Effective Date of Rule: Thirty-one days after filing.

     Purpose: The department is eliminating coverage for electrical neural stimulation devices and supplies (including battery chargers and all other supplies for client-owned devices) for in-home use.

     Citation of Existing Rules Affected by this Order: Amending WAC 388-543-1150, 388-543-1300, 388-543-1600, 388-543-2800, 388-545-300, and 388-545-500.

     Statutory Authority for Adoption: Section 1109, chapter 564, Laws of 2009 (ESHB 1244), WAC 388-501-0055, RCW 74.08.090.

      Adopted under notice filed as WSR 10-08-086 on April 6, 2010.

     A final cost-benefit analysis is available by contacting Erin Mayo, DSHS-HRSA, P.O. Box 45560, Olympia, WA 98504-5560, phone (360) 725-1729, fax (360) 586-9727, e-mail Erin.Mayo@dshs.wa.gov.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 6, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 6, Repealed 0.

     Date Adopted: June 23, 2010.

Susan N. Dreyfus

Secretary

     (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; or

     (e) 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;

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

     (c) Test strips and lancets for an insulin dependent diabetic - one hundred of each, per month; and

     (d) Test strips and lancets for a noninsulin dependent diabetic - one hundred of each, per three-month period.

     (3) Braces, belts and supportive devices:

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

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

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

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

     (ii) Two hundred 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 per month.

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

     (i) Two 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 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))) (7) 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))) (8) 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) Nontoxic gel (e.g., LiceOut TM) for use with lice combs - one bottle per twelve month period.

     (f) Nonsterile gloves - one hundred per box, two box per month.

     (g) Sterile gloves - thirty pair, per month.

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

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

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

     (((11))) (10) 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))) (11) Positioning devices:

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

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

     (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))) (12) 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))) (13) 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))) (14) Noninvasive bone growth((/nerve)) stimulators((:

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

     (b))) (such as osteogenesis stimulators) - one in a five-year period.

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

     (((17))) (16) 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.

[Statutory Authority: 2009 c 564 § 1109, RCW 74.04.050, 74.04.057, and 74.08.090. 09-22-047, § 388-543-1150, filed 10/28/09, effective 11/28/09. Statutory Authority: RCW 74.08.090 and 74.04.050. 07-17-062, § 388-543-1150, filed 8/13/07, effective 9/13/07. 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.]

     (2) The department pays only for prosthetics or orthotics that are listed as such by the Centers for Medicare and Medicaid Services (CMS) that meet the definition of prosthetic and orthotic as defined in WAC 388-543-1000 and are prescribed per WAC 388-543-1100 and 388-543-1200.

     (3) The department considers all requests for covered DME, related supplies and services, medical supplies, prosthetics, orthotics, and related services under the provisions of WAC 388-501-0165.

     (4) The department evaluates a request for any DME item listed as noncovered in this chapter under the provisions of WAC 388-501-0160. When early and periodic screening, diagnosis and treatment (EPSDT) applies, the department evaluates a noncovered service, equipment, or supply according to the process in WAC 388-501-0165 to determine if it is medically necessary, safe, effective, and not experimental (see WAC 388-543-0100 for EPSDT rules).

     (5) The department specifically excludes services and equipment in this chapter from fee-for-service (FFS) scope of coverage when the services and equipment do not meet the definition for a covered item, or the services are not typically medically necessary. This exclusion does not apply if the services and equipment are:

     (a) Included as part of a managed care plan service package;

     (b) Included in a waivered program;

     (c) Part of one of the medicare programs for qualified medicare beneficiaries; or

     (d) Requested for a child who is eligible for services under the EPSDT program. The department reviews these requests according to the provisions of chapter 388-534 WAC.

