Original Notice.

     Preproposal statement of inquiry was filed as WSR 09-12-043.

     Title of Rule and Other Identifying Information: Chapter 388-543 WAC, Durable medical equipment and related supplies, prosthetics, orthotics, medical supplies and related services.

     Hearing Location(s): Office Building 2, Auditorium, DSHS Headquarters, 1115 Washington, Olympia, WA 98504 (public parking at 11th and Jefferson. A map is available at http://www1.dshs.wa.gov/msa/rpau/RPAU-OB-2directions.html

or by calling (360) 664-6094), on June 7, 2011, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than June 8, 2011.

     Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504-5850, delivery Office Building 2, DSHS Headquarters, 1115 Washington, Olympia, WA 98504, e-mail DSHSRPAURulesCoordinator@dshs.wa.gov, fax (360) 664-6185, by 5 p.m. on June 7, 2011.

     Assistance for Persons with Disabilities: Contact Jennisha Johnson, DSHS rules consultant, by May 10, 2011, TTY (360) 664-6178 or (360) 664-6094 or by e-mail at jennisha.johnson@dshs.wa.gov.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: These proposed amendments to chapter 388-543 WAC, Durable medical equipment and related supplies, prosthetics, orthotics, medical supplies and related services are necessary in order to reorganize the order of the rules to easier use, to eliminate duplicate information, to propose clearer titles, offer a more logical flow, remove old acronyms, cross references, definitions, update coverage policy, update documentation requirements, update client eligibility, clarify proof of delivery requirements, update reimbursement methodology, clarify rental verses purchase, clarify a valid prescription, update authorization requirements, and clarified limits.

     Reasons Supporting Proposal: As sections were added to the chapter over the years, the size of the chapter expanded to mammoth proportions. It became clear that it was time for a major overhaul to update the chapter and to reorganize the order of the sections to match other medical assistance rule chapters recently filed.

     Statutory Authority for Adoption: RCW 74.08.090, 74.04.050.

     Statute Being Implemented: RCW 74.08.090.

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

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

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

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule amendments and determined that there are no new costs associated with these changes and they do not impose disproportionate costs on small businesses.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Erin Mayo, P.O. Box 45506, Olympia, WA 98504-5506, fax (360) 586-9727, e-mail Erin.Mayo@dshs.wa.gov.

March 31, 2011

Katherine I. Vasquez

Rules Coordinator

     (2) The department covers the DME and related supplies, prosthetics, orthotics, and related services including modifications, accessories, and repairs, and medical supplies listed in this chapter, according to department rules and subject to the limitations and requirements in this chapter.

     (3) The department pays for DME and related supplies, prosthetics, orthotics, and related services including modifications, accessories, and repairs, and medical supplies when it is:

     (a) Covered;

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

     (c) Medically necessary, as defined in WAC 388-500-0005;

     (d) Prescribed by a physician, advanced registered nurse practitioner (ARNP), or physician assistant certified (PAC) within the scope of his or her licensure, except for dual eligible medicare/medicaid clients when medicare is the primary payer and the department is being billed for a co-pay and/or deductible only;

     (e) Authorized, as required within this chapter, chapters 388-501 and 388-502 WAC, and the department's published billing instructions and numbered memoranda;

     (f) Billed according to this chapter, chapters 388-501 and 388-502 WAC, and the department's published billing instructions and numbered memorandum; and

     (g) Provided and used within accepted medical or physical medicine community standards of practice.

     (4) The department requires prior authorization for covered DME and related supplies, prosthetics, orthotics, medical supplies, and related services when the clinical criteria set forth in this chapter are not met, including the criteria associated with the expedited prior authorization process.

     (a) The department evaluates requests requiring prior authorization on a case-by-case basis to determine medical necessity, according to the process found in WAC 388-501-0165.

     (b) Refer to WAC 388-543-7000, 388-543-7001, and 388-543-7003 for specific details regarding authorization.

     (5) 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 388-543-7100 for PA and WAC 388-543-7300 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.

     (6) 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).

     (7) The department may terminate a provider's participation with the department according to WAC 388-502-0030 and 388-502-0040.

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

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     (("Artificial limb" - See "prosthetic device."

     "Augmentative communication device (ACD)" - See "speech generating device (SGD)."

     "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)) A method of payment in which the department determines the amount it will pay for a service when the rate for that service is not included in the department's published fee schedules. The provider must submit a report which describes the nature, extent, time, effort and/or equipment necessary to deliver the service.

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

     "Digitized speech" (also referred to as devices with whole message speech output) - Words or phrases that have been recorded by an individual other than the speech generating device (SGD) user for playback upon command of the SGD user.

     "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" - 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)) healthcare services((,)) in which providers use a set of numeric codes to indicate to ((MAA)) the department which acceptable ((indications/conditions/MAA-defined)) indications, conditions, or department-defined criteria are applicable to a particular request for ((DME)) authorization. EPA is a form of prior authorization.

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

     "((Health care financing administration)) Healthcare 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).

     "Home" - For the purposes of this chapter, means location, other than hospital or skilled nursing facility where the client receives care.

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

     "Limitation extension" ((means a process for requesting and approving covered services and reimbursement that exceeds a coverage limitation (quantity, frequency, or duration) set in WAC, billing instructions, or numbered memoranda. Limitation extensions require prior authorization)) - A client-specific authorization by the department for additional covered services beyond the set amount allowed under department rules. See WAC 388-501-0169.

     (("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.

     "Medically necessary" - See WAC 388-500-0005.

     "National provider indicator (NPI)" - A federal system for uniquely identifying all providers of healthcare services, supplies, and equipment.

     "Other durable medical equipment (other DME)" - All durable medical equipment, excluding wheelchairs and wheelchair-related items.

     "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 or caregiver.

     (("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."

     "Pricing cluster" - A group of manufacturers' list prices for brands/models of DME, medical supplies and nondurable medical equipment that the department considers when calculating the reimbursement rate for a procedure code that does not have a fee established by medicare.

     "Prior authorization" ((means 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)) The requirement that a provider must request, on behalf of a client and when required by rule, the department's approval to render a healthcare service or write a prescription in advance of the client receiving the healthcare service or prescribed drug, device, or drug-related supply. The department's approval is based on medical necessity. Receipt of prior authorization does not guarantee payment. Expedited prior authorization and limitation extension are types of prior authorization.

     "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 involved.

     "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.

     "Speech generating device (SGD)" ((means)) - An electronic device or system that compensates for the loss or impairment of a speech function due to a congenital condition, an acquired disability, or a progressive neurological disease. The term includes only that equipment used for the purpose of communication. Formerly known as "augmentative communication device (ACD)."

     "Synthesized speech" - Is a technology that translates a user's input into device-generated speech using algorithms representing linguistic rules, unlike prerecorded messages of digitized speech. A SGD that has synthesized speech is not limited to prerecorded messages but rather can independently create messages as communication needs dictate.

