Geographic Variation in Qualified Health Plan Coverage and Prior Authorization Requirements for HIV Preexposure Prophylaxis.

Importance: HIV preexposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) Initiative to curb new HIV diagnoses. In October 2019, emtricitabine/tenofovir alafenamide was added as an approved formulation for PrEP in addition to emtricitabine/tenofovir disoproxil fumarate; despite availability of another formulation with a similar prevention indication, variations in coverage may limit access. Objective: To assess qualified health plan (QHP) coverage, prior authorization (PA) requirements, and specialty tiering for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide following emtricitabine/tenofovir alafenamide approval as a PrEP treatment. Design, Setting, and Participants: This cross-sectional study analyzed QHPs in the US that were compliant with the Patient Protection and Affordable Care Act from 2018 to 2020. QHPs were categorized by region and EHE priority jurisdictions. Data analysis occurred from March 2022 to March 2023. Exposures: Enrollment in a qualified health plan certified by the Patient Protection and Affordable Care Act. Main Outcome and Measures: Annual variation in QHP coverage and PA requirement for emtricitabine/tenofovir disoproxil fumarate and/or emtricitabine/tenofovir alafenamide. Descriptive statistics were reported for all outcomes. A secondary outcome was whether the PrEP formulation was determined by the QHP to be placed on a specialty drug tier. Results: A total of 58 087 QHPs (19 533 for 2018; 17 007 for 2019; and 21 547 for 2020) were analyzed. QHPs covered emtricitabine/tenofovir disoproxil fumarate (19 165 QHPs [98.1%] in 2018; 16 970 QHPs [99.8%] in 2019; 20 045 QHPs [94.8%] in 2020) at a higher rate than emtricitabine/tenofovir alafenamide (17 391 QHPs [91.9%] in 2018; 15 757 QHPs [92.7%] in 2019; 18 836 QHPs [87.4%] in 2020). QHPs in the South required exclusive PA (ie, PA for 1 of the formulations even if the QHP covered both) for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide at the highest rates in all 3 years. In the South, the rate of PA for emtricitabine/tenofovir disoproxil fumarate increased from 806 of 8023 QHPs (10.0%) in 2018 to 3466 of 7401 QHPs (46.8%) in 2020. QHPs with exclusive PA requirement for emtricitabine/tenofovir disoproxil fumarate were higher in EHE jurisdictions than non-EHE jurisdictions (difference: 2018, 0.9 percentage points; 2019, 3.5 percentage points; 2020, 29.1 percentage points). QHPs were more likely to place emtricitabine/tenofovir disoproxil fumarate on a specialty tier compared with emtricitabine/tenofovir alafenamide (difference: 2018, 1.8 percentage points; 2019, 3.7 percentage points; 2020, 4.1 percentage points). Conclusions and Relevance: In this cross-sectional study, despite similar indications for biomedical prevention, QHPs were more likely to cover emtricitabine/tenofovir disoproxil fumarate than emtricitabine/tenofovir alafenamide, and QHPs were also more likely to subject emtricitabine/tenofovir disoproxil fumarate to PA or place it on a specialty tier despite the broader clinical indication. QHP PA requirements of emtricitabine/tenofovir disoproxil fumarate following emtricitabine/tenofovir alafenamide approval does not reflect clinical guidelines. The requirements could reflect differences in clinical indication, manufacturer discounts, or anticipation of a changing regulations and emerging generics. High rates of exclusive PA for emtricitabine/tenofovir disoproxil fumarate in areas where rates of HIV diagnoses are highest and PrEP is most needed (eg, the South and EHE priority jurisdictions) is concerning; policy solutions to address the growing PrEP health equity crisis could include regulator actions and a national PrEP program.

Ryan White HIV/AIDS Part B and AIDS Drug Assistance Programs during COVID-19: safety net public health programs' challenges and innovations.

