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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
machine offered the best solution for capturing patient-level differences in the cost of dialysis sessions and would be superior to the current case-mix adjusters.
We included discussions about expanding the data elements, moving to a patient-data focused model, and the use of time on machine to determine patient level variation in dialysis treatment costs in the CY 2019 ESRD
PPS final rule 83 FR 56963 through 56970 as well as the CY 2020 ESRD
PPS proposed rule 84 FR 38396
through 38400 A comment letter from a large dialysis organization in response to the CY 2019 ESRD PPS proposed rule stated that costs in the remaining categorywages, salaries, and benefitsaccount for nearly 40 percent of the market basket weight.
Additionally, the large dialysis organization noted that these costs represent the majority of expenses associated with dialysis treatment and will vary by patient because they are dependent on dialysis treatment times.
The large dialysis organization stated that time on machine was a good proxy for costs in dialysis.
Based on information gathered from our stakeholders and panelists from the first two TEP meetings and comments received based on RFIs in the CY 2020
ESRD PPS proposed rule, CMS took steps towards developing a patient-data focused model. Based on stakeholder input, CMS chose to utilize time on machine to determine patient level variation in dialysis treatment costs. In order to collect this information from ESRD facilities, CMS petitioned the National Uniform Billing Committee NUBC for a new value code for time on machine. This value code allows CMS to add time on machine to the ESRD claim. In April 2020, NUBC
approved the request. CMS included a requirement to collect time on machine data effective January 1, 2021 in two technical direction letters and two Medicare Learning Network articles.
CMS later rescinded the time on machine requirement,295 but we are discussing this potential requirement in this RFI as a possible future refinement of the ESRD PPS to address allocation of composite rate costs, case mix, and patient level adjustments.
During the 2020 TEP, the data contractor for CMS presented and the panelists discussed potential refinement to concerns regarding the current casemix adjustment. One of the refinements discussed was collecting time on machine data on the 72x claim using a 295 https www.cms.gov/files/document/
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value code. Specifically, the suggested method includes the costs per beneficiary-facility-month which are the sum of formerly separately billable costs, directly calculated from claims quantities and from Part B prices, and composite rate costs for each beneficiary-facility-month, calculated by allocating annual facility costs less formerly separately billable costs to the beneficiary-facility-month level using time on machine duration of all treatments. For some modalities and settings, time on machine is not available and must be imputed. Finally, a regression is run of beneficiaryfacility-month costs on case-mix adjusters and facility characteristics.
Following a presentation by the data contractor, the panelists agreed that this method would identify a magnitude of factors that best reflect variation in this measure of total cost per treatment. This method would select a set of case-mix adjusters that account for a significant portion of the variance of total costs, subject to intuitive clinical relationship to dialysis treatment costs, reasonable number of risk adjusters, easy to diagnose, identify, or report, and not gameable.
Panelists at the TEPs and stakeholder comments received in response to the CY 2019 ESRD PPS proposed rule believe this one-equation model is more intuitive than current ESRD PPS casemix adjusters.296 The suggested casemix adjusters discussed during the December 2019 and 2020 TEPS are derived relative to variation in total cost of case and that the change in reporting burden is small and would change claims in two ways, including reporting total machine reported treatment minutes and reporting codes for new comorbidities. Finally, stakeholders believe that a magnitude of case-mix adjusters appears to be significantly attenuated relative to the existing ESRD
PPS adjusters. As discussed in the TEP
Report for the December 2020 TEP,297 a budget neutral implementation of such a system would result in a 510 percent increase in the base rate. Options discussed by the panelists included the one-equation model and keeping the current ESRD PPS case-mix adjustments. CMS is seeking feedback from the public on these options and 296 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.
297 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.

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any additional approaches not yet considered.
5. Request for Information on Calculation of the Case-Mix Adjustments CMS welcomes the opportunity to inform the public and solicit stakeholder feedback on potential changes to the modeling used to develop the case-mix payment adjustments under the ESRD PPS, in order to inform future model refinements. CMS is considering alternative approaches to calculating the case-mix adjustment that directly address stakeholder concerns, and more appropriately reflects resource use and costs, and is issuing this RFI both to seek feedback on the suggested approach discussed previously, and to solicit information that will better inform future modifications to this methodology. In particular, we are soliciting comments on the methodology to collect data to reflect patient-level differences in composite rate costs, including the use of a value code to collect time on machine on the claim. In addition to any other input the public wants to provide regarding the calculation of the case-mix adjustment, we are requesting responses to the following questions.
Which of the five composite rate cost components that is, age, BSA, BMI, onset of dialysis, comorbidities are most likely to vary with treatment duration?
Should new information for these cost components be collected on cost reports, for use in better inferring the composite rate costs associated with treatment duration?
What are the advantages and disadvantages of obtaining treatment duration information from blood urea nitrogen time on dialysis through the End Stage Renal Disease Quality Reporting System EQRS our new system that has replaced the Consolidated Renal Operations in a Web-enabled Network CROWNWeb, versus collecting treatment duration through new fields on claims?
What challenges would be encountered in reporting treatment duration on claims, using one of the options discussed?
Are there alternative proxies for resource utilization that can be reported at the patient/treatment level?
E. Calculation of the Outlier Payment Adjustment 1. Background on the Outlier Payment Adjustment Section 1881b14Dii of the Act requires that the ESRD PPS include a
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