Public Input Needed: Offer Input on HIV, STI, Vaccine, and Hepatitis Policies

The Office of Infectious Disease and HIV/AIDS Policy (OIDP) at the Department of Health and Human Services (HHS), alongside the White House Office of National AIDS Policy (ONAP), has released a Request for Information (RFI) to inform the 2026–2030 national strategic plans for HIV/AIDS, sexually transmitted infections (STIs), vaccines, and viral hepatitis. This RFI represents a key opportunity for public health stakeholders to shape policies that will directly impact prevention, treatment, and care for millions of people across the country.

Why Strategic Planning Matters

National strategic plans guide public health efforts at federal, state, and local levels. They establish priorities, direct resource allocation, and shape policies that determine the availability and quality of health services. The upcoming 2026–2030 plans aim to build on past progress while addressing new and evolving challenges.

For instance, the National HIV/AIDS Strategy for 2022–2025 set ambitious goals to reduce new HIV infections by 75% by 2025 and by 90% by 2030. Similarly, the Viral Hepatitis National Strategic Plan aims to eliminate viral hepatitis as a public health threat by 2030. These strategies are powerful tools that help us move toward improved health outcomes by setting clear goals and priorities.

What the Strategic Plans Address

Each of the four national strategies addresses unique public health challenges:

1. National HIV/AIDS Strategy – Sets forth a roadmap to end the HIV epidemic in the United States, with goals including:

   • Prevent New HIV Infections: Increasing awareness, testing, and access to prevention tools like PrEP and PEP, while reducing HIV-related stigma.

   • Improve Health Outcomes for People with HIV: Promoting early linkage to care, long-term retention, and viral suppression through integrated and culturally competent health services.

   • Reduce Disparities and Inequities: Addressing structural factors such as stigma and discrimination and focusing efforts on disproportionately affected populations.

   • Achieve Integrated, Coordinated Efforts: Promoting collaboration across sectors to integrate HIV prevention with services for STIs, viral hepatitis, and mental health, among others.

2. Sexually Transmitted Infections National Strategic Plan – Aims to respond to rising STI rates by:

   • Preventing New STIs: Increasing awareness, expanding prevention activities, and improving vaccination rates for HPV.

   • Improving Health Outcomes: Expanding screening and treatment in impacted communities.

   • Accelerating STI Research and Innovation: Supporting the development of vaccines, diagnostic tools, and treatment options.

   • Reducing STI Disparities and Inequities: Addressing stigma, expanding culturally competent services, and addressing social determinants of health.

   • Achieving Integrated, Coordinated Efforts: Promoting collaboration across STI, HIV, and viral hepatitis prevention efforts.

3. Vaccines National Strategic Plan – Focuses on eliminating vaccine-preventable diseases by:

   • Fostering Innovation in Vaccine Development: Supporting research and development of new vaccines and technologies.

   • Maintaining Vaccine Safety: Enhancing safety monitoring and public awareness of vaccine-related risks.

   • Increasing Vaccine Knowledge and Confidence: Addressing vaccine misinformation and improving public understanding of vaccine benefits.

   • Improving Access and Uptake: Reducing barriers to vaccine access and improving coverage, especially in underserved populations.

   • Supporting Global Immunization Efforts: Strengthening international collaboration on vaccine initiatives.

4. Viral Hepatitis National Strategic Plan – Targets the elimination of viral hepatitis as a public health threat, with goals such as:

   • Preventing New Infections: Increasing vaccination for hepatitis A and B and addressing transmission among people who use drugs.

   • Improving Health Outcomes: Ensuring timely testing, treatment, and retention in care for people with viral hepatitis.

   • Reducing Disparities and Inequities: Addressing stigma, enhancing culturally competent care, and focusing resources on high-risk populations.

   • Improving Surveillance and Data Usage: Enhancing data collection and sharing to better understand and address viral hepatitis trends.

   • Achieving Integrated, Coordinated Efforts: Promoting partnerships that address viral hepatitis, HIV, STIs, and substance use disorders together.

The Importance of Public Input

Public participation in the RFI process ensures that these plans reflect the real needs of communities. When stakeholders provide insights based on their experiences, it helps to ensure that strategic plans are grounded in the realities of public health challenges. The voices of people living with HIV (PLWH) and their advocates have led to a greater emphasis on reducing stigma and expanding access to essential services like mental health and substance use support. This type of feedback is needed in order to ensure that health strategies address barriers to care, particularly among marginalized populations, and incorporate promising approaches to delivering services and engaging communities.

By providing input, you can help shape strategies for integrating services across HIV, STIs, viral hepatitis, and vaccine-preventable diseases, making it easier for patients to navigate the healthcare system. Your insights could also highlight ways to leverage new technologies and data systems to improve health outcomes, ultimately influencing policies that determine the availability and quality of health services across the country.

How to Participate

To make your feedback impactful, it's important to examine the existing strategic plans (linked above) and identify areas that could benefit from improvement or expansion. Consider submitting detailed, data-driven feedback based on your experiences or expertise, connecting your observations with broader public health trends or research. Highlighting emerging issues that are currently underrepresented in the plans can also make a significant difference. Additionally, sharing effective practices from your work or community that could be scaled nationally will help ensure that these strategies are practical and inclusive.

The deadline for submitting comments is December 6, 2024, at 11:59 pm ET. You can participate by submitting your feedback through the online form. Your contribution can help create a public health system that is responsive to the needs of all communities.

Why Your Input Matters

By contributing to this RFI, you help ensure that public health strategies are grounded in evidence and lived experience, and are responsive to the communities most affected by HIV, STIs, viral hepatitis, and vaccine-preventable diseases. Your feedback can shape policies that address the most pressing needs of people impacted by these conditions, advance evidence-based approaches, reduce health disparities, and promote equity. Moreover, your input can help improve coordination across healthcare systems and levels of government, ultimately leading to better health outcomes for millions of people.

Your voice matters in shaping the future of public health. Participate in advocacy campaigns by joining public health advocacy groups working to ensure equitable health policies. Share this information with colleagues, networks, and community members who might also want to contribute their insights. Engaging in webinars or public discussions related to the strategic plans can also help you stay informed and connected, providing more opportunities to make an impact.

Final Thoughts

The 2026–2030 national strategic plans will shape public health policy in the U.S. for years to come. Your participation in the RFI process gives you a voice in crafting strategies that are effective, equitable, and responsive to community needs. By sharing your knowledge and experiences, you can help create a future where public health efforts truly serve all communities.

Together, we can make a difference—let's ensure that these plans reflect the needs of everyone, especially those most impacted.

Biden’s Inaction Leaves Copay Assistance in Limbo

Inflated prescription drug costs in the United States continue to place a significant burden on people living with chronic conditions. Copay assistance programs, designed to help people afford their medications, have become essential. Yet recent policy decisions and industry practices have put these programs at risk, potentially jeopardizing access to necessary treatments.

The Biden Administration's recently proposed 2026 Notice of Benefit and Payment Parameters (NBPP) rule omits crucial regulations that patient advocates have long been demanding. This inaction allows insurers and pharmacy benefit managers (PBMs) to continue profiting from billions of dollars of drug manufacturer copay assistance intended for patients.

The State of Copay Assistance

Copay assistance programs, primarily offered by pharmaceutical manufacturers, provide financial support to help cover out-of-pocket costs for prescription medications. As health insurance plans increasingly shift costs to patients through higher deductibles and copayments, these programs have become crucial.

According to the latest data from The IQVIA Institute, manufacturer copay assistance offset patient costs by $23 billion in 2023, a $5 billion increase from the previous year. This figure represents 25% of what retail prescription costs would have been without such assistance. Over the past five years, copay assistance has totaled $84 billion, highlighting its importance in maintaining access to medications.

Despite the significance of copay assistance, copay accumulator and maximizer programs accounted for $4.8 billion of copay assistance in 2023—more than double the amount in 2019. Implemented primarily by pharmacy benefit managers (PBMs) and insurers, these programs prevent assistance from counting towards patients' deductibles and out-of-pocket maximums. This practice effectively nullifies the intended benefit of copay assistance, leaving people to face unexpected and often unaffordable costs later in the year.

Recent scrutiny of PBMs has brought attention to these practices. As discussed in our recent article on PBMs, the Federal Trade Commission (FTC) has filed a lawsuit against the largest PBMs for alleged anticompetitive practices that inflate drug costs and limit access to medications. These developments underscore concerns about how PBM practices, including the implementation of copay accumulator programs, impact medication affordability and access.

The impact on access is serious. IQVIA reports that in 2023, patients abandoned 98 million new therapy prescriptions at pharmacies, with abandonment rates rising as out-of-pocket costs increase. This trend highlights the critical role copay assistance plays in helping people not only initiate but also maintain their prescribed treatments.

Public opinion strongly supports action on this issue. A Kaiser Family Foundation survey found that 80% of adults believe prescription drug costs are unreasonable, with broad support for various policy proposals to lower drug costs. This sentiment reflects the public's recognition of the financial challenges faced in accessing necessary medications.

The Legal and Regulatory Landscape

The regulatory environment surrounding copay assistance programs has been in flux, with significant developments in recent years. On September 29, 2023, a federal court struck down a rule that allowed insurers to decide whether copay assistance would count towards patients' out-of-pocket maximums. This ruling reinstated the 2020 NBPP rule, which required insurers to count copay assistance towards patient cost-sharing, except for brand-name drugs with available generic equivalents.

Despite this, the federal government declared that it would not enforce the court's decision or the 2020 NBPP rule until new regulations are issued. This inaction has left patients facing continued uncertainty about the status of their copay assistance.

On January 16, 2024, the Biden Administration dropped its appeal of the court decision. While this action confirms that the 2020 NBPP rule will generally apply until new rules are issued, the lack of enforcement leaves plans and insurers in a gray area regarding their copay accumulator programs.

At the state level, there has been a growing movement to address copay accumulator programs. As of 2024, 21 states, the District of Columbia, and Puerto Rico have enacted laws addressing the use of these programs by insurers or PBMs. These laws generally require any payments made by or on behalf of the patient to be applied to their annual out-of-pocket cost-sharing requirement. While these state actions provide important protections, they do not cover all insurance plans, particularly those regulated at the federal level.

The 2026 Notice of Benefit and Payment Parameters Proposal

The proposed 2026 NBPP rule, released by the Centers for Medicare & Medicaid Services (CMS), has drawn criticism from patient advocacy groups for significant omissions related to copay assistance and essential health benefits (EHB).

Notably absent from the proposed rule are regulations clarifying whether copay assistance will count toward patient cost-sharing. This omission perpetuates uncertainty created by previous conflicting rules and court decisions, allowing insurers and PBMs to continue implementing copay accumulator programs that can leave people with unexpected and unaffordable out-of-pocket costs.

The proposal also fails to include a provision to ensure that all drugs covered by large group and self-funded plans are considered essential health benefits, despite previous indications that such a provision would be forthcoming. This failure to close the EHB loophole allows employers, in collaboration with PBMs and third-party vendors, to designate certain covered drugs as "non-essential," circumventing Affordable Care Act (ACA) cost-sharing limits designed to protect people from excessive expenses.

By exploiting this loophole, plan sponsors can collect copay assistance provided by manufacturers without applying it to beneficiaries' cost-sharing requirements. This practice effectively doubles the financial burden on patients: first, by accepting the copay assistance, and second, by requiring them to pay their full out-of-pocket costs as if no assistance had been provided.

Recent research by the HIV+Hepatitis Policy Institute has revealed that over 150 employers and insurers are taking advantage of the EHB loophole. This list includes:

• Major companies such as Chevron, Citibank, Home Depot, Target, and United Airlines

• Universities including Harvard, Yale, and New York University

• Unions like the New York Teamsters and the Screen Actors Guild

• States such as Connecticut and Delaware

• Insurers, including several Blue Cross/Blue Shield plans

Patient advocacy groups have reacted strongly to these omissions. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, stated, "Every day these rules are delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients who are struggling to afford their drugs." This sentiment reflects the frustration of many who have long advocated for stronger protections.

The widespread exploitation of the EHB loophole underscores the urgent need for federal action to protect patients from these practices. The failure to address these critical issues in the 2026 NBPP proposed rule highlights a significant setback in efforts to improve medication affordability and access for people living with chronic conditions.

The Impact on Patients: Data and Experiences

The real-world impact of copay accumulator programs and the EHB loophole is reflected in both data and personal experiences. IQVIA reports that patient out-of-pocket costs reached $91 billion in 2023, an increase of $5 billion from the previous year. This rise in costs comes despite the $23 billion in copay assistance provided by manufacturers, highlighting the growing financial burden on patients.

Prescription abandonment is particularly concerning. Patients abandoned 98 million new therapy prescriptions at pharmacies in 2023, with abandonment rates increasing as out-of-pocket costs rise. More than half of new prescriptions for novel medicines go unfilled, and only 31% of patients remained on therapy for a year. These statistics highlight the direct link between cost and medication adherence.

People across the country are facing these challenges. For example, a mother whose daughter lives with cystic fibrosis shared her experience with a copay accumulator program. In early 2019, her family's out-of-pocket cost for her daughter's medication suddenly jumped from $30 to $3,500 per month when their insurance plan stopped applying copay assistance to their deductible. This unexpected change forced the family to put the cost on credit cards, creating significant financial strain and unnecessary medical debt.

Similarly, a person living with psoriasis faced steep increases in medication costs when their insurance company stopped counting copay assistance towards their deductible. The copay rose from $35 to $1,250 monthly, leaving them with only $26 from their disability payment after covering the copay.

These stories are not isolated incidents. People living with conditions such as HIV, hepatitis, multiple sclerosis, and hemophilia are facing similar challenges. The impact extends beyond financial stress, affecting medication adherence and, ultimately, health outcomes. For many, the choice becomes one between essential medications and other basic needs such as food and shelter—a decision no one should have to make.

Policy Recommendations and Advocacy Efforts

Patient advocacy groups are intensifying efforts for policy changes at both the federal and state levels. The All Copays Count Coalition, comprising over 80 organizations representing people living with serious and chronic illnesses, has been at the forefront of these efforts. In a letter to federal officials, the coalition urged for a revision of the cost-sharing rule to include clear protections ensuring that copayments made by or on behalf of a patient are counted towards their annual cost-sharing contributions. Specific recommendations include:

1. Maintaining the protections included in the 2020 Notice of Benefit and Payment Parameters.

2. Ensuring that copay assistance counts for medically appropriate medications, even when generic alternatives are available.

3. Limiting Health Savings Account-High Deductible Health Plan (HSA-HDHP) carve-outs to situations where using copay assistance would result in HSA ineligibility.

At the state level, advocacy efforts have led to the passage of laws restricting copay accumulator programs in 20 states, the District of Columbia, and Puerto Rico as of summer 2023. However, these state-level protections do not cover all insurance plans, particularly those regulated at the federal level, highlighting the need for comprehensive federal action.

Advocates are calling for:

1. Immediate enforcement of the 2020 NBPP rule, requiring insurers to count copay assistance towards patient cost-sharing in most cases.

2. Swift action to close the essential health benefits loophole for all plans, including large group and self-funded plans.

3. Increased oversight and regulation of PBM practices, particularly regarding copay accumulator and maximizer programs.

4. Passage of comprehensive federal legislation to protect those relying on copay assistance.

As Carl Schmid emphasized, "While they have gone on record that they will issue these rules, the clock is ticking and there isn't much time left." This reflects the growing frustration among patient advocates with the administration's delays in addressing these issues.

Policymakers must act swiftly to close the essential health benefits loophole and ensure that all copay assistance counts towards patients' out-of-pocket costs. Stakeholders across the healthcare ecosystem—from insurers and PBMs to pharmaceutical companies and patient advocacy groups—must collaborate to develop solutions that prioritize access and affordability. The health and well-being of millions depend on these critical policy changes.

FTC Sues Major PBMs for Unfair Practices Affecting Drug Costs

Pharmacy Benefit Managers (PBMs) have long been influential yet often obscure intermediaries in pharmaceutical pricing and distribution. They negotiate drug prices with manufacturers, develop formularies for health plans, and manage pharmacy networks. Today, the three largest—CVS Caremark, Express Scripts, and OptumRx—control about 80% of the market.

On September 20, 2024, the Federal Trade Commission (FTC) filed an administrative complaint against these major PBMs and their affiliated group purchasing organizations (GPOs). The complaint alleges that they engaged in anticompetitive and unfair rebating practices, artificially inflating insulin prices and impairing access to lower-cost alternatives.

The FTC's action marks a critical juncture in the struggle for fair drug pricing and access, emphasizing the need for robust enforcement and comprehensive PBM reform. The outcome could reshape the healthcare industry and significantly impact care across the United States.

The FTC's Case Against PBMs

The FTC alleges that PBMs have engaged in anticompetitive and unfair rebating practices that have artificially inflated the list prices of insulin and other essential medications. Grounded in Section 5 of the Federal Trade Commission Act, which prohibits unfair competition and deceptive practices, the FTC asserts that PBMs' rebate strategies and patient steering harm consumers and competition.

For example, the list price of Humalog, a widely used insulin product, increased from $21 in 1999 to over $274 in 2017—a rise of more than 1,200%. The FTC argues that this dramatic inflation is linked to PBMs' "chase-the-rebate" strategy, where they demand larger rebates from manufacturers in exchange for favorable formulary placement.

Another key aspect of the complaint focuses on patient steering practices. The FTC alleges that PBMs have systematically excluded lower-cost insulin alternatives from their formularies in favor of higher-priced options that generate larger rebates. This practice limits choice and forces many to pay more out-of-pocket for their medications.

Rahul Rao, Deputy Director of the FTC's Bureau of Competition, emphasized: "Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed."

The FTC seeks to fundamentally change how PBMs operate. The complaint aims to prohibit PBMs from excluding or disadvantaging lower-cost versions of drugs, prevent them from accepting compensation based on a drug's list price, and stop them from designing benefit plans that base out-of-pocket costs on inflated list prices rather than net costs.

FTC Chair Lina Khan stated, "The FTC's administrative action seeks to put an end to the Big Three PBMs' exploitative conduct and marks an important step in fixing a broken system—a fix that could ripple beyond the insulin market and restore healthy competition to drive down drug prices for consumers."

Impact on People Living with HIV

While the FTC's case primarily focuses on insulin pricing, PBM practices significantly affect people living with HIV (PLWH) and other chronic conditions. Recent cases highlight the challenges faced in accessing affordable medications due to PBM and insurer practices.

In April 2024, CVS Health failed in its latest attempt to dismiss a class action lawsuit alleging discrimination against PLWH by requiring them to receive medications via mail order, limiting access to essential pharmacy services and counseling. U.S. District Judge Edward Chen noted that CVS was on notice that this program could likely discriminate against PLWH, as plaintiffs had repeatedly requested to opt out.

In another case, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) closed a complaint without penalties against Blue Cross Blue Shield of North Carolina (BCBS NC) after the insurer lowered the pricing tier for HIV medications. The original complaint alleged that BCBS NC had placed almost all HIV antiretroviral medications, including generics, on the highest-cost prescription tiers.

While BCBS NC changed its formulary, the lack of penalties raises concerns about enforcement and accountability. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, expressed disappointment: "It was incredibly disheartening and deeply concerning to see them let the state's largest insurer get away with such blatant discrimination."

These cases illustrate how PBM practices and insurer policies create significant barriers to care for people living with HIV. High out-of-pocket costs, restricted pharmacy access, and discriminatory formulary designs can lead to medication non-adherence, resulting in adverse health outcomes and increased healthcare costs in the long term.

In North Carolina, about 37,000 people are living with HIV, with Black people representing 58% of new HIV diagnoses despite being only 22% of the state's population. Nationally, according to the Centers for Disease Control and Prevention (CDC), approximately 1.2 million people in the United States are living with HIV. PBM practices that inflate drug costs or limit access exacerbate these disparities and hinder efforts to end the HIV epidemic.

PBM Practices Under Scrutiny

The FTC's complaint has brought controversial PBM practices into sharp focus, highlighting concerns long raised by patients, healthcare providers, and policymakers.

The FTC's interim staff report reveals that PBMs often prioritize higher rebates over lower net prices, leading to exclusion of lower-cost alternatives and driving up drug prices—a practice known as "rebate walls." Patient steering directs consumers to PBM-owned pharmacies, limiting choice and disadvantaging independent pharmacies.

A Congressional hearing in July 2024 further exposed these issues. PBM executives faced tough questioning about their role in rising prescription drug costs. Lawmakers pressed the executives on how PBMs have monopolized the pharmaceutical marketplace and pushed anticompetitive policies that undermine local pharmacies and harm patients.

Representative Virginia Foxx (R-N.C.) highlighted the lack of transparency, questioning PBM executives about the pass-through of rebates and fees to plan sponsors. The executives' responses did little to clarify the complex and opaque financial flows within the PBM industry.

PBMs defend their practices as necessary for managing drug costs. Phil Blando, Executive Director for Corporate Communications at CVS Caremark, stated, "We work to negotiate the lowest net cost for drugs... driving better health outcomes and lower out-of-pocket costs for consumers." However, critics argue that these claimed benefits are not reflected in patient experiences or overall drug pricing trends.

Real-World Impact on Patients and Pharmacies

Jeremy G. Counts, PharmD, a spokesperson for Pharmacists United for Truth and Transparency (PUTT), explains that the vertical integration of the Big Three PBMs allows them to limit access through restrictive networks, under-reimbursement, and aggressive patient steering. These practices harm independent pharmacies and jeopardize health by disrupting continuity of care.

