Increasing Organ Transplant Access (IOTA) Model Frequently Asked Questions

Table of Contents

• Model Goals and Final Rule
• Data and Quality Measures
• Data Collection and Sharing
• Performance Assessment and Scoring
• Kidney Transplant Targets and Volumes in the Achievement Domain
• Payment and Financial Considerations
• Other Care Delivery Requirements
• Selection, Participation, and Model Overlap
• Collaboration and Additional Stakeholders
• Timeline and Logistics

Model Goals and Final Rule

How does the model help increase access to kidney transplants?

The Increasing Transplant Access (IOTA) Model aims to help more patients with end-stage renal disease (ESRD) receive kidney transplants by:

• Encouraging transplant hospitals to use more available kidneys
• Reducing the number of discarded kidneys
• Supporting and educating potential living donors
• Improving care coordination and patient-centered care
• Enhancing the quality of care before, during, and after receiving a transplant
   

How does the IOTA Model aim to improve care for people with end-stage renal disease?

The model aims to improve care for people with end-stage renal disease by:

• Enhancing the quality of care for those on the kidney transplant waitlist
• Providing quicker access to kidney transplants
• Increasing engagement from care teams before, during, and after receiving a transplant
• Offering more support and engagement for individuals considering living donation
   

What are the main differences between the IOTA Model proposed rule and final rule?

MS made several changes in the final rule to address feedback received on the Notice of Proposed Rulemaking for the IOTA Model. The revisions address concerns related to burden for transplant hospitals selected to participate in the model and improve the model to best meet the needs of people with chronic kidney disease.

The final rule moves back the start date of the model to July 1, 2025, from the proposed date of January 1, 2025, to give IOTA participants and other groups impacted by the model more time to prepare for the IOTA Model’s launch. Other major changes include:

• Increasing the maximum amount an IOTA participant may receive from CMS based on its performance score (upside risk payment) from $8,000 to $15,000 per Medicare kidney transplant.
• Removing the requirement for providers to review organ offers declined on behalf of the attributed patient.
• Updating the points allocation for the achievement domain to make the thresholds for achieving top performance more attainable.
• Adjusting the transplant target in the achievement domain to reflect the average number of deceased donor kidney transplants and average number of living donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older during the relevant baseline years, rather than the highest count. This average is then trended forward by the national growth rate, or zero should the national growth rate be negative, resulting in the transplant target for a given performance year (PY).
• Adjusting the quality strategy in the quality domain to allow for additional time for measure identification and stakeholder input, including removing three quality measures from the quality domain.

• Updating the points allocation in the quality domain for the composite graft survival rate to compensate for the removal of the quality measure set.

   

What are the standard provisions for CMS Innovation Center models included in the final rule for the IOTA Model?

The final rule includes standard provisions for all mandatory CMS Innovation Center models starting on or after January 1, 2025. These provisions apply to the ESRD Treatment Choices Model and others, not just the IOTA Model. They aim to enhance transparency, efficiency, and clarity. Key provisions cover:

Data and Quality Measures

Data Collection and Sharing

How will the data be collected?

CMS will obtain IOTA participant data. There are currently no data submission requirements for IOTA participants, but that may change in later years of the model. Please stay updated on the IOTA Model by signing up for the listserv via the form linked here.

Will IOTA participant and beneficiary data be shared?

Yes, IOTA participant and beneficiary data will be shared under specific conditions to assist IOTA participants in evaluating the health needs of their patients, improving health outcomes, and producing efficiencies in the provision and use of services. Please review additional data sharing information below:

Beneficiary-Identifiable Data

• Will be provided to IOTA participants for their Medicare beneficiaries who are attributed patients, upon request
• Intends to help IOTA participants evaluate health needs, improve health outcomes, and enhance service efficiency

Aggregate Data

• Will be de-identified in accordance with the HIPAA Privacy Rule (45 CFR 164.514(b))
• Will be provided to help IOTA participants understand their performance against the transplant target information for each PY

Conditions for Data Sharing

• IOTA participants, their IOTA collaborators, and other related entities must observe all relevant statutory and regulatory provisions regarding data use, confidentiality, and privacy
• Compliance with the terms of the data sharing agreement is mandatory
   

Performance Assessment and Scoring

Reconsideration review process

How will IOTA participants’ performance be measured under the IOTA Model, and will they be paid?

