15-08-080

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:

KING ONE	KING TWO	KING THREE
98028 Kenmore	98101 Business District	98070 Vashon
98103 Green Lake	98102 Eastlake	98106 White Center/West Seattle
98105 Laurelhurst	98104 Business District	98116 Alki/West Seattle
98107 Ballard	98108 Georgetown	98126 West Seattle
98115 View Ridge/Wedgwood	98109 Queen Anne	98136 West Seattle
98117 Crown Hill	98112 Madison/Capitol Hill	98146 West Seattle
98125 Lake City	98118 Columbia City	98168 Riverton
98133 Northgate	98119 Queen Anne
98155 Shoreline/Lake Forest Park	98121 Denny Regrade
98177 Richmond Beach	98122 Madrona
98195 University of Washington	98134 Harbour Island
	98144 Mt. Baker/Rainier Valley
	98199 Magnolia

KING FOUR	KING FIVE	KING SIX
98148 SeaTac	98003 Federal Way	98011 Bothell
98158 SeaTac	98023 Federal Way	98033 Kirkland
98166 Burien/Normandy Park		98034 Kirkland
98188 Tukwila/SeaTac		98052 Redmond
98198 Des Moines		98053 Redmond
		98072 Woodinville
		98077 Woodinville

KING SEVEN	KING EIGHT	KING NINE
98004 Bellevue	98014 Carnation	98055 Renton
98005 Bellevue	98019 Duvall	98056 Renton
98006 Bellevue	98024 Fall City	98058 Renton
98007 Bellevue	98045 North Bend	98059 Renton
98008 Bellevue	98065 Snoqualmie	98178 Skyway
98027 Issaquah
98029 Issaquah
98039 Medina
98040 Mercer Island
98074 Sammamish
98075 Sammamish

KING TEN	KING ELEVEN	KING TWELVE
98030 Kent	98001 Auburn	98022 Enumclaw
98031 Kent	98002 Auburn
98032 Kent	98010 Black Diamond
98038 Maple Valley	98047 Pacific
98042 Kent	98092 Auburn
98051 Ravensdale

(b) Pierce County is divided into five planning areas as follows:

PIERCE ONE	PIERCE TWO	PIERCE THREE
98354 Milton	98304 Ashford	98329 Gig Harbor
98371 Puyallup	98323 Carbonade	98332 Gig Harbor
98372 Puyallup	98328 Eatonville	98333 Fox Island
98373 Puyallup	98330 Elbe	98335 Gig Harbor
98374 Puyallup	98360 Orting	98349 Lakebay
98375 Puyallup	98338 Graham	98351 Longbranch
98390 Sumner	98321 Buckley	98394 Vaughn
98391 Bonney Lake

PIERCE FOUR	PIERCE FIVE
98402 Tacoma	98303 Anderson Island
98403 Tacoma	98327 DuPont
98404 Tacoma	98387 Spanaway
98405 Tacoma	98388 Steilacoom
98406 Tacoma	98430 Tacoma
98407 Ruston	98433 Tacoma
98408 Tacoma	98438 Tacoma
98409 Lakewood	98439 Lakewood
98416 Tacoma	98444 Parkland
98418 Tacoma	98445 Parkland
98421 Tacoma	98446 Parkland
98422 Tacoma	98447 Tacoma
98424 Fife	98467 University Place
98443 Tacoma	98498 Lakewood
98465 Tacoma	98499 Lakewood
98466 Fircrest	98580 Roy

(c) Snohomish County is divided into three planning areas as follows:

SNOHOMISH ONE	SNOHOMISH TWO	SNOHOMISH THREE
98223 Arlington	98201 Everett	98012 Mill Creek/Bothell
98241 Darrington	98203 Everett	98020 Edmonds/Woodway
98252 Granite Falls	98204 Everett	98021 Bothell
98271 Tulalip Reservation/ Marysville	98205 Everett	98026 Edmonds
98282 Camano Island	98208 Everett	98036 Lynnwood/Brier
98292 Stanwood	98251 Gold Bar	98037 Lynnwood
	98224 Baring	98043 Mountlake Terrace
	98258 Lake Stevens	98087 Lynnwood
	98270 Marysville	98296 Snohomish
	98272 Monroe
	98275 Mukilteo
	98288 Skykomish
	98290 Snohomish
	98294 Sultan

(d) Spokane County is divided into two planning areas as follows:

SPOKANE ONE	SPOKANE TWO
99001 Airway Heights	99003 Chattaroy
99004 Cheney	99005 Colbert
99011 Fairchild Air Force Base	99006 Deer Park
99012 Fairfield	99009 Elk
99016 Greenacres	99021 Mead
99018 Latah	99025 Newman Lake
99019 Liberty Lake	99026 Nine Mile Falls
99022 Medical Lake	99027 Otis Orchards
99023 Mica	99205 Spokane
99030 Rockford	99207 Spokane
99031 Spangle	99208 Spokane
99036 Valleyford	99217 Spokane
99037 Veradale	99218 Spokane
99201 Spokane	99251 Spokane
99202 Spokane
99203 Spokane
99204 Spokane
99206 Spokane Valley
99212 Spokane Valley
99216 Spokane/Spokane Valley
99223 Spokane
99224 Spokane

(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).