• Restrictive Networks and Steering: PBMs often require patients to use their own pharmacies, frequently through mail order, misleading them into believing they have no other options. Even when plans allow the use of independent pharmacies, PBMs make it tedious to opt out, effectively limiting choice.

• Under-Reimbursement and Clawbacks: Independent pharmacies that serve patients despite low reimbursements face financial strain. PBMs may pay below cost or use fees and recoupment methods to claw back margins, forcing some pharmacies to turn away patients.

• Barriers to Medication Access: PBMs impose onerous prior authorization processes for medications that do not provide them with high rebates, delaying care and increasing costs. Counts notes that this has become a deadly issue in oncology care.

• Aggressive Patient Pursuit: For profitable medications, PBMs aggressively pursue patients and their prescriptions, sometimes transferring prescriptions without permission or shipping medications without their knowledge.

These practices not only harm independent pharmacies but also jeopardize health by disrupting access to necessary medications.

Healthcare consultant Rita Numerof calls the FTC's investigation a "pivotal moment" in reforming the industry to serve patients' best interests.

The Need for Enforcement

The lack of punitive action in cases like the BCBS NC complaint raises concerns about the effectiveness of current enforcement mechanisms. Carl Schmid of the HIV+Hepatitis Policy Institute pointed out, "Without action to improve federal and state regulation, oversight, and enforcement, such discriminatory practices will continue." The BCBS NC case demonstrates that while policy changes can be achieved through advocacy and complaints, there is often little consequence for discriminatory practices.

Counts emphasizes that "PBMs are masters at derailing legislative attempts to rein them in." He argues that FTC enforcement is critical, as PBMs often ignore laws unless compelled to comply. Counts asserts that attacking the problem from multiple fronts is essential, and FTC action provides immediate and targeted intervention.

PBM Response and Industry Perspective

In response to mounting scrutiny, PBM executives have defended their practices. During the July 2024 Congressional hearing, leaders from CVS Caremark, Express Scripts, and OptumRx maintained that they do not engage in patient steering or discriminatory practices. They argued that PBMs play a crucial role in negotiating lower drug prices and improving healthcare affordability.

David Joyner, president of CVS Caremark, stated, "We're making health care more affordable and accessible for the millions of people we serve every day."

However, these assertions have been met with skepticism. The House Committee on Oversight and Accountability, led by Chairman James Comer (R-Ky.), has accused PBM executives of making statements that contradict findings about self-benefitting practices.

Legislative Efforts: The Pharmacists Fight Back Act

In addition to regulatory actions by the FTC, legislative initiatives are crucial for comprehensive reform. The Pharmacists Fight Back Act (H.R. 9096), introduced by Representatives Jake Auchincloss (D-MA) and Diana Harshbarger (R-TN), aims to:

1. Establish Standard Pharmacy Reimbursement:

   • Proposes a reimbursement model based on the National Average Drug Acquisition Cost (NADAC) plus a state dispensing fee and an additional 2%. This model prevents underpayment to independent pharmacies and curbs price gouging by PBM-owned pharmacies.

2. Prohibit Predatory PBM Tactics:

   • Seeks to ban practices such as steering patients to PBM-owned pharmacies, exclusionary network designs, retroactive fees, spread pricing, and reimbursement clawbacks.

3. Mandate Rebate Transparency and Application:

   • Requires that 80% of all PBM-negotiated rebates and fees reduce patients' out-of-pocket costs, with the remaining 20% lowering insurance premiums.

Counts stresses the urgency of passing this legislation to save pharmacies and reduce drug pricing: "Its immediate passage is critical to stopping the pharmacy closure and drug pricing crisis in this country."

Potential Outcomes and Industry Impact

If successful, the FTC's action could reshape the pharmaceutical industry by forcing PBMs to prioritize lower net drug prices, benefiting patients with more affordable medications and increased pharmacy choice. A ruling against PBMs could set a legal precedent, opening the door for further regulatory action or private lawsuits against PBMs and other healthcare intermediaries.

Independent pharmacies stand to benefit considerably from potential reforms. If the FTC's action results in more transparent pricing practices and limitations on patient steering, these businesses may be better able to compete with PBM-owned pharmacies.

However, given PBMs' significant resources and influence, changes may be hard-fought and take time to implement. There is the possibility that PBMs may find new ways to maintain their market position and profitability.

Impact on Independent Pharmacies

Independent pharmacies are closing at an alarming rate—nine per day, with 2,275 closures so far in 2024. This trend reduces access to personalized care and diminishes competition, further consolidating PBMs' market power.

Counts conducted a study in Virginia, matching pharmacy closures against openings using data from the Virginia Board of Pharmacy. He found that "community pharmacies are closing at twice the rate they are opening, and this rate is accelerating." Without significant reform, including FTC enforcement and the passage of H.R. 9096, the pharmacy infrastructure in the United States will continue to erode.

Conclusion and Call to Action

The FTC's actions, along with legislative efforts like the Pharmacists Fight Back Act, are critical steps toward creating a fairer pharmaceutical industry that prioritizes access and affordability.

We urge readers to:

1. Stay Informed: Follow developments in PBM regulation and reform efforts.

2. Research Legislation: Contact your representatives to inquire about pending legislation.

3. Engage with Advocacy Groups: Support organizations like PUTT (www.truthrx.org) and the HIV+Hepatitis Policy Institute (www.hivhep.org).

4. Share Experiences: Raise awareness by sharing your experiences with PBM practices. PUTT is collecting stories to highlight the real-world impact of PBM practices. Visit their PBM Horror Stories page to share your story anonymously.

Collective action is essential to ensure meaningful and lasting change in drug pricing and access. The FTC's action is a significant step, but it's up to all of us to ensure this momentum leads to a more transparent, equitable, and patient-centered healthcare system in the United States.

The Great Disenrollment: Examining Medicaid's Post-Pandemic Shift

The Medicaid unwinding process that began in April 2023 has significantly impacted healthcare access and coverage retention across the United States. The unwinding, triggered by the end of pandemic-era continuous enrollment provisions, led to substantial shifts in Medicaid enrollment and revealed both strengths and weaknesses in our healthcare system. The process disproportionately affected communities of color and highlighted the need for targeted policy interventions to maintain healthcare access for vulnerable groups, including people living with HIV (PLWH).

The Scope of Medicaid Unwinding

During the COVID-19 pandemic, the Families First Coronavirus Response Act implemented the continuous enrollment provision in March 2020. This policy prohibited states from disenrolling Medicaid beneficiaries in exchange for enhanced federal funding, ensuring that people maintained health coverage during a time of unprecedented health and economic uncertainty. As a result, Medicaid enrollment surged from 71 million people in February 2020 to 94 million by April 2023, according to a Kaiser Family Foundation (KFF) analysis.

The end of the continuous enrollment provision on March 31, 2023, initiated a complex process of eligibility redeterminations for all Medicaid enrollees—a task of immense scale and complexity. By the end of the unwinding period, over 25 million people had been disenrolled from Medicaid, while over 56 million had their coverage renewed, as reported by KFF. The overall disenrollment rate stood at 31%, with significant variation across states. For instance, Montana reported a 57% disenrollment rate, while North Carolina's rate remained below 20%.

Systemic Challenges in the Unwinding Process

One of the most concerning aspects of the unwinding process was the high rate of procedural disenrollments. Of those who lost coverage, 69% were disenrolled for procedural reasons, such as not returning renewal paperwork, rather than being determined ineligible. This suggested that many people who lost coverage may have still been eligible for Medicaid but faced significant challenges navigating the renewal process successfully.

The Government Accountability Office (GAO) highlighted that administrative barriers contributed significantly to these procedural disenrollments. These barriers included:

1. Outdated Technology Systems: At least 11 states reported that their systems were old or difficult to use, making it challenging to produce real-time analytics essential for processing renewals effectively. This technological lag complicated efforts to implement necessary changes swiftly and efficiently.

2. Staffing Shortages: High turnover rates among eligibility workers led to vacancy rates reaching up to 20% in some states. Reports of low morale and burnout further affected the workforce's ability to handle the increased workload during the unwinding process.

3. Communication Barriers: States struggled to effectively engage people in the renewal process, particularly those facing language barriers. Non-English speakers often encountered longer wait times and struggled to reach assistance through call centers. These issues were compounded by a lack of robust state communication and engagement strategies.

4. Complex Paperwork: The renewal process often involved complicated forms and documentation requirements, which proved challenging for many enrollees to navigate, especially those with limited literacy or language skills.

Dr. Benjamin Sommers, a health policy expert at Harvard T.H. Chan School of Public Health, noted during the process, "The high rate of procedural disenrollments is particularly troubling. It indicates that we're not just seeing people leave Medicaid because they no longer qualify, but because they're struggling with the administrative hurdles of the renewal process."

These challenges led to frustration among enrollees and advocacy groups, highlighting the need for more streamlined and accessible renewal processes. The experience underscored the importance of investing in modernized eligibility systems, adequate staffing, and comprehensive communication strategies to ensure that eligible patients can maintain their coverage during future eligibility redeterminations.

National Enrollment Trends and State-Level Variations

Despite significant disenrollments during the unwinding process, Medicaid enrollment remained higher than pre-pandemic levels. As of May 2024, 81 million people were enrolled in Medicaid, an increase of about 10 million compared to pre-pandemic enrollment. However, this growth was not uniform across all populations. While adult enrollment remained over 20% above February 2020 levels, child enrollment was only about 5% higher.

Several factors influenced these disparities:

1. The pandemic's economic impact led to more adults becoming eligible for Medicaid due to job losses and income reductions.

2. States that expanded Medicaid under the Affordable Care Act saw more substantial increases in adult enrollment.

3. Children's enrollment remained relatively stable due to higher pre-pandemic enrollment rates and broader eligibility criteria through programs like the Children's Health Insurance Program (CHIP).

The impact of the unwinding process varied significantly across states, reflecting differences in policies, system capacities, and approaches. States that expanded Medicaid under the Affordable Care Act generally showed higher retention rates. Additionally, states that adopted strategies to streamline the renewal process, such as increasing ex parte (automated) renewals, saw better outcomes.

For example, Arizona, North Carolina, and Rhode Island achieved ex parte renewal rates exceeding 90%, while states like Pennsylvania and Texas had rates of 11% or less. These differences underscored the importance of state-level policies and systems in determining unwinding outcomes.

The Centers for Medicare & Medicaid Services (CMS) reported that states with higher ex parte renewal rates tended to have modernized eligibility systems that could effectively leverage data from other programs to confirm eligibility. This reduced the administrative burden on patients and helped maintain continuous coverage.

These variations highlighted the critical role of state-level decision-making and infrastructure in shaping Medicaid enrollment outcomes during and after the unwinding process. They also pointed to potential best practices for maintaining coverage and streamlining enrollment processes in the future.

Racial and Ethnic Disparities in Medicaid Disenrollment

A particularly concerning aspect of the unwinding process is its disproportionate impact on communities of color. According to the Southern Poverty Law Center (SPLC), more than half of the people who lost coverage were people of color. This disparity is exacerbated by existing barriers to healthcare access. The SPLC notes that communities of color face more barriers to healthcare access, such as limited internet, transportation, and inflexible job schedules.

The impact is particularly severe in states that have not expanded Medicaid. The SPLC report highlights that "residents from Alabama, Florida, Georgia, and Mississippi make up over 40% of the adults in the coverage gap nationwide. People of color make up about 60% of the coverage gap nationwide."

The Human Impact of Coverage Loss

The impact of coverage loss extends beyond statistics. Personal stories highlight the real-world consequences of the unwinding process. Justin Gibbs, a 53-year-old from Ohio, had to go without blood pressure medication for a week after losing his Medicaid coverage in December, according to CNN. Such disruptions in care can have serious health implications, particularly for people managing chronic conditions.

A KFF survey reveals the broader health impacts of coverage loss. Among those who became uninsured after losing Medicaid:

• 75% reported worrying about their physical health

• 60% worried about their mental health

• 56% said they skipped or delayed getting needed health care services or prescription medications

Impact on HIV Care and Policy Implications

The Medicaid unwinding process also highlighted significant challenges in maintaining healthcare access for people living with HIV (PLWH). While specific data on Medicaid disenrollment among PLWH during the unwinding were limited, general trends among vulnerable populations indicated potential risks. A KFF report found that many of those who lost Medicaid coverage experienced increased out-of-pocket costs, interruptions in medication adherence, and deteriorating health outcomes. These challenges were particularly critical for PLWH, for whom continuous access to antiretroviral therapy (ART) is essential.

Key considerations for PLWH during the unwinding process included:

1. Continuity of ART: Ensuring uninterrupted access to antiretroviral medications is mandatory for maintaining viral suppression and overall health.

2. Role of Ryan White HIV/AIDS Program: This program played a critical role in filling coverage gaps, but it's not a substitute for comprehensive health insurance.

3. Targeted Outreach: Community-based organizations and AIDS Service Organizations (ASOs) were essential in providing specialized support and enrollment assistance to PLWH.

4. Data Collection: Improving data collection on Medicaid disenrollment rates among PLWH can inform targeted interventions and policy adjustments.

The unwinding process underscored the need for policies that safeguard continuous healthcare access for PLWH. Implementing strategies that address these specific needs can help prevent coverage disruptions and improve overall health outcomes for people living with HIV.

Economic Implications of the Unwinding Process

The Medicaid unwinding process had significant economic implications for patients, healthcare providers, and states. For people who lost Medicaid coverage, the consequences often included financial instability and increased medical debt. A study by the Urban Institute found that adults who experienced a gap in Medicaid coverage were more likely to report problems paying medical bills and to have medical debt.

Healthcare providers, particularly safety-net hospitals and community health centers, faced increased rates of uncompensated care as a result of the unwinding process. This strained their financial resources and potentially affected their ability to provide care to their communities. The Commonwealth Fund noted that increased uninsured rates could lead to higher healthcare costs in the long term due to delayed care and increased emergency room visits.

For states, the unwinding process presented complex economic challenges. As the enhanced federal matching rate provided during the pandemic phased out, many states grappled with increased administrative costs associated with the unwinding process. A report from the Brookings Institution highlighted that states faced a complex set of trade-offs as they navigated the unwinding process, balancing the need to control Medicaid spending with the imperative to maintain access to care for vulnerable populations.

The full economic impact of the unwinding process continues to unfold, with ongoing implications for state budgets, healthcare provider finances, and patient economic well-being. These insights will be important in shaping future Medicaid policies and developing strategies to mitigate economic challenges associated with coverage transitions.

Policy Recommendations and Best Practices

To address these challenges, several key strategies have been identified:

• Streamlining Renewal Processes: Increasing ex parte (automated) renewal rates can reduce the burden on people and minimize procedural disenrollments. For instance, Louisiana achieved a 49% ex parte renewal rate by leveraging data from other public benefit programs and improving data matching processes.

• Targeted Outreach: Conducting outreach to vulnerable populations, including communities of color and people with chronic conditions, can help reduce disenrollments. The Ohio Department of Medicaid partnered with community-based organizations for door-to-door outreach in areas with high procedural disenrollments.

• Implementing Continuous Eligibility: Policies that provide 12-month continuous eligibility can stabilize coverage and reduce churn. Oregon implemented a two-year continuous eligibility policy for children under six.

• Enhanced Federal Oversight: Strengthening monitoring and enforcement of federal requirements ensures state compliance. CMS should leverage new authorities to require corrective action plans from states with high procedural disenrollments.

• Improving Data Collection: Robust data collection and timely reporting enable quick identification of problems. States should report disaggregated data on disenrollments by race, ethnicity, and other demographics to address disparities.

• Leveraging Technology: Modernizing eligibility systems improves accuracy and efficiency. Implementing text messaging, email communication, and mobile-friendly online portals helps people update information and complete renewals more easily.

• Expanding Presumptive Eligibility: Allowing qualified entities to make preliminary eligibility determinations provides temporary coverage while full applications are processed, ensuring continuous access to care.

Addressing Systemic Inequities and Long-Term Solutions

The unwinding process exposed systemic inequities within the healthcare system, particularly affecting communities of color and rural areas. Long-term solutions include:

• Investing in Underserved Communities: Enhancing access to healthcare services in marginalized areas.

• Improving Health Literacy: Providing education to help people understand their health coverage options and navigate the system.

• Strengthening Social Safety Nets: Expanding programs that address social determinants of health, such as housing, nutrition, and transportation.

Without significant policy interventions, coverage losses could lead to worse health outcomes and increased disparities, as emphasized by the Urban Institute.

Conclusion

The Medicaid unwinding process revealed both challenges and opportunities in our healthcare system. It highlighted the need for more efficient, equitable, and resilient approaches to health coverage. Key lessons include the importance of streamlined processes, targeted outreach, and robust oversight.

Moving forward, policymakers, healthcare providers, and advocates must work together to implement solutions that ensure continuous, accessible care for all, especially vulnerable populations. This effort is not just about health policy—it's a matter of equity and human rights.

As we continue to navigate the evolving healthcare landscape, our goal should be to build a system that provides stable, continuous coverage and leaves no one behind. This commitment is essential for improving health outcomes, reducing disparities, and strengthening our nation's overall health infrastructure.

Gaming as a New HIV Prevention Tool

The latest data from the Centers for Disease Control and Prevention (CDC) indicate that people aged 13 to 34 accounted for more than half (56%) of all new HIV diagnoses in the United States in 2022. This concerning trend underscores a critical need for HIV prevention methods that resonate with younger demographics and at-risk communities. Gamification—the strategic integration of game elements into non-game contexts—may offer a promising solution. By leveraging the inherent appeal of games to engage, motivate, and provide personalized feedback, gamification has the potential to transform HIV prevention efforts. It can bridge knowledge gaps, promote behavior change, and empower people, thereby contributing significantly to public health goals aimed at ending the HIV epidemic.

Gamification: A Powerful Tool for Public Health

Gamification involves incorporating game mechanics such as points, challenges, and rewards into websites, apps, or learning systems to enhance user engagement and motivation. The goal is to inspire collaboration and interaction, fostering higher engagement and loyalty among consumers, employees, and partners. According to a report by Deloitte, "Gamification has proliferated to the point that elements have entered consumers' daily lives, transforming inconvenient tasks into fun activities."

The effectiveness of gamification stems from its ability to tap into fundamental psychological and behavioral principles. One framework that helps in understanding these principles is the Octalysis Framework, developed by gamification expert Yu-kai Chou. The Octalysis Framework identifies eight core drives that motivate human behavior:

1. Epic Meaning & Calling: The belief that one is doing something greater than oneself.

2. Development & Accomplishment: The internal drive for making progress, developing skills, and eventually overcoming challenges.

3. Empowerment of Creativity & Feedback: Engaging users in a creative process where they have to repeatedly figure things out and try different combinations.

4. Ownership & Possession: Users are motivated because they feel ownership over something.

5. Social Influence & Relatedness: Activities driven by social elements, including mentorship, social acceptance, and competition.

6. Scarcity & Impatience: The desire to have something because it is rare or immediately unattainable.

7. Unpredictability & Curiosity: The drive stemming from not knowing what will happen next.

8. Loss & Avoidance: The motivation to avoid negative consequences.

By incorporating these core drives, gamification strategies can effectively engage and motivate users.

For instance, rewards and recognition act as powerful motivators, encouraging users to actively participate and achieve desired outcomes. This aligns with the Octalysis Framework's core drive of Development & Accomplishment, where users are motivated by a sense of progress and achievement.

Game mechanics such as challenges, levels, and progress bars transform potentially mundane tasks into interactive and enjoyable experiences. Continuous feedback and a clear sense of progress reinforce positive behaviors and encourage sustained engagement. This relates to the core drive of Empowerment of Creativity & Feedback, where users feel empowered by their ability to influence outcomes and track their progress.

Moreover, gamification can foster a sense of community and healthy competition among users, providing social support and enhancing motivation. This leverages the power of Social Influence & Relatedness, where users are motivated by connection, comparison, and collaboration.

By understanding and applying these core drives, gamification can create engaging experiences that motivate users to adopt and maintain healthy behaviors—crucial in the context of HIV prevention.

Real-World Applications in Healthcare

The application of gamification in healthcare is not merely theoretical. Real-world examples demonstrate its impact:

• Medisafe, a medication reminder app with over 5 million users, reports that two-thirds of patients with hypertension, diabetes, and depression using their app have improved their medication adherence. The app uses personalized reminders, progress tracking, and rewards for adherence, effectively applying gamification principles to improve health outcomes.

• Re-Mission, a set of online games designed for young people with cancer, allows players to control a nanobot that fights cancer cells and manages side effects. This makes the challenging experience of cancer treatment more engaging and empowering.

These examples illustrate how gamification can activate patients, encouraging them to take ownership of their health and become active participants in their care. By making health education more engaging and effective, gamification can lead to better understanding and retention of information—important factors in HIV prevention.

A l'Assaut du Sida (AADS): A Case Study in Gamified HIV Prevention

"A l'Assaut du Sida" (AADS), meaning "Tackling AIDS," is a compelling example of gamification's potential to drive meaningful change in HIV prevention. This interactive mobile game app, developed by SYL, a Côte d’Ivoire-based technology company, has reached over 300,000 young people in the country.

The app's development and distribution were a collaborative effort between SYL, UNAIDS, UNICEF, the Global Fund, and the Côte d’Ivoire Ministry of Health. This partnership ensured the app's alignment with national HIV prevention goals, access to funding and resources, and widespread promotion. A key factor in AADS's success was its strategic promotion during the African Cup of Nations football tournament. By leveraging the popularity of this major sporting event, the app effectively engaged young people, particularly boys and men who are often harder to reach with traditional HIV prevention campaigns.

