Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

FTC Sues Major PBMs for Unfair Practices Affecting Drug Costs

Pharmacy Benefit Managers (PBMs) have long been influential yet often obscure intermediaries in pharmaceutical pricing and distribution. They negotiate drug prices with manufacturers, develop formularies for health plans, and manage pharmacy networks. Today, the three largest—CVS Caremark, Express Scripts, and OptumRx—control about 80% of the market.

On September 20, 2024, the Federal Trade Commission (FTC) filed an administrative complaint against these major PBMs and their affiliated group purchasing organizations (GPOs). The complaint alleges that they engaged in anticompetitive and unfair rebating practices, artificially inflating insulin prices and impairing access to lower-cost alternatives.

The FTC's action marks a critical juncture in the struggle for fair drug pricing and access, emphasizing the need for robust enforcement and comprehensive PBM reform. The outcome could reshape the healthcare industry and significantly impact care across the United States.

The FTC's Case Against PBMs

The FTC alleges that PBMs have engaged in anticompetitive and unfair rebating practices that have artificially inflated the list prices of insulin and other essential medications. Grounded in Section 5 of the Federal Trade Commission Act, which prohibits unfair competition and deceptive practices, the FTC asserts that PBMs' rebate strategies and patient steering harm consumers and competition.

For example, the list price of Humalog, a widely used insulin product, increased from $21 in 1999 to over $274 in 2017—a rise of more than 1,200%. The FTC argues that this dramatic inflation is linked to PBMs' "chase-the-rebate" strategy, where they demand larger rebates from manufacturers in exchange for favorable formulary placement.

Another key aspect of the complaint focuses on patient steering practices. The FTC alleges that PBMs have systematically excluded lower-cost insulin alternatives from their formularies in favor of higher-priced options that generate larger rebates. This practice limits choice and forces many to pay more out-of-pocket for their medications.

Rahul Rao, Deputy Director of the FTC's Bureau of Competition, emphasized: "Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed."

The FTC seeks to fundamentally change how PBMs operate. The complaint aims to prohibit PBMs from excluding or disadvantaging lower-cost versions of drugs, prevent them from accepting compensation based on a drug's list price, and stop them from designing benefit plans that base out-of-pocket costs on inflated list prices rather than net costs.

FTC Chair Lina Khan stated, "The FTC's administrative action seeks to put an end to the Big Three PBMs' exploitative conduct and marks an important step in fixing a broken system—a fix that could ripple beyond the insulin market and restore healthy competition to drive down drug prices for consumers."

Impact on People Living with HIV

While the FTC's case primarily focuses on insulin pricing, PBM practices significantly affect people living with HIV (PLWH) and other chronic conditions. Recent cases highlight the challenges faced in accessing affordable medications due to PBM and insurer practices.

In April 2024, CVS Health failed in its latest attempt to dismiss a class action lawsuit alleging discrimination against PLWH by requiring them to receive medications via mail order, limiting access to essential pharmacy services and counseling. U.S. District Judge Edward Chen noted that CVS was on notice that this program could likely discriminate against PLWH, as plaintiffs had repeatedly requested to opt out.

In another case, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) closed a complaint without penalties against Blue Cross Blue Shield of North Carolina (BCBS NC) after the insurer lowered the pricing tier for HIV medications. The original complaint alleged that BCBS NC had placed almost all HIV antiretroviral medications, including generics, on the highest-cost prescription tiers.

While BCBS NC changed its formulary, the lack of penalties raises concerns about enforcement and accountability. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, expressed disappointment: "It was incredibly disheartening and deeply concerning to see them let the state's largest insurer get away with such blatant discrimination."

These cases illustrate how PBM practices and insurer policies create significant barriers to care for people living with HIV. High out-of-pocket costs, restricted pharmacy access, and discriminatory formulary designs can lead to medication non-adherence, resulting in adverse health outcomes and increased healthcare costs in the long term.

In North Carolina, about 37,000 people are living with HIV, with Black people representing 58% of new HIV diagnoses despite being only 22% of the state's population. Nationally, according to the Centers for Disease Control and Prevention (CDC), approximately 1.2 million people in the United States are living with HIV. PBM practices that inflate drug costs or limit access exacerbate these disparities and hinder efforts to end the HIV epidemic.

