wa-26-21-076: Insurance Commissioner, Office of the — WSR 26-21-076

WSR 26-21-076 (26-21)WSR 26-21-076PROPOSED RULESOFFICE OF THEINSURANCE COMMISSIONER[Insurance Commissioner Matter R 2025-13—Filed October 20, 2026, 1:41 p.m.]Original Notice.Preproposal statement of inquiry was filed as WSR 25-17-075.Title of Rule and Other Identifying Information: Implementation of E2SHB 1432 (2025) Improving access to appropriate mental health and substance use disorder services.Hearing Location(s): On Tuesday, December 1, 2026, at 11:00 a.m., via virtual hearing. Information can be found on the office of the insurance commissioner (OIC) website at https://www.insurance.wa.gov/laws-rules/legislation-and-rulemaking/rulemaking/mental-health-parity-rulemaking-r-2025-13. Written comments are due to OIC by 11:59 p.m. on December 2, 2026. Comments can be emailed to rulescoordinator@oic.wa.gov.Date of Intended Adoption: December 9, 2026.Submit Written Comments to: Rules Coordinator, P.O. Box 40260, Olympia, WA 98504-0260, email RulesCoordinator@oic.wa.gov, fax 360-586-3109, beginning 8:00 a.m. PT on October 22, 2026, by December 2, 2026, at 11:59 p.m. PT.Assistance for Persons with Disabilities: Contact rules coordinator, phone 360-725-7171, fax 360-586-3109, TTY 360-586-0241, email rulescoordinator@oic.wa.gov, by November 30, 2026, at 5:00 p.m. PT.Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: OIC is proposing rule making due to the recent passage of E2SHB 1432 and other changes in law. Multiple provisions of health care and insurance regulations in WAC may need to be updated by OIC to be consistent with the legislation passed and codified in RCW. This rule making creates new sections in chapter 284-43 WAC and updates include, but are not limited to, the following authorities: Chapter 284-43 WAC, Subchapter K; and WAC 284-43-0160, 284-43-2020, 284-43-2021, 284-43A-080, 284-170-130, and 284-170-200. Reasons Supporting Proposal: With the enactment of E2SHB 1432 (2025), it's necessary to create new WAC sections and update existing WAC chapters to follow the new law. These rules will facilitate implementation of the new law and ensure affected entities understand their rights and obligations.Statutory Authority for Adoption: RCW 48.02.060; section 9, chapter 227, Laws of 2025; and RCW 48.43.766, 48.43.016, 48.43.410, 48.43.520, 48.43.535, 48.43.600, and 48.43.830 (to effectuate chapter 227, Laws of 2025). Statute Being Implemented: Chapter 227, Laws of 2025.Rule is not necessitated by federal law, federal or state court decision.Name of Proponent: OIC, governmental.Name of Agency Personnel Responsible for Drafting: Delika Steele, P.O. Box 40255, Olympia, WA 98504-0255, 360-725-7000; Implementation: Todd Lovshin, 5000 Capitol Boulevard S.E., Tumwater, WA 98501, 360-725-7000; and Enforcement: Sofia Pasarow, 5000 Capitol Boulevard S.E., Tumwater, WA 98501, 360-725-7000.A school district fiscal impact statement is not required under RCW 28A.305.135.A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Rules Coordinator, P.O. Box 40260, Olympia, WA 98504, phone 360-725-7171, email rulescoordinator@oic.wa.gov.This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal: Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule; rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect; and rule content is explicitly and specifically dictated by statute.Is exempt under RCW 19.85.025(4).Explanation of exemptions: The proposed rule language either adopts or incorporates by reference without material change from the state statutes, is explicitly dictated by statute, or adds clarifying language without changing the underlying effect of the regulation.The industry directly impacted by this rule making is health insurers (direct health and medical insurance carriers, North American Industry Classification System code: 524114); specifically, those who offer mental health coverage. Based on preliminary 2025 employment security department covered employment data, health insurance carriers have an average of 85 employees per firm (7,236 average annual employment/85 average firms). Therefore, OIC determined that this rule is exempt from small business economic impact statement requirements.Scope of exemption for rule proposal:Is fully exempt.October 20, 2026Patty KudererInsurance CommissionerRDS-7506.3AMENDATORY SECTION(Amending WSR 26-05-001, filed 2/4/26, effective 3/7/26)WAC 284-43-0160Definitions.Except as defined in other subchapters and unless the context requires otherwise, the following definitions shall apply throughout this chapter.(1) "Adverse determination" has the same meaning as the definition of adverse benefit determination in RCW 48.43.005, and includes:(a) The determination includes any decision by a health carrier's designee utilization review organization that a request for a benefit under the health carrier's health benefit plan does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness or is determined to be experimental or investigational and the requested benefit is therefore denied, reduced, or terminated or payment is not provided or made, in whole or in part for the benefit;(b) The denial, reduction, termination, or failure to provide or make payment, in whole or in part, for a benefit based on a determination by a health carrier or its designee utilization review organization of a covered person's eligibility to participate in the health carrier's health benefit plan;(c) Any prospective review or retrospective review determination that denies, reduces, or terminates or fails to provide or make payment in whole or in part for a benefit;(d) A rescission of coverage determination; or(e) A carrier's denial of an application for coverage.(2) "Authorization" or "certification" means a determination by the carrier that an admission, extension of stay, or other health care service has been reviewed and, based on the information provided, meets the clinical requirements for medical necessity, appropriateness, level of care, or effectiveness in relation to the applicable health plan.(3) "Behavioral health agency" means an agency licensed or certified under RCW 71.24.037.(4) "Clinical review criteria" except as provided in RCW 48.43.766, means the written screens or screening procedures, decision rules, medical protocols, or clinical practice guidelines used by the carrier as an element in the evaluation of medical necessity and appropriateness of requested admissions, procedures, and services, including prescription drug benefits, under the auspices of the applicable plan. Clinical approval criteria has the same meaning as clinical review criteria.(5) "Core treatment" has the same meaning as set forth in RCW 48.43.766.(6) "Covered health condition" means any disease, illness, injury or condition of health risk covered according to the terms of any health plan.(((6)))(7) "Covered person" or "enrollee" means an individual covered by a health plan including a subscriber, policyholder, or beneficiary of a group plan.(((7)))(8) "Emergency fill" means a limited dispensed amount of medication that allows time for the processing of a preauthorization request. Emergency fill only applies to those circumstances where a patient presents at a contracted pharmacy with an immediate therapeutic need for a prescribed medication that requires a prior authorization.(((8)))(9) "Emergency medical condition" has the meaning set forth in RCW 48.43.005.(((9)))(10) "Emergency services" has the meaning set forth in RCW 48.43.005.(((10)))(11) "Enrollee point-of-service cost-sharing" or "cost-sharing" ((means amounts paid to health carriers directly providing services, health care providers, or health care facilities by enrollees and may include copayments, coinsurance, or deductibles))has the same meaning as set forth in RCW 48.43.005.(((11)))(12) "Expedited prior authorization request" has the meaning set forth in RCW 48.43.830.(((12)))(13) "Facility" means an institution providing health care services including, but not limited to, hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory, and imaging centers, and rehabilitation and other therapeutic settings, and as defined in RCW 48.43.005.(((13)))(14) "Formulary" means a listing of drugs used within a health plan. A formulary must include drugs covered under an enrollee's medical benefit.(((14)))(15) "Generally accepted standards of mental health and substance use care" has the same meaning as RCW 48.43.766.(16) "Grievance" has the same meaning set forth in RCW 48.43.005.(((15)))(17) "Health care provider" or "provider" ((means:(a) A person regulated under Title 18 RCW or chapter 70.127 RCW, to practice health or health-related services or otherwise practicing health care services in this state consistent with state law; or(b) An employee or agent of a person described in (a) of this subsection, acting in the course and scope of his or her employment))has the same meaning as set forth in RCW 48.43.005.(((16)))(18) "Health care service" or "health service" ((means that service offered or provided by health care facilities and health care providers relating to the prevention, cure, or treatment of illness, injury, or disease))has the same meaning as set forth in RCW 48.43.005.(((17)))(19) "Health carrier" or "carrier" ((means a disability insurance company regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, and a health maintenance organization as defined in RCW 48.46.020, and includes "issuers" as that term is used in the Patient Protection and Affordable Care Act (P.L. 111-148, as amended (2010))))has the same meaning as set forth in RCW 48.43.005.(((18)))(20) "Health plan" or "plan" ((means any individual or group policy, contract, or agreement offered by a health carrier to provide, arrange, reimburse, or pay for health care service except the following:(a) Long-term care insurance governed by chapter 48.83 or 48.84 RCW;(b) Medicare supplemental health insurance governed by chapter 48.66 RCW;(c) Limited health care service offered by limited health care service contractors in accordance with RCW 48.44.035;(d) Disability income;(e) Coverage incidental to a property/casualty liability insurance policy such as automobile personal injury protection coverage and homeowner guest medical;(f) Workers' compensation coverage;(g) Accident only coverage;(h) Specified disease and hospital confinement indemnity when marketed solely as a supplement to a health plan;(i) Employer-sponsored self-funded health plans;(j) Dental only and vision only coverage; and(k) Plans deemed by the insurance commissioner to have a short-term limited purpose or duration, or to be a student-only plan that is guaranteed renewable while the covered person is enrolled as a regular full-time undergraduate or graduate student at an accredited higher education institution, after a written request for such classification by the carrier and subsequent written approval by the insurance commissioner.(l) Supplemental long-term care insurance governed by chapter 48.212 RCW))has the same meaning as set forth in RCW 48.43.005.(((19)))(21) "Immediate therapeutic needs" means those needs where passage of time without treatment would result in imminent emergency care, hospital admission or might seriously jeopardize the life or health of the patient or others in contact with the patient.(((20)))(22) "Indian health care provider" means:(a) The Indian Health Service, an agency operated by the U.S. Department of Health and Human Services established by the Indian Health Care Improvement Act, Section 601, 25 U.S.C. §1661;(b) An Indian tribe, as defined in the Indian Health Care Improvement Act, Section 4(14), 25 U.S.C. §1603(14), that operates a health program under a contract or compact to carry out programs of the Indian Health Service pursuant to the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. §450 et seq.;(c) A tribal organization, as defined in the Indian Health Care Improvement Act, Section 4(26), 25 U.S.C. §1603(26), that operates a health program under a contract or compact to carry out programs of the Indian Health Service pursuant to the ISDEAA, 25 U.S.C. §450 et seq.;(d) An Indian tribe, as defined in the Indian Health Care Improvement Act, Section 4(14), 25 U.S.C. §1603(14), or tribal organization, as defined in the Indian Health Care Improvement Act, Section 4(26), 25 U.S.C. §1603(26), that operates a health program with funding provided in whole or part pursuant to 25 U.S.C. §47 (commonly known as the Buy Indian Act); or(e) An urban Indian organization that operates a health program with funds in whole or part provided by Indian Health Service under a grant or contract awarded pursuant to Title V of the Indian Health Care Improvement Act, Section 4(29), 25 U.S.C. §1603(29).(((21)))(23) "Managed care plan" means a health plan that coordinates the provision of covered health care services to a covered person through the use of a primary care provider and a network.(((22)))(24) "Medically necessary" or "medical necessity," except as provided in RCW 48.43.766, in regard to ((mental health services and)) pharmacy services is a carrier determination as to whether a health service is a covered benefit because the service is consistent with generally recognized standards within a relevant health profession.(((23)))(25) "Mental health or substance use disorder provider" means a health care provider or a health care facility authorized by state law to provide mental health or substance use disorder services.(((24) "Mental health services" means in-patient or out-patient treatment including, but not limited to, partial hospitalization, residential treatment, out-patient facility-based treatment, intensive outpatient treatment, emergency services, or prescription drugs to manage, stabilize or ameliorate the effects of a mental disorder listed in the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association, including diagnoses and treatment for substance use disorder.(25)))(26) "Mental health and substance use disorder services" has the same meaning as set forth in RCW 48.43.766.