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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
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public through this proposed rule. We are seeking comments from all perspectives, including differing beneficiary populations of ESRD
facilities and ESRD facilities located in remote locations and their infrastructure issues. Obtaining a variety of perspectives enables CMS to ultimately work toward an improved payment methodology for the ESRD PPS that is both patient-data focused and accounts for the changing landscape in providing renal dialysis services to Medicare beneficiaries.
We encourage the public, and all stakeholders to provide comments and recommend approaches that will assist CMS in making refinements to the ESRD
PPS through rulemaking in the future.
We are soliciting comments this year so that we have time to consider them for potential proposals in the CY 2023
ESRD PPS proposed rule for a CY 2025
implementation.
B. Technical Expert Panels TEPs CMS contractor held three TEPs to discuss refinements to the ESRD PPS.
The TEPs included panelists representing dialysis providers, independent researchers, patient advocates, and representatives from professional associations and industry groups. The first TEP held in 2018
explored the components of the existing ESRD PPS, and identified limitations of the current model. The TEP discussed topics such as current measures of ESRD
PPS costs, costs associated with length of dialysis treatment, variations in cost associated with complex patients, facility level drivers of cost, and additional patient attributes necessary for developing a revised ESRD payment model. One of the main goals of the TEP
was to identify items and services potentially appropriate for either itemized data collection on claims or improved reporting on the cost reports.
The second TEP held in 2019 elaborated on the previous TEPs themes and focused on alternative approaches to measuring the cost of a dialysis session to better reflect treatment-level variation in cost. Topics included measurement of costs for determining case-mix adjustments, wage index, low volume payment adjustments and rural adjustments, TDAPA, outlier determinations, TPNIES, and home dialysis. The third TEP held in 2020
focused on aspects of the ESRD PPS for which refinements or enhancements were being considered. The topics discussed included adult and pediatric case-mix adjustments, low volume payment adjustments, the acute kidney injury payment system, and cost report revisions.

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During each TEP, the data contractor presented to the panelists, and the panelists presented to all the TEP
participants, innovative methodological approaches that addressed stakeholder concerns about the current payment model and presented alternative approaches with the goal of soliciting specific input for developing a more refined case-mix adjusted payment system. Panelists discussed potential approaches while weighing the ESRD
facility burden those approaches may require. Alternative approaches were presented to solicit feedback from panelists about feasibility and acceptability of the options. The TEPs did not provide formal recommendations, but discussion items and suggestions were captured in three subsequent reports. The materials from the TEPs and summary reports can be found at https www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/ESRDpayment/Educational_
Resources.
The following sections of this RFI
provide information and solicit feedback specifically on the following topics: Low-volume payment adjustment LVPA, calculations for case-mix adjustment, the calculation for the outlier payment adjustment, the current pediatric dialysis payment model, recommendations for ESRD PPS
and hospital cost report modifications, recommendations for modifying the pediatric cost report, and home dialysis for Medicare beneficiaries with acute kidney injury. While TEP discussions are noted in each section, CMS
encourages the public to reference the TEP reports on CMS website, noted above, for more details.
C. Calculation of the Low-Volume Payment Adjustment LVPA
1. Background on the LVPA
Section 1881b14Diii of the Act provides that the ESRD PPS shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities as defined by the Secretary in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent.
In the CY 2011 ESRD PPS final rule 75 FR 49118 through 49125, we finalized the methodology used to target the appropriate population of ESRD
facilities that were low-volume and to determine the treatment threshold for those facilities identified. After
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consideration of public comments, we established an 18.9 percent adjustment for facilities that furnish less than 4,000
treatments annually with the intention of encouraging small facilities to continue providing access to care.
In the CY 2016 ESRD PPS proposed rule 80 FR 37819, we analyzed ESRD
facilities that met the definition of lowvolume under 413.232b as part of the updated regression analysis and found that the facilities still had higher costs compared to other facilities. A
regression analysis of CYs 2012 and 2013 low-volume facility claims and cost report data indicated a multiplier of 1.239 percent; therefore, we proposed an updated LVPA adjustment factor of 23.9 percent in the CY 2016 ESRD PPS
proposed rule 80 FR 37819 and finalized this policy in the CY 2016
ESRD PPS final rule 80 FR 69001. In CY 2019, 332 facilities received the LVPA and using the most recent available data for CY 2020, the number of facilities receiving the LVPA was 344
as of April 2021.
2. Current LVPA Methodology Under 413.232b, a low-volume facility is an ESRD facility that, based on the submitted documentation: 1
Furnished less than 4,000 treatments in each of the 3 cost reporting years based on as-filed or final settled 12consecutive month costs reports, whichever is most recent preceding the payment year; and 2 has not opened, closed, or received a new provider number due to a change in ownership in the three cost reporting years based on as-filed or final settled 12consecutive month cost reports, whichever is most recent preceding the payment year.
In addition, under 413.232c, for purposes of determining the number of treatments furnished by the ESRD
facility, the number of treatments considered furnished by the ESRD
facility equals the aggregate number of treatments furnished by the ESRD
facility and the number of treatments furnished by other ESRD facilities that are both under common ownership with, and 5 road miles or less from, the ESRD facility in question. In order to receive the LVPA, an ESRD facility must submit a written attestation statement to its Medicare Administrative Contractor MAC confirming that it meets all of the requirements specified in 413.232 and qualifies as a low-volume ESRD facility.
For purposes of determining eligibility for the LVPA, treatments mean total hemodialysis equivalent treatments Medicare and non-Medicare. For peritoneal dialysis patients, one week of peritoneal dialysis is considered
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