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A BILL TO BE ENTITLED
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AN ACT
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relating to access to individualized investigational treatments |
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for patients with life-threatening or severely debilitating |
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illnesses. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle C, Title 6, Health and Safety Code, is |
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amended by adding Chapter 491 to read as follows: |
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CHAPTER 491. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENTS |
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FOR PATIENTS WITH LIFE-THREATENING OR SEVERELY DEBILITATING |
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ILLNESSES |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 491.001. DEFINITIONS. In this chapter: |
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(1) "Individualized investigational treatment" means |
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a drug, biological product, or device unique to and produced |
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exclusively for use by a patient, based on the patient's genetic |
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profile. The term includes individualized gene therapy antisense |
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oligonucleotides and individualized neoantigen vaccines. |
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(2) "Life-threatening illness" means a disease or |
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condition with: |
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(A) a significantly increased likelihood of |
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death unless the course of the disease or condition is interrupted; |
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or |
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(B) potentially fatal outcomes and for which the |
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goal of clinical trials is survival. |
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(3) "Severely debilitating illness" means a disease or |
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condition that causes major irreversible morbidity. |
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SUBCHAPTER B. ACCESS TO INDIVIDUALIZED INVESTIGATIONAL TREATMENT |
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Sec. 491.051. HEALTH CARE FACILITY ELIGIBILITY. A health |
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care facility is eligible to provide an individualized |
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investigational treatment under this chapter if the facility is |
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operating under a federal assurance for the protection of human |
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subjects under 42 U.S.C. Section 289(a) and 45 C.F.R. Part 46 and is |
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subject to the federal assurance laws, regulations, policies, and |
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guidelines. |
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Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible |
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to access an individualized investigational treatment under this |
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chapter if: |
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(1) the patient: |
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(A) has a life-threatening illness or severely |
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debilitating illness; |
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(B) has considered all other treatment options |
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currently approved by the United States Food and Drug |
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Administration; and |
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(C) has given written informed consent for access |
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to the treatment; and |
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(2) the patient's physician: |
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(A) attests to the patient's life-threatening |
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illness or severely debilitating illness and the patient's |
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eligibility under this section; and |
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(B) recommends the treatment for the patient |
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based on analysis of the patient's genomic sequence, human |
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chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene |
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products such as enzymes and other types of proteins, or |
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metabolites. |
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Sec. 491.053. INFORMED CONSENT. (a) An eligible patient |
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may not access an individualized investigational treatment unless |
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the patient provides written informed consent. If the patient is a |
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minor or lacks the mental capacity to provide informed consent, a |
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parent, legal guardian, managing conservator, or patient's agent as |
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defined by Section 166.151 may provide written informed consent on |
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the patient's behalf. |
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(b) Informed consent under this chapter must be attested to |
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in writing by the patient's physician and a witness. |
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(c) Informed consent under this chapter must include at a |
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minimum: |
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(1) an explanation of the currently approved |
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treatments for the patient's disease or condition; |
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(2) the patient's attestation that the patient concurs |
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with the assessment of the patient's physician that all currently |
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approved and conventionally recognized treatments are unlikely to |
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prolong the patient's life; |
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(3) clear identification of the specific proposed |
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individualized investigational drug, biological product, or device |
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the patient's physician recommends; |
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(4) a description, based on the physician's knowledge |
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of the proposed treatment in conjunction with an awareness of the |
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patient's disease or condition, of the potentially best and worst |
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outcomes of using the treatment, and of the most likely outcome, |
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including the possibility that new, unanticipated, different, or |
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worse symptoms might result and that death could be hastened by the |
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treatment; |
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(5) a statement that the patient's health benefit plan |
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issuer or third-party administrator and provider are not obligated |
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to pay the cost of any care related to the use of the treatment |
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unless payment is specifically required by law or contract; |
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(6) a statement that the patient's eligibility for |
