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.

Equitable Access to Long-Acting HIV Treatment

For people living with HIV (PLWH), adherence to antiretroviral therapy (ART) is crucial. Achieving and maintaining viral suppression, the primary goal of HIV treatment, depends on taking medication as prescribed. Yet, consistent adherence can be challenging due to busy schedules, pill fatigue, stigma, and side effects. Suboptimal adherence has serious consequences, including increased viral load rebound, drug resistance, and disease progression. It also hinders public health efforts to control the HIV epidemic. Long-acting injectable (LAIs) antiretroviral therapies offer a promising alternative by providing sustained viral suppression with less frequent dosing. However, a significant barrier remains: equitable access. Some State AIDS Drug Assistance Programs (ADAPs), designed to support low-income PLWH, do not adequately cover these medications due to cost concerns .

This limited coverage is a public health issue and a moral failing. State ADAPs must provide equitable access to the most effective HIV treatments available that meet the unique needs of the patient, regardless of cost. While the initial expense of LAIs may be high, their potential to improve adherence, viral suppression, and long-term health outcomes far outweighs the financial investment. It's time for ADAPs to prioritize the health of PLWH by ensuring access to LAIs and supporting efforts to end the HIV epidemic.

The Promise of LAIs

LAIs represent a major advancement in HIV treatment. Unlike daily oral ART, which requires daily ingestion and absorption, LAIs are administered as intramuscular injections, typically once a month or every two months. These injections provide a steady release of medication, ensuring consistent drug levels and effective viral suppression.

The benefits of LAIs are significant. The MOCHA study found that adolescents overwhelmingly favored LAIs due to the convenience of less frequent dosing . This reduces the daily burden of remembering to take pills, leading to improved adherence rates—a key factor for successful HIV treatment.

Improved adherence through LAIs also enhances long-term health outcomes and reduces the risk of HIV transmission. When the virus is undetectable, it cannot be sexually transmitted, a concept known as Undetectable = Untransmittable (U=U). By promoting optimal adherence and sustained viral suppression, LAIs become a powerful tool in the fight against the HIV epidemic.

Evidence of Effectiveness

The effectiveness of LAIs is supported by considerable scientific evidence. The MOCHA study found that after 24 weeks of treatment with long-acting cabotegravir/rilpivirine, none of the nearly 150 participants experienced virological failure. This highlights the potential of LAIs to achieve durable viral suppression, especially among younger populations who often struggle with adherence to daily oral regimens.

The LATITUDE study, focusing on PLWH with a history of suboptimal adherence to oral ART, found that long-acting injectable therapy was superior in suppressing HIV replication compared to daily oral medication . The compelling results led the National Institutes of Health Data and Safety Monitoring Board to recommend offering the long-acting medication to all eligible participants.

These studies, along with a growing body of research, show that LAIs are effective in achieving viral suppression and are particularly beneficial for those who struggle with adherence to traditional oral ART. This makes LAIs a critical tool for addressing disparities in HIV treatment outcomes and advancing health equity among PLWH.

Impact on the HIV Epidemic

The effectiveness of LAIs in maintaining viral suppression has significant implications for public health, especially the Ending the HIV Epidemic (EHE) initiative, which aims to reduce new HIV infections in the United States by 90% by 2030. Achieving this goal requires expanding access to effective prevention and treatment options.

LAIs support this effort by fostering optimal adherence and sustained viral suppression. By ensuring that PLWH have access to medications that effectively suppress the virus, we improve health outcomes and reduce the likelihood of transmission, moving closer to the EHE goal.

LAIs also align with the 95-95-95 targets set by UNAIDS, adopted by the EHE initiative, which aim to ensure that 95% of PLWH know their status, 95% of those diagnosed receive sustained ART, and 95% of those on treatment achieve viral suppression. By improving adherence and facilitating viral suppression, LAIs contribute to achieving these targets and reducing new cases.

The International Association of Providers of AIDS Care (IAPAC) emphasized the importance of LAI access for supporting the goals of the Fast-Track Cities initiative . This initiative aims to accelerate progress towards ending the HIV epidemic at the local level. IAPAC argues that providing PLWH with access to effective ART options like LAIs is essential for achieving these ambitious targets.

The Cost Conundrum

The benefits of LAIs are often overshadowed by concerns about cost. Critics, including some state ADAP administrators, point to the high upfront price of these medications compared to generic oral ART options. A 2023 article on AIDSmap highlighted that the price of long-acting cabotegravir would need to drop considerably to be cost-effective compared to daily oral PrEP . This concern about cost is echoed in discussions surrounding LAIs for treatment, with some stakeholders questioning whether the potential benefits justify the higher price tag.

A recent article in TheBody revealed that the annual cost of Cabenuva, a commonly prescribed LAI, is approximately $40,000. This figure highlights the need for careful consideration of drug pricing within ADAP formularies. For comparison, the annual retail cost of the popular oral ART treatment Biktarvy is just over $50,000. However, as of January 2023, only 78% of state ADAPs covered Cabenuva.

This gap in coverage disproportionately affects the most vulnerable PLWH. In states without Cabenuva coverage, nearly two-thirds of ADAP clients live at or below the federal poverty level, compared to 43% in states with coverage. Additionally, ADAP clients in states lacking Cabenuva coverage are more likely to be Black or Hispanic .

While cost is a valid concern, focusing solely on upfront expenses overlooks the potential for long-term savings. ADAPs can negotiate lower drug prices and must consider the broader economic and public health benefits of LAIs.

A Holistic Cost-Benefit Analysis

A comprehensive cost-benefit analysis must consider the long-term impact on healthcare expenditures and public health outcomes. A narrow focus on upfront costs ignores the potential of LAIs to generate significant savings over time.

The HIV+Hepatitis Policy Institute modeled the impact of long-acting PrEP on HIV case aversion and medical cost savings, concluding that improved adherence leads to better health outcomes and reduced transmission, ultimately saving costs for the healthcare system. They projected that increased uptake of long-acting PrEP would avert 139,296 person-years of HIV treatment over ten years, saving $4.25 billion .

Preventing new HIV infections through improved adherence not only saves on direct treatment costs but also reduces the need for costly interventions related to managing complications and comorbidities of advanced HIV. By minimizing the risk of transmission, LAIs contribute to a decrease in HIV prevalence, further reducing long-term healthcare costs and saving lives in the process.

Intangible Benefits

The benefits of LAIs extend beyond economics. These medications significantly improve the quality of life and overall well-being of PLWH.

The MOCHA study highlighted that young people preferred LAIs due to reduced treatment anxiety and fatigue. They appreciated the increased privacy, as they no longer needed to take daily pills that might disclose their HIV status.

ADAP Advocacy emphasizes the importance of patient empowerment and choice in HIV care. LAIs provide PLWH with greater autonomy in managing their health, aligning treatment with their personal needs and lifestyles. This sense of control improves mental health, self-esteem, and quality of life.

By reducing the frequency of medication-related tasks, LAIs help minimize the stigma associated with HIV. Daily pill-taking can serve as a constant reminder of one's HIV status, triggering feelings of shame or fear of disclosure. LAIs, with less frequent dosing, allow PLWH to integrate their care more seamlessly into their lives, reducing the psychological burden.

These intangible benefits, while difficult to quantify economically, should weighed equally when making decisions that affect patient care and access. They highlight the profound impact of LAIs on the lives of PLWH, extending beyond viral suppression to encompass improved quality of life, reduced stigma, and increased autonomy.

Ethical Considerations

Equitable access to LAIs is an ethical imperative. State ADAPs, as safety-net programs for low-income PLWH, have a moral duty to provide access to the most effective HIV treatments, regardless of cost. Denying access based on price perpetuates health disparities and undermines equity.

IAPAC argues that access to innovative treatments like LAI-ART should not depend on socioeconomic status. Providing ADAP coverage for LAIs is crucial for equitable healthcare.

Restricting LAI access disproportionately impacts those already facing systemic barriers, including people of color, those with low income, and those in rural areas. These populations are more likely to have adherence challenges due to social, economic, and structural factors. Denying them access to LAIs further entrenches health inequities.

A commitment to health equity demands prioritizing the needs of the most vulnerable. Cost concerns, while valid, cannot justify denying essential healthcare to those who need it most. State ADAPs must ensure all PLWH can benefit from LAIs, regardless of financial circumstances.

Addressing Barriers and Implementing Solutions

Ensuring equitable access to LAIs requires a multi-faceted approach, addressing cost concerns and systemic barriers. Policy changes at federal and state levels are necessary for creating a more just healthcare system for PLWH.

Policy Recommendations for ADAPs

• Mandate LAI Coverage: State legislatures should require ADAPs to cover all FDA-approved LAIs for HIV treatment. This would ensure all eligible PLWH have access to these medications.

• Streamline Prior Authorization: ADAPs should streamline prior authorization processes for LAIs, minimizing delays and ensuring timely access to treatment. This could include standardized approval criteria, expedited review processes, and clear communication between providers and ADAP administrators.

• Increase Funding Allocations: State and federal governments must prioritize increased funding for ADAPs, recognizing the growing demand for LAIs and their long-term cost savings potential.

Provider Education and Training

The ADAP Advocacy Association underscores the need for robust provider education and training on LAIs. They advocate for targeted education about providing LAIs within a modified clinic flow model.

Ongoing education initiatives should focus on:

• LAI Pharmacology and Administration: Providers need a thorough understanding of LAIs, including dosing schedules, potential side effects, and proper administration techniques.

