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.

Transgender Community's Fight Against Systemic Discrimination

Transgender people grapple with profound healthcare barriers, intensified by systemic discrimination including a recent surge in legislative actions aimed at curtailing their rights. The National Center for Transgender Equality's (NCTE) 2022 U.S. Trans Survey (USTS) - the largest of its kind - highlights these impediments, demonstrating how discrimination not only obstructs access to general healthcare but also critically undermines HIV prevention and treatment efforts. This situation is compounded by healthcare providers' lack of familiarity with transgender health issues and the absence of supportive policies, exacerbating health disparities among transgender people. In the face of an unprecedented wave of anti-trans legislation in the last several years, the imperative for swift, decisive action to safeguard equitable healthcare access has never been more urgent.

Navigating the Healthcare Landscape for Transgender Communities

The 2022 USTS Early Insights Report underscores the significant healthcare barriers transgender folks face, characterized by systemic discrimination and economic challenges. This comprehensive survey, gathering insights from over 92,000 respondents, sheds light on the challenges confronting both binary and nonbinary transgender people.

Challenges in Healthcare Access and Provider Education

A notable 42% of USTS respondents have found themselves in the position of educating their healthcare providers about transgender care, underscoring a critical gap in medical education. This necessity not only burdens transgender people but also reflects wider issues of healthcare accessibility and inclusivity. Additionally, prohibitive costs deter 25% of the community from seeking necessary medical care, highlighting the financial barriers obstructing access to essential services.

The pervasive lack of provider education on transgender health issues is further critiqued in an American Medical Association’s Journal of Ethics article, emphasizing the negative impact of this educational deficiency on care quality and accessibility. Addressing this gap is essential for creating a healthcare environment that respects and adequately serves transgender people.

Socioeconomic Impact on Healthcare Access

Economic instability exacerbates healthcare disparities for transgender communities. The USTS reveals that 34% of respondents live in poverty, and 18% are unemployed, significantly diverging from national averages. This financial precarity, compounded by a 30% homelessness rate among respondents which is associated with experiences of housing and employment discrimination as well as experiences of domestic or intimate partner violence, severely limits healthcare access.

Insurance coverage disparities are stark, with 15% of transgender respondents uninsured, nearly triple the rate of the general U.S. population. Additionally, 29% experienced insurance lapses in the year before the survey, jeopardizing access to critical healthcare services, including HIV prevention and treatment.

A Center for American Progress report further highlights the economic barriers that disproportionately affect transgender people's healthcare access, emphasizing the need for policy interventions to mitigate these disparities.

The Toll of Harassment and Violence

Harassment and violence are prevalent issues within transgender communities, with 30% reporting verbal harassment and 39% facing online harassment due to their gender identity over the past year. This hostile environment not only impacts mental and physical health but also deters many from accessing healthcare services for fear of discrimination.

Centers for Disease Control and Prevention (CDC) research reveals that nearly 70% of transgender women experience discrimination, particularly in employment, directly affecting healthcare access and utilization. This discrimination creates significant barriers to health insurance, medical care due to cost, and access to transgender-specific and gender-affirming procedures.

The mental health crisis among transgender people, defined by discrimination, violence, and systemic barriers, is highlighted in a Washington Post feature on transgender healthcare. Nearly half of transgender adults report encountering healthcare providers lacking knowledge in transgender care, contributing to a crisis of depression, anxiety, and suicidal ideation. Addressing this crisis requires systemic changes in healthcare delivery and education to ensure comprehensive healthcare services are inclusive, accessible, and culturally competent.

Addressing Discrimination's Impact on HIV Risk in Transgender Communities

Discrimination against transgender people is a profound social injustice, critically escalating HIV risk. The CDC's report on the Prevalence of Discrimination reveals that nearly 70% of transgender women face discrimination that acutely affects employment, housing, and access to healthcare opportunities. These obstacles represent an incredible public health challenge, directly undermining efforts to combat HIV.

Discrimination leads to a marked hesitancy among transgender people to seek healthcare, including essential HIV testing and treatment. This hesitancy is intensified by a lack of culturally competent healthcare providers who understand the specific health needs of transgender people. The CDC highlights the critical role of HIV testing as the cornerstone of treatment and prevention, pointing out a significant diagnostic gap among transgender women living with HIV. This underscores the pressing need for healthcare environments that are both accessible and affirming.

Transgender women, especially those of color, face a myriad of societal challenges that increase their risk of HIV. The CDC's report on Syndemics outlines how factors like condomless anal intercourse, homelessness, incarceration, and substance use, compounded by discrimination, heighten this risk. A comprehensive approach that includes social support, housing stability, and anti-discrimination initiatives is essential to address these interconnected challenges. Despite the critical role of social support, the CDC also notes the limitations of support networks in mitigating the HIV risk associated with violence and harassment. This calls for a broader, systemic strategy to address the root causes of discrimination and violence against transgender people.

In addressing HIV risk, it's crucial to recognize the specific challenges faced by transgender men, highlighting the need for prevention strategies tailored to their experiences. Misunderstandings about the HIV risk for transgender men, particularly those engaging in sexual activities with cisgender men, overlook the reality that a segment of this community is involved in behaviors that increase their HIV and STI exposure. This issue is exacerbated by the insufficient HIV prevention resources tailored to transmen and their underrepresentation in health research. The dynamics of power within their sexual relationships can complicate safe sex practices. Factors like the heightened libido from testosterone therapy may lead to riskier sexual choices, further influenced by societal discrimination. Effective interventions must therefore embrace inclusive healthcare and societal support, promoting environments where transgender men can confidently express their sexuality while ensuring their health and well-being.

PrEP and Hormone Therapy: Navigating Concerns

Pre-exposure prophylaxis (PrEP) is a key strategy in preventing HIV among transgender people at risk. Despite its proven effectiveness, the adoption of PrEP by transgender women is disproportionately low, impeded by systemic obstacles and concerns about interactions with hormone therapy. The CDC has confirmed that there are no adverse interactions between PrEP medications and feminizing hormones, emphasizing the need to debunk myths and promote PrEP as a cornerstone of HIV prevention.

Echoing these concerns, a MedPage Today article delves into how homelessness, employment discrimination, and violence not only compound the HIV risk but also significantly obstruct access to crucial prevention tools like PrEP. Despite widespread awareness, the translation into action—PrEP uptake—remains alarmingly low among transgender women, spotlighting the chasm between knowledge and accessible, actionable health interventions, widened by entrenched systemic inequalities.

Navigating Legislative Barriers and Societal Challenges

The need for legislative action and provider education to improve healthcare accessibility are illustrated in the story of Robert Eads, a tragic example of the dire consequences of healthcare related discrimination. Eads, a transgender man from Georgia, encountered significant barriers to receiving treatment for ovarian cancer, with numerous doctors refusing care due to his gender identity and ultimately leading to his death. His experience underscores the critical need for healthcare systems that are accessible and inclusive, ensuring that transgender people receive the care they need without discrimination.

Unfortunately, the landscape of transgender rights and healthcare access in the United States is moving in the opposite direction thanks to a surge in anti-trans legislation, marking a concerning trend toward restricting the freedoms and healthcare access of transgender folks. A 2024 report from USA Today highlights this alarming escalation, noting that as of February 14th 130 bills targeting transgender rights had been filed nationwide. This legislative push not only seeks to limit access to gender-affirming care but also poses a broader threat to the visibility and rights of transgender people in public life.

The American College of Physicians (ACP) has voiced concern over the growing number of states implementing bans on gender-affirming healthcare. Following Arkansas's 2021 ban on such care for transgender minors, at least 12 other states have enacted similar restrictions, contributing to a hostile legislative environment that has put over 146,300 transgender youth and young adults at risk of being denied access to vital medical care known to mitigate risks of depression and suicide.

The burgeoning wave of anti-trans legislation casts a long shadow over the lives of transgender people, creating an atmosphere rife with fear and exclusion. The narrative shared by Ashley Andreou in Scientific American brings to light the chilling effect these laws have on both the mental and physical well-being of transgender people and the medical professionals dedicated to their care. Andreou's personal connection to the issue, through the loss of a family member to the mental trauma of transgender discrimination, underscores the profound human cost of these legislative actions. The laws, fueled by deliberate misinformation and detached from evidence-based medical practice, not only threaten the rights and dignity of transgender people but also jeopardize the very essence of patient-centered care.

Critically, the most recent wave of anti-trans legislation specifically targets access to care and even weaponizes accessing care for transgender patients, in and of itself. With some states adopting laws or administrative policies to pursue the medical records of transgender patients, even outside of those particular states, and the refusal of those medical institutions to protect patient privacy at the risk of facing state-sponsored legal challenges.

In the face of such legislative adversity, the call for advocacy and legal resistance becomes ever more critical. The experiences detailed by Andreou, from the criminalization of physicians providing gender-affirming care to the forced closure of clinics like Texas's GENECIS, highlight the urgent need for policies that protect the healthcare rights of transgender people. This legislative hostility not only undermines the autonomy of transgender people but also places an undue burden on healthcare providers, stifling their ability to offer essential care.

Empowering Transgender Health: Education, Advocacy, and Policy Reform

Equitable healthcare for transgender communities hinges on a unified strategy encompassing education, advocacy, and public policy. At the core of this strategy are the CDC's Transforming Health guidelines, which equip healthcare providers with a framework for delivering care that respects the unique needs of transgender people. These guidelines underscore the necessity of a well-informed healthcare team to create an environment that is affirming and respectful for all patients.

The Biden Administration's initiative to fund sex education for trans boys marks a critical step in addressing the educational gaps in sexual health for transgender and non-binary youth. This move fills a crucial need and sets a precedent for future policies aimed at improving health outcomes for transgender youth. It also specifically speaks to a significant gap in even existing outreach to transgender people. Transgender women are over-represented in many studies and programming due to the heightened violence this community faces. Transgender men on the other hand have often been left behind in programming and research - the Biden Administration’s move is unique in its effort to meet the needs of young transgender men.

However, the potential for a rollback of protections under administrations like the previous one's underscores the fragile nature of transgender rights. The ease with which previous gains can be reversed highlights the need for continuous advocacy and vigilance. Advocates must remain prepared to counter any attempts to diminish protections for transgender people, employing a combination of legal, policy, and grassroots strategies to safeguard the rights and health of transgender communities.

