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TX SB984
Bill
Status
5/29/2025
Primary Sponsor
Paul Bettencourt
Click for details
AI Summary
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Creates Chapter 491 in the Health and Safety Code establishing a framework for patients with life-threatening or severely debilitating illnesses to access individualized investigational treatments, including gene therapy antisense oligonucleotides and neoantigen vaccines customized based on a patient's genetic profile
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Requires patients to have a life-threatening or severely debilitating illness, have considered all FDA-approved treatment options, provide written informed consent, and have a physician attestation recommending the treatment based on genomic analysis
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Health care facilities must operate under federal human subjects protection assurance (42 U.S.C. Section 289(a) and 45 C.F.R. Part 46) to be eligible to provide these treatments; manufacturers may charge patients for treatment costs but are not required to provide treatments
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Protects health care providers from license revocation or adverse Medicaid participation actions based solely on recommending individualized investigational treatments; shields manufacturers and providers from private causes of action if they comply in good faith with the chapter
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Health benefit plans, third-party administrators, and government agencies are not required to cover treatment costs; patients are liable for all expenses, though heirs are not liable for outstanding treatment debt if the patient dies
Legislative Description
Relating to access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.
Health
Last Action
Effective on 9/1/25
5/29/2025