The bill amends the Prior Authorization Act to expand the categories of drugs that are exempt from prior authorization and step therapy protocols. It introduces new definitions, including "off-label" medications and "rare disease or condition," and specifies that medications approved by the FDA for treating autoimmune disorders, cancer, rare diseases, or substance use disorders will not require prior authorization, provided that a medical necessity determination is made by a qualified healthcare professional. Additionally, the bill mandates that medical necessity determinations must be automatically approved within specified timeframes for both standard and emergency cases.

Furthermore, the bill prohibits health insurers from imposing step therapy requirements for off-label medications prescribed for rare diseases, ensuring that patients have timely access to necessary treatments. The provisions of this act will apply to any health insurance policies issued on or after July 1, 2025, thereby enhancing patient access to essential medications while streamlining the prior authorization process.

Statutes affected:
introduced version: 59A-22B-2, 59A-22B-5, 59A-22B-8