Amid systemic barriers and discrimination, advocacy is crucial in securing the rights of transgender people to access gender-affirming care and protection from healthcare discrimination. Key actions include:

• Strengthen Legal and Policy Advocacy: Monitoring policy changes affecting transgender rights, challenging discriminatory policies through legal avenues, and collaborating with policymakers to advocate for inclusive laws.

• Enhance Public Education and Awareness: Leveraging research and reports to educate the public, healthcare providers, and policymakers about the challenges faced by transgender people.

• Mobilize Community and Allies: Organizing community support and direct actions to advocate for inclusive policies at institutional and governmental levels.

• Invest in Research and Documentation: Continuing to document health disparities and experiences of discrimination to support advocacy and policy reform.

• Pursue Strategic Litigation: Using the courts to challenge discriminatory practices and secure legal protections for transgender people. This would be particularly notable if initiated or otherwise supported by executive agencies of the federal government.

Achieving healthcare equity for transgender communities demands:

• Comprehensive training on transgender health issues for healthcare providers to ensure empathetic, respectful care.

• Advocacy for inclusive policies that protect transgender people from discrimination in healthcare institutions.

• Support for gender-affirming care to be included in health insurance coverage and made accessible for all transgender people.

• Development and funding of mental health services tailored to the needs of transgender communities.

• Building supportive community environments that empower transgender people and provide essential resources for their well-being.

By adopting these strategies, we move closer to a future where healthcare equity for transgender people is a reality, reflecting a commitment to human rights and dignity. We can create a healthcare system that recognizes and meets the needs of every person, regardless of gender identity, and moves us closer to Ending the HIV Epidemic with comprehensive and collaborative efforts between allies.

Payers Seek to Expand Telehealth, in Libraries

In Louisiana's public libraries, a significant transformation is taking place. Amidst the traditional setting of books and quiet study areas, telehealth booths are emerging as highly accessible resources for health and wellness. These innovative installations, described by the State Library of Louisiana as looking like “futuristic phone booths,” are not merely modern fixtures; they represent an essential expansion of healthcare access, particularly benefiting those in low income and rural areas, and people experiencing homelessness.

Yet, this progress faces challenges from the current culture war, notably the attacks on LGBTQIA+ communities and the removal of related literature and displays. Libraries, long-standing bastions of knowledge and inclusivity, are now at the center of ideological disputes, potentially impacting the very access they aim to provide.

The Culture War's Impact on Library Access

Recent reports from Vice, Book Riot, and AP News highlight a concerning trend: libraries are increasingly becoming ideological battlegrounds. In Louisiana, actions such as the banning of LGBTQIA+ themed books and the removal of pride-related displays have created an environment of fear and exclusion.

The politicization of libraries could deter potential partners and funders, hindering the expansion of healthcare services. Insurance companies, crucial stakeholders in the telehealth initiative, may view libraries as contentious spaces and reconsider their support. This could significantly impact the availability and expansion of telehealth services, particularly to marginalized communities who stand to benefit the most. The culture war's escalation within these traditionally neutral and inclusive spaces poses a real threat to the continued provision and growth of essential health services in libraries.

Despite these hurdles, Louisiana’s telehealth initiative, supported by the Blue Cross and Blue Shield of Louisiana Foundation, demonstrates resilience. Telehealth booths in libraries like West Baton Rouge provide private spaces for virtual healthcare consultations, essential for those with limited access to healthcare or who are afraid of stigmatizing interactions at traditional points of service.

Of the most...interesting aspects of this partnership includes Louisiana’s incoming Governor, Jeff Landry, joining the board of directors of Blue Cross Shield of Louisiana. Landry has been a vocal critic of libraries running up to his gubernatorial campaign, though his tone has since softened some. By, “interesting”, we mean uniquely “Louisiana weird”.

The Role of Insurance Payers in Library Telehealth Initiatives

As telehealth services expand the role of insurance payers becomes pivotal. Their involvement is not just about funding; it's about influencing the broader narrative to support public health initiatives in nontraditional spaces like libraries. Amidst the escalating culture war, their decision to back libraries can be a powerful statement in favor of inclusivity and access to healthcare. By supporting telehealth in libraries, they can help ensure that these spaces remain open, welcoming, and free from the divisive impacts of cultural conflicts.

The integration of telehealth services into public libraries represents a significant leap forward in making healthcare more accessible and equitable. It's essential for insurance payers and other key stakeholders to recognize the role libraries and other nontraditional spaces play in bridging healthcare gaps. Their support can help counteract the negative impacts of the culture war, ensuring that libraries continue to serve as welcoming hubs of health and knowledge for all community members.

In this challenging landscape, the support of insurance payers and stakeholders is more than just a financial commitment; it's a commitment to upholding the principles of equity and access in healthcare. Their involvement can help steer the conversation away from divisive politics and towards a focus on the health and well-being of entire communities, no matter their minority status. As we navigate these complex issues, it's crucial to keep libraries as inclusive and supportive environments, where everyone has access to the health services they need, free from the constraints of political discord.

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.

Health Inequity: Barriers Caused by Abusive Payer Practices

On February 2, 2023, ProPublica, the publication with a mission to “expose abuses of power” and particularly known for their extraordinary thoroughness of investigation, published a piece exposing United Healthcare’s practices denying medically necessary care for one patient, Christopher McNaughton, who is diagnosed with ulcerative colitis. The barriers caused by abusive payer practices is nothing new to patients living with chronic health conditions, including HIV and viral hepatitis.

McNaughton’s disease state is particularly challenging and his treatment was costing United Healthcare about $2 million per year. McNaughton, after receiving repeated coverage denials of live-improving and life-saving medication from United Healthcare, many appeals, conflicting results from “third-party” medical reviewers, and an insistence from United Healthcare that McNaughton’s care was not “medically necessary”, McNaughton’s family sued. What that lawsuit uncovered was a trove of data, recordings, emails, reports, and more that showed distain for McNaughton’s family seeking the care he needs, a cover up of a review which properly identified the medical necessity for McNaughton’s treatment in alignment with his provider’s recommendations, and even more grossly abusive legal tricks to disrupt and complicate the lawsuit process.

McNaughton receives his insurance coverage through Penn State University, where he goes to school and his parents work. Amid all of the turmoil of navigating denials, McNaughton and his family had reached out to the sponsor of his health cover only to find an extraordinary lack of help. The curious detail there is the university’s “health insurance coordinator” turns out to be a full-time employee of United Healthcare, despite no disclosure of that fact on Penn State’s webpages and the coordinator being assigned both a Penn State email address and phone number. Arguably, as the sponsor of the plan, Penn State has a role to play here, too, much like large employers and even the government in public payer programs.

Similarly, the New York Times covered the issue of payers refusing to cover the cost of high-cost, life-saving care, especially when that care includes newer medications. All the advancements in the world can’t change the course of a person’s life, if they can’t afford those advancements or the cost of those advancements might bankrupt a patient. While some public payer programs help to protect patients from these burdens, with complex regulatory requirements, even those are often farmed out to the same private payer entities responsible for McNaughton’s experiences, or those described by the numerous patients included in New York Times’ piece. For Medicaid, these entities are called managed care organizations (MCOs) and in Medicare they can been under the Medicare Advantage program. For many patients in private plans, formulary restrictions are quite common. This is still also true in Medicaid and Medicare Advantage plans, in which a patient and/or their provider has to chase after a series of costly administrative barriers in order to get an exception, which may or may not be denied at the end of the day. Indeed, MCOs and private payers have a history of refusing to add new medications to formularies, arguing “cost-effectiveness”, despite U.S. Food and Drug Administration (FDA) approvals and study designs showing greater efficacy, curative potential, or meeting a unique need. We won’t argue how placing greater value on “cost-savings” in the short-term in the face of more efficacious medication for patients is both morally and ethically abominable. Ultimately, these types of moves just shift cost-burdens to patients, namely in the expense of their health and even their lives. Similarly, newer medications may be placed on higher tiers, requiring higher co-pays or step-therapy (failing a different medication before having access to a newer one). Program designs with high deductibles and copay schemes (sometimes called co-insurance) are leaving more and more patients behind, as evidenced by work from Dr. Jalpa Doshi, a professor at the University of Pennsylvania, which showed rates of medication abandonment increase dramatically as co-pays rise.

Digging into the details of navigation, a Kaiser Family Foundation (KFF) analysis found Medicare Advantage plans forced patients through the process of securing permission from their payer before getting coverage of care – or as we like to call it, getting care – known as prior authorization. In theory, prior authorizations should align with a patient’s medical necessity as identified by their provider, encourage exploration of less costly treatment courses, and save both the plan and patients some money in the process. In practice, prior authorizations, particularly with regard to medication benefit coverage, is used to delay and deny care very similar to auto insurers looking to get out paying for a claim. KFF’s analysis found that in 2021, Medicare Advantage plans received 35 million prior authorization requests. Medicare Advantage only has 23 million enrollees in the contracts reviewed, thus averaging about 1.5 prior authorization per enrollee. The application of these requests is not uniform. Kaiser Permanente (no affiliation with KFF) had a prior authorization rate of 0.3% per enrollee and Anthem had a rate nearly time times higher at 2.9% per enrollee. To be fair, Kaiser Permanente’s network of providers work at entities Kaiser Permanente owns. The overall denial rate of prior authorizations across Medicare Advantage plans in 2021 was about 5% (or 2 million partial or full denials). Navigating denials, as shown in the ProPublica piece, is more than a little bit challenging when payers are bound and determined to limit their own costs. This is easily displayed in seeing the appeal rate for those 2 million denials of coverage was just 11% (or about 220,000). Of those appeals, a full 82% were overturned (or about 180,400). An Office of the Inspector General (OIG) report found more than 10% of a small sample of denials were “inappropriate” and would have generally been covered by traditional Medicare. It’s safe to say, at least 200,000 patients in Medicare Advantage plans alone have experienced delayed, medically necessary care…just because.