     (6) Excluded services and equipment include, but are not limited to:

     (a) Services, procedures, treatment, devices, drugs, or the application of associated services that the Food and Drug Administration (FDA) and/or the Centers for Medicare and Medicaid Services (CMS) consider investigative or experimental on the date the services are provided;

     (b) Any service specifically excluded by statute;

     (c) A client's utility bills, even if the operation or maintenance of medical equipment purchased or rented by the department for the client contributes to an increased utility bill (refer to the aging and disability services administration's (ADSA) COPES program for potential coverage);

     (d) Hairpieces or wigs;

     (e) Material or services covered under manufacturers' warranties;

     (f) Shoe lifts less than one inch, arch supports for flat feet, and nonorthopedic shoes;

     (g) Outpatient office visit supplies, such as tongue depressors and surgical gloves;

     (h) Prosthetic devices dispensed solely for cosmetic reasons;

     (i) Home improvements and structural modifications, including but not limited to the following:

     (i) Automatic door openers for the house or garage;

     (ii) Saunas;    

     (iii) Security systems, burglar alarms, call buttons, lights, light dimmers, motion detectors, and similar devices;

     (iv) Swimming pools;

     (v) Whirlpool systems, such as jacuzzies, hot tubs, or spas; or

     (vi) Electrical rewiring for any reason;

     (vii) Elevator systems and elevators; and

     (viii) Lifts or ramps for the home; or

     (ix) Installation of bathtubs or shower stalls.

     (j) Nonmedical equipment, supplies, and related services, including but not limited to, the following:

     (i) Back-packs, pouches, bags, baskets, or other carrying containers;

     (ii) Bed boards/conversion kits, and blanket lifters (e.g., for feet);

     (iii) Car seats for children under five, except for positioning car seats that are prior authorized. Refer to WAC 388-543-1700(13) for car seats;

     (iv) Cleaning brushes and supplies, except for ostomy-related cleaners/supplies;

     (v) Diathermy machines used to produce heat by high frequency current, ultrasonic waves, or microwave radiation;

     (vi) Electronic communication equipment, installation services, or service rates, including but not limited to, the following:

     (A) Devices intended for amplifying voices (e.g., microphones);

     (B) Interactive communications computer programs used between patients and healthcare providers (e.g., hospitals, physicians), for self care home monitoring, or emergency response systems and services (refer to ADSA COPES or outpatient hospital programs for emergency response systems and services);

     (C) Two-way radios; and

     (D) Rental of related equipment or services;

     (vii) Environmental control devices, such as air conditioners, air cleaners/purifiers, dehumidifiers, portable room heaters or fans (including ceiling fans), heating or cooling pads, and light boxes;

     (viii) Ergonomic equipment;

     (ix) Exercise classes or equipment such as exercise mats, bicycles, tricycles, stair steppers, weights, trampolines;

     (x) Generators;

     (xi) Computer software other than speech generating, printers, and computer accessories (such as anti-glare shields, backup memory cards);

     (xii) Computer utility bills, telephone bills, internet service, or technical support for computers or electronic notebooks;

     (xiii) Any communication device that is useful to someone without severe speech impairment (e.g., cellular telephone, walkie-talkie, pager, or electronic notebook);

     (xiv) Racing strollers/wheelchairs and purely recreational equipment;

     (xv) Room fresheners/deodorizers;

     (xvi) Bidet or hygiene systems, sharp containers, paraffin bath units, and shampoo rings;

     (xvii) Timers or electronic devices to turn things on or off, which are not an integral part of the equipment;

     (xviii) Vacuum cleaners, carpet cleaners/deodorizers, and/or pesticides/insecticides; or

     (xix) Wheeled reclining chairs, lounge and/or lift chairs (e.g., geri-chair, posture guard, or lazy boy).

     (k) Blood monitoring:

     (i) Sphygmomanometer/blood pressure apparatus with cuff and stethoscope;

     (ii) Blood pressure cuff only; and

     (iii) Automatic blood pressure monitor.

