John W. Walsh Alpha-1 Home Infusion Act of 2025
- Bill Number
- H.R. 2343
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-03-25: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-06-03T08:05:44Z
AI-Generated Summary
Purpose
This legislation, titled the "John W. Walsh Alpha-1 Home Infusion Act of 2025," aims to expand Medicare coverage under Part B (the outpatient medical insurance part of Medicare) to include treatment for Alpha-1 Antitrypsin Deficiency Disorder (a rare genetic condition that can cause lung and liver damage due to low levels of a protective protein). Specifically, it provides for home-based infusion therapy to make treatment more accessible and less burdensome for patients.
Key Provisions
- Coverage Definition: Adds a new category under Medicare for "Alpha-1 Antitrypsin Deficiency Disorder treatment," defined as augmentation therapy (intravenous replacement of the missing Alpha-1 protein using an FDA-approved inhibitor) delivered in the patient's home by qualified home infusion therapy suppliers (specialized providers certified to administer such therapies at home).
- Eligibility requires: The patient to be under the care of a physician, nurse practitioner, or physician assistant; enrolled in both Medicare Parts A (hospital insurance) and B; not in a Medicare Advantage plan (Part C); and medically needing the therapy.
- "Home" is defined as the patient's primary residence.
- Payment System: Establishes payments to qualified suppliers for intravenous administration kits (equipment needed for the infusion) and nursing services (up to 2 hours per session, coordinated with the therapy).
- Payments are set at 80% of the lesser of the actual charge or a determined amount under a new Medicare payment rule.
- Direct payments go to the home infusion supplier, bypassing some traditional billing processes.
- Exclusions and Adjustments: Specifies that this treatment is separate from standard home health services under Medicare, ensuring it isn't bundled into other benefits.
- Effective Date: Applies to services starting January 1, 2027.
Significant Changes to Existing Law
- Amends Section 1861 of the Social Security Act to explicitly include this therapy as a covered service under Medicare Part B, which previously did not cover home infusion for Alpha-1 augmentation therapy in this structured way.
- Introduces a dedicated payment subsection (Section 1834(aa)) for kits and nursing, creating a new reimbursement model tailored to home infusion—unlike broader home health payments that require a full home health agency plan.
- Makes conforming updates to payment references (Section 1833), physician billing (Section 1842), and home health definitions (Section 1861(m)) to integrate this without overlapping existing coverages, ensuring seamless administration.
Potential Impacts
- On Citizens: Improves access to life-sustaining treatment for the estimated 100,000 Americans with undiagnosed or diagnosed Alpha-1 deficiency, allowing home administration to reduce hospital stays, travel burdens, and infection risks—potentially lowering personal costs and improving quality of life.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) must develop and implement the new payment system, which could involve updating regulations, supplier accreditation processes, and claims processing—potentially increasing short-term administrative workload but streamlining long-term care delivery.
- On International Relations: No direct impact, as this is a domestic healthcare policy focused on U.S. Medicare beneficiaries.
Main Stakeholders Affected
- Patients: Individuals with Alpha-1 Antitrypsin Deficiency Disorder, particularly those eligible for Medicare (typically adults over 65 or with disabilities), who gain new coverage options.
- Healthcare Providers: Physicians, nurse practitioners, physician assistants (who oversee care), and qualified home infusion therapy suppliers (who deliver the treatment and receive payments).
- Government Entities: CMS and the Department of Health and Human Services (HHS), responsible for oversight and funding; Congress, through committees like Energy and Commerce and Ways and Means.
- Other: Advocacy groups for rare diseases (e.g., Alpha-1 Foundation, implied by the bill's naming after John W. Walsh, a prominent advocate), and pharmaceutical manufacturers of augmentation therapies.
Notable Legal, Constitutional, or Political Implications
- Legal: Expands the scope of Medicare Part B benefits under the Social Security Act, potentially setting a precedent for covering other rare disease home infusions; requires CMS rulemaking to define payment amounts, which could face administrative law challenges if not implemented equitably.
- Constitutional: No major issues, as it aligns with Congress's authority to regulate interstate commerce and provide for public welfare through social insurance programs like Medicare.
- Political: Demonstrates bipartisan support (introduced by a diverse group of House members), highlighting focus on rare diseases; could influence future healthcare funding debates by emphasizing home-based care to control costs amid rising Medicare expenditures, without altering broader program structures.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Salazar, Maria Elvira [R-FL-27]
Cosponsors (54)
Rep. Pingree, Chellie [D-ME-1], Rep. Smith, Christopher H. [R-NJ-4], Rep. Johnson, Henry C. "Hank" [D-GA-4], Rep. Owens, Burgess [R-UT-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Kim, Young [R-CA-40], Rep. Rouzer, David [R-NC-7], Rep. Tonko, Paul [D-NY-20], Rep. Kennedy, Timothy M. [D-NY-26], Rep. Lawler, Michael [R-NY-17], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Sherrill, Mikie [D-NJ-11], Rep. Ruiz, Raul [D-CA-25], Rep. Craig, Angie [D-MN-2], Rep. Carter, Troy A. [D-LA-2], Rep. Keating, William R. [D-MA-9], Rep. Neguse, Joe [D-CO-2], Rep. Panetta, Jimmy [D-CA-19], Rep. Kean, Thomas H. [R-NJ-7], Rep. Watson Coleman, Bonnie [D-NJ-12], Rep. Malliotakis, Nicole [R-NY-11], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Gottheimer, Josh [D-NJ-5], Rep. McIver, LaMonica [D-NJ-10], Rep. Matsui, Doris O. [D-CA-7], Rep. Larson, John B. [D-CT-1], Rep. Rutherford, John H. [R-FL-5], Rep. Bynum, Janelle S. [D-OR-5], Rep. Latimer, George [D-NY-16], Rep. Conaway, Herbert C. [D-NJ-3], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Valadao, David G. [R-CA-22], Rep. Ross, Deborah K. [D-NC-2], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Maloy, Celeste [R-UT-2], Rep. Smith, Adrian [R-NE-3], Rep. Mackenzie, Ryan [R-PA-7], Rep. McBride, Sarah [D-DE-At Large], Rep. Flood, Mike [R-NE-1], Rep. Bacon, Don [R-NE-2], Rep. Lynch, Stephen F. [D-MA-8], Rep. Kennedy, Mike [R-UT-3], Rep. Elfreth, Sarah [D-MD-3], Rep. Gillen, Laura [D-NY-4], Rep. Garbarino, Andrew R. [R-NY-2], Rep. Riley, Josh [D-NY-19], Rep. McClain Delaney, April [D-MD-6], Rep. Miller, Carol D. [R-WV-1], Rep. Thompson, Mike [D-CA-4], Rep. Garamendi, John [D-CA-8] and 4 more
Recent Actions
- 2025-03-25: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-03-25: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-03-25: Introduced in House
- 2025-03-25: Introduced in House
Bill Versions
- John W. Walsh Alpha-1 Home Infusion Act of 2025 — issued 2025-03-25 — PDF (6 pages)