All of this incredibly noteworthy as the Biden Administration works to finalize an audit rule for Medicare Advantage plans which is expected to generate some potential $2 billion dollars returned to the government for overbilling, or claiming patients were sicker than they were. These payers are posed to argue simultaneously that patients don’t need medically necessary care despite being sicker than they actually are. It’s truly a remarkable moment to see predatory practices barrel their ways towards one another in the name of payer profits.

The New York Times piece notably reminds readers, when payers or even government officials argue for “cost savings”, they’re not necessarily talking about cost-savings for patients. The Inflation reduction Act, for example, requires manufacturers to refund the difference of medication’s cost rising higher than inflation to the government, but the government isn’t required to pass those savings make it back to patients. Again, to be fair, it might be particularly challenging for public program administrators to ensure those savings make it back to patients because those administrators are already saving plenty of money into their own pockets through bulk purchasing, already negotiating lower costs, and discount or rebate programs. On the double dipping end of the never-ending double dip, these same payers are fighting back against a series of programs run by medication manufacturers known patient assistance programs. The most common form of patient assistance programs is designed as co-pay assistance, helping patients cover their out-of-pocket costs of a particular medication. Right now, payers are using several dirty tricks to make sure they get the benefit of those billing dollars, rather than patients. The HIV + HepC Institute have joined other advocates in suing the Biden Administration over a rule issued under the previous administration to ensure those assistance programs designed to benefit patients and extend access to care are actually being used that way.

States are taking on efforts to combat abusive prior authorization practices introducing or having already passed “gold card” programs, in which providers with a history of successfully meeting prior authorization requirements in previous years may be exempt from needing to go through those processes for a certain period of time. The Biden Administration, for their part have also introduced a set of rules to streamline prior authorization processes, in an effort to expedite the experiences patients and providers have in navigating payment for care. And Congress is expected to see what was known as the Safe Step Act reintroduced this year, a bi-partisan and exceedingly popular piece of legislation aimed at curbing fail-first practices.

But patients, advocates, and policymakers should be careful about unintended consequences and keep an eye out for payers to adjust their practices. In gold-card programs, payers could just expand their prior authorization requirements, narrow formularies, and increase their rate of denials in order to disqualify providers who were previously qualified for the programs. We should also get creative in seeking to close some of these loopholes in the Affordable Care Act’s promise to bring a more equitable and easier to navigate health care landscape. Introducing parity between medical benefit profit caps (known as medical loss ratio) and pharmacy benefit profit caps might encourage (read: require) pharmacy benefit managers to share the savings, have discounts follow patients, expand formularies, and otherwise ensure their program dollars are being used to the maximum benefit of patients.

Industry’s Changes to 340B Drug Discount Program

****The following is a joint statement by Jen Laws, President & CEO of the Community Access National Network, and Brandon M. Macsata, CEO of the ADAP Advocacy Association****

The Community Access National Network (CANN) and ADAP Advocacy Association, back in October 2020, issued a Dear Colleague letter to our industry partners in the pharmaceutical manufacturing space surrounding HIV therapies. We detailed our concerns regarding the 340B Discount Drug Program and the necessity to ensure safety-net public health programs do not “get caught in the crossfire between pharmaceutical companies and contract pharmacies.” Our efforts led to constructive conversation, as well as a commitment to protect patients access to timely, appropriate care and treatment. Essentially, we sought a “carve out” for certain Covered Entities, namely the Ryan White Grantees (“Grantees”) serving clients living with HIV/AIDS.

In the time since, considering our collective concerns for the sustainability, stability, and honest efforts to provide necessary services to PLWAHA, many of our industry partners have ensured additional efforts at transparency and accountability do not add to already existing reporting burdens of the Grantees. We still contend that the carve-out is essential to avoiding possible damaging effects on the safety-net programs crucial to the HIV-positive community.

Unfortunately, a few of our industry partners have express concerns about “bad actors” trying to encroach on the federal grantee carve-outs industry partners have thus far offered in requesting additional reporting of 340B Covered Entities. It has been our earnest position that solving the problems facing the 340B Drug Discount Program are achieved in a way that preserves benefit to patients and intent of the program while protecting against bad actors. However, any effort requires a scalpel, not a hatchet. The carve-out of these additional reporting requirements, in light of the oversight already offered by being federal grantees, has helped our industry partners align their values with their actions in working to ensure program integrity and minimize risks to patient benefit.

It is important to recognize the historical and current reality many Grantees face. Yet, should pharmaceutical manufacturers insist on blanket reporting requirements for all Covered Entities void of any carve-outs, it should be done by supporting these Grantees, and thus the services and medications their patients rely upon. We urge our industry partners to pair any new reporting requirements with funding for the following activities:

·        necessary expertise to navigate the establishment of third-party administrator and contract pharmacy agreements.

·        extend program initiation funding for the 3 years after qualification to meet the labor needs of fulfilling this reporting requirement.

·        develop other programming clinics specifically identify to work collaboratively.

Whereas our two organizations have long-supported reforms to the 340B Drug Pricing Program, because they are overdue and opportunities exist to ensure every single penny squeezed out of the program directly benefits patients, let’s not throw the baby out with the bathwater. Provided our industry partners are genuine in their expression and desire to preserve 340B’s intent to benefit patients, the aforementioned steps are modest and support appropriate transparency and accountability.

Respectfully, we believe any genuine effort to introduce added reporting burden on Grantees, of which are already most closely monitored in the 340B space, must also include support to meet these burdens. Any adjustments to Grantees’ reporting supported by funding and programming designed for Grantees to be “set up for success” on all accounts. We believe our industry partners are up to the task at hand and maintain the integrity to align actions and values.

Provider Survey: Prior Authorizations Harm Patients

The issue of prior authorizations (PAs) comes across my plate quite frequently. Really, it’s bigger than PAs. PAs are but one of several types of practices known as “utilization management” and it’s also one of the fastest ways to get me hot under the collar in a way reminiscent of the fury and frustration of a poison oak rash. But PAs are particularly notorious because they’re one of the methods of utilization management health care providers have to directly engage with, rather than something saddled in the lap of a pharmacist or patient at the point of sale. If you haven’t run into the issue of prior authorizations, let me back up some and give you a brief explanation.

The health insurance you get when it’s branded with a major corporation’s name (rather than a government program) is either a commercial plan or that of the same entity working as a “managed care organization” on behalf of a government funded program. But that package is generally two different types of benefits packaged as one, medical coverage over the cost of seeing your doctors and getting labs and pharmacy coverage over your prescription medications. Just like when your medical coverage limits the type of provider you can see or the facility “in-network” they’ll pay for you to go to, your pharmacy benefit may include a limit or design to steer you toward a limited network of pharmacies and that benefit decides what types of medications they’ll cover, what they’ll make you pay in cost sharing (co-pays), and what hoops you have to jump through when they don’t want to cover a particular medication because it’s costly. One of the ways both of these types of benefits seek to discourage patients from seeking out expensive care or medications is by making your provider ask them pretty please if you can have a particular treatment. This is a prior authorization.

But who calls the shots when your doctor and the pharmacy benefit manager (PBM) disagree about you needing that specific treatment? That’s a complicated answer and what happens to patients navigating that space of waiting for your doctor and PBM to communicate and figure things out is not well studied in clinical terms. PBMs generally ask a third-party with expertise to make a medical decision on if you really need that particular treatment or if something else might be…ok based on the reasons your provider says you need that specific treatment. The thing is, the PBMs both pick and pay that third-party. There is no truly independent arbiter to navigate a coverage decision. That third-party has a vested interest in maintaining their business model and keeping the folks who write their checks happy. And those folks aren’t you or your doctor. They tend to view the PA under the lens of a singular condition, lacking the whole context of your health needs and history, and while “medical necessity” is the most common claim needed to get around a PA, proving that can often be a onerous and sometimes lengthy process.

None of that addresses that your doctor is your doctor for a reason. They’re intimate with your personal medical situation, co-occurring conditions, things like how big a pill you can swallow without choking, what vitamins you take, and more. There is never a better decision-making process than the one made between patient and provider.

The best way to explain the PA process is calling it “deny and delay”. Deny the claim, delay a patient getting the care they need. There’s a quiet and underlying assumption that patients and providers are picking their care based on what costs the most, which neglects the fact that plan designs already make it ridiculously challenging for the average person to afford even basic care, much less care required to manage chronic conditions. Sky-high premiums and deductibles to tune of thousands of dollars mean most patients simply can’t afford to pursue costly care, even if you need it.

The American Medical Association has sought to measure these experiences and outcomes with a physician survey, asking doctors and their administrative staff to quantify what’s going on for doctors offices and patients when running up against PAs. The survey findings are shocking but not surprising if you, dear reader, can recall any time you’ve already had to navigate a PA. Let’s run down the top line numbers:

- 93% of participants said PAs delay care for patients (up from 92% in 2017)
- 82% of physicians said PAs lead to medication abandonment at least sometimes (24% said “often” and 2% said “always”)
- 91% said PAs have a “somewhat or significant” negative clinical impact on patients
- 51% said their patients had to take time off work in order to navigate a PA
- physicians said they had to manage about 41 prior authorizations a week and have to dedicate about 2 full days a week to navigating PAs with about 40% of their staff solely working to manage the paperwork associated with PAs

Patient outcomes were seriously impacted by PAs with 34% of physicians reporting they had patients experience adverse events as a result of delayed care due to PAs, 24% of physicians said they’ve had patients hospitalized waiting on an approval from their insurer, 18% reported that a PA lead to a life threatening event for a patient, and 8 % of participating physicians said PAs have lead to patients becoming disabled, experiencing cognitive anomaly, permanent bodily damage, birth defects, or even death.

Here’s the kicker, while 98% of providers have found claims by insurers their PA policies are evidenced based, only 30% of physicians agreed those policies in practice were actually evidenced-based.

All of this is to say, providers see payer abuses of utilization management harming patients quite regularly all in the name of profit making for insurers and PBMs. An insurance policy isn’t worth the paper it’s written on much less the money spent if, in the end, patients can’t actually get the care they’re paying for. If a provider’s contentious process of educating a patient about their health, why they need a particular treatment, and monitoring of that health condition to a patient’s benefit is how a consumer would generally define “practicing medicine”, then the denial of that specific care must also be considered “practicing medicine”. We don’t pay insurers to practice medicine, we pay them to cover the costs of our care.