PBM Practices Under Scrutiny

The FTC's complaint has brought controversial PBM practices into sharp focus, highlighting concerns long raised by patients, healthcare providers, and policymakers.

The FTC's interim staff report reveals that PBMs often prioritize higher rebates over lower net prices, leading to exclusion of lower-cost alternatives and driving up drug prices—a practice known as "rebate walls." Patient steering directs consumers to PBM-owned pharmacies, limiting choice and disadvantaging independent pharmacies.

A Congressional hearing in July 2024 further exposed these issues. PBM executives faced tough questioning about their role in rising prescription drug costs. Lawmakers pressed the executives on how PBMs have monopolized the pharmaceutical marketplace and pushed anticompetitive policies that undermine local pharmacies and harm patients.

Representative Virginia Foxx (R-N.C.) highlighted the lack of transparency, questioning PBM executives about the pass-through of rebates and fees to plan sponsors. The executives' responses did little to clarify the complex and opaque financial flows within the PBM industry.

PBMs defend their practices as necessary for managing drug costs. Phil Blando, Executive Director for Corporate Communications at CVS Caremark, stated, "We work to negotiate the lowest net cost for drugs... driving better health outcomes and lower out-of-pocket costs for consumers." However, critics argue that these claimed benefits are not reflected in patient experiences or overall drug pricing trends.

Real-World Impact on Patients and Pharmacies

Jeremy G. Counts, PharmD, a spokesperson for Pharmacists United for Truth and Transparency (PUTT), explains that the vertical integration of the Big Three PBMs allows them to limit access through restrictive networks, under-reimbursement, and aggressive patient steering. These practices harm independent pharmacies and jeopardize health by disrupting continuity of care.

  • Restrictive Networks and Steering: PBMs often require patients to use their own pharmacies, frequently through mail order, misleading them into believing they have no other options. Even when plans allow the use of independent pharmacies, PBMs make it tedious to opt out, effectively limiting choice.

  • Under-Reimbursement and Clawbacks: Independent pharmacies that serve patients despite low reimbursements face financial strain. PBMs may pay below cost or use fees and recoupment methods to claw back margins, forcing some pharmacies to turn away patients.

  • Barriers to Medication Access: PBMs impose onerous prior authorization processes for medications that do not provide them with high rebates, delaying care and increasing costs. Counts notes that this has become a deadly issue in oncology care.

  • Aggressive Patient Pursuit: For profitable medications, PBMs aggressively pursue patients and their prescriptions, sometimes transferring prescriptions without permission or shipping medications without their knowledge.

These practices not only harm independent pharmacies but also jeopardize health by disrupting access to necessary medications.

Healthcare consultant Rita Numerof calls the FTC's investigation a "pivotal moment" in reforming the industry to serve patients' best interests.

The Need for Enforcement

The lack of punitive action in cases like the BCBS NC complaint raises concerns about the effectiveness of current enforcement mechanisms. Carl Schmid of the HIV+Hepatitis Policy Institute pointed out, "Without action to improve federal and state regulation, oversight, and enforcement, such discriminatory practices will continue." The BCBS NC case demonstrates that while policy changes can be achieved through advocacy and complaints, there is often little consequence for discriminatory practices.

Counts emphasizes that "PBMs are masters at derailing legislative attempts to rein them in." He argues that FTC enforcement is critical, as PBMs often ignore laws unless compelled to comply. Counts asserts that attacking the problem from multiple fronts is essential, and FTC action provides immediate and targeted intervention.

PBM Response and Industry Perspective

In response to mounting scrutiny, PBM executives have defended their practices. During the July 2024 Congressional hearing, leaders from CVS Caremark, Express Scripts, and OptumRx maintained that they do not engage in patient steering or discriminatory practices. They argued that PBMs play a crucial role in negotiating lower drug prices and improving healthcare affordability.

David Joyner, president of CVS Caremark, stated, "We're making health care more affordable and accessible for the millions of people we serve every day."

However, these assertions have been met with skepticism. The House Committee on Oversight and Accountability, led by Chairman James Comer (R-Ky.), has accused PBM executives of making statements that contradict findings about self-benefitting practices.