AADS addresses significant knowledge gaps about HIV among youth in Côte d’Ivoire. A survey revealed that only 40% of respondents knew that antiretroviral treatment for HIV exists. The app provides comprehensive content covering topics such as stigma, human rights, gender equality, and gender-based violence, educating users on crucial aspects of HIV prevention and care.

The positive impact of AADS is evident in both its reach and user feedback. Young players reported learning a great deal about HIV and related topics through the app's engaging quiz format. Côte d’Ivoire’s Minister of Health, Pierre Dimba, acknowledged the app’s success, stating, "This fun and educational online game is a response to young people's need for true and accurate information via social media."

Looking ahead, national partners are working to distribute a scholastic version of the game to schools nationwide, demonstrating their commitment to scaling up this innovative approach to HIV prevention. The app's low cost and adaptability make it a sustainable model for HIV prevention efforts, particularly in the context of potentially decreasing international funding.

Reaching the LGBTQ+ Gaming Community: A Critical Audience

The gaming community has witnessed a significant increase in the representation of LGBTQ+ players, creating a unique opportunity for targeted HIV prevention efforts. Within this diverse community, a significant subculture known as "gaymers" has emerged. The term "gaymers" is a blend of "gay" and "gamers" and is commonly used within the LGBTQ+ gaming community. It refers to LGBTQ+ gamers who share a passion for video games and often form their own networks and communities both online and offline.

According to a 2024 GLAAD study, 17% of active gamers identify as LGBTQ+, representing a 70% increase from 2020. This growth is even more pronounced among younger gamers, with 23–28% of gamers under 35 identifying as LGBTQ+. The rise of the gaymer subculture underscores the increasing visibility and representation of LGBTQ+ people in gaming.

The Growing Presence of Transgender and Nonbinary Gamers

The prevalence of transgender and nonbinary gamers has also risen notably. Between 2015 and 2018, they comprised approximately 1–2% of the gaming population. By 2021, this number increased to around 5%. Additionally, research from the International Journal of Environmental Research and Public Health estimates that 1.2–2.7% of the adolescent population are gender-diverse. This growing representation underscores a significant and expanding audience within the gaming community that can be reached through tailored interventions.

The Appeal of Gaming for LGBTQ+ People

Video games offer a sense of escapism and a platform for self-expression, allowing players to immerse themselves in alternative realities and explore different identities free from real-world constraints. This can be especially appealing for LGBTQ+ people who may face challenges or discrimination based on their sexual orientation or gender identity. Games that allow for character customization, narrative exploration, and community interaction can be profoundly liberating and affirming.

Multiplayer games provide opportunities for social connection and community building. These online spaces can foster a sense of belonging, particularly for those who may feel isolated or lack access to supportive LGBTQ+ communities in their offline lives. The ability to interact anonymously can also allow people to explore and express their identities more freely.

Challenges and Opportunities

Despite the potential of reaching LGBTQ+ people through gaming, significant challenges exist. Homophobia, transphobia, and bigotry persist within the gaming community, creating hostile environments for many LGBTQ+ players. This underscores the need for interventions that not only provide information about HIV prevention but also address issues of stigma, discrimination, and online harassment.

However, the increasing representation of LGBTQ+ gamers presents substantial opportunities:

• Growing Audience: The rising number of LGBTQ+ gamers, particularly among younger demographics, means that gaming platforms can be effective channels for HIV prevention messaging.

• Tailored Content: Understanding the specific preferences and motivations of transgender and nonbinary gamers allows for the development of interventions that are culturally relevant and engaging.

• Community Engagement: Multiplayer and community-based games offer opportunities for social connection, peer support, and the dissemination of health information within a supportive environment.

Tailored Strategies for Engagement

Developing gamified HIV prevention strategies that resonate with LGBTQ+, transgender, and nonbinary gamers is a massive opportunity. Public health data underscores the importance of this approach, as these groups are at a disproportionately high risk for acquiring HIV. For instance, the CDC reports that men who have sex with men (MSM) accounted for 67% of new HIV infections in 2022, and an estimated 14% of transgender women in the United States are living with HIV.

Interventions focusing on themes of self-discovery, community building, and personal empowerment may be particularly effective. Research from Quantic Foundry indicates that transgender and nonbinary gamers often prioritize games that allow for:

• Self-Expression and Creativity: Games that offer customizable avatars, inclusive narratives, and opportunities for creative input engage transgender and nonbinary gamers effectively.

• Exploration of Identity: Interactive experiences that allow players to explore different aspects of their identity in a safe and affirming environment can be particularly impactful.

• Community Building: Features that foster social connections and peer support can enhance engagement and provide valuable platforms for disseminating HIV prevention information.

Addressing Unique Challenges

Incorporating elements that address the specific challenges faced by LGBTQ+ people—such as stigma, discrimination, and barriers to healthcare access—can enhance the relevance and impact of these interventions. By fostering a sense of community and belonging within the gaming environment, gamified strategies can promote peer support and encourage positive health behaviors.

For example, gamified interventions could include:

• Narratives that Reflect Diverse Experiences: Storylines that incorporate LGBTQ+ characters and experiences promote inclusivity and resonance.

• Resources and Support: In-game links to resources on HIV prevention, testing, and support services tailored for these communities.

• Safe Online Spaces: Moderated environments that protect players from harassment and discrimination, ensuring a positive and affirming gaming experience.

The Potential for Impact

The increasing representation of LGBTQ+ people in gaming underscores the potential of this medium as a channel for targeted HIV prevention efforts. By aligning game design with the preferences and motivations of these gamers, public health initiatives can more effectively reach these at-risk populations and contribute to reducing HIV transmission rates.

Moving Forward

Gamification holds immense potential to transform HIV prevention efforts among young people and at-risk communities, including the LGBTQ gaming community. To fully realize this potential, we should consider:

• Increased Investment: Funding agencies should prioritize gamification in HIV prevention research grants, providing resources for the development and evaluation of innovative interventions.

• Collaborative Partnerships: Building partnerships between game developers, public health organizations, LGBTQ advocacy groups, and researchers is essential. Such collaboration ensures that games are culturally relevant and resonate with diverse audiences.

• Rigorous Evaluation: Implementing evidence-based design and conducting rigorous evaluations are key for assessing the effectiveness of gamified interventions and making necessary adjustments.

• Ethical Design: Ethical considerations, particularly related to data privacy, informed consent, and cultural sensitivity, must be at the forefront of game development.

Advancing Policy

Policymakers, healthcare providers, educators, and community organizations all have a role to play in advancing gamified HIV prevention:

• Policymakers can support legislation that promotes digital health innovation and ensures equitable access to technology.

• Healthcare Providers can incorporate gamified tools into their practice to enhance patient education and engagement.

• Educators can utilize gamified interventions like AADS in school curricula to provide comprehensive sexual education.

• Community Organizations can collaborate with developers to create interventions that address the specific needs of their communities.

As we move forward, embracing innovation and collaboration is essential. By leveraging the power of gamification, we can create engaging, effective, and inclusive HIV prevention strategies that resonate with at-risk communities. Gamification has the potential not only to educate and inform but also to empower and inspire, creating a generation equipped with the knowledge, skills, and motivation to protect themselves and their communities from HIV.

Together, we can level up our efforts and make significant strides toward ending the HIV epidemic.

Why Mental Health is Central to Ending the HIV Epidemic

Have you ever felt like you were living two lives—one presented to the world, while the other is buried under secrecy and shame? For many people living with or at risk of HIV, this dual reality is painfully familiar. World Suicide Prevention Day might trend on social media, but hashtags rarely touch on the quiet, insidious epidemic where HIV meets a mental health crisis that too often remains in the shadows.

We’ve made significant strides in treating HIV, but the virus isn’t the only battle. There’s another battle just as critical: the mental toll—the invisible wounds and lingering trauma often overlooked despite medical advances. And all the progress in the world won’t matter if we ignore the mental and emotional realities of those living with HIV. We need more than medicine—we need a mindset shift that sees mental health as equally important and valid as physical health.

It’s time to confront the deeper issues directly: the stigma, the trauma, the daily fears. We need a mental healthcare system that understands, listens, and treats the whole person—not just the virus. Until we address these challenges head-on, we aren’t truly ending the HIV epidemic.

Navigating Mental Health Challenges with HIV

Living with HIV is not solely a medical challenge; it is a continuous mental marathon. The numbers show that we’re dealing with more than just a virus. People living with HIV are 100 times more likely to die by suicide than other populations. Anxiety disorders affect 15.5% of people living with HIV, compared to 3.6% in the general population, and depression is 2 to 5 times more common. Even more concerning, up to 70% have experienced trauma—20 times the rate of the general population.

These numbers represent real people navigating complex challenges. While not every person living with HIV faces mental health issues, for many, these struggles are a significant part of their experience. As one researcher notes, "The significantly higher prevalence compared to the general population suggests that anxiety disorders are a critical global public health concern among people living with HIV, requiring urgent prevention and treatment efforts."

To fully understand the scope of these challenges, we must consider "weathering"—the cumulative wear and tear on the body and mind from chronic stress and adversity. Dr. Sannisha K. Dale explains that for people living with HIV, this process is worsened by relentless stigma, discrimination, limited access to resources, systemic inequities, and other enduring social barriers. Weathering isn’t just about feeling worn down; it accelerates aging in a very real, biological way, leading to more chronic illnesses, cognitive decline, and other issues that hit harder and sooner for people with HIV. Research in iScience shows this accelerated aging can start almost immediately—within three years of acquiring HIV—due to cellular changes that affect overall health.

And it’s not just biology. Behavior plays a significant role too. A study in Translational Psychiatry reveals that maladaptive coping mechanisms like smoking or substance use, often developed in response to constant adversity, can accelerate aging and complicate HIV management. This highlights the importance of addressing both psychological and behavioral factors in HIV care, not just the virus itself.

Take Malcolm, a 66-year-old who’s been living with HIV for 28 years. Despite his resilience, he faces daily struggles: managing not only his HIV but also high blood pressure, Type 2 diabetes, and the mental toll of juggling multiple health conditions. As he puts it, "I'm just happy to be here," but that statement carries the weight of a lifetime of survival amid a complex landscape of healthcare challenges, stigma, and aging with HIV. Malcolm’s experience highlights the compounded difficulties faced by many older adults with HIV, where trauma is often a chronic companion rather than a singular event.

His story reflects a broader pattern: trauma, whether from the loss of friends to the epidemic, ongoing health challenges, or societal discrimination, often persists and manifests as PTSD, depression, substance use, and other mental health struggles. As such, the need for comprehensive care that addresses both the psychological scars and the physical realities of living with HIV has never been more urgent.

As Dr. Dale puts it, "Systemic oppression and mental health struggles faced by people living with HIV throughout their lives may accelerate the aging process and continue to negatively impact their physical health and wellbeing as they age." This isn’t just a health crisis—it’s a call to fundamentally rethink how we approach care and compassion for those most affected, demanding action that is both immediate and transformative.

Understanding weathering in the context of HIV is critical to developing effective care strategies. Research from the HIV Vaccine Trials Network makes it clear: it’s not just about treating the virus; it’s about recognizing the full scope of what people are up against—mental health challenges, trauma, and social determinants of health. Only by addressing all these factors can we create interventions that truly support healthier aging and improve the quality of life for people living with HIV.

Why Mental Health is Key to Effective HIV Care

Mental health and HIV care are inextricably linked, with research showing that untreated mental health conditions can significantly undermine adherence to antiretroviral therapy (ART), complicating efforts to achieve viral suppression and maintain overall health. The Substance Abuse and Mental Health Services Administration (SAMHSA) highlights this connection, stating, "Untreated behavioral health conditions can significantly hinder HIV care engagement, medication adherence, and overall health outcomes."

Yet, accessing mental healthcare while living with HIV is often a challenge. Limited services, cultural gaps among providers, and pervasive stigma are just some of the hurdles. This is compounded by a fragmented healthcare system that treats HIV care and mental health services separately. To address these gaps, we need to urgently improve provider education and competency in addressing both HIV and mental health needs. The World Health Organization and UNAIDS advocate for integrating mental health and HIV care. Their call for a holistic approach goes beyond just medical checklists—it’s about addressing psychological and social factors too. Integrated care models have shown promise, improving both mental health outcomes and adherence to HIV treatment.

Studies have shown that integrating mental health services into HIV care can significantly improve outcomes. This approach has been shown to reduce depressive symptoms by 25-50%, enhance adherence to antiretroviral therapy (ART), and increase the rates of viral suppression up to 95%. Collaborative care models, where mental health professionals and HIV providers work together, have proven effective in reducing hospitalizations, improving patient engagement, and promoting overall better health for people living with HIV.

However, getting there isn’t easy. SAMHSA's Center for Integrated Health Solutions identifies big hurdles, like funding limitations, workforce shortages, and resistance to organizational change. Despite these challenges, integrated care remains a critical goal—one that could significantly improve the health and well-being of people living with HIV.

And we can't ignore the impact of stigma. The Well Project notes that stigma in healthcare settings can worsen trauma and deter people from seeking care. Training providers in trauma-informed care and cultural competency is essential to creating safe, inclusive spaces for people living with HIV.

How Politics and Society Shape the HIV Experience

The mental health of people living with HIV is profoundly influenced by the broader social and cultural context in which they live. Systemic stigma, discrimination, and social exclusion intersect with issues like racism, homophobia, transphobia, and economic inequality, creating significant barriers to care and support. Research published in the American Journal of Public Health illustrates how these overlapping forms of discrimination increase stress, social isolation, and complicate access to healthcare. The study presents a framework demonstrating how HIV-related stigma, when combined with other forms of social marginalization, can negatively impact treatment adherence and overall health outcomes for people living with HIV.

HIV criminalization laws are another piece of this complex puzzle. As highlighted by Xtra Magazine, Canada and the U.S. still lead the world in criminalizing HIV, perpetuating stigma and further alienating those affected. Furthermore, the World Health Organization notes that discriminatory policies in employment, housing, and education create additional barriers, directly impacting mental well-being. Media and entertainment also plays a critical role. Sensationalized coverage and inaccurate portrayals continue to fuel harmful stereotypes, adding to the stigma people living with HIV experience.

Cultural and religious beliefs in certain communities can further exacerbate HIV-related stigma, leading to isolation, rejection, or even violence. UNAIDS emphasizes the importance of addressing these deeply ingrained attitudes.

However, positive messaging also has the power to reshape perceptions. The Undetectable = Untransmittable (U=U) campaign is a key example. HIV.gov explains that effective ART leading to undetectable viral loads prevents transmission, challenging outdated misconceptions and empowering those living with HIV.

This messaging has made a significant impact. Research has shown that U=U reduces anxiety and changes perceptions, helping people with HIV feel less like a threat. Similarly, PrEP (pre-exposure prophylaxis) offers another powerful tool, proving highly effective in preventing HIV transmission and fostering open, honest conversations about sexual health.

Building Resilience: Strategies for Mental Wellness

Supporting the mental health of people living with or at risk of HIV means thinking beyond a one-size-fits-all approach. We need to tackle this from multiple angles. Integrated care models that combine mental health and HIV services are proving to be effective. Programs like the Collaborative Care Model and the Mental Health Integration Programme show how treating the whole person—not just the virus—leads to better outcomes.

Trauma-informed care is crucial for creating environments where people feel truly safe and supported. This means training healthcare workers in sensitive communication, empowering patients in their care, and recognizing how trauma affects health behaviors and outcomes.

Monte Ephraim, a clinical social worker, sums it up: “Everyone has the possibility of living a satisfying and meaningful life, regardless of what happened to them or what health challenges they are living with.” Their approach centers on acknowledging trauma, promoting healing through relationships, and building resilience.

Community-based organizations are also vital. They offer support groups, peer counseling, and advocacy, using the power of shared experiences to reduce isolation and build resilience. For people living with HIV, resilience isn’t just a buzzword—it’s a lifeline. Research highlights that engaging in helpful coping mechanisms, like relying on social support, spirituality, creative expression, and activism can improve resilience. Practices like mindfulness, stress reduction, and positive psychology can also help. Each person’s way of coping will differ, and that’s perfectly fine. What’s important is finding what brings peace and comfort, in whatever form that takes.

Moving Forward: A Call to Action

If we’re serious about ending the HIV epidemic, we have to face the reality that mental health isn’t just part of the equation—it’s central to it. This isn’t a side issue or an optional extra. It's a fundamental piece of the puzzle that must be integrated into every aspect of HIV care and prevention.

To make progress, we need a strong commitment from all fronts—policymakers, healthcare providers, and communities:

• Policymakers: Fund mental health services, integrate mental health care into all HIV programs, mandate trauma-informed training, and address social determinants of health.

• Healthcare Providers: Implement trauma-informed approaches, conduct routine mental health screenings, and build strong referral networks.

• Communities: Challenge stigma, support local organizations, and advocate for policy changes that promote mental health and HIV care.

We’re not just fighting a virus; we’re fighting for the dignity, health, and well-being of people living with HIV. This battle calls for a holistic, compassionate approach that treats the whole person—mind and body. It’s about creating a healthcare system that goes beyond the virus to address the real, lived experiences of those affected.

By integrating mental health care, tackling stigma, and fostering supportive communities, we can help ensure a future where people living with HIV not only survive but thrive. Let’s not just aim for zero new transmissions or deaths; let’s strive for a world where every person living with HIV is valued, empowered, and has the chance to live their fullest life.

Ensuring Equitable Access to PrEP for Minors in the South

In 2022, young people under 35 accounted for over half (56%) of all new HIV diagnoses in the United States. The Southern states bore a disproportionate burden of this epidemic, accounting for more than half of new HIV diagnoses that year. Particularly high rates among youth in this region highlight the urgent need for effective HIV prevention strategies tailored to young people. This alarming statistic underscores the urgent need to ensure that all young people, regardless of where they live or their family circumstances, have access to effective HIV prevention tools, including pre-exposure prophylaxis (PrEP). The CHOOSE study (Combatting HIV Or Other STIs Early), currently underway, offers a promising approach to increasing PrEP uptake among young gay, bisexual, and other men who have sex with men (YGBMSM) aged 13-24, a population at elevated risk for HIV. CHOOSE leverages the power of mobile health technology to provide tailored information, support, and reminders to help young people choose and adhere to PrEP.

However, the promise of CHOOSE and other similar PrEP initiatives for young people is threatened by a wave of restrictive policies and legal decisions in the United States, creating significant barriers for minors seeking to protect their health, especially those who live in the South. In Texas, the 5th Circuit Court of Appeals ruled that Title X-funded clinics must notify parents before providing sexual and reproductive healthcare services to minors, including contraception. This ruling has far-reaching implications for PrEP access, as Title X clinics are often the only source of sexual health services for young people, particularly those without access to private insurance. Similarly, in Tennessee, the state government's politically motivated decision to reject federal HIV prevention funding and redirect resources away from organizations serving marginalized communities, including those providing PrEP, further jeopardizes the health of young people.

These actions demonstrate a concerning trend of policies that prioritize parental control over the health and well-being of young people, even when those policies contradict evidence-based public health strategies and potentially put youth at risk. We must address these barriers to ensure that all young people in the South have equitable access to PrEP and other life-saving HIV prevention tools. Failing to do so will not only do material harm to vulnerable people but also hinder our collective progress towards ending the HIV epidemic.

The Landscape of PrEP Access for Minors

PrEP has proven highly effective in reducing the risk of HIV acquisition, particularly for young gay, bisexual, and other men who have sex with men. When taken as prescribed, PrEP can reduce the risk of sexual HIV transmission by up to 99%. Studies have shown that a majority of young people on PrEP demonstrate adequate adherence, further supporting its effectiveness as a prevention tool. However, realizing the full potential of PrEP for young people hinges on ensuring equitable access, a goal hindered by a complex and often restrictive legal landscape surrounding minors' consent to healthcare. While PrEP offers a powerful tool for HIV prevention, accessing this medication can be challenging for young people, particularly due to the complex legal landscape surrounding minor consent to healthcare.

The legal framework for minor consent to healthcare varies significantly across states, creating a patchwork of access for young people seeking PrEP and other sexual health services. Many state laws governing a minor's ability to give informed consent for STI and HIV services do not explicitly mention PrEP. This lack of clarity within these statutes leaves it unclear whether minors can consent to PrEP independently and confidentially. This ambiguity can deter healthcare providers from offering PrEP to minors and leave young people uncertain of their rights. The situation is particularly concerning in the South, where restrictive parental consent laws are prevalent and often extend to sexual and reproductive healthcare services more broadly.

The 5th Circuit ruling in Texas, requiring parental notification for Title X services, exemplifies this trend. Planned Parenthood, a leading provider of sexual and reproductive healthcare, condemned the ruling as "a significant and dangerous departure from decades of precedent that has allowed all young people to confidentially get basic health care like birth control through Title X." This ruling, and the legislation it protects, creates significant barriers for young people seeking basic sexual and reproductive healthcare, including PrEP. For example, a young person in Texas seeking PrEP who fears being outed to unsupportive parents due to their sexual orientation might forgo seeking this essential prevention method altogether to avoid mandatory parental notification, putting their health at risk. For those experiencing family conflict, abuse, or rejection due to their sexual orientation or gender identity, mandatory parental notification can be particularly dangerous, deterring them from seeking essential care.

However, recent actions by the federal government offer a glimmer of hope. In a case involving Oklahoma, the Supreme Court upheld the Biden administration's right to redirect federal family planning funds from states that restrict access to abortion information. This decision demonstrates the potential for using federal funding as leverage to incentivize states to comply with public health guidelines and protect access to care, even in politically charged areas like sexual and reproductive health.