     "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 ((nonmedicaid clients, including clients with other third-party coverage)) patients who are not medical assistance clients.

     (("Warranty-wheelchair" means a warranty)) "Warranty-period" - A guarantee or assurance, according to manufacturers' or provider's guidelines, of ((not less than one year)) set duration 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. 02-16-054, § 388-543-1000, filed 8/1/02, effective 9/1/02; 01-01-078, § 388-543-1000, filed 12/13/00, effective 1/13/01.]

     (14) Bilirubin lights are limited to rentals, for at-home newborns with jaundice)) (1) Durable medical equipment (DME) and related services, prosthetics and orthotics, medical supplies and related services are available to clients who are eligible for services under one of the following medical assistance programs:

     (a) Categorically needy (CN);

     (b) Children's healthcare as described in WAC 388-505-0210;

     (c) Medically needy (MN);

     (d) Disability lifeline (formerly GA U/ADATSA) (within Washington state or designated border cities); or

     (e) Alien emergency medical (AEM) as described in WAC 388-438-0110, when the medical services are necessary to treat a qualifying emergency medical condition.

     (2) Clients who are eligible for services under medicare and medicaid (medically needy program-qualified medicare beneficiaries) are eligible for DME and related services, prosthetics and orthotics, medical supplies and related services.

     (3) Clients who are enrolled in a department contracted managed care organization (MCO) must arrange for DME and related services, prosthetics and orthotics, medical supplies and related services directly through his or her department-contracted MCO. The department does not pay for medical equipment and/or services provided to a client who is enrolled in a department-contracted MCO, but chose not to use one of the MCO's participating providers.

     (4) For clients who reside in a skilled nursing facility, see WAC 388-543-5700.

[Statutory Authority: RCW 74.08.090 and 74.04.050. 07-17-062, § 388-543-1100, 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, § 388-543-1100, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.04.050, 74.04.57 [74.04.057], and 74.08.090. 05-21-102, § 388-543-1100, filed 10/18/05, effective 11/18/05. Statutory Authority: RCW 74.08.090, 34.05.353. 03-12-005, § 388-543-1100, filed 5/22/03, effective 6/22/03. Statutory Authority: RCW 74.08.090, 74.09.530. 02-16-054, § 388-543-1100, filed 8/1/02, effective 9/1/02; 01-01-078, § 388-543-1100, filed 12/13/00, effective 1/13/01.]

     (iii) All other circumstances will be considered on a case-by-case basis, based on medical necessity)) pays qualified providers for durable medical equipment (DME) and related supplies, prosthetics, orthotics, medical supplies, repairs, and related services on a fee-for-service basis as follows:

     (a) DME providers for DME and related repair services;

     (b) Medical equipment dealers, pharmacies, and home health agencies under their national provider indicator (NPI) for medical supplies;

     (c) Prosthetics and orthotics providers who are licensed by the Washington state department of health in prosthetics and orthotics. Medical equipment dealers and pharmacies that do not require licensure to provide selected prosthetics and orthotics may be paid for those selected prosthetics and orthotics only;

     (d) Physicians who provide medical equipment and supplies in the office. The department may pay separately for medical supplies, subject to the provisions in the department's resource-based relative value scale fee schedule; and

     (e) Out-of-state orthotics and prosthetics providers who meet their state regulations.

     (2) Providers and suppliers of durable medical equipment (DME) and related supplies, prosthetics, orthotics, medical supplies and related items must:

     (a) Meet the general provider requirements in chapter 388-502 WAC;

     (b) Have the proper business license and be certified, licensed and/or bonded if required, to perform the services billed to the department;

     (c) Have a valid prescription;

     (i) To be valid, a prescription must:

     (A) Be written on the department's Prescription Form (DSHS 13-794). The department's electronic forms are available online at: http://www.dshs.wa.gov/msa/forms/eforms.html;

     (B) Be written by a physician, advanced registered nurse practitioner (ARNP), or physician's assistant certified (PAC);

     (C) Be written, signed (including the prescriber's credentials), and dated by the prescriber on the same day and before delivery of the supply, equipment, or device. Prescriptions must not be back-dated;

     (D) Be no older than one year from the date the prescriber signs the prescription; and

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

     (ii) For dual eligible medicare/medicaid clients when medicare is the primary payer and the department is being billed for the co-pay and/or deductible only, subsection (2)(a) of this section does not apply.

     (d) Provide instructions for use of equipment;

     (e) Furnish only new equipment to clients that includes full manufacturer and dealer warranties. See WAC 388-543-2250(3);

     (f) Furnish documentation of proof of delivery, upon department request (see WAC 388-543-2200); and

     (g) Bill the department using only the allowed procedure codes listed in published DME and related supplies, prosthetics and orthotics, medical supplies and related items billing instructions.

[Statutory Authority: RCW 74.08.090 and 74.04.050. 07-17-062, § 388-543-2000, filed 8/13/07, effective 9/13/07. Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-2000, filed 12/13/00, effective 1/13/01.]

     (5) MAA implements wheelchair rate changes on April 1 of the base year, and the rates are effective until the next rate change)) An interested party may request the department to include new equipment/supplies in the department's durable medical equipment (DME) and related supplies, prosthetics, orthotics, medical supplies and related services billing instructions.

     (2) The request should include credible evidence, including but not limited to:

     (a) Manufacturer's literature;

     (b) Manufacturer's pricing;

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

     (d) Proof of certification from the centers for medicare and medicaid services (CMS), if applicable; and

     (e) Any additional information the requester feels would aid the department in its determination

     (3) Requests should be sent to the DME Program Management Unit, PO Box 45505, Olympia WA 98504-5506.

[Statutory Authority: RCW 74.04.050, 74.04.057, 74.08.090, and Public Law 104-191. 03-19-083, § 388-543-2100, filed 9/12/03, effective 10/13/03. Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-2100, filed 12/13/00, effective 1/13/01.]

     (6) Clients who are eligible for both medicare and medicaid must apply first to medicare for an SGD. If medicare denies the request and the client requests an SGD from MAA, MAA evaluates the request based on medical necessity and the requirements in this section. The request for an SGD must meet the authorization requirements in this section)) When a provider delivers an item directly to the client or the client's authorized representative, the provider must furnish the proof of delivery when the department requests that information. All of the following apply:

     (a) The department requires a delivery slip as proof of delivery, and it must:

     (i) Be signed and dated by the client or the client's authorized representative (the date of signature must be the date the item was received by the client);

     (ii) Include the client's name and a detailed description of the item(s) delivered, including the quantity and brand name; and

     (iii) For durable medical equipment (DME) that may require future repairs, include the serial number.

     (b) When the provider or supplier submits a claim for payment to the department, the date of service on the claim must be one of the following:

     (i) For a one-time delivery, the date the item was received by the client or the client's authorized representative; or

     (ii) For nondurable medical supplies for which the department has established a monthly maximum, on or after the date the item was received by the client or the client's authorized representative.

