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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
equivalent to two hemodialysis treatments 80 FR 68994. Section 413.232e imposes a yearly November 1
deadline for attestation submissions, with a few exceptions where the deadline is December 31. The November 1 timeframe provides 60 days for a MAC
to verify that an ESRD facility meets the LVPA eligibility criteria 76 FR 70236.
The ESRD facility would then receive the LVPA payment for all the Medicareeligible treatments in the payment year.
Once a facility is determined to be eligible for the LVPA, a 23.9 percent increase is applied to the ESRD PPS
base rate for all treatments furnished by the facility 80 FR 69001.
In the CY 2021 ESRD PPS final rule 85 FR 71443, we finalized a policy to allow ESRD facilities flexibility for LVPA eligibility due to the COVID19
PHE. Under 413.232g4, for purposes of determining ESRD facilities eligibility for payment years 2021, 2022, and 2023, we will only consider total dialysis treatments for any 6 months of their cost-reporting period ending in 2020. ESRD facilities will attest that their total dialysis treatments for those 6 months of their cost reporting period ending in 2020 are less than 2,000. The attestation must further include that although the total number of treatments furnished in the entire year otherwise exceeded the LVPA threshold, the excess treatments furnished were due to temporary patient shifting resulting from the COVID19 PHE. MACs will annualize the total dialysis treatments for the total treatments reported in those 6 months by multiplying by 2.

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3. Current Issues and Stakeholder Concerns ESRD facilities, the Medicare Payment Advisory Commission MedPAC, and the Government Accountability Office 288 have recommended that we make refinements to the LVPA to better target ESRD facilities that are critical to beneficiary access to dialysis care in remote or isolated areas.289 These groups have also have expressed concern that the strict treatment count introduces a cliff-effect that may incentivize facilities to restrict their patient caseload to remain below the 4,000 treatments per year for the LVPA
threshold.290
288 http www.medpac.gov/docs/default-source/
reports/jun20_ch7_reporttocongress_
sec.pdf?sfvrsn=0.
289 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.
290 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.

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In addition, we have heard from stakeholders that the eligibility criteria for the LVPA are very explicit and leave little room for flexibility in certain circumstances 85 FR 71442. Finally, some view the attestation process as burdensome to facilities and believe it may discourage participation by small facilities with limited resources that would otherwise qualify for the LVPA.291 Given these concerns, we have been asked to consider alternative approaches to the LVPA that would reduce burden, remove negative incentives that may cause gaming, and better target facilities that are critical for beneficiary access.
4. Suggestions for Calculating the LVPA
a. Census Tract During the 2020 ESRD PPS TEP, panelists discussed alternatives to the current LVPA. One methodology discussed utilized census tracts to identify geographic areas with low demand, which suggested increased beneficiary access by incentivizing dialysis organizations to continue operating facilities in otherwise nonviable locations.292 As discussed during the TEP, an advantage to this approach would be a shift in the focus from identifying low volume facilities to identifying geographical areas, specifically census tracts, with low demand for dialysis.
This census tract methodology often results in a single facility being the only dialysis provider for a number of miles.
The process would involve dividing the U.S. into geographic areas based on a reasonable assessment of ESRD
beneficiaries ability or willingness to travel. Latent demand is then calculated by counting the number of ESRD
beneficiaries near each facility. Near is defined by driving time to facilities.
Latent demand is calculated by multiplying the number of beneficiaries near an ESRD facility by average number of treatments for ESRD
beneficiaries. The LVPA threshold is then applied by determining the threshold of adjusted latent demand.
That is, those facilities, which fall below the threshold are LVPA eligible. The panelists noted that this methodology appears administratively simple and could eliminate the burden associated with the LVPA attestation process for facilities and MACs.
291 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.
292 https www.cms.gov/files/document/endstage-renal-disease-prospective-payment-systemtechnical-expert-panel-summary-report-april2021.pdf.

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b. Low-Volume and Isolated LVI
Adjustment In its June 2020 report to Congress, MedPAC recommended that the Secretary replace the LVPA and rural adjustment under the ESRD PPS with a single payment adjustment, a lowvolume and isolated LVI adjustment, in an effort to better protect isolated, low-volume ESRD facilities that are critical to ensure beneficiary access.293
A determination that a facility is low volume and isolated would be based on that facilitys distance from the nearest facility and its total treatment volume.
MedPAC stated that the facilities that would receive the adjustment would be more appropriately targeted. This methodology would be accomplished via a single facility-level regression approach instead of the current tworegression approach utilized by CMS.
As an example of how the LVI
adjustment would more directly target isolated, low-volume dialysis facilities, the TEP compared the current LVPA
and suggested LVI methodologies using 2017 data. In this example, 575 facilities would have been eligible for the LVI
verses 1,734 facilities under the current LVPA and rural adjustment methodology.
5. Request for Information on Calculating the LVPA
CMS is considering alternative approaches to the LVPA that directly address stakeholder concerns, and is issuing a request for information to seek feedback on the approaches suggested above, other alternate approaches, and support of the current LVPA
methodology. We are soliciting information that will better inform potential future modifications to the methodology. In addition to any other input the public wants to provide regarding the LVPA under the ESRD
PPS, we are requesting responses to the following questions.
Should a distinction other than census tract information be considered?
What criteria should be used to determine the thresholds of adjusted latent demand in treatment counts which determine LVPA eligibility for example, a threshold of high average cost per-treatment?
What are the concerns for facilities that would lose the LVPA under the LVI
methodology?
What are the concerns about the potential for gaming within the LVI
methodology?
293 http www.medpac.gov/docs/default-source/
reports/jun20_ch7_reporttocongress_
sec.pdf?sfvrsn=0.

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