Bipartisan Hepatitis C Elimination Plan Presents Critical Lame Duck Opportunity

The presidential election results have created an urgent six-week window for advancing the National Hepatitis C (HCV) Elimination plan. With significant changes to federal healthcare policy likely under the incoming administration, Senators Bill Cassidy (R-LA) and Chris Van Hollen (D-MD) see the lame duck session as a critical opportunity to secure this public health initiative. The legislation's prospects benefit from Senator Cassidy's likely chairmanship of the Senate Health, Education, Labor and Pensions (HELP) Committee in the next Congress, providing potential continuity for implementation oversight despite the broader administrative transition.

The Congressional Budget Office's analysis provides compelling economic justification for swift action. Current estimates indicate between 2.5 and 3.0 million people in the United States are living with HCV, yet only one in three people diagnosed receive treatment within 12 months. This treatment gap resulted in over 14,000 deaths from HCV-related complications in 2020 alone - deaths that could have been prevented with existing curative treatments that demonstrate 95% effectiveness.

The scope of this crisis demands federal intervention. State-level efforts, while demonstrating potential, have proven insufficient for achieving elimination goals. The Cassidy-Van Hollen legislation addresses fundamental barriers beyond medication costs, including provider education, treatment infrastructure, and implementation support. These comprehensive elements, combined with projected long-term savings, position this bill as a rare opportunity for bipartisan achievement in public health policy during a period of political transition.

Economic Analysis Reveals Complex Implementation Challenges

The Congressional Budget Office's June 2024 analysis examines two treatment expansion scenarios among Medicaid enrollees, revealing both significant savings potential and implementation complexities. Under a conservative 10% peak increase in treatment rates, averted healthcare spending would reach $0.7 billion over ten years against $0.5 billion in testing and treatment costs. A more aggressive 100% peak increase could generate $7 billion in averted costs against $4 billion in treatment expenses.

These projections, however, exclude critical implementation costs that could significantly impact program effectiveness. The CBO notes successful expansion requires substantial investment in outreach activities, provider education, and infrastructure development. As treatment rates increase, identifying and engaging people who need treatment becomes progressively more complex and costly - a challenge demonstrated by state-level experiments with subscription models.

Louisiana's program illustrates both the potential and limitations of cost-focused approaches. While reducing projected costs from $760 million to $35 million annually and treating over 1,600 people since 2019, treatment rates have steadily declined. Washington state's experience proves more concerning - treatment rates fell below pre-subscription levels, dropping from 6,649 prescriptions in 2017 to 2,409 in 2021.

The CBO's analysis particularly focuses on Medicaid enrollees, noting this population includes many people at elevated risk for HCV, including people who inject drugs and people who have been involved with the criminal justice system. This targeted approach allows for more precise cost projections while addressing a key demographic in HCV elimination efforts. Notably, the standard 10-year budget window may undervalue long-term benefits, as many health complications from untreated HCV develop over decades.

State experiences reveal important lessons for federal policy design. Washington's planned initiatives - including emergency room screening programs, mobile testing units, and expanded clinic access - remained largely unrealized due to budget constraints. Louisiana's model, despite demonstrating viable cost-control mechanisms, approaches expiration without renewal funding. These outcomes emphasize the need for sustained federal support rather than relying on state-level innovation.

Carceral Settings Reveal Critical Implementation Lessons

Treatment access in prisons provides critical insight into healthcare system readiness for HCV elimination. Despite controlled environments ideal for treatment delivery, systematic failures in carceral settings expose fundamental weaknesses in current approaches. Between 2014-2019, 1,013 people died from HCV-related complications while incarcerated, with the prison death rate reaching 10.0 per 100,000 people by 2019 - more than double the 4.3 per 100,000 rate in the general population.

State-level data reveals how policy choices, rather than medical constraints, drive treatment disparities. Florida reported 7,000 untreated cases in 2021 despite court-ordered treatment expansion. Texas provided treatment to only half of its known HCV-positive population of 11,301-15,563 people. Oklahoma's statistics prove particularly alarming - its prison death rate of 71.9 per 100,000 exceeds its general population rate by more than five times, despite the corrections department requesting nearly $100 million for increased treatment.

Recent investigations have catalyzed improvements in several states' treatment protocols. The FDA's 2024 approval of point-of-care testing technology enables rapid diagnosis and treatment initiation in carceral settings. However, implementation remains inconsistent across state systems, with many maintaining restrictive eligibility criteria that delay treatment until people develop severe liver damage. Texas, for example, still lacks universal screening protocols at intake facilities, leaving countless cases unidentified and untreated.

Legal challenges have prompted some progress. Florida, under court order, treated over 3,000 people between 2018 and 2021. Texas agreed to treat at least 1,200 people annually following a 2020 settlement. However, these court-mandated improvements highlight both the potential for rapid treatment expansion and the need for comprehensive federal policy to ensure consistent care delivery.

These systemic failures in controlled environments underscore broader implementation challenges. If consistent HCV treatment proves difficult in settings with stable populations and established healthcare infrastructure, addressing treatment gaps in the general population requires even more robust support systems and sustained funding commitments.

Implementation Barriers Demand Federal Solutions

Provider engagement represents a critical barrier beyond cost reduction. Despite HCV treatment's relative simplicity compared to managing diabetes, primary care providers often hesitate to initiate treatment. A recent study found that while 94% of specialists prescribe HCV treatment, only 23% of primary care providers do so. Insurance authorization processes exacerbate this reluctance - a single prior authorization request consumes 35 minutes of staff time responding to questions often designed to find denial justifications rather than facilitate treatment.

Geographic barriers particularly impact rural communities. In Louisiana, people in certain parishes travel 50-70 miles to reach HCV treatment providers. This distance barrier disproportionately affects people receiving Medicaid who often lack reliable transportation. Rural provider shortages compound these access issues - many rural clinics lack staff trained in HCV care, while others face chronic understaffing that limits capacity for managing complex prior authorization requirements.

Louisiana's experience highlights how workforce challenges undermine treatment expansion even when medication costs are controlled. The state's STI, HIV, and Hepatitis Program struggles with chronic understaffing due to uncompetitive wages and complex contracting arrangements. These staffing limitations directly impact program effectiveness - outreach activities decrease, patient engagement suffers, and treatment initiation rates decline despite medication availability.

The proposed federal legislation addresses these systemic barriers through targeted investments in:

• Provider education and ongoing support programs

• Infrastructure development for treatment expansion

• Resources for patient engagement and retention

• Support for innovative delivery models including mobile clinics

• Integration with existing healthcare systems and substance use treatment programs

• Workforce development and training initiatives

Early state experiences demonstrate that successful implementation requires simultaneous investment across these domains. Washington's inability to realize planned initiatives - including emergency room screening programs and mobile testing units - despite cost controls highlights the need for comprehensive federal support beyond medication access.

Political Window Demands Swift Advocacy Action

The lame duck session presents a rare confluence of political factors favoring HCV elimination policy. Senator Cassidy's likely ascension to HELP Committee chair in the next Congress, combined with his partnership with Senator Van Hollen, bridges current and future implementation efforts. The CBO's projection that a national elimination program could prevent 24,000 deaths and save $18.1 billion in healthcare costs provides compelling economic justification for swift action.

Recent developments strengthen the case for immediate passage. The FDA's approval of point-of-care testing technology enables rapid diagnosis and treatment initiation, particularly in high-impact settings. Louisiana's subscription model expiration creates urgency for federal intervention to sustain successful state initiatives. These factors, combined with potential changes to federal healthcare policy under the incoming administration, make the current legislative window critical for securing comprehensive HCV elimination policy.

The evidence from state experiences demonstrates both the promise and limitations of isolated initiatives. Federal legislation can build on these lessons, providing comprehensive support for implementation while ensuring sustained political commitment through bipartisan leadership. With only weeks remaining in the current congressional session, advocates must emphasize the unique opportunity this moment presents for achieving significant public health progress.

Conclusion

The opportunity for action is narrow, but the potential impact is immense. The bipartisan momentum behind the National Hepatitis C Elimination plan is a chance to advance public health policy at a time when it is desperately needed. The barriers are clear: implementation challenges, provider hesitancy, and geographic and economic obstacles. Yet the solutions are within reach, and the economic and human benefits are undeniable. Federal intervention can address the systemic gaps that state efforts alone cannot fill, providing comprehensive support to save lives and reduce costs.

However, uncertainty looms over the future of public health funding and support under a second Trump Administration, which looks to bring significant changes to federal healthcare priorities. This adds urgency to the current push for bipartisan action.

As advocates, the time to push is now. The lame duck session represents a rapidly closing window to secure funding, address legislative gaps, and ensure continuity into the next Congress. Swift passage of this legislation would not only demonstrate the power of bipartisan collaboration but also offer a meaningful legacy—one that saves thousands of lives and sets a precedent for effective, equitable public health initiatives in the United States. We cannot afford to let this window close without taking action.

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

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

The Scope of Medicaid Unwinding

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

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

Systemic Challenges in the Unwinding Process

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

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

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

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

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

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

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

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

National Enrollment Trends and State-Level Variations

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

Several factors influenced these disparities:

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

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

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

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

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

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

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

Racial and Ethnic Disparities in Medicaid Disenrollment

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

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

The Human Impact of Coverage Loss

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

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

• 75% reported worrying about their physical health

• 60% worried about their mental health

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

Impact on HIV Care and Policy Implications

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

Key considerations for PLWH during the unwinding process included:

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

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

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

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

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

Economic Implications of the Unwinding Process

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

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

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

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

Policy Recommendations and Best Practices

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

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

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

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

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

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

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

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

Addressing Systemic Inequities and Long-Term Solutions

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

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

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

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

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

Conclusion

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

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

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

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.

