376.1350.  Definitions. — For purposes of sections 376.1350 to 376.1390^*, the following terms mean:

  (1)  "Adverse determination", a determination by a health carrier or a utilization review entity that an admission, availability of care, continued stay or other health care service furnished or proposed to be furnished to an enrollee has been reviewed and, based upon the information provided, does not meet the utilization review entity or health carrier's requirements for medical necessity, appropriateness, health care setting, level of care or effectiveness, or are experimental or investigational, and the payment for the requested service is therefore denied, reduced or terminated;

  (2)  "Ambulatory review", utilization review of health care services performed or provided in an outpatient setting;

  (3)  "Case management", a coordinated set of activities conducted for individual patient management of serious, complicated, protracted or other health conditions;

  (4)  "Certification", a determination by a health carrier or a utilization review entity 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, and that payment will be made for that health care service provided the patient is an enrollee of the health benefit plan at the time the service is provided;

  (5)  "Clinical peer", a physician or other health care professional who holds a nonrestricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review;

  (6)  "Clinical review criteria", the written policies, written screening procedures, drug formularies or lists of covered drugs, determination rules, decision abstracts, clinical protocols, medical protocols, practice guidelines, and any other criteria or rationale used by the health carrier or utilization review entity to determine the necessity and appropriateness of health care services;

  (7)  "Concurrent review", utilization review conducted during a patient's hospital stay or course of treatment;

  (8)  "Covered benefit" or "benefit", a health care service that an enrollee is entitled under the terms of a health benefit plan;

  (9)  "Director", the director of the department of commerce and insurance;

  (10)  "Discharge planning", the formal process for determining, prior to discharge from a facility, the coordination and management of the care that a patient receives following discharge from a facility;

  (11)  "Drug", any substance prescribed by a licensed health care provider acting within the scope of the provider's license and that is intended for use in the diagnosis, mitigation, treatment or prevention of disease.  The term includes only those substances that are approved by the FDA for at least one indication;

  (12)  "Emergency medical condition", the sudden and, at the time, unexpected onset of a health condition that manifests itself by symptoms of sufficient severity, regardless of the final diagnosis that is given, that would lead a prudent lay person, possessing an average knowledge of medicine and health, to believe that immediate medical care is required, which may include, but shall not be limited to:

  (a)  Placing the person's health in significant jeopardy;

  (b)  Serious impairment to a bodily function;

  (c)  Serious dysfunction of any bodily organ or part;

  (d)  Inadequately controlled pain; or

  (e)  With respect to a pregnant woman who is having contractions:

  a.  That there is inadequate time to effect a safe transfer to another hospital before delivery; or

  b.  That transfer to another hospital may pose a threat to the health or safety of the woman or unborn child;

  (13)  "Emergency service", a health care item or service furnished or required to evaluate and treat an emergency medical condition, which may include, but shall not be limited to, health care services that are provided in a licensed hospital's emergency facility by an appropriate provider;

  (14)  "Enrollee", a policyholder, subscriber, covered person or other individual participating in a health benefit plan;

  (15)  "FDA", the federal Food and Drug Administration;

  (16)  "Facility", 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;

  (17)  "Grievance", a written complaint submitted by or on behalf of an enrollee regarding the:

  (a)  Availability, delivery or quality of health care services, including a complaint regarding an adverse determination made pursuant to utilization review;

  (b)  Claims payment, handling or reimbursement for health care services; or

  (c)  Matters pertaining to the contractual relationship between an enrollee and a health carrier;

  (18)  "Health benefit plan", a policy, contract, certificate or agreement entered into, offered or issued by a health carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services; except that, health benefit plan shall not include any coverage pursuant to liability insurance policy, workers' compensation insurance policy, or medical payments insurance issued as a supplement to a liability policy;

  (19)  "Health care professional", a physician or other health care practitioner licensed, accredited or certified by the state of Missouri to perform specified health services consistent with state law;

  (20)  "Health care provider" or "provider", a health care professional or a facility;

  (21)  "Health care service", a service for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease, including but not limited to the provision of drugs or durable medical equipment;

  (22)  "Health carrier", an entity subject to the insurance laws and regulations of this state 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 nonprofit hospital and health service corporation, or any other entity providing a plan of health insurance, health benefits or health services; except that such plan shall not include any coverage pursuant to a liability insurance policy, workers' compensation insurance policy, or medical payments insurance issued as a supplement to a liability policy;

  (23)  "Health indemnity plan", a health benefit plan that is not a managed care plan;

  (24)  "Managed care plan", a health benefit plan that either requires an enrollee to use, or creates incentives, including financial incentives, for an enrollee to use, health care providers managed, owned, under contract with or employed by the health carrier;

  (25)  "Participating provider", a provider who, under a contract with the health carrier or with its contractor or subcontractor, has agreed to provide health care services to enrollees with an expectation of receiving payment, other than coinsurance, co-payments or deductibles, directly or indirectly from the health carrier;

  (26)  "Peer-reviewed medical literature", a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the International Committee of Medical Journal Editors to have met the uniform requirements for manuscripts submitted to biomedical journals or is published in a journal specified by the United States Department of Health and Human Services pursuant to Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. Section 1395x), as amended, as acceptable peer-reviewed medical literature.  Peer-reviewed medical literature shall not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier;

  (27)  "Person", an individual, a corporation, a partnership, an association, a joint venture, a joint stock company, a trust, an unincorporated organization, any similar entity or any combination of the foregoing;

  (28)  "Prior authorization", a certification made pursuant to a prior authorization review, or notice as required by a health carrier or utilization review entity prior to the provision of health care services;

  (29)  "Prior authorization review", utilization review conducted prior to an admission or a course of treatment, including but not limited to pre-admission review, pretreatment review, utilization review, and case management;

  (30)  "Retrospective review", utilization review of medical necessity that is conducted after services 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;

  (31)  "Second opinion", an opportunity or requirement to obtain a clinical evaluation by a provider other than the one originally making a recommendation for a proposed health service to assess the clinical necessity and appropriateness of the initial proposed health service;

  (32)  "Stabilize", with respect to an emergency medical condition, that no material deterioration of the condition is likely to result or occur before an individual may be transferred;

  (33)  "Standard reference compendia":

  (a)  The American Hospital Formulary Service-Drug Information; or

  (b)  The United States Pharmacopoeia-Drug Information;

  (34)  "Utilization review", 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, prior authorization review, second opinion, certification, concurrent review, case management, discharge planning or retrospective review.  Utilization review shall not include elective requests for clarification of coverage;

  (35)  "Utilization review entity", a utilization review agent as defined in section 374.500, or an individual or entity that performs prior authorization reviews for a health carrier or health care provider.  A health carrier or health care provider is a utilization review entity if it performs prior authorization review.