Kidney Care Access Protection Act
- Sponsor
- Rep. Miller, Carol D. [R-WV-1]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Nov 20, 2025
Bottom line
This bill aims to incentivize innovation and improve patient access to advanced treatments and preventative care for end-stage renal disease within the Medicare program.
What it actually does
This bill amends the Social Security Act to modify Medicare's payment system for End-Stage Renal Disease (ESRD) services. It extends transitional add-on payments for new renal dialysis drugs, biologicals, and devices, establishes a permanent post-transitional add-on payment for these innovations, and clarifies the definition of renal dialysis services to exclude certain comorbid disease treatments. It also adjusts the ESRD market basket labor adjustment, expands Medicare annual wellness benefits to include kidney disease screening, and increases access to kidney disease education benefits.
Proponents argue
Proponents argue that the bill will accelerate patient access to cutting-edge therapies and devices for ESRD by ensuring adequate reimbursement for providers, fostering innovation in kidney care, and addressing staffing barriers. They also emphasize the importance of expanding preventative screenings and education to manage kidney disease earlier, potentially improving long-term patient outcomes.
Opponents contend
Opponents might argue that the permanent add-on payments and expanded eligibility for transitional payments could lead to increased Medicare spending without sufficient cost controls, potentially burdening taxpayers. They might also raise concerns about the potential for over-utilization of new, expensive therapies if not carefully managed, and the administrative complexity of implementing multiple new payment adjustments.
The bill is moderately technical, requiring a careful read to understand the Medicare payment system changes, but is manageable within a reasonable timeframe for an informed reader.
Sec. 101(a)
Extended Transitional Drug Add-On Payment Adjustment (TDAPA) Period
This provision extends the period for which Medicare provides an additional payment adjustment for new renal dialysis drugs or biological products from the current two years to not less than three years. This applies to products approved by the FDA on or after January 1, 2020, and furnished on or after January 1, 2026, aiming to provide more time for market penetration and return on investment for manufacturers.
Supporters argue
Supporters argue this extension is crucial for incentivizing pharmaceutical companies to invest in research and development for new ESRD treatments, ensuring that innovative therapies reach patients more quickly and are financially viable for providers to administer.
Critics contend
Critics might argue that extending the TDAPA period could lead to higher Medicare expenditures for a longer duration, potentially without clear evidence of superior clinical outcomes for all new products, and could delay the integration of these costs into the base rate.
Tradeoffs
This provision balances the need to incentivize innovation and patient access to new therapies against concerns about Medicare spending and the long-term sustainability of higher payments for new drugs.
Sec. 101(b)
Permanent Post-TDAPA Adjustment for Drugs and Biologicals
This provision establishes a permanent add-on payment adjustment to the base rate for renal dialysis services for new drugs or biological products that previously received a TDAPA. This adjustment, effective January 1, 2026, is calculated based on a percentage of utilization and average sales price (or WAC/invoice if ASP is unavailable) and is updated annually for inflation. It explicitly states it will not be budget neutral.
Sec. 101(c)
Exclusion of Comorbid Disease Drugs from ESRD Payment System
This amendment clarifies that the definition of 'renal dialysis services' for payment purposes does not include drugs or biological products used to treat comorbid diseases or conditions (like cardiovascular disease, cancer, diabetes, obesity) that may occur in ESRD patients, if these products are approved by the FDA after December 31, 2025, and do not substitute for a drug already in the ESRD prospective payment system base rate. It also requires a specific modifier (AY) on claims for such products.
Sec. 101(d)
Revisions to Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
This provision extends the TPNIES period for new renal dialysis devices to not less than three years, effective January 1, 2026. It also makes devices designated as 'breakthrough devices' by the FDA automatically eligible for TPNIES starting January 1, 2026. Additionally, it removes the exclusion of capital-related assets from TPNIES, allowing them to qualify for the adjustment.
Sec. 102
Direct Payments for Innovative Therapies in Medicare Advantage
This section mandates that, starting January 1, 2026, the Secretary of HHS will make direct payment adjustments to providers or renal dialysis facilities for new renal dialysis drugs/biologicals receiving TDAPA or items/services receiving TPNIES, when furnished to Medicare Advantage enrollees. The amount and duration of these direct payments will match those under the ESRD prospective payment system.
