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AB-1944 Individualized investigational treatment.(2023-2024)

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Date Published: 01/29/2024 09:00 PM
AB1944:v99#DOCUMENT


CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill
No. 1944

Introduced by Assembly Member Waldron

January 29, 2024

An act to add Article 4.7 (commencing with Section 111549) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to drugs and devices.


LEGISLATIVE COUNSEL'S DIGEST


AB 1944, as introduced, Waldron. Individualized investigational treatment.
Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA). Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application. Existing federal law also regulates biomedical and behavioral research involving human subjects.
Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. The Sherman Food, Drug, and Cosmetic Law prohibits, among other things, the sale, delivery, or giving away of a new drug or new device unless either the department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and Cosmetic Act.
Existing law provides for the licensure and regulation of various healing arts professions and vocations by boards within the Department of Consumer Affairs. For instance, the Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and the Osteopathic Act provides for the licensure and regulation of osteopathic physicians and surgeons by the Osteopathic Medical Board of California, among others.
This bill, the Right to Try Individualized Investigational Treatments Act, would permit a manufacturer of an individualized investigational treatment, as defined, to make the product available to eligible patients with life-threatening or severely debilitating illness, as specified. The bill would authorize, but not require, a health benefit plan, as defined, to provide coverage for any individualized investigational treatment made available pursuant to these provisions.
The bill would prohibit a state regulatory board from taking any action against a health care provider’s license solely on a provider’s recommendation of or providing access to an individualized investigational treatment.
The bill would prohibit a state agency from altering any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider's certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that a patient have access to an individualized investigational treatment.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Article 4.7 (commencing with Section 111549) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read:
Article  4.7. Right to Try Individualized Investigational Treatments

111549.
 This article shall be known, and may be cited, as the Right to Try Individualized Treatments Act.

111549.1.
 For the purposes of this article, the following definitions apply:
(a) “Eligible facility” means an institution that is operating under a Federalwide Assurance for the Protection of Human Subjects under Section 289 of Title 42 of the United States Code and Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations, and in compliance with Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20).
(b) “Eligible patient” means an individual who meets all of the following conditions:
(1) Has a life-threatening or severely debilitating illness that has been attested to by the patient’s treating physician.
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration.
(3) Has received a recommendation from their physician for an individualized investigational treatment, based on analysis of the patient’s metabolites, genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, immunology panel, genes, or gene products, including, but not limited to, enzymes and other proteins.
(4) Has given written, informed consent for the use of the individualized investigational treatment.
(5) Has documentation from their physician that they meet the requirements of this subdivision.
(c) “Health benefit plan” means a plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. “Health benefit plan” includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer.
(d) “Individualized investigational treatment” means a drug, biological product, or device that is unique to, and produced exclusively for use for, an individual patient, based on their own genetic or cellular profile. It includes, but is not limited to, individualize gene therapy antisense oligonucleotides and individualized neoantigen vaccines.
(e) “Life-threatening or severely debilitating illness” means the same as in Section 312.8 of Title 21 of the Code of Federal Regulations.
(f) “Written, informed consent” means a form and method of consent consistent with the informed consent requirements of the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20) and attested to by the patient’s physician and a witness. In addition to these requirements, all of the following requirements shall be included:
(1) An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers.
(2) An attestation that the patient concurs with their physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life.
(3) Clear identification of the specific proposed individualized investigational treatment that the patient is seeking to use.
(4) A description of the potentially best and worst outcomes of using the individualized investigational treatment and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition.
(5) A statement that the patient’s health benefit plan, insurance plan, or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the individualized investigational treatment, unless they are specifically required to do so by law or contract.
(6) A statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational treatment and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements.
(7) A statement that the patient understands that they are liable for all expenses consequent to the use of the individualized investigational treatment and that this liability extends to the patient’s estate, unless a contract between the patient and manufacturer of the treatment states otherwise.

111549.2.
 (a) Notwithstanding Sections 110280, 111520, and 111550, or any other law, a manufacturer operating within an eligible facility and in compliance with federal laws, regulations, policies, and guidelines, including renewals or updates, of a Federalwide Assurance for the Protection of Human Subjects may make available an individualized investigational treatment to an eligible patient, and an eligible patient may request an individualized investigational treatment from an eligible facility or a manufacturer operating within an eligible facility. A manufacturer is not required to make available an individualized investigational treatment to an eligible patient.
(b) An eligible facility or manufacturer operating within an eligible facility may do either of the following:
(1) Provide an individualized investigational treatment to an eligible patient without requesting compensation.
(2) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational treatment.

111549.3.
 (a) A health or care facility licensed under this code is not required to provide new or additional services pursuant to this article, unless approved by the hospital or facility.
(b) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code.
(c) This article does not require a health benefit plan to provide coverage for the cost of an individualized investigational treatment, or the costs of services related to the use of an individualized investigational treatment under this article. A health benefit plan may provide coverage for an individualized investigational treatment made available pursuant to this article.

111549.4.
 If a patient dies while being treated with an individualized investigational treatment, the patient’s heirs are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment.

111549.5.
 (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, suspend, or take any action against a health care provider’s license based solely on the health care provider’s recommendations to an eligible patient regarding access to, or treatment with, an individualized investigational treatment.
(b) A state agency shall not alter any recommendation made to the federal Centers for Medicare or Medicaid Services based solely on the health care provider’s recommendation that a patient have access to an individualized investigational treatment.
(c) A violation of this article is not subject to Chapter 8 (commencing with Section 111825).

111549.6.
 An official, employee, or agent of the state shall not block or attempt to block an eligible patient’s access to an individualized investigational treatment. Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section.

111549.7.
 This article does not create a private cause of action against a manufacturer of an individualized investigational treatment or against any other person or entity involved in the care of an eligible patient using the individualized investigational treatment for any harm done to the eligible patient resulting from the individualized investigational treatment, if the manufacturer or other person or entity is complying in good faith with the terms of this article and has exercised reasonable care.