• Patient Selection and Counseling: Training should equip providers to identify appropriate candidates for LAIs, considering personalized patient needs and potential adherence barriers. Effective counseling strategies are necessary for addressing concerns and ensuring informed decisions.

• Addressing Provider Bias: Some providers may hold misconceptions about LAIs, such as concerns about patient acceptance or injection-related anxiety. Training programs should address these biases, providing evidence-based information and dispelling myths.

By investing in comprehensive provider education and training, we can empower healthcare professionals to embrace LAIs confidently, facilitating broader access and improved health outcomes for PLWH.

Patient Advocacy and Support

Community activism has been a hallmark of the U.S. HIV response, and PLWH should work with clinicians to advocate for state ADAPs to prioritize patient choice and treatment preferences.

PLWH and community organizations can play a powerful role by:

• Sharing Their Stories: Personal narratives are powerful tools for raising awareness and influencing policy change. PLWH who have benefited from LAIs can highlight the positive impact, while those denied access can shed light on the challenges and the need for equitable coverage.

• Engaging with ADAP Advisory Committees: Many state ADAPs have advisory committees of stakeholders, including PLWH. Participating in these committees provides an opportunity to voice concerns and advocate for policy changes.

• Collaborating with Advocacy Organizations: Partnering with national and local organizations can amplify voices, provide resources, and facilitate collective action for policy changes.

• Educating Their Peers: PLWH can educate peers about LAIs, dispelling myths and sharing information about the benefits and potential challenges. Peer-to-peer support can empower people to advocate for their health and make informed treatment decisions.

By raising voices, sharing experiences, and engaging in collective action, we can drive progress towards equitable LAI access, ensuring all can benefit from these transformative medications.

Conclusion

Long-acting injectable antiretroviral therapies (LAIs) represent a major advancement in HIV treatment, offering a powerful tool for improving adherence, achieving sustained viral suppression, and ending the HIV epidemic. While cost concerns are valid, a holistic cost-benefit analysis shows that the long-term benefits of LAIs far outweigh the initial investment.

The time for action is now. Contact your state legislators, ADAP representatives, and other stakeholders. Demand equitable LAI coverage and support policies that prioritize the health and well-being of all PLWH. Together, we can dismantle barriers to access and ensure no one is left behind in the fight to end the HIV epidemic.

ADA & HIV Legal Protections

The fight for disability rights has been long and arduous, marked by significant milestones and persistent challenges. For people living with HIV (PLWH), this struggle intersects with ongoing battles against stigma, misinformation, and discrimination. While legislation like the Americans with Disabilities Act (ADA) has provided important protections, achieving true equality and inclusion demands vigilance and robust, consistent enforcement.

Systemic barriers often obstruct PLWH from educational opportunities and professional fulfillment. Take Robin Dugas, a cosmetology student in Arkansas. Despite being fully qualified, she was denied her license by the Arkansas Board of Cosmetology solely because she disclosed her HIV-positive status. This blatant discrimination, challenged by Dugas and the ACLU, exemplifies the ingrained stigma PLWH continue to face.

The ADA guarantees equal opportunity and prohibits discrimination against people with disabilities, including PLWH, recognizing that HIV, even in asymptomatic stages, can limit major life activities. However, as Dugas' case shows, legal protections alone don't ensure lived equality. PLWH still face stigma and discrimination, especially in healthcare, employment, and access to services.

The emergence of HIV in the 1980s led to widespread fear, misinformation, and discrimination, affecting marginalized communities and resulting in societal rejection, job loss, and denial of healthcare.

In response, the ADA was passed in 1990, marking a turning point against HIV discrimination by recognizing people with HIV as having a disability. This ensures their right to equal opportunities in employment, public accommodations, housing, essential services, and as we have seen recently, the justice system. The ADA’s impact was solidified in the Supreme Court case Bragdon v. Abbott (1998), where the Court ruled that even asymptomatic HIV qualifies as a disability. This decision underscored that discrimination based on HIV status is unlawful and affirmed the rights of PLWH.

The ADA as a Tool for Change

The ADA requires ongoing interpretation, enforcement, and adaptation. Recently, the U.S. Department of Health and Human Services (HHS) updated Section 504 of the Rehabilitation Act to strengthen protections against disability discrimination, particularly relevant to PLWH. Research shows that healthcare professionals sometimes harbor biases against PLWH, leading to a lower standard of care and poor health outcomes. The updated rule directly combats this by explicitly prohibiting discrimination in medical treatment decisions based on biases, stereotypes, or judgments about the value of life based on disability. Healthcare providers cannot deny, delay, or provide lower quality care to PLWH simply because of their HIV status.

Additionally, this update mandates accessibility for websites and mobile applications and works to ensure equal access for people with disabilities, including providing sign language interpreters and accessible medical diagnostic equipment, such as exam tables and mammography machines.

These updates enhance the legal framework to hold healthcare providers accountable for discriminatory practices and empower patients to advocate for their rights. As HHS Office of Civil Rights Director Melanie Fontes Rainer stated, “By removing barriers to healthcare and social services, this rule advances justice for people with disabilities who have for too long been subject to discrimination.”

Persistent Challenges: Evidence of Ongoing HIV Discrimination

Despite ADA protections, many PLWH still face discrimination. Recent cases and public health data highlight the need for robust ADA enforcement, education, and state-level policy reforms.

A 2021 UNAIDS fact sheet showed that in 7 out of 11 countries surveyed, 21% of PLWH were denied healthcare in the past year, and over 50% experienced job loss due to HIV-related discrimination. These findings highlight the global scope of the problem.

The ViiV Healthcare Positive Perspectives survey (Wave 1) found that 39% of respondents experienced institutional stigma, including denial of jobs, visas, health services, or education. Nearly a quarter worried that their HIV status would negatively impact their relationship with their primary care provider.

These data emphasize the need for interventions addressing HIV stigma and discrimination, particularly those intersecting with race, gender identity, and socioeconomic status. Legal protections like the ADA are essential but must be supported by enforcement, public education, and efforts to dismantle systemic barriers. Indeed, the necessity of robust enforcement and education becomes apparent when examining real-world incidents where these protections falter.

Case Study: Tractor Supply Company

In 2024, Tractor Supply Company settled a lawsuit filed by the Equal Employment Opportunity Commission (EEOC) for $75,000 on behalf of a Mississippi woman with HIV. The manager disclosed her HIV status to coworkers and then fired her after she complained about the resulting harassment. The woman endured verbal abuse and discriminatory treatment from colleagues fearing HIV transmission. The EEOC argued that Tractor Supply failed to protect her from a hostile work environment and retaliated against her for reporting the discrimination.

Marsha Rucker, a regional attorney for the EEOC, stated, “Tractor Supply Company created and maintained a hostile work environment for this employee by publicizing her private medical information and then failing to address the harassment this generated. Rather than protect this employee from harassment, the company fired her.” This case highlights the vulnerability of PLWH to workplace discrimination, even with clear legal protections.

Case Study: Tennessee’s Aggravated Prostitution Law

The criminal justice system can also be used as a tool of discrimination. The lawsuit OutMemphis v. Lee, brought by OutMemphis, the ACLU, and the Transgender Law Center, challenges Tennessee’s aggravated prostitution statute under the ADA and the U.S. Constitution. This ongoing case highlights how such laws disproportionately target and punish PLWH, effectively barring them from various social, employment, and housing opportunities due to the requirement to register as sex offenders.

Parallel to this, the Center for HIV Law and Policy (CHLP) submitted complaints to the Department of Justice (DOJ) which launched its own investigation, focusing on the discriminatory enforcement of the aggravated prostitution statute in Shelby County. The DOJ’s investigation found that the state and the Shelby County District Attorney’s Office violated Title II of the ADA by subjecting people living with HIV to harsher criminal penalties solely because of their HIV status.

When asked about the strategy to challenge the aggravated prostitution statute, Jada Hicks, staff attorney with CHLP’s Positive Justice Project explained, “if a person is accused of being a sex worker… that's a misdemeanor charge. If they then find out that they're HIV positive, it's a felony. That's it. That's all it takes. That is the most clear violation of the ADA that I can think of. It’s the perfect example of how you can violate the ADA based on someone's health status.”

The impact of this legal challenge has been profound, resulting in a landmark settlement agreement and a major win in the fight against HIV criminalization. This case marked the first time the ADA has been successfully used to challenge and dismantle such a law. Sean McCormick, a staff attorney at CHLP, highlighted the significance of this achievement: "This really reflects a tremendous milestone in this fight to use the ADA to attack HIV criminalization [as it] represents the first tangible, concrete change to laws, policies, practices that promote and enable HIV criminalization." There are currently 10 other states with similar aggravated prostitution laws that could be impacted by the Tennessee case, underscoring the broader potential for reform and the importance of strategic advocacy to address these unjust laws on a national scale.

In apparent backlash to these legal actions, Tennessee passed an amendment that expands the offense of aggravated rape to include cases where the defendant, knowing they are infected with HIV, commits rape and transmits the virus to the victim. This amendment, enacted in May of 2024, reflects ongoing legislative efforts that may further stigmatize and criminalize PLWH, highlighting the need for vigilant advocacy and legal challenges.

McCormick reflects on the role of HIV criminalization laws in oppressing marginalized groups, "the Tennessee experience with aggravated prostitution really speaks to the way that HIV criminalization continues to oppress marginalized folks... these laws are used as a way to target marginalized communities, particularly black trans and cisgender sex workers."

