(a) Participant eligibility. A kidney transplant hospital is eligible to be selected as an IOTA participant, in accordance with the methodology described in paragraph (c) of this section, if the kidney transplant hospital 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.

(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.

(b) IOTA participant selection. CMS uses the following process to select IOTA participants for inclusion in the model.

(1) DSA stratification criteria. CMS uses the following criteria to stratify DSAs using the list of DSAs as of January 1, 2024:

(i) Census division of the DSA.

(ii) Total number of adult kidney transplants performed per year across eligible kidney transplant hospitals in the DSA during PY 1's baseline years.

(2) DSA stratification process. Prior to sampling DSAs, CMS uses the following steps to group DSAs into mutually exclusive groups.

(i) CMS assigns each DSA to one of the nine Census Divisions. CMS assigns each DSA to the Census Division where the majority of the DSA's population resides. CMS determines each DSA's population, and the share of a DSA's population in the applicable Census Division(s) using data from the 2020 Census.

(A) CMS assigns the Puerto Rico DSA to the South Atlantic Census Divisions.

(B) CMS combines the Middle Atlantic and New England Census Divisions and all DSAs therewithin creating eight groups of Census Divisions.

(ii) CMS identifies all kidney transplant hospitals located in each DSA within each Census Division group.

(iii) For each DSA within its assigned Census Division group, CMS identifies the eligible kidney transplant hospitals using the criteria specified in paragraph (a) of this section.

(iv) Using data from each of the baseline years for PY 1, CMS determines the average number of adult kidney transplants performed annually by eligible transplant hospitals located in each DSA as follows:

(A) Sums the number of adult kidney transplants performed across eligible kidney transplant hospitals in a DSA during each of the baseline years for PY 1; and

(B) Divides each DSA's sum resulting from the calculation in paragraph (b)(2)(iv)(A) of this section by three to determine the average number of adult kidney transplants furnished during the baseline years for PY 1.

(v) CMS separates DSAs in each Census Division group into two mutually exclusive groups of the same size, based on the average number of adult kidney transplants performed annually across the baseline years for PY 1, except where there are an odd number of DSAs within a Census Division group:

(A) DSAs with a higher number of adult kidney transplants per year across the baseline years for PY 1.

(B) DSAs with a lower number of adult kidney transplants per year across the baseline years for PY 1.

(vi) Where there are an odd number of DSAs within a Census Division group CMS uses the methodology set forth in paragraph (b)(3) of this section.

(3) Random sampling of DSAs. (i) For each DSA group within a Census Division group containing an odd number of DSAs, CMS randomly selects one DSA and determines its participation in the IOTA Model with a 50 percent probability.

(ii) CMS randomly samples, without replacement, 50 percent of the remaining DSAs in each group within each Census Division group created in paragraph (b)(2)(v) of this section.

(c) Selection of IOTA participants in selected DSAs. All eligible kidney transplant hospitals in the selected DSAs are required to participate in the IOTA Model.

(d) Notification of participation. CMS notifies IOTA participants of their selection to participate in the IOTA Model in a form and manner chosen by CMS at least 3 months prior to the start of the model performance period.

(a) General. (1) CMS attributes kidney transplant waitlist patients and kidney transplant patients to IOTA participants based on the attribution criteria as described in paragraphs (b)(1) and (b)(2) of this section, for all of the following purposes:

(i) Sharing Medicare claims data for attributed beneficiaries with IOTA participants.

(ii) Assessing each IOTA participant's performance across the achievement domain, efficiency domain, and quality domain.

(iii) Determining performance-based payments paid to or by IOTA participants.

(2) Once a kidney transplant waitlist patient or kidney transplant patient is attributed to an IOTA participant, that respective patient may not opt out of attribution to an IOTA participant and remains attributed to the IOTA participant for the duration of the model performance period, unless the attributed patient meets the de-attribution criteria under paragraph (b)(3) of this section during annual attribution reconciliation as described in paragraph (b)(3) of this section.

(b) Patient attribution and de-attribution criteria—(1) IOTA waitlist patient attribution. (i) At the time CMS conducts attribution, as described in paragraph (c) of this section, if a kidney transplant waitlist patient meets the definition of an IOTA waitlist patient, as defined at § 512.402, CMS attributes the kidney transplant waitlist patient as an IOTA waitlist patient to an IOTA participant.

(ii) [Reserved]

(2) IOTA transplant patient attribution. (i) At the time CMS conducts attribution, as described in paragraph (c) of this section, CMS attributes a kidney transplant patient as an IOTA transplant patient if the kidney transplant patient meets all of the following:

(A) The definition of an IOTA transplant patient, as defined at § 512.402.

(B) Is 18 years of age or older at the time of the patient's kidney transplant.

(C) Is alive.

(ii) [Reserved]

(3) De-attribution from an IOTA participant. During annual attribution reconciliation, CMS uses the fourth quarter attribution list for each IOTA participant and de-attributes any attributed patients who, as of the last day of the PY being reconciled, meet any of the following de-attribution criteria:

(A) An IOTA waitlist patient that was removed from and remains unregistered on an IOTA participant's kidney transplant waitlist.

(B) An IOTA waitlist patient that has died at any point during the PY.

(C) An IOTA transplant patient that has died at any point during the PY.

(D) An IOTA transplant patient who experiences transplant failure at any point during the model performance period and has not rejoined an IOTA participant's kidney transplant waitlist or received another transplant from an IOTA participant before the last day of the respective PY.

(c) Attribution methodology. CMS employs the following methodology to attribute kidney waitlist patients and kidney transplant patients to an IOTA participant after identifying all kidney waitlist patients and kidney transplant patients that meet the attribution criteria as specified in paragraphs (b)(1) and (b)(2) of this section:

(1)(i) Initial attribution. Prior to the model start date, CMS conducts initial attribution, as defined at § 512.402.

(ii) Initial attribution list. (A) CMS provides the initial attribution list to the IOTA participant no later than 15 days prior to the start of PY 1 and in a form and manner as determined by CMS.

(B) The initial attribution list includes a list of IOTA waitlist patients identified through initial attribution, effective on the model start date.

(2)(i) Quarterly attribution. CMS conducts attribution, as defined at § 512.402, on a quarterly basis after the model start date, and updates the quarterly attribution list, as defined at § 512.402, for each IOTA participant, except in the event of termination in accordance with § 512.466.

(ii) Quarterly attribution list. CMS provides the quarterly attribution list, as defined at § 512.402, to the IOTA participant no later than 15 days prior to the start of each quarter and in a form and manner determined by CMS. The quarterly attribution list includes, at minimum, all of the following:

(A) A list of all newly attributed patients, whose attribution to the IOTA participant becomes effective on the first day of the relevant upcoming quarter.

(B) A list of all attributed patients who continue to be attributed to the IOTA participant from the previous quarter.

(C) The dates in which attribution began, changed, or ended, where applicable for attributed patients.

(D) The attributed patient's data sharing preferences under § 512.440(b).

(3)(i) Annual attribution reconciliation. After the fourth quarter of each PY, CMS conducts annual attribution reconciliation as defined at § 512.402.

(ii) Annual attribution reconciliation list. CMS provides the annual reconciliation list to the IOTA participant before the second quarter of the following PY. Using the fourth quarter quarterly attribution list for each IOTA participant, the annual attribution reconciliation list identifies, at a minimum, all of the following, where applicable:

(A) A list of all attributed patients who remain attributed to the IOTA participant because they satisfied the attribution criteria under §§ 512.414(b)(1) and (2) for the respective PY.

(B) The dates in which attribution began, changed, or ended, where applicable.

(C) A list of all attributed patients who are de-attributed because they failed to satisfy the attribution criteria under § 512.414(b)(1) and (2).

(D) A list of all attributed patients who are de-attributed because they satisfy a de-attribution criterion under § 512.414(b)(3).

(E) The dates on which each attributed patient satisfied a de-attribution criterion as specified under § 512.414(b)(3).

(F) A list of the de-attribution criterion each attributed patient satisfied under § 512.414(b)(3).

(a) Basis. This subpart implements the test of the Increasing Organ Transplant Access (IOTA) Model under section 1115A(b) of the Act.

(b) Scope. This subpart sets forth the following:

(1) The method for selecting IOTA participants.

(2) The patient population.

(3) The methodology for IOTA participant performance assessment and scoring for purposes of the achievement domain, efficiency domain, and quality domain, including beneficiary attribution and transplant target calculation.

(4) The schedule and methodologies for the upside risk payment and downside risk payment.

(5) Data sharing.

(6) Other IOTA Model requirements.

(7) Beneficiary protections.

(8) Financial arrangements.

(9) Monitoring.

(10) Evaluation.

(11) Termination.

(12) Except as specifically noted in this subpart, the regulations under this subpart do not affect the applicability of other provisions affecting providers and suppliers under Medicare fee for service, including the applicability of provisions regarding payment, coverage, or program integrity.

(c) Applicability. IOTA participants are subject to the standard provisions for Innovation Center models specified in subpart A of this part 512 and in subpart K of part 403 of this chapter.

For purposes of this subpart, the following definitions apply:

Achievement domain means the performance assessment category in which CMS assesses the IOTA participant's performance based on the number of transplants performed relative to the transplant target.

Alignment payment means a payment from an IOTA collaborator to an IOTA participant that is made in accordance with a sharing arrangement.

Annual attribution reconciliation means the yearly process in which CMS—

(1) Creates the final list of each IOTA participant's attributed patients for the prior performance year by retrospectively de-attributing from each IOTA participant any attributed patients that satisfy a criterion for de-attribution under § 512.414(c); and

(2) Creates a final list of each IOTA participant's attributed patients who remain attributed for the performance year being reconciled, subject to the attribution criteria under §§ 512.414(b)(1) and (2).

Annual attribution reconciliation list means the final cumulative record of attributed patients that CMS generates annually for whom each IOTA participant is accountable for during the applicable PY as described at § 512.414(c)(2).

Attributed patient means an IOTA waitlist patient or an IOTA transplant patient.

Attribution means the process by which CMS identifies the patients for whom each IOTA participant is accountable during the model performance period, as described in § 512.414.