     (2) When a provider uses a delivery/shipping service to deliver items which are not fitted to the client, the provider must furnish proof of delivery that the client received the equipment and/or supply, when the department requests that information.

     (a) If the provider uses a delivery/shipping service, the tracking slip is the proof of delivery. The tracking slip must include:

     (i) The client's name or a reference to the client's package(s);

     (ii) The delivery service package identification number; and

     (iii) The delivery address.

     (b) If the provider/supplier does the delivering, the delivery slip is the proof of delivery. The delivery slip must include:

     (i) The client's name;

     (ii) The shipping service package identification number;

     (iii) The quantity, detailed description(s), and brand name(s) of the items being shipped; and

     (iv) For DME that may require future repairs, the serial number.

     (c) When billing the department:

     (i) Use the shipping date as the date of service on the claim if the provider uses a delivery/shipping service; or

     (ii) Use the actual date of delivery as the date of service on the claim if the provider/supplier does the delivery.

     (3) A provider must not use a delivery/shipping service to deliver items which must be fitted to the client.

     (4) Providers must obtain prior authorization when required before delivering the item to the client. The item must be delivered to the client before the provider bills the department.

     (5) The department does not pay for DME and related supplies, prosthetics and orthotics, medical supplies and related items furnished to the department's clients when:

     (a) The medical professional who provides medical justification to the department for the item provided to the client is an employee of, has a contract with, or has any financial relationship with the provider of the item; or

     (b) The medical professional who performs a client evaluation is an employee of, has a contract with, or has any financial relationship with a provider of DME and related supplies, prosthetics and orthotics, medical supplies, and related items.

[Statutory Authority: RCW 74.08.090, 74.09.530. 02-16-054, § 388-543-2200, filed 8/1/02, effective 9/1/02; 01-01-078, § 388-543-2200, filed 12/13/00, effective 1/13/01.]

     (2) A provider must not bill the department for the rental or purchase of equipment supplied to the provider at no cost by suppliers/manufacturers.

     (3) The department purchases new DME equipment only.

     (a) A new DME item that is placed with a client initially as a rental item is considered a new item by the department at the time of purchase.

     (b) A used DME item that is placed with a client initially as a rental item must be replaced by the supplier with a new item prior to purchase by the department.

     (4) The department requires a dispensing provider to ensure the DME rented to a client is:

     (a) In good working order; and

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

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

     (6) The department authorizes rental equipment for a specific period of time. The provider must request authorization from the department for any extension of the rental period.

     (7) The department's reimbursement amount for rented DME includes all of the following:

     (a) Delivery to the client;

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

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

     (d) Return pickup by the provider.

     (8) The department considers rented equipment to be purchased after twelve months' rental unless the equipment is restricted as rental only.

     (9) DME and related supplies, prosthetics, and orthotics purchased by the department for a client are the client's property.

     (10) The department rents, but does not purchase, certain DME for clients. This includes, but is not limited to, the following:

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

     (b) Electric hospital-grade breast pumps.

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

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

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

     (b) Medicare considers the equipment purchased.

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

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

[Statutory Authority: RCW 74.08.090, 74.09.530. 01-01-078, § 388-543-3000, filed 12/13/00, effective 1/13/01.]

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

     (2) Traction equipment - one per client in a five-year period.

     (3) Trapeze bars - one per client in a five-year period. The department requires prior authorization for rental.

     (4) Fracture frames - one per client in a five-year period. The department requires prior authorization for rental.

     (5) Transfer board or devices - one per client in a five-year period.

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

     (2) Prone stander (infant, child, youth, or adult size) -one per client is a five-year period. The prone stander must be prescribed by a physician and the client must not be residing in a skilled nursing facility.

     (3) Adjustable standing frame (for child/adult who is thirty to 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 per client in a five-year period.

     (4) Positioning car seats - one per client, eight years of age and older or four feet nine inches or taller, in a five-year period.

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     (2) The department pays for the purchase of non-spinal bone growth stimulators, only when:

     (a) The stimulators have pulsed electromagnetic field (PEMF) simulation; and

     (b) The client meets one or more of the following clinical criteria:

     (i) Has a nonunion of a long bone fracture (which includes clavicle, humerus, phalanx, radius, ulna, femur, tibia, fibula, metacarpal and metatarsal) after three months have elapsed since the date of injury without healing; or

     (ii) Has a failed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery.

     (3) The department pays for the purchase of spinal bone growth stimulators, when:

     (a) Prescribed by a neurologist, an orthopedic surgeon, or a neurosurgeon and;

     (b) The client meets one or more of the following clinical criteria:

     (i) Has a failed spinal fusion where a minimum of nine months have elapsed since the last surgery; or

     (ii) Is post-op from a multilevel spinal fusion surgery; or

     (iii) Is post-op from spinal fusion surgery where there is a history of a previously failed spinal fusion.

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     (a) One artificial larynx, any type, without prior authorization, per client in a five-year period; and

     (b) One speech generating device (SGD), with prior authorization, per client every two years.

     (2) The department pays only for those approved speech generating devices (SGDs) that have:

     (a) Digitized speech output, using pre-recorded messages;

     (b) Synthesized speech output requiring message formation by spelling and access by physical contact with the device; or

     (c) Synthesized speech output, permitting multiple methods of message formulation and multiple methods of device access.

     (3) The department requires prior authorization for SGDs and reviews requests on a case-by-case basis. Requests to the department for prior authorization must meet all of the following:

     (a) The client must have a severe expressive speech impairment and the client's medical condition warrants the use of a device to replace verbal communication (e.g., to communicate medical information); and

     (b) The request must be in writing and be accompanied by:

     (i) A completed General Information for Authorization form (DSHS 13-835). The department's electronic forms are available online (see WAC 388-543-7000 Authorization); and

     (ii) A completed Speech Language Pathologist (SLP) Evaluation for Speech Generating Devices form (DSHS 15-310). The department requires, at a minimum, the following information:

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

     (B) A written assessment by a licensed speech language pathologist (SLP); and    

     (C) Documentation of all of the following:

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

     (II) The client has demonstrated the cognitive and physical abilities to utilize the equipment effectively and independently to communicate; and

     (III) The client's treatment plan includes a training schedule for the selected device.

     (iii) A copy of the prescription for the SGD from the client's treating physician written on a department Prescription form (DSHS 13-794) (see WAC 388-543-2000(2)).

     (4) The department may require trial-use rental of a SGD. The department applies the rental costs for the trial-use to the purchase price.

     (5) The department pays for the repair or modification of an SGD when all of the following are met:

     (a) All warranties are expired;

     (b) The cost of the repair or modification is less than fifty percent of the cost of a new SGD and the provider has supporting documentation; and

     (c) The repair has a warranty for a minimum of ninety days.

     (6) The department does not pay for devices requested for the purpose of education.

     (7) The department pays for replacement batteries for a SGD in accordance with WAC 388-543-5500(3). The department does not pay for back-up batteries for a SGD.