Beyond Medicine: Medicaid's Role in Bridging Healthcare and Housing

The evolving landscape of healthcare now acknowledges housing as a crucial element of well-being, marking a significant shift in public health recognizing certain goals advocates have trumpeted for decades - housing can be healthcare. Highlighted by a California Healthline article, this shift challenges old paradigms by recognizing stable, affordable housing as essential for optimal health outcomes. With states like California, Oregon, and New York at the forefront and thanks to a slew of waiver opportunitjes offered from the Biden Administration, some Medicaid programs are increasingly integrating housing services, reflecting a broader understanding that health is inextricably linked to our living conditions.

The Case for Housing as Healthcare: A Closer Look at the Evidence

The role of housing as a fundamental component of healthcare is being increasingly recognized among policymakers and supported by a growing body of evidence that underscores the critical impact of stable living conditions on health outcomes. The American Medical Association (AMA) has highlighted the essential nature of stable housing, pointing out that its absence significantly elevates the risk of various health issues, including severe infections that may necessitate amputation, and an increased likelihood of experiencing violent trauma.

Research featured in Health Affairs strengthens this viewpoint by establishing a clear link between housing stability and better health outcomes, emphasizing housing's non-negotiable position within a comprehensive healthcare framework. The benefits of stable housing can extend beyond physical health, with some studies showing significant mental health improvements through housing stability interventions, such as rental and foreclosure assistance.

The AMA further notes that people with access to stable housing are less prone to the stressors that lead to physical and mental health issues. Such environments reduce the risk of infectious diseases by providing a clean and secure living space conducive to health, facilitating easier access to medical care. Moreover, stable housing is linked to better chronic condition management, as it encourages an environment in which people can adhere to treatment plans and maintain regular contact with healthcare providers and is often accompanied with other medication necessities, such as food security and potable water.

Cost Savings and Healthcare Efficiency Through Housing

Integrating housing services into healthcare significantly enhances health outcomes and generates notable cost savings. By transitioning towards stable housing, reliance on high-cost healthcare services, such as emergency visits and hospital admissions, markedly decreases. A compelling study in Oregon demonstrated that providing affordable housing to nearly 10,000 individuals with unstable living situations resulted in a 12% reduction in Medicaid expenditures. Furthermore, this initiative increased outpatient primary care utilization by 20% and reduced emergency department visits by 18%, highlighting a shift towards preventive care.

This approach not only improves the health of Medicaid beneficiaries but also leads to more judicious healthcare spending. Allocating resources to housing services supports preventive care and vital services, amplifying the impact of stable housing on individual health and the overall healthcare system. Medicaid's strategic involvement in providing housing may prove a crucial tool for achieving better health outcomes and optimizing healthcare expenditure.

Medicaid Waivers and Housing Initiatives: Navigating New Pathways

The integration of housing services within Medicaid, facilitated by Section 1115 waivers and the innovative In Lieu of Services (ILOS) guidelines, represents a transformative approach to healthcare. These policy mechanisms are enabling states to address housing as a fundamental social determinant of health, acknowledging its critical impact on health outcomes.

Section 1115 Waivers: Expanding Medicaid's Reach

Section 1115 waivers grant states the flexibility to use Medicaid funds in novel ways that can include addressing housing instability, a key factor affecting health. The Kaiser Family Foundation reports on various state initiatives that leverage these waivers to directly tackle the housing needs of Medicaid enrollees. For example, some states have received approval to use Medicaid dollars for supportive housing services, such as helping people find and maintain stable housing. The programs with the best outcomes not o ly provide a method of entry but also work to ensure continuing housing stability. These waivers are instrumental in demonstrating how targeted housing support can lead to better health outcomes and reduced healthcare costs by minimizing the need for emergency care and hospital readmissions.

ILOS: Streamlining Support for Housing Needs

The Centers for Medicare & Medicaid’s (CMS) recent guidance on ILOS marks a significant policy shift, allowing Medicaid programs to offer housing-related services as enhancements to traditional medical interventions. This guidance enables states to provide a range of housing supports, including housing navigation assistance and one-time financial aid for security deposits or first month's rent. Importantly, while ILOS does not cover ongoing housing costs, it addresses critical barriers to stable housing for Medicaid enrollees, emphasizing the role of housing stability in achieving health equity.

State-Led Innovations in Housing and Health

States are at the forefront of integrating housing solutions within Medicaid, driven by the opportunities presented by Section 1115 waivers and ILOS guidelines. Shelterforce highlights innovative state programs that are setting precedents for how Medicaid can be utilized to support housing needs. For instance, initiatives that fund temporary housing for individuals transitioning out of hospital care not only provide immediate shelter but also contribute to better health outcomes and lower the likelihood of readmission. These programs exemplify the potential of Medicaid to address the holistic needs of its enrollees, underscoring the necessity of stable housing for overall health and well-being.

Through the strategic use of Section 1115 waivers and ILOS, Medicaid is evolving to meet the complex health and social needs of its enrollees. By recognizing housing as a critical component of healthcare, these policy innovations are paving the way for more integrated and effective approaches to improving health outcomes and advancing health equity. The success of state-led initiatives in leveraging these tools to address housing instability highlights the significant role of Medicaid in not only providing medical care but also in addressing the broader determinants of health.

Applying a Harm Reduction Perspective to Housing

Harm reduction in housing services adopts a compassionate approach, recognizing the varied challenges and needs of those facing housing instability. It emphasizes meeting people "where they are," providing flexible support without coercion, and respecting each person's autonomy and circumstances. This strategy is crucial for addressing the spectrum of housing stability, which ranges from homelessness to permanent, secure living situations. Each stage has unique health implications, with instability often worsening health conditions and hindering access to consistent healthcare.

Harm reduction aims to alleviate these health impacts by offering immediate, sometimes temporary, support to navigate towards more stable housing. This approach is vital for those with chronic health issues, mental health concerns, or substance use disorders, where a stable home can significantly influence health outcomes and quality of life. By tailoring services to meet personal needs—including healthcare access, mental health support, and substance use treatment—harm reduction in housing can effectively reduce the harms of instability and facilitate a path to stable living conditions.

Navigating Oversight in Medicaid's Housing Initiatives

The expansion of Medicaid to include housing services, aimed at addressing social determinants of health, introduces significant management and oversight challenges. A key concern is the potential for program exploitation, where resources meant for the most vulnerable are diverted or misused. The AIDS Healthcare Foundation (AHF) case, reported by the Los Angeles Times, exemplifies such risks, highlighting the need for stringent oversight to prevent organizations from prioritizing performance over patient care, qualityof life, and more permanent outcomes for program participants.

Ensuring Transparency and Accountability:

To counteract exploitation risks and guarantee the effective delivery of housing services, a strong emphasis on transparency, accountability, and comprehensive oversight is essential. The Center on Budget and Policy Priorities (CBPP) provides strategies for overseeing housing initiatives, stressing the importance of clear objectives, performance metrics, and consistent audits. These measures are vital for tracking service implementation, assessing health outcome impacts, and promoting ethical, efficient fund use.

Developing Robust Oversight Frameworks:

Implementing effective oversight requires layered scrutiny, including internal audits, external reviews, regular site audits, and autonomous, third-party feedback mechanisms for beneficiaries. Building partnerships across Medicaid programs, housing providers, healthcare entities, and community organizations can enrich oversight through varied insights and expertise. Such collaborative oversight efforts are pivotal in identifying and disseminating best practices, learning from experiences, and crafting innovative solutions to the intricate challenges of merging housing with healthcare services.

As Medicaid ventures into housing services, its success in enhancing health outcomes for vulnerable groups hinges on overcoming oversight hurdles. Committing to transparency, accountability, and strong oversight will protect against misuse, optimize resource allocation, and ensure housing's role as an integral part of comprehensive healthcare.

The Path Forward: Enhancing Medicaid's Role in Housing and Health Integration

As Medicaid evolves to more fully recognize housing as a crucial component of healthcare, a strategic and multifaceted approach is essential to ensure the effective integration of housing services. This approach should leverage the insights from recent policy developments and successful state initiatives, focusing on policy adjustments, increased funding, cross-sector collaboration, and robust oversight mechanisms.

Policy Adjustments and Increased Funding: A Foundation for Success

1. Policy Adjustments: Recent guidance on In Lieu of Services (ILOS) and the innovative use of Section 1115 waivers illustrate the potential for Medicaid to directly address housing instability. States should be encouraged to explore these and other policy tools to expand Medicaid's capacity to fund housing-related services, thereby acknowledging the profound impact of stable housing on health outcomes. Legislative and regulatory frameworks must evolve to support these changes, ensuring Medicaid can effectively contribute to housing stability for its enrollees.

2. Increased Funding: The expansion of housing initiatives within Medicaid necessitates substantial investment. This includes not only funding for direct housing assistance but also for the development of infrastructure that facilitates the delivery and coordination of services. Advocacy efforts are crucial to secure increased federal and state funding, aiming to bolster Medicaid's ability to meet the housing and health needs of its beneficiaries comprehensively.

Cross-Sector Collaboration: Building Bridges for Better Health

The success of housing initiatives within Medicaid is significantly enhanced by cross-sector collaboration. Partnerships among Medicaid agencies, housing authorities, healthcare providers, and community organizations are vital. These collaborations can draw on the strengths and resources of each sector to address the multifaceted challenges at the nexus of health and housing, creating integrated solutions that improve outcomes for individuals and communities alike.

Implementing Comprehensive Oversight and Adaptive Management

1. Comprehensive Oversight: To safeguard the integrity of housing initiatives and ensure resources are used effectively, a framework for comprehensive oversight is imperative. This framework should include clear implementation guidelines, success metrics, and regular evaluations to monitor impact and guide continuous improvement.

2. Adaptive Management: Effective management strategies are critical to navigate the complexities of integrating housing services within Medicaid. This includes ongoing training for program administrators and service providers, as well as the development of care models that seamlessly coordinate healthcare and housing services, ensuring that Medicaid enrollees receive the support they need to achieve and maintain stable housing.

