Section 246-310-812 - Kidney disease treatment centers-MethodologyA 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.Wash. Admin. Code § 246-310-812
Adopted by WSR 17-04-062, Filed 1/27/2017, effective 1/1/2018Amended by WSR 24-18-006, Filed 8/22/2024, effective 9/22/2024