Shown verbatim: the complete text as captured from the official PDF posted by the Arkansas General Assembly, fetched 2026-07-23. Page and line markers are part of the official record; nothing is edited or removed. The official bill page.
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1 State of Arkansas A Bill
2 95th General Assembly
3 Regular Session, 2025 SENATE BILL 136
4
5 By: Senator J. Boyd
6 By: Representative Gramlich
7
8 For An Act To Be Entitled
9 AN ACT TO CREATE THE RIGHT TO TRY INDIVIDUALIZED
10 INVESTIGATIONAL TREATMENT ACT; TO ESTABLISH
11 PROCEDURES FOR PATIENTS TO TRY INDIVIDUALIZED
12 INVESTIGATIONAL TREATMENTS; TO ENSURE THAT PATIENTS
13 WITH LIFE-THREATENING OR SEVERELY DEBILITATING
14 ILLNESS HAVE ACCESS TO INDIVIDUALIZED INVESTIGATIONAL
15 TREATMENT; AND FOR OTHER PURPOSES.
16
17
18 Subtitle
19 TO CREATE THE RIGHT TO TRY
20 INDIVIDUALIZED INVESTIGATIONAL TREATMENT
21 ACT; AND TO ENSURE THAT PATIENTS HAVE
22 ACCESS TO INDIVIDUALIZED INVESTIGATIONAL
23 TREATMENT.
24
25 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS:
26
27 SECTION 1. Arkansas Code Title 20, Chapter 15, is amended to add an
28 additional subchapter to read as follows:
29 Subchapter 25 -- Right to Try Individualized Investigational Treatment Act
30
31 20-15-2501. Title.
32 This subchapter shall be known and may be cited as the "Right to Try
33 Individualized Investigational Treatment Act".
34
35 20-15-2502. Definitions.
36 As used in this subchapter:
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1 (1) "Costs associated with the manufacture of the individualized
2 investigational treatment" means the actual out-of-pocket costs incurred in
3 providing the individualized investigational treatment to the patient in his
4 or her specific case;
5 (2) "Eligible facility" means an institution that is operating
6 under a Federalwide Assurance for the Protection of Human Subjects under 42
7 U.S.C. � 289(a) and 45 C.F.R. Part 46, as existing on January 1, 2025, and is
8 subject to the laws, regulations, policies, and guidelines relating to
9 Federalwide Assurance for the Protection of Human Subjects, including
10 renewals or updates;
11 (3) "Eligible patient" means a person who meets the requirements
12 of eligibility under � 20-15-2503;
13 (4) "Individualized investigational treatment" means a drug,
14 biological product, or device that is unique to and produced exclusively for
15 use for an individual patient, based on his or her own genetic profile,
16 including without limitation an individualized gene therapy antisense
17 oligonucleotide and individualized neoantigen vaccines;
18 (5) "Life-threatening" means a disease or condition:
19 (A) Where the likelihood of death is high unless the
20 course of the disease or condition is interrupted; and
21 (B) With a potentially fatal outcome, where the endpoint
22 of clinical trial analysis is survival;
23 (6) "Physician" means an individual licensed to practice
24 medicine in the State of Arkansas under the Arkansas Medical Practices Act, �
25 17-95-201 et seq., � 17-95-301 et seq., and � 17-95-401 et seq.; and
26 (7) "Severely debilitating" means a disease or condition that
27 causes major irreversible morbidity.
28
29 20-15-2503. Eligibility.
30 In order for a patient to access an individualized investigational
31 treatment under this subchapter, a physician shall document in the patient's
32 medical record and chart that the patient:
33 (1) Has a life-threatening or severely debilitating illness;
34 (2) Has considered all other treatment options currently
35 approved by the United States Food and Drug Administration;
36 (3) Has received a recommendation from the physician for an
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1 individualized investigational treatment based on analysis of the patient's
2 genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid,
3 genes, gene products such as enzymes and other types of proteins, or
4 metabolites;
5 (4)(A) Has given written, informed consent for the use of the
6 individualized investigational treatment.
7 (B) If the patient is a minor or lacks the mental capacity
8 to provide informed consent, a parent or legal guardian may provide written,
9 informed consent on the patient's behalf.