Baseline year means a 12-month period within a 3-year historical baseline period, that begins 48 months (or 4 years) before the start of each model PY and ends 12 months (or 1 year) before the start of each model PY, as described in § 512.424.

Bypassed response means an organ offer not received due to expedited placement or a decision by a kidney transplant hospital to have all of its kidney transplant waitlist patients skipped during the organ allocation process based on a set of pre-defined filters selected by the kidney transplant hospital matching the characteristics of the potential organ to be transplanted.

Change in control means at least one of the following:

(1) The acquisition by any “person” (as this term is used in sections 13(d) and 14(d) of the Securities Exchange Act of 1934) of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Securities Exchange Act of 1934), directly or indirectly, of voting securities of the IOTA participant representing more than 50 percent of the IOTA participant's outstanding voting securities or rights to acquire such securities.

(2) The acquisition of the IOTA participant by any other individual or entity.

(3) Any merger, division, dissolution, or expansion of the IOTA participant.

(4) The sale, lease, exchange, or other transfer (in one transaction or a series of transactions) of all or substantially all the assets of the IOTA participant.

(5)(i) The approval and completion of a plan of liquidation of the IOTA participant; or

(ii) An agreement for the sale or liquidation of the IOTA participant.

Collaboration agent means an individual or entity that is not an IOTA collaborator and that is a member of a PGP, NPPGP, or TGP that has entered into a distribution arrangement with the same PGP, NPPGP, or TGP in which he or she is an owner or employee, and where the PGP, NPPGP, or TGP is an IOTA collaborator.

Composite graft survival rate means the rolling unadjusted total number of functioning grafts relative to the total number of adult kidney transplants performed, as described in § 512.428.

CORF stands for comprehensive outpatient rehabilitation facility.

Critical access hospital (CAH) means a hospital as defined in section 1861(mm)(1) of the Act.

Days means calendar days unless otherwise specified by CMS.

Distribution arrangement means a financial arrangement between an IOTA collaborator that is an PGP, NPPGP, or TGP and a collaboration agent for the sole purpose of distributing some or all of a gainsharing payment received by the PGP, NPPGP, or TGP.

Distribution payment means a payment from an IOTA collaborator that is a PGP, NPPGP, or TGP to a collaboration agent, under a distribution arrangement, composed only of gainsharing payments.

Donation service area (DSA) means a geographical area of sufficient size to ensure maximum effectiveness in the procurement and equitable distribution of organs and that either includes an entire metropolitan statistical area (MSA) or does not include any part of such an area and that meets the standards of 42 CFR part 486 subpart G as defined in 42 CFR 486.302.

Downside risk payment means the lump sum payment the IOTA participant must pay to CMS after the close of a performance year if the IOTA participant's final performance score falls within the ranges specified in § 512.430.

Efficiency domain means the performance assessment category in which CMS assesses the IOTA participant's performance using the organ offer acceptance rate ratio as described in § 512.426.

EFT stands for electronic funds transfer.

Eligible attributed patient means an attributed patient that receives immunosuppressive drug coverage through Part B or Part D but that does not have secondary insurance that could provide cost sharing support.

Final performance score means the sum total of the scores earned by the IOTA participant across the achievement domain, efficiency domain, and quality domain for a given PY.

Gainsharing payment means a payment that is made from an IOTA participant to an IOTA collaborator, under a sharing arrangement as set forth in § 512.452 and in accordance with § 512.452(c).

Health equity goals mean the targeted outcomes relative to the health equity plan performance measures for the first PY and all subsequent PYs.

Health equity plan intervention means the initiative(s) the IOTA participant creates and implements to reduce target health disparities.

Health equity plan performance measure(s) means one or more quantitative metrics that the IOTA participant uses to measure the reductions in target health disparities arising from the health equity plan interventions.

Health equity project plan means the timeline for the IOTA participant to implement the IOTA participant's health equity plan.

HHA means a Medicare-enrolled home health agency.

Hospital has the meaning set forth in section 1861(e) of the Act.

Improvement benchmark rate means 120 percent of the IOTA participants' performance on the organ offer acceptance rate ratio as specified under § 512.426(c)(1)(ii)(A).

Initial attribution means the process by which CMS identifies and prospectively attributes patients who meet the criteria specified under § 512.414(a)(2)(b) to an IOTA participant prior to the model start date.

IOTA activities mean the activities related to promoting accountability for the quality, cost, and overall care for attributed patients and performance across the achievement domain, efficiency domain and quality domain, including any of the following:

(1) Managing and coordinating care.

(2) Encouraging investment in infrastructure and redesigned care processes for high quality and efficient service delivery.

(3) The provision of items and services pre- or post-transplant in a manner that reduces costs and improves quality.

(4) Carrying out any other obligation or duty under the IOTA Model.

IOTA collaborator means the following Medicare-enrolled providers and suppliers that enter into a sharing arrangement with an IOTA participant:

(1) Nephrologist.

(2) ESRD facility.

(3) Skilled nursing facility (SNF).

(4) Home health agency (HHA).

(5) Long-term care hospital (LTCH).

(6) Inpatient rehabilitation facility (IRF).

(7) Physician.

(8) Nonphysician practitioner.

(9) Therapist in a private practice.

(10) CORF.

(11) Provider or supplier of outpatient therapy services.

(12) Physician group practice (PGP).

(13) Hospital.

(14) CAH.

(15) Non-physician provider group practice (NPPGP).

(16) Therapy group practice (TGP).

IOTA participant means a kidney transplant hospital, as defined at § 512.402, that is required to participate in the IOTA Model under § 512.412.

IOTA transplant patient means a kidney transplant patient who receives a kidney transplant at the age of 18 years of age or older from an IOTA participant at any time during the model performance period and meets the criteria set forth in § 512.414(b)(2).

IOTA waitlist patient means a kidney transplant waitlist patient, regardless of payer type and waitlist status, who meets all of the following:

(1) Is alive.

(2) 18 years of age or older.

(3) Registered on a waitlist (as defined in § 512.402) to one or more IOTA participants, as identified by the OPTN computer match program.

IRF stands for inpatient rehabilitation facility which must meet all of the following:

(1) The general criteria set forth in § 412.22.

(2) The criteria to be classified as a rehabilitation hospital or rehabilitation unit set forth in §§ 412.23(b), 412.25, and 412.29 for exclusion from the inpatient hospital prospective payment systems specified in § 412.1(a)(1).

Kidney transplant means the procedure in which a kidney is surgically transplanted from a living or deceased donor to a transplant recipient, either alone or in conjunction with any other organ(s).

Kidney transplant hospital means a transplant hospital with a Medicare approved kidney transplant program.

Kidney transplant patient means a patient who was a transplant candidate, as defined in § 121.2, and received a kidney transplant furnished by a kidney transplant hospital, regardless of payer type.

Kidney transplant waitlist patient means a patient who is a transplant candidate, as defined in § 121.2, and who is registered to a waitlist for a kidney at one or more kidney transplant hospitals.

LTCH stands for long-term care hospital that meets the requirements as stated in 42 CFR part 483 subpart B.

Match run means a computerized ranking of transplant candidates based upon donor and candidate medical compatibility and criteria defined in OPTN policies.

Medicare kidney transplant means a kidney transplant furnished to a attributed patient in the IOTA Model whose primary or secondary insurance is Medicare fee for service (FFS), as identified in Medicare FFS claims with MS-DRGs 008, 019, 650, 651, and 652.

Member of the NPPGP or NPPGP member means a nonphysician practitioner or therapist who is an owner or employee of an NPPGP and who has reassigned to the NPPGP their right to receive Medicare payment.

Member of the PGP or PGP member means a physician, nonphysician practitioner, or therapist who is an owner or employee of the PGP and who has reassigned to the PGP their right to receive Medicare payment.

Member of the TGP or TGP member means a therapist who is an owner or employee of a TGP and who has reassigned to the TGP their right to receive Medicare payment.

Missing responses means organ offers that a kidney transplant hospital received from the OPO but did not submit a response (accepting or rejecting) in the allotted 1-hour timeframe from the time the offer was made per OPTN policy 5.6.B.

Model performance period means the 72-month period from the model start date and is comprised of 6 individual performance years.

Model-specific payment means a payment made by CMS only to IOTA participants, or a payment adjustment made only to payments made to IOTA participants, under the terms of the IOTA Model that is not applicable to any other providers or suppliers and includes, unless otherwise specified, both of the following:

(1) The IOTA Model upside risk payment.

(2) The IOTA Model downside risk payment.

Model start date means the date on which the model performance period begins, July 1, 2025.

National growth rate means the percentage increase or decrease in the number of kidney transplants performed over a 12-month period by all kidney transplant hospitals except for pediatric kidney transplant hospitals, as defined at § 512.402.

National Provider Identifier (NPI) means the standard unique health identifier used by health care providers for billing payors, assigned by the National Plan and Provider Enumeration System (NPPES) in accordance with 45 CFR part 162.

Neutral zone means the final performance score range in which the IOTA participant neither owes a downside risk payment to CMS nor receives an upside-risk payment from CMS, in accordance with § 512.430(b)(2).

Non-pediatric facility means a kidney transplant hospital that furnishes more than 50 percent of their kidney transplants annually to patients 18 years of age or older.

Nonphysician practitioner means (except for purposes of 42 CFR part 510 subpart G) one of the following:

(1) A physician assistant who satisfies the qualifications set forth at § 410.74(a)(2)(i) and (ii) of this chapter.

(2) A nurse practitioner who satisfies the qualifications set forth at § 410.75(b) of this chapter.

(3) A clinical nurse specialist who satisfies the qualifications set forth at § 410.76(b) of this chapter.

(4) A certified registered nurse anesthetist (as defined at § 410.69(b)).

(5) A clinical social worker (as defined at § 410.73(a)).

(6) A registered dietician or nutrition professional (as defined at § 410.134).

NPPGP means an entity that is enrolled in Medicare as a group practice, includes at least one owner or employee who is a nonphysician practitioner, does not include a physician owner or employee, and has a valid and active TIN.

OPTN computer match program means a set of computer-based instructions which compares data on a cadaveric organ donor with data on transplant candidates on the waiting list and ranks the candidates according to OPTN policies to determine the priority for allocating the donor organ(s).

Organ procurement and transplantation network or OPTN means the network established under section 372 of the Public Health Service Act.

