As used in this part 1, unless the context otherwise requires:
(1) (a) Eligible patient means a person who has:
(I) A terminal illness, attested to by the patient's treating physician;
(II) Considered all other treatment options currently approved by the United States food and drug administration;
(III) Been unable to participate in a clinical trial for the terminal illness within one hundred miles of the patient's home address or not been accepted to the clinical trial within one week of completion of the clinical trial application process;
(IV) Received a recommendation from his or her physician for an investigational drug, biological product, or device;
(V) 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
(VI) Documentation from his or her physician that he or she meets the requirements of this paragraph (a).
(b) Eligible patient does not include a person being treated as an inpatient in a hospital licensed or certified pursuant to section 25-3-101.
(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 and attested to by the patient's physician and a witness that, at a minimum:
(a) Explains the currently approved products and treatments for the disease or condition from which the patient suffers;
(b) Attests to the fact 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) Clearly identifies the specific proposed investigational drug, biological product, or device that 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 physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition;
(e) Makes clear that 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) Makes clear that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment and care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements;
(g) Makes clear that in-home health care may be denied if treatment begins; and
(h) States 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 drug, biological product, or device states otherwise.
Source: L. 2014: Entire article added, (HB 14-1281), ch. 220, p. 824, � 1, effective May 17. L. 2025: IP amended, (HB 25-1270), ch. 211, p. 953, � 2, effective May 19.
25-45-104. Drug manufacturers - availability of investigational drugs, biological products, or devices - costs - insurance coverage. (1) A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patients pursuant to this part 1. This part 1 does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(2) A manufacturer may:
(a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or
(b) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.
(3) (a) Nothing in this part 1 expands the coverage provided in section 10-16-104 (20) or 10-16-104.6.
(b) A health insurance carrier may, but is not required to, provide coverage for the cost of an investigational drug, biological product, or device.
(c) An insurer may deny coverage to an eligible patient from the time the eligible patient begins use of the investigational drug, biological product, or device through a period not to exceed six months from the time the investigational drug, biological product, or device is no longer used by the eligible patient; except that coverage may not be denied for a preexisting condition and for coverage for benefits which commenced prior to the time the eligible patient begins use of such drug, biological product, or device.
(4) If a patient dies while being treated by an investigational drug, biological product, or device, the patient's heirs are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment.
Source: L. 2014: Entire article added, (HB 14-1281), ch. 220, p. 825, � 1, effective May 17. L. 2025: (1) and (3)(a) amended, (HB 25-1270), ch. 211, p. 953, � 3, effective May 19.
25-45-105. Action against health-care provider's license or medicare certification prohibited. Notwithstanding any other law, a licensing board may not revoke, fail to renew, suspend, or take any action against a health-care provider's license issued pursuant to title 12, C.R.S., based solely on the health-care provider's recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product, or device, as long as the recommendations are consistent with medical standards of care. Action against a health-care provider's medicare certification based solely on the health-care provider's recommendation that a patient have access to an investigational drug, biological product, or device is prohibited.
Source: L. 2014: Entire article added, (HB 14-1281), ch. 220, p. 826, � 1, effective May 17.
25-45-106. Access to investigational drugs, biological products, and devices. An official, employee, or agent of this state shall not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device. Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health-care provider is not a violation of this section.
Source: L. 2014: Entire article added, (HB 14-1281), ch. 220, p. 826, � 1, effective May 17.