     (8) Clients who are eligible for both medicare and medicaid must apply first to medicare for an SGD. If medicare denies the request and the client requests an SGD from the department, the department evaluates the request according to the rules of this section.

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

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

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

     (2) The department pays for replacement underarm pads for crutches and replacement handgrips and tips for canes, crutches, and walkers. Prior authorization is not required.

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     (2) For manual or power-drive wheelchairs for clients who reside at home, requests for prior authorization must include all of the following completed forms:

     (a) General Information for Authorization form (DSHS 13-835). The department's electronic forms are available online (see WAC 388-543-7000 Authorization);

     (b) A Prescription form (DSHS 13-794); and

     (c) Medical Necessity for Wheelchair Purchase (for home clients only) form (DSHS 13-727) from the client's physician or therapist. The date on this form (DSHS 13-727) must not be prior to the date on the Prescription form (DSHS-13-794).

     (3) The department does not pay for manual or power-drive wheelchairs that have been delivered to a client without prior authorization from the department.

     (4) When the department determines that a wheelchair is medically necessary, according to the process found in WAC 388-501-0165, for six months or less, the department rents a wheelchair for clients who live at home. For clients who reside in a skilled nursing facility, see WAC 388-543-5700.

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     (1) The department determines the type of manual wheelchair for a home client as follows:

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

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

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

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

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

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

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

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

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

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

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

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

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

     (f) A rigid wheelchair for a client:

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

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

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

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

     (h) Pediatric wheelchairs/positioning strollers having a narrower seat and shorter depths more suited to pediatric patients, usually adaptable to modifications for a growing child.

     (2) The department pays for both a manual wheelchair and a power-drive wheelchair only for noninstitutionalized clients in limited circumstances. See WAC 388-543-4200(5).

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     (a) The client can independently and safely operate a power-drive wheelchair;

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

     (c) A power-drive wheelchair will:

     (i) Provide the client the only means of independent mobility; or

     (ii) Enable a child to achieve age-appropriate independence and developmental milestones.

     (2) The following additional information is required for a three or four-wheeled power-drive scooter/power-operated vehicle (POV):

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

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

     (3) When the department approves a power-drive wheelchair for a client who already has a manual wheelchair, the power-drive wheelchair becomes the client's primary chair, unless the client meets the criteria in subsection (5) of this section.

     (4) The department pays to maintain only the client's primary wheelchair, unless the conditions of subsection (6) of this section apply.

     (5) The department pays for one manual wheelchair and one power-drive wheelchair for noninstitutionalized clients only when one of the following circumstances applies:

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

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

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

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

     (ii) Cabulance, public buses, or personal transit are not available, practical, or possible for financial or other reasons.

     (6) When the department approves both a manual wheelchair and a power-drive wheelchair for a noninstitutionalized client who meets one of the circumstances in subsection (5) of this section, the department pays to maintain both wheelchairs.

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     (a) A completed General Information for Authorization form (DSHS 13-835). The department's electronic forms are available online (see WAC 388-543-7000 Authorization);

     (b) A completed Prescription form (DSHS 13-794);

     (c) A completed Medical Necessity for Wheelchair Purchase (for home clients only) form (DSHS 13-727). The date on this form (DSHS 13-727) must not be dated prior to the date on the Prescription form (DSHS-13-794);

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

     (e) The modification requested; and

     (f) Any specific information regarding the client's medical condition that necessitates the modification.

     (2) The department pays for transit option restraints only when used for client-owned vehicles.

     (3) The department covers, with prior authorization, wheelchair repairs. To receive payment, providers must submit the following to the department:

     (a) General Information for Authorization form (DSHS 13-835). The department's electronic forms are available online (see WAC 388-543-7000);

     (b) A completed Medical Necessity for Wheelchair Purchase form (for home clients only) (DSHS 13-727);

     (c) The make, model, and serial number of the wheelchair to be repaired; and

     (d) The repair requested.

     (4) Prior authorization is required for the repair and modification of client-owned equipment.

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     (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.

     (2) The department pays only licensed prosthetic and orthotic providers to supply prosthetics and orthotics. This requirement does not apply to the following:

     (a) Selected prosthetics and orthotics that do not require specialized skills to provide; and

     (b) Out-of-state providers, who must meet the licensure requirements of that state.

     (3) The department pays only for prosthetics or orthotics that are listed as such by the centers 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 WAC 388-543-1200.

     (4) The department pays for repair or modification of a client's current prosthesis. To receive payment, all of the following must be met:

     (a) All warranties are expired;

     (b) The cost of the repair or modification is less than fifty percent of the cost of a new prosthesis and the provider has supporting documentation; and

     (c) The repair is warranted for a minimum of ninety days.

     (5) The department requires the client to take responsibility for routine maintenance of a prosthetic or orthotic. If the client does not have the physical or mental ability to perform the task, the department requires the client's caregiver to be responsible. The department requires prior authorization for extensive maintenance to a prosthetic or orthotic.

     (6) For prosthetics dispensed for purely cosmetic reasons, see WAC 388-543-3800 Noncovered-DME.

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     (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;

     (2) Bandages, dressings, and tapes;

     (3) Batteries - replacement batteries:

     (a) The department pays for the purchase of replacement batteries for wheelchairs.

     (b) The department does not pay for wheelchair replacement batteries that are used for speech generating devices (SGDs) or ventilators. See WAC 388-543-3400 for speech generating devices and chapter 388-548 WAC for ventilators.

     (4) 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) Diabetic test strips as follows:

     (i) For clients, twenty years of age and younger, as follows:

     (A) Insulin dependent, three hundred test strips and three hundred lancets per client, per month.

     (B) For noninsulin dependent, one hundred test strips and one hundred lancets per client, per month.

     (ii) For clients, twenty-one years of age and older:

     (A) Insulin dependent, one hundred test strips and one hundred lancets per client, per month.

     (B) For noninsulin dependent, one hundred test strips and one hundred lancets per client, every three months.

     (iii) For pregnant women with gestational diabetes, the department pays for the quantity necessary to support testing as directed by the client's physician, up to sixty days postpartum.

     (d) See WAC 388-543-5500(13) for blood glucose monitors.

     (5) 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.

     (6) Decubitus care products:

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

     (b) Synthetic or lamb's wool sheepskin pad - one per twelve-month period;

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

     (7) 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 pay for either of the following when billed in combination with an ostomy faceplate:

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

     (ii) Drainable pouches with rubber face plate.

     (8) Syringes and needles;

     (9) 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 back sheet that is moisture impervious and is at least 1.00 mm thick, designed to protect clothing and linens;

     (vi) Have a top sheet 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 back sheet 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 back sheet 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 pays for urological products when they are used alone. The following are examples of products which the department does not pay for when used in combination with each other:

     (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) The department approves a client's use of a combination of products only when the client uses different products for daytime and nighttime use. Example: pull-up pants for daytime use and disposable diapers for nighttime use. The total quantity of all products in this section used in combination cannot exceed the monthly limitation for the product with the highest limit.

