Original Notice.

     Preproposal statement of inquiry was filed as WSR 07-04-018.

     Title of Rule and Other Identifying Information: WAC 388-543-1100 Scope of coverage and coverage limitations for DME and related supplies, prosthetics, orthotics, medical supplies and related services, 388-543-1150 Limits and limitation extensions, 388-543-1600 Items and services which require prior authorization, 388-543-1700 When MAA covers rented DME, 388-543-2000 Wheelchairs, and 388-543-2800 Reusable and disposable medical supplies.

     Hearing Location(s): Blake Office Park East, Rose Room, 4500 10th Avenue S.E., Lacey, WA 98503 (one block north of the intersection of Pacific Avenue S.E. and Alhadeff Lane. A map or directions are available at http://www1.dshs.wa.gov/msa/rpau/docket.html or by calling (360) 664-6097), on June 26, 2007, at 10:00 a.m.

     Date of Intended Adoption: Not earlier than June 27, 2007.

     Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504-5850, delivery 4500 10th Avenue S.E., Lacey, WA, e-mail at schilse@dshs.wa.gov, fax (360) 664-6185, by 5:00 p.m. on June 26, 2007.

     Assistance for Persons with Disabilities: Contact Stephanie Schiller by June 22, 2007, TTY (360) 664-6178 or (360) 664-6097 or by at e-mail schilse@dshs.wa.gov.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule changes:

•	Fix cross references;
•	Change all references to "MAA" to "the department;"
•	Clarify the department's coverage of a speech generating device, wheelchair, and/or specialty bed for clients in a nursing facility;
•	Clarify that a heavy duty bariatric bed is not considered a specialty bed;
•	Remove the following from WAC 388-543-1150 Limits and limitation extensions:

&sqbul;	Lice comb from list of covered products because these combs are included with the "nontoxic gel" which is covered;
&sqbul;	Diaphragmatic pacing antennae;
&sqbul;	Deluxe floor sitter/feeder seat, including floor sitter wedge, shoulder harness, and hip strap;
&sqbul;	High back activity chair, including adjustable footrest, two pairs of support blocks, and hip strap.

•	Add the following to WAC 388-543-1150 Limits and limitation extensions:

&sqbul;	Breast pumps;
&sqbul;	Pneumatic compressor;
&sqbul;	Positioning car seat;
&sqbul;	All prosthetics and orthotics not specifically listed within the "limits and limitation extension" list - are limited to one per twelve month period per limb;
&sqbul;	Beds, mattresses, and related equipment;
&sqbul;	Other patient room equipment;
&sqbul;	Noninvasive bone growth/nerve stimulators;
&sqbul;	Communication devices - Artificial larynx, any type;
&sqbul;	Ambulatory aids;
&sqbul;	Bathroom equipment;
&sqbul;	Blood monitoring.

•	Remove diaphragmatic pacing antennae from limits list;
•	Clarify prescribing requirements for dual-eligible clients; and
•	Add and remove items from covered services list such as positioning devices.

     Reasons Supporting Proposal: The proposed changes clarify DME coverage for clients in nursing facilities, for dual-eligible clients, and clarify/add/remove items from the coverage, limits and limitation extension section.

     Statutory Authority for Adoption: RCW 74.04.050 and 74.08.090.

     Statute Being Implemented: RCW 74.04.050 and 74.08.090.

     Rule is not necessitated by federal law, federal or state court decision.

     Name of Proponent: Department of social and health services, governmental.

     Name of Agency Personnel Responsible for Drafting: Wendy L. Boedigheimer, P.O. Box 45504, Olympia, WA 98504-5504, (360) 725-1306; Implementation and Enforcement: Erin Mayo, P.O. Box 45506, Olympia, WA 98504-5506, (360) 725-1729.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has determined that the proposed rule will not create more than minor costs for affected small businesses.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Erin Mayo, P.O. Box 45506, Olympia, WA 98504-5506, phone (360) 725-1729, e-mail mayoe@dshs.wa.gov.

May 8, 2007

Stephanie E. Schiller

Rules Coordinator

     (1) The department covers DME and related supplies, prosthetics, orthotics, medical supplies, related services, repairs and labor charges when they are:

     (a) Within the scope of an eligible client's medical care program (see WAC 388-501-0060 and 388-501-0065);

     (b) Within accepted medical or physical medicine community standards of practice;

     (c) Prior authorized as described in WAC 388-543-1600, 388-543-1800, and 388-543-1900;

     (d) Prescribed by a physician, advanced registered nurse practitioner (ARNP), or physician assistant certified (PAC). Except for dual eligible medicare/medicaid clients((, the prescription must)) when medicare is the primary payer and the department is being billed for co-pay and/or deductible only:

     (i) ((Be dated and signed by the prescriber)) The prescriber must use DSHS 13-794 (Health and Recovery Services (HRSA) Prescription Form) to write the prescription. The form is available for download at http://www1.dshs.wa.gov/msa/forms/eforms.html; and;

     (ii) The prescription (DSHS 13-794) must:

     (A) Be signed and dated by the prescriber;

