CDI Bulletin 2021-10 - Preventive Services Coverage for HIV PrEP (PrEP)

Sep 27, 2026

Bulletin 2021-10 instructs California disability insurers on mandatory preventive care coverage for HIV preexposure prophylaxis (PrEP) without patient cost sharing. It explains obligations under the federal USPSTF “A” grade recommendation and clarifies that not only PrEP antiretroviral drugs, but also initiation, follow-up, and monitoring services as specified by CDC guidance, must be covered. The bulletin also addresses limits on prior authorization, step therapy, and exception processes under California law, including restrictions and insurer requirements when therapeutic equivalents exist.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

Background

USPSTF requirements and cost-sharing prohibitions

CDC-guided PrEP initiation, follow-up, and monitoring

Federal and state limits on medical management

Prior authorization, step therapy, and exceptions process

BULLETIN 2021-10 TO: All Disability Insurers Providing Health Insurance Coverage in California FROM: Insurance Commissioner Ricardo Lara DATE: December 29, 2021 RE: Preventive Services Coverage for HIV Preexposure Prophylaxis (PrEP) with Provider-Administered Antiretroviral Drug Therapy I. Background Pursuant to California Insurance Code section 10112.2 and section 2713 of the federal Public Health Service Act , non-grandfathered group and individual health insurance policies 1 must cover certain preventive health services without patient cost sharing, including “A” and “B” grade recommendations of the U.S. Preventive Services Task Force (USPSTF) , for plan years that begin on or after the date that is one year after the date the recommendation or guideline is issued. The USPSTF, on June 11, 2019, issued a new “A” grade recommendation for preexposure prophylaxis (PrEP) with effective antiretroviral therapy for persons who are at high risk of human immunodeficiency virus (HIV) acquisition.2 On June 10, 2020, I issued a Notice to disability insurers providing health insurance coverage in California, clarifying the services that must be covered without cost sharing under the USPSTF recommendation for PrEP. My Notice specified that in addition to the antiretroviral drug itself, services necessary for PrEP initiation and ongoing follow-up and monitoring, as specified in the Centers for Disease Control and Prevention’s (CDC’s) most recently updated clinical guidance and determined by a person’s attending health care provider, must also be covered without cost sharing.3 1 Under federal law, student health insurance is considered individual coverage and must comply with Section 2713 of the Public Health Service Act (42 USC § 300gg-13) , including by covering “A” and “B”grade recommendations of the USPSTF without cost sharing. See 45 CFR §§ 147. 130, 147.145. 2 U.S. Preventive Services Task Force Final Recommendation Statement, Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis (June 11, 2019) . 3 Insurance Commissioner Ricardo Lara, Notice Re: Preventive Health Services Coverage for HIV Preexposure Prophylaxis (PrEP) (June 10, 2020) . On July 21, 2021 , the federal Departments of Labor, Health and Human Services, and the Treasury released FAQs About Affordable Care Act Implementation Part 47, affirming the requirements set forth in my June 10, 2020 Notice.4 FAQs Part 47 confirmed that the CDC’s clinical practice guideline on PrEP is incorporated in the USPSTF recommendation. Also consistent with my previous Notice, FAQs Part 47 provides that “[t] he USPSTF Final Recommendation Statement encompasses FDAapproved PrEP antiretroviral medications ” Therefore, both FAQs Part 47 and my Notice require insurers to cover antiretroviral drug therapy approved by the FDA, as well as services that are integral to the furnishing of PrEP, 5 under the preventive care benefit without any cost sharing, including a deductible, coinsurance, or copayment , when obtained from a participating provider or pharmacy. Federal law permits limited, reasonable medical management of preventive care drugs under some circumstances.6 But state law, at Insurance Code section 10123.1933 , categorically prohibits insurers from imposing prior authorization or step therapy requirements on antiretroviral drugs for preventing HIV, except if one or more therapeutic equivalents are available and at least one is covered without prior authorization or step therapy.7 Furthermore, under section 10123.1933 , an insurer cannot decline to cover any pharmaceutically unique drug that is FDA approved for PrEP. For example, an insurer cannot designate an outpatient prescription drug without another available FDA-approved therapeutic equivalent drug “non-formulary,” because prior authorization (an “exception”) would be needed to obtain a coverage determination.8 If one therapeutic equivalent of a PrEP drug is covered without u

FAQs

What preventive services must California disability insurers cover for PrEP without cost sharing?

Insurers must cover the FDA-approved PrEP antiretroviral drug therapy and the services integral to PrEP initiation, ongoing follow-up, and monitoring as specified by the CDC clinical guidance, without deductibles, coinsurance, or copayments when obtained from participating providers or pharmacies.

How did the bulletin relate USPSTF and earlier guidance issued by the Insurance Commissioner?

The bulletin references the USPSTF 2019 “A” grade recommendation for PrEP and explains that the Commissioner’s June 10, 2020 notice clarified which PrEP-related services must be covered without cost sharing under the USPSTF requirements. It further notes that federal FAQs affirmed these requirements and incorporated the CDC guidance into the USPSTF recommendation.

When can insurers use prior authorization or step therapy for PrEP medications?

State law generally prohibits insurers from imposing prior authorization or step therapy requirements on antiretroviral drugs for preventing HIV, except under limited circumstances involving therapeutic equivalents. Even when limitations apply, insurers must provide an accessible, transparent, and not unduly burdensome exceptions process and must defer to the attending provider’s individualized medical-necessity determination.

Sep 27, 2026

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