Original Notice.

Preproposal statement of inquiry was filed as WSR 01-05-027.

Title of Rule: Amending WAC 388-543-1000 Definitions for durable medical equipment (DME) etc., 388-543-1300 Equipment, etc. not covered, and 388-543-2200 Augmentative communication devices (ACD).

Purpose: The amended sections are being updated and clarified to correctly reflect department policy. The rules are necessary in order to define an ACD more clearly, to further explain the criteria for a department-covered ACD, and to ensure that department policy more closely follows Medicare guidelines.

Statutory Authority for Adoption: RCW 74.08.090, 74.09.530.

Statute Being Implemented: RCW 74.08.090, 74.09.530.

Summary: The proposed rules clarify the definition of augmentative communication device (ACD) and clearly explain eligibility and coverage criteria for ACDs.

Reasons Supporting Proposal: To clarify department policy regarding ACDs.

Name of Agency Personnel Responsible for Drafting: Ann Myers, DPS/RIP, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1345; Implementation and Enforcement: Sharon Morrison, DHSQS/QU, P.O. Box 45506, Olympia, WA 98504-5506, (360) 725-1671.

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

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

Explanation of Rule, its Purpose, and Anticipated Effects: The rule proposed clarify department policy regarding augmentative communication devices (ACDs), especially the criteria for a device to be classified as a department-covered ACD.

The purpose of the rule is to clearly state department policy.

The anticipated effect is to make department policy clearly understandable to providers and clients.

Proposal Changes the Following Existing Rules: The rules amend WAC 388-543-1000, 388-543-1300, and 388-543-2200 to clarify current policy. This includes amending the definition of ACD and further explaining the criteria for a device to be classified as a department-covered ACD.

No small business economic impact statement has been prepared under chapter 19.85 RCW. MAA analyzed the proposed rules and concluded that they will not place "a more than minor" impact on the businesses affected by them. Therefore, a comprehensive SBEIS is not required.

RCW 34.05.328 applies to this rule adoption. MAA has analyzed the proposed rules and concludes that they meet the definition of a "significant legislative rule." MAA evaluated the probable costs and probable benefits of the proposed rules, taking into account both the qualitative and quantitative benefits and costs. MAA's analysis revealed that any new costs imposed on the businesses affected by them would be minor. The probable benefits of having clearly product specifications exceed the probable costs. A complete evaluation is available from the department representative identified above.

Hearing Location: Blake Office Building East, 4500 10th Avenue S.E., Rose Room, Lacey, WA 98503, on November 27, 2001, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by November 20, 2001, phone (360) 664-6094, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.

Submit Written Comments to: Identify WAC Numbers, Rules Coordinator, Rules and Policies Assistance Unit, P.O. Box 45850, Olympia, WA 98504-5850, fax (360) 664-6185, by 5:00 p.m., November 27, 2001.

Date of Intended Adoption: No sooner than November 28, 2001.

October 17, 2001

Brian Lindgren, Manager

Rules and Policies Assistance Unit

"Artificial limb" - See "prosthetic device."

"Augmentative communication device (ACD)" means a dedicated medical device, used solely by a client with a severe speech impairment, that transmits or produces messages or symbols, either by voice output or in writing, in a manner that compensates for the impairment or disability of a client with severe expressive or language communication and comprehension disorders. The communication device may use mechanical or electrical impulses to produce messages or symbols that supplement or replace speech. ACDs covered by Medicare are known as speech generating devices (SGDs).

"Base year" means the year of the data source used in calculating prices.

"By report (BR)" means a method of reimbursement for covered items, procedures, and services for which the department has no set maximum allowable fees.

"Date of delivery" means the date the client actually took physical possession of an item or equipment.

"Dedicated device" means a speech-generating device that serves the single medical purpose of replacing the speaking ability of a client who has a severe speech impairment, and that cannot integrate or interact with a computer system in such a manner as to allow the device to be infected by a computer virus. Dedicated speech-generating devices are primarily medical in nature, are useful only to a person with a severe speech impairment, and cannot run software for purposes other than for speech generation.

"Disposable supplies" means supplies which may be used once, or more than once, but are time limited.

"Durable medical equipment (DME)" means equipment that: (1) Can withstand repeated use;

(2) Is primarily and customarily used to serve a medical purpose;

(3) Generally is not useful to a person in the absence of illness or injury; and

(4) Is appropriate for use in the client's place of residence.