Organ procurement organization or OPO means an entity designated by the Secretary under section 1138(b) of the Act and under 42 CFR 486.304.

Part B and Part D immunosuppressive drug cost sharing support means cost sharing support related to immunosuppressive drugs covered by Medicare Part B, the Medicare Part B Immunosuppressive Drug Benefit (Part B-ID), or Medicare Part D that is provided by an IOTA participant to an eligible attributed patient as codified at § 512.456.

Pediatric kidney transplant hospital means a kidney transplant hospital that performs 50 percent or more of its transplants in a 12-month period on patients under the age of 18.

Performance year (PY) means a 12-month period beginning on July 1 and ending on June 30 of each year during the model performance period.

PGP stands for physician group practice.

Physician has the meaning set forth in section 1861(r) of the Act.

Post-transplant period means the 90-day period following an attributed patient's receipt of a kidney transplant.

Preliminary performance assessment and payment calculations means the process by which CMS—

(1) Assesses each IOTA participant's performance in accordance with §§ 512.424, 512.426, 512.428; and

(2) Calculates performance-based payments in accordance with § 512.430.

Provider of outpatient therapy services means an entity that is enrolled in Medicare as a provider of therapy services and furnishes one or more of the following:

(1) Outpatient physical therapy services as defined in § 410.60 of this chapter.

(2) Outpatient occupational therapy services as defined in § 410.59 of this chapter.

(3) Outpatient speech-language pathology services as defined in § 410.62 of this chapter.

Quality domain means the performance assessment category in which CMS assesses the IOTA participant's performance using a performance measure focused on improving the quality of transplant care as described in § 512.428.

Quality Health Information Network (QHIN) means a network of organizations that agrees to common terms and conditions regarding data exchange with each other (a “Common Agreement”) and to the functional and technical requirements for such data exchange (as specified in the QHIN Technical Framework or “QTF”) under section 4003(b) of the 21st Century Cures Act (Pub. L. 114-255).

Quarterly attribution list means the quarterly CMS-generated attributed patient list that CMS provides to the IOTA participant in advance of each quarter during the model performance period in accordance with § 512.414(c)(ii)(2).

Resource gap analysis means the resources needed to implement the health equity plan interventions and identifies any gaps in the IOTA participant's current resources and the additional resources needed.

Scientific Registry of Transplant Recipients or SRTR means the registry of information on transplant recipients established under section 373 of the Public Health Service Act.

Selected DSAs means those DSAs selected by CMS for purposes of selecting kidney transplant hospitals for participation in the IOTA Model.

Sharing arrangement means a financial arrangement to only share the upside risk payment and the downside risk payment lump-sum amount as set forth in § 512.452.

SNF stands for skilled nursing facility that meets all applicable requirements in section of 1819 of the Act.

Target health disparities mean health disparities experienced by one or more communities within the IOTA participant's population of attributed patients that the IOTA participant aims to reduce.

Targeted review process means the process in which an IOTA participant may dispute performance and payment calculations made, and issued, by CMS as set forth in § 512.434.

Taxpayer identification number (TIN) means a Federal taxpayer identification number or employer identification number as defined by the Internal Revenue Service in 26 CFR 301.6109-1.

TGP means an entity that is enrolled in Medicare as a therapy group in private practice, includes at least one owner or employee who is a therapist in private practice, does not include an owner or employee who is a physician or nonphysician practitioner, and has a valid and active TIN.

Therapist means one of the following individuals as defined at § 484.4 of this chapter:

(1) Physical therapist.

(2) Occupational therapist.

(3) Speech-language pathologist.

Therapist in private practice means a therapist that complies with one of the following special provisions:

(1) For physical therapists in private practice in § 410.60(c) of this chapter.

(2) For occupational therapists in private practice in § 410.59(c) of this chapter.

(3) For speech-language pathologists in private practice in § 410.62(c) of this chapter.

Transplant hospital means a hospital that furnishes organ transplants as defined in 42 CFR 121.2.

Transplant physician means a physician who provides non-surgical care and treatment to transplant patients before and after transplant as defined in 42 CFR 121.2.

Transplant program means a component within a transplant hospital which provides transplantation of a particular type of organ as defined in 42 CFR 121.2.

Transplant recipient means a person who has received an organ transplant as defined in 42 CFR 121.2.

Transplant target means the target number of kidney transplants calculated by CMS for the IOTA participant to measure the IOTA participant's performance in the achievement domain, as described in § 512.424.

Underserved communities mean populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life as defined by Executive Order 13985 of January 20, 2021.

Upside risk payment means the lump sum payment CMS makes to an IOTA participant if the IOTA participant's final performance score for a performance year falls within the payment range specified in § 512.430.

Waitlist means a list of transplant candidates, as defined in 42 CFR 121.2, registered to the waiting list, as defined in 42 CFR 121.2, maintained by a transplant hospital in accordance with 42 CFR 482.94(b).

(a) General. (1) CMS establishes the performances measures described in §§ 512.424, 512.426, and 512.428 to assess IOTA participants in the achievement domain, efficiency domain and quality domain.

(2) CMS assigns each set of metrics within a domain a point value with the total possible points awarded to an IOTA participant across the three domains equaling 100, as described in §§ 512.424, 512.426, and 512.428.

(b) Data sources. (1) CMS uses Medicare claims data and Medicare administrative data about beneficiaries, providers, suppliers, and data from the OPTN, to calculate performance for the IOTA participant based on the methodologies under §§ 512.424, 512.426, and 512.428.

(2) CMS may also use model-specific data reported by an IOTA participant to CMS under the IOTA Model to calculate IOTA participant performance in the domains.

(a) General. (1) After each PY, CMS calculates the number of kidney transplants that each IOTA participant performed for the respective PY, in accordance with the provisions in paragraph (d) of this section.

(2) CMS compares the number of kidney transplants that an IOTA participant performed during the PY to the IOTA participant's transplant target to determine the IOTA participant's score for the achievement domain.

(b) Transplant target methodology. CMS determines the IOTA participant's transplant target for each PY as follows:

(1) Analysis of baseline years. CMS analyzes the baseline years for the relevant PY and identifies:

(i) The mean number of deceased donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older across the baseline years, as defined at § 512.402; and

(ii) The mean number of living donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older across the baseline years, as defined at § 512.402.

(2) Mean of kidney transplants. CMS sums the numbers in paragraphs (b)(1)(i) and (ii) of this section.

(3) National growth rate calculation. CMS calculates the national growth rate, as defined at § 512.402, using the baseline years for the relevant PY as follows:

(i) Subtracts the total number of kidney transplants furnished to patients 18 years of age or older during the second baseline year from the total number of kidney transplants furnished to patients 18 years of age or older during the third baseline year.

(ii) Divides the amount resulting from the calculation in paragraph (b)(3)(i) of this section by the total number of kidney transplants furnished to patients 18 years of age or older during the third baseline year. The resulting amount is the national growth rate for the relevant PY.

(4) Calculation of transplant target. If the national growth rate calculated in paragraph (b)(3) of this section is—

(i) Positive, CMS multiples that national growth rate by the sum calculated in paragraph (b)(2) of this section. The resulting amount is an IOTA participant's transplant target for the relevant PY; or

(ii) Negative, CMS does not multiply the national growth rate by the sum calculated in paragraph (b)(2) of this section. The IOTA participant's transplant target for the relevant PY is the sum calculated in paragraph (b)(2) of this section.

(c) Notification of transplant target. CMS notifies the IOTA participant of the transplant target by the first day of the start of each PY in a form and manner determined by CMS.

(d) Calculation of kidney transplants performed during the PY. (1)(i) After each PY, CMS counts the number of kidney transplants performed by the IOTA participant on patients who were 18 years of age or older at the time of transplant, during the PY.

(ii) CMS identifies kidney transplants performed by the IOTA participant using OPTN data, regardless of payer, and Medicare claims data.

(2) CMS counts each kidney transplant described in paragraph (d)(1) of this section as one transplant.

(e) [Reserved]

(f) Achievement domain scoring. For each PY, CMS awards the IOTA participant zero to 60 points for its performance in the achievement domain.

(1) CMS compares the total number of kidney transplants identified under paragraph (d)(2) of this section to the IOTA participant's transplant target, as described in paragraph (b) of this section.

(2) CMS uses the following scoring methodology to determine an IOTA participant's score on the achievement domain.

(a) General. For each PY, CMS assesses each IOTA participant on the metric described in paragraph (b) of this section to determine the IOTA participant's score for the efficiency domain.

(b) Metric included in the efficiency domain. For each PY, CMS assesses the IOTA participant on the following metric:

(1) Organ-offer acceptance rate ratio. For each PY, CMS calculates the organ-offer acceptance rate ratio by dividing the number of kidneys the IOTA participant accepted by the risk-adjusted number of expected organ-offer acceptances using SRTR's methodology as described in equation 1 to paragraph (b)(1) introductory text of this section.

(i) CMS uses both of the following:

(A) SRTR data to calculate the organ-offer acceptance rate ratio.

(B) SRTR's adult kidney model strata risk-adjustment methodology and most available set of coefficients to calculate the number of expected organ-offer acceptances.

(ii) CMS includes all of the following kidney offers when calculating the organ-offer acceptance rate ratio for the IOTA participant:

(A) Offers that are ultimately accepted and transplanted.

(B) Offers to candidates on a single organ waitlist (except for kidney/pancreas candidates that are also listed for kidney alone).

(iii) CMS excludes the following kidney offers when calculating the organ-offer acceptance rate:

(A) Offers with multiple match runs from the same donor combined and duplicate offers.

(B) Offers with no match run acceptances.

(C) Offers that occurred after the last acceptance in a match run.

(D) Offers with a missing or bypassed response.

(E) Offers to multi-organ candidates (except for kidney/pancreas candidates that are also listed for kidney alone).

(c) Efficiency domain scoring. For each PY, CMS awards the IOTA participant 0 to 20 points for its performance in the efficiency domain.

(1) General. CMS determines the IOTA participant's score for the efficiency domain for each PY by taking the IOTA participant's score for the organ offer acceptance rate ratio, as described under paragraph (c)(2) of this section. This number is the IOTA participant's score for the efficiency domain for the PY.