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hospice care may be withdrawn if the patient begins the treatment |
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and that care may be reinstated if the treatment ends and the |
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patient meets hospice eligibility requirements; and |
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(7) a statement that the patient understands the |
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patient is liable for all expenses related to the use of the |
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treatment and the liability extends to the patient's estate, unless |
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a contract between the patient and the manufacturer of the |
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treatment provides otherwise. |
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Sec. 491.054. ACCESS TO TREATMENT; COSTS. (a) A |
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manufacturer operating within an eligible health care facility and |
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in compliance with all applicable federal assurance laws and |
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regulations may make available an individualized investigational |
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treatment, and an eligible patient may request access to the |
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treatment from an eligible health care facility or manufacturer |
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operating within an eligible health care facility under this |
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chapter. |
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(b) A manufacturer is not required under this chapter to |
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make available an individualized investigational treatment to an |
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eligible patient. |
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(c) An eligible health care facility or manufacturer |
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operating within an eligible health care facility may: |
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(1) provide an individualized investigational |
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treatment to an eligible patient without receiving compensation; or |
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(2) require an eligible patient to pay the costs of, or |
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the costs associated with, the manufacture of the treatment. |
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Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a |
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patient dies while receiving an individualized investigational |
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treatment, the patient's heirs are not liable for any outstanding |
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debt related to the treatment or lack of health coverage due to the |
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treatment. |
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Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does |
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not create a private cause of action against a manufacturer of an |
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individualized investigational treatment or against any other |
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person involved in the care of an eligible patient using the |
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treatment for any harm to the patient resulting from the treatment |
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if the manufacturer or other person is complying in good faith with |
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the terms of this chapter and has exercised reasonable care. |
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Sec. 491.057. PROHIBITED STATE INTERFERENCE WITH ACCESS TO |
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TREATMENT. (a) An officer, employee, or agent of this state may |
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not block or attempt to block an eligible patient's access to an |
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individualized investigational treatment that complies with this |
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chapter and rules adopted under this chapter. |
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(b) Notwithstanding Subsection (a), counseling, advice, or |
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a recommendation consistent with medical standards of care from a |
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licensed health care provider is not a violation of this section. |
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SUBCHAPTER C. HEALTH COVERAGE, COSTS, AND SERVICES |
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Sec. 491.101. HEALTH COVERAGE. This chapter does not |
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affect: |
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(1) the coverage required of an insurer under the |
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Insurance Code; or |
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(2) health care coverage of enrollees in clinical |
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trials under Chapter 1379, Insurance Code. |
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Sec. 491.102. COVERAGE OPTIONAL. A health benefit plan |
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issuer, third-party administrator, or governmental agency may, but |
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is not required to, provide coverage for the cost of an |
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individualized investigational treatment or the cost of services |
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related to the use of an individualized investigational treatment |
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under this chapter. |
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Sec. 491.103. HOSPITAL SERVICES. This chapter does not |
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require a hospital or health care facility licensed under Subtitle |
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B, Title 4, to provide new or additional services unless approved by |
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the hospital or facility. |
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Sec. 491.104. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR |
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COSTS. This chapter does not require a governmental agency to pay |
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costs associated with the use, care, or treatment of a patient |
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accessing an individualized investigational treatment. |
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SUBCHAPTER D. HEALTH CARE PROVIDERS |
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Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE HOLDER OR |
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MEDICAID PARTICIPANT. (a) A state licensing board may not revoke, |
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fail to renew, suspend, or take any action against a health care |
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provider's license issued under Title 3, Occupations Code, based |
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solely on the provider's recommendation to an eligible patient |
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regarding access to or treatment with an individualized |
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investigational treatment. |
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(b) The Health and Human Services Commission may not take |
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action against a health care provider that adversely affects the |
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provider's participation in Medicaid based solely on the provider's |
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recommendation for a patient to access an individualized |
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investigational treatment. |
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SECTION 2. This Act takes effect September 1, 2025. |