Legislative Efforts: The Pharmacists Fight Back Act

In addition to regulatory actions by the FTC, legislative initiatives are crucial for comprehensive reform. The Pharmacists Fight Back Act (H.R. 9096), introduced by Representatives Jake Auchincloss (D-MA) and Diana Harshbarger (R-TN), aims to:

  1. Establish Standard Pharmacy Reimbursement:

    • Proposes a reimbursement model based on the National Average Drug Acquisition Cost (NADAC) plus a state dispensing fee and an additional 2%. This model prevents underpayment to independent pharmacies and curbs price gouging by PBM-owned pharmacies.

  2. Prohibit Predatory PBM Tactics:

    • Seeks to ban practices such as steering patients to PBM-owned pharmacies, exclusionary network designs, retroactive fees, spread pricing, and reimbursement clawbacks.

  3. Mandate Rebate Transparency and Application:

    • Requires that 80% of all PBM-negotiated rebates and fees reduce patients' out-of-pocket costs, with the remaining 20% lowering insurance premiums.

Counts stresses the urgency of passing this legislation to save pharmacies and reduce drug pricing: "Its immediate passage is critical to stopping the pharmacy closure and drug pricing crisis in this country."

Potential Outcomes and Industry Impact

If successful, the FTC's action could reshape the pharmaceutical industry by forcing PBMs to prioritize lower net drug prices, benefiting patients with more affordable medications and increased pharmacy choice. A ruling against PBMs could set a legal precedent, opening the door for further regulatory action or private lawsuits against PBMs and other healthcare intermediaries.

Independent pharmacies stand to benefit considerably from potential reforms. If the FTC's action results in more transparent pricing practices and limitations on patient steering, these businesses may be better able to compete with PBM-owned pharmacies.

However, given PBMs' significant resources and influence, changes may be hard-fought and take time to implement. There is the possibility that PBMs may find new ways to maintain their market position and profitability.

Impact on Independent Pharmacies

Independent pharmacies are closing at an alarming rate—nine per day, with 2,275 closures so far in 2024. This trend reduces access to personalized care and diminishes competition, further consolidating PBMs' market power.

Counts conducted a study in Virginia, matching pharmacy closures against openings using data from the Virginia Board of Pharmacy. He found that "community pharmacies are closing at twice the rate they are opening, and this rate is accelerating." Without significant reform, including FTC enforcement and the passage of H.R. 9096, the pharmacy infrastructure in the United States will continue to erode.

Conclusion and Call to Action

The FTC's actions, along with legislative efforts like the Pharmacists Fight Back Act, are critical steps toward creating a fairer pharmaceutical industry that prioritizes access and affordability.

We urge readers to:

  1. Stay Informed: Follow developments in PBM regulation and reform efforts.

  2. Research Legislation: Contact your representatives to inquire about pending legislation.

  3. Engage with Advocacy Groups: Support organizations like PUTT (www.truthrx.org) and the HIV+Hepatitis Policy Institute (www.hivhep.org).

  4. Share Experiences: Raise awareness by sharing your experiences with PBM practices. PUTT is collecting stories to highlight the real-world impact of PBM practices. Visit their PBM Horror Stories page to share your story anonymously.

Collective action is essential to ensure meaningful and lasting change in drug pricing and access. The FTC's action is a significant step, but it's up to all of us to ensure this momentum leads to a more transparent, equitable, and patient-centered healthcare system in the United States.

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Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

Profit Over Patients: Challenging the Understaffing Crisis in Healthcare

On December 31, 2023 former U.S. Representative Eddie Bernice Johnson suffered and died in a completely preventable yet entirely foreseeable tragedy. Rep. Johnson, a dedicated nurse and a fervent advocate for equitable healthcare, succumbed to an infection contracted in a rehabilitation facility, a direct consequence of medical neglect. This incident is a glaring example of the systemic issues plaguing our healthcare institutions, where intentional understaffing and profit-driven motives often come at the expense of patient care and staff well-being. Her experience tragically highlights the broader systemic issues in healthcare, including rampant understaffing and the consequences of healthcare system consolidation.