The path forward for Medicaid's integration of housing services presents a unique opportunity to significantly improve health outcomes and advance health equity. By adopting a strategic approach that includes policy innovation, increased funding, cross-sector collaboration, and rigorous oversight, Medicaid can play a pivotal role in addressing the housing needs of its enrollees. This comprehensive strategy not only meets immediate housing challenges but also lays the groundwork for a healthier, more equitable future.

A Call to Action for Housing as Healthcare

The journey towards integrating housing into healthcare through Medicaid is not just a policy shift; it's a moral imperative. As we've seen, stable housing is not merely a foundation for individual well-being; it's a cornerstone of public health. The evidence is clear: when people have access to safe, stable housing, their health improves, healthcare costs go down, and communities thrive.

The Growing Burden of Medical Debt for Insured Americans

Health insurance, designed as a financial safeguard against illness and chronic conditions, presents a paradox in America: many insured individuals are burdened by substantial medical debt. This contradiction highlights systemic flaws in our healthcare system, where high out-of-pocket costs, aggressive debt collection by hospitals, and policy gaps create a crisis impacting financial stability, equitable healthcare access, economic mobility, and both financial and health disparities.

The Rising Tide of Medical Debt Among the Insured

Penelope Wingard's experience, a 58-year-old black woman from Charlotte, North Carolina, starkly illustrates the human cost of medical debt for the insured. After her breast cancer treatment in 2014, she faced a new challenge: escalating medical bills. Despite Medicaid coverage during treatment, she found herself uninsured and overwhelmed by costs for follow-up care. "My hair hadn’t even grown back from chemo, and I couldn’t see my oncologist," she recalls, underscoring the immediate financial burden of her illness.

Her financial woes deepened with subsequent medical issues, including an aneurysm and vision problems, leading to tens of thousands of dollars in debt. "It’s like you’re being punished for being sick," Wingard's experience reflects a broader trend affecting many insured Americans - not just the uninsured.

This trend is echoed in recent reporting by The Guardian, showing most hospital debt in the U.S. now involves insured patients, rather than uninsured patients, often due to high deductibles and unexpected out-of-pocket costs. The Kaiser Family Foundation’s 2023 Employer Health Benefits Survey further highlights it, noting a rise in high-deductible health plans, which, despite lower premiums, can lead to significant financial strain during medical emergencies. This change also represents employers selecting benefit designs that shift costs to employees or, more directly, a lower overall value of compensation packages.

Wingard's ordeal and these findings paint a concerning picture of U.S. healthcare, where insurance all too frequently fails to provide adequate financial protection, underscoring the need for a critical reevaluation of insurance structures and policies.

The Role of Hospitals and Aggressive Collection Practices

The medical debt crisis in the U.S. is worsened by many hospital systems, particularly so-called nonprofit hospitals, adopting aggressive debt collection tactics. A Nonprofit Quarterly article highlights that these hospitals, despite tax exemptions, often pursue lawsuits, wage garnishments, and home liens, exacerbating patients' financial woes.

The Human Rights Watch report, "In Sheep’s Clothing," reveals that about 60% of U.S. community hospitals are tax-exempt nonprofits, yet they spend significantly less on charity care than they receive in tax benefits, raising questions about their commitment to community service.

Additionally, the decline in charity care, vital for both uninsured and insured patients facing high out-of-pocket costs, is alarming. Hospitals' aggressive pursuit of unpaid bills, including legal actions and debt sales, seemingly contradicts their community-serving role and intensifies the medical debt crisis.

In response, legislative measures like New York State's Fair Medical Debt Reporting Act are emerging. This law, preventing hospitals from reporting unpaid medical debts to credit agencies, marks progress towards protecting patients and signals a shift towards more ethical debt management practices in healthcare.

Policy Gaps and the Need for Reform

The Affordable Care Act (ACA) and Medicaid Expansion stand as monumental efforts to increase coverage. Yet, the persistence of medical debt among the insured underscores a critical disconnect between policy intentions and real-world outcomes.

The ACA and Medicaid Expansion: Coverage vs. Cost

While the ACA and Medicaid Expansion have expanded healthcare access, they often fail to protect individuals from medical debt due to rising out-of-pocket costs. The Peterson-KFF Health System Tracker Brief indicates that the ACA’s maximum out-of-pocket limit is increasing faster than wages, burdening insured individuals with escalating healthcare expenses.

High-deductible health plans (HDHPs) exacerbate this affordability crisis. These plans, with lower premiums but higher initial costs, are increasingly common. The Kaiser Family Foundation’s 2023 Employer Health Benefits Survey shows a rise in HDHP enrollment, leading to significant debt for families as they pay more out-of-pocket before insurance coverage starts.

Coverage limitations under the ACA also contribute to this issue. Essential health benefits vary by state and plan, often leaving gaps in coverage for critical services like mental health or certain prescriptions. This variability, coupled with high deductibles, results in insured individuals facing substantial medical debt, contradicting the purpose of insurance.

Addressing this requires reevaluating health insurance structures and regulatory frameworks to balance affordable premiums with comprehensive, consistent coverage, reducing the risk of overwhelming medical debt for insured individuals.

Commonwealth Fund's 2023 Health Care Affordability Survey: Key Insights

The Commonwealth Fund's 2023 Health Care Affordability Survey reveals more than statistics; it highlights the real struggles of Americans with healthcare costs. The survey underscores the healthcare affordability crisis, showing that insurance doesn't always shield from financial burdens.

A major finding is the impact of high deductibles and copayments, which consume a significant part of many people's incomes, forcing tough choices like delaying medical care or incurring debt. Particularly affected are lower-income families, those with chronic conditions, and older adults, who often face a cycle of debt and deferred care, worsening health disparities.

The survey also points to a trend of underinsurance, especially in employer-sponsored plans with high deductibles, leaving many at financial risk. These insights call for urgent policy reforms to make healthcare truly affordable, focusing on reducing out-of-pocket costs, restructuring insurance plans, and enhancing subsidies for those in need.

State-Level Initiatives: Pioneering Change

States are at the forefront of combating medical debt with innovative solutions. The Commonwealth Fund State Protections report highlights diverse strategies to mitigate medical debt's impact.

Key initiatives include laws to limit aggressive hospital debt collection practices, crucial for protecting vulnerable groups like low-income families and those with chronic conditions. Some states have set legal boundaries on pursuing unpaid medical bills and capped interest rates on medical debt.

Expanding eligibility for charity care and financial assistance is another significant move. This broadening ensures more people, particularly those with limited resources, can access medical care without the fear of crippling debt, thereby improving community health outcomes.

States are also focusing on enhancing transparency in medical billing and insurance coverage, ensuring patients have clear information about service costs and their financial obligations. This clarity is essential for informed healthcare decisions and avoiding unexpected bills.

Furthermore, states are strengthening consumer protection laws to defend against unfair medical billing practices, holding providers and insurers accountable for billing errors and offering patients better dispute resolution options.

These state-level actions, varying in scope but united in purpose, demonstrate encouraging progress toward a more equitable healthcare system. They address not only the symptoms of medical debt but also several of the root causes, paving the way for broader healthcare reforms. These initiatives, alongside federal efforts, are shaping a future where healthcare affordability is accessible to all, not a privilege for a few. State governments' role in this fight is pivotal, with their policies and programs serving as models for national reform and effective strategies to alleviate medical debt.

Federal Actions: A Unified Approach with Enhanced Consumer Protection

Federally, initiatives like the White House Convening on Medical Debt and the Consumer Financial Protection Bureau's (CFPB) plan are key in combating medical debt. These efforts merge federal oversight with state innovation, addressing medical debt's complexities.

The White House Convening united federal and state policymakers, healthcare experts, and advocates to strategize on reducing medical debt and improving healthcare policies. This meeting was pivotal for sharing insights and identifying best practices for nationwide implementation, recognizing medical debt as a multifaceted issue.

Additionally, the CFPB's plan, noted in a National Consumer Law Center (NCLC) announcement, marks a significant move towards consumer protection. It proposes prohibiting medical debts from being reported on credit reports, a major relief for those burdened by medical debt. This initiative is widely supported by consumer groups and reflects an understanding of the disproportionate impact of medical debt on financial stability.

The collaboration of federal agencies like the Department of Health and Human Services, the CFPB, and the Centers for Medicare & Medicaid Services is crucial in formulating effective healthcare policies. Their joint efforts are expected to lead to comprehensive strategies that significantly alleviate the burden of medical debt.

This federal approach, emphasizing interagency cooperation and stakeholder engagement, is helping to create policies and practices that effectively reduce medical debt, integrating federal oversight with state-level innovation and consumer protection measures like the CFPB's plan. This integrated strategy is essential for relieving American families of medical debt and advancing towards a more equitable healthcare system.

The Blind Spot: Medical Credit Cards

Despite the good intentions of these proposals, a “blind spot” persists and more and more hospital systems are taking advantage of it by pressuring patients to agree to take on “medical credit” debt, prior to providing services - even in emergency departments. The most popular of these programs is known as “Care Credit” and the American public assumed some $23 billion in medical credit card debt across- more than 11 million users from 2018 through 2020. Unlike traditional medical debt, these medical credit programs accrue interest and do not qualify for financial assistance or charity care. They result in as much if not more damage to patient-consumer credit reports as traditional medical debt.

Once primarily limited to dental costs, which are not a required covered benefit for adults, the company that owns Care Credit says it believes patients typically generate this debt through “elective procedures”. However, patients urged to accept credit based medical debt in an emergency room or when facing cancer care or even in seeking dental care for an infected tooth may not feel these procedures are “elective” and the financial institution is not necessarily going to operate with the same definitions the general public would. Indeed, it does not serve Synchony’s interests to do so. In fact, Synchrony partners with multiple provider associations and as of 2023 with at least 17 hospital systems or about 300 hospitals but, when interviewed, refused to provide details because those agreements likely include “sponsorships” or what would otherwise be called a kick back scheme. That scheme structure is very likely prohibited by federal law protecting patients of public health programs like Medicare from providers and their affiliates that would take advantage of needy or elderly patients.