     (h) Purchased disposable diapers (any size) are limited to two hundred per month for clients three years of age and older.

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

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

     (ii) Rented - two hundred per month.

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

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

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

     (k) 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.

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

     (m) 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.

     (10) Urological supplies - urinary retention:

     (a) Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube - two per month. The department does not pay for these when 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. The department does not pay for these when 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. The department does not pay for these when billed in combination with other insertion trays that include drainage bag, catheters, and/or individual lubricant packets.

     (ii) With indwelling catheters - three per month. The department does not pay for these when 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. The department does not pay for these when 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). The department does not pay for these when billed in combination with irrigation tray or tubing.

     (i) Irrigation tray with syringe (bulb or piston) - thirty per month. The department does not pay for these when billed in combination with irrigation syringe (bulb or piston), or irrigation tubing set.

     (j) Irrigation tubing set - thirty per month. The department does not pay for these when billed in combination with an irrigation tray or irrigation syringe (bulb or piston).

     (k) Leg straps (latex foam and fabric), 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. The department does not pay for these when 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. The department does not pay for these when billed in combination with drainage bag and without catheter.

     (p) Urinary leg bag, latex - one per month. The department does not pay for these when billed in combination with or without catheter.

     (11) Miscellaneous supplies:

     (a) Bilirubin light therapy supplies when provided with a bilirubin light which the department prior authorized - five days supply.

     (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., LiceOff TM) for use with lice combs - one bottle per twelve-month period.

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

     (i) For clients residing in an assisted living facility, the department pays, with prior authorization, for additional nonsterile gloves up to the quantity necessary as directed by the client's physician, not to exceed a total of four hundred per client, per month.

     (ii) Prior authorization requests must include a completed:

     (A) General Information for Authorization form (DSHS 13-835). The department's electronic forms are available online (see WAC 388-543-7000 Authorization); and

     (B) Limitation Extension Request Incontinent Supplies and Gloves form (DSHS 13-870).

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

     (12) Miscellaneous DME:

     (a) Bilirubin light or light pad - five days rental per twelve-month period for at-home newborns with jaundice.

     (b) Blood glucose monitor (specialized or home) - one in a three-year period. See WAC 388-543-5500(4) for blood monitoring/testing supplies. The department does not pay for continuous glucose monitoring systems including related equipment and supplies.

     (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 with 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.

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     (2) The department pays for the following covered DME and related supplies outside of the skilled nursing facility per diem rate, subject to the limitations in this section:

     (a) Manual or power-drive wheelchairs;

     (b) Speech generating devices (SGD); and

     (c) Specialty beds.

     (3) The department pays for one manual or one power-drive wheelchair for clients who reside in a skilled nursing facility, with prior authorization, according to the requirements in WAC 388-543-4100, 388-543-4200, and 388-543-4300. Requests for prior authorization must:

     (a) Be for the exclusive full-time use of a skilled nursing facility resident;

     (b) Not be included in the skilled nursing facility's per diem rate;

     (c) Include a completed General Information for Authorization form (DSHS 13-835);

     (d) Include a copy of the telephone order, signed by the physician, for the wheelchair assessment;

     (e) Include a completed Medical Necessity for Wheelchair Purchase for Nursing Facility Clients form (DSHS 13-729).

     (4) The department pays for wheelchair accessories and modifications that are specifically identified by the manufacturer as separate line item charges, with prior authorization. To receive payment, providers must submit the following to the department:

     (a) A completed Prescription form (DSHS 13-794);

     (b) A completed Medical Necessity for Wheelchair Purchase for Nursing Facility Clients form (DSHS 13-729). The date on this form (DSHS 13-727) must not be prior to the date on the Prescription form (DSHS-13-794). The department's electronic forms are available online (see WAC 388-543-7000 Authorization);

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

     (d) The modification requested; and

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

     (5) The department pays for wheelchair repairs, with prior authorization. To receive payment, providers must submit the following to the department:

     (a) A completed Medical Necessity for Wheelchair Purchase for Nursing Facility Clients form (DSHS 13-729). The department's electronic forms are available online (see WAC 388-543-7000 Authorization);

     (b) The make, model, and serial number of the wheelchair to be repaired; and

     (c) The repair requested.

     (6) Prior authorization is required for the repair and modification of client-owned equipment.

     (7) The skilled nursing facility must provide a house wheelchair as part of the per diem rate, when the client resides in a skilled nursing facility.

     (8) When the client is eligible for both medicare and medicaid and is residing in a skilled nursing facility in lieu of hospitalization, the department does not reimburse for DME and related supplies, prosthetics, orthotics, medical supplies, related services, and related repairs and labor charges under fee-for-service (FFS).

     (9) The department pays for the purchase and repair of a speech generating device (SGD), with prior authorization. The department pays for replacement batteries for SGDs in accordance with WAC 388-543-5500(3).

     (10) The department pays for the purchase or rental of a specialty bed (a heavy duty bariatric bed is not a specialty bed), with prior authorization, when:

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

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

     (11) The department considers decubitus care products to be included in the skilled nursing facility per diem rate and does not reimburse for these separately.

     (12) See WAC 388-543-9200 for reimbursement for wheelchairs.

     (13) The department pays for the following medical supplies for a client in a skilled nursing facility outside the skilled nursing facility per diem rate:

     (a) Medical supplies or services that replace all or parts of the function of a permanently impaired or malfunctioning internal body organ. This includes, but is not limited to the following:

     (i) Colostomy and other ostomy bags and necessary supplies (see WAC 388-97-1060(3)); and

     (ii) Urinary retention catheters, tubes, and bags, excluding irrigation supplies.

     (b) Supplies for intermittent catheterization programs, for the following purposes:

     (i) Long term treatment of atonic bladder with a large capacity; and

     (ii) Short term management for temporary bladder atony.

     (c) Surgical dressings required as a result of a surgical procedure, for up to six weeks post-surgery.

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     (1) 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;

     (2) Instructional materials such as pamphlets and video tapes;

     (3) Hairpieces or wigs;

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

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

     (6) Supplies and equipment used during a physician office visit, such as tongue depressors and surgical gloves;

     (7) Prosthetic devices dispensed for cosmetic reasons;

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

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

     (b) Electrical rewiring for any reason;

     (c) Elevator systems and elevators;

     (d) Installation of, or customization of existing, bathtubs or shower stalls;

     (e) Lifts or ramps for the home;

     (f) Overhead ceiling track lifts;

     (g) Saunas;

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

     (i) Swimming pools; and

     (j) Whirlpool systems, such as jacuzzis, hot tubs, or spas.

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

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

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

     (c) Car seats for children seven years of age and younger or less than four feet nine inches tall, except for prior authorized positioning car seats under WAC 388-543-3200;

     (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;

     (iii) Two-way radios;

     (iv) Rental of related equipment or services; and

     (v) Devices requested for the purpose of education.

