Proposed Cigna-Humana Merger Raises Stakes for Healthcare Access Amid Election Uncertainty

Cigna Group and Humana are once again discussing a merger that could create a $140 billion insurance giant, further consolidating the U.S. healthcare system. The talks are in preliminary stages after collapsing last December over disagreements about financial terms. FierceHealthcare notes that while discussions have resumed, no formal agreements have been made yet.

The stakes of this merger extend far beyond corporate boardrooms; it directly impacts millions of people's access to essential healthcare services and affordable medications. With Cigna’s Express Scripts commanding 24% of the PBM market and Humana operating the fourth-largest PBM with 8%, the merger raises serious questions about market concentration and its impact on healthcare affordability and accessibility.

Election Outcome Could Determine Merger’s Fate

The timing of the renewed merger talks between Cigna and Humana is no coincidence, occurring just weeks before a presidential election that could heavily influence the merger’s prospects. Bloomberg reports, Wall Street analysts believe that the deal's future hinges on the election outcome, with talks likely "only tangibly moving forward if Trump wins."

Under a Trump Administration, a more favorable regulatory environment might be expected given the GOP's general preference for deregulation. However, skepticism about large corporate mergers from Trump's base and running mate JD Vance complicates this picture. Vance has even praised current FTC Chair Lina Khan, saying she is "one of the few people in the Biden Administration who I think is doing a pretty good job," indicating a potentially less favorable view of healthcare consolidation than the GOP has historically maintained. On the other hand, a Harris Administration would likely continue the Biden Administration's stricter stance on healthcare consolidation, focusing particularly on protecting underserved and rural communities.

TD Cowen analyst Ryan Langston suggests that any formal merger announcement before the election is unlikely, further underscoring the centrality of the election to the deal’s future. Meanwhile, federal scrutiny of pharmacy benefit managers (PBMs) remains high, with the Federal Trade Commission (FTC) accusing the largest PBMs of using negotiation tactics that inflate drug costs, adding another layer of complexity to the regulatory landscape.

Understanding the Scale and Implications of the Proposed Merger

The proposed Cigna-Humana merger would unite two companies with largely complementary business models. Modern Healthcare reports that Cigna dominates in commercial coverage with 16.1 million members, while maintaining a smaller Medicare presence. In contrast, Humana has fewer than 600,000 commercial customers and is withdrawing from employer-sponsored insurance, while standing as the second-largest Medicare insurer with 8.8 million members.

This complementary structure could ease some antitrust concerns, but the combined PBM operations present a more complex challenge. The American Medical Association's (AMA) position on the CVS-Aetna merger highlighted similar concerns, noting that such consolidation can limit competition and reduce patient access to specialty drugs, which may parallel the challenges presented by this merger. Healthcare Huddle's analysis suggests that a merger would create a PBM entity large enough to rival market leader CVS Caremark, potentially controlling 32% of the market. Such concentration in the PBM space has already drawn scrutiny from regulators and policymakers.

To address regulatory hurdles, Cigna is planning to finalize the sale of its Medicare Advantage business to Health Care Service Corporation for $3.3 billion, a move that Modern Healthcare suggests could ease antitrust concerns by eliminating overlapping services. Meanwhile, Humana has faced challenges, with its value dropping nearly 40% this year due to declining Medicare plan enrollments and performance shortfalls resulting in the Centers for Medicare and Medicaid Services (CMS) downgrading their Medicare Advantage (MA) plans’ star ratings.

The combined entity would have a market capitalization of around $121 billion based on October 2024 valuations. While still smaller than UnitedHealth Group's $528 billion market cap, the merger would establish a stronger competitor across both the insurance and PBM markets, potentially reshaping competitive dynamics in the healthcare sector.

PBM Consolidation: Increased Scrutiny as FTC Takes a Stand

The potential merger's impact on pharmacy benefit management deserves particular attention, especially given recent FTC actions against PBMs. Currently, three PBMs control approximately 80% of the market, with Cigna's Express Scripts commanding about 24% and Humana's pharmacy division holding 8% market share, according to Bloomberg Law analysis.

