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South Dakota House Bill HB1139

South Dakota 2025 Regular Session

South Dakota House Bill HB1139 Compare Versions

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1-25.588.12 100th Legislative Session 1139
1+25.588.11 100th Legislative Session 1139
22
33
44 2025 South Dakota Legislature
55 House Bill 1139
6-ENROLLED
7-
8-AN ACT
9-
10-
11-ENTITLED An Act to allow individualized investigative treatments for patients with
12-life-threatening or debilitating diseases or conditions.
13-BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA:
14-Section 1. That § 34-51-1 be AMENDED:
15-34-51-1. Terms used in this chapter mean:
16-(1) "Eligible facility," an institution operating under a federalwide assurance for the
17-protection of human subjects, pursuant to 45 C.F.R. Part 46 (January 1, 2025);
18-(2) "Eligible patient," an individual who has:
19-(a) A disease or condition that is life-threatening or severely debilitating, as
20-those terms are defined in 21 C.F.R § 312.81 (January 1, 2025), attested
21-by the patient's treating physician;
22-(b) Considered all other treatment options approved by the United States Food
23-and Drug Administration;
24-(c) Received a recommendation from the individual's treating physician for a
25-general investigative treatment, or an individualized investigative treatment
26-based on an analysis of the individual's genomic sequence, human
27-chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene
28-products, or metabolites;
29-(d) Given informed consent for the general or individualized investigative
30-treatment; and
31-(e) Documentation from the individual's treating physician that the individual
32-meets the requirements of this chapter;
33-(3) "General investigative treatment," any drug, biological product, or device that has
34-successfully completed phase one of a clinical trial but has not yet been approved
35-for general use by the United States Food and Drug Administration and remains 25.588.12 2 1139
36-HB1139 ENROLLED
37-under investigation in a clinical trial approved by the United States Food and Drug
38-Administration;
39-(4) "Individualized investigative treatment," any drug, biological product, or device,
40-from a manufacturer operating within an eligible facility, which is unique to and
41-produced exclusively for an individual patient's use based on the patient's genetic
42-profile; and
43-(5) "Physician," any individual licensed pursuant to chapter 36-4.
44-Section 2. That § 34-51-3 be AMENDED:
45-34-51-3. To receive a general or individualized investigative treatment, an eligible
46-patient must give informed consent.
47-For the purposes of this section, "informed consent," means a written document
48-that:
49-(1) Is signed by the eligible patient; the patient's parent or legal guardian, if the patient
50-is a minor; or an appointed guardian, attorney-in-fact, or person with authority
51-pursuant to chapter 34-12C, if the patient is incapacitated as defined in § 34-12C-
52-1;
53-(2) Is attested to by the treating physician;
54-(3) Explains the currently approved products and treatments for the disease or
55-condition from which the patient suffers;
56-(4) Contains the patient's concurrence with the treating physician that no treatment
57-approved by the United States Food and Drug Administration would likely prolong
58-the patient's life;
59-(5) Clearly identifies the specific proposed general or individualized investigative
60-treatment that the patient is seeking to use;
61-(6) Describes, based on the treating physician's knowledge of the general or
62-individualized investigative treatment and the patient's condition, the potential
63-outcomes of using the treatment, and any possibility of worsening symptoms or
64-death hastened by the treatment;
65-(7) States that the:
66-(a) Patient's health insurance carrier is not obligated to pay for any care or
67-treatments consequent to the use of the general or individualized
68-investigative treatment; and
69-(b) Patient understands that the patient is liable for all expenses consequent to
70-the use of the treatment; and 25.588.12 3 1139
71-HB1139 ENROLLED
72-(8) States that the patient's eligibility for hospice care may be withdrawn if the patient
73-begins curative treatment with the general or individualized investigative
74-treatment, and that care may be reinstated if this treatment ends and the patient
75-meets hospice eligibility requirements.
76-Section 3. That § 34-51-4 be AMENDED:
77-34-51-4. A manufacturer of a general investigative treatment, or a manufacturer
78-of an individualized investigative treatment operating within an eligible facility, may make
79-the treatment available to an eligible patient, with or without compensation. An eligible
80-facility, or a manufacturer operating within an eligible facility, may require an eligible
81-patient to pay the costs of, or the costs associated with, the manufacture of the
82-individualized investigative treatment.
83-An eligible patient may request a general or individualized investigative treatment
84-pursuant to this chapter.