     (B) Be ((less than six months in duration)) no older than one year from the date the prescriber signs the prescription; and

     (((iii))) (C) State the specific item or service requested, diagnosis, estimated length of need (weeks, months, or years), and quantity;

     (e) Billed to the department as the payor of last resort only. The department does not pay first and then collect from medicare and;

     (f) Medically necessary as defined in WAC 388-500-0005. The provider or client must submit sufficient objective evidence to establish medical necessity. Information used to establish medical necessity includes, but is not limited to, the following:

     (i) A physiological description of the client's disease, injury, impairment, or other ailment, and any changes in the client's condition written by the prescribing physician, ARNP, PAC, licensed prosthetist and/or orthotist, physical therapist, occupational therapist, or speech therapist; and/or

     (ii) Video and/or photograph(s) of the client demonstrating the impairments as well and client's ability to use the requested equipment, when applicable.

     (2) The department evaluates a request for any equipment or device listed as noncovered in WAC 388-543-1300 under the provisions of WAC 388-501-0160.

     (3) The department evaluates a request for a service that is in a covered category, but has been determined to be experimental or investigational under WAC 388-531-0550, under the provisions of WAC 388-501-0165.

     (4) The department evaluates requests for covered services in this chapter that are subject to limitations or other restrictions and approves such services beyond those limitations or restrictions under the provisions of WAC 388-501-0165 and 388-501-0169.

     (5) The department does not reimburse for DME and related supplies, prosthetics, orthotics, medical supplies, related services, and related repairs and labor charges under fee-for-service (FFS) when the client is any of the following:

     (a) An inpatient hospital client;

     (b) Eligible for both medicare and medicaid, and is staying in a nursing facility in lieu of hospitalization;

     (c) Terminally ill and receiving hospice care; or

     (d) Enrolled in a risk-based managed care plan that includes coverage for such items and/or services.

     (6) The department covers medical equipment and related supplies, prosthetics, orthotics, medical supplies and related services, repairs, and labor charges listed in the department's published issuances, including Washington Administrative Code (WAC), billing instructions, and numbered memoranda.

     (7) An interested party may request the department to include new equipment/supplies in the billing instructions by sending a written request plus all of the following:

     (a) Manufacturer's literature;

     (b) Manufacturer's pricing;

     (c) Clinical research/case studies (including FDA approval, if required); and

     (d) Any additional information the requester feels is important.

     (8) The department bases the decision to purchase or rent DME for a client, or to pay for repairs to client-owned equipment on medical necessity.

     (9) The department covers replacement batteries for purchased medically necessary DME equipment covered within this chapter.

     (10) The department covers the following categories of medical equipment and supplies only when they are medically necessary, prescribed by a physician, ARNP, or PAC, are within the scope of his or her practice as defined by state law, and are subject to the provisions of this chapter and related WACs:

     (a) Equipment and supplies prescribed in accordance with an approved plan of treatment under the home health program;

     (b) Wheelchairs and other DME;

     (c) Prosthetic/orthotic devices;

     (d) Surgical/ostomy appliances and urological supplies;

     (e) Bandages, dressings, and tapes;

     (f) Equipment and supplies for the management of diabetes; and

     (g) Other medical equipment and supplies listed in department published issuances.

     (11) The department evaluates a BR item, procedure, or service for its medical appropriateness and reimbursement value on a case-by-case basis.

     (12) For a client in a nursing facility, the department covers only the following when medically necessary. All other DME and supplies identified in the department's billing instructions are the responsibility of the nursing facility, in accordance with chapters 388-96 and 388-97 WAC. See also WAC 388-543-2900 (3) and (4).

     (a) The department covers:

     (((a))) (i) The purchase and repair of a speech generating device (SGD)((, a)) and one of the following:

     (A) A powered or manual wheelchair for the exclusive full-time use of a permanently disabled nursing facility resident when the wheelchair is not included in the nursing facility's per diem rate((, or a specialty bed; and

     (b) The rental of)); or

     (B) A specialty bed or the rental of a specialty bed outside of the skilled nursing facility per-diem when:

     (I) The specialty bed is intended to help the client heal; and

     (II) The client's nutrition and laboratory values are within normal limits.

     (b) A heavy duty bariatric bed is not considered a ((speciality)) specialty bed.

     (13) Vendors must provide instructions for use of equipment; therefore, instructional materials such as pamphlets and video tapes are not covered.

     (14) Bilirubin lights are limited to rentals, for at-home newborns with jaundice.

[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 06-24-036, § 388-543-1100, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.04.050, 74.04.57 [74.04.057], and 74.08.090. 05-21-102, § 388-543-1100, filed 10/18/05, effective 11/18/05. Statutory Authority: RCW 74.08.090, 34.05.353. 03-12-005, § 388-543-1100, filed 5/22/03, effective 6/22/03. Statutory Authority: RCW 74.08.090, 74.09.530. 02-16-054, § 388-543-1100, filed 8/1/02, effective 9/1/02; 01-01-078, § 388-543-1100, filed 12/13/00, effective 1/13/01.]

