Stricken language would be deleted from and underlined language would be added to present law.
Act 201 of the Regular Session
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State of Arkansas 1
95th General Assembly A Bill 2
Regular Session, 2025 SENATE BILL 136 3
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By: Senator J. Boyd 5
By: Representative Gramlich 6
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For An Act To Be Entitled 8
AN ACT TO CREATE THE RIGHT TO TRY INDIVIDUALIZED 9
INVESTIGATIONAL TREATMENT ACT; TO ESTABLISH 10
PROCEDURES FOR PATIENTS TO TRY INDIVIDUALIZED 11
INVESTIGATIONAL TREATMENTS; TO ENSURE THAT PATIENTS 12
WITH LIFE-THREATENING OR SEVERELY DEBILITATING 13
ILLNESS HAVE ACCESS TO INDIVIDUALIZED INVESTIGATIONAL 14
TREATMENT; AND FOR OTHER PURPOSES. 15
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Subtitle 18
TO CREATE THE RIGHT TO TRY 19
INDIVIDUALIZED INVESTIGATIONAL TREATMENT 20
ACT; AND TO ENSURE THAT PATIENTS HAVE 21
ACCESS TO INDIVIDUALIZED INVESTIGATIONAL 22
TREATMENT. 23
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BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 25
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SECTION 1. Arkansas Code Title 20, Chapter 15, is amended to add an 27
additional subchapter to read as follows: 28
Subchapter 25 — Right to Try Individualized Investigational Treatment Act 29
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20-15-2501. Title. 31
This subchapter shall be known and may be cited as the "Right to Try 32
Individualized Investigational Treatment Act". 33
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20-15-2502. Definitions. 35
As used in this subchapter: 36 SB136
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(1) “Costs associated with the manufacture of the individualized 1
investigational treatment” means the actual out -of-pocket costs incurred in 2
providing the individualized investigational treatment to the patient in his 3
or her specific case; 4
(2) "Eligible facility" means an institution that is operating 5
under a Federalwide Assurance for the Protection of Human Subjects under 42 6
U.S.C. § 289(a) and 45 C.F.R. Part 46, as existing on January 1, 2025, and is 7
subject to the laws, regulations, policies, and guidelines relating to 8
Federalwide Assurance for the Protection of Human Subjects, including 9
renewals or updates; 10
(3) “Eligible patient” means a person who meets the requirements 11
of eligibility under § 20 -15-2503; 12
(4) "Individualized investigational treatment" means a drug, 13
biological product, or device that is unique to and produced exclusively for 14
use for an individual patient, based on his or her own genetic profile, 15
including without limitation an individualized gene therapy antisense 16
oligonucleotide and individualized neoantigen vaccines; 17
(5) "Life-threatening" means a disease or condition: 18
(A) Where the likelihood of death is high unless the 19
course of the disease or condition is interrupted; and 20
(B) With a potentially fatal outcome, where the endpoint 21
of clinical trial analysis is survival; 22
(6) “Physician” means an individual licensed to practice 23
medicine in the State of Arkansas under the Arkansas Medical Practices Act, § 24
17-95-201 et seq., § 17-95-301 et seq., and § 17 -95-401 et seq.; and 25
(7) "Severely debilitating" means a disease or condition that 26
causes major irreversible morbidity. 27
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20-15-2503. Eligibility. 29
In order for a patient to access an individualized investigational 30
treatment under this subchapter, a physician shall document in the patient's 31
medical record and chart that the patient: 32
(1) Has a life-threatening or severely debilitating illness ; 33
(2) Has considered all other treatment options currently 34
approved by the United States Food and Drug Administration; 35
(3) Has received a recommendation from the physician for an 36 SB136
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individualized investigational treatment based on analysis of the patient's 1
genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, 2
genes, gene products such as enzymes and other types of proteins, or 3
metabolites; 4
(4)(A) Has given written, informed consent for the use of the 5
individualized investigational treatment. 6
(B) If the patient is a minor or lacks the mental capacity 7
to provide informed consent, a parent or legal guardian may provide written, 8
informed consent on the patient's behalf. 9
(C) The written, informed consent shall include at a 10
minimum: 11
(i) An explanation of the currently approved 12
products and treatments for the disease or condition of which the patient 13
suffers; 14
(ii) An attestation that the patient, or if the 15
patient is a minor or lacks the mental capacity to concur, a parent or legal 16
guardian, concurs with his or her physician in believing that all currently 17
approved and conventionally recognized treatments are unlikely to prolong the 18
patient’s life; 19
(iii) Clear identification of the specific proposed 20
individualized investigational treatment that the patient is seeking to use; 21
(iv) A description of the potentially best and worst 22
outcomes of using the individualized investigational treatment and a 23
realistic description of the most likely outcome, including without 24
limitation the possibility that new, unanticipated, different, or worse 25
symptoms might result, and that death could be hastened by the individualized 26
investigational treatment, which is based on the physician’s knowledge of the 27
