This provision defines terms such as eligible patient, investigational drug/biological product/device, terminal illness, and written informed consent.
As used in this chapter, the following words have the following meanings: (1) ELIGIBLE PATIENT. An individual who meets all of the following conditions: a. Has a terminal illness, attested to by the patient’s treating physician. b. Has considered all other treatment options currently approved by the U.S. Food and Drug Administration. c. Has received a recommendation from his or her physician for an investigational drug, biological product, or device. d. Has given written, informed consent for the use of the investigational drug, biological product, or device. e. Has documentation from his or her physician that he or she meets the requirements of this subdivision. (2) INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, or DEVICE. 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 U.S. Food and Drug Administration and remains under investigation in a U.S. Food and Drug Administration approved clinical trial. (3) TERMINAL ILLNESS. A progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current Federal Drug Administration approved and available treatments, and that, without life-sustaining procedures, will soon result in death. (4) WRITTEN, INFORMED CONSENT. A written document that is signed by the patient or the parent or legal guardian, if the patient is a minor, and attested to by the patient’s physician and a witness and that, at a minimum, includes all of the following: a. A general 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 his or her 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 general description of the best and worst potential outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome. If applicable, 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 obliged to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device, unless they are specifically required to do so by law or contract. f. A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements. g. A statement that the patient understands that he or she is liable 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 investigational drug, biological product, or device states otherwise.