(2) Scoring for organ offer acceptance rate ratio. CMS calculates the IOTA participant's achievement score, as described in paragraph (c)(2)(i) of this section, and improvement score, as described under paragraph (c)(2)(ii) of this section, for the organ offer acceptance rate ratio, compares the IOTA participant's achievement score and improvement score and awards to the IOTA participant the points that correspond to the higher score.

(i) Achievement scoring. CMS calculates the IOTA participant's achievement score based on the IOTA participant's performance on organ offer acceptance rate ratio relative to national ranking, including all eligible kidney transplant hospitals, using the scoring methodology described in table 1 to paragraph (c)(1)(i) of this section.

(ii) Improvement scoring. CMS compares the IOTA participant's organ offer acceptance rate ratio during the PY, calculated as described under paragraph (c)(1)(i) of this section, to the IOTA participant's improvement benchmark rate, calculated as described under paragraph (c)(1)(ii)(A) of this section.

(A) Improvement benchmark rate. CMS calculates an improvement benchmark rate for the IOTA participant. To determine an IOTA participant's improvement benchmark rate for a given PY, CMS multiplies an IOTA participant's organ offer acceptance rate ratio during the third baseline year by 120 percent.

(B) Improvement score calculation. For each PY, CMS uses the following methodology to determine each IOTA participant's improvement score on the organ offer acceptance rate ratio:

(1) If the IOTA participant's organ-offer acceptance rate ratio is greater than or equal to the improvement benchmark rate, CMS awards the IOTA participant 15 points in the efficiency domain.

(2) If the IOTA participant's organ offer acceptance rate ratio is equal to or less than the IOTA participant's organ-offer acceptance rate ratio in the third baseline year for that respective PY, CMS awards the IOTA participant 0 points in the efficiency domain.

(3) If the IOTA participant's organ offer acceptance rate ratio is greater than the IOTA participant's organ-offer acceptance rate ratio in the third baseline year for that respective PY but less than the improvement benchmark rate, CMS uses the following equation:

(a) General. For each PY, CMS assesses each IOTA participant on the metric described under paragraph (b)(1) of this section to determine the IOTA participant's quality domain score, as described under paragraphs (c) through (e) of this section, for the quality domain.

(b) Metrics included in the quality domain. For each PY, CMS assesses each IOTA participant using the following quality metrics:

(1) Post-transplant graft survival. For each PY, CMS calculates an IOTA participant's composite graft survival rate by dividing the cumulative number of all functioning kidney grafts for the IOTA participant's IOTA transplant patients by the cumulative number of all kidney transplants performed by the IOTA participant during the first PY and all subsequent PYs on patients 18 years or older at the time of the transplant, as described in equation 1 to paragraph (b)(1) introductory text of this section.

(i) For the first PY, CMS calculates the IOTA participant's composite graft survival rate based solely on the number of functioning grafts furnished to IOTA transplant patients during that PY and the number of completed kidney transplants during that PY, as described in paragraph (b)(1) of this section.

(ii) For all subsequent PYs, CMS calculates the IOTA participant's cumulative composite graft survival rate using the same calculation methodology described in paragraph (b)(1) of this section.

(iii) CMS excludes the following from the numerator when calculating the composite graft survival rate:

(A) Graft failure, based on OPTN adult kidney transplant recipient follow-up forms for all completed kidney transplants to determine failed grafts as defined by SRTR.

(B) Re-transplant.

(C) Death.

(D) Patients who are under the age of 18 years of age at the time of the kidney transplant.

(E) Offers to multi-organ candidates (except for kidney/pancreas candidates that are also listed for kidney alone).

(iv)(A) When calculating the composite graft survival rate, CMS only includes kidney transplants for patients who are 18 years of age and older at the time of the kidney transplant in the number of kidney transplants performed by the IOTA participant during each PY in the denominator.

(B) CMS identifies kidney transplants performed by the IOTA participant using OPTN data, regardless of payer, and Medicare claims data.

(2)-(3) [Reserved]

(c) Quality domain scoring. For each PY, CMS awards the IOTA participant zero to 20 points for the IOTA participant's performance in the quality domain, in accordance with the following:

(1) For composite graft survival rate, as described under paragraph (d) of this section, the IOTA participant may receive up to 20 points.

(2) [Reserved]

(d) Composite graft survival rate scoring. CMS awards points to the IOTA participant based on the IOTA participant's performance on the composite graft survival rate, as described in paragraph (b)(1) of this section, ranked nationally, inclusive of all eligible kidney transplant hospitals. CMS awards points to the IOTA participant for composite graft survival rate as described in table 1 to paragraph (d) of this section:

(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 60 points or above, 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 41 to 59 points (inclusive), the IOTA participant qualifies for the neutral zone.

(3) Downside risk payment calculation methodology. If an IOTA participant is at or 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 at least 60 days after the date which the demand letter is issued.

(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) Downside risk payment. In the event of an extreme and uncontrollable circumstance, as determined by the Quality Payment Program, CMS may reduce the amount of the IOTA participant's downside risk payment, if applicable, prior to recoupment. CMS determines the amount of the reduction by multiplying the downside risk payment by both of 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.

(a) General. CMS shares certain beneficiary-identifiable data as described in paragraph (b) of this section and certain aggregate data as described in paragraph (c) of this section with IOTA participants regarding attributed patients who are Medicare beneficiaries and performance under the model.

(b) Beneficiary-identifiable data. CMS shares beneficiary-identifiable data with IOTA participants as follows:

(1) CMS makes available certain beneficiary-identifiable data described in paragraphs (b)(4) and (5) of this section for IOTA participants to request for purposes of conducting health care operations work that falls within the first or second paragraph of the definition of health care operations at 45 CFR 164.501 on behalf of their attributed patients who are Medicare beneficiaries.

(2) An IOTA participant that wishes to receive beneficiary-identifiable data for its attributed patients who are Medicare beneficiaries must do all of the following:

(i) Submit a formal request for the data, on an annual basis in a manner and form and by a date specified by CMS, which identifies the data being requested and attests that—

(A) The IOTA participant is requesting this beneficiary-identifiable data as a HIPAA covered entity or as a business associate, as those terms are defined at 45 CFR 160.103, to the IOTA participant's providers and suppliers who are HIPAA covered entities; and

(B) The IOTA participant's request reflects the minimum data necessary, as set forth in paragraph (b)(6) of this section, for the IOTA participant to conduct health care operations work that falls within the first or second paragraph of the definition of health care operations at 45 CFR 164.501.

(ii) Limit the request to Medicare beneficiaries whose name appears on the quarterly attribution list who have been notified in compliance with § 512.450 that the IOTA participant has requested access to beneficiary-identifiable data, and who did not decline having their claims data shared with the IOTA participant as provided in paragraph (b)(7) of this section.

(iii) Sign and submit a data sharing agreement with CMS as set forth in paragraph (b)(8) of this section.

(3) CMS shares beneficiary-identifiable data with an IOTA participant on the condition that the IOTA participant, its IOTA collaborators, and other individuals or entities performing functions or services related to the IOTA participant's activities observe all relevant statutory and regulatory provisions regarding the appropriate use of data and the confidentiality and privacy of individually identifiable health information and comply with the terms of the data sharing agreement described in paragraph (b)(8) of this section.

(4) CMS omits from the beneficiary-identifiable data any information that is subject to the regulations in 42 CFR part 2 governing the confidentiality of substance use disorder patient records.

(5) The beneficiary-identifiable data will include, when available, the following information:

(i) Quarterly attribution lists. For the relevant PY, CMS shares with the IOTA participant the quarterly attribution lists, which will include but may not be limited to the following information for each attributed patient:

(A) The year that CMS attributed the patient to the IOTA participant.

(B) The effective date of the patient's attribution to the IOTA participant.

(C) The effective date of the patient's de-attribution from the IOTA participant and the reason for such removal (if applicable).

(D) For Medicare beneficiaries, the attributed patient's data sharing preference.

(ii) Beneficiary-identifiable claims data. CMS makes available certain beneficiary-identifiable claims data for retrieval by IOTA participants no later than 1 month after the start of each PY, in a form and manner specified by CMS. IOTA participants may retrieve the following data at any point during the relevant PY. This claims data includes all of the following:

(A) Three years of historical Parts A, B, and D claims data files from the 36 months immediately preceding the effective date of each attributed patient who is a Medicare beneficiary's attribution to the IOTA participant.

(B) Monthly Parts A, B, and D claims data files for attributed patients who are Medicare beneficiaries.

(C) Monthly Parts A, B, and D claims data files for Medicare beneficiaries who have been de-attributed from the IOTA participant for claims with a date of service before the date the Medicare beneficiary was de-attributed from the IOTA participant.

(6) The IOTA participant must limit its attributed Medicare beneficiary identifiable data requests to the minimum necessary to accomplish a permitted use of the data.

(i) The minimum necessary Parts A and B data elements may include but are not limited to the following data elements:

(A) Medicare beneficiary identifier (ID).

(B) Procedure code.

(C) Gender.

(D) Diagnosis code.

(E) Claim ID.

(F) The from and through dates of service.

(G) The provider or supplier ID.

(H) The claim payment type.

(I) Date of birth and death, if applicable.

(J) Tax identification number (TIN).

(K) National provider identifier (NPI).

(ii) The minimum necessary Part D data elements may include but are not limited to the following data elements:

(A) Beneficiary ID.

(B) Prescriber ID.

(C) Drug service date.

(D) Drug product service ID.

(E) Quantity dispensed.

(F) Days supplied.

(G) Brand name.

(H) Generic name.

(I) Drug strength.

(J) TIN.

(K) NPI.

(L) Indication if on formulary.

(M) Gross drug cost.

(7)(i)(A) IOTA participants must send Medicare beneficiaries a notification about the IOTA Model and the opportunity to decline claims data sharing as required under § 512.450.

(B) Such notifications must do both of the following:

(1) State that the IOTA participant may have requested beneficiary-identifiable claims data about the Medicare beneficiary for purposes of its care coordination, quality improvement work, and population-based activities relating to improving health or reducing health care costs.

(2) Inform the Medicare beneficiary how to decline having his or her claims information shared with the IOTA participant in the form and manner specified by CMS.

