HLS 24RS-2081 ENGROSSED
2024 Regular Session
HOUSE BILL NO. 899
BY REPRESENTATIVE WRIGHT
HEALTH/MEDICAL TREATMENT: Provides relative to the Hope for Louisiana Patients
Law
1 AN ACT
2To enact Part VIII of Chapter 5-G of Title 40 of the Louisiana Revised Statutes of 1950, to
3 be comprised of R.S. 40:1300.71 through R.S. 40:1300.80, relative to individualized
4 investigational treatments, drugs, or devices; relative to enact the Hope for Louisiana
5 Patients Law; to provide access to individualized investigative treatment for patients
6 with life-threatening illnesses; to provide a short title; to provide definitions; to
7 permit the expansion of existing insurance coverage provisions; to prohibit actions
8 against healthcare providers; to establish provisions for the death of a patient; to
9 prohibit private causes of action and insurance mandates; to establish provisions for
10 the treatment of unemancipated minors; to provide for severability; and to provide
11 for related matters.
12Be it enacted by the Legislature of Louisiana:
13 Section 1. Part VIII of Chapter 5-G of Title 40 of the Louisiana Revised Statutes of
141950, comprised of R.S. 40:1300.71 through R.S. 40:1300.80, is hereby enacted to read as
15follows:
16 PART VIII. HOPE FOR LOUISIANA PATIENTS
17 §1300.71. Short title
18 This Part shall be known and may be cited as the "Hope for Louisiana
19 Patients Law".
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1 §1300.72. Definitions
2 As used in this Part, the following terms have the meanings ascribed to them:
3 (1) "Eligible facility" means an institution that is operating with a
4 Federalwide Assurance for the Protection of Human Subjects, in accordance with 42
5 U.S.C. 289(a) and 45 CFR Part 46, and an eligible facility that is subject to the
6 Federalwide Assurance for the Protection of Human Subjects laws, regulations,
7 policies, and guidelines, including renewals and updates.
8 (2) "Eligible patient" means an individual who meets all of the following
9 conditions:
10 (a) Has considered all other treatment options currently approved by the
11 United States Food and Drug Administration.
12 (b) Has received a recommendation from his physician for an individualized
13 investigational treatment, based on analysis of the patient's genomic sequence,
14 human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products,
15 such as enzymes, and other types of proteins, or metabolites.
16 (c) Has a life-threatening, severely debilitating illness or serious disease or
17 condition associated with morbidity that has a substantial impact on day-to-day
18 functioning and is attested to by the patient's treating physician.
19 (d) Has given written, informed consent for the use of the investigational
20 drug, biological product, or device.
21 (e) Has documentation from his physician that he meets the requirements of
22 this Part.
23 (3) "Individualized investigational treatment" means drugs, biological
24 products, or devices that are unique to and produced exclusively for use for an
25 individual patient, based on his own genetic profile.
26 (a) "Individualized investigational treatment" includes but is not limited to
27 individualized gene therapy antisense oligonucleotides and individualized neoantigen
28 vaccines.
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1 (b) "Individualized investigational treatment" does not include any drug,
2 biological product, or device derived from human primary or secondary embryonic
3 stem cells or cell lines, or tissues or cells derived from abortion, but does include any
4 drug, biological product, or device derived from human perinatal tissues, cells, and
5 secreted factors not obtained from an abortion.
6 (4) "Life-threatening or severely debilitating illness," has the same meaning
7 as provided in Section 312.81 of Title 21, Code of Federal Regulations, or any
8 successor law or regulation, as applicable.
9 (5) "Written, informed consent" means a written document that is signed by
10 the patient, or if the patient is a minor, by any person authorized to consent in
11 accordance with the Louisiana Medical Consent Law, R.S. 40:1159.4, et seq., and
12 attested to by the patient's physician and a witness and that, at a minimum, includes
13 all of the following:
14 (a) An explanation of the currently approved products and treatments for the
15 illness, disease, or condition from which the patient suffers.
16 (b) An attestation that the patient concurs with his physician in believing that
17 all currently approved and conventionally recognized treatments are unlikely to
18 prolong the patient's life.
19 (c) Clear identification of the specific proposed individualized
20 investigational drug, biological product, or device that the patient is seeking to use.
21 (d)(i) A description of the potentially best and worst outcomes of using the
22 individualized investigational drug, biological product, or device and a realistic
23 description of the most likely outcome.
24 (ii) The description shall include the possibility that new, unanticipated,
25 different, or worse symptoms might result and that death could be hastened by the
26 proposed treatment.
27 (iii) The description shall be based on the physician's knowledge of the
28 proposed treatment in conjunction with an awareness of the patient's condition.
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1 (e) A statement that the patient's health plan or third-party administrator and
2 provider are not obligated to pay for any care or treatments consequent to the use of
3 the individualized investigational drug, biological product, or device, unless they are
4 specifically required to do so by law or contract.
