Kidney Care Access Protection Act
Kidney Care Access Protection Act aims to strengthen Medicare’s support for innovative kidney treatments and modernize how ESRD (end-stage renal disease) services are paid. Key changes include extending and making permanent certain add-on payments for new dialysis drugs, biologics, and equipment, so providers can access innovative therapies without immediate base-rate reductions. The bill also tightens how “renal dialysis services” are defined to exclude certain comorbidity drugs, moves to include capital assets in new-technology add-ons, and requires Medicare Advantage plans to directly adjust payments for a portion of these innovations. Additionally, it adds a new mechanism to improve payment accuracy by introducing a forecast-error adjustment to the ESRD market basket update, starting in 2026. The provisions become effective January 1, 2026.
Key Points
- 1Extend TDAPA (transitional drug add-on payment adjustment) for at least 3 years for any new renal dialysis drug/biological approved after January 1, 2020 and furnished on or after January 1, 2026.
- 2Create a permanent post-TDAPA add-on: for new renal dialysis drugs/biologics that previously received TDAPA, establish a permanent base-rate add-on starting in 2026, calculated from recent usage and pricing data, set at 65% of the calculated amount, updated for inflation, and applied to claims immediately after the TDAPA period ends. Not budget neutral and not subject to usual case-mix adjustments.
- 3Refine the definition of renal dialysis services: exclude certain drugs/biologics used to treat comorbid conditions (approved after 2025 and not substituting for base-rate ESRD drugs) from the ESRD base rate, and require an AY modifier on claims to track these innovative drugs.
- 4Revise TDAPA for new and innovative equipment and supplies (TPNIES): extend eligibility for at least 3 years for new dialysis devices after January 1, 2026; include FDA Breakthrough devices; begin including capital-related assets in the add-on calculation beginning in 2026; remove the prior exclusion of capital assets from the add-on.
- 5Medicare Advantage alignment: beginning 2026, allow direct payment adjustments in MA plans to providers for (A) new renal dialysis drugs/biologics with TDAPA and (B) items/services with TPNIES, with the adjustment amount equal to the ESRD Prospective Payment System (PPS) amount.
- 6Effective date: all amendments take effect January 1, 2026, applying to items/services furnished on or after that date.
- 7Title II also adds a forecast-error adjustment to the ESRD market basket update process starting in 2026 to account for differences between forecasted and actual price changes in the renal dialysis service mix, triggered if the forecast error exceeds 0.5 percentage points.