Plain English Breakdown
The effective date is tied to contract renewal dates starting in 2027; existing contracts may be unaffected until renewed.
Prescription Drug Coverage Rules for Rare Diseases
Starting in January 2027, health plans must finish approval checks within 30 days and cannot require step therapy for certain rare disease drugs prescribed by specialists.
What This Bill Does
- Requires health care service plan contracts or insurance policies issued on or after January 1, 2027, to complete prior authorization or other reviews within 30 days of the first request for specific rare disease drugs.
- Applies these rules only if a specialist with expertise in the condition prescribes the drug and determines it is medically necessary.
- Exempts drugs from this rule if a biosimilar, interchangeable biologic, or generic version is available.
- Prohibits health plans from using step therapy requirements for these specific rare disease drugs.
Who It Names or Affects
- Health care service plan contracts issued, amended, or renewed on or after January 1, 2027.
- Health insurance policies issued, amended, or renewed on or after January 1, 2027.
- Patients prescribed drugs for rare diseases by specialists with expertise in the condition.
Terms To Know
- Prior authorization
- A process where a health plan must approve a drug before it will pay for the cost of that drug.
- Step therapy
- A rule requiring patients to try cheaper or different drugs first before getting approval for their prescribed medication.
- Biosimilar
- A medicine that is very similar to an already approved biologic drug but made by a different company.
Limits and Unknowns
- The rules only apply to contracts and policies issued, amended, or renewed on or after January 1, 2027.
- The official text does not define exactly what counts as 'expertise' for a specialist.