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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
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kidneys. The U.S. Renal Data System 306
reported 22,393 kidney transplants in 2018 compared to a kidney transplant waiting list 307 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.
6 Effects of the Transplant Waitlist Rate This proposed rule includes the transplant waitlist rate described in the Specialty Care Models final rule 512.365 with the following proposed modifications. First, we are proposing to exclude Medicare beneficiaries with a diagnosis of and treatment with chemotherapy or radiation for vital solid organ cancers. In our analysis of beneficiaries eligible for the ETC
Model, we found that less than 1
percent of the beneficiaries had claims for any vital solid organ cancers.
Therefore, the effect of this proposed exclusion criterion is to make the beneficiaries included in the calculation of the transplant rate an improved representation of beneficiaries who are able to join the transplant waitlist and/
or receive pre-emptive living donor kidney transplantation. But, due to the very low number of ETC Model potential beneficiaries with these types of cancer, the exclusion criterion is unlikely to have any significant impact on the transplant waitlist rate.
Two of the changes proposed in this proposed rule have the potential to generate higher scores for a limited subset of health care 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 allowed 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
306 United States Renal Data System. 2020. ADR
Reference Table E6 Renal Transplants by Donor Type. https adr.usrds.org/2020/reference-tables.

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score who demonstrated a sufficiently significant improvement on the transplant rate among their attributed beneficiaries who are dual eligible or receive the LIS.
Furthermore, we proposed to modify the transplant waitlist rate achievement and improvement benchmarks by incrementally increasing the benchmarks every two measurement periods 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 the proposed stratification and the Health Equity Incentive, roughly preserving the overall savings level estimated at baseline for the model parameters previously finalized before the changes offered in this proposed rule.
7 Effects on Kidney Disease Patient Education Services and HD Training Add-Ons The changes in this proposed rule do not impact the findings reported for the 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 61355.
b. Effects on Medicare Beneficiaries The changes in this 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 changes could also marginally improve take-up of the in-center nocturnal dialysis treatment modality compared to how the model was finalized previously since these dialysis methods were not directly incentivized that is, accounted for in the home dialysis rate and in-center self dialysis rate numerator in the Specialty Care Models final rule.
As previously 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 would 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
307 Organ Procurement and Transplantation Network. 2021. Current US Waiting List, Overall
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same 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 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.
c. Alternatives Considered Throughout this proposed rule, we have identified our policies and alternatives that we have considered, and provided information as to the likely effects of these alternatives and the rationale for each of our policies.
This proposed rule addresses a model specific to ESRD. It provides descriptions of the requirements that we would waive, identifies the performance metrics and payment adjustments proposed to be tested, and presents rationales for our proposals, and where relevant, alternatives that we considered. We carefully considered the alternatives to this proposed rule, including the degree that benchmark targets should be prospectively updated to provide greater transparency to ETC
Participants while preserving the expectation for model net savings for the program. For context related to alternatives previously considered when establishing the ETC Model we refer readers to the Specialty Cares Model final rule 85 FR 61114 for more information on policy-related stakeholder comments, our responses to those comments, and statements of final policy preceding the limited modifications proposed here.
C. Accounting Statement As required by OMB Circular A4
available at https www.whitehouse.
gov/sites/whitehouse.gov/files/omb/
circulars/A4/a-4.pdf, in Table 20, we have prepared an accounting statement showing the classification of the transfers and costs associated with the various provisions of this proposed rule.

by Organ. https optn.transplant.hrsa.gov/data/
view-data-reports/national-data/.

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