BILL ANALYSIS

C.S.H.B. 4014

By: Bucy

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

The bill author has informed the committee that there are currently several psychedelic compounds that have received FDA breakthrough therapy designations and are nearing approval for medical use. However, the bill author has further informed the committee that integrating these novel treatments into existing regulatory frameworks presents complex challenges, including patient accessibility and cost considerations, treatment guidelines, provider training and licensure, provider availability, medication supply, and more. C.S.H.B. 4014 seeks to provide for a comprehensive study on the use of psychedelic therapies for the treatment of certain mental health conditions.

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

C.S.H.B. 4014 requires the Health and Human Services Commission (HHSC) to conduct a study on the use of psychedelic therapies for treatment of post-traumatic stress disorder (PTSD), depression, and other co‑occurring conditions. The bill requires HHSC, in conducting the study, to do the following:

· review clinical trials on the efficacy of using psychedelic therapies, current literature regarding the use of psychedelic therapies, and actions of the FDA regarding psychedelic therapies for treatment of those conditions;

· evaluate treatment guidelines for use of psychedelic therapies to treat those conditions and recommend guidelines and best practices for providers; and

· evaluate patient access to current treatment for those conditions and recommend legislative or other actions necessary to ensure patient access to psychedelic therapies following approval by the FDA, including considerations of provider availability, affordability, accessibility, training and licensure, and other regulatory requirements.

The bill authorizes HHSC to solicit and accept federal funds and gifts, grants, or donations from any source to administer and finance the study conducted under this section in addition to any money appropriated by the legislature.

C.S.H.B. 4014 requires HHSC, not later than December 1, 2026, to submit to the governor, the lieutenant governor, the speaker of the house of representatives, and the chair of the standing committee of each house of the legislature with primary jurisdiction over HHSC a written report that includes the results of the study and any recommendations for legislative or other action necessary to ensure patient access to psychedelic therapies for treatment of PTSD, depression, and other co-occurring conditions after those therapies are approved by the FDA. The bill's provisions expire September 1, 2027.

C.S.H.B. 4014 establishes that HHSC is required to implement a provision of this bill only if the legislature appropriates money specifically for that purpose. If the legislature does not appropriate money specifically for that purpose, HHSC may, but is not required to, implement a provision of this bill using other money available for that purpose.

EFFECTIVE DATE

September 1, 2025.

COMPARISON OF INTRODUCED AND SUBSTITUTE

While C.S.H.B. 4014 may differ from the introduced in minor or nonsubstantive ways, the following summarizes the substantial differences between the introduced and committee substitute versions of the bill.

The substitute changes from DSHS in consultation with certain medical schools as in the introduced to HHSC the agency required to conduct a study on the use of psychedelic therapies for treatment of PTSD, depression, and other co-occurring conditions and submit a written report that includes the results of the study and any recommendations for legislative or other action necessary to ensure patient access to psychedelic therapies for treatment of PTSD, depression, and other co-occurring conditions after those therapies are approved by the FDA.

The substitute includes the following provisions absent from the introduced which:

· authorize HHSC to solicit and accept federal funds and gifts, grants, or donations from any source to administer and finance the study conducted under the bill's provisions in addition to any money appropriated by the legislature; and

· establish that HHSC is required to implement a provision of this bill only if the legislature appropriates money specifically for that purpose. If the legislature does not appropriate money specifically for that purpose, HHSC may, but is not required to, implement a provision of this bill using other money available for that purpose.