Hicks adds, "People who sit at the intersection of multiple identities are at an increased risk of interacting with the criminal legal system. For instance, if you're black, trans, inject drugs, and you're an immigrant, it's just increasing your chances of having an interaction with the carceral system."

This case serves as a potent example of how the ADA can be utilized to challenge similar laws in other states. As McCormick points out, "The most obvious translation is other states with very similar sentences and sentence enhancements for people who are convicted of aggravated prostitution." CHLP is actively working with advocates in states like Ohio and Pennsylvania to replicate the success achieved in Tennessee.

The Need for State-Level Reform

While federal laws like the ADA provide crucial protections for PLWH, as we have seen, state-level laws remain inconsistent and often inadequate. This patchwork of protections creates confusion and vulnerability, as PLWH may face different consequences depending on their state. Outdated HIV criminalization laws and sentence enhancements are still on the books in 30 states, highlighting the ongoing need for state-level advocacy and reform.

Realities Facing PLWH:

• Indiana: Indiana has HIV-specific criminal statutes that classify nondisclosure of HIV status to sexual partners, needle-sharing partners, or exposure to bodily fluids as felonies or misdemeanors. These laws discourage HIV testing and disclosure, perpetuating stigma and discrimination. Additionally, these statutes do not account for modern medical understanding of HIV transmission, leading to potentially unjust legal consequences.

• Tennessee: Despite removing aggravated prostitution as a "violent sex offense" requiring sex offender registration, Tennessee maintains the aggravated prostitution offense. This law penalizes PLWH harshly for consensual sex work, disproportionately affecting those who are already marginalized by race, gender identity, poverty and other intersectional social determinants.

• Louisiana: Louisiana's HIV-specific laws are particularly concerning. The state's broadly written statute criminalizes "intentional" exposure to HIV through sexual contact, even without transmission risk. The law's failure to define "intent" leaves interpretation to law enforcement and prosecutors, discouraging open communication about HIV status and leading to potential prosecutions without intent to harm. No actual transmission is required for conviction, meaning PLWH can be prosecuted for behaviors like spitting, biting, or consensual sex with a condom. The Center for HIV Law and Policy's analysis highlights how Louisiana courts have interpreted "sexual contact" broadly, allowing subjective enforcement and encompassing acts with no risk of HIV transmission.

The journey toward equality for people living with HIV (PLWH) has seen notable achievements, such as the protections offered by the Americans with Disabilities Act (ADA), yet it remains hindered by ongoing stigma and discrimination. Despite legal safeguards like the ADA, real-world equality requires consistent enforcement and proactive advocacy.

Discrimination in healthcare, employment, and through punitive laws like Tennessee’s aggravated prostitution statute highlights the significant challenges PLWH face. These laws disproportionately affect those at the intersection of multiple marginalized identities, making the vigorous application of the ADA across states crucial. The updated Section 504 of the Rehabilitation Act by the U.S. Department of Health and Human Services (HHS) is a step forward, ensuring that biases in healthcare and other services do not undermine the rights of PLWH.

Looking ahead, it's essential to support litigation efforts, push for legislative reforms, and educate the public to dismantle systemic barriers. Organizations like the ACLU and CHLP play a critical role in this fight, but broader community engagement is vital for sustained change.

By enhancing ADA protections and advocating for their robust enforcement, we can transform societal attitudes and ensure that all individuals with HIV live dignified lives, free from prejudice. For more information, visit the Americans with Disabilities Act homepage and the Center for HIV Law and Policy.

Equitable and Data-Driven Viral Hepatitis Quality Measures

Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.

Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.

OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.

The Landscape of Disparities and the Need for Action

The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."

These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."

Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.

Analyzing the Proposed Measures

At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.

This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.

The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.

Data Considerations

The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.

Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.

Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.

Collaborative Action

The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.

The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."

Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.

Conclusion

OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.

Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.

Improving HIV Care After Incarceration

People incarcerated in state and federal prisons are disproportionately affected by HIV, with case rates three times higher than the general population. This disparity highlights a critical gap in our healthcare system—continuity of care post-release. The Health Resources and Services Administration (HRSA) has recognized this urgent issue through Policy Clarification Notice 18-02 (PCN 18-02). This policy, alongside insights from the Technical Expert Panel (TEP) Executive Summary, seeks to bridge the care gap by enhancing service linkage and reducing barriers for people living with HIV (PLWH) as they reintegrate into society.

Understanding PCN 18-02: Enhancements to Transitional HIV Care

HRSA’s Policy Clarification Notice 18-02 (PCN 18-02) represents a significant shift in the approach to HIV care for people transitioning from incarceration to community reintegration. Recognizing the unique challenges faced during this critical period, PCN 18-02 enables the Ryan White HIV/AIDS Program to fund a broader array of services, thereby facilitating a more seamless transition and reducing the risk of healthcare discontinuation. This policy not only expands the scope of support prior to release but also ensures that patients have the necessary healthcare connections immediately upon re-entering society.

Overview of PCN 18-02's Changes and Their Impact:

• Expanded Funding: Utilization of Ryan White funds has been broadened to cover extensive care starting within correctional facilities and continuing into community reintegration.

• Pre-release Services: Enhanced eligibility for support services before release, such as healthcare enrollment and medication access, ensures no interruption in care.

• Broader Eligibility: Services now extend beyond state and federal prisons to include those exiting local and county jails.

• Holistic Support: A comprehensive approach now integrates direct medical care with essential services that address key social determinants like housing and employment, crucial for effective reintegration.

Impact of These Changes:

• Continuity of Care: These measures ensure seamless care continuity, essential for maintaining health and preventing HIV progression or transmission.

• Comprehensive Support: By addressing medical needs and social determinants, the policy supports people in stabilizing their lives post-release, potentially reducing recidivism and enhancing public health outcomes.

• Inclusivity and Reach: Extending care to a broader demographic within the carceral system allows a larger number of affected people to receive the necessary support for a successful transition back into society.

The approach promoted by PCN 18-02 is poised to significantly improve the outcomes for people living with HIV as they navigate the complex process of reintegration into society, aiming not just at immediate medical needs but also at long-term well-being and stability.

Challenges in Implementing Continuous HIV Care

The implementation of HRSA's Policy Clarification Notice 18-02, while a significant advancement, faces considerable hurdles that underscore the need for an integrated and responsive healthcare approach. These challenges include systemic fragmentation, unpredictable release times, and enduring stigma, each of which can severely hinder the continuity of HIV care from incarceration to community reintegration.

• Systemic Fragmentation: Effective implementation requires coordinated collaboration across diverse sectors—correctional facilities, healthcare providers, and community organizations. Current systems often operate in silos, which can delay or disrupt essential healthcare services during the transition period.

• Unpredictability of Release Times: The often erratic nature of release schedules complicates the delivery of continuous care. This unpredictability makes it challenging to ensure that patients receive timely medical treatment and linkage to support services immediately upon release.

• Persistent Stigma: Stigma within healthcare settings and the broader community continues to be a significant barrier. It discourages people from seeking necessary care, fueled by fears of discrimination and breaches of confidentiality—issues that are particularly acute for those living with HIV and are amplified by the stigma associated with incarceration.

Strategic Responses to Address Challenges

• Enhanced Coordination: Developing integrated care pathways that involve all relevant stakeholders can streamline the transition process. Patient navigation programs have proven particularly effective by guiding patients through the healthcare system, ensuring they receive necessary services promptly upon release. This aligns with findings that patient navigators improve linkage to care and adherence to treatment.

• Flexible Healthcare Systems: Adapting health services to the unpredictability of release schedules involves flexible scheduling and maintaining open lines of communication between correctional facilities and healthcare providers. Furthermore, incorporating technology-supported interventions, such as telehealth services and mobile health applications, can enhance engagement and continuity of care. These tools have been underutilized but offer significant potential to reach people in remote or underserved areas.

• Combating Stigma and Integrating Substance Use Treatment: In addition to education and training programs aimed at reducing stigma, integrating substance use treatment into HIV care plans is essential. Effective management of substance use disorders, including the provision of medication-assisted treatment within carceral settings, significantly improves HIV care outcomes by maintaining or achieving viral suppression.

By tackling these challenges with proactive and coordinated strategies, the healthcare community can significantly enhance support for people living with HIV as they navigate the transition from incarceration back into society, thereby improving outcomes and promoting overall public health.

TEP Insights: Why This Guidance Matters

The Technical Expert Panel (TEP) convened by HRSA's HIV/AIDS Bureau provides essential context that deepens our understanding of the systemic and societal challenges in improving HIV care for justice-involved populations. The TEP's insights reinforce the importance of HRSA's Policy Clarification Notice 18-02 (PCN 18-02) and highlight specific areas where integrated strategies can make a significant impact.

• Stigma and Discrimination: TEP findings reveal that stigma, particularly within correctional settings, exacerbates challenges in HIV care, leading to confidentiality breaches and discriminatory practices such as segregation. This calls for enhanced training programs for correctional and healthcare staff that emphasize the rights and needs of PLWH, aligning with strategies to combat stigma and foster a more inclusive care environment.

• Comorbidities and Holistic Care: Acknowledging the prevalence of comorbid conditions such as substance use disorders and mental health issues among the incarcerated population with HIV, the TEP emphasizes the need for integrated care that addresses these complex health needs. This supports the strategic response of forming multidisciplinary care teams and enhancing services that tackle these social determinants of health.

