1. (a) Medical conditions that may be eligible for investigational stem cell treatments pursuant to the Health and Safety Code, Chapter 1003 must affect one or more body system.

2. (b) The medical condition identified by the patient's treating physician documented in the patient's medical record is a medical condition that is the subject of an investigational stem cell treatment approved and overseen by an institutional review board that is affiliated with:

   1. (1) a medical school as defined by the Education Code, §61.501; or
   2. (2) a hospital licensed under the Health and Safety Code, Chapter 241 that has at least 150 beds.

3. (c) The medical condition is documented by the patient's treating physician in the patient's medical record as specifically meeting the definition of severe chronic disease as described in paragraph (1) of this subsection or specifically meeting the definition of terminal illness as described in paragraph (2) of this subsection.

   1. (1) Severe Chronic Disease. A condition, injury, or illness that:

      1. (A) may be treated;
      2. (B) is never cured or eliminated; and
      3. (C) entails significant functional impairment or severe pain.
   2. (2) Terminal Illness. An advanced state of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.

Source Note:The provisions of this §1.461 adopted to be effective July 10, 2018, 43 TexReg 4986.