(27) "Network" means the group of participating providers and facilities providing health care services to a particular health plan or line of business (individual, small, or large group). A health plan network for issuers offering more than one health plan may be smaller in number than the total number of participating providers and facilities for all plans offered by the carrier.(((26)))(28) "Nonprofit professional association" has the same meaning set forth in RCW 48.43.766.(29) "Participating provider" and "participating facility" means a facility or provider who, under a contract with the health carrier or with the carrier's ((contractor or subcontractor))health care benefit manager as defined in RCW 48.200.020, has agreed to provide health care services to covered persons with an expectation of receiving payment, other than coinsurance, copayments, or deductibles, from the health carrier rather than from the covered person.(((27)))(30) "Person" means an individual, a corporation, a partnership, an association, a joint venture, a joint stock company, a trust, an unincorporated organization, any similar entity, or any combination of the foregoing.(((28)))(31) "Pharmacy services" means the practice of pharmacy as defined in chapter 18.64 RCW and includes any drugs or devices as defined in chapter 18.64 RCW.(((29)))(32) "Predetermination request" means a voluntary request from an enrollee or provider or facility for a carrier or its designated or contracted representative to determine if a service is a benefit, in relation to the applicable plan.(((30)))(33) "Preservice requirement" means any requirement that a carrier places on a provider or facility that may limit their ability to deliver a service that requires prior authorization. Examples include limits on the type of provider or facility delivering the service, a service that must be provided before a specific service will be authorized, site of care/place of service, and whether a provider administered medication needs to be obtained from a specialty pharmacy.(((31)))(34) "Primary care provider" means a participating provider who supervises, coordinates, or provides initial care or continuing care to a covered person, and who may be required by the health carrier to initiate a referral for specialty care and maintain supervision of health care services rendered to the covered person.(((32) "Preexisting condition" means any medical condition, illness, or injury that existed any time prior to the effective date of coverage.(33) "Premium" means all sums charged, received, or deposited by a health carrier as consideration for a health plan or the continuance of a health plan. Any assessment or any "membership," "policy," "contract," "service," or similar fee or charge made by a health carrier in consideration for a health plan is deemed part of the premium. "Premium" shall not include amounts paid as enrollee point-of-service cost-sharing.(34)))(35) "Preexisting condition" has the same meaning as set forth in RCW 48.43.005.(36) "Premium" has the same meaning as set forth in RCW 48.43.005.(37) "Prior authorization" means a mandatory process that a carrier or its designated or contracted representative requires a provider or facility to follow to determine if a service is a benefit and meets the requirements for medical necessity, clinical appropriateness, level of care, or effectiveness in relation to the applicable plan. Prior authorization occurs before the service is delivered. For purposes of WAC 284-43-2050 and 284-43-2060, any term used by a carrier or its designated or contracted representative to describe this process is prior authorization. For example, prior authorization has also been referred to as "prospective review," "preauthorization," or "precertification."(((35)))(38) "Refill" means a second or subsequent filling of a previously issued prescription.(((36)))(39) "Serious mental illness" means a mental disorder, as defined in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association, the diagnostic categories listed in the mental, behavioral, and neurodevelopmental chapters of the most recent version of the International Classification of Diseases, or the most recent version of the DC:0-5 Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood, that results in serious functional impairment that substantially interferes with or limits one or more major life activities.(((37)))(40) "Service area" means the geographic area or areas where a specific product is issued, accepts members or enrollees, and covers provided services. A service area must be defined by the county or counties included unless, for good cause, the commissioner permits limitation of a service area by zip code. Good cause includes geographic barriers within a service area, or other conditions that make offering coverage throughout an entire county unreasonable.(((38)))(41) "Small group plan" means a health plan issued to a small employer as defined under RCW 48.43.005 comprising from one to 50 eligible employees.(((39)))(42) "Standard prior authorization request" has the meaning set forth in RCW 48.43.830.(((40)))(43) "Step therapy protocol" means a drug utilization management prior authorization protocol or program that establishes the specific sequence in which prescription drugs are covered by a health carrier for a medical condition.(((41) "Substance use disorder" means a substance-related or addictive disorder listed in the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association.(42)))(44) "Substitute drug" means a prescription medication, drug or therapy that a carrier covers based on an exception request. When the exception request is based on therapeutic equivalence, a substitute drug means a therapeutically equivalent substance as defined in chapter 69.41 RCW.(((43)))(45) "Supplementary pharmacy services" or "other pharmacy services" means pharmacy services involving the provision of drug therapy management and other services not required under state and federal law but that may be rendered in connection with dispensing, or that may be used in disease prevention or disease management.(((44)))(46) "Withdrawal management services" means 24 hour medically managed or medically monitored detoxification and assessment and treatment referral for adults or adolescents withdrawing from alcohol or drugs, which may include induction of medications for addiction recovery.AMENDATORY SECTION(Amending WSR 25-02-084, filed 12/27/24, effective 1/27/25)WAC 284-43-2020Drug utilization review—Generally.(1) These definitions apply to the prescription drug utilization management timelines covered in this section only, excluding prescription drug prior authorization timelines, which are covered in WAC 284-43-2050:(a) "Nonurgent review request" means any request for approval of care or treatment, or a renewal of a previously approved request that is not an urgent care request.(b) "Urgent care review request" means any request for approval of care or treatment where the passage of time could seriously jeopardize the life or health of the patient, seriously jeopardize the patient's ability to regain maximum function or, in the opinion of a provider with knowledge of the patient's medical condition, would subject the patient to severe pain that cannot be adequately managed without the care or treatment that is the subject of the request.(2) Each issuer must maintain a documented drug utilization review program that meets the definitions and requirements of RCW 48.43.400 and 48.43.410. "Utilization review" has the same meaning as defined in RCW 48.43.005. The program must include a method for reviewing and updating criteria. Issuers must make drug review criteria available upon request to a participating provider. Beginning January 1, 2021, an issuer must post its clinical review criteria for prescription drugs and the drug utilization management exception process on its website. An issuer must also require any entity performing prescription drug benefit administration on the issuer's behalf to post the drug utilization management exception process and clinical review criteria used for the issuer's enrollees on the entity's website. The review criteria must be accessible to both providers and enrollees and presented in plain language that is understandable to both providers and enrollees. The clinical review criteria must include all rules and criteria related to the prescription drug utilization management exception process including the specific information and documentation that must be submitted by a health care provider or enrollee to be considered a complete exception request.(3) The drug utilization review program must meet accepted national certification standards such as those used by the National Committee for Quality Assurance except as otherwise required by this chapter.(4) Beginning January 1, 2027, for prescription drugs prescribed to treat mental health or substance use disorder conditions, clinical review criteria must meet the requirements of RCW 48.43.766.(5) The drug utilization review program must have staff who are properly qualified, trained, supervised, and supported by explicit written clinical review criteria and review procedures.(((5)))(6) Each issuer must have written procedures to assure that reviews are conducted in a timely manner.(a) If the review request from a provider or enrollee is not accompanied by all necessary information, the issuer must tell the provider or enrollee what additional information is needed and the deadline for its submission. Upon the sooner of the receipt of all necessary information or the expiration of the deadline for providing information, the time frames for issuer determination and notification must be no less favorable than United States Department of Labor standards, and are as follows:(i) For urgent care review requests:(A) Must approve the request within 48 hours if the information provided is sufficient to approve the claim;(B) Must deny the request within 48 hours if the requested service is not medically necessary and the information provided is sufficient to deny the claim; or(C) Within 24 hours, if the information provided is not sufficient to approve or deny the claim, the issuer must request that the provider submits additional information to make the utilization management determination:(I) The issuer must give the provider 48 hours to submit the requested information;(II) The issuer must then approve or deny the request within 48 hours of the receipt of the requested additional information and include the authorization number in its approval;(ii) For nonurgent care review requests:(A) Must approve the request within five calendar days if the information is sufficient to approve the claim and include the authorization number in its approval;(B) Must deny the request within five calendar days if the requested service is not medically necessary and the information provided is sufficient to deny the claim; or(C) Within five calendar days, if the information provided is not sufficient to approve or deny the claim, the issuer must request that the provider submits additional information to make the utilization management determination:(I) The issuer must give the provider five calendar days to submit the requested additional information;(II) The issuer must then approve or deny the request within four calendar days of the receipt of the additional information and include the authorization number in its approval.(b) Notification of the utilization management determination must be provided as follows:(i) Information about whether a request was approved must be made available to the provider;(ii) Whenever there is an adverse determination resulting in a denial the issuer must notify the requesting provider by one or more of the following methods; phone, fax and/or secure electronic notification, and the covered person in writing or via secure electronic notification. Status information will be communicated to the billing pharmacy, via electronic transaction, upon the issuer's receipt of a claim after the request has been denied. The issuer must transmit these notifications within the time frames specified in (a)(i) and (ii) of this subsection in compliance with United States Department of Labor standards.(((6)))(7) When a provider or enrollee requests an exception to an issuer's drug utilization program, the urgent and nonurgent time frames established in RCW 48.43.420, WAC 284-43-2021 and 284-43-2022 shall apply.(((7)))(8) No issuer may penalize or threaten a pharmacist or pharmacy with a reduction in future payment or termination of participating provider or participating facility status because the pharmacist or pharmacy disputes the issuer's determination with respect to coverage or payment for pharmacy service.AMENDATORY SECTION(Amending WSR 20-24-105, filed 12/1/20, effective 1/1/21)WAC 284-43-2021Prescription drug utilization management exception and substitution process.(1) For purposes of this section and WAC 284-43-2022:(a) "Emergency fill" means a limited dispensed amount of medication that allows time for the processing of prescription drug utilization management.(b) "Medically appropriate" means prescription drugs that under the applicable standard of care are appropriate:(i) To improve or preserve an enrollee's health, life, or function;(ii) To slow the deterioration of an enrollee's health, life, or function; or(iii) For the early screening, prevention, evaluation, diagnosis, or treatment of a disease, condition, illness, or injury.(2) Beginning January 1, 2027, for prescription drugs prescribed to treat mental health or substance use disorder conditions, clinical review criteria must meet the requirements of RCW 48.43.766.(3) Beginning January 1, 2021, a carrier must establish an exception request program so that enrollees and providers may request substitution of a preferred drug, therapy or medication, and exceptions to prescription drug benefit limitations and procedures under a carrier's drug utilization management program. The process must include both nonurgent and urgent exception request procedures.