39-9403. DEFINITIONS. As used in this chapter:

(1) "Eligible patient" or "patient" means an individual who has a terminal illness and has:

(a) Considered all other treatment options currently approved by the United States food and drug administration;

(b) Received a recommendation from the patient’s treating physician for an investigational drug, biological product or device for purposes related to the terminal illness;

(c) Given written, informed consent for the use of the recommended investigational drug, biological product or device; and

(d) Received documentation from the eligible patient’s treating physician that the eligible patient meets the requirements of this subsection.

(2) "Investigational drug, biological product or device" means a drug, biological product or device that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial.

(3) "Terminal illness" means a progressive disease or medical or surgical condition that:

(a) Entails functional impairment that significantly impacts the patient’s activities of daily living;

(b) Is not considered by a treating physician to be reversible even with administration of current United States food and drug administration-approved and available treatments; and

(c) Without life-sustaining procedures, will soon result in death.

(4) "Written, informed consent" means a written document that is signed by the eligible patient and, if the patient is a minor, a parent or legal guardian, which document is attested to by the patient’s physician and a witness and that includes the following:

(a) An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;

(b) An attestation that the patient concurs with the patient’s physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life;

(c) Clear identification of the specific proposed investigational drug, biological product or device that the patient is seeking to use;

(d) A description of the potentially best and worst outcomes of using the investigational drug, biological product or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition;

(e) A statement that the patient’s health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product or device unless specifically required to do so by law or contract;

(f) A statement that the patient’s eligibility for hospice care might be withdrawn if the patient begins curative treatment with the investigational drug, biological product or device and that care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements; and

(g) A statement that the patient understands that the patient is responsible for all expenses consequent to the use of the investigational drug, biological product or device and that this liability extends to the patient’s estate unless a contract between the patient and the manufacturer of the drug, biological product or device states otherwise.

History:

[(39-9403) 39-9303, added 2016, ch. 168, sec. 1, p. 466; am. and redesig. 2017, ch. 58, sec. 19, p. 114.]