     (l) Bathroom equipment:

     (i) Bath stools;

     (ii) Bathtub wall rail (grab bars);

     (iii) Bed pans;

     (iv) Control unit for electronic bowel irrigation/evacuation system;

     (v) Disposable pack for use with electronic bowel system;

     (vi) Potty chairs;

     (vii) Raised toilet seat;

     (viii) Safety equipment (e.g. belt, harness or vest);

     (ix) Shower/commode chairs;

     (x) Sitz type bath or equipment;

     (xi) Standard and heavy duty bath chairs;

     (xii) Toilet rail;

     (xiii) Transfer bench tub or toilet;

     (xiv) Urinal male/female.

     (m) Disinfectant spray - one twelve-ounce bottle or can per six-month period.

     (n) Personal and comfort items including but not limited to the following:

     (i) Bathroom items, such as antiperspirant, astringent, bath gel, conditioner, deodorant, moisturizer, mouthwash, powder, shampoo, shaving cream, shower cap, shower curtains, soap (including antibacterial soap), toothpaste, towels, and weight scales;

     (ii) Bedding items, such as bed pads, blankets, mattress covers/bags, pillows, pillow cases/covers, sheets, and bumper pads;

     (iii) Bedside items, such as bed trays, carafes, and over-the-bed tables;

     (iv) Clothing and accessories, such as coats, gloves (including wheelchair gloves), hats, scarves, slippers, socks, custom vascular supports (CVS), surgical stockings, gradient compression stockings, and graduated compression stockings for pregnancy support (pantyhose style);

     (v) Clothing protectors, surgical masks, and other protective cloth furniture coverings;

     (vi) Cosmetics, including corrective formulations, hair depilatories, and products for skin bleaching, commercial sun screens, and tanning;

     (vii) Diverter valves and handheld showers for bathtub;

     (viii) Eating/feeding utensils;

     (ix) Emesis basins, enema bags, and diaper wipes;

     (x) Health club memberships;

     (xi) Hot or cold temperature food and drink containers/holders;

     (xii) Hot water bottles and cold/hot packs or pads not otherwise covered by specialized therapy programs;

     (xiii) Impotence devices;

     (xiv) Insect repellants;

     (xv) Massage equipment;

     (xvi) Medication dispensers, such as med-collators and count-a-dose, except as obtained under the compliance packaging program. See chapter 388-530 WAC;

     (xvii) Medicine cabinet and first-aid items, such as adhesive bandages (e.g., Band-Aids, Curads), cotton balls, cotton-tipped swabs, medicine cups, thermometers, and tongue depressors;

     (xviii) Page turners;

     (xix) Radio and television;

     (xx) Telephones, telephone arms, cellular phones, electronic beepers, and other telephone messaging services; and

     (xxi) Toothettes and toothbrushes, waterpics, and peridontal devices whether manual, battery-operated, or electric.

     (o) Certain wheelchair features and options are not considered by the department to be medically necessary or essential for wheelchair use. This includes, but is not limited to, the following:

     (i) Attendant controls (remote control devices);

     (ii) Canopies, including those for strollers and other equipment;

     (iii) Clothing guards to protect clothing from dirt, mud, or water thrown up by the wheels (similar to mud flaps for cars);

     (iv) Identification devices (such as labels, license plates, name plates);

     (v) Lighting systems;

     (vi) Speed conversion kits; and

     (vii) Tie-down restraints, except where medically necessary for client-owned vehicles.

     (p) Electrical neural stimulation devices and supplies for in-home use, including battery chargers.

[Statutory Authority: 2009 c 564 § 1109, RCW 74.04.050, 74.04.057, and 74.08.090. 09-22-047, § 388-543-1300, filed 10/28/09, effective 11/28/09. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-04-036, § 388-543-1300, filed 1/29/07, effective 3/1/07. Statutory Authority: RCW 74.08.090, 74.09.530. 02-16-054, § 388-543-1300, filed 8/1/02, effective 9/1/02; 01-01-078, § 388-543-1300, filed 12/13/00, effective 1/13/01.]

