RCW 48.43.420
Prescription drug utilization management—Exception request process—Conditions, requirements, and time frames for approval or denial of requests—Emergency fill coverage—Notice of new policies and procedures.
For health plans delivered, issued for delivery, or renewed on or after January 1, 2021:
(1) When coverage of a prescription drug for the treatment of any medical condition is subject to prescription drug utilization management, the patient and prescribing practitioner must have access to a clear, readily accessible, and convenient process to request an exception through which the prescription drug utilization management can be overridden in favor of coverage of a prescription drug prescribed by a treating health care provider. A health carrier or prescription drug utilization management entity may use its existing medical exceptions process to satisfy this requirement. The process must be easily accessible on the health carrier and prescription drug utilization management entity's website. Approval criteria must be clearly posted on the health carrier and prescription drug utilization management entity's website. This information must be in plain language and understandable to providers and patients.
(2) Health carriers must disclose all rules and criteria related to the prescription drug utilization management process to all participating providers, including the specific information and documentation that must be submitted by a health care provider or patient to be considered a complete exception request.
(3) An exception request must be granted if the health carrier or prescription drug utilization management entity determines that the evidence submitted by the provider or patient is sufficient to establish that:
(a) The required prescription drug is contraindicated or will likely cause a clinically predictable adverse reaction by the patient;
(b) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen;
(c) The patient has tried the required prescription drug or another prescription drug in the same pharmacologic class or a drug with the same mechanism of action while under his or her current or a previous health plan, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
(d) The patient is currently experiencing a positive therapeutic outcome on a prescription drug recommended by the patient's provider for the medical condition under consideration while on his or her current or immediately preceding health plan, and changing to the required prescription drug may cause clinically predictable adverse reactions, or physical or mental harm to, the patient; or
(e) The required prescription drug is not in the best interest of the patient, based on documentation of medical appropriateness, because the patient's use of the prescription drug is expected to:
(i) Create a barrier to the patient's adherence to or compliance with the patient's plan of care;
(ii) Negatively impact a comorbid condition of the patient;
(iii) Cause a clinically predictable negative drug interaction; or
(iv) Decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities.
(4) Upon the granting of an exception, the health carrier or prescription drug utilization management entity shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.
(5)(a) For nonurgent exception requests, the health carrier or prescription drug utilization management entity must:
(i) Within three business days notify the treating health care provider that additional information, as disclosed under subsection (2) of this section, is required in order to approve or deny the exception request, if the information provided is not sufficient to approve or deny the request; and
(ii) Within three business days of receipt of sufficient information from the treating health care provider as disclosed under subsection (2) of this section, approve a request if the information provided meets at least one of the conditions referenced in subsection (3) of this section or if deemed medically appropriate, or deny a request if the requested service does not meet at least one of the conditions referenced in subsection (3) of this section.
(b) For urgent exception requests, the health carrier or prescription drug utilization management entity must:
(i) Within one business day notify the treating health care provider that additional information, as disclosed under subsection (2) of this section, is required in order to approve or deny the exception request, if the information provided is not sufficient to approve or deny the request; and
(ii) Within one business day of receipt of sufficient information from the treating health care provider as disclosed under subsection (2) of this section, approve a request if the information provided meets at least one of the conditions referenced in subsection (3) of this section or if deemed medically appropriate, or deny a request if the requested service does not meet at least one of the conditions referenced in subsection (3) of this section.
(c) If a response by a health carrier or prescription drug utilization management entity is not received within the time frames established under this section, the exception request is deemed granted.
(d) For purposes of this subsection, exception requests are considered 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 an enrollee is undergoing a current course of treatment using a nonformulary drug.
(6) Health carriers must cover an emergency supply fill if a treating health care provider determines an emergency fill is necessary to keep the patient stable while the exception request is being processed. This exception shall not be used to solely justify any further exemption.