5 (f) A statement that the patient's eligibility for hospice care may be
6 withdrawn if the patient begins curative treatment with the individualized
7 investigational drug, biological product, or device and that care may be reinstated if
8 this treatment ends and the patient meets hospice eligibility requirements.
9 (g) A statement that the patient understands that he is liable for all expenses
10 consequent to the use of the individualized investigational drug, biological product,
11 or device and that this liability extends to the patient's estate, unless a contract
12 between the patient and the manufacturer of the drug, biological product, or device
13 states otherwise.
14 §1300.73. Individualized investigational drugs; facility and manufacturer abilities
15 A. A manufacturer operating within an eligible facility and in accordance
16 with all applicable Federalwide Assurance for the Protection of Human Subjects
17 laws and regulations may make available an individualized investigative treatment
18 and an eligible patient may request an individualized investigational drug, biological
19 product, or device from an eligible facility or manufacturer operating within an
20 eligible facility in accordance with this Part. This Part shall not require a
21 manufacturer to make available an individualized investigational drug, biological
22 product, or device to an eligible patient.
23 B. An eligible facility or manufacturer operating within an eligible facility
24 may do all of the following:
25 (1) Provide an individualized investigational drug, biological product, or
26 device to an eligible patient without receiving compensation.
27 (2) Require an eligible patient to pay the costs of, or the costs associated
28 with, the manufacture of the investigational drug, biological product, or device.
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1 §1300.74. Coverage expansion; permissible; not required
2 A. This Part shall not expand the coverage required of an insurer in
3 accordance with any provisions of Title 22 of the Louisiana Revised Statutes of
4 1950.
5 B. A health plan, third-party administrator, or governmental agency may
6 provide coverage for the cost of an individualized investigational drug, biological
7 product, or device or the cost of services related to the use of an individualized
8 investigational drug, biological product, or device in accordance with this Part.
9 C. This Part shall not require any governmental agency to pay costs
10 associated with the use, care, or treatment of a patient with an individualized
11 investigational drug, biological product, or device.
12 D. This Part shall not require a hospital or facility licensed in accordance
13 with R.S. 40:2006(A) and operating or planning to operate within the state, to
14 provide new or additional services unless approved by the hospital or facility.
15 §1300.75. Patient death; insurance provisions
16 If a patient's death is proximately caused by treatment with an individualized
17 investigational drug, biological product, or device, the patient's estate, heirs, or
18 devisees are not liable for any debt remaining after payment by insurance for charges
19 directly incurred for the treatment. However, this provision shall not provide an
20 exemption to liability for charges for non-experimental treatments provided to the
21 patient, including non-experimental treatments rendered to the patient due to
22 complications or consequences of the experimental treatment.
23 §1300.76. Prohibition of actions taken against licensure of healthcare providers
24 A. A licensing board or disciplinary subcommittee shall not revoke, fail to
25 renew, suspend, or take any action against a healthcare provider's license issued in
26 accordance with Chapter 15 of Title 37 of the Louisiana Revised Statutes of 1950,
27 and based solely on the healthcare provider's recommendations to an eligible patient
28 regarding access to or treatment with an individualized investigational drug,
29 biological product, or device.
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1 B. An entity responsible for Medicare certification shall not take action
2 against a healthcare provider's Medicare certification based solely on the healthcare
3 provider's recommendation that a patient has access to an individualized
4 investigational drug, biological product, or device.
5 §1300.77. Eligible patient's access to individualized investigational drugs,
6 biological products, or devices
7 A. An official, employee, or agent of this state shall not block or attempt to
8 block an eligible patient's access to an individualized investigational drug, biological
9 product, or device.
10 B. Counseling, advice, or a recommendation consistent with medical
11 standards of care from a licensed healthcare provider shall not be a violation of this
12 Section.
13 §1300.78. Prohibition of private causes of action and insurance mandates
14 A. This Part shall not create a private cause of action against a manufacturer
15 of an individualized investigational drug, biological product, or device or against any
16 other person or entity involved in the care of an eligible patient using the
17 individualized investigational drug, biological product, or device for any harm done
18 to the eligible patient resulting from the individualized investigational drug,
19 biological product, or device, if the manufacturer or other person or entity is
20 complying in good faith with the terms of this Part and has exercised reasonable
21 care.
22 B. This Part shall not affect any mandatory healthcare coverage for
23 participation in clinical trials in accordance with any provisions provided in Title 22
24 of the Louisiana Revised Statutes of 1950.
25 §1300.79. Persons authorized to consent to treatment for unemancipated minors
26 A. It is hereby recognized and established that, in addition to such other
27 persons as may be so authorized and empowered, any one of the following persons
28 who is reasonably available, in descending order of priority, is authorized and
29 empowered to consent on behalf of an unemancipated minor, either orally or
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1 otherwise, to any surgical or medical treatment or procedures not prohibited by law
2 which may be suggested, recommended, prescribed, or directed by a duly licensed
3 physician:
4 (1) The minor's guardian or custodian.