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.
AMENDATORY SECTION(Amending WSR 09-22-047, filed 10/28/09, effective 11/28/09)

WAC 388-543-1600   Items and services which require prior authorization.   (1) 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.) The department considers all of the following when establishing utilization criteria:

     (a) High cost;

     (b) Potential for utilization abuse;

     (c) Narrow therapeutic indication; and

     (d) Safety.

     (2) 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 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 the department's published issuances, including billing instructions and numbered memoranda;

     (e) Decubitus care products and supplies;

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

     (((p))) (o) Limitation extensions.

[Statutory Authority: 2009 c 564 § 1109, RCW 74.04.050, 74.04.057, and 74.08.090. 09-22-047, § 388-543-1600, filed 10/28/09, effective 11/28/09. Statutory Authority: RCW 74.08.090 and 74.04.050. 07-17-062, § 388-543-1600, filed 8/13/07, effective 9/13/07. Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-1600, filed 12/13/00, effective 1/13/01.]

     (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) 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). 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) 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) The department categorizes medical supplies and non-DME (MSE) as follows (see WAC 388-543-1150, 388-543-1600, and 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))) (i) Urological supplies (e.g., diapers, urinary retention catheters, pant liners, and doublers); and

     (((k))) (j) Miscellaneous supplies.

[Statutory Authority: RCW 74.08.090 and 74.04.050. 07-17-062, § 388-543-2800, filed 8/13/07, effective 9/13/07. 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.]

     (a) A licensed occupational therapist;

     (b) A licensed occupational therapy assistant supervised by a licensed occupational therapist; and

     (c) An occupational therapy aide, in schools, trained and supervised by a licensed occupational therapist.

     (2) Clients in the following ((MAA)) department programs are eligible to receive occupational therapy services described in this chapter:

     (a) Categorically needy;

     (b) Children's health;

     (c) General assistance unemployable (within Washington state or border areas only);

     (d) Alcoholism and drug addiction treatment and support act (ADATSA) (within Washington state or border areas only);

     (e) Medically indigent program for emergency hospital-based services only; or

     (f) Medically needy program only when the client is either:

     (i) Twenty years of age or younger and referred by a screening provider under the early and periodic screening, diagnosis and treatment program (healthy kids program) as described in chapter 388-534 WAC; or

     (ii) Receiving home health care services as described in chapter 388-551 WAC, subchapter II.

     (3) Occupational therapy services received by ((MAA)) department eligible clients must be provided:

     (a) As part of an outpatient treatment program for adults and children;

     (b) By a home health agency as described under chapter 388-551 WAC, subchapter II;

     (c) As part of the physical medicine and rehabilitation (PM&R) program as described in WAC 388-550-2551;

     (d) By a neurodevelopmental center;

     (e) By a school district or educational service district as part of an individual education program or individualized family service plan as described in WAC 388-537-0100; or

     (f) When prescribed by a provider for clients age twenty-one or older. The therapy must:

     (i) Prevent the need for hospitalization or nursing home care;

     (ii) Assist a client in becoming employable;

     (iii) Assist a client who suffers from severe motor disabilities to obtain a greater degree of self-care or independence; or

     (iv) Be a part of a treatment program intended to restore normal function of a body part following injury, surgery, or prolonged immobilization.

     (4) ((MAA)) The department pays only for covered occupational therapy services listed in this section when they are:

     (a) Within the scope of an eligible client's medical care program;

     (b) Medically necessary, when prescribed by a provider; and

     (c) Begun within thirty days of the date prescribed.

     (5) ((MAA)) The department covers the following occupational therapy services per client, per calendar year:

     (a) Unlimited occupational therapy program visits for clients twenty years of age or younger;

     (b) One occupational therapy evaluation. The evaluation is in addition to the twelve program visits allowed per year;

     (c) Two durable medical equipment needs assessments. The assessments are in addition to the twelve program visits allowed per year;

     (d) Twelve occupational therapy program visits;

     (e) Twenty-four additional outpatient occupational therapy program visits when the diagnosis is any of the following:

     (i) A medically necessary condition for developmentally delayed clients;

     (ii) Surgeries involving extremities, including:

