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

Led by Assembly Members Mark González and Haney, with Senator Wiener as principal coauthor and additional support from colleagues Jackson, Wallis, and Ward, the PrEPARE Act of 2025 reframes health plan and insurer coverage for HIV prevention by limiting how prior authorization and step therapy can be used for antiretroviral drugs, devices, and products used in PrEP and PEP, and by expanding access and protections around those therapies. The central change is a prohibition on requiring prior authorization or step therapy for medically necessary PrEP/PEP medications, with an exception only if at least one therapeutically equivalent version is covered without such requirements. The bill also clarifies that long-acting products are not therapeutically equivalent to other long-acting products with a different duration.

Key mechanisms accompany the core prohibition. The measure bars health plans and their delegated pharmacy benefit managers from restricting dispensing of PrEP/PEP and requires coverage of PrEP/PEP furnished by a pharmacist, including the pharmacist’s services and related testing, with reimbursement in-network or (where applicable) out-of-network. It expands coverage to nongrandfathered plans with zero cost sharing for FDA-approved PrEP drugs, devices, or products, and it prohibits cost sharing on nonformulary PrEP therapies that are therapeutically equivalent to formulary options when covered via an exception. The bill also requires plans that cover non-self-administered PrEP as a medical benefit to include those products as an outpatient prescription drug benefit, and it applies protections regardless of whether the therapy is self-administered. Medi-Cal managed care plans are carved out to the extent those services are excluded under their contracts. The statute also addresses cost-sharing in high deductible health plans and imposes a framework for enforcement and rulemaking.

Enforcement, implementation, and scope are addressed through a combination of criminal and administrative mechanisms. Willful violations by a health care plan would constitute a crime, creating a state-mandated local program, while enforcement by the Department and the Insurance Commissioner would be carried out under the Administrative Procedure Act, with penalties and hearing procedures defined accordingly. The act provides no formal statewide reimbursement for local entities and does not specify an explicit effective date within the text, leaving rulemaking and timetables to agency regulation. Medi-Cal carve-outs, and the interplay between medical-benefit coverage and outpatient prescription-drug coverage, further define who is governed by the new requirements.

Viewed in context, the proposal sits alongside existing laws that already restrict unnecessary barriers to HIV prevention medications, but it adds explicit protections for pharmacist dispensing, expands zero-cost-sharing coverage for nongrandfathered plans, and strengthens enforcement options. The bill defines terms such as therapeutically equivalent versions, non-self-administered PrEP, and outpatient prescription drug benefits to guide implementation, while leaving certain practical details—like exact timelines and penalty levels—for future regulations. The measure thereby aims to broaden access to PrEP/PEP while imposing new compliance obligations on plans, insurers, and pharmacy entities, aligned with a policy objective of reducing barriers to HIV prevention within the existing regulatory framework.