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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
comment rulemaking. In the CY 2022
ESRD PPS proposed rule, the changes listed with bullets were proposed for MY3 beginning January 1, 2022
through the final MY of ETC Model MY10.
Include nocturnal in-center dialysis in the home dialysis rate calculation for Managing Clinicians and ESRD facilities not owned in whole or in part by an ETC LDO.
Modify the PPA achievement benchmarking methodology:
++Stratify the home dialysis and transplant rate benchmark by the proportion of beneficiaries who are dual-eligible for Medicare and Medicaid, or, receive the Low-Income Subsidy LIS, resulting in two strata.
++Increase the home dialysis and transplant rate benchmarks by 10
percent for each MY couplet that is, 1.10 for MY3 and MY4, 1.20 for MY5
and MY6, 1.30 for MY7 and MY8, and 1.40 for MY9 and MY10.
Modify the PPA improvement benchmarking methodology:
++Health Equity Incentive:
Participants can earn 0.5 improvement points in addition to their improvement score for a 5 percentage point increase in the home dialysis rate or transplant rate among dual eligible or LIS recipient beneficiaries.
++Modify improvement calculation to ensure that the Benchmark Year rate cannot be zero, such that improvement is calculable for all participants.
In this final rule, we finalized all of the changes proposed in the CY 2022
ESRD PPS proposed rule, with certain modifications. The two such modifications most likely to affect the impact estimate for the ETC Model are:
Modify the home dialysis rate calculation by including nocturnal dialysis in the numerator of the home dialysis rate calculation for all ESRD
facilities, rather than only those ESRD
facilities not owned in whole or in part by an ETC LDO.
Modify the methodology for the Health Equity Incentive by reducing the threshold to earn the additional 0.5
improvement points from a 5-percentage point increase to a 2.5-percentage point increase from the Benchmark Year to the MY.
More detail on these changes are provided in sections V.B.3.c and V.B.6.c.2 of this final rule. The ETC
Model is not a total cost of care model.
ETC Participants will still bill FFS
Medicare, and items and services not subject to the ETC Models payment adjustments will continue to be paid as they will in the absence of the Model.

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2. Data and Methods A stochastic simulation was created to estimate the financial impacts of the changes to the ETC Model relative to baseline expenditures, where baseline expenditures were defined as data from CYs 2018 and 2019 without the changes applied. The simulation relied upon statistical assumptions derived from retrospectively constructed ESRD
facilities and Managing Clinicians Medicare dialysis claims, transplant claims, and transplant waitlist data reported during 2018 and 2019, the most recent years with complete data available. Both datasets and the riskadjustment methodologies for the ETC
Model were developed by the CMS
Office of the Actuary OACT.
The ESRD facilities and Managing Clinicians datasets were restricted to the following eligibility criteria.
Beneficiaries must be residing in the United States, 18 years of age or older, and enrolled in Medicare Part B.
Beneficiaries enrolled in Medicare Advantage or other cost or Medicare managed care plans, who have elected hospice, are receiving dialysis for acute kidney injury AKI only, with a diagnosis of dementia, who are receiving dialysis in a nursing facility, or reside in a skilled nursing facility were excluded. In addition, beneficiaries who have a diagnosis of and are receiving treatment with chemotherapy or radiation for a vital solid organ cancer were excluded from the transplant rate calculations.
Diagnosis of a vital solid organ cancer was defined as a beneficiary that had a claim with any of 39 ICD10CM codes ranging from C22.0 through C79.02.
Treatment of a vital solid organ cancer was defined as a beneficiary with a claim with any of 2,087 radiation administration ICD10PCS codes, 19
chemotherapy administration CPT
codes, or 41 radiation administration CPT codes. Last, the HRR was matched to the claim service facility ZIP CodeTM
or the rendering physician ZIP Code for ESRD facility and Managing Clinician, respectively.280
For the modeling exercise used to estimate changes in payment to providers and suppliers and the resulting savings to Medicare, OACT
maintained the previous method to identify ESRD facilities with common ownership, the low-volume exclusion threshold, and the aggregation assumptions as CMS is not making changes to these model policies. To clarify OACTs methodology, the ESRD
facilities data were aggregated to the 280 ZIP Code is a trademark owned by the United States Postal Service.

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CMS Certification Number CCN level for beneficiaries on dialysis identified by outpatient claims with Type of Bill 072X to capture all dialysis services furnished at or through ESRD facilities.
Beneficiaries receiving home dialysis services were defined as condition codes 74 and 76 512.340. Condition code 75 was removed from the home dialysis definition because that billing code is no longer in use. Condition code 80 was removed because we want to exclude beneficiaries who received home dialysis furnished in a SNF or nursing facility. Beneficiaries receiving in-center dialysis services were defined using condition code 71. Two new variables were created: In-center selfdialysis, condition code 72 512.365
and in-center nocturnal dialysis, based on any of the claims lines 15 HCPCS
codes equal to the UJ modifier. Selfcare in training and ESRD self-care retraining, condition codes 73 and 87, respectively, were only included in the denominator for the home dialysis rate calculation. For consistency with the exclusion in 512.385a, after grouping within each HRR, aggregated ESRD
facilities with less than 132 total attributed beneficiary months during a given MY were excluded. When constructing benchmarks, for consistency with the methodology for aggregating performance for purposes of the PPA calculation, we aggregated all ESRD facilities owned in whole or in part by the same dialysis organization located in the same HRR.
The Managing Clinicians performance data were aggregated to the Tax Identification Number TIN level for group practices and the individual National Provider Identifier NPI level for solo practitioners. For purposes of calculating the home dialysis rate, beneficiaries on home dialysis were identified using outpatient claims with CPT codes 90965 and 90966
512.345. Beneficiaries receiving incenter dialysis were identified by outpatient claims with CPT codes 90957, 90958, 90959, 90960, 90961, and 90962 512.360. Last, following the low-volume threshold described in 512.385b, after grouping within each HRR, Managing Clinicians with less than 132 total attributed beneficiary months during a given MY were excluded.
The Scientific Registry of Transplant Recipients SRTR transplant waitlist data were obtained from the Center for Clinical Standards and Quality CCSQ.
To construct the transplant waitlist rate, the numerator was based on per-patient counts and included every addition to the waitlist for a patient in any past year. The waitlist counts for the
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