     (1) Antiseptics and germicides:

     (a) Alcohol (isopropyl) or peroxide (hydrogen) - one pint per month;

     (b) Alcohol wipes (box of two hundred) - one box per month;

     (c) Betadine or pHisoHex solution - one pint per month;

     (d) Betadine or iodine swabs/wipes (box of one hundred) - one box per month;

     (e) Disinfectant spray - one twelve-ounce bottle or can per six-month period; or

     (f) Periwash (when soap and water are medically contraindicated) - one five-ounce bottle of concentrate solution per six-month period.

     (2) Blood monitoring/testing supplies:

     (a) Replacement battery of any type, used with a client-owned, medically necessary home or specialized blood glucose monitor - one in a three-month period; and

     (b) Spring-powered device for lancet - one in a six-month period.

     (3) Braces, belts and supportive devices:

     (a) Custom vascular supports (CVS) - two pair per six-month period. CVS fitting fee - two per six-month period;

     (b) Surgical stockings (below-the-knee, above-the-knee, thigh-high, or full-length) - two pair per six-month period;

     (c) Graduated compression stockings for pregnancy support (pantyhose style) - two per twelve-month period;

     (d) Knee brace (neoprene, nylon, elastic, or with a hinged bar) - two per twelve-month period;

     (e) Ankle, elbow, or wrist brace - two per twelve-month period;

     (f) Lumbosacral brace, rib belt, or hernia belt - one per twelve-month period;

     (g) Cervical head harness/halter, cervical pillow, pelvic belt/harness/boot, or extremity belt/harness - one per twelve-month period.

     (4) Decubitus care products:

     (a) Cushion (gel, sacroiliac, or accuback) and cushion cover (any size) - one per twelve-month period;

     (b) Synthetic or lambs wool sheepskin pad - one per twelve-month period;

     (c) Heel or elbow protectors - four per twelve-month period.

     (5) Ostomy supplies:

     (a) Adhesive for ostomy or catheter: Cement; powder; liquid (e.g., spray or brush); or paste (any composition, e.g., silicone or latex) - four total ounces per month.

     (b) Adhesive or nonadhesive disc or foam pad for ostomy pouches - ten per month.

     (c) Adhesive remover or solvent - three ounces per month.

     (d) Adhesive remover wipes, fifty per box - one box per month.

     (e) Closed pouch, with or without attached barrier, with a one- or two-piece flange, or for use on a faceplate - sixty per month.

     (f) Closed ostomy pouch with attached standard wear barrier, with built-in one-piece convexity - ten per month.

     (g) Continent plug for continent stoma - thirty per month.

     (h) Continent device for continent stoma - one per month.

     (i) Drainable ostomy pouch, with or without attached barrier, or with one- or two-piece flange - twenty per month.

     (j) Drainable ostomy pouch with attached standard or extended wear barrier, with or without built-in one-piece convexity - twenty per month.

     (k) Drainable ostomy pouch for use on a plastic or rubber faceplate (only one type of faceplate allowed) - ten per month.

     (l) Drainable urinary pouch for use on a plastic, heavy plastic, or rubber faceplate (only one type of faceplate allowed) - ten per month.

     (m) Irrigation bag - two every six months.

     (n) Irrigation cone and catheter, including brush - two every six months.

     (o) Irrigation supply, sleeve - one per month.

     (p) Ostomy belt (adjustable) for appliance - two every six months.

     (q) Ostomy convex insert - ten per month.

     (r) Ostomy ring - ten per month.

     (s) Stoma cap - thirty per month.

     (t) Ostomy faceplate - ten per month. The department does not allow the following to be used on a faceplate in combination with drainable pouches (refer to the billing instructions for further details):

     (i) Drainable pouches with plastic face plate attached; or

     (ii) Drainable pouches with rubber face plate.

     (6) Supplies associated with client-owned transcutaneous electrical nerve stimulators (TENS):

     (a) For a four-lead TENS unit - two kits per month. (A kit contains two leads, conductive paste or gel, adhesive, adhesive remover, skin preparation material, batteries, and a battery charger for rechargeable batteries.)

     (b) For a two-lead TENS unit - one kit per month.

     (c) TENS tape patches (for use with carbon rubber electrodes only) are allowed when they are not used in combination with a kit(s).

     (d) A TENS stand alone replacement battery charger is allowed when it is not used in combination with a kit(s).

     (7) Urological supplies - diapers and related supplies:

     (a) The standards and specifications in this subsection apply to all disposable incontinent products (e.g., briefs, diapers, pull-up pants, underpads for beds, liners, shields, guards, pads, and undergarments). See subsections (b), (c), (d), and (e) of this section for additional standards for specific products. All of the following apply to all disposable incontinent products:

     (i) All materials used in the construction of the product must be safe for the client's skin and harmless if ingested;

     (ii) Adhesives and glues used in the construction of the product must not be water-soluble and must form continuous seals at the edges of the absorbent core to minimize leakage;

     (iii) The padding must provide uniform protection;

     (iv) The product must be hypoallergenic;

     (v) The product must meet the flammability requirements of both federal law and industry standards; and

     (vi) All products are covered for client personal use only.

