WSR 11-16-061

EMERGENCY RULES

OFFICE OF

INSURANCE COMMISSIONER

[ Insurance Commissioner Matter No. R 2011-14 -- Filed July 29, 2011, 10:20 a.m. , effective July 29, 2011, 10:20 a.m. ]


     Effective Date of Rule: Immediately.

     Purpose: To bring Washington state's requirements for nongrandfathered health plans into compliance with the Affordable Care Act (ACA) requirements for review of adverse benefit determinations, and provide that all plans, both grandfathered and nongrandfathered, must continue to address grievances.

     Citation of Existing Rules Affected by this Order: Amending WAC 284-43-410, 284-43-615, and 284-43-620.

     Statutory Authority for Adoption: RCW 48.02.060, 48.43.530.

     Other Authority: P.L. 111-148 (2010, as amended) and implementing regulations.

     Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest; and that state or federal law or federal rule or a federal deadline for state receipt of federal funds requires immediate adoption of a rule.

     Reasons for this Finding: In guidance issued by the United States Department of Health and Human Services (HHS), states were advised that HHS would review state law as of July 31, 2011, to determine whether the state process was compliant with the ACA's requirements for review of adverse benefit determinations. If a state is not deemed compliant, as of January 1, 2012, the federal government preempts the state appeal process, and a state must reapply to use its process. Because carriers and health plans need time to amend plan documents and file them for approval with this office, and because the commissioner finds that the stability of the individual and small group markets is best served by being deemed compliant with federal law, adoption of these rules on an emergency basis is justified.

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 12, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 2, Amended 2, Repealed 0.

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

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

     Date Adopted: July 29, 2011.

Mike Kreidler

Insurance Commissioner



AMENDATORY SECTION [(Amending Matter No. R 2000-02, filed 1/9/01)]WAC 284-43-130   Definitions.   Except as defined in other subchapters and unless the context requires otherwise, the following definitions shall apply throughout this chapter.

     (1) "Adverse determination and noncertification" means a decision by a health carrier to deny, modify, reduce, or terminate payment, coverage, authorization, or provision of health care services or benefits including the admission to or continued stay in a facility.

     (2) "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) "Clinical review criteria" means the written screens, decision rules, medical protocols, or guidelines used by the carrier as an element in the evaluation of medical necessity and appropriateness of requested admissions, procedures, and services under the auspices of the applicable health plan.

     (4) "Covered health condition" means any disease, illness, injury or condition of health risk covered according to the terms of any health plan.

     (5) "Covered person" means an individual covered by a health plan including an enrollee, subscriber, policyholder, or beneficiary of a group plan.

     (6) "Emergency medical condition" means the emergent and acute onset of a symptom or symptoms, including severe pain, that would lead a prudent layperson acting reasonably to believe that a health condition exists that requires immediate medical attention, if failure to provide medical attention would result in serious impairment to bodily functions or serious dysfunction of a bodily organ or part, or would place the person's health in serious jeopardy.

     (7) "Emergency services" means otherwise covered health care services medically necessary to evaluate and treat an emergency medical condition, provided in a hospital emergency department.

     (8) "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.

     (9) "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.

     (10) "Formulary" means a listing of drugs used within a health plan.

     (11) "Grievance" means a written or an oral complaint submitted by or on behalf of a covered person regarding:

     (a) Denial of health care services or payment for health care services; or

     (b) Iissues other than health care services or payment for health care services including dissatisfaction with health care services, delays in obtaining health care services, conflicts with carrier staff or providers, and dissatisfaction with carrier practices or actions unrelated to health care services.

     (12) "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.

     (13) "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.

     (14) "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.

     (15) "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 48.84 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.

     (16) "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.

     (17) "Medically necessary" or "medical necessity" in regard to mental health services and pharmacy services is a carrier determination as to whether a health service is a covered benefit if the service is consistent with generally recognized standards within a relevant health profession.

     (18) "Mental health provider" means a health care provider or a health care facility authorized by state law to provide mental health services.

     (19) "Mental health services" means in-patient or out-patient treatment, partial hospitalization or out-patient treatment to manage or ameliorate the effects of a mental disorder listed in the Diagnostic and Statistical Manual (DSM) IV published by the American Psychiatric Association, excluding diagnoses and treatments for substance abuse, 291.0 through 292.9 and 303.0 through 305.9.

     (20) "Network" means the group of participating providers and facilities providing health care services to a particular health plan. A health plan network for carriers 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.

     (21) "Out-patient therapeutic visit" or "out-patient visit" means a clinical treatment session with a mental health 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.

     (22) "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, 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.

     (23) "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.

     (24) "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.

     (25) "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.

     (26) "Preexisting condition" means any medical condition, illness, or injury that existed any time prior to the effective date of coverage.

     (27) "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.

     (28) "Small group" means a health plan issued to a small employer as defined under RCW 48.43.005(24) comprising from one to fifty eligible employees.

     (29) "Substitute drug" means a therapeutically equivalent substance as defined in chapter 69.41 RCW.

     (30) "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.

[Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.100, 48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-130, filed 1/9/01, effective 7/1/01. Statutory Authority: RCW 48.02.060, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.200, 2000 c 79 § 26, and RCW 48.30.040, 48.44.110, 48.46.400. 01-03-032 (Matter No. R 2000-04), § 284-43-130, filed 1/9/01, effective 2/9/01. Statutory Authority: RCW 48.02.060, 48.30.010, 48.44.050, 48.46.200, 48.30.040, 48.44.110 and 48.46.400. 99-19-032 (Matter No. R 98-7), § 284-43-130, filed 9/8/99, effective 10/9/99. Statutory Authority: RCW 48.02.060, 48.20.450, 48.20.460, 48.30.010, 48.44.020, 48.44.050, 48.44.080, 48.46.030, 48.46.060(2), 48.46.200 and 48.46.243. 98-04-005 (Matter No. R 97-3), § 284-43-130, filed 1/22/98, effective 2/22/98.]

     Reviser's note: The bracketed material preceding the section above was supplied by the code reviser's office.

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.

     Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.

AMENDATORY SECTION [(Amending Matter No. R 2009-19, filed 11/10/10)]WAC 284-43-410   Utilization review -- Generally.   (1) These definitions apply to this section:

     (a) "Concurrent care review request" means any request for an extension of a previously authorized inpatient stay or a previously authorized ongoing outpatient service, e.g., physical therapy, home health, etc.

     (b) "Immediate review request" means any request for approval of an intervention, care or treatment where passage of time without treatment would, in the judgment of the provider, result in an imminent emergency room visit or hospital admission and deterioration of the patient's health status. Examples of situations that do not qualify under an immediate review request include, but are not limited to, situations where:

     (i) The requested service was prescheduled, was not an emergency when scheduled, and there has been no change in the patient's condition;

     (ii) The requested service is experimental or in a clinical trial;

     (iii) The request is for the convenience of the patient's schedule or physician's schedule; and

     (iv) The results of the requested service are not likely to lead to an immediate change in the patient's treatment.

     (c) "Nonurgent preservice review request" means any request for approval of care or treatment where the request is made in advance of the patient obtaining medical care or services and is not an urgent care request.

     (d) "Postservice review request" means any request for approval of care or treatment that has already been received by the patient.

     (e) "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 physician 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 carrier must maintain a documented utilization review program description and written clinical review criteria based on reasonable medical evidence. The program must include a method for reviewing and updating criteria. Carriers must make clinical review criteria available upon request to participating providers. A carrier need not use medical evidence or standards in its utilization review of religious nonmedical treatment or religious nonmedical nursing care.

     (3) The 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 and must have staff who are properly qualified, trained, supervised, and supported by explicit written clinical review criteria and review procedures.

     (4) Each carrier when conducting utilization review must:

     (a) Accept information from any reasonably reliable source that will assist in the certification process;

     (b) Collect only the information necessary to certify the admission, procedure or treatment, length of stay, or frequency or duration of services;

     (c) Not routinely require providers or facilities to numerically code diagnoses or procedures to be considered for certification, but may request such codes, if available;

     (d) Not routinely request copies of medical records on all patients reviewed;

     (e) Require only the section(s) of the medical record during prospective review or concurrent review necessary in that specific case to certify medical necessity or appropriateness of the admission or extension of stay, frequency or duration of service;

     (f) For prospective and concurrent review, base review determinations solely on the medical information obtained by the carrier at the time of the review determination;

     (g) For retrospective review, base review determinations solely on the medical information available to the attending physician or order provider at the time the health service was provided;

     (h) Not retrospectively deny coverage for emergency and nonemergency care that had prior authorization under the plan's written policies at the time the care was rendered unless the prior authorization was based upon a material misrepresentation by the provider;

     (i) Not retrospectively deny coverage or payment for care based upon standards or protocols not communicated to the provider or facility within a sufficient time period for the provider or facility to modify care in accordance with such standard or protocol; and

     (j) Reverse its certification determination only when information provided to the carrier is materially different from that which was reasonably available at the time of the original determination.

     (5) Each carrier must reimburse reasonable costs of medical record duplication for reviews.

     (6) Each carrier must have written procedures to assure that reviews and second opinions are conducted in a timely manner.

     (a) Review time frames must be appropriate to the severity of the patient condition and the urgency of the need for treatment, as documented in the review request.

     (b) If the review request from the provider is not accompanied by all necessary information, the carrier must tell the provider 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 carrier review determination and notification must be no less favorable than federal Department of Labor standards, as follows:

     (i) For immediate request situations, within one business day when the lack of treatment may result in an emergency visit or emergency admission;

     (ii) For concurrent review requests that are also urgent care review requests, as soon as possible, taking into account the medical exigencies, and no later than twenty-four hours, provided that the request is made at least twenty-four hours prior to the expiration of previously approved period of time or number of treatments;

     (iii) For urgent care review requests received before July 1, 2011, within forty-eight hours;

     (iv) For urgent care review requests received on or after July 1, 2011, within twenty-four hours;

     (viv) For nonurgent preservice review requests, including nonurgent concurrent review requests, within five calendar days; or

     (vi) For postservice review requests, within thirty calendar days.