For each PY, an IOTA participant either receives an upside risk payment from CMS; falls in a neutral zone in which the IOTA participant neither receives an upside risk payment nor owes a downside risk payment; or, beginning in PY 2, owes a downside risk payment to CMS. The payments are based on an IOTA participant’s final performance score for each PY. The final performance score is out of 100 possible points and is calculated on a set of metrics in three domains: achievement, efficiency, and quality. The maximum positive payment per Medicare kidney transplant, as defined in § 512.402, under the model (the upside risk payment) is $15,000. The maximum negative payment per Medicare kidney transplant under the model (the downside risk payment) is $2,000.
 

What metrics will be used to calculate performance scores in the IOTA Model?

The IOTA Model will include metrics in three domains to calculate the performance scores for IOTA participants, as described in § 512.422.

• Achievement domain: For the calculation of the transplant target, the model uses the average number of deceased donor kidney transplants and average number of living donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older across the relevant baseline years and trends the total average forward using the national growth rate.
• Efficiency domain: Based on the Organ Procurement and Transplantation Network (OPTN) organ offer acceptance rate ratio.
• Quality domain: Based on the composite graft survival rate.
   

Is the organ acceptance rate ratio measure risk adjusted?

Per § 512.426(b)(1)(i)(B), the IOTA Model uses the Scientific Registry of Transplant Recipients (SRTR) adult kidney model strata risk-adjustment methodology and most available set of coefficients to calculate the number of expected organ-offer acceptances.

How is CMS calculating graft survival in the quality domain?

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 § 512.428.

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. For all subsequent PYs, CMS calculates the IOTA participant's cumulative composite graft survival rate using the same calculation methodology described in § 512.428(b)(1).

Data and Quality Measures

How can CMS prevent the IOTA Model from penalizing IOTA participants for uncontrollable factors, such as limited organs and matching challenges?

CMS acknowledges the multitude of factors that can impact kidney transplant hospital volume—from a community level to a nationwide level—and also acknowledges that kidney transplant volume expansion may require increased resources, particularly staffing. To prevent penalizing IOTA participants for uncontrollable factors, the IOTA Model incorporates several strategies. The IOTA Model includes three performance domains: achievement, efficiency, and quality. This structure helps offset challenges in the achievement domain by considering other aspects of performance.

Transplant targets are calculated each PY based on an IOTA participant's historical kidney transplant volume during the relevant baseline years (as described in § 512.424(b)). The national growth rate is also calculated each PY to trend the sum of the mean deceased donor kidney transplant volume and sum of the mean living donor kidney transplant volume during the relevant baseline years trended forward by the national growth rate. This approach ensures transplant targets are realistic and tailored to each IOTA participant's historical performance.

There are no prescriptive specifications requiring IOTA participants to meet transplant target volumes in a specific way. This flexibility allows IOTA participants to choose the best methods to optimize their kidney transplant volume.
PY 1 does not include any downside risk payments, regardless of the final performance score. This creates a buffer period for IOTA participants to adjust and anticipate the resources needed for success in subsequent years.

The neutral zone has a final performance score range of 41-59 points (inclusive) for PYs 2-6, as described in § 512.430(b)(2) of the final rule. This approach aims to be more flexible and accommodating to IOTA participants with no, or limited, Alternative Payment Model (APM) experience, or that are more limited in terms of resources and capabilities.

Events may occur outside the purview and control of the IOTA participant that may affect their performance in the model. In the event of extreme and uncontrollable circumstances, such as a public health emergency, CMS may reduce the downside risk payment, if any, prior to recoupment by an amount determined by multiplying the downside risk payment by the percentage of total months during the PY affected by an extreme and uncontrollable circumstance, and by the percentage of attributed patients who reside in an area affected by the extreme and uncontrollable circumstance, as described in § 512.436. CMS will address only the downside risk payment under this policy to mitigate the harm to entities due to extreme and uncontrollable circumstances.