Introduction: We characterized the challenges and innovations of states' Ryan White HIV/AIDS Program (RWHAP) Part B programs, including AIDS Drug Assistance Programs (ADAPs), during the COVID-19 pandemic. In the United States, these are important safety net programs for HIV healthcare, providing essential medical and support services, and medications, to people with HIV with low incomes who are uninsured/underinsured. Methods: Data were collected via the 2021-2022 NASTAD National RWHAP Part B and ADAP Monitoring Project Report, a cross-sectional survey of state, district, and territorial programs through a mixed method study design. For quantitative data, we used descriptive statistics. Qualitative responses were coded and analyzed using content analysis. Results: Forty-seven RWHAP Part B and ADAPs responded (92% response rate). The majority of respondents reported that maintaining client eligibility (78%) and working remotely (70%) were the most challenging aspects of the pandemic, particularly in regards to implementing new telehealth and e-certification platforms. In response to COVID-19, programs introduced enrollment "grace periods" (19%), bolstered client outreach (11%), allowed more than a 30 day supply of medications (79%), and supported medication home delivery for clients (80%). Discussion: Despite the challenges of the COVID-19 pandemic, RWHAP Part B and ADAPs implemented several operational innovations in order to continue providing essential medicines and services. Other public health programs may adopt similar innovations, including digital innovations, for greater public health benefit. Future studies should assess the retention of policy innovations over time, their impact on the individual client level satisfaction or health outcomes, and what factors may improve the acceptability of telehealth and e-certification platforms.

Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018-2020.

BACKGROUND: A pillar of the United States' Ending the HIV Epidemic (EHE) initiative is to rapidly provide antiretroviral therapy (ART) in order to achieve HIV viral suppression. However, insurance benefit design can impede ART access. The primary objective of this study is to understand how Affordable Care Act (ACA) Marketplace qualified health plan (QHP) formularies responded to two new ART single tablet regimens (STRs): dolutegravir/abacavir/lamivudine (DTG/ABC/3TC; approved in 2014) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; approved in 2018). METHODS: We conducted a descriptive study of individual and small group QHPs to assess coverage, cost sharing (coinsurance vs. copay), specialty tiering, prior authorization, and out-of-pocket (OOP) costs for DTG/ABC/3TC and BIC/FTC/TAF. All individual and small group QHPs offered in state ACA Marketplaces from 2018-2020 were identified using plan-level formulary data from Ideon linked to end-of-year data from Robert Wood Johnson Foundation's Individual Market Health Insurance Exchange (HIX). RESULTS: For 2018, 2019, and 2020, respectively, we identified 19,533, 17,007, and 21,547 QHPs. While DTG/ABC/3TC coverage was above 91% from 2018-2020, BIC/FTC/TAF coverage improved from 60 to 86%. Coverage of BIC/FTC/TAF improved in EHE priority jurisdictions from 73 to 90% driven by increased coverage with coinsurance. Although BIC/FTC/TAF had a higher wholesale acquisition cost than DTG/ABC/3TC, monthly OOP cost trends differed regionally in the Midwest but did not differ by EHE priority jurisdiction status. CONCLUSIONS: QHP coverage of STRs is heterogeneous across the US. While coverage of BIC/FTC/TAF increased over time, many QHPs in EHE priority jurisdictions required coinsurance. Access to new ART regimens may be slowed by delayed QHP coverage and benefit design.

Economic benefits of the United States' AIDS drug assistance Program: A systematic review of cost analyses to guide research and policy priorities.

As part of the Ryan White HIV/AIDs Program, the federally-funded, state-administered AIDS Drug Assistance Program (ADAP) provides prescription drug medications, including antiretroviral therapy, for people with HIV (PWH) who are uninsured/underinsured and have a low income. ADAP expenditures are ∼$2.4 billion annually, but there is a dearth of formal economic analysis supporting the societal perspective. We conducted a systematic review of economic analyses of the United States' AIDS Drug Assistance Program to establish future research priorities based on gaps in knowledge. We searched six electronic databases for articles published before January 2022 that met inclusion criteria. We used the 2022 Consolidated Health Economic Evaluation Reporting Standards to assess the quality of reporting of the economic evaluations. We extracted data into categories to assess gaps and needs for future economic evaluation. Seven studies met inclusion criteria. Two used the same modeling approaches but were published with slightly different outcomes. The few economic analyses that focused solely on ADAP were conducted using 2008 or older data. The most recent study modeled the net cost per quality-adjusted life-year (QALY) secondary to reducing new HIV cases among those virally suppressed, but did not include the economic or health benefits for PWH. ADAP programs' delivery of antiretroviral therapy has shifted from primarily direct provision to subsidizing insurance plans. None of the models take these shifts into account. Updated person-centered cost effectiveness models assessing ADAP are needed on a national and state-by-state level to guide policy decisions and coverage determinations.