     (c) Notification of the determination must be provided as follows:

     (i) Information about whether a request was approved or denied must be made available to the attending physician, ordering provider, facility, and covered person. Carriers must at a minimum make the information available on their web site or from their call center.

     (ii) Whenever there is an adverse determination the carrier must notify the ordering provider or facility and the covered person. The carrier must inform the parties in advance whether it will provide notification by phone, mail, fax, or other means. For an adverse determination involving an urgent care review request, the carrier may initially provide notice by phone, provided that a written or electronic notification meeting United States Department of Labor standards is furnished within three days seventy-two hours of the oral notification.

     (d) As appropriate to the type of request, notification must include the number of extended days, the next anticipated review point, the new total number of days or services approved, and the date of admission or onset of services.

     (e) The frequency of reviews for the extension of initial determinations must be based on the severity or complexity of the patient's condition or on necessary treatment and discharge planning activity.

     (7) No carrier may penalize or threaten a provider or facility with a reduction in future payment or termination of participating provider or participating facility status because the provider or facility disputes the carrier's determination with respect to coverage or payment for health care service.

[Statutory Authority: RCW 48.02.060 and 48.43.520. 10-23-051 (Matter No. R 2009-19), § 284-43-410, filed 11/10/10, effective 12/11/10. Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.100, 48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-410, filed 1/9/01, effective 7/1/01.]

     Reviser's note: The bracketed material preceding the section above was supplied by the code reviser's office.

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.SUBCHAPTER E


ADVERSE BENEFIT DETERMINATION PROCESS REQUIREMENTS


For Non-Grandfathered Plans
NEW SECTION
WAC 284-43-510   Scope and intent.   This subchapter sets forth the requirements that carriers and non-grandfathered health plans must implement when establishing the adverse benefit determination process required by RCW 48.43.530 and RCW 48.43.535. A health plan is non-grandfathered if it does not meet the definition and standards for a grandfathered health plan contained in the Affordable Care Act (2010), P.L. 111-148, as amended, and the Affordable Care Act's implementing federal regulations. These rules apply to any health plan issued, renewed or in effect on or after January 1, 2012.

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NEW SECTION
WAC 284-43-515   Definitions.   These definitions apply to the sections in subchapter E, WAC 284-43-510 through 284-43-550:

     "Adverse benefit determination" refers to the definition found in RCW 48.43.005. An adverse benefit determination includes a carrier or health plan's denial of enrollment status.

     "Appellant" means an applicant or a person enrolled as an enrollee, subscriber, policy holder, participant or beneficiary of an individual or group health plan, and when designated, their representative. Providers seeking expedited review of an adverse benefit determination on behalf of an appellant may act as an appellant's representative even if the appellant has not formally notified the health plan or carrier of the designation.

     "Internal appeal" means the request by an appellant to a carrier or health plan to review and reconsider an adverse benefit determination.

     "External appeal or review" means the request by an appellant for an independent review organization to determine whether the carrier or health plan's internal appeal decisions are correct.

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NEW SECTION
WAC 284-43-525   Review of adverse benefit determinations -- Generally.   (1) Each carrier and health plan must establish and implement a comprehensive process for the review of adverse benefit determinations. The process must meet the accepted national certification standards such as those used by the National Committee for Quality Assurance except as otherwise required by this chapter. A carrier and health plan may not take or threaten to take any punitive action against a provider acting on behalf or in support of an appellant. Unless the request for review is made by an applicant, coverage must be continued while an adverse benefit determination is reviewed. Appellants must be notified that they may be responsible for the cost of services if the adverse benefit determination is upheld.

     (2) The process must offer an appellant the opportunity for both internal review, and external review of an adverse benefit determination.

     (3) A carrier must accept a request for internal review of an adverse benefit determination if it is submitted within at least sixty days of the appellant's receipt of a determination applicable to an individual health plan, and within one-hundred-eighty days of an appellant's receipt of a determination applicable to a group health plan.

     (4)(a) A carrier must clearly communicate in writing the right to review an adverse benefit determination. At a minimum, the notice must be sent at the following times:

     (i) Upon request; and

     (ii) As part of the notice of adverse benefit determination; and

     (iii) To new enrollees at the time of enrollment; and

     (iv) Annually thereafter to enrollees, group administrators and subcontractors of the carrier.

     (v) The notice requirement under 4 (a)(iii) and (iv) of this section is satisfied if the description of the internal and external review process is included in or attached to the summary health plan descriptions, policy, certificate, membership booklet, outline of coverage or other evidence of cover provided to participants, beneficiaries, or enrollees.

     (b) Each carrier and health plan must ensure that its network providers receive a written explanation of the manner in which adverse benefit determinations may be reviewed on both an expedited and non-expedited basis.