By incorporating these components, the IOTA Model aims to provide a balanced and fair assessment of IOTA participant performance, while acknowledging and mitigating the impact of uncontrollable factors.

How can CMS prevent the IOTA Model from penalizing smaller and/or newer kidney transplant hospitals?

As described in section III.C.5.c(1) of the final rule, the updated methodology for calculating transplant targets in the achievement domain each PY will be based on the average number of kidney transplants performed in the relevant baseline years, trended forward by the national growth rate. Therefore, CMS believes all model participants can improve their kidney transplant rates, regardless of size. CMS acknowledges that kidney transplant hospitals of different sizes will have different challenges in increasing kidney transplant volume. To address this, the IOTA Model includes a low volume threshold. Kidney transplant hospitals that performed fewer than 11 kidney transplants for patients aged 18 years or older in each of the baseline years were not eligible to be selected to participate in the IOTA Model, as described in section III.C.3(c) of the final rule.

CMS recognizes that some IOTA participants may have to make upfront investments, but the low volume threshold of 11 or more adult kidney transplants for each kidney transplant hospital in each of the baseline years will substantially mitigate the demands placed on newer, smaller kidney transplant hospitals.

Kidney Transplant Targets and Volumes in the Achievement Domain

Where can IOTA participants go to view their transplant targets? When?

Once IOTA participants complete the onboarding process to 4innovation (4i), they will be able to access data and reports pertinent to their transplant hospital. The transplant target report will provide the target number of kidney transplants set for each IOTA participant to measure performance in the achievement domain for the relevant PY. CMS will notify each IOTA participant of the transplant target by the first day of the start of each PY.
 

How is the transplant target for each IOTA participant calculated?

For each PY, the transplant target for each IOTA participant is calculated by determining the average of the total number of deceased donor and living donor kidney transplants furnished to patients 18 years of age or older during the relevant baseline years, which is then trended forward by the national growth rate, or zero should the national growth rate be negative.

For more information about the achievement domain, view § 512.424.
 

Is the transplant target different for each PY?

The transplant target is not static or fixed. The IOTA Model will set a transplant target that is specific to each IOTA participant, while still accounting for the national growth rate and the average of the total number of deceased donor and living donor kidney transplants furnished to patients 18 years of age or older during the relevant baseline years. Due to the calculation methodology, the transplant target could change for an IOTA participant from one PY to the next.

Payment and Financial Considerations

How do performance scores translate to payments?

Each IOTA participant's final performance score will determine whether:

1. CMS will pay an upside risk payment to the IOTA participant;
2. The IOTA participant will fall into a neutral zone where no performance-based incentive payment will be paid to or owed by the IOTA participant; or
3. The IOTA participant will owe a downside risk payment to CMS.

As described in § 512.430, for a final performance score of 60 and above, CMS will apply the formula for the upside risk payment. CMS calculates the IOTA participant's upside risk payment by subtracting 60 from the IOTA participant’s final performance score, dividing the result by 40, and multiplying the resulting amount by $15,000. CMS then multiplies the result from the calculation by the total number of Medicare kidney transplants performed by the IOTA participant during the PY.

Final performance scores below 60 in PY 1 and final performance scores of 41 to 59 (inclusive) in PYs 2-6 will fall in the neutral zone where there will be no payment owed to the IOTA participant or CMS.

For PYs 2-6, final performance scores of 40 and below will fall in the downside payment zone, requiring payment to CMS. CMS calculates the downside risk payment by subtracting the IOTA participant’s final score from 40, dividing the resulting amount by 40, then multiplying the resulting amount by $2,000. CMS then multiplies the resulting amount 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.
 

Can you clarify how all transplant patients (Medicare and non-Medicare) are included in measuring performance, but payments relate to Medicare only?