(ii) Medicare beneficiary requests to decline claims data sharing remain in effect unless and until a beneficiary subsequently contacts CMS to amend that request to permit claims data sharing with IOTA participants.

(iii) The opportunity to decline having claims data shared with an IOTA participant under paragraph (b)(7)(i) of this section does not apply to any of the following:

(A) The aggregate data that CMS provides to IOTA participants under paragraph (c) of this section.

(B) The initial attribution lists that CMS provides to IOTA participants as defined at § 512.402 and specified under § 512.414(c)(1)(ii).

(C) The quarterly attribution lists that CMS provides to IOTA participants as defined at § 512.402 and specified under § 512.414(c)(2)(ii).

(D) The annual attribution reconciliation list that CMS provides to IOTA participants as defined at § 512.402 and specified under § 512.414(c)(3)(ii).

(8)(i) If an IOTA participant wishes to retrieve any beneficiary-identifiable data specified in paragraph (b) of this section, the IOTA participant must complete and submit, on an annual basis, a signed data sharing agreement, to be provided in a form and manner specified by CMS, under which the IOTA participant agrees to all of the following:

(A) To comply with the requirements for use and disclosure of this beneficiary-identifiable data that are imposed on covered entities by the HIPAA regulations at 45 CFR part 160 and part 164, subparts A and E, and the requirements of the IOTA Model set forth in this part.

(B) To comply with additional privacy, security, breach notification, and data retention requirements specified by CMS in the data sharing agreement.

(C) To contractually bind each downstream recipient of the beneficiary-identifiable data that is a business associate of the IOTA participant, including all IOTA collaborators, to the same terms and conditions to which the IOTA participant is itself bound in its data sharing agreement with CMS as a condition of the business associate's receipt of the beneficiary-identifiable data retrieved by the IOTA participant under the IOTA Model.

(D) That if the IOTA participant misuses or discloses the beneficiary-identifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the data sharing agreement, CMS may do all of the following:

(1) Deem the IOTA participant ineligible to retrieve the beneficiary-identifiable data under paragraph (b) of this section for any amount of time.

(2) Terminate the IOTA participant's participation in the IOTA Model under § 512.466.

(3) Subject the IOTA participant to additional sanctions and penalties available under the law.

(ii) An IOTA participant must comply with all applicable laws and the terms of the data sharing in order to retrieve beneficiary-identifiable data.

(c) Aggregate data. (1) CMS shares aggregate performance data with IOTA participants, in a form and manner to be specified by CMS, which has been de-identified in accordance with 45 CFR 164.514(b). This aggregate data includes, when available, certain de-identified data detailing the IOTA participant's performance against the transplant target information for each PY.

(2) [Reserved]

(a) Publication of transplant patient selection criteria. The IOTA participant must publicly post on its website the criteria used by the IOTA participant for evaluating and selecting patients for addition to their kidney transplant waitlist by the end of PY 1.

(b) [Reserved]

(c) Review of acceptance criteria. IOTA participants must review transplant organ offer acceptance criteria with their IOTA waitlist patients who are Medicare beneficiaries at least once every 6 months that the Medicare beneficiary is on their waitlist.

(1) The IOTA participant must conduct this review via patient visit, phone, email or mail on an individual basis, unless the Medicare beneficiary declines this review.

(2) [Reserved]

(a) For each PY, an IOTA participant may voluntarily submit a health equity plan, by a date and in a form and manner determined by CMS, that meets the following requirements:

(1) Identifies target health disparities.

(2) Identifies the data sources used to inform the identification of target health disparities.

(3) Describes the health equity plan intervention.

(4) Includes a resource gap analysis.

(5) Includes a health equity project plan.

(6) Identifies health equity plan performance measure(s).

(7) Identifies health equity goals and describes how the IOTA participant will use the health equity goals to monitor and evaluate progress in reducing targeted health disparities.

(b) [Reserved]

(a) General. (1) IOTA participants must provide notice to attributed patients that they are participating in the IOTA Model.

(2) CMS provides a notification template that IOTA participants must use. The template, at minimum does all of the following:

(i) Indicates content that the IOTA participant must not change.

(ii) Indicates where the IOTA participant may insert its own content.

(iii) Includes information regarding the attributed patient's opportunity to opt-out of data sharing with IOTA participants and how they may opt out if they choose to do so.

(3) To notify attributed patients of their rights and protections and that the IOTA participant is participating in the IOTA Model, the IOTA participant must do all of the following:

(i) Prominently display informational materials in each of their office or facility locations where attributed patients receive treatment.

(ii) Include this notification in a clear manner on its public facing website.

(iii) Provide this notification to each attributed patient in a paper format.

(b) Applicability of general Innovation Center model provisions. (1) The requirements described in § 512.120(c) do not apply to the CMS-provided materials described in paragraph (a) of this section.

(2) All other IOTA participant communications that are descriptive model materials and activities as defined under § 512.110 must meet the requirements described in § 512.120(c).

(a) General. (1) The IOTA participant—

(i) May enter into a sharing arrangement with an IOTA collaborator to make a gainsharing payment, or to receive an alignment payment, or both; and

(ii) Must not make a gainsharing payment or receive an alignment payment except in accordance with a sharing arrangement.

(2) A sharing arrangement must comply with the provisions of this section and all other applicable laws and regulations, including the applicable fraud and abuse laws and all applicable payment and coverage requirements.

(3) The IOTA participant must develop, maintain, and use a set of written policies for selecting providers and suppliers to be IOTA collaborators.

(i) The selection criteria must include the quality of care delivered by the potential IOTA collaborator.

(ii) The selection criteria cannot be based directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among any of the following:

(A) The IOTA participant.

(B) Any IOTA collaborator.

(C) Any collaboration agent.

(D) Any individual or entity affiliated with an IOTA participant, IOTA collaborator, or collaboration agent.

(iii) The written policies must contain criteria related to, and inclusive of, the anticipated contribution to performance across the achievement domain, efficiency domain, and quality domain by the potential IOTA collaborator.

(4) The board or other governing body of the IOTA participant must have responsibility for overseeing the IOTA participant's participation in the IOTA Model, including but not limited to all of the following:

(i) Arrangements with IOTA collaborators.

(ii) Payment of gainsharing payments.

(iii) Receipt of alignment payments.

(iv) Use of beneficiary incentives in the IOTA Model.

(5) If an IOTA participant enters into a sharing arrangement, its compliance program must include oversight of sharing arrangements and compliance with the applicable requirements of the IOTA Model.

(b) Requirements. (1) A sharing arrangement must be—

(i) In writing;

(ii) Signed by the parties; and

(iii) Entered into before care is furnished to an attributed patient during the PY under the sharing arrangement.

(2) Participation in a sharing arrangement must be voluntary and without penalty for nonparticipation.

(3) Participation in the sharing arrangement must require the IOTA collaborator to comply with the requirements of this model, as those pertain to their actions and obligations.

(4) The sharing arrangement—

(i) Must set out the mutually agreeable terms for the financial arrangement between the parties to guide and reward model care redesign for future performance across the achievement domain, efficiency domain, and quality domain;

(ii) Must not reflect the results of model PYs that have already occurred; and

(iii) Where the financial outcome of the sharing arrangement terms are known before signing.

(5) The sharing arrangement must require the IOTA collaborator and its employees, contractors (including collaboration agents), and subcontractors to comply with all of the following:

(i) The applicable provisions of this part (including requirements regarding beneficiary notifications, access to records, record retention, and participation in any evaluation, monitoring, compliance, and enforcement activities performed by CMS or its designees).

(ii) All applicable Medicare provider enrollment requirements at § 424.500 of this chapter, including having a valid and active TIN or NPI, during the term of the sharing arrangement.

(iii) All other applicable laws and regulations.

(6) The sharing arrangement must require the IOTA collaborator to have or be covered by a compliance program that includes oversight of the sharing arrangement and compliance with the requirements of the IOTA Model that apply to its role as an IOTA collaborator, including any distribution arrangements.

(7) The sharing arrangement must not pose a risk to beneficiary access, beneficiary freedom of choice, or quality of care.

(8) The written agreement memorializing a sharing arrangement must specify all of the following:

(i) The purpose and scope of the sharing arrangement.

(ii) The identities and obligations of the parties, including specified IOTA activities and other services to be performed by the parties under the sharing arrangement.

(iii) The date of the sharing arrangement.

(iv) Management and staffing information, including type of personnel or contractors that would be primarily responsible for carrying out IOTA activities.

(v) The financial or economic terms for payment, including all of the following:

(A) Eligibility criteria for a gainsharing payment.

(B) Eligibility criteria for an alignment payment.

(C) Frequency of gainsharing or alignment payment.

(D) Methodology and accounting formula for determining the amount of a gainsharing payment that is substantially based on performance across the achievement domain, efficiency domain and quality domain, and the provision of IOTA activities.

(E) Methodology and accounting formula for determining the amount of an alignment payment.

(9) The sharing arrangement must not—

(i) Induce—

(A) The IOTA participant;

(B) The IOTA collaborator; or

(C) Any employees, contractors, or subcontractors of the IOTA participant or IOTA collaborator to reduce or limit medically necessary services to any attributed patient; or

(ii) Restrict the ability of an IOTA collaborator to make decisions in the best interests of its patients, including the selection of devices, supplies, and treatments.

(c) Gainsharing payments and alignment payments. (1) Gainsharing payments, if any, must meet all of the following:

(i) Be derived solely from upside risk payments.

(ii) Be distributed on an annual basis (not more than once per performance year).

(iii) Not be a loan, advance payment, or payment for referrals or other business.

(iv) Be clearly identified as a gainsharing payment at the time it is paid.

(2) To be eligible to receive a gainsharing payment an IOTA collaborator must contribute to performance across the achievement domain, efficiency domain or quality domain for the PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment. The contribution to performance across the achievement domain, efficiency domain, or quality domain criteria must be established by the IOTA participant and directly related to the care of attributed patients.

(3) To be eligible to receive a gainsharing payment, or to be required to make an alignment payment:

(i) An IOTA collaborator other than PGP, NPPGP, or TGP must have directly furnished a billable item or service to an attributed patient that occurred in the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment or incurred a downside risk payment.

