88R12381 KKR-F
 
  By: King of Hemphill, Kacal, H.B. No. 4059
      A. Johnson of Harris, Thompson of Harris,
 
 
 
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, 2023.