King Bill Opens A State Path To Custom Experimental Treatments

The text as introduced · 1,282 words

89R1259 KKR-F

By: King
H.B. No. 3318

A BILL TO BE ENTITLED

AN ACT

relating to access to individualized investigational treatments

for patients with life-threatening or severely debilitating

illnesses.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Subtitle C, Title 6, Health and Safety Code, is

amended by adding Chapter 491 to read as follows:

CHAPTER 491. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS

FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING

ILLNESSES

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 491.001. DEFINITIONS. In this chapter:

(1) "Individualized investigational treatment" means

a drug, biological product, or device unique to and produced

exclusively for use by a patient, based on the patient's genetic

profile. The term includes individualized gene therapy antisense

oligonucleotides and individualized neoantigen vaccines.

(2) "Life-threatening illness" means a disease or

condition with:

(A) a significantly increased likelihood of

death unless the course of the disease or condition is interrupted;

or

(B) potentially fatal outcomes and for which the

goal of clinical trials is survival.

(3) "Severely debilitating illness" means a disease or

condition that causes major irreversible morbidity.

SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT

Sec. 491.051. HEALTH CARE FACILITY ELIGIBILITY. A health

care facility is eligible to provide an individualized

investigational treatment under this chapter if the facility is

operating under a federal assurance for the protection of human

subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is

subject to the federal assurance laws, regulations, policies, and

guidelines.

Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible

to access an individualized investigational treatment under this

chapter if:

(1) the patient:

(A) has a life-threatening illness or severely

debilitating illness;

(B) has considered all other treatment options

currently approved by the United States Food and Drug

Administration; and

(C) has given written informed consent for access

to the treatment; and

(2) the patient's physician:

(A) attests to the patient's life-threatening

illness or severely debilitating illness and the patient's

eligibility under this section; and

(B) recommends the treatment for the patient

based on analysis of the patient's genomic sequence, human

chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene

products such as enzymes and other types of proteins, or

metabolites.

Sec. 491.053. INFORMED CONSENT. (a) An eligible patient

may not access an individualized investigational treatment unless

the patient provides written informed consent. If the patient is a

minor or lacks the mental capacity to provide informed consent, a

parent, legal guardian, managing conservator, or patient's agent as

defined by Section 166.151 may provide written informed consent on

the patient's behalf.

(b) Informed consent under this chapter must be attested to

in writing by the patient's physician and a witness.

(c) Informed consent under this chapter must include at a

minimum:

(1) an explanation of the currently approved

treatments for the patient's disease or condition;

(2) the patient's attestation that the patient concurs

with the assessment of the patient's physician 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 drug, biological product, or device

the patient's physician recommends;

(4) a description, based on the physician's knowledge

of the proposed treatment in conjunction with an awareness of the

patient's disease or condition, of the potentially best and worst

outcomes of using the treatment, and of the most likely outcome,

including the possibility that new, unanticipated, different, or

worse symptoms might result and that death could be hastened by the

treatment;

(5) a statement that the patient's health benefit plan

issuer or third-party administrator and provider are not obligated

to pay the cost of any care related to the use of the treatment

unless payment is specifically required by law or contract;

(6) a statement that the patient's eligibility for

hospice care may be withdrawn if the patient begins the treatment

and that care may be reinstated if the treatment ends and the

patient meets hospice eligibility requirements; and

(7) a statement that the patient understands the

patient is liable for all expenses related to the use of the

treatment and the liability extends to the patient's estate, unless

a contract between the patient and the manufacturer of the

treatment provides otherwise.

Sec. 491.054. ACCESS TO TREATMENT; COSTS. (a) A

manufacturer operating within an eligible health care facility and

in compliance with all applicable federal assurance laws and

regulations may make available an individualized investigational

treatment, and an eligible patient may request access to the

treatment from an eligible health care facility or manufacturer

operating within an eligible health care facility under this

chapter.

(b) A manufacturer is not required under this chapter to

make available an individualized investigational treatment to an

eligible patient.

(c) An eligible health care facility or manufacturer

operating within an eligible health care facility may:

(1) provide an individualized investigational

treatment to an eligible patient without receiving compensation; or

(2) require an eligible patient to pay the costs of, or

the costs associated with, the manufacture of the treatment.

Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a

patient dies while receiving an individualized investigational

treatment, the patient's heirs are not liable for any outstanding

debt related to the treatment or lack of health coverage due to the

treatment.

Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does

not create a private cause of action against a manufacturer of an

individualized investigational treatment or against any other

person involved in the care of an eligible patient using the

treatment for any harm to the patient resulting from the treatment

if the manufacturer or other person is complying in good faith with

the terms of this chapter and has exercised reasonable care.

Sec. 491.057. PROHIBITED STATE INTERFERENCE WITH ACCESS TO

TREATMENT. (a) An officer, employee, or agent of this state may

not block or attempt to block an eligible patient's access to an

individualized investigational treatment that complies with this

chapter and rules adopted under this chapter.

(b) Notwithstanding Subsection (a), counseling, advice, or

a recommendation consistent with medical standards of care from a

licensed health care provider is not a violation of this section.

SUBCHAPTER C. HEALTH COVERAGE, COSTS, AND SERVICES

Sec. 491.101. HEALTH COVERAGE. This chapter does not

affect:

(1) the coverage required of an insurer under the

Insurance Code; or

(2) health care coverage of enrollees in clinical

trials under Chapter 1379, Insurance Code.

Sec. 491.102. COVERAGE OPTIONAL. A health benefit plan

issuer, third-party administrator, or governmental agency may, but

is not required to, provide coverage for the cost of an

individualized investigational treatment or the cost of services

related to the use of an individualized investigational treatment

under this chapter.

Sec. 491.103. HOSPITAL SERVICES. This chapter does not

require a hospital or health care facility licensed under Subtitle

B, Title 4, to provide new or additional services unless approved by

the hospital or facility.

Sec. 491.104. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR

COSTS. This chapter does not require a governmental agency to pay

costs associated with the use, care, or treatment of a patient

accessing an individualized investigational treatment.

SUBCHAPTER D. HEALTH CARE PROVIDERS

Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE HOLDER OR

MEDICAID PARTICIPANT. (a) A state licensing board may not revoke,

fail to renew, suspend, or take any action against a health care

provider's license issued under Title 3, Occupations Code, based

solely on the provider's recommendation to an eligible patient

regarding access to or treatment with an individualized

investigational treatment.

(b) The Health and Human Services Commission may not take

action against a health care provider that adversely affects the

provider's participation in Medicaid based solely on the provider's

recommendation for a patient to access an individualized

investigational treatment.

SECTION 2. This Act takes effect September 1, 2025.