Sec. 201
ESRD Market Basket Forecast Error Adjustment
This section amends the Social Security Act to require the Secretary to compute an annual adjustment to the ESRD market basket increase factor, starting in 2026, to account for forecast error. The initial adjustment in 2026 will consider cumulative forecast error for 2021 and 2022. Subsequent adjustments will use the most recent available year's data. This adjustment applies when the difference between forecasted and actual price changes for renal dialysis goods and services exceeds 0.5 percentage points.
Sec. 301
Kidney Disease Screening in Annual Wellness Visits
This provision amends the Social Security Act to include 'Chronic kidney disease screening as defined by the Secretary' as part of the Medicare annual wellness benefit, effective January 1, 2026. This aims to integrate routine kidney health checks into standard preventative care for Medicare beneficiaries.
Sec. 302
Expanded Eligibility for Kidney Disease Education Services
This section expands eligibility for Medicare kidney disease education services to individuals with 'stage V' (in addition to stage IV) chronic kidney disease. It also allows physician assistants, nurse practitioners, or clinical nurse specialists to assist in treating the individual's kidney condition for referral purposes. Furthermore, it permits renal dialysis facilities with qualified personnel to provide these education services, and specifies that payment for these services to renal dialysis facilities will be made separately under Medicare Part B, not bundled into the ESRD payment system.
These subclauses specify alternative pricing mechanisms (100 percent of wholesale acquisition cost or manufacturer's invoice) for calculating the permanent post-TDAPA add-on adjustment if the most recent available full calendar quarter of average sales price (ASP) data reflects zero or negative sales, or if WAC is unavailable.
Sec. 101(b)(J)(ii)(I)(bb) and (cc)
Why it matters:This is standard legislative practice for technical payment formula details, ensuring that a payment mechanism has fallback options for data anomalies. It's a technical fix to ensure continuous reimbursement.
Case for: Ensures that new renal dialysis drugs and biological products continue to receive appropriate reimbursement even if standard pricing data (ASP) is unavailable or anomalous, preventing payment disruptions that could hinder patient access.
Case against: Could potentially lead to higher payments than market rates if ASP data is genuinely low for reasons other than data anomalies, or if WAC/invoice prices are not adequately scrutinized, potentially increasing Medicare costs.
Estimated impact: Ensures financial viability for certain new drugs and biologicals, potentially impacting millions of dollars in reimbursement for specific products if ASP data issues arise.
This clause requires that a claim for a drug or biological product excluded from the definition of renal dialysis services (i.e., for comorbid conditions, approved after Dec 31, 2025, and not a substitute for an ESRD PPS drug) must contain the 'AY modifier' (or a successor modifier) to be payable under Medicare Part B.
Sec. 101(c)(6)(iii)
Why it matters:This is standard legislative practice for implementing new billing rules and ensuring correct claims processing within Medicare. It's an operational necessity for the policy to function as intended.
Case for: Ensures proper identification and separate payment for drugs treating comorbid conditions, preventing them from being inappropriately bundled into the ESRD prospective payment system. This facilitates accurate tracking and reimbursement.
Case against: Adds an additional administrative step and potential for billing errors for providers if not clearly communicated and implemented by CMS, potentially leading to claim denials or delays.
Estimated impact: Facilitates correct payment for a new category of drugs, potentially impacting hundreds of millions of dollars in Part B expenditures annually, depending on the volume and cost of such drugs.
This subclause mandates that, beginning January 1, 2026, the Secretary shall not apply the criterion that excludes capital-related assets from the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES). This means capital-related devices can now qualify for TPNIES.
Sec. 101(d)(3)
Why it matters:While technically part of TPNIES revisions, removing a long-standing exclusion for capital assets is a substantive policy shift. Its placement might be seen as standard legislative drafting, but its impact is considerable.
Case for: Proponents argue this change is crucial for incentivizing investment in costly, innovative renal dialysis equipment (which are often capital assets), ensuring that providers can afford to adopt the latest technologies to improve patient care.
Case against: Critics might argue that including capital-related assets in TPNIES could significantly increase Medicare expenditures for equipment, potentially without sufficient long-term cost-effectiveness data, and could shift more financial risk to the federal program.
Estimated impact: This change could impact hundreds of millions to billions of dollars in Medicare spending over time, depending on the cost and adoption rate of new capital-intensive dialysis devices.