CMS has released the final rule for the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model to encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD, while reducing Medicare expenditures and preserving or enhancing the quality of care furnished to beneficiaries with ESRD. Both of these modalities have support among health care providers and patients as preferable alternatives to in-center hemodialysis, but utilization has been less than in other developed nations. The Model will begin on January 1, 2021.
Studies have shown that for patients who require dialysis, dialyzing at home is often preferred by patients and physicians. The benefits include increased independence and quality of life. The rate of home dialysis in the U.S. – about 12% in 2016 – falls far below that of other developed nations.
Transplantation is widely viewed as the optimal treatment for most patients with ESRD, generally increasing survival and quality of life while reducing medical expenditures. However, in 2016 only 29.6% of prevalent ESRD patients in the US had a functioning transplant and only 2.8% of incident patients received a preemptive transplant. These rates are below those of other developed nations. The U.S. was ranked 39th of 61 countries reporting to the USRDS in 2016.
One of the goals of the ETC model is to give ESRD beneficiaries the freedom and choice of ESRD treatment that best works with their lifestyles. For example, if a beneficiary chooses home dialysis, they would have greater flexibility to adjust the hours and frequency of their treatment. Under the ETC Model, CMS will make certain payment adjustments that will encourage participating ESRD facilities and Managing Clinicians to ensure that ESRD beneficiaries have access to and receive education about their kidney disease treatment options. Specifically, CMS will positively adjust certain Medicare payments to participating ESRD facilities and Managing Clinicians for the first three years of the model for home dialysis and dialysis-related services.
The model will require the Medicare payment adjustments for the selected ESRD facilities and Managing Clinicians. For the model, a Managing Clinician is a Medicare-enrolled physician or non-physician practitioner who furnishes and bills the monthly capitation payment (MCP) for managing one or more adult ESRD beneficiary. Payment to ESRD facilities and Managing Clinicians not selected to participate in the model would not be affected.
To implement a model test that would require participation on the part of certain health care providers, CMS is required to issue a Notice of Proposed Rulemaking (NPRM). Accordingly, CMS’s proposals for the ETC Model are included in the proposed rule for Specialty Care Models to Improve Quality of Care and Reduce Expenditures. This NPRM was issued on July 10, 2019 CMS reviewed public comments and published the final rule for the model on September 18, 2020.
In July 2021, CMS proposed changes to the ETC Model to address health and socioeconomic disparities, which are a major contributor to chronic kidney disease and ESRD. These proposed changes were part of the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Notice of Proposed Rulemaking. The proposed changes include incentives for participating ESRD facilities and Managing Clinicians to address health equity among their patients. They also include incentives that would reduce the disparities in which ESRD patients of lower socioeconomic status are able to access alternatives to in-center dialysis, specifically home dialysis and transplantation.
If these changes are finalized, the ETC Model would be the agency’s first CMS Innovation Center model to directly address health equity.
CMS is requiring participation in order to minimize the potential for selection effect. Selection effect occurs when only the potential participants who would benefit financially from a model choose to participate. Selection effect may reduce the amount of savings that a model can generate. Requiring participation for certain models helps CMS understand the impact on a variety of provider types so that the resulting data would be more broadly representative.
CMS will select ESRD facilities and Managing Clinicians to participate in the model according to their location in randomly selected geographic areas so as to account for approximately 30 percent of the ESRD facilities and Managing Clinicians in the 50 States and District of Columbia. A specific element of the selection will be that ESRD facilities and Managing Clinicians in Maryland would generally be included in the model’s interventions, so as to be consistent with the Total Cost of Care Model being tested in that State. Across the U.S., certain facilities and clinicians will be excluded from certain portions of the model’s interventions on account of serving low volumes of adult ESRD beneficiaries.
Beneficiaries will be attributed on a month-by-month basis. A beneficiary will be attributed to the ESRD facility accounting for the most dialysis claims during the month, and the Managing Clinician billing the first MCP for the month.
Two types of payment adjustments will apply. The first will be a uniformly positive adjustment on Medicare claims for home dialysis during the initial three years of the model, providing an additional payment to selected facilities and clinicians for supporting beneficiaries dialyzing at home. The second adjustment will apply to both home and in-center dialysis and related claims, and could be either positive or negative. These adjustments, either upward or downward, would be made to the per treatment payment for dialysis based on the rate of home dialysis and transplant rate calculated as the sum of the transplant waitlist rate and the living donor transplant rate . Greater positive and negative adjustments for model participants would be phased in over the performance period of the model.
The proposed ESRD Treatment Choices Model is included in the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures Notice of Proposed Rule Making. The public comment period for the Notice of Proposed Rule Making closed on September 16, 2019. CMS reviewed comments and published a final rule on September 18, 2020.
The model went into effect January 1, 2021.
In July 2021, ETC Model proposed changes were part of the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Notice of Proposed Rulemaking. Public comments are due August 31, 2021.
For any questions, please email the ETC Model team atETC-CMMI@cms.hhs.gov.
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- ESRD Treatment Choices Introductory Webinar - Wednesday, 12/9/2020 from 1:00 - 2:00 pm - Transcript (PDF) | Slides (PDF) | Recording (MP4)
- ETC Model Achievement Benchmarks for Measurement Year 1 (January 1, 2021 – December 31, 2021: Updated May 27, 2021) (PDF)
- ETC Model Achievement Benchmarks for Measurement Year 2 (July 1, 2021 – June 30, 2022) (PDF)
- ETC Model Fact Sheet (September 2020)
- ETC Model Press Release (September 2020)
- ETC Model Fact Sheet (July 2021)
- ETC Model Press Release (July 2021)
- ETC List of Selected Geographic Areas: PDF | XLS
- Specialty Care Models Final Rule
- ETC Model Beneficiary Notification Form and Guidance - English (PDF)
- ETC Model Beneficiary Notification Form and Guidance - Spanish (PDF)
- Advancing American Kidney Health
- ETC Model Archived Materials