North Dakota § 23-48-01 - Definitions

§ 23-48-01. Definitions

As used in this chapter, unless the context otherwise requires: 1. a. "Eligible patient" means an individual who: (1) Has a terminal illness that is attested to by the patient's treating physician; (2) Considered all other treatment options currently approved by the United States food and drug administration; (3) If there is a clinical trial for the terminal illness within one hundred miles of the patient's home address for the terminal illness, is unable to participate in the clinical trial or within one week of completion of the clinical trial application process is not accepted to the clinical trial; (4) Has a recommendation from the patient's treating physician for an investigational drug, biological product, or device; (5) Has given written, informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written, informed consent on the patient's behalf; and (6) Has documentation by the patient's treating physician the patient meets the requirements of this subdivision. b. The term does not include an individual treated as an inpatient in a hospital licensed under chapter 23-16. 2. "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one 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 disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely. 4. "Written, informed consent" means a written document signed by the patient or the patient's parent or legal guardian and attested to by the patient's treating physician and by a witness which: a. Explains the currently approved products and treatments for the terminal illness from which the patient suffers; b. Attests to the fact the patient concurs with the patient's treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; c. Identifies the specific proposed investigational drug, biological product, or device the patient is seeking to use; d. Describes the potentially best and worst outcomes of using the investigational drug, biological product, or device with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different, or worse symptoms might result, and that death could be hastened by the proposed treatment, based on the treating physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition; e. States the patient's health insurer and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device; f. States the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment and that hospice care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements; g. States in-home health care may be denied if treatment begins; and h. Attests that the patient understands the patient is liable for all expenses consequent to the use of the investigational drug, biological product, or device, and that this liability may extend to the patient's estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.