H.R. 6214 — Kidney Care Access Protection Act

This section refines the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) to support new renal dialysis drugs, biological products, and devices. (As background, the ESRD PPS, under SSA §1881(b)(14), bundles payments to dialysis facilities for dialysis services furnished to Medicare beneficiaries with ESRD; temporary add-on payments such as the Transitional Drug Add-On Payment Adjustment (TDAPA), under 42 CFR 413.234(c), and Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES), under 42 CFR 413.236, reimburse facilities for certain new drugs, biologicals, equipment, and supplies above the bundled rate during a transition period.) Specifically, the section (1) requires a TDAPA of not less than three years for any new renal dialysis drug or biological approved by FDA on or after January 1, 2020, under the Federal Food, Drug, and Cosmetic Act or Public Health Service Act, that qualifies for TDAPA and is furnished on or after January 1, 2026; (2) establishes a permanent post-TDAPA add-on adjustment to the ESRD PPS base rate, for claims on or after January 1, 2026, for such drugs or biologicals furnished on or after January 1, 2024 to treat or manage ESRD conditions as defined in 42 CFR 413.234(a)—calculated as 65% of expenditures divided by dialysis services during the relevant period (using the most recent 12-month utilization and average sales price data, or wholesale acquisition cost if sales data are zero/negative, or invoice if unavailable), updated annually for inflation, applied immediately post-TDAPA, and implemented without budget neutrality or patient case-mix adjustments; (3) amends the definition of renal dialysis services under SSA §1881(b)(14)(B) to exclude, effective upon enactment, drugs or biologicals approved after December 31, 2025, for comorbid conditions (e.g., cardiovascular disease, cancer) in ESRD patients that do not substitute for bundled drugs, requiring use of the AY claim modifier (or successor); and (4) extends TPNIES to not less than three years for qualifying new renal dialysis devices furnished on or after January 1, 2026; makes breakthrough devices under FD&C Act §515B eligible for TPNIES beginning January 1, 2026; and includes capital-related assets in TPNIES and any post-TPNIES adjustment beginning January 1, 2026.

This section directs the Secretary, beginning January 1, 2026, to make direct payment adjustments to Medicare Advantage providers of services and renal dialysis facilities for enrollees with end-stage renal disease (ESRD) equal to amounts under the ESRD prospective payment system (ESRD PPS) in SSA section 1881(b)(14)—for (1) new renal dialysis drugs or biological products receiving transitional drug add-on payment adjustments under 42 CFR 413.234(c) or (2) items or services receiving transitional add-on payment adjustments for new and innovative equipment and supplies under 42 CFR 413.236—for the duration of such transitional payments. (As background, the ESRD PPS provides bundled payments to dialysis facilities for services to Medicare ESRD beneficiaries, including these transitional add-ons to support adoption of innovative therapies; this ensures parallel support in Medicare Advantage.) This section also makes conforming amendments to MA eligibility provisions for ESRD enrollees under SSA section 1851(i).

This section modifies the annual update factor for Medicare payments to renal dialysis facilities under the end-stage renal disease (ESRD) prospective payment system (PPS) (i.e., bundled payments for institutional dialysis services, home dialysis supplies and equipment, and related physician services furnished to ESRD beneficiaries). Specifically, it updates cross-references in subclauses (I) and (II) to incorporate a new subclause (IV), which requires the Secretary, beginning in 2026, to adjust the prior-year increase factor to account for forecast error in the renal dialysis services market basket whenever the difference between forecasted and actual percentage price changes exceeds 0.5 percentage points. (Thus, the 2026 adjustment addresses cumulative forecast errors for 2021 and 2022, with subsequent annual adjustments using the most recent year for which final data are available.)

This section expands the required elements of the Medicare annual wellness visit (i.e., personalized prevention plan services furnished under Medicare Part B) to include chronic kidney disease screening, as defined by the Secretary of Health and Human Services (redesignating current subparagraph (O) as (P)), for services furnished on or after January 1, 2026. (As background, the annual wellness visit enables eligible beneficiaries to receive an annual personalized prevention service, including detection of chronic kidney disease risk factors.)

This section expands Medicare coverage of kidney disease education (KDE) services—counseling for beneficiaries with advanced chronic kidney disease (CKD) on disease management, treatment options, and modalities such as dialysis or transplantation—to individuals with stage V CKD (from stage IV only); allows physician assistants, nurse practitioners, or clinical nurse specialists assisting in a beneficiary's kidney treatment to order such services; and adds renal dialysis facilities (subject to ESRD Prospective Payment System requirements) with qualified personnel as eligible providers. The section further requires separate payment for KDE services furnished by renal dialysis facilities under the physician fee schedule (separating it from the bundled ESRD payment), on an assignment-related basis. The changes apply to services furnished on or after January 1, 2026.