HB3318 - Relating to access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.

  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.