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A BILL TO BE ENTITLED
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AN ACT
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relating to the right to try cutting-edge treatments for patients |
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with life-threatening or severely debilitating illnesses. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Title 6, Health and Safety Code, is amended by |
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adding Subtitle C-1 to read as follows: |
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SUBTITLE C-1. INVESTIGATIONAL TREATMENTS |
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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 that is unique to and produced |
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exclusively for use by an individual patient, based on the |
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patient's genetic profile. The term includes individualized gene |
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therapy antisense oligonucleotides and individualized neoantigen |
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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 and renewals or updates to the laws, regulations, |
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policies, and guidelines. |
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Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible |
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to receive 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 the |
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use of the individualized investigational 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 that the patient meets |
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the requirements under this section; and |
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(B) recommends an individualized investigational |
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treatment for the patient based on analysis of the patient's |
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genomic sequence, human chromosomes, deoxyribonucleic acid, |
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ribonucleic acid, genes, gene products such as enzymes and other |
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types of proteins, or metabolites. |
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Sec. 491.053. INFORMED CONSENT. (a) An eligible patient |
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may not receive 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 products |
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and treatments for the patient's disease or condition; |
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(2) an attestation that the patient concurs with the |
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patient's physician in believing that all currently approved and |
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conventionally recognized treatments are unlikely to prolong the |
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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 individualized investigational treatment, |
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and of the most likely outcome, including the possibility that new, |
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unanticipated, different, or worse symptoms might result and that |
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death could be hastened by the proposed 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 or treatments related to the use of the |
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individualized investigational treatment unless payment is |
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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 curative |
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treatment with the individualized investigational treatment and |
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that care may be reinstated if this treatment ends and the patient |
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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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individualized investigational treatment and the liability extends |
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to the patient's estate, unless a contract between the patient and |
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the manufacturer of the individualized investigational treatment |
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states otherwise. |
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Sec. 491.054. PROVISION OF 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 investigative |
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treatment, and an eligible patient may request to receive an |
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individualized investigational treatment from an eligible health |
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care facility or manufacturer operating within an eligible health |
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care facility under this 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 individualized |
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investigational treatment. |
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Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a |
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patient dies while being treated under an individualized |
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investigational treatment, the patient's heirs are not liable for |
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any outstanding debt related to the treatment or lack of health |
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coverage due to the 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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individualized investigational treatment for any harm to the |
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eligible patient resulting from the individualized investigational |
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treatment if the manufacturer or other person is complying in good |
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faith with the terms of this chapter and has exercised reasonable |
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care. |
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Sec. 491.057. STATE MAY NOT INTERFERE 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 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. 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 with |
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an individualized investigational treatment. |
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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. 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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SUBCHAPTER D. HEALTH CARE PROVIDERS |
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Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE OR |
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CERTIFICATION HOLDER. (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 health care provider's recommendation to an eligible |
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patient 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's Medicare certification |
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based solely on the health care provider's recommendation that a |
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patient have access to an individualized investigational |
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treatment. |
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SECTION 2. This Act takes effect September 1, 2023. |