Innovation as a Change Agent for Patients Leaving Incarceration
For Dontrace Young, leaving incarceration means stepping back into a world saturated with risk. Two of his cousins died from opioid overdoses in their early twenties, and drug use touches nearly every branch of his family tree. He knows the statistics – that the risk of a fatal overdose skyrockets in the weeks after leaving jail. But thanks to a program at the New Orleans jail, Dontrace is now equipped with Narcan and the knowledge to use it, skills that could save his life or the life of someone he loves. Dontrace’s story highlights a harsh truth: for many people leaving incarceration, access to healthcare is not a guarantee, and navigating a complex and often unwelcoming system can feel impossible. This challenge is not unique to those involved with the justice system.
Across the United States, systemic inequities create significant barriers to healthcare access, disproportionately impacting communities of color and those living in poverty. In rural areas, lack of insurance further exacerbates healthcare disparities. While technological innovation promises to revolutionize healthcare, these advancements often fail to reach the margins, sometimes even widening existing gaps. As the Stanford Social Innovation Review notes, an over-reliance on technology without addressing systemic issues can actually worsen health disparities. However, two innovative programs – one in New Orleans and one in Connecticut – offer a different approach, demonstrating that achieving health equity requires meeting people where they are and addressing the social factors that influence well-being.
Overdose Prevention: Preparing for Reentry in New Orleans
Inside the walls of the Orleans Justice Center, a program spearheaded by Dr. Anjali Niyogi is working to equip people leaving incarceration with a life-saving tool: knowledge. Recognizing the heightened risk of overdose for those reentering society after time in the carceral system, Dr. Niyogi founded the Formerly Incarcerated Transitions (FIT) Clinic, a program that provides a bridge between incarceration and healthcare access. A core component of the FIT Clinic’s work involves regular visits to the jail, where a team led by Dr. Niyogi, and including formerly incarcerated community health workers Haki Sekou and Danielle Metz, provides overdose prevention training and distributes Narcan to those preparing for release. The need for such a program cannot be overstated. As a 2007 study in the New England Journal of Medicine revealed, the risk of overdose is 129 times higher for people in the weeks after they leave jail. Factors like reduced tolerance and the increasingly prevalent presence of fentanyl in the drug supply contribute to this alarming statistic. By providing education and resources within the jail setting, Dr. Niyogi aims to mitigate this risk and provide people with the tools they need to stay safe.
Central to the program’s success is the involvement of Sekou and Metz. Having both experienced incarceration themselves, they possess an intimate understanding of the challenges faced by those leaving the justice system. Their presence helps to break down barriers and build trust with a population often wary of traditional healthcare providers. As Sekou explains, “They think doctors are going to use them as a guinea pig. That’s one of the words they use commonly.” By offering a listening ear, sharing their own stories, and providing practical support, Sekou and Metz create a space where people feel seen, heard, and empowered to prioritize their health. For people like Dontrace Young, the FIT Clinic’s impact extends far beyond overdose prevention training. The program connected Dontrace with resources to address his mental health, offering a pathway to a healthier future. By building trust, providing essential knowledge, and fostering connections to ongoing care, the FIT Clinic exemplifies the power of meeting people where they are and addressing health needs within the broader context of their lives.
Healthcare on Wheels: Reaching the Underserved in Connecticut
Recognizing that access to healthcare extends far beyond the doctor’s office, a team at Yale University has launched a groundbreaking initiative: the nation’s first mobile pharmacy. Housed in a retrofitted Winnebago, this innovative program brings a full range of pharmacy services directly to communities facing significant barriers to care, including people experiencing homelessness, those with chronic illnesses, and people with substance use disorders. The mobile pharmacy, the brainchild of Dr. Sandra Springer, a specialist in HIV and addiction treatment at Yale Medical School, aims to bridge the gaps in traditional healthcare delivery. “If we’re going to provide health care and you’re going to provide medication, you better be able to provide that medication,” asserts Dr. Springer. “We should be trying to help people get those services.” The mobile unit, staffed by a team of pharmacists and healthcare providers, travels to locations such as homeless encampments, food pantries, and community clinics, ensuring that essential medications and healthcare services are available to those who need them most.
