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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
to support the projection that higher rates of home dialysis and kidney transplants would likely reduce Medicare expenditures, and, not only enhance beneficiary choice, independence, and quality of life, but also preserve or enhance the quality of care for ESRD beneficiaries.
As described in detail in section V of this proposed rule, we believe it is necessary to propose certain changes to the ETC Model. Under the proposed changes to the ETC Model, ETC
Participants would continue to receive adjusted payments but beginning for MY3, certain aspects of the ETC Model that determine those payment adjustments would change. The proposed change to the achievement benchmarking methodology is necessary to the ETC Model as this change maintains the ETC Models expectation of savings. The proposed changes to the transplant rate, the achievement benchmarking methodology, and the improvement benchmarking and scoring methodology are necessary to increase accuracy and fairness of performance assessment. The proposed changes to the home dialysis rate, data sharing, and kidney disease patient education services waivers are necessary to support ETC Participants operating in the ETC Model.
3. Overall Impact a. ESRD PPS
We estimate that the proposed revisions to the ESRD PPS would result in an increase of approximately $140
million in payments to ESRD facilities in CY 2022, which includes the amount associated with updates to the outlier thresholds, and updates to the wage index.

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b. AKI
We estimate that the proposed updates to the AKI payment rate would result in an increase of approximately $1 million in payments to ESRD
facilities in CY 2022.
c. ESRD QIP
For PY 2024 and PY 2025, we have reestimated the costs associated with the information collection requirements under the ESRD QIP with updated estimates of the total number of dialysis facilities, the total number of patients nationally, wages for Medical Records and Health Information Technicians or similar staff, and a refined estimate of the number of hours needed to complete data entry for EQRS reporting. We have made no changes to our methodology for calculating the annual burden associated with the information collection requirements for the EQRS

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validation study previously known as the CROWNWeb validation study, the NHSN validation study, and EQRS
reporting. As discussed in section IV.C
and section IV.D of this proposed rule, we are proposing measure suppressions that would apply for PY 2022 and updates to the scoring methodology and payment reductions for the PY 2022
ESRD QIP. We also announce an extension of EQRS reporting requirements for facilities due to systems issues. However, we believe that none of the policies proposed in this proposed rule would affect our estimates of the annual burden associated with the Programs information collection requirements, as facilities are still expected to continue to collect measure data during this time period.
We also updated the payment reduction scale using more recent data for the measures in the ESRD QIP
measure set. We estimate approximately $215 million in information collection burden, which includes the cost of complying with this rule, and an additional $17 million in estimated payment reductions across all facilities for PY 2024.
For PY 2025, we estimate that the proposed revisions to the ESRD QIP
would result in $215 million in information collection burden, and $17
million in estimated payment reductions across all facilities, for an impact of $232 million as a result of the policies we have previously finalized and the policies we have proposed in this proposed rule.
d. ETC Model We estimate that the proposed changes to the ETC Model would increase the Models projected direct savings from payment adjustments alone by $7 million over the duration of the Model. We estimate that the Model would generate $38 million in direct savings related to payment adjustments over 6.5 years with the proposed changes, and would generate $31
million in savings in the absence of the proposed changes.
4. Regulatory Review Cost Estimation If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule or final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last years proposed rule will be the number of reviewers of this proposed
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rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last years rule in detail, and it is possible that some reviewers chose not to comment on the proposed rule.
For these reasons, we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities, which will review this proposed rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We seek comments on this assumption.
Using the wage information from the BLS for medical and health service managers Code 119111, we estimate that the cost of reviewing this rule is $110.74 per hour, including overhead and fringe benefits https www.bls.gov/
oes/current/oes_nat.htm. Assuming an average reading speed, we estimate that it would take approximately 6.25 hours for the staff to review half of this proposed rule. For each entity that reviews the rule, the estimated cost is $692.13 6.25 hours $110.74.
Therefore, we estimate that the total cost of reviewing this regulation is $ 78,903
$692.13 114.
B. Detailed Economic Analysis 1. CY 2021 End-Stage Renal Disease Prospective Payment System a. Effects on ESRD Facilities To understand the impact of the changes affecting payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2021 to estimated payments in CY 2022. To estimate the impact among various types of ESRD
facilities, it is imperative that the estimates of payments in CY 2021 and CY 2022 contain similar inputs.
Therefore, we simulated payments only for those ESRD facilities for which we are able to calculate both current payments and new payments.
For this proposed rule, we used CY
2020 data from the Part A and Part B
Common Working Files as of February 12, 2021, as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2020 claims to 2021 and 2022 using various updates.
The updates to the ESRD PPS base rate are described in section II.B.1.d of this proposed rule. Table 9 shows the impact of the estimated CY 2022 ESRD PPS

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