In this article, unless the context otherwise requires:

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1. "Clinical practice guidelines" means a systematically developed statement to assist health care providers and patients in making decisions about appropriate health care for specific clinical circumstances and conditions.

2. "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines that are used by a health care insurer, pharmacy benefit manager or utilization review agent to determine the medical necessity and appropriateness of health care services.

3. "Exigent circumstance" means the action of a health care insurer, pharmacy benefit manager or utilization review agent on a step therapy protocol exception request within the application of the time periods for making a nonexpedited decision, as determined and documented by the prescribing provider, could seriously jeopardize the insured’s, enrollee’s or subscriber’s life, health or ability to regain maximum function or cause a significant negative change in the patient’s medical condition.

4. "Health care insurer" has the same meaning prescribed in section 20-2501.

5. "Health care plan" means a policy, contract or evidence of coverage that a health care insurer issues to an insured, enrollee or subscriber.

6. "Medically necessary" means, with respect to a prescription drug, appropriate under the applicable standard of care:

(a) To improve or preserve health, life or function.

(b) To slow the deterioration of health, life or function.

(c) For the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury.

7. "Methodologist" means a person that manages research design for the purpose of accurate and unbiased data collection and that has experience testing questions that are germane to the subject of the research.

8. "Pharmaceutical sample" means a unit of a prescription drug that is not intended to be sold but is intended to promote the sale of the prescription drug.

9. "Pharmacy benefit manager" has the same meaning prescribed in section 20-3321.

10. "Serious adverse reaction":

(a) Means an adverse event or suspected adverse reaction if, in the view of either the investigator or sponsor, the event or reaction results in any of the following outcomes:

(i) Death.

(ii) A life-threatening adverse event.

(iii) Inpatient hospitalization or prolonging existing hospitalization.

(iv) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

(v) A congenital anomaly or birth defect.

(b) Includes an event or reaction that might not result in death, be life threatening or require hospitalization but, based on appropriate medical judgment, could jeopardize the patient’s health or medical situation by requiring medical or surgical intervention to prevent at least one of the outcomes listed in subdivision (a) of this paragraph.

11. "Step therapy exception" means a step therapy protocol that is overridden in favor of immediate coverage of a health care provider’s selected prescription drug.

12. "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs that are for a specified medical condition and that are medically necessary for a particular patient are covered by a health care insurer under a health care plan.

13. "Utilization review" has the same meaning prescribed in section 20-2501.

14. "Utilization review agent" has the same meaning prescribed in section 20-2530.