25.588.12 100th Legislative Session 1139
2025 South Dakota Legislature
House Bill 1139
ENROLLED
AN ACT
ENTITLED An Act to allow individualized investigative treatments for patients with
life-threatening or debilitating diseases or conditions.
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) "Eligible facility," an institution operating under a federalwide assurance for the
protection of human subjects, pursuant to 45 C.F.R. Part 46 (January 1, 2025);
(2) "Eligible patient," an individual who has:
(a) A disease or condition that is life-threatening or severely debilitating, as
those terms are defined in 21 C.F.R § 312.81 (January 1, 2025), attested
by the patient's treating physician;
(b) Considered all other treatment options approved by the United States Food
and Drug Administration;
(c) Received a recommendation from the individual's treating physician for a
general investigative treatment, or an individualized investigative treatment
based on an analysis of the individual's genomic sequence, human
chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene
products, or metabolites;
(d) Given informed consent for the general or individualized investigative
treatment; and
(e) Documentation from the individual's treating physician that the individual
meets the requirements of this chapter;
(3) "General investigative treatment," any 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 25.588.12 2 1139
HB1139 ENROLLED
under investigation in a clinical trial approved by the United States Food and Drug
Administration;
(4) "Individualized investigative treatment," any drug, biological product, or device,
from a manufacturer operating within an eligible facility, which is unique to and
produced exclusively for an individual patient's use based on the patient's genetic
profile; and
(5) "Physician," any individual licensed pursuant to chapter 36-4.
Section 2. That § 34-51-3 be AMENDED:
34-51-3. To receive a general or individualized investigative treatment, an eligible
patient must give informed consent.
For the purposes of this section, "informed consent," means a written document
that:
(1) Is signed by the eligible patient; the patient's parent or legal guardian, if the patient
is a minor; or an appointed guardian, attorney-in-fact, or person with authority
pursuant to chapter 34-12C, if the patient is incapacitated as defined in § 34-12C-
1;
(2) Is attested to by the treating physician;
(3) Explains the currently approved products and treatments for the disease or
condition from which the patient suffers;
(4) Contains the patient's concurrence with the treating physician that no treatment
approved by the United States Food and Drug Administration would likely prolong
the patient's life;
(5) Clearly identifies the specific proposed general or individualized investigative
treatment that the patient is seeking to use;
(6) Describes, based on the treating physician's knowledge of the general or
individualized investigative treatment and the patient's condition, the potential
outcomes of using the treatment, and any possibility of worsening symptoms or
death hastened by the treatment;
(7) States that the:
(a) Patient's health insurance carrier is not obligated to pay for any care or
treatments consequent to the use of the general or individualized
investigative treatment; and
(b) Patient understands that the patient is liable for all expenses consequent to
the use of the treatment; and 25.588.12 3 1139
HB1139 ENROLLED
(8) States that the patient's eligibility for hospice care may be withdrawn if the patient
begins curative treatment with the general or individualized investigative
treatment, and that care may be reinstated if this treatment ends and the patient
meets hospice eligibility requirements.
Section 3. That § 34-51-4 be AMENDED:
34-51-4. A manufacturer of a general investigative treatment, or a manufacturer
of an individualized investigative treatment operating within an eligible facility, may make
the treatment available to an eligible patient, with or without compensation. An eligible
facility, or a manufacturer operating within an eligible facility, may require an eligible
patient to pay the costs of, or the costs associated with, the manufacture of the
individualized investigative treatment.
An eligible patient may request a general or individualized investigative treatment
pursuant to this chapter.
This chapter does not require a manufacturer or eligible facility to make available
the general or individualized investigative treatment to an eligible patient.
Section 4. That § 34-51-6 be AMENDED:
34-51-6. If a patient dies while receiving a general or individualized investigative
treatment, the manufacturer or eligible facility may not seek reimbursement for any
outstanding debt related to the treatment or lack of insurance due to the treatment from
the patient's or caretaker's estate.
Section 5. That § 34-51-7 be AMENDED:
34-51-7. No licensing board may revoke, fail to renew, suspend, or take any action
against a physician's license pursuant to chapter 36-4, based solely on the physician's
recommendations to an eligible patient regarding access to or receipt of a general or
individualized investigative treatment. No entity responsible for medicare certification may
take action against a physician's medicare certification based solely on the physician's
recommendation regarding a general or individualized investigative treatment.
Section 6. That § 34-51-9 be AMENDED:
34-51-9. No official, employee, or agent of this state may block or attempt to
block an eligible patient's access to a general or individualized investigative treatment. 25.588.12 4 1139
HB1139 ENROLLED
Counseling, advice, or a recommendation consistent with medical standards of care from
a licensed health care provider is not a violation of this section.
Section 7. That § 34-51-10 be AMENDED:
34-51-10. This chapter does not create a private cause of action against a
manufacturer of a general or individualized investigative treatment, or against another
person or entity involved in the care of an eligible patient receiving the treatment, for any
harm done to the eligible patient resulting from treatment if the manufacturer or other
person or entity is complying in good faith with the terms of this chapter and exercised
reasonable care.
Section 8. That a NEW SECTION be added to chapter 34-51:
Nothing in this chapter requires:
(1) A governmental agency to pay any costs associated with the use, care, or
treatment of an eligible patient with an individualized investigative treatment;
(2) A health plan, health carrier, or third-party administrator to provide coverage for
the cost of an individualized investigative treatment or other costs of services
related to the treatment; or
(3) A health care facility, licensed in accordance with chapter 34-12, to provide new or
additional services, unless approved by the facility.
Section 9. That § 34-51-2 be REPEALED.
Section 10. That § 34-51-5 be REPEALED. 25.588.12 5 1139
HB1139 ENROLLED
An Act to allow individualized investigative treatments for patients with life-threatening or
debilitating diseases or conditions.
I certify that the attached Act originated in
the:
House as Bill No. 1139
Chief Clerk
Speaker of the House
Attest:
Chief Clerk
President of the Senate
Attest:
Secretary of the Senate
House Bill No. 1139
File No. ____
Chapter No. ______
Received at this Executive Office
this _____ day of _____________,
2025 at ____________M.
By
for the Governor
The attached Act is hereby
approved this ________ day of
______________, A.D., 2025
Governor
STATE OF SOUTH DAKOTA ,
ss.
Office of the Secretary of State
Filed ____________, 2025
at _________ o'clock __M.
Secretary of State
By
Asst. Secretary of State