     (g) 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;

     (h) Ergonomic equipment;

     (i) Durable medical equipment that is used in a clinical setting;

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

     (k) Generators;

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

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

     (n) Any communication device that is useful to someone without severe speech impairment (including but not limited to cellular telephone and associated hardware, walkie-talkie, two-way radio, pager, or electronic notebook);

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

     (p) Room fresheners/deodorizers;

     (q) Bidet or hygiene systems, "sharps" containers, paraffin bath units, and shampoo rings;

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

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

     (t) Wheeled reclining chairs, lounge and/or lift chairs (including but not limited to geri-chair, posture guard, or lazy boy).

     (10) Blood pressure monitoring:

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

     (b) Blood pressure cuff only; and

     (c) Automatic blood pressure monitor.

     (11) Transcutaneous electrical nerve stimulation (TENS) devices and supplies, including battery chargers;

     (12) Functional electrical stimulation (FES) bike;

     (13) Wearable defibrillators;

     (14) Disinfectant spray;

     (15) Periwash;

     (16) Bathroom equipment used inside or outside of the physical space of a bathroom:

     (a) Bath stools;

     (b) Bathtub wall rail (grab bars);

     (c) Bed pans;

     (d) Bedside commode chair;

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

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

     (g) Potty chairs;

     (h) Raised toilet seat;

     (i) Safety equipment (including but not limited to belt, harness or vest);

     (j) Shower chairs;

     (k) Shower/commode chairs;

     (l) Sitz type bath or equipment;

     (m) Standard and heavy duty bath chairs;

     (n) Toilet rail;

     (o) Transfer bench for tub or toilet;

     (p) Urinal male/female.

     (17) Personal and/or comfort items, including but not limited to the following:

     (a) Bathroom and hygiene 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 mattress pads, blankets, mattress covers/bags, pillows, pillow cases/covers, sheets, and bumper pads;

     (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, socks, custom vascular supports (CVS), surgical stockings, gradient compression stockings, and custom compression garments and lumbar supports for pregnancy;

     (e) Clothing protectors, surgical masks, 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 and handheld showers 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;

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

     (18) Certain wheelchair features and options including, but not limited to, the following:

     (a) Attendant controls (remote control devices);

     (b) Canopies, including those used 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) Decals;

     (e) Hub Lock brake;

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

     (g) Lighting systems;

     (h) Replacement key or extra key;

     (i) Speed conversion kits; and

     (j) Trays for clients in a skilled nursing facility.

     (19) New durable medical equipment, supplies, or related technology that the department has not evaluated for coverage. See WAC 388-543-2100.

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     (a) For prior authorization (PA), a provider must submit a written request to the department as specified in the department's published billing instructions (see WAC 388-543-7100). All requests for prior authorization must be accompanied by a completed General Information for Authorization form (DSHS 13-835) in addition to any program specific DSHS forms as required within this chapter. The department's electronic forms are available online at: http://www.dshs.wa.gov/msa/forms/eforms.html.

     (b) For expedited prior authorization (EPA), a provider must meet the clinically appropriate EPA criteria outlined in the department's published billing instructions. The appropriate EPA number must be used when the provider bills the department (see WAC 388-543-7200).

     (2) When a service requires authorization, the provider must properly request authorization in accordance with the department's rules, billing instructions, and numbered memoranda.

     (3) The department's authorization of service(s) does not necessarily guarantee payment.

     (4) When authorization is not properly requested, the department rejects and returns the request to the provider for further action. The department does not consider the rejection of the request to be a denial of service.

     (5) Authorization requirements in this chapter are not a denial of service to the client.

     (6) The department may recoup any payment made to a provider if the department later determines that the service was not properly authorized or did not meet the EPA criteria. Refer to WAC 388 502 0100 (1)(c).

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     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.
NEW SECTION
WAC 388-543-7100   Prior authorization.   (1) The department requires providers to obtain prior authorization for certain items and services before delivering that item or service to the client, except for dual-eligible medicare/medicaid clients when medicare is the primary payer. The item or service must also be delivered to the client before the provider bills the department.

     (2) All prior authorization requests must be accompanied by a completed General Information for Authorization form (DSHS 13-835), in addition to any program specific department forms as required within this chapter. Department forms are available online at http://www.dshs.wa.gov/msa/forms/eforms.html.

     (3) When the department receives the initial request for prior authorization, the prescription(s) for those items or services must not be older than three months from the date the department receives the request.

     (4) The department requires certain information from providers in order to prior authorize the purchase or rental of equipment. This information includes, but is not limited to, the following:

     (a) The manufacturer's name;

     (b) The equipment model and serial number;

     (c) A detailed description of the item; and

     (d) Any modifications required, including the product or accessory number as shown in the manufacturer's catalog.

     (5) For prior authorization requests, the department requires the prescribing provider to furnish patient-specific justification for base equipment and each requested line item accessory or modification as identified by the manufacturer as a separate charge. The department does not accept general standards of care or industry standards for generalized equipment as justification.

     (6) The department considers requests for new durable medical equipment (DME) and related supplies, prosthetics, orthotics, medical supplies and related equipments that do not have assigned healthcare common procedure coding system (HCPCS) codes and are not listed in the department's published issuances, including billing instructions or numbered memoranda. These items require prior authorization. The provider must furnish all of the following information to the department to establish medical necessity:

     (a) A detailed description of the item(s) or service(s) to be provided;

     (b) The cost or charge for the item(s);

     (c) A copy of the manufacturer's invoice, price-list or catalog with the product description for the item(s) being provided; and

     (d) A detailed explanation of how the requested item(s) differs from an already existing code description.

     (7) The department does not pay for the purchase, rental, or repair of medical equipment that duplicates equipment the client already owns or rents. If the provider believes the purchase, rental, or repair of medical equipment is not duplicative, the provider must request prior authorization and submit the following to the department:

     (a) Why the existing equipment no longer meets the client's medical needs; or

     (b) Why the existing equipment could not be repaired or modified to meet the client's medical needs.

     (c) Upon request, documentation showing how the client's condition met the criteria for PA or EPA.

     (8) A provider may resubmit a request for prior authorization for an item or service that the department has denied. The department requires the provider to include new documentation that is relevant to the request.

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     (2) Certain covered items have limitations on quantity and frequency. These limits are designed to avoid the need for prior authorization for items normally considered medically necessary and for quantities sufficient for a thirty-day supply for one client.

     (3) The department requires a provider to request prior authorization for a limitation extension (LE) in order to exceed the stated limits for nondurable medical equipment and medical supplies. All requests for prior authorization must be accompanied by a completed General Information for Authorization form (DSHS 13-835) in addition to any program specific DSHS forms as required within this chapter. Department forms are available online at http://www.dshs.wa.gov/msa/forms/eforms.html.

     (4) The department evaluates such requests for LE under the provisions of WAC 388-501-0169.

