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

     Purpose: At the direction of the state legislature, the health care authority (HCA) is implementing a drug formulary in accordance with the provisions of Section 1927 of the Social Security Act. As part of the implementation, the agency is establishing a process through which medicaid prescribers may request authorization for their patient to receive a nonformulary medication. The proposed rules also include housekeeping changes (e.g., replacing "DSHS" and "the department" with "HCA" and "the agency").

     Citation of Existing Rules Affected by this Order: Amending WAC 182-501-0070, 182-501-0160, 182-502-0160, 182-530-1050, 182-530-2100, and 182-531-0100.

     Statutory Authority for Adoption: RCW 41.05.021.

     Other Authority: Section 1927 of the Social Security Act.

      Adopted under notice filed as WSR 12-13-075 on June 19, 2012.

     Changes Other than Editing from Proposed to Adopted Version: WAC 182-530-2200 How the medicaid agency develops and maintains the formulary.

     (5) At the DUR board's discretion, a drug removed from the formulary for a specified indication or subpopulation will remain covered for clients already stable on the medication at the time the drug is removed from the formulary.

     (7) (8) The agency covers nonformulary drugs for specific clients for the treatment of a specific disease or condition according to the nonformulary justification process defined in WAC 182-530-2300(4).

     (8) (9) If a dispensing pharmacist makes a professional judgment that the client's need for a nonformulary drug is an emergency, the pharmacist may dispense a nonformulary drug without approval through the nonformulary justification (NFJ) process defined in WAC 182-530-2300(4). The agency will reimburse for the dispensed medication if justification for the emergency is provided to the agency within seventy-two hours of the date of dispense, excluding weekends and Washington state holidays.

     WAC 182-530-2300 The medicaid agency's nonformulary justification process.

     (2) The agency may approves, on a case-by-case basis, an NFJ when the agency determines the drug is medically necessary as defined in WAC 182-500-0070. The agency assesses medical necessity for an NFJ based on the The process the agency uses to assess whether a nonformulary drug is medically necessary is based on evaluation of submitted client-specific information and documentation establishing:

     (a) Evidence showing the The client's clinical condition is different from the majority of individuals with the same or similar diagnosis whose treatment needs are met within the scope of covered services;

     (b) Evidence that medical Medical treatment, items of service, and all formulary drugs covered under the client's medical assistance program and which, under accepted standards of medical practice, are indicated as appropriate for the treatment of the illness or condition, have been found to be:

     (i) Medically ineffective in the treatment of the client's condition after an adequate trial at the maximum dose approved by the FDA; or

     (ii) Medically inappropriate for that specific client.

     (c) Evidence that the The requested nonformulary drug can be reasonably expected to successfully treat or improve the client's function and the condition the nonformulary drug is prescribed to treat when other treatments, items of service, and all formulary outpatient drugs covered under the client's medical assistance program have proven to be medically ineffective or inappropriate for the client.

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

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

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

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 2, Amended 6, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 2, Amended 6, Repealed 0.

     Date Adopted: August 31, 2012.

Kevin M. Sullivan

Rules Coordinator

OTS-4849.1

AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)

WAC 182-501-0070   Healthcare coverage -- Noncovered services.   (1) The ((department)) medicaid agency or its designee does not pay for any healthcare service not listed or referred to as a covered healthcare service under the medical programs described in WAC ((388-501-0060)) 182-501-0060, regardless of medical necessity. For the purposes of this section, healthcare services includes treatment, equipment, related supplies, and drugs. Circumstances in which clients are responsible for payment of healthcare services are described in WAC ((388-502-0160)) 182-502-0160.

     (2) This section does not apply to healthcare services provided as a result of the early and periodic screening, diagnosis, and treatment (EPSDT) program as described in chapter ((388-534)) 182-534 WAC.

     (3) The department does not pay for any ancillary healthcare service(s) provided in association with a noncovered healthcare service.

     (4) The following list of noncovered healthcare services is not intended to be exhaustive. Noncovered healthcare services include, but are not limited to:

     (a) Any healthcare service specifically excluded by federal or state law;

     (b) Acupuncture, Christian Science practice, faith healing, herbal therapy, homeopathy, massage, massage therapy, naturopathy, and sanipractice;

     (c) Chiropractic care for adults;

     (d) Cosmetic, reconstructive, or plastic surgery, and any related healthcare services, not specifically allowed under WAC ((388-531-0100)) 182-531-0100(4).

     (e) Discography;

     (f) Ear or other body piercing;

     (g) Face lifts or other facial cosmetic enhancements;

     (h) Fertility, infertility or sexual dysfunction testing, and related care, drugs, and/or treatment including but not limited to:

     (i) Artificial insemination;

     (ii) Donor ovum, sperm, or surrogate womb;

     (iii) In vitro fertilization;

     (iv) Penile implants;

     (v) Reversal of sterilization; and

     (vi) Sex therapy.

     (i) Gender reassignment surgery and any surgery related to trans-sexualism, gender identity disorders, and body dysmorphism, and related healthcare services or procedures, including construction of internal or external genitalia, breast augmentation, or mammoplasty;

     (j) Hair transplants, epilation (hair removal), and electrolysis;

     (k) Marital counseling;

     (l) Motion analysis, athletic training evaluation, work hardening condition, high altitude simulation test, and health and behavior assessment;

     (m) Nonmedical equipment;

     (n) Penile implants;

     (o) Prosthetic testicles;

     (p) Psychiatric sleep therapy;

     (q) Subcutaneous injection filling;

     (r) Tattoo removal;

     (s) Transport of Involuntary Treatment Act (ITA) clients to or from out-of-state treatment facilities, including those in bordering cities;

     (t) Upright magnetic resonance imaging (MRI); and

     (u) Vehicle purchase - New or used vehicle.

     (5) For a specific list of noncovered healthcare services in the following service categories, refer to the WAC citation:

     (a) Ambulance transportation and nonemergent transportation as described in chapter ((388-546)) 182-546 WAC;

     (b) Dental services for clients twenty years of age and younger as described in chapter ((388-535)) 182-535 WAC;

     (c) ((Dental services for clients twenty-one years of age and older as described in chapter 388-535 WAC;

     (d))) Durable medical equipment as described in chapter ((388-543)) 182-543 WAC;

     (((e))) (d) Hearing care services as described in chapter ((388-547)) 182-547 WAC;

     (((f))) (e) Home health services as described in WAC ((388-551-2130)) 182-551-2130;

     (((g))) (f) Hospital services as described in WAC ((388-550-1600)) 182-550-1600;

     (((h) Physician-related)) (g) Healthcare professional services as described in WAC ((388-531-0150)) 182-531-0150;

     (((i))) (h) Prescription drugs as described in chapter ((388-530)) 182-530 WAC; ((and

     (j))) (i) Vision care services as described in chapter ((388-544)) 182-544 WAC; and

     (j) Vision care exams as described in WAC 182-531-1000.