The Tragic Circumstances of Rep. Johnson's Passing

According to a Texas Tribune report, Rep. Johnson died a “terrible, painful death” from an infection caused by negligence at her Dallas recovery facility following back surgery. The infection was a result of being left to lie in her own feces and urine for roughly an hour while she repeatedly called for help that didn’t come. The facility reportedly told family that all staff were unavailable as she called for help due to being in a training. Her son, Kirk Johnson, minced no words as he stated, "She was screaming out in pain, asking for help. If she had gotten the proper care, she would be here today.”

The family notified Baylor Scott & White Health System and Baylor Scott & White Institute for Rehabilitation of their intention to sue on the grounds of medical negligence. The lawsuit, if not settled, will highlight the deadly consequences of inadequate patient care in healthcare facilities. This legal battle is complicated by Texas law, which limits medical malpractice lawsuit awards to $250,000. Such legislative decisions, influenced by powerful hospital lobbies, not only restrict legal recourse for patients but also reflect deeper systemic issues in healthcare governance where institutional profits often overshadow patient rights.

The limitation on medical malpractice awards in Texas exemplifies a troubling trend in healthcare legislation. These laws, as detailed in a Miller & Zois report, often protect healthcare institutions at the expense of patient health and safety while significantly limiting patients' ability to seek fair compensation for medical negligence.

This legislative backdrop, coupled with intentional understaffing in healthcare facilities, creates a perilous situation where patient rights are limited and institutions are insulated from liability when their cost cutting measures cost lives. Maximizing profit and administrative and shareholder value by understaffing care facilities heightens the risk of medical errors, burns out staff, and creates unsafe working conditions. Yet, when these cost-cutting measures lead to harm, patients find their legal recourse severely restricted by malpractice caps while hospital staff burns out and are exposed to greater occupational hazards. The only ones not on the losing end are the hospitals and their executives.

Staffing Shortages or Healthcare Profiteering?

Across the country, as healthcare corporations report burgeoning profits, the reality within their healthcare facilities tells a story of compromised care and strained resources. Let’s take Hospital Corporation of America (HCA), the largest hospital system in the country, as an example. As reported in The Guardian, a study by the Service Employees International Union (SEIU) highlights the disparities, revealing that staffing ratios at HCA Hospitals in 2020 were alarmingly 30% lower than national averages. Despite $7 billion in profits and $8 billion allocated to stock buybacks and paying out nearly $5 billion in dividends to shareholders, the investment in patient care, particularly in terms of staffing, remains inadequate.

The prevailing narrative of a nursing shortage in the United States is rigorously challenged by facts and voices from within the healthcare sector. National Nurses United (NNU) asserts that the core issue is not a lack of nurses but rather the widespread unwillingness of nurses to work under unsafe conditions. This perspective contradicts the healthcare industry's narrative and points to systemic issues in workforce management and underinvestment in medical staffing by hospital executives.

The intentional understaffing by healthcare facilities, as seen in cases like HCA Hospitals, is often driven by financial motivations. By keeping staffing levels low, these facilities aim to maximize profits, often at the expense of both patient care and staff well-being. This approach has led to a situation where the healthcare workforce is being pushed to its limits, leading to high turnover rates and a growing reluctance among nurses to work in such conditions.

The narrative of worker shortages is further complicated by the trend of healthcare system consolidation, which significantly reshapes healthcare markets, often at the expense of patient care and staff well-being. In May of 2023 The RAND Corporation gave testimony to the U.S. House of Representatives Committee on Ways and Means, Subcommittee on Health which underscored that consolidation frequently leads to higher healthcare costs without corresponding improvements in quality. Characterized by mergers and acquisitions across markets, this trend typically results in reduced competition, higher prices, and a focus on revenue generation over patient-centric values. Moreover, when private equity is involved, as highlighted by The British Medical Journal (BMJ), it often exacerbates patient harm.

The Human Cost of Cost-Cutting

Impact on Healthcare Workers: Nurses and other healthcare staff, the backbone of patient care, are stretched to their limits. A study by the University of Pennsylvania highlights the high levels of nurse burnout, a direct consequence of inadequate staffing. The study surveyed over 70,000 nurses and found that the chronic stress caused by high nurse-to-patient ratios significantly impacts their mental and physical health. The turnover rate in nursing, as reported by STAT News, is a testament to the unsustainable working conditions, with many nurses leaving the profession or seeking less demanding roles.