(((3)))(4) A carrier must treat an exception request as urgent when an enrollee is experiencing a health condition that may seriously jeopardize the enrollee's life, health or ability to regain maximum function, or when the enrollee is undergoing a current course of treatment using a nonformulary drug.(((4)))(5) A carrier's exception request standards, procedures and the process description must be available to the commissioner for review upon request. A carrier must require any entity the carrier uses to administer its prescription drug benefit or to make coverage decisions for prescription drug, therapy, or medication coverage, to comply with the carrier's exception process requirements. Neither the exception request process criteria nor the type or volume of documentation required to support an exception request may be unreasonably burdensome to the enrollee or their provider.(((5)))(6) The exception request procedures must:(a) Clearly explain the process a provider and enrollee may use to request approval from the carrier, or any entity providing benefit administration, to substitute one drug, therapy or medication for another drug, therapy or medication on both an urgent and nonurgent basis. (b) Explain how the exception process provides an enrollee with access to drugs, therapies, or medication that are both on and off the carrier's formulary.(c) Permit an enrollee and their provider to use the exception request process when a formulary's tiering structure changes during the year and an enrollee is using a drug affected by the change.(d) Permit a request for an exception to utilization management restrictions applied by the carrier or any entity providing benefit administration, such as a requirement for step therapy, dosage limitations, or therapeutic substitution.(e) Permit substitution coverage for nonspecialty and specialty drugs, biologics, self-administered medication, and off-label prescriptions of medications, which means a prescription of a medication, drug, or therapy for an indication that deviates significantly from the approved U.S. Food and Drug Administration labeling. An indication is defined as a diagnosis, illness, injury, syndrome, condition or other clinical parameter for which a drug may be given. A carrier is not required to permit substitution coverage for vaccines.(((6)))(7) A carrier must not establish a special formulary tier or copayment or other cost-sharing requirement that is only applicable to prescription drugs approved for coverage under an exception request. When an enrollee or their provider requests a formulary or tiering exception to obtain a nonpreferred drug that is in a higher cost-sharing tier, a carrier may apply the cost-share for the substituted drug based on the substituted drug's placement on the formulary. For a drug that is not on the formulary, the carrier must apply the enrollee's share of cost to their out-of-pocket maximum calculations. A carrier's prescription drug benefit must include a description of the enrollee's cost-share obligation for off-formulary coverage of substituted drugs, therapies, or medications accessed through the exception process.(((7)))(8) A carrier must not require the enrollee to submit a new exception request for a refill if the enrollee's prescribing physician or other prescriber continues to prescribe the drug and the drug continues to be approved by the U.S. Food and Drug Administration for treating the enrollee's disease or medical condition, or if the drug was prescribed as part of the enrollee's participation in a clinical trial.(a) If the substituted drug is for an off-label drug use, a carrier may require the enrollee to submit a new exception request when a prescription fill and renewal cycle ends.(b) A carrier may require an enrollee to try an AB-rated generic equivalent or a biological product that is an interchangeable biological product prior to providing coverage for the equivalent branded prescription drug.(c) A carrier must consider exception requests for a U.S. Food and Drug Administration approved drug used for purposes other than what is indicated on the official label if the use is medically acceptable. A carrier must take into consideration major drug compendia, authoritative medical literature, and accepted standards of practice when making its decision.(((8)))(9) Subject to the terms and conditions of the policy that otherwise limit or exclude coverage, the carrier must grant the exception request if it can determine at least one of the following from the information submitted by a provider or enrollee in support of the exception request:(a) The enrollee does not tolerate the covered generic or formulary drug or such drug is contraindicated;(b) The enrollee's provider has determined that the covered generic or formulary drug is not therapeutically efficacious for an enrollee. A carrier may require the provider to submit specific clinical documentation as part of the exception request;(c) The enrollee's provider has determined clinically efficacious treatment requires a dosage that differs from a carrier's formulary dosage limitation for the covered drug. A carrier may require the provider to submit specific clinical documentation as part of the exception request and must review that documentation prior to making a decision;(d) The enrollee has tried the required prescription drug or another prescription drug in the same pharmacologic class or a drug with the same mechanism of action and, based on the enrollee's documented history, establishes to their provider's satisfaction that they discontinued use of that drug because it was not therapeutically efficacious, effective, had a diminished effect or caused the enrollee an adverse event. A carrier may not deny an exception request solely on the basis that the enrollee's prior use of the required or preferred drug was not within a specific time frame;(e) The provider has determined that changing from a currently prescribed drug to a drug required by the carrier's formulary management protocols may cause clinically predictable adverse reactions, or physical or mental harm to the enrollee. A carrier's exception program must include uniform standards for the type of clinical documentation required to establish that an adverse reaction, or physical or mental harm is clinically predictable; or(f) The drug required by the carrier's formulary management protocols is not in the best interest of the enrollee. To grant an exception request under this standard, a carrier must require submission of documentation of medical appropriateness, including an explanation of why the provider expects the enrollee's use of the required drug to either create a barrier to the enrollee's adherence to or compliance with their plan of care, to negatively impact a comorbid condition of the enrollee, to cause a clinically predictable negative drug interaction or to decrease the enrollee's ability to achieve or maintain reasonable functional ability in performing daily activities. (((9)))(10) A carrier must include specific direction in its process explaining how an enrollee may request coverage for an emergency fill of a substitute drug, therapy or medication. A carrier must cover an emergency fill if the treating health care provider determines that the emergency fill is necessary to keep the enrollee stable while the exception request is being processed.(a) A carrier is not required to grant an exception request for a substitute drug on the basis that an emergency fill was requested.(b) The emergency fill exception request process in subchapter D of this chapter provides an exception to the carrier's emergency fill policy as required by WAC 284-170-470(8).NEW SECTIONWAC 284-43-2040Utilization review for mental health and substance use disorder services.(1) Each health carrier must conduct utilization review for mental health and substance use disorder services and use clinical review criteria in a manner consistent with the requirements of RCW 48.43.766 and 48.43.016. "Utilization review" has the same meaning as defined in RCW 48.43.005. (2) When conducting utilization reviews relating to service intensity or level of care placement, continued stay, or transfer or discharge, health carriers must apply relevant age-appropriate patient placement criteria from nonprofit professional associations and authorize placement at the service intensity and level of care consistent with that criteria.(a) Nonprofit professional associations as defined in RCW 48.43.766 may include, but are not limited to:(i) American Academy of Child and Adolescent Psychiatry;(ii) American Academy of Family Physicians;(iii) American Academy of Neurology;(iv) American Academy of Pediatrics;(v) American Academy of Sleep Medicine;(vi) American Association for Community Psychiatry;(vii) American College of Physicians;(viii) American Medical Association;(ix) American Psychiatric Association;(x) American Psychological Association;(xi) American Society of Addiction Medicine;(xii) Canadian Network for Mood and Anxiety Treatments;(xiii) Council of Autism Service Providers;(xiv) World Professional Association for Transgender Health.(b) A health carrier conducting utilization review under this subsection may:(i) Use software-based clinical decision support tools, including those developed by commercial entities, when such tools incorporate and apply with fidelity the relevant age-appropriate patient placement criteria; and(ii) Use patient placement criteria in addition to the relevant age-appropriate placement only to approve requested services.(c) A health carrier conducting utilization reviews described in this subsection may not:(i) Apply criteria that conflicts with or is more restrictive than the relevant age-appropriate patient placement criteria; or(ii) Rely on additional patient placement criteria to issue an adverse benefit determination or otherwise deny, restrict, or limit access to requested services.(d) Utilization review determinations concerning service intensity, level of care placement, continued stay, and transfer or discharge that are within the scope of the following criteria will be considered compliant with this section:(i) For a primary substance use disorder diagnosis in adolescents and adults, the ASAM Criteria by the American Society of Addiction Medicine.(ii) For a primary mental health diagnosis in adults 19 years of age and older, Level of Care Utilization System (LOCUS) by the American Association for Community Psychiatry.(iii) For a primary mental health diagnosis in children six to 18 years of age, Child and Adolescent Level of Care/Service Intensity Utilization System (merged CALOCUS-CASII) by the American Association for Community Psychiatry and the American Academy of Child and Adolescent Psychiatry.(iv) For a primary mental health diagnosis in children five years of age and younger, Early Child Service Intensity Instrument (ECSII) by the American Academy of Child and Adolescent Psychiatry.(v) Nothing in this subsection prohibits a carrier from using other relevant age-appropriate patient placement criteria from nonprofit professional associations to perform utilization review determinations concerning service intensity, level of care placement, continued stay, and transfer or discharge.(e) When a carrier's application of relevant age-appropriate patient placement criteria is inconsistent with the service intensity or level of care placement requested by a covered person or their provider, any adverse benefit determination notice must provide the full details of the carrier's assessment including the clinical review criteria applied and the specific reasons for the adverse benefit determination.(3) Except as provided in subsection (2) of this section, when relevant age-appropriate patient placement criteria from nonprofit professional associations that determine the service intensity or level of care placement, continued stay, or transfer or discharge for a mental health or substance use disorder service do not exist, a carrier may use other clinical criteria to conduct utilization review provided that:(a) The gap-filling utilization review criteria is based on generally accepted standards of mental health and substance use disorder care and the carrier documents the sources, and evidence supporting the clinical appropriateness, of each of the gap-filling utilization review criteria in a clinical policy; and(b) The carrier develops and maintains, and provides upon request by an enrollee, the following records:(i) The clinical policy containing the gap-filling utilization review criteria that the carrier uses to perform utilization review of the mental health or substance use disorder service;(ii) A comparative analysis and all underlying supporting documentation demonstrating that the gap-filling utilization review criteria were designed, and in practice are applied, in compliance with WAC 284-43-7060; and(iii) A written justification prepared by appropriately qualified health care professionals that includes a description of the nonprofit professional association sources the carrier examined and the process the carrier followed to make its finding that nonprofit professional association clinical criteria that determine the service intensity or level of care placement, continued stay, or transfer or discharge for a mental health or substance use disorder service do not exist and an explanation of the clinical rationale and evidence supporting the insurer's determination that the gap-filling utilization review criteria are based on generally accepted standards of mental health and substance use disorder care.(4) For utilization reviews not described in subsection (2) or (3) of this section, a carrier may use clinical review criteria from either for-profit or nonprofit sources provided that the clinical review criteria does not deviate from generally accepted standards of mental health and substance use disorder care.