(7) When responding to a prescription drug utilization management exception request, a health carrier or prescription drug utilization management entity shall clearly state in their response if the exception request was approved or denied. The health carrier must use clinical review criteria as referenced in RCW 48.43.410 for the basis of any denial. Any denial must be based upon and include the specific clinical review criteria relied upon for the denial and include information regarding how to appeal denial of the exception request. If the exception request from a treating health care provider is denied for administrative reasons, or for not including all the necessary information, the health carrier or prescription drug utilization management entity must inform the provider what additional information is needed and the deadline for its submission.
(8) The health carrier or prescription drug utilization management entity must permit a stabilized patient to remain on a drug during an exception request process.
(9) A health carrier must provide sixty days' notice to providers and patients for any new policies or procedures applicable to prescription drug utilization management protocols. New health carrier policies or procedures may not be applied retroactively.
(10) This section does not prevent:
(a) A health carrier or prescription drug utilization management entity from requiring a patient 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;
(b) A health carrier or prescription drug utilization management entity from denying an exception for a drug that has been removed from the market due to safety concerns from the federal food and drug administration; or
(c) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
[ 2019 c 171 § 3.]
NOTES:
Rules—2019 c 171: "The insurance commissioner shall adopt rules necessary for the implementation of this act." [ 2019 c 171 § 4.]
Structure Revised Code of Washington
Chapter 48.43 - Insurance Reform.
48.43.008 - Enrollment in employer-sponsored health plan—Person eligible for medical assistance.
48.43.009 - Health care sharing ministries.
48.43.012 - Health plans—Preexisting conditions—Rules.
48.43.01211 - Health plans—Eligibility—Health status-related factors—Rules.
48.43.0123 - Health plans—Rescission of coverage—Rules.
48.43.0124 - Health plans—Cost sharing for essential health benefits—Rules.
48.43.0125 - Essential health benefits—Annual or lifetime dollar limits.
48.43.0127 - Group health plans—Waiting period—Rules.
48.43.016 - Utilization management standards and criteria—Health carrier requirements—Definitions.
48.43.021 - Personally identifiable health information—Restrictions on release.
48.43.022 - Enrollee identification card—Social security number restriction.
48.43.023 - Pharmacy identification cards—Rules.
48.43.028 - Eligibility to purchase certain health benefit plans—Small employers and small groups.
48.43.035 - Group health benefit plans—Guaranteed issue and continuity of coverage—Exceptions.
48.43.038 - Individual health plans—Guarantee of continuity of coverage—Exceptions.
48.43.041 - Individual health benefit plans—Mandatory benefits.
48.43.043 - Colorectal cancer examinations and laboratory tests—Required benefits or coverage.
48.43.045 - Health plan requirements—Annual reports—Exemptions.
48.43.047 - Health plans—Minimum coverage for preventative services—No cost-sharing requirements.
48.43.055 - Procedures for review and adjudication of health care provider complaints—Requirements.
48.43.059 - Payments made by a second-party payment process—Definition.
48.43.0725 - Reproductive health plan coverage—Immediate postpartum contraception devices.
48.43.073 - Required abortion coverage—Limitations.
48.43.081 - Anatomic pathology services—Payment for services—Definitions.
48.43.083 - Chiropractor services—Participating provider agreement—Health carrier reimbursement.
48.43.091 - Health carrier coverage of outpatient mental health services—Requirements.
48.43.093 - Health carrier coverage of emergency medical services—Requirements—Conditions.
48.43.094 - Pharmacist provided services—Health plan requirements.
48.43.097 - Filing of financial statements—Every health carrier.
48.43.105 - Preparation of documents that compare health carriers—Immunity—Due diligence.
48.43.125 - Coverage at a long-term care facility following hospitalization—Definition.
48.43.176 - Eosinophilic gastrointestinal associated disorder—Elemental formula.
48.43.180 - Denturist services.
48.43.185 - General anesthesia services for dental procedures.
48.43.190 - Payment of chiropractic services—Parity.
48.43.195 - Contraceptive drugs—Twelve-month refill coverage.