Once assumed as a means of paying for medical care, medical credit card debt reports just like traditional credit card debt and patient-consumers are no longer protected from those specific protections policymakers are considering now.

Conclusion and Call to Action

It's evident that this crisis is not just financial but a moral and systemic failure. The experiences of individuals like Penelope Wingard and findings from the Commonwealth Fund's 2023 Health Care Affordability Survey underscore the need for compassionate healthcare reform.

Policymakers, healthcare providers, patient advocates, and citizens must unite to address this crisis's root causes and reshape our healthcare system.

For Policymakers:

• Implement policies that go beyond expanding coverage to ensure affordability and accessibility.

• Reassess high-deductible health plans and their impact on families.

• Mandate comprehensive coverage in health plans, including closing the essential benefits loophole and ensuring network parity for services like mental health and chronic disease management.

• Enforce regulations ensuring hospitals commit to community-serving mandates, particularly in providing sufficient levels of charity care to justify nonprofit status. This can be implemented on both the state and federal levels.

For Healthcare Providers and Institutions:

• Prioritize ethical patient care over financial gains.

• Establish transparent billing practices and expand charity care programs.

• Collaborate with community organizations to identify and support vulnerable patients.

• Train staff in empathy and patient advocacy, focusing on the human aspect of healthcare.

For Patient Advocates and Community Members:

• Support legislation that protects patients from aggressive debt collection and unfair billing.

• Educate communities about their rights and resources regarding medical debt.

• Partner with local health systems to develop patient-centered care models.

For All Stakeholders:

• Collaborate to create a healthcare system that balances efficiency with empathy, justice, and accessibility.

• Strive to make medical debt a rarity, ensuring healthcare access for all, regardless of insurance status.

• Remember the human element in healthcare.

We possess the knowledge and resources to drive change. Let's collectively push for policies that safeguard the vulnerable and work towards a healthcare system where access is a right, not a privilege. The time to act is now and it is past time that our state and federal policymakers evaluate their allegiance to hospitals systems abusing government programs, the dollars that support those programs, and the patients those dollars are meant to benefit.

Unveiling Disparities: OIG Report on HIV Care in Medicaid

A recent report by the U.S. Department of Health & Human Services’ (HHS) Office of Inspector General (OIG) unveiled a startling revelation: one in four Medicaid enrollees with HIV may not have received critical services in 2021. At a time when healthcare systems worldwide were grappling with the COVID-19 pandemic, these findings highlight the compounded struggles faced by People Living with HIV (PLWH) in accessing essential care.

Beyond safeguarding the health of PLWH, viral suppression plays a pivotal role in curbing HIV transmission, a critical metric in the public health effort to end HIV. In alignment with HHS guidelines, achieving consistent viral suppression necessitates three foundational elements: routine medical consultations, ongoing viral load assessments, and unwavering commitment to ART regimens.

Unveiling the Care Gaps

The OIG's analysis reveals pressing challenges within our system:

• Out of the 265,493 Medicaid enrollees diagnosed with HIV, a startling 27% were missing evidence of receiving at least one of the pivotal services last year.

• 10% were missing evidence of medical visits, and 11% were missing evidence of an ART prescription, raising concerns around disease progression and higher incidence of AIDS diagnosis, increased risk of transmitting the virus, and developing antiviral resistance.

• The most pronounced gap? Viral load tests. A staggering 23% of enrollees lacked evidence of even a single viral load test in 2021. This absence not only impedes clinicians from making informed decisions but also hampers our collective ability to monitor and respond to the evolving nature of the HIV epidemic.

• Perhaps most concerning is the fact that more than 11,000 of these enrollees didn't have evidence of availing any of the three critical services. This is not just a statistic; it's a reflection of real individuals, facing amplified health risks due to system inadequacies.

Jen Laws, CANN's President and CEO, poignantly remarked, "Medicaid represents the greatest public program coverage of PLWH. It also represents the greatest public program coverage of people at risk of acquiring HIV. Medicaid compliance and efficacy is critical to Ending the HIV Epidemic and this report has identified gaps where states have failed to meet their obligations to Medicaid beneficiaries and where CMS has failed to ensure compliance. We must do better if we are going to reach our public health goals."

The report underscores stark disparities in care access between Medicaid-only and dual-eligible enrollees (those with both Medicaid and Medicare). Specifically, Medicaid-only enrollees were three times more likely to lack evidence of any of the three critical services compared to dual-eligible enrollees, with 6% of Medicaid-only enrollees missing out, as opposed to just 2% of the dual-eligible group. Such disparities might stem from various factors, including Medicare's higher fee-for-service rates and the observed long-standing adherence patterns among older adults who have had HIV for prolonged periods.

State-wide Disparities: A Complex Landscape

The disparities in HIV care access across states offer both a grim reality check and a clarion call for systemic reform. Drawing from the OIG report, certain states, notably Arizona, Arkansas, the District of Columbia, and Utah, have alarmingly high proportions of Medicaid-only enrollees without evidence of at least one of the three critical services. For instance, Utah stands out with a staggering 87% of such enrollees missing out on essential care. These aren't just numbers; they represent real individuals grappling with a system that's failing them.

Conversely, some states demonstrate better compliance and efficacy in delivering HIV care, which suggests potential models or strategies that could be emulated across the board. However, the stark variability across states points to the undeniable influence of state-specific policies, the quality of local HIV care infrastructures, and broader challenges associated with healthcare access.

State agencies clearly have much work ahead. These disparities not only indicate potential inefficiencies or gaps in policy implementation but also suggest a pressing need for introspection and reform at the state level. Coupled with challenges in the broader Medicaid system, there's a compelling case for a comprehensive overhaul.

The onus is on both state agencies and the Centers for Medicare & Medicaid Services (CMS) to rise to the occasion. The disparities, as evidenced in the report, necessitate a deep dive to understand the underlying causes. Is it a matter of policy misalignment, funding constraints, administrative challenges, or a combination thereof?

For instance, the significant variation in care access among dual-eligible enrollees, ranging from 9% to 53% across states, speaks volumes about the discrepancies in policy implementation and oversight. It's vital to pinpoint these issues, develop tailored interventions, and ensure that every Medicaid enrollee, irrespective of their state, receives the essential services they need.

The Pandemic's Shadow

The COVID-19 pandemic exerted immense pressure on healthcare systems, with profound implications for HIV care. The OIG report highlights the challenges faced by Medicaid enrollees with HIV during the COVID-19 pandemic. A significant finding from the report is the notable deficiency in viral load tests among these enrollees. This underscores the need for healthcare systems to effectively manage and prioritize essential services, even amidst broader healthcare crises. The report serves as a reminder of the importance of consistent and uninterrupted care for conditions like HIV, even when healthcare systems face external pressures.

Steering Towards a Brighter Future

Addressing the glaring disparities laid out in the OIG report goes beyond mere policy recalibration; it challenges our collective resolve to uphold equitable healthcare. In the shadow of the pandemic's aftermath, it's imperative that essential services for PLWH are not just nominally available but are genuinely accessible.

The OIG report's findings don't merely spotlight discrepancies; they highlight systemic lapses. States have fallen short in fulfilling their obligations to Medicaid beneficiaries, and the CMS has not adequately ensured compliance.

To translate this call to action into meaningful change, it's essential to:

1. Strengthen state-level accountability frameworks to ensure Medicaid obligations are met comprehensively, particularly among states utilizing Managed Care Organizations – ensuring those contracted for-profit insurance companies are meeting their contractual obligations to states. The tools for accountability already exist within these contracts, they merely must be used.

2. Bolster CMS oversight mechanisms, driving proactive interventions that hold states to account and rectify compliance lapses.

3. Engage in continuous dialogue with stakeholders, including healthcare providers and beneficiaries, to identify and remedy bottlenecks in care access.

The findings from the OIG report serve as a stark reminder of the work ahead. As Jen Laws aptly states, "We must do better." HIV advocates should consider assessing our engagement with their state Medicaid programs and look for opportunities to act, akin to our engagement Ryan White programs. With concerted efforts, policy reforms, and collective commitment, we can bridge the gaps and ensure comprehensive care for all PLWH.

Medicaid Unwinding is Going Terribly: By the Numbers

April 1st came quickly in the state of Florida this year. It was the day that began the unwinding of the state’s continuous coverage of Medicaid as part of the federal government’s COVID-19 pandemic response. Not every state began at the same time and the Biden Administration had issued guidance to states that amounted to “take your time, please. Don’t rush this.” But Florida, among other states, wasn’t so interested in taking advantage of waivers the Centers for Medicare and Medicaid Services (CMS) offered, to help ease the speed in which states might end up disenrolling patients thanks, in some part, to automated redeterminations. Now, these redeterminations are supposed to cross reference available tax and income data in order to tap the breaks some when it comes to financial eligibility of a beneficiary. How efficiently that’s happening, well… here’s some updates to paint the picture.

In June 2023, Kaiser Family Foundation (KFF) issued an analysis that between 8 million and 24 million beneficiaries would potentially lose coverage during the unwinding period (about 18 months), largely dependent on how states handled the redetermination process. As of their effort, KFF’s tracker estimates about 5.5 million beneficiaries have been disenrolled and about 8.9 million have retained their Medicaid coverage in the 45 states (and D.C.) providing data. Of those 5.5 million, about 1.15 million are children or about 43% in the states providing data with age breakouts (that is, only about 15 states). 74% of all disenrollments are for “procedural” reasons, rather than any determination of actual eligibility.

Florida is one of just two states to decline taking any of the 17 types of waivers CMS offered states to ease the unwinding process. Montana is the other. Every state received letters earlier in the month outlining CMS’ concerns regarding three core areas of concern, which are situated in requirements under federal law and regulations; slow application processing, long call center wait times, and high rates of people losing coverage due to paperwork issues. While 36 states got flagged for being weak on at least one criterion, five states were behind on all three: Alaska, New Mexico, Rhode Island and – you guessed it – Florida and Montana. 16 states were cited for long call center wait times. 16 states were cited for having not processed applications within a 45-day window.

