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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules and were projected to represent only relatively modest increases in Medicare spending each year.
The key assumptions underlying the impact estimate are that each consolidated ESRD facility or Managing Clinicians share of total maintenance dialysis provided in the home setting was assumed to grow by up to an assumed maximum growth averaging 3-percentage points per year. Factors underlying this assumption about the home dialysis growth rate include:
Known limitations that may prevent patients from being able to dialyze at home, such as certain common disease types that make peritoneal dialysis impractical for example, obesity;
current equipment and staffing constraints; and the likelihood that a patient new to maintenance dialysis starts dialysis at home compared to the likelihood that a current dialysis patient who dialyzes in center switches to dialysis at home. In any given trial of the simulation, the maximum growth rate was chosen from a uniform distribution of 0 to 5-percentage points per year. Preliminary data from CMS
show that the growth rate for home dialysis was 3.9 percent in CY 2020 for beneficiaries meeting the eligibility criteria for the ETC Model. This growth rate is within range to what was observed prior to the establishment of the Advancing American Kidney Health initiative in 2019 and it also shows that the COVID19 PHE did not cause the home dialysis growth assumption to become invalid. The 3-percentage point per year average max growth rate will, in effect, move the average market peritoneal dialysis rate about 10
percent to the highest market baseline peritoneal dialysis rate for example, Bend, Oregon HRR at about 25 percent, which we believe is a reasonable upper bound on growth over the duration of the ETC Model for the purposes of this actuarial model.
Consolidated ESRD facilities at the HRR level or Managing Clinicians were assumed to achieve anywhere from zero to 100 percent of such maximum growth in any given year. Thus, the average projected growth for the share of maintenance dialysis provided in the home was 1.5-percentage points per year expressed as the percentage of total dialysis. In contrast, we do not include an official assumption that the overall number of kidney transplants will increase and provide justification for this assumption in sections VI.C.2.b.4 and VI.C.2.b.5 of the Specialty Care Models final rule 85 FR
61355. However, as part of the sensitivity analysis for the savings calculations for the model, we laid out
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a different savings scenario if the ETC
Learning Collaborative described in VI.C.2.b.6 of the Specialty Care Models final rule 85 FR 61355 were to be successful in decreasing the discard rate of deceased donor kidneys and increasing the utilization rate of deceased donor kidneys that have been retrieved.
a Sensitivity Analysis: Medicare Savings EstimateResults for the 10th and 90th Percentiles Using the primary specification for the Medicare estimate with preset benchmark updates for home dialysis and transplant waitlist rates, we compare the results for the top 10th and 90th percentiles of the 400 individual simulations to the average of all simulation results reported in Table 18.
Since the impact on Medicare spending for the ETC Model using the present benchmark updates is estimated to be in savings rather than losses, the top 10th and 90th percentiles represent the most optimistic and conservative projections, respectively. The overall net PPA and HDPA for the top 10th and 90th percentiles using the present benchmark updates method are $117 million in savings and $3 million in losses encompassing the mean estimate of $53
million in savings in Table 18. The overall uncertainty of the impact of the model is further illustrated in Table 18, the change from baseline, where the mean $7 million dollars in savings reported for the Overall PPA Net &
HDPA has $83 million in savings and $75 million in losses, for the top 10th and 90th percentiles, respectively.
4 Effects on the Home Dialysis Rate This proposed rule proposes to modify the home dialysis rate equation by adding 0.5 multiplied by the sum of the self-dialysis beneficiary months and the in-center nocturnal dialysis beneficiary months to the numerator such that 1-beneficiary year is comprised of 12-beneficiary months.
The proposed modification was different for ESRD facilities with an aggregation group that had facilities owned by an ETC LDO, for which the nocturnal dialysis months were not included in the numerator.
Less than 1 percent of beneficiaries eligible for attribution into the ETC
Model were receiving either self-dialysis or nocturnal in-center dialysis in CY
2019. In addition, in CY 2020, the annual growth rate decreased by 89.9
and 91.3 percent for beneficiaries receiving self-dialysis or nocturnal dialysis, respectively. The sharp decline in these dialysis modalities is potentially in response to the COVID19

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pandemic. The low historical take-up for self-dialysis and shortage of historical years for nocturnal dialysis that is, a nocturnal dialysis claims line instruction became effective in 2017
result in these proposed modifications having an insignificant impact on the savings to Medicare.
Two of the changes proposed in this proposed rule have the potential to generate higher PPA scores for a limited subset of providers and therefore a small negative impact on estimated savings for the model. First, we proposed two strata for the achievement and improvement benchmarking based on a 50 percent cutpoint for the proportion of attributed beneficiaries with dual eligibility status or receipt of the LIS. This proposed modification would allow participants to be compared to participants who serve ESRD patients with a similar socioeconomic status, essentially making the comparison groups fairer and potentially increasing the cost to Medicare. Second, the proposed Health Equity Incentive rewarded participants with 0.5 points to their improvement score who demonstrated a sufficiently significant improvement on the home dialysis rate among their attributed beneficiaries who are dual eligible or receive the LIS.
Furthermore, we modeled the home dialysis rate achievement and improvement benchmarks by incrementally increasing every two measurement periods the benchmarks by 10 percent relative to ESRD facilities and Managing Clinicians not selected for participation. Applying the preset benchmarks update method balanced out the negative impact to Medicare savings generated from stratification and the Health Equity Incentive, essentially preserving the overall savings level reported in the Specialty Care Models final rule.
5 Effects on Kidney Transplantation Kidney transplantation is considered the optimal treatment for most ESRD
beneficiaries. The PPA includes a onethird weight on the ESRD facilities or Managing Clinicians transplant waitlist rate, with the ultimate goal of increasing the rate of kidney transplantation.
However, the changes proposed in this proposed rule do not impact our decision in the previous final rule to not include an assumption that the overall number of kidney transplants will increase. The number of ESRD patients on the kidney transplant waitlist has for many years far exceeded the annual number of transplants performed.
Transplantation rates have not increased to meet such demand because of the limited supply of deceased donor
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