This innovative approach tackles multiple barriers to care simultaneously. For those without reliable transportation, the mobile pharmacy eliminates a significant hurdle. For people experiencing homelessness, who may feel stigmatized or unwelcome in traditional healthcare settings, the mobile unit offers a safe and accessible alternative. And for those struggling with chronic conditions, the mobile pharmacy provides consistent access to medications and support, reducing the likelihood of complications and hospitalizations.
The mobile pharmacy’s impact extends far beyond simply filling prescriptions. The team provides a range of services, including chronic disease management for conditions like diabetes and hypertension, wound care for those struggling with infections or injuries, and connections to mental health and addiction treatment resources. Jillian Corbin, executive director of the St. Vincent de Paul Place daytime shelter in Norwich, where the mobile pharmacy has become a lifeline for many, attests to its transformative impact: “When the staff from the pharmacy van first arrived in February, the impact to the community was immediate and life-changing.” By meeting diverse needs with compassion and expertise, Yale’s mobile pharmacy serves as a powerful model for how to bring healthcare directly to those who are too often left behind.
Redefining Innovation: Lessons from the Margins
The programs in New Orleans and Connecticut offer a powerful counter-narrative to the prevailing notion of healthcare innovation as synonymous with technological advancement. They illuminate a critical truth: true progress towards health equity requires a fundamental shift in how we define and approach innovation. As Infectious Diseases of Poverty asserts, “social innovation can best be understood as innovation in social relations, in power dynamics and in governance transformations, and may include institutional and systems transformations.” These programs are not simply delivering services; they are transforming systems by dismantling barriers, challenging assumptions, and centering the needs of those most often relegated to the margins. This requires a commitment to investing in what the Stanford Social Innovation Review calls “health-focused social innovations,” rather than solely prioritizing technology-driven solutions that may fail to address the root causes of health disparities, or make them worse.
What makes these programs so effective? They embody key principles of equitable innovation:
Community Engagement: Both programs prioritize the active involvement of their target populations. The FIT Clinic relies on formerly incarcerated community health workers who bring invaluable lived experience and trust to their work. Yale’s mobile pharmacy team collaborates with local organizations and community members to ensure their services are accessible and responsive to local needs.
Culturally Responsive Care: These programs recognize that healthcare is not one-size-fits-all. They approach each interaction with cultural sensitivity, understanding that historical trauma, systemic racism, and other forms of oppression profoundly impact health outcomes and shape people’s experiences with healthcare systems.
Trust and Relationships: Building authentic relationships based on trust and mutual respect is paramount. For those who have experienced stigma, discrimination, or mistreatment within healthcare settings, trust is not a given. Both programs address this by prioritizing empathy, transparency, and a genuine commitment to meeting people where they are, both physically and emotionally.
Addressing Social Determinants of Health: These programs understand that health outcomes are shaped by a complex interplay of social, economic, and environmental factors. By providing transportation, addressing food insecurity, and connecting patients to essential resources, they go beyond treating immediate medical needs and work to create conditions that support overall well-being.
The success of these programs is a call to action for all of us working towards a more just and equitable healthcare system. We must:
Support and invest in community-based programs: Funding should be directed towards initiatives that prioritize social innovation, community engagement, and culturally responsive care.
Shift funding priorities: While technology has a role to play, we must move away from an over-reliance on expensive technological solutions that often fail to reach those most in need.
Advocate for policy change: Systemic change requires advocating for policies that address the root causes of health disparities, such as poverty, discrimination, and lack of access to quality education and employment opportunities.
Amplify marginalized voices: Those most impacted by health inequities must be at the forefront of designing and implementing solutions. We must listen to, learn from, and follow the lead of those with lived experience.
By embracing a broader vision of healthcare innovation – one that centers equity, community, and the lived experiences of those most marginalized – we can begin to create a healthcare system that truly works for everyone.
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:
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.
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.
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.
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.
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.
