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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
ESRD Facility size based on of dialysis treatments
of low volume ESRD
Facilities per Table 9

%of total number of ESRD
facilities
Individual ESRD facility revenue per treatment including low volume adjustment
Annual total treatment revenue perESRD
facility based on 3999
treatments or less
Total annual treatment revenue to all low volume ESRD facilities <4000

643

12%

$311

$1.26M

$800M

We do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis.
Individuals and states are not included in the definition of a small entity.
For purposes of the RFA, we estimate that approximately 11 percent of ESRD
facilities are small entities as that term is used in the RFA which includes small businesses, nonprofit organizations, and small governmental jurisdictions. This amount is based on the number of ESRD facilities shown in the ownership category in Table 9.
Using the definitions in this ownership category, we consider 515 facilities that are independent and 378 facilities that are shown as hospital-based to be small entities. The ESRD facilities that are owned and operated by Large Dialysis Organizations LDOs and regional chains would have total revenues of more than $41.5 million in any year when the total revenues for all locations are combined for each business individual LDO or regional chain, and are not, therefore, included as small entities.
For the ESRD PPS updates proposed in this rule, a hospital-based ESRD
facility as defined by type of ownership, not by type of dialysis facility is estimated to receive a 1.3
percent increase in payments for CY
2022. An independent facility as defined by ownership type is estimated to receive a 1.1 percent increase in payments for CY 2022.
For AKI dialysis, we are unable to estimate whether patients would go to ESRD facilities, however, we have estimated there is a potential for $52
million in payment for AKI dialysis
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treatments that could potentially be furnished in ESRD facilities.
For ETC Model, this proposed rule includes as ETC Participants Managing Clinicians and ESRD facilities required to participate in the Model pursuant to 512.325a. We assume for the purposes of the regulatory impact analysis that the great majority of Managing Clinicians are small entities and that the greater majority of ESRD
facilities are not small entities.
Throughout the proposed rule we describe how the adjustments to certain payments for dialysis services and dialysis-related services furnished to ESRD beneficiaries may affect Managing Clinicians and ESRD facilities participating in the ETC Model. The great majority of Managing Clinicians are small entities by meeting the SBA
definition of a small business having minimum revenues of less than $8
million to $41.5 million in any 1 year, varying by type of provider and highest for hospitals with a minimum threshold for small business size of $41.5 million https www.sba.gov/
document/support--table-size-standards http www.sba.gov/content/smallbusinesssize-standards. The great majority of ESRD facilities are not small entities, as they are owned, partially or entirely by entities that do not meet the SBA definition of small entities.
The HDPA in the ETC Model is a positive adjustment on payments for specified home dialysis and home dialysis-related services. The PPA in the ETC Model, which includes both positive and negative adjustments on payments for dialysis services and dialysis-related services, excludes aggregation groups with fewer than 132
attributed beneficiary-months during the relevant year.

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The aggregation methodology groups ESRD facilities owned in whole or in part by the same dialysis organization within a Selected Geographic Area and Managing Clinicians billing under the same TIN within a Selected Geographic Area. This aggregation policy increases the number of beneficiary months, and thus statistical reliability, of the ETC
Participants home dialysis and transplant rate for ESRD facilities that are owned in whole or in part by the same dialysis organization and for Managing Clinicians that share a TIN
with other Managing Clinicians.
Taken together, the low volume threshold exclusions and aggregation policies previously described, coupled with the fact that the ETC Model would affect Medicare payment only for select services furnished to Medicare FFS
beneficiaries; we have determined that the provisions of the proposed rule would not have a significant impact on spending for a substantial number of small entities defined as greater than 5
percent impact.
Therefore, the Secretary has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities. The economic impact assessment is based on estimated Medicare payments revenues and HHSs practice in interpreting the RFA
is to consider effects economically significant only if greater than 5
percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. We solicit comment on the RFA analysis provided.
In addition, section 1102b of the Act requires us to prepare a RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603

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TABLE 21: Revenue Table for Low Volume ESRD Facilities for CY 2022 ESRD PPS
Proposed Rule