Addressing the High Burden of HCV in HIV-Positive MSM

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

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

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

The Case for DAAs

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

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

The Economics of DAAs

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

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

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

The Consequences of Limited Coverage

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

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

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

Policy Barriers and Provider Discouragement

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

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

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

Moving Towards Equitable HCV Care and Elimination

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

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

Policy Changes are Needed:

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

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

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

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

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

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

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

This includes:

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

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

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

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

A Shared Responsibility for Health Equity

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

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

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

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

Equitable Access to Long-Acting HIV Treatment

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

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

The Promise of LAIs

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

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

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

Evidence of Effectiveness

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

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

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

Impact on the HIV Epidemic

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

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

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

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

The Cost Conundrum

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

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

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

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

A Holistic Cost-Benefit Analysis

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

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

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

Intangible Benefits

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

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

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

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

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

Ethical Considerations

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

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

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

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

Addressing Barriers and Implementing Solutions

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

Policy Recommendations for ADAPs

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

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

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

Provider Education and Training

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

Ongoing education initiatives should focus on:

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

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

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

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

Patient Advocacy and Support

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

PLWH and community organizations can play a powerful role by:

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

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

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

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

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

Conclusion

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

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

Dire Consequences of the Change Healthcare Cyberattack

On February 21, 2024, the healthcare sector faced a seismic disruption when Change Healthcare, a cornerstone in the healthcare data exchange ecosystem, fell victim to a sophisticated cyberattack. Orchestrated by the notorious ransomware group known as ALPHV/Blackcat, this attack not only compromised the integrity of Change Healthcare's systems but also sent shockwaves across the entire healthcare landscape, affecting providers, insurers, and patients alike. Change Healthcare, now part of Optum under the umbrella of UnitedHealth Group thanks to a controversial $13 billon dollar acquisition, plays a central role in processing medical claims, verifying insurance eligibility, and facilitating electronic prescriptions for as many as half of all claims processed in the U.S. The immediate fallout from this cyberattack has spotlighted the fragility of our interconnected healthcare infrastructure and raised urgent questions about cybersecurity, patient care continuity, and the broader implications of healthcare consolidation.

As of March 6, 2024, the situation surrounding the Change Healthcare cyberattack remains critical. UnitedHealth Group has made strides in implementing workarounds and temporary solutions to restore some level of functionality to pharmacy, claims, and payment systems. While progress in providing temporary solutions is a positive development, the absence of a definitive timetable for fully restoring all affected services continues to pose significant challenges for providers, independent pharmacies, and patients alike. The financial strain on these entities persists, compounded by UnitedHealth Group's continued collection of patient premiums amidst the outage. With UnitedHealth Group's net worth standing at $433,790,000,000, the contrast between the corporation's financial standing and the ongoing struggles within the healthcare sector is stark, underscoring the urgent need for a comprehensive resolution to this unprecedented crisis.

Direct Impact on Patient Access and Care

The cyberattack on Change Healthcare has not only disrupted the healthcare data exchange ecosystem but has also led to significant patient distress and financial uncertainty. This crisis has been further compounded by the emergence of potential litigation from patients left to grapple with whether insurance will cover their treatments or medications. Patients, regardless of their plan type, are finding themselves at a heightened risk of incurring unexpected bills, exacerbating the already dire situation.

Take, for instance, the experience of Mara Furlich. Battling escalating Covid-19 symptoms and unable to get her claim processed due to the cyberattack, Furlich was forced to pay $1,600 out of pocket for Paxlovid. Similarly, one of the Community Access National Network’s (CANN) very own board members was confronted with a balance bill of over $2,000 from CVS Specialty Pharmacy for HIV medication when their Patient Assistance Program benefits were unable to be processed, illustrating the financial and access barriers erected by the cyberattack. This scenario, emblematic of the difficulties in processing Patient Assistance Programs (PAPs), underscores the significant disruptions to medication access, especially critical for managing chronic conditions.

Jen Laws, President & CEO of CANN, articulates the broader ramifications for people living with HIV (PLWH). "We've been in contact with our partners, including funders, to raise the concern around maintaining continuous access to care for PLWH, regardless of their payor," Jen states. "The reality is patients need to be aware their pharmacies, providers, and labs may be struggling to communicate and deliver timely service because of the sheer breadth of Change's reach."

This incident, alongside the litigation threats reported by Axios, underscores the acute disruptions to medication access and the financial jeopardy faced by patients. Kathy Oubre, CEO of Pontchartrain Cancer Center in Louisiana, shares similar concerns, noting the center has had to dispense drugs at risk due to the benefits verification process being down, leaving providers and patients "flying blind."

