As used in this part 2, unless the context otherwise requires:

1. (1) Eligible facility means an institution operating under the federalwide assurance for the protection of human subjects in accordance with 45 CFR 46 and 42 U.S.C. sec. 289a.

2. (2) Eligible patient means an individual who has:

   1. (a) A life-threatening or severely debilitating illness, as attested to by the patient's treating physician;
   2. (b) In consultation with the treating physician, considered all other treatment options currently approved by the United States food and drug administration;
   3. (c) Received a recommendation from the treating physician for use of an individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness;
   4. (d) Given written, informed consent for the use of the individualized 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
   5. (e) Documentation from the treating physician that the patient meets the requirements of this subsection (2), including attestation from the treating physician that the treating physician was consulted in the creation of the written, informed consent given under this part 2.
3. (3) Individualized investigational drug, biological product, or device means a drug, biological product, or device that is unique and produced exclusively for use by an eligible patient, based on the patient's own genetic profile, including individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines.
4. (4) Institution has the meaning set forth in 45 CFR 46.102 (f).
5. (5) Life-threatening or severely debilitating illness has the meaning set forth in 21 CFR 312.81.
6. (6) Minor means an individual who is under eighteen years of age.

7. (7) Written, informed consent means a written document signed by an eligible patient; by a parent or legal guardian, if the patient is a minor; or by a designated health-care agent pursuant to a health-care power of attorney, if the patient is incapacitated, that, at a minimum:

   1. (a) Explains the currently approved products and treatments for the life-threatening or severely debilitating illness from which the eligible patient suffers;
   2. (b) Attests that the eligible patient concurs with the treating physician's belief that all currently approved treatments are unlikely to prolong the patient's life;
   3. (c) Clearly identifies the specific individualized investigational drug, biological product, or device proposed for treatment of the eligible patient's life-threatening or severely debilitating illness;
   4. (d) Describes the potential best and worst outcomes resulting from use of the individualized 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 physician's knowledge of the proposed treatment in conjunction with an awareness of the eligible patient's condition;
   5. (e) Makes clear that the patient's eligibility for hospice care may be withdrawn if the eligible patient begins treatment of the life-threatening or severely debilitating illness with an individualized investigational drug, biological product, or device and that hospice care may be reinstated if such treatment ends and the patient again meets hospice care eligibility requirements;
   6. (f) Makes clear that in-home health care may be denied if treatment begins;
   7. (g) Makes clear that the eligible patient's health insurance provider or health-care provider is not obligated to pay for any care or treatments consequent to the use of the individualized investigational drug, biological product, or device unless specifically required by law or contract;
   8. (h) States that the patient understands that they are liable for all expenses consequent to the use of the individualized 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 individualized investigational drug, biological product, or device states otherwise; and
   9. (i) States that the eligible patient, or, for an eligible patient who is a minor or who lacks capacity to provide informed consent, the parent or legal guardian, consents to the use of the individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness.

Source: L. 2025: Entire part added, (HB 25-1270), ch. 211, p. 954, § 5, effective May 19.