Even in states where minors can legally consent to PrEP, confidentiality is not always guaranteed. Some states allow or require providers to notify parents or guardians, potentially compromising young people's privacy and putting them at risk. Additionally, the inadvertent disclosure of sensitive health information through insurance Explanation of Benefits (EOBs) sent to parents or guardians can further erode confidentiality. These policies fail to recognize the unique vulnerabilities of young people and the importance of confidential healthcare access in fostering trust and encouraging early intervention.

Political Interference: The Case of Tennessee

While restrictive laws present a significant barrier to PrEP access for minors, the case of Tennessee illustrates how political agendas can further undermine public health efforts, even in the absence of explicit legal restrictions. In 2023, the Tennessee government made the controversial decision to reject $6.2 million in annual funding from the Centers for Disease Control and Prevention (CDC) specifically designated for HIV treatment and prevention programs, including those supporting PrEP access. This decision, projected to result in 166 additional HIV transmissions and 190 additional deaths over 10 years, jeopardized years of progress in reducing new HIV diagnoses and expanding PrEP uptake in a state with one of the highest HIV burdens in the country.

This funding rejection was not driven by evidence-based public health priorities but rather by a politically motivated agenda to defund organizations like Planned Parenthood and shift resources away from communities deemed undesirable by those in power. The state government attempted to justify its actions by claiming a desire to prioritize other populations, such as first responders, but these groups have significantly lower HIV transmission rates, making this rationale dubious at best.

Following a public outcry and intense advocacy efforts by HIV organizations, the Tennessee legislature ultimately approved $9 million in state funding for HIV, and the CDC intervened by directly allocating $4 million to community-based organizations, resulting in a net increase in funding. While this outcome appears positive on the surface, the disruption caused by the initial funding rejection and the ongoing uncertainty surrounding the state's commitment to evidence-based HIV prevention strategies raise serious concerns.

The Tennessee case exemplifies the dangers of political interference in public health. The initial funding cuts disproportionately impacted marginalized communities, including young people, people of color, and LGBTQ+ people, who already face significant barriers to accessing healthcare. The attempt to redirect funding away from proven prevention strategies towards less vulnerable populations further demonstrates a disregard for health equity and the principles of evidence-based policymaking. This case also highlights the critical role of advocacy in holding policymakers accountable and protecting the health of vulnerable communities. The mobilization of HIV organizations and community members was essential in securing a partial reversal of the funding decision, demonstrating the power of collective action in challenging harmful policies.

The Promise of Telehealth and Other Innovative Solutions

As we grapple with the legal and political barriers hindering PrEP access for minors, it's important to explore innovative solutions that can circumvent these obstacles and reach young people where they are. Telehealth has emerged as a particularly promising approach, offering the potential to expand access, enhance confidentiality, and reduce stigma, especially in the South, where geographic barriers and social conservatism can be significant.

Studies have shown that telehealth interventions can effectively increase PrEP initiation among young people. For example, the PrEPTECH study demonstrated that a telehealth platform providing online education, home testing, and PrEP prescriptions significantly increased PrEP uptake among young men who have sex with men (MSM) and transgender women (TW) in Florida and California. Telehealth offers a convenient and discreet way for young people to access PrEP services, potentially overcoming logistical barriers and reducing the stigma associated with seeking sexual healthcare in person.

However, while telehealth holds promise, it's not a panacea. It's essential to recognize the limitations of telehealth and develop comprehensive strategies that address adherence challenges, digital equity, and the broader social determinants of health that can impact PrEP access and effectiveness. For example, young people may need additional support to adhere to daily PrEP regimens, and those without reliable internet access or digital literacy skills may face challenges navigating telehealth platforms.

Therefore, a multi-pronged approach is needed that combines telehealth with other innovative solutions tailored to the unique needs of young people. Youth-friendly clinics that prioritize confidentiality and provide non-judgmental care can create safe spaces for young people seeking sexual health services, including PrEP. Mobile testing units can bring PrEP services directly to communities with limited access to healthcare, and community-based outreach programs can raise awareness, reduce stigma, and connect young people to PrEP providers. By embracing a combination of strategies, we can create a more robust and equitable system for delivering PrEP to young people in the South.

Policy Recommendations and Call to Action

To truly protect future generations from the burden of HIV, we must move beyond simply acknowledging the barriers to PrEP access for minors in the South and embrace a proactive policy agenda that centers the needs of young people. This requires an approach that leverages our collective expertise and influence as advocates, healthcare professionals, and policymakers.

First, we must challenge the existing legal framework that hinders minor access to PrEP. Advocating for clear and consistent state laws explicitly granting minors the right to consent to PrEP confidentially is paramount. Removing ambiguity in statutory language and eliminating provider discretion will ensure legal clarity and empower young people to seek PrEP without fear of parental notification. Simultaneously, we must push for stronger confidentiality protections for all sexual and reproductive healthcare services for minors, recognizing the unique vulnerabilities and potential risks associated with mandatory parental notification.

Second, we must address the systemic inequities that disproportionately impact PrEP access for young people of color, LGBTQ+ people, and those living in rural communities. Adopting the PrEP Equity Ratio (PER) and other equity metrics as standard practice in program design and evaluation is necessary for monitoring progress and holding stakeholders accountable for achieving equitable PrEP access.

Third, we must actively engage in the political process to safeguard and increase federal funding for HIV prevention programs, particularly those targeting youth and communities of color. The Tennessee case exemplifies the vulnerability of public health funding to political interference. We must advocate for policies that protect these funding streams and ensure that resources are allocated based on epidemiological evidence and public health needs, not ideological agendas.

Finally, we must leverage the power of innovation to expand PrEP access and address the unique needs of young people. This includes supporting the expansion of telehealth services, promoting youth-friendly clinics, and investing in community-based outreach programs tailored to the specific challenges faced by young people in the South.

This is not a passive call to action; it is a call to mobilize our expertise, resources, and influence to create a policy environment that prioritizes the health and well-being of all young people. The time for bold action is now. Let us work together to ensure that no young person is denied the opportunity to protect themselves from HIV.

Data Gaps Exist for Transgender Patients Living with HIV, Despite Need

The current unequal representation and inadequate amounts of data on transgender people in terms of HIV poorly represents this subpopulation group in the LGBTQ+ community in the US. Diana Tordoff writes about this issue in an article published in STAT, where she writes that the scarce amount of data concerning trans people affects how policy is shaped in the country.

Per a study published by the National Institute of Health, several barriers hindering participation from trans people were things like logistical concerns, mistrust, lack of awareness, and psychosocial/emotional concerns related to being “outed”. This separate study provides probable insight on why there may be less amounts of data on transgender people in terms of HIV.

The Centers for Disease Control (CDC) recently published data about HIV prevalence among trans people based on public health surveillance data, however gender identity data is not collected consistently across local jurisdictions. As a result, mathematical models can’t be built effectively to help policymakers if there are poor amounts of data regarding trans people and their experience with HIV.

Tordoff writes that there are likely hundreds of mathematical models focused on HIV. Only seven of these models include trans people at all. There are two key problems that Tordoff and her co-authors note in models that do include trans people. The first problem is that there are models only including trans women and not trans men or nonbinary people. Tordoff notes that there seems to be regurgitated information across such models and this first problem may be a reason why.

In a separate study published by the National Institute of Health, researchers state that by acknowledging less visible identities, transgender individuals may be better represented by research studies. The study also refers to recent research highlighting the experience that transgender people have had in completing questionnaires for research studies. Questionnaires will often only include the choices “male” or “female”, and even if there are options like “transgender male” or “transgender female”, researchers are at risk of ignoring nonbinary identities.

The second problem is that such models assume trans women exclusively partnering with cisgender men, however there are other choices that trans women make when choosing who to partner with.

There’s evidence that access to gender-affirming care (e.g., hormones) can increase adherence to other types of disease prevention among trans people (PrEP and getting STI-tested). In general, researchers and advocates have long called for the inclusion of SOGIE data (sexual orientation, gender identity expression) to get a better understanding of these sidelined populations.

Tordoff notes a separate study where Minalga looked at 41 milestone HIV trials between 1991-2023 and this study found that out of more than 170,000 total participants, less than 1% were identified as part of the trans community and 94% of those were trans women.

Minalga notes that when data from such studies gets analyzed and published, that data does not make it back to trans people.

The analysis notes that lack of data on trans people is harmful to trans people and policies, but it is also harmful to other areas of health that aren’t publicly tied to LGBTQ+ populations. An example of this is clinicians not having enough data on how interventions or treatment may work for trans patients. A lack of this data often leads clinicians to extrapolate data from cisgender people despite some physicians not being comfortable with that.

The Centers for Medicare and Medicaid Services (CMS) introduced optional questions on SOGIE data for state Medicaid programs to collect from applicants. CMS recommended collecting information on sex assigned at birth, gender identity and sexual orientation.

Although this data would not be nationally representative, self-reported SOGIE data has never been collected on such a large scale according to Nathaniel Tran at the University of Illinois at Chicago School of Public Health in JAMA. This is good because only a few states collect this type of data.

Legislation continues to restrict gender-affirming care across the country, preventing the collection of additional meaningful data on queer populations.

Queer people living in states that restrict access to gender-affirming care don’t trust the state to protect their personal data. On the other hand, most clinicians simply don’t know much about LGBTQ+ populations in the first place. Trans people are often frustrated by the way they are considered in the research they participate in. Despite the need, data gaps will continue to hamper policy changes designed to improve access to care and services for this already underserved population.

HCV Prevalence Burden Higher Among HIV-Positive MSM

In a study published in the Oxford Academic, researchers established the New York Acute C Surveillance Network to study potential risk behaviors leading to primary Hepatitis C Virus (HCV) infection and reinfection among men who have sex with men (MSM) with HIV. The study was performed over the span of two decades from 2000-2018 to determine both incidence factors and risk factors for HCV reinfection among MSM with HIV in New York City. 

The World Health Organization published a systematic review outlining that there is an elevated HCV prevalence among HIV-positive MSM and that this burden is higher among this community compared to the general population. The study found that primary HCV infection rates among MSM with HIV were lower than among individuals who inject drugs but that reinfection rates are higher for MSM and higher compared to individuals who inject drugs. Researchers define HCV clearance as an undetectable HCV viral load at or greater than 12 weeks after the end of treatment.

The study asked participants about behavioral risk factors for primary HCV infection. First, the study asked about receipt of semen ejaculated into the rectum with condomless receptive anal intercourse (CRAI). Second, the study asked about methamphetamine use during sex and if the route of use was by injection.

Besides risk factors for primary infection, the study also assessed MSM with HIV for reinfection beginning on January 1, 2000. Researchers defined HCV reinfection as the detection of new HCV viremia after clearance of a previous infection. The date of onset of reinfection was recorded in two ways–either by detection of new HCV viremia or of alanine aminotransferase (ALT) elevation. A study published by the National Library of Medicine (NLM) defines ALT as a surrogate marker and predictor of liver disease and liver-related mortality.

Data collected and considered as risk factors for reinfection were:

• Date of birth 

• Race

• Ethnicity 

• Health insurance type (public or private)

• HCV genotype

• Interferon (IFN) λ3

• Haplotype 

• Calendar year of clearance of primary HCV

• Mode of clearance of primary HCV 

• Timing of HCV clearance 

• CD4 cell count 

• HIV VL suppression: defines as <50 copies/mL 

The study determined the incidence rates of first reinfection, second reinfection and overall reinfection. 

Researchers observed 304 MSM with HIV with clearance of a primary HCV infection for reinfection. At the time of clearance, the median age of participants was recorded to be 45 years of age. About 18% were black and 21% were hispanic. Public health coverage funded for 160 participants and private health coverage funded for 140 participants. 

About 10% of participants were spontaneously cleared for HCV and 90% were cleared by treatment either with an IFN-based regimen or a direct-acting antiviral (DAA) regimen. The study recorded that 37% of participants were cleared with an IFN-based regimen and 61% were cleared with a DAA regimen.

Researchers found that for recurrent events with reinfection as an outcome, receiving semen in the rectum was associated with HCV reinfection but that sexualized methamphetamine use was not associated with reinfection. Reinfection therefore was associated with sexual behaviors but not with drug use behaviors. 

The study further discussed that MSM that participated in sexualized methamphetamine use belonged to sexual networks that had a high HCV prevalence enough to result in onward HCV transmission. On the other hand, those not participating in sexualized methamphetamine use were part of sexual networks in which HCV prevalence was low enough to result in fewer transmissions of HCV. Researchers noted that semen transmits most HCV infections among MSM with HIV and that those who participate in sexualized methamphetamine use are more likely to receive HCV-containing semen in their rectums.

The study notes additional issues that likely result in an increased transmission of HCV among MSM with HIV. 

First, delays in insurance companies prescribing DAA treatments are likely a factor in the increased transmission of HCV. Second, MSM have not accepted condom use as a means to prevent HCV infection. Third, DAA treatments can’t help individuals who do not attend care. Individuals who have untreated HCV are less likely to engage in HIV care, further perpetuating these high-prevalence sexual networks. 

With the findings that researchers gathered, they note that there is a need for novel interventions to prevent sexual transmission of HCV among MSM.

Grindr Launches At-Home STI Testing Initiative

In an approach to combat elevated sexually transmitted infection (STI) rates among gay, bi, trans and queer people, the social dating app Grindr rolled out a new initiative providing users the chance to order at-home STI testing kits. Ellen Jenne wrote about this very issue in a recent blog post highlighting the new service the app rolled out to address elevated rates of STI infections among gay and bisexual men who have sex with me (GBMSM) in London.

Grindr partnered with Prepster at The Love Tank to deliver this initiative. PrEPster is a program part of the broader ‘The Love Tank’ community organization, a not-for-profit community interest community (CIC) providing education and research to under-served communities. This trailblazing partnership is why the initiative of providing at-home STI testing kits to users of the Grindr app is now introduced in London.

Grindr writes that this initiative will not only help users obtain knowledge of their health status but also help the app serve as a role model for other social networking apps to also make an emphasis on sexual health matters.

The initiative has already been successful in other countries like Ireland, Georgia, New Zealand and the US. The rate of STI diagnosis among GBMSM in London is recorded to be 15 times higher compared to that of the general population. This statistic is a reason why the initiative has been introduced in London and Grindr also writes that these numbers represent true people with actual struggles relating to fear and discrimination.

In their Grindr Unwrapped for 2023, the app shared statistics about what city users explored the most to attempt a connection with another user and London ranked first. Although a statistic from the previous year, the city’s popularity for being searched the most in one year highlights the importance of introducing the initiative in London overall.

The at-home self-test kits address common fears around STI testing such as physical transportation, fear of judgment and limited clinic hours. The at-home self-test kits address physical transportation barriers in allowing users to test at the convenience of their own homes at any time and be free of any judgment they would otherwise face in a physical clinic location.

Additionally, Grindr promises to not share information it obtains from its users when collecting data to send the kits to users.

Here is how the free and confidential service works:

• Access: Users access the service directly from their profile by clicking on the button “Free STI Kit”

• Eligibility: After clicking the “Free STI Kit” button, users will be guided through the basic steps to confirm their eligibility for the free testing kit.

• Privacy: Once confirmed, the kit will be discreetly delivered to the user’s address. Users can then collect their samples in the privacy of their own homes.

• Return: After collecting samples, users can return the kit using the provided free postage.

• Results: Within a couple of days of returning the kit, users receive their results via notifications through SHL’s secure platform.

• Confidentiality: Throughout the entire process, from ordering to receiving results, users’ information remains strictly confidential and is never shared with Grindr.

This public health push from one of the world’s largest social dating apps provides clear access, guided steps and convenient knowledge of health status. Ordering an STI self-test kit to reduce common burdens faced from members of the GBMSM community will help individuals achieve peace of mind in their community in an attempt to lower the overall heightened STI rates among these individuals.

Innovation as a Change Agent for Patients Leaving Incarceration

For Dontrace Young, leaving incarceration means stepping back into a world saturated with risk. Two of his cousins died from opioid overdoses in their early twenties, and drug use touches nearly every branch of his family tree. He knows the statistics – that the risk of a fatal overdose skyrockets in the weeks after leaving jail. But thanks to a program at the New Orleans jail, Dontrace is now equipped with Narcan and the knowledge to use it, skills that could save his life or the life of someone he loves. Dontrace’s story highlights a harsh truth: for many people leaving incarceration, access to healthcare is not a guarantee, and navigating a complex and often unwelcoming system can feel impossible. This challenge is not unique to those involved with the justice system.

Across the United States, systemic inequities create significant barriers to healthcare access, disproportionately impacting communities of color and those living in poverty. In rural areas, lack of insurance further exacerbates healthcare disparities. While technological innovation promises to revolutionize healthcare, these advancements often fail to reach the margins, sometimes even widening existing gaps. As the Stanford Social Innovation Review notes, an over-reliance on technology without addressing systemic issues can actually worsen health disparities. However, two innovative programs – one in New Orleans and one in Connecticut – offer a different approach, demonstrating that achieving health equity requires meeting people where they are and addressing the social factors that influence well-being.

Overdose Prevention: Preparing for Reentry in New Orleans

Inside the walls of the Orleans Justice Center, a program spearheaded by Dr. Anjali Niyogi is working to equip people leaving incarceration with a life-saving tool: knowledge. Recognizing the heightened risk of overdose for those reentering society after time in the carceral system, Dr. Niyogi founded the Formerly Incarcerated Transitions (FIT) Clinic, a program that provides a bridge between incarceration and healthcare access. A core component of the FIT Clinic’s work involves regular visits to the jail, where a team led by Dr. Niyogi, and including formerly incarcerated community health workers Haki Sekou and Danielle Metz, provides overdose prevention training and distributes Narcan to those preparing for release. The need for such a program cannot be overstated. As a 2007 study in the New England Journal of Medicine revealed, the risk of overdose is 129 times higher for people in the weeks after they leave jail. Factors like reduced tolerance and the increasingly prevalent presence of fentanyl in the drug supply contribute to this alarming statistic. By providing education and resources within the jail setting, Dr. Niyogi aims to mitigate this risk and provide people with the tools they need to stay safe.

Central to the program’s success is the involvement of Sekou and Metz. Having both experienced incarceration themselves, they possess an intimate understanding of the challenges faced by those leaving the justice system. Their presence helps to break down barriers and build trust with a population often wary of traditional healthcare providers. As Sekou explains, “They think doctors are going to use them as a guinea pig. That’s one of the words they use commonly.” By offering a listening ear, sharing their own stories, and providing practical support, Sekou and Metz create a space where people feel seen, heard, and empowered to prioritize their health. For people like Dontrace Young, the FIT Clinic’s impact extends far beyond overdose prevention training. The program connected Dontrace with resources to address his mental health, offering a pathway to a healthier future. By building trust, providing essential knowledge, and fostering connections to ongoing care, the FIT Clinic exemplifies the power of meeting people where they are and addressing health needs within the broader context of their lives.

Healthcare on Wheels: Reaching the Underserved in Connecticut

Recognizing that access to healthcare extends far beyond the doctor’s office, a team at Yale University has launched a groundbreaking initiative: the nation’s first mobile pharmacy. Housed in a retrofitted Winnebago, this innovative program brings a full range of pharmacy services directly to communities facing significant barriers to care, including people experiencing homelessness, those with chronic illnesses, and people with substance use disorders. The mobile pharmacy, the brainchild of Dr. Sandra Springer, a specialist in HIV and addiction treatment at Yale Medical School, aims to bridge the gaps in traditional healthcare delivery. “If we’re going to provide health care and you’re going to provide medication, you better be able to provide that medication,” asserts Dr. Springer. “We should be trying to help people get those services.” The mobile unit, staffed by a team of pharmacists and healthcare providers, travels to locations such as homeless encampments, food pantries, and community clinics, ensuring that essential medications and healthcare services are available to those who need them most.

This innovative approach tackles multiple barriers to care simultaneously. For those without reliable transportation, the mobile pharmacy eliminates a significant hurdle. For people experiencing homelessness, who may feel stigmatized or unwelcome in traditional healthcare settings, the mobile unit offers a safe and accessible alternative. And for those struggling with chronic conditions, the mobile pharmacy provides consistent access to medications and support, reducing the likelihood of complications and hospitalizations.

The mobile pharmacy’s impact extends far beyond simply filling prescriptions. The team provides a range of services, including chronic disease management for conditions like diabetes and hypertension, wound care for those struggling with infections or injuries, and connections to mental health and addiction treatment resources. Jillian Corbin, executive director of the St. Vincent de Paul Place daytime shelter in Norwich, where the mobile pharmacy has become a lifeline for many, attests to its transformative impact: “When the staff from the pharmacy van first arrived in February, the impact to the community was immediate and life-changing.” By meeting diverse needs with compassion and expertise, Yale’s mobile pharmacy serves as a powerful model for how to bring healthcare directly to those who are too often left behind.

Redefining Innovation: Lessons from the Margins

The programs in New Orleans and Connecticut offer a powerful counter-narrative to the prevailing notion of healthcare innovation as synonymous with technological advancement. They illuminate a critical truth: true progress towards health equity requires a fundamental shift in how we define and approach innovation. As Infectious Diseases of Poverty asserts, “social innovation can best be understood as innovation in social relations, in power dynamics and in governance transformations, and may include institutional and systems transformations.” These programs are not simply delivering services; they are transforming systems by dismantling barriers, challenging assumptions, and centering the needs of those most often relegated to the margins. This requires a commitment to investing in what the Stanford Social Innovation Review calls “health-focused social innovations,” rather than solely prioritizing technology-driven solutions that may fail to address the root causes of health disparities, or make them worse.

