What are the main differences between the Increasing Organ Transplant Access Model proposed rule and final rule?
CMS made several changes in the final rule for the Increasing Organ Transplant Access Model to address feedback received on the Notice of Proposed Rulemaking for the 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 participants and other groups impacted by the model more time to prepare for the model’s launch.The requirement to review organ offers, declined on behalf of the attributed patient who is a Medicare beneficiary, was removed to respond to feedback that the requirement, as proposed, would place too high an administrative burden on model participants and may cause beneficiary confusion without clear actionable next steps to take based on the information. The CMS Innovation Center will continue to discuss this proposal with interested parties and may amend and propose changes to this policy in future rulemaking.
CMS updated the metrics in the three domains used to calculate the performance scores for transplant hospitals. Performance scores are used to determine whether hospitals receive upside risk payments from CMS; fall in a neutral zone in which the hospital neither receives an upside risk payment nor owes a downside risk payment; or, beginning in performance year two, owe downside risk payments to CMS. Specific changes to the metrics include:
- Achievement domain: For the calculation of the transplant target, the model uses the average number of transplants performed during baseline years and trends the average forward using the national growth rate. The proposed health equity performance adjustment was removed, and the points allocation for this domain was updated to make the thresholds for achieving top performance more attainable.
- Efficiency domain: Remains as proposed and is based on the organ offer acceptance rate ratio.
- Quality domain: Three quality measures were removed, and the points allocation for the composite graft survival ratio was updated to compensate for the removal of the quality measure set.
Other updates to the model in the final rule include: - Health equity plans will be voluntary for the duration of the model.
- The maximum upside risk payment has been increased to $15,000 per Medicare kidney transplant, as opposed to $8,000 per Medicare kidney transplant in the proposed rule.
What is the model performance period?
The model is a six-year mandatory model with a performance period that begins July 1, 2025, and ends June 30, 2031.
How does the model help increase access to kidney transplants?
The goal of the Increasing Organ Transplant Access Model is to ensure more people with end-stage renal disease get access to transplants, by increasing the use of kidneys suitable for transplant that become available in the United States and increasing the number of transplants from living donors. To achieve these goals, the model provides incentives for transplant hospitals to optimally use deceased donor kidney for people with ESRD or improve kidney transplantation rates by reducing numbers of kidneys that are inappropriately discarded; assist potential donors with education and support through the living donor transplant process; improve care coordination and patient-centeredness in the kidney transplant process; and improve quality of care before, during, and after transplantation.
How are transplant hospitals selected to participate in the model?
Participation is determined by donation service area (DSA). CMS is selecting half of the DSAs in the country and all eligible transplant hospitals in those areas with an active kidney transplant program 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).
What is a collaborator? How is this different from a transplant hospital participant?
The required model participants are the transplant hospitals selected for inclusion in the model. Model collaborators are Medicare providers and suppliers with whom participants may choose to partner in order to achieve the goals of the model.
How will participating hospitals’ performance be measured under the model, and will they be paid?
Participating transplant hospitals receive upside risk payments from CMS; fall in a neutral zone in which the hospitals neither receive an upside risk payment nor owe a downside risk payment; or, beginning in performance year two, owe downside risk payments to CMS. The payments are based on a participating transplant hospital’s final performance score after each performance year. The final performance score is out of 100 possible points and is calculated on a set of proposed metrics in three domains: achievement, efficiency, and quality. The maximum positive payment per Medicare fee-for-service (FFS) transplant under the model (the upside risk payment) is $15,000. The maximum negative payment per Medicare FFS transplant under the model (the downside risk payment) is $2,000.
How do individuals know if they are receiving care from a participating transplant hospital?
Attributed individuals receive a notice of attribution from the participating transplant hospital. Individuals always retain their freedom of choice to seek care from any Medicare provider and are not limited to seeking care from their attributed transplant hospital.
How does the model improve care for people with end-stage renal disease?
CMS expects that people living with end-stage renal disease while on the kidney transplant waitlist could experience greater quality of care from a participating transplant hospital; for example, by having their care teams work to address their health-related social needs, greater access to a kidney transplant sooner, and increased engagement from their care teams post-transplant. Similarly, individuals considering living donation could experience greater engagement from the transplant hospital as they navigate the process of becoming a living donor.
Is the model an Advanced or MIPS Alternative Payment Model (APM)?
This model does not qualify as an Advanced APM or a MIPS APM.
What are the standard provisions for CMS Innovation Center models included in the final rule for the Increasing Organ Transplant Access Model?
Standard provisions for Innovation Center models are included in the final rule that are applicable to the ESRD Treatment Choices Model, as well as all mandatory Innovation Center models with a performance period that starts on or after January 1, 2025, not just the Increasing Organ Transplant Access Model. The standard provisions include terms that have been repeatedly memorialized, with minimal variation, in existing models’ governing documentation throughout the years. By adopting these standard provisions through rulemaking, the Innovation Center will increase transparency, efficiency, and clarity in the operation and governance of mandatory Innovation Center models and avoid the need to restate the provisions in each model’s governing documentation. The standard provisions address beneficiary protections, cooperation in model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, model termination by CMS, limitations on review, provisions on bankruptcy and other notifications, and the reconsideration review process.
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