The timing is particularly sensitive given the FTC's September 2024 administrative complaint against major PBMs. As previously reported by CANN, the FTC alleges these companies engaged in anticompetitive rebating practices that artificially inflated drug prices. The FTC investigation has revealed troubling practices, with PBMs frequently prioritizing higher rebates over lower net prices, leading to the exclusion of lower-cost alternatives and driving up drug prices. A combined Cigna-Humana PBM would control 32% of the market, potentially creating an entity large enough to rival market leader CVS Caremark.

This level of concentration raises serious concerns about negotiating power and drug pricing. Bloomberg Law notes that employer groups are particularly wary of the merger, fearing it could make an already complicated market even more opaque for health plans and potentially lead to higher costs for company health plans.

Impact on Healthcare Access and Specialty Care

Healthcare consolidation has long presented significant barriers for patients who rely on specialized care, including those living with chronic conditions like HIV. For example, patients often face more restrictive formularies, meaning fewer options for necessary medications, and increased prior authorization requirements, which can delay access to critical treatments. This is especially problematic for patients with chronic conditions like HIV, where timely and consistent access to specific medications is critical for maintaining health. Research published by Tufts Center for the Evaluation of Value and Risk in Health shows that consolidation often leads to restricted specialty care access, which can be particularly detrimental to people requiring ongoing care management. For instance, patients with cancer may find it harder to access specialized oncologists or newer, targeted therapies due to narrower provider networks and limited formularies. These barriers do more than inconvenience patients—they delay treatments, ultimately impacting patient outcomes.

The National Academy for State Health Policy (NASHP) reports that consolidated health systems frequently use their market power to implement restrictive contracts that can limit patient choice. These contracts often include clauses that prevent insurers from steering patients to higher-value care providers or limit the ability to negotiate better prices, ultimately restricting patient options and driving up healthcare costs. This can particularly impact people relying on specialty medications and services, like those living with HIV who need consistent access to specialists and specific drug regimens.

Consolidated systems often impose more stringent prior authorization requirements and narrower specialty pharmacy networks, as noted in the BMC Health Services Research study. The AMA highlights that merged entities often use their power to make access to specialty drugs more restrictive, which further limits patient options and exacerbates challenges for those needing specialized care. For people living with HIV, disruptions or delays in accessing antiretroviral medications could have serious health implications.

The combined entity's negotiating power could lead to more restricted provider networks. NASHP's research shows that consolidated entities often leverage market power to demand higher reimbursement rates, resulting in narrower networks that limit access to specialists, including HIV care providers.

Navigating Complex Regulatory Hurdles

The proposed Cigna-Humana merger faces significant regulatory scrutiny at both federal and state levels. The merger is likely to undergo a 12- to 24-month regulatory review, particularly given the current antitrust enforcement environment. Regulatory challenges are expected to include a detailed examination of the potential impact on competition, particularly in the PBM market, and whether the merger could lead to increased healthcare costs for consumers. The recent FTC crackdowns on healthcare companies, which could provide additional insights into the type of scrutiny expected during the review, particularly regarding anti-competitive practices and market concentration. Both the FTC and the U.S. Department of Justice are likely to scrutinize any potential overlap in services and demand divestitures to ensure that competition remains intact. Additionally, state-level reviews could require concessions to protect local markets from becoming overly concentrated.

Kaiser Family Foundation's analysis highlights how the FTC and Department of Justice have increased their focus on both horizontal and vertical integration effects. They now examine broader implications for healthcare costs and access, beyond direct market overlap.

State-level review adds another layer of complexity. KFF notes that 34 states and DC require notification of health insurance mergers, with 13 states requiring explicit approval. This multi-state review process could extend the timeline and require concessions to address state-level concerns.

Looking Ahead: Implications for Healthcare Access and Affordability

The proposed Cigna-Humana merger represents more than a business combination—it embodies the tension between market consolidation and healthcare accessibility. While the companies argue that their complementary business models could improve efficiency, the merger's impact on PBM market concentration and healthcare access demands careful scrutiny.

The immediate path forward hinges significantly on the November 5th election outcome, with analysts suggesting meaningful progress is unlikely before then. Beyond the election, the regulatory review process could extend into 2026, as federal and state regulators examine the merger’s implications for competition, drug pricing, and healthcare access.