These developments signal a critical juncture in the healthcare sector's response to the cyberattack, highlighting the urgent need for systemic solutions to restore patient access to care and address the financial uncertainties exacerbated by this crisis.

The Role and Response of UnitedHealth Group

UnitedHealth Group found itself at the heart of this crisis. The conglomerate's response has been a blend of damage control and strategic measures aimed at mitigating the fallout. UnitedHealth Group's acknowledgment of the cyberattack was swift, with public assurances of their commitment to rectify the situation and restore full services. Part of their response has been the launch of a temporary financial assistance program, as outlined on UnitedHealth Group's website. This program, offering interest-free loans to affected healthcare providers, has been promoted as a means to ease the financial burden wrought by the cyberattack, facilitating the recovery of disrupted cash flows and delayed payments.

Yet, this initiative has not been universally welcomed. Criticism from the American Hospital Association (AHA) and other healthcare stakeholders has been vocal, with many decrying the financial assistance terms as burdensome, highlighting the disconnect between UnitedHealth's proposed solutions and the actual needs of the healthcare providers struggling in the cyberattack's aftermath.

The plight of Dr. Christine Meyer's primary care practice in Exton, PA, as reported by The New York Times, exemplifies the dire straits many healthcare providers find themselves in due to the cyberattack on Change Healthcare. Dr. Meyer's account of resorting to mailing "hundreds and hundreds" of pages of Medicare claims highlights the drastic measures providers are forced to take to navigate the bureaucratic maze in the absence of functional digital systems. The stark reality of having to consider cuts to essential services, like vaccine supplies, to conserve cash underscores the severity of the situation. Through Optum’s temporary funding assistance program, Dr. Meyer said she received a loan of $4,000, compared with the roughly half-million dollars she typically submits through Change. “That is less than 1 percent of my monthly claims and, adding insult to injury, the notice came with this big red font that said, you have to pay all of this back when this is resolved,” Dr. Meyer said. “It is all a joke.”

Moreover, UnitedHealth Group's continued collection of patient premiums amidst this turmoil has sparked further controversy, raising ethical questions about corporate responsibility versus profitability during a healthcare crisis. UnitedHealth Group's role in this crisis and its response to the cyberattack highlight the complex interplay between healthcare infrastructure, corporate governance, and patient care. As the healthcare sector navigates the aftermath of the cyberattack, the actions taken by UnitedHealth Group will likely continue to be a focal point for analysis and discussion, underscoring the need for robust, patient-centered solutions in the face of unprecedented challenges.

ADAPs and PAPs: Navigating the Cyberattack Crisis

The cyberattack has exposed the vulnerabilities of essential healthcare support systems, notably AIDS Drug Assistance Programs (ADAPs) and Patient Assistance Programs (PAPs). These programs, a critical safety net for providing vulnerable populations with access to necessary medications, have faced significant challenges in maintaining their operations amidst the cyberattack's disruptions.

In response, NASTAD issued guidance to ADAP administrators in an email, indicating that, due to delays in prescription fills caused by the outage, programs might need to temporarily cover medication costs directly, later seeking reimbursement from pharmacies. This measure, while ensuring that ADAP remains the 'payer of last resort,' highlights the operational and financial complexities these programs are navigating to keep access to care uninterrupted.

The repercussions of the cyberattack go beyond operational disruptions, threatening the very fabric of the healthcare safety net. The interim 'full pay' solution underscores the delicate balance between ensuring immediate access to medications and the long-term sustainability of these programs.

Amidst this crisis, the collective action of healthcare stakeholders is imperative. The NASTAD memo not only outlines immediate actions for ADAP administrators but also calls for widespread support to uphold these critical programs, encouraging ready communication to case managers and patients regarding the situation, status updates, and navigating alternative access to care as needed. As the sector continues to address the fallout from the cyberattack, the adaptability and resilience of ADAPs and PAPs are paramount in ensuring continuous care for those who depend on them most.

Reassessing Healthcare's "Too Big to Fail" Doctrine

This unprecedented disruption of critical services has exposed serious vulnerabilities associated with the healthcare sector's consolidation, particularly following UnitedHealth Group's acquisition of Change Healthcare. This event has reignited the debate over the "too big to fail" concept within healthcare, a concern that the Federal Trade Commission (FTC) had previously filed suit over due to potential risks of market dominance and a centralized point of failure.