10 (C) The written, informed consent shall include at a
11 minimum:
12 (i) An explanation of the currently approved
13 products and treatments for the disease or condition of which the patient
14 suffers;
15 (ii) An attestation that the patient, or if the
16 patient is a minor or lacks the mental capacity to concur, a parent or legal
17 guardian, concurs with his or her physician in believing that all currently
18 approved and conventionally recognized treatments are unlikely to prolong the
19 patient's life;
20 (iii) Clear identification of the specific proposed
21 individualized investigational treatment that the patient is seeking to use;
22 (iv) A description of the potentially best and worst
23 outcomes of using the individualized investigational treatment and a
24 realistic description of the most likely outcome, including without
25 limitation the possibility that new, unanticipated, different, or worse
26 symptoms might result, and that death could be hastened by the individualized
27 investigational treatment, which is based on the physician's knowledge of the
28 individualized investigational treatment in conjunction with an awareness of
29 the patient's condition;
30 (v) A statement that the patient's health plan or
31 third-party administrator and provider are not obligated to pay for any care
32 or treatments consequent to the use of the individualized investigational
33 treatment, unless the patient's health plan or third-party administrator and
34 provider are specifically required to do so by law or contract;
35 (vi) A statement that the patient's eligibility for
36 hospice care may be withdrawn if the patient receives an individualized
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1 investigational treatment and that care may be reinstated if the
2 individualized investigational treatment ends and the patient meets hospice
3 eligibility requirements; and
4 (vii) A statement that the patient understands that
5 he or she is liable for all expenses consequent to the use of the
6 individualized investigational treatment and that this liability extends to
7 the patient's estate, unless a contract between the patient and the
8 manufacturer of the individualized investigational treatment states
9 otherwise; and
10 (5) Has received written documentation from a physician that the
11 patient meets the requirements of this subchapter.
12
13 20-15-2504. Availability.
14 (a) A manufacturer of an individualized investigational treatment
15 operating within an eligible facility may make available an individualized
16 investigational treatment available to eligible patients under this
17 subchapter.
18 (b) This section does not require that a manufacturer make available
19 an individualized investigational treatment to an eligible patient.
20
21 20-15-2505. Costs.
22 (a) A manufacturer of an individualized investigational treatment or
23 an eligible facility may:
24 (1) Provide an individualized investigational treatment to an
25 eligible patient without receiving compensation; or
26 (2) Require an eligible patient to pay the costs associated with
27 the manufacture of the individualized investigational treatment.
28 (b) If an eligible patient dies while receiving individualized
29 investigational treatment, the eligible patient's heirs are not liable for
30 any outstanding debt to the manufacturer related to the individualized
31 investigational treatment.
32
33 20-15-2506. Insurance coverage.
34 (a) An insurance company:
35 (1) May, but is not required to, provide coverage for an
36 individualized investigational treatment; and
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1 (2) Shall not deny coverage for an item or service that is
2 otherwise covered by an insurance contract between the eligible person and
3 the insurance company.
4 (b) This subchapter does not affect any mandatory healthcare coverage
5 for participation in clinical trials or expand the health care coverage
6 required of an insurance company.
7
8 20-15-2507. Prohibited sanctions.
9 The recommendation, prescription, treatment, or participation in the
10 treatment of a life-threatening or severely debilitating illness with an
11 individualized investigational treatment shall not permit:
12 (1) A state agency or licensing board to revoke a license, fail
13 to renew a license, or take any other action against a medical professional's
14 license or a healthcare provider's license;
15 (2) A state agency, state official, or employee or agent of the
16 state to block or attempt to block an eligible patient's access to an
17 individualized investigational treatment; or
18 (3) An action against a hospital's Medicare certification.
19
20 20-15-2508. Counseling, advice, or recommendation not violation.
21 The counseling, advice, or recommendation consistent with medical
22 standards of care by a medical professional licensed under state law is not a
23 violation of this subchapter.
24
25 20-15-2509. Immunity.
26 (a) Except in the case of gross negligence or willful misconduct, a
27 person or entity that manufacturers, imports, distributes, prescribes,
28 dispenses, administers, or is otherwise involved in the care of an eligible
29 patient using an individualized investigational treatment is immune from
30 civil liability for any loss, damage, or injury arising out of, relating to,
31 or resulting from the individualized investigational treatment if the person
32 or entity is substantially complying in good faith with this subchapter and
33 has exercised reasonable care.
34 (b) This subchapter does not require a medical professional who is
35 licensed under the laws of this state to counsel, advise, prescribe,
36 dispense, administer, or otherwise be involved in the care of an eligible
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1 patient using an individualized investigational treatment.
2 (c) This subchapter does not require a hospital licensed under � 20-9-
3 213 to provide any new or additional service related to an individualized
4 investigational treatment, unless approved by the hospital.
5
6 20-15-2510. Medicaid coverage.
7 This subchapter does not require the Department of Human Services or
8 the Arkansas Medicaid Program to provide additional coverage for an
9 individualized investigational treatment.
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6 01/28/2025 7:59:29 AM JMB027Every fact on this page links to its source, starting with the official bill record.