ESRD Treatment Choices (ETC) Model

CMS recognizes the ongoing disruptions to patient care and the health care ecosystem resulting from the tremendous impacts of Hurricane Helene to Baxter’s North Cove manufacturing site. As we monitor its implications on participants in the ESRD Treatment Choices (ETC) Model and their ability to deliver home dialysis services across the country, we will continue to hear from model participants and explore options to best accommodate participants on key performance metrics in this mandatory model.

Impacts on performance metrics for participants will be examined for Measurement Years (MYs) 7, 8, and 9 (CY 2024 Q3 and Q4 through CY 2025 Q1 and Q2) and Benchmark Years (BYs) 7, 8, and 9. Achievement Benchmarks for each MY are based on national performance from a previous 12- month period to calculate historical performance rates in comparison geographic areas. A decrease in home dialysis in these time periods would begin to affect model performance payment adjustments in July 2025.

The CMS Innovation Center is considering an array of options to address the challenges created by the impact of Hurricane Helene, including potential policy and or payment changes to the model.

As the volume of new patients starts to gradually increase to pre-Hurricane Helene levels, we plan to provide transparent communications to stakeholders and formally announce any updates or changes to our model through rulemaking. Questions or concerns should be submitted to ETC-CMMI@cms.hhs.gov.

On November 12, 2024, proposed modifications to the ETC Model were finalized in the CY2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-1805-F). The final rule is available here: https://www.federalregister.gov/documents/2024/11/12/2024-25486/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis.

The End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model is a mandatory model intended 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 have been used less than in other developed nations. The model began on January 1, 2021. In fall 2021, it became one of the first CMS Innovation Center models to directly address health equity, as social determinants of health have a significant impact on chronic kidney disease and end-stage renal disease.

Highlights

  • Many patients with end-stage renal disease do not receive education about their treatment options, including the choice to get dialysis at home rather than at a center or the possibility of a kidney transplant. Both these treatment options are known to offer patients increased quality of life.
  • The goal of the ESRD Treatment Choices (ETC) Model is for patients to have greater independence and flexibility by receiving home dialysis and have longer, healthier lives resulting from a kidney transplant.
  • Dialysis facilities and doctors who are part of the ETC Model are encouraged to offer patients education to support their choice of treatment option to replace kidney function.
  • The ETC Model provides additional support to health care providers who treat underserved patients, including those who are dually eligible for Medicare and Medicaid, as well as Medicare beneficiaries who are eligible to receive assistance with prescription drug costs through the Part D program (also known as the Low-Income Subsidy).
  • The ETC Model is a mandatory model for approximately 30% of ESRD facilities and Managing Clinicians in the U.S. For the purposes of 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 beneficiaries. Payment to ESRD facilities and Managing Clinicians not selected to participate in the model are not affected.

Background

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 U.S. 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.

Model Details

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 makes certain payment adjustments that encourage participating ESRD facilities and Managing Clinicians to ensure that ESRD beneficiaries have access to and receive education about and have access to their kidney disease treatment options. Specifically, CMS positively adjusts 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 requires the Medicare payment adjustments for selected ESRD facilities and Managing Clinicians. CMS requires 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.

To implement a model test that would require participation on the part of certain health care providers, CMS was required to issue a Notice of Proposed Rulemaking (NPRM). Accordingly, CMS’s proposals for the ETC Model were included in the proposed rule 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, Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures (85 FR 61114), on September 18, 2020.

On October 29, 2021, CMS finalized changes to the ETC Model through the CY 2020 End Stage Renal Disease Prospective Payment System Final Rule. The changes to the ETC Model policies aim to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model one of the agency’s first CMS Innovation Center models to directly address health equity. While people from all backgrounds can be diagnosed with ESRD, it is more common in minority and low-income populations. Social determinants of health impact not just who ends up with ESRD, but the quality of health care they are able to access. Closing these health equity gaps would help address this devastating disease, provide better accessibility to care, and reduce costs to the U.S. healthcare system.

CMS finalized a two-tiered approach to address disparities in home dialysis and transplant rates through the ETC Model’s benchmarking and scoring methodology. 

  1. CMS added a Health Equity Incentive to the improvement scoring methodology for both the home dialysis rate and the transplant rate. With the Health Equity Incentive, ETC Participants who demonstrate significant improvement in the home dialysis rate or transplant rate among their attributed beneficiaries who are dual-eligible for Medicare and Medicaid or Low Income Subsidy (LIS) recipients can earn additional improvement points.
     
  2. CMS will stratify achievement benchmarks by the proportion of beneficiaries who are dual-eligible for Medicare and Medicaid or are LIS recipients to ensure that ETC Participants who see a high volume of these patients are not disproportionately negatively affected under the achievement benchmark methodology.

