You are using an unsupported browser. This web site is designed for the current versions of Microsoft Edge, Google Chrome, Mozilla Firefox, or Safari.
The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. We recommend you directly contact the agency associated with the content in question.
If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below.
If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency
Enhanced content is provided to the user to provide additional context.
This content is from the eCFR and is authoritative but unofficial.
Navigate by entering citations or phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR).
Choosing an item from citations and headings will bring you directly to the content. Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to search results.
Background and more details are available in the Search & Navigation guide.
| Payment | 512.430 – 512.436 | ||||||||||
| |||||||||||
42 U.S.C. 1302, 1315a, and 1395hh.
85 FR 61362, Sept. 29, 2020, unless otherwise noted.
89 FR 96445, Dec. 4, 2024, unless otherwise noted.
This content is from the eCFR and may include recent changes applied to the CFR. The official, published CFR, is updated annually and available below under "Published Edition". You can learn more about the process here.
Subscribe to: 42 CFR Part 512 Subpart D - Payment
View the most recent official publication:
These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
Information and documentation can be found in our developer resources.
The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.
Learn more about the eCFR, its status, and the editorial process.
(a) General. CMS determines if an IOTA participant qualifies for an upside risk payment, downside risk payment, or the neutral zone for each PY based on the IOTA participant's final performance score, in accordance with paragraphs (b)(1) through (3) of this section.
(b) Upside risk payment, neutral zone, and downside risk payment calculation methodology —
(1) Upside risk payment calculation methodology. If in PYs 1-6 the IOTA participant's final performance score is above 60 points, CMS calculates the IOTA participant's upside risk payment as follows:
(i) Subtracts 60 from the IOTA participant's final performance score.
(ii) Divides the amount resulting from the calculation in paragraph (b)(1)(i) of this section by 40.
(iii) Multiplies the amount resulting from the calculation in paragraph (b)(1)(ii) of this section by $15,000.
(iv) Multiplies the amount resulting from the calculation in paragraph (b)(1)(iii) of this section by the total number of Medicare kidney transplants performed by the IOTA participant during the PY.
(2) Neutral zone.
(i) For PY 1, an IOTA participant with a final performance score below 60 points qualifies for the neutral zone and neither owes a downside risk payment to CMS nor receives an upside risk payment from CMS.
(ii) For PYs 2 through 6, if an IOTA participant's final performance is between 40 to 60 points (inclusive), the IOTA participant qualifies for the neutral zone.
(3) Downside risk payment calculation methodology. If an IOTA participant is below 40 points in PYs 1 through 6, the IOTA participant qualifies for a downside risk payment. The downside risk payment is calculated as follows:
(i) For PY 1, this paragraph does not apply, and the IOTA participant does not owe a downside risk payment to CMS.
(ii) For PYs 2 through 6, CMS calculates the IOTA participant's downside risk payment as follows:
(A) Subtracts the IOTA participant's final performance score from 40.
(B) Divides the amount resulting from the calculation in paragraph (b)(3)(ii)(A) of this section by 40.
(C) Multiplies the amount resulting from the calculation in paragraph (b)(3)(ii)(B) of this section by $2,000.
(D) Multiplies the amount resulting from the calculation in paragraph (b)(3)(ii)(C) of this section by the total number of Medicare kidney transplants performed by the IOTA participant during the PY to calculate the amount of the IOTA participant's downside risk payment.
(c) [Reserved]
(d) Upside risk payment and downside risk payment timeline.
(1) CMS conducts and calculates preliminary performance assessment and payment calculations at least 3 to 6 months after the end of each PY.
(2) CMS notifies the IOTA participant of their preliminary performance assessment and payment calculations in a form and manner determined by CMS at least 5 to 9 months after the end of each PY.
(3) CMS gives IOTA participants 30 days to review preliminary performance assessment and payment calculations and request targeted reviews under § 512.434.
(4) CMS notifies the IOTA participant of their final performance score and any associated upside risk payment or downside risk payment at least 30 days after notifying the IOTA participant of their preliminary performance assessment and payment calculations.
(5) Upside risk payment. After CMS notifies the IOTA participant of their final performance score and any associated upside risk payment, and by a date determined by CMS, CMS issues the upside risk payment to the tax identification number (TIN) on file for the IOTA participant in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS).
(6) Downside risk payment. After CMS notifies the IOTA participant of their final performance score and any associated downside risk payment and by a date determined by CMS, CMS issues a demand letter to the TIN on file for the IOTA participant in PECOS for any downside risk payment owed to CMS.
(i) CMS includes all of the following details in the demand letter:
(A) IOTA participant performance in the model.
