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).