     (A) Fractures; or

     (B) Open wounds with tendon involvement;

     (iii) Intracranial injuries;

     (iv) Burns;

     (v) Traumatic injuries;

     (f) Twenty-four additional occupational therapy program visits following a completed and approved inpatient PM&R program. In this case, the client no longer needs nursing services but continues to require specialized outpatient therapy for any of the following:

     (i) Traumatic brain injury (TBI);

     (ii) Spinal cord injury (paraplegia and quadriplegia);

     (iii) Recent or recurrent stroke;

     (iv) Restoration of the levels of function due to secondary illness or loss from multiple sclerosis (MS);

     (v) Amyotrophic lateral sclerosis (ALS);

     (vi) Cerebral palsy (CP);

     (vii) Extensive severe burns;

     (viii) Skin flaps for sacral decubitus for quads only;

     (ix) Bilateral limb loss; or

     (x) Acute, infective polyneuritis (Guillain-Barre' syndrome).

     (g) Additional medically necessary occupational therapy services, regardless of the diagnosis, must be approved by ((MAA)) the department.

     (6) ((MAA will pay for one visit to instruct in the application of transcutaneous neurostimulator (TENS), per client, per lifetime.

     (7) MAA)) The department does not cover occupational therapy services that are included as part of the reimbursement for other treatment programs. This includes, but is not limited to, hospital inpatient and nursing facility services.

[Statutory Authority: RCW 74.08.090. 01-02-075, § 388-545-300, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 74.08.090 and 74.09.520. 99-16-068, § 388-545-300, filed 8/2/99, effective 9/2/99.]

     (a) A licensed physical therapist or physiatrist; or

     (b) A physical therapist assistant supervised by a licensed physical therapist.

     (2) Clients in the following ((MAA)) department programs are eligible to receive physical therapy services described in this chapter:

     (a) Categorically needy (CN);

     (b) Children's health;

     (c) General assistance-unemployable (GA-U) (within Washington state or border areas only);

     (d) Alcoholism and drug addiction treatment and support act (ADATSA) (within Washington state or border areas only);

     (e) Medically indigent program (MIP) for emergency hospital-based services only; or

     (f) Medically needy program (MNP) only when the client is either:

     (i) Twenty years of age or younger and referred under the early and periodic screening, diagnosis and treatment program (EPSDT/healthy kids program) as described in WAC 388-86-027; or

     (ii) Receiving home health care services as described in chapter 388-551 WAC.

     (3) Physical therapy services that ((MAA)) department eligible clients receive must be provided as part of an outpatient treatment program:

     (a) In an office, home, or outpatient hospital setting;

     (b) By a home health agency as described in chapter 388-551 WAC;

     (c) As part of the acute physical medicine and rehabilitation (acute PM&R) program as described in the acute PM&R subchapter under chapter 388-550 WAC;

     (d) By a neurodevelopmental center;

     (e) By a school district or educational service district as part of an individual education or individualized family service plan as described in WAC 388-537-0100; or

     (f) For disabled children, age two and younger, in natural environments including the home and community settings in which children without disabilities participate, to the maximum extent appropriate to the needs of the child.

     (4) ((MAA)) The department pays only for covered physical therapy services listed in this section when they are:

     (a) Within the scope of an eligible client's medical care program;

     (b) Medically necessary and ordered by a physician, physician's assistant (PA), or an advanced registered nurse practitioner (ARNP);

     (c) Begun within thirty days of the date ordered;

     (d) For conditions which are the result of injuries and/or medically recognized diseases and defects; and

     (e) Within accepted physical therapy standards.

     (5) Providers must document in a client's medical file that physical therapy services provided to clients age twenty-one and older are medically necessary. Such documentation may include justification that physical therapy services:

     (a) Prevent the need for hospitalization or nursing home care;

     (b) Assist a client in becoming employable;

     (c) Assist a client who suffers from severe motor disabilities to obtain a greater degree of self-care or independence; or

     (d) Are part of a treatment program intended to restore normal function of a body part following injury, surgery, or prolonged immobilization.

