As used in this chapter, unless the context otherwise requires:

“Adverse action” means an adverse determination or a final adverse determination.

“Adverse determination” means a determination by a health carrier or its designated utilization review organization that an admission, availability of care, continued stay, or other health care service that is a covered benefit has been reviewed and, based upon the information provided, does not meet the health carrier’s requirements for medical necessity, appropriateness, health care setting, level of care, or effectiveness, and the requested service or payment for the service is therefore denied, reduced, or terminated.

“Ambulatory review” means a utilization review of health care services performed or provided in an outpatient setting.

“Appeal” means a request from an enrollee to change a previous decision made by the health carrier.

“Appointed representative” means a person who is expressly permitted by the enrollee or who has the power under Hawaii law to make health care decisions on behalf of the enrollee, including:

(1) A person to whom an enrollee has given express written consent to represent the enrollee in an external review;

(2) A person authorized by law to provide substituted consent for an enrollee;

(3) A family member of the enrollee or the enrollee’s treating health care professional, only when the enrollee is unable to provide consent;

(4) A court-appointed legal guardian;

(5) A person who has a durable power of attorney for health care; or

(6) A person who is designated in a written advance directive;

provided that an appointed representative shall include an “authorized representative” as used in the federal Patient Protection and Affordable Care Act.

“Best evidence” means evidence based on:

(1) Randomized clinical trials;

(2) If randomized clinical trials are not available, cohort studies or case-control studies;

(3) If the trials in paragraphs (1) and (2) are not available, case-series; or

(4) If the sources of information in paragraphs (1), (2), and (3) are not available, expert opinion.

“Case-control study” means a prospective evaluation of two groups of patients with different outcomes to determine which specific interventions the patients received.

“Case management” means a coordinated set of activities conducted for individual patient management of serious, complicated, protracted, or other health conditions.

“Case-series” means an evaluation of patients with a particular outcome, without the use of a control group.

“Certification” means a determination by a health carrier or its designated utilization review organization that an admission, availability of care, continued stay, or other health care service has been reviewed and, based on the information provided, satisfies the health carrier’s requirements for medical necessity, appropriateness, health care setting, level of care, and effectiveness.

“Clinical review criteria” means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

“Cohort study” means a prospective evaluation of two groups of patients with only one group of patients receiving a specific intervention.

“Commissioner” means the insurance commissioner.

“Complaint” means an expression of dissatisfaction, either oral or written.

“Concurrent review” means a utilization review conducted during a patient’s hospital stay or course of treatment.

“Covered benefits” or “benefits” means those health care services to which an enrollee is entitled under the terms of a health benefit plan.

“Discharge planning” means the formal process for determining, prior to discharge from a facility, the coordination and management of the care that an enrollee receives following discharge from a facility.

“Disclose” means to release, transfer, or otherwise divulge protected health information to any person other than the individual who is the subject of the protected health information.

“Emergency services” means services provided to an enrollee when the enrollee has symptoms of sufficient severity, including severe pain, such that a layperson could reasonably expect, in the absence of medical treatment, to result in placing the enrollee’s health or condition in serious jeopardy, serious impairment of bodily functions, serious dysfunction of any bodily organ or part, or death.

“Enrollee” means a person who enters into a contractual relationship under or who is provided with health care services or benefits through a health benefit plan.

“Evidence-based standard” means the conscientious, explicit, and judicious use of the current best evidence based on the overall systematic review of the research in making decisions about the care of individual patients.

“Expert opinion” means a belief or interpretation by specialists with experience in a specific area about the scientific evidence pertaining to a particular service, intervention, or therapy.

“External review” means a review of an adverse determination (including a final adverse determination) conducted by an independent review organization pursuant to this chapter.

“Facility” means an institution providing health care services or a health care setting, 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 health settings.

“Final adverse determination” means an adverse determination involving a covered benefit that has been upheld by a health carrier or its designated utilization review organization at the completion of the health carrier’s internal grievance process procedures, or an adverse determination with respect to which the internal appeals process is deemed to have been exhausted under section 432E-33(b).

“Health benefit plan” means a policy, contract, certificate or agreement offered or issued by a health carrier to provide, deliver, arrange for, pay or reimburse any of the costs of health care services.

“Health care professional” means an individual licensed, accredited, or certified to provide or perform specified health care services in the ordinary course of business or practice of a profession consistent with state law.

“Health care provider” or “provider” means a health care professional.

“Health care services” means services for the diagnosis, prevention, treatment, cure, or relief of a health condition, illness, injury, or disease.