85-This chapter does not require a manufacturer or eligible facility to make available
86-the general or individualized investigative treatment to an eligible patient.
87-Section 4. That § 34-51-6 be AMENDED:
88-34-51-6. If a patient dies while receiving a general or individualized investigative
89-treatment, the manufacturer or eligible facility may not seek reimbursement for any
90-outstanding debt related to the treatment or lack of insurance due to the treatment from
91-the patient's or caretaker's estate.
92-Section 5. That § 34-51-7 be AMENDED:
93-34-51-7. No licensing board may revoke, fail to renew, suspend, or take any action
94-against a physician's license pursuant to chapter 36-4, based solely on the physician's
95-recommendations to an eligible patient regarding access to or receipt of a general or
96-individualized investigative treatment. No entity responsible for medicare certification may
97-take action against a physician's medicare certification based solely on the physician's
98-recommendation regarding a general or individualized investigative treatment.
99-Section 6. That § 34-51-9 be AMENDED:
100-34-51-9. No official, employee, or agent of this state may block or attempt to
101-block an eligible patient's access to a general or individualized investigative treatment. 25.588.12 4 1139
102-HB1139 ENROLLED
103-Counseling, advice, or a recommendation consistent with medical standards of care from
104-a licensed health care provider is not a violation of this section.
105-Section 7. That § 34-51-10 be AMENDED:
106-34-51-10. This chapter does not create a private cause of action against a
107-manufacturer of a general or individualized investigative treatment, or against another
108-person or entity involved in the care of an eligible patient receiving the treatment, for any
109-harm done to the eligible patient resulting from treatment if the manufacturer or other
110-person or entity is complying in good faith with the terms of this chapter and exercised
111-reasonable care.
112-Section 8. That a NEW SECTION be added to chapter 34-51:
113-Nothing in this chapter requires:
114-(1) A governmental agency to pay any costs associated with the use, care, or
115-treatment of an eligible patient with an individualized investigative treatment;
116-(2) A health plan, health carrier, or third-party administrator to provide coverage for
117-the cost of an individualized investigative treatment or other costs of services
118-related to the treatment; or
119-(3) A health care facility, licensed in accordance with chapter 34-12, to provide new or
120-additional services, unless approved by the facility.
121-Section 9. That § 34-51-2 be REPEALED.
122-Section 10. That § 34-51-5 be REPEALED. 25.588.12 5 1139
123-HB1139 ENROLLED
124-An Act to allow individualized investigative treatments for patients with life-threatening or
125-debilitating diseases or conditions.
126-
127-
128-
129-
130-I certify that the attached Act originated in
131-the:
132-
133-House as Bill No. 1139
134-
135-
136-
137-Chief Clerk
138-
139-
140-
141-
142-Speaker of the House
143-
144-Attest:
145-
146-
147-
148-
149-Chief Clerk
150-
151-
152-
153-
154-President of the Senate
155-
156-Attest:
1576
1587
1598
1609
16110
162-Secretary of the Senate
16311
12+Introduced by: Representative Andera
16413
165-
166-House Bill No. 1139
167-File No. ____
168-Chapter No. ______
169-
170-
171-
172-Received at this Executive Office
173-this _____ day of _____________,
174-
175-2025 at ____________M.
176-
177-
178-
179-By
180-for the Governor
181-
182-
183-The attached Act is hereby
184-approved this ________ day of
185-______________, A.D., 2025
186-
187-
188-
189-
190-
191-Governor
192-
193-STATE OF SOUTH DAKOTA ,
194-ss.
195-Office of the Secretary of State
196-
197-
198-Filed ____________, 2025
199- at _________ o'clock __M.
200-
201-
202-
203-
204-
205-Secretary of State
206-
207-
208-
209-By
210-Asst. Secretary of State
211-
212-
14+ Underscores indicate new language.
15+ Overstrikes indicate deleted language.
