The bill amends the Prior Authorization Act to expand the categories of drugs that are exempt from prior authorization and step therapy protocols. Specifically, it adds coverage for medications approved by the federal Food and Drug Administration (FDA) that are prescribed for on-label or off-label use in the treatment of autoimmune disorders, cancer, rare diseases, or substance use disorders, provided that a medical necessity determination is made. This exemption applies unless a biosimilar, interchangeable biologic, or generic version of the medication is available.

Additionally, the bill defines "rare disease" as a condition affecting fewer than two hundred thousand people in the United States. This clarification aims to ensure that patients with less common medical conditions have improved access to necessary medications without the burden of prior authorization requirements.

Statutes affected:
introduced version: 59A-22B-8