     (b) In addition to the standards in subsection (a) of this section, diapers must meet all the following specifications. They must:

     (i) Be hourglass shaped with formed leg contours;

     (ii) Have an absorbent filler core that is at least one-half inch from the elastic leg gathers;

     (iii) Have leg gathers that consist of at least three strands of elasticized materials;

     (iv) Have an absorbent core that consists of cellulose fibers mixed with absorbent gelling materials;

     (v) Have a backsheet that is moisture impervious and is at least 1.00 mm thick, designed to protect clothing and linens;

     (vi) Have a topsheet that resists moisture returning to the skin;

     (vii) Have an inner lining that is made of soft, absorbent material; and

     (viii) Have either a continuous waistband, or side panels with a tear-away feature, or refastenable tapes, as follows:

     (A) For child diapers, at least two tapes, one on each side.

     (B) The tape adhesive must release from the backsheet without tearing it, and permit a minimum of three fastening/unfastening cycles.

     (c) In addition to the standards in subsection (a) of this section, pull-up pants and briefs must meet the following specifications. They must:

     (i) Be made like regular underwear with an elastic waist or have at least four tapes, two on each side or two large tapes, one on each side;

     (ii) Have an absorbent core filler that is at least one-half inch from the elastic leg gathers;

     (iii) Have an absorbent core that consists of cellulose fibers mixed with absorbent gelling;

     (iv) Have leg gathers that consist of at least three strands of elasticized materials;

     (v) Have a backsheet that is moisture impervious, is at least 1.00 mm thick, and is designed to protect clothing and linens;

     (vi) Have an inner lining made of soft, absorbent material; and

     (vii) Have a top sheet that resists moisture returning to the skin.

     (d) In addition to the standards in subsection (a) of this section, underpads are covered only for incontinent purposes in a client's bed and must meet the following specifications:

     (i) Have an absorbent layer that is at least one and one-half inches from the edge of the underpad;

     (ii) Be manufactured with a waterproof backing material;

     (iii) Be able to withstand temperatures not to exceed one hundred-forty degrees Fahrenheit;

     (iv) Have a covering or facing sheet that is made of nonwoven, porous materials that have a high degree of permeability, allowing fluids to pass through and into the absorbent filler. The patient contact surface must be soft and durable;

     (v) Have filler material that is highly absorbent. It must be heavy weight fluff filler or the equivalent; and

     (vi) Have four-ply, nonwoven facing, sealed on all four sides.

     (e) In addition to the standards in subsection (a) of this section, liners, shields, guards, pads, and undergarments are covered for incontinence only and must meet the following specifications:

     (i) Have channels to direct fluid throughout the absorbent area, and leg gathers to assist in controlling leakage, and/or be contoured to permit a more comfortable fit;

     (ii) Have a waterproof backing designed to protect clothing and linens;

     (iii) Have an inner liner that resists moisture returning to the skin;

     (iv) Have an absorbent core that consists of cellulose fibers mixed with absorbent gelling materials;

     (v) Have pressure-sensitive tapes on the reverse side to fasten to underwear; and

     (vi) For undergarments only, be contoured for good fit, have at least three elastic leg gathers, and may be belted or unbelted.

     (f) The department covers the products in this subsection only when they are used alone; they cannot be used in combination with each other. The department approves a client's use of a combination of products only when the client uses different products for daytime and nighttime use (see department billing instructions for how to specify this when billing). The total quantity of all products in this section used in combination cannot exceed the monthly limitation for the product with the highest limit (see subsections (g), (h), (i), (j), (k), (l), and (m) of this section for product limitations). The following products cannot be used together:

     (i) Disposable diapers;

     (ii) Disposable pull-up pants and briefs;

     (iii) Disposable liners, shields, guards, pads, and undergarments;

     (iv) Rented reusable diapers (e.g., from a diaper service); and

     (v) Rented reusable briefs (e.g., from a diaper service), or pull-up pants.

     (g) Purchased disposable diapers (any size) are limited to:

     (i) Three hundred per month for a child three to eighteen years of age; and

     (ii) Two hundred forty per month for an adult nineteen years of age and older.

     (h) Reusable cloth diapers (any size) are limited to:

     (i) Purchased - thirty-six per year; and

     (ii) Rented - two hundred forty per month.

     (i) Disposable briefs and pull-up pants (any size) are limited to:

     (i) Three hundred per month for a child age three to eighteen years of age; and

     (ii) One hundred fifty per month for an adult nineteen years of age and older.

     (j) Reusable briefs, washable protective underwear, or pull-up pants (any size) are limited to:

     (i) Purchased - four per year.

     (ii) Rented - one hundred fifty per month.

     (k) Disposable pant liners, shields, guards, pads, and undergarments are limited to two hundred forty per month.

     (l) Underpads for beds are limited to:

     (i) Disposable (any size) - one hundred eighty per month.

     (ii) Purchased, reusable (large) - forty-two per year.

     (iii) Rented, reusable (large) - ninety per month.