“Health carrier” means an entity subject to the insurance laws and rules of this State, or subject to the jurisdiction of the commissioner, that contracts or offers to contract to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services, including a sickness and accident insurance company, a health maintenance organization, a mutual benefit society, a nonprofit hospital and health service corporation, or any other entity providing a plan of health insurance, health benefits or health care services.

“Health maintenance organization” means a health maintenance organization as defined in § 432D-1.

“Independent review organization” means an independent entity that conducts independent external reviews of adverse determinations and final adverse determinations.

“Internal review” means the review under § 432E-5 of an enrollee’s complaint by a health carrier.

“Managed care plan” means any plan, policy, contract, certificate, or agreement, regardless of form, offered or administered by any person or entity, including but not limited to an insurer governed by chapter 431, a mutual benefit society governed by chapter 432, a health maintenance organization governed by chapter 432D, a preferred provider organization, a point of service organization, a health insurance issuer, a fiscal intermediary, a payor, a prepaid health care plan, and any other mixed model, that provides for the financing or delivery of health care services or benefits to enrollees through:

(1) Arrangements with selected providers or provider networks to furnish health care services or benefits; and

(2) Financial incentives for enrollees to use participating providers and procedures provided by a plan;

provided that for the purposes of this chapter, an employee benefit plan shall not be deemed a managed care plan with respect to any provision of this chapter or to any requirement or rule imposed or permitted by this chapter that is superseded or preempted by federal law.

“Medical director” means the person who is authorized under a health carrier and who makes decisions for the health carrier denying or allowing payment for medical treatments, services, or supplies based on medical necessity or other appropriate medical or health plan benefit standards.

“Medical necessity” means a health intervention that meets the criteria enumerated in section 432E-1.4.

“Medical or scientific evidence” means evidence found in the following sources:

(1) Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally-recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts, who are not part of the editorial staff;

(2) Peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia, and other medical literature that meet the criteria of the National Institutes of Health’s National Library of Medicine for indexing in Index Medicus and Elsevier Science Ltd. for indexing in Excerpta Medicas;

(3) Medical journals recognized by the United States Secretary of Health and Human Services under section 1861(t)(2) of the federal Social Security Act;

(4) The following standard reference compendia:

(A) The American Hospital Formulary Service-Drug Information;

(B) Drug Facts and Comparisons;

(C) The American Dental Association Accepted Dental Therapeutics; and

(D) The United States Pharmacopeia Drug Information;

(5) Findings, studies, or research conducted by or under the auspices of federal government agencies and nationally-recognized federal research institutes, including:

(A) The federal Agency for Healthcare Research and Quality;

(B) The National Institutes of Health;

(C) The National Cancer Institute;

(D) The National Academy of Sciences;

(E) The Centers for Medicare and Medicaid Services;

(F) The federal Food and Drug Administration; and

(G) Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or

(6) Any other medical or scientific evidence that is comparable to the sources listed in paragraphs (1) through (5).

“Participating provider” means a licensed or certified provider of health care services or benefits, including mental health services and health care supplies, who has entered into an agreement with a health carrier to provide those services or supplies to enrollees.

“Prospective review” means utilization review conducted prior to an admission or a course of treatment.

“Protected health information” means health information as defined in the federal Health Insurance Portability and Accountability Act and related federal rules.

“Randomized clinical trial” means a controlled, prospective study of patients who have been randomized into an experimental group and a control group at the beginning of the study with only the experimental group of patients receiving a specific intervention, which includes study of the groups for variables and anticipated outcomes over time.

“Retrospective review” means a review of medical necessity conducted after services that have been provided to a patient, but does not include the review of a claim that is limited to an evaluation of reimbursement levels, veracity of documentation, accuracy of coding, or adjudication for payment.

“Reviewer” means an independent reviewer with clinical expertise either employed by or contracted by an independent review organization to perform external reviews.

“Second opinion” means an opportunity or requirement to obtain a clinical evaluation by a provider other than the one originally making a recommendation for a proposed health care service to assess the clinical necessity and appropriateness of the initial proposed health care service.

“Specifically excluded” means that the coverage provisions of the health care plan, when read together, clearly and specifically exclude coverage for a health care service.

“Utilization review” means a set of formal techniques designed to monitor the use of, or evaluate the clinical necessity, appropriateness, efficacy, or efficiency of, health care services, procedures, or settings. Techniques may include ambulatory review, prospective review, second opinion, certification, concurrent review, case management, discharge planning, or retrospective review.

“Utilization review organization” means an entity that conducts utilization review other than a health carrier performing a review for its own health benefit plans.