(ii) An IOTA collaborator that is a PGP, NPPGP, or TGP must meet the following criteria:

(A) The PGP, NPPGP, or TGP must have billed for an item or service that was rendered by one or more PGP member, NPPGP member, or TGP member respectively to an attributed patient that occurred during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment or incurred a downside risk payment.

(B) The PGP, NPPGP, or TGP must have contributed to IOTA activities and been clinically involved in the care of attributed patients during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment or incurred a downside risk payment.

(4) The total amount of a gainsharing payment for a PY paid to an IOTA collaborator that is a physician or nonphysician practitioner must not exceed 50 percent of the Medicare-approved amounts under the PFS for items and services billed by that physician or nonphysician practitioner to the IOTA participant's attributed patients during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment being made.

(5) The total amount of a gainsharing payment for a PY paid to an IOTA collaborator that is a PGP, NPPGP, or TGP must not exceed 50 percent of the Medicare-approved amounts under the PFS for items and services billed by that PGP, NPPGP, or TGP and furnished to the IOTA participant's attributed patients by the PGP members, NPPGP members, or TGP members respectively during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment being made.

(6) The amount of any gainsharing payments must be determined in accordance with a methodology that is substantially based on contribution to the performance across the achievement domain, efficiency domain or quality domain and the provision of IOTA activities. The methodology may take into account the amount of such IOTA activities provided by an IOTA collaborator relative to other IOTA collaborators.

(7) For a PY, the aggregate amount of all gainsharing payments that are derived from the upside risk payment the IOTA participant receives from CMS must not exceed the amount of that upside risk payment.

(8) No entity or individual, whether a party to a sharing arrangement or not, may condition the opportunity to make or receive gainsharing payments or to make or receive alignment payments directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the IOTA participant, any IOTA collaborator, any collaboration agent, or any individual or entity affiliated with an IOTA participant, IOTA collaborator, or collaboration agent.

(9) An IOTA participant must not make a gainsharing payment to an IOTA collaborator that is subject to any action for noncompliance with this part, or the fraud and abuse laws, or for the provision of substandard care to attributed patients or other integrity problems.

(10) The sharing arrangement must require the IOTA participant to recoup any gainsharing payment that contained funds derived from a CMS overpayment on an upside risk payment or was based on the submission of false or fraudulent data.

(11) Alignment payments from an IOTA collaborator to an IOTA participant may be made at any interval that is agreed upon by both parties, and must not be—

(i) Issued, distributed, or paid prior to the calculation by CMS of a payment amount reflected in the notification of the downside risk payment;

(ii) Loans, advance payments, or payments for referrals or other business; or

(iii) Assessed by an IOTA participant if the IOTA participant does not owe a downside risk payment.

(12) The IOTA participant must not receive any amounts under a sharing arrangement from an IOTA collaborator that are not alignment payments.

(13) For a PY, the aggregate amount of all alignment payments received by the IOTA participant must not exceed 50 percent of the IOTA participant's downside risk payment amount.

(14) The aggregate amount of all alignment payments from a single IOTA collaborator to the IOTA participant may not be greater than 25 percent of the IOTA participant's downside risk payment over the course of a single PY for an IOTA collaborator.

(15) The amount of any alignment payments must be determined in accordance with a methodology that does not directly account for the volume or value of referrals or business otherwise generated by, between or among the IOTA participant, any IOTA collaborator, any collaboration agent, or any individual or entity affiliated with an IOTA participant, IOTA collaborator, or collaboration agent.

(16) All gainsharing payments and any alignment payments must be administered by the IOTA participant in accordance with generally accepted accounting principles (GAAP) and Government Auditing Standards (The Yellow Book).

(17) All gainsharing payments and alignment payments must be made by check, EFT, or another traceable cash transaction.

(d) Documentation requirements. (1) The IOTA participant must do all of the following:

(i) Document the sharing arrangement contemporaneously with the establishment of the arrangement.

(ii) Maintain accurate current and historical lists of all IOTA collaborators, including IOTA collaborator names and addresses. With respect to these lists the IOTA participant must—

(A) Update such lists on at least a quarterly basis; and

(B) On a web page on the IOTA participant's website, the IOTA participant must—

(1) Publicly report the current and historical lists of IOTA collaborators; and

(2) Include any written policies for selecting individuals and entities to be IOTA collaborators required by the IOTA participant.

(iii) Maintain and require each IOTA collaborator to maintain contemporaneous documentation with respect to the payment or receipt of any gainsharing payment or alignment payment that includes at a minimum all of the following:

(A) Nature of the payment (gainsharing payment or alignment payment).

(B) Identity of the parties making and receiving the payment.

(C) Date of the payment.

(D) Amount of the payment.

(E) Date and amount of any recoupment of all or a portion of an IOTA collaborator's gainsharing payment.

(F) Explanation for each recoupment, such as whether the IOTA collaborator received a gainsharing payment that contained funds derived from a CMS overpayment of an upside risk payment or was based on the submission of false or fraudulent data.

(2) The IOTA participant must keep records of all of the following:

(i) Its process for determining and verifying its potential and current IOTA collaborators' eligibility to participate in Medicare.

(ii) A description of current health information technology, including systems to track upside risk payments and downside risk payments.

(iii) Its plan to track gainsharing payments and alignment payments.

(3) The IOTA participant must retain and provide access to, and must require each IOTA collaborator to retain and provide access to, the required documentation in accordance with §§ 512.460 and 1001.952(ii).

(a) General. (1) An IOTA collaborator may distribute all or a portion of any gainsharing payment it receives from the IOTA participant only in accordance with a distribution arrangement, as defined at § 512.402.

(2) All distribution arrangements must comply with the provisions of this section and all other applicable laws and regulations, including the fraud and abuse laws.

(b) Requirements. (1) All distribution arrangements must be in writing and signed by the parties, contain the date of the agreement, and be entered into before care is furnished to attributed patients under the distribution arrangement.

(2) Participation in a distribution arrangement must be voluntary and without penalty for nonparticipation.

(3) The distribution arrangement must require the collaboration agent to comply with all applicable laws and regulations.

(4) The opportunity to make or receive a distribution payment must not be conditioned directly or indirectly on the volume or value of referrals or business otherwise generated by, between or among the IOTA participant, any IOTA collaborator, any collaboration agent, or any individual or entity affiliated with an IOTA participant, IOTA collaborator, or collaboration agent.

(5) The amount of any distribution payments from an NPPGP to an NPPGP member, or from a TGP to a TGP member must be determined in accordance with a methodology that is substantially based on contribution to performance across the achievement domain, efficiency domain, and quality domain and the provision of IOTA activities and that may take into account the amount of such IOTA activities provided by a collaboration agent relative to other collaboration agents.

(6) The amount of any distribution payments from a PGP must be determined either in a manner that complies with § 411.352(g) of this chapter or in accordance with a methodology that is substantially based on contribution to performance across the achievement domain, efficiency domain and quality domain and the provision of IOTA activities and that may take into account the amount of such IOTA activities provided by a collaboration agent relative to other collaboration agents.

(7) Except for a distribution payment from a PGP to a PGP member that complies with § 411.352(g) of this chapter, a collaboration agent is eligible to receive a distribution payment only if the collaboration agent furnished or billed for an item or service rendered to an attributed patient that occurred during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment being distributed.

(8) Except for a distribution payment from a PGP to a PGP member that complies with § 411.352(g) of this chapter, the total amount of distribution payments for a PY paid to a collaboration agent must not exceed 50 percent of the total Medicare-approved amounts under the PFS for items and services billed by that PGP, NPPGP or TGP for items and services furnished by PGP members, NPPGP members or TGP members respectively to attributed patients that occurred during the same PY for which the IOTA participant earned the upside risk payment that comprises the gainsharing payment being distributed.

(9) With respect to the distribution of any gainsharing payment received by a PGP, NPPGP, or TGP, the total amount of all distribution payments must not exceed the amount of the gainsharing payment received by the IOTA collaborator from the IOTA participant.

(10) All distribution payments must be made by check, electronic funds transfer, or another traceable cash transaction.

(11) The collaboration agent must retain the ability to make decisions in the best interests of the patient, including the selection of devices, supplies, and treatments.

(12) The distribution arrangement must not—

(i) Induce the collaboration agent to reduce or limit medically necessary items and services to any Medicare beneficiary; or

(ii) Reward the provision of items and services that are medically unnecessary.

(13) The IOTA collaborator must maintain contemporaneous documentation regarding distribution arrangements in accordance with § 512.454, including the following:

(i) The relevant written agreements.

(ii) The date and amount of any distribution payment(s).

(iii) The identity of each collaboration agent that received a distribution payment.

(iv) A description of the methodology and accounting formula for determining the amount of any distribution payment.

(14) The IOTA collaborator may not enter into a distribution arrangement with any collaboration agent that has a sharing arrangement with the same IOTA participant.

(15) The IOTA collaborator must retain and provide access to and must require collaboration agents to retain and provide access to, the required documentation in accordance with § 512.460.

(a) OIG authority. Nothing contained in the terms of the IOTA Model or this part limits or restricts the authority of the HHS Office of Inspector General, including its authority to audit, evaluate, investigate, or inspect the IOTA participant, IOTA collaborators, or any other person or entity or their records, data, or information, without limitation.

(b) Other authority. Nothing contained in the terms of the IOTA Model or this part limits or restricts the authority of any government agency permitted by law to audit, evaluate, investigate, or inspect the participant hospital, IOTA collaborators, or any other person or entity or their records, data, or information, without limitation.

(a) Cost sharing support for Part B and Part D immunosuppressive drugs. For immunosuppressive drugs covered under Medicare Part B or Medicare Part D and prescribed to an attributed patient, the IOTA participant may subsidize, in whole or in part, the cost sharing associated with the immunosuppressive drugs under Part B and Part D immunosuppressive drug cost sharing support defined at § 512.402 if all of the following conditions are met:

(1) The attributed patient is an eligible attributed patient as defined at § 512.402.

(2) The IOTA participant must provide a written policy in a form and manner specified by CMS for the provision of Part B and Part D immunosuppressive drug cost sharing support that is approved by CMS before the PY in which the cost sharing support is made available.