Rhode Island is the only state that issued a statement to Politico in response to the letters saying that it was delaying ending coverage for families and children until the beginning of 2024.

Despite Florida having a relatively low disenrollment rate of 31% (Texas’ disenrollment rate is 72% and the highest in the country, 11 states have a disenrollment rate above 50%), families in the state have had enough. Representing two specific families and the families like them across the state, the Florida Health Justice Project and the National Health Law Program sued the state of Florida on August 22nd. One family’s toddler missed weeks of their cystic fibrosis medication after being cut off and the other had their one-year-old miss a routine vaccination after their provider notified them the appointment was canceled due to lack of coverage. Both families are alleging they were not properly notified or given the chance to appeal the decision before termination of coverage – both are federal requirements.

This is the type of claim the Biden Administration is going to be itching at intervening on because it validates the concerns they’re been broadcasting about the unwinding process.

With all that comes the very real risk of a judiciary changed by the previous administration taking aim at the federal government’s powers and programs targeted at helping poorer communities. Advocates exercising legal strategy should watch these developments closely and engage with their state and federal legislators to ensure the outcomes of these processes, be they executive or judicial, actually reflect what they intend.

Mid-Year Public Health Policy Update

Ya’ll…the last 4 months have been wild.

Let’s start with the “win”, shall we?

Last week, the Supreme Court of the United States (SOCTUS) issued its ruling in Talevski, authored by Justice Jackson and siding 7-2 in favor of patients’ private right of action to initiate lawsuits when their rights issued by law or regulation relative to a federally funded program are violated by an entity paid under that program. Now, the Taleski family still has to go back to district court to fight the Health and Hospital Corporation of Marion County (HHC) – SCOTUS just denied the effort by HHC to claim patients didn’t have a right to seek remedy when the payor was the government. As we described in January, this idea that patients couldn’t initiate lawsuits when federally funded programs weren’t administered fairly or didn’t comport with the statutory language or regulatory definitions is pretty bonkers. Indeed, for most actions regarding any kind of federally funded programming, the government typically comes in after the fact and those injured have to initiate the court processes themselves. Some advocates, particularly disability and Medicaid advocates, called the potential of the court to rule restrictively in Talevski “the Dobbs of Medicaid”, and urged the parties to consider settling ahead of a ruling. However, the potential crisis was averted because, as Justice Jackson put it, “Hewing to [the relevant statute]’s text and history (not to mention our precedent and constitutional role), we reject HHC’s request, and reaffirm that ‘laws’ in [the statute’s text] means what it says.”

Fancy that, laws meaning what they say.

Speaking of laws and problematic folks tryna skirt them, the 5th Circuit Court of Appeals heard oral arguments as to the stay – not the whole merits of the case – of Judge Reed O’Connor’s effort to strip the Affordable Care Act’s (ACA) preventative coverage mandate by way of extraordinary bigotry – targeting HIV prevention medication because “ewww, the gays”. As our friend, Chris Geidner, over at Law Dork covered those arguments and boy howdy! I wouldn’t wanna be Jonathan Mitchell – well for a lot of reasons but this one is pretty good, too. Mitchell’s name should look familiar as he’s arguing for book bans, helped author Texas’ head-hunting abortion law known as SB8, and is, in general, a deeply rotten human being. During thee oral arguments Mitchell fell more than a little flat, in no small part because the Department of Justice’s attorney, Alisa Klein, was gracious in asking “what’s the harm in putting in a stay?” In essence, she argued the physicians that Mitchell represented – who have themselves claimed to have never personally administered to an abortion or anyone needing HIV-related services but might, maybe, one day have to help a patient who experienced adverse events as a result of these extremely safe medications on the off chance they respond poorly to them – don’t actually have a tangible harm in putting off implementing O’Connor’s “universal remedies”, while some 2 million health plans as an industry and millions of patients across the country certainly will experience an impact if the ruling were to go into effect while being appealed. Mitchell kinda fell flat footed and basically asked the court to speculate what would happen if the stay wasn’t implemented. Hint: Courts aren’t actually supposed to pull conclusions out of thin air, “facts” must be presented inside of defined rules. So Mitchell then hedges cuz everybody suddenly seems real skeptical in how this might relate to standing and he asks of he can maybe meet with the DOJ to come up with some settlement agreement between the parties on the stay.

Now for the not so good news and there’s two bits to this one we’re gonna need to watch for quite some time; 1. Medicaid unwinding and 2. public health funding claw backs in the debt ceiling deal.

Last week, CANN hosted it’s third and final Community Roundtable in a series on COVID-19 impacts on public health and all the bad news is related to that intersection.

Because the House and the Senate voted to end the COVID-19 public health emergency a month early, Medicaid’s continuous coverage unwinding began pretty chaotically. To literally no one’s surprise, millions of folks are already losing their Medicaid coverage and not necessarily because they don’t qualify. The administrative or procedural disenrollments happen not because of a person or family no longer being qualified for Medicaid, but because a program administrator has not received necessary document responses. But the thing about that is, not a whole lot of folks who gained coverage for the first time during COVId-19 actually know a whole lot about the process, according to a Kaiser Family Foundation survey. And not every state is making it easy. Indeed, Arkansas and Florida are in a massive rush to get folks off Medicaid rolls – so fast that advocates are begging those states’ governors to slow down the process in order to reduce the risks of losing people to care who might otherwise qualify. Those states’ governors aren’t likely to respond to these pleas, despite guidance from the Centers for Medicare and Medicaid (CMS) to “not rush” the process. Those disproportionately at risk for being thrown off Medicaid are also those who are most at risk for acquiring HIV or already living with HIV and being covered by Medicaid. Again, about 40% of people living with HIV are covered by Medicaid, it stands to reason our patient population is at risk of potentially falling out of care if these processes are rushed.

Back in April, CANN reviewed annual sexually transmitted infection (STI) surveillance data released by the Centers for Disease Control and Prevention (CDC). In doing so, we pointed out the potential hazards of the Biden Administration failing to uphold its promise to reinvest in public health programming, specifically million dedicated to replenishing the workforce via disease intervention specialists (DIS). Those dollars were promised under the American Rescue Plan (ARP) but, as with all federal programs, take time to disburse. In the case of workforce development in state health departments, that means identifying an appropriate vendor to contract with to provide training, then contracting them to develop a curriculum, then giving guidance as to qualifying certification, then disbursing dollars to contract provider entities, then actually hiring people (in which there’s serious churn), training them, and so on. It takes time. But states weren’t quick to use those dollars and many of them remained unspent as the debt ceiling approached. A late-minute deal was struck between the White House and House Republicans in which certain public health funding allocated under the ARP are being clawed back. How this impacts our nation’s ability to provide meaningful public health services and address rising crises like STIs, we’ll find out in the worst possible way. For what it’s worth, our friends over at the National Coalition of STD Directors has called on the Administration to protect the public health workforce in light of the country’s first STI National Strategic Plan and how cutting those dollars risks any tangible ability to respond.

Advocates have tons more to pay attention to as the Biden Administration begins responding to this state legislative session’s “Hate Slate”, targeting LGBTQ people and our care. And because Congress is working to address things like reforming pharmacy benefit managers and 340B.

In all, advocates should work to focus on their strengths, strengthening relationships with service providers and legislators – sharing the human costs of these moves – and taking care themselves. With so much going on all of the time, we have to celebrate our wins while fighting for a fairer system serving patients. In order to do that, we have to also take care of ourselves.

Hepatitis C Medicaid Access Dashboard Provides 2023 Updates

In February, the Hepatitis C State of Medicaid Access project, operated by the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) and the National Viral Hepatitis Roundtable (NVHR), updated snapshot of the variety of restrictions and barriers to care prevalent in state Medicaid programs regarding accessing life-saving Hepatitis C (HCV) treatment. The project has been working to expand access to HCV treatment since 2014 and is a ready tool of state advocates seeking to end discriminatory program policies.

Last year, the project updated the monitored metrics to adjust to successes in advocating for policy and program changes but to also begin monitoring new ways programs are finding to restrict access to and coverage of care. Evidenced by the 2021 snapshot report citing changes since 2017, including 32 states having eliminated or reduced fibrosis restrictions, 21 states having loosened sobriety restrictions, and 25 states having scaled back provider restrictions, the 2022 report began tracking retreatment restrictions, disparities between fee-for-service (FFS) access and managed care organizations (MCOs) access policies, and “additional restrictions” including time-based lab requirements, past adherence to other prescription medications, and policies which prohibit replacement of lost or stolen medication. Restrictions not tracked yet but may be in the future include monthly prescribing limits and specialty pharmacy requirements.

The 2023 update notes that since 2022, seven states removed prior authorization requirements for most patients, no changes in fibrosis restrictions (with Arkansas and South Dakota being the only states remaining with this policy), six states having removed substance use restrictions, one state (Nevada) having removed prescriber restrictions, three states removing re-treatment restrictions, and, cumulatively, three more states have addressed disparities in FFS and MCO access to HCV treatment. Similarly, the 2023 snapshot also includes some nuanced updates with regard to prescriber restrictions, now noting a lack of restrictions for a “simplified” or “initial” treatment offering in Hawaii, Kansas, Kentucky, Utah, and West Virginia. Additionally, the FFS versus MCO access portion introduced layers of understanding, segregating out states which do not use MCOs from the overall graphic. While Colorado, Ohio, New York, and West Virginia addressed the issue of additional restrictions or a lack of transparency, Texas took a step backwards and found itself being added to the list of states with a lack of clarity and additional MCO restrictions on HCV care. One hallmark metric of the project also received a “facelift” by introducing a “grading” system for each state’s prior authorization policies, ranking from “A+” to “F”; 9 states received an A+ for having no prior authorization requirement for most patients, 12 states received an A for having removed prior authorization requirements for most patients and having minimal restrictions, 11 states received a B for removing prior authorization requirements for most patients with some restrictions, 12 states received a C for requiring all patients to obtain prior authorization though having few restrictions on accessing care, 6 states received a D for requiring prior authorizations for all patients with “many restrictions”, and 2 states received an F due to requiring all patients to obtain prior authorization and having “harsh” restrictions.