     (6) A client has a right to request an administrative hearing, if one is available under state and federal law. When the ((department)) agency or its designee denies all or part of a request for a noncovered healthcare service(s), the ((department)) agency or its designee sends the client and the provider written notice, within ten business days of the date the decision is made, that includes:

     (a) A statement of the action the ((department)) agency or its designee intends to take;

     (b) Reference to the specific WAC provision upon which the denial is based;

     (c) Sufficient detail to enable the recipient to:

     (i) Learn why the ((department's)) agency's or its designee's action was taken; and

     (ii) Prepare a response to the ((department's)) agency's or its designee's decision to classify the requested healthcare service as noncovered.

     (d) The specific factual basis for the intended action; and

     (e) The following information:

     (i) Administrative hearing rights;

     (ii) Instructions on how to request the hearing;

     (iii) ((Acknowledgement)) Acknowledgment that a client may be represented at the hearing by legal counsel or other representative;

     (iv) Instructions on how to request an exception to rule (ETR) or nonformulary justification (NFJ);

     (v) Information regarding ((department-covered)) agency-covered healthcare services, if any, as an alternative to the requested noncovered healthcare service; and

     (vi) Upon the client's request, the name and address of the nearest legal services office.

     (7) A client can request an exception to rule (ETR) as described in WAC ((388-501-0160)) 182-501-0160.

[11-14-075, recodified as § 182-501-0070, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 09-23-112, § 388-501-0070, filed 11/18/09, effective 12/19/09; 07-04-036, § 388-501-0070, filed 1/29/07, effective 3/1/07.]

     (1) The ((department)) agency or its designee cannot approve an exception to rule if the requested service is excluded under state statute.

     (2) The item or service(s) for which an exception is requested must be of a type and nature which falls within accepted standards and precepts of good medical practice;

     (3) All exception requests must represent cost-effective utilization of medical assistance program funds as determined by the ((department)) agency or its designee;

     (4) A request for an exception to rule must be submitted to the ((department)) agency or its designee in writing within ninety days of the date of the written notification denying authorization for the noncovered service. For the ((department)) agency or its designee to consider the exception to rule request:

     (a) The client and/or the client's healthcare provider must submit sufficient client-specific information and documentation to ((health and recovery services administration's)) the agency's medical director or designee which demonstrate the client's clinical condition is so different from the majority that there is no equally effective, less costly covered service or equipment that meets the client's need(s).

     (b) The client's healthcare professional must certify that medical treatment or items of service which are covered under the client's medical assistance program and which, under accepted standards of medical practice, are indicated as appropriate for the treatment of the illness or condition, have been found to be:

     (i) Medically ineffective in the treatment of the client's condition; or

     (ii) Inappropriate for that specific client.

     (5) Within fifteen business days of receiving the request, the ((department)) agency or its designee sends written notification to the provider and the client:

     (a) Approving the exception to rule request;

     (b) Denying the exception to rule request; or

     (c) Requesting additional information.

     (i) The additional information must be received by the ((department)) agency or its designee within thirty days of the date the information was requested.

     (ii) The ((department)) agency or its designee approves or denies the exception to rule request within five business days of receiving the additional information.

     (iii) If the requested information is insufficient or not provided within thirty days, the ((department)) agency or its designee denies the exception to rule request.

     (6) The ((HRSA)) agency's medical director or designee evaluates and considers requests on a case-by-case basis. The ((HRSA)) agency's medical director has final authority or approve or deny a request for exception to rule.

     (7) Clients do not have a right to a fair hearing on exception to rule decisions.

[11-14-075, recodified as § 182-501-0160, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 06-24-036, § 388-501-0160, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.08.090, 74.04.050, 74.09.035. 00-03-035, § 388-501-0160, filed 1/12/00, effective 2/12/00. Statutory Authority: RCW 74.08.090. 94-10-065 (Order 3732), § 388-501-0160, filed 5/3/94, effective 6/3/94. Formerly WAC 388-81-030.]

OTS-4231.2

AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)

WAC 182-502-0160   Billing a client.   (1) The purpose of this section is to specify the limited circumstances in which:

     (a) Fee-for-service or managed care clients can choose to self-pay for medical assistance services; and

     (b) Providers (as defined in WAC ((388-500-0005)) 182-500-0085) have the authority to bill fee-for-service or managed care clients for medical assistance services furnished to those clients.

     (2) The provider is responsible for:

     (a) Verifying whether the client is eligible to receive medical assistance services on the date the services are provided;

     (b) Verifying whether the client is enrolled with a ((department-contracted)) medicaid agency-contracted managed care organization (MCO);

     (c) Knowing the limitations of the services within the scope of the eligible client's medical program (see WAC ((388-501-0050 (4)(a) and 388-501-0065)) 182-501-0050 (4)(a) and 182-501-0065);

     (d) Informing the client of those limitations;

     (e) Exhausting all applicable ((department)) medicaid agency or ((department-contracted)) agency-contracted MCO processes necessary to obtain authorization for requested service(s);

     (f) Ensuring that translation or interpretation is provided to clients with limited English proficiency (LEP) who agree to be billed for services in accordance with this section; and

     (g) Retaining all documentation which demonstrates compliance with this section.

     (3) Unless otherwise specified in this section, providers must accept as payment in full the amount paid by the ((department)) agency or ((department-contracted)) agency-contracted MCO for medical assistance services furnished to clients. See 42 C.F.R. § 447.15.

     (4) A provider must not bill a client, or anyone on the client's behalf, for any services until the provider has completed all requirements of this section, including the conditions of payment described in ((department's)) the agency's rules, the ((department's)) agency's fee-for-service billing instructions, and the requirements for billing the ((department-contracted)) agency-contracted MCO in which the client is enrolled, and until the provider has then fully informed the client of his or her covered options. A provider must not bill a client for:

     (a) Any services for which the provider failed to satisfy the conditions of payment described in ((department's)) the agency's rules, the ((department's)) agency's fee-for-service billing instructions, and the requirements for billing the ((department-contracted)) agency-contracted MCO in which the client is enrolled.

     (b) A covered service even if the provider has not received payment from the ((department)) agency or the client's MCO.

