HR6214-119

What This Bill Does

The Kidney Care Access Protection Act is a Medicare kidney-care payment and benefit bill. Section 101 requires HHS to pay the transitional drug add-on payment adjustment, or TDAPA, for at least three years for new renal dialysis drugs and biological products approved by FDA on or after January 1, 2020, that qualify and are furnished on or after January 1, 2026. It also creates a permanent post-TDAPA add-on to the ESRD prospective payment system base rate for claims beginning January 1, 2026, based on utilization and average sales price, wholesale acquisition cost, or invoice data, set at 65 percent of the calculated amount, updated for inflation, applied immediately after TDAPA expires, and not implemented budget-neutrally or adjusted by patient case mix. Section 102 requires direct Medicare Advantage payment adjustments to providers and renal dialysis facilities for TDAPA drugs and transitional add-on payments for new and innovative equipment and supplies, for the duration of the transitional payment. Section 201 adds an ESRD payment update forecast-error adjustment beginning in 2026 whenever forecasted and actual prices differ by more than 0.5 percentage points, with the first adjustment accounting for 2021 and 2022. Section 301 adds chronic kidney disease screening, as defined by the Secretary, to the Medicare annual wellness benefit for items and services furnished on or after January 1, 2026. Section 302 expands kidney disease education to stage V chronic kidney disease, allows physician assistants, nurse practitioners, and clinical nurse specialists involved in kidney treatment to participate, lets renal dialysis facilities provide the education with qualified personnel, and pays those services separately under the physician fee schedule rather than through the ESRD bundle.

Who Benefits and How

End-stage renal disease patients benefit if longer TDAPA and permanent add-on payments improve access to new renal dialysis drugs and biological products. Renal dialysis facilities benefit from direct payment adjustments and separate payment for kidney disease education services. Renal drug manufacturers benefit because new dialysis drugs and biologicals receive at least three years of transitional add-on payment and a pathway to permanent add-on payment. Medicare Advantage enrollees with ESRD benefit because providers and facilities receive direct payment adjustments for innovative kidney therapies and equipment. Medicare beneficiaries at risk of kidney disease benefit because chronic kidney disease screening becomes part of the annual wellness benefit. Physician assistants and nurse practitioners in kidney care benefit because the education benefit recognizes their role assisting in treatment.

Who Bears the Burden and How

CMS Medicare payment staff must calculate TDAPA duration, post-TDAPA add-ons, Medicare Advantage direct payments, and annual forecast-error adjustments. Medicare program spending increases because add-ons are not budget-neutral and kidney education is paid outside the ESRD bundle. Renal dialysis facilities must document qualifying drugs, equipment, education services, and claims to receive the new payment adjustments. Medicare Advantage plan administrators must coordinate with CMS direct payment adjustments for ESRD innovative products. Federal taxpayers bear the cost of expanded Medicare payments for kidney drugs, equipment, screening, and education.

Key Provisions

• Requires at least three years of TDAPA payment for qualifying new renal dialysis drugs and biological products furnished on or after January 1, 2026.
• Establishes a permanent post-TDAPA add-on adjustment to the ESRD prospective payment system base rate.
• Requires Medicare Advantage direct payments to providers and renal dialysis facilities for innovative kidney therapies and equipment.
• Adds annual ESRD payment forecast-error adjustments beginning in 2026.
• Adds chronic kidney disease screening to the Medicare annual wellness benefit.
• Expands kidney disease education to stage V CKD, advanced practice clinicians, and renal dialysis facilities with separate payment.