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     (2) The department requires a provider to create an authorization number for EPA for selected DME procedure codes. The process and criteria used to create the authorization number is explained in the department published DME-related billing instructions. The authorization number must be used when the provider bills the department.

     (3) Upon request, a provider must provide documentation to the department showing how the client's condition met the criteria for EPA.

     (4) A written or telephone request for prior authorization is required when a situation does not meet the EPA criteria for selected DME procedure codes.

     (5) The department may recoup any payment made to a provider under this section if the provider did not follow the expedited authorization process and criteria.

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     (2) The department does not pay a DME provider for medical supplies used in conjunction with a physician office visit. The department pays the office physician for these supplies when appropriate. Refer to the department's physician-related services billing instructions.

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     (1) The department stops paying for any rented equipment on the last day of the month preceding the month in which the client becomes enrolled in the MCO.

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

     (3) A client may become an MCO enrollee before the department completes the purchase of prescribed medical equipment. The department considers the purchase complete when the product is delivered and the department is notified of the serial number. If the client becomes an MCO enrollee before the department completes the purchase:

     (a) The department rescinds the department's authorization with the vendor until the MCO's primary care provider (PCP) evaluates the client; then

     (b) The department requires the PCP to write a new prescription if the PCP determines the equipment is still medically necessary as defined in WAC 388-500-0005; then

     (c) The MCO's applicable reimbursement policies apply to the purchase or rental of the equipment.

     (4) A client may be disenrolled from an MCO and placed into fee-for-service before the MCO completes the purchase of prescribed medical equipment.

     (a) The department rescinds the MCO's authorization with the vendor until the client's primary care provider (PCP) evaluates the client; then

     (b) The department requires the PCP to write a new prescription if the PCP determines the equipment is still medically necessary as defined in WAC 388-500-0005; then

     (c) The department's applicable reimbursement policies apply to the purchase or rental of the equipment.

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     (1) The department requires a provider to accept medicare assignment before any medicaid reimbursement;

     (2) In accordance with WAC 388-502-0110(3):

     (a) If the service provided is covered by medicare and medicaid, the department pays only the deductible and/or coinsurance up to medicare's or medicaid's allowed amount, whichever is less.

     (b) If the service provided is covered by medicare but is not covered by the department, the department pays only the deductible and/or coinsurance up to medicare's allowed amount.

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     (a) To department-enrolled DME providers, pharmacies, and home health agencies under their national provider identifier (NPI) numbers, subject to the limitations of this chapter, and according to the procedures and codes in the department's current DME billing instructions; and

     (b) In accordance with the healthcare common procedure coding system (HCPCS) guidelines for product classification and code assignation.

     (2) The department sets, evaluates, and updates the maximum allowable fees for DME and related supplies, prosthetics, orthotics, medical supplies and related services at least once yearly using available published information, including but not limited to:

     (a) Commercial databases;

     (b) Manufacturers' catalogs;

     (c) Medicare fee schedules; and

     (d) Wholesale prices.

     (3) The department may adopt policies, procedure codes, and/or rates that are inconsistent with those set by medicare if the department determines that such actions are necessary.

     (4) The department updates the maximum allowable fees for DME and related supplies, prosthetics, orthotics, medical supplies and related services at least once per year, unless otherwise directed by the legislature or deemed necessary by the department.

     (5) The department's maximum payment for DME and related supplies, prosthetics, orthotics, medical supplies and related services is the lesser of either of the following:

     (a) Providers' usual and customary charges; or

     (b) Established rates, except as provided in WAC 388-543-8200.

     (6) The department is the payor of last resort for clients with medicare or third party insurance.

     (7) The department does not pay for medical equipment and/or services provided to a client who is enrolled in a department-contracted managed care plan, but who did not use one of the plan's participating providers.

     (8) The department's reimbursement rate for purchased or rented covered DME and related supplies, prosthetics, orthotics, medical supplies and related services includes all of the following:

     (a) Any adjustments or modifications to the equipment that are required within three months of the date of delivery or are covered under the manufacturer's warranty. This does not apply to adjustments required because of changes in the client's medical condition;

     (b) Any pick-up and/or delivery fees or associated costs (e.g., mileage, travel time, gas, etc.);

     (c) Telephone calls;

     (d) Shipping, handling, and/or postage;

     (e) Routine maintenance of DME that includes testing, cleaning, regulating, and assessing the client's equipment;

     (f) Fitting and/or set-up; and

     (g) Instruction to the client or client's caregiver in the appropriate use of the equipment, device, and/or supplies.

     (9) DME, supplies, repairs, and related services supplied to eligible clients under the following reimbursement methodologies are included in those methodologies and are not reimbursed under fee-for-service:

     (i) Hospice providers' per diem reimbursement;

     (ii) Hospitals' diagnosis-related group (DRG) reimbursement;

     (iii) Managed care plans' capitation rate;

     (iv) Skilled nursing facilities' per diem rate; and

     (v) Professional services' resource-based relative value system reimbursement (RBRVS) rate.

     (10) The provider must make warranty information, including date of purchase, applicable serial number, model number or other unique identifier of the equipment, and warranty period, available to the department upon request.

     (11) The dispensing provider who furnishes the equipment, supply or device to a client is responsible for any costs incurred to have a different provider repair the equipment when:

     (a) Any equipment that the department considers purchased requires repair during the applicable warranty period;

     (b) The provider refuses or is unable to fulfill the warranty; and

     (c) The equipment, supply or device continues to be medically necessary.

     (12) If the rental equipment, supply or device must be replaced during the warranty period, the department recoups fifty percent of the total amount previously paid toward rental and eventual purchase of the equipment, supply or device delivered to the client if:

     (a) The provider is unwilling or unable to fulfill the warranty; and

     (b) The equipment, supply or device continues to be medically necessary.

     (13) See WAC 388-543-9100, 388-543-9200, 388-543-9300, and 388-543-9400 for other reimbursement methodologies.

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     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.
NEW SECTION
WAC 388-543-9100   Reimbursement method--Other DME.   (1) The department sets, evaluates and updates the maximum allowable fees for purchased other durable medical equipment (DME) at least once yearly using one or more of the following:

     (a) The current medicare rate, as established by the federal centers for medicare and medicaid services (CMS), for a new purchase if a medicare rate is available;

     (b) A pricing cluster; or

     (c) On a by-report basis.

     (2) Establishing reimbursement rates for purchased other DME based on pricing clusters.

     (a) A pricing cluster is based on a specific healthcare common procedure coding system (HCPCS) code.

     (b) The department's pricing cluster is made up of all the brands/models for which the department obtains pricing information. However, the department may limit the number of brands/models included in the pricing cluster. The department considers all of the following when establishing the pricing cluster:

     (i) A client's medical needs;

     (ii) Product quality;

     (iii) Introduction, substitution or discontinuation of certain brands/models; and/or

     (iv) Cost.

