Bill > H98

This bill aims to provide eligible patients the right to try individualized investigational drugs, biological products, and devices to treat life-threatening or severely debilitating illnesses. The key provisions include: 1. Defining eligible patients as those with a life-threatening or severely debilitating illness who have considered all other approved treatments and received a recommendation from their treating physician for the use of an individualized investigational product. 2. Allowing manufacturers operating within eligible facilities to make their individualized investigational products available to eligible patients, but not requiring them to do so. 3. Prohibiting the revocation or disciplinary action against healthcare providers' licenses or Medicare certifications based solely on their recommendations to patients regarding access to these investigational products. 4. Preventing state officials from blocking eligible patients' access to these products, while clarifying that counseling or coverage denials by healthcare providers or Medicaid do not constitute a violation. 5. Providing liability protection for manufacturers and others involved in the care of eligible patients using these investigational products, as long as they have made a good-faith effort to comply with the law. The bill aims to expand access to experimental treatments for patients with serious illnesses, while also establishing safeguards and limitations to protect both patients and providers.

Government Affairs, Health and Social Services, Justice

https://www.ncleg.gov/BillLookUp/2023/H98