Taken together, these two changes provide an incentive for ETC Participants to reduce disparities among their Medicare beneficiaries and acknowledge that socioeconomic disparities in access to alternative renal replacement modalities exist and may impact the ability of ETC Participants to perform well in the ETC Model.

On October 31, 2022, CMS finalized three changes to the ETC Model in the final rule, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. These changes include additional beneficiary protections related to the furnishing of kidney disease patient education services and changes to the Performance Payment Adjustment (PPA) achievement scoring methodology. In addition, and in line with CMMI efforts to increase data transparency final, the rule also describes CMMI’s intention to publish ETC Participant performance information.

On November 12, 2024, CMS finalized a minor change to the ETC Model through the CY 2025 End Stage Renal Disease Prospective Payment System Final Rule. The finalized policy allows for a methodological change to the definition of an ESRD Beneficiary for the purposes of attribution in the model to more accurately identify transplant failures. The second criterion of our definition of an ESRD Beneficiary at § 512.310 will specify that the beneficiary’s latest transplant date must be identified by more than one of the following:  (1) two or more MCP claims in the 180 days following the date on which the kidney transplant was received; (2) 24 or more maintenance dialysis treatments at any time after 180 days following the transplant date; or (3) indication of a transplant failure after the beneficiary’s date of transplant based on data from the Scientific Registry of Transplant Recipients (SRTR).   

Methodologies

CMS selects 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 is that ESRD facilities and Managing Clinicians in Maryland are generally included in the model’s interventions to be consistent with the Total Cost of Care Model being tested in that State. Across the U.S., certain facilities and clinicians are excluded from certain portions of the model’s interventions on account of serving low volumes of adult ESRD beneficiaries.

Beneficiaries are attributed on a month-by-month basis. A beneficiary is 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 apply. The first is 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 applies to both home and in-center dialysis and related claims, and could be either positive or negative. These adjustments, either upward or downward, are 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 are phased in over the performance period of the model.

Timeline

The proposed ESRD Treatment Choices Model was 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 were due August 31, 2021. CMS reviewed comments and published a final rule on October 29, 2021. 

For any questions, please email the ETC Model team at ETC-CMMI@cms.hhs.gov.

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The End-Stage Renal Disease Treatment Choices Learning Collaborative (ETCLC)

The Centers for Medicare & Medicaid Services (CMS) and Health Resources & Services Administration (HRSA) End-Stage Renal Disease Treatment Choices Learning Collaborative (ETCLC) was finalized in the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures final rule (85 FR 61114) in September 2020 and launched in August of 2021.

The goal of the ETCLC is to engage ETC Participants, as well as transplant centers, Organ Procurement Organizations (OPOs), large donor hospitals, transplant recipients, and donor family members to spread the use of highly effective practices that will increase kidney procurement, recovery, and utilization currently in use throughout the organ procurement and kidney transplant community to achieve the following three AIMs:

  • AIM #1: Increase the number of deceased donor kidneys transplanted 
  • AIM #2: 
    • Decrease the non-use rate for KDPI < 60.
    • Decrease the non-use rate for KDPI ≥ to 60. 
  • AIM #3: Increase the number of kidneys recovered for transplant with a KDPI ≥ 60. 

On a broad scale, the ETCLC hosts monthly Pacing Events, as well as technical assistance focused virtual calls. These calls are designed to showcase data-driven high performers who are consistently moving the kidney community closer to achieving the ETCLC Aims. The collaborative is also supported by a cadre of Quality Improvement Coaches and Co-coaches who lead twenty-five quality improvement teams made up of ETCLC member organizations committed to reducing the kidney discard rate by improving access to kidney transplant for all those on the kidney transplant waitlist. 

Those who enroll in the ETCLC are supported by a National Faculty and Leadership Coordinating Council comprised of thought leaders and subject matter experts from patient and professional advocacy organizations. The intentional design of this project is to engage the greater kidney transplant community in ongoing learning and action activities that continuously advance the practice of kidney donation, recovery, and transplantation. The ETCLC emphasizes health equity when designing its events and assigning speakers to its events. Together, we will work to overcome any barrier to make systemic changes that lead to sustainable practice improvements as well as, increase the number of lives touched by kidney transplantations.

The Centers for Medicare & Medicaid Services, Technical Assistance, Quality Improvement, and Learning (TAQIL) contractor is Health Services Advisory Group. For additional information about the ETCLC or to join the collaborative contact TAQILinfo@hsag.com or call (844) 472-4880. Please do not use this contact information for inquiries about the ETC Model. In order to have questions resolved in a timely manner, email the ETC Model team at ETC-CMMI@cms.hhs.gov.

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