Ways and Means Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
The Kidney Care Access Protection Act seeks to enhance Medicare beneficiaries' access to innovative treatments for end-stage renal disease (ESRD). It extends the Transitional Drug Add-On Payment Adjustment (TDAPA) period for new renal dialysis drugs and biological products to at least three years, for those approved after January 1, 2020, and furnished after January 1, 2026. Furthermore, it establishes a permanent post-TDAPA add-on adjustment to the base rate for these innovative drugs and biologicals, ensuring continued support after the transitional period. This permanent adjustment will be calculated based on utilization and average sales price, updated annually, and applied immediately upon TDAPA expiration, without budget neutrality or case-mix adjustments. The bill also clarifies that certain new drugs or biologicals approved after December 31, 2025, for comorbid conditions in ESRD patients, which do not substitute existing ESRD drugs, will not be included in the renal dialysis services definition and will be paid separately. For devices, it extends the Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) to three years for new renal dialysis devices furnished after January 1, 2026. Importantly, breakthrough devices become eligible for TPNIES, and the exclusion of capital-related assets from TPNIES calculations is removed, allowing them to receive this adjustment. To ensure comprehensive coverage, the legislation mandates that Medicare Advantage plans make direct payment adjustments to providers for these innovative renal dialysis drugs, biologicals, and devices during their respective transitional payment periods, starting January 1, 2026. Additionally, it addresses staffing barriers by requiring an annual forecast error adjustment to the ESRD payment update factor, beginning in 2026, to account for discrepancies between forecasted and actual price changes in goods and services. Finally, the Act expands preventive care and education for kidney disease. It broadens the Medicare annual wellness benefit to include chronic kidney disease screening, effective January 1, 2026. Access to the Medicare kidney disease education benefit is increased by allowing physician assistants, nurse practitioners, and clinical nurse specialists to provide these services, and by permitting renal dialysis facilities to offer them, with separate payment from the single renal dialysis service payment.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
The Kidney Care Access Protection Act seeks to enhance Medicare beneficiaries' access to innovative treatments for end-stage renal disease (ESRD). It extends the Transitional Drug Add-On Payment Adjustment (TDAPA) period for new renal dialysis drugs and biological products to at least three years, for those approved after January 1, 2020, and furnished after January 1, 2026. Furthermore, it establishes a permanent post-TDAPA add-on adjustment to the base rate for these innovative drugs and biologicals, ensuring continued support after the transitional period. This permanent adjustment will be calculated based on utilization and average sales price, updated annually, and applied immediately upon TDAPA expiration, without budget neutrality or case-mix adjustments. The bill also clarifies that certain new drugs or biologicals approved after December 31, 2025, for comorbid conditions in ESRD patients, which do not substitute existing ESRD drugs, will not be included in the renal dialysis services definition and will be paid separately. For devices, it extends the Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) to three years for new renal dialysis devices furnished after January 1, 2026. Importantly, breakthrough devices become eligible for TPNIES, and the exclusion of capital-related assets from TPNIES calculations is removed, allowing them to receive this adjustment. To ensure comprehensive coverage, the legislation mandates that Medicare Advantage plans make direct payment adjustments to providers for these innovative renal dialysis drugs, biologicals, and devices during their respective transitional payment periods, starting January 1, 2026. Additionally, it addresses staffing barriers by requiring an annual forecast error adjustment to the ESRD payment update factor, beginning in 2026, to account for discrepancies between forecasted and actual price changes in goods and services. Finally, the Act expands preventive care and education for kidney disease. It broadens the Medicare annual wellness benefit to include chronic kidney disease screening, effective January 1, 2026. Access to the Medicare kidney disease education benefit is increased by allowing physician assistants, nurse practitioners, and clinical nurse specialists to provide these services, and by permitting renal dialysis facilities to offer them, with separate payment from the single renal dialysis service payment.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.