Treatment Choice and Outcomes for End Stage Renal Disease: Evidence from the First Year of a Nationwide Randomized Evaluation

2021-01-01

2021-12-31

Percentage of Patients Receiving Any Home Dialysis in the First 90 Days

It is defined as the percentage of patients in our baseline sample who have any home dialysis claims within the first 90 days since the start of dialysis treatment.

- Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
- Percentage of Dialysis Sessions at Home in First 90 Days
- Dialysis Rate per Capita
- Total Number of Dialysis Patients
- Pre-Dialysis Elixhauser Index
- Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020

- Percentage of Weeks Receiving Any Home Dialysis in First 90 Days: For each patient, this is the number of weeks the patient received dialysis at home or receiving training for home dialysis within the first 90 days divided by the number of weeks the patient received dialysis in any modality in the first 90 days. For the 13th week since the start of dialysis, we only count the 6 days that fall within the 90 day period and weight it at 6/7 of the other weeks when computing this measure.

- Percentage of Dialysis Sessions at Home in First 90 Days: For each patient, this is the number of dialysis sessions at home divided by the total number of dialysis sessions in the first 90 days, weighting peritoneal dialysis sessions as 3/7 of hemodialysis sessions.

- Dialysis Rate per Capita: This is the number of Traditional Medicare patients aged 66 and above who start dialysis in either modality in our baseline sample divided by the number of Traditional Medicare patients aged 66 and above.

- Total Number of Dialysis Patients: This is the number of Medicare patients who are on dialysis in either modality. We include all dialysis patients when computing this measure, not just new patients.

- Pre-Dialysis Elixhauser Index: This is the average pre-dialysis Elixhauser index among patients in our baseline sample.

- Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020: This is defined the same way as our primary outcome, except that we measure outcomes using data from the year prior to ETC (2020).

We propose to study the ESRD Treatment Choice (ETC) program, a nationwide randomized-controlled trial (RCT) of ESRD treatment that was designed by the Centers for Medicare and Medicaid Services (CMS) to encourage greater use of home dialysis. The RCT creates payment adjustments for ESRD facilities and clinicians based on the rates of home dialysis and transplantation. The RCT was first announced in July 2019 for a start date of January 1, 2020 which was later delayed to January 1, 2021. In September 2020, 30% of hospital referral regions (HRRs) were assigned to treatment through a stratified randomization procedure. The RCT is scheduled to last until June 2027.
The ETC model makes two types of payment adjustments for facilities and managing clinicians, an adjustment to the reimbursement rate for home dialysis, and a performance adjustment. The first adjustment, Home Dialysis Payment Adjustment (HDPA), raises the reimbursement rate for home dialysis for the first three years of the program; the amount of increase is 3% in 2021, and reduces to 2% in 2022, and 1% in 2023. The second adjustment, Performance Payment Adjustment (PPA), is an increase or decrease in the reimbursement rate based on the home dialysis rate and the transplant rate attributable to the participating facility or clinician.

HRRs were assigned to treatment through a stratified randomization procedure.

Hospital Referral Regions (HRRs)

Yes

302 HRRs

According to 2016 data, the analysis sample includes approximately 19,000 beneficiaries. We expect a similar number of observations in 2021.

Treatment: 91 HRRs (estimated 6,000 beneficiaries)
Control: 211 HRRs (estimated 13,000 beneficiaries)

Importance: Home dialysis rates for end-stage kidney disease (ESKD) treatment are substantially lower in the US than in other high-income countries, yet there is limited knowledge on how to increase these rates.

Objective: To report results from the first year of a nationwide randomized clinical trial that provides financial incentives to ESKD facilities and managing clinicians to increase home dialysis rates.

Design, Setting, and Participants: Results were analyzed from the first year of the End-Stage Renal Disease Treatment Choice (ETC) model, a multiyear, mandatory-participation randomized clinical trial designed and implemented by the US Center for Medicare & Medicaid Innovation. Data were reported on Medicare patients with ESKD 66 years or older who initiated treatment with dialysis in 2021, with data collection through December 31, 2021; the study included all eligible ESKD facilities and managing clinicians. Eligible hospital referral regions (HRRs) were randomly assigned to the ETC (91 HRRs) or a control group (211 HRRs).

Interventions: The ESKD facilities and managing clinicians received financial incentives for home dialysis use.

Main Outcomes and Measures: The primary outcome was the percentage of patients with ESKD who received any home dialysis during the first 90 days of treatment. Secondary outcomes included other measures of home dialysis and patient volume and characteristics.

Results: Among the 302 HRRs eligible for randomization, 18 621 eligible patients initiated dialysis treatment during the study period (mean [SD] age, 74.8 [1.05] years; 7856 women [42.1%]; 10 765 men [57.9%]; 859 Asian [5.2%], 3280 [17.7%] Black, 730 [4.3%] Hispanic, 239 North American Native, and 12 394 managing clinicians. The mean (SD) share of patients with any home dialysis during the first 90 days was 20.6% (7.8%) in the control group and was 0.12 percentage points higher (95% CI, −1.42 to 1.65 percentage points; P = .88) in the ETC group, a statistically nonsignificant difference. None of the secondary outcomes differed significantly between groups.

Conclusions and Relevance: The trial results found that in the first year of the US Center for Medicare & Medicaid Innovation–designed ETC model, HRRs assigned to the model did not have statistically significantly different rates in home dialysis compared with control HRRs. This raises questions about the efficacy of the financial incentives provided, although further evaluation is needed, as the size of these incentives will increase in subsequent years.

Ji Y, Einav L, Mahoney N, Finkelstein A. Financial Incentives to Facilities and Clinicians Treating Patients With End-stage Kidney Disease and Use of Home Dialysis: A Randomized Clinical Trial. JAMA Health Forum. 2022;3(10):e223503. doi:10.1001/jamahealthforum.2022.3503

https://jamanetwork.com/journals/jama-health-forum/fullarticle/2797080