     (c) A covered service when the ((department)) agency or its designee denies an authorization request for the service because the required information was not received from the provider or the prescriber under WAC ((388-501-0165)) 182-501-0165 (7)(c)(i).

     (5) If the requirements of this section are satisfied, then a provider may bill a fee-for-service or a managed care client for a covered service, defined in WAC ((388-501-0050(9))) 182-501-0050(9), or a noncovered service, defined in WAC ((388-501-0050(10) and 388-501-0070)) 182-501-0050(10) and 182-501-0070. The client and provider must sign and date the ((DSHS)) HCA form 13-879, Agreement to Pay for Healthcare Services, before the service is furnished. ((DSHS)) Form 13-879, including translated versions, is available to download at ((http://www1.dshs.wa.gov/msa/forms/eforms.html)) http://hrsa.dshs.wa.gov/mpforms.shtml. The requirements for this subsection are as follows:

     (a) The agreement must:

     (i) Indicate the anticipated date the service will be provided, which must be no later than ninety calendar days from the date of the signed agreement;

     (ii) List each of the services that will be furnished;

     (iii) List treatment alternatives that may have been covered by the ((department)) agency or ((department-contracted)) agency-contracted MCO;

     (iv) Specify the total amount the client must pay for the service;

     (v) Specify what items or services are included in this amount (such as pre-operative care and postoperative care). See WAC ((388-501-0070(3))) 182-501-0070(3) for payment of ancillary services for a noncovered service;

     (vi) Indicate that the client has been fully informed of all available medically appropriate treatment, including services that may be paid for by the ((department)) agency or ((department-contracted)) agency-contracted MCO, and that he or she chooses to get the specified service(s);

     (vii) Specify that the client may request an exception to rule (ETR) in accordance with WAC ((388-501-0160)) 182-501-0160 when the ((department)) agency or its designee denies a request for a noncovered service other than a nonformulary drug and that the client may choose not to do so;

     (viii) Specify that the client and their prescriber may request a nonformulary justification (NFJ) in accordance with WAC 182-530-2300 for a nonformulary drug and that the client may choose not to do so;

     (ix) Specify that the client may request an administrative hearing in accordance with chapter 182-526 WAC ((388-526-2610)) to appeal the ((department's)) agency's or its designee denial of a request for prior authorization of a covered service and that the client may choose not to do so;

     (((ix))) (x) Be completed only after the provider and the client have exhausted all applicable ((department)) agency or ((department-contracted)) agency-contracted MCO processes necessary to obtain authorization of the requested service, except that the client may choose not to request an ETR or an administrative hearing regarding ((department)) agency or agency designee denials of authorization for requested service(s); and

     (((x))) (xi) Specify which reason in subsection (b) below applies.

     (b) The provider must select on the agreement form one of the following reasons (as applicable) why the client is agreeing to be billed for the service(s). The service(s) is:

     (i) Not covered by the ((department)) agency or the client's ((department-contracted)) agency-contracted MCO and the ETR process as described in WAC ((388-501-0160)) 182-501-0160 or the NFJ process as described in WAC 182-530-2300 has been exhausted and the service(s) is denied;

     (ii) Not covered by the ((department)) agency or the client's ((department-contracted)) agency-contracted MCO and the client has been informed of his or her right to an ETR or NFJ and has chosen not to pursue an ETR as described in WAC ((388-501-0160)) 182-501-0160 or the NFJ process as described in WAC 182-530-2300;

     (iii) Covered by the ((department)) agency or the client's ((department-contracted)) agency-contracted MCO, requires authorization, and the provider completes all the necessary requirements; however the ((department)) agency or its designee denied the service as not medically necessary (this includes services denied as a limitation extension under WAC ((388-501-0169)) 182-501-0169); or

     (iv) Covered by the ((department)) agency or the client's ((department-contracted)) agency-contracted MCO and does not require authorization, but the client has requested a specific type of treatment, supply, or equipment based on personal preference which the ((department)) agency or MCO does not pay for and the specific type is not medically necessary for the client.

     (c) For clients with limited English proficiency, the agreement must be the version translated in the client's primary language and interpreted if necessary. If the agreement is translated, the interpreter must also sign it;

     (d) The provider must give the client a copy of the agreement and maintain the original and all documentation which supports compliance with this section in the client's file for six years from the date of service. The agreement must be made available to the ((department)) agency or its designee for review upon request; and

     (e) If the service is not provided within ninety calendar days of the signed agreement, a new agreement must be completed by the provider and signed by both the provider and the client.

     (6) There are limited circumstances in which a provider may bill a client without executing ((DSHS)) form 13-879, Agreement to Pay for Healthcare Services, as specified in subsection (5) of this section. The following are those circumstances:

     (a) The client, the client's legal guardian, or the client's legal representative:

     (i) Was reimbursed for the service directly by a third party (see WAC ((388-501-0200)) 182-501-0200); or

     (ii) Refused to complete and sign insurance forms, billing documents, or other forms necessary for the provider to bill the third party insurance carrier for the service.

     (b) The client represented himself/herself as a private pay client and not receiving medical assistance when the client was already eligible for and receiving benefits under a medical assistance program. In this circumstance, the provider must:

     (i) Keep documentation of the client's declaration of medical coverage. The client's declaration must be signed and dated by the client, the client's legal guardian, or the client's legal representative; and

     (ii) Give a copy of the document to the client and maintain the original for six years from the date of service, for ((department)) agency or the agency's designee review upon request.

     (c) The bill counts toward the financial obligation of the client or applicant (such as spenddown liability, client participation as described in WAC 388-513-1380, emergency medical expense requirement, deductible, or copayment required by the ((department)) agency or its designee). See subsection (7) of this section for billing a medically needy client for spenddown liability;

     (d) The client is under the ((department's)) agency's or ((a department-contracted)) an agency-contracted MCO's patient review and coordination (PRC) program (WAC ((388-501-0135)) 182-501-0135) and receives nonemergency services from providers or healthcare facilities other than those to whom the client is assigned or referred under the PRC program;

     (e) The client is a dual-eligible client with medicare Part D coverage or similar creditable prescription drug coverage and the conditions of WAC ((388-530-7700)) 182-530-7700 (2)(a)(iii) are met;

     (f) The services provided to a TAKE CHARGE or family planning only client are not within the scope of the client's benefit package;

     (g) The services were noncovered ambulance services (see WAC ((388-546-0250(2))) 182-546-0250(2));

     (h) A fee-for-service client chooses to receive nonemergency services from a provider who is not contracted with the ((department)) agency or its designee after being informed by the provider that he or she is not contracted with the ((department)) agency or its designee and that the services offered will not be paid by the client's healthcare program; and

     (i) ((A department-contracted)) An agency-contracted MCO enrollee chooses to receive nonemergency services from providers outside of the MCO's network without authorization from the MCO, i.e., a nonparticipating provider.