(5) Outpatient mental health office visits and outpatient substance use disorder office visits described in RCW 48.43.016 include, but are not limited to:(a) Psychotherapy;(b) Counseling;(c) Medication evaluation and management;(d) Testing and assessments to determine whether an enrollee is receiving necessary care or whether a specific form of treatment is effective;(e) Screenings;(f) Diagnostic testing;(g) Annual wellness visits; and(h) Intake activities and other periodic assessments;(i) Outpatient mental health office visits do not include procedures performed on an outpatient basis.(6) When a new version of the Diagnostic and Statistical Manual of Mental Disorders, the mental, behavioral, and neurodevelopmental chapters of the International Classification of Diseases, or the DC:0-5 Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood is published, a carrier has 60 days from the date of publishing to comply with the new version. For nonprofit professional association criteria used to comply with the requirements of subsection (2) or (3) of this section, a carrier has 60 days from the date of publishing to adopt and comply with new versions of the relevant criteria. For clinical review criteria used for utilization reviews not described in subsection (2) or (3) of this section, a carrier has 60 days from the date of publishing to comply with the updated criteria.This section applies to any health care benefit manager, as defined in RCW 48.200.020 or contracted provider that performs utilization review functions directly or indirectly on a health carrier's behalf.AMENDATORY SECTION(Amending WSR 26-01-148, filed 12/19/25, effective 1/19/26)WAC 284-43-7010Definitions.Aggregate lifetime limit means a dollar limitation on the total amount of specified benefits that may be paid under a plan (or health insurance coverage offered in connection with a plan) for any coverage unit.Annual dollar limit means a dollar limitation on the total amount of specified benefits that may be paid in a 12-month period under a plan (or health insurance coverage offered in connection with a plan) for any coverage unit.Approved treatment program means a discrete program of substance use disorder treatment provided by a treatment program certified by the department of health as meeting standards adopted under chapter 71.24 RCW.Classification of benefits means a group into which all medical/surgical benefits and mental health or substance use disorder benefits offered by a plan must fall. For the purposes of this rule, the only classifications that may be used are: Inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs.Clinical review criteria has the same meaning as set forth in RCW 48.43.766.Core treatment has the same meaning as set forth in RCW 48.43.766.Coverage unit means the way in which a plan or issuer groups individuals for purposes of determining benefits, or premiums or contributions. For example, different coverage units include self-only, family, and employee-plus-spouse.Cumulative financial requirements means financial requirements that determine whether or to what extent benefits are provided based on accumulated amounts and include deductibles and out-of-pocket maximums. Financial requirements do not include aggregate lifetime or annual dollar limits.Cumulative quantitative treatment limitations means treatment limitations that determine whether or to what extent benefits are provided based on accumulated amounts, such as annual or lifetime day or visit limits.((Emergency condition, for the purpose of this subchapter, means a medical, mental health or substance use disorder condition manifesting itself by acute symptoms of sufficient severity, including severe emotional or physical distress or a combination of severe emotional and physical distress, that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical, mental health or substance use disorder treatment attention to result in a condition placing the health of the individual, or with respect to a pregnant woman, the health of the woman or her unborn child, in serious jeopardy.))DSM means the most current version of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders.DC:0-5 means the most current version of the DC:0-5 Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood.Emergency medical condition has the same meaning as set forth in RCW 48.43.005.Essential health benefits (EHBs). EHBs have the same definition as found in WAC ((284-43-5602 or)) 284-43-5604, as appropriate. The definition of EHBs includes mental health and substance use disorder services, including behavioral health treatment. For EHBs, including mental health and substance use disorder benefits, federal and state law prohibit limitations on age, condition, lifetime and annual dollar amounts.Evidentiary standards are any evidence, sources, or standards that a health plan (or health carrier offering coverage in connection with such a plan) considered or relied upon in designing or applying a factor with respect to a nonquantitative treatment limitation, including specific benchmarks or thresholds. Evidentiary standards may be empirical, statistical, or clinical in nature, and include: Sources acquired or originating from an objective third party, such as recognized medical literature, professional standards and protocols (which may include comparative effectiveness studies and clinical trials), published research studies, payment rates for items and services (such as publicly available databases of the "usual, customary and reasonable" rates paid for items and services), and clinical treatment guidelines; internal plan or issuer data, such as claims or utilization data or criteria for assuring a sufficient mix and number of network providers; and benchmarks or thresholds, such as measures of excessive utilization, cost levels, time or distance standards, or network participation percentage thresholds.Factors are all information, including processes and strategies (but not evidentiary standards), that a health plan (or health carrier offering coverage in connection with such a plan) considered or relied upon to design a nonquantitative treatment limitation, or to determine whether or how the nonquantitative treatment limitation applies to benefits under the plan or coverage. Examples of factors include, but are not limited to: Provider discretion in determining a diagnosis or type or length of treatment; clinical efficacy of any proposed treatment or service; licensing and accreditation of providers; claim types with a high percentage of fraud; quality measures; treatment outcomes; severity or chronicity of condition; variability in the cost of an episode of treatment; high cost growth; variability in cost and quality; elasticity of demand; and geographic location.Financial requirements means cost sharing measures such as deductibles, copayments, coinsurance, and out-of-pocket maximums. Financial requirements do not include aggregate lifetime or annual dollar limits.Generally accepted standards of mental health and substance use care has the same meaning as RCW 48.43.766.Health carrier or issuer has the same meaning as RCW 48.43.005.Health plan has the same meaning as RCW 48.43.005.ICD means the most current version of the World Health Organization's International Classification of Diseases.Medical/surgical benefits means benefits with respect to items or services for medical conditions or surgical procedures, as defined under the terms of the plan or health insurance coverage and in accordance with applicable federal and state law, but does not include mental health or substance use disorder benefits. Any condition defined by the plan or coverage as being a medical/surgical condition must be defined to be consistent with generally recognized independent standards of current medical practice (for example, the most current version of the International Classification of Diseases (ICD) or state guidelines). To the extent generally recognized independent standards of current medical practice do not address whether a condition or procedure is a medical condition or surgical procedure, plans and issuers may define the condition or procedure in accordance with applicable federal and state law.Medically necessary((or medical necessity:(a) With regard to substance use disorder is defined by the most recent version of The ASAM Criteria, Treatment Criteria for Addictive, Substance Related, and Co-Occurring Conditions as published by the American Society of Addiction Medicine (ASAM).(b) With regard to mental health services, pharmacy services, and any substance use disorder benefits not governed by ASAM, is a carrier determination as to whether a health service is a covered benefit because the service is consistent with generally recognized standards within a relevant health profession))has the same meaning as set forth in RCW 48.43.766.Mental health benefits means benefits with respect to items or services for mental health and substance use disorder conditions, as defined under the terms of the plan or health insurance coverage and in accordance with applicable federal and state law, but does not include medical/surgical benefits. Any condition defined by the plan or coverage as being a mental health condition must be defined to be consistent with generally accepted standards of mental health and substance use disorder care. For the purposes of this subsection, to be consistent with generally accepted standards of mental health and substance use disorder care, the definition must include all conditions covered under the plan that fall under:(a) The most current version of the ((Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association))DSM;(b) The diagnostic categories listed in the mental, behavioral, and neurodevelopmental chapters of the most current version of the ICD; or(c) The diagnostic categories listed in the most current version of the DC:0-5.Mental health and substance use disorder services has the same meaning as set forth in RCW 48.43.766.Nonprofit professional association has the same meaning as set forth in RCW 48.43.766.Nonquantitative treatment limitations (NQTL) means processes, strategies, or evidentiary standards, or other factors that are not expressed numerically, but otherwise limit the scope or duration of benefits for treatment. NQTLs include, but are not limited to:(a) Medical management standards limiting or excluding benefits based on medical necessity or medical appropriateness, or based on whether the treatment is experimental or investigative;(b) Formulary design for prescription drugs;(c) For plans with multiple network tiers (such as preferred providers and participating providers), network tier design;(d) Standards for provider admission to participate in a network, including reimbursement rates;(e) Plan methods for determining usual, customary, and reasonable charges;(f) Refusal to pay for higher-cost therapies until it can be shown that a lower-cost therapy is not effective (also known as fail-first policies or step therapy protocols);(g) Exclusions based on failure to complete a course of treatment; and(h) Restrictions based on geographic location, facility type, provider specialty, and other criteria that limit the scope or duration of benefits for services provided under the plan or coverage.Plan means a health plan, a short-term limited duration medical plan, or a student-only health plan.Predominant level: If a type of financial requirement or quantitative treatment limitation applies to substantially all medical surgical benefits in a classification, the predominant level is the level that applies to more than one-half of the medical/surgical benefits in that classification subject to the financial requirement or quantitative treatment limitation.Processes are actions, steps, or procedures that a health plan (or health carrier offering coverage in connection with such a plan) uses to apply a nonquantitative treatment limitation, including actions, steps, or procedures established by the plan or issuer as requirements in order for a participant or beneficiary to access benefits, including through actions by a participant's or beneficiary's authorized representative or a provider or facility. Processes include, but are not limited to: Procedures to submit information to authorize coverage for an item or service prior to receiving the benefit or while treatment is ongoing (including requirements for peer or expert clinical review of that information); provider referral requirements that are used to determine when and how a participant or beneficiary may access certain services; and the development and approval of a treatment plan used in a concurrent review process to determine whether a specific request should be granted or denied. Processes also include the specific procedures used by staff or other representatives of a plan or carrier (or the service provider of a plan or carrier) to administer the application of nonquantitative treatment limitations, such as how a panel of staff members applies the nonquantitative treatment limitation (including the qualifications of staff involved, number of staff members allocated, and time allocated), consultations with panels of experts in applying the nonquantitative treatment limitation, and the degree of reviewer discretion in adhering to criteria hierarchy when applying a nonquantitative treatment limitation.Quantitative parity analysis means a mathematical test by which plans and issuers determine what level of a financial requirement or quantitative treatment limitation, if any, is the most restrictive level that could be imposed on mental health or substance use disorder benefits within a classification.Quantitative treatment limitations means types of objectively quantifiable treatment limitations such as frequency of treatments, number of visits, days of coverage, days in a waiting period or other similar limits on the scope or duration of treatment.Short-term limited duration medical plan means a plan deemed by the commissioner to have a short-term limited purpose or duration.Strategies are practices, methods, or internal metrics that a health plan (or health carrier offering coverage in connection with such a plan) considers, reviews, or uses to design a nonquantitative treatment limitation. Strategies include, but are not limited to: The development of the clinical rationale used in approving or denying benefits; the method of determining whether and how to deviate from generally accepted standards of care in concurrent reviews; the selection of information deemed reasonably necessary to make medical necessity determinations; reliance on treatment guidelines or guidelines provided by third-party organizations in the design of a nonquantitative treatment limitation; and rationales used in selecting and adopting certain threshold amounts to apply a nonquantitative treatment limitation, professional standards and protocols to determine utilization management standards, and fee schedules used to determine provider reimbursement rates, used as part of a nonquantitative treatment limitation. Strategies also include the method of creating and determining the composition of the staff or other representatives of a plan or carrier (or the service provider of a plan or carrier) that deliberates, or otherwise makes decisions, on the design of nonquantitative treatment limitations, including the plan's or carrier's methods for making decisions related to the qualifications of staff involved, number of staff members allocated, and time allocated; breadth of sources and evidence considered; consultations with panels of experts in designing the nonquantitative treatment limitation; and the composition of the panels used to design a nonquantitative treatment limitation.Student-only health plan means a health plan that is guaranteed renewable while the covered person is enrolled as a regular, full-time undergraduate student at an accredited higher education institution.