For their part, the AMA has also previously suggested 21 principles in the reform of utilization management in order to stop the practice of payers practicing medicine by utilization review. Clearly, more needs to be done on the legislative and regulatory fronts in order to protect patients from these predatory and abusive practices. Insurers and PBMs are excellent at planning ways to punish legislative action and patients if constraints are placed on them. It’s time our law makers and government begin responding to existing abuses of our health care ecosystem and affirmatively anticipate market adjustments favoring profit over patients. It’s beyond time government funded programs require payers to actively engage patients in feedback processes and meet minimum metrics of patient success and satisfaction as the government does with all other stakeholders receiving those dollars. Payers can no longer be exempt from the basic decency required to be a full-fledged player in health care rather than the grifter status they enjoy right now. Patients simply can’t afford it.

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!

2021: A Year in Reflection

The end of 2021 is upon us and that makes this a timely opportunity to reflect on the work by the Community Access National Network (CANN). During an exceedingly busy news cycle, we have published fifty blogs (including this one) on a variety of topics ranging from the latest on policy and regulatory issues, as well as some personal perspectives. Our HIV-HCV Coinfection Watch and our Annual Monitoring Report tracked Hepatitis C (HCV) therapies covered under the State AIDS Drug Assistance Programs, Medicaid, Veterans Administration, as well as patient access via patient assistance programs, and other relevant news items affecting our patient community. We also conducted a community roundtable seeking to highlight the impacts of Covid-19 on public health programs aimed at addressing HIV, HCV, and substance use disorder (SUD).

Notably, CANN published the following six-part series designed to educate patients on various aspects of the 340B Drug Discount Program:

·        A Patient’s Guide to 340B: Why the Program Matters to You

·        A Patient’s Guide to 340B: Why Transparency Matters to You

·        A Patient’s Guide to 340B: Why Accountability Matters to You

·        A Patient’s Guide to 340B: Why the Decline in Charity Care Matters to You

·        A Patient’s Guide to 340B: Why the Middlemen Matters to You

·        A Patient’s Guide to 340B: Why Program Reform Matters to You

With Congress engaged in high-conflict communication, to abuse a euphemism, navigating public policy developments and pertinent issues to patients can be challenging. CANN remains committed to being an essential source of two-way communication, information, and education wherein patients write the narrative driving policy reforms and priorities. In this, we are ever grateful to the patients and caretakers who have engaged with us at every turn. Your stories matter and you are not alone in your experiences.

The diverse partnerships behind this work are critical to our success and as we end the year, we want to offer our gratitude to these essential partnerships, ranging from other patient advocacy organizations, public health associations, and industry partners.

The issues affecting our public health space of patient advocacy have not relented this year. Covid-19 has only emphasized the need to ensure these programs are effective and efficient while also highlighting the existing weaknesses and strengths of these programs. To be clear, the structural and pervasive drivers of health disparities have been named; racism, sexism, classism, ableism, and all other biases which reflect a moral justification for out ethical failings must be addressed in tandem with policy changes and adequate public health program funding in order for us to succeed in these fights for patient lives. Health equity cannot be meaningfully segregated from the policy mechanisms in which these disparities have survived in the face of another pandemic – when our collective awareness of these inequities and leverage to progress on these issues should have been their strongest and yet were not.

It’s with these things in mind, we want to leave you with the enduring sentiment that next year offers us yet another opportunity to approaches these challenges with fresh eyes and fresh ideas. We are indeed stronger together and we sincerely look forward to working with you all to move closer in realizing a world of greater access to care, fewer and smaller health disparities, and, ultimately, a more fair and loving environment in which to live our lives and raise our families.

Author’s note: I often end certain professional meetings with telling my colleagues “Love ya’ll”. It’s a sentiment I mean to depths of my soul. I am fortunate to work with some of the most amazing people in the world – folks who share an unbridled commitment to improving the lives of those around them. It’s from this same space I wish to offer each of you reading this a moment to breathe and the same open heartedness. I want to leave you all with a short story that has shaped me in more ways than I can count, The Perfect Heart, and an encouragement to tell someone you love them as soon as you can. May this next year be gentler with us all and find us giving away more pieces of our hearts.  

A Patient’s Guide to 340B: Why Program Reform Matters to You

***This is the final report in a six-part series to educate patients about the 340B Drug Pricing Program***

The 340B Drug Pricing Program has no doubt added benefit for patients and providers, alike. The measure of this benefit, however, is shrouded by uncertainty over the lack of transparency and accountability, decline in hospital charity care, as well as the explosive middleman growth in contract pharmacies and pharmacy benefit managers. Twenty-nine years after the program’s inception, it is now unclear to both regulators and patients, both qualitatively and quantitatively, if the Congressional intent is being met.

With all the noise around whether rebate programs might encourage pharmaceutical manufacturers to raise the cost of their products, there is no conversation on how those rebate dollars are used. The lack of the requisite transparency reporting among non-federal grantee covered entities participating in the 340B program makes it impossible to distinguish between anecdotal claims of abuses versus legitimate use of these rebate dollars to the benefit of patients.

These combined situations place the future of the 340B program at exceptional risk, if only by politicization of the national conversation on medication affordability alone. That national conversation churns now, as Congress debates drug pricing legislation. Aside from notorious stump speeches about the prices other countries pay for their medications, nowhere in these discussions do we talk about payers (insurers) and the middleman dictating the at-the-counter prices of medications realized by patients. The ongoing political debate is absent of the larger impacts on safety-net programs benefitting from 340B revenue and the impact on the poorest patients among us. Without clear guidance, all patients can come to expect is more squabbling among covered entities, drug manufacturers, hospitals, and regulators. It is this type of environment in which an idealistic program finds itself at risk.

Lawmakers have reasonably argued federal regulators have not demonstrated a particular need for additional regulatory powers because the Health Services and Resources Administration (HRSA) has not adequately flexed their current oversight muscle (…much less that such would be exercised efficiently). Therefore, regulatory interpretation should be updated, specifically regarding the patient definition, and possibly with further defining “low-income” for more clarity on who the program should benefit most. To the extent of “cracking open the legislation”, there is a singular area in which lawmakers from both sides and the Biden Administration agree: the issue of transparency in reporting. Earlier this year, the Biden Administration’s discretionary budget included an ask of Congress to specifically fund greater oversight and administration of 340B, explicitly including requirements on reporting of how non-grantee entities use these dollars. In this space, where few agreements can be made found, this is one area where legislators can and should move swiftly. The data generated by transparent reporting on use of these dollars is invaluable in evaluating the efficacy of 340B in benefitting patients or otherwise meeting the intent of the program.

To the extent HRSA may need more room for rulemaking, legislators desperately need extend rulemaking authority to include allowable uses for 340B dollars and clarity on the intent of the program. Federal grantees already have to report use of these dollars while other covered entities aren’t. With executives reaping in millions of dollars, reasonable people can grow concerned these dollars are being used to prop up the profiteering and personal enrichment administrators may be enjoying at the expense of employees providing care and patients themselves. Employees of federal grantees don’t generally get to enjoy much in the way of raises and their pay is not on par with the private sector. Hardware and software systems lag in terms of keeping up with modern technology. Sustaining non-revenue generating or underfunded patient benefit programs is absolutely something many entities enjoy as a use of their 340B dollars. There is no doubt these dollars can be used to patient benefit beyond directly sharing the savings with patients, though sharing the savings is the most direct means patients benefit from 340B. Putting guardrails on allowable uses of these dollars would serve well everyone touched by the program. Frankly, anyone fighting this transparency as a suggested method of shoring up 340B in meeting its intended purpose has something to hide and deserves closer scrutiny.

As an additional area of critical need to consider, for non-grantee covered entity hospitals, records of charity care and minimum realized values in served communities should be determinative for qualification to participate as a covered entity. The current calculation of disproportionate share hospitals as 340B participants or non-340B participants by the Government Accountability Office has shown a steadier and steeper decline of charity care among 340B hospitals than among non-340B hospitals. Additionally, hospitals carry the highest issuance of medical debt in the United States, disproportionately affecting low-income patients. Part of ensuring low-income patients get the most benefit from the discount drug program was and remains the ability to extend no- and low-cost care, writing off costs of providing that care, without punishing patients for having a need. If hospitals are to receive the benefit of this program, that same benefit should be extended to patients.

Lastly, in addressing the sheer size of the 340B discount drug program, the most significant areas of growth with questionable benefit to patients are among contract pharmacies. HRSA’s recognized this potential in commentary with its 2010 final rule only to realize those cautionary concerns and integrate guidance curbing the use and growth of contract pharmacies in the no-shelved 2015 “mega-guidance”. While the mega-guidance has been shelved, the abuse of the program by contract pharmacies has not abated. Among reducing the number of contract pharmacies a covered entity may make agreements with, and other geographic requirements, lawmakers and regulators should consider establishing market appropriate flat fees associated with services and a database of fees charged by pharmacy benefits managers, contract pharmacies, and third-party administrators, similar to the 340B ceiling price database established under the Office of Pharmacy Affairs Information System. A similarly situated claims hub would also allow for greater clarity in audits, assessment of potential duplicate discounts, and (if appropriately structured and compliant with patient privacy laws) detect potential diversion.

340B is a massive program which, arguably, has not yet been realized by much of the patient population. Not doing anything in this case doesn’t mean “keeping things status quo”, rather it means leaving the program open to attack, inefficiency, ineffectiveness, and abuse.  We can and should do more to ensure patients are aware of the program, how the program is used by covered entities nearest to them, and how this critical support to federally funded health care programs might be impacted by additional health care policy reform efforts. If ensuring the health and well-being of the country is the priority of all players in this system, then its time patients know it.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

A Patient’s Guide to 340B: Why the Middlemen Matters to You

***This is the fifth report in a six-part series to educate patients about the 340B Drug Pricing Program***

When the 340B Drug Pricing Program was enacted in 1992, there were a few “gaps” between the law’s statutory language and the program’s practical application. Among them was the realization that some covered entities that couldn’t afford to operate their own pharmacy. The Health Resources and Services Administration (HRSA) issued guidance to address the gap. After all, what’s the use of a discount drug program if providers can’t realize those discounts simply because they don’t have a pharmacy?