     (8) Urological supplies - urinary retention:

     (a) Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube - two per month. This cannot be billed in combination with any of the following:

     (i) With extension drainage tubing for use with urinary leg bag or urostomy pouch (any type, any length), with connector/adapter; and/or

     (ii) With an insertion tray with drainage bag, and with or without catheter.

     (b) Bedside drainage bottle, with or without tubing - two per six month period.

     (c) Extension drainage tubing (any type, any length), with connector/adapter, for use with urinary leg bag or urostomy pouch. This cannot be billed in combination with a vinyl urinary leg bag, with or without tube.

     (d) External urethral clamp or compression device (not be used for catheter clamp) - two per twelve-month period.

     (e) Indwelling catheters (any type) - three per month.

     (f) Insertion trays:

     (i) Without drainage bag and catheter - one hundred and twenty per month. These cannot be billed in combination with other insertion trays that include drainage bag, catheters, and/or individual lubricant packets.

     (ii) With indwelling catheters - three per month. These cannot be billed in combination with: Other insertion trays without drainage bag and/or indwelling catheter; individual indwelling catheters; and/or individual lubricant packets.

     (g) Intermittent urinary catheter - one hundred twenty per month. These cannot be billed in combination with: An insertion tray with or without drainage bag and catheter; or other individual intermittent urinary catheters.

     (h) Irrigation syringe (bulb or piston) - cannot be billed in combination with irrigation tray or tubing.

     (i) Irrigation tray with syringe (bulb or piston) - thirty per month. These cannot be billed in combination with irrigation syringe (bulb or piston), or irrigation tubing set.

     (j) Irrigation tubing set - thirty per month. These cannot be billed in combination with an irrigation tray or irrigation syringe (bulb or piston).

     (k) Leg straps (latex foam and fabric). Allowed as replacement only.

     (l) Male external catheter, specialty type, or with adhesive coating or adhesive strip - sixty per month.

     (m) Urinary suspensory with leg bag, with or without tube - two per month. This cannot be billed in combination with: a latex urinary leg bag; urinary suspensory without leg bag; extension drainage tubing; or a leg strap.

     (n) Urinary suspensory without leg bag, with or without tube - two per month.

     (o) Urinary leg bag, vinyl, with or without tube - two per month. This cannot be billed in combination with: A leg strap; or an insertion tray with drainage bag and without catheter.

     (p) Urinary leg bag, latex - one per month. This cannot be billed in combination with an insertion tray with drainage bag and with or without catheter.

     (9) Miscellaneous supplies:

     (a) Bilirubin light therapy supplies - five days' supply. The department reimburses only when these are provided with a prior authorized bilirubin light.

     (b) Continuous passive motion (CPM) softgoods kit - one, with rental of CPM machine.

     (c) Eye patch with elastic, tied band, or adhesive, to be attached to an eyeglass lens - one box of twenty.

     (d) Eye patch (adhesive wound cover) - one box of twenty.

     (e) ((Lice comb (e.g., LiceOut TM, or LiesMeister [LiceMeister] TM, or combs of equivalent quality and effectiveness) - one per year.

     (f))) Nontoxic gel (e.g., LiceOut TM) for use with lice combs - one bottle per twelve month period.

     (((g))) (f) Syringes and needles ("sharps") disposal container for home use, up to one gallon size - two per month.

     (10) Miscellaneous DME:

     (a) Bilirubin light or light pad - five days rental per twelve-month period.

     (b) Blood glucose monitor (specialized or home) - one in a three-year period.

     (c) Continuous passive motion (CPM) machine - up to ten days rental and requires prior authorization.

     (d) ((Diaphragmatic pacing antennae - four per twelve month-period.

     (e))) Lightweight protective helmet/soft shell (including adjustable chin/mouth strap) - two per twelve-month period.

     (((f))) (e) Lightweight ventilated hard-shell helmet (including unbreakable face bar, woven chin strap w/adjustable buckle and snap fastener, and one set of cushion pads for adjusting fit to head circumference) - two per twelve-month period.

     (f) Breast pumps - one allowed per lifetime.

     (g) Pneumatic compressor - one in a five-year period.

     (h) Positioning car seat - one in a five-year period.

     (11) Prosthetics and orthotics:

     (a) Thoracic-hip-knee-ankle orthosis (THKAO) standing frame - one every five years.

     (b) Preparatory, above knee "PTB" type socket, nonalignable system, pylon, no cover, SACH foot plaster socket, molded to model - one per lifetime, per limb.

     (c) Preparatory, below knee "PTB" type socket, nonalignable system, pylon, no cover, SACH foot thermoplastic or equal, direct formed - one per lifetime, per limb.

     (d) Socket replacement, below the knee, molded to patient model - one per twelve-month period.

     (e) Socket replacement, above the knee/knee disarticulation, including attachment plate, molded to patient model - one per twelve-month period.

     (f) All other prosthetics and orthotics are limited to one per twelve-month period per limb.

     (12) Positioning devices:

     (a) ((Deluxe floor sitter/feeder seat (small, medium, or large), including floor sitter wedge, shoulder harness, and hip strap - one in a three-year period.