INTRODUCTION Disrupting the Status Quo: Building Equitable Access to HIV PrEP in the US through Innovative Financing.

This special edition of JLME centers on a novel proposal for a national PrEP access program with the potential to break through a failed status quo.

Financing and Delivering Pre-Exposure Prophylaxis (PrEP) to End the HIV Epidemic.

The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.

Access to Medications for Opioid Use Disorder for Persons With Human Immunodeficiency Virus in the United States: Gaps in Coverage by State AIDS Drug Assistance Programs.

Life-saving medications for opioid use disorder are inaccessible for people with human immunodeficiency virus relying on the AIDS Drug Assistance Programs (ADAP) in 40% of jurisdictions. Funding/policies should address this through increasing access through ADAP and the Ryan White HIV/AIDS Program (RWHAP), partnerships between RWHAP and substance use programs, and other state/federal initiatives.

Worsening Disparities in State-Level Uptake of Human Immunodeficiency Virus Preexposure Prophylaxis, 2014-2018.

Retrospective analysis of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) use among individuals with PrEP indications demonstrates worsening disparities in uptake between early- and late-adopting states from 2014 to 2018. To end the HIV epidemic, federal and state governments must close gaps by translating successful policies from early-adopting states to late-adopting states.

Insurance coverage and financing landscape for HIV treatment and prevention in the USA.

In 2010, the US health insurance system underwent one of its most substantial transformations with the passage of the Affordable Care Act, which increased coverage for millions of people in the USA, including those with and at risk of HIV. Even so, the system of HIV care and prevention services in the USA is a complex patchwork of payers, providers, and financing mechanisms. People with HIV are primarily covered by Medicaid, Medicare, private insurance, or a combination of these; many get care through other programmes, particularly the Ryan White HIV/AIDS Program, which serves as the nation's safety net for people with HIV who remain uninsured or underinsured but offers modest to no support for prevention services. While uninsurance has drastically declined over the past decade, the USA trails other high-income countries in key HIV-specific metrics, including rates of viral suppression. In this paper in the Series, we provide an overview of the coverage and financing landscape for HIV treatment and prevention in the USA, discuss how the Affordable Care Act has changed the domestic health-care system, examine the major programmes that provide coverage and services, and identify remaining challenges.

Assisters Succeed in Insurance Navigation for People Living with HIV and People at Increased Risk of HIV in a Complex Coverage Landscape.

Insurance enrollment is complex for people living with HIV (PLWH) and people at increased risk for HIV, in part, owing to needing to ensure access to adequate provider networks and appropriate formularies. Insurance for PLWH facilitates access to HIV care/treatment and, ultimately, viral suppression, which has the individual benefit of longevity and the public health benefit of decreased HIV transmission. For people at increased risk for HIV, access to insurance facilitates improved access to HIV biomedical prevention, which has the individual benefit of elimination of transmission risk and the public health benefit of decreased HIV transmission. The objective of this study was to explore perceptions of priorities related to plan navigation, barriers and facilitators for enrolling and maintaining insurance coverage, and questions related to regional, state, and federal policies impacting plans provided both on and off the Affordable Care Act (ACA) marketplace. We interviewed a national sample of assisters (n = 40), who specialize in insurance plan selection for these populations. We found that assisters tailor their approaches to HIV-specific and person-specific concerns by navigating challenges related to affordability, formularies, and provider networks. In a complex coverage landscape during a time of uncertainty about the long-term future of the ACA, assisters have mastered the ability to simplify the insurance selection process for a vulnerable population. Assisters have excelled at incorporating insurance literacy education and encouraging client engagement in the process. Assisters play an essential role in the current complicated and fragmented United States' health care delivery system for PLWH and people at increased risk for HIV and could be incorporated into the Ending the HIV Epidemic initiative.