((Substance use disorder means a substance-related or addictive disorder listed in the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association.))Substance use disorder benefits means benefits with respect to items or services for substance use disorders, as defined under the terms of the plan or health insurance coverage and in accordance with applicable federal and state law, but does not include medical or surgical benefits. Any disorder defined by the plan or coverage as being a substance use disorder must be defined to be consistent with generally accepted standards of mental health and substance use disorder care. For the purposes of this subsection, to be consistent with generally accepted standards of mental health and substance use disorder care, the definition must include all conditions covered under the plan that fall under:(a) The substance-related and addictive disorder (or equivalent category) of the most current version of the DSM; or(b) The diagnostic categories listed as a mental or behavioral disorder due to psychoactive substance use (or equivalent category) in the mental, behavioral, and neurodevelopmental disorders chapter (or equivalent chapter) of the ICD.(c) Substance use disorder benefits must include payment for reasonable charges for medically necessary treatment and supporting service rendered to an enrollee either within an approved treatment program or by a health care professional that meets the requirements as part of the approved treatment plan.Substantially all: A type of financial requirement or quantitative treatment limitation considered to apply to substantially all medical/surgical benefits in a classification of benefits if it applies to at least two-thirds of all medical/surgical benefits in that classification as determined by WAC 284-43-7040 (2)(a).Treatment limitations means limits on benefits based on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment. Treatment limitations include both quantitative treatment limitations, which are expressed numerically (such as 50 outpatient visits per year), and nonquantitative treatment limitations (such as standards related to network composition), which otherwise limit the scope or duration of benefits for treatment under a plan or coverage. A ((permanent))complete exclusion of all benefits for a particular condition or disorder, however, is not a treatment limitation for purposes of this section.AMENDATORY SECTION(Amending WSR 20-24-040, filed 11/23/20, effective 12/24/20)WAC 284-43-7020Classification of benefits.(1) A plan providing any benefits for a mental health or substance use disorder ((benefits,)) must provide meaningful benefits for those mental health or substance use disorder benefits in every classification in which medical/surgical benefits are provided. "Meaningful benefits" has the same meaning set forth in RCW 48.43.766.(2) Parity requirements must be applied to the following six classifications of benefits: Inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. These are the only classifications of benefits that can be used in addition to the permitted subclassifications described in subsection (6) of this section.(a) Inpatient, in-network. Benefits furnished on an inpatient basis and within a network of providers established or recognized under a plan or health insurance coverage.(b) Inpatient, out-of-network. Benefits furnished on an inpatient basis and outside any network of providers established or recognized under a plan or health insurance coverage. This classification includes inpatient benefits under a plan (or health insurance coverage) that has no network of providers.(c) Outpatient, in-network. Benefits furnished on an outpatient basis and within a network of providers established or recognized under a plan or health insurance coverage. (d) Outpatient, out-of-network. Benefits furnished on an outpatient basis and outside any network of providers established or recognized under a plan or health insurance coverage. This classification includes outpatient benefits under a plan (or health insurance coverage) that has no network of providers.(e) Emergency care. Benefits for treatment of an emergency condition related to a mental health or substance use disorder. Such benefits must comply with the requirements for emergency medical services in RCW 48.43.093. Medically necessary detoxification must be covered as an emergency medical condition according to RCW 48.43.093, and may be provided in hospitals licensed under chapter 70.41 RCW. Medically necessary detoxification services must not require prenotification.(f) Prescription drugs. Benefits for prescription drugs.(3) In determining the classification in which a particular benefit belongs, a plan must apply the same standards to medical/surgical benefits as applied to mental health or substance use disorder benefits.An issuer or plan must assign covered intermediate mental health/substance use disorder benefits such as residential treatment, partial hospitalization, and intensive outpatient treatment, to the existing six classifications in the same way that they assign comparable intermediate medical/surgical benefits to these classifications. For example, if a plan classifies medical care in skilled nursing facilities as inpatient benefits, then it must also treat covered mental health care in residential treatment facilities as inpatient benefits. If a plan or issuer treats home health care as an outpatient benefit, then any covered intensive outpatient mental health or substance use disorder services and partial hospitalization must be considered outpatient benefits as well.(4) A plan or issuer may not apply any financial requirement or treatment limitation to mental health or substance use disorder benefits that is more restrictive than the predominant financial requirement or treatment limitation applied to medical/surgical benefits. This parity analysis must be calculated for each type of financial requirement or treatment limitation within a coverage unit for each classification of services.(5) Medical/surgical benefits and mental health or substance use disorder benefits cannot be categorized as being offered outside of these six classifications and therefore not subject to the parity analysis.(a) A plan or issuer must treat the least restrictive level of the financial requirement or quantitative treatment limitation that applies to at least two-thirds of medical/surgical benefits across all provider tiers in a classification as the predominant level that it may apply to mental health or substance use disorder benefits in the same classification.(b) If a plan or issuer classifies providers into tiers, and varies cost-sharing based on the different tiers, the criteria for classification must be applied to generalists and specialists providing mental health or substance use disorder services no more restrictively than such criteria are applied to medical/surgical benefit providers.(6) Permitted subclassifications:(a) A plan or issuer is permitted to divide benefits furnished on an outpatient basis into two subclassifications:(i) Office visits; and(ii) All other outpatient items and services.(b) A plan or issuer may divide its benefits furnished on an in-network basis into subclassifications that reflect network tiers, if the tiering is based on reasonable factors and without regard to whether a provider is a mental health or substance use disorder provider or a medical/surgical provider.(c) After network tiers are established, the plan or issuer may not impose any financial requirement or treatment limitation on mental health or substance use disorder benefits in any tier that is more restrictive than the predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in that tier.(d) If a plan applies different levels of financial requirements to different tiers of prescription drug benefits based on reasonable factors and without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to mental health/substance use disorder benefits, the plan satisfies the parity requirements with respect to prescription drug benefits. Reasonable factors include: Cost, efficacy, generic versus brand name, and mail order versus pharmacy pick-up.(e) A parity analysis applying the financial requirement and treatment rules found in WAC 284-43-7040 and 284-43-7060 must be performed for each type of financial requirement or quantitative treatment limitation within a coverage unit for each subclassification of services.(7) Prohibited subclassifications: All subclassifications other than the permitted subclassification listed in subsection (6) of this section are specifically prohibited. For example, a plan is prohibited from basing a subclassification on generalists and specialists. Unless specifically permitted under subsection (6) of this section, subclassifications are not permitted when applying requirements of this section.NEW SECTIONWAC 284-43-7030Coverage of mental health and substance disorder services.(1) Each health plan covering providing coverage for medical and surgical services must provide coverage for mental health and substance use disorder services as defined in RCW 48.43.766.(2) Any cost sharing for mental health and substance use disorder services and any treatment limitations related to mental health and substance use disorder services must comply with the quantitative and nonquantitative treatment limitation requirements in 89 Fed. Reg. 77586 et seq. as published in the Federal Register on September 23, 2024.(3) If there is no core treatment for a covered mental health condition or substance use disorder with respect to a classification, a health carrier required to provide meaningful benefits, as defined in RCW 48.43.766, is not required to provide benefits for a core treatment for such condition or disorder in that classification but must provide benefits for such condition or disorder in every classification in which medical or surgical benefits are provided.AMENDATORY SECTION(Amending WSR 20-24-040, filed 11/23/20, effective 12/24/20)WAC 284-43-7040Measuring plan benefits—Financial requirements and quantitative treatment limitations.(1) Classification of benefits must be measured as follows:(a) By type and level of financial requirement or treatment limitation.(i) A financial requirement or treatment limitation type includes deductibles, copayments, coinsurance, and out-of-pocket maximums. Types of quantitative treatment limitations include annual, episode, and lifetime day and visit limits.(ii) A financial requirement or treatment limitation level includes the amount of the financial requirement or treatment limitation type. For example, different levels of coinsurance include ((twenty))20 percent and ((thirty))30 percent; different levels of a copayment include ((fifteen dollars and twenty dollars))$15 and $20; different levels of a deductible include ((two hundred fifty dollars and five hundred dollars))$250 and $500; and different levels of an episode limit include ((twenty-one))21 inpatient days per episode and ((thirty))30 inpatient days per episode.(b) A plan or issuer may not apply any financial requirement or quantitative treatment limitation to mental health/substance use disorder benefits in any classification that is more restrictive than the predominant financial requirement or quantitative treatment limitation of that type applied to substantially all medical/surgical benefits in the same classification. Whether a financial requirement or treatment limitation is a predominant financial requirement or treatment limitation that applies to substantially all medical/surgical benefits in a classification is determined separately for each type of financial requirement or treatment limitation. A plan or issuer may not impose any financial requirement or treatment limitation that is applicable only with respect to mental health or substance use disorder benefits and not to any medical/surgical benefits in the same benefit classification.(c) The determination of the portion of medical/surgical benefits in a classification of benefits subject to a financial requirement or quantitative treatment limitation (or subject to any level of a financial requirement or quantitative treatment limitation) is based on the dollar amount of all plan payments for medical/surgical benefits in the classification expected to be paid under the plan for the plan year.