Ripple Effect: How PBMs and Counterfeit Drugs Threaten Patients
The infiltration of counterfeit drugs into the legitimate pharmaceutical supply chain poses a significant risk to patient health and safety, particularly for those living with HIV. While counterfeit drugs are nothing new, the criminals threatening our safety have a surprising new ally: Pharmacy Benefit Managers (PBMs). A report by the Partnership for Safe Medicines unveils how criminal entities exploit vulnerabilities in the supply chain, made worse by PBMs, whose reimbursement policies often leave pharmacies on the edge of financial viability.
The fight against HIV/AIDS is significantly hindered by the infiltration of counterfeit medications into the pharmaceutical supply chain, an issue that transcends mere regulatory challenges or financial losses. It directly impacts the health and safety of people living with HIV (PLWH), undermining the global effort to manage and eventually End the HIV Epidemic.
A striking example of the severity of this issue is the investigation conducted by Gilead Sciences Inc., which was extensively covered by The Wall Street Journal. This investigation uncovered that over two years, a staggering 85,247 counterfeit bottles of Gilead's HIV medications Biktarvy and Descovy, valued at more than $250 million, had been distributed within pharmacies. These counterfeit products, the result of sophisticated criminal networks exploiting supply chain vulnerabilities, ranged from being filled with harmless over-the-counter painkillers to dangerous antipsychotic drugs, posing significant health risks to unsuspecting patients. “Harmless” is relatively qualified here because when PLWH are not receiving necessary antiretroviral medications, conditions can develop quickly with deadly consequences, medication resistance can bloom, and new transmissions can occur.
The presence of counterfeit medications not only endangers the lives of PLWH but also severely erodes trust within communities, particularly those that are already marginalized and financially strained. The breach in the supply chain security caused by these counterfeit drugs highlights a critical public health issue that demands immediate and concerted action from all sectors involved in healthcare delivery.
Addressing the Challenges Posed by Pharmacy Benefit Managers and Under-Reimbursement
PBMs are at the heart of growing scrutiny for practices exacerbating healthcare system challenges, notably impacting the economic viability of pharmacies, and facilitating the entry of counterfeit drugs into the supply chain.
Their primary role is to negotiate drug prices and manage prescription drug benefits on behalf of health insurers, under the guise of controlling costs and streamline the prescription process. The reality is, PBMs do not necessarily pass on “savings” to patients or plan sponsors and have, in truth, become a self-dealing entity working hard to maximize the profits of insurance company shareholders. PBMs often implement reimbursement policies that pay pharmacies less than the actual cost of acquiring and dispensing medications when those pharmacies are not owned by the PBM itself. This under-reimbursement pressures pharmacies, especially independent ones, to find ways to sustain their operations amidst shrinking margins. In other instances, PBMs offer higher reimbursement rates to their mail-order pharmacy and work hard to steer patients away from independent pharmacies.
This economic squeeze leads to a consequential gap in the market: the demand for medications that the legitimate supply chain cannot adequately supply at the prices set by PBMs. Counterfeiters exploit this gap, introducing fake or substandard medications into the supply chain and offering the fakes at a lower acquisition cost than legitimate wholesalers. The cycle perpetuated by PBM under-reimbursement practices not only undermines the financial stability of pharmacies but also compromises patient safety. Pharmacies, caught in the vise of financial pressures, may unknowingly procure medications from less reputable sources, inadvertently becoming conduits for counterfeit drugs. This situation is exacerbated in rural and underserved communities, where pharmacies are often the sole healthcare providers, making the impact of counterfeit medications even more devastating. These counterfeit drugs find their way into pharmacies struggling to balance financial viability with the provision of quality care. The allure of lower cost options in the face of under-reimbursement makes these counterfeit products dangerously appealing for pharmacists seeking to meet patient needs.
The financial strain on independent pharmacies due to PBM policies is further highlighted by the National Community Pharmacists Association's (NCPA) support for a class action lawsuit against Express Scripts. This legal action accuses Express Scripts and several smaller PBMs of colluding to manipulate reimbursement rates and impose higher fees on pharmacies, further squeezing their financial resources and compromising their ability to provide quality services.