For healthcare stakeholders, especially those relying on specialty care and medications, the merger’s outcome could significantly impact their care access and costs. The combined entity's expanded market power in both insurance and PBM sectors could reshape provider networks, prior authorization processes, and drug formulary designs.

Advocacy organizations and policymakers must carefully monitor and engage in the regulatory review process to ensure that any approved merger includes meaningful protections for healthcare access and affordability. The FTC’s current focus on PBM practices provides an important opportunity to address long-standing concerns about drug pricing and access in any merger approval conditions.

Biden’s Inaction Leaves Copay Assistance in Limbo

Inflated prescription drug costs in the United States continue to place a significant burden on people living with chronic conditions. Copay assistance programs, designed to help people afford their medications, have become essential. Yet recent policy decisions and industry practices have put these programs at risk, potentially jeopardizing access to necessary treatments.

The Biden Administration's recently proposed 2026 Notice of Benefit and Payment Parameters (NBPP) rule omits crucial regulations that patient advocates have long been demanding. This inaction allows insurers and pharmacy benefit managers (PBMs) to continue profiting from billions of dollars of drug manufacturer copay assistance intended for patients.

The State of Copay Assistance

Copay assistance programs, primarily offered by pharmaceutical manufacturers, provide financial support to help cover out-of-pocket costs for prescription medications. As health insurance plans increasingly shift costs to patients through higher deductibles and copayments, these programs have become crucial.

According to the latest data from The IQVIA Institute, manufacturer copay assistance offset patient costs by $23 billion in 2023, a $5 billion increase from the previous year. This figure represents 25% of what retail prescription costs would have been without such assistance. Over the past five years, copay assistance has totaled $84 billion, highlighting its importance in maintaining access to medications.

Despite the significance of copay assistance, copay accumulator and maximizer programs accounted for $4.8 billion of copay assistance in 2023—more than double the amount in 2019. Implemented primarily by pharmacy benefit managers (PBMs) and insurers, these programs prevent assistance from counting towards patients' deductibles and out-of-pocket maximums. This practice effectively nullifies the intended benefit of copay assistance, leaving people to face unexpected and often unaffordable costs later in the year.

Recent scrutiny of PBMs has brought attention to these practices. As discussed in our recent article on PBMs, the Federal Trade Commission (FTC) has filed a lawsuit against the largest PBMs for alleged anticompetitive practices that inflate drug costs and limit access to medications. These developments underscore concerns about how PBM practices, including the implementation of copay accumulator programs, impact medication affordability and access.

The impact on access is serious. IQVIA reports that in 2023, patients abandoned 98 million new therapy prescriptions at pharmacies, with abandonment rates rising as out-of-pocket costs increase. This trend highlights the critical role copay assistance plays in helping people not only initiate but also maintain their prescribed treatments.

Public opinion strongly supports action on this issue. A Kaiser Family Foundation survey found that 80% of adults believe prescription drug costs are unreasonable, with broad support for various policy proposals to lower drug costs. This sentiment reflects the public's recognition of the financial challenges faced in accessing necessary medications.

The Legal and Regulatory Landscape

The regulatory environment surrounding copay assistance programs has been in flux, with significant developments in recent years. On September 29, 2023, a federal court struck down a rule that allowed insurers to decide whether copay assistance would count towards patients' out-of-pocket maximums. This ruling reinstated the 2020 NBPP rule, which required insurers to count copay assistance towards patient cost-sharing, except for brand-name drugs with available generic equivalents.

Despite this, the federal government declared that it would not enforce the court's decision or the 2020 NBPP rule until new regulations are issued. This inaction has left patients facing continued uncertainty about the status of their copay assistance.

On January 16, 2024, the Biden Administration dropped its appeal of the court decision. While this action confirms that the 2020 NBPP rule will generally apply until new rules are issued, the lack of enforcement leaves plans and insurers in a gray area regarding their copay accumulator programs.

At the state level, there has been a growing movement to address copay accumulator programs. As of 2024, 21 states, the District of Columbia, and Puerto Rico have enacted laws addressing the use of these programs by insurers or PBMs. These laws generally require any payments made by or on behalf of the patient to be applied to their annual out-of-pocket cost-sharing requirement. While these state actions provide important protections, they do not cover all insurance plans, particularly those regulated at the federal level.

