CMS is proposing 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.
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 proposed 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 proposed ETC Model, CMS would make certain payment adjustments that would 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 would 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 proposed model would require the Medicare payment adjustments for the selected ESRD facilities and Managing Clinicians. For the proposed 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 will review all public comments before establishing final policies.
CMS is proposing required 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 would 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 50 percent ESRD facilities and Managing Clinicians in the 50 States and District of Columbia. A specific element of the selection would 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 would be excluded from certain portions of the model’s interventions on account of serving low volumes of adult ESRD beneficiaries.
Beneficiaries would be attributed on a month-by-month basis. A beneficiary would be attributed to the ESRD facility accounting for the most dialysis claims during the month, and the Managing Clinician billing the MCP for the month.
Two types of payment adjustments would apply. The first would 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 would 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. Greater positive and negative adjustments for model participants would be phased in over the five year 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.
The Specialty Care Models to Improve Quality of Care and Reduce Expenditures Notice of Proposed Rule Making proposed that payment adjustments for the selected ESRD facilities and Managing Clinicians would begin on January 1, 2020. As this date has already passed and we have not yet issued a final rule, payment adjustments under the ETC Model, if finalized, would not begin on this date. If finalized, we would provide information on the effective date of payment adjustments under the ETC Model in the final rule.
The Fall 2019 Unified Agenda lists the Specialty Care Models to Improve Quality of Care And Reduce Expenditures Final Rule (CMS-5527-F) as a long-term action with a final action date of July, 2022 and includes the following procedural language:
- “We schedule all Medicare final regulations for publication within the three-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for three (3) years if we are able to publish it sooner.”
By statute, there is a three (3) year window from the time a Notice of Proposed Rulemaking (NPRM) is published to when a Final Rule must be published, or a new NPRM would need to be issued. This procedural language is not specific to the ESRD Treatment Choices Model or potential finalization of the Model, and the date listed in the Unified Agenda does not indicate the date on which a final rule for the ESRD Treatment Choices Model, if finalized, would be published. Every regulation goes through a clearance process for which the timing varies.
For any questions, please email the ETC Model team at ETC-CMMI@cms.hhs.gov.
- Fact Sheet
- Press Release
- ETC Model Infographic (PDF)
- Advancing American Kidney Health
- Notice of Proposed Rule Making