     (7) Under chapter ((388-519)) 182-519 WAC, an individual who has applied for medical assistance is required to spend down excess income on healthcare expenses to become eligible for coverage under the medically needy program. An individual must incur healthcare expenses greater than or equal to the amount that he or she must spend down. The provider is prohibited from billing the individual for any amount in excess of the spenddown liability assigned to the bill.

     (8) There are situations in which a provider must refund the full amount of a payment previously received from or on behalf of an individual and then bill the ((department)) agency for the covered service that had been furnished. In these situations, the individual becomes eligible for a covered service that had already been furnished. Providers must then accept as payment in full the amount paid by the ((department)) agency or its designee or managed care organization for medical assistance services furnished to clients. These situations are as follows:

     (a) The individual was not receiving medical assistance on the day the service was furnished. The individual applies for medical assistance later in the same month in which the service was provided and the ((department)) agency or its designee makes the individual eligible for medical assistance from the first day of that month;

     (b) The client receives a delayed certification for medical assistance as defined in WAC ((388-500-0005)) 182-500-0025; or

     (c) The client receives a certification for medical assistance for a retroactive period according to 42 C.F.R. § 435.914(a) and defined in WAC ((388-500-0005)) 182-500-0095.

     (9) Regardless of any written, signed agreement to pay, a provider may not bill, demand, collect, or accept payment or a deposit from a client, anyone on the client's behalf, or the ((department)) agency or its designee for:

     (a) Copying, printing, or otherwise transferring healthcare information, as the term healthcare information is defined in chapter 70.02 RCW, to another healthcare provider. This includes, but is not limited to:

     (i) Medical/dental charts;

     (ii) Radiological or imaging films; and

     (iii) Laboratory or other diagnostic test results.

     (b) Missed, ((cancelled)) canceled, or late appointments;

     (c) Shipping and/or postage charges;

     (d) "Boutique," "concierge," or enhanced service packages (e.g., newsletters, 24/7 access to provider, health seminars) as a condition for access to care; or

     (e) The price differential between an authorized service or item and an "upgraded" service or item (e.g., a wheelchair with more features; brand name versus generic drugs).

[11-14-075, recodified as § 182-502-0160, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090. 10-19-057, § 388-502-0160, filed 9/14/10, effective 10/15/10. Statutory Authority: RCW 74.08.090 and 42 C.F.R. 447.15. 10-10-022, § 388-502-0160, filed 4/26/10, effective 5/27/10. Statutory Authority: RCW 74.08.090, 74.09.055, 2001 c 7, Part II. 02-12-070, § 388-502-0160, filed 5/31/02, effective 7/1/02. Statutory Authority: RCW 74.08.090. 01-21-023, § 388-502-0160, filed 10/8/01, effective 11/8/01; 01-05-100, § 388-502-0160, filed 2/20/01, effective 3/23/01. Statutory Authority: RCW 74.08.090 and 74.09.520. 00-14-069, § 388-502-0160, filed 7/5/00, effective 8/5/00.]

OTS-4850.2

AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)

WAC 182-530-1050   Definitions.   In addition to the definitions and abbreviations found in chapter 182-500 WAC ((388-500-0005)), Medical definitions, the following definitions apply to this chapter.

     "Active ingredient" - The chemical component of a drug responsible for a drug's prescribed/intended therapeutic effect. The ((department)) medicaid agency or its designee limits coverage of active ingredients to those with an eleven-digit national drug code (NDC) and those specifically authorized by the ((department)) agency or its designee.

     "Actual acquisition cost (AAC)" - The net cost a provider paid for a drug, device, or drug-related supply marketed in the package size purchased. The AAC includes discounts, rebates, charge backs and other adjustments to the price of the drug, device or drug-related supply, but excludes dispensing fees.

     "Administer" - Includes the direct application of a prescription drug or device by injection, insertion, inhalation, ingestion, or any other means, to the body of a patient by a practitioner, or at the direction of the practitioner.

     "Appointing authority" - For the evidence-based prescription drug program of the participating agencies in the state-operated health care programs, the following persons acting jointly: The ((administrator)) director of the health care authority (HCA), the secretary of the department of social and health services (DSHS), and the director of the department of labor and industries (L&I).

     "Automated authorization" - Adjudication of claims using submitted NCPDP data elements or claims history to verify that the ((department's)) medicaid agency's or its designee's authorization requirements have been satisfied without the need for the ((department)) medicaid agency or its designee to request additional clinical information.

     "Automated maximum allowable cost (AMAC)" - The rate established by the ((department)) medicaid agency or its designee for a multiple-source drug that is not on the maximum allowable cost (MAC) list and that is designated by two or more products at least one of which must be under a federal drug rebate contract.

     "Average manufacturer price (AMP)" - The average price paid to a manufacturer by wholesalers for drugs distributed to retail pharmacies.

     "Average sales price (ASP)" - The weighted average of all nonfederal sales to wholesalers net of charge backs, discounts, rebates, and other benefits tied to the purchase of the drug product, whether it is paid to the wholesaler or the retailer.

     "Average wholesale price (AWP)" - The average price of a drug product that is calculated from wholesale list prices nationwide at a point in time and reported to the ((department)) medicaid agency or its designee by the ((department's)) agency's drug file contractor.

     "Combination drug" - A commercially available drug including two or more active ingredients.

     "Compendia of drug information" includes the following:

     (1) The American Hospital Formulary Service Drug Information;

     (2) The United States Pharmacopeia Drug Information; and

     (3) DRUGDEX Information System.

     "Compounding" - The act of combining two or more active ingredients or adjusting therapeutic strengths in the preparation of a prescription.

     "Deliver or delivery" - The transfer of a drug or device from one person to another.

     "Dispense as written (DAW)" - An instruction to the pharmacist forbidding substitution of a generic drug or a therapeutically equivalent product for the specific drug product prescribed.

     "Dispensing fee" - The fee the ((department)) medicaid agency or its designee sets to pay pharmacy providers for dispensing ((department-covered)) agency-covered prescriptions. The fee is the ((department's)) agency's maximum reimbursement for expenses involved in the practice of pharmacy and is in addition to the ((department's)) agency's reimbursement for the costs of covered ingredients.