In 1996, after the urging of some covered entities, HRSA issued guidance telling covered entities and manufacturers that covered entities could contract with a single, independent pharmacy to provide pharmacy services necessary to engage the discount program. The idea was simple: create an access pipeline to the program, so it could be accessed by small providers, but not abused. In 2001, HRSA began to allow a few pilot projects, for lack of a better term, wherein covered entities would have more than one contract pharmacy. In theory, it isn’t a bad idea. Different pharmacies have different distributors, and as such supply can sometimes be an issue (i.e., natural disasters).

Additionally, it allows industrious covered entities to open the door for competition on “value added” services from contract pharmacies – such as programmatic record keeping for the purposes of 340B and/or financial reporting for federal grantees. And since the pharmacy was the one handling the purchasing and distribution of the medications to patients, that’s one less labor task for smaller covered entities to fund. In 2010, HRSA would later expand these pilot project allowance for multiple contract pharmacies per covered entity.

Sounds great, right? More patients have access to discounted outpatient medications, right?

Right? Not exactly!

Under the 340B program, patients don’t always get their share of the savings from the rebates and discounts. Arguably, it would appear everyone is directly benefiting one way or another from the program and its lucrative revenue stream, except for patients.

Contract pharmacies all want their piece of this pie, too. For example, take the dispensing fees that a pharmacy charges to fill a prescription medication. Indeed, dispensing fees for 340B contact pharmacies are so wildly non-standard a Government Accountability Office (GAO) report from 2018 found dispensing fees ranging from $0 to almost $2000 per fill on 340B eligible drugs. Those fees come out of 340B revenue, which could be supporting a patient’s ability to pay copays or the cost of a drug and instead.

Can you imagine, if you will, you’re a person living with HIV or Hepatitis C, living at about 200% of the Federal Poverty Level (FPL; 200% in 2021 is approximately $25,760 per year for a single person), but thankfully receiving insurance coverage for your medical care. Yet, co-pays and deductibles drain your finances when you could be getting your medications at no cost if the pharmacy or covered entity was applying 340B dollars to your bill? How many Rx fills would that be?

If the payer wasn’t applying a co-pay accumulator or co-pay maximizer program, the dispensing fee of two fills could mean extending your ability to access care for an entire coverage year – not just for medications, but for all health care. If the intent behind the 340B program is to extend limited federal resources, ensuring those exorbitant dispensing fees weren’t so exorbitant would certainly be one way to do it. Ultimately, 340B is a pie – when there’s more taken out, hacked at along the payment pipeline of getting medications to patients, there’s fewer resources left for patients to benefit from.

What’s more concerning about the explosive growth in the number of contract pharmacies with their hands in the 340B cookie jar, is HRSA knew when the 2010 guidance was issued that diversion and duplicate discount increases, abuses of the program, would most certainly follow. In part, because the program would grow and at such a pace that HRSA couldn’t keep up. In fact, GAO included that warning in a 2011 report, stating “…increased use of the 340B Program by contract pharmacies and hospitals may result in a greater risk of drug diversion, further heightening concerns about HRSA’s reliance on participants’ self-policing to oversee the program.”

The best part? By the “best”, I mean the worst: contract pharmacies, like non-grantee hospital entities, don’t have to show any benefit to patients for any of the dollars. Clearly, it raises questions over the legislative intent of the program and whether it is being met?

Now, contract pharmacies, like hospitals, like to massage and carefully select data to pitch answers to these concerns (there are a great number of “concerns”) by saying “we served X many 340B eligible patients”. They get around having to say if those patients realized any of those savings and benefitted from the program, without defining what they mean by “eligible”, and without defining “patient”. Contract pharmacies and hospitals get away with not having to provide meaningful information because statutory language doesn’t define “low-income” or “eligible” and regulatory guidance has an outdated definition of “patient”. Regardless of the existing language in regulation, a bona fide relationship should exist in order to call a consumer a “patient”, otherwise this is all just pocketing dollars meant for extending medication access to needy people.

All this lack of transparency fees assessed against the program could easily be solved with merely requiring contract pharmacies to establish a “flat”, reasonable dispensing fee and to describe what those fees actually cover. If the contract pharmacy is providing an additional navigation benefit to patients or an in-house location for a federally qualified health center, reasonable people can see fees being slightly elevated to cover additional costs. However, those costs should be outlined like any other contractor would be expected to do in any other contract for service. Most hospitals already have their own in-house pharmacy, they shouldn’t be contracting that service out and thus giving room for inappropriate 340B related rebate claims. And if HRSA just does not have the capacity to meaningfully audit 340B claims and the use of these dollars, they could at the very least make more room for the other mechanism in the statute for audit: manufacturer-originated audits. That’s right. The statutory language of 340B anticipated HRSA wouldn’t be able to keep up if the program was successful or even particularly abused. So, legislators reasoned if manufacturers were taking a cut of their potential profits through discounts and rebates, manufacturers should be able to audit the claims seeking those discounts and rebates to make sure everything was in line. When a retailer offers a discount to veterans, they typically require proof of veteran status. Why would medication discounts be any different?

In the end, if contract pharmacies don’t have anything to hide, then they need to stop hiding so very much. There are enough hands in the 340B cookie jar that patients are being squeezed out and left with crumbs. When legislators ask “is the intent of the program being met?”, these are the questions on their minds. Patients should have them on their minds as well.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Fein, J. Adam (2020, May 19). Copay Maximizers Are Displacing Accumulators—But CMS Ignores How Payers Leverage Patient Support. Drug Channels. Retrieved online at https://www.drugchannels.net/2020/05/copay-maximizers-are-displacing.html

• U.S Government Accountability Office (September 2011). DRUG PRICING: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement. GAO-11-836. Retrieved online at https://www.gao.gov/assets/gao-11-836.pdf

• U.S. Government Accountability Office (June 2018). DRUG DISCOUNT PROGRAM: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement. GAO-18-480. Retrieved online at https://www.gao.gov/assets/gao-18-480.pdf

• Office of the Federal Register (1996, August 23). 61 FR 43549 - Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services. GovInfo.gov. Retrieved online at https://www.govinfo.gov/app/details/FR-1996-08-23/96-21485 

• Office of the Federal Register (2010, April 5). 75 FR 10272 - Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services. GovInfo.gov. Retrieved online at https://www.govinfo.gov/app/details/FR-2010-03-05/2010-4755

A Patient’s Guide to 340B: Why the Decline in Charity Care Matters to You

***This is the fourth report in a six-part series to educate patients about the 340B Drug Pricing Program***

A cornerstone argument in favor of the 340B Drug Pricing Program centers on so-called charity care rates of the participating Disproportionate Share Hospitals (DSH). Those covered entities, specifically DSHs, should be able to leverage their 340B dollars to extend care and out-patient medications to offset losses from uncompensated care. In the ideal, offsetting the costs associated with charity care to provide more care to low-income patients is noble and moral and just, and one society should support. The problem occurs when charity care is wrapped up or conflated with all “uncompensated, unreimbursed care” because a significant portion of uncompensated care is written off as bad debt, and that debt all too often gets reported to patients’ credit reports. Whereas charity care is care provided at no cost or debt to the patient. Moving forward, we must not confuse, conflate, or combine generalized uncompensated care with charity care.

The argument from the American Hospital Association is narrowly focused to present the rosiest picture, touting the totality of charity care provided by 340B DSH covered entities ($64 billion in of 2017, the latest available data as of the AHA’s statement). It ignores 340B participating hospitals have seen a steady decline in both charity care and uncompensated care, according to the Government Accountability Office’s 2018 report. The AHA’s own data reveals the same thing, despite exponential growth of the 340B program, largely attributed to hospitals and contract pharmacies. Unlike Federally Qualified Health Centers (FQHCs, a type of federal grantee entity in the 340B program), which are required provide care “regardless of ability to pay”, hospital systems, in large part, have a much more extensive debt collection program; they are not necessarily beholden to rules regarding debt collection practices. FQHCs, as an example, may be required to seek debt payments from internal billing specialists, but don’t generally have contracts to sell the bad debt to collections companies or report to credit bureaus. Furthermore, they are prohibited from doing so in certain circumstances.

While the Affordable Care Act (ACA) prohibited certain types of hospital-originated debt from being reported to credit bureaus, it doesn’t stop the hospital from selling the debt and then the collection company reporting the debt. Indeed, hospitals are notorious for reporting medical debt and sending bills to collections. If 340B dollars are meant to offset some of these expenses, with program growing about 23% per year, why does the Census Bureau report that about 20% of Americans are under some form of medical debt? Why has that medical debt grown from $81 billion in 2016 to $140 billion in 2019?

The ACA required non-profit hospitals to offer charity care programs, and the vast majority of hospitals across the country are non-profit hospitals. Adding insult to injury, that tax designation and the requirement to offer charity care hasn’t stopped these “non-profit” hospitals from chasing after low-income patients and further impoverishing them. A recent Kaiser Health News “An Arm and a Leg” podcast dove into just one state’s effort to tackle an epidemic of “non-profit” hospitals suing patients as a result of medical debt. The effort found a massive coalition of 60 entities, including a nurses’ union, and startling data supporting the need for Maryland’s now-passed “Medical debt Protection Act.”

Data included notation of almost 150,000 lawsuits against patients over the last 10 years, making almost $60 million from patients who would otherwise automatically qualify for charity care, and hospitals negotiating with for state funds to support charity care taking in $119 million than they actually gave out in charity care. And that’s just in one state. Indeed, according to information behind this report, Johns Hopkins – a 340B hospital – alone raked in $36 million more from this state-funded charity care support than they spent. While Maryland already had certain patient protections from these predatory practices on the books, too few patients knew about those protections and the state awarded these dollars without ever investigating the existing status of bad debt to charity care ratios. All the paper in the world written into the law is meaningless if affected people and corporations are not made to be transparent and held accountable.