     (b) High-back activity chair, including adjustable footrest, two pairs of support blocks, and hip strap - one in a three-year period.

     (c))) Positioning system/supine boards (small or large), including padding, straps adjustable armrests, footboard, and support blocks - one in a five-year period.

     (((d))) (b) Prone stander (child, youth, infant or adult size) - one in a five-year period.

     (((e))) (c) Adjustable standing frame (for child/adult thirty - sixty-eight inches tall), including two padded back support blocks, a chest strap, a pelvic strap, a pair of knee blocks, an abductor, and a pair of foot blocks - one in a five-year period.

     (13) Beds, mattresses, and related equipment:

     (a) Pressure pad, alternating with pump - one in a five-year period.

     (b) Dry pressure mattress - one in a five-year period.

     (c) Gel or gel-like pressure pad for mattress - one in a five-year period.

     (d) Gel pressure mattress - one in a five-year period.

     (e) Water pressure pad for mattress - one in a five-year period.

     (f) Dry pressure pad for mattress - one in a five-year period.

     (g) Mattress, inner spring - one in a five-year period.

     (h) Mattress, foam rubber - one in a five-year period.

     (i) Hospital bed, semi-electric - one in a ten-year period.

     (j) Bedside rails - one in a ten-year period.

     (14) Other patient room equipment:

     (a) Patient lift, hydraulic, with seat or sling - one in a five-year period.

     (b) Traction equipment - one in a five year period.

     (c) Trapeze bars - one in a five-year period.

     (d) Fracture frames - one in a five-year period.

     (e) Transfer board or devices - one in a five-year period.

     (15) Noninvasive bone growth/nerve stimulators:

     (a) Transcutaneous electrical nerve stimulation device (TNS) - one in a five-year period.

     (b) Osteogenesis stimulators - one in a five-year period.

     (16) Communication devices - artificial larynx, any type - one in a five-year period.

     (17) Ambulatory aids:

     (a) Canes - one in a five-year period.

     (b) Crutches - one in a five-year period.

     (c) Walkers - one in a five-year period.

     (18) Bathroom equipment:

     (a) Commode chairs - one in a five-year period.

     (b) Tub stool or bench - one in a five-year period.

     (c) Transfer bench for tub or toilet - one in a five-year period.

     (d) Bed pans - one in a five-year period.

     (e) Urinals - one in a five-year period.

     (f) Shower/commode chairs - one in a five-year period.

     (g) Bath seats/chairs - one in a five-year period.

     (h) Potty chairs - one in a five-year period.

     (19) Blood monitoring:

     (a) Sphygmomanometer/blood pressure apparatus - one in a five-year period.

     (b) Automatic blood pressure monitor - one in a five-year period.

[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 06-24-036, § 388-543-1150, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.04.050, 74.04.57 [74.04.057], and 74.08.090. 05-21-102, § 388-543-1150, filed 10/18/05, effective 11/18/05. Statutory Authority: RCW 74.04.050, 74.04.057, 74.08.090, and Public Law 104-191. 03-19-082, § 388-543-1150, filed 9/12/03, effective 10/13/03. Statutory Authority: RCW 74.08.090, 74.09.530. 01-16-141, § 388-543-1150, filed 7/31/01, effective 8/31/01.]

     (a) High cost;

     (b) Potential for utilization abuse;

     (c) Narrow therapeutic indication; and

     (d) Safety.

     (2) ((MAA)) The department requires providers to obtain prior authorization for certain items and services, except for dual-eligible medicare/medicaid clients when medicare is the primary payer. This includes, but is not limited to, the following:

     (a) Augmentative communication devices (ACDs);

     (b) Certain by report (BR) DME and supplies as specified in ((MAA's)) the department's published issuances, including billing instructions and numbered memoranda;

     (c) Blood glucose monitors requiring special features;

     (d) Certain equipment rentals and certain prosthetic limbs, as specified in ((MAA's)) the department's published issuances, including billing instructions and numbered memoranda;

     (e) Decubitus care products and supplies;

     (((g))) (f) Decubitus care mattresses, including flotation or gel mattress, if the provider fails to meet the criteria in WAC 388-543-1900;

     (g) Equipment parts and labor charges for repairs or modifications and related services;

     (h) Hospital beds, if the provider fails to meet the requirements in WAC 388-543-1900;

     (i) Low air loss flotation system, if the provider fails to meet the requirements in WAC 388-543-1900;

     (j) Orthopedic shoes and selected orthotics;

     (k) Osteogenic stimulator, noninvasive, if the provider fails to meet the requirements in WAC 388-543-1900;

     (l) Positioning car seats for children under five years of age;

     (m) Transcutaneous electrical nerve stimulators, if the provider fails to meet the requirements in WAC 388-543-1900;

     (n) Wheelchairs, wheelchair accessories, wheelchair modifications, air, foam, and gel cushions, and repairs;

     (o) Wheelchair-style shower/commode chairs;

     (p) Other DME not specifically listed in ((MAA's)) the department's published issuances, including billing instructions and numbered memoranda, and submitted as a miscellaneous procedure code; and

     (q) Limitation extensions.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-1600, filed 12/13/00, effective 1/13/01.]

