Sponsors (17)
Official title: To amend title XVIII of the Social Security Act to improve access to innovative treatment options for end-stage renal disease under the Medicare program, and for other purposes.
Introduced November 20, 2025 by Carol Devine Miller · Last progress November 20, 2025
The bill improves access to new dialysis drugs/devices, strengthens payment predictability for providers, and expands CKD screening and patient education, but does so at the expense of higher Medicare/taxpayer costs and added administrative complexity with risks of misaligned clinical incentives.
Medicare beneficiaries receiving dialysis maintain guaranteed transitional payment coverage for new FDA‑approved renal drugs/biologics for at least three years, reducing disruptions in access when new therapies enter the market.
Dialysis providers and facilities receive more predictable, higher transitional/add‑on payments (including device eligibility and annual inflation updates) and timelier payment adjustments, improving financial predictability and encouraging adoption of dialysis innovations.
Medicare beneficiaries with or at risk for chronic kidney disease gain annual CKD screening coverage beginning Jan 1, 2026, supporting earlier detection and potential earlier interventions.
The bill increases Medicare program spending and could raise costs for taxpayers and the Medicare Trust Fund; higher drug payments may also be passed through to Medicare Advantage enrollees via higher plan costs or premiums.
New payment rules, forecast‑error calculations, and separate assignment‑related payments increase administrative complexity and compliance burdens for CMS and providers, disproportionately straining smaller dialysis providers and increasing operational costs.
Payment design choices—notably excluding patient‑level case‑mix adjustments and creating TDAPA incentives—risk misaligned incentives that could produce overpayments for some treatments and encourage use of dialysis‑administered drugs over non‑dialysis alternatives, complicating clinical decision‑making.
Based on analysis of 4 sections of legislative text.
Extends TDAPA for new dialysis drugs, creates a permanent 65%-of‑per‑service add‑on post‑TDAPA, adds a forecast error adjustment for dialysis updates, and expands CKD screening and education payment rules.
Requires Medicare to pay transitional add-on (TDAPA) for new FDA‑approved renal dialysis drugs/biologics for at least three years and creates a permanent post‑TDAPA add‑on equal to 65% of per‑service drug spending (with annual inflation updates) for drugs that received TDAPA. Adds a forecast‑error adjustment for annual dialysis payment updates and expands Medicare coverage and payment rules for chronic kidney disease (CKD) screening and kidney disease education, including new provider categories and assignment‑based payments for education furnished by dialysis facilities.