What makes these programs so effective? They embody key principles of equitable innovation:

• Community Engagement: Both programs prioritize the active involvement of their target populations. The FIT Clinic relies on formerly incarcerated community health workers who bring invaluable lived experience and trust to their work. Yale’s mobile pharmacy team collaborates with local organizations and community members to ensure their services are accessible and responsive to local needs.

• Culturally Responsive Care: These programs recognize that healthcare is not one-size-fits-all. They approach each interaction with cultural sensitivity, understanding that historical trauma, systemic racism, and other forms of oppression profoundly impact health outcomes and shape people’s experiences with healthcare systems.

• Trust and Relationships: Building authentic relationships based on trust and mutual respect is paramount. For those who have experienced stigma, discrimination, or mistreatment within healthcare settings, trust is not a given. Both programs address this by prioritizing empathy, transparency, and a genuine commitment to meeting people where they are, both physically and emotionally.

• Addressing Social Determinants of Health: These programs understand that health outcomes are shaped by a complex interplay of social, economic, and environmental factors. By providing transportation, addressing food insecurity, and connecting patients to essential resources, they go beyond treating immediate medical needs and work to create conditions that support overall well-being.

The success of these programs is a call to action for all of us working towards a more just and equitable healthcare system. We must:

• Support and invest in community-based programs: Funding should be directed towards initiatives that prioritize social innovation, community engagement, and culturally responsive care.

• Shift funding priorities: While technology has a role to play, we must move away from an over-reliance on expensive technological solutions that often fail to reach those most in need.

• Advocate for policy change: Systemic change requires advocating for policies that address the root causes of health disparities, such as poverty, discrimination, and lack of access to quality education and employment opportunities.

• Amplify marginalized voices: Those most impacted by health inequities must be at the forefront of designing and implementing solutions. We must listen to, learn from, and follow the lead of those with lived experience.

By embracing a broader vision of healthcare innovation – one that centers equity, community, and the lived experiences of those most marginalized – we can begin to create a healthcare system that truly works for everyone.

The Promise of a Cure: Why Are We Still Failing People with HCV?

Hepatitis C virus (HCV) infection affects millions of Americans, contributing to thousands of preventable deaths each year. While a cure for HCV, in the form of direct-acting antiviral (DAA) medications, has been available for over a decade, achieving widespread treatment access has been a persistent challenge. This challenge is particularly acute among younger adults, who experience the highest rates of new HCV transmissions, often associated with injection drug use.

Historically, the high cost of DAAs led many state Medicaid programs to implement restrictive coverage policies, limiting treatment access based on factors like liver disease severity, sobriety, and prescriber specialty. In 2022, CANN highlighted in a blog post, these policies not only created barriers to care but also undermined public health efforts to interrupt HCV transmission. Advocacy and legal action have played a crucial role in dismantling these restrictions, as evidenced by the Center for Health Law and Policy Innovation's (CHLPI) successful litigation efforts in 13 states, which served as a model for similar efforts nationwide.

While this progress is encouraging, the fight to eliminate HCV as a public health threat is far from over. We must address the remaining barriers to care, particularly those that continue to disproportionately impact people who use drugs and those that persist within managed care organizations.

The Promise and Progress of HCV Treatment

Direct-acting antivirals represent a monumental advancement in HCV treatment. These medications offer cure rates of 95% or higher, achieving sustained virologic response in the vast majority of people treated. The benefits of DAA treatment extend far beyond individual health outcomes. Expanding access to these curative therapies holds immense promise for improving public health by reducing HCV-related mortality, interrupting transmission chains, and generating long-term cost savings.

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 14,200 HCV-related deaths occurred in the United States in 2019 alone, a stark reminder of the urgent need for effective treatment. Treating HCV not only saves lives but also prevents ongoing transmission of the virus. When a person achieves sustained virologic response, they are no longer able to transmit HCV to others. Furthermore, a study published in JAMA Network Open found that HCV treatment is associated with reduced healthcare costs in the long term, as cure prevents the need for expensive interventions related to managing complications like cirrhosis and liver cancer.

The dismantling of restrictive Medicaid policies has been instrumental in increasing treatment access. A JAMA Health Forum study analyzing data from 39 state Medicaid programs found that easing or eliminating restrictions on DAAs led to a significant increase in treatment uptake. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries per quarter compared to states that maintained restrictions. This finding underscores the tangible impact of removing barriers to care.

Further progress is evident in the growing trend of states removing prior authorization requirements for DAAs. The 2024 National Snapshot Report from CHLPI and National Viral Hepatitis Roundtable (NVHR) reveals that, for the first time, more states have eliminated prior authorization for most patients than those that still require it. This shift toward streamlining access represents a critical step in ensuring timely treatment initiation.

Persistent Barriers to HCV Treatment Access

Despite the progress made in expanding HCV treatment access, significant barriers remain, particularly for people who use drugs. The 2024 National Snapshot Report from CHLPI and NVHR reveals that nine states still impose substance use restrictions, requiring sobriety or counseling as a prerequisite for DAA treatment. These restrictions are not only medically unnecessary but also demonstrably harmful, as the JAMA Network Open study found a significant association between sobriety requirements and reduced HCV treatment rates. The HealthHIV State of Harm Reduction survey further underscores this point, with respondents reporting that stigma and community resistance pose substantial obstacles to accessing drug user health services, including HCV care.

Retreatment restrictions present another hurdle for people seeking HCV care. According to the 2024 National Snapshot Report, 15 states impose stricter criteria for retreatment than for initial therapy, often denying access based on factors like adherence challenges or previous treatment failure. These policies fail to recognize the complex social and structural factors that can contribute to reinfection or treatment interruptions, particularly among people who use drugs.

Furthermore, disparities in treatment rates among Medicaid recipients persist. The CDC's Vital Signs report found that Medicaid recipients who are Black were 7% less likely to initiate timely DAA treatment compared to White recipients. These disparities reflect the systemic inequities that permeate the healthcare system and demand targeted interventions to ensure equitable access to care.

Discrepancies between state Medicaid policies and managed care organization (MCO) practices present an additional layer of complexity. While many states have eased restrictions on DAAs, the JAMA Health Forum study revealed that these policy changes did not translate into increased treatment uptake in states where DAAs were predominantly reimbursed by MCOs. This finding aligns with the 2022 National Summary Report from CHLPI and NVHR, which found that MCOs often impose more restrictive criteria for HCV treatment access than their fee-for-service counterparts.

These persistent barriers raise serious ethical concerns. Denying treatment based on substance use or adherence challenges perpetuates harmful stereotypes and undermines the principles of patient autonomy and healthcare equity. As Jen Laws argues, "We don't get to tell patients how to prioritize their care based on a payer or provider's biases." The HealthHIV harm reduction survey echoes this sentiment, with respondents emphasizing the importance of meeting people "where they're at" and respecting their right to make informed decisions about their health.

Other administrative barriers, such as requirements to fill prescriptions at specialty pharmacies, further complicate access. The 2022 National Summary Report highlights the challenges posed by specialty pharmacies, which often impose additional restrictions and logistical hurdles that can delay or prevent treatment initiation, particularly for people experiencing homelessness or housing instability.

Harm Reduction and HCV Elimination: A Holistic Approach

Achieving HCV elimination requires a holistic approach that goes beyond simply removing treatment restrictions. We must recognize that HCV treatment access is inextricably linked to broader harm reduction efforts. As Jen Laws aptly stated, "If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what's working and what's not." This means embracing a comprehensive strategy that addresses the social, economic, and structural factors that contribute to HCV risk and disparities.

A 50-state survey of harm reduction laws conducted by the Network for Public Health Law revealed significant variations in the legal landscape surrounding syringe access and naloxone distribution. These variations underscore the need for a coordinated national effort to expand access to these life-saving interventions. The HealthHIV State of Harm Reduction survey further highlights the importance of harm reduction in HCV prevention and care, with respondents emphasizing the need for services that prioritize their safety and well-being.

A truly comprehensive approach to HCV elimination must encompass the following key elements:

• Removal of All Remaining Medicaid Restrictions: Eliminating all restrictions based on substance use, retreatment history, and other arbitrary factors is essential for ensuring equitable access to DAAs.

• Ensuring Parity Between State Medicaid Policies and MCO Practices: States must strengthen oversight and enforcement mechanisms to ensure that MCOs adhere to state Medicaid policies and do not impose additional barriers to HCV treatment.

• Expanding Access to Harm Reduction Services: Increasing the availability of syringe exchange programs, naloxone distribution, and other harm reduction services is critical for preventing new HCV transmissions and connecting people who use drugs to care. However, even in states that do have syringe exchange programs, access can vary widely, with many programs facing funding limitations, geographic restrictions, and community resistance. For example, a 2017 report indicated that 26 states had either no syringe exchange programs or limited these services to one or two major cities. Research suggests that existing programs meet only a fraction of the estimated need, highlighting the need for continued advocacy and policy reform.

• Addressing Social Determinants of Health: HCV elimination efforts must address the underlying social and economic factors that contribute to HCV risk and disparities, such as poverty, homelessness, and lack of access to healthcare. The HealthHIV harm reduction survey found that inadequate housing and transportation were significant barriers to clients engaging in care. Investing in housing, transportation, and other social support services is necessary for creating a more equitable and effective HCV response.

The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing many of these challenges. The plan's key elements include a subscription-based payment model for medications, investment in rapid point-of-care testing, and increased federal support for community-based healthcare infrastructure and provider training. However, as CANN CEO Jen Laws emphasizes, successful implementation requires more than just affordable drugs. The plan must prioritize reinvestment of cost savings into public health systems, support community-based testing and integrated treatment models, and address logistical barriers to care. Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would further strengthen the plan's foundation.

Conclusion

While significant progress has been made in expanding HCV treatment access, the fight to eliminate HCV as a public health threat demands a sustained and multifaceted effort. The Biden Administration's proposed plan offers a promising roadmap, but its success hinges on congressional budget approval and addressing the systemic barriers that continue to impede progress.

To effectively combat HCV, we must move beyond a narrow focus on medication access and embrace a holistic approach that prioritizes harm reduction, addresses social determinants of health, and ensures equitable access to care for all. CANN’s latest HIV/HCV Co-Infection Watch report provides a valuable resource for understanding the current landscape of HCV treatment access and harm reduction programs across the United States, empowering advocates and communities to push for meaningful change. Together, we can translate the promise of a cure into a reality for all Americans affected by HCV.

Prescription Drug Affordability Boards and the ADA: A Potential Conflict?

Could state efforts to lower prescription drug prices inadvertently violate a federal civil rights law? It’s a question being asked about Prescription Drug Affordability Boards (PDABs) as they gain traction across the United States. PDABs are state-level entities designed to address the soaring cost of prescription medications, a crisis impacting millions of Americans. As policymakers seek solutions to improve affordability, PDABs have emerged as a popular strategy, with a growing number of states enacting legislation to establish these boards. While the intent behind PDABs is laudable, their implementation requires careful consideration to ensure they do not inadvertently create barriers for people with disabilities. The potential conflict between well-intentioned affordability initiatives and the Americans with Disabilities Act (ADA) highlights the need for vigilance to protect the rights of people with disabilities in the pursuit of lower drug prices. Our analysis reveals that PDABs are disproportionately focusing on medications used to treat conditions likely classified as disabilities under the ADA, raising concerns about potential ADA violations.

A Disproportionate Focus on Drugs for Disabilities

A recent analysis conducted by Community Access National Network (CANN) reveals a concerning trend: PDABs are disproportionately targeting medications used to treat conditions highly likely or likely to be classified as disabilities under the ADA. This finding raises serious questions about the potential for PDABs to create disparate impact and limit access to essential medications for people with disabilities.

The table below summarizes the key data points from the CANN Data Analysis Report:

State	Total Drugs Eligible	HIGHLY LIKELY	LIKELY	Total Potentially Disabling	% Potentially Disabling	% HIGHLY LIKELY	% LIKELY
CO-E	343	306	28	334	97.4%	89.2%	8.2%
CO-S	4	2	2	4	100%	50.0%	50.0%
MD	8	3	5	8	100%	37.5%	62.5%
OR	39	24	15	39	100%	61.5%	38.5%
WA	188	94	68	162	86.2%	50.0%	36.2%

Note: Percentages are based on the total number of drugs on each state's "Eligible for Review" list (or "Selected for Review" in Maryland's case), which represents the medications the PDAB could choose for a full affordability review. The Colorado data is presented in two rows: “CO-E” represents the 343 drugs eligible for review, and “CO-S” represents the four drugs ultimately selected for review by the PDAB. It is important to note that a lack of data transparency from some states limited our ability to perform a complete analysis for all PDABs. To determine a drug's relevance to this analysis, we evaluated each condition a drug treats based on its likelihood of being classified as a disability under the ADA, using a four-tiered ranking system: HIGHLY LIKELY, LIKELY, UNLIKELY, and VERY UNLIKELY.

In Colorado, 97.4% of the drugs initially eligible for review by the PDAB treat conditions categorized as “HIGHLY LIKELY” or “LIKELY” disabilities under the ADA. In Maryland and Oregon, every drug eligible for review falls into these categories. Even in Washington, where the percentage is lower, 86.2% of the drugs on the "Eligible for Review" list treat potentially disabling conditions.

This data demonstrates a clear pattern: PDABs are predominantly focusing on medications used by people with disabilities. This trend is particularly concerning given the variability and uncertainty surrounding PDAB processes for setting upper payment limits (UPLs), as highlighted by a recent analysis in Health Affairs.

A closer look at the specific condition categories targeted by PDABs further underscores this concern. In Colorado, the most frequently targeted categories include cancer, genetic disorders, autoimmune disorders, and hematological disorders. Maryland's PDAB focuses on endocrine disorders, autoimmune disorders, and respiratory disorders. Oregon’s list includes autoimmune disorders, addictive disorders, cancer, and endocrine disorders. Washington’s PDAB targets a similarly broad range of conditions, including autoimmune disorders, cancer, neurological disorders, and endocrine disorders. These categories encompass numerous conditions with a high likelihood of being classified as disabilities under the ADA.

The potential for PDABs to negatively impact people with disabilities is not merely hypothetical. In Colorado, the PDAB has already conducted affordability reviews on Enbrel and Stelara, two drugs used to treat conditions highly likely to be considered disabilities under the ADA. The Board determined that both medications are unaffordable, potentially leading to the establishment of UPLs, which would set limits on how much payers can reimburse for these drugs. If UPLs are set on these medications, it could significantly limit access for people who rely on them to manage their conditions.

Navigating the Legal Landscape: The ADA and Health Care

The disproportionate targeting of medications used by people with disabilities raises serious concerns about the potential for PDABs to violate the Americans with Disabilities Act. This landmark civil rights law prohibits discrimination against people with disabilities in all areas of public life, including healthcare.

A key concept in ADA law is disparate impact. This occurs when a policy or practice, even if seemingly neutral on its face, has a disproportionately negative impact on people with disabilities. As legal scholar Sara Rosenbaum explains, "Disparate impact claims arise when a plaintiff can demonstrate that a facially neutral policy disproportionately burdens or harms people with disabilities." In the context of PDABs, disparate impact could occur if, for example, the setting of UPLs on medications for disabling conditions leads to greater utilization management or formulary restrictions, effectively limiting access for people with disabilities while having a less pronounced impact on people without disabilities. The potential for supply chain disruptions and the lack of guaranteed cost savings for patients, as highlighted in the recent Health Affairs article, further underscore the risk of disparate impact.

The ADA also requires covered entities, including healthcare providers and insurers, to provide reasonable accommodations to people with disabilities. Reasonable accommodations are adjustments to policies, practices, or procedures that enable people with disabilities to participate fully and equally in programs and services. However, the ADA does recognize that some accommodations may pose an "undue burden" on covered entities, meaning they would require significant difficulty or expense. The ADA National Network provides relevant examples in the healthcare context, such as modified meeting formats, accessible materials (e.g., large print, Braille), and the provision of sign language interpreters. PDABs must proactively incorporate reasonable accommodations into their processes to ensure meaningful participation for people with disabilities. This includes providing accessible meeting locations and materials, offering alternative formats for public comments, and ensuring that people with disabilities have equal opportunities to engage in the PDAB’s decision-making process.

Any limitations on access to medications resulting from PDAB actions must be justified by legitimate, non-discriminatory reasons. Historically, a common defense used to shield discriminatory coverage designs from legal challenges has been the "fundamental alteration" defense. This defense argues that modifying a benefit plan to accommodate the needs of people with disabilities would fundamentally alter the nature of the plan and is therefore not required under the ADA. However, the Affordable Care Act (ACA)'s emphasis on comprehensive coverage and non-discrimination weakens this defense. As the Supreme Court recognized in Alexander v. Choate, the benefit provided through a healthcare program is not merely the individual services offered, but also the opportunity for meaningful access to those services. The ACA's statutory language in Section 1557 reinforces this principle, prohibiting discrimination in benefit design and requiring coverage of essential health benefits. This shift in healthcare law strengthens the legal basis for challenging discriminatory PDAB practices that limit access to medications for people with disabilities.

The QALY Conundrum: Undervaluing Life with a Disability

Compounding the risk of discrimination in PDAB practices is the potential for these boards to rely on a flawed metric known as the Quality-Adjusted Life Year (QALY) when evaluating drug affordability. The QALY is a measure used to assess the value of medical interventions by considering both the quantity and quality of life gained. While seemingly objective, the QALY inherently devalues life with a disability.

The problem lies in how the QALY calculates "quality" of life. It relies on societal perceptions of health and functioning, often derived from surveys of the general public. As the Disability Rights Education & Defense Fund (DREDF) explains in a recent report, "The QALY equation relies on a baseline of 'perfect health' that is calculated by society’s conception of health and functioning." This means that people with disabilities are automatically assigned a lower quality-of-life score, regardless of their own lived experiences.

The DREDF report provides compelling examples of how the QALY can lead to discriminatory coverage decisions. For instance, the drug Trikafta, a breakthrough treatment for cystic fibrosis, has been shown to significantly extend the lives of people with this condition. However, because cystic fibrosis often involves functional limitations, the QALY undervalues the life extension benefit of Trikafta, potentially leading payers to deem it too expensive to cover. Similarly, medications for opioid use disorder, which can dramatically improve daily functioning and quality of life for people with this condition, are often undervalued by the QALY due to societal stigma and negative perceptions of opioid use disorder.

Some proponents of the QALY have proposed an alternative measure called the Equal Value of Life Years Gained (evLYG). The evLYG avoids discounting life extension based on quality of life. However, as the DREDF report points out, the evLYG fails to account for quality-of-life improvements, making it an incomplete solution.

The potential for PDABs to rely on QALY-based analyses is a serious concern. While some states explicitly prohibit the use of QALYs in setting UPLs, the lack of consistent language across all states and the continued focus on cost-related factors raise concerns about the perpetuation of bias in drug valuation. If PDABs utilize the QALY or similar metrics that fail to account for the true value of medications for people with disabilities, they risk exacerbating existing disparities and undermining the ADA’s guarantee of equal access to healthcare.

Can PDABs Overcome Inherent Bias in Drug Selection?

The establishment of PDABs, despite their purported goal of lowering drug costs, raises serious concerns about potential discrimination against people with disabilities. Our data analysis reveals a deeply troubling pattern: across all states examined, the vast majority of drugs targeted by PDABs are those used to treat conditions highly likely or likely to be classified as disabilities under the ADA. This striking trend, with some states demonstrating an exclusive focus on medications for potentially disabling conditions, calls into question the fundamental fairness and equity of PDAB drug selection processes.

This overwhelming focus on medications for potentially disabling conditions raises a fundamental question: can PDABs, as currently designed, ever truly operate in a manner that is equitable and non-discriminatory? The very nature of these boards, tasked with identifying "unaffordable" drugs and setting limits on their reimbursement, appears inherently biased against medications vital to the health and well-being of people with disabilities. Furthermore, the potential for PDABs to negatively impact the 340B Drug Pricing Program adds another layer of concern. As previous CANN articles have highlighted, UPLs set by PDABs could significantly reduce the revenue generated by 340B discounts, undermining a major source of funding for safety-net providers and jeopardizing access to care for vulnerable communities.

Proposals for mandatory ADA compliance reviews, data transparency, and stakeholder engagement, while necessary, are unlikely to fully address this fundamental flaw. Compliance reviews are reactive and cannot prevent all discriminatory outcomes. Data transparency, while necessary for accountability, does not guarantee equitable decision-making. And even meaningful engagement with disability rights organizations and people with disabilities cannot fully compensate for the inherent biases that may be embedded in PDAB processes.

Given the clear evidence of implicit bias in PDAB drug selection, more investment needs to be made in studying the potential discriminatory nature of these boards.

• Quantify the Disparate Impact: Conduct comprehensive analyses to determine the extent to which PDAB drug selection and UPL-setting processes disproportionately impact people with disabilities.

• Evaluate Alternative Strategies: Explore and compare the potential impact of various drug affordability strategies, including PDABs and alternatives such as direct price negotiations, expanded patient assistance programs, and bulk purchasing agreements, on access to medications for people with disabilities.

• Develop Robust Safeguards: If states choose to move forward with PDABs, they must develop and implement comprehensive safeguards to mitigate the risk of discrimination. These safeguards should include mandatory ADA compliance reviews, comprehensive data transparency requirements, and meaningful engagement with disability rights organizations and people with disabilities throughout all stages of the PDAB process.

