Section 198.5 - Use of Investigational Stem Cell Treatments for Patients with Certain Severe Chronic Diseases or Terminal Illnesses(a) The Legislature recognizes the need for patient access to innovative medical treatments. At the same time, the health and welfare of Texas citizens must be protected. These goals must be carefully balanced.(b) The purpose of this subchapter is to set out the requirements for a patient to be eligible for consideration of receiving investigational stem cell treatment and under what circumstances a certified physician may administer or provide investigational stem cell treatments. The implementation of this rule is contingent upon qualifying chronic diseases or terminal illness being defined, as set out in § 1003.052 of the Texas Health and Safety Code.(c) This rule does not require an eligible patient to receive such treatment, but rather the statute sets the eligibility standards and the parameters under which treatment may be provided to an individual with a qualifying severe chronic disease or terminal illness.(d) Stem cell treatments which are under investigation in a clinical trial and being administered to human participants:(1) may be administered or provided to eligible patients with qualifying terminal illnesses or severe chronic diseases as defined by the executive commissioner of the Health and Human Services Commission; and(2) must be done in compliance with applicable law.(e) In order for a patient to be eligible to receive treatment with investigational stem cells, the eligible patient must: (1) be enrolled in a clinical trial investigating the use of adult stem cells in humans;(2) sign a written informed consent, before receiving treatment, which includes documentation of compliance with § 1003.053(2)(a) of the Texas Health and Safety Code;(3) receive treatment from a physician certified under § 1003.055 of the Texas Health and Safety Code by: (B) a medical school as defined by § 61.501 of the Education Code; or(C) a hospital licensed under Chapter 241 of the Texas Health and Safety Code; and(4) receive treatment in a qualifying facility under § 1003.055 of the Texas Health and Safety Code.22 Tex. Admin. Code § 198.5
Adopted by Texas Register, Volume 43, Number 28, July 13, 2018, TexReg 4757, eff. 7/19/2018