"EPSDT((/healthy kids))" - see WAC 388-500-0005.

"Expedited prior authorization (EPA)" means the process for obtaining authorization for selected durable medical equipment, and related supplies, prosthetics, orthotics, medical supplies and related services, in which providers use a set of numeric codes to indicate to MAA which acceptable indications/conditions/MAA-defined criteria are applicable to a particular request for DME authorization.

"Fee-for-service (FFS)," means the general payment method MAA uses to reimburse for covered medical services provided to clients, except those services covered under MAA's managed care programs.

"Health care financing administration common procedure coding system (HCPCS)" means a coding system established by the Health Care Financing Administration (HCFA) to define services and procedures. HCFA is now known as the Centers for Medicare and Medicaid Services (CMS).

"House wheelchair" means a nursing facility wheelchair that is included in the nursing facility's per-patient-day rate under chapter 74.46 RCW.

"Limitation extension" means an authorization process to exceed a coverage limitation (quantity, frequency, or duration) set in WAC, billing instructions, or numbered memoranda. Limitation extensions require prior authorization.

"Nonreusable supplies" are disposable supplies, which are used once and discarded.

"Manual wheelchair" - see "wheelchair - manual."

"Medical supplies" means supplies that are:

(1) Primarily and customarily used to service a medical purpose; and

(2) Generally not useful to a person in the absence of illness or injury.

"Orthotic device" or "orthotic" means a corrective or supportive device that:

(1) Prevents or corrects physical deformity or malfunction; or

(2) Supports a weak or deformed portion of the body.

"Personal or comfort item" means an item or service which primarily serves the comfort or convenience of the client.

"Personal computer (PC)" means any of a variety of electronic devices that are capable of accepting data and instructions, executing the instructions to process the data, and presenting the results. A PC has a central processing unit (CPU), internal and external memory storage, and various input/output devices such as a keyboard, display screen, and printer. A computer system consists of hardware (the physical components of the system) and software (the programs used by the computer to carry out its operations).

"Power-drive wheelchair" - see "wheelchair - power."

"Prior authorization" means a process by which clients or providers must request and receive MAA approval for certain medical equipment and related supplies, prosthetics, orthotics, medical supplies and related services, based on medical necessity, before the services are provided to clients, as a precondition for provider reimbursement. Expedited prior authorization and limitation extension are types of prior authorization. Also see WAC 388-501-0165.

"Prosthetic device" or "prosthetic" means a replacement, corrective, or supportive device prescribed by a physician or other licensed practitioner of the healing arts, within the scope of his or her practice as defined by state law, to:

(1) Artificially replace a missing portion of the body;

(2) Prevent or correct physical deformity or malfunction; or

(3) Support a weak or deformed portion of the body.

"Resource based relative value scale (RBRVS)" means a scale that measures the relative value of a medical service or intervention, based on the amount of physician resources involve.

"Reusable supplies" are supplies which are to be used more than once.

"Scooter" means a federally-approved, motor-powered vehicle that:

(1) Has a seat on a long platform;

(2) Moves on either three or four wheels;

(3) Is controlled by a steering handle; and

(4) Can be independently driven by a client.

"Specialty bed" means a pressure reducing support surface, such as foam, air, water, or gel mattress or overlay.

"Three- or four-wheeled scooter" means a three- or four-wheeled vehicle meeting the definition of scooter (see "scooter") and which has the following minimum features:

(1) Rear drive;

(2) A twenty-four volt system;

(3) Electronic or dynamic braking;

(4) A high to low speed setting; and

(5) Tires designed for indoor/outdoor use.

"Trendelenburg position" means a position in which the patient is lying on his or her back on a plane inclined thirty to forty degrees. This position makes the pelvis higher than the head, with the knees flexed and the legs and feet hanging down over the edge of the plane.

"Usual and customary charge" means the amount the provider typically charges to fifty percent or more of his or her non-Medicaid clients, including clients with other third-party coverage.

"Warranty-wheelchair" means a warranty, according to manufacturers' guidelines, of not less than one year from the date of purchase.

"Wheelchair - manual" means a federally-approved, nonmotorized wheelchair that is capable of being independently propelled and fits one of the following categories:

(1) Standard:

(a) Usually is not capable of being modified;

(b) Accommodates a person weighing up to two hundred fifty pounds; and

(c) Has a warranty period of at least one year.