Access to care, and freedom to access care, are two different things. Access to care being an open door, and freedom to access care is the freedom to walk through that door without fearing a dire financial consequence. While some special interests may argue the program is critical to hospitals extending access to care, their rhetoric lacks practical application when patients don’t have the freedom to access that care without fear of acquiring life-altering debt. The fear of medical debt keeps people away from seeking care. In fact, one of the most immediate and meaningful ways to tackle the country’s medical debt crisis would be for 340B covered entities to share the savings with patients. A patient’s medical debt reported to their personal credit file can, and does, perpetuate cycles of poverty; it is harming patients’ wealth, health, and overall well-being. If 340B dollars are supposed to be aimed at ensuring access to care, then concerns over medical financial toxicity shouldn’t be discounted.

Hospitals, in large part, though not universally, have seen a significant decrease in uncompensated care due to the ACA’s expansion of Medicaid. With more patients qualifying for Medicaid, meaning an ability for providers to be reimbursed where none previously existed, hospitals should be able to shift their uncompensated care burden from bad debt to patient financial assistance and charity care programs.

On the other end of decreases in charity care provided by 340B hospitals, are truly magnificent non-profit hospital chief executive officer compensation.  In a 2019 hearing, CEOs admitted to having salaries in the millions of dollars per year range – that’s before bonuses. They also admitted to holding more money in reserves than they generally need in order to operate safely or not run the risk of running out of funding. Other instances of concern from this hearing include a hospital group using their 340B dollars to acquire a stand-alone oncology center. Typically, when these types of purchases are made, patients experience an increase in costs of care and sometimes experience a reduction in ability to access care due to an increase in patient load without subsequent staffing support or their provider’s office is physically moved as part of the consolidation effort, reducing a patient’s ability to physically get to and from office visits.

In addressing potential reforms that would benefit patient experiences, increase the sense of freedom patients feel to access care, and improve program efficacy, policy and law makers should both distinguish between generalized uncompensated care and charity care in annual financial reporting and 340B related audits and require a threshold of charity care for hospitals seeking to qualify for the 340B program. If hospitals are dissatisfied with their Medicare or Medicaid reimbursement rates and what that means for boosting their bottom line, they would do well to send their lobbyists after reimbursement dollars rather than disingenuously justifying their pilfer effort to rob 340B of its noble cause. Either way, it’s time these entities see requirements tied to their dollars, including rules around charging off debt against low-income patients.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• American Hospital Association (September 2020). 340B Hospital Community Benefit Analysis. Retrieved online at https://www.aha.org/guidesreports/2020-09-10-340b-hospital-community-benefit-analysis.

• American Hospital Association (December 2017). UNCOMPENSATED HOSPITAL CARE COST FACT SHEET. Retrieved online at https://www.aha.org/system/files/2018-01/2017-uncompensated-care-factsheet.pdf.

• Bennett, N., Eggleston, J., Mykyta, L., & Sullivan, B. (2021, April 7). 19% of U.S. Households Could Not Afford to Pay for Medical Care Right Away. U.S. Census Bureau. Retrieved online at https://www.census.gov/library/stories/2021/04/who-had-medical-debt-in-united-states.html.

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Committee on Energy and Commerce, Subcommittee on Oversight & Investigations (2017, October 11). EXAMINING HOW COVERED ENTITIES UTILIZE THE 340B DRUG PRICING PROGRAM. U.S. House of Representatives. Retrieved online at https://www.govinfo.gov/content/pkg/CHRG-115hhrg27577/html/CHRG-115hhrg27577.htm.

• Kliff, S. & Sanger-Katz, M. (2021, July 20). Americans’ Medical Debts Are Bigger Than Was Known, Totaling $140 Billion. The New York Times. Retrieved online at https://www.nytimes.com/2021/07/20/upshot/medical-debt-americans-medicaid.html.

• U.S. Government Accountability Office (2018, June 18). Drug Discount Program: Characteristics of Hospitals Participating and Not Participating in the 340B Program. GAO-18-521R. Retrieved online at https://www.gao.gov/assets/gao-18-521r.pdf.

• Weissmann, Dan (2021, October 7). PODCASTS – ‘An Arm and a Leg’: How One State Protects Patients From Hospital Lawsuits. Kaiser Health News. Retrieved online at https://khn.org/news/article/podcast-an-arm-and-a-leg-how-one-state-protects-patients-from-hospital-lawsuits/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=168013149&_hsenc=p2ANqtz-_sXa4onkYlNPYAtzOv-Hn4b_y9OgQhBcwhnxYvtugSLuAXK1sYZ1_OWiArpRr29-YxGGpHZCZ9t4IhZVASXKpQZ-lS5A&utm_content=168013149&utm_source=hs_email.

A Patient’s Guide to 340B: Why Accountability Matters to You

***This is the third report in a six-part series to educate patients about the 340B Drug Pricing Program***

The word accountable is defined as “being required or expect to justify actions or decisions.” Accountability is often broadly discussed on a variety of levels about governmental and social issues, and the 340B Drug Pricing Program is certainly no exception. The 340B program exists to address the health care needs of a segment of society – social needs. As such, program accountability is of paramount importance since patient health depends on it.

Accountability in use of 340B dollars follows the benchmarks of transparency in reporting: federal grantees are required by contract to demonstrate patient benefit in use of program dollars and non-grantee covered entities are held to no such standard. Without fiscal transparency, non-grantee entities cannot be held accountable for their use of these revenues. The Health Resources Services Administration (HRSA) largely selects covered entities for audit based on a selection of “risk” characteristics. While some criticism of manufacturers is warranted in terms of accountability, manufacturers have only one statutory requirement. That requirement is to provide discounts or rebates on qualifying medications to covered entities. HRSA selects manufacturers for audit based on complaints from covered entities. Areas of complaint about manufacturers typically consist of overcharging a covered entity, not making a particular medication available, or not being transparent about the “ceiling price” of a drug.

To be fair, the statutory accountability requirements of 340B program are…limited and…vague. However, according to a 2020 report by the Government Accountability Office (GAO-20-108), the Health Resources and Services Administration (HRSA) severely lacks meaningful oversight, uniform assessment and request standards, and, as with many other reports, finds HRSA’s administration of the program to be largely inadequate.

As an example, GAO identified HRSA audits from 2017 and 2018 reviewed less than 10% of all non-governmental hospitals enrolled in the program. HRSA primarily relies upon hospitals to self-attest their eligibility. Of the selected hospitals participating in the GAO review, 18 submitted documents that would constitute a government contract – any description of a community program – and when HRSA found these instances, allowed the hospitals to avoid getting in trouble by acquiring contracts with retroactive applicability. All of that meaning, these hospitals in question did not experience any reprimand for failing to provide programming to low-income people but they got to enjoy the perks of unaccountable 340B dollars until they got caught. At the rate HRSA reviews these entities, it’s possible for a non-compliant or otherwise non-qualifying entity could go an entire decade soaking up dollars meant for patients in needs.

While HRSA’s annual 340B audits are primarily targeted toward covered entities, drug manufacturers are also audited to ensure they’re not charging covered entities more than they should be for 340B medications, to ensure drug manufacturers are not discriminating against covered entities, and make sure drug manufacturers are making sure their products are made available in compliance with the 340B program. Manufacturers represent about ten percent of annual audits, while covered entities represent about 90 percent and there are about 900 drug manufacturers participating in the program (dramatically less than covered entities). To be fair, GAO concluded HRSA also needed to provide clearer guidance to drug manufacturers regarding what qualifies as an acceptable distribution restriction due to anticipated or actual supply shortages and to provide specific guidance as to what constitutes “discrimination” of covered entity participants.

This issue of defining discrimination is developing and playing out in “real-time”. In May of 2021, HRSA announced notification letters sent to 6 manufacturers regarding their new policies requiring additional reporting from covered entities with contract pharmacies (as opposed to in-house pharmacies). HRSA’s interpretation of statutory language (“…shall…each covered entity…”) as non-discretionary on the part of manufacturers. In essence, if an entity is registered with HRSA for the program, a manufacturer is required by law to offer medications at ceiling price or below to that entity, regardless of any potential for a covered entity to use program dollars outside of the intent of the program. While skepticism of non-grantee use of these dollars may be warranted due to lack of transparency in use of these dollars, diversion, or duplicate discount concerns, given that federal grantees are already required to report use of these dollars to their federal funders, a more narrowly tailored policy directed exclusively at non-grantee covered entities would be more appropriate to address the interest needs of manufacturers, the public, and program stability. However, given HRSA’s interpretation of the statutory language, even such a proposal might run the risk of rubbing regulators wrong. At the time of this writing, at least one of the manufacturers has sued the Department of Health and Human Services to prevent any monetary penalties related to these letters from being imposed. A judge has dismissed the government’s opposition to the suit in June of 2021. And on September 22, 2021 HRSA issued letters to the manufacturers in question, stating the issue had been referred to the Office of the Inspector General.

Lack of transparency means less accountability. Patients are better served when 340B-related dollars remain within the same geographic area they were generated by the covered entities. After all, if serving low-income patients means serving community and getting usable revenue required to be used on low-income patients, those dollars should be put back into the same community in which they were generated, right? But covered entities with large networks and multiple covered entity sites aren’t required to show those revenues are reinvested in the same area they were generated. For instance, monies made off the health and illness of an Atlanta community should not be spent to buy up profit generating imaging machines in a well-to-do suburban area outside of Los Angeles. But, without both transparency and accountability, 340B dollars can easily become a slush fund of revenues for any industrious non-grantee covered entity.

Indeed, many large contract pharmacies offer software programs to covered entities as a measure of their own “transparency” with internal reporting but the real goal is to show the covered entities “here’s how you can make more 340B dollars” – but at a cost of providing the service and without uniform assessment metrics. That means the contract pharmacy can tilt the experience of a patient by applying pressure to the covered entities very subtly through software programs telling the provider, “You can make more money off this patient by prescribing…”. Advocates have very good reason to be suspicious of contract pharmacies associated with (or even owning) pharmacy benefit managers who, then, can very easily provide programming that targets their profits over ensuring rebate dollars make it back to a patient.

Statutory clarification could greatly benefit the intended purpose of the 340B program – ensuring low-income patients get the care they need by taking a few, simple steps, specifying reporting requirements that mirror existing transparency and accountability found among grantees. Additional oversight is needed in numerous areas, all designed to further benefit patient access to care and medications. Among them, non-grantee entities should be required to report how 340B dollars are being used, by which payer source a claim is generated, how much charity care a non-grantee entity provides, and how much revenue is generated from pharmacy sales (and how much is generated from 340B sales). Patients might not understand the nuances behind the program complexities, but they do understand when they cannot access the care they need and deserve. If the purpose of the 340B program is to expand access to care and medications, then why not go that extra mile?