• Peer Support and Multidisciplinary Care: The TEP advocates for the use of peer support specialists, who with their lived experiences, can bridge the gap between incarceration and community re-entry. This insight underpins the importance of strengthening peer involvement, ensuring continuous support and relatability, which are key during the transition phase.

• Transitional Challenges: Highlighting the barriers during the transition from correctional facilities to the community, such as unpredictable release dates and access to healthcare, the TEP reinforces the necessity for flexible healthcare systems and enhanced coordination as previously discussed. These strategies are essential to mitigate the risks associated with interrupted care and to facilitate smoother reintegration.

Enhancing the Guidance with TEP Insights

Integrating these TEP insights into HRSA’s guidance through PCN 18-02 requires a commitment to holistic and collaborative approaches. By focusing on education, strengthening peer support, and addressing social determinants of health, the implementation of PCN 18-02 can be significantly fortified. The comprehensive review by the TEP not only underscores the critical need for these policy changes but also highlights the integrated approach needed to ensure successful reintegration and improved health outcomes for people living with HIV during and after their transition out of incarceration.

Adapting Models of Success

To ensure continuity of care for people living with HIV during their transition out of incarceration, it's beneficial to look at established, successful models. These models provide effective frameworks that can be adapted to various settings and illustrate how to overcome the systemic challenges of reintegration.

• The Care Coach Model: This approach involves dedicated care coaches who provide personalized, holistic support to patients. Care coaches help with healthcare navigation, medication management, and the coordination of social services like housing and employment. This direct support helps bridge the gap between the structured environment of incarceration and the complexities of community reintegration, ensuring that people do not lose access to necessary healthcare services during this vulnerable transition period.

• The Change Team Model: Developed to enhance communication and workflows within and between correctional facilities and community health services, this model involves stakeholders from various sectors coming together to identify and address systemic barriers. It utilizes a collaborative approach where correctional health staff, community healthcare providers, and social workers coordinate to prepare for a person’s release, streamlining processes such as medical record transfers, appointment scheduling, and immediate post-release support.

Strategic Implementation of Successful Models:

Adopting these models involves creating partnerships that extend beyond traditional healthcare settings to include correctional facilities and community organizations. Such collaborations are vital for addressing the fragmentation typically seen in the current systems and for adapting the flexibility needed in healthcare provision, especially given the unpredictability of release times.

By integrating elements from both the Care Coach and Change Team Models, health services can ensure more reliable and effective care transitions for people living with HIV. These models serve not only as blueprints for delivering comprehensive care tailored to the unique challenges faced by formerly incarcerated persons but also stress the importance of continuity in care, which is essential for improving health outcomes and supporting successful community reintegration.

Addressing Needs of Marginalized Populations

While adapting models of success, it's imperative to focus on interventions that specifically address the needs of marginalized populations, including cisgender and transgender women, who often face unique barriers to accessing HIV care. This involves designing interventions that tackle these barriers directly, such as gender-specific patient navigation systems, and peer support programs that address intersectional stigma and discrimination.

A Pathway to Transformation

The HRSA's Policy Clarification Notice 18-02 is a landmark step towards improving HIV care for incarcerated populations, addressing continuity of care from incarceration to community reintegration. By expanding eligibility and enhancing services, PCN 18-02 aims to ensure a smooth transition for those reintegrating into society. Despite its potential, the policy faces significant challenges like systemic fragmentation, unpredictability of release, and stigma, which require coordinated efforts across multiple sectors to overcome.

We must embrace a holistic approach that goes beyond immediate medical needs, addressing long-term well-being and stability to transform the landscape of HIV care for formerly incarcerated people. This transformation can lead to improved health outcomes, reduced recidivism, and a more equitable society.

As stakeholders from various sectors, it is imperative we collaborate to implement these changes effectively, ensuring that those affected by HIV receive the comprehensive support they need to lead healthier, more stable lives post-incarceration.

MPOX and Beyond: Reforming Emergency Response

The MPOX—a smallpox-related virus outbreak of 2022 served as a painful reminder that the United States remains alarmingly unprepared for public health emergencies. In the early stages of the outbreak, CANN highlighted the need for swift action and equitable responses to mitigate its spread and impact. However, mirroring the challenges experienced during previous crises, the response to MPOX was plagued by familiar, deeply concerning failures – sluggish testing rollouts, inadequate communication, and a failure to prioritize the needs of the most vulnerable. A recent Government Accountability Office (GAO) report examining the U.S. Department of Health and Human Services (HHS) underscores these recurring failings, emphasizing systemic and persistent weaknesses continue to jeopardize the nation’s response capabilities. New data from the Centers for Disease Control and Prevention (CDC) indicates a troubling resurgence of MPOX cases, with this year's infection numbers already close to double those seen in 2022. If we fail to heed the lessons learned from the MPOX response and the countless warnings that emerged throughout past outbreaks, we risk even greater health inequities and unnecessary suffering in the next inevitable crisis.

GAO Report Highlights Recurring Crisis Weaknesses

GAO’s report on the MPOX response offers a damning indictment of the nation's emergency preparedness, concluding that "persistent gaps" continue to undermine effective responses to public health crises. Among the most critical failures exposed by the report were severe delays in scaling up testing capacity and a lack of clear and consistent communication from HHS. The report emphasizes that "delays in testing capacity...limited the ability to understand the scope of the outbreak," hindering efforts to target resources and protective measures effectively. Similarly, the absence of a cohesive HHS communication strategy led to confusion and mistrust, ultimately slowing the rollout of vaccines, treatments, and preventative information needed to contain the spread. GAO's Mary Denigan-Macauley underscored this reality on the GAO Podcast: "So communication is key. Who's being infected by this?... They also needed to make sure that they knew exactly how much of the vaccine was coming, because we don't have an unlimited supply…Some officials said CDC's risk communication at the beginning of the mpox outbreak did not clearly identify those who were most at-risk for mpox (men who have sex with men) and the most common mode of transmission (sexual contact).”

The GAO report goes beyond the specific issues surrounding the MPOX response to stress the recurring nature of these problems. Notably, HHS faced challenges with delays in testing capacity, communication hurdles, and a lack of interagency coordination – problems that directly mirror those seen in previous public health emergencies. The GAO criticizes the lack of a centralized, coordinated approach: "HHS–as the designated lead for the federal public health and medical response to emergencies—does not have a coordinated, department-wide after-action program to identify and resolve recurring emergency response challenges." This lack of a cohesive strategy and failure to learn from previous outbreaks has grave implications, with the GAO warning that it "may affect the department’s ability to respond to future emergencies that could be more infectious and lethal than mpox."

Community Impacts

The systemic failures highlighted in the GAO report weren't merely abstract concepts; their consequences were acutely felt within affected communities. The podcast analysis we conducted amplified concerns related to the very same issues raised by the GAO. Speakers emphasized how access barriers and limited testing, particularly within marginalized communities, exacerbated the spread of MPOX. Additionally, the lack of clear and inclusive messaging perpetuated harmful stigma, causing significant delays in people seeking testing or treatment.

Failures during the MPOX response didn't affect everyone equally. CDC’s data reveals significant disparities in MPOX case rates along the lines of race, ethnicity, and gender. Hispanic/Latinx and Black/African American people were disproportionately impacted. Underscoring the urgency of addressing this disparity, the CDC highlighted the reality that: as of April 2023, 78% of Black persons and 75% of non-Hispanic American Indian or Alaska Native (AI/AN) persons remained unvaccinated against MPOX. The CDC further states, "Achieving equitable progress in JYNNEOS vaccination coverage will require substantial decreases in shortfalls among Black and AI/AN persons." These disparities underscore the inequities at the heart of the U.S. healthcare system and crisis response mechanisms. The MPOX outbreak is merely a symptom of this larger systemic failure, demonstrating how pre-existing disparities create vulnerabilities that worsen the impact of any public health emergency.

The Need for Reform

The GAO analysis goes beyond identifying the problems to offering concrete recommendations. To prevent these same systemic failures from hindering future public health responses, the GAO calls for two key changes:

• Coordinated After-Action Program: The creation of a department-wide after-action program within HHS that would systematically and centrally analyze the lessons learned from each crisis. This program would ensure a comprehensive and coordinated understanding of recurring problems, essential to developing effective solutions.

• Stakeholder Involvement: The GAO emphasizes the importance of including "relevant external stakeholders", in these after-action reviews. This inclusion of community voices, public health experts, and other critical partners would bring diverse insights into the analysis, ensuring that solutions are comprehensive and address the on-the-ground needs that can often be missed in a purely bureaucratic approach.

Key Takeaway: The GAO's analysis highlights that the failures during the MPOX outbreak aren't isolated incidents but symptoms of systemic weaknesses within the nation's emergency preparedness systems. Unless these weaknesses are addressed with coordinated reform, the nation remains vulnerable to ineffective and inequitable responses to future health threats.

Case Surge: A Warning Sign

The specter of MPOX looms large once again. As of this writing, MPOX cases in the U.S. have nearly doubled compared to the same period last year. This surge, particularly in regions like New York City, DC/Virginia, California, and Florida, underscores the continued vulnerability to MPOX outbreaks and highlights the urgent need to address the root causes of the persistent failures observed during the 2022 outbreak. Complacency in the face of this surge poses a danger, especially given the devastating outbreak in the Democratic Republic of Congo (DRC).