(B) Amount of downside risk payment owed to CMS by the IOTA participant.
(C) How the IOTA participant may make payments to CMS.
(ii) The IOTA participant must pay the downside risk payment to CMS in a single payment within 60 days after the date on which the demand letter is issued. If full payment is not received by CMS within 60 days after demand is made, CMS will invoke all legal means to collect the debt, including referral of the remaining debt to the United States Department of the Treasury, in accordance with 31 U.S.C. 3711(g).
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32871, June 1, 2026]
(a) General. Subject to the limitations on review in paragraph (c) of this section, an IOTA participant may submit a targeted review request for one or more calculations made, and issued by, CMS within the preliminary performance assessment and payment calculations, if either of the following occur:
(1) The IOTA participant believes an error occurred in calculations due to data quality or other issues.
(2) The IOTA participant believes an error occurred in calculations due to misapplication of methodology.
(b) Requirements. The request must satisfy the following criteria:
(1) Be submitted within 30 days, or another time period as specified by CMS, of receiving its preliminary performance assessment and payment calculations from CMS.
(2) Include supporting information in a form and manner as specified by CMS.
(c) Limitations on review.
(1) CMS does not provide IOTA participants the ability to dispute the policy or methodology, as the targeted review process would be limited to the dispute of calculations. CMS would not consider targeted review requests regarding, without limitation, the following:
(i) The selection of the kidney transplant hospital to be an IOTA participant.
(ii) The attribution of IOTA waitlist patients and the attribution of IOTA transplant patients to the IOTA participant, or to any other kidney transplant hospital selected for participation in the IOTA Model, or to any kidney transplant hospital not selected for participation in the IOTA Model.
(iii) The methodology used for determining the achievement domain, efficiency domain, and quality domain.
(iv) The methodology used for calculating and assigning points for each metric within the achievement domain, efficiency domain, and quality domain.
(v) The methodology used for calculating the payment amount per Medicare kidney transplant paid to an IOTA participant.
(2) CMS may review a targeted review request that includes one or more of the limitations in paragraph (c)(1) of this section, provided that all remaining considerations of the request meet all other criteria for consideration by CMS in this section.
(d) Targeted review process. The IOTA participant must submit a request for targeted review in accordance with paragraphs (a) through (c) of this section. The process for a targeted review is as follows:
(1) Initial and final assessments. Upon receipt of a targeted review request from an IOTA participant CMS conducts an initial and final assessment as follows:
(i) Initial assessment.
(A) CMS determines if the targeted review request meets the targeted review requirements in paragraph (b) of this section and contains sufficient information to substantiate the request.
(B) If the request is not compliant with paragraphs (a) through (c) of this section or requires additional information:
(1) CMS follows up with the IOTA participant to request additional information in a form and manner as specified by CMS.
(2) The IOTA participant must respond within 30 days of CMS's request for additional information in a form and manner as specified by CMS.
(3) An IOTA participant's non-responsiveness to the request for additional information from CMS may result in the closure of the targeted review request.
(ii) Final assessment.
(A) Upon completion of an initial assessment, as described in paragraph (d)(1)(i) of this section, CMS determines whether it erred in calculation, as disputed by the IOTA participant.
(B) If a calculation error is found as a result of an IOTA participant's targeted review request—
(1) CMS—
(i) Notifies the IOTA participant within 30 days of any findings in a form and manner as specified by CMS; and
(ii) Resolves and corrects any resulting error or discrepancy in the amount of the upside risk payment or downside risk payment in a time and manner as determined by CMS.
(2) CMS' correction of any error or discrepancy may delay the effective date of an IOTA participant's upside risk payments or downside risk payments.
(2) Targeted review decisions. Targeted review decisions made by CMS are final, unless submitted for administrative review as described in § 512.190.
(a) General. CMS—
(1) Applies determinations made under the Quality Payment Program with respect to whether an extreme and uncontrollable circumstance has occurred and the affected area during the PY; and
(2) Has sole discretion to determine the period during which an extreme and uncontrollable circumstance occurred and the percentage of attributed patients residing in affected areas.
(b) Impact on payments. In the event of an extreme and uncontrollable circumstance, as described in paragraph (a) of this section, CMS may adjust the magnitude and direction of the IOTA participant's upside or downside risk payment, if applicable, prior to recoupment or payment, if the IOTA participant is participating in the IOTA Model when CMS has declared such an emergency period. CMS may determine any adjustment made based in part on the following:
(1) The percentage of total months during the PY affected by the extreme and uncontrollable circumstance.
(2) The percentage of attributed patients who reside in an area affected by the extreme and uncontrollable circumstance.
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32871, June 1, 2026]