The snapshot and grade systems have proven to be extraordinary tools in targeting advocacy, including litigation, to improve access to curative HCV treatment for Medicaid patients. Recognizing access to care is not granted, even in public payer programs, also allows advocates and policymakers to make more conscious policy decisions and empower practical programmatic design aimed toward benefiting highly affected communities.

Areas of additional support are necessary as payer policy is but one barrier to care. Advocates can and should seek changes which address provider discrimination, incentivize screening by way of establishing HCV screening as a standard of care or otherwise covered in a state’s “essential health benefit” design, and encouraging policymakers to address disparities in screening and treatment in carceral settings. Addressing HCV in carceral settings might start by requiring state prisons and local jails to report these metrics to state health departments on a regular basis, rather than hiding data behind jail systems which require and are often slow to respond to public records requests.

Much work remains and we’re ever grateful to our friends over at CHLPI and NVHR for their astounding work.

Of Pride and Prejudice: Biden Administration Combats State Discriminatory Actions

Fairly regularly, our CANN Blog tends to highlight impacts of various public health actions as they relate to LGBTQIA+ populations because these communities are disproportionately impacted by a variety of social determinants of health as found in the 2015 United States Transgender Survey, conducted and published by the National Center for Transgender Equality (NCTE). It’s important to note, NCTE will be launching data gathering efforts later this year to provide updated data. Public health programs have long been leveraged to either help or harm (often via neglect of data pointing toward broader protections and specific programming) trans and non-binary people, depending on the ideological lean of the administration issuing regulations and rules, both on the federal and state levels.

2022 has been particularly challenging for transgender youth. We’ve witnessed state legislatures and governors through administrative agencies have sought to limit access to gender-affirming care. There remains deep community concern, despite some governors vetoing sports and health care related bills, judges regularly ruling against these actions, a lack of clear political support, and commitments from the Biden Administration to defend the rights of transgender people. These actions, however, aren’t just limited to transgender youth. Florida, for example, is currently proposing a rule that would prohibit the state’s Medicaid program from covering gender-affirming care for anyone, again, despite similar rules and laws having been struck down as recently as November 2021. (Editor’s Note: Florida’s rule, by the way, is open to public comment through July 8th.) Advocates for equitable access to care in public health programs and concerned on issues of health equity should readily take the time to comment. Public comment on state and federal rulemaking is a key element for policy engagement and can sometimes be used to reflect bad faith efforts on the part of these regulatory agencies, as was seen when Kentucky’s Medicaid work requirement waiver was initially squashed for failing to adequately address concerns raised in public comments.

In response to these moves, the Biden Administration has issued new executive orders including directing various agencies to assess more appropriate data gathering of sexual orientation and gender identity (SOGI) data of people participating in federally funded programs. Additionally, Biden has directed federal agencies to review existing data for information on when LGBTQIA+ youth and parents are separated from their families in child welfare matters, and issue rules to both define discrimination and protect LGBTQIA+ people from discrimination in federally funded programs. Indeed, on June 23rd, the U.S. Department of Education released a proposed rule that would extend certain protections for transgender students and seeks to further protect sexual assault and harassment victims in educational settings. An additional rule is expected later this year which would provide guidance on integrating transgender youth into school sports. We’re also still awaiting – any day now – the U.S. Department of Health and Human Services issue a new proposed rule regarding the Affordable Care Act’s non-discrimination provision known as Section 1557. The Trump Administration sought to narrowly define these protections in 2020, but it was blocked shortly after the U.S. Supreme Court issued its decision in Bostock v. Clayton County when a federal judge ruled against the Trump Administration after noted health clinic Whitman Walker sued to stop the discriminatory rule from going into effect.

These state efforts are aimed at finding “carve outs” to the precedents and rules protecting transgender people from stigma, violence, and discrimination merely as a political tactic. But just because this population is being used as a political football, doesn’t mean there aren’t severe public health consequences, some which may reach beyond the issue of gender identity. “Trans health is the canary in the coal mine,” a long-time advocate, Riley Johnson, said to me when discussing Florida’s effort to limit access to gender affirming care in its Medicaid program. “Once they can redefine ‘medically necessary’ to mean whatever they want it to mean, despite standards of care, every legitimate medical association, and decades of data, who’s to say they don’t decide to re-define ‘medical necessity’ for people living with HIV or STIs or hepatitis C, and return us to the days of moralistic ‘you did this to yourself’ or ‘it’s a choice’.” Johnson continued, “It’s real easy to look at substance users and decide their care doesn’t matter when we’re looking for reasons to justify the cruelty of denying people life-saving care.”

Johnson is correct in highlighting how bias-driven rulemaking affecting public health programs turns into a slippery slope. Experienced advocates should be mindful of intersecting issues of public health and encourage those budding advocates to take advantage of these…interesting times to build their knowledge, engage in policy development and evaluation processes, and invest in strengthening the public health advocate pipeline.

Treatment Restrictions Hampering Hep C Harm Reduction Efforts

In January, Harvard’s Center for Health Law and Policy Innovation (CHLPI) and the National Viral Hepatitis Roundtable (NVHR) issued their 7th update to the Hepatitis C: State of Medicaid Access report. Originally published in 2017, the report seeks to evaluate and document the nuances of Hepatitis C treatment access in state Medicaid programs and was borne out of the payer originated barriers instituted after curative direct acting agents (DAAs) came to market as concerns over cost rose, especially in light of the fact that a patient being cured does not mean they cannot be re-infected and the most at-risk population for contracting HCV are drug users. The combination of moralized policy making and fiscal fears set the stage for Medicaid to offer curative HCV treatments as a “yes, but…” situation.

Medicaid coverage of treatment came with layers of restrictions on patients and providers alike. From more common utilization management practices, like prior authorizations, to restrictions in who can access treatments (sobriety and fibrosis requirements) and requiring patients to visit a specialist in order to receive coverage (when a primary care physician should be able to manage the necessary care), barriers abound. Harm reduction advocates rightly pointed out refusing treatment coverage worked against best practices in interrupting HCV chains of transmission. Indeed, the American Association for the Study of Liver Diseases has strongly discouraged sobriety requirements because doing so artificially inserts barriers to care and harms public health efforts to eliminate HCV, stating:

… there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, miss an opportunity to decrease HCV transmission, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Instead, scaling up HCV treatment in PWID is necessary to positively impact the HCV epidemic in the US and globally.

The pushback against the moralized argument, which frames drug users as “unworthy” of receiving potentially life-saving care, is that people who use drugs are still patients and we don’t get to tell patients how to prioritize their care based on a payer or provider’s biases. Just as providing gender affirming care results in improved health outcomes in transgender people living with HIV, providing people who use drugs with the medical care they need to cure HCV improve the behavioral health factors that contributed to drug use in the first place.

CHLPI and NVHR’s work has contributed to awareness of these policy issues, with the updated report being used as an effective tool in advocacy for removing these unethical restrictions on accessing HCV treatments. Since the 2017 report, 33 states have eliminated or reduced their fibrosis requirements, 29 states have eliminated or significantly relaxed their sobriety requirements, and 28 states have reduced their qualifying prescriber requirements.

Similar qualitative evaluation of other “harm reduction” policies, should be done to consider how these policies may potentially work against the goals of why they were instituted in the first place; including but not limited to Good Samaritan laws (where carve outs for those reporting over doses may result in the reporter being charged with a crime, rather than protected for seeking help) and “lock-in” laws and policies (where a patient may not be allowed to seek a different pharmacy or provider). In each of the two examples, people who use drugs are discouraged from engaging with public service personnel by disempowerment and threat of criminalization, risking either losing a patient in care or losing a life.

The mark of quality policy making, much like the mark of good science, is being willing and able to consider changing things when the facts of a given situation change or the available information changes. 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. And we have to learn not to repeat our mistakes in the coverage restrictions finally falling out of favor.

2022: New Beginnings, New Changes

The Community Access National Network (CANN) ushers in a new beginning with the 2022 New Year, evidenced not only by the changing of the guard with our new President & CEO, but also with some important programmatic changes with our organization. We felt it important to share these changes with you.

Our weekly blog, previously branded as the HEAL Blog (Hepatitis Education, Advocacy & Leadership), is being repurposed to serve our broader mission “to define, promote, and improve access to healthcare services and supports for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking.” As such it is now the CANN Blog, and its areas of interest will focus on HIV/AIDS, viral hepatitis, substance use disorder, harm reduction, patient assistance programs (PAPs), Medicare, Medicaid, and the ongoing Covid-19 pandemic and its impact on public health. In keeping with the desire to monitor broader public health-related issues and appropriately engage stakeholders, our CANN Blog will be disseminated to a larger audience. Therefore, some of you may notice one more email in your inbox each Monday morning since we’re employing our general listserv to share the blog posts. It is our hope that you’ll deem the added email of value and thus maintain yourself on our listserv.

Additionally, our acclaimed HIV/HCV Co-Infection Watch will also be shared with our general listserv. But don’t worry, it only means one additional email each quarter! The HIV/HCV Co-Infection Watch offers a patient-centric informational portal serving three primary groups - patients, healthcare providers, and AIDS Service Organizations. The quarterly Watches are published in January, April, July, and October.

In 2022, our Groups will also be more active. Since 1996, our National ADAP Working Group (NAWG) has served as the cornerstone of CANN’s advocacy work on public policy. Whereas NAWG will continue to engage our HIV/AIDS stakeholders with monthly news updates, we will also convene periodic stakeholder meetings to discuss important issues facing the HIV community. Likewise, our Hepatitis Education, Advocacy & Leadership (HEAL) Group has served as an interactive national platform for the last decade on relevant issues facing people living with viral hepatitis. Periodic stakeholder meetings to discuss important issues facing the Hepatitis community will now complement the HEAL monthly newsletter. If you would like to join either the NAWG or HEAL listserv, then please do so using this link.