American Pharmacy Cooperative, Inc. (APCI)'s initiative to engage Vanguard Inc., a significant investor in the conglomerates owning the "Big 3" PBMs, exemplifies the urgent need for systemic reform. This effort, celebrated by Pharmacists United for Truth & Transparency (PUTT), emphasizes the necessity of reforms that ensure transparency, fair reimbursement, and ethical conduct to safeguard the pharmaceutical supply chain.
Prescription Drug Affordability Boards (PDABs) and Their Impact
Prescription Drug Affordability Boards (PDABs) are quickly gaining popularity among states, being sold as an attempt to make healthcare more affordable. These boards, armed with the authority to scrutinize and cap drug prices, aim to shield the public from the soaring costs of essential medications. However, there's concern that these actions might limit access to medications for marginalized communities and create more challenges for pharmacies.
A recent webinar hosted by the National Minority Quality Forum (NMQF) brought to light the challenges PDABs face in balancing drug affordability with healthcare equity. Jen Laws, President and CEO of the Community Access National Network (CANN), voiced a critical perspective, highlighting the limitations of PDABs' current toolkit, which primarily revolves around setting upper payment limits. Laws pointed out, "The only tool that the PDABs have been provided is an upper payment limit, and they are not being encouraged to explore other tools or learn how to make investments into issues of health equity and access. When we take money out of systems, the people not represented lose out first." Few of these boards have patients appointed to them. This insight underscores the complexity of ensuring drug affordability does not come at the expense of access, particularly for those in marginalized communities.
Echoing this sentiment, Gretchen C. Wartman, Vice President for Policy and Program and Director of the Institute for Equity in Health Policy and Practice at NMQF, emphasized the need for PDABs to broaden their approach. "We must pursue efforts to ensure that PDABs are improving access to medicines, rather than constraining that access in the interest of financial risk mitigation," Wartman stated, advocating for a more holistic strategy that aligns drug affordability with comprehensive access to care.
The discussions surrounding PDABs, particularly highlighted in the NMQF webinar and our CANN blog, reveal a critical need for a nuanced approach to drug affordability that doesn't inadvertently compromise access or exacerbate vulnerabilities in the pharmaceutical supply chain. By focusing narrowly on upper payment limits (UPLs) as a primary tool for cost containment, there's a real risk of creating gaps in the medication supply that counterfeiters could exploit, further endangering patient safety and public health. This scenario underscores the importance of developing comprehensive strategies that not only address the immediate issue of drug costs but also consider the broader implications for healthcare equity, pharmacy viability, and the integrity of the medication supply chain. Policymakers and stakeholders must work collaboratively to ensure that efforts to control drug prices do not inadvertently introduce new risks, particularly for marginalized communities and the pharmacies that serve them.
A Legislative Response: The Florida Prescription Drug Reform Act
The Florida Prescription Drug Reform Act stands as a major legislative response to the pressing issues within the pharmaceutical supply chain, particularly addressing the detrimental practices of Pharmacy Benefit Managers (PBMs) that contribute to pharmacy under-reimbursement and indirectly foster an environment ripe for counterfeit drugs.
Focused Provisions:
Regulating PBM Operations: The Act mandates PBMs to obtain a certificate of authority, introducing a layer of accountability and transparency previously absent. This requirement aims to scrutinize and regulate PBM practices more closely, ensuring they operate in a manner that supports rather than undermines pharmacy financial stability.
Prohibiting Harmful Practices: Specifically targeting practices that have strained pharmacies, the Act prohibits PBMs from engaging in retroactive fee recoupments and spread pricing strategies. Such practices have historically placed pharmacies in precarious financial positions, making the supply chain vulnerable to counterfeit medications as pharmacies seek cost-saving measures.
Ensuring Fair Reimbursement: By enforcing a pass-through pricing model, the Act ensures that pharmacies are reimbursed the actual cost paid by the health plan to the PBM for medications. This approach directly addresses the issue of under-reimbursement, reducing the financial pressures that can lead pharmacies to inadvertently engage with dubious suppliers.
