

H.R.5622 — To amend title XXVII of the Public Health Service Act to allow for premium rates in the group and individual health insurance markets to vary during the COVID-19 emergency period based on COVID-19 vaccination status, and for other purposes. Sponsor: Rep. Gallego, Ruben [D-AZ-7]; Committees: House - Energy and Commerce; Judiciary

H.R.5613 — To prohibit the Federal Government from mandating vaccination against COVID-19 for interstate travel. Sponsor: Rep. Cawthorn, Madison [R-NC-11]; Committees: House - Energy and Commerce; Transportation and Infrastructure

H.R.5612 — To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and would be offset by using unobligated funds from the Provider Relief Fund. Sponsor: Rep. Burgess, Michael C. [R-TX-26]; Committees: House - Energy and Commerce; Ways and Means; Appropriations

H.R.5611 — To empower communities to establish a continuum of care for individuals experiencing mental or behavioral health crisis, and for other purposes. Sponsor: Rep. Blunt Rochester, Lisa [D-DE-At Large]; Committees: House - Energy and Commerce; Ways and Means; Armed Services; Veterans’ Affairs; Oversight and Reform

H.R.5610 — To streamline enrollment in health insurance affordability programs and minimum essential coverage, and for other purposes. Sponsor: Rep. Bera, Ami [D-CA-7]; Committees: House - Energy and Commerce; Ways and Means

H.R.5607 — To amend title 38, United States Code, to extend increased dependency and indemnity compensation paid to surviving spouses of veterans who die from amyotrophic lateral sclerosis, regardless of how long the veterans had such disease prior to death. Sponsor: Rep. Slotkin, Elissa [D-MI-8]; Committees: House - Veterans’ Affairs

October 25, 2021: | Page 1 Page 2 Page 3