HB975 - Relating to the right to try cutting-edge treatments for patients with life-threatening or severely debilitating illnesses.

      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.