CMS will determine an IOTA participant’s performance across the achievement, efficiency, and quality domains based on all IOTA waitlist patients and IOTA transplant patients, regardless of payer type.

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. CMS then calculates each IOTA participant’s payment based on both the final performance score and the number of Medicare kidney transplants, as defined in § 512.402. The payment calculation methodology is specified in § 512.430.

CMS attributes kidney transplant waitlist patients and kidney transplant patients to IOTA participants based on the attribution criteria as described in § 512.414 for all the following purposes:

• Sharing Medicare claims data for attributed beneficiaries with IOTA participants.
• Assessing each IOTA participant's performance across the achievement domain, efficiency domain, and quality domain.
• Determining performance-based payments paid to or by IOTA participants.

Other Care and Delivery Requirements

Are IOTA participants required to review organ offer acceptance criteria twice per year with every patient?

Per § 512.442(c), 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. IOTA participants must conduct this review via a patient visit, phone call, email, or mail on an individual basis, unless the Medicare beneficiary declines this review.

Generally discussing organ offer acceptance criteria is a first step in increasing patient's awareness about why certain organs may or may not be accepted at a particular transplant program. As IOTA participants may choose to analyze data to better understand ideal organ offer filters, these findings can be used as supporting evidence when explaining to beneficiaries why their kidney transplant program may or may not accept certain kidney transplant offers.
 

What are IOTA Model “flexibilities” to assist with supporting their transplant population?

CMS provides additional flexibilities under the IOTA Model to allow IOTA participants to support attributed patients in overcoming challenges associated with remaining active on the kidney transplant waitlist and adhering to comprehensive post-transplant care.

Per § 512.458, IOTA participants may choose to provide any or all of the following types of attributed patient engagement incentives below, under the conditions described in § 512.458(b).

• 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.
• Transportation to and from a transplant hospital that is an IOTA participant and between other providers and suppliers involved in the provision of ESRD care.
• Mental health services to address an attributed patient's behavioral health symptoms pre- and post-transplant.
• In-home care to support the health of the attributed patient or the kidney transplant in the post-transplant period.

Per § 512.456, IOTA Participants may also offer the following beneficiary incentive: Part B and Part D immunosuppressive drug cost sharing support.

Selection, Participation, and Model Overlap

How were donation service areas (DSAs) and kidney transplant hospitals selected to participate in the IOTA Model?

CMS selected half of the DSAs in the country, and all eligible kidney transplant hospitals in the selected DSAs are required to participate in the model. The other half of transplant hospitals will serve as the comparison group for evaluation purposes. CMS selected 103 hospitals and published the list of participating kidney transplant hospitals (XLSX).
 

Do you plan to add more participants to the IOTA Model?

CMS expects that no additional participant selections would be made for the IOTA Model after its start date unless 10 percent or more of selected participants are terminated from the model during the model performance period (section III.C.3.d(2)). If this were to occur, CMS would address the selection of new participants in future rulemaking.
 

Can you discuss any model overlap considerations?

The IOTA Model is allowing overlaps between the IOTA Model and other Innovation Center models and CMS programs. There could be situations where a Medicare beneficiary attributed to an IOTA participant could be assigned to another Innovation Center model or CMS program, and overlap could also occur among providers at the individual or organization level.

CMS believes that the IOTA Model will be compatible with existing models and programs that provide opportunities to improve care and reduce spending. The IOTA Model will not be replacing any covered services or changing the payments that participating hospitals receive through the Medicare inpatient prospective payment system (IPPS) or outpatient prospective payment system (OPPS). Rather, the IOTA Model implements performance-based payments separate from what participants will be paid by CMS for furnishing kidney transplants to Medicare beneficiaries. Additionally, the IOTA Model will work to resolve any potential overlaps between the IOTA Model and other Innovation Center models or CMS programs that could result in duplicative payments for services, or duplicative counting of savings or other reductions in expenditures.
 

Is the model an Advanced or MIPS Alternative Payment Model (APM)?

