Kidney Care Access Protection Act

This bill amends the Social Security Act to improve access to innovative treatments for end-stage renal disease (ESRD) under Medicare. It extends payment adjustments for new drugs, biologicals, and devices, ensures Medicare Advantage supports these therapies, and adjusts payment updates for forecast errors.

Sec. 101, Refining the ESRD payment system: Extends the transitional drug add-on payment adjustment (TDAPA) for at least 3 years for new renal dialysis drugs or biologicals approved on or after January 1, 2020, and furnished on or after January 1, 2026. Establishes a permanent post-TDAPA add-on adjustment starting January 1, 2026, calculated based on utilization and average sales price data, set at 65% of expenditures per dialysis service, updated annually for inflation, and not budget neutral. Clarifies that renal dialysis services do not include drugs or biologicals for comorbid conditions approved after December 31, 2025, unless they substitute for a drug in the base rate, and requires claims for such drugs to include an AY modifier. Extends the transitional add-on payment for new and innovative equipment and supplies (TPNIES) for at least 3 years for devices furnished on or after January 1, 2026, makes breakthrough devices eligible, and removes the exclusion of capital-related assets from TPNIES.

Sec. 102, Ensuring Medicare Advantage supports innovative therapies: Requires the Secretary to make direct payment adjustments to providers or renal dialysis facilities for new renal dialysis drugs or biologicals receiving TDAPA, or items/services receiving TPNIES, beginning January 1, 2026. The payment amount equals the ESRD prospective payment system amount, and payments last for the duration of the transitional payment.

Sec. 201, Ensuring accuracy and stability in kidney care payment: Amends the ESRD payment update to include a forecast error adjustment beginning in 2026. The initial adjustment accounts for cumulative forecast error for 2021 and 2022, and subsequent adjustments use the most recent year with final data. The adjustment applies when the difference between forecasted and actual price changes exceeds 0.5 percentage points.