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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations numerator included waitlists for kidney transplants, alone or with another organ, active and inactive records, multi-organ listings, and patients that have subsequently been removed from the waitlist. The denominator was a unique count of prevalent dialysis patients as of the end of the year. Only patients on dialysis as of December 31st for the selected year were included. Facility attribution was based on the facility the patient was admitted to on the last day of the year.
For MY1 and MY2, the home dialysis score and transplant score for the PPA
were calculated using the following methodology for the ESRD facilities and Managing Clinicians. ETC Participant behavior for each year was simulated by adjusting the ETC Participants baseline home dialysis or transplant rate for a simulated statistical fluctuation and then summing with the assumed increase in home dialysis or transplant rate multiplied by a randomly generated improvement scalar. The achievement and improvement scores were assigned by comparing the ETC Participants simulated home dialysis or transplant rate for the MY to the percentile distribution of home dialysis or transplant rates in the prior year. Last, the MPS was calculated using the weighted sum of the higher of the achievement or improvement score for the home dialysis rate and the transplant waitlist rate. The home dialysis rate constituted two-thirds of the MPS, and the transplant rate onethird of the MPS.
For MY3 through MY10, the home dialysis rate calculation accounts for modifications in this final rule compared to the CY 2022 ESRD PPS
proposed rule. The revisions include changing the numerator for the home dialysis rate from the home dialysis beneficiary months to the home dialysis beneficiary months + 0.5 in-center selfdialysis beneficiary months + 0.5
nocturnal in-center dialysis beneficiary months, such that 1-beneficiary year is comprised of 12-beneficiary months for all ETC Participants.
The number of beneficiaries on incenter self-dialysis who met the eligibility criteria for the ETC Model was very small, ranging from 102 to 277
over the period 20122019 and decreasing 89.9 percent to 22
beneficiaries in 2020 based on preliminary 2020 data at CMS. With such a small sample size, the growth rate vacillated significantly. In addition, the in-center nocturnal dialysis UJ
modifier code did not become effective until January 1, 2017; therefore, there were insufficient data to generate growth rate assumptions. The in-center
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nocturnal dialysis beneficiary growth rate decreased by 91.3 percent in 2020.
As a solution to these data limitations, to simulate the impact of incorporating in-center self-dialysis and in-center nocturnal dialysis for the purpose of the savings to Medicare estimate, the simulation assumed any given ESRD
facility or Managing Clinician will have a one percent chance of receiving an increased achievement score due to this policy.
The overall process for generating achievement and improvement scoring followed modeling from section VI.C.2
of the Specialty Care Models final rule 85 FR 61352, with the exception of the following changes proposed in the CY
2022 ESRD PPS proposed rule, which we are finalizing in this final rule.
Beginning for MY3 and beyond, the achievement benchmarking methodology included two modifications. First, the home dialysis rate and transplant waitlist rate benchmarks were increased by a total of 10 percent relative to ESRD facilities and Managing Clinicians not selected for participation, every two MYs. To clarify, no changes to the achievement benchmarking methodology were made to MYs 1 and 2. The latter MY couplets achievement benchmarking included the following preset benchmark updates:
MYs 3 and 4: Comparison Geographic Area percentiles1.10, MYs 5 and 6: Comparison Geographic Area percentiles1.20, MYs 7 and 8: Comparison Geographic Area percentiles1.30, and MYs 9 and 10: Comparison Geographic Area percentiles1.40.
The percentiles represented the 30th, 50th, 75th, and 90th percentile of the home dialysis rate and transplant rate for ESRD facilities and Managing Clinicians not selected for participation.
The preset benchmark updates method provides greater certainty to ETC
Participants than the rolling updates described in section IV.C.2.b3 of the Specialty Care Models final rule 85 FR
61353.
Second, we incorporated two proxies for socioeconomic status, dual eligibility status or receipt of the Low Income Subsidy LIS, as part of the achievement benchmarking starting for MY3 and beyond. Dual eligibility status was defined as a Medicare beneficiary with any of the following full-time dual type codes: 02 = Eligible is entitled to Medicare Qualified Medicare Beneficiary QMB and Medicaid coverage including prescription drugs, 04 = Eligible is entitled to Medicare Specified Low-Income Medicare Beneficiary SLMB and Medicaid
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coverage including prescription drugs, or 08 = Eligible is entitled to Medicare Other dual eligible with Medicaid coverage including prescription drugs.
Separately, a yes/no indicator was created for any beneficiary that was either deemed or determined by the Social Security Administration SSA to be receiving the LIS. The home dialysis rate and transplant waitlist rate achievement benchmarks were then stratified by the proportion of attributed beneficiaries who are dual-eligible or receive the LIS. Two strata were created with a cutpoint of approximately 50
percent for participants with any dualeligible or LIS recipient beneficiaries and those who do not have beneficiaries meeting these two socioeconomic status proxies.
Third, a Health Equity Incentive was added to improvement scoring starting in MY3. For the purpose of the estimates in this Regulatory Impact Analysis, we incorporated a random variable to simulate each ETC
Participants baseline variation and behavioral improvement for each MY. If the participants simulated improvement behavior in MY3 through MY10 was greater than 2.5 percent, then the participant received a 0.5-point increase on their improvement score, allowing for a maximum of 2.0 total points. The threshold for receiving the Health Equity Incentive was reduced from the 5-percentage point threshold proposed in the CY 2022 ESRD PPS
proposed rule to a 2.5-percentage point threshold in this final rule.
For all MYs, the transplant waitlist benchmarks were annually inflated by approximately 3-percentage points growth. This was a modification from section VI.C.2 of the Specialty Care Models final rule 85 FR 61352, where the waitlist benchmarks were annually inflated by approximately 2-percentage points growth observed during years 2017 through 2019 in the CCSQ data, to project rates of growth. The additional 1 percentage point growth in this final rule was included to account for uncertainty from the COVID19 PHE
disruption and section 17006 of the 21st Century Cures Act Cures Act Pub. L.
114255, which amended the Act to increase enrollment options for individuals with ESRD into Medicare Advantage. To clarify, applying the 3percentage point annual growth from the median transplant waitlist rate across HRR condensed facilities grew from 8 percent in 2017 to 11 percent in 2018 to 14 percent in 2019 that is, not a growth rate of 1.03 percent per year.
To assess the impact of the COVID
19 PHE on the kidney transplant waitlist, we analyzed data from the
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