16+An Act to allow individualized investigative treatments for patients with life -1
17+threatening or debilitating diseases or conditions. 2
18+BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: 3
19+Section 1. That § 34-51-1 be AMENDED: 4
20+34-51-1. Terms used in this chapter mean: 5
21+(1) "Advanced illness," any progressive disease, medical, or surgical condition that 6
22+entails significant functional impairment, that is not considered by a treating 7
23+physician to be reversible even with administration of current federally approved 8
24+and available treatments, and that without life sustaining procedures, would result 9
25+in death; 10
26+(2) "Eligible facility," an institution operating under a federalwide assurance for the 11
27+protection of human subjects, pursuant to 45 C.F.R. Part 46 (January 1, 2025); 12
28+(2) "Eligible patient," an individual who has: 13
29+(a) A disease or condition that is life-threatening or severely debilitating, as 14
30+those terms are defined in 21 C.F.R § 312.81 (January 1, 2025), attested 15
31+by the patient's treating physician; 16
32+(b) Considered all other treatment options approved by the United States Food 17
33+and Drug Administration; 18
34+(c) Received a recommendation from the individual's treating physician for a 19
35+general investigative treatment, or an individualized investigative treatment 20
36+based on an analysis of the individual's genomic sequence, human 21
37+chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene 22
38+products, or metabolites; 23
39+(d) Given informed consent for the general or individualized investigative 24
40+treatment; and 25 25.588.11 2 1139
41+ Underscores indicate new language.
42+ Overstrikes indicate deleted language.
43+(e) Documentation from the individual's treating physician that the individual 1
44+meets the requirements of this chapter; 2
45+(3) "Investigational drug, biological product, or device General investigative 3
46+treatment," any drug, biological product, or device that has successfully completed 4
47+phase 1 one of a clinical trial but has not yet been approved for general use by the 5
48+United States Food and Drug Administration and remains under investigation in a 6
49+clinical trial approved by the United States Food and Drug Administration approved 7
50+clinical trial; 8
51+(4) "Individualized investigative treatment," any drug, biological product, or device, 9
52+from a manufacturer operating within an eligible facility, which is unique to and 10
53+produced exclusively for an individual patient's use based on the patient's genetic 11
54+profile; and 12
55+(3)(5) "Physician," any person who is individual licensed pursuant to the provisions of 13
56+chapter 36-4. 14
57+Section 2. That § 34-51-3 be AMENDED: 15
58+34-51-3. For purposes of this chapter, the term, written, To receive a general or 16
59+individualized investigative treatment, an eligible patient must give informed consent, 17
60+consists of a signed writing executed. 18
61+For the purposes of this section, "informed consent," means a written document 19
62+that: 20
63+(1) Is signed by the eligible patient,; the patient's parent, or legal guardian, if the 21
64+patient is a minor,; or substitute informed consent from an appointed guardian, an 22
65+attorney-in-fact, or a person with authority pursuant to chapter 34-12C, if the 23
66+patient is incapacitated as defined in § 34-12C-1, and; 24
67+(2) Is attested to by the treating physician, that:; 25
68+(1)(3) Explains the currently approved products and treatments for the disease or 26
69+condition from which the patient suffers; 27
70+(2)(4) Attests to the fact that the patient concurs with his or her Contains the patient's 28
71+concurrence with the treating physician that no current treatment approved by the 29
72+United States Food and Drug Administration approved treatment would likely 30
73+prolong the patient's life; 31
74+(3)(5) Clearly identifies the specific proposed investigational drug, biological product, or 32
75+device general or individualized investigative treatment that the patient is seeking 33
76+to use; 34 25.588.11 3 1139
77+ Underscores indicate new language.
78+ Overstrikes indicate deleted language.
79+(4)(6) Describes, based on the treating physician's knowledge of the general or 1
80+individualized investigative treatment and the patient's condition, the potential 2
81+outcomes of using investigational drug, biological product, or device. The 3
82+description shall include the treatment, and any possibility of worsening symptoms 4
83+and or death hastened by the treatment; 5
84+(5)(7) Contains a statement States that the patient's: 6
85+(a) Patient's health insurance carrier is not obligated to pay for any care or 7
86+treatments consequent to the use of the investigational drug, biological 8
87+product, or device general or individualized investigative treatment; and 9
88+(b) Patient understands that the patient is liable for all expenses consequent to 10
89+the use of the treatment; and 11
90+(6)(8) Makes clear States that the patient's eligibility for hospice care may be withdrawn 12
91+if the patient begins curative treatment with the investigational drug, biological 13
92+product, or device general or individualized investigative treatment, and that care 14
93+may be reinstated if this treatment ends and the patient meets hospice eligibility 15
94+requirements; and 16
95+(7) Makes clear that the patient understands that he or she is liable for all expense 17
96+consequent to the use of the investigational drug, biological product, or device. 18
97+Section 3. That § 34-51-4 be AMENDED: 19
98+34-51-4. A manufacturer of an investigational drug, biological product, or device 20
99+a general investigative treatment, or a manufacturer of an individualized investigative 21
100+treatment operating within an eligible facility, may make the treatment available, and an 22
101+to an eligible patient, with or without compensation. An eligible facility, or a manufacturer 23
102+operating within an eligible facility, may require an eligible patient to pay the costs of, or 24
103+the costs associated with, the manufacture of the individualized investigative treatment. 25
104+An eligible patient may request the manufacturer's investigational drug, biological 26
105+product, or device for a general or individualized investigative treatment pursuant to this 27
106+chapter. 28
107+This chapter does not require that a manufacturer or eligible facility to make 29
108+available an investigational drug, biological product, or devices the general or 30
109+individualized investigative treatment to an eligible patient. 31
110+Section 4. That § 34-51-6 be AMENDED: 32 25.588.11 4 1139
111+ Underscores indicate new language.