The DRC is experiencing its largest ever MPOX outbreak, with about 400 suspected cases reported each week – the majority in children. This outbreak presents a "triple threat": a deadlier strain of the virus circulating with a fatality rate of nearly 1 in 10, alongside the virus' spread into new areas, new populations (including sex workers), and in new ways – including sexually – and evading diagnostic tests. This crisis emphasizes the need for global cooperation and proactive solutions to prevent the spread of deadlier strains and future outbreaks.

Beyond MPOX: Systemic Failures Demand Systemic Change

On the heels of the COVID-19 pandemic, the MPOX outbreak of 2022 was further evidence that recurring failures and persistent inequities within the U.S. healthcare system leave the nation dangerously unprepared for public health emergencies. The GAO's critical report highlights a chronic reliance on reactive crisis management and failures in coordination, directly contributing to the ineffective MPOX response. While containing MPOX remains important, the nation cannot afford to repeat the mistakes of the past. The GAO's call for a coordinated after-action program and stakeholder inclusion offers a starting point for the reforms needed to address these systemic weaknesses.

These recommendations aren't abstract ideals but a roadmap to protect public health, especially for the most vulnerable in our society. In order to effect change, policymakers, healthcare organizations, and all stakeholders must prioritize the following for effective crisis preparedness:

Recommendation 1: Proactive Preparedness

The GAO report highlights a chronic reliance on reactive crisis management, condemning the tendency to delay action until a health threat has escalated. To break this dangerous cycle, we must advocate for a shift towards data-driven early detection and proactive response planning. Investing in innovative surveillance and data systems is critical. As Mary Denigan-Macauley states, "It really wasn't until the White House stepped in and took control that... it became a better response from the federal government." We cannot afford to wait for the next crisis to strike before mobilizing the resources needed for timely intervention. And we can’t afford for agencies such as HHS to wait for the White House to react to a crisis. Policymakers should consider carefully how to equip agencies and subject matter experts to respond and act in the best interest of the nation and humanity when next public health crisis emerges.

Recommendation 2: Community-Centered Response

Public health experts and CDC data illuminate how failing to center the needs of marginalized communities can devastate crisis response efforts. Stigma, lack of culturally-competent communication, and inadequate access to testing and treatment all exacerbated the disparate impact of MPOX. Preparedness plans, communication strategies, and resource allocation must prioritize the specific needs of those historically underserved if we hope to prevent the repetition of such failures.

Recommendation 3: Tackling Systemic Inequities

The MPOX case, like so many public health crises, underscores that systemic inequities are at the root of health disparities. Policy changes are urgently needed to address structural barriers (lack of access, discrimination, etc.) that worsen the impact of outbreaks on vulnerable populations. While the specifics of these changes require development and debate, the World Health Organization emphasizes the importance of global collaboration, investment in health systems particularly in underserved regions, and addressing stigma to ensure an equitable and effective response to future outbreaks.

This focus requires investment, policy reform, and sustained advocacy to dismantle the chronic failures that turn each new health threat into a disproportionate crisis for marginalized communities.

*Editor’s Note: This blog uses the term MPOX to be consistent with CDC and GAO terminology, but CANN's earlier policy materials used the previous designation MPV.

Aaron Rodgers' Dangerous Game

High-profile figures like New York Jets quarterback Aaron Rodgers promote dangerous conspiracies that the HIV/AIDS epidemic was government-engineered and that zidovudine (AZT), a lifesaving drug, was intended to harm patients. These falsehoods have severe consequences for public health, endangering lives and perpetuating existing stigma. An estimated 1 in 7 Americans living with HIV are unaware of their status, highlighting how celebrity-backed misinformation can deter people from seeking essential care. Despite its initial side effects, AZT was a breakthrough that paved the way for more effective treatments. Claims that it was intentionally harmful are medically inaccurate and undermine decades of HIV care progress.

A History of Distrust

Acknowledging historical failings is crucial, as the early mishandling of the AIDS crisis by the government and health institutions fueled fear and skepticism. This understandable distrust is rooted in the spread of falsehoods during the early days of the epidemic – groups like the "Heubach group" promoted the idea that HIV was a government-created hoax. These claims, though swiftly debunked by science, preyed on existing anxieties. Sadly, figures like Rodgers exploit this justified distrust, twisting it into a weapon. They promote baseless conspiracies, painting themselves as brave truth-tellers while actively eroding progress and endangering lives.

A Modern Threat

Rodgers and other celebrities wield immense influence as public figures, yet they disregard the potential consequences when they amplify harmful misinformation to vast audiences. When celebrities endorse baseless conspiracy theories, it cloaks fringe ideas in an illusion of legitimacy, jeopardizing public trust in proven medicine. Their reckless actions reveal a blatant disregard of their responsibility to prioritize evidence-based information, a choice with deadly consequences when lives hang in the balance.

Aaron Rodgers amplifies dangerous ideas surrounding HIV-related conspiracies. He has endorsed conspiracy theories about both the HIV/AIDS and COVID-19 pandemics, urging his audience to read Robert Kennedy Jr.'s book and promoting the debunked idea that AZT was intentionally harmful to patients. On the "Look Into It" podcast, he further distorted the truth by drawing a false parallel between the AIDS crisis and COVID-19: “The blueprint, the game plan, was made in the '80s. Create a pandemic with a virus that’s going wild... create an environment where only one thing works. Back then AZT; now, Remdesivir until we get a vaccine.”

Rodgers continued, expressing a cynical distrust of scientific research and the pharmaceutical industry: “I can do my own research, which was so vilified, to even question authority.” He plays into a popular but flawed narrative: the lone maverick challenging corrupt systems. Rodgers' "do your own research" approach ignores the complexities of scientific knowledge, our susceptibility to cognitive biases, and that without expertise, it's easy to misinterpret information.

Rodgers uses a common tactic seen in the spread of misinformation: he questions the integrity of science while simultaneously claiming to be persecuted for doing so. This creates a trap. He undermines trust in established institutions by preying on anxieties about authority. Then, when his claims are inevitably challenged by experts, he positions himself as a brave truth-teller being silenced by the establishment. This manufactured martyrdom only reinforces the original mistrust, further validating his position in the eyes of some followers. These dangerous falsehoods damage public health by eroding trust in the decades of medical progress that have saved countless lives.

Rodgers is part of a broader trend highlighted in the World Health Organization's 2022 infodemic report. Medical misinformation spreads rapidly across social media, exploiting societal anxieties, and can have deadly consequences. Rodgers’ endorsement of HIV/AIDS denialism is particularly harmful because his assertions tap into the fear, stigma, and systemic distrust prevalent in communities of color historically marginalized by the medical system. This creates fertile ground for misleading narratives, leading to disastrous cyclical consequences.

In case you’re of the mind that words don’t matter, a study published in European Psychologist found a 23% decrease in HIV testing in communities highly exposed to HIV denialism, signifying a direct threat to the lives of people at risk. The benefits of early diagnosis and treatment with antiretroviral therapy (ART) are well-documented, and by promoting the idea that the virus is benign or that ART is hazardous, denialists delay essential testing and care, feeding into the stigma that discourages many from seeking the help they need.

These conspiracy theories exploit vulnerabilities in our information landscape, tapping into societal anxieties and magnifying them through social media platforms that prioritize engagement over factual accuracy. This dynamic is especially perilous in health-related discourse, where misinformation can lead to fatal outcomes.

Stigma & Public Health Risk

Aaron Rodgers’ endorsement of HIV/AIDS denialism illustrates the persistent influence of health misinformation. His assertions exploit long-standing fears, stigma, and systemic mistrust, especially prevalent in communities of color historically marginalized by the medical system. These real and profound injustices make communities susceptible to misleading narratives that claim HIV is a fabrication or that lifesaving treatments are harmful, thereby perpetuating a cycle of misinformation and stigma.

According to the Centers for Disease Control and Prevention (CDC), stigma deters many from seeking HIV testing and treatment, creating a sense of fear, judgment, and social isolation. This leads countless people to forgo life-saving medical care. This is particularly damaging to young people, as demonstrated by GLAAD's 2023 State of HIV Stigma report. It revealed a concerning generational gap: over 60% of Gen X adults consider themselves well-informed about HIV, yet only 34% of Gen Z adults say the same. A study published in The Guardian in August 2023 highlighted that teenagers are significantly more likely to believe online conspiracy theories than adults, underscoring the vulnerability of Gen Z to extremist rhetoric.

Young people’s vulnerability has serious public health implications, as those aged 13-34 account for 57% of new HIV diagnoses. The dangerous conspiracy theories promoted by Rodgers and Kennedy directly contribute to this crisis by perpetuating stigma. This disproportionately affects marginalized communities and exacerbates homophobia, transphobia, racism, and systemic inequalities.

The impact of this cycle is both profound and destructive:

• Misinformation: Campaigns spread dangerous falsehoods about HIV, misleading the public about its origins, and the efficacy of treatments.

• Stigma: Misinformation fosters stigma, fueled by fear, a profound distrust in medical advice, and manipulative media tactics. It discourages testing and treatment, promoting silence rather than open discussion about HIV status.

• Public Health Crisis: Misinformation and stigma lead to inadequate testing, poor treatment adherence, and a decreased likelihood of status disclosure – crucial steps for stopping HIV transmission.

Stigma kills. To save lives, we must go beyond medical solutions and dismantle the harmful social barriers erected by misinformation. This requires targeted education and awareness campaigns designed specifically for Gen Z and Gen Alpha, who are most at risk.