The 2026 Notice of Benefit and Payment Parameters Proposal

The proposed 2026 NBPP rule, released by the Centers for Medicare & Medicaid Services (CMS), has drawn criticism from patient advocacy groups for significant omissions related to copay assistance and essential health benefits (EHB).

Notably absent from the proposed rule are regulations clarifying whether copay assistance will count toward patient cost-sharing. This omission perpetuates uncertainty created by previous conflicting rules and court decisions, allowing insurers and PBMs to continue implementing copay accumulator programs that can leave people with unexpected and unaffordable out-of-pocket costs.

The proposal also fails to include a provision to ensure that all drugs covered by large group and self-funded plans are considered essential health benefits, despite previous indications that such a provision would be forthcoming. This failure to close the EHB loophole allows employers, in collaboration with PBMs and third-party vendors, to designate certain covered drugs as "non-essential," circumventing Affordable Care Act (ACA) cost-sharing limits designed to protect people from excessive expenses.

By exploiting this loophole, plan sponsors can collect copay assistance provided by manufacturers without applying it to beneficiaries' cost-sharing requirements. This practice effectively doubles the financial burden on patients: first, by accepting the copay assistance, and second, by requiring them to pay their full out-of-pocket costs as if no assistance had been provided.

Recent research by the HIV+Hepatitis Policy Institute has revealed that over 150 employers and insurers are taking advantage of the EHB loophole. This list includes:

• Major companies such as Chevron, Citibank, Home Depot, Target, and United Airlines

• Universities including Harvard, Yale, and New York University

• Unions like the New York Teamsters and the Screen Actors Guild

• States such as Connecticut and Delaware

• Insurers, including several Blue Cross/Blue Shield plans

Patient advocacy groups have reacted strongly to these omissions. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, stated, "Every day these rules are delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients who are struggling to afford their drugs." This sentiment reflects the frustration of many who have long advocated for stronger protections.

The widespread exploitation of the EHB loophole underscores the urgent need for federal action to protect patients from these practices. The failure to address these critical issues in the 2026 NBPP proposed rule highlights a significant setback in efforts to improve medication affordability and access for people living with chronic conditions.

The Impact on Patients: Data and Experiences

The real-world impact of copay accumulator programs and the EHB loophole is reflected in both data and personal experiences. IQVIA reports that patient out-of-pocket costs reached $91 billion in 2023, an increase of $5 billion from the previous year. This rise in costs comes despite the $23 billion in copay assistance provided by manufacturers, highlighting the growing financial burden on patients.

Prescription abandonment is particularly concerning. Patients abandoned 98 million new therapy prescriptions at pharmacies in 2023, with abandonment rates increasing as out-of-pocket costs rise. More than half of new prescriptions for novel medicines go unfilled, and only 31% of patients remained on therapy for a year. These statistics highlight the direct link between cost and medication adherence.

People across the country are facing these challenges. For example, a mother whose daughter lives with cystic fibrosis shared her experience with a copay accumulator program. In early 2019, her family's out-of-pocket cost for her daughter's medication suddenly jumped from $30 to $3,500 per month when their insurance plan stopped applying copay assistance to their deductible. This unexpected change forced the family to put the cost on credit cards, creating significant financial strain and unnecessary medical debt.

Similarly, a person living with psoriasis faced steep increases in medication costs when their insurance company stopped counting copay assistance towards their deductible. The copay rose from $35 to $1,250 monthly, leaving them with only $26 from their disability payment after covering the copay.

These stories are not isolated incidents. People living with conditions such as HIV, hepatitis, multiple sclerosis, and hemophilia are facing similar challenges. The impact extends beyond financial stress, affecting medication adherence and, ultimately, health outcomes. For many, the choice becomes one between essential medications and other basic needs such as food and shelter—a decision no one should have to make.

Policy Recommendations and Advocacy Efforts

Patient advocacy groups are intensifying efforts for policy changes at both the federal and state levels. The All Copays Count Coalition, comprising over 80 organizations representing people living with serious and chronic illnesses, has been at the forefront of these efforts. In a letter to federal officials, the coalition urged for a revision of the cost-sharing rule to include clear protections ensuring that copayments made by or on behalf of a patient are counted towards their annual cost-sharing contributions. Specific recommendations include:

1. Maintaining the protections included in the 2020 Notice of Benefit and Payment Parameters.

2. Ensuring that copay assistance counts for medically appropriate medications, even when generic alternatives are available.