Congress could go a great deal further to ensure these billions of dollars serve patients, rather than the interests of shareholders in private hospital systems or propping-up senior management compensation packages, or other non-medically-related expenses. Congress could also opt to provide for additional minimum requirements in order to qualify as a covered entity – especially with regard to private hospitals providing a certain percentage of charity care.  

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Health Resources Services Administration (September 2021). 340B Drug Pricing Program – Program Integrity. HRSA Correspondence to Stakeholders 2021. U.S. Department of Health & Human Resources. Retrieved online at https://www.hrsa.gov/opa/program-integrity/index.html

• Lagasse, Jeff (June 2021). Judge dismisses HHS Challenge of AstraZeneca's 340B Contract Pharmacies Lawsuit. HealthCare Finance. Retrieved online at https://www.healthcarefinancenews.com/news/judge-dismisses-hhs-challenge-astrazenecas-340b-contract-pharmacies-lawsuit

• U.S. Government Accountability Office (December 2019). 340B DRUG DISCOUNT PROGRAM: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements. GAO-20-108. Retrieved online at https://www.gao.gov/assets/gao-20-108.pdf

A Patient’s Guide to 340B: Why Transparency Matters to You

***This is the second report in a six-part series to educate patients about the 340B Drug Pricing Program***

All public-private partnerships require transparency to instill confidence in program function, private business operations, and government accountability. Transparency is an essential part of the equation; it brings us more accountability and more effective programs. It helps to identify areas of improvement in operations or enforcement, as well as limiting waste, fraud, and abuse. The 340B Drug Discount Program is no exception because transparency ensures investments into patient access to medications for critically vulnerable populations are reaching patients. Transparency – in every programmatic aspect – serves the public interest and is, frankly, just good government. It builds confidence in the efficacy of the program and good will of the participating entities.

In general, under the 340B program, those entities receiving federal grant funding – known as “federal grantees” – under other programs (i.e., federally qualified health centers, Ryan White HIV/AIDS clinics, hemophilia centers, and others) receive a great deal over oversight on how they use their discounts and rebates from 340B, though that oversight comes as part of their fiscal reporting under those other programs. For non-grantee covered entities, oversight is primarily dependent on audits and self-attestation of compliance and corrections to issues. With non-grantee covered entities lacking dedicated oversight like federal grantees, there’s a lack of transparency in how those entities qualify under the program and how those entities are using 340B-generated revenues to benefit low-income patients.

Regardless of program, dollars meant to serve low-income patients are often scarce. As such, patients lose when the investments needed to support and expand services for vulnerable populations are directed elsewhere (outside of the community those dollars originated from or for-profit building purposes). Patients lose out on funding support that keeps programs stable, ensures access to critical health programs nearest to them, and ultimately threatens to destabilize a program relied upon by the federal government and community stakeholders to keep clinic and hospital doors open.

At the inception of the 340B program, legislation such as the Patient Protection and Affordable Care Act did not exist, and only 29 million people nationwide were enrolled in Medicaid. Fast forward to 2018, Medicaid rolls had grown to 72 million people – meaning in all but the hold-out “non-expansion states” nearly any hospital in the country might qualify as a “disproportionate share hospital” – a situation 340B never considered at inception. The development and growth of the program was analyzed in a 2018 report issued by the U.S. House of Representatives’ Committee on Energy & Commerce.

According to a Government Accountability Office report (GAO-21-107) about 80% of current covered entities are federal grantees and 20% of covered entities are hospitals. However, many of these entities, especially hospitals operate multiple sites – not all entities are created equal in terms of generating program revenue. Of the approximate 37,500 covered entity sites participating in the program, about 75% of those sites are hospital affiliated with hospitals, not federal grantees. Hospitals are able to qualify specifically because of the low threshold of “disproportionate share” of low-income patients who can now afford to seek care thanks to Medicaid expansion – even if the hospital entity is generally well off enough to not actually need those dollars in order to provide care. In order to better understand how these changes have impacted growth and qualification of the program, “disproportionate share” may not be the best formula to ensure 340B dollars are helping those who need it most. Particularly, given the decreasing share of charity care certain hospital entities have offered over the years, evaluating charity care percentages and qualifying patients by income and payer type (self-pay, Medicaid, private insurance, etc.) may be more accurate in ensuring entities are actually serving low-income communities.

To be clear, “charity care” is a specific type of “uncompensated care” – or when patients receive care but can’t pay their bills. Unlike other types of uncompensated care, whereby providers may send a patient’s bill to a collections company, charity care releases the patient from a portion or all of their financial responsibility. Typically, charity care is limited to those who have to choose between putting food on their table and seeking preventative care like mammograms or having to decide in what life-saving neonatal care a family might need. Given the intersection of race and poverty in this country, charity care is a critical, even if anecdotal measure of how much a hospital is invested in their local community and combating community health disparities like pregnancy-related mortality.

The 340B program’s statutory language is largely silent on how these revenues dollars may be spent and because of that, there’s little to ensure these dollars are actually going to benefit patients instead of hospital networks or pad executive pay. Patient advocates have long crowed about the need for non-grantee covered entities to meet the same transparency requirements federal grantees are required to meet. Indeed, one of the biggest challenges facing the 340B program is better understanding how these dollars are spent. Now, typically, where statute is vague, government agencies tasked with managing programs have the regulatory power to make rules and the man power to enforce them. That’s just not the case with 340B and the Health Resources and Services Administration (HRSA) has repeatedly stated a lack of surety in its ability to regulate beyond guidance and frequently cited an inability to expand auditing capacity due to lack of funding. So much so that President Biden included $17 million in his budget request to strengthen and expand oversight of the program specifically in terms of auditing how 340B revenues are generated and spent among on-grantee covered entities.

Given the program’s growth, there’s reason and need to further clarify the intent of the program, cemented into unambiguous statutory language to reflect the country’s health care landscape of today and ensure the revenues generated are actually helping patients and not padding executive pockets. In our next blog, we’ll discuss the accountability processes currently in play for covered entities and manufacturers and the glaring holes in that part of the oversight “net”.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here 2018 report.

Sources:

• Centers for Disease Control & Prevention (2020, February 4). Infographic: Racial/Ethnic Disparities in Pregnancy-Related Deaths — United States, 2007–2016. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/reproductivehealth/maternal-mortality/disparities-pregnancy-related-deaths/infographic.html

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• House Committee on Energy & Commerce (2018). Review of the 340B Drug Pricing Program. U.S. House of Representatives. Retrieved online at https://republicans-energycommerce.house.gov/wp-content/uploads/2018/01/20180110Review_of_the_340B_Drug_Pricing_Program.pdf

• King, Robert (2021, June 1). From 340B to a public option: 4 healthcare items you may have missed in Biden's budget. Fierce Healthcare. Retrieved online at https://www.fiercehealthcare.com/hospitals/from-340b-to-a-public-option-4-healthcare-items-you-may-have-missed-biden-s-budget

• U.S. Government Accountability Office (December 2020). DRUG PRICING PROGRAM: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements. GAO-21-107. Retrieved online at https://www.gao.gov/assets/gao-21-107.pdf

A Patient’s Guide to 340B: Why the Program Matters to You

***This is the first report in a six-part series to educate patients about the 340B Drug Pricing Program***

In 1992, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients: If pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple; drug manufacturers could have a guaranteed income from participation in the Medicaid program, and “covered entities” could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates, affording healthcare providers a way to fund much-needed care to patients who could not otherwise afford it.

This payment program is little known but, now it is significantly large. It is the 340B Drug Pricing Program.

“At the inception [of the 340B program], these entities [Hemophilia Treatment Centers (caring for all patients with both bleeding and clotting disorders), Ryan White Clinics and FQHCs were specifically identified] were the prime targets to benefit from the  three major goals of the initial PHS pricing program: first, that pharmaceutical products would be purchased at markedly reduced 340B pricing; secondly, the discounts would be passed on to the payors and finally that a small, reasonable, percentage would go to the entity itself, to sustain Covered Entities to care and expand diagnostic and clinical services.”
– Dr. Diane Nugent, National Commission on 340B (2018)

Initially, covered entities were exceptionally restricted, including but not limited to federally qualified heath centers (FQHCs), Ryan White HIV/AIDS clinics, hemophilia treatment centers, and only one category of hospitals, so-called “disproportionate share hospitals” (DSH). DSH is a hospital entity that provides a “disproportionate” number of low-income patients, evaluated quarterly and calculated through a formula dictated by statute. Of these entities, those receiving federal grant dollars under any number of federally funded programs are called “federal grantees”.

Federal grantees are required by statutory language to certain transparency in how they spend their 340B-related revenue. In trade, participating drug manufacturers are also required to be transparent in their contributions to the program.

In addition, federal grantees are required to be transparent and accountable regarding their 340B-generated dollars by their federal grants, not by the statutory language of the 340B program. That means every dollar a federal grantee generates is held accountable to serving the needs of low-income patients. How these dollars may be used from grantee to grantee may look a little different but they’re still required to fit within the guardrails of the grant and, for many federal grantees, the most direct way of achieving this goal is sharing the savings with patients at the pharmacy counter. By its very nature, 340B’s purpose is to reduce the amount of tax dollars spent on these grants by providing an avenue of program revenue, and thus support existing efforts to provide care for the most vulnerable.

Over the years, covered entities have expanded to include contract pharmacies, family planning centers, children’s hospitals, critical access hospitals, rural referral centers, freestanding cancer centers, and sole community hospitals. From 1992 until about 2001, participation in the program by covered entities was fairly static – it didn’t grow or change in any massive quantity. After 2001, covered entities able to access the 340B program began to grow at an exceedingly fast pace, with even more growth among “covered entity sites” and the greatest amount of growth among contracted pharmacies. This was reflected in 340B sales, as well. According to the Drug Channels Institute, 340B purchases grew from about $2.4 billion in 2005 to more than $38 billion in 2020.