The FTC's apprehensions about the merger highlighted fears of creating an overly centralized healthcare data exchange ecosystem, susceptible to significant disruptions from single points of failure. These theoretical concerns have been realized in the wake of the cyberattack, illustrating the tangible systemic risks of such consolidation. The incident underscores the precarious balance between efficiency gains through consolidation and the increased risk of widespread service disruptions. It should also seriously call into question prioritizing corporate profits and shareholder value over patient care and access.

The U.S. Department of Justice's recent launch of an antitrust investigation into UnitedHealth Group, as reported by The Wall Street Journal, adds a new layer to the ongoing debate. This investigation, focusing on UnitedHealth's expansive reach across the healthcare sector and its potential effects on competition and consumer choice, signals a critical moment in the U.S. government's efforts to address monopolistic consolidation practices within the healthcare industry.

Furthermore, the disproportionate impact on smaller entities, such as independent pharmacies and patient assistance programs, underlines the broader implications of healthcare consolidation. These challenges highlight the need for a healthcare infrastructure that values diversity and decentralization, fostering resilience against such cyber threats.

In light of the antitrust investigation and the fallout from the cyberattack, there's a pressing need for a comprehensive reassessment of healthcare consolidation trends. Strategic regulatory oversight, significant investments in cybersecurity, and comprehensive contingency planning are essential to mitigate the "too big to fail" risks. The healthcare system's integrity, resilience, and commitment to patient care in an increasingly digital age demand a vigilant approach to ensuring that consolidation does not compromise the sector's ability to serve the public effectively.

Call for Policy Intervention and Sector-wide Reforms

The cyberattack on Change Healthcare has catalyzed a unified call for urgent policy interventions and comprehensive sector-wide reforms from leading healthcare organizations, including the American Hospital Association (AHA) and the Medical Group Management Association (MGMA). These calls to action emphasize the critical need to fortify cybersecurity defenses, guarantee equitable patient access to care, and critically evaluate the prevailing trends of healthcare consolidation that have left the sector vulnerable.

The AHA has been at the forefront, advocating for robust support to help healthcare providers weather the storm caused by the cyberattack. Their public statement underscores the profound operational and financial challenges healthcare providers are facing, urging for greater flexibility from payers and governmental intervention to alleviate the crisis's immediate impacts.

Echoing this sentiment, the MGMA has highlighted the dire circumstances medical groups are navigating, as detailed in their communication to HHS Secretary Xavier Becerra. The association's plea for comprehensive support from the Department of Health and Human Services (HHS) reflects the broader necessity for guidance, financial aid, and regulatory leniency to ensure the sustainability of medical practices during these turbulent times.

Both organizations also spotlight the broader issue of healthcare consolidation, critiquing the increased centralization of healthcare services as a significant factor exacerbating the cyberattack's impact. This consolidation not only poses heightened cybersecurity risks but also threatens the diversity and resilience of the healthcare ecosystem. In response, there's a pressing demand for policy reforms that address both the immediate cybersecurity vulnerabilities and the long-term implications of healthcare consolidation, aiming to cultivate a more robust, diverse, and equitable healthcare system.

Urgent Calls to Action:

1. UnitedHealth Group must significantly expand its financial assistance program to offer real relief to the affected healthcare providers, pharmacies, and patients, ensuring the aid is substantial and derived from its vast resources, not at the expense of American taxpayers.

2. Regulatory bodies, including the FTC, must critically assess healthcare consolidation's impact, implementing measures to mitigate the risks of such centralization and prevent future vulnerabilities.

3. A united front of healthcare providers, associations, and advocacy groups is essential to demand accountability and transparency from UnitedHealth Group and similar entities, ensuring commitments to cybersecurity and continuity of care are upheld.

4. Legislators and policymakers are called upon to enact stringent cybersecurity regulations for the healthcare sector, emphasizing the need for comprehensive security protocols, consistent audits, and effective contingency planning.

5. A broader dialogue on healthcare consolidation's future is necessary, advocating for a healthcare model that prioritizes patient welfare, system resilience, and equitable access above corporate profitability.

In the wake of the Change Healthcare cyberattack, the path forward requires not just immediate remedial actions but also a deep, systemic reevaluation of the healthcare sector's structure and policies. It's time for decisive action and meaningful reform to ensure a secure, resilient healthcare system that serves the needs of all patients, safeguarding against future crises and fostering a healthcare environment where patient care is paramount.

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.

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.