3. Limiting Health Savings Account-High Deductible Health Plan (HSA-HDHP) carve-outs to situations where using copay assistance would result in HSA ineligibility.

At the state level, advocacy efforts have led to the passage of laws restricting copay accumulator programs in 20 states, the District of Columbia, and Puerto Rico as of summer 2023. However, these state-level protections do not cover all insurance plans, particularly those regulated at the federal level, highlighting the need for comprehensive federal action.

Advocates are calling for:

1. Immediate enforcement of the 2020 NBPP rule, requiring insurers to count copay assistance towards patient cost-sharing in most cases.

2. Swift action to close the essential health benefits loophole for all plans, including large group and self-funded plans.

3. Increased oversight and regulation of PBM practices, particularly regarding copay accumulator and maximizer programs.

4. Passage of comprehensive federal legislation to protect those relying on copay assistance.

As Carl Schmid emphasized, "While they have gone on record that they will issue these rules, the clock is ticking and there isn't much time left." This reflects the growing frustration among patient advocates with the administration's delays in addressing these issues.

Policymakers must act swiftly to close the essential health benefits loophole and ensure that all copay assistance counts towards patients' out-of-pocket costs. Stakeholders across the healthcare ecosystem—from insurers and PBMs to pharmaceutical companies and patient advocacy groups—must collaborate to develop solutions that prioritize access and affordability. The health and well-being of millions depend on these critical policy changes.

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.

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

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

The Scope of Medicaid Unwinding

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

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

Systemic Challenges in the Unwinding Process

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

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

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

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

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

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

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

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

National Enrollment Trends and State-Level Variations

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

Several factors influenced these disparities:

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

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

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

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

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

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

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

Racial and Ethnic Disparities in Medicaid Disenrollment

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

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

The Human Impact of Coverage Loss

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

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

• 75% reported worrying about their physical health

• 60% worried about their mental health

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

Impact on HIV Care and Policy Implications

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

Key considerations for PLWH during the unwinding process included:

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

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

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

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

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

Economic Implications of the Unwinding Process

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

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

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

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

Policy Recommendations and Best Practices

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

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

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

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

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

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

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

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

Addressing Systemic Inequities and Long-Term Solutions

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

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

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

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

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

Conclusion

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

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

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

Grindr Launches At-Home STI Testing Initiative

In an approach to combat elevated sexually transmitted infection (STI) rates among gay, bi, trans and queer people, the social dating app Grindr rolled out a new initiative providing users the chance to order at-home STI testing kits. Ellen Jenne wrote about this very issue in a recent blog post highlighting the new service the app rolled out to address elevated rates of STI infections among gay and bisexual men who have sex with me (GBMSM) in London.

Grindr partnered with Prepster at The Love Tank to deliver this initiative. PrEPster is a program part of the broader ‘The Love Tank’ community organization, a not-for-profit community interest community (CIC) providing education and research to under-served communities. This trailblazing partnership is why the initiative of providing at-home STI testing kits to users of the Grindr app is now introduced in London.

Grindr writes that this initiative will not only help users obtain knowledge of their health status but also help the app serve as a role model for other social networking apps to also make an emphasis on sexual health matters.

The initiative has already been successful in other countries like Ireland, Georgia, New Zealand and the US. The rate of STI diagnosis among GBMSM in London is recorded to be 15 times higher compared to that of the general population. This statistic is a reason why the initiative has been introduced in London and Grindr also writes that these numbers represent true people with actual struggles relating to fear and discrimination.

In their Grindr Unwrapped for 2023, the app shared statistics about what city users explored the most to attempt a connection with another user and London ranked first. Although a statistic from the previous year, the city’s popularity for being searched the most in one year highlights the importance of introducing the initiative in London overall.

The at-home self-test kits address common fears around STI testing such as physical transportation, fear of judgment and limited clinic hours. The at-home self-test kits address physical transportation barriers in allowing users to test at the convenience of their own homes at any time and be free of any judgment they would otherwise face in a physical clinic location.