Breaking the Cycle

The resurgence of HIV denialism is a wake-up call. Misinformation purveyors prioritize sensationalism over saving lives. People like Rodgers prey on our understandable fears and anxieties during health crises, and their disregard for the consequences of their words is inexcusable. We must hold them accountable for the harm they cause and demand better from those whose voices reach millions. It's equally important to demand better from social platforms that profit from algorithms that prioritize divisive content over truth.

As citizens, we must all become savvier consumers of information, developing critical thinking skills and fostering a healthy skepticism of emotionally charged narratives that lack credible evidence. We have allies in this fight: the CDC, reputable journalists, fact-checkers, publications, and countless dedicated researchers. By seeking out evidence-based information and supporting their efforts, we can counter misinformation and protect public health.

Let's take concrete actions:

• Demand accountability: from both the purveyors of misinformation and the platforms that amplify them.

• Educate ourselves: Seek out reliable sources, develop critical thinking tools, and support organizations dedicated to media literacy.

• Elevate evidence-based information: Amplify the voices of credible scientific institutions and share accurate information within our circles of influence.

These actions will help dismantle the harmful cycle of misinformation and push us closer to a world where science, not fear and lies, guides our approach to ending the HIV epidemic.

HCV Cases Down, But Not Out

The Centers for Disease Control and Prevention (CDC) recently released data analysis from 2022 indicating a 6% decrease in new viral Hepatitis C (HCV) infections, a revelation that leaves infectious disease specialists cautiously optimistic. Yet, despite the existence of a cure, thousands of Americans still die needlessly from this disease each year. Systemic barriers – restrictive insurance policies, inefficient testing, and neglect of marginalized communities – prevent many from accessing the lifesaving treatment they need. These failures fuel a public health crisis, with over 14,000 Americans dying from HCV complications in 2020 alone. The most vulnerable suffer the worst consequences, including young people, people impacted by substance use and the justice system, and those experiencing homelessness. While experts remain cautious, this decline after a decade of steady increases could signal a turning point. "We've had a decade of bad news…I am cautiously encouraged," said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable. "This could be a sign the tide has turned."

Systemic Barriers to HCV Care

Despite the existence of a cure, a shockingly low percentage of those with HCV achieve viral clearance. Systemic barriers rooted in insurance practices, fragmented testing, and neglect of marginalized communities prevent countless Americans from accessing the treatment they need.

Insurance Roadblocks

Insurance restrictions present a formidable obstacle to HCV treatment, often creating a maze of administrative hurdles. State Medicaid programs frequently require proof of months-long sobriety, specialist-only prescriptions for treatment, or evidence of existing liver damage before approving care. These arbitrary restrictions fly in the face of medical best practices and delay treatment, increasing the risk of liver failure, liver cancer, and even death.

Even those with commercial insurance face barriers to HCV care. Despite the high cost of HCV medications, many insurers impose prior authorization requirements. These delays, coupled with restrictive formularies and high copays, discourage patients and providers. The fact that only about 50% of commercially insured patients in a recent CDC study achieved viral clearance speaks volumes about how deep-seated this issue is, impacting people regardless of their insurance status.

The Burden of Diagnosis

A shocking number of people live with Hepatitis C without knowing it, with the CDC estimating over 40% of those infected are unaware of their status. This highlights a problem of insufficient screening and inefficient testing procedures. The current multi-step diagnostic process, requiring separate blood draws for the initial HCV antibody check and subsequent confirmation, creates logistical barriers. Many face issues like needing multiple appointments, additional travel costs, or potential delays in results.

Populations most impacted by HCV, including young people, those experiencing homelessness or substance use, and people who are incarcerated, often face additional challenges accessing even basic healthcare. Routine HCV screening within prisons, expanded outreach testing in underserved communities, and integration of HCV screening into substance use treatment programs are essential to reaching those at heightened risk.

Modern medicine offers rapid point-of-care tests for many conditions, including HIV. Similar technology exists for HCV, yet approval and widespread use lag behind. Streamlining the diagnostic process through rapid, single-visit testing would revolutionize care by connecting people to treatment far earlier, minimizing disease progression and preventing transmission.

How Barriers Foster Disparities

HCV treatment disparities highlight a system that consistently fails our most vulnerable populations. Cure rates are lowest among those without insurance and people on Medicaid, a stark reflection of restrictive insurance practices and a lack of support to navigate complex healthcare systems. The disease disproportionately impacts marginalized communities, including:

• Young People: Driven by the opioid crisis, new HCV cases have surged among millennials and Gen Z, with over 60% of new chronic infections found in these younger populations. This highlights the need for increased prevention and treatment efforts tailored to this age group.

• People Experiencing Homelessness: Lack of stable housing leads to missed appointments, medication storage issues, and prioritization of immediate survival over long-term health concerns.

• Incarcerated People: An estimated 13% of those moving through prisons and jails annually have HCV, yet treatment is rarely offered. Post-release, they face navigating insurance and accessing care with limited support.

• Those with Substance Use Disorders: Stigma and outdated treatment requirements often bar this population from receiving HCV care. Integrated treatment models, combining HCV care with substance use treatment and harm reduction services, are vital to reaching this underserved population.

Untreated HCV is a Public Health Threat

The systemic barriers discussed – restrictive insurance practices, the cumbersome diagnostic process, and inadequate outreach to marginalized communities – contribute to a critical public health issue: a significant portion of people living with HCV remain undiagnosed and untreated. This compromises their health and increases the risk of unknowingly transmitting the virus through unprotected sex or sharing drug paraphernalia. Ensuring equitable access to HCV testing, treatment, and care is essential to protecting public health. By dismantling these barriers and ensuring everyone has the opportunity to be diagnosed and cured, we can protect those most vulnerable and achieve a future free from HCV.

Cost of Inaction

The human and economic toll of failing to address HCV is staggering:

• Deaths: More than 14,800 Americans died from HCV-related complications in 2020.

• Liver Cancer: HCV is a leading cause of liver cancer, with rates of new cases rising 38% between 2003 and 2012.

• Economic Burden: The Biden Administration's proposed HCV elimination plan projects that over 10 years, it would prevent 24,000 deaths and save $18.1 billion in healthcare costs.

National Strategy & the Biden Plan

The persistent low cure rates, widening health disparities, and the staggering human and economic cost of untreated HCV reveal that relying on any single solution won't achieve elimination. A coordinated national strategy is essential to overcome existing systemic failures and ensure that no one falls through the cracks. The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing these challenges, but its success hinges on learning from the lessons of past initiatives.

Key Elements of the Biden Plan:

• The "Netflix Model": To address insurance barriers, this model proposes a subscription approach, where the government negotiates a fixed price with drug companies to provide treatment for vulnerable groups (uninsured, Medicaid, incarcerated, and others). This simplifies coverage and ensures those who need it most can access life-saving medication.

• Rapid Testing & Community Focus: Investment in rapid point-of-care testing would enable same-day diagnosis and treatment initiation, revolutionizing care. Federal funding to support expanded testing in non-traditional settings, like mobile clinics, prisons, and substance use treatment centers, would directly reach the populations most impacted by HCV.

• Federal Support & Coordination: Centralized guidance, resources, and funding for healthcare providers are crucial for expanding screening, streamlining care models, and educating both providers and communities.. This investment in public health infrastructure would create a ripple effect, increasing capacity for effective HCV treatment long-term.

Subscription models like those piloted in Louisiana and Washington have demonstrated the potential to reduce medication costs. However, as Jen Laws, CEO of CANN, highlights, even with affordable drugs, systemic shortcomings remain a significant barrier to care. The Biden Plan must recognize that:

• Price isn't the only issue: Drug costs are a major factor but investment in community-based healthcare infrastructure, provider training, outreach programs, and addressing logistical barriers to care and testing are just as crucial.

• Reinvestment of savings is key: The substantial cost-savings generated from the "Netflix model" must be reinvested directly into strengthening public health systems, ensuring long-term success.

• Policy-driven solutions are essential: Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would provide a powerful foundation to support and guide the Biden Plan.

Addressing Disparities

The Biden Plan's focus on equity directly confronts the health disparities highlighted earlier. By specifically targeting uninsured and Medicaid populations, it helps ensure that financial barriers don't translate into needless deaths. The emphasis on community-based testing and integrated treatment models is crucial for reaching marginalized populations like:

• Young People: Increased outreach and testing aligned with this age group is vital to curbing the surge of new infections fueled by the opioid epidemic.

• People Experiencing Homelessness: Integrating HCV screening and care into supportive services for this population is essential to address their often complex healthcare needs.

• Incarcerated People: By treating HCV within prisons, not only would patient health outcomes improve, but it could also help prevent transmission within facilities and in communities upon release.

• Those with Substance Use Disorders: The plan's support for harm reduction strategies and integrated treatment models recognizes the need to address HCV without discriminatory sobriety restrictions.

The Cost-Benefit Argument

The Biden Plan isn't just compassionate; it's a sound fiscal investment. Projections indicate it would save 24,000 lives and $18.1 billion in healthcare costs over ten year. By preventing long-term HCV complications like liver failure, cancer, and transplants, we can reduce the significant future economic burden of this preventable disease.

Despite a small, yet significant decrease in new HCV infections, there remains the staggering toll of untreated HCV. The promise of the Biden Plan demands immediate action, according to advocates, because it addresses preventable deaths, widening health disparities, and the economic strain of a solvable public health crisis. It will take a larger, systemic approach to remove many of the barriers impending the elimination of Hepatitis C in the United States.