Implications for Supply Chain Security:
These targeted reforms within the Florida Prescription Drug Reform Act are designed to directly impact the economic pressures pharmacies face due to PBM policies. By ensuring more equitable and transparent reimbursement practices, the Act mitigates one of the key factors that have made the pharmaceutical supply chain susceptible to counterfeit drugs. It represents a significant step towards safeguarding pharmacies from the financial instability that can compromise patient safety and healthcare integrity.
In essence, the Act provides a comprehensive framework for other states and federal entities to consider, highlighting the importance of addressing PBM practices as a critical component of enhancing supply chain security and protecting patient health.
Advocating for Change: Strategic Policy Reforms and Mobilization
The challenges posed by PBMs, PDABs, and drug affordability impact not just the healthcare industry and policymakers but directly affect patients seeking affordable, safe medications. This underscores the urgency for a unified advocacy movement towards systemic reform. Drawing on the initiatives of groups like PUTT and APCI, as well as the framework set by Florida's Prescription Drug Reform Act, we have a clear path to advocate for transparency, equity, and patient access across healthcare.
Calls to Advocacy
Broadened Engagement with Policymakers, Investors, and the Public: Advocacy efforts must expand to encompass not just policymakers but also investors and the broader public. Echoing APCI’s engagement with Vanguard Inc., it's critical to advocate for investor responsibility in healthcare practices. Moreover, by leveraging the legislative model of Florida's Prescription Drug Reform Act, advocates can champion similar transparency and regulatory measures nationwide. This expanded advocacy should also include a focus on ensuring PDABs operate with a mandate that balances drug affordability with the need for access to innovative treatments.
Unified Support for Legislative and Regulatory Reforms: Stakeholders are encouraged to unite in supporting and proposing legislative initiatives that tackle the foundational issues of PBM reform and the effective operation of PDABs. Advocacy should push for laws that not only enhance drug pricing transparency and regulate PBM reimbursement rates but also ensure PDABs do not inadvertently limit access to essential medications for marginalized communities.
Active Participation in Rulemaking Processes with Strategic Alliances: Stakeholders should actively participate in the rulemaking process, forming strategic alliances to influence the regulations governing PBMs and PDABs. This collective action is vital in shaping policies that promote fair reimbursement practices, safeguard pharmacy access, and ensure PDABs contribute positively to healthcare equity.
Comprehensive Educational Campaigns to Foster Awareness and Action: Initiating educational campaigns that explain the roles and impacts of PBMs and PDABs in the healthcare system is essential. By incorporating success stories from state and federal legislative achievements and insights from advocacy efforts, these campaigns can underscore the benefits of reform for pharmacies, patients, and the healthcare system at large. The goal is to inform the public, inspire support for reform efforts, and motivate active participation in advocacy initiatives.
The path toward meaningful reform in pharmacy benefit management, drug pricing, and the equitable implementation of PDABs is fraught with challenges. Yet, the successes achieved in regions like Florida provide hope that meaningful reform is possible. By rallying for targeted policy reforms and engaging in proactive advocacy, we can drive systemic changes that ensure the pharmaceutical supply chain operates with transparency, equity, and a steadfast commitment to patient health. Together, we have the power to reshape the landscape of drug affordability and access, guaranteeing that all people receive the comprehensive care and medications they deserve.
Beyond Medication: Tech Advances in Care Delivery
Broad telehealth acceptance is just the tip of the iceberg when it comes to technology advancements and innovations in the general health care space. From mobile Apps designed to encourage patient-provider communication and medication reminders to drone being the next home delivery pharmacy tool, much hope and concern rests on the horizon of health-in-your-hand-and-on-demand.