Additionally, Grindr promises to not share information it obtains from its users when collecting data to send the kits to users.

Here is how the free and confidential service works:

• Access: Users access the service directly from their profile by clicking on the button “Free STI Kit”

• Eligibility: After clicking the “Free STI Kit” button, users will be guided through the basic steps to confirm their eligibility for the free testing kit.

• Privacy: Once confirmed, the kit will be discreetly delivered to the user’s address. Users can then collect their samples in the privacy of their own homes.

• Return: After collecting samples, users can return the kit using the provided free postage.

• Results: Within a couple of days of returning the kit, users receive their results via notifications through SHL’s secure platform.

• Confidentiality: Throughout the entire process, from ordering to receiving results, users’ information remains strictly confidential and is never shared with Grindr.

This public health push from one of the world’s largest social dating apps provides clear access, guided steps and convenient knowledge of health status. Ordering an STI self-test kit to reduce common burdens faced from members of the GBMSM community will help individuals achieve peace of mind in their community in an attempt to lower the overall heightened STI rates among these individuals.

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.

The Promise of a Cure: Why Are We Still Failing People with HCV?

Hepatitis C virus (HCV) infection affects millions of Americans, contributing to thousands of preventable deaths each year. While a cure for HCV, in the form of direct-acting antiviral (DAA) medications, has been available for over a decade, achieving widespread treatment access has been a persistent challenge. This challenge is particularly acute among younger adults, who experience the highest rates of new HCV transmissions, often associated with injection drug use.

Historically, the high cost of DAAs led many state Medicaid programs to implement restrictive coverage policies, limiting treatment access based on factors like liver disease severity, sobriety, and prescriber specialty. In 2022, CANN highlighted in a blog post, these policies not only created barriers to care but also undermined public health efforts to interrupt HCV transmission. Advocacy and legal action have played a crucial role in dismantling these restrictions, as evidenced by the Center for Health Law and Policy Innovation's (CHLPI) successful litigation efforts in 13 states, which served as a model for similar efforts nationwide.

While this progress is encouraging, the fight to eliminate HCV as a public health threat is far from over. We must address the remaining barriers to care, particularly those that continue to disproportionately impact people who use drugs and those that persist within managed care organizations.

The Promise and Progress of HCV Treatment

Direct-acting antivirals represent a monumental advancement in HCV treatment. These medications offer cure rates of 95% or higher, achieving sustained virologic response in the vast majority of people treated. The benefits of DAA treatment extend far beyond individual health outcomes. Expanding access to these curative therapies holds immense promise for improving public health by reducing HCV-related mortality, interrupting transmission chains, and generating long-term cost savings.

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 14,200 HCV-related deaths occurred in the United States in 2019 alone, a stark reminder of the urgent need for effective treatment. Treating HCV not only saves lives but also prevents ongoing transmission of the virus. When a person achieves sustained virologic response, they are no longer able to transmit HCV to others. Furthermore, a study published in JAMA Network Open found that HCV treatment is associated with reduced healthcare costs in the long term, as cure prevents the need for expensive interventions related to managing complications like cirrhosis and liver cancer.

The dismantling of restrictive Medicaid policies has been instrumental in increasing treatment access. A JAMA Health Forum study analyzing data from 39 state Medicaid programs found that easing or eliminating restrictions on DAAs led to a significant increase in treatment uptake. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries per quarter compared to states that maintained restrictions. This finding underscores the tangible impact of removing barriers to care.

Further progress is evident in the growing trend of states removing prior authorization requirements for DAAs. The 2024 National Snapshot Report from CHLPI and National Viral Hepatitis Roundtable (NVHR) reveals that, for the first time, more states have eliminated prior authorization for most patients than those that still require it. This shift toward streamlining access represents a critical step in ensuring timely treatment initiation.

Persistent Barriers to HCV Treatment Access

Despite the progress made in expanding HCV treatment access, significant barriers remain, particularly for people who use drugs. The 2024 National Snapshot Report from CHLPI and NVHR reveals that nine states still impose substance use restrictions, requiring sobriety or counseling as a prerequisite for DAA treatment. These restrictions are not only medically unnecessary but also demonstrably harmful, as the JAMA Network Open study found a significant association between sobriety requirements and reduced HCV treatment rates. The HealthHIV State of Harm Reduction survey further underscores this point, with respondents reporting that stigma and community resistance pose substantial obstacles to accessing drug user health services, including HCV care.

