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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations PPS proposed rule, where the mean $10
million dollars in savings reported for the Overall PPA Net & HDPA has $64
million in savings and $97 million in losses, for the top 10th and 90th percentiles, respectively.

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5. Effects on the Home Dialysis Rate The two changes in this final rule have the potential to increase ETC
Participants home dialysis rate, therefore reducing the overall savings to Medicare estimate. First, this final rule modifies 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 for Managing Clinicians and all ESRD
facilities, regardless of ownership.
However, 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 in-center nocturnal dialysis, respectively. The sharp decline in these dialysis modalities is potentially in response to the COVID19 pandemic.
The low historical take-up for selfdialysis and shortage of historical years for in-center nocturnal dialysis that is, a nocturnal dialysis claims line instruction became effective in 2017
result in these modifications having an insignificant impact on the savings to Medicare.
The second change in this final rule that has 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 is the Health Equity Incentive.
The Health Equity Incentive proposed in the CY 2022 ESRD PPS proposed rule 86 FR 36427 would have rewarded ETC Participants with an additional 0.5
points to their improvement score who improved the home dialysis rate or transplant rate among their attributed beneficiaries who are dual eligible or receive the LIS by at least 5 percentage points between the Benchmark Year to the MY. In this final rule, the threshold to earn the 0.5 improvement points was reduced to a 2.5-percentage point increase from the Benchmark Year to the MY. The $10 million decrease in the savings to Medicare estimate in this final rule relative to the CY 2022 ESRD
PPS proposed rule was primarily due to the change in the Health Equity Incentive threshold.

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6. 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 in this final rule do not impact our decision in the CY
2022 ESRD PPS proposed rule or the Specialty Care Models 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 kidneys. The U.S. Renal Data System 282
reported 22,393 kidney transplants in 2018 compared to a kidney transplant waiting list 283 of over 98,000. Refer to section VI.C.2.b4 in the Specialty Care Models final rule 85 FR 61355 for a detailed justification for our assumption that the overall number of kidney transplants will not increase in response to ESRD facilities and Managing Clinicians participating in the ETC
Model.
7. Effects of the Transplant Rate The ETC Model continues to include the transplant rate described in the Specialty Care Models final rule 512.365.
The change in this final rule that has the potential to generate higher scores for a limited subset of ETC Participants and therefore a small reduction in the estimated savings for the Model relative to the CY 2022 ESRD PPS proposed rule is the modification to the Health Equity Incentive threshold. By lowering the threshold for earning the Health Equity Incentive threshold in this final rule relative to the threshold proposed in the CY 2022 ESRD PPS proposed rule, more ETC Participants have the potential to earn the additional 0.5 points to their improvement score.
8. Effects on Kidney Disease Patient Education Services and HD Training Add-Ons The changes to the ETC Model finalized in this final rule relative to the Specialty Care Models final rule do not impact the findings reported for the 282 United States Renal Data System. 2020. ADR
Reference Table E6 Renal Transplants by Donor Type. https adr.usrds.org/2020/reference-tables.
283 Organ Procurement and Transplantation Network. 2021. Current US Waiting List, Overall by Organ. https optn.transplant.hrsa.gov/data/
view-data-reports/national-data/.

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effects of the ETC Model on the Kidney Disease Patient education services and HD training add-ons described in section VI.C.2.b6 in the Specialty Care Models final rule 85 FR 6135657.
9. Effects on Medicare Beneficiaries The changes in this final rule relative to the CY 2022 ESRD PPS proposed rule could incentivize ESRD facilities and Managing Clinicians serving dual eligible or LIS recipient Medicare beneficiaries to potentially improve access to care for those beneficiaries.
The final rules changes could also marginally improve uptake of the incenter nocturnal dialysis treatment modality since this dialysis method was not directly incentivized that is, accounted for in the home dialysis rate for all ESRD facilities under the ETC
Model. The changes made to the final rule may have marginally increased uptake of in-center nocturnal dialysis for ESRD facilities owned in whole or in part by an ETC LDO relative to the CY
2022 ESRD PPS proposed rule, which had proposed to exclude ESRD facilities owned in whole or in part by an ETC
LDO from the in-center nocturnal dialysis policy.
As noted in section VI.C.3.B of the Specialty Care Models final rule 85 FR
61357, we continue to anticipate that the ETC Model will have a negligible impact on the cost to beneficiaries receiving dialysis. Under current policy, Medicare FFS beneficiaries are generally responsible for 20 percent of the allowed charge for services furnished by providers and suppliers. This policy will remain the same for most beneficiaries under the ETC Model.
However, we will waive certain requirements of title XVIII of the Act as necessary to test the PPA and HDPA
under the ETC Model and to hold beneficiaries harmless from any effect of these payment adjustments on cost sharing. In addition, the Medicare beneficiarys quality of life has the potential to improve if the beneficiary elects to have home dialysis, or nocturnal in-center dialysis, as opposed to in-center dialysis. Studies have found that home dialysis patients experienced improved quality of life as a result of their ability to continue regular work schedules or life plans; as well as better overall, physical, and psychological health in comparison to other dialysis options.
10. Alternatives Considered Throughout this final rule, we have identified our policies and alternatives that we have considered, and provided information as to the likely effects of
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