S. 2730 — Kidney Care Access Protection Act

This section refines Medicare payments under the end-stage renal disease (ESRD) prospective payment system (PPS) by extending and establishing add-on adjustments for new renal dialysis drugs, biological products, equipment, and supplies. (The ESRD PPS bundles payments to dialysis facilities for dialysis treatments and related services, including drugs and devices; transitional add-on payment adjustments (TDAPA for drugs/biologicals and TPNIES for equipment/supplies) provide temporary payments of average sales price minus 6% during a two-year transition period to facilitate incorporation into the bundled rate.) Specifically, the section (1) extends the TDAPA period to not less than three years (from two years) under 42 CFR 413.234(c) for qualifying new renal dialysis drugs or biological products approved by the FDA on or after January 1, 2020, under 21 USC 355 or 42 USC 262, when furnished on or after January 1, 2026; (2) requires a permanent post-TDAPA add-on adjustment to the ESRD PPS base rate under SSA sec. 1881(b)(14) (added as new subparagraph (J)), calculated as 65% of average expenditures per dialysis treatment using the most recent 12-month utilization and average sales price data (or 100% of wholesale acquisition cost if ASP reflects zero/negative sales, or invoice if WAC unavailable), updated annually for inflation, for claims on or after January 1, 2026, involving drugs furnished on or after January 1, 2024 (not implemented in budget-neutral manner or subject to case-mix adjustments); (3) amends the definition of renal dialysis services under SSA sec. 1881(b)(14)(B) to exclude drugs or biologicals approved after December 31, 2025, for treating comorbid conditions (e.g., cardiovascular disease, cancer) in ESRD patients if they do not substitute for bundled drugs, and requires the AY claim modifier (or successor) for such items; and (4) extends the TPNIES period to not less than three years (from two years) under 42 CFR 413.236 for qualifying new renal dialysis devices furnished on or after January 1, 2026, deems FDA breakthrough devices under 21 USC 360e-3 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 providers of services or renal dialysis facilities under Medicare Advantage (MA) for enrollees with end-stage renal disease (ESRD) for (1) any new renal dialysis drug or biological product receiving a transitional drug add-on payment adjustment (TDAPA) under 42 CFR §413.234(c), or (2) an item or service receiving a transitional add-on payment adjustment for new and innovative equipment and supplies under 42 CFR §413.236. The adjustment amount equals the amount determined under the ESRD prospective payment system (ESRD PPS) in SSA §1881(b)(14), with payments made for the duration of the applicable ESRD PPS transitional payment. (Thus, MA plans receive supplementary funding for these therapies provided directly to dialysis facilities rather than solely through capitated payments.) This section also makes conforming amendments to SSA §1851(i) to reference the new MA payment provision for ESRD enrollees.

This section modifies the annual increase factor for Medicare bundled payments to end-stage renal disease (ESRD) dialysis facilities by incorporating a new forecast error adjustment beginning in 2026 (i.e., to the update of payment amounts established under SSA section 1881(b)(14) for the previous year). The adjustment accounts for cumulative forecast error from 2021 and 2022 initially, and from the most recent year with final data thereafter, whenever the difference between forecasted and actual percentage change in prices for an appropriate mix of goods and services used in renal dialysis services exceeds 0.5 percentage points. (Thus, it applies the adjustment after other factors and promotes payment stability under the ESRD Prospective Payment System, which provides bundled payments to facilities for dialysis and related services to Medicare beneficiaries with ESRD.)