Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Part 512</CFR> <DEPDOC>[CMS-5544-P]</DEPDOC> <RIN>RIN 0938-AV65</RIN> <SUBJECT>Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below, by February 9, 2026. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-5544-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5544-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5544-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">CMMItransplant@cms.hhs.gov,</E> for questions related to the Increasing Organ Transplant Access Model. Thomas Duvall, (410) 786-8887, for questions related to the Increasing Organ Transplant Access Model. Christina McCormick, (410) 786-4012, for questions related to the Increasing Organ Transplant Access Model. Lina Gebremariam, (410) 786-8893, for questions related to the Increasing Organ Transplant Access Model. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: <E T="03">http://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. CMS will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this rule may be found at <E T="03">https://www.regulations.gov/.</E> <HD SOURCE="HD1">I. Executive Summary and Background</HD> <HD SOURCE="HD2">A. Executive Summary</HD> <HD SOURCE="HD3">1. Purpose</HD> This proposed rule would make changes to the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2, which will begin on July 1, 2026, and future PYs. <HD SOURCE="HD3">2. Summary of the Major Provisions</HD> The following is a summary of the major provisions in this proposed rule. A general summary of the changes in this proposed rule is presented in section II.B of the preamble of this proposed rule. <HD SOURCE="HD3">a. IOTA Participants</HD> In the 2024 Final Rule, CMS finalized that a kidney transplant hospital is eligible to be selected as an IOTA participant if it meets both of the following criteria: (1) The kidney transplant hospital annually performed 11 or more kidney transplants for patients aged 18 years or older, regardless of payer, each of the baseline years; and (2) the kidney transplant hospital annually performed more than 50 percent of its kidney transplants on patients 18 years of age or older each of the baseline years. However, per section 1835(d) of the Social Security Act (the Act) as codified in 42 CFR 411.6, Medicare does not pay for services furnished by a Federal provider of services or other Federal agency, nor does Medicare pay for services that are paid for directly or indirectly by a government entity, with only limited exceptions. Therefore, we are proposing to modify the eligible kidney transplant hospital criteria to exclude Department of Veteran's Affairs (VA) medical facilities and Military medical treatment facilities (MTFs) from the IOTA Model for PYs 2 through 6, as described in section II.B.1.b. of this proposed rule. In the 2024 Final Rule, CMS established a low volume threshold requiring kidney transplant hospitals to have performed 11 or more kidney transplants for patients aged 18 years or older annually in each of the 3 baseline years in order to be eligible for selection into the IOTA Model, designed to protect beneficiary confidentiality and align with minimum CMS data display standards while ensuring statistical significance. However, in response to some IOTA participants expressing concern about their ability to participate in the model and our experience in operating the model, we believe it is necessary to reevaluate the low volume threshold requiring a kidney transplant hospital to have performed at least 11 kidney transplants annually in each of the 3 baseline years in order to be eligible for selection into the IOTA Model. As such, as described in section II.B.1.b. of this proposed rule, we are proposing to raise the low volume threshold from a minimum of 11 kidney transplants performed annually during each of the baseline years to a minimum of 15 kidney transplants performed annually during each of the baseline years. <HD SOURCE="HD3">b. Performance Assessment</HD> In the 2024 Final Rule, we finalized a policy to assess IOTA participant performance each PY in the quality domain on post-transplant outcomes using the composite graft survival rate. While the model performance period has begun, we indicated that for certain policies, such as the inclusion of a risk-adjustment methodology when calculating the composite graft survival rate to account for the complexities of donors and recipients, and their associated risks, we would go through rulemaking in the future to promulgate new or updated policies that would be finalized after the model start date. Therefore, as described in section II.B.2.b.(2).(a). of this proposed rule, we are proposing updates to the composite graft survival rate metric that would include the following modifications: • Adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics (for example, transplant recipient and donor age, diabetes status, sex, kidney function (eGFR/creatinine). • Excluding multi-organ transplants from the composite graft survival rate exclusion and inclusion criteria, in recognition of their more complicated results for kidney transplant recipients. • Updating the allocation of points awarded for performance on the composite graft survival rate. A detailed description of each proposed policy change and the corresponding scoring criteria can be found in section II.B.2.b. of this proposed rule. <HD SOURCE="HD3">c. Payment</HD> As finalized in the 2024 Final Rule, each IOTA participant's final performance score will determine whether: (1) CMS will pay an upside risk payment to the IOTA participant; (2) the IOTA participant will fall into a neutral zone where no performance-based incentive payment will be paid to or owed by the IOTA participant; or (3) the IOTA participant will owe a downside risk payment to CMS. For a final performance score greater than 60, CMS will apply the formula for the upside risk payment, which will be equal to the IOTA participant's final performance score minus 60, then divided by 40, then multiplied by $15,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to attributed patients with Medicare fee-for-service (FFS) as their primary or secondary payer during the PY. Final performance scores below 60 in PY 1 and final performance scores of 40 to 60 (inclusive) in PYs 2 through 6 will fall in the neutral zone where there will be no payment owed to the IOTA participant or CMS. Currently, IOTA Model regulations stipulate that IOTA participants must remit the downside risk payment to CMS in a single payment at least 60 days after the date on which the demand letter is issued. As described in section II.B.3.c.(2). of this proposed rule, CMS is proposing to modify the policy previously finalized in the 2024 Final Rule such that IOTA participants must remit the downside risk payment to CMS in a single payment within 60 days after the date on which the demand letter is issued. As proposed in section II.B.3.c.(2). of this proposed rule, if full payment is not received by CMS within 60 days after demand is made, the remaining amount owed will be considered a delinquent debt. Finally, in the 2024 Final Rule, CMS established an Extreme and Uncontrollable Circumstance (E ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 266k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━