In general, 340B-related income looks like an insurer reimbursing the cost of a medication for a patient to a covered entity, a pharmacy filling the medication at the rebated cost with addition of a minor dispensing fee, and the covered entity keeping the excess as savings. Covered entities are allowed spend those excess funds in particular ways which qualify as “expanding access” to medication or care. For entities applying those funds directly to outpatient medications, this is known as “following the patient” or “sharing the savings”. Other uses may include anything that directly impacts access to or quality of care for low-income patients. Notable examples may include technology upgrades to be in-line with patient security and best practices in extending scarce human resources (i.e. how efficient care can be delivered to patients), acquiring new care technology to provide care not previously available (i.e. imaging and x-ray machines), and infrastructure like mobile medical units in order to bring care to patients rather than bringing patients to care or opening new locations in order to be more accessible to their served communities. 340B prohibits covered entities on double dipping on discounts or applying rebate dollars to inpatient medications or to a particular patient that does not qualify as low-income (“diversion”).

That patient getting their share of the savings makes a great deal of sense. Indeed, a Government Accountability Office report (GAO-18-480) of selected covered entities stated of 55 interviewees, 30 reported providing low-income, uninsured patients on 340B dispensed medications and all “30 covered entities providing patients with discounts reported providing discounts on the drug price for some or all 340B drugs dispensed at contract pharmacies. Federal grantees were more likely than hospitals to provide such discounts and to provide them at all contract pharmacies.” Patients realize the savings of the rebate program immediately. Benefits of the program which may be less recognizable to patients for a similar report from 2011 (GAO-11-836) included funding a non-revenue-generating case management program, patient and family education programs similar to guidance pharmacists provide on medication interactions, and transportation to and from care appointments. All of which are critically necessary in terms of creating a safety net of accessible care for vulnerable communities and patients.

For more information on the issues facing the 340B Drug Pricing Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here 340B Drug Pricing Program.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Hasan, Shiraz, and Sofi Peterson (2021, April 16). 340B Drug Discount Program Growth Drivers. IQVIA. Retrieved online at https://www.iqvia.com/locations/united-states/blogs/2021/04/340b-drug-discount-program-growth-drivers

• Health Resources & Services Administration (2021). Sec. 340B PUBLIC HEALTH SERVICE ACT. U.S. Department of Health & Human Services. Retrieved online at https://www.hrsa.gov/sites/default/files/opa/programrequirements/phsactsection340b.pdf

• U.S. Government Accountability Office (2011, September). DRUG PRICING: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement. GAO-11-836. Retrieved online at https://www.gao.gov/assets/gao-11-836.pdf

• U.S. Government Accountability Office (2018, June). DRUG DISCOUNT PROGRAM: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement. GAO-18-480. Retrieved online at https://www.gao.gov/assets/gao-18-480.pdf

SCOTUS Sets Dangerous Precedent for Incarcerated People Needing Care

The 8th Amendment to the United States Constitution reads as follows:

“Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”

Long standing precedent, Estelle v. Gamble, sets one standard of “cruel and unusual punishment” as “deliberate indifference” to the medical needs of incarcerated people. Additional precedents include an affirmative need to evaluate these medical needs on an individual basis, cannot be excused as mere neglect when an incarcerated person is at “substantial risk of harm” if that need is not met, and that providing care that is “grossly inadequate as well as by a decision to take an easier but less efficacious course of treatment” are also considered measures of “deliberate indifference”.

In August 2020, the US Court of Appeals for the 6th Circuit added an asterisk: “…if the state decides it can afford to…” provide the care required under the 8th amendment [paraphrasing].

Last month, the Supreme Court of the United States refused to hear the appeal of Atkins v. Parker, where a group of incarcerated people alleged their 8th amendment rights were violated because the state was rationing their HCV related care. In the 6th Circuit appeal, the state argued, successfully, that rationing care was “reasonable” due to budgetary constraints supposedly outside the control of the prison system.

Coverage of both appeals referred to a 2018 settlement in Michigan, wherein the state’s Medicaid program, after suit, expanded coverage to include direct acting agents. However, in a lone descent, Judge Gilman drew more direct parallels in other SCOTUS and 11th Circuit rulings regarding prison overcrowding and access to AZT (case was in 1991) for incarcerated people, ruling in part “The fast moving status of research and medical advances in AIDS treatment is continually redefining what constitutes reasonable treatment.”, respectively. Indeed, in Atkins, the state’s position boils down to “new drugs are too expensive” to be “reasonable” for incarcerated people to have access to. The majority argued because Tennessee’s Department of Corrections Medical Director, Dr. Williams, had only recently restructured the state’s rationing of DAAs and individual assessments, the state had fulfilled its obligations, within budgetary constraints. Judge Gilman correctly argued the state’s medical administrator for the prisons was obligated to request appropriate funding to meet these needs in order to fulfill the state’s 8th amendment requirements – of which, no evidence was presented to prove Dr. Williams did make such a request. Judge Gilman closes the descent with well-established citation that treating HCV early reduces overall costs of care compared to delayed or denied care.

That said, with SCOTUS refusing to hear the appeal, affected people in prisons are facing a dangerous precedent of state officials shirking their Constitutional responsibilities to provide a basic standard of care to the people in their custody. Legislatures merely need to neglect increasing a budget, as we’ve seen in other state-run health care programs, in order to avoid meeting their Constitutional duties.

Interestingly, also in April, the Department of Justice filed a statement of interest in a case in the Georgia, where an incarcerated transgender woman has been subject to violent attacks and refusal of care. The Biden administration’s position here is denying incarcerated people gender affirming medical care is a violation of the 8th amendment’s protections and is thus “deliberate indifference” to the person’s medical needs.

There’s an intersection between Diamond and Atkins that cannot be missed. While the timing of Atkins didn’t favor intervention by the current administration, this administration must also recognize the precedent set forth by Atkins, fight for appropriate funding measures to meet the medical needs of incarcerated people, and update Federal Bureau of Prisons HCV guidance to with regard to prioritization not justifying rationing of care. As with nearly every infectious disease, prisons are both a “canary in the coal mine” of the local community and the ideal environment for manifesting new diagnoses.

The most startling statistic in Atkins is even after DAAs were available, at least 109 incarcerated people had died due to HCV complications. Death by neglect, by rationing is still a death sentence.

Even as I write this, President Biden argued “health care should be a right, not a privilege.”

As it turns out, according to the 6th Circuit, it’s a right, with a large asterisk.

To ensure this injustice is answered for, advocates must remember the courts do not always find justice and our advocacy must reach every level of government. If we don’t, the asterisks will continue to add up.

One Shot or Two? Necessity of COVID-19 Vaccination Among People Living with HIV and/or Chronic Liver Disease

At the time of this writing, the United States’ Food and Drug Administration (FDA) has provided Emergency Use Authorizations (EUAs) to 3 COVID-19 vaccines, with Novavax’s product potentially leading the race to become the fourth. While some have fretted over “which vaccine” is “the best”, governors and clinicians have resoundingly adopted a simple answer: “which ever vaccine you can get”. While President Biden has pushed to expand eligibility to all adults in the US by May 1st, as we’re all too familiar with in patient advocacy, eligibility does not necessarily equate to access and, in this respect, demand still vastly outstrips vaccine supply domestically.

The debate on who should get a vaccine and when began well before the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations in December 2020. ACIP’s recommendations focused primarily on constructing an ethical model based on hospitalizations and mortality, with an eye toward those performing duties most necessary to meet the health care demands of the moment. Ultimately, outside of this job-based prioritization, ACIP gave top priority via age-based allocation and then ascertaining those at-risk for these outcomes based on pre-existing conditions. Most states adopted some version of these prioritized populations. The debate on the efficacy of this model continues to rage on – what about those in marginalized communities more impacted by COVID-19 than more affluent communities? What about younger people with comorbidities? Which health conditions should be prioritized?

Regardless of where one’s local government falls on this debate, evidence catalogued by the CDC indicates a very real need for people living with HIV and those with chronic liver diseases to seek a vaccine as readily as possible as these cohorts are at increased risk for complications related to a COVID-19 infection. Studies have found PLWH experiencing an acute COVID-19 infection may see as much as 50% drop in CD4 T-cells compared to their historical levels, a condition known as lymphopenia – of which, is also an indicator for severe COVID-19 and protracted recovery or death. Additionally, the same study found key clinical metrics used to measure inflammation were similarly increased among PLWH. Another study out of Wuhan, examining people with chronic, yet controlled Hepatitis B infections may see a reactivation of viral activity and/or potentially face significant progression of liver cirrhosis during and after a COVID-19 diagnosis. Another study found SARS-CoV-2 may target certain cells in the bile tract and cause focused damage to the systems serving a person’s liver, with another study suggesting the need for health care providers to emphasize liver repair post COVID diagnosis.

While Janssen ensured PLWH were enrolled in phase 3 clinical trials for their product, none of the currently authorized products included solid organ transplant recipients in their trials. While the American Society of Transplantation notes COVID-19 vaccine administration recommendations for solid organ transplant recipients remains the same as other vaccines (either completed at least 2 weeks prior to transplant or initiated at least 1 month after transplant). Which may pose a problem according to a study published in March showing transplant recipients having received the first shot in the series mounted an antibody response just 17% of the time. While antibody responses are not necessary to confer immunity, they are the leading indication of an immune response. The authors of this study will be seeking to answer that question later this year.

Furthermore, additional research is needed in assessing post-acute COVID-19 infections and the implications of “long COVID”. Most research at this moment on long-COVID is tied to assessing symptom presentation and frequency of health care needs. However, there is a minor bit of information regarding organ function post-hospitalization with COVID-19 – none of it is “good news”. In particular, people experiencing chronic liver diseases were almost 2 times as likely to experience “major adverse events” after being released from the hospital due to COVID-19.

All of this information culminates with a sense of urgency some states are heeding in expanding vaccine access “ahead of schedule” to include people living with HIV or specific programming targeted to provide vaccines to these communities.

Brandon Macsata, CEO of ADAP Advocacy Association, recently penned a blog addressing any hesitancy among people living with HIV around getting their vaccines: “Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!”

With the CDC’s guidance on prioritizing our communities in vaccination schemes, I couldn’t agree more.