The IOTA Model is a MIPS APM.
 

Which patients will be attributed to IOTA Model participants?

The following patients who are alive at the time CMS conducts attribution would be attributed to an IOTA participant:

1. A kidney transplant waitlist patient, regardless of payer type and waitlist status, who is alive, 18 years of age or older, and is registered on a waitlist, to one or more IOTA participants, as identified by the OPTN computer match program; and,
2. A kidney transplant patient who receives a kidney transplant at the age of 18 years or older from an IOTA participant at any time during the model performance period.

These patients will be referred to as IOTA waitlist patients and IOTA transplant patients, respectively, for purposes of assessing each IOTA participant's performance and performance- based payments. View § 512.414(b) for more patient attribution and de-attribution criteria information.

CMS understands that many patients on the waiting list are registered at multiple transplant hospitals. Therefore, the model will attribute each of these waitlisted patients to every IOTA participant where they are registered on a waitlist during a given month in the applicable quarter. However, a “kidney transplant patient,” as defined in § 512.402, will be attributed to the IOTA participant that furnished the kidney transplant.
 

How do patients know if they are receiving care from an IOTA participant?

Attributed patients will receive a notice of attribution from the IOTA participant. Patients always retain their freedom of choice to seek care from any Medicare provider and are not limited to seeking care from their attributed IOTA participant.

Collaboration and Additional Stakeholders

What is an IOTA collaborator? How is this different from a kidney transplant hospital participant?

The required model participants are the kidney transplant hospitals selected for inclusion in the model. IOTA collaborators, as defined in § 512.402, are Medicare-enrolled providers and suppliers that enter a sharing arrangement with an IOTA participant.
 

Will there be a workgroup or learning system and when?

Yes, a learning system will be launched during PY 1.
 

How will the IOTA Model work to streamline the waitlist evaluation process?

CMS believes that providing transplant patient selection criteria for patients under evaluation for a kidney transplant creates transparency for both patients and for their referring nephrologists. Referring nephrologists have more patient contact than a transplant nephrologist at time of referral, and therefore are key in referring patients for kidney transplant evaluation and in having the ability to guide the patient to the kidney transplant hospital that may be most ideal for the patient. With the overwhelming amount of information that a kidney transplant patient learns during their multi-hour initial transplant evaluation, CMS believes prompts for early transplant discussions between a referring nephrologist and patient can create opportunities for a more fruitful evaluation experience for the patient. This may also open communication between transplant nephrologists and referring nephrologists.

Timeline and Logistics

What is the IOTA Model performance period?

The IOTA Model performance period begins July 1, 2025, and ends June 30, 2031.

When are the PYs?

When will IOTA participants know their final performance scores?

Per § 512.430(d), CMS conducts and calculates preliminary performance assessment and payment calculations at least 3 to 6 months after the end of each PY. 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. CMS gives IOTA participants 30 days to review preliminary performance assessment and payment calculations and request targeted reviews, as described in § 512.434. 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.
 

What is the baseline year?

Baseline year, as defined in § 512.402, 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.

When will IOTA participants send or receive payment?

Per § 512.430(d), 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.

• 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).
• 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.
  • CMS includes all the following details in the demand letter:
    • IOTA participant performance in the model.
    • Amount of downside risk payment owed to CMS by the IOTA participant.
    • How the IOTA participant may make payments to CMS.
  • 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.
     

Can there be more than one primary contact or individual who has access to 4i?

There can be more than one individual per IOTA participant who has access to 4i. Only one user is required for onboarding. Once the initial 4i user has been onboarded, they will be able to invite as many relevant individuals to access 4i as they would like. There are also different contact types in 4i that may be selected when adding new users.
 

How do I sign up for the listserv and stay updated on the IOTA Model?

• To stay updated on the IOTA Model, sign up for the listserv via the form linked here.
• If you are an IOTA participant and a representative from your team has not previously provided CMS with contact information, please share your contact information by
  emailing CMMItransplant@cms.hhs.gov. 

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