BILL ANALYSIS

 

 

 

H.B. 5147

By: King

Public Health

Committee Report (Unamended)

 

 

 

BACKGROUND AND PURPOSE

 

The bill author has informed the committee that investigational adult stem cell treatments offer hope for patients with a variety of diseases and conditions, that current regulations limit patient access to these treatments, and that additional safeguards are available that serve to promote patient safety and ethical medical practices. H.B. 5147 seeks to grant patients greater access to investigational adult stem cell treatments by allowing those treatments to be administered in additional health care settings, including outpatient facilities providing level II anesthesia services.

 

CRIMINAL JUSTICE IMPACT

 

It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.

 

RULEMAKING AUTHORITY

 

It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.

 

ANALYSIS

 

H.B. 5147 amends the Health and Safety Code to establish that "investigational stem cell treatment" means an adult stem cell treatment that uses only adult stem cells that satisfy current good manufacturing practices adopted by the FDA in addition to the conditions in current law for purposes of the provision of investigational stem cell treatments to patients with certain severe chronic diseases or terminal illnesses.

 

H.B. 5147 includes on the required notice on the informed consent form that the executive commissioner of the Health and Human Services Commission is required to adopt by rule and an eligible patient must sign before receiving an investigational stem cell treatment that such treatment has not been approved for general use by the FDA. The bill requires such treatment to be provided in an outpatient setting listed by a physician registered to provide level II anesthesia services in that setting. The bill includes being registered by the Office for Human Research Protections under the U.S. Department of Health and Human Services, in accordance with federal regulations relating to institutional review boards, among the conditions that an institutional review board that oversees investigational stem cell treatments is authorized to satisfy in order for the board to be authorized to certify a physician to provide an investigational stem cell treatment.

 

H.B. 5147 includes any serious adverse events related to investigational stem cell treatment in the annual report that each institutional review board overseeing an investigational stem cell treatment must submit to the Texas Medical Board on the review board's findings based on the records on each person to whom a physician administers the treatment. The bill removes a requirement that the report be made available to the public in both written and electronic form.

 

EFFECTIVE DATE

 

September 1, 2025.