CANN will also launch its 340B Action Center this year. It is designed to provide patients with content-drive educational resources about the 340B Drug Discount Program and why the program matters to you. The importance of the 340B Program cannot be under-stated, and CANN remains committed to taking a balanced “money follows the patient” approach on the issues facing the program and advocating for needed reforms.

Finally, like most advocacy organizations, CANN is constantly evaluating whether it is safe (or not) to host in-person stakeholder meetings. Covid-19 has changed the advocacy landscape. Over the last two years our two signature meetings (Community Roundtable and Annual National Monitoring Report on HIV/HCV Co-Infection) have been hosted virtually, rather than in-person. CANN is taking a “wait and see” approach on how best to proceed in 2022 with these events. We will keep you apprised of our decision.

As we close the door on 2021 and open it for 2022, CANN looks forward to working with all of its community partners, industry partners, and you!

Coverages & Pitfalls: Pandemic-Related Health Care Expansion

On September 17th, the Centers for Medicare and Medicaid Services (CMS) announced its first complete rule on health care marketplaces (federal and state – HealthCare.gov and SBEs), certain expectations of insurers participating in the health care marketplace, and a slate of other issues. This final rule serves as a regulatory tool amid a raft of information the federal government has provided regarding health insurance coverage during the pandemic.

Portions of the rule were fairly well expected (extending the annual open enrollment period from the slimmed down 45 days the previous administration imposed and revamping the “navigators” program), while other portions sought to more narrowly address – read “stop” or “reverse” – changes from the previous administration (specifically those introduced in 2018 and others introduced on January 19, 2021). The rule also aims to address some pressing concerns from legislators and health care access advocates about affordability of insurance as the economic future of the country remains unstable with the COVID-19 pandemic still wreaking havoc on much of the country.

One September 14th and 15th, the Census Bureau and the Department of Health and Human Services (HHS), respectively, issued data related to insurance coverage among residents of the United States in 2020 and 2021. The Census data diverged slightly from the HHS data in that the Census data did not show an increase in the number of people enrolled in Medicaid from 2018 to 2020, whereas previously released CMS data had shown a substantial increase (15.6% or about 10.5 million people) in Medicaid and Children’s Health Insurance Program (CHIP) enrollment from February 2020 through March 2021. A report from the Urban Institute cites potential for the remainder of 2021 to net an additional 17 million people enrolled into the safety net health insurance programs. All of this coincides with the Census data showing the uninsured rate was near static from 2018 to 2020 (8.6% compared to 8.5%).

This is a pretty remarkable comparison, given the pandemic’s effects on the country’s economy. The Census does cite a reported drop in employment related coverage during 2020, with the highest rate of employer sponsored coverage drop occurring among those employed less than full-time. Indeed, the data shows the largest drop in employer sponsored coverage occurred for those at the lowest end of the compensation scale.

Part of why tying together the employment data of the Census and the Medicaid and CHIP enrollment growth data together is to better understand the severe risks to vulnerable people and families as the seeks to wrap up the public health emergency declarations (likely sometime next year). While the administration’s payment rule highlights efforts to keep afloat lower- and middle-income families afloat and insured, the same can’t be said of the lowest-income earners. While the Biden Administration has extended the period for states to return to enrollment recertifications for Medicaid, federal matching funds (a boosted benefit to states during the pandemic) are expected to end on a similar timeframe, giving states some added financial motivation to move through disenrolling current recipients quickly, rather than in a staggered fashion.

While we outlined steps state Medicaid programs and safety net providers could take at the wrap up of the PHE in a blog earlier this month, the Biden Administration must seek even more moves than currently planned, to ensure “back to normal” doesn’t amount to “back to broke” for low-income families across the country.

Biden Administration’s Healthcare Future is One of Promise & Peril

Last month, the Biden Administration issued a press release outlining a look toward the future of American health care policy. Priorities in the presser include ever elusive efforts around prescription drug pricing and items with steep price tags like expanding Medicare coverage to include dental, hearing, and vision benefits, a federal Medicaid look-alike program to fill the coverage gaps in non-expansion states, and extending Affordable Care Act (ACA) subsidies enhancements instituted under the American Rescue Plan (ARP) in March. Many of these efforts are tied to the upcoming $3.5 trillion reconciliation package.

President Biden renewed his call in support of the Democrats effort to negotiate Medicare prescription drug costs, enshrined in H.R. 3. Drug pricing reform has been an exceptional challenge despite relatively popular support among the voting public, in particular among seniors. The pharmseutical industry has long touted drug prices set by manufacturers do not represent the largest barriers to care and mandating lower drug costs would harm innovation and development of new products. Indeed, for most Americans, some form of insurance payer, public or private, is the arbiter of end-user costs by way of cost-sharing (co-pays and co-insurance payments). To even get to that point, consumers need to be able to afford monthly premiums which can range from no-cost to the enrollee to hundreds of dollars for those without access to Medicaid or federal subsidies. The argument from the drug-making industry giants is for Congress to focus efforts that more directly impact consumers’ own costs, not health care industry’s costs. Pharmaceutical manufacturers further argue mandated price negotiation proposals would harm the industry’s ability to invest the development of new products. To this end, the Congressional Budget Office (CBO) recently released a report giving some credence to this claim. The CBO’s report found immediate drug development would hardly be impacted as those medications currently “in the pipeline” would largely be safe, but a near 10% reduction in new drugs over the next 30 years. While new drug development has largely been focused on “personalized” medicine – or more specific treatments for things like cancer – implementing mRNA technology into vaccines is indeed a matter of innovation (having moved from theoretical to shots-in-arms less than a year ago). With a pandemic still bearing down on the globe, linking the need between development and combating future public health threats should be anticipated.

The administration’s effort to leverage Medicare isn’t limited to drug pricing. Another tectonic plate-sized move would seek to expand “basic” Medicare to include dental, hearing, and vision coverage. Congressional Democrats, while generally open to the idea, are already struggling with timing of such an expansion, angering Senator Bernie Sanders (I-VT) by suggesting a delay until 2028. While any patient with any ailments related to their oral health, hearing, and vision will readily tell you these are critical and necessary coverages, even some of the most common of needs, the private health care insurance industry generally requires adult consumers to get these benefits as add-ons and the annual benefit cap is dangerously low (with dental coverage rarely offering more than $500 in benefit and vision coverage capping at one set of frames, both with networks so narrow as to be near meaningless for patients with transportation challenges). While the ACA expanded a mandatory coverage for children to include dental and vision benefits in-line with private adult coverage caps, the legislation did nothing to mandate similar coverages for adults and did not require private payers to make access to these types of care more meaningful (expanded networks and larger program benefits to more accurately match costs of respective care).

The other two massive proposals the Biden Administration is seeking support for, more directly impact American health care consumers than any other effort from the administration: maintaining expanded marketplace subsidies and a federal look-a-like for people living in the 12 states that have not yet expanded Medicaid under the ACA’s Medicaid expansion provisions. The administration has decent data to back this idea, as the Centers for Disease Control and Prevention released a report showing a drop in the uninsured rate from 2019 to 2020 by 1.9 million people, largely attributed by pandemic-oriented programs requiring states to maintain their Medicaid rolls. The administration and Congressional Democrats are expected to argue subsequently passed legislation allowing for expanded subsidies and maintained Medicaid rolls improved access to and affordability of care for vulnerable Americans during the pandemic. As the nation rides through another surge of illness, hospitalizations, and death from the same pandemic “now isn’t the time to stop”, or some argument along those lines, will likely be the rhetoric driving these initiatives.

Speaking of the pandemic, President Biden outlined his administration’s next steps in combating COVID-19 on Thursday, September 9th. The six-pronged approach, entitled “Path out of the Pandemic”, includes leveraging funding to support mitigation measures in schools (including back-filling salaries for those affected by anti-mask mandates and improving urging the Food and Drug Administration [FDA] to authorize vaccines for children under the age of 12), directing the Occupational Safety and Health Administration (OSHA) to issue a rule mandating vaccines or routinized testing for employers with more than 100 employees (affecting about 80 million employees) and mandating federally funded health care provider entities to require vaccination of all staff, pushing for booster shots despite the World Health Organization’s call for a moratorium until greater global equity in access can be attained, supporting small businesses through previously used loan schemes, and an effort to expand qualified health care personnel to distribute COVID-19 related care amid a surge threatening the nation’s hospitals ability to provide even basic care. Notably missing from this proposal are infrastructure supports for schools to improve ventilation, individual financial support (extension of pandemic unemployment programs or another round of direct stimulus payments), longer-term disability systems to support “long-COVID” patients and any yet-unknown post-viral syndromes, and housing support – which is desperately needed as the administration’s eviction moratorium has fallen victim to ideological legal fights, states having been slow to distribute rental assistance funds, and landlords are reportedly refusing rental assistance dollars in favor of eviction. While the plan outlines specific “economic recovery”, a great deal is left to be desired to ensure families and individuals succeed in the ongoing pandemic. Focusing on business success has thus far proven a limited benefit to families and more needs to be done to directly benefit patients and families navigating an uncertain future.

President Biden did not address global vaccine equity in his speech, later saying a plan would come “later”. The problem, of course, is in a viral pandemic, variant development has furthered risks to wealthy countries with robust vaccine access and threatened the economic future of the globe.

To top off all of this policy-making news, Judge Reed O’Connor is taking another swing at dismantling some of the most popular provisions of the ACA. Well, rather, yet another plaintiff has come to the sympathetic judge’s court in an effort to gut the legislation’s preventative care provisions by both “morality” and “process” arguments in Kelley v. Becerra. The suit takes exception to a requirement that insurers must cover particular preventative care as prescribed by three entities within the government (the Health Resources Services Administration – HRSA, the Advisory Committee on Immunization Practices – ACIP, and the Preventative Services Takes Force – PSTF), which require coverage of contraceptives and pre-exposure prophylaxis (PrEP) with no-cost sharing to the patient, among a myriad of other things – including certain vaccine coverage. By now, between O’Connor’s rabid disregard for the rights of lesbian, gay, bisexual, and transgender Americans and obsessive effort to dismantle the ACA at every chance he can – both to his own humiliation after the Supreme Court finally go their hands on his rulings – Reed O’Connor may finally have his moment to claim a victory – I mean – the plaintiffs in Kelley may well succeed due to the Supreme Court’s most recent makeover.

