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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations 1. Calculation of the Low-Volume Payment Adjustment LVPA

4. Calculation of the Pediatric Dialysis Payment Adjustment
Of the fourteen responses to the LVPA
RFI, all commenters supported either eliminating or revising the current LVPA or rural adjustment. One small dialysis organization within a large nonprofit health system responded that they are reliant upon the LVPA and the rural adjustment, and support both adjustments, albeit with modifications.
Several commenters agreed with MedPACs suggestion for the low volume and isolated LVI adjustment.
Several commenters opposed the census tract methodology with some stating that it is complex and lacks transparency.

In the response to RFI for calculation of pediatric dialysis payment adjustment, all the commenters expressed that the total costs of ESRD
care delivered to pediatric dialysis patients are not covered by the current ESRD bundled payment and existing pediatric multipliers. Several commenters stated that they did not believe that using duration of treatment is a valid proxy for composite rate costs.
Some commenters recommended that a combination of age, weight and pediatric-specific comorbidities be used as a proxy for composite rate costs for pediatric patients. A few commenters recommended streamlining the reporting for claims and cost reports.

2. Calculation of the Case-Mix Adjustments In response to the RFI for current case-mix methodology, several commenters recommended changes or removal of the case-mix adjusters, including refinement of the age and weight BSA and BMI adjustments and removal of the comorbidity adjustments, based on declining frequency of claims containing comorbidities. Commenters expressed their belief that the comorbidity categories no longer protect beneficiary access and no longer correlate with increased costs.
Numerous commenters expressed support for the current onset of dialysis adjustment. Most commenters did not support the collection of time on machine data on claims or cost reports to allocate composite rate costs.
MedPAC recommended that CMS
develop a one-equation regression model in place of the current twoequation model currently used as the basis for the ESRD PPS.

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3. Calculation of the Outlier Adjustment In response to the current RFI for the calculation of the outlier payment adjustment, several commenters recommended changes to the outlier policy, expressing concerns about the current outlier policy because it continues to achieve less than the target amount of outlier payments equal to 1.0
percent of total PPS payments. They suggested various strategies for addressing the outlier policy, including reducing the outlier threshold, and excluding TDAPA and TPNIES
payments in the outlier calculation methodology. Several commenters supported the use of the FDL trend using historical utilization data.
Commenters also recommended the creation of a mechanism to return unpaid outlier amounts to the ESRD
PPS.

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5. Modifying the Pediatric Dialysis, ESRD PPS and Hospital Cost Reports In the responses to RFI for modifying the pediatric cost report, commenters supported updating the pediatric cost report to allow facilities to include costs that cannot be currently reported on the cost report. Specific recommendations included breakdown of patient age groups, pediatric-specific dialysis supplies, additional overhead at hospital outpatient dialysis facilities, psychosocial support, specialized pharmacy needs and costs unique to the pediatric population for home dialysis.
Several commenters noted that, despite best efforts to educate reporting and billing staff, hospitals often triage their cost reporting obligations, focusing on those that affect payment over those that do not; they stated that this is particularly true with pediatric dialysis costs. In order to improve reporting, the commenters recommended streamlining the reporting required and making it more consistent with reporting required from the State Medicaid programs or the private payers.
In the responses to RFI for modifying the ESRD PPS and Hospital Cost Reports, we received input from ten commenters consisting of large, small, and non-profit dialysis organizations; an advocacy organization; a coalition of dialysis organizations; a large non-profit health system; an independent commenter; and MedPAC. All the commenters expressed support for making improvements to the cost report that will streamline reporting and improve accuracy of information collected that informs payment policy.
Additionally, commenters recommended CMS consider modifying hospital cost report reporting instructions to ensure complete, consistent, and accurate data reporting
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as well as make timely updates to reflect changes to payment policies, including the TDAPA and TPNIES. These commenters cautioned CMS that prior to making changes, CMS should weigh the burden of data collection against the benefit to the system in collecting it.
6. Modifying Site of Services Provided to Medicare Beneficiaries With Acute Kidney Injury AKI
The responses to the RFI for modifying site of service provided to Medicare beneficiaries included numerous requests to allow payment for home dialysis for patients with AKI. Of the 16 total comments received on this topic, 15 discussed modification of the site of service requirements, with commenters supporting payment for AKI patients receiving dialysis in home settings, including skilled nursing facilities. Several commenters favored modification of the site of service requirements in concert with payment of home dialysis for AKI patients when deemed appropriate by health care providers.
7. CMS Response to Public Comments We appreciate the public input and comments on suggested refinements to the ESRD PPS in response to our RFI in the CY 2022 ESRD PPS proposed rule.
We will take all of these comments into consideration for possible future rulemaking.
VII. Collection of Information Requirements A. Legislative Requirement for Solicitation of Comments Under the Paperwork Reduction Act of 1995, we are required to provide 60day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget OMB for review and approval. In order to fairly evaluate whether an information collection requirement should be approved by OMB, the Paperwork Reduction Act of 1995 44 U.S.C. 3506c2A requires that we solicit comment on the following issues:
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We solicited public comment on each of these issues for the following sections
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