Harrison Bill Lets Patients Try Treatments Tailored To Their Genes

The text as introduced · 1,330 words

By: Harrison
H.B. No. 975

A BILL TO BE ENTITLED

AN ACT

relating to the right to try cutting-edge treatments for patients

with life-threatening or severely debilitating illnesses.

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

SECTION 1. Title 6, Health and Safety Code, is amended by

adding Subtitle C-1 to read as follows:

SUBTITLE C-1. INVESTIGATIONAL TREATMENTS

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 that is unique to and produced

exclusively for use by an individual 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 and renewals or updates to the laws, regulations,

policies, and guidelines.

Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible

to receive 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 the

use of the individualized investigational treatment; and

(2) the patient's physician:

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

illness or severely debilitating illness and that the patient meets

the requirements under this section; and

(B) recommends an individualized investigational

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 receive 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 products

and treatments for the patient's disease or condition;

(2) an attestation that the patient concurs with the

patient's 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 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 individualized investigational 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 proposed 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 or treatments related to the use of the

individualized investigational 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 curative

treatment with the individualized investigational treatment and

that care may be reinstated if this 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

individualized investigational treatment and the liability extends

to the patient's estate, unless a contract between the patient and

the manufacturer of the individualized investigational treatment

states otherwise.

Sec. 491.054. PROVISION OF 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 investigative

treatment, and an eligible patient may request to receive an

individualized investigational 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 individualized

investigational treatment.

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

patient dies while being treated under 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

individualized investigational treatment for any harm to the

eligible patient resulting from the individualized investigational

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. STATE MAY NOT INTERFERE 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 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. 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 with

an individualized investigational treatment.

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. 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.

SUBCHAPTER D. HEALTH CARE PROVIDERS

Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE OR

CERTIFICATION HOLDER. (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 health care 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's Medicare certification

based solely on the health care provider's recommendation that a

patient have access to an individualized investigational

treatment.

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