(i) The IOTA participant must revalidate the written policy with CMS and in a form and manner specified by CMS for the provision of Part B and Part D immunosuppressive drug cost sharing support before its provision in a subsequent PY.

(ii) The IOTA participant's initial written policy and the revalidation of the written policy must establish and justify the criteria that qualify an eligible attributed patient to receive Part B and Part D immunosuppressive drug cost sharing support.

(iii) The IOTA participant's written policy and the revalidation of the written policy must include an attestation that the IOTA participant will not, in providing Part B and Part D immunosuppressive drug cost sharing support, take into consideration the type, cost, generic status, or manufacturer of the immunosuppressive drug(s) or limit an eligible attributed patients' choice of pharmacy.

(b) Restrictions. (1) An IOTA participant must not take into consideration the type, cost, generic status, or manufacturer of the immunosuppressive drug(s) or limit an eligible attributed patients' choice of pharmacy when providing Part B and Part D immunosuppressive drug cost sharing support.

(2) An IOTA participant may not receive financial or operational support for Part B and Part D immunosuppressive drug cost sharing support from pharmacies and pharmaceutical manufacturers.

(c) Documentation. (1) An IOTA participant must maintain contemporaneous documentation that includes all of the following:

(i) The identity of the eligible attributed patient to whom Part B and Part D immunosuppressive drug cost sharing support was provided.

(ii) The date or dates on which Part B and Part D immunosuppressive drug cost sharing support was provided.

(iii) The amount or amounts of Part B and Part B immunosuppressive drug cost sharing support that was provided.

(2) An IOTA participant must retain and make available records pertaining to Part B and Part D immunosuppressive drug cost sharing support to the Federal Government in accordance with § 512.460.

(a) General. An IOTA participant may choose to provide any or all of the following types of attributed patient engagement incentives to an attributed patient under the conditions described in paragraph (b) of this section:

(1) Communication devices and related communication services directly pertaining to communication with an IOTA participant or IOTA collaborator to improve communication between an attributed patient and an IOTA participant or IOTA collaborator.

(2) Transportation to and from an IOTA participant and between other providers and suppliers involved in the provision of ESRD care.

(3) Mental health services to address an attributed patient's behavioral health symptoms pre- and post-transplant.

(4) In-home care to support the health of the attributed patient or the kidney transplant in the post-transplant period.

(b) Conditions. An IOTA participant may provide attributed patient engagement incentives of the type described in paragraphs (a)(1) through (4) of this section when all of the following conditions are met:

(1) An IOTA participant provides a written policy, in a form and manner specified by CMS, for the provision of attributed patient engagement incentives.

(2) CMS approves an IOTA participants written policy before the first PY in which an attributed patient engagement incentive is first made available.

(3) CMS revalidates the IOTA participant's written policy in a form and manner specified by CMS prior to each PY in which an attributed patient engagement incentive is offered subsequently.

(4) The IOTA participant includes in its written policy:

(i) A description of the items or services that will be provided as attributed patient engagement incentives.

(ii) An explanation of how each item or service that will be an attributed patient engagement incentive has a reasonable connection to any of the following:

(A) An attributed patient achieving and maintaining active status on a kidney transplant waitlist.

(B) An attributed patient accessing the kidney transplant procedure.

(C) The health of the attributed patient or the kidney transplant in the post-transplant period.

(D) A justification for the need for the attributed patient engagement incentives that is specific to the IOTA participant's attributed patient population.

(iii) An attestation that items that are attributed patient engagement incentives will be provided directly to an attributed patient.

(iv) An attestation that the IOTA participant will pay service providers directly for services that are attributed patient engagement incentives.

(v) An attestation that any items or services acquired by the IOTA participant that will be furnished as attributed patient engagement incentives will be acquired for the minimum amount necessary for an attributed patient to achieve the goals described in paragraphs (3)(ii)(A) through (C) of this paragraph.

(c) Restrictions. (1) An IOTA participant must provide items that are attributed patient engagement incentives directly to an attributed patient.

(2) An IOTA participant must pay service providers directly for any services that are offered as attributed patient engagement incentive.

(3) An IOTA participant must not offer an attributed patient engagement incentive that is tied to the receipt of items or services from a particular provider or supplier.

(4) An IOTA participant must not advertise or promote an item or service that is an attributed patient engagement incentive, except to make an attributed patient aware of the availability of the items or services at the time an attributed patient could reasonably benefit from them.

(5) An IOTA participant must not receive donations directly or indirectly to purchase attributed patient engagement incentives.

(6) An IOTA participant must retrieve items that that are attributed patient engagement incentives from the attributed patient when the attributed patient is no longer eligible for the that item or at the conclusion of the IOTA Model, whichever is earlier.

(i) Documented, diligent, good faith attempts to retrieve items that are attributed patient engagement incentives are deemed to meet the retrieval requirement.

(ii) [Reserved]

(7) Items that are communication devices:

(i) May not exceed $1,000 in retail value for any one attributed patient in any one PY;

(ii) Must remain the property of the IOTA participant;

(iii) Must be retrieved from the attributed patient by the IOTA participant—

(A) When the attributed patient is no longer eligible for the communication device or at the conclusion of the IOTA Model, whichever is earlier; and

(B) Before another communication device may be made available to the same attributed patient.

(d) Documentation. The IOTA participant must do all of the following:

(1) Maintain contemporaneous documentation of items and services furnished as attributed patient engagement incentives that includes, at minimum all of the following:

(i) The date the attributed patient engagement incentive is provided.

(ii) The identity of the attributed patient to whom the item or service was provided.

(2) Document all retrieval attempts of items that are attributed patient engagement incentives, including the ultimate date of retrieval.

(3)(i) Retain records pertaining to furnished attributed patient engagement incentives.

(ii) Make the records available to the Federal Government in accordance with § 512.460.

(a) Application of the CMS-sponsored model arrangements safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model arrangements (42 CFR 1001.952(ii)(1)) is available to protect remuneration furnished in the IOTA Model in the form of the Sharing Arrangement's gainsharing payments, the Sharing Arrangement's alignment payments, and the Distribution Arrangement's distribution payments that meet all safe harbor requirements set forth in 42 CFR 1001.952(ii), 512.452, and 512.454.

(b) Application of the CMS-sponsored model patient incentives safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives (42 CFR 1001.952(ii)(2)) is available to protect remuneration furnished in the IOTA Model in the form of Part B and Part D immunosuppressive drug cost sharing support and the attributed patient engagement incentives that meet all safe harbor requirements set forth in 42 CFR 1001.952(ii), 512.456 and 512.458.

(a) Right to audit. The Federal Government, including CMS, HHS, and the Comptroller General, or their designees, has the right to audit, inspect, investigate, and evaluate any documents and other evidence regarding implementation of the IOTA Model.

(b) Access to records. The IOTA participant and its IOTA collaborators must maintain and give the Federal Government, including, but not limited to, CMS, HHS, and the Comptroller General, or their designees, access to all such documents (including books, contracts, and records) and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the implementation of the IOTA Model, including without limitation, documents, and other evidence regarding all of the following:

(1) Compliance by the IOTA participant and its IOTA collaborators with the terms of the IOTA Model.

(2) The accuracy of model-specific payments made under the IOTA Model.

(3) The IOTA participant's downside risk payments owed to CMS under the IOTA Model.

(4) Quality measure information and the quality of services performed under the terms of the IOTA Model.

(5) Utilization of items and services furnished under the IOTA Model.

(6) The ability of the IOTA participant to bear the risk of potential losses and to repay any losses to CMS, as applicable.

(7) Contemporaneous documentation of cost sharing support furnished under Part B and Part D immunosuppressive drug cost sharing support that includes the following:

(i) The identity of the eligible attributed patient to whom Part B and Part D immunosuppressive drug cost sharing support was provided.

(ii) The date or dates on which Part B and Part D immunosuppressive drug cost sharing support was provided.

(iii) The amount or amounts of the cost sharing support provided to the attributed patient.

(8) Contemporaneous documentation of items and services furnished as attributed patient engagement incentives in accordance with § 512.458 that includes all of the following, at minimum:

(i) The date the attributed patient engagement incentive is provided.

(ii) The identity of the attributed patient to whom the item or service was provided.

(9) Patient safety.

(10) Any other program integrity issues.

(c) Record retention. (1) The IOTA participant and its IOTA collaborators must maintain the documents and other evidence described in paragraph (b) of this section and other evidence for a period of 6 years from the last payment determination for the IOTA participant under the IOTA Model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—

(i) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the IOTA participant at least 30 days before the normal disposition date; or

(ii) There has been a termination, dispute, or allegation of fraud or similar fault against the IOTA participant or its IOTA collaborators, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.

(2)(i) If CMS notifies the IOTA participant of the special need to retain a record or group of records in accordance with paragraph (c)(1)(i) of this section, the IOTA participant must maintain the records for such period of time as determined by CMS.

(ii) If CMS notifies the IOTA participant of a special need to retain records in accordance with paragraph (c)(1)(ii) of this section, the IOTA participant must notify its IOTA collaborators of this need to retain records for the additional period specified by CMS.

(a) Compliance with laws. The IOTA participant must comply with all applicable laws and regulations.

(b) CMS monitoring activities. (1) CMS, or its approved designee, may conduct monitoring activities to ensure compliance by the IOTA participant and IOTA collaborators with the terms of the IOTA Model under this subpart to—

(i) Understand IOTA participants' use of model-specific payments; and

(ii) Promote the safety of attributed patients and the integrity of the IOTA Model.

(2) Monitoring activities may include, without limitation, all of the following:

(i) Documentation requests sent to the IOTA participant and its IOTA collaborators, including surveys and questionnaires.

(ii) Audits of claims data, quality measures, medical records, and other data from the IOTA participant and its IOTA collaborators.

(iii) Interviews with the IOTA participant, including leadership personnel, medical staff, other associates, and its IOTA collaborators.

(iv) Interviews with attributed patients and their caregivers.

(v) Site visits to the IOTA participant and its IOTA collaborators, performed in a manner consistent with paragraph (c) of this section.

(vi) Monitoring quality outcomes and attributed patient data.

(vii) Tracking beneficiary complaints and appeals.

(viii) Monitoring the definition of and justification for the subpopulation of the IOTA participant's eligible attributed patients that may receive Part B and Part D immunosuppressive drug cost sharing support in accordance with § 512.456.