Retreatment restrictions present another hurdle for people seeking HCV care. According to the 2024 National Snapshot Report, 15 states impose stricter criteria for retreatment than for initial therapy, often denying access based on factors like adherence challenges or previous treatment failure. These policies fail to recognize the complex social and structural factors that can contribute to reinfection or treatment interruptions, particularly among people who use drugs.

Furthermore, disparities in treatment rates among Medicaid recipients persist. The CDC's Vital Signs report found that Medicaid recipients who are Black were 7% less likely to initiate timely DAA treatment compared to White recipients. These disparities reflect the systemic inequities that permeate the healthcare system and demand targeted interventions to ensure equitable access to care.

Discrepancies between state Medicaid policies and managed care organization (MCO) practices present an additional layer of complexity. While many states have eased restrictions on DAAs, the JAMA Health Forum study revealed that these policy changes did not translate into increased treatment uptake in states where DAAs were predominantly reimbursed by MCOs. This finding aligns with the 2022 National Summary Report from CHLPI and NVHR, which found that MCOs often impose more restrictive criteria for HCV treatment access than their fee-for-service counterparts.

These persistent barriers raise serious ethical concerns. Denying treatment based on substance use or adherence challenges perpetuates harmful stereotypes and undermines the principles of patient autonomy and healthcare equity. As Jen Laws argues, "We don't get to tell patients how to prioritize their care based on a payer or provider's biases." The HealthHIV harm reduction survey echoes this sentiment, with respondents emphasizing the importance of meeting people "where they're at" and respecting their right to make informed decisions about their health.

Other administrative barriers, such as requirements to fill prescriptions at specialty pharmacies, further complicate access. The 2022 National Summary Report highlights the challenges posed by specialty pharmacies, which often impose additional restrictions and logistical hurdles that can delay or prevent treatment initiation, particularly for people experiencing homelessness or housing instability.

Harm Reduction and HCV Elimination: A Holistic Approach

Achieving HCV elimination requires a holistic approach that goes beyond simply removing treatment restrictions. We must recognize that HCV treatment access is inextricably linked to broader harm reduction efforts. As Jen Laws aptly stated, "If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what's working and what's not." This means embracing a comprehensive strategy that addresses the social, economic, and structural factors that contribute to HCV risk and disparities.

A 50-state survey of harm reduction laws conducted by the Network for Public Health Law revealed significant variations in the legal landscape surrounding syringe access and naloxone distribution. These variations underscore the need for a coordinated national effort to expand access to these life-saving interventions. The HealthHIV State of Harm Reduction survey further highlights the importance of harm reduction in HCV prevention and care, with respondents emphasizing the need for services that prioritize their safety and well-being.

A truly comprehensive approach to HCV elimination must encompass the following key elements:

• Removal of All Remaining Medicaid Restrictions: Eliminating all restrictions based on substance use, retreatment history, and other arbitrary factors is essential for ensuring equitable access to DAAs.

• Ensuring Parity Between State Medicaid Policies and MCO Practices: States must strengthen oversight and enforcement mechanisms to ensure that MCOs adhere to state Medicaid policies and do not impose additional barriers to HCV treatment.

• Expanding Access to Harm Reduction Services: Increasing the availability of syringe exchange programs, naloxone distribution, and other harm reduction services is critical for preventing new HCV transmissions and connecting people who use drugs to care. However, even in states that do have syringe exchange programs, access can vary widely, with many programs facing funding limitations, geographic restrictions, and community resistance. For example, a 2017 report indicated that 26 states had either no syringe exchange programs or limited these services to one or two major cities. Research suggests that existing programs meet only a fraction of the estimated need, highlighting the need for continued advocacy and policy reform.

• Addressing Social Determinants of Health: HCV elimination efforts must address the underlying social and economic factors that contribute to HCV risk and disparities, such as poverty, homelessness, and lack of access to healthcare. The HealthHIV harm reduction survey found that inadequate housing and transportation were significant barriers to clients engaging in care. Investing in housing