5 (2) The minor's parent.
6 (3) An adult brother or sister of the minor.
7 (4) The minor's grandparent.
8 B. If none of the individuals eligible in accordance with Subsection A of this
9 Section is reasonably available, an adult who has exhibited special care and concern
10 for the minor and who is reasonably available may take action. The adult shall
11 communicate the assumption of authority as promptly and as practicably to the
12 individuals specified in Subsection A of this Section who can be readily contacted.
13 C. Any female, regardless of age or marital status, is empowered to give
14 consent for herself in connection with pregnancy or childbirth.
15 §1300.80. Severability
16 If one or more provisions of this Part or the application thereof is found to be
17 unconstitutional, the provision shall be declared severable and the balance of this
18 Part shall remain effective notwithstanding such unconstitutionality.
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 899 Engrossed 2024 Regular Session Wright
Abstract: Establishes the Hope for Louisiana Patients Law.
Proposed law shall be known and may be cited as the Hope for Louisiana Patients Law.
Proposed law defines "eligible facility", "eligible patient", "individualized investigational
treatment", "life-threatening or severely debilitating illness", and "written, informed
consent".
Proposed law allows a manufacturer operating within an eligible facility that complies with
federal laws and regulations to make available an individualized investigative treatment to
an eligible patient.
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Proposed law also allows an eligible patient to request an individualized investigational
drug, biological product, or device from an eligible facility or manufacturer operating within
an eligible facility in accordance with proposed law.
Proposed law further provides that a manufacturer shall not be required to make available
an individualized investigational drug, biological product, or device to an eligible patient.
Proposed law allows an eligible facility or manufacturer operating within an eligible facility
to do all of the following:
(1)Provide an individualized investigational drug, biological product, or device to an
eligible patient without receiving compensation.
(2)Require an eligible patient to pay the costs of, or the costs associated with, the
manufacture of the investigational drug, biological product, or device.
Proposed law does not require expansion of the coverage required for an insurer in
accordance with any provisions set forth in present law.
Proposed law allows a health plan, third-party administrator, or governmental agency to
provide coverage for the cost of an individualized investigational drug, biological product,
or device, or the cost of services related to the use of an individualized investigational drug,
biological product, or device.
Proposed law does not require any governmental agency to pay costs associated with the use,
care, or treatment of a patient with an individualized investigational drug, biological product,
or device. Proposed law also does not require a hospital or facility licensed in accordance
with present law, to provide new or additional services, unless approved by the hospital or
facility.
Proposed law establishes certain provisions in the event of a patient's death as a result of
treatment with an individualized investigational drug, biological product, or device.
Proposed law provides that a licensing board or disciplinary subcommittee shall not revoke,
fail to renew, suspend, or take any action against a healthcare provider's license issued in
accordance with present law based solely on the healthcare provider's recommendations to
an eligible patient regarding access to or treatment with an individualized investigational
drug, biological product, or device.
Proposed law provides that an entity responsible for Medicare certification shall not take
action against a healthcare provider's Medicare certification based solely on the healthcare
provider's recommendation.
Proposed law prohibits an official, employee, or agent of this state from blocking or
attempting to block an eligible patient's access to an individualized investigational drug,
biological product, or device.
Proposed law provides that counseling, advice, or a recommendation consistent with medical
standards of care from a licensed healthcare provider is also permitted in accordance with
proposed law.
Proposed law provides that nothing in proposed law shall create a private cause of action
against a manufacturer of an individualized investigational drug, biological product, or
device or against any other person or entity involved in the provision of such care. Proposed
law further provides that proposed law shall not affect any mandatory healthcare coverage
for participation in clinical trials.
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Proposed law provides that the following persons are authorized and empowered to consent
on behalf of an unemancipated minor, either orally or otherwise, to any surgical or medical
treatment or procedures not prohibited by law, which may be suggested, recommended,
prescribed, or directed by a duly licensed physician:
(1)The minor's guardian or custodian.
(2)The minor's parent.
(3)An adult brother or sister of the minor.
(4)The minor's grandparent.
Proposed law provides that if no such eligible person is reasonably available to provide such
consent, an adult who has exhibited special care and concern for the minor and who is
reasonably available may take action by communicating the assumption of authority as
promptly and as practicably to the individuals identified in proposed law.
Proposed law provides that any female, regardless of age or marital status, is empowered to
give consent for herself in connection with pregnancy or childbirth.
Proposed law declares that if any provisions of proposed law or the application thereof to
any person or circumstance is found to be unconstitutional, it shall be severable and the other
provisions of proposed law shall remain effective notwithstanding such unconstitutionality.
(Adds R.S. 40:1300.71-1300.80)
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