DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

CMS-1503-FC 1423
for managed care.
For purposes of the RFA, approximately 80 percent of clinical diagnostic
laboratories are considered small businesses according to the SBA size standards.
Ambulance providers and suppliers for purposes of the RFA are also considered
to be small entities.
In addition, most ESRD facilities are considered small entities for purposes of the
RFA, either based on nonprofit status or by having revenues of $34.5 million or less in
any year. We note that a considerable number of ESRD facilities are owned and operated
by large dialysis organizations (LDOs) or regional chains, which would have total
revenues more than $34.5 million in any year if revenues from all locations are
combined. However, the claims data we use to estimate payments for this RFA and RIA
does not identify which dialysis facilities are parts of an LDO, regional chain, or other
type of ownership. Each individual dialysis facility has its own provider number and
bills Medicare using this number. Therefore, we consider each ESRD facility to be a
small entity for purposes of the RFA. We consider a substantial number of entities to be
significantly affected if the final rule with comment period has an annual average impact
on small entities of 3 to 5 percent or more. The majority of ESRD facilities will
experience impacts of approximately 2 percent of total revenues. There are 976 nonprofit
ESRD facilities with a combined increase of 2.1 percent in overall payments relative to
current overall payments. We note that although the overall effect of the wage index
changes is budget neutral, there are increases and decreases based on the location of
individual facilities. The analysis and discussion provided in this section and elsewhere
in this final rule with comment period complies with the RFA requirements.