An Act to expand the ability for patients to seek investigational drugs, biological products, or devices.
Be it enacted by the Legislature of the State of South Dakota:
Section 1. That 34-51-1 be AMENDED:
34-51-1. Terms used in this chapter mean:
(1) "Advanced illness," any progressive disease, 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 federally approved and available treatments, and that without life sustaining procedures, would result in death;
(2) "Investigational drug, biological product, or device," any 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 United States Food and Drug Administration and remains under investigation in a United States Food and Drug Administration approved clinical trial;
(3) "Physician," any person who is licensed pursuant to the provisions of chapter 36-4;
(4) "Serious illness," any disease, medical condition, or surgical condition that entails extreme pain, permanent disability, or a condition that is considered by a treating physician to not be reversible even with administration of current federally approved and available treatments.
Section 2. That 34-51-2 be AMENDED:
34-51-2. For the purposes of this chapter, the term, eligible patient, means a patient who meets all the following qualifications:
(1) Has an advanced illness or serious illness, attested by the patient's treating physician;
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration;
(3) Has received a recommendation from the patient's treating physician for an investigational drug, biological product, or device;
(4) Has given written, informed consent for the use of the investigational drug, biological product, or device; and
(5) Has documentation from the patient's treating physician that the patient meets requirements pursuant to this chapter.
Section 3. That 34-51-3 be AMENDED:
34-51-3.
For purposes of
this chapter, the term, written, informed consent,
consists of
means a signed
writing executed by the patient, parent, or legal guardian, if the
patient is a minor, or substitute informed consent from an appointed
guardian, an attorney-in-fact, or a person with authority pursuant to
chapter 34-12C,
if the patient is incapacitated as defined in 34-12C-1
or has otherwise relinquished their personal authority to their
attorney-in-fact,
and attested to by the treating physician, that:
(1) Explains the currently approved products and treatments for the disease or condition from which the patient suffers;
(2) Attests to the fact that the
patient concurs with his or her treating physician that no current
United States Food and Drug Administration approved or
alternative treatment
would
likely prolong
possibly:
(a) Prolong the patient's life, in the case of advanced illness; or
(b) Improve the patient's prognosis, in the case of serious illness;
(3) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use;
(4) Describes the potential outcomes of using investigational drug, biological product, or device. The description shall include any possibility of worsening symptoms and death hastened by the treatment;
(5) Contains a statement that the patient's health insurance carrier is not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device;
(6) Makes clear that, in the case of advanced illness, 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 patient meets hospice eligibility requirements; and
(7) Makes clear that the patient understands that he or she is liable for all expense consequent to the use of the investigational drug, biological product, or device.