     "Drug evaluation matrix" - The criteria-based scoring sheet used to objectively and consistently evaluate the food and drug administration (FDA) approved drugs to determine drug coverage status.

     "Drug file" - A list of drug products, pricing and other information provided to the ((department)) medicaid agency or its designee and maintained by a drug file contractor.

     "Drug file contractor" - An entity which has been contracted to provide regularly updated information on drugs, devices, and drug-related supplies at specified intervals, for the purpose of pharmaceutical claim adjudication. Information is provided specific to individual national drug codes, including product pricing.

     "Drug rebates" - Reimbursements provided by pharmaceutical manufacturers to state medicaid programs under the terms of the manufacturers' agreements with the Department of Health and Human Services (DHHS).

     "Drug-related supplies" - Nondrug items necessary for the administration, delivery, or monitoring of a drug or drug regimen.

     "Drug use review (DUR)" - A review of covered outpatient drug use that assures prescriptions are appropriate, medically necessary, and not likely to result in adverse medical outcomes.

     "Effectiveness" - The extent to which a given intervention is likely to produce beneficial results for which it is intended in ordinary circumstances.

     "Efficacy" - The extent to which a given intervention is likely to produce beneficial effects in the context of the research study.

     "Emergency kit" - A set of limited pharmaceuticals furnished to a nursing facility by the pharmacy that provides prescription dispensing services to that facility. Each kit is specifically set up to meet the emergency needs of each nursing facility's client population and is for use during those hours when pharmacy services are unavailable.

     "Endorsing practitioner" - A practitioner who has reviewed the Washington preferred drug list (PDL) and has enrolled with the health care authority (HCA), agreeing to allow therapeutic interchange (substitution) of a preferred drug for any nonpreferred drug in a given therapeutic class on the Washington PDL.

     "Estimated acquisition cost (EAC)" - The ((department's)) medicaid agency's estimate of the price providers generally and currently pay for a drug marketed or sold by a particular manufacturer or labeler.

     "Evidence-based" and "evidenced-based medicine (EBM)" - The application of a set of principles and a method for the review of well-designed studies and objective clinical data to determine the level of evidence that proves to the greatest extent possible, that a healthcare service is safe, effective and beneficial when making population-based coverage policies or individual medical necessity decisions.

     "Evidence-based practice center" - A research organization that has been designated by the Agency for Healthcare Research and Quality (AHRQ) of the U.S. government to conduct systematic reviews of all the evidence to produce evidence tables and technology assessments to guide health care decisions.

     "Federal upper limit (FUL)" - The maximum allowable reimbursement set by the Centers for Medicare and Medicaid Services (CMS) for a multiple-source drug.

     "Formulary" - All drugs covered under WAC 182-530-2000 and not removed from the formulary by the DUR board (see WAC 182-530-2200).

     "Formulary drug" - A drug covered under WAC 182-530-2000 and not removed from the formulary by the DUR board with respect to the treatment of a specific disease or condition for an identified population (see WAC 182-530-2200).

     "Four brand name prescriptions per calendar month limit" - The maximum number of paid prescription claims for brand name drugs that the ((department)) medicaid agency or its designee allows for each client in a calendar month without a complete review of the client's drug profile.

     "Generic drug" - A nonproprietary drug that is required to meet the same bioequivalency tests as the original brand name drug.

     "Inactive ingredient" - A drug component that remains chemically unchanged during compounding but serves as the:

     (1) Necessary vehicle for the delivery of the therapeutic effect; or

     (2) Agent for the intended method or rate of absorption for the drug's active therapeutic agent.

     "Ingredient cost" - The portion of a prescription's cost attributable to the covered drug ingredients or chemical components.

     "Innovator multiple source drug" - As set forth in Section 1927 (k)(7)(A)(ii) of the Social Security Act, includes all covered outpatient drugs approved under a new drug application (NDA), product license approval (PLA), establishment license approval (ELA), or antibiotic drug approval (ADA). A covered outpatient drug marketed by a cross-licensed producer or distributor under the approved new drug application will be included as an innovator multiple source drug when the drug product meets this definition.

     "Less than effective drug" or "DESI" - A drug for which:

     (1) Effective approval of the drug application has been withdrawn by the Food and Drug Administration (FDA) for safety or efficacy reasons as a result of the drug efficacy study implementation (DESI) review; or

     (2) The secretary of the Department of Health and Human Services (DHHS) has issued a notice of an opportunity for a hearing under section 505(e) of the federal Food, Drug, and Cosmetic Act on a proposed order of the secretary to withdraw approval of an application for such drug under such section because the secretary has determined the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling.

     "Long-term therapy" - A drug regimen a client receives or will receive continuously through and beyond ninety days.

     "Maximum allowable cost (MAC)" - The maximum amount that the ((department)) medicaid agency or its designee reimburses for a drug, device, or drug-related supply.

     "Medically accepted indication" - Any use for a covered outpatient drug:

     (1) Which is approved under the federal Food, Drug, and Cosmetic Act; or

     (2) The use of which is supported by one or more citations included or approved for inclusion in any of the compendia of drug information, as defined in this chapter.

     "Modified unit dose delivery system" (also known as blister packs or "bingo/punch cards") - A method in which each patient's medication is delivered to a nursing facility:

     (1) In individually sealed, single dose packages or "blisters"; and

     (2) In quantities for one month's supply, unless the prescriber specifies a shorter period of therapy.

     "Multiple-source drug" - A drug marketed or sold by:

     (1) Two or more manufacturers or labelers; or

     (2) The same manufacturer or labeler:

     (a) Under two or more different proprietary names; or

     (b) Under a proprietary name and a generic name.

     "National drug code (NDC)" - The eleven-digit number the FDA and manufacturer or labeler assigns to a pharmaceutical product and attaches to the product container at the time of packaging. The NDC is composed of digits in 5-4-2 groupings. The first five digits comprise the labeler code assigned to the manufacturer by the Food and Drug Administration (FDA). The second grouping of four digits is assigned by the manufacturer to describe the ingredients, dose form, and strength. The last grouping of two digits describes the package size.

     "Noncontract drugs" - Are drugs manufactured or distributed by manufacturers/labelers who have not signed a drug rebate agreement with the federal Department of Health and Human Services.

     "Nonformulary drug" - A drug:

     (a) Removed from the formulary by the DUR board with respect to treatment of a specific disease or condition for an identified population (see WAC 182-530-2200);

     (b) Prescribed for the treatment of the specific disease or condition identified in (a) of this definition nonformulary drug;

     (c) Prescribed for a client in the identified population in (a) of this definition nonformulary drug; and

     (d) Included on the agency's nonformulary list with a written explanation of the basis for the drug's removal from the formulary.