     (a) Delivery to the client;

     (b) Fitting, set-up, and adjustments;

     (c) Maintenance, repair and/or replacement of the equipment; and

     (d) Return pickup by the provider.

     (2) ((MAA)) The department requires a dispensing provider to ensure the DME rented to a ((MAA)) client is both of the following:

     (a) In good working order; and

     (b) Comparable to equipment the provider rents to clients with similar medical equipment needs who are either private pay clients or who have other third-party coverage.

     (3) ((MAA)) The department considers rented equipment to be purchased after twelve months' rental unless one of the following apply:

     (a) The equipment is restricted as rental only; or

     (b) Other ((MAA)) department published issuances state otherwise.

     (4) ((MAA)) The department rents, but does not purchase, certain medically necessary equipment for clients. This includes, but is not limited to, the following:

     (a) Bilirubin lights for newborns at home with jaundice; and

     (b) Electric breast pumps.

     (5) ((MAA's)) The department's minimum rental period for covered DME is one day.

     (6) If a fee-for-service (FFS) client becomes a managed care plan client, both of the following apply:

     (a) ((MAA)) The department stops paying for any rented equipment on the last day of the month preceding the month in which the client becomes enrolled in the managed care plan; and

     (b) The plan determines the client's continuing need for the equipment and is responsible for reimbursing the provider.

     (7) ((MAA)) The department stops paying for any rented equipment effective the date of a client's death. ((MAA)) The department prorates monthly rentals as appropriate.

     (8) For a client who is eligible for both medicaid and medicare, ((MAA)) the department pays only the client's coinsurance and deductibles. ((MAA)) The department discontinues paying client's coinsurance and deductibles for rental equipment when either of the following applies:

     (a) The reimbursement amount reaches medicare's reimbursement cap for the equipment; or

     (b) Medicare considers the equipment purchased.

     (9) ((MAA)) The department does not obtain or pay for insurance coverage against liability, loss and/or damage to rental equipment that a provider supplies to a ((MAA)) DSHS client.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-1700, filed 12/13/00, effective 1/13/01.]

     (2) The following apply when ((MAA)) the department determines that a wheelchair is medically necessary for six months or less:

     (a) If the client lives at home, ((MAA)) the department rents a wheelchair for the client; or

     (b) If the client lives in a nursing facility, the nursing facility must provide a house wheelchair as part of the per diem rate paid by the aging and disability services administration (AASA).

     (3) ((MAA)) The department considers rental or purchase of a manual wheelchair for a home client who is nonambulatory or has limited mobility and requires a wheelchair to participate in normal daily activities. ((MAA)) The department determines the type of manual wheelchair based on the following:

     (a) A standard wheelchair if the client's medical condition requires the client to have a wheelchair to participate in normal daily activities;

     (b) A standard lightweight wheelchair if the client's medical condition is such that the client:

     (i) Cannot self-propel a standard weight wheelchair; or

     (ii) Requires custom modifications that cannot be provided on a standard weight wheelchair.

     (c) A high-strength lightweight wheelchair for a client:

     (i) Whose medical condition is such that the client cannot self-propel a lightweight or standard weight wheelchair; or

     (ii) Requires custom modifications that cannot be provided on a standard weight or lightweight wheelchair.

     (d) A heavy duty wheelchair for a client who requires a specifically manufactured wheelchair designed to:

     (i) Support a person weighing up to three hundred pounds; or

     (ii) Accommodate a seat width up to twenty-two inches wide (not to be confused with custom heavy duty wheelchairs).

     (e) A custom heavy duty wheelchair for a client who requires a specifically manufactured wheelchair designed to:

     (i) Support a person weighing over three hundred pounds; or

     (ii) Accommodate a seat width over twenty-two inches wide.

     (f) A rigid wheelchair for a client:

     (i) With a medical condition that involves severe upper extremity weakness;

     (ii) Who has a high level of activity; and

     (iii) Who is unable to self-propel any of the above categories of wheelchair.

     (g) A custom manufactured wheelchair for a client with a medical condition requiring wheelchair customization that cannot be obtained on any of the above categories of wheelchairs.

     (4) ((MAA)) The department considers a power-drive wheelchair when the client's medical needs cannot be met by a less costly means of mobility. The prescribing physician must certify that the client can safely and effectively operate a power-drive wheelchair and that the client meets all of the following conditions:

     (a) The client's medical condition negates his or her ability to self-propel any of the wheelchairs listed in the manual wheelchair category; and

     (b) A power-drive wheelchair will provide the client the only means of independent mobility; or

     (c) A power-drive wheelchair will enable a child to achieve age-appropriate independence and developmental milestones.

     (d) All other circumstances will be considered based on medical necessity and on a case-by-case basis.

     (e) The following additional information is required for a three or four-wheeled power-drive scooter/cart:

     (i) The prescribing physician certifies that the client's condition is stable; and

     (ii) The client is unlikely to require a standard power-drive wheelchair within the next two years.

