Current through Register Vol. 24-18, September 15, 2024
A kidney disease treatment center that provides hemodialysis
or peritoneal dialysis, training, or backup must meet the following standards
in addition to applicable review criteria in WAC
246-310-210,
246-310-220,
246-310-230, and
246-310-240.
(1) Applications for new stations may only
address projected station need in the planning area in which the center is to
be located.
(a) If there is no existing
center in an adjacent planning area, the application may also address the
projected station need in that planning area.
(b) Station need projections must be
calculated separately for each planning area within the application.
(2) Data used to project station
need must be the most recent five-year resident end-of-year in-center patient
data available from the Network as of the letter of intent submission date,
concluding with the base year at the time of application.
(3) Projected station need must be based on
4.8 resident in-center patients per station (4.8 planning area) for all
planning areas except Adams, Columbia, Douglas, Ferry, Garfield, Jefferson,
Kittitas, Klickitat, Lincoln, Okanogan, Pacific, Pend Oreille, San Juan,
Skama-nia, Stevens, Wahkiakum, and Whitman counties. The projected station need
for these exception planning areas must be based on 3.2 resident in-center
patients per station (3.2 planning area).
(4) The number of dialysis stations projected
as needed in a planning area will be determined by using the following
methodology:
(a) Determine the type of
regression analysis to be used to project resident in-center station need by
calculating the annual growth rate in the planning area using the end-of-year
number of resident in-center patients for each of the previous six consecutive
years, concluding with the base year.
(i) If
the planning area has experienced less than six percent growth in any of the
previous five annual changes calculations, use linear regression to project
station need; or
(ii) If the
planning area has experienced six percent or greater growth in each of the
previous five annual changes, use nonlinear (exponential) regression to project
station need.
(b)
Project the number of resident in-center patients in the projection year using
the regression type determined in (a) of this subsection. When performing the
regression analysis use the previous five consecutive years of end-of-year data
concluding with the base year. For example, if the base year is 2015, use
end-of-year data for 2011 through 2015 to perform the regression
analysis.
(c) Determine the number
of dialysis stations needed to serve resident in-center patients in the
planning area in the projection year by dividing the result of (b) of this
subsection by the appropriate resident in-center patient per station number
from subsection (3) of this section. In order to assure access, fractional
numbers are rounded up to the nearest whole number. For example, 5.1 would be
rounded to 6.0. Rounding to a whole number is only allowed for determining the
number of stations needed.
(d) To
determine the net station need for a planning area, subtract the number
calculated in (c) of this subsection from the total number of certificate of
need approved stations located in the planning area. This number does not
include the one department recognized exempt isolation station defined in WAC
246-310-800(9),
nor does it include any dialysis stations added during a temporary emergency
situation. For example, a kidney disease treatment center that is certificate
of need approved and certified for 11 stations would subtract the one exempt
isolation station and use 10 stations for the methodology
calculations.
(5) Before
the department approves new in-center kidney dialysis stations in a 4.8
planning area, all certificate of need counted stations at each center in the
planning area must be operating at 4.5 in-center patients per station. However,
when a planning area has one or more centers with stations not meeting the
in-center patients per stations standard, the department will consider the 4.5
in-center patients per station standard met for those centers when:
(a) All stations for a center have been in
operation for at least three years, excluding temporary emergency situation
stations; or
(b) Certificate of
need approved stations for a center have not become operational within the
timeline as represented in the approved application. For example, an applicant
states the stations will be operational within eight months following the date
of the certificate of need approval. The eight months would start from the date
of an uncontested certificate of need approval. If the certificate of need
approval is contested, the eight months would start from the date of the final
department or judicial order. However, the department, at its sole discretion,
may approve a one-time modification of the timeline for purposes of this
subsection upon submission of documentation that the applicant was prevented
from meeting the initial timeline due to circumstances beyond its control.
Both resident and nonresident patients using the kidney
disease treatment center are included in this calculation. Data used to make
this calculation must be from the most recent quarterly modality report from
the Network as of the letter of intent submission date; or
(c) If a center was affected by a temporary
emergency situation at the time of the patient census estimates presented in
the most recent quarterly modality report from the Network as of the letter of
intent submission date, then the in-center census data for the affected center
must come from the quarterly modality report from the Network that directly
precedes the date that the temporary emergency situation exemption request was
submitted to the department for the affected center.
(6) Before the department approves new
in-center kidney dialysis stations in a 3.2 planning area, all certificate of
need counted stations at each center in the planning area must be operating at
or above 3.2 in-center patients per station. If the certificate of need
approval is contested, the eight months would start from the date of the final
department or judicial order. However, when a planning area has centers with
stations not meeting the in-center patients per station standard, the
department will consider the 3.2 in-center patients per station standard met
for those centers when:
(a) All stations for a
center have been in operation for at least three years, excluding temporary
emergency situation stations; or
(b) Certificate of need approved stations for
a center have not become operational within the timeline as represented in the
approved application. For example, an applicant states the stations will be
operational within eight months following the date of the certificate of need
approval. The eight months would start from the date of an uncontested
certificate of need approval. However, the department, at its sole discretion,
may approve a one-time modification of the timeline for the purposes of this
subsection upon submission of documentation that the applicant was prevented
from meeting the initial timeline due to circumstances beyond its control.
Both resident and nonresident patients using the kidney
disease treatment center are included in this calculation. Data used to make
this calculation must be from the most recent quarterly modality report from
the Network as of the letter of intent submission date; or
(c) If a center was affected by a temporary
emergency situation at the time of the patient census estimates presented in
the most recent quarterly modality report from the Network as of the letter of
intent submission date, then the in-center census data for the affected center
must come from the quarterly modality report from the Network that directly
precedes the date that the temporary emergency situation exemption request was
submitted to the department for the affected center.
(7) If a kidney disease treatment center was
affected by a temporary emergency situation other than a staffing shortage, the
department will continue to include the affected center's total number of
certificate of need approved permanent stations in the supply for the planning
area, unless, in the department's discretion, including the affected center's
stations in the supply would negatively impact access to dialysis
services.
(8) When there are
relocated stations within a planning area pursuant to WAC
246-310-830(3)
and data is not available for the relocated stations, the department will use
the station use rate from the previous location as reported on the last
quarterly modality report from the Network.
(9) If a provider, including any affiliates,
submits multiple applications for projected need in a planning area, the
department will use the following process:
(a)
Each application will be scored as an individual application to determine
superiority.
(b) The sum of the
stations requested in the applications cannot exceed the projected need at the
time of applications in the planning area.