     "Nonformulary justification" or "NFJ" - See WAC 182-530-2300.

     "Nonformulary list" - The agency's list of nonformulary drugs and the reasons for removal from the formulary by the DUR board.

     "Nonpreferred drug" - A drug that has not been selected as a preferred drug within the therapeutic class(es) of drugs on the preferred drug list.

     "Obsolete NDC" - A national drug code replaced or discontinued by the manufacturer or labeler.

     "Over-the-counter (OTC) drugs" - Drugs that do not require a prescription before they can be sold or dispensed.

     "Peer reviewed medical literature" - A research study, report, or findings regarding the specific use of a drug that has been submitted to one or more professional journals, reviewed by experts with appropriate credentials, and subsequently published by a reputable professional journal. A clinical drug study used as the basis for the publication must be a double blind, randomized, placebo or active control study.

     "Pharmacist" - A person licensed in the practice of pharmacy by the state in which the prescription is filled.

     "Pharmacy" - Every location licensed by the state board of pharmacy in the state where the practice of pharmacy is conducted.

     "Pharmacy and therapeutic (P&T) committee" - The independent Washington state committee created by RCW 41.05.021 (1)(a)(iii) and 70.14.050. At the election of the ((department)) medicaid agency or its designee, the committee may serve as the drug use review board provided for in WAC ((388-530-4000)) 182-530-4000.

     "Point-of-sale (POS)" - A pharmacy claims processing system capable of receiving and adjudicating claims on-line.

     "Practice of pharmacy" - The practice of and responsibility for:

     (1) Accurately interpreting prescription orders;

     (2) Compounding drugs;

     (3) Dispensing, labeling, administering, and distributing of drugs and devices;

     (4) Providing drug information to the client that includes, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices;

     (5) Monitoring of drug therapy and use;

     (6) Proper and safe storage of drugs and devices;

     (7) Documenting and maintaining records;

     (8) Initiating or modifying drug therapy in accordance with written guidelines or protocols previously established and approved for a pharmacist's practice by a practitioner authorized to prescribe drugs; and

     (9) Participating in drug use reviews and drug product selection.

     "Practitioner" - An individual who has met the professional and legal requirements necessary to provide a health care service, such as a physician, nurse, dentist, physical therapist, pharmacist or other person authorized by state law as a practitioner.

     "Preferred drug" - Drug(s) of choice within a selected therapeutic class that are selected based on clinical evidence of safety, efficacy, and effectiveness.

     "Preferred drug list (PDL)" - The ((department's)) medicaid agency's list of drugs of choice within selected therapeutic drug classes.

     "Prescriber" - A physician, osteopathic physician/surgeon, dentist, nurse, physician assistant, optometrist, pharmacist, or other person authorized by law or rule to prescribe drugs. See WAC 246-863-100 for pharmacists' prescriptive authority.

     "Prescription" - An order for drugs or devices issued by a practitioner authorized by state law or rule to prescribe drugs or devices, in the course of the practitioner's professional practice, for a legitimate medical purpose.

     "Prescription drugs" - Drugs required by any applicable federal or state law or regulation to be dispensed by prescription only or that are restricted to use by practitioners only.

     "Prospective drug use review (Pro-DUR)" - A process in which a request for a drug product for a particular client is screened, before the product is dispensed, for potential drug therapy problems.

     "Reconstitution" - The process of returning a single active ingredient, previously altered for preservation and storage, to its approximate original state. Reconstitution is not compounding.

     "Retrospective drug use review (Retro-DUR)" - The process in which drug utilization is reviewed on an ongoing periodic basis to identify patterns of fraud, abuse, gross overuse, or inappropriate or not medically necessary care.

     "Risk/benefit ratio" - The result of assessing the side effects of a drug or drug regimen compared to the positive therapeutic outcome of therapy.

     "Single source drug" - A drug produced or distributed under an original new drug application approved by the Food and Drug Administration (FDA).

     "Substitute" - To replace a prescribed drug, with the prescriber's authorization, with:

     (1) An equivalent generic drug product of the identical base or salt as the specific drug product prescribed; or

     (2) A therapeutically equivalent drug other than the identical base or salt.

     "Systematic review" - A specific and reproducible method to identify, select, and appraise all the studies that meet minimum quality standards and are relevant to a particular question. The results of the studies are then analyzed and summarized into evidence tables to be used to guide evidence-based decisions.

     "Terminated NDC" - An eleven-digit national drug code (NDC) that is discontinued by the manufacturer for any reason. The NDC may be terminated immediately due to health or safety issues or it may be phased out based on the product's shelf life.

     "Therapeutic alternative" - A drug product that contains a different chemical structure than the drug prescribed, but is in the same pharmacologic or therapeutic class and can be expected to have a similar therapeutic effect and adverse reaction profile when administered to patients in a therapeutically equivalent dosage.

     "Therapeutic class" - A group of drugs used for the treatment, remediation, or cure of a specific disorder or disease.

     "Therapeutic interchange" - To dispense a therapeutic alternative to the prescribed drug when an endorsing practitioner who has indicated that substitution is permitted, prescribes the drug. See therapeutic interchange program (TIP).

     "Therapeutic interchange program (TIP)" - The process developed by participating state agencies under RCW 69.41.190 and 70.14.050, to allow prescribers to endorse a Washington preferred drug list, and in most cases, requires pharmacists to automatically substitute a preferred, equivalent drug from the list.

     "Therapeutically equivalent" - Drug products that contain different chemical structures but have the same efficacy and safety when administered to an individual, as determined by:

     (1) Information from the Food and Drug Administration (FDA);

     (2) Published and peer-reviewed scientific data;

     (3) Randomized controlled clinical trials; or

     (4) Other scientific evidence.

     "Tiered dispensing fee system" - A system of paying pharmacies different dispensing fee rates, based on the individual pharmacy's total annual prescription volume and/or the drug delivery system used.

     "True unit dose delivery" - A method in which each patient's medication is delivered to the nursing facility in quantities sufficient only for the day's required dosage.

     "Unit dose drug delivery" - True unit dose or modified unit dose delivery systems.

     "Usual and customary charge" - The fee that the provider typically charges the general public for the product or service.

     "Washington preferred drug list (Washington PDL)" - The list of drugs selected by the appointing authority to be used by applicable state agencies as the basis for purchase of drugs in state-operated health care programs.