     (5) ((MAA)) The department considers the power-drive wheelchair to be the client's primary chair when the client has both a power-drive wheelchair and a manual wheelchair.

     (6) In order to consider purchasing a wheelchair, ((MAA)) the department requires the provider to submit the following information from the prescribing physician, physical therapist, or occupational therapist:

     (a) Specific medical justification for the make and model of wheelchair requested;

     (b) Define the degree and extent of the client's impairment (such as stage of decubitus, severity of spasticity or flaccidity, degree of kyphosis or scoliosis); and

     (c) Documented outcomes of less expensive alternatives (aids to mobility) that have been tried by the client.

     (7) In addition to the basic wheelchair, ((MAA)) the department may consider wheelchair accessories or modifications that are specifically identified by the manufacturer as separate line item charges. The provider must submit specific medical justification for each line item, with the modification request.

     (8) ((MAA)) The department considers wheelchair modifications to a medically necessary wheelchair when the provider submits all of the following with the modification request:

     (a) The make, model, and serial number of the wheelchair to be modified;

     (b) The modification requested; and

     (c) Specific information regarding the client's medical condition that necessitates the modification.

     (9) ((MAA)) The department may consider wheelchair repairs to a medically necessary wheelchair; the provider must submit to ((MAA)) the department the make, model, and serial number of the wheelchair for which the repairs are requested.

     (10) ((MAA)) The department may cover two wheelchairs, a manual wheelchair and a power-drive wheelchair, for a noninstitutionalized client in certain situations. One of the following must apply:

     (a) The architecture of the client's home is completely unsuitable for a power-drive wheelchair, such as narrow hallways, narrow doorways, steps at the entryway, and insufficient turning radii;

     (b) The architecture of the client's home bathroom is such that power-drive wheelchair access is not possible, and the client needs a manual wheelchair to safely and successfully complete bathroom activities and maintain personal cleanliness;

     (c) The client has a power-drive wheelchair, but also requires a manual wheelchair because the power-drive wheelchair cannot be transported to meet the client's community, workplace, or educational activities; the manual wheelchair would allow the caregiver to transport the client in a standard automobile or van. In these cases, ((MAA)) the department requires the client's situation to meet the following conditions:

     (i) The client's activities that require the second wheelchair must be located farther than one-fourth of a mile from the client's home; and

     (ii) Cabulance, public buses, or personal transit are neither available, practical, nor possible for financial or other reasons.

     (iii) All other circumstances will be considered on a case-by-case basis, based on medical necessity.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-2000, filed 12/13/00, effective 1/13/01.]

     Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.
AMENDATORY SECTION(Amending WSR 05-21-102, filed 10/18/05, effective 11/18/05)

WAC 388-543-2800   Reusable and disposable medical supplies.   (1) ((MAA)) The department requires that a physician, advanced registered nurse practitioner (ARNP), or physician's assistant certified (PAC) prescribe reusable and disposable medical supplies. Except for dual eligible medicare/medicaid clients, the prescription must:

     (a) Be dated and signed by the prescriber;

     (b) Be less than six months in duration from the date the prescriber signs the prescription; and

     (c) State the specific item or service requested, diagnosis, estimated length of need (weeks, months, or years), and quantity.

     (2) ((MAA)) The department bases its determination about which DME and related supplies, prosthetics, orthotics, medical supplies and related services require prior authorization (PA) or expedited prior authorization (EPA) on utilization criteria (see WAC 388-543-1000 for PA and WAC 388-543-1800 for EPA). ((MAA)) The department considers all of the following when establishing utilization criteria:

     (a) High cost;

     (b) The potential for utilization abuse;

     (c) A narrow therapeutic indication; and

     (d) Safety.

     (3) ((MAA)) The department requires a provider to obtain a limitation extension in order to exceed the stated limits for nondurable medical equipment and medical supplies. See WAC 388-501-0165.

     (4) ((MAA)) The department categorizes medical supplies and non-DME (MSE) as follows (see WAC 388-543-1150, 388-543-1600, and ((MAA's)) department's billing instructions for further information about specific limitations and requirements for PA and EPA):

     (a) Antiseptics and germicides;

     (b) Bandages, dressings, and tapes;

     (c) Blood monitoring/testing supplies;

     (d) Braces, belts, and supportive devices;

     (e) Decubitus care products;

     (f) Ostomy supplies;

     (g) Pregnancy-related testing kits and nursing equipment supplies;

     (h) Supplies associated with transcutaneous electrical nerve stimulators (TENS);

     (i) Syringes and needles;

     (j) Urological supplies (e.g., diapers, urinary retention catheters, pant liners, and doublers); and

     (k) Miscellaneous supplies.

[Statutory Authority: RCW 74.04.050, 74.04.57 [74.04.057], and 74.08.090. 05-21-102, § 388-543-2800, filed 10/18/05, effective 11/18/05. Statutory Authority: RCW 74.08.090, 74.09.530. 01-16-141, § 388-543-2800, filed 7/31/01, effective 8/31/01; 01-01-078, § 388-543-2800, filed 12/13/00, effective 1/13/01.]

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