Original Notice.

     Preproposal statement of inquiry was filed as WSR 03-08-086.

     Title of Rule: Part 2 of 3, chapter 388-543 WAC, Durable medical equipment; amending WAC 388-543-1150 Limits and limitations extensions.

     Purpose: To avoid federal penalties, the department is amending these rules by October 16, 2003, to comply with the requirements of federal Health Insurance Portability and Accountability Act (HIPAA) of 1996.

     Statutory Authority for Adoption: RCW 74.04.050, 74.04.057, and 74.08.090.

     Statute Being Implemented: Health Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191.

     Summary: Elimination of state-unique codes per HIPAA, required making limitations on purchasing and renting of cloth, reusable diapers consistent for children and adults.

     Reasons Supporting Proposal: Complies with the HIPAA requirements and avoids federal penalties by amending rules to be HIPAA-compliant by October 16, 2003.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Kevin Sullivan, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1344.

     Name of Proponent: Department of Social and Health Services, governmental.

     Rule is necessary because of federal law, Public Law 104-191 (Health Insurance Portability and Accountability Act of 1996).

     Explanation of Rule, its Purpose, and Anticipated Effects: See Purpose and Summary above.

     Proposal Changes the Following Existing Rules: See Summary above.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has determined that the proposed rules will have no economic impact on small businesses.

     RCW 34.05.328 applies to this rule adoption. The rules meet the definition of a "significant legislative rule." The department has prepared a memo regarding the cost benefits of this rule change. A copy of the memo can be obtained from the department representative listed above.

     Hearing Location: Blake Office Park (behind Goodyear Courtesy Tire), 4500 10th Avenue S.E., Rose Room, Lacey, WA 98503, on September 9, 2003, at 10:00 a.m.

     Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by September 5, 2003, phone (360) 664-6094, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.

     Submit Written Comments to: Identify WAC Numbers, DSHS Rules Coordinator, Rules and Policies Assistance Unit, mail to P.O. Box 45850, Olympia, WA 98504-5850, deliver to 4500 10th Avenue S.E., Lacey, WA, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., September 9, 2003.

     Date of Intended Adoption: Not sooner than September 10, 2003.

August 1, 2003

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

     (1) Antiseptics and germicides:

     (a) Alcohol (isopropyl) or peroxide (hydrogen) - one eight ounce bottle 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 ounces 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. MAA 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., adult briefs/child diapers, pull-up training pants, underpads for beds, and liners/shields). 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; and

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

     (b) In addition to the standards in subsection (a) of this section, adult briefs/child 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 adult briefs, at least four tapes, two on each side.

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

     (C) 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 training pants and incontinent pants must meet the following specifications. They must:

     (i) Be made like regular underwear with an elastic waist;

     (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 for beds must meet the following specifications. They must:

     (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

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

     (e) In addition to the standards in subsection (a) of this section, liners/shields (including pads and undergarments) must meet the following specifications. They must:

     (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) MAA covers the products in this subsection only when they are used alone; they cannot be used in combination with each other. MAA approves a client's use of a combination of products only when the client uses different products for daytime and nighttime use (see MAA's billing instructions for how to specify this when billing). The total of all products used 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 briefs (incontinent pants)/diapers;

     (ii) Disposable pull-up training pants;

     (iii) Disposable liners/pads;

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

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

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

     (i) Three hundred per month for a child age three and older; and

     (ii) Two hundred forty per month for an adult.

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

     (i) ((Forty-eight per year for a child age three and older; and

     (ii))) Purchased - thirty-six per year ((for an adult)) ; and

     (ii) Rented - two hundred forty per month.

     (i) ((Rented cloth, reusable diapers (any size) are limited to:

     (i) Three hundred per month for a child age three and older; and

     (ii) Two hundred forty per month for an adult.

     (j))) Disposable briefs (incontinent pants) and pull-up training pants (any size) are limited to:

     (i) Three hundred per month for a child age three and older; and

     (ii) One hundred fifty per month for an adult.

     (((k))) (j) Reusable briefs (incontinent pants) or pull-up training pants (any size) are limited to:

     (i) Purchased - four per year.

     (ii) Rented - one hundred fifty per month.

     (((l))) (k) Disposable pant liner/pads are limited to two hundred forty per month.

     (((m))) (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. MAA 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 TM, or combs of equivalent quality and effectiveness) - one per year.

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

     (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.

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

     (e) 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.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-16-141, § 388-543-1150, filed 7/31/01, effective 8/31/01.]

     Reviser's note: The typographical errors in the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.

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