Kidney Care Access Protection Act
- Bill Number
- H.R. 6214
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-11-20: 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.
- Last Updated
- 2026-06-11T08:07:14Z
AI-Generated Summary
Purpose of the Legislation
The Kidney Care Access Protection Act (H.R. 6214) aims to enhance Medicare coverage for end-stage renal disease (ESRD), a severe kidney condition requiring dialysis or transplant. It focuses on improving access to new drugs, devices, and treatments; stabilizing payments to dialysis facilities; and expanding prevention and education efforts to help patients manage or avoid kidney disease progression.
Key Provisions
The bill is organized into three titles, amending the Social Security Act (title XVIII, which covers Medicare).
Title I: Protecting Patient Access to Kidney Care Innovation
- Extension of Transitional Drug Add-On Payment Adjustment (TDAPA): Extends Medicare's temporary extra payments for new FDA-approved renal dialysis drugs or biological products (e.g., medications used during dialysis) to at least three years for items approved after January 1, 2020, and furnished starting January 1, 2026. These payments help cover costs of innovative treatments not yet bundled into standard rates.
- Permanent Post-TDAPA Adjustment: Introduces a ongoing add-on payment to the base dialysis rate after the TDAPA ends, calculated based on recent usage and sales data (or wholesale costs if sales data is unavailable). This adjustment equals 65% of calculated costs, is updated annually for inflation, and applies starting January 1, 2026, without reducing overall Medicare spending (non-budget neutral).
- Clarification of Renal Dialysis Services Definition: Excludes from bundled payments certain new FDA-approved drugs or biologicals (after December 31, 2025) used for co-existing conditions like heart disease, cancer, or diabetes in ESRD patients, if they don't replace existing bundled treatments. Claims for these must use a specific billing code (AY modifier).
- Revisions to Transitional Add-On Payment for New and Innovative Equipment and Supplies (TPNIES): Extends extra payments for new dialysis devices to at least three years starting January 1, 2026. Includes "breakthrough devices" (FDA-designated for fast-track review) and capital-related assets (e.g., expensive equipment like machines), removing prior exclusions.
Title II: Addressing Staffing Barriers with ESRD Market Basket Labor Adjustments
- Forecast Error Adjustment in Payments: Adds a correction to annual dialysis payment updates starting in 2026 to fix inaccuracies in predicting labor costs (part of the "market basket" that adjusts for inflation in goods and services). If forecast errors exceed 0.5 percentage points (based on actual vs. predicted price changes), payments are adjusted using data from recent years, starting with 2021-2022 cumulative errors. This promotes payment stability for facilities facing staffing challenges.
Title III: Preventing Kidney Disease and Expanding Awareness and Education
- Expansion of Medicare Annual Wellness Benefit: Adds chronic kidney disease screening to the free annual wellness visit for Medicare beneficiaries starting January 1, 2026, allowing early detection through simple tests defined by the Secretary of Health and Human Services.
- Increased Access to Kidney Disease Education Benefit: Broadens eligibility to include stage V kidney disease (pre-dialysis failure). Allows physician assistants, nurse practitioners, or clinical nurse specialists to deliver education. Permits renal dialysis facilities (with qualified staff) to provide and bill for these services separately from bundled dialysis payments, paid under Medicare's physician fee schedule starting January 1, 2026.
Most provisions take effect January 1, 2026.
Significant Changes to Existing Law
- Payment Extensions and Permanence: Previously, TDAPA and TPNIES lasted up to two years; now extended to at least three, with a new permanent add-on for drugs/biologicals post-TDAPA. This shifts from temporary to sustained support for innovations.
- Exclusions from Bundled Payments: The ESRD Prospective Payment System (ESRD PPS) bundles most dialysis costs into one rate; the bill carves out specific new treatments for comorbidities, preventing them from being underpaid.
- Forecast Adjustments: Introduces a new mechanism to correct labor cost predictions in the market basket update, addressing past inaccuracies not previously accounted for.
- Wellness and Education Expansions: Adds kidney screening to wellness visits (previously focused on other conditions) and removes limits on education providers/facilities, allowing broader access without prior restrictions on stages or personnel.
Potential Impacts
- On Citizens: ESRD patients (over 500,000 Medicare beneficiaries) gain better access to cutting-edge drugs, devices, and screenings, potentially improving treatment outcomes, reducing complications from comorbidities, and slowing disease progression through education. This could lower out-of-pocket costs and enhance quality of life.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) must update regulations, calculate new adjustments, and process claims with modifiers, increasing administrative workload. Medicare spending may rise due to non-budget-neutral payments, affecting federal budgets without offsets.
- On International Relations: No direct impacts; the bill is domestic-focused on U.S. healthcare policy.
Main Stakeholders Affected
- ESRD Patients and Medicare Beneficiaries: Primary beneficiaries of expanded treatments, screenings, and education.
- Renal Dialysis Facilities and Providers: Gain stable payments, ability to bill for education, and support for staffing costs, aiding operations in over 7,000 U.S. facilities.
- Drug and Device Manufacturers: Benefit from extended and permanent reimbursements, encouraging innovation in renal therapies.
- Medicare Advantage Plans: Required to pass through add-on payments for innovative ESRD treatments, ensuring parity with traditional Medicare.
- Health and Human Services Department (HHS/CMS): Responsible for implementation, data analysis, and rulemaking.
Notable Legal, Constitutional, or Political Implications
- Legal Implications: Strengthens Medicare's bundled payment system by clarifying exclusions and add-ons, reducing disputes over innovative treatments. Requires new billing modifiers, potentially leading to audits or litigation if implementation is delayed. Non-budget neutrality could face challenges under pay-as-you-go rules but aligns with congressional spending authority.
- Constitutional Implications: Falls within Congress's enumerated powers to tax and spend for public welfare (Social Security Act amendments), with no apparent free speech, due process, or equal protection issues.
- Political Implications: Promotes bipartisan kidney care priorities (introduced by representatives from different parties), potentially influencing future healthcare reforms by prioritizing innovation and prevention amid rising ESRD rates (linked to diabetes and aging). May increase scrutiny on Medicare costs in budget debates.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Miller, Carol D. [R-WV-1]
Cosponsors (14)
Rep. Sewell, Terri A. [D-AL-7], Rep. Clarke, Yvette D. [D-NY-9], Rep. Rulli, Michael A. [R-OH-6], Rep. Tenney, Claudia [R-NY-24], Rep. Kelly, Mike [R-PA-16], Rep. Carter, Troy A. [D-LA-2], Rep. Murphy, Gregory F. [R-NC-3], Rep. Davis, Donald G. [D-NC-1], Rep. Wilson, Joe [R-SC-2], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Panetta, Jimmy [D-CA-19], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Moore, Blake D. [R-UT-1], Rep. Fields, Cleo [D-LA-6]
Recent Actions
- 2025-11-20: 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.
- 2025-11-20: 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.
- 2025-11-20: Introduced in House
- 2025-11-20: Introduced in House
Bill Versions
- Kidney Care Access Protection Act — issued 2025-11-20 — PDF (15 pages)