Health care coverage: antiretroviral drugs, drug devices, and drug products.

Removed formal enrolled bill formatting elements including page numbers, Chief Clerk and Secretary signatures, Governor's receipt date block, and Private Secretary of the Governor line.

Added web page navigation elements (menu items, search fields, version history links, share buttons) that are part of the legislative website interface rather than the bill text itself.

The Health and Safety Code and Insurance Code sections now become operative on January 1, 2027 instead of expiring on that date. Previously the provisions were in effect immediately with a sunset; now they are delayed until 2027.

Added the phrase 'medically necessary' before 'for the prevention of HIV/AIDS' in the prior authorization and step therapy prohibition, narrowing which drugs are protected from utilization management restrictions.

The no-cost-sharing coverage requirement is narrowed from drugs approved for 'preexposure prophylaxis' to specifically 'HIV preexposure prophylaxis,' potentially excluding some CDC-recommended but not FDA-approved products.

Added 'mental health' to the list of specialized plan types exempted from the bill's requirements (alongside dental and vision).

New provision prohibits plans and insurers from imposing cost sharing on a nonformulary antiretroviral drug covered pursuant to an exception request if it is therapeutically equivalent to a formulary drug already covered without cost sharing.

New requirement that if a plan or insurer covers non-self-administered antiretroviral drugs approved by FDA for HIV prevention as a medical benefit, they must also include those drugs as an outpatient prescription drug benefit.

Changed 'long-acting injectable' to 'long-acting' in the therapeutic equivalence rule, broadening the non-equivalence determination beyond just injectable formulations to all long-acting products with different durations.

Changed 'civil penalty' to 'administrative penalty' in the Insurance Code enforcement provision for violations by health insurers.

Removed 'or recommended by the federal Centers for Disease Control and Prevention (CDC)' from the definition of covered drugs throughout the bill. Coverage is now limited to antiretroviral drugs, drug devices, or drug products that are approved by the FDA (or medically necessary) for HIV/AIDS prevention, rather than also including CDC-recommended products.

Deleted the entirely separate Section 3 (adding a new Section 1342.74 to the Health and Safety Code) and Section 5 (adding a new Section 10123.1933 to the Insurance Code) that were designed to take effect on January 1, 2027 for individual and small group plans. The bill now only amends existing sections.

Eliminated the provision delaying application of coverage requirements to individual and small group health care service plan contracts and health insurance policies until January 1, 2027. The bill now applies uniformly to all plan types without a phased implementation.

Removed sunset provisions that would have repealed Section 1342.74 (Health and Safety Code) as of January 1, 2027, and removed the separate operative date of January 1, 2027 for the added sections targeting individual and small group plans.

Simplified the therapeutic equivalent exception in paragraph (2). Previously, if at least one therapeutic equivalent was covered without prior authorization or step therapy, the plan also had to provide coverage for a noncovered therapeutic equivalent without cost sharing pursuant to an exception request. The new version removes this additional requirement, stating only that the section does not require covering all therapeutic equivalents without prior authorization or step therapy if at least one is covered without such requirements.

Expanded the nonformulary cost-sharing prohibition to specifically require that both the nonformulary and formulary antiretroviral drug be approved by the FDA for HIV preexposure prophylaxis, making the provision more precise about which drugs qualify for the no-cost-sharing requirement.

Changed 'civil penalty' to 'administrative penalty' in the Insurance Code enforcement provision (Section 10123.1933), reflecting a shift in the characterization of the penalty type.

The prohibition on prior authorization, step therapy, and other treatment-delay protocols now explicitly covers both preexposure prophylaxis AND postexposure prophylaxis for health care service plans (Section 1342.74) and health insurers (Section 10123.1933). The March version only referenced preexposure prophylaxis in these key provisions.

The March version included provisions that would delete existing law requiring health care service plans to cover postexposure prophylaxis furnished by pharmacists and would delete provisions preventing plans from prohibiting pharmacy providers from dispensing PEP. The May version removes these deletions, preserving the existing statutory protections for pharmacist-furnished PEP.

The coverage mandate for nongrandfathered and grandfathered plans changed from prohibiting 'cost-sharing or utilization review requirements' to prohibiting only 'cost sharing.' This is likely a technical clarification since utilization review mechanisms (prior authorization, step therapy) are already separately prohibited in subsection (a)(1).

Amendment date updated from March 3 to May 23, 2025; author formatting adjusted; a typo ('propyhlaxis') appears in one instance of the new text.

The zero-cost-sharing mandate in both the Health and Safety Code (Section 1342.74) and Insurance Code (Section 10123.1933) was narrowed. Previously it applied to antiretroviral drugs 'for the prevention of HIV/AIDS, including preexposure prophylaxis.' Now it applies only to drugs 'for preexposure prophylaxis.' This removes coverage requirements for other HIV prevention uses such as postexposure prophylaxis (PEP) under the zero-cost-sharing provision.

The out-of-network pharmacy exception was changed from 'an emergency' to 'a medical emergency,' slightly narrowing the circumstances under which plans must cover out-of-network pharmacist-provided PrEP/PEP.

The definition of therapeutic equivalence for long-acting injectables was expanded from 'a long-acting injectable drug' to 'a long-acting injectable drug, drug device, or drug product,' making the non-equivalence rule (different duration means not equivalent) apply more broadly across product types.

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

The prohibition on coverage restrictions now covers 'any other protocol designed to delay treatment' in addition to prior authorization and step therapy, closing a loophole that would have allowed plans to use other administrative barriers to block access.

Postexposure prophylaxis (PEP) is now explicitly included alongside preexposure prophylaxis (PrEP) throughout the bill. The introduced version only required coverage of PrEP in several sections; the amended version requires coverage of both PrEP and PEP for health care service plans and health insurers.

The bill was formally named the 'Protecting Rights, Expanding Prevention, and Advancing Reimbursement for Equity (PrEPARE) Act of 2025' in a new Section 1.

New language specifies that a long-acting injectable drug is not therapeutically equivalent to a long-acting injectable drug with a different duration. This prevents plans from denying a longer-duration injectable (such as a 6-month formulation) by pointing to a shorter-duration version as an 'equivalent' alternative.

The phrase 'that are medically necessary' was removed from the description of covered drugs, so coverage is triggered solely by FDA approval or CDC recommendation for HIV/AIDS prevention rather than requiring a separate medical necessity determination.

Pharmacist dispensing authority references were expanded from Section 4052.02 alone to Sections 4052.02 and 4052.03 of the Business and Professions Code, broadening the scope of pharmacist services that must be covered.