Real-world Impact of the United States Preventive Services Task Force (USPSTF) Guidelines on HIV-1 Pre-Exposure Prophylaxis (PrEP) Ancillary Service Cost Sharing: Segmented Change Pre- and Post-Milestone USPSTF Timepoints

Author(s)

Li Tao, MD, MS, PhD, Juan Yang, PhD, Alice Hsiao, PharmD, JeanPierre Coaquira Castro, MPH, Chris Nguyen, PharmD, Joshua Gruber, PhD, MPH, Woodie Zachry, RPh, PhD.
Gilead Sciences, Inc., Foster City, CA, USA.
OBJECTIVES: USPSTF guidelines recommend PrEP for individuals who may acquire HIV-1; following this recommendation, the Affordable Care Act mandated zero-cost sharing for PrEP-related ancillary healthcare services. We evaluated the effect of USPSTF guidelines on zero-cost sharing trends for PrEP ancillary services.
METHODS: USPSTF guideline adherence was assessed as percentage of zero-cost sharing claims (IQVIA-LAAD database; January 2019-August 2024) among PrEP ancillary services, including testing for HIV-1, sexually transmitted infections (STIs), hepatitis B/C, lipids, and creatinine, and counseling visits. Services were identified using CPT/HCPCS codes linked to PrEP use (Z29.81) or behaviors associated with HIV-1 acquisition (Z20.6, Z72.5X). Segmented regression in a time-series analysis compared the percentage of zero-cost sharing claims at pre- and post-milestone USPSTF guideline timepoints (initial Grade A recommendation [June 2019]; zero-cost coverage requirement [June 2020]; implementation clarification [July 2021]; Grade A recommendation [August 2023]).
RESULTS: For 64,866 individuals with 563,096 PrEP ancillary services in the USA, the number of claims and percentage of zero-cost sharing claims increased from 4695 (81%) in June 2019 to 14,382 (94%) in August 2023. Highest percentages of zero-cost sharing claims were for HIV-1 (87%, June 2019; 93%, August 2023) and STI testing (81%, June 2019; 96%, August 2023). Greatest increases in monthly zero-cost sharing between June 2019 and August 2023 were for creatinine testing (18%) and counseling visits (26%). Monthly zero-cost sharing claims increased over time for almost all services; however, complete adherence (100% zero-cost sharing) was not observed. Individuals in Midwestern states had 89% zero-cost sharing for HIV-1 testing versus 95% in Northeastern states. Medicaid beneficiaries had 97% zero-cost sharing for all services versus 89% for commercial insurance users.
CONCLUSIONS: This analysis highlights increasing adherence with USPSTF guidelines for PrEP ancillary services over time. Full implementation of zero-cost sharing remains incomplete; therefore, efforts are ongoing to improve adherence and overcome regional and payer-based disparities.

Conference/Value in Health Info

2025-05, ISPOR 2025, Montréal, Quebec, CA

Value in Health, Volume 28, Issue S1

Code

HPR18

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine)

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