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42 U.S.C. 1302, 1315a, and 1395hh.
85 FR 61362, Sept. 29, 2020, unless otherwise noted.
89 FR 96445, Dec. 4, 2024, unless otherwise noted.
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Subscribe to: 42 CFR Part 512 Subpart D - Beneficiary Protections and Financial Arrangements, Beneficiary Incentives, and Compliance
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(a) General.
(1) IOTA participants must provide notice to attributed patients who are Medicare beneficiaries 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)
(A) Provide the notification described in paragraph (a) of this section to each applicable attributed patient in a paper format at their first office visit or other outpatient visit after the start of the IOTA Model; or
(B) If the applicable attributed patient has affirmatively opted out of receiving paper communication or has chosen to receive communication through electronic methods, the notification described in paragraph (a) of this section may be distributed through that agreed upon electronic method.
(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).
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32872, June 1, 2026]
(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.
(xi) Monitoring the publication of selection criteria provision in accordance with § 512.442(a).
(xii) Monitoring the review of acceptance criteria provision in accordance with § 512.442(c).
(xiii) Monitoring the change in waitlist status provision in accordance with § 512.442(d).
(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.
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32872, June 1, 2026]
(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 any of the following:
(A) Is subject to sanctions or other actions of an accrediting organization or a Federal, State, or local government agency.
(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 any of the following:
(1) Being subject to the filing of a complaint or filing of a criminal charge.
(2) Being subject to an indictment.
(3) Being named as a defendant in a False Claims Act qui tam matter in which the government has intervened, or similar action.
(C) If HHS or the OPTN has determined that an IOTA participant has violated the OPTN's policies, OPTN's Management and Membership policies, or HHS regulations (42 CFR part 121) upon a review conducted under 42 CFR 121.10.
(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.
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32873, June 1, 2026]
(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.