Prescription drug coverage for rare diseases.

The bill text was reformatted from a traditional printed legislative document style (with line numbers, page headers, and column layout) to a web-based presentation format that includes navigation links, search functionality, and a digest key section.

Added requirement that the drug must be the only FDA-approved treatment for the rare disease. Previously, the bill applied to any FDA-approved rare disease drug prescribed by a specialist who deemed it medically necessary, with an exception if a biosimilar, interchangeable biologic, or generic was available. Now the drug must be the sole FDA-approved option, which is a much narrower set of drugs.

The exception for when a biosimilar, interchangeable biologic, or generic version of the drug is available was removed. This exception is now effectively replaced by the stricter 'only FDA-approved treatment' requirement, which is narrower because it covers all FDA-approved versions (not just generics and biosimilars).

The step therapy prohibition was entirely deleted from both the Health and Safety Code section (for health care service plans) and the Insurance Code section (for health insurers). Previously, plans and policies could not require patients to try other drugs first before covering a rare disease drug prescribed by a specialist. This protection no longer exists in the bill.

The phrase 'prior authorization or other utilization review' was narrowed to just 'prior authorization' throughout the bill. This means the 30-day deadline and automatic approval provisions no longer apply to other forms of utilization review (such as concurrent review or retrospective review).

Prior authorization for rare disease drugs prescribed by specialists changed from a complete prohibition to a 30-day completion requirement. Plans and insurers must now finish the review within 30 days of the initial request, but they are no longer barred from imposing prior authorization at all.

Added an automatic approval mechanism: if a decision has not been made by the end of the 30-day period, or if a dispute between the plan/insurer and the provider or patient is still ongoing at that point, the prior authorization is deemed immediately approved.

The coauthor list was reorganized to consolidate Senator Blakespear as a principal coauthor alongside Senator Becker, and Assembly Member Addis was moved from a standalone coauthor line into the general coauthor group with Bauer-Kahan, Connolly, and Pellerin.

Prior authorization and other utilization review for rare disease drugs are no longer outright banned. Instead, plans and insurers must complete the review within 30 days of the initial request.

A new automatic approval provision: if no decision is made by the end of the 30-day period, or if a dispute between the plan/insurer and the provider or patient is still ongoing at that point, the prior authorization or utilization review is immediately approved.

Defines 'initial request' as occurring when a health care provider or the provider's staff sends a prior authorization or utilization review request to the plan, insurer, or their delegate.

Step therapy prohibition is separated into its own subdivision (b) and remains a full ban (not subject to the 30-day deadline), while prior authorization/utilization review is subject to the new time limit instead of a complete prohibition.

Additional coauthors added: Assembly Member Alanis as principal coauthor, Senator Blakespear as principal coauthor, and Assembly Members Bauer-Kahan, Connolly, and Pellerin as coauthors.

New savings clauses state that the 30-day timeline does not affect existing timelines in Section 1367.01(h)(2) (for health care service plans) or Section 10123.135(h)(2) (for health insurers).

The requirement for when utilization review (prior authorization, step therapy) is prohibited was narrowed. Originally, any prescribing health care professional who determined the drug was medically necessary would trigger the protection. The amendment requires that the drug be prescribed by a specialist with expertise in the specific condition or disease being treated, and that specialist must determine the drug is medically necessary.

Assembly Member Addis was added as a coauthor of the bill.