Regional Disparities in Qualified Health Plans' Prior Authorization Requirements for HIV Pre-exposure Prophylaxis in the United States.

Importance: With the goal of ending the HIV epidemic in the United States, access to HIV pre-exposure prophylaxis (PrEP) is essential to help curb new HIV infections. There has been differential uptake of PrEP by region, with the South lagging behind other regions. Discriminatory benefit design (benefit design that prevents or delays people with complex or expensive conditions from obtaining appropriate treatment) through prior authorization requirements could be a systemic barrier that contributes to the decreased PrEP uptake in the South. Objectives: To investigate whether there are regional disparities in prior authorization requirements for combined tenofovir disoproxil fumarate and emtricitabine for qualified health plans (QHPs) and to assess whether any QHP characteristics explain the disparities. Design, Setting, and Participants: This design was a cross-sectional study of QHPs offered in the 2019 Affordable Care Act Marketplace. The QHPs studied included all Affordable Care Act-compliant individual and small-group market plans in the United States. Exposures: The primary exposure was the 4 census regions (Northeast, West, Midwest, and South). Additional covariates included other plan characteristics. Main Outcomes and Measures: Prior authorization requirement for combined tenofovir disoproxil fumarate and emtricitabine at the QHP level. Results: In total, 16 853 QHPs were analyzed (18.2% in the Northeast, 19.5% in the West, 25.0% in the Midwest, and 37.3% in the South). Overall, 18.9% of QHPs required prior authorization for combined tenofovir disoproxil fumarate and emtricitabine. This percentage varied by region, with 2.3%, 6.2%, 13.3%, and 37.3% of plans requiring prior authorization in the Northeast, West, Midwest, and South, respectively. Compared with QHPs in the Northeast, QHPs in the South were 15.89 (95% CI, 12.57-20.09) times as likely to require prior authorization, whereas the Midwest and West were 5.69 (95% CI, 4.45-7.27) and 2.65 (95% CI, 2.02-3.47) times as likely, respectively. Other plan characteristics did not account for the regional variation. Conclusions and Relevance: Compared with QHPs in the Northeast, QHPs in the South were almost 16 times as likely to require prior authorization for PrEP, and the reasons for these disparities are unknown. The prior authorization requirement is a possible barrier to PrEP access in the South, which is the region of the United States with the most annual new HIV diagnoses. There is limited regulation of QHPs' prior authorization requirements. Federal- or state-level health policy laws may be necessary to remove this system-level barrier to ending the HIV epidemic in the United States.

Addressing Ethical Challenges in US-Based HIV Phylogenetic Research.

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

Considerations for Modernized Criminal HIV Laws and Assessment of Legal Protections Against Release of Identified HIV Surveillance Data for Law Enforcement.

In November 2018, the Centers for Disease Control and Prevention distributed guidance to funded agencies under its Integrated HIV Surveillance and Prevention Programs Initiative to support the implementation of the program's third strategy: HIV transmission cluster investigation and outbreak response efforts. Cluster detection seeks to identify persons infected with HIV (diagnosed and undiagnosed) who are linked to infections in single or related sexual and injection drug networks. Identifying expanding clusters allows public health personnel to intervene directly where active HIV transmissions occur.However, in the context of HIV infection where most US states have enacted criminal exposure laws, these efforts have sparked concerns about the protection of HIV surveillance data from court order or subpoena for law enforcement purposes. The Centers for Disease Control and Prevention calls for funded agencies to evaluate relevant confidentiality laws to ensure that these are sufficient to protect the confidentiality of HIV surveillance data from use by law enforcement.We present four often overlooked factors about the criminalization of HIV exposure and HIV surveillance data protections that should be considered in statutory assessments.