Patient Safety and Care Quality: The impact of understaffing on patients is equally alarming. According to the National Center for Biotechnology Information (NCBI), inadequate staffing in nursing homes is linked to increased incidents of falls, bedsores, and a general decline in the quality of care. This neglect is not limited to nursing homes; hospitals across the nation face similar challenges. As in the case of Rep. Johnson, patients often experience delayed care, unmet basic needs, and an increased risk of medical errors due to the high workload on understaffed healthcare workers.

The understaffing crisis extends beyond individual facilities. As National Nurses United points out, the issue is systemic and has become an industry standard practice. These ethically dubious practices have far-reaching consequences, eroding the sustainability of the healthcare system and diminishing public trust in its ability to provide competent and compassionate care.

Upholding Ethical Standards in Healthcare

The ethical implications of understaffing and system consolidation are profound. It's not merely a matter of operational efficiency; at its core, it's about honoring a fundamental commitment to patient care and worker dignity. The primary ethical concern in healthcare should be the obligation to provide safe, effective, and compassionate patient care, an obligation that is often directly undermined by profit-driven decisions.

The direct consequences of understaffing and consolidation, such as compromised patient safety, increased medical errors, and a decline in the quality of care, represent a breach of the ethical duty healthcare providers owe to their patients. When financial priorities overshadow patient needs, the very essence of healthcare's moral foundation is shaken. This shift not only impacts patient outcomes but also erodes public trust in healthcare systems.

The alarming levels of burnout, stress, and turnover among healthcare workers, particularly nurses, reflect a work environment that neglects their physical, emotional, and professional well-being. This neglect raises serious ethical concerns about the healthcare industry's commitment to its workforce. When staff well-being is compromised for operational efficiency or financial gain, the entire healthcare system suffers, leading to a demoralized workforce and diminished patient care.

The healthcare industry faces a critical ethical dilemma: balancing financial responsibilities with the imperative of humanistic care. While healthcare facilities have fiscal duties to their stakeholders, these must never be allowed to eclipse their ethical obligation to prioritize high-quality patient care and foster a safe and supportive work environment. The pursuit of profit must be balanced with the moral imperative to care for both patients and healthcare workers humanely. This balance is essential not only for the integrity of healthcare providers but also for the long-term sustainability of the healthcare system as a whole.

Addressing these ethical challenges is not just a moral imperative but a crucial step towards systemic reform for a more humane and effective healthcare system and, frankly, reducing costs to patients by way sufficient retention of nursing talent - reduced turn over means reduced labor costs which then translates to reduced insurance billing and less medical debt.

Concrete Steps Towards Reform

The reality of understaffing and the challenges posed by healthcare system consolidation in our healthcare system demand immediate and decisive action. We must engage in targeted advocacy and policy reform. Here are specific actions that individuals and organizations can undertake to drive meaningful change:

  1. Contact Legislators: Advocate for federal and state legislation that mandates safe staffing ratios in healthcare facilities, addresses the challenges of healthcare consolidation and transparency, and holds hospitals accountable for malpractice. This includes challenging laws that limit malpractice awards, as these can protect healthcare institutions at the expense of patient rights.

  2. Support Nursing Unions: Participate in advocacy campaigns of unions like National Nurses United, supporting their efforts for better working conditions and fair staffing levels. These unions play a crucial role in voicing the concerns of healthcare workers and advocating for their rights.

  3. Engage with Healthcare Boards: Advocate for ethical staffing practices and policies that prioritize patient care over profit in healthcare organization board meetings. It's essential to influence decision-makers at the highest level to bring about systemic changes.

  4. Advocate Against Unchecked Consolidation: Support policies that scrutinize healthcare mergers and acquisitions, as highlighted by the National Conference of State Legislatures (NCSL), to ensure they prioritize patient care and staff welfare. This includes backing state and federal initiatives to enhance oversight on healthcare mergers and acquisitions.