48.43.200 - Disclosure of certain material transactions—Report—Information is confidential.
48.43.205 - Material acquisitions or dispositions.
48.43.210 - Asset acquisitions—Asset dispositions.
48.43.215 - Report of a material acquisition or disposition of assets—Information required.
48.43.220 - Material nonrenewals, cancellations, or revisions of ceded reinsurance agreements.
48.43.600 - Overpayment recovery—Carrier.
48.43.605 - Overpayment recovery—Health care provider.
48.43.650 - Fixed payment insurance products—Commissioner's annual report.
48.43.670 - Plan or contract renewal—Modification of wellness program.
48.43.680 - Lifetime limit on transplants—Definition.
48.43.690 - Assessments under RCW 70.290.040 considered medical expenses.
48.43.700 - Exchange—Plans that a carrier must offer—Review—Rules.
48.43.705 - Plans offered outside of exchange.
48.43.710 - Certification as qualified health plan not an exemption.
48.43.720 - Reinsurance and risk adjustment programs—Affordable care act—Rules.
48.43.733 - Rates and forms of group health benefit plans—Timing of filings—Exceptions—Rules.
48.43.734 - Health carrier rate filings—Review of surplus, capital, and profit levels.
48.43.740 - Dental only plan—Emergency dental conditions—Definitions.
48.43.743 - Dental only plan—Annual data statement—Contents—Public use—Definition.
48.43.755 - Health care provider credentialing applications—Use of electronic database by providers.
48.43.757 - Health care provider credentialing applications—Reimbursement requirements.
48.43.760 - Opioid use disorder—Coverage without prior authorization.
48.43.762 - Opioid overdose reversal medication bulk purchasing and distribution program.
48.43.765 - Health carrier network adequacy—Mental health and substance abuse treatment.
48.43.770 - Individual market health plan availability—Annual report.
48.43.775 - Qualified health plan participation—Reimbursement rate for other health plans.
48.43.780 - Insulin drugs—Cap on enrollee's required payment amount—Cost-sharing requirements.
48.43.785 - COVID-19 personal protective equipment expenses—Health care provider reimbursement.
48.43.790 - Behavioral services—Next-day appointments.
48.43.795 - Qualified health plans—Acceptance of premium and cost-sharing assistance.
48.43.800 - Primary care expenditures assessment—Review.
48.43.805 - Prescription drug upper payment limit—Rules.
48.43.810 - Biomarker testing—Standards—Construction.
48.43.815 - Donor human milk—Standards.
48.43.820 - Consolidated appropriations act enforcement—Implementation of federal regulations.
48.43.320 - Authorized control level event—Commissioner's options.
48.43.325 - Mandatory control level event—Commissioner's duty—Regulatory control.
48.43.330 - Carrier's right to hearing—Request by carrier—Date set by commissioner.
48.43.340 - Powers or duties of commissioner not limited—Rules.
48.43.350 - No liability or cause of action against commissioner or department.
48.43.355 - Notice by commissioner to carrier—When effective.
48.43.360 - Initial RBC reports—Calculation of initial RBC levels—Subsequent reports.
48.43.366 - Self-funded multiple employer welfare arrangements.
48.43.370 - RBC standards not applicable to certain carriers.
48.43.400 - Prescription drug utilization management—Definitions.
48.43.430 - Prescription medication—Maximum charge at point of sale—Requirements.
48.43.435 - Prescription medication—Cost-sharing calculation—Application—Rules.
48.43.500 - Intent—Purpose—2000 c 5.
48.43.515 - Access to appropriate health services—Enrollee options—Rules.
48.43.525 - Prohibition against retrospective denial of health plan coverage—Rules.
48.43.540 - Requirement to designate a licensed medical director—Exemption.
48.43.545 - Standard of care—Liability—Causes of action—Defense—Exception.
48.43.550 - Delegation of duties—Carrier accountability.
48.43.902 - Effective date—1996 c 312.
48.43.904 - Construction—Chapter applicable to state registered domestic partnerships—2009 c 521.