In this, as with many developments in care delivery and equitable access, the space of chronic care, specifically HIV, has long helped lead the way for the rest of the industry. A 2018 post on HIV.gov and 2020 post on webMD cite several mobile Apps with focuses on prevention services, linkage to care, care support, and social support. Some study has been done about effective strategies of user engagement with mobile Apps, with a particular focus on younger demographics. One such study, from University of North Carolina at Chapel Hill and Duke University, with participants ranging from 16-24 years of age, found extraordinary efficacy with a “gamifying” approach, including “badges” and “tokens” among users as rewards for adherence and completing tasks or engaging with the App. At 13 weeks, frequent users of the App were more than 56% more likely to achieve viral suppression and regular App users were more than twice as likely to self-report near perfect ART adherence at benchmark periods of the study. Another study, offering social support, with participants at or above 60 years of age across a period of 6 months showed the 30 participants accessed the App more than 2400 times for an average nearing 9 minutes per session.
Many of the studies working to understand best practices in client engagement, messaging, and positive outcomes are exceptionally limited. Beyond the cohort size, technology barriers appear to the biggest hurdles; including ensuring clients have appropriate devices for any particular App design, updated software, ensuring App accessibility across hardware platforms (phones, tablets, computers), appropriate data plans, and access to mobile data signal or Wi-Fi services.
Another avenue under exploration includes modernizing the time-tested aid delivery method of airdrops with drones to reach hard-to-reach rural area health care providers. However, as Uganda Medical Association’s secretary general, Mukuzi Muhereza, cited, drones only address medication transportation to health centers, not issues of medication shortages or transportation barriers from client homes to those same health care providers.
When given this topic for this week, my contract manager questioned “if this can be done in Uganda, why can’t it be done in rural Alabama?” Which is a good question…with lots of discussion worthy of following.
The business that cannot be escaped when discussing consumer data and tech also cannot be avoided in discussing health care delivery systems innovation: Amazon. In 2018, Amazon acquired PillPak, including all their state-based pharmacy licensing agreements, now billed toward Prime customers as Amazon Pharmacy. While posing as a potential exploration into the health care landscape, Amazon Pharmacy’s effort builds upon a concurrent effort to make the company’s voice assistants HIPAA compliant. However, much of Amazon’s effort don’t necessarily fall inside the entity scope requiring patient privacy compliance as HIPPA and explicitly cites compliance with law enforcement activities, recalling community fears associated with molecular surveillance and the criminalization of HIV status. Particularly, Amazon has been known to exploit its collection of user data for the sake of profit, skirt regulatory requirements on technicalities and mutilation of language, and frankly, lacks ethical grounds worthy of potentially courting government funding in light of its anti-labor practices. Additionally, Amazon has faced numerous data breaches in the last few years and European Union former executives for Amazon have warned the company does not do enough to ensure security of users’ information. Garfield Benjamin gives a deeper dive into the history and context of these concerns, many already experienced in the United Kingdom, here.
That doesn’t mean Amazon, or any company making similar inroads into direct-to-consumer care models, is “always” a bad actor. Indeed, with the Federal Aviation Administration’s recent approval to study Amazon’s drone delivery system, known as Amazon Air, the possibility of delivery to your door within the hour of an appointment is deeply appealing to many consumers seeking easier access to medication. It just means the risks of the moment, of unanswered questions and unregulated technicalities needs to be addressed – and with expediency. Because just as with injectable ARVs being the next wave of innovation in ARVs, streamlining the consumer experience with greater privatization and expanded home delivery options is also on the horizon.
We have this brief moment, now. Where the mega-movers, like Amazon, and regulators, can reach outside of the provider and payer communities and discus with patient and consumer communities to ask us what we’re worried about. If public payers are not prepared to integrate appropriate reimbursements, leverage those reimbursements to ensure our privacy and access to care, to further Health Justice, then we run the risk of only furthering existing disparities, even more than COVID has. Between the rural hospital crisis only deepening and the Biden administration already running into push back on including expanding broadband access in its infrastructure package, as easy examples of the necessary “what-abouts” if we’re to meet this moment for its actual potential – for either good or ill.
Stakeholders across the spectrum should look beyond any development of their own proprietary App functions and into the broadest approach to this space to ensure consumer trust is maintained as one of the highest priorities, collaborative rather than competitive efforts so as not to duplicate efforts or get lost in the sea of App developments, and ensure our technology reflects our values as communities, not just that of those who may find new avenues of profit on our backs.