Addressing the complex intersection of drug affordability and disability rights requires a nuanced and evidence-based approach. Until we have a deeper understanding of the potential for discrimination and the efficacy of safeguards, the viability of PDABs remains in question.

Together TakeMeHome: One Year of Progress, Challenges Ahead

A newly published report from the Centers for Disease Control & Prevention (CDC) offers promising initial results from the first year of Together TakeMeHome (TTMH), a groundbreaking program that provides free HIV self-tests by mail to people across the U.S., including Puerto Rico, making it the largest HIV self-testing program in the nation's history. This direct-to-consumer approach aims to address persistent gaps in HIV testing coverage and reach those who have not engaged with traditional testing services, particularly within priority populations disproportionately affected by HIV.

The report reveals that TTMH has already exceeded expectations, distributing 443,813 tests to 219,360 people in its first year, far surpassing its initial goal of distributing 200,000 tests annually. Significantly, 24.1% of TTMH users reported never having previously received HIV testing, demonstrating the program's success in reaching those who may face barriers to traditional testing methods.  This success builds upon the growing recognition of HIV self-testing (HIVST) as a valuable tool in the global effort to increase testing rates and achieve earlier diagnoses. The World Health Organization recommends HIVST as an additional approach to HIV testing services, recognizing its potential to overcome common barriers such as stigma, privacy concerns, cost, and lack of access to clinics.

Successes of TTMH and the Benefits of HIVST

The initial data from TTMH not only highlights the program's impressive reach but also provides valuable insights into its effectiveness in engaging priority populations and identifying new diagnoses. The report shows that 67.9% of TTMH users identify as members of groups disproportionately affected by HIV, including gay and bisexual men, Black women, and transgender women. This targeted reach is particularly important given that these communities often face greater barriers to accessing traditional testing services. Furthermore, the program's success in utilizing dating apps as a primary outreach platform, with nearly 70% of orders originating from these sources, demonstrates its ability to connect with people in online spaces where they feel comfortable. While comprehensive data on new HIV diagnoses among all TTMH users is not yet available, initial findings suggest that the program is successfully identifying people who are unaware of their HIV status. Among a subset of participants who completed a follow-up survey and had not previously reported an HIV diagnosis, 1.9% received a reactive result on their self-test.

These promising results are consistent with the broader benefits of HIVST demonstrated by research on other programs. For example, the eSTAMP study, a randomized clinical trial published in JAMA Internal Medicine, found that participants who received HIV self-tests were significantly more likely to test for HIV at least three times during the trial compared to a control group. Significantly, eSTAMP participants reported 34 newly identified transmissions among members of their social networks who used the study self-tests, highlighting the potential for HIVST to extend its reach beyond the initial user. The TakeMeHome program demonstrated that HIVST can be delivered at a reasonable cost, identifying 18 confirmed new HIV diagnoses in its first year at a cost of $9440 per diagnosis. This cost falls within the range of $3500 to $36,300 per diagnosis reported for traditional HIV testing methods implemented in various healthcare and non-healthcare settings. Moreover, research on the eSTAMP trial, a similar HIVST program, suggests that such programs can be cost-saving in the long run due to their potential to avert new transmissions and reduce lifetime HIV treatment costs. A scoping review published in Patient Preference and Adherence further supports the value of HIVST, finding that it is generally preferred over traditional testing methods due to its convenience, privacy, and the control it affords users.

One of the most significant advantages of HIVST is its ability to combat stigma, a persistent barrier to HIV testing. As noted in the Journal of Public Health Management and Practice, "Many men who have sex with men (MSM) prefer to test for HIV in privacy rather than at clinical settings or testing sites." This preference for privacy is particularly relevant for marginalized communities who may face discrimination or judgment in traditional healthcare settings. HIVST empowers people to learn their status in a safe and confidential environment. The HIV.gov blog succinctly captures this empowerment, stating that "HIV self-testing enables a person to learn their HIV status by placing control directly into the hands of users. With HIV self-tests, people can discreetly and conveniently test themselves in private, bypassing the potential discomfort or discrimination they might face in traditional settings."

Addressing the Needs of Diverse Populations

While promising, TTMH and other HIVST programs must acknowledge that HIV does not affect all communities equally. Disparities in HIV testing rates and outcomes persist, requiring tailored strategies to ensure equitable access to HIVST. For example, testing rates vary across racial and ethnic groups, with Asian people and Native Hawaiian and Pacific Islanders reporting lower rates than some other communities of color.

People who inject drugs (PWID) and those in rural communities face unique barriers to HIV testing. Research suggests that while PWID are willing to utilize at-home testing, structural barriers, such as stigma and limited access to healthcare, result in lower test completion rates. Similarly, rural communities often lack sufficient HIV prevention and testing infrastructure, and residents may face transportation challenges. To address these issues, we must partner with relevant organizations, offer alternative delivery methods, provide clear instructions and support, increase funding for rural programs, and collaborate with rural providers to promote HIVST.

Furthermore, recognizing the intersections of race/ethnicity, gender identity, and immigration status is crucial. Black and Hispanic immigrants face lower testing rates than their U.S.-born counterparts, even with known risk factors. Fear of deportation, fueled by policies like the "public charge" rule, can deter Latinx immigrants from seeking testing. Undocumented African immigrants face similar challenges, compounded by HIV-related stigma within their communities. HIVST programs must partner with organizations serving these populations, provide clear information about confidentiality and its separation from immigration enforcement, and offer culturally appropriate support.

Transgender people, especially transgender women of color, experience disproportionately high rates of HIV. HIVST can offer a more private and affirming option, but programs must be trans-inclusive and address anticipated stigma, which can be a significant barrier to testing. Similarly, people engaged in sex work often face stigma and marginalization, hindering access to healthcare. Outreach efforts should prioritize building trust, ensuring confidentiality, and partnering with organizations that serve this population.

Addressing the unique needs of diverse populations is essential for HIVST programs to achieve health equity and ensure that everyone has the tools they need to know their status and engage in appropriate care and prevention.

Strengthening Linkage to Care

While HIVST programs like TTMH are effective in expanding access to testing and identifying new diagnoses, their true impact hinges on ensuring that people who test reactive are seamlessly connected to appropriate care and support services. As highlighted in my previous blog post, there is a significant gap in linkage to care following HIVST. This gap is concerning, as timely linkage to care is essential for initiating treatment, improving health outcomes, and reducing the risk of onward transmission.

Unfortunately, we lack specific data on linkage to care outcomes for the TTMH program. However, the program website does provide information on the resources available to users who test reactive. These resources include referrals to local testing sites for confirmatory testing, contact information for HIV care providers, and links to support services. While these resources are valuable, they may not be sufficient to ensure that all people who test reactive are successfully linked to care.

To strengthen linkage to care for TTMH and other HIVST programs, we need a more robust and proactive approach. This includes implementing strategies such as:

• Telehealth Follow-Up: Offering telehealth consultations for post-test counseling, linkage to care, and ongoing support can help address logistical barriers and provide immediate access to guidance.

• Partnerships with Local Providers: Establishing formal partnerships with HIV testing sites, clinics, and community-based organizations can streamline referrals and ensure that people have a clear pathway to care.

• Peer Navigation: Utilizing peer navigators who have lived experience with HIV can provide invaluable support and guidance to people navigating the complexities of the care system. Peer navigators can offer emotional support, assist with appointment scheduling, and help address any barriers to accessing care.

• Data Collection and Monitoring: Implementing comprehensive data collection and monitoring systems to track linkage to care outcomes is essential for identifying gaps and areas for improvement. This data can help programs tailor their services to better meet the needs of their users.

By investing in these strategies, we can bridge the gap in linkage to care after HIVST and ensure that everyone who tests reactive receives the timely and comprehensive care they deserve.

Policy Enhancements

The successes of the TTMH program underscore the transformative potential of HIVST to expand access to testing, reach those who have traditionally been left behind, and combat stigma. To fully realize this potential and solidify HIVST as a cornerstone of the Ending the HIV Epidemic (EHE) initiative, we must advocate for policies that support its long-term sustainability, equitable reach, and seamless integration with other health services. This includes:

• Increased Funding: Sustained and increased funding for TTMH and similar HIVST programs is paramount to ensuring their continued operation, expansion, and ability to reach diverse communities.

• Targeted Outreach: Developing and implementing tailored outreach strategies for PWID, rural communities, BIPOC, and other marginalized groups, is essential for addressing the unique barriers they face and promoting equitable access to HIVST.

• Public Awareness Campaigns: Comprehensive public awareness campaigns are needed to promote HIVST, address stigma surrounding HIV testing and status, and educate the public on the importance of knowing their HIV status.

• Integration with Other Services: Integrating HIVST with other health services, such as STI testing and treatment, PrEP, and primary care, can create a more holistic and patient-centered approach to sexual health, facilitating access to a broader range of prevention and care services.

The EHE initiative, launched in 2019, aims to reduce new HIV transmissions in the U.S. by 90% by 2030. HIV testing is a critical first step in achieving this goal. As the CDC aptly states, "The COVID-19 pandemic has shown how critical HIV self-testing services are to sustaining momentum to end the HIV epidemic." TTMH has demonstrated that HIVST can effectively reach those who have not engaged with traditional testing services, combat stigma, and identify new diagnoses.

We must continue to advocate for policies and programs that support HIVST and ensure that everyone, regardless of their background or circumstances, has access to convenient, confidential, and empowering testing options. Together, we can make HIV testing a routine part of healthcare, reduce new transmissions, and move closer to ending the HIV epidemic in the U.S.

Addressing the High Burden of HCV in HIV-Positive MSM

The threat of Hepatitis C (HCV) co-infection casts a long shadow over the lives of men who have sex with men (MSM) living with HIV, demanding a swift and decisive response. Globally, 7% of this group also faces chronic HCV infection—a disproportionately high burden compared to the estimated 1% prevalence in the general population. A recent meta-analysis published in Health Sciences Reports, which synthesized data from 56 studies across various countries, also revealed a 9% global prevalence of hepatitis B virus (HBV) among MSM living with HIV, further highlighting their vulnerability to viral hepatitis co-infection.

While highly effective direct-acting antiviral (DAA) therapies offer a cure for HCV, access to these life-saving medications remains uneven, perpetuating health disparities and undermining global elimination efforts. This disparity is driven by a complex interplay of factors, including shared transmission routes for HIV and HCV, persistent stigma surrounding both viruses, and structural barriers such as poverty, homelessness, and lack of access to healthcare.

To dismantle these barriers and chart a path towards HCV elimination and health equity, we need a comprehensive strategy. This includes expanding ADAP coverage of DAA therapies, streamlining convoluted authorization processes, and implementing tailored interventions that address the unique needs and vulnerabilities of MSM living with HIV.

The Case for DAAs

The advent of direct-acting antiviral (DAA) therapies has revolutionized HCV treatment, offering a cure for a disease that was once considered a chronic, debilitating condition. DAAs are now the standard of care for HCV, providing a safe and effective cure for most people within a relatively short treatment duration, typically 8 to 12 weeks.

The benefits of DAA treatment extend beyond curing HCV. Studies have demonstrated a profound impact on long-term health outcomes, including a lower risk of both liver and non-liver complications. A large, real-world analysis published in JAMA Internal Medicine found that DAA therapy was associated with a remarkable 57% reduction in all-cause mortality among patients with chronic HCV. This underscores the life-saving potential of these medications and the importance of ensuring timely access for all who need them.

The Economics of DAAs

Despite the high initial cost of DAAs, concerns about affordability are countered by the substantial long-term cost savings they generate. A 2022 study in the Journal of Managed Care & Specialty Pharmacy demonstrated that treating HCV with DAAs in the Veterans Affairs (VA) system resulted in $7 billion in savings over a lifetime compared to pre-DAA treatments. These savings are achieved through reduced healthcare utilization, as fewer patients experience the costly complications of advanced liver disease. The study further highlighted that DAAs become less expensive than both pre-DAA treatments and no treatment within just five years, demonstrating a rapid return on investment.

The budgetary impact of expanded HCV treatment extends beyond individual payers like the VA. The Congressional Budget Office (CBO) has reported that increased HCV treatment leads to net budget savings for the federal government due to averted healthcare spending. Even a modest 10% increase in Medicaid treatment rates could save $700 million over 10 years, according to the CBO's estimates. This underscores the fiscal responsibility of investing in HCV elimination efforts, as treating the disease upfront prevents more costly interventions down the line.

Furthermore, the CBO highlights the importance of considering the long-term budgetary impact of HCV treatment, particularly the savings that accrue beyond the typical 10-year budget window. As HCV is a slow-progressing disease, the full economic benefits of treatment may not be realized within a decade. By taking a longer-term perspective, policymakers can better appreciate the true value of investing in HCV elimination and the potential for significant cost savings over time.

The Consequences of Limited Coverage

Despite the transformative potential of DAAs and the compelling evidence for their cost-effectiveness, access to these life-saving therapies remains uneven for people living with HIV (PLWH). A significant barrier is the limited coverage of HCV therapies by some state AIDS Drug Assistance Programs (ADAPs). CANN's HIV/HCV Co-Infection Watch for April 2024 reveals that only 47 out of 56 ADAPs in the United States offer some form of coverage for HCV treatment, meaning that a substantial number of PLWH, particularly those who rely on ADAPs as a safety net, face significant financial barriers to accessing the care they need.

This echoes the challenges faced within Medicaid programs, where restrictive policies driven by cost concerns have historically limited HCV treatment access. A 2024 study published in JAMA Health Forum analyzed data from 39 state Medicaid programs and found that easing restrictions related to liver disease severity, sobriety, or prescriber specialty led to a substantial increase in DAA utilization. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries each quarter. This evidence strongly suggests that similar policy shifts within ADAPs could significantly expand access to curative therapies for PLWH.

The consequences of limited ADAP coverage are far-reaching. Without access to DAAs, PLWH face a higher risk of progressing to advanced liver disease, experiencing debilitating complications, and ultimately succumbing to HCV-related mortality. This not only jeopardizes patient health outcomes but also undermines public health efforts to control and eliminate HCV. Furthermore, the financial burden imposed by limited coverage exacerbates existing health disparities. People of color, low-income persons, and those living in rural areas are more likely to rely on ADAPs and also experience higher rates of HCV infection. Denying them access to curative treatment perpetuates a cycle of inequity, further entrenching health disparities and undermining the goal of achieving health justice for all.

Policy Barriers and Provider Discouragement

The path to HCV treatment for MSM living with HIV is fraught with obstacles, a tangled web of restrictive policies and a healthcare system that often fails to prioritize their needs. Compounding the challenges of limited ADAP coverage are state-level restrictions that create a patchwork of barriers, disproportionately impacting vulnerable populations. Stringent eligibility criteria, complex authorization processes, sobriety requirements, and limited provider networks—often justified by cost concerns—prioritize short-term budget considerations over the long-term health and well-being of PLWH.

These policy barriers intersect with personal and systemic biases to create a system that perpetuates inequities in HCV care. A 2019 study published in the International Journal of STD & AIDS revealed that Medicare enrollees and patients with drug abuse diagnoses were significantly less likely to initiate DAA treatment, highlighting the impact of cost-sharing requirements and stigma. Stigma surrounding substance use can discourage patients from seeking treatment or disclosing their drug use history, while providers may harbor biases about the effectiveness of DAAs in this population.

This complex landscape also contributes to provider discouragement, further limiting access to HCV care. The administrative complexity of ADAPs, with their varying formularies, eligibility criteria, and authorization processes, creates a confusing and burdensome system for providers. Many providers also lack familiarity with newer DAA regimens and the latest treatment guidelines, particularly those who primarily focus on HIV care. Persistent stigma surrounding HCV and substance use can also lead to provider fatigue and bias, compounding these challenges.

Moving Towards Equitable HCV Care and Elimination

The evidence is clear: MSM living with HIV face significant and unjust barriers to accessing life-saving HCV treatment. We must act decisively to dismantle these barriers and create a healthcare system that prioritizes equity, accessibility, and the well-being of all PLWH.

Achieving this vision requires a bold policy agenda that addresses the systemic issues driving disparities in HCV care. We must demand action from policymakers and hold them accountable for creating a more just and equitable healthcare system.

Policy Changes are Needed:

1. Mandate DAA Coverage for All ADAPs: Every state ADAP must be required to cover all FDA-approved DAA regimens for HCV treatment, ensuring that no PLWH is denied access to a cure based solely on their geographic location.

2. Streamline Prior Authorization Processes: The administrative burden of navigating complex and inconsistent prior authorization processes within ADAPs discourages both providers and patients. We must demand a streamlined, standardized system, ideally with a single prior authorization form that can be used across all payers, including ADAPs and Medicaid, as recommended by NASTAD. Better yet, remove the need for prior authorizations all together.

3. Increase Funding Allocations for ADAPs: ADAPs are a lifeline for PLWH, yet these programs are chronically underfunded. We must advocate for increased federal and state funding allocations, ensuring they have the resources to provide comprehensive HCV care, including DAA treatment, without imposing undue restrictions.

4. Expand Financial Assistance Programs for Medicare Enrollees: Medicare's cost-sharing requirements create a significant financial barrier to DAA access for many PLWH. ADAPs must expand financial assistance programs to cover out-of-pocket costs for DAA treatment for Medicare enrollees with HIV/HCV co-infection.

These policy recommendations are concrete steps that can be taken to create a more just and equitable healthcare system for PLWH. By advocating for these changes, we can dismantle the barriers to HCV treatment, improve health outcomes, and move closer to eliminating HCV.

Tailored Interventions: Addressing the Unique Needs of MSM Living with HIV

While expanding ADAP coverage and addressing cost concerns are crucial, policy changes alone are insufficient to achieve equitable HCV care. We must also invest in tailored public health interventions that address the unique needs of MSM living with HIV.

This includes:

• Targeted Testing and Linkage to Care: MSM living with HIV should be routinely screened for HCV, with a focus on re-engaging those who have fallen out of care or disengaged from traditional healthcare settings. Implementing targeted testing programs in community-based organizations, substance use treatment facilities, and MSM-centric settings, coupled with robust linkage to care services, is essential.

• Peer Support Programs: Peer support programs, led by MSM living with HIV who have successfully navigated HCV treatment, can be powerful tools for addressing stigma, providing emotional support, and promoting adherence to DAA regimens.

• Provider Training and Education: Provider training programs are necessary for addressing implicit bias, promoting harm reduction, and fostering patient-centered communication. These programs should equip providers with the knowledge, skills, and attitudes necessary to provide equitable and compassionate care to all PLWH, regardless of substance use history or other social challenges.

By investing in these tailored interventions, we can create a more responsive and equitable healthcare system that meets the unique needs of MSM living with HIV. Combining policy reform with targeted programmatic efforts will empower PLWH to access life-saving HCV treatment, improve health outcomes, and advance our shared goal of eliminating HCV.

A Shared Responsibility for Health Equity

The disproportionate burden of HCV among MSM living with HIV is a reminder of the persistent health disparities that plague our healthcare system. We have the tools to eliminate HCV, yet systemic barriers and inequities continue to impede access to life-saving treatment for many vulnerable populations.

Addressing HCV co-infection among MSM living with HIV is critical for improving patient health outcomes and essential for achieving broader public health goals, including the Ending the HIV Epidemic (EHE) initiative. Eliminating HCV among PLWH will reduce liver-related morbidity and mortality, improve overall health, and contribute to reducing HIV transmission.

Achieving HCV elimination and health equity for all PLWH is a shared responsibility. Policymakers must enact bold reforms that expand access to DAAs, simplify authorization processes, increase funding for ADAPs, and address systemic inequities. Healthcare providers must embrace patient-centered care, commit to ongoing education, and actively dismantle stigma and bias. Communities must mobilize to advocate for change, support peer-led initiatives, and create a culture of support and empowerment for PLWH.

The time for action is now. By working together, we can create a healthcare system that upholds the dignity and well-being of all PLWH, ensures equitable access to life-saving HCV treatment, and paves the way for a future free from the burden of this devastating disease.

FTC Ramps Up Efforts Against Hospital Consolidation in Wake of Rising Costs

In June 2024, a class-action lawsuit against Hartford HealthCare (HHC) in Connecticut exposed the reality of hospital consolidation: dramatically inflated medical costs. The lawsuit claims that Hartford HealthCare, a dominant force in Connecticut's healthcare landscape, leverages its market power to overcharge for medical services, such as colonoscopies which cost $3,800 at HHC’s St. Vincent’s Medical Center compared to just $1,400 at nearby Bridgeport Hospital, owned by Yale New Haven Health. This drastic difference in pricing underscores a broader, concerning trend impacting the U.S. healthcare system, and the Federal Trade Commission (FTC) is taking notice.

Hospital consolidation has been reshaping the healthcare system, characterized by a surge in mergers and acquisitions—from horizontal and vertical mergers to cross-market consolidations. The American Hospital Association notes a significant uptick in such activities, with over 2,000 mergers since 1998. This trend has led to an increase in the number of community and nonprofit hospitals integrated into larger systems, rising from 53% in 2005 to 68% in 2022, according to Kaiser Family Foundation research. Such market dominance has serious implications, limiting competition and choice, escalating costs, and potentially degrading the quality of care provided to patients.