(i) The dollar amount of plan payments is based on the amount the plan allows (before enrollee cost sharing) rather than the amount the plan pays (after enrollee cost sharing) because payment based on the allowed amount covers the full scope of the benefits being provided.(ii) A reasonable actuarial method must be used to determine the dollar amount expected to be paid under a plan for medical/surgical benefits subject to a financial requirement or quantitative treatment limitation.(d) Clarifications for certain threshold requirements when performing "substantially all" and "predominant" tests.(i) For any deductible, the dollar amount of plan payments includes all plan payments with respect to claims that would be subject to the deductible if it had not been satisfied.(ii) For any out-of-pocket maximum, the dollar amount of plan payments includes all plan payments associated with out-of-pocket payments that are taken into account towards the out-of-pocket maximum as well as all plan payments associated with out-of-pocket payments that would have been made towards the out-of-pocket maximum if it had not been satisfied.(iii) ((Similar rules))The rules of this section apply for any other thresholds at which the rate of plan payment changes.(2) Application to different coverage units. If a plan or insurer applies different levels of a financial requirement or quantitative treatment limitation to different coverage units in a classification of medical/surgical benefits, the "predominant" level that applies to "substantially all" medical/surgical benefits in the classification is determined separately for each coverage unit.(a) Determining "substantially all": A type of financial requirement or quantitative treatment limitation is considered to apply to substantially all medical/surgical benefits in a classification of benefits if it applies to at least two-thirds of all medical/surgical benefits in that classification.(i) Benefits subject to a zero level for a type of financial requirement are treated as benefits not subject to that type of financial requirement. Benefits with no quantitative treatment limitations or with a quantitative treatment limitation that is unlimited are treated as benefits not subject to that type of quantitative treatment limitation.(ii) If a type of financial requirement or quantitative treatment limitation does not apply to at least two-thirds of all medical/surgical benefits in a classification, the financial requirement or quantitative treatment limitation of that type cannot be applied to mental health or substance use disorder benefits in that classification.(b) Determining "predominant":(i) If a type of financial requirement or quantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits in a classification as determined under (a) of this subsection, the level of the financial requirement or quantitative treatment limitation that applies to more than one-half of medical/surgical benefits in that classification subject to the financial requirement or quantitative treatment limitation is the predominant level of that type in a classification of benefits.(ii) If a type of financial requirement or quantitative treatment limitation applies to at least two-thirds of all medical/surgical benefits in a classification and there is no single level that applies to more than one-half of medical/surgical benefits in the classification subject to the financial requirement or quantitative treatment limitation, the plan or issuer must combine levels until the combination of levels applies to more than one-half of medical/surgical benefits subject to the financial requirement or quantitative treatment limitation in the classification.(iii) The least restrictive level within the combination is considered the predominant level of that type in the classification. (For this purpose, a plan must combine the most restrictive levels first, with each less restrictive level added to the combination until the combination applies to more than one-half of the benefits subject to the financial requirement or treatment limitation.)(3) Cumulative financial requirements and cumulative quantitative treatment limitations.(a) A plan or issuer may not apply cumulative financial requirements (such as deductibles and out-of-pocket maximums) or cumulative quantitative treatment limitations (such as annual or lifetime day or visit limits) for mental health or substance use disorder benefits in a classification that accumulate separately from any cumulative requirement or limitation established for medical/surgical benefits in the same classification.(b) Cumulative requirements and limitation must also satisfy the quantitative parity analysis.AMENDATORY SECTION(Amending WSR 20-24-040, filed 11/23/20, effective 12/24/20)WAC 284-43-7060((Measuring plan benefits—))Nonquantitative treatment limitations.(1) ((A plan or issuer may not impose an NQTL with respect to mental health or substance use disorder in any classification unless, under the terms of the plan as written and in operation, any processes, strategies, evidentiary standards or other factors used in applying the NQTL to mental health or substance use disorder benefits in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the limitation with respect to medical/surgical benefits in the same classification.))Beginning January 1, 2027, a plan or issuer must impose nonquantitative treatment limitations (NQTLs) with respect to mental health and substance use disorder benefits in accordance with the provisions of 89 Fed. Reg. 77586 et seq., as published on September 23, 2024.(2) All plan standards, such as in-and-out-of-network geographic limitations, limitations on inpatient services for situations where the enrollee is a threat to self or others, exclusions for court-ordered and involuntary holds, experimental treatment limitations, service coding, exclusions for services provided by clinical social workers, and network adequacy, while not specifically enumerated in the illustrative list of NQTLs must be applied in a manner that complies with this subsection.(3) Beginning January 1, 2027, a plan or issuer that provides both medical/surgical benefits and mental health or substance use disorder benefits and that imposes any nonquantitative treatment limitation on mental health or substance use disorder benefits, must perform and document a comparative analysis of the design and application of each nonquantitative treatment limitation applicable to mental health or substance use disorder benefits in accordance with the provisions of 89 Fed. Reg. 77586 et seq., as published on September 23, 2024.RDS-7507.1AMENDATORY SECTION(Amending WSR 16-23-168, filed 11/23/16, effective 1/1/17)WAC 284-43A-080Criteria and considerations for independent review determinations.(1) General criteria and considerations.(a) The determination must be consistent with the standards in RCW 48.43.537, 48.43.535, and 48.43.766, and chapter 284-43A WAC.(b) The expert reviewers from a certified IRO will make determinations regarding the medical necessity or appropriateness of, and the application of health plan coverage provisions to, health care services for an enrollee.(c) The IRO shall ensure that determinations are consistent with the scope of covered benefits as outlined in the medical coverage agreement.(i) Clinical reviewers may override the health plan's medical necessity or appropriateness standards only if the standards are determined upon review to be unreasonable or inconsistent with sound, evidence-based medical practice, or experimental or investigational treatment protocols. For reviews of mental health and substance use disorder services, as defined in RCW 48.43.766, the clinical reviewers must conduct reviews and make determinations in a manner consistent with the requirements of RCW 48.43.766.(ii) Reviewers may make determinations about the application of general health plan coverage provisions to specific issues concerning health care services for an enrollee. For example, whether a specific service is excluded by more general benefit exclusion language may require independent interpretation.(2) Medical necessity and appropriateness - Criteria and considerations. Only clinical reviewers may determine whether a service, which is the subject of an adverse decision, is medically necessary and appropriate. These determinations must be based upon their expert clinical judgment, after consideration of relevant medical, scientific, and cost-effectiveness evidence, and medical standards of practice in Washington state.(a) Medical standards of practice include the standards appropriately applied to physicians or other health care providers, as pertinent to the case.(b) In considering medical standards of practice within Washington state:(i) Clinical reviewers may use national standards of care, absent evidence presented by the health plan or enrollee that the Washington state standard of care is different.(ii) A health care service or treatment should be considered part of the Washington state standard of practice if reviewers believe that failure to provide it would be inconsistent with that degree of care, skill and learning expected of a reasonably prudent health care provider acting in the same or similar circumstances.(c) Medical necessity will be a factor in most cases referred to an IRO, but not necessarily in all. See WAC 284-43A-080.(3) Health plan coverage provisions - Criteria and considerations. The following requirements must be observed when a review requires making determinations about the application of health plan coverage provisions to issues concerning health care services for an enrollee.(a) These determinations must be made by one or more contract specialists meeting the requirements of WAC 284-43A-060(4), except that a clinical determination of medical necessity or appropriateness, by itself, is not an interpretation of the scope of covered benefits and does not require a contract specialist.(b) If the full health plan coverage agreement has not already been provided by the carrier under WAC 284-43A-140, the IRO shall request additional provisions from the health plan coverage agreement in effect during the relevant period of the enrollee's coverage, as necessary to have an adequate context for determinations.(c) In general, the IRO and its contract specialists may assume that the contractual health plan coverage provisions themselves are consistent with the Washington Insurance Code (Title 48 RCW), absent information to the contrary. Primary responsibility for determining consistency with the insurance code, when at issue, rests with the commissioner.(4) No provision of this chapter should be interpreted to establish a standard of medical care, or to create or eliminate any cause of action.RDS-7508.2AMENDATORY SECTION(Amending WSR 26-05-001, filed 2/4/26, effective 3/7/26)WAC 284-170-130Definitions.Except as defined in other subchapters and unless the context requires otherwise, the following definitions shall apply throughout this chapter.(1) "Adverse determination" has the same meaning as the definition of adverse benefit determination in RCW 48.43.005, and includes:(a) The determination includes any decision by a health carrier's designee utilization review organization that a request for a benefit under the health carrier's health benefit plan does not meet the health carrier's requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness or is determined to be experimental or investigational and the requested benefit is therefore denied, reduced, or terminated or payment is not provided or made, in whole or in part for the benefit;(b) The denial, reduction, termination, or failure to provide or make payment, in whole or in part, for a benefit based on a determination by a health carrier or its designee utilization review organization of a covered person's eligibility to participate in the health carrier's health benefit plan;(c) Any prospective review or retrospective review determination that denies, reduces, or terminates or fails to provide or make payment in whole or in part for a benefit;(d) A rescission of coverage determination; or(e) A carrier's denial of an application for coverage.(2) "Allowed amount" has the meaning set forth in RCW 48.43.005.(3)(a) "Audio-only telemedicine" means the delivery of health care services through the use of audio-only technology, permitting real-time communication between the patient at the originating site and the provider, for the purpose of diagnosis, consultation, or treatment.(b) "Audio-only telemedicine" does not include:(i) The use of facsimile, email, or text messages, unless the use of text-like messaging is necessary to ensure effective communication with individuals who have a hearing, speech, or other disability; or(ii) The delivery of health care services that are customarily delivered by audio-only technology and customarily not billed as separate services by the provider, such as the sharing of laboratory results.(4) "Authorization" or "certification" means a determination by the carrier that an admission, extension of stay, or other health care service has been reviewed and, based on the information provided, meets the clinical requirements for medical necessity, appropriateness, level of care, or effectiveness in relation to the applicable health plan.(5) "Clinical review criteria" except as provided for in RCW 48.43.766, means the written screens, or screening procedures, decision rules, medical protocols, or clinical practice guidelines used by the carrier as an element in the evaluation of medical necessity and appropriateness of requested admissions, procedures, and services, including prescription drug benefits, under the auspices of the applicable health plan. Clinical approval criteria has the same meaning as clinical review criteria.