Closing the EHB Loophole: Louisiana Leads, But National Action is Needed

"Jason," a Utah AIDS Foundation client, confronted a brutal truth in the wake of his HIV diagnosis: a healthcare system more interested in profits than patients. Faced with a staggering $3,200 co-pay for his HIV medication—well beyond his financial reach—Jason's plight was exacerbated by his insurance company's implementation of a co-pay accumulator policy. This policy effectively nullified the assistance he once relied on, leaving him stranded without his medication for months. "I felt scared and discouraged when I was told I have a $3,200 co-pay to pick up my HIV meds. I don’t even make that much money each month," Jason shared, his voice a stark indictment of a system failing its most vulnerable. His story, spotlighted by The Utah All Copays Count Coalition, underscores a pervasive issue: patients across the nation are cornered into impossible choices between health and financial ruin, casualties of an insurance industry's practices that blatantly prioritize margins over meaningful care.

Understanding the Problem

Jason's heartbreaking story sheds light on interconnected issues fueling the healthcare affordability crisis: co-pay accumulators and the Essential Health Benefits (EHB) loophole. These tactics have a devastating effect on patient well-being, so let's break them down:

Co-pay Accumulators: A Profit-Driven Scheme at the Expense of Patients

These programs allow insurers to take the value of manufacturer-provided coupons or patient assistance and apply it towards an annual deductible, but not towards a patient's out-of-pocket maximum. This means even with generous assistance, patients can face thousands of dollars in additional costs, forcing them to ration medication or abandon treatment altogether. The numbers reveal the widespread impact:

• The AIDS Institute reports that co-pay accumulator adjustment programs (CAAPs) are present in a shocking 66% of individual Affordable Care Act (ACA) marketplace plans nationwide, with some states showing 75-100% of available plans utilizing these tactics.

Co-pay Maximizers: A Further Threat to Affordability

Insurers are increasingly employing an even more severe tactic known as 'co-pay maximizers'. These programs set a patient's co-pay to the full amount of available assistance, even if it's intended to cover an entire year's medication cost. Unlike accumulators, which prevent assistance from counting towards the out-of-pocket maximum, maximizers essentially 'use up' all available assistance in a single payment. This leaves patients facing the full, often unaffordable, cost of medication for the rest of the year. The combined use of maximizers and accumulators is becoming increasingly common, leaving patients with limited options and magnifying the financial burden of life-saving treatments. A staggering 72% of commercially insured beneficiaries in the United States were enrolled in plans with co-pay maximizers as of 2023, according to a Drug Channels analysis.

This highlights the alarming prevalence of these practices and the immense pressure they place on patients struggling to manage chronic conditions.

The Essential Health Benefits (EHB) Loophole: Insurers Exploit Gaps in Coverage

Under the ACA, states have flexibility in selecting the 'essential' healthcare services that insurers must cover. Some insurers manipulate this system by classifying necessary medications (especially for chronic conditions) as 'non-essential'. This lets them continue using co-pay accumulators and maximizers on these medications, further undermining patient affordability.

• Centers for Medicate & Medicaid Services’ (CMS) data reveals that in many states, critical treatments for chronic disease management are not guaranteed coverage under 'essential' benefits. This means patients could be subject to accumulators and maximizers indefinitely, locked in a cycle of escalating costs even when reaching their out-of-pocket maximums.

The takeaway is clear: these practices prioritize the shareholder profits of insurance companies over the health and well-being of patients, especially those battling chronic and complex conditions.

Federal Action – Progress and Pitfalls

The CMS Notice of Benefit and Payment Parameters for 2025 signals a notable yet incomplete step towards remedying the healthcare affordability crisis. It attempts to close the Essential Health Benefits loophole starting in 2027 by mandating routine, non-pediatric dental coverage as an essential benefit. While seemingly tangential, this amendment serves as a precursor to addressing broader coverage issues, demonstrating the potential to mitigate part of the financial burdens that patients like Jason face. However, it underscores a significant gap in the rule's scope—its silence on co-pay accumulators and maximizers.

Limitations of the CMS Rule Change

The rule change’s failure to directly address co-pay accumulators and maximizers leaves a significant gap in patient protection. These payor-driven barriers systematically undermine patient affordability and access, especially for those managing chronic conditions. The absence of direct action against these schemes allows insurers to deploy cost-containment strategies that, while ostensibly designed to control expenditures, place the financial burden squarely on patients.

This oversight perpetuates financial hardship and deepens healthcare disparities. Accumulator and maximizer practices disproportionately affect marginalized populations, highlighting the limitations of regulatory changes that fail to comprehensively address the complex dynamics of healthcare affordability and access.

Without targeted measures to dismantle these financial mechanisms, efforts to expand coverage and close loopholes may achieve only superficial improvements. A significant portion of the population, particularly those managing chronic diseases, will continue to face insurmountable financial barriers to accessing essential treatments. This situation underscores the need for a more holistic approach to healthcare reform—one that confronts the financial mechanisms impairing patient care and seeks to eliminate systemic practices that prioritize profit over patient well-being.

Court Challenges: A Victory Shadowed by Continued Uncertainty

The battle against co-pay accumulators achieved a notable legal milestone when a federal court ruled these practices violated the Affordable Care Act's mandates. Despite this victory, the landscape remains fraught with ambiguity, largely due to the federal government's tepid response. The government’s retraction of its appeal in 2022, while upholding the court's decision, did not establish a nationwide prohibition on co-pay accumulators, leaving insurers in a legal gray area.

The HIV+Hepatitis Policy Institute has spotlighted the risk posed by the federal government's refusal to enforce the court's ruling against co-pay accumulators, shifting focus instead to addressing insurers' classification of certain drugs as “non-essential health benefits.” While the final 2025 Notice of Benefits and Payment Parameters rule curbs the classification of covered drugs beyond state benchmarks as non-essential, the government's inaction on co-pay accumulators marks a troubling disconnect between legal victories and their practical implementation.

This gap between legal wins and real-world application emphasizes the need for interventions at the state level. Louisiana's SB 210 emerges as a key measure, proposing tangible solutions to bridge the gap left by federal inaction and protect patients from the financial burdens imposed by insurers' exploitative tactics.

State Solutions: Louisiana as a Model

Louisiana's Legislative Response with SB 210

In an assertive move to safeguard healthcare affordability and accessibility, Senator Bob Owen's SB 210 targets the mechanisms of co-pay accumulators and the Essential Health Benefits (EHB) loophole. The legislation mandates comprehensive coverage under EHBs and holistic accumulator protections, ensuring all cost-sharing payments contribute towards the ACA's out-of-pocket maximums.

This legislative approach not only challenges the status quo but also highlights Louisiana's proactive stance in addressing healthcare disparities. By mandating that insurers recognize all federally designated EHB services and medications as essential, SB 210 directly confronts insurers' manipulative practices, ensuring patients receive the comprehensive coverage promised under the ACA.

Addressing the ‘Endless Deductible’

In a letter to the Louisiana State Senate Insurance Committee, CANN President and CEO Jen Laws warns that without robust protections like SB 210, insurers can impose what patients call "the endless deductible." This term illustrates the loophole that allows insurers to employ exploitative accounting practices, negating the ACA's intent to cap patient spending on healthcare. SB 210's provisions aim to close this loophole, ensuring patients are not burdened with exorbitant costs for essential treatments, thus preserving the ACA's core promise of affordable care.

In his letter, Laws reveals that Louisiana's health plan benchmarks do not guarantee coverage for essential cancer treatments such as radiation or chemotherapy, underlining the significance of SB 210. By ensuring that expenditures for such critical treatments are counted towards patients' out-of-pocket maximums, the bill offers a lifeline to those facing the daunting financial implications of treating life-threatening conditions. This measure is pivotal in bridging the gap left by the current healthcare system's shortcomings, providing patients with much-needed financial relief and access to life-saving treatments.

A Blueprint for National Reform

Louisiana's initiative serves as a compelling model for tackling the challenges posed by ambiguous EHB classifications, federal inaction, and exploitative co-pay practices. SB 210's success could inspire a wave of legislative efforts across the United States, advocating for a healthcare system that prioritizes patient well-being over payor profits. This approach highlights the potential for state-level innovations to influence national healthcare policy, paving the way for reforms that ensure healthcare accessibility and affordability for all, especially those living with chronic and life-threatening conditions.

Call to Action

The legislative changes proposed in Louisiana represent a critical juncture in the fight for healthcare affordability and access. To realize the full potential of these reforms, a concerted effort is needed from key stakeholders across the healthcare ecosystem:

For U.S. Policymakers:

Legislators at both state and federal levels must embrace proactive strategies to close the EHB loophole and regulate co-pay accumulator and maximizer use. Crafting and enacting policies that guarantee comprehensive coverage of essential health benefits and ensure all forms of patient assistance contribute towards out-of-pocket maximums are essential steps toward protecting patients from undue financial strain. Supporting state-level initiatives like Louisiana's SB 210 can serve as a foundation for broader national reforms, underscoring the importance of legislative action in safeguarding patient interests.

Healthcare Providers:

Medical professionals and healthcare institutions play a crucial role in advocating for their patients' rights and navigating the evolving insurance landscape. By staying informed about the implications of insurance policies on treatment access and affordability, healthcare providers can better support their patients in accessing the care they need. Engaging in policy discussions and supporting legislative efforts to address the EHB loophole and co-pay accumulator issue are necessary contributions to the broader push for healthcare reform.