     (c) The written explanation of the review process must include information about the availability of Washington's designated ombudsman's office, as that term is referenced in the Affordable Care Act (2010) P.L. 111-148, as amended. A carrier and health plan must also specifically direct appellants to the Office of the Insurance Commissioner's Consumer Protection Division for assistance with questions and complaints.

     (5) The review process must be accessible to persons who are limited-English speakers, who have literacy problems, or who have physical or mental disabilities that impede their ability to request review or participate in the review process. Carriers and health plans must conform to federal requirements to provide notice of the process in a culturally and linguistically appropriate manner to those seeking review. Carriers and health plans in counties where ten percent or more of the population is literate in a non-English language must include in notices a statement prominently displayed in the relevant language stating that oral assistance and a written notice will be available on request in the non-English language.

     (6) Within seventy-two hours of receiving a request for review, each carrier and health plan must notify an appellant of its receipt of the request.

     (7) Each carrier and health plan must consistently assist appellants with understanding the review process. Carriers and health plans may not use procedures and practices that the commissioner determines discourage an appellant from seeking expedited internal or independent external review, or concurrent expedited review.

     (8) If a carrier or health plan reverses its initial adverse benefit determination, which it may at any time during the review process, the carrier or health plan must immediately provide appellant with written or electronic notification of the decision.

     (9) Each carrier and health plan must track requests for review until final resolution by maintaining a log of each review, its resolution, and the dates of receipt, notification, and determination.

     (a) The carrier must make its review log available to the commissioner upon request in a form accessible by the commissioner. The log must be maintained by the carrier for a six year period.

     (b) Each carrier must identify, evaluate and make available to the commissioner data and reports on trends in reviews for at least a six year time frame, including the areas of the number of appeals, the subject matter of appeals and their outcome.

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     Reviser's note: The typographical errors in the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 284-43-526   Initial notice and explanation of adverse benefit determination -- General requirements.   (1) A carrier and health plan's notification of an adverse benefit determination must be provided in writing or electronically. The notification must be provided to:

     (a) An appellant or their authorized representative; and

     (b) To the provider if the adverse benefit determination involves a denial of treatment or procedure prescribed by the provider.

     (2) A carrier and health plan's notification must include a description of:

     (a) The specific reasons for the adverse benefit determination in plain language;

     (b) The specific health plan provisions on which the determination is based, including references to the provisions;

     (c) The plan's review procedures;

     (d) The time limits applicable to such procedures; and

     (e) The right of appellants and their providers to present evidence as part of a review of an adverse benefit determination.

     (3) If an adverse benefit determination is based on a medical necessity or experimental treatment or similar exclusion or limit, the notification must contain either an explanation of the scientific or clinical basis and judgment for the determination, applying the terms of the health plan to the appellant's medical circumstances, or a statement that such explanation will be provided free of charge upon request.

     (4) If an internal rule, guideline, protocol, or other similar criterion was relied upon in making the adverse determination, the notification must contain either the specific rule, guideline, protocol, or other similar criterion; or a statement that such a rule, guideline, protocol, or other similar criterion was relied upon in making the adverse determination and that a copy of such rule, guideline, protocol, or other criterion will be provided free of charge to the claimant upon request.

     (5) The notice of an adverse benefit determination must include an explanation of the right to review the records of relevant information related to the adverse benefit determination, and any evidence used by the carrier or the carrier's representative that influenced or supported the decision to make the adverse benefit determination. For purposes of this subsection, relevant information means information relied on in making the determination, or that was submitted, considered or generated in the course of making the determination, regardless of whether the document, record or information was relied on in making the determination. Relevant information includes any statement of policy, procedure or administrative process concerning the denied treatment option or benefit for the diagnosis, regardless of whether it was relied on in making the determination.

     (6) If the carrier and health plan determines that additional information is necessary to perfect the claim, the carrier and health plan must provide a description of such additional material or information, with an explanation of why such material is necessary, as soon as the need is identified.

     (7) An enrollee or covered person may request that a carrier and health plan identify medical or vocational experts whose advice was obtained in connection with an adverse benefit determination, without regard to whether the advice was relied on in making the determination.

     (8) The notification must include language similar to the following: If you request a review of this adverse benefit determination, {company name} will continue to provide coverage for the disputed benefit pending the outcome of the review. If {company name} prevails in the appeal, you may be responsible for the cost of coverage received during the review period. The decision at the next level of review is binding unless other remedies are available under state or federal law. [Company name] must provide benefits, including making payment on a claim, pursuant to the final external review decision without delay, regardless of whether [company name] intends to seek judicial review of the external review decision, and unless or until there is a judicial decision changing the final determination."

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     Reviser's note: The brackets and enclosed material in the text of the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.

     Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 284-43-528   Electronic disclosure and communication by carriers.   (1) Except as otherwise provided by applicable law, rule, or regulation, a carrier or health plan furnishing documents through electronic media is deemed to satisfy the notice and disclosure requirements regarding adverse benefit determinations with respect to applicants, covered persons, and appellants or their representative, if the carrier takes appropriate and necessary measures reasonably calculated to ensure that the system for furnishing documents:

     (a) Results in actual receipt of transmitted information (e.g., using return-receipt or notice of undelivered electronic mail features, conducting periodic reviews or surveys to confirm receipt of the transmitted information); and

     (b) Protects the confidentiality of personal information relating to the individual's accounts and benefits (e.g., incorporating into the system measures designed to preclude unauthorized receipt of or access to such information by individuals other than the individual for whom the information is intended);

     (c) Notice is provided in electronic or nonelectronic form, at the time a document is furnished electronically, that apprises the recipient of the significance of the document when it is not otherwise reasonably evident as transmitted (e.g., the attached document describes the internal review process used by your plan) and of the right to request and obtain a paper version of such document; and

     (d) Upon request, the appellant or their representative is furnished a paper version of the electronically furnished documents.

     (2) Subsection (1) of this section only applies to the following individuals:

     (a) An appellant who affirmatively consents, in electronic or nonelectronic form, to receiving documents through electronic media and has not withdrawn such consent.

     (b) In the case of documents to be furnished through the internet or other electronic communication network, has affirmatively consented or confirmed consent electronically, in a manner that reasonably demonstrates the individual's ability to access information in the electronic form that will be used to provide the information that is the subject of the consent, and has provided an address for the receipt of electronically furnished documents;

     (c) Prior to consenting, is provided, in electronic or nonelectronic form, a clear and conspicuous statement indicating:

     (i) The types of documents to which the consent would apply;

     (ii) That consent can be withdrawn at any time without charge;

     (iii) The procedures for withdrawing consent and for updating the individual's electronic address for receipt of electronically furnished documents or other information;

     (iv) The right to request and obtain a paper version of an electronically furnished document, including whether the paper version will be provided free of charge; and

     (v) Any hardware and software requirements for accessing and retaining the documents.

     (d) Following consent, if a change in hardware or software requirements needed to access or retain electronic documents creates a material risk that the individual will be unable to access or retain electronically furnished documents, the carrier must provide a statement of the revised hardware or software requirements for access to and retention of electronically furnished documents, and provide the individual receiving electronic communications with the right to withdraw consent without charge and without the imposition of any condition or consequence that was not disclosed at the time of the initial consent. The carrier or health plan must request and receive a new consent following a hardware or software requirement change as described in this subsection, to the receipt of documents through electronic media.

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NEW SECTION
WAC 284-43-529   Internal review of adverse benefit determinations.   Each carrier and health plan must include in its review process the opportunity for internal review of an adverse benefit determination. An appellant seeking review of an adverse benefit determination must use the carrier and health plan's review process. Treating providers may seek review on a patient's behalf, regardless of whether the provider is affiliated with the carrier on a contracted basis.

     (1) When a carrier and health plan receive a written request for review, the carrier must reconsider the adverse benefit determination, and notify the appellant of its decision within fourteen days of receipt of the request for review.

     (2) For good cause, carriers may extend the time to make a review determination by no more than thirty days from the date of receiving the request for review. The thirty day response time may be waived if an appellant provides informed consent in writing, to extend the review period to a specific, agree-upon date for determination.

     (3) The carrier or health plan must provide the appellant with any new or additional evidence considered, whether relied upon, generated by or at the direction of the carrier or health plan, in connection with the claim. The evidence must be provided free of charge to the appellant, and sufficiently in advance of the date the notice of final internal review determination must be provided that the appellant has a reasonable opportunity to respond prior to that date. (4) Before a carrier and health plan may issue a final internal adverse determination based on a new or additional rationale, the appellant must be provided with the new or additional rationale free of charge as soon as possible. If appellant requests an extension in order to respond to a new or additional rationale, a carrier and health plan must extend the determination date for a reasonable amount of time.

     (4) Before a carrier and health plan may issue a final internal adverse determination based on a new or additional rationale, the appellant must be provided with the new or additional rationale free of charge as soon as possible. The new rationale must be provided sufficiently in advance of the date the notice of final determination must be provided by the carrier or health plan, so that the appellant has a reasonable opportunity to respond prior to that date. If appellant requests an extension in order to respond to a new or additional rationale, a carrier and health plan must extend the determination date for a reasonable amount of time.

     (5) A carrier and health plan's review process must provide appellant with the opportunity to submit information, documents, written comments, records, evidence, and testimony, including information and records obtained through a second opinion. An appellant has the right to review the carrier and health plan's file and obtain a free copy of all documents, records and information relevant to any claim that is the subject of the determination being appealed.

     (6) A carrier and health plan's review process must include the requirement that the carrier and health plan affirmatively review and investigate the determination being reviewed, and consider all information submitted by the appellant prior to issuing a determination.

     (7) Reviews of adverse determinations must be performed by health care providers or staff who were not involved in the initial decision, and who are not subordinates of the persons involved in the initial decision. If the determination involves, even in part, medical judgment, the reviewer must be or must consult with a health care professional who has appropriate training and experience in the field of medicine encompassing the appellant's condition or disease and make a determination within the clinical standard of care for an appellant's condition or disease.