(6) "Covered health condition" means any disease, illness, injury or condition of health risk covered according to the terms of any health plan.(7) "Covered person" or "enrollee" means an individual covered by a health plan including a subscriber, policyholder, or beneficiary of a group plan.(8) "Disciplining authority" has the meaning set forth in RCW 18.130.020.(9) "Distant site" has the meaning set forth in RCW 48.43.735.(10) "Emergency medical condition" has the meaning set forth in RCW 48.43.005.(11) "Emergency services" has the meaning set forth in RCW 48.43.005.(12) "Enrollee point-of-service cost-sharing" or "cost-sharing" has the meaning set forth in RCW 48.43.005.(13) "Established relationship" means the provider providing audio-only telemedicine has access to sufficient health records to ensure safe, effective, and appropriate care services and:(a) The covered person has had, within the past three years, at least one in-person appointment, or at least one real-time interactive appointment using both audio and video technology, with:(i) The provider providing audio-only telemedicine;(ii) A provider employed at the same medical group, at the same clinic, or by the same integrated delivery system operated by a carrier licensed under chapter 48.44 or 48.46 RCW as the provider providing audio-only telemedicine; or(iii) A locum tenens or other provider who is the designated back up or substitute provider for the provider providing audio-only telemedicine who is on leave and is not associated with an established medical group, clinic, or integrated delivery system operated by a carrier licensed under chapter 48.44 or 48.46 RCW; or(b) The covered person was referred to the provider providing audio-only telemedicine by another provider who has:(i) Had, within the past three years, at least one in-person appointment, or at least one real-time interactive appointment using both audio and video technology, with the covered person; and(ii) Provided relevant medical information to the provider providing audio-only telemedicine.(iii) A referral includes circumstances in which the provider who has had at least one in-person appointment, or at least one real-time interactive appointment using both audio and video technology, with the covered person participates in the audio-only telemedicine encounter with the provider to whom the covered person has been referred.(14) "Expedited prior authorization request" has the meaning set forth in RCW 48.43.830.(15) "Facility" means an institution providing health care services including, but not limited to, hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory, and imaging centers, and rehabilitation and other therapeutic settings, and as defined in RCW 48.43.005.(16) "Formulary" means a listing of drugs used within a health plan.(17) "Grievance" has the meaning set forth in RCW 48.43.005.(18) "Health care provider" or "provider" means:(a) A person regulated under Title 18 RCW or chapter 70.127 RCW, to practice health or health-related services or otherwise practicing health care services in this state consistent with state law; or(b) An employee or agent of a person described in (a) of this subsection, acting in the course and scope of his or her employment.(19) "Health care service" or "health service" means that service offered or provided by health care facilities and health care providers relating to the prevention, cure, or treatment of illness, injury, or disease.(20) "Health carrier" or "carrier" means a disability insurance company regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, and a health maintenance organization as defined in RCW 48.46.020, and includes "issuers" as that term is used in The Patient Protection and Affordable Care Act (P.L. 111-148, as amended (2010)).(21) "Health plan" or "plan" means any individual or group policy, contract, or agreement offered by a health carrier to provide, arrange, reimburse, or pay for health care service except the following:(a) Long-term care insurance governed by chapter 48.83 or 48.84 RCW;(b) Supplemental long-term care insurance governed by chapter 48.212 RCW;(c) Medicare supplemental health insurance governed by chapter 48.66 RCW;(d) Limited health care service offered by limited health care service contractors in accordance with RCW 48.44.035;(e) Disability income;(f) Coverage incidental to a property/casualty liability insurance policy such as automobile personal injury protection coverage and homeowner guest medical;(g) Workers' compensation coverage;(h) Accident only coverage;(i) Specified disease and hospital confinement indemnity when marketed solely as a supplement to a health plan;(j) Employer-sponsored self-funded health plans;(k) Dental only and vision only coverage; and(l) Plans deemed by the insurance commissioner to have a short-term limited purpose or duration, or to be a student-only plan that is guaranteed renewable while the covered person is enrolled as a regular full-time undergraduate or graduate student at an accredited higher education institution, after a written request for such classification by the carrier and subsequent written approval by the insurance commissioner.(22) "Hospital" has the meaning set forth in RCW 48.43.735.(23) "Indian health care provider" means:(a) The Indian Health Service, an agency operated by the U.S. Department of Health and Human Services established by the Indian Health Care Improvement Act, Section 601, 25 U.S.C. Sec. 1661;(b) An Indian tribe, as defined in the Indian Health Care Improvement Act, Section 4(14), 25 U.S.C. Sec. 1603(14), that operates a health program under a contract or compact to carry out programs of the Indian Health Service pursuant to the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. Sec. 450 et seq.;(c) A tribal organization, as defined in the Indian Health Care Improvement Act, Section 4(26), 25 U.S.C. Sec. 1603(26), that operates a health program under a contract or compact to carry out programs of the Indian Health Service pursuant to the ISDEAA, 25 U.S.C. Sec. 450 et seq.;(d) An Indian tribe, as defined in the Indian Health Care Improvement Act, Section 4(14), 25 U.S.C. Sec. 1603(14), or tribal organization, as defined in the Indian Health Care Improvement Act, Section 4(26), 25 U.S.C. Sec. 1603(26), that operates a health program with funding provided in whole or part pursuant to 25 U.S.C. Sec. 47 (commonly known as the Buy Indian Act); or(e) An urban Indian organization that operates a health program with funds in whole or part provided by Indian Health Service under a grant or contract awarded pursuant to Title V of the Indian Health Care Improvement Act, Section 4(29), 25 U.S.C. Sec. 1603(29).(24) "Managed care plan" means a health plan that coordinates the provision of covered health care services to a covered person through the use of a primary care provider and a network.(25) "Medically necessary" or "medical necessity," except as provided for in RCW 48.43.766, in regard to ((mental health services and)) pharmacy services is a carrier determination as to whether a health service is a covered benefit because the service is consistent with generally recognized standards within a relevant health profession.(26) "Mental health or substance use disorder provider" means a health care provider or a health care facility authorized by state law to provide mental health or substance use disorder services.(27) "Mental health ((services" means in-patient or out-patient treatment including, but not limited to, partial hospitalization, residential treatment, out-patient facility-based treatment, intensive outpatient treatment, emergency services, or prescription drugs to manage, stabilize, or ameliorate the effects of a mental disorder listed in the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association, including diagnoses and treatment for substance use disorder))and substance use disorder services" has the same meaning as set forth in RCW 48.43.766.(28) "Network" means the group of participating providers and facilities providing health care services to a particular health plan or line of business (individual, small, or large group). A health plan network for issuers offering more than one health plan may be smaller in number than the total number of participating providers and facilities for all plans offered by the carrier.(29) "Originating site" means the physical location of a patient receiving health care services through telemedicine, and includes those sites described in WAC 284-170-433.(30) "Out-patient therapeutic visit" or "out-patient visit" means a clinical treatment session with a mental health or substance use disorder provider of a duration consistent with relevant professional standards used by the carrier to determine medical necessity for the particular service being rendered, as defined in Physicians Current Procedural Terminology, published by the American Medical Association.(31) "Participating provider" and "participating facility" mean a facility or provider who, under a contract with the health carrier or with the carrier's ((contractor or subcontractor))health care benefit manager as defined in RCW 48.200.020, has agreed to provide health care services to covered persons with an expectation of receiving payment, other than coinsurance, copayments, or deductibles, from the health carrier rather than from the covered person.(32) "Patient consent" means a voluntary and informed decision by a patient, following an explanation by the provider or auxiliary personnel under the general supervision of the provider presented in a manner understandable to the patient that is free of undue influence, fraud or duress, to consent to a provider billing the patient or the patient's health plan for an audio-only telemedicine service under RCW 48.43.735 or WAC 284-170-433.(33) "Person" means an individual, a corporation, a partnership, an association, a joint venture, a joint stock company, a trust, an unincorporated organization, any similar entity, or any combination of the foregoing.(34) "Pharmacy services" means the practice of pharmacy as defined in chapter 18.64 RCW and includes any drugs or devices as defined in chapter 18.64 RCW.(35) "Primary care provider" means a participating provider who supervises, coordinates, or provides initial care or continuing care to a covered person, and who may be required by the health carrier to initiate a referral for specialty care and maintain supervision of health care services rendered to the covered person.(36) "Preexisting condition" means any medical condition, illness, or injury that existed any time prior to the effective date of coverage.(37) "Premium" means all sums charged, received, or deposited by a health carrier as consideration for a health plan or the continuance of a health plan. Any assessment or any "membership," "policy," "contract," "service," or similar fee or charge made by a health carrier in consideration for a health plan is deemed part of the premium. "Premium" shall not include amounts paid as enrollee point-of-service cost-sharing.(38) "Real time communication" means synchronous and live communication between a provider and a patient. It does not include delayed or recorded messages, such as email, facsimile or voicemail.(39) "Same amount of compensation" means providers are reimbursed by a carrier using the same allowed amount for telemedicine services as they would if the service had been provided in-person unless negotiation has been undertaken under RCW 48.43.735 or WAC 284-170-433. Where consumer cost-sharing applies to telemedicine services, the consumer's payment combined with the carrier's payment must be the same amount of compensation, or allowed amount, as the carrier would pay the provider if the telemedicine service had been provided in person. Where an alternative payment methodology other than fee-for-service payment would apply to an in-person service, "same amount of compensation" means providers are reimbursed by a carrier using the same alternative payment methodology that would be used for the same service if provided in-person, unless negotiation has been undertaken under RCW 48.43.735 or WAC 284-170-433.(40) "Service area" means the geographic area or areas where a specific product is issued, accepts members or enrollees, and covers provided services. A service area must be defined by the county or counties included unless, for good cause, the commissioner permits limitation of a service area by zip code. Good cause includes geographic barriers within a service area, or other conditions that make offering coverage throughout an entire county unreasonable.(41) "Small group plan" means a health plan issued to a small employer as defined under RCW 48.43.005 comprising from one to 50 eligible employees.(42) "Standard prior authorization request" has the meaning set forth in RCW 48.43.830.(43) "Store and forward technology" has the meaning set forth in RCW 48.43.735.(44) (("Substance use disorder services" means in-patient or out-patient treatment including, but not limited to, partial hospitalization, residential treatment, or out-patient facility-based treatment, intensive outpatient treatment, emergency services, or prescription drugs to manage, stabilize, or ameliorate the effects of a substance use disorder listed in the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association, including diagnoses and treatment for substance use disorder.(45))) "Substitute drug" means a prescription medication, drug or therapy that a carrier covers based on an exception request. When the exception request is based on therapeutic equivalence, a substitute drug means a therapeutically equivalent substance as defined in chapter 69.41 RCW.(((46)))(45) "Supplementary pharmacy services" or "other pharmacy services" means pharmacy services involving the provision of drug therapy management and other services not required under state and federal law but that may be rendered in connection with dispensing, or that may be used in disease prevention or disease management.