We must shift the focus from profit margins to the pillars of empathy, compassion, and quality care. It's time to honor the legacy of advocates like Rep. Eddie Bernice Johnson and ensure that our healthcare system upholds its fundamental commitment to patient care and worker dignity. Implementing these actions can lead to a more empathetic, compassionate healthcare environment, where patient care and staff welfare are prioritized, paving the way for a sustainable and trustworthy healthcare system.

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Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

Alcohol Use Does Not Harm DAA Efficacy, Yet Payer Barriers Persist

In healthcare, the interplay between perceptions and policies can sometimes adversely affect the very individuals they intend to benefit. One such area of contention is the perceived impact of alcohol use on the effectiveness of treatments for hepatitis C Virus (HCV). A recent study, published in JAMA Network Open and spotlighted by MedPage Today, led by Christopher T. Rentsch, PhD, and co-authored by Emily J. Cartwright, MD, explored this relationship. Their findings were clear: alcohol use and alcohol use disorder (AUD) did not diminish the odds of achieving a sustained virologic response with Direct-Acting Antiviral (DAA) therapy for chronic HCV infection.

Yet, despite such evidence, certain clinicians still hesitate or even refuse to administer HCV therapy to patients who consume alcohol. Furthermore, some payers mandate alcohol abstinence as a precondition for reimbursing DAA therapy for HCV. This stance becomes even more alarming in light of the Center for Disease Control & Prevention's (CDC) recent data, which shows a staggering 129% surge in reported cases of acute hepatitis C since 2014. It's imperative that we prioritize evidence over misconceptions, especially when lives are at stake.

The NIH's Perspective

A study supported by the National Institutes of Health (NIH) echoes these findings, revealing that individuals with alcohol use disorder (AUD) are less likely to receive antiviral treatments for hepatitis C. Despite current guidelines recommending such treatment irrespective of alcohol use, the study, led by scientists at Yale University, found that those with AUD, even if they were currently abstinent, were less likely to receive curative DAA treatment for hepatitis C within one or three years of diagnosis compared to those without AUD. This treatment gap, attributed to stigma around substance use and concerns about treatment adherence, underscores the need to address these disparities, especially among those with AUD.

The Case for Change

The implications of these studies are clear: policies need revision. Evidence-based policies in healthcare are paramount. Denying HCV patients access to DAA therapy based on their alcohol consumption habits is not only unwarranted but also counterproductive. As the study's authors have highlighted, such restrictions could pose unnecessary barriers for patients and hinder efforts to eliminate HCV.

Both state-specific policies and national guidelines, like those from The American Association for the Study of Liver Diseases (AASLD), need to evolve in light of these findings. Healthcare providers, policymakers, and advocacy groups have a pivotal role in driving this change, ensuring that all HCV patients, irrespective of their alcohol consumption habits, have access to the best possible care.

Charting a Path Forward

The revelations from these studies underscore more than just the need for policy adjustments; they challenge our collective commitment to championing evidence-based healthcare. In an era where misinformation can easily cloud judgment, it's crucial that treatments for HCV are not just theoretically available but are genuinely accessible to all, regardless of their alcohol consumption habits.

The findings from both the NIH and JAMA studies don't merely point out gaps; they expose deep-rooted systemic issues. Current policies have not adequately addressed the needs of HCV patients, and there's a pressing need for more inclusive guidelines.

To transform this call to action into tangible progress, we must:

  • Reassess and Revise Existing Policies: Ensure that guidelines, especially those from influential bodies like AASLD, are updated in line with the latest scientific evidence, removing any unwarranted barriers related to alcohol consumption. As demonstrated by the efficacy of the Center for Health Law and Policy Innovation’s (CHLPI) work in assessing and breaking down barriers to curative DAAs in Medicaid programs, further work must be done to break these payer-based barriers to care in private and employer sponsored plans.

  • Strengthen Advocacy and Awareness: Engage with healthcare providers, policymakers, and patients to spread awareness about the non-impact of alcohol on DAA therapy's efficacy, countering prevailing misconceptions.

  • Promote Continuous Research and Dialogue: Encourage further studies and maintain an open dialogue with all stakeholders to continuously refine our understanding and approach to HCV treatment.

The conclusions drawn from these studies underscore the challenges and opportunities that lie ahead of us. As the research emphatically states, alcohol consumption should not be a barrier to HCV treatment. Such restrictions are discriminatory in nature and threaten efforts in the fight to eliminate HCV. With evidence-based policy decisions and unwavering dedication, we can eliminate the barriers and ensure access to curative HCV treatment.