(2) Lightweight:

(a) Composed of lightweight materials;

(b) Capable of being modified;

(c) Accommodates a person weighing up to two hundred fifty pounds; and

(d) Usually has a warranty period of at least three years.

(3) High strength lightweight:

(a) Is usually made of a composite material;

(b) Is capable of being modified;

(c) Accommodates a person weighing up to two hundred fifty pounds;

(d) Has an extended warranty period of over three years; and

(e) Accommodates the very active person.

(4) Hemi:

(a) Has a seat-to-floor height lower than eighteen inches to enable an adult to propel the wheelchair with one or both feet; and

(b) Is identified by its manufacturer as "Hemi" type with specific model numbers that include the "Hemi" description.

(5) Pediatric: Has a narrower seat and shorter depth more suited to pediatric patients, usually adaptable to modifications for a growing child.

(6) Recliner: Has an adjustable, reclining back to facilitate weight shifts and provide support to the upper body and head.

(7) Tilt-in-space: Has a positioning system, which allows both the seat and back to tilt to a specified angle to reduce shear or allow for unassisted pressure releases.

(8) Heavy Duty:

(a) Specifically manufactured to support a person weighing up to three hundred pounds; or

(b) Accommodating a seat width of up to twenty-two inches wide (not to be confused with custom manufactured wheelchairs).

(9) Rigid: Is of ultra-lightweight material with a rigid (nonfolding) frame.

(10) Custom heavy duty:

(a) Specifically manufactured to support a person weighing over three hundred pounds; or

(b) Accommodates a seat width of over twenty-two inches wide (not to be confused with custom manufactured wheelchairs).

(11) Custom manufactured specially built:

(a) Ordered for a specific client from custom measurements; and

(b) Is assembled primarily at the manufacturer's factory.

"Wheelchair - power" means a federally-approved, motorized wheelchair that can be independently driven by a client and fits one of the following categories:

(1) Custom power adaptable to:

(a) Alternative driving controls; and

(b) Power recline and tilt-in-space systems.

(2) Noncustom power: Does not need special positioning or controls and has a standard frame.

(3) Pediatric: Has a narrower seat and shorter depth that is more suited to pediatric patients. Pediatric wheelchairs are usually adaptable to modifications for a growing child.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, 388-543-1000, filed 12/13/00, effective 1/13/01.]

MAA pays only for prosthetics or orthotics that are listed as such by the federal Center for Medicare and Medicaid Services (CMS), formerly known as HCFA, 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. MAA considers all requests for covered DME, related supplies and services, medical supplies, prosthetics, orthotics, and related services and noncovered equipment, related supplies and services, supplies and devices, under the provisions of WAC 388-501-0165 ((which relate to medical necessity)). When MAA considers that a request does not meet the requirement for medical necessity, the definition(s) of covered item(s), or is not covered, the client may appeal that decision under the provisions of WAC 388-501-0165.

MAA 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 ((required under the EPSDT/healthy kids program)), included as part of a managed care plan service package, included in ((a)) an MAA waivered program, or part of one of the Medicare programs for qualified Medicare beneficiaries. MAA reviews requests for DME and related supplies, medical supplies, and related services for children who are eligible for services under the EPSDT program according to the provisions of WAC 388-534-0100. Excluded services and equipment include, but are not limited to:

(1) Services, procedures, treatment, devices, drugs, or the application of associated services that the department of the Food and Drug Administration (FDA) and/or the Health Care Financing Administration (HCFA) consider investigative or experimental on the date the services are provided;

(2) Any service specifically excluded by statute;

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

(4) Hairpieces or wigs;

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

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

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

(8) Prosthetic devices dispensed solely for cosmetic reasons (refer to WAC 388-531-0150 (1)(d);

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

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

(b) Saunas;

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

(d) Swimming pools;

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

(f) Electrical rewiring for any reason;

(g) Elevator systems and elevators; and

(h) Lifts or ramps for the home; or

(i) Installation of bathtubs or shower stalls.