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     Reviser's note: The typographical errors in the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 284-43-530   Exhaustion of internal review remedies.   (1) If a carrier or health plan fails to strictly adhere to its requirements with respect to the internal review, the internal review process is deemed exhausted, and the appellant may request external review without receiving an internal review determination from the carrier or health plan.

     (a) Exception: When an appellant seeks external review based on this section, a carrier or health plan may challenge the request on the basis that its violations are de minimis, and do not cause and are not likely to cause, prejudice or harm to the appellant. The carrier or health plan may challenge external review on this basis either in court or to the independent review organization.

     (i) This exception applies only if the external reviewer or court determines that the carrier has demonstrated that the violation was for good cause or due to matters beyond the control of the issuer and that the violation occurred in the context of an ongoing, good faith exchange of information between the carrier or health plan and the appellant.

     (ii) This exception is not available if the violation is part of a pattern or practice of violations by the carrier or health plan.

     (b) The appellant may request a written explanation of the violation from the carrier and the carrier must provide such explanation within 10 calendar days, including a specific description of its basis, if any, for asserting that the violation should not cause the internal claims and appeals process to be deemed exhausted.

     (c) If the independent review organization or court determines that an appellant has not exhausted the internal review process based on such a challenge on the basis that the carrier or health plan met the standards for this exception, the carrier or health plan must provide the appellant with notice of the opportunity to resubmit and pursue the internal appeal of the claim within a reasonable time, not to exceed 10 days, of receiving the independent review organization determination. The appellant's time frame to refile the request for review begins to run upon receipt of the notice from the carrier.

     (2) The review process for group health plans must not contain any provision or be administered so that an appellant must file more than two requests for review prior to bringing a civil action. For individual health plans, carriers must provide for only one level of internal review before issuing a final determination, and may not require two levels of internal review.

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NEW SECTION
WAC 284-43-535   Notice of internal review determination.   Each carrier and health plan's review process must require delivery of written notification to the appellant of the internal review determination. In addition to the requirements of WAC 284-43-526, the written determination must include:

     (a) The actual reasons for the determination;

     (b) Instructions for obtaining further review of the determination, either through a second level of internal review or using the external review process;

     (c) The clinical rationale for the decision, which may be in summary form; and

     (d) Instructions on obtaining the clinical review criteria used to make the determination.

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NEW SECTION
WAC 284-43-540   Expedited review.   (1) A carrier and health plan's internal and external review processes must permit an expedited review of an adverse benefit determination at any time in the review process, or concurrently, if:

     (a) The appellant is currently receiving or is prescribed treatment for a medical condition; and

     (b) any treating provider for the appellant, regardless of their affiliation with the carrier and health plan, believes that a delay in treatment based on the standard review time may seriously jeopardize the appellant's life, overall health or ability to regain maximum function, or would subject the appellant to severe and intolerable pain, or

     (c) the determination is related to an issue related to admission, availability of care, continued stay or health care services received on an emergency basis where the appellant has not been discharged.

     (2) An appellant is not entitled to expedited review if the treatment has already been delivered, and the review involves payment for the delivered treatment, if the situation is not urgent or if the situation does not involve the delivery of services for an existing condition, illness or disease.

     (3) A carrier and health plan's expedited review process must:

     (a) Permit the covered person, their authorized representative or their provider to file an expedited appeal orally;

     (b) Require the carrier to respond as expeditiously as possible, preferably within twenty-four hours, but in no case longer than seventy-two hours. The carrier's response to an expedited review may be delivered verbally, and must be reduced to and issued in writing not later than seventy-two hours after the date of the decision. Regardless of who makes the carrier and health plan's determination in response to requests for expedited review, the time frame for providing a response begins when the carrier first receives the request;

     (c) Notify the appellant as soon as possible if additional information is necessary to determine whether the service or treatment request being reviewed is covered under the health plan or eligible for benefits.

     (4) If a treating health care provider determines that delay could jeopardize the covered person's health or ability to regain maximum function, a carrier must presume the need for expeditious review, including the need for an expeditious determination in any independent review under RCW 48.43.535.

     (5) A carrier may not require exhaustion of the internal appeal process to request an external review in urgent care situations that justify expedited review.

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NEW SECTION
WAC 284-43-545   Concurrent expedited review of adverse benefit determinations.   A carrier and health benefit plan must offer the right to request concurrent expedited internal and external reviews of adverse benefit determinations. When responding to a request for concurrent expedited internal and external review, a carrier and health benefit plan may not extend the timelines by making the decision consecutively, but must apply the requisite timelines concurrently. A carrier and health benefit plan may not deny a request for concurrent expedited review, unless the conditions for expedited review in WAC 284-43-540 are not met. Neither a carrier nor a health plan may require exhaustion of internal review if concurrent expedited review is requested by an appellant.

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NEW SECTION
WAC 284-43-550   External review of adverse benefit determinations.   When the internal review of an adverse benefit determination is final, or is deemed exhausted, the appellant may request an external review of the final internal adverse benefit determination. If the appellant requests an external review of a final internal adverse determination, the carrier or health plan must cooperatively participate in that review. Carriers and health plans must inform appellants of their right to external review, and explain the process that they must use to exercise that right.