(((47)))(46) "Telemedicine" means the delivery of health care services through the use of interactive audio and video technology or audio-only technology, permitting real-time communication between the patient at the originating site and the provider, for the purpose of diagnosis, consultation, or treatment. For purposes of this chapter, "telemedicine" does not include facsimile, email, or text messaging, unless the use of text-like messaging is necessary to ensure effective communication with individuals who have a hearing, speech, or other disability.AMENDATORY SECTION(Amending WSR 23-01-110, filed 12/19/22, effective 1/19/23)WAC 284-170-200Network access—General standards.(1) An issuer must maintain each provider network for each health plan in a manner that is sufficient in numbers and types of providers and facilities to assure that, to the extent feasible based on the number and type of providers and facilities in the service area, all health plan services provided to enrollees will be accessible in a timely manner appropriate for the enrollee's condition. An issuer must demonstrate that for each health plan's defined service area, a comprehensive range of primary, specialty, institutional, and ancillary services are readily available without unreasonable delay to all enrollees and that emergency services are accessible 24 hours per day, seven days per week without unreasonable delay.(2) Each enrollee must have adequate choice among health care providers, including those providers which must be included in the network under WAC 284-170-270, and for qualified health plans and qualified stand-alone dental plans, under WAC 284-170-310.(3) An issuer's service area must not be created in a manner designed to discriminate or that results in discrimination against persons because of age, gender, gender identity, sexual orientation, disability, national origin, sex, family structure, ethnicity, race, health condition, employment status, or socioeconomic status.(4) An issuer must establish sufficiency and adequacy of choice of providers based on the number and type of providers and facilities necessary within the service area for the plan to meet the access requirements set forth in this subchapter. Where an issuer establishes medical necessity or other prior authorization procedures, the issuer must ensure sufficient qualified staff is available to provide timely prior authorization decisions on an appropriate basis, without delays detrimental to the health of enrollees.(5) In any case where the issuer has an absence of or an insufficient number or type of participating providers or facilities to provide a particular covered health care service, the issuer must ensure through referral by the primary care provider or otherwise that the enrollee obtains the covered service from a provider or facility within reasonable proximity of the enrollee at no greater cost to the enrollee than if the service were obtained from network providers and facilities. An issuer must satisfy this obligation even if an alternate access delivery request has been submitted and is pending commissioner approval.An issuer may use facilities in neighboring service areas to satisfy a network access standard if one of the following types of facilities is not in the service area, or if the issuer can provide substantial evidence of good faith efforts on its part to contract with the facilities in the service area. Such evidence of good faith efforts to contract will include documentation about the efforts to contract but not the substantive contract terms offered by either the issuer or the facility. This applies to the following types of facilities:(a) Tertiary hospitals;(b) Pediatric community hospitals;(c) Specialty or limited hospitals, such as burn units, rehabilitative hospitals, orthopedic hospitals, and cancer care hospitals;(d) Neonatal intensive care units; and(e) Facilities providing transplant services, including those that provide solid organ, bone marrow, and stem cell transplants.(6) An issuer must establish and maintain adequate arrangements to ensure reasonable proximity of network providers and facilities to the business or personal residence of enrollees, and located so as to not result in unreasonable barriers to accessibility. Issuers must make reasonable efforts to include providers and facilities in networks in a manner that limits the amount of travel required to obtain covered benefits.(7) A single case provider reimbursement agreement must be used only to address unique situations that typically occur out-of-network and out of service area, where an enrollee requires services that extend beyond stabilization or one time urgent care. Single case provider reimbursement agreements must not be used to fill holes or gaps in the network and do not support a determination of network access.(8) An issuer must disclose to enrollees that limitations or restrictions on access to participating providers and facilities may arise from the health service referral and authorization practices of the issuer. A description of the health plan's referral and authorization practices, including information about how to contact customer service for guidance, must be set forth as an introduction or preamble to the provider directory for a health plan. In the alternative, the description of referral and authorization practices may be included in the summary of benefits and explanation of coverage for the health plan.(9) To provide adequate choice to enrollees who are American Indians/Alaska Natives, each health issuer must maintain arrangements that ensure that American Indians/Alaska Natives who are enrollees have access to covered medical and behavioral health services provided by Indian health care providers.Issuers must ensure that such enrollees may obtain covered medical and behavioral health services from an Indian health care provider at no greater cost to the enrollee than if the service were obtained from network providers and facilities, even if the Indian health care provider is not a contracted provider. Issuers are not responsible for credentialing providers and facilities that are part of the Indian health system. Nothing in this subsection prohibits an issuer from limiting coverage to those health services that meet issuer standards for medical necessity, care management, and claims administration or from limiting payment to that amount payable if the health service were obtained from a network provider or facility.(10) An issuer must have a demonstrable method and contracting strategy to ensure that contracting hospitals in a plan's service area have the capacity to serve the entire enrollee population based on normal utilization.(11) At a minimum, an issuer's provider network must adequately provide for mental health and substance use disorder treatment, including behavioral health therapy. An issuer must include a sufficient number and type of mental health and substance use disorder treatment providers and facilities within a service area based on normal enrollee utilization patterns.(a) Adequate networks must include crisis intervention and stabilization, psychiatric inpatient hospital services, including voluntary psychiatric inpatient services, and services from mental health and substance use disorder providers.(b) There must be mental health and substance use disorder providers of sufficient number and type to provide diagnosis and medically necessary treatment of conditions covered by the plan through providers acting within their scope of license and scope of competence established by education, training, and experience to diagnose and treat conditions found in the most recent version of the Diagnostic and Statistical Manual of Mental Disorders; the diagnostic categories listed in the mental, behavioral, and neurodevelopmental chapters of the most recent version of the International Classification of Diseases; the diagnostic categories listed in the most recent version of the DC:0-5 Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood; or other recognized diagnostic manual or standard.(c) An issuer must establish a reasonable standard for the number and geographic distribution of mental health and substance use disorder providers who can treat serious mental illness of an adult and serious emotional disturbances of a child, taking into account the various types of mental health practitioners acting within the scope of their licensure.The issuer must measure the adequacy of the mental health and substance use disorder network against this standard at least twice a year, and submit an action plan with the commissioner if the standard is not met.(d) Emergency mental health services and substance use disorder services, including services provided by behavioral health emergency services providers, as defined in RCW 48.43.005, must be included in an issuer's provider network.(e) An issuer's monitoring of network access and adequacy must be based on its classification of mental health and substance use disorder services to either primary or specialty care, ensuring that a sufficient number of providers of the required type are in its network to provide the services as classified. An issuer may use the classifications established in WAC 284-43-7020 for this element of its network assessment and monitoring.(f) An issuer must ensure that an enrollee can identify information about mental health services and substance use disorder treatment including benefits, providers, coverage, and other relevant information by calling a customer service representative during normal business hours, by using the issuer's transparency tool developed pursuant to RCW 48.43.007 and by referring to the network provider directory.(12) The provider network must include preventive and wellness services, including chronic disease management and smoking cessation services as defined in RCW 48.43.005 and WAC 284-43-5640(9) and 284-43-5642(9). If these services are provided through a quit-line or help-line, the issuer must ensure that when follow-up services are medically necessary, the enrollee will have access to sufficient information to access those services within the service area. Contracts with quit-line or help-line services are subject to the same conditions and terms as other provider contracts under this section.(13) For the essential health benefits category of ambulatory patient services, as defined in WAC 284-43-5640(1) and 284-43-5642(1), an issuer's network is adequate if:(a) The issuer establishes a network that affords enrollee access to urgent appointments without prior authorization within 48 hours, or with prior authorization, within 96 hours of the referring provider's referral.(b) For primary care providers the following must be demonstrated:(i) The ratio of primary care providers to enrollees within the issuer's service area as a whole meets or exceeds the average ratio for Washington state for the prior plan year;(ii) The network includes such numbers and distribution that 80 percent of enrollees within the service area are within 30 miles of a sufficient number of primary care providers in an urban area and within 60 miles of a sufficient number of primary care providers in a rural area from either their residence or work; and(iii) Enrollees have access to an appointment, for other than preventive services, with a primary care provider within 10 business days of requesting one.(c) For specialists:(i) The issuer documents the distribution of specialists in the network for the service area in relation to the population distribution within the service area; and(ii) The issuer establishes that when an enrollee is referred to a specialist, the enrollee has access to an appointment with such a specialist within 15 business days for nonurgent services.(d) For preventive care services, and periodic follow-up care including, but not limited to, standing referrals to specialists for chronic conditions, periodic office visits to monitor and treat pregnancy, cardiac or mental health conditions, and laboratory and radiological or imaging monitoring for recurrence of disease, the issuer permits scheduling such services in advance, consistent with professionally recognized standards of practice as determined by the treating licensed health care provider acting within the scope of his or her practice.(14) The network access requirements in this subchapter apply to stand-alone dental plans offered through the exchange or where a stand-alone dental plan is offered outside of the exchange for the purpose of providing the essential health benefit category of pediatric oral benefits. All such stand-alone dental plans must ensure that all covered services to enrollees will be accessible in a timely manner appropriate for the enrollee's conditions.(a) An issuer of such stand-alone dental plans must demonstrate that, for the dental plan's defined service area, all services required under WAC 284-43-5700(3) and 284-43-5702(4), as appropriate, are available to all enrollees without unreasonable delay.(b) Dental networks for pediatric oral services must be sufficient for the enrollee population in the service area based on expected utilization.(15) Issuers must meet all requirements of this subsection for all provider networks. An alternate access delivery request under WAC 284-170-210 may be proposed only if:(a) There are sufficient numbers and types of providers or facilities in the service area to meet the standards under this subchapter but the issuer is unable to contract with sufficient providers or facilities to meet the network standards in this subchapter; or(b) An issuer's provider network has been previously approved under this section, and a provider or facility type subsequently becomes unavailable within a health plan's service area; or(c) A county has a population that is 50,000 or fewer, and the county is the sole service area for the plan, and the issuer chooses to propose an alternative access delivery system for that county; or(d) A qualified health plan issuer is unable to meet the standards for inclusion of essential community providers, as provided under WAC 284-170-310(3).