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

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

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

(c) 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;

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

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

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

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

(ii) 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 ((AASA COPES or)) MAA outpatient hospital programs or AASA COPES for emergency response systems and services);

(iii) Two-way radios; and

(iv) Rental of related equipment or services;

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

(h) Ergonomic equipment;

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

(j) Generators;

(k) Personal computers, including ((laptops, computer)) software, printers, ((computer)) accessories (((such as)) e.g., anti-glare shields, backup memory cards), and ((computer)) equipment ((other than specified in WAC 388-543-2200));

(l) Laptop computers, desktop computer, or personal digital assistants (PDAs), which may be programmed to perform the same function as a speech generating device;

(m) Devices that are not dedicated speech devices (dedicated speech devices are used solely by the client who has a severe speech impairment);

(n) Devices capable of running software for purposes other than for speech generation (e.g., devices that can also run a word processing package, an accounting program, or perform other nonmedical functions);

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

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

(((m))) (q) Room fresheners/deodorizers;

(((n))) (r) Bidet or hygiene systems, paraffin bath units, and shampoo rings;

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

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

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

(11) Personal and comfort items that do not meet the DME definition, including but not limited to the following:

(a) 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;

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

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

(d) Clothing and accessories, such as coats, gloves (including wheelchair gloves), hats, scarves, slippers, and socks;

(e) Clothing protectors and other protective cloth furniture coverings;

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

(g) Diverter valves for bathtub;

(h) Eating/feeding utensils;

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

(j) Health club memberships;

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

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

(m) Impotence devices;

(n) Insect repellants;

(o) Massage equipment;

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

(q) 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;

(r) Page turners;

(s) Radio and television;

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

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

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

(a) Attendant controls (remote control devices);

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

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

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

(e) Lighting systems;

(f) Speed conversion kits; and

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

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, 388-543-1300, 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 01-01-078, filed 12/13/00, effective 1/13/01)

WAC 388-543-2200   Augmentative communication devices (ACD).   (1) MAA considers all requests ((on a case-by-case basis)) for augmentative communication devices (ACDs) ((for the purpose of appropriately relaying)) on a case-by-case basis. The ACD requested must be for a severe speech impairment, and the medical condition must warrant the use of a device to replace verbal communication (e.g., to communicate medical information).

(2) In order for MAA to cover an ADC, the ACD must be a dedicated speech device used solely by the individual who has a severe speech impairment, and have one of the following characteristics:

(a) Have digitized speech output, using pre-recorded messages; or

(b) Have synthesized speech output or written responses that permit multiple methods of formulating the message (e.g., spelling, icons, touch screen), and multiple methods of accessing the device.

(3) MAA does not cover speech generating devices that do not meet the definition of ACD under WAC 388-543-1000. MAA considers all requests for noncovered devices under the provisions of WAC 388-501-0165.

(4) MAA requires a provider to submit a prior authorization request for ACDs. The request must be in writing and contain all of the following information:

(a) A detailed description of the client's therapeutic history;

(b) An assessment by a licensed speech pathologist of the client's verbal capabilities. The pathologist must be knowledgeable about selecting ACDs that meet the client's needs;

(c) If the client has a physical disability, condition, or impairment that requires equipment, such as a wheelchair, or a device to be specially adapted to accommodate an ACD, an assessment by the prescribing physician, licensed occupational therapist or physical therapist; and

(d) Documented evaluations and/or trials of each ACD that the client has tried. This includes less costly types/models, and the effectiveness of each device in promoting the client's ability to communicate with health care providers, caregivers, and others.

(((3))) (5) MAA requires the provider to show or the client to demonstrate all of the following:

(a) The client has reliable and consistent motor response, which can be used to communicate with the help of an ACD;

(b) The client has the cognitive ability to utilize the equipment effectively and independently ((utilize the equipment)); and

(c) With the ADC, the client will be able to do all of the following:

(i) Communicate with the personal physician about the medical condition, complaint, ailment, or symptoms;

(ii) Communicate with the personal caregiver about both urgent medical needs and routine personal care needs; and

(iii) Communicate with medical personnel who provide emergency services, rehabilitative care, and other therapeutic treatment.

(((4))) (6) MAA covers ACDs only once every two years for a client who meets the criteria in subsection (((3))) (5) of this section. MAA does not approve a new or updated component, modification, or replacement model for a client whose ACD is less than two years old. MAA may make exceptions to the criteria in this subsection based strictly on a finding of unforeseeable and significant changes to the client's medical condition. The prescribing physician is responsible for justifying why the changes in the client's medical condition were unforeseeable.

(7) Clients who are eligible for both Medicare and Medicaid must apply first to Medicare for a speech generating device (SGD). If Medicare denies the request and the client requests an ACD from MAA, MAA evaluates the request based on medical necessity.

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, 388-543-2200, filed 12/13/00, effective 1/13/01.]

Washington State Code Reviser's Office