25.588.11 100th Legislative Session 1139
2025 South Dakota Legislature
House Bill 1139
Introduced by: Representative Andera
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An Act to allow individualized investigative treatments for patients with life -1
threatening or debilitating diseases or conditions. 2
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: 3
Section 1. That § 34-51-1 be AMENDED: 4
34-51-1. Terms used in this chapter mean: 5
(1) "Advanced illness," any progressive disease, medical, or surgical condition that 6
entails significant functional impairment, that is not considered by a treating 7
physician to be reversible even with administration of current federally approved 8
and available treatments, and that without life sustaining procedures, would result 9
in death; 10
(2) "Eligible facility," an institution operating under a federalwide assurance for the 11
protection of human subjects, pursuant to 45 C.F.R. Part 46 (January 1, 2025); 12
(2) "Eligible patient," an individual who has: 13
(a) A disease or condition that is life-threatening or severely debilitating, as 14
those terms are defined in 21 C.F.R § 312.81 (January 1, 2025), attested 15
by the patient's treating physician; 16
(b) Considered all other treatment options approved by the United States Food 17
and Drug Administration; 18
(c) Received a recommendation from the individual's treating physician for a 19
general investigative treatment, or an individualized investigative treatment 20
based on an analysis of the individual's genomic sequence, human 21
chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene 22
products, or metabolites; 23
(d) Given informed consent for the general or individualized investigative 24
treatment; and 25 25.588.11 2 1139
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(e) Documentation from the individual's treating physician that the individual 1
meets the requirements of this chapter; 2
(3) "Investigational drug, biological product, or device General investigative 3
treatment," any drug, biological product, or device that has successfully completed 4
phase 1 one of a clinical trial but has not yet been approved for general use by the 5
United States Food and Drug Administration and remains under investigation in a 6
clinical trial approved by the United States Food and Drug Administration approved 7
clinical trial; 8
(4) "Individualized investigative treatment," any drug, biological product, or device, 9
from a manufacturer operating within an eligible facility, which is unique to and 10
produced exclusively for an individual patient's use based on the patient's genetic 11
profile; and 12
(3)(5) "Physician," any person who is individual licensed pursuant to the provisions of 13
chapter 36-4. 14
Section 2. That § 34-51-3 be AMENDED: 15
34-51-3. For purposes of this chapter, the term, written, To receive a general or 16
individualized investigative treatment, an eligible patient must give informed consent, 17
consists of a signed writing executed. 18
For the purposes of this section, "informed consent," means a written document 19
that: 20
(1) Is signed by the eligible patient,; the patient's parent, or legal guardian, if the 21
patient is a minor,; or substitute informed consent from an appointed guardian, an 22
attorney-in-fact, or a person with authority pursuant to chapter 34-12C, if the 23
patient is incapacitated as defined in § 34-12C-1, and; 24
(2) Is attested to by the treating physician, that:; 25
(1)(3) Explains the currently approved products and treatments for the disease or 26
condition from which the patient suffers; 27
(2)(4) Attests to the fact that the patient concurs with his or her Contains the patient's 28
concurrence with the treating physician that no current treatment approved by the 29
United States Food and Drug Administration approved treatment would likely 30
prolong the patient's life; 31
(3)(5) Clearly identifies the specific proposed investigational drug, biological product, or 32
device general or individualized investigative treatment that the patient is seeking 33
to use; 34 25.588.11 3 1139
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(4)(6) Describes, based on the treating physician's knowledge of the general or 1
individualized investigative treatment and the patient's condition, the potential 2
outcomes of using investigational drug, biological product, or device. The 3
description shall include the treatment, and any possibility of worsening symptoms 4
and or death hastened by the treatment; 5
(5)(7) Contains a statement States that the patient's: 6
(a) Patient's health insurance carrier is not obligated to pay for any care or 7
treatments consequent to the use of the investigational drug, biological 8
product, or device general or individualized investigative treatment; and 9
(b) Patient understands that the patient is liable for all expenses consequent to 10
the use of the treatment; and 11
(6)(8) Makes clear States that the patient's eligibility for hospice care may be withdrawn 12
if the patient begins curative treatment with the investigational drug, biological 13
product, or device general or individualized investigative treatment, and that care 14
may be reinstated if this treatment ends and the patient meets hospice eligibility 15