112+ Overstrikes indicate deleted language.
113+34-51-6. If a patient dies while being treated by an investigational drug, biological 1
114+product, or device, receiving a general or individualized investigative treatment, the 2
115+manufacturer or eligible facility may not seek reimbursement for any outstanding debt 3
116+related to the treatment or lack of insurance due to the treatment from the patient's or 4
117+caretaker's estate. 5
118+Section 5. That § 34-51-7 be AMENDED: 6
119+34-51-7. No licensing board may revoke, fail to renew, suspend, or take any action 7
120+against a health care provider's physician's license pursuant to the provisions of chapter 8
121+36-4, based solely on the health care provider's physician's recommendations to an 9
122+eligible patient regarding access to or treatment with an investigational drug, biological 10
123+product, or device receipt of a general or individualized investigative treatment. No entity 11
124+responsible for Medicare medicare certification may take action against a health care 12
125+provider's Medicare physician's medicare certification based solely on the health care 13
126+provider's physician's recommendation regarding an investigational drug, biological 14
127+product, or device a general or individualized investigative treatment. 15
128+Section 6. That § 34-51-9 be AMENDED: 16
129+34-51-9. No official, employee, or agent of this state may block or attempt to 17
130+block an eligible patient's access to an investigational drug, biological product, or device 18
131+a general or individualized investigative treatment . Counseling, advice, or a 19
132+recommendation consistent with medical standards of care from a licensed health care 20
133+provider is not a violation of this section. 21
134+Section 7. That § 34-51-10 be AMENDED: 22
135+34-51-10. This chapter does not create a private cause of action against a 23
136+manufacturer of an investigational drug, biological product, or device, a general or 24
137+individualized investigative treatment, or against another person or entity involved in the 25
138+care of an eligible patient using receiving the investigational drug, biological product, or 26
139+device treatment, for any harm done to the eligible patient resulting from treatment if the 27
140+manufacturer or other person or entity is complying in good faith with the terms of this 28
141+chapter and exercised reasonable care. 29
142+Section 8. That a NEW SECTION be added to chapter 34-51: 30 25.588.11 5 1139
143+ Underscores indicate new language.
144+ Overstrikes indicate deleted language.
145+Nothing in this chapter requires: 1
146+(1) A governmental agency to pay any costs associated with the use, care, or 2
147+treatment of an eligible patient with an individualized investigative treatment; 3
148+(2) A health plan, health carrier, or third-party administrator to provide coverage for 4
149+the cost of an individualized investigative treatment or other costs of services 5
150+related to the treatment; or 6
151+(3) A health care facility, licensed in accordance with chapter 34-12, to provide new or 7
152+additional services, unless approved by the facility. 8
153+Section 9. That § 34-51-2 be REPEALED. 9
154+For the purposes of this chapter, the term, eligible patient, means a patient who 10
155+meets all the following qualifications: 11
156+(1) Has an advanced illness, attested by the patient's treating physician; 12
157+(2) Has considered all other treatment options currently approved by the United States 13
158+Food and Drug Administration; 14
159+(3) Has received a recommendation from the patient's treating physician for an 15
160+investigational drug, biological product, or device; 16
161+(4) Has given written, informed consent for the use of the investigational drug, 17
162+biological product, or device; and 18
163+(5) Has documentation from the patient's treating physician that the patient meets 19
164+requirements pursuant to this chapter. 20
165+Section 10. That § 34-51-5 be REPEALED. 21
166+A manufacturer may provide an investigational drug, biological product, or device 22
167+to an eligible patient without receiving compensation. 23