     "Wholesale acquisition cost" - The price paid by a wholesaler for drugs purchased from a manufacturer.

[11-14-075, recodified as § 182-530-1050, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.700, 2008 c 245. 08-21-107, § 388-530-1050, filed 10/16/08, effective 11/16/08. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-1050, filed 9/26/07, effective 11/1/07. Statutory Authority: RCW 74.08.090, 70.14.050, 69.41.150, 69.41.190, chapter 41.05 RCW. 05-02-044, § 388-530-1050, filed 12/30/04, effective 1/30/05. Statutory Authority: RCW 74.09.080, 74.04.050 and 42 C.F.R. Subpart K, subsection 162.1102. 02-17-023, § 388-530-1050, filed 8/9/02, effective 9/9/02. Statutory Authority: RCW 74.08.090, 74.04.050. 01-24-066, § 388-530-1050, filed 11/30/01, effective 1/2/02; 01-01-028, § 388-530-1050, filed 12/7/00, effective 1/7/01. Statutory Authority: RCW 74.08.090. 96-21-031, § 388-530-1050, filed 10/9/96, effective 11/9/96.]

     (a) A drug that is:

     (i) Not approved by the Food and Drug Administration (FDA); or

     (ii) Prescribed for a nonmedically accepted indication, including diagnosis, dose, or dosage schedule that is not evidenced-based.

     (b) A drug prescribed:

     (i) For weight loss or gain;

     (ii) For infertility, frigidity, impotency;

     (iii) For sexual or erectile dysfunction;

     (iv) For cosmetic purposes or hair growth; or

     (v) For treatment of cough or cold symptoms, except as listed in WAC ((388-530-2000)) 182-530-2000 (1)(i).

     (c) Drugs used to treat sexual or erectile dysfunction, in accordance with section 1927 (d)(2)(K) of the Social Security Act, unless such drugs are used to treat a condition other than sexual or erectile dysfunction, and these uses have been approved by the Food and Drug Administration.

     (d) Drugs listed in the federal register as "less-than-effective" ("DESI" drugs) or which are identical, similar, or related to such drugs.

     (e) Outpatient drugs for which the manufacturer requires as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or manufacturer's designee.

     (f) A product:

     (i) With an obsolete national drug code (NDC) for more than two years;

     (ii) With a terminated NDC;

     (iii) Whose shelf life has expired; or

     (iv) Which does not have an eleven-digit NDC.

     (g) Over-the-counter (OTC) drugs, vitamins, and minerals, except as allowed under WAC ((388-530-2000)) 182-530-2000 (1)(i).

     (h) Any drug regularly supplied by other public agencies as an integral part of program activity (e.g., immunization vaccines for children).

     (i) Free pharmaceutical samples.

     (j) Over-the-counter or prescription drugs to promote smoking cessation unless the client is eighteen years old or older and participating in a ((department-approved)) medicaid agency-approved cessation program.

     (k) A nonformulary drug except as allowed by WAC 182-530-2300(4).

     (2) A noncovered drug can be requested:

     (a) As described in WAC 182-530-2300 for a nonformulary drug; or

     (b) As described in WAC 182-501-0160 for all other noncovered drugs.

     (3) If a noncovered drug is prescribed through the early and periodic screening, diagnosis, and treatment (EPSDT) process, an authorization request may be submitted indicating that the request is EPSDT related, and the request will be evaluated according to the process in WAC ((388-501-0165)) 182-501-0165. (See WAC ((388-534-0100)) 182-534-0100 for EPSDT rules).

     (((3) A client can request an exception to rule (ETR) as described in WAC 388-501-0160.))

[11-14-075, recodified as § 182-530-2100, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, SSA § 1927 (42 U.S.C. 1396r-8(d)(2)(D)), and 2009 c 564 § 1109. 09-22-005, § 388-530-2100, filed 10/22/09, effective 11/22/09. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 09-05-007, § 388-530-2100, filed 2/5/09, effective 3/8/09. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.700, 2008 c 245. 08-21-107, § 388-530-2100, filed 10/16/08, effective 11/16/08. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-2100, filed 9/26/07, effective 11/1/07.]

     (1) The formulary includes all drugs covered under WAC 182-530-2000 and not removed from the formulary by the DUR board according to the process described in subsection (2) of this section.

     (2) The agency periodically presents drugs labeled by the food and drug administration (FDA) for treatment of a specific disease or condition for an identified population, or which have a medically accepted indication for the treatment of the specific disease or condition to the DUR board for review. The following categories of drugs cannot be presented by the agency to the DUR board for review:

     (a) Antiretroviral drugs used to treat HIV/AIDS;

     (b) Anticancer medication used to kill or slow the growth of cancerous cells;

     (c) Antihemophilic drugs;

     (d) Insulin or other drugs to lower blood glucose;

     (e) Immunosuppressive drugs;

     (f) Drugs in therapeutic classes included in the Washington preferred drug list.

     (3) If a drug is found by the DUR board to have no significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome for treatment of a specific disease or condition for an identified population over other drugs on the formulary, the drug may be removed from the formulary for treatment of the specific disease or condition for the identified population, provided that the DUR board's written explanation of the basis for removal is made available to the public.

     (4) At the DUR board's discretion, nonformulary drugs may be added back to the formulary.

     (5) At the DUR board's discretion, a drug removed from the formulary for a specified indication or subpopulation will remain covered for clients already stable on the medication at the time the drug is removed from the formulary.

     (6) The agency maintains a nonformulary list on a publicly accessible internet site detailing the:

     (a) Nonformulary drugs;

     (b) Specific disease or condition for an identified population for which the drug is nonformulary; and

     (c) DUR board's written explanation of the basis for the drug's removal from the formulary.

     (7) Formulary drugs may be subject to authorization requirements and other restrictions detailed in this chapter.

     (8) The agency covers nonformulary drugs for specific clients for the treatment of a specific disease or condition according to the nonformulary justification process defined in WAC 182-530-2300.

     (9) If a dispensing pharmacist makes a professional judgment that the client's need for a nonformulary drug is an emergency, the pharmacist may dispense a nonformulary drug without approval through the nonformulary justification (NFJ) process defined in WAC 182-530-2300. The agency will reimburse for the dispensed medication if justification for the emergency is provided to the agency within seventy-two hours of the date of dispense, excluding weekends and Washington state holidays.

     (10) The nonformulary status of a drug does not constitute a denial of service.