Community Advocates and Patients:

The voices of patient advocacy groups and people affected by the healthcare system's complexities are instrumental in driving change. By raising awareness about the challenges posed by the EHB loophole and co-pay accumulators, mobilizing communities to demand reform, and sharing personal stories, advocates can influence policy decisions and encourage insurers to prioritize patient needs. Engaging in public discussions and advocating for policies that protect patients from harmful insurance practices are critical steps in building a more equitable healthcare system.

Actionable Next Steps:

• Reach out to state and federal representatives to express support for policies that ensure comprehensive coverage of essential health benefits and address the challenges posed by co-pay accumulators.

• Educate oneself and others about the impact of the EHB loophole and co-pay accumulators on healthcare affordability and access, leveraging resources and information provided by reputable patient advocacy organizations.

By uniting in the pursuit of meaningful healthcare reform, stakeholders across the spectrum can contribute to a future where healthcare accessibility and affordability are realities for all, especially for those facing chronic and life-threatening conditions. The journey toward closing the EHB loophole and eliminating unfair insurance practices demands collective action and unwavering commitment to patient well-being. Let's join forces to advocate for a healthcare system that truly serves the needs of its patients, ensuring equitable access to essential treatments and protections against financial hardship.

Focus on Hepatitis B: WHO's New Guidelines and Their Global Implications

At the 2024 Asian Pacific Conference for the Study of Liver Disease in Kyoto, the World Health Organization (WHO) introduced transformative guidelines for the prevention, diagnosis, care, and treatment of chronic Hepatitis B virus (HBV) infection. HBV is a major global health challenge affecting approximately 296 million people worldwide. If left untreated, it results in nearly 900,000 deaths annually from complications like liver disease and cancer.

The new guidelines aim to increase testing access and expand treatment eligibility, particularly in sub-Saharan Africa which accounts for 70% of all new HBV infections. They provide evidence-based recommendations based on updated scientific data about antiviral effectiveness, diagnostic test performance, and service delivery models. By simplifying testing and extending treatment eligibility, these guidelines address longstanding access barriers. They represent a significant step towards achieving the 2030 goal of eliminating HBV as a major public health threat.

Key Changes in the New Guidelines

The WHO's new guidelines focus on making HBV testing and treatment more accessible for those who need it most. Key changes include:

Simplified Testing Recommendations

The WHO's revisions highlight the importance of streamlined testing methods such as dried blood spot sampling and point-of-care viral load assessments. The goal is to expand early diagnosis. Coupled with community-based testing, these methods aim to enhance accessibility, particularly in areas with limited resources. They facilitate early intervention and aim to reduce the stigma associated with traditional diagnostic procedures.

There is also an emphasis on expanding testing among pregnant women to prevent transmission of HBV from mother to child during birth or through breastfeeding, which is the primary way the virus is transmitted.

Previous recommendations advised pregnant women with active HBV infection to receive temporary treatment until their child was fully vaccinated against the disease. The new guidelines take into account that not every health facility has the tests to determine if a woman has an active infection. They suggest that health care providers consider administering prophylaxis to pregnant women with HBV, even if they cannot determine the status of their infection.

Expanded Treatment Eligibility and Access

Nearly 300 million people currently live with HBV, and the disease causes approximately 820,000 deaths each year. Prior guidelines typically limited treatment to those with advanced liver disease or significant fibrosis, which made it challenging for patients to access care until their conditions had substantially deteriorated. The new guidelines propose a more inclusive treatment approach, expanding eligibility for antiviral therapy to millions more people. This change should increase the portion of people living with HBV eligible for treatment from the current 8% to 15% to around 50%. The World Health Organization now strongly recommends treatment for all people aged 12 and older who have chronic HBV and exhibit early signs of liver damage or other indicators, including co-infections such as HIV. The previous guidelines often recommended treatment only at more advanced disease stages and for patients above 30 years old, a significant hardship considering that 25% of infections in the region occur in people under 20.

The updated guidelines provide a more comprehensive approach to the management of hepatitis B virus (HBV) infection. These guidelines notably broaden the recommended treatments. Previously, the guidelines strongly advocated for single-drug therapies as the preferred treatment option. However, in recognition of the ongoing shortage of these single-drug therapies in some low- and middle-income countries, the updated guidelines now also endorse two dual regimens as alternate treatment options when the preferred monotherapies are not readily accessible.

This shift in treatment recommendations is a direct response to the pressing need to ensure that effective therapies are available in all regions, irrespective of their economic status. The scarcity of the preferred monotherapies in some parts of the world has necessitated the inclusion of the dual regimens in the guidelines.

Furthermore, the expansion of the recommended treatments is grounded in a growing body of scientific evidence. This evidence increasingly suggests that initiating treatment at an earlier stage of the disease can have a significant positive impact on long-term health outcomes for people living with HBV infection. Early intervention also has the potential to markedly reduce transmission rates. By taking this approach, we can address the global HBV burden more effectively and ensure a healthier future for those affected by this disease.

Improving Patient Support

Improvements in patient support mechanisms, such as the introduction of peer support and digital adherence tools, show a thorough and empathetic understanding of the many challenges faced by people living with chronic Hepatitis B virus (HBV) infection. These patient-focused initiatives, an evolution of the regulations that governed HIV testing and treatment, are based on real-world experiences and insights. They are carefully designed with two critical objectives in mind.

First, they aim to significantly enhance treatment adherence. This is crucial, as consistent adherence to prescribed treatment regimens is a key factor in the success of long-term antiviral therapy. Without proper adherence, the effectiveness of the treatment is compromised, potentially leading to less than optimal health outcomes for the people affected.

Second, these initiatives also aim to reduce the risk of drug resistance. Drug resistance is a major concern in managing chronic diseases like HBV, as it can make first-line treatments less effective over time. This can complicate the disease management process and potentially lead to worse health outcomes.

By addressing the dual challenges of treatment adherence and drug resistance, these improved patient support mechanisms represent a significant step forward in the comprehensive and patient-centered management of chronic HBV.

Integrating HBV into Existing Services

The guidelines suggest integrating existing HIV, tuberculosis, and primary care programs to offer streamlined services for Hepatitis B Virus (HBV). This leverages the existing infrastructures, resources, and patient engagement strategies of these programs, potentially resulting in early detection and effective management of HBV.

By making use of these existing programs, healthcare systems can effectively expand HBV services. This method ensures patients receive coordinated care for their various health needs, fostering a more holistic patient care approach. Not only does this integration yield immediate patient benefits, but it also presents long-term advantages for the entire healthcare system, aiding healthcare providers in efficient resource allocation and reducing overall costs. Additionally, the improved patient outcomes resulting from this integration could decrease the long-term expenses associated with managing chronic conditions.

Potential Impact of the Guidelines

The global impact of these guidelines could be transformative. By simplifying the diagnostic process and expanding treatment access, the WHO aims to significantly increase the rate of early HBV diagnoses. This method aims to improve health outcomes for people living with HBV, reducing liver cancer, cirrhosis, and other disease-related complications. Additionally, preventing HBV progression to severe liver diseases could substantially lessen the economic burden on global healthcare systems. This aligns with the WHO's goal of eliminating HBV as a public health threat by 2030. Experts anticipate:

• Increased Diagnosis and Treatment: Expanded eligibility and easier testing could lead to more HBV diagnoses and access to lifesaving antiviral therapy.

• Improved Health Outcomes: Earlier intervention and broader treatment may reduce rates of liver cancer, cirrhosis, and HBV-related deaths.

• Reduced Healthcare Costs: Preventing long-term HBV consequences could alleviate strains on healthcare systems and lower economic burdens.

Considerations for the United States

The WHO's new Hepatitis B guidelines could have significant implications for U.S. healthcare policy. Domestic adoption could improve HBV management in the U.S. and demonstrate the country's commitment to global health initiatives. While the WHO guidelines provide a global framework, their implementation in the U.S. requires policy-level action. Advocates could focus on:

• Streamlining Screening Programs: Encouraging community-based testing and simplifying recommendations could raise diagnosis rates, particularly in underserved populations.

• Expanding Access to Treatment: Prioritizing the removal of insurance-based barriers and addressing treatment access disparities.

• Implementing Supportive Care Models: Exploring strategies like peer support programs to improve patient adherence and ensure everyone benefits from treatment.

Aligning with the WHO's Hepatitis B guidelines requires substantial shifts in U.S. public health policy. This includes integrating streamlined testing protocols into existing healthcare frameworks for more accessible diagnostic services. Expanding treatment eligibility may require revising healthcare policies to include a broader range of HBV-affected populations. This could mean changes in insurance coverage and healthcare provider guidelines to implement broader treatment protocols.

The U.S. can lead global efforts in adopting these guidelines through its role in global health initiatives. By advocating for and implementing these guidelines, the U.S. can demonstrate the effectiveness of simplified and accessible HBV care, encouraging other nations to follow. This leadership role can include providing technical support, sharing best practices, and offering financial assistance to resource-limited countries, thereby enhancing global health security and moving closer to eliminating HBV as a public health threat by 2030. Researchers have estimated that $6 billion annually is needed to meet the global hepatitis targets in 67 low- and middle-income countries alone.

The WHO's revised guidelines for Hepatitis B management represents a significant step towards addressing this global health challenge. They provide a plan for simple, accessible, and effective HBV care, with a focus on early diagnosis and expanded treatment eligibility to enhance patient outcomes and reduce transmission.