     (1) Appellants must be provided the right to external review of adverse benefit determinations based on medical necessity, appropriateness, health care setting, level of care, or effectiveness of a covered benefit. The carrier and health plan may not establish a minimum dollar amount restriction as a predicate for an appellant to seek external review.

     (2) Carriers must use the rotational registry system of certified independent review organizations (IRO) established by the commissioner, and must select reviewing IROs in the rotational manner described in the rotational registry system. A carrier may not make an assignment to an IRO out of sequence for any reason other than the existence of a conflict of interest, as set forth in WAC 246-305-030.

     (3) The rotational registry system, a current list of certified IROs, IRO assignment instructions, and an IRO assignment form to be used by carriers are available on the insurance commissioner's web site (www.insurance.wa.gov).

     (4) In addition to the requirements set forth in RCW 48.43.535, the carrier and health plan must:

     (a) Make available to the appellant and to any provider acting on behalf of the appellant all materials provided to an IRO reviewing the carrier's determination;

     (b) Provide IRO review without imposing any cost to the appellant or their provider; and

     (c) Provide IROs with:

     (i) All relevant clinical review criteria used by the carrier and other relevant medical, scientific, and cost-effectiveness evidence;

     (ii) The attending or ordering provider's recommendations; and

     (iii) A copy of the terms and conditions of coverage under the relevant health plan.

     (d) Within one day of selecting the IRO, notify the appellant the name of the IRO and its contact information. This requirement is intended to comply with the federal standard that appellants receive notice of the IRO's identity and contact information within one day of assignment. The notice from the carrier must explain that the appellant is permitted five business days from receipt of the notice to submit additional information in writing to the IRO. The IRO must consider this information when conducting its review.

     (5) A carrier may waive a requirement that internal appeals must be exhausted before an appellant may proceed to an independent review of an adverse determination.

     (6) Upon receipt of the information provided by the appellant to the IRO pursuant to RCW 48.43.535 and this section, a carrier may reverse its final internal adverse determination. If it does so, it must immediately notify the IRO and the appellant.

     (7) Carriers must report to the commissioner each assignment made to an IRO not later than one business day after an assignment is made. Information regarding the enrollee's personal health may not be provided with the report.

     (8) The requirements of this section are in addition to the requirements set forth in RCW 48.43.535 and 43.70.235, and rules adopted by the department of health in chapter 246-305 WAC.

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Subchapter F


GRIEVANCE AND COMPLAINT PROCEDURES GRANDFATHERED HEALTH PLAN APPEAL PROCEDURES

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.
NEW SECTION
WAC 284-43-610   Application of Subchapter F.   For any grandfathered health plan, a carrier may continue to implement its grievance and complaint process as required by RCW 48.43.530 and RCW 48.43.535 by complying with the procedures and standards set forth in WAC 284-43-615 through 284-43-630. A health plan is grandfathered if the carrier correctly designates it as such under the federal definition standards for grandfathered health plans as set forth in the Affordable Care Act (2010), P.L. 111-148, as amended, and its implementing federal regulations.

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     Reviser's note: The above new section was filed by the agency as WAC 284-43-610, however WAC 284-43-610 was repealed in 2001 and WAC 284-43-610 should not be reused. Pursuant to RCW 34.08.040, the section is in the same form as filed by the agency.

AMENDATORY SECTION [(Amending Matter No. R 2000-02, filed 1/9/01)]WAC 284-43-615   Grievance and complaint Appeal procedures -- Generally.   (1) Each carrier must adopt and implement a comprehensive process for the resolution of covered persons' grievances and appeals of adverse determinations. This process shall meet accepted national certification standards such as those used by the National Committee for Quality Assurance except as otherwise required by this chapter.

     (2) This process must conform to the provisions of this subchapter F and each carrier must:

     (a) Provide a clear explanation of the grievance appeal process upon request, upon enrollment to new covered persons, and annually to covered persons and subcontractors of the carrier.

     (b) Ensure that the grievance appeal process is accessible to enrollees who are limited-English speakers, who have literacy problems, or who have physical or mental disabilities that impede their ability to file an appeal grievance.

     (c) Process as a grievance a covered person's expression of dissatisfaction about customer service or the quality or availability of a health service.

     (dc) Implement procedures for registering and responding to oral and written grievances appeals in a timely and thorough manner including the notification of a covered person that a grievance or appeal has been received.

     (ed) Assist the covered person with all grievance and appeal processes.

     (fe) Cooperate with any representative authorized in writing by the covered person.

     (gf) Consider all information submitted by the covered person or representative.

     (hg) Investigate and resolve all grievances and appeals.

     (ih) Provide information on the covered person's right to obtain second opinions.

     (ji) Track each appeal until final resolution; maintain, and make accessible to the commissioner for a period of three years, a log of all appeals; and identify and evaluate trends in appeals.