     (c) When establishing the fee for other DME items in a pricing cluster, the maximum allowable fee is the median amount of available manufacturers' list prices for all brands/models as noted in subsection (2)(b) of this section.

     (3) The department evaluates a by report (BR) item, procedure, or service for medical necessity, appropriateness and reimbursement value on a case-by-case basis. The department calculates the reimbursement rate for these items at eighty-five percent of the manufacturer's list price.

     (4) Monthly rental reimbursement rates for other DME. The department's maximum allowable fee for monthly rental is established using one of the following:

     (a) For items with a monthly rental rate on the current medicare fee schedule as established by the federal centers for medicare and medicaid services (CMS), the department equates its maximum allowable fee for monthly rental to the current medicare monthly rental rate;

     (b) For items that have a new purchase rate but no monthly rental rate on the current medicare fee schedule as established by the federal centers for medicare and medicaid services (CMS), the department sets the maximum allowable fee for monthly rental at one-tenth of the new purchase price of the current medicare rate;

     (c) For items not included in the current medicare fee schedule as established by the federal centers for medicare and medicaid services (CMS), the department considers the maximum allowable monthly reimbursement rate as by-report. The department calculates the monthly reimbursement rate for these items at one-tenth of eighty-five percent of the manufacturer's list price.

     (5) Daily rental reimbursement rates for other DME. The department's maximum allowable fee for daily rental is established using one of the following:

     (a) For items with a daily rental rate on the current medicare fee schedule as established by the centers for medicare and medicaid services (CMS), the department equates its maximum allowable fee for daily rental to the current medicare daily rental rate;

     (b) For items that have a new purchase rate but no daily rental rate on the current medicare fee schedule as established by CMS, the department sets the maximum allowable fee for daily rental at one-three-hundredth of the new purchase price of the current medicare rate;

     (c) For items not included in the current medicare fee schedule as established by CMS, the department considers the maximum allowable daily reimbursement rate as by-report. The department calculates the daily reimbursement rate at one-three-hundredth of eighty-five percent of the manufacturer's list price.

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

     (a) An inpatient hospital client;

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

     (c) Terminally ill and receiving hospice care; or

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

     (7) The department rescinds any purchase order for a prescribed item if the equipment was not delivered to the client before the client:

     (a) Dies;

     (b) Loses medical eligibility;

     (c) Becomes covered by a hospice agency; or

     (d) Becomes covered by a managed care organization.

     (8) A provider may incur extra costs for customized equipment that may not be easily resold. In these cases, for purchase orders rescinded in subsection (7) of this section, the department may pay the provider an amount it considers appropriate to help defray these extra costs. The department requires the provider to submit justification sufficient to support such a claim.

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     (a) A client's medical needs;

     (b) Product quality;

     (c) Cost; and

     (d) Available alternatives.

     (2) The department sets, evaluates and updates the maximum allowable fees at least once yearly for wheelchair purchases, wheelchair rentals, and wheelchair accessories (e.g., cushions and backs) using the lesser of the following:

     (a) The current medicare fees;

     (b) The actual invoice for the specific item; or

     (c) A percentage of the manufacturer's list price. The department uses the following percentages:

     (i) For basic standard wheelchairs, sixty-five percent;

     (ii) For add-on accessories and parts, eighty-four percent;

     (iii) For up-charge modifications and cushions, eighty percent;

     (iv) For all other manual wheelchairs, eighty percent; and

     (v) For all other power-drive wheelchairs, eighty-five percent.

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     (a) For items with a rate on the current medicare fee schedule, as established by the federal centers for medicare and medicaid services (CMS), the department equates its maximum allowable fee to the current medicare rate; and

     (b) For those items not included in the medicare fee schedule, as established by CMS, the rate is considered by-report. The department evaluates a by-report item, procedure, or service based upon medical necessity criteria, appropriateness, and reimbursement value on a case-by-case basis. The department calculates the reimbursement for these items at eighty-five percent of the manufacturer's list price.

     (2) The department follows healthcare common procedure coding system (HCPCS) guidelines for product classification and code assignation.

     (3) The department's reimbursement for a prosthetic or orthotic includes the cost of any necessary molds, fitting, shipping, handling or any other administrative expenses related to provision of the prosthetic or orthotic to the client.

     (4) The department's hospital reimbursement rate includes any prosthetics and/or orthotics required for surgery and/or placed during the hospital stay.

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     (a) The current medicare rate, as established by the federal centers for medicare and medicaid services (CMS), if a medicare rate is available;

     (b) A pricing cluster;

     (c) Based on input from stakeholders or other relevant sources that the department determines to be reliable and appropriate; or

     (d) On a by-report basis.

     (2) Establishing reimbursement rates for medical supplies and non-DME items based on pricing clusters.

     (a) A pricing cluster is based on a specific healthcare common procedure coding system (HCPCS) code.

     (b) The department's pricing cluster is made up of all the brands for which the department obtains pricing information. However, the department may limit the number of brands included in the pricing cluster if doing so is in the best interests of its clients as determined by the department. The department considers all of the following when establishing the pricing cluster:

     (i) A client's medical needs;

     (ii) Product quality;

     (iii) Cost; and

     (iv) Available alternatives.

     (c) When establishing the fee for medical supplies or other nonDME items in a pricing cluster, the maximum allowable fee is the median amount of available manufacturers' list prices.

     (3) The department evaluates a by report (BR) item, procedure, or service for its medical necessity, appropriateness and reimbursement value on a case-by-case basis. The department calculates the reimbursement rate at eighty-five percent of the manufacturer's list price.

     (4) For clients residing in skilled nursing facilities, see WAC 388-543-5700.

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     The following sections of the Washington Administrative Code are repealed:

WAC 388-543-1150	Limits and limitation extensions.
WAC 388-543-1200	Providers who are eligible to provide services.
WAC 388-543-1225	Provider requirements.
WAC 388-543-1300	Equipment, related supplies, or other nonmedical supplies, and devices that are not covered.
WAC 388-543-1400	General reimbursement for DME and related services, prosthetics, orthotics, medical supplies and related services.
WAC 388-543-1500	When MAA purchases DME and related supplies, prosthetics, and orthotics.
WAC 388-543-1600	Items and services which require prior authorization.
WAC 388-543-1700	When the department covers rented DME.
WAC 388-543-1800	Prior authorization -- General policies for DME and related supplies, prosthetics, orthotics, medical supplies and related services.
WAC 388-543-1900	Expedited prior authorization criteria for DME and related supplies, prosthetics, orthotics, medical supplies, and related services.
WAC 388-543-2400	Hospital beds.
WAC 388-543-2500	Reimbursement methodology for other durable medical equipment.
WAC 388-543-2600	Prosthetics and orthotics.
WAC 388-543-2700	Prosthetics and orthotics -- Reimbursement.
WAC 388-543-2800	Reusable and disposable medical supplies.
WAC 388-543-2900	Medical supplies and nondurable medical equipment (MSE) -- Reimbursement methodology.

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