HB 98 Summary

• Establishes a "Right to Try" law allowing eligible patients with life-threatening or severely debilitating illnesses to access individualized investigational drugs, biological products, and devices produced exclusively for their genetic profile, including gene therapy and neoantigen vaccines.

• Requires eligible patients to have a treating physician's attestation of their illness, consultation on all FDA-approved treatment options, physician recommendation for the investigational treatment, and written informed consent that includes detailed disclosures about potential outcomes, hospice implications, and financial liability.

• Prohibits manufacturers from being required to provide the treatment but permits them to provide it with or without compensation; patients remain liable for all costs unless otherwise contracted with the manufacturer.

• Protects health care providers from licensing board discipline or Medicare certification action based solely on recommending access to individualized investigational treatments.

• Shields manufacturers and care providers from private lawsuits for harm caused by the investigational treatment if they made good-faith efforts to comply with the law and exercised reasonable care; protects heirs from inheriting treatment-related debt.