KY HB543

Allows eligible patients with life-threatening or severely debilitating illnesses to access individualized investigational drugs, biological products, or devices (including gene therapy and neoantigen vaccines) that are not yet FDA-approved, after consulting with their physician and exhausting approved treatment options

Requires comprehensive written informed consent documenting the patient's condition, potential outcomes including death, financial liability, and impact on hospice eligibility and insurance coverage

Protects health care providers from licensing board discipline and Medicare/Medicaid certification actions based solely on recommending individualized investigational treatments to eligible patients

Shields manufacturers and care providers from private lawsuits for harm caused by investigational treatments, provided they made good-faith compliance efforts and exercised reasonable care

Explicitly states insurers, Medicaid, and hospitals are not required to cover or provide these experimental treatments, and patient estates remain liable for costs unless otherwise contracted with the manufacturer