Dialysis-Related Amyloidosis Treatment Act of 2025

Bill Number

H.R. 4055

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-06-20: 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

2025-09-19T08:07:36Z

AI-Generated Summary

Purpose

The Dialysis-Related Amyloidosis Treatment Act of 2025 aims to expand Medicare coverage to include specific treatments for dialysis-related amyloidosis—a condition where proteins build up in the body due to long-term dialysis for kidney failure. It ensures these treatments are paid for separately rather than being bundled with standard dialysis services, improving access for affected patients.

Key Provisions

• Coverage Addition: Amends Section 1861(s)(2) of the Social Security Act to explicitly include "treatments for dialysis-related amyloidosis" as a covered Medicare benefit under Part B (outpatient services).
• Definition of Treatments: Adds a new subsection (nnn) to Section 1861, defining these treatments as any FDA-approved items or services provided in dialysis facilities (either standalone or hospital-based), including necessary supplies or adjunct services.
• Exclusion from Bundled Payments: Modifies Section 1881(b)(14)(B) to exclude these treatments from the existing bundle of renal dialysis services, preventing them from being grouped under a single payment rate.
• Separate Payment Mechanism: Updates Section 1833(a)(1)(E) to require payment for these treatments at 100% of reasonable charges, outside of any prospective payment systems or comprehensive fees for dialysis.
• Effective Date: All changes take effect immediately upon the bill's enactment into law.

Significant Changes to Existing Law

• Prior to this bill, treatments for dialysis-related amyloidosis may not have been explicitly covered under Medicare or could have been included in the bundled payment for end-stage renal disease (ESRD) services, potentially limiting reimbursement and access.
• This legislation introduces a new, standalone coverage category, ensuring separate billing and full payment, which shifts from the bundled payment model established under prior laws like the 2011 ESRD Prospective Payment System.

Potential Impacts

• On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to update billing codes, guidelines, and payment systems to handle separate reimbursements, which could increase administrative workload and Medicare expenditures for ESRD care.
• On Citizens: Medicare beneficiaries undergoing dialysis who develop amyloidosis will gain better access to specialized treatments without financial barriers from bundling, potentially improving quality of life and health outcomes for this vulnerable group (estimated at thousands of long-term dialysis patients).
• On International Relations: No direct impacts, as this is a domestic healthcare policy focused on U.S. Medicare.

Main Stakeholders Affected

• Medicare Beneficiaries with ESRD: Primary beneficiaries, especially those with dialysis-related amyloidosis, who will receive expanded treatment options.
• Dialysis Facilities and Providers: Freestanding or hospital-based centers will be able to bill separately for these services, potentially increasing revenue and encouraging adoption of FDA-approved treatments.
• Food and Drug Administration (FDA): Plays a role in approving treatments, which will now directly influence Medicare coverage eligibility.
• CMS and Taxpayers: CMS implements the changes, while broader Medicare funding (from federal budgets and premiums) may see modest cost increases.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens Medicare's framework for covering emerging treatments in chronic care by carving out exceptions to bundled payments, potentially serving as a model for future unbundling of specialized therapies; no conflicts with existing anti-fraud provisions in the Social Security Act.
• Constitutional: Aligns with Congress's authority under the Spending Clause to regulate federal programs like Medicare; no apparent free speech, due process, or equal protection issues.
• Political: Highlights bipartisan interest in kidney health (introduced by Rep. Babin), but could spark debates on Medicare costs and the balance between bundled efficiency versus targeted coverage; may influence future ESRD policy reforms amid rising chronic disease rates.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Babin, Brian [R-TX-36]

Cosponsors (2)

Rep. Nadler, Jerrold [D-NY-12], Rep. Valadao, David G. [R-CA-22]

Recent Actions

• 2025-06-20: 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.
• 2025-06-20: 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.
• 2025-06-20: Introduced in House
• 2025-06-20: Introduced in House

Bill Versions

• Dialysis-Related Amyloidosis Treatment Act of 2025 — issued 2025-06-20 — PDF (3 pages)