Complaint letter to OPM on BCBSA federal employee plan PrEP coverage
Associate Director, Healthcare and Insurance
US Office of Personnel Management
1900 E Street NW
Washington DC 20415
Dear Associate Director Kiley:
The HIV+Hepatitis Policy Institute is a leading national HIV and hepatitis policy organization promoting quality and affordable healthcare for people and communities affected by HIV, hepatitis, and other serious and chronic health conditions. We are writing to urge you to require Blue Cross Blue Shield Federal Employee Plan (FEP), the largest carrier in the Federal Employees Health Benefits (FEHB) Program, to fully cover long-acting injectable PrEP products.
We are most concerned that BCBS is charging cost-sharing for Yeztugo (lenacapavir), violating OPM’s requirement that carriers cover all FDA-approved PrEP drugs without cost-sharing. Additionally, FEP requires prior authorization for both long-acting injectable PrEP drugs, Apretude (cabotegravir) and Yeztugo. These unnecessary barriers violate federal preventive health coverage requirements, are inconsistent with a no-barrier preventive benefit and discourage enrollees and prescribers from choosing these transformative drugs.
PrEP is one of the most important tools available to prevent HIV, and expanding its use is central to national and local efforts to end the HIV epidemic. The promise of PrEP has been limited, however, by the significant number of people who struggle to adhere to a daily oral regimen. Long-acting PrEP is transformative because it replaces daily dosing with far longer dosing intervals, bringing effective protection to people who have not been well served by daily oral PrEP. As new formulations emerge, including long-acting orals and ultra-long-acting PrEP, PrEP is only as effective as it is accessible. PrEP users and their providers must be able to choose which formulation best suits their needs. That is why cost- and barrier-free coverage of all FDA-approved PrEP medications is important, and why this protection is increasingly made explicit in federal and state legislation and policy.
FEP Charges Cost-Sharing for Yeztugo
Under the ACA, insurers must cover preventive services such as PrEP that have been given an “A” or “B“ grade recommendation by the United States Preventive Services Task Force (USPSTF) without cost-sharing. OPM requires FEHB carriers to do the same, specifically stating in the January 2025 carrier letter that “OPM requires FEHB and PSHB carriers to cover, without cost-sharing, all U.S. Food and Drug Administration (FDA)-approved drugs indicated for HIV PrEP,” consistent with federal guidance issued in October 2024.[1] The letter describes the three formulations listed in the USPSTF recommendation as those the recommendation “currently lists,” rather than as the limit of the requirement.[2]
OPM’s FEHB Program Carrier Letter of March 20, 2025, further directs carriers to describe in their proposal narratives how they “make HIV PrEP medications, associated testing, and follow-up care available without cost-sharing” and goes on to note that “all formulary submissions should also reflect that HIV PrEP medications are covered with $0 cost-share.”[3]
FEP nevertheless charges cost-sharing for Yeztugo, which was approved by FDA in June 2025 and is the longest-acting PrEP formulation with twice-yearly injections. Enrollees in Blue Focus are charged a $350 copay;[4] Blue Standard enrollees are charged 50% coinsurance;[5] and Blue Basic enrollees are charged 60% coinsurance.[6]
Charging excessively high cost-sharing for Yeztugo is an obvious business decision not based on clinical criteria. It will deter PrEP users, particularly those most vulnerable to HIV acquisition and least able to afford the cost, from starting and continuing the PrEP medication they need. This will undermine the very prevention efforts PrEP coverage requirements were designed to advance.
FEP Imposes Prior Authorization on Long-Acting PrEP
FEP imposes prior authorization requirements for both long-acting PrEP formulations, Apretude (an injectable dosed every two months)[7] and Yeztugo,[8] noting that “prior approval is required to ensure the safe, clinically appropriate, and cost-effective use of [the drug] while maintaining optimal therapeutic outcomes.”
Prior authorization is an unnecessary and counterproductive barrier for a preventive service like PrEP, as recognized in the federal guidance the OPM Call Letter of January 2025 mirrors, which does not allow the use of prior authorization to steer individuals towards particular PrEP formulations. Medicare also does not allow prior authorization for PrEP.
We recognize that the clinical criteria for both medications appear to restate FDA labeling, and include safeguards such as confirming HIV-negative status, counseling patients on dosing, and monitoring for adverse reactions. These safeguards, however, are already built into FDA labeling and standard clinical practice. Requiring clinicians to attest to them annually creates an administrative burden on both prescribers and enrollees.
Lastly, we would note that cost-effectiveness is not a permissible basis for imposing prior authorization on a drug which must be covered as a preventive drug without cost-sharing.
In conclusion, we urge FEP to take the following steps:
- Eliminate cost-sharing for Yeztugo
- Remove the prior authorization requirements for Apretude and Yeztugo
If you have any questions, comments, or would like to discuss these issues further, please contact Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute at cschmid@hivhep.org or (202) 462-3042, or Kevin Herwig, Health Policy Director, HIV+Hepatitis Policy Institute at kherwig@hivhep.org or (617) 666-6634.
Sincerely,
Carl E. Schmid, II
Executive Director
cc: David Yoder, Senior Vice President, BCBSA Federal Employee Program
Vanessa Hatch, PharmD, Vice President, Clinical Operations, BCBSA FEP
Jerry Wong, PharmD, Director of Pipeline Stra
[1] FAQs About Affordable Care Act and Women’s Health and Cancer Rights Act Implementation Part 68, October 21, 2024, https://www.cms.gov/files/document/faqs-implementation-part-68.pdf
[2] OPM, FEHB Program Carrier Letter 2025-01, FEHB and PSHB Programs Call Letter (January 15, 2025), pages 5-6, https://www.opm.gov/healthcare-insurance/carriers/fehb/2025/2025-01.pdf
[3] OPM, FEHB Program Carrier Letter 2025-05, Technical Guidance and Instructions for 2026 Benefit Proposals (March 20, 2025), pages 25 and 47, https://www.opm.gov/healthcare-insurance/carriers/fehb/2025/2025-05.pdf
[4] FEP Blue Focus Drug Formulary Effective 08/07/2026, https://www.caremark.com/content/dam/enterprise/headless/caremark/cmk/en/assets/clinical/drug-lists-client/drug-lists-fep/FEP_Blue_Focus_Formulary.pdf
[5] FEP Blue Standard Drug Formulary Effective 08/07/2026, https://www.caremark.com/content/dam/enterprise/headless/caremark/cmk/en/assets/clinical/drug-lists-client/drug-lists-fep/z6500_drug_list.pdf
[6] FEP Blue Basic Drug Formulary Effective 08/07/2026, https://www.caremark.com/content/dam/enterprise/headless/caremark/cmk/en/assets/clinical/drug-lists-client/drug-lists-fep/z6500_drug_list807.pdf
[7] FEP Medical Policy 5.01.075 (Apretude), https://info.caremark.com/content/dam/enterprise/caremark/microsites/dig/pdfs/pa-fep/fep-criteria/FEP_Criteria_Apretude.pdf
[8] FEP Medical Policy 5.01.080 (Yeztugo), https://info.caremark.com/content/dam/enterprise/caremark/microsites/dig/pdfs/pa-fep/fep-criteria/FEP_Criteria_Yeztugo.pdf