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HI SB857
Bill
Status
1/20/2023
Primary Sponsor
Stanley Chang
Click for details
AI Summary
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Permits manufacturers of investigational drugs and biological products to provide these treatments to terminally ill patients beginning January 1, 2024, without requiring FDA approval.
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Establishes "eligible patient" requirements including: terminal illness attestation by treating physician, consideration of all FDA-approved treatments, inability to access clinical trials within 100 miles or acceptance within one week, physician recommendation, and written informed consent.
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Allows manufacturers to provide investigational drugs either at no cost or by requiring patients to pay manufacturing costs; health insurers may deny coverage for up to six months after treatment ends but cannot deny coverage for preexisting conditions.
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Prohibits state licensing boards from revoking, suspending, or taking action against healthcare providers' licenses for recommending investigational drugs to eligible patients or addressing terminal illness symptoms and palliative care.
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Protects manufacturers and healthcare providers from private lawsuits for harm resulting from investigational drugs when complying in good faith with the law and exercising reasonable care; patient heirs are not liable for outstanding debts if patient dies during treatment.
Legislative Description
Relating To Access To Treatment For Terminally Ill Patients.
Terminally Ill Patients
Last Action
Report adopted; Passed Second Reading, as amended (SD 1) and referred to CPN/JDC.
2/17/2023