[Statutory Authority: RCW 48.02.060, 48.18.120, 48.20.450, 48.20.460, 48.30.010, 48.44.050, 48.46.100, 48.46.200, 48.43.505, 48.43.510, 48.43.515, 48.43.520, 48.43.525, 48.43.530, 48.43.535. 01-03-033 (Matter No. R 2000-02), § 284-43-615, filed 1/9/01, effective 7/1/01.]

     Reviser's note: The bracketed material preceding the section above was supplied by the code reviser's office.

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.

AMENDATORY SECTION [(Amending Matter No. R 2000-02, filed 1/9/01)]WAC 284-43-610   Procedures for review and appeal of adverse determinations.   (1) A covered person or the covered person's representative, including the treating provider (regardless of whether the provider is affiliated with the carrier) acting on behalf of the covered person may appeal an adverse determination in writing. The carrier must reconsider the adverse determination and notify the covered person of its decision within fourteen days of receipt of the appeal unless the carrier notifies the covered person that an extension is necessary to complete the appeal; however, the extension cannot delay the decision beyond thirty days of the request for appeal, without the informed, written consent of the coverage covered person.

     (2) Whenever a health carrier makes an adverse determination and delay would jeopardize the covered person's life or materially jeopardize the covered person's health, the carrier shall expedite and process either a written or an oral appeal and issue a decision no later than seventy-two hours after receipt of the appeal. If the treating health care provider determines that delay could jeopardize the covered person's health or ability to regain maximum function, the carrier shall presume the need for expeditious review, including the need for an expeditious determination in any independent review under WAC 284-43-630.

     (3) A carrier may not take or threaten to take any punitive action against a provider acting on behalf or in support of a covered person appealing an adverse determination.

     (4) Appeals of adverse determinations shall be evaluated by health care providers who were not involved in the initial decision and who have appropriate expertise in the field of medicine that encompasses the covered person's condition or disease.

     (5) All appeals must include a review of all relevant information submitted by the covered person or a provider acting on behalf of the covered person.

     (6) The carrier shall issue to affected parties and to any provider acting on behalf of the covered person a written notification of the adverse determination that includes the actual reasons for the determination, the instructions for obtaining an appeal of the carrier's decision, a written statement of the clinical rationale for the decision, and instructions for obtaining the clinical review criteria used to make the determination.

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     Reviser's note: The bracketed material preceding the section above was supplied by the code reviser's office.

     Reviser's note: The above section, filed by the agency as an amendment of WAC 284-43-610 , appears to be an amendment of WAC 284-43-620, there being no WAC 284-43-610 in existence. Pursuant to RCW 34.08.040, the section is published in the same form as filed by the agency.

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.SUBCHAPTER G


GRIEVANCES
NEW SECTION
WAC 284-43-710   Definition.   This definition applies to subchapter G. "Grievant" means a person filing a grievance as defined in WAC 284-43-130, and is not an appellant under either Subchapter E or F of this chapter.

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     Reviser's note: The above new section was filed by the agency as WAC 284-43-710, however WAC 284-43-710 was repealed in 2008 and WAC 284-43-710 should not be reused. Pursuant to RCW 34.08.040, the section is in the same form as filed by the agency.
NEW SECTION
WAC 284-43-720   Grievance process -- Generally.   (1) Each carrier and health plan must offer applicants, covered persons, and providers a way to resolve grievances. A carrier must promptly provide information regarding the use of its grievance process to an applicant or enrollee who wants to submit a grievance, and assist that person in the filing of the grievance when a complaint is stated and assistance requested to put that complaint into writing.

     (2) Each carrier must maintain a log or otherwise register oral and written grievances, and retain this log or record for six years. It must be available for review by the commissioner upon request. The log must identify the health plan, if any, under which the person was enrolled, the name of the grievant, the resolution of each grievance, the date of receipt, the date of resolution, and if different than the resolution date, the date notice was provided to the person registering the grievance. If a health plan is administered by a third party under contract to the carrier, the third party may keep the log and make it available through the carrier if requested by the commissioner, or can forward the information to the carrier to maintain.

     (3) Each carrier and health plan must send notice of receipt of a grievance to the grievant within two business days of receiving the grievance.

     (4) When resolving a grievance, a carrier must consider all information submitted by the person registering the grievance, and perform a reasonable investigation or review of the facts policies, procedures or practices related to the grievance. A carrier and health plan must determine its resolution in response to the grievance within forty-five business days, and must notify the grievant of its determination within five business days of making its determination.

     (5) Grievance determinations are not adverse benefit determinations and do not establish the right to internal or external review of a carrier or health plan's resolution of the grievance.

     (6) Nothing in this section prohibits a carrier from creating or using its own system to categorize the nature of grievances in order to collect data if the system permits reporting of the data specified in (2) of this section.

     (7) This section is effective as of July 29, 2011.

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     Reviser's note: The above new section was filed by the agency as WAC 284-43-720, however WAC 284-43-720 was repealed in 2008 and WAC 284-43-720 should not be reused. Pursuant to RCW 34.08.040, the section is in the same form as filed by the agency.

     Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.

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