PolicyBrief
H.R. 4055
119th CongressJun 20th 2025
Dialysis-Related Amyloidosis Treatment Act of 2025
IN COMMITTEE

This Act mandates that Medicare separately cover FDA-approved treatments for dialysis-related amyloidosis at 100% of reasonable charges, removing them from the standard bundled dialysis payment.

Brian Babin
R

Brian Babin

Representative

TX-36

LEGISLATION

Medicare Mandates Full Coverage for Specialized Dialysis Complication Treatments, Paid Separately from Bundled Rates

The newly introduced Dialysis-Related Amyloidosis Treatment Act of 2025 is a targeted piece of legislation that changes how Medicare pays for treating a serious complication many dialysis patients face. Simply put, if you’re on dialysis and develop amyloidosis—a condition where abnormal proteins build up in your organs—Medicare must now cover the specific treatments for it.

The Fine Print: Unbundling Specialized Care

For those who haven't had to deal with it, kidney dialysis services are usually paid for by Medicare through a comprehensive, bundled payment. This single payment covers the procedure itself, plus many of the drugs and supplies that go along with it. The problem is that specialized, expensive treatments for complications like dialysis-related amyloidosis (DRA) can get squeezed out or inadequately covered under that fixed bundle.

This Act fixes that. It states that treatments for DRA—specifically those FDA-approved items and services provided at a dialysis facility—cannot be included in the standard bundled payment for renal dialysis services (SEC. 2). Instead, Medicare must pay for these specific amyloidosis treatments separately. This is a huge deal for patients, ensuring that facilities can’t claim the cost is already covered by the bundled rate, potentially limiting access to necessary care.

What 100% of 'Reasonable Charges' Actually Means

This is where the bill gets interesting for both patients and the Medicare budget. For these newly unbundled treatments, the law mandates Medicare pay 100 percent of the "reasonable charges" for the items and services (SEC. 2). For the patient, this is great news: it means financial access to potentially life-saving specialized care is significantly improved, as the costs of treating this serious complication are now fully covered by Medicare, effective immediately upon the Act becoming law.

However, paying 100% of reasonable charges, rather than negotiating a lower rate or including it in a fixed prospective payment, raises some flags for the Medicare program itself. While this is limited only to FDA-approved treatments for this specific condition, it means the government is writing a blank check for these services, which could lead to higher costs overall for taxpayers funding the program. If a new, highly effective but extremely expensive drug is approved for DRA, Medicare is on the hook for the full charge.

Who Benefits and Why It Matters

This legislation is a clear win for the most vulnerable patients—those on long-term dialysis who develop a serious complication. It removes a major financial barrier to specialized treatment. Imagine a patient who needs a specific, FDA-approved drug to stop protein build-up; this bill ensures that drug is covered, no questions asked, without the facility having to juggle it within the existing tight budget constraints of the standard dialysis payment system.

On the practical side, the bill also covers “any supplies or services that are absolutely necessary alongside that main treatment” (SEC. 2). While this clause ensures comprehensive care, it’s a somewhat vague term that the Centers for Medicare & Medicaid Services (CMS) will need to clarify quickly. Facilities will need clear guidance on what qualifies as “absolutely necessary” to ensure they get reimbursed and patients get the full scope of care intended by the Act.