As elected officials are gearing up for their midterm campaigns, how these next few months play out will be pretty critical in setting the frame for public policy “successes” and “failures”. Journalists would do well to tap into the expertise of patient advocates in contextualizing the real-world application of these policies, both during and after budget-making lights the path to our future – for better or worse.

Post-PHE: Continuity in Care for Vulnerable Populations is Critical

On July 20th, the United States extended its existing declaration of Public Health Emergency (PHE) in response to the COVID-19 pandemic for 90 days. Previously, the PHE had been renewed 6 times under the previous and current administrations. The PHE declaration may be extended past October 20th, 2021, should the Secretary of Health and Human Services (HHS), Xavier Becerra, renew the declaration.

Pandemic response and relief funding from the federal government has come with strings attached in order to ensure those funds are directed toward those who need the help the most. Most of these strings operate as both “stick and carrot” and one of the more interesting “carrots” was the increase of federal dollars supporting state Medicaid programs for the trade-off of maintaining those Medicaid rolls, temporarily ceasing redetermination and reenrollment activities, allowing people to remain on Medicaid rolls through the PHE without having to go through the usual hoops of proving their eligibility on a more regular basis.

While the previous administration directed states to anticipate a return to usual work after the PHE, engaging in a massive redetermination effort inside of 6 months of the PHE ending, earlier this month, the Biden administration informed states that redetermination period would be extended to 12 months in order to avoid an artificial “bulge” of redeterminations and eligibility checks and, ultimately, a potential annual cycle of concentrated renewals in a short window of time. It’s important to remember, as we discuss Medicaid redetermination, rules vary by state and those disenrolled during redetermination are not necessarily ineligible, they may merely not have had an opportunity to respond to a request for information for a variety of reasons.

The guidance from the Biden Administration speaks directly to this issue, stating states should consider providing a “reasonable” amount of time for clients to provide additional information for redetermination. The administration’s idea of a reasonable amount of time is 30 days. Louisiana, as an example, typically only allows for 10 days from the date in which a paper letter has been mailed to a Medicaid recipient for that same recipient to respond. If the recipient is ill, needs to gather supporting evidence from multiple sources, the mail is slow, or any number of factors outside of their control, they may be unceremoniously disenrolled. A mass redetermination effort in a shortened period of time runs a significant risk of disenrolling otherwise eligible clients but for a process that leaves less than no room for delay or mistake. Indeed, a 2019 report from Louisiana’s Health department found that 85% of eligibility cases were closed for a lack of response to a request for information. Louisiana isn’t alone in these burdensome processes, which on the surface, appear to be aimed at discouraging residents from accessing Medicaid by way of process burden.

Overall, Medicaid and the Children’s Health Insurance Program (CHIP) saw an increase in enrollment starting in March 2020 and continuing today, though with a slower pace, after at least 2 years of decreasing enrollment, according to a Kaiser Family Foundation report. The same report shows Medicaid program enrollment has increased by about 20% - to about 81 million people – since February 2020 and expects many remain on Medicaid and CHIP rolls as a result of economic uncertainty and instability. 

At the intersection of Medicaid, COVID, and economic uncertainty are vulnerable communities, experiencing some of the highest rates of viral hepatitis and HIV. A tertiary benefit of Medicaid’s maintenance of coverage through the public health emergency is those living with viral hepatitis and HIV have been able to more readily seek coverage and care. The problem is a complete lack of “warm hand-off” between Medicaid programs and other assistance programs clients could be significantly advantaged by. Particularly, because of the overlap in intersections of oppression and risk (which some more readily recognize as “social determinants of health”), AIDS Drug Assistance Programs, Ryan White services, and other support services (both publicly and privately funded) are critical tools in our public health safety net.

Tossed off the front burner of public health efforts, “Ending the HIV Epidemic” activities have still been chugging along throughout the COVID-19 crisis. The only other concurrent running pandemic didn’t suddenly go away because COVID-19 came rushing to the forefront of our public health efforts. One of the things these other support programs struggle the most with is ensuring the public (and even health department and hospital case managers) know these programs exist. State Medicaid programs, AIDS service organizations, Ryan White Clinics, and all other safety net programs should be coordinating for the shift in patient load across appropriate programs now. These planning activities should not wait until the midnight hour. For county run COVID-19 testing sites and vaccination sites should be providing information to every, single person seeking a vaccine about available programming to meet the needs of community members. From rental assistance to food pantries to ADAPs, programs already reaching communities and families are the most ideal for starting the process of maintain care after the PHE ends. That starts with passive efforts like brochures and should continue with more active efforts, like engaging a state’s 311 information system with linkage to care tools, and more active still by employing navigators at the Medicaid level to assist clients in finding services, should those clients find themselves ineligible post-PHE.

While we’re not there yet (and it make take significantly longer than any of us like due to a lack of equitable global vaccine access and variant development), advocates, states, service providers, and patients should be planning for what comes next when the PHE eventually comes to an end. We cannot afford to lose people to care at this critical juncture.

Medicaid Access: HCV Medication Stalls

In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a stark warning to state managers of Medicaid programs regarding restrictive limits on accessing newly developed and emerging direct acting agents (DAAs) for the therapeutic and curative treatment of Hepatitis C. Since then, Harvard’s Center for Health Law and Policy Innovation (CHLPI) has steadily tracked the three most impactful methods of restricting access to DAAs in Medicaid programs: fibrosis restrictions, sobriety requirements, and prescribing provider requirements.

Briefly, fibrosis restrictions require a patient to have advanced in the amount of liver damage to a specific degree in order to qualify for care, sobriety requirements restrict access to DAAs based on a person’s self-attested stated or clinically documented sobriety, and prescribing provider requirements restrict recognition of “medical necessity” to that of a specialist or with consultation of specialist in order to receive coverage of a particular DAA. CHLPI’s most recent survey of Medicaid programs outlines progress of the policies of restriction by state. As of the date of the survey, 4 states maintain fibrosis restrictions, 13 states require some period of abstinence/sobriety with an additional 15 states requiring a patient to participate in some level of alcohol and/or drug screening and counseling, and 18 sates have some level of specialist prescriber requirements. Additionally, Community Access National Network’s quarterly HIV-HCV Coinfection Watch Report details which states cover which Hepatitis C therapies and DAAs under their Medicaid preferred drug lists (PDLs).

Of particular note, the 2015 CMS notice specifically highlight the practices of fibrosis stage and sobriety requirements as running counter to various provisions under Section 1927 of the Social Security Act. A 2020 legal review by CHLPI’s Phil Waters describes various case law and potential enforcement mechanisms in which to combat these restrictions, which may prove prescient for federal enforcement agencies and advocates alike. Of particular note, Waters argues the Americans with Disability Act (ADA) presents a “novel” approach in addressing the most caustic and immediate barrier to accessing DAAs by Medicaid recipients: sobriety restrictions/abstinence requirements. Waters notes opposition to this method of seeking enforcement may argue such policies “benefit” the class of persons affected by same. While 2018 guidance from the Department for Health and Human Services (HHS) recognizes substance use disorder as a disability, the same guidance specifically exempts people currently using illicit and illegal drugs from the protections afforded by the ADA.

As we referenced in a blog earlier this year, the Centers for Disease Control and Prevention (CDC) Hepatitis C surveillance data indicates an extraordinary increase in new HCV diagnoses relative to the opioid epidemic. Arguably, requiring an otherwise qualified Medicaid client to undergo additional, non-emergency treatment or engage in non-medical activities in order to gain coverage of a live saving therapy is necessarily discriminatory. After all, a particular Medicaid pharmacy and therapeutics committee cannot evaluate the degree of limitations a person’s experience with substance use disorder causes and imposing additional requirements that specifically target this particular is counter to best practices. Indeed, requiring a person to “get clean” before receiving life-saving medical care is the exact opposite of managing substance use recovery. Relieving pressures of medical need, housing, and other negative pressures related to determinants of health are what set people up for success in combating substance use.

In order for the Biden administration to fulfill its promises with regard to combating the opioid epidemic, for states to fulfill their responsibilities under the National Viral Hepatitis Strategy, and to meaningfully address the intersection of these syndemics, federal agencies tasked with enforcement of these rules and Medicaid directors should consult and act in alignment with advocates with lived experience and best practices in combating both the opioid epidemic and resulting infectious disease outbreaks and diagnosis, including HIV and Hepatitis C. Just as with strategic, culturally competent approaches to combatting HIV and STIs focus on sex-positive education and access to resources, including prevention and treatment interventions, barrier reduction is critically necessary in order to succeed in this fight. As it stands, Medicaid programs present one of the best opportunities to ensure and enact meaningful access to care in an effort to eliminate Hepatitis C. These access limiting policies also present the biggest barriers to achieving that goal.

Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona

[Editor’s Note: This blog is, in part, a replication of a blog hosted by the ADAP Advocacy Association. Supplementary policy analysis on hepatitis treatments continues in this blog]

It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted here, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.

However, like all health care policy, the details matter.

In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers.

In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.

For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.

In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”

To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.

“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”

The state’s ADAP and Medicaid formularies also present a similar situation for medications used to treat Hepatitis C, leaving a critical gap in available health care services and treatment for those at risk of contracting Hepatitis C. While the state’s ADAP coverage includes most direct acting agents, Arizona’s Medicaid formulary only covers Epclusa, Mavyret, Ribovirin, and Peginterferon.

Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs, tackle the absolutely critical inclusion of treatment and retention in prevention efforts, and to eliminate viral hepatitis, the details matter and advocates will need to adapt old fights to new environments.