§ 25-45-103 — Definitions

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.

Legislative History

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.