Kidney Care Access Protection Act

This bill amends the Medicare program to improve access to innovative treatments for end-stage renal disease (ESRD). It extends and makes permanent certain add-on payments for new drugs, biologicals, and devices, ensures Medicare Advantage plans support these therapies, adjusts payment calculations for labor costs, and expands kidney disease screening and education benefits.

Title I, Protecting Patient Access to Kidney Care Innovation: Sec. 101 extends the transitional drug add-on payment adjustment (TDAPA) for new renal dialysis drugs or biologicals approved after January 1, 2020, for at least 3 years for items furnished on or after January 1, 2026. It establishes a permanent post-TDAPA add-on adjustment to the base rate, calculated using recent utilization and sales data, set at 65% of expenditures per service, updated annually for inflation, and not implemented in a budget-neutral manner. It clarifies that renal dialysis services do not include drugs or biologicals for comorbid conditions approved after December 31, 2025, that do not substitute for a base-rate drug, and requires a specific modifier on claims. It also extends the transitional add-on payment for new 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 Kidney Care Innovative Therapies: Beginning January 1, 2026, the Secretary must make direct payment adjustments to providers or renal dialysis facilities for new renal dialysis drugs or biologicals receiving TDAPA, or items/services receiving TPNIES, equal to the amount under the ESRD prospective payment system, for the duration of the transitional payment.

Title II, Addressing Staffing Barriers with ESRD Market Basket Labor Adjustments: Sec. 201 amends the ESRD payment system to require, starting in 2026, a forecast error adjustment to the annual update factor. The initial adjustment accounts for cumulative forecast error for 2021 and 2022, with subsequent adjustments for the most recent year with final data, applied when the difference between forecasted and actual price changes exceeds 0.5 percentage points.

Title III, Preventing Kidney Disease and Expanding Awareness and Education: Sec. 301 adds chronic kidney disease screening to the Medicare annual wellness benefit, effective January 1, 2026.

Sec. 302 expands the Medicare kidney disease education benefit to include individuals with stage V kidney disease, allows physician assistants, nurse practitioners, or clinical nurse specialists to provide the education, and adds renal dialysis facilities with qualified personnel as providers. Payment for these services will be made separately from the single ESRD payment, on an assignment-related basis under section 1848, effective January 1, 2026.