The Detrimental Impacts of Hospital Consolidation

Higher Prices

Hospital consolidation typically results in higher healthcare costs, affecting patients, employers, and taxpayers through reduced competition. Mergers provide hospitals greater leverage over insurance negotiations, often leading to increased prices. Research has shown that hospitals in concentrated markets secure higher reimbursement rates, which drives up premiums and overall costs. A New England Journal of Medicine study confirms that acquisitions lead to higher prices for commercially insured patients, while a Harvard Business School report indicates cross-market mergers also contribute to rising costs. In areas with high hospital concentration, Marketplace insurance premiums are 5% higher than in less concentrated markets. Hospitals without nearby competitors can charge prices 12% higher than those in competitive markets, imposing a significant financial burden on patients. Given that hospitals constitute 42% of Americans' premium dollars, a 12% price increase translates into more than $1,000 annually for families and about $370 for single people on employer-sponsored plans. These price increases significantly burden consumers, especially under the strain of high-deductible health plans (HDHPs), exacerbating the healthcare affordability crisis. Making matters worse, even with regulations requiring hospitals to be transparent about their pricing, comparison shopping for healthcare services remains difficult. Inconsistencies in how hospitals present pricing information and a lack of standardization make it challenging for patients to accurately compare costs across different providers, further limiting their ability to make informed choices.

Reduced Access and Quality of Care

Despite potential efficiencies, evidence suggests consolidation may compromise care quality, affecting patient experience, mortality rates, and service accessibility. A New England Journal of Medicine study noted a decline in patient satisfaction following mergers, without improvements in readmission or mortality rates. Experts from a Penn LDI seminar highlight that consolidation often leads to higher prices without quality gains, particularly impacting access in consolidated markets. Rural and underserved areas suffer most, experiencing reductions in essential services such as obstetrics, and even specialized services like pediatric care are curtailed, increasing wait times and pressure on remaining providers. This consolidation-driven reduction in services can translate into restricted access to care for patients. Longer wait times for appointments, the need to travel greater distances to find available specialists, and the closure of facilities in underserved communities all create significant barriers to receiving timely and appropriate care.

Negative Impacts on Healthcare Workers

Consolidation also detrimentally impacts healthcare workers by typically leading to lower wages, heavier workloads, and reduced job mobility. Hospitals gain market power that suppresses wages, especially for skilled professionals such as nurses. Increased workloads and staffing shortages result in burnout and higher turnover. Notably, a complaint by labor unions against UPMC highlighted anti-competitive practices that worsen working conditions for healthcare staff.

Ethical Concerns

The ethical implications of consolidation are profound, often prioritizing profit over patient care, exacerbating health disparities and limiting access for marginalized communities. The closure of services in economically disadvantaged areas or restrictions imposed by new owners can severely impact vulnerable populations. As noted by Penn LDI, such practices especially affect low-income women and rural residents, challenging the foundational ethics of healthcare.

These issues underscore the need for a high level of scrutiny around mergers and policies that prioritize patient care quality, affordability, and fair labor practices in the face of ongoing hospital consolidation.

The FTC’s Fight Against Anti-Competitive Mergers

Amid growing concerns about the negative effects of hospital consolidation, the Federal Trade Commission stands as a key defender of patient interests and market competition in healthcare. Under the Biden Administration, the FTC has intensified its stance against anti-competitive mergers, demonstrating a strong commitment to safeguarding consumers from the adverse outcomes of unchecked consolidation.

The FTC has notably succeeded in obstructing several hospital mergers recently. For example, in June 2024, Novant Health in North Carolina canceled its acquisition plans for two hospitals after the FTC argued that the deal would create near-monopoly conditions, leading to higher prices and diminished care quality. Other successful FTC actions include blocking RWJBarnabas Health's merger with St. Peter’s Healthcare System in New Jersey in June 2022, and a similar intervention in March 2022 against a merger between Hackensack Meridian Health and Englewood Healthcare Foundation.

These victories highlight a shift towards more assertive regulatory actions, reflecting the FTC’s renewed vigor under the Biden Administration’s directives. In July 2021, President Biden issued an executive order encouraging greater antitrust enforcement to foster a competitive healthcare marketplace. This order critiqued the rampant hospital mergers and directed the FTC to enhance its antitrust enforcement, even allowing for the retrospective challenge of mergers that might have anti-competitive effects.

As per Kaiser Health News reports, this directive has rejuvenated FTC efforts, increasing the agency’s readiness to tackle hospital mergers that might have previously been overlooked. ProPublica’s analysis indicates a significant uptick in enforcement, with the FTC blocking four mergers in the first two years of Biden’s presidency, compared to fewer than one per year during the previous administration.

Evolving Enforcement Strategies

The FTC is also broadening its enforcement strategies, exploring new legal theories and focusing more on diverse aspects of market competition, including labor markets. FTC Chair Lina Khan emphasized in December 2021 the importance of examining how mergers affect not just prices but also employment conditions, highlighting the potential of increased antitrust actions to improve pay and working conditions for healthcare workers.

Moreover, the FTC is scrutinizing vertical mergers more closely, such as those involving hospitals acquiring physician practices, which had traditionally been perceived as beneficial for efficiency. Recent studies, however, suggest these mergers might increase prices and reduce competition, as hospitals gain more control over referrals and insurer negotiations.

This proactive approach by the FTC, fueled by the Biden Administration’s push for more competition, marks a potential turning point in the battle against the detrimental impacts of hospital consolidation. This shift underscores a comprehensive strategy to protect competition and patient welfare in the healthcare sector.

Limitations of Current Enforcement Mechanisms

Despite the FTC's strong stance against anti-competitive hospital mergers, the agency confronts significant barriers that hinder its effectiveness in tackling consolidation. These challenges stem from outdated guidelines, limited resources, and the complexities of proving competition harm in complex healthcare markets.

The FTC's enforcement focus has been predominantly on single-market mergers, as per guidelines last updated in 2010. This approach overlooks the rising trend of cross-market mergers, where healthcare entities expand across different regions, enhancing their market power and leverage over insurers. The effects of these mergers can significantly diminish competition even without direct geographic overlap.

Moreover, stagnant funding levels have strained the FTC's capacity to adequately investigate and legally contest the growing volume of hospital mergers. According to ProPublica, the agency's budget constraints limit its ability to hire necessary expert staff and sustain prolonged legal battles against well-funded healthcare giants. Consequently, many potentially harmful mergers proceed without challenge, consolidating markets further and reducing competition.

Challenging cross-market mergers in court presents its own set of hurdles. These cases tend to lack solid legal precedents, complicating the FTC's task of demonstrating their anti-competitive nature. The nuanced market dynamics involved, such as insurer behavior and potential spillover effects, add to the complexity, making it difficult for the FTC to establish clear legal grounds for opposition.

To truly curb anti-competitive hospital mergers, the FTC needs updated guidelines that reflect the realities of cross-market mergers, increased funding for enforcement activities, and innovative legal strategies to tackle these complex consolidations effectively.

The Medical Credit Card Blind Spot

As policymakers and regulators grapple with the complex issue of hospital consolidation, a related problem is emerging that demands attention: the proliferation of medical credit cards and their disproportionate impact on vulnerable patients. These financial products, often promoted by healthcare providers themselves, are creating a new avenue for medical debt, trapping patients in a cycle of high-interest payments and jeopardizing their financial security.

The Consumer Financial Protection Bureau (CFPB) reports a staggering growth in medical credit card use, with the number of cardholders nearly tripling in the last decade. From 2018 through 2020, Americans charged almost $23 billion in healthcare expenses to these cards, accumulating over $1 billion in deferred interest payments alone. This trend is particularly concerning for older Americans, whose unpaid medical debt has surged in recent years, reaching $53.8 billion in 2020.

The promotion of these cards by healthcare providers, who often receive financial incentives from credit card companies, raises serious ethical concerns. Patients, facing the stress of a medical diagnosis or treatment, are particularly vulnerable to persuasive sales tactics and may not fully understand the complex terms of these credit products. This practice is especially egregious when providers push these cards onto patients who might be eligible for financial assistance programs (FAPs), designed to help low-income patients cover medical expenses.

To protect patients from predatory medical credit practices, policymakers must implement regulations. This includes prohibiting deferred interest promotions, capping interest rates on medical credit cards, requiring clear and conspicuous disclosures of terms and conditions, and strengthening enforcement of FAP requirements to ensure eligible patients are aware of and receive the financial assistance they deserve. We must address this blind spot to prevent unnecessary medical debt and safeguard the financial well-being of vulnerable Americans.

A Multi-Pronged Policy Strategy

Addressing the pervasive effects of hospital consolidation requires a comprehensive strategy aimed at fostering a competitive, patient-centered healthcare system. This strategy must include bolstering antitrust enforcement, revising payment models, regulating medical credit practices, and empowering patients as informed consumers.

Strengthening Antitrust Enforcement:

The FTC's current efforts, while commendable, fall short in tackling the full breadth of consolidation issues. As discussed, guidelines need updating to address cross-market mergers explicitly. This includes assessing the broader implications of mergers that impact common customers across different markets. Congress should also enhance FTC funding, enabling more investigations and legal actions against complex healthcare mergers.

Reforming Payment Models:

The prevailing fee-for-service model, which rewards quantity over quality, exacerbates consolidation as providers seek greater market dominance. Transitioning to shared-risk and population-based payment models, as suggested by the Health Care Payment Learning and Action Network, would incentivize providers to prioritize care quality and efficiency. Supporting smaller providers in this transition is necessary, including offering infrastructure investments and adapting risk arrangements to ensure their viable participation in value-based care.

Empowering Patients as Consumers:

We have to empower patients to become knowledgeable consumers. This involves improving price transparency and access to comprehensive quality and performance data, enabling patients to make informed healthcare choices. Policies should also promote patient involvement in decision-making processes, ensuring treatments align with patient preferences and values.

Addressing Integrated Finance and Delivery Systems Concerns:

While systems integrating insurance and healthcare provision can enhance coordination and efficiency, they also pose risks of further consolidating markets and reducing competition. Regulatory oversight is essential to curb anti-competitive practices and ensure these systems do not disadvantage certain patient groups or perpetuate health disparities.

Conclusion

The Hartford HealthCare lawsuit exemplifies the repercussions of unchecked hospital consolidation. This trend, left unaddressed, threatens to compromise the accessibility and affordability of healthcare, deepening disparities and imposing undue financial strain on Americans.

The urgency for comprehensive healthcare reform has never been more apparent. It is time that all stakeholders — policymakers, healthcare providers, patient advocates, and the public — collaborate to redefine the priorities of our healthcare system. We must advocate for a system that values patient well-being above profit, promotes fair competition, and ensures that care quality is rewarded.

By taking decisive action and implementing targeted reforms, we can address the pervasive issues brought on by hospital consolidation. This collective effort is essential to fostering a healthcare environment that upholds the highest standards of equity and excellence, ensuring that all Americans have access to the care they need at prices they can afford.

Prescription Drug Affordability Boards: A Threat to Ending the HIV Epidemic?

The Community Access National Network (CANN) continues to be active in the advocacy and policy space concerning Prescription Drug Advisory Boards (PDABs), also known as Prescription Drug Affordability Boards. PDAB activity is growing and advancing. Not only are more states considering or working through PDAB creation legislation, but a few recent drug-specific advisory board decisions have already been made.

A previous blog post untangles the warnings and concerns regarding PDABs. On the surface, they are presented as a simple solution to a complex issue. The complex problem is the extremely high healthcare expenditure in the United States. Accessing modern healthcare results in high amounts of spending from costs associated with hospitals and other facilities, medical technology creation and utilization, and even prescription drugs. Although prescription drug expenditures are only a small part of the billions spent annually on healthcare, the price of prescriptions is the low-hanging fruit that PDABs aim to attack. The money patients pay for prescription drugs is assuredly a financial burden for many. However, while PDABs aim to expressly lower the direct cost of prescription drugs for patients, their trajectory does not achieve that goal. Their actions have the potential to cause access issues in addition to potentially increasing out-of-pocket costs to consumers. This is especially true since the primary means PDABs lean toward to lower costs is the upper payment limit, otherwise known as UPL. Moreover, while CANN has a focus on PDAB potential outcomes regarding HIV drugs, all drugs are of concern, given that people living with HIV (PLWH) have multiple co-morbidities. Any threat to any drug utilized by vulnerable chronic disease communities is a threat to all.

Currently, CANN is monitoring several states that are looking to activate boards or already have active boards. Those states are Colorado, Maine, Maryland, Minnesota, New Hampshire, New Jersey, Ohio, Oregon, and Washington. Attending virtual PDAB meeting sessions, engaging by contributing both written and verbal commentary/testimony, and communicating with nationwide advocacy partners have revealed trends and developing paradigms that are problematic. Currently, the PDAB that is most far along in processes is Colorado. They have already deemed two medications, Enbrel and Cosentyx, as unaffordable, thus making them eligible for a UPL. Although every state’s PDAB is different operationally, due to the language of the legislation they are created by, states are watching Colorado. They will watch each other and potentially network in the future.

A sweeping, troublesome focus of PDABs is price. The stated intent of PDABs is to reduce the out-of-pocket costs patients pay for prescription drugs. However, the focus of analysis and discussion is how much manufacturers charge for drugs instead of how much patients pay. Focusing on drug prices could potentially lower the costs of drugs for the system, i.e., health plans, sponsors, and payers, but that does not directly help the patient cost burden.

A UPL sets a limit on the reimbursement rates of entities such as state health plans. It does not directly affect what patients pay out of pocket or change what manufacturers charge for drugs. A recent board discussion revealed the thought process that a UPL would equal more drug pricing transparency, eliminate hidden price variation caused by opaque rebates and discount structures, and increase patient access. Additionally, an assumption with consensus was that a lower price via UPL suggests an insurance company would be less likely to put a drug on a higher tier, less likely to require prior authorizations and be a barrier to pricing issues caused by payer vertical integration. These thought processes are not sound.

A UPL does not automatically lower the price of a drug. It has no bearing on what a manufacturer charges for a medication. A manufacturer would have to voluntarily lower its price to be at or near the UPL. Additionally, if a UPL were set to be lower than the acquisition cost for pharmacies, pharmacies would lose money stocking medications. They cannot operate at a constant loss which lowers patient access since some pharmacies would have to stop carrying certain medications. If a pharmacy can’t fill a prescription, patients are put at risk due to treatment interruptions or even treatment cessation. Deliberations on boards proceed with the assumption that a UPL would not hinder access, with no discussions of contingency plans or safeguards to guard access against unintended consequences. Unfortunately, the prevailing attitude is that loss of access to medications as a result of UPLs is an unwarranted fear.

UPLs also threaten the 340B Drug Pricing Program. The value of 340B is found in the spread between reimbursement rates and a reduced acquisition cost by way of drug manufacturer 340B rebates. UPLs will significantly reduce reimbursement rates, devaluing the funding realized by 340B rebates. Taking dollars out of the 340B program means that entities benefiting from 340B rebates will lose the ability to provide services to the vulnerable communities they serve. Furthermore, state AIDS Drug Assistance Programs (ADAP) heavily depend on savings and revenues from the 340B program. For states like Michigan, New Jersey, and Oregon, roughly 70 percent of their state ADAP budgets comes from 340B funding, and Oregon doesn’t receive any state contribution. According to NASTAD, a majority of ADAP clients live at or below 300% of the Federal Poverty Level. Thus, even if they qualify for Medicaid, they still need assistance.

In reality, insurance plan benefit design is what directly translates into what patients pay out of pocket. The convoluted utilization of tools such as copays, coinsurance, high cost-sharing tiers, and copay accumulators directly determines direct patient expenditures. Most importantly, a drug’s price doesn’t determine the utilization management techniques an insurance plan uses. Many different factors are at play there, and those factors benefit many parties but not patients.

Drug manufacturers have patient assistance programs (PAP) that actually directly lower consumer out-of-pocket costs. One type of PAP is copay assistance programs that help pay most or all of the copays patients pay for medications due to their insurance plans. Another type of PAP is where a manufacturer will provide medications entirely for free for those who are uninsured, underinsured, those whose insurance does not cover a particular medication, or those who cannot afford their copay or coinsurance while not qualifying for other help.

Although PAPs directly facilitate low out-of-pocket costs and bolster access, they are deleteriously used to support UPLs in PDAB board deliberations. The circular argument is that the mere existence of PAPs indicates that manufacturer drug pricing is too high. Additionally, discourse hints at the sentiment that PAPs are self-serving to drug manufacturers because it enables them to enjoy considerable tax advantages under the guise of charitable giving. As Jen Laws, CEO of Community Access National Network, points out, drug manufacturers have PAPs because “they are being made to shoulder discriminatory, profit-driven plan designs and supplement the under-reimbursement issue, all while patients are subject to predatory practices by payors.”

PDABs, those currently active and those that are upcoming, are well-intentioned in wanting to lower drug pricing for consumers. They state that when identifying drugs they deem are unaffordable for consumers, they will consider other ways to reduce costs besides just the UPL. However, although things such as PBM reform and effecting policy change regulating insurance plans are superior options, the UPL remains the de facto consideration. It is essential that patients learn about and stay aware of PDAB activity. Above all, it is imperative that patients engage with PDABs because they are not receiving enough feedback from consumers and caregivers. Their deliberations are based on minuscule sample sizes of survey responses and low turn-out, with opportunities for in-person or virtual commentary from the public.

Boards feel as if they are aggressively seeking patient engagement but aren’t receiving it. Regardless of the veracity of PDAB's efforts to obtain robust patient-centered data, it is imperative that patients and caregivers stay informed and intentionally make their voices heard. Being vocal and active does make positive change happen. As a result of education efforts from patient advocacy groups and FQHCs regarding the damage of UPLs on 340B funding, this week, Oregon’s PDAB decided to revamp its entire affordability review process. CANN is committed to continued education, engagement, and advocacy to empower patients individually and collectively, irrespective of medical condition.

How the IRA's Price Controls Could Backfire on Patients

For millions of Americans, health insurance offers a false promise. Despite paying premiums, deductibles, and copays, many still find themselves struggling to afford essential healthcare. In fact, a recent survey found that a staggering 43% of adults with employer-sponsored insurance—often considered the gold standard of coverage—find healthcare difficult to afford. This affordability crisis is poised to worsen, as the latest National Health Expenditure projections from the Centers for Medicare & Medicaid Services (CMS) reveal a troubling trend: while government spending on prescription drugs is projected to decrease, patient out-of-pocket costs are expected to rise. The projections forecast an 8.9% increase in hospital expenditures, coupled with a 1.4% decrease in retail prescription drug spending. This shift, driven in part by the Inflation Reduction Act's (IRA) price control provisions, threatens to undermine the law's intended goal of affordable healthcare and exacerbate existing health inequities. While the IRA aims to lower drug costs, its focus on price controls, rather than comprehensive patient protection mechanisms, is creating misaligned incentives that could backfire on the very people it aims to help.

The IRA's Price Controls: A Double-Edged Sword

The IRA's approach to lowering drug costs centers on empowering the government to directly negotiate prices with pharmaceutical companies. This change tackles a provision in the Medicare Part D program known as the "non-interference" clause, which previously prevented the government from directly negotiating drug prices. As a Kaiser Family Foundation (KFF) issue brief explains, "The Part D non-interference clause has been a longstanding target for some policymakers because it has limited the ability of the federal government to leverage lower prices, particularly for high-priced drugs without competitors." While this "non-interference" clause has long been a target for reform, the IRA's implementation creates a ripple effect that extends beyond simply lowering the sticker price of medications. The Congressional Budget Office (CBO) estimates that these drug pricing provisions will reduce the federal deficit by $237 billion over 10 years, suggesting a significant shift in spending away from the government. However, this shift comes at a cost. The IRA's emphasis on price controls, rather than comprehensive patient protection mechanisms, disrupts existing rebate structures that have been crucial in expanding access to medications, particularly for low-income patients and those with chronic conditions.

Programs like 340B and Medicaid rely on a system of manufacturer rebates to make medications more affordable. In essence, drug companies provide rebates to these programs in exchange for having their drugs included on formularies and made available to a large pool of patients. These rebates help offset the cost of medications, allowing safety-net providers to stretch their limited resources and serve more patients. However, the IRA's price controls could disrupt this delicate balance. By directly negotiating lower prices with manufacturers, the government might inadvertently reduce the incentive for companies to offer substantial rebates to programs like 340B and Medicaid. This could lead to higher costs for these programs and ultimately limit access to medications for vulnerable populations.

This means that programs like 340B and Medicaid, which rely on manufacturer rebates to offset costs and provide affordable medications to vulnerable populations, could be significantly undermined by the IRA's price control measures.

Further complicating the issue is the potential for pharmaceutical companies to adapt to the IRA's price controls by strategically setting higher launch prices for new drugs. This tactic allows them to recoup potential losses from negotiated prices in the future, effectively shifting the cost burden onto other payers, including patients. The CBO projects that this trend of higher launch prices would disproportionately impact Medicaid spending, placing a greater strain on a program already facing significant enrollment fluctuations and budgetary pressures. The KFF brief warns that, "Drug manufacturers may respond to the inflation rebates by increasing launch prices for drugs that come to market in the future." This means that while the IRA might appear to lower drug costs in the short term, it could inadvertently fuel a long-term trend of rising prices for new medications, ultimately impacting patient affordability and access to innovative therapies.

Hospitals: Benefiting from the System While Patients Pay the Price

The CMS projections forecast an alarming 8.9% increase in hospital expenditures, raising questions about the drivers of this unsustainable growth. A closer look reveals a troubling connection between this trend and the 340B Drug Pricing Program, a federal initiative designed to help safety-net hospitals provide affordable medications to low-income patients. The CBO's analysis of 340B spending reveals an explosive 19% average annual growth from 2010 to 2021, significantly outpacing overall healthcare spending growth. This dramatic increase is largely attributed to hospitals, particularly those specializing in oncology, which are increasingly purchasing high-priced specialty drugs through the program. As the CBO presentation states, "340B facilities benefit from the program because the difference between the acquisition cost and the amount they are paid (often called the 'spread') is larger for drugs acquired through the 340B program." This suggests that hospitals are capitalizing on the 340B program's discounts to acquire expensive medications, potentially driving up their overall spending. But are these savings being passed on to patients? Evidence suggests otherwise.