     (6) ((MAA)) The department determines physical therapy program units as follows:

     (a) Each fifteen minutes of timed procedure code equals one unit; and

     (b) Each nontimed procedure code equals one unit, regardless of how long the procedure takes.

     (7) ((MAA)) The department does not limit coverage for physical therapy services listed in subsections (8) through (10) of this section if the client is twenty years of age or younger.

     (8) ((MAA)) The department covers, without requiring prior authorization, the following ordered physical therapy services per client, per diagnosis, per calendar year, for clients twenty-one years of age and older:

     (a) One physical therapy evaluation. The evaluation is in addition to the forty-eight program units allowed per year;

     (b) Forty-eight physical therapy program units;

     (c) Ninety-six additional outpatient physical therapy program units when the diagnosis is any of the following:

     (i) A medically necessary condition for developmentally delayed clients;

     (ii) Surgeries involving extremities, including:

     (A) Fractures; or

     (B) Open wounds with tendon involvement.

     (iii) Intracranial injuries;

     (iv) Burns;

     (v) Traumatic injuries;

     (vi) Meningomyelocele;

     (vii) Down's syndrome;

     (viii) Cerebral palsy; or

     (ix) Symptoms involving nervous and musculoskeletal systems and lack of coordination;

     (d) Two durable medical equipment (DME) needs assessments. The assessments are in addition to the forty-eight physical therapy program units allowed per year. Two program units are allowed per DME needs assessment; and

     (e) One wheelchair needs assessment in addition to the two durable medical needs assessments. The assessment is in addition to the forty-eight physical therapy program units allowed per year. Four program units are allowed per wheelchair needs assessment.

     (f) The following services are allowed, per day, in addition to the forty-eight physical therapy program units allowed per year:

     (i) Two program units for orthotics fitting and training of upper and/or lower extremities.

     (ii) Two program units for checkout for orthotic/prosthetic use.

     (iii) One muscle testing procedure. Muscle testing procedures cannot be billed in combination with each other.

     (g) Ninety-six additional physical therapy program units are allowed following a completed and approved inpatient acute PM&R program. In this case, the client no longer needs nursing services but continues to require specialized outpatient physical therapy for any of the following:

     (i) Traumatic brain injury (TBI);

     (ii) Spinal cord injury (paraplegia and quadriplegia);

     (iii) Recent or recurrent stroke;

     (iv) Restoration of the levels of functions due to secondary illness or loss from multiple sclerosis (MS);

     (v) Amyotrophic lateral sclerosis (ALS);

     (vi) Cerebral palsy (CP);

     (vii) Extensive severe burns;

     (viii) Skin flaps for sacral decubitus for quadriplegics only;

     (ix) Bilateral limb loss;

     (x) Open wound of lower limb; or

     (xi) Acute, infective polyneuritis (Guillain-Barre' syndrome).

     (9) For clients age twenty-one and older, ((MAA)) the department covers physical therapy services which exceed the limitations established in subsection (8) of this section if the provider requests prior authorization and ((MAA)) the department approves the request.

     (10) ((MAA will pay for one visit to instruct in the application of transcutaneous neurostimulator (TENS) per client, per lifetime.

     (11))) Duplicate services for occupational therapy and physical therapy are not allowed for the same client when both providers are performing the same or similar procedure(s).

     (((12) MAA)) (11) The department does not cover physical therapy services that are included as part of the reimbursement for other treatment programs. This includes, but is not limited to, hospital inpatient and nursing facility services.

     (((13) MAA)) (12) The department does not cover physical therapy services performed by a physical therapist in an outpatient hospital setting when the physical therapist is not employed by the hospital. Reimbursement for services must be billed by the hospital.

[Statutory Authority: RCW 74.08.090. 01-02-075, § 388-545-500, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 74.08.090 and 74.09.520. 00-04-019, § 388-545-500, filed 1/24/00, effective 2/24/00.]

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