requirements; and 16
(7) Makes clear that the patient understands that he or she is liable for all expense 17
consequent to the use of the investigational drug, biological product, or device. 18
Section 3. That § 34-51-4 be AMENDED: 19
34-51-4. A manufacturer of an investigational drug, biological product, or device 20
a general investigative treatment, or a manufacturer of an individualized investigative 21
treatment operating within an eligible facility, may make the treatment available, and an 22
to an eligible patient, with or without compensation. An eligible facility, or a manufacturer 23
operating within an eligible facility, may require an eligible patient to pay the costs of, or 24
the costs associated with, the manufacture of the individualized investigative treatment. 25
An eligible patient may request the manufacturer's investigational drug, biological 26
product, or device for a general or individualized investigative treatment pursuant to this 27
chapter. 28
This chapter does not require that a manufacturer or eligible facility to make 29
available an investigational drug, biological product, or devices the general or 30
individualized investigative treatment to an eligible patient. 31
Section 4. That § 34-51-6 be AMENDED: 32 25.588.11 4 1139
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34-51-6. If a patient dies while being treated by an investigational drug, biological 1
product, or device, receiving a general or individualized investigative treatment, the 2
manufacturer or eligible facility may not seek reimbursement for any outstanding debt 3
related to the treatment or lack of insurance due to the treatment from the patient's or 4
caretaker's estate. 5
Section 5. That § 34-51-7 be AMENDED: 6
34-51-7. No licensing board may revoke, fail to renew, suspend, or take any action 7
against a health care provider's physician's license pursuant to the provisions of chapter 8
36-4, based solely on the health care provider's physician's recommendations to an 9
eligible patient regarding access to or treatment with an investigational drug, biological 10
product, or device receipt of a general or individualized investigative treatment. No entity 11
responsible for Medicare medicare certification may take action against a health care 12
provider's Medicare physician's medicare certification based solely on the health care 13
provider's physician's recommendation regarding an investigational drug, biological 14
product, or device a general or individualized investigative treatment. 15
Section 6. That § 34-51-9 be AMENDED: 16
34-51-9. No official, employee, or agent of this state may block or attempt to 17
block an eligible patient's access to an investigational drug, biological product, or device 18
a general or individualized investigative treatment . Counseling, advice, or a 19
recommendation consistent with medical standards of care from a licensed health care 20
provider is not a violation of this section. 21
Section 7. That § 34-51-10 be AMENDED: 22
34-51-10. This chapter does not create a private cause of action against a 23
manufacturer of an investigational drug, biological product, or device, a general or 24
individualized investigative treatment, or against another person or entity involved in the 25
care of an eligible patient using receiving the investigational drug, biological product, or 26
device treatment, for any harm done to the eligible patient resulting from treatment if the 27
manufacturer or other person or entity is complying in good faith with the terms of this 28
chapter and exercised reasonable care. 29
Section 8. That a NEW SECTION be added to chapter 34-51: 30 25.588.11 5 1139
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Nothing in this chapter requires: 1
(1) A governmental agency to pay any costs associated with the use, care, or 2
treatment of an eligible patient with an individualized investigative treatment; 3
(2) A health plan, health carrier, or third-party administrator to provide coverage for 4
the cost of an individualized investigative treatment or other costs of services 5
related to the treatment; or 6
(3) A health care facility, licensed in accordance with chapter 34-12, to provide new or 7
additional services, unless approved by the facility. 8
Section 9. That § 34-51-2 be REPEALED. 9
For the purposes of this chapter, the term, eligible patient, means a patient who 10
meets all the following qualifications: 11
(1) Has an advanced illness, attested by the patient's treating physician; 12
(2) Has considered all other treatment options currently approved by the United States 13
Food and Drug Administration; 14
(3) Has received a recommendation from the patient's treating physician for an 15
investigational drug, biological product, or device; 16
(4) Has given written, informed consent for the use of the investigational drug, 17
biological product, or device; and 18
(5) Has documentation from the patient's treating physician that the patient meets 19
requirements pursuant to this chapter. 20
Section 10. That § 34-51-5 be REPEALED. 21
A manufacturer may provide an investigational drug, biological product, or device 22
to an eligible patient without receiving compensation. 23