individualized investigational treatment in conjunction with an awareness of 28
the patient’s condition; 29
(v) A statement that the patient’s health plan or 30
third-party administrator and provider are not obligated to pay for any care 31
or treatments consequent to the use of the individualized investigational 32
treatment, unless the patient’s health plan or third -party administrator and 33
provider are specifically required to do so by law or contract; 34
(vi) A statement that the patient’s eligibility for 35
hospice care may be withdrawn if the patient receives an individualized 36 SB136
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investigational treatment and that care may be reinstated if the 1
individualized investigational treatment ends and the patient meets hospice 2
eligibility requirements; and 3
(vii) A statement that the patient understands that 4
he or she is liable for all expenses consequent to the use of the 5
individualized investigational treatment and that this liability extends to 6
the patient’s estate, unless a contract between the patient and the 7
manufacturer of the individualized investigational treatment states 8
otherwise; and 9
(5) Has received written documentation from a physician that the 10
patient meets the requirements of this subchapter. 11
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20-15-2504. Availability. 13
(a) A manufacturer of an individualized investigational treatment 14
operating within an eligible facility may make available an individualized 15
investigational treatment available to eligible patients under this 16
subchapter. 17
(b) This section does not require that a manufacturer make available 18
an individualized investigational treatment to an eligible patient. 19
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20-15-2505. Costs. 21
(a) A manufacturer of an individualized investigational treatment or 22
an eligible facility may: 23
(1) Provide an individualized investigational treatment to an 24
eligible patient without receiving compensation; or 25
(2) Require an eligible patient to pay the costs associated with 26
the manufacture of the individualized investigational treatment. 27
(b) If an eligible patient dies while receiving individualized 28
investigational treatment, the eligible patient's heirs are not liable for 29
any outstanding debt to the manufacturer related to the individualized 30
investigational treatment. 31
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20-15-2506. Insurance coverage. 33
(a) An insurance company: 34
(1) May, but is not required to, provide coverage for an 35
individualized investigational treatment; and 36 SB136
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(2) Shall not deny coverage for an item or service that is 1
otherwise covered by an insurance contract between the eligible person and 2
the insurance company. 3
(b) This subchapter does not affect any mandatory healthcare coverage 4
for participation in clinical trials or expand the health care coverage 5
required of an insurance company. 6
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20-15-2507. Prohibited sanctions. 8
The recommendation, prescription, treatment, or participation in the 9
treatment of a life-threatening or severely debilitating illness with an 10
individualized investigational treatment shall not permit: 11
(1) A state agency or licensing board to revoke a license, fail 12
to renew a license, or take any other action against a medical professional's 13
license or a healthcare provider's license; 14
(2) A state agency, state official, or employee or agent of the 15
state to block or attempt to block an eligible patient's access to an 16
individualized investigational treatment; or 17
(3) An action against a hospital's Medicare certification. 18
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20-15-2508. Counseling, advice, or recommendation not violation. 20
The counseling, advice, or recommendation consistent with medical 21
standards of care by a medical professional licensed under state law is not a 22
violation of this subchapter. 23
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20-15-2509. Immunity. 25
(a) Except in the case of gross negligence or willful misconduct, a 26
person or entity that manufacturers, imports, distributes, prescribes, 27
dispenses, administers, or is otherwise involved in the care of an eligible 28
patient using an individualized investigational treatment is immune from 29
civil liability for any loss, damage, or injury arising out of, relating to, 30
or resulting from the individualized investigational treatment if the person 31
or entity is substantially complying in good faith with this subchapter and 32
has exercised reasonable care. 33
(b) This subchapter does not require a medical professional who is 34
licensed under the laws of this state to counsel, advise, prescribe, 35
dispense, administer, or otherwise be involved in the care of an eligible 36 SB136
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patient using an individualized investigational treatment. 1
(c) This subchapter does not require a hospital licensed under § 20 -9-2
213 to provide any new or additional service related to an individualized 3
investigational treatment, unless approved by the hospital. 4
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20-15-2510. Medicaid coverage. 6
This subchapter does not require the Department of Human Services or 7
the Arkansas Medicaid Program to provide additional coverage for an 8
individualized investigational treatment. 9
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APPROVED: 2/27/25 12
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