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Jen Laws, President & CEO Jen Laws, President & CEO

Payers Finally Facing Scrutiny for Denying Coverage

In February of this year, we covered the issues of inequity and administrative barriers patients face when seeking medically necessary care, especially when that care is for chronic or complex conditions. The blog followed ProPublica’s review of Christopher McNaughton’s trials (quite literally – there was a lawsuit) and tribulations with United Healthcare’s refusal of coverage. The situation highlighted how the payer had never intended to cover McNaughton’s care, regardless of necessity, and shopped “appeals” doctors in order to avoid finding his care was “medically necessary” and therefore required to be covered.

The ProPublica article was published some two years after United Healthcare (UHC) had floated instituting a policy of retroactive review and denial of emergency room care – the scheme went something along the lines of “if we think you didn’t really need to go to the ER, we’ll make you pay the whole bill yourself.” The tactic was roundly shouted down by advocates and providers as dangerous. Afterall, a payor reviewing documents rather than actually serving in an emergency room is never going to grasp the details of certain situations – like the unique symptoms women face when having a heart attack. Eventually UHC pressed the pause button and after some jockeying back and forth between the payer and the American Hospital Association, UHC said the entity wouldn’t enact the policy. Turns out, that might not have been an honest assertation according to a lawsuit issued by the U.S. Department of Labor (DOL). To be clear, the payer entity that’s targeted in the suit is a third-party administrator within UHC’s subsidiary – called UMR – but arguing that nuance isn’t going to matter to a patient who had their care claim unjustly denied.

The lawsuit asserts that UMR denied “thousands” of urine drug screenings and emergency room visits and violated the Affordable Care Act’s “prudent layperson” standard. That standard requires that payers reviewing claims consider how the average patient might approach concerns or symptoms they’re experiencing, not a medical professional. Now, there’s a thing about when these denials took place, 2015 to 2018, means UHC’s proposed policy of retroactive denial might have been an improvement over their previous policy of denying every urinalysis claim. Which is just…wild. Further, the suit alleges that UHC wouldn’t clearly tell doctors what additional information they needed during appeals processes – which sounds strikingly related to McNaught’s troubles with the payer.

DOL wants UHC to review all denied claims and adopt new policies which wouldn’t result in what amounts to an automatic denial process. And it’s not unheard of. In 2020, a judge in California found another UHC subsidiary automatically denied coverage of care to patients seeking to use their mental health and substance use treatment benefits and ordered some 67,000 claims to be re-reviewed and new processing policies to be adopted.

Similarly, Cigna is coming under scrutiny. A class action lawsuit filed in California is alleging Cigna denied some 300,000 claims in just two months last year. The absolutely bonkers part about that is Cigna used an algorithm that spent just 1.2 seconds on each claims review before sending them off to doctors to sign them – meaning those claims might not have ever actually been seen by human eyes in what amounts to an automatic denial process. Cigna, for its part, decided its public facing comment would be to call ProPublica’s coverage of their denial process “poorly written”. All that despite the House found ProPublica’s investigation worthwhile enough to drag Cigna in front of the Energy and Commerce Committee for a hearing on the legality of these denials. Mike Kreidler, the insurance commissioner for Washington characterized Cigna’s operation as an “abhorrent” practice “to routinely deny just to enhance the bottom line.”

All of this coming just weeks after the Office of Inspector General released a report on how Medicaid managed care organizations (MCOs) are utilizing prior authorizations processes and denial of care in an abusive fashion, harming the poorest patients in the country and with little oversight by the states contracting these MCOs. Among those listed with a prior authorization denial rate higher than 25% was United Healthcare. And none of that touching that more and more providers are contracted by UHC, meaning those denials were denials of care in which their own providers had decided what was medically necessary.

The scrutiny of payors coming by way of lawsuits is welcomed but advocates and policymakers shouldn’t wait for judges to determine the scope of harm patients are experiencing. We need to seek a statutory and regulatory reigning-in of these run-away practices bilking our healthcare systems at the expense of patient health. And we need to do it now.

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