WSR 15-08-080 EMERGENCY RULES DEPARTMENT OF HEALTH [Filed March 31, 2015, 10:52 a.m., effective March 31, 2015, 10:52 a.m.] Effective Date of Rule: Immediately upon filing.
Purpose: WAC 246-310-280 Kidney dialysis treatment centers—Definitions, amending the definition of "training services." This rule amends the definition of training services to indicate that training is considered a service and such services are not associated with a kidney dialysis center's certificate of need approved station count. Amending the definition will increase a center's ability to provide more patients with routine in-center dialysis treatments.
Citation of Existing Rules Affected by this Order: Amending WAC 246-310-280.
Statutory Authority for Adoption: RCW 43.70.040, 70.38.135.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: The Centers for Medicare and Medicaid Services (CMS) changed its reporting requirements so that stations used for training are no longer included in the certified station count. Emergency rules are necessary to immediately align certificate of need kidney dialysis rules with the recent CMS changes in order to increase patient access to in-center dialysis services.
"Training services" as currently defined in WAC 246-310-280 requires kidney dialysis training stations to be reported in the count of approved certified dialysis stations. CMS now considers training as a service and is not associated with an approved number of certified stations at a facility. Under the new requirements, facilities may use additional rooms or space in the facility for training services freeing up stations for certification to be used for life-preserving, in-center dialysis treatments.
If emergency rules are not adopted, chronically ill patients requiring kidney dialysis will have fewer stations to use within treatment centers for critical dialysis treatments. Emergency rules are necessary to immediately align existing certificate of need kidney dialysis rules with the recent CMS changes in order to increase patient access to in-center dialysis services. Training stations will still be available to train patients for home dialysis.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 1, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.
Date Adopted: March 31, 2015.
Dennis E. Worsham
Deputy Secretary
for John Wiesman, DrPH, MPH
Secretary
AMENDATORY SECTION (Amending WSR 06-24-050, filed 12/1/06, effective 1/1/07)
WAC 246-310-280 Kidney disease treatment centers—Definitions.
The following definitions apply to WAC 246-310-280, 246-310-282, 246-310-284, 246-310-286, 246-310-287, 246-310-288, and 246-310-289:
(1) "Base year" means the most recent calendar year for which December 31 data is available as of the first day of the application submission period from the Northwest Renal Network's Modality Report or successor report.
(2) "Capital expenditures," as defined by Generally Accepted Accounting Principles (GAAP), are expenditures made to acquire tangible long-lived assets. Long-lived assets represent property and equipment used in a company's operations that have an estimated useful life greater than one year. Acquired long-lived assets are recorded at acquisition cost and include all costs incurred necessary to bring the asset to working order. The definition of a capital expenditure includes the following types of expenditures or acquisitions:
(a) A force account expenditure or acquisition (i.e., an expenditure for a construction project undertaken by a facility as its own contractor).
(b) The costs of any site planning services (architect or other site planning consultant) including but not limited to studies, surveys, designs, plans, working drawings, specifications, and other activities (including applicant staff payroll and employee benefit costs, consulting and other services which, under GAAP or Financial Accounting Standards Board (FASB) may be chargeable as an operating or nonoperating expense).
(c) Capital expenditure or acquisition under an operating or financing lease or comparable arrangement, or through donation, which would have required certificate of need review if the capital expenditure or acquisition had been made by purchase.
(d) Building owner tenant improvements including, but not limited to: Asbestos removal, paving, concrete, contractor's general conditions, contractor's overhead and profit, electrical, heating, ventilation and air conditioning systems (HVAC), plumbing, flooring, rough and finish carpentry and millwork and associated labor and materials, and utility fees.
(e) Capital expenditures include donations of equipment or facilities to a facility.
(f) Capital expenditures do not include routine repairs and maintenance costs that do not add to the utility of useful life of the asset.
(3) "Concurrent review" means the process by which applications competing to provide services in the same planning area are reviewed simultaneously by the department. The department compares the applications to one another and these rules.
(4) "End-of-year data" means data contained in the fourth quarter modality report or successor report from the Northwest Renal Network. For these rules, end-of-year and year-end have the same meaning.
(5) "End-of-year in-center patients" means the number of in-center hemodialysis (HD) and self-dialysis training patients receiving in-center kidney dialysis at the end of the calendar year based on end-of-year data.
(6) "Kidney disease treatment center" means any place, institution, building or agency or a distinct part thereof equipped and operated to provide services, including outpatient dialysis, to persons who have end-stage renal disease (ESRD). In no case shall all stations at a given kidney disease treatment center be designated as self-dialysis training stations. For purposes of these rules, kidney disease treatment center and kidney dialysis facility have the same meaning.
(7) "Kidney dialysis facility" means any place, institution, building or agency or a distinct part thereof equipped and operated to provide services, including outpatient dialysis, to persons who have end-stage renal disease (ESRD). In no case shall all stations at a given kidney disease treatment center be designated as self-dialysis training stations. For purposes of these rules, kidney dialysis facility and kidney disease treatment center have the same meaning.
(8) "Planning area" means an individual geographic area designated by the department for which kidney dialysis station need projections are calculated. For purposes of kidney dialysis projects, planning area and service area have the same meaning.
(9) "Planning area boundaries": Each county is a separate planning area, except for the planning subareas identified for King, Snohomish, Pierce, and Spokane counties. If the United States Postal Service (USPS) changes zip codes in the defined planning areas, the department will update areas to reflect the revisions to the zip codes to be included in the certificate of need definitions, analyses and decisions.
(a) King County is divided by zip code into twelve planning areas as follows:
(b) Pierce County is divided into five planning areas as follows:
(c) Snohomish County is divided into three planning areas as follows:
(d) Spokane County is divided into two planning areas as follows:
(10) "Projection year" means the fourth year after the base year. For example, reviews using 2005 year-end data as the base year will use 2009 as the projection year.
(11) "Resident in-center patients" means in-center hemodialysis (HD) and self-dialysis training patients that reside within the planning area. If more than fifty percent of a facility's patients reside outside Washington state, the facility may include these out-of-state patients in the resident count for the planning area.
(12) "Service area" means an individual geographic area designated by the department for which kidney dialysis station need projections are calculated. For purposes of kidney dialysis projects, service area and planning area have the same meaning.
(13) "Training services" means services provided by a kidney dialysis facility to train patients for home dialysis. Home training stations are not used to provide in-center dialysis treatments. Stations used for training are not included in the facility's station count for projecting future station need or utilization. Types of home dialysis include at least, but are not limited to, the following:
(a) Home peritoneal dialysis (HPD); and
(b) Home hemodialysis (HHD).
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