(ix) Monitoring the provision of attributed patient engagement incentives provided in accordance with § 512.458.

(x) Monitoring out of sequence allocation of kidneys by—

(A) Assessing the frequency at which IOTA waitlist patients, top-ranked on an IOTA participant's kidney transplant waitlist, receive the organ that was initially offered to them; and

(B) Determining the reasons behind cases where IOTA waitlist patients identified in paragraph (b)(x)(A) of this section, did not receive the kidney offered to them.

(3) In conducting monitoring and oversight activities, CMS or its designees may use any relevant data or information including without limitation all Medicare claims submitted for items or services furnished to IOTA transplant patients or IOTA waitlist patients or both.

(c) Site visits. (1) The IOTA participant must cooperate in periodic site visits performed by CMS or its designees in order to facilitate the evaluation of the IOTA Model in accordance with section 1115A(b)(4) of the ACT and the monitoring of the IOTA participant's compliance with the terms of the IOTA Model, including this subpart.

(2) When scheduling the site visit, CMS or its designee provides, to the extent practicable, the IOTA participant with no less than 15 days advance notice of any site visit. CMS—

(i) Attempts, to the extent practicable, to accommodate a request for particular dates in scheduling site visits; and

(ii) Does not accept a date request from the IOTA participant that is more than 60 days after the date of the initial site visit notice from CMS.

(3) The IOTA participant must ensure that personnel with the appropriate responsibilities and knowledge associated with the purpose of the site visit are available during all site visits.

(4) CMS may perform unannounced site visits at the office of the IOTA participant at any time to investigate concerns about the health or safety of attributed patients or other program integrity issues.

(5) Nothing in this part may be construed to limit or otherwise prevent CMS from performing site visits permitted or required by applicable law.

(d) Reopening of payment determinations. (1) CMS may reopen an IOTA Model-specific payment determination on its own motion or at the request of the IOTA participant, within 4 years from the date of the determination, for good cause (as defined at § 405.986 of this chapter) except if there exists reliable evidence that the determination was procured by fraud or similar fault as defined at § 405.902 of this chapter. In the case of fraud or similar fault, CMS may reopen an IOTA Model specific payment determination at any time.

(2) CMS' decision regarding whether to reopen a model-specific payment determination is binding and not subject to appeal.

(a) Grounds for remedial action. CMS may impose one or more remedial actions described in paragraph (b) of this section if CMS determines that:

(1) The IOTA participant has failed to furnish 11 or more kidney transplants for patients aged 18 years or older, regardless of payer, during a PY or any baseline years.

(2) The IOTA participant or its IOTA collaborator has failed to comply with any of the terms of the IOTA Model, including this subpart.

(3) The IOTA participant has failed to comply with transparency requirements described at § 512.442.

(4) The IOTA participant or its IOTA collaborator has failed to comply with any applicable Medicare program requirement, rule, or regulation.

(5) The IOTA participant or its IOTA collaborator has taken any action that threatens the health or safety of an attributed patient.

(6) The IOTA participant or its IOTA collaborator has submitted false data or made false representations, warranties, or certifications in connection with any aspect of the IOTA Model.

(7) The IOTA participant or its IOTA collaborator has undergone a change in control that presents a program integrity risk.

(8) The IOTA participant or its IOTA collaborator is subject to any sanctions of an accrediting organization or a Federal, State, or local government agency.

(9) The IOTA participant or its IOTA collaborator is subject to investigation or action by HHS (including the HHS Office of Inspector General or CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including any of the following:

(i) Being subject to the filing of a complaint or filing of a criminal charge.

(ii) Being subject to an indictment.

(iii) Being named as a defendant in a False Claims Act qui tam matter in which the Federal Government has intervened, or similar action.

(10) The IOTA participant or its IOTA collaborator has failed to demonstrate improved performance following any remedial action imposed under this section.

(11) The IOTA participant has misused or disclosed beneficiary-identifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the applicable data sharing agreement.

(b) Remedial actions. If CMS determines that one or more grounds for remedial action described in paragraph (a) of this section has taken place, CMS may take one or more of the following remedial actions:

(1) Notify the IOTA participant and, if appropriate, require the IOTA participant to notify its IOTA collaborators of the violation.

(2) Require the IOTA participant to provide additional information to CMS or its designees.

(3) Subject the IOTA participant to additional monitoring, auditing, or both.

(4) Prohibit the IOTA participant from distributing model-specific payments, as applicable.

(5) Require the IOTA participant to terminate, immediately or by a deadline specified by CMS, its sharing arrangement with an IOTA collaborator with respect to the IOTA Model.

(6) Terminate the IOTA participant from the IOTA Model.

(7) Suspend or terminate the ability of the IOTA participant to provide Part B and Part D immunosuppressive drug cost sharing support in accordance with § 512.456 or attributed patient engagement incentives in accordance with § 512.458.

(8) Require the IOTA participant to submit a corrective action plan in a form and manner and by a deadline specified by CMS.

(9) Discontinue the provision of data sharing and reports to the IOTA participant.

(10) Recoup model-specific payments.

(11) Reduce or eliminate a model-specific payment otherwise owed to the IOTA participant.

(12) [Reserved]

(13) Any other action as may be permitted under the terms of this part.

(a) Termination of IOTA participant from the IOTA Model by CMS. CMS may immediately or with advance notice terminate an IOTA participant from participation in the model if CMS does any of the following:

(1) Determines that it no longer has the funds to support the IOTA Model.

(2) Modifies or terminates the IOTA Model in accordance with section 1115A(b)(3)(B) of the Act.

(3) Determines that the IOTA participant has done any of the following:

(i) Failed to comply with any model requirements or any other Medicare program requirement, rule, or regulation.

(ii) Failed to comply with a monitoring or auditing plan or both.

(iii) Failed to submit, obtain approval for, implement or fully comply with the terms of a corrective action plan.

(iv) Failed to demonstrate improved performance following any remedial action.

(v) Taken any action that threatens the health or safety of a Medicare beneficiary or other patient.

(vi) Submitted false data or made false representations, warranties, or certifications in connection with any aspect of the IOTA Model.

(vii) Undergoes a change in control.

(viii) Assigns or purports to assign any of the rights or obligations under the IOTA Model, voluntarily or involuntarily, whether by merger, consolidation, dissolution, operation of law, or any other manner, without the written consent of CMS.

(ix) Poses significant program integrity risks, including but not limited to—

(A) Is subject to sanctions or other actions of an accrediting organization or a Federal, State, or local government agency; or

(B) Is subject to investigation or action by HHS (including OIG and CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including being subject to the filing of a complaint, filing of a criminal charge, being subject to an indictment, being named as a defendant in a False Claims Act qui tam matter in which the government has intervened, or similar action.

(b) Termination of Model participation by IOTA participant. The IOTA participant may not terminate their participation in the IOTA Model.

(c) Financial settlement upon termination. If CMS terminates the IOTA participant's participation in the IOTA Model, CMS calculates the final performance score and any upside risk payment or downside risk payment, if applicable, for the entire PY in which the IOTA participant's participation in the model was terminated.

(1) If CMS terminates the IOTA participant's participation in the IOTA Model, CMS determines the IOTA participant's effective date of termination.

(2) If CMS terminates the IOTA participant for any reasons listed under § 512.466:

(i) CMS does not make any payments of upside risk payment for the PY in which the IOTA participant was terminated; and

(ii) The IOTA participant will remain liable for payment of any downside risk payment up to and including the PY in which termination becomes effective.

(d) Termination of the IOTA Model by CMS. (1) The general provisions for the Innovation Center model termination by CMS listed under § 512.165 apply to the IOTA Model.

(i) CMS may terminate the IOTA Model for reasons including, but not limited to, those set forth in § 512.165(a).

(ii) If CMS terminates the IOTA Model, CMS provides written notice to IOTA participants specifying the grounds for model termination and the effective date of such termination.

(2) In accordance with section 1115A(d)(2) of the Act and § 512.170(e), termination of the IOTA Model under section 1115A(b)(3)(B) of the Act is not subject to administrative or judicial review.

(3) If CMS terminates the IOTA Model, the financial settlement terms described in paragraph (c) of this section apply.

(a) Notice of bankruptcy. (1) If the IOTA participant has filed a bankruptcy petition, whether voluntary or involuntary, the IOTA participant must provide written notice of the bankruptcy to CMS and to the U.S. Attorney's Office in the district where the bankruptcy was filed, unless final payment has been made by either CMS or the IOTA participant under the terms of each model tested under section 1115A of the Act in which the IOTA participant is participating or has participated and all administrative or judicial review proceedings relating to any payments under such models have been fully and finally resolved.

(2) The notice of bankruptcy must meet all of the following:

(i) Be sent by certified mail no later than 5 days after the petition has been filed.

(ii) Contain—

(A) A copy of the filed bankruptcy petition (including its docket number); and

(B) A list of all models tested under section 1115A of the Act in which the IOTA participant is participating or has participated.

(b) Change in control. (1) The IOTA participant must provide written notice to CMS at least 90 days before the effective date of any change in control.

(2) CMS may terminate an IOTA participant from the IOTA Model under § 512.466 if the IOTA participant undergoes a change in control.

(c) Prohibition on assignment. (1) Unless CMS provides prior written consent, an IOTA participant must not transfer, including by merger (whether the IOTA participant is the surviving or disappearing entity), consolidation, dissolution, or otherwise any—

(i) Discretion granted it under the model;

(ii) Right that it has to satisfy a condition under the model;

(iii) Remedy that it has under the model; or

(iv) Obligation imposed on it under the model.

(2) The IOTA participant must provide CMS 90 days advance written notice of any such proposed transfer.

(3) This obligation remains in effect after the expiration or termination of the model, or the IOTA participant's participation in the model, and until final payment by the IOTA participant under the model has been made.

(4) CMS may condition its consent to such transfer on full or partial reconciliation of upside risk payments and downside risk payments.

(5) Any purported transfer in violation of this requirement is voidable at the discretion of CMS.

CMS waives the requirements of sections 1881(b), 1833(a) and 1833(b) of the Act only to the extent necessary to make the payments under the IOTA Model described in this subpart.