[]

     (1) The medicaid agency only reviews a request for a noncovered service as an NFJ when:

     (a) The NFJ is submitted by the prescriber on the form provided by the agency;

     (b) The drug is a nonformulary drug; and

     (c) The NFJ conforms with the agency's minimum requirements in current published billing instructions, numbered memoranda, provider notices, and any additional requirements in the Washington Administrative Code (WAC) and/or Revised Code of Washington (RCW).

     (2) The agency approves, on a case-by-case basis, an NFJ when the agency determines the drug is medically necessary as defined in WAC 182-500-0070. The process the agency uses to assess whether a nonformulary drug is medically necessary is based on evaluation of submitted client-specific information and documentation establishing:

     (a) The client's clinical condition is different from the majority of individuals with the same or similar diagnosis whose treatment needs are met within the scope of covered services;

     (b) Medical treatment, items of service, and all formulary drugs covered under the client's medical assistance program and which, under accepted standards of medical practice, are indicated as appropriate for the treatment of the illness or condition, have been found to be:

     (i) Medically ineffective in the treatment of the client's condition after an adequate trial at the maximum dose approved by the FDA; or

     (ii) Medically inappropriate for that specific client.

     (c) The requested nonformulary drug can be reasonably expected to successfully treat or improve the client's function and the condition the nonformulary drug is prescribed to treat when other treatments, items of service, and all formulary outpatient drugs covered under the client's medical assistance program have proven to be medically ineffective or inappropriate for the client.

     (3)(a) When the agency receives a request for an NFJ, the agency acknowledges receipt within:

     (i) Twenty-four hours if the NFJ is received during normal state business hours; or

     (ii) Twenty-four hours of opening for business on the next business day if the NFJ is received outside normal state business hours.

     (b) Within five business days the agency:

     (i) Approves the NFJ if the requested nonformulary drug is medically necessary according to subsection (2) of this section; or

     (ii) Denies the NFJ if the requested nonformulary drug is not medically necessary according to subsection (2) of this section; and

     (iii) Sends written notification to the client and a facsimile to the client's prescriber of the agency's determination.

     (c) The agency's pharmacists or medical consultants have final authority of approval or denial of the NFJ.

     (4) Nonformulary drugs which meet all other conditions of coverage with the exception of their nonformulary status are covered services for the specific client for the treatment of a specific disease or condition when approved under subsection (3) of this section.

     (5) A client has the right to request an administrative hearing on NFJ denials.

     (6) Drugs determined to be noncovered according to WAC 182-530-2100 (1)(a) through (j) will be reviewed according to the exception to rule (ETR) process in WAC 182-501-0160.

[]

OTS-4851.1

AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)

WAC 182-531-0100   Scope of coverage for physician-related and healthcare professional services -- General and administrative.   (1) The ((department)) medicaid agency covers healthcare services, equipment, and supplies listed in this chapter, according to ((department)) agency rules and subject to the limitations and requirements in this chapter, when they are:

     (a) Within the scope of an eligible client's medical assistance program. Refer to WAC ((388-501-0060)) 182-501-0060 and ((388-501-0065)) 182-501-0065; and

     (b) Medically necessary as defined in WAC ((388-500-0005)) 182-500-0070.

     (2) The ((department)) agency evaluates a request for a service that is in a covered category under the provisions of WAC ((388-501-0165)) 182-501-0065.

     (3) The ((department)) agency evaluates requests for covered services that are subject to limitations or other restrictions and approves such services beyond those limitations or restrictions as described in WAC ((388-501-0169)) 182-501-0169.

     (4) The ((department)) agency covers the following physician-related services and healthcare professional services, subject to the conditions in subsections (1), (2), and (3) of this section:

     (a) Allergen immunotherapy services;

     (b) Anesthesia services;

     (c) Dialysis and end stage renal disease services (refer to chapter ((388-540)) 182-540 WAC);

     (d) Emergency physician services;

     (e) ENT (ear, nose, and throat) related services;

     (f) Early and periodic screening, diagnosis, and treatment (EPSDT) services (refer to WAC ((388-534-0100)) 182-534-0100);

     (g) Reproductive health services (refer to chapter ((388-532)) 182-532 WAC);

     (h) Hospital inpatient services (refer to chapter ((388-550)) 182-550 WAC);

     (i) Maternity care, delivery, and newborn care services (refer to chapter ((388-533)) 182-533 WAC);

     (j) Office visits;

     (k) Vision-related services (refer to chapter ((388-544)) 182-544 WAC for vision hardware for clients twenty years of age and younger);

     (l) Osteopathic treatment services;

     (m) Pathology and laboratory services;

     (n) Physiatry and other rehabilitation services (refer to chapter ((388-550)) 182-550 WAC);

     (o) Foot care and podiatry services (refer to WAC ((388-531-1300)) 182-531-1300);

     (p) Primary care services;

     (q) Psychiatric services, provided by a psychiatrist;

     (r) Psychotherapy services for children as provided in WAC ((388-531-1400)) 182-531-1400;

     (s) Pulmonary and respiratory services;

     (t) Radiology services;

     (u) Surgical services;

     (v) Cosmetic, reconstructive, or plastic surgery, and related services and supplies to correct physiological defects from birth, illness, or physical trauma, or for mastectomy reconstruction for post cancer treatment;

     (w) Oral healthcare services for emergency conditions for clients twenty-one years of age and older, except for clients of the division of developmental disabilities (refer to WAC ((388-531-1025)) 182-531-1025); and

     (x) Other outpatient physician services.

     (5) The ((department)) agency covers physical examinations for medical assistance clients only when the physical examination is one or more of the following:

     (a) A screening exam covered by the EPSDT program (see WAC ((388-534-0100)) 182-534-0100);

     (b) An annual exam for clients of the division of developmental disabilities; or

     (c) A screening pap smear, mammogram, or prostate exam.

     (6) By providing covered services to a client eligible for a medical assistance program, a provider who has signed an agreement with the ((department)) agency accepts the ((department's)) agency's rules and fees as outlined in the agreement, which includes federal and state law and regulations, billing instructions, and ((department)) agency issuances.

     (7) Outpatient drugs are not subject to the rules in this chapter. For rules about outpatient drugs see chapter 182-530 WAC.

[11-14-075, recodified as § 182-531-0100, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090. 11-14-055, § 388-531-0100, filed 6/29/11, effective 7/30/11. Statutory Authority: RCW 74.09.521. 08-12-030, § 388-531-0100, filed 5/29/08, effective 7/1/08. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 06-24-036, § 388-531-0100, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0100, filed 12/6/00, effective 1/6/01.]