This suspicion of hospitals leveraging the 340B program for profit is further reinforced by a UC Berkeley School of Public Health study which found that hospitals are charging insurers exorbitant markups for infused specialty drugs, many of which are likely acquired through 340B. The study reveals that hospitals eligible for 340B discounts charge insurers a staggering 300% more for these drugs than their acquisition costs, effectively pocketing a substantial profit margin. This practice raises serious concerns about whether the 340B program, designed to help vulnerable patients access affordable medications, is instead being exploited by hospitals to boost their bottom line. As Christopher Whaley, a co-author of the UC Berkeley study, aptly points out, "It is ironic that some hospitals earn more from administering drugs than do drug firms for developing and manufacturing those drugs. At least drug firms invest part of their revenues in innovation; hospitals invest nothing." This highlights a perverse incentive structure where hospitals benefit financially from a program intended to help patients, while those same patients are often left facing inflated prices for essential medications and crippling medical debt.

The Affordability Crisis: A Broken Promise for Patients

This concerning trend of rising healthcare costs and shifting burdens is not limited to those reliant on safety-net programs. The Commonwealth Fund's 2023 Health Care Affordability Survey paints a bleak picture of the widespread affordability crisis facing Americans across all insurance types. The survey found that 43% of adults with employer coverage find healthcare difficult to afford, shattering the illusion that employer-sponsored insurance guarantees financial protection. These findings challenge the fundamental assumption that health insurance in the United States equates to affordable access to care. As the survey report states, "While having health insurance is always better than not having it, the survey findings challenge the implicit assumption that health insurance in the United States buys affordable access to care." This sentiment is echoed by millions of Americans who, despite having insurance, are forced to make difficult choices between their health and their financial well-being.

Even the IRA's lauded out-of-pocket (OOP) cap on Part D drug costs, while offering some relief, fails to address the root causes of this affordability crisis. An analysis by Avalere reveals that even with the cap in place, a significant number of Medicare beneficiaries will continue to face high healthcare costs, particularly those with lower incomes or specific health conditions. The analysis projects that 182,000 beneficiaries will spend over 10% of their income on Part D drug costs in 2025, despite the OOP cap. This sobering statistic underscores the limitations of focusing solely on OOP costs without addressing the underlying drivers of high drug prices and healthcare spending. As the Avalere analysis cautions, "High OOP costs are expected to result in many enrollees still facing affordability challenges in 2025." The findings from both the Avalere analysis and the Commonwealth Fund survey highlight a critical gap in the IRA's approach: it fails to adequately protect the most vulnerable patients from the financial burden of healthcare.

A Call for Patient-Centered Solutions

The CMS projections, alongside independent analyses of the pharmaceutical market and patient affordability, paint a clear picture: the current trajectory of US healthcare spending is unsustainable and inequitable. The IRA's price control provisions, while well-intentioned, risk exacerbating the affordability crisis by disrupting existing rebate structures, incentivizing higher launch prices for new drugs, and shifting costs onto patients. This shift is further compounded by unchecked hospital spending, particularly on high-priced specialty medications acquired through the 340B program. The result is a system where hospitals and pharmaceutical companies benefit, while patients—especially those with lower incomes or chronic conditions—are left struggling to afford essential care.

To be sure, the IRA includes provisions aimed at directly helping patients, such as the out-of-pocket cap on Part D drug costs and the expansion of subsidies for marketplace plans. These are positive steps towards easing the financial burden of healthcare for many Americans. However, the law's broader focus on price controls, without sufficient attention to patient protection mechanisms and the potential for unintended consequences, threatens to undermine these gains and create new challenges for those who rely on safety-net programs like 340B and Medicaid.

It's time for a fundamental shift in our approach to healthcare reform. Policymakers must move beyond a narrow focus on price controls and embrace a patient-centered approach that prioritizes affordability, access, and equity. This requires a multi-pronged strategy that includes:

• Reassessing the IRA's reliance on price controls: Instead of simply dictating prices, policymakers should explore alternative approaches that strengthen patient protections, preserve rebate structures that support broader access, and address the potential for cost-shifting onto patients.

• Tackling hospital pricing practices: Increased transparency and accountability in hospital pricing, particularly for inpatient medications, is necessary to ensure that safety-net programs like 340B are truly benefiting patients and not being exploited for profit.

• Investing in alternative care models: Promoting value-based care and investing in primary and preventive care can reduce reliance on expensive hospital stays, improve health outcomes, and make healthcare more affordable for everyone.

The promise of affordable, accessible healthcare for all Americans remains unfulfilled. We must demand a healthcare system that puts patients first, not profits. Only then can we ensure that everyone has the opportunity to live a healthy and fulfilling life, regardless of their income or health status.

Combating Shame and Stigma in the Fight for LGBTQIA+ Health Equity

I’m writing this as we navigate another Pride Month, and as I reflect on the joy and resilience of our community, it’s impossible to ignore the ever-present weight of our collective trauma. Eight years ago, on a warm June night, our world shattered. The joyous celebration of Pride Month at Pulse Nightclub in Orlando transformed into a scene of unimaginable horror, the echoes of gunshots forever seared into our collective memory. Forty-nine souls, beautiful and full of promise, were tragically stolen from us, victims of a hate-fueled act of violence that shook the LGBTQIA+ community to its core. My own gay wedding was set to be held one week after the massacre. I remember all too well the conversations we had, the fear we held for our safety and the safety of our guests. The tears we shed as we stood up to the hate, held a moment of silence for our lost queer family, and recited our vows, in defiance.

We carry a legacy of loss within the queer community. The Pulse nightclub shooting is forever seared into our collective memory; a horrific reminder of the violence fueled by hatred and bigotry that continues to plague our society. We remember the 49 lives lost that night, and countless others targeted for simply daring to live their truths. We remember the generation decimated by HIV/AIDS, a generation denied care and compassion in its time of greatest need. We must never forget that we have always been marginalized, attacked, and killed simply for existing. Yet, even in the face of unimaginable grief and persistent oppression, we find the strength to rise. We draw strength from the legacy of those who came before us, those who fought tirelessly for a better world. Theirs is a legacy of resilience, of love, of unwavering pride that fuels our fight for a brighter future.

This fight, however, is far from over. This Pride Month, we are reminded that the struggle for LGBTQIA+ equality, a struggle deeply intertwined with the fight against HIV, is a marathon fueled by defiance. And they—those who seek to erase us, silence us, deny our humanity—are banking on our exhaustion. They are counting on us to falter, to grow weary, to surrender to the constant battle for our right to simply exist. Their weapon of choice? Shame, wielded through stigma.

Stigma is the weapon they wield, launching attacks of misinformation, fear, and prejudice. Shame is the wound that festers when those attacks land, making us doubt our worth, our identities, our right to exist. It’s the insidious force behind discriminatory legislation, the hateful rhetoric that paints us as dangerous or deviant. It's the fear that prevents someone from seeking an HIV test, the silence that keeps people from accessing life-saving treatment, the isolation that breeds despair. It’s the reason why, even in 2024, HIV continues to disproportionately impact marginalized communities, and why accessing quality, affirming healthcare can still feel like navigating a minefield for so many LGBTQIA+ people. Shame is what happens when we internalize that stigma; when we start to believe the lies that we are broken, unworthy, deserving of judgment and rejection.

And they know it.

We see their tactics everywhere we look. The relentless attacks on LGBTQIA+ rights, particularly the venomous campaign of hate targeting transgender and gender-nonconforming people, are designed to instill fear, to divide us, to make us question our worth. These attacks, often disguised as concerns about "parental rights" or "religious freedom," create a climate of intolerance that directly impacts healthcare access for the most vulnerable members of our community.

This politically-motivated hate manifests in insidious ways. We see it in the surge of anti-LGBTQ+ legislation sweeping the nation, legislation that seeks to control our bodies, our identities, our very right to exist. While we celebrate the small victories—the decrease in anti-LGBTQ+ bills passed this year, a testament to the power of our collective advocacy—we know that the 37 that passed are 37 too many. These bills, particularly those targeting transgender youth, represent a direct attack on the well-being of our community.

And the assault doesn't stop there. They try to control the narrative, to erase us from history, ban our stories, to keep lifesaving information out of the hands of our youth. Efforts to restrict comprehensive sex education in schools, to erase queer people from discussions about health and relationships, are a blatant attempt to perpetuate a cycle of stigma, shame, and silence.

But here's where our power lies: in pride. Not just the parades and parties—though those hold their own significance—but the deep, abiding pride that serves as the antidote to shame. The pride that is rooted in self-respect, in solidarity, in the unwavering belief that our lives, our loves, our identities are valid and worthy of celebration. This is the pride we carry in our hearts, the pride that fuels our resilience and fuels our fight for a better world.

This Pride Month, let us honor the memory of those we lost at Pulse and in the decades-long fight against HIV/AIDS by continuing their legacy of resistance and queer joy. Let us transform our grief and anger into action. Let us demand better from our elected officials, holding them accountable and demanding policies that prioritize public health over prejudice. Let us challenge discriminatory policies that restrict access to essential healthcare services, including HIV prevention, testing, and treatment. Let us advocate fiercely for comprehensive sex education that is inclusive of LGBTQIA+ experiences and identities.

Our fight is far from over, but we are strong. We are resilient. We are proud. And we will not be silenced.

New CDC Guidance Backs DoxyPEP Amid STI Surge, Political Controversy

The United States is grappling with a surge in sexually transmitted infections (STIs), with alarming increases in syphilis, gonorrhea, and chlamydia. According to the Centers for Disease Control & Prevention (CDC), syphilis rates have risen by 80% since 2018, gonorrhea cases have increased by 11%, and chlamydia remains high despite a slight decrease. This underscores the urgent need for innovative prevention strategies. One such strategy, Doxycycline Post-Exposure Prophylaxis (DoxyPEP), has emerged as a powerful tool in the fight against STIs, but it has also become a target of politically-motivated attacks fueled by misinformation and bigotry. DoxyPEP involves taking a dose of the antibiotic doxycycline after condomless sex to prevent bacterial STIs. While studies have repeatedly demonstrated its safety and efficacy, certain politicians, most notably Florida Senator Marco Rubio, have launched a crusade against DoxyPEP, jeopardizing the health and well-being of countless people.

While Senator Rubio and others leverage misinformation to fuel a politically-motivated crusade against the CDC’s new DoxyPEP guidelines, the evidence is clear: DoxyPEP is a safe, effective, and urgently needed tool to combat the nation's skyrocketing STI rates, particularly among the LGBTQ+ community already facing systemic healthcare disparities.

DoxyPEP: Backed by Science, Embraced by Communities

Fortunately, the effectiveness of DoxyPEP isn't based on conjecture or political ideology; it's firmly rooted in scientific evidence. Numerous studies have demonstrated its remarkable ability to reduce STI rates among those most vulnerable. In the groundbreaking DoxyPEP trial, researchers observed a sustained decrease in STI incidence among participants taking DoxyPEP, even with a short-term increase in sexual partners and condomless sex acts, as reported in Infectious Disease Special Edition. Further bolstering these findings, a separate study from the University of California, San Francisco, revealed that DoxyPEP reduced the risk of chlamydia and gonorrhea by nearly 70% among participants. These findings, along with a growing body of research, make it clear that DoxyPEP is a powerful tool with the potential to significantly impact the STI epidemic.

Real-World Success

The positive impact of DoxyPEP extends beyond clinical trials and into real-world settings. In San Francisco, where public health officials have proactively implemented DoxyPEP, the results have been significant. A study by the San Francisco Department of Public Health found that among participants, overall STI incidence fell by 58% after starting DoxyPEP. Chlamydia cases dropped by 67%, and early syphilis cases decreased by 78%. These real-world outcomes highlight the potential of DoxyPEP to effectively curb STI transmission when embraced by the community.

Addressing Resistance Concerns

One of the most frequently raised concerns about DoxyPEP is its potential to contribute to antibiotic resistance. While this is a valid concern that warrants careful consideration, the evidence suggests that the benefits of DoxyPEP outweigh the risks when implemented responsibly. As the CDC states in its report, "The potential for DoxyPEP to increase antimicrobial resistance is a theoretical concern, but current data do not suggest that DoxyPEP use has resulted in substantial increases in resistance." This finding is further bolstered by a study from the University of California, San Francisco, which found no significant increase in antibiotic resistance genes among DoxyPEP users. Additionally, the CDC emphasizes that the short course of doxycycline used in DoxyPEP, coupled with ongoing monitoring for resistance trends, can help mitigate this risk. These findings should reassure policymakers and the public that DoxyPEP, when implemented responsibly as part of a comprehensive STI prevention strategy, is unlikely to exacerbate the already concerning issue of antibiotic resistance.

Community Acceptance

Not only is DoxyPEP backed by robust scientific evidence, but it has also been met with enthusiasm and acceptance from the very communities it aims to protect. When offered DoxyPEP as a prevention option, people at risk for STIs have demonstrated a strong desire to incorporate this tool into their sexual health practices. In San Francisco, for example, Dr. Hyman Scott reported that "about 39% of people ultimately decided that they wanted DoxyPEP as an STI prevention tool." This positive reception speaks volumes about the willingness of people to take charge of their sexual health and embrace new strategies for protecting themselves and their partners.

Political Roadblocks: Rubio's Disinformation Campaign

Despite the overwhelming scientific evidence and the positive response from those most impacted by STIs, DoxyPEP faces a formidable roadblock: a politically-motivated disinformation campaign spearheaded by figures like Senator Rubio. Driven by what appears to be a combination of ideological opposition and a disregard for evidence-based policymaking, Rubio has repeatedly attempted to discredit DoxyPEP and undermine its adoption.

In a press release riddled with inflammatory language, Senator Rubio proclaimed, “The CDC’s unscientific recommendation is dangerous and could lead to more antibiotic-resistant infections and deaths." This statement, however, directly contradicts the findings of the CDC itself, which clearly show that current data do not suggest that DoxyPEP use has resulted in substantial increases in resistance. Furthermore, Rubio's assertion that the CDC's recommendation is "unscientific" ignores the rigorous research and clinical trials that have consistently demonstrated DoxyPEP's safety and efficacy.

By cherry-picking statistics about antibiotic resistance without acknowledging the nuances of DoxyPEP's implementation and the evidence mitigating those risks, Rubio engages in a dangerous game of misinformation. His tactics, unfortunately, have the potential to dissuade patients from accessing a potentially life-saving prevention tool and hinder efforts to curb the STI epidemic.

Unmasking the Agenda

A closer look at Senator Rubio's record reveals a disturbing pattern of opposition to policies that benefit the LGBTQ+ community, raising serious questions about the motivations behind his crusade against DoxyPEP. His voting history, as reflected in his 0 out of 100 score on the Human Rights Campaign's Congressional Scorecard, paints a picture of an anti-LGBTQ+ agenda. From opposing marriage equality to supporting discriminatory bathroom bills, Rubio has consistently aligned himself with those who seek to marginalize and harm the LGBTQ+ community.

As HRC President Kelley Robinson aptly stated, "Throughout his career, Sen. Rubio has repeatedly put his personal beliefs ahead of the needs of his constituents, particularly LGBTQ+ Floridians." His stance on DoxyPEP, a measure that would primarily benefit men who have sex with men (MSM) and transgender women, aligns with this pattern of disregard for the well-being of the LGBTQ+ community. By framing a scientifically sound public health intervention as "dangerous" and "unscientific," Rubio perpetuates harmful stereotypes and undermines efforts to address a health crisis that disproportionately impacts LGBTQ+ people.

The Dangers of Politicized Health

The case of DoxyPEP lays bare a disturbing trend in contemporary politics: the cynical manipulation of public health for political gain. When evidence-based interventions like DoxyPEP are distorted and demonized, the consequences extend far beyond a single policy debate. Allowing political agendas to dictate public health decisions undermines trust in science, erodes support for vital programs, and ultimately puts lives at risk.

This pattern of politically-motivated attacks on healthcare is particularly pronounced when it comes to the LGBTQ+ community. Across the country, conservative lawmakers at all levels of government are pushing a discriminatory agenda that seeks to restrict access to essential healthcare services for LGBTQ+ people. From attempts to ban gender-affirming care for transgender youth to efforts to allow healthcare providers to refuse service to LGBTQ+ patients, these attacks represent a clear and present danger to the health and well-being of an already marginalized community.

Senator Rubio's crusade against DoxyPEP must be understood within this broader context. His actions are not about protecting public health; they are about scoring political points by exploiting prejudice and fear. When those in positions of power prioritize ideology over evidence and demonize vulnerable communities, the consequences can be devastating.

The Path Forward: Equity, Access, and Comprehensive Prevention

To effectively address the STI epidemic, we must move beyond the politically-motivated roadblocks erected by those who prioritize ideology over evidence. A truly effective response requires a commitment to equity, access, and comprehensive prevention strategies that center the needs of those most impacted.

It's crucial to acknowledge that STIs do not impact all communities equally. As highlighted in the U.S. Department of Health and Human Services' National Strategic Plan for addressing STIs, certain populations, including gay and bisexual men, transgender people, and young people, bear a disproportionate burden of these infections. This disparity is driven by a complex interplay of factors, including stigma, discrimination, and barriers to accessing quality healthcare. For example, in 2018, more than 50% of primary and secondary syphilis infections occurred among MSM. These disparities demand a targeted and equitable approach to STI prevention, one that prioritizes the needs of those most vulnerable and addresses the systemic factors that contribute to their increased risk.

The Urgency of Action

The urgency of the STI epidemic demands swift and decisive action. We can no longer afford to let misinformation and political maneuvering hinder the implementation of evidence-based solutions like DoxyPEP. As Dr. Jonathon Cherabie, an Infectious Disease physician, pointedly stated on Twitter, "To state that this move [DoxyPEP implementation] is 'political' when two MAJOR trials have shown how beneficial this intervention is, in the midst of a massive increase in STIs especially syphilis is disingenuous." Dr. Cherabie goes on to highlight the hypocrisy of fixating on unfounded fears of antibiotic resistance with DoxyPEP while ignoring its use for other purposes like acne and malaria prophylaxis. His words serve as a potent reminder that the opposition to DoxyPEP often stems not from legitimate scientific concerns, but from a desire to undermine the health and well-being of LGBTQ+ people. Every day that passes without readily available DoxyPEP represents missed opportunities to prevent new infections and protect the health of marginalized communities.

A Multifaceted Approach

It's important to recognize that DoxyPEP, while a powerful tool, is not a standalone solution to the STI epidemic. To truly make a lasting impact, we need a comprehensive approach that addresses the complex nature of this public health crisis.

This comprehensive strategy must prioritize:

• Expanded Access to Testing and Treatment: Timely and affordable access to STI testing and treatment is paramount. We must remove financial and logistical barriers that prevent people from seeking care, ensuring that everyone can get tested and treated promptly and effectively.

• Comprehensive Sexual Health Education: Accurate, inclusive, and age-appropriate sexual health education is fundamental to empowering people to make informed decisions about their sexual health. We must move away from abstinence-only approaches and embrace education that encompasses a wide range of topics, including consent, contraception, and STI prevention methods.

• Addressing Stigma and Discrimination: Stigma surrounding STIs prevents people from seeking testing and treatment, perpetuating the cycle of transmission. We must foster open and honest conversations about sexual health, challenge harmful stereotypes, and create a more supportive and inclusive environment for those affected by STIs, especially at points of care.

• Adequate Funding for Public Health Initiatives: Effectively combating the STI epidemic requires robust and sustained funding for public health programs. This includes resources for research, surveillance, prevention programs, and healthcare infrastructure.

Conclusion

The alarming rise of STIs in the United States demands our unwavering attention and a commitment to evidence-based solutions. Inaction is not an option; it carries the weight of preventable infections, long-term health complications, and lives needlessly impacted. DoxyPEP represents “the most exciting intervention for STI prevention in two decades,” a scientifically sound intervention with the potential to significantly curb the STI epidemic, particularly among the LGBTQ+ community. We cannot allow political maneuvering and misinformation campaigns to derail this progress.

As advocates, policymakers, and industry professionals, we have the power to turn the tide against this epidemic:

1. Integrate DoxyPEP into Policy Agendas: For policymakers, champion legislation and funding initiatives that expand access to DoxyPEP, ensuring its inclusion in Medicaid, ADAPs, and private insurance plans. Advocate for comprehensive sexual health education and robustly funded public health programs.

2. Harness Your Platform to Disseminate Accurate Information: Leverage your professional networks, social media platforms, and public speaking engagements to counter misinformation surrounding DoxyPEP. Share the overwhelming scientific evidence supporting its efficacy and safety, and challenge those who prioritize political agendas over public health.

3. Advocate for FDA Approval: While the CDC has issued guidelines for DoxyPEP, it remains an off-label use of doxycycline. Advocate for the FDA to formally approve this use, which would further solidify its legitimacy, potentially expand insurance coverage, and increase confidence among healthcare providers and patients.

The fight for effective STI prevention is a fight for public health, for equity, and for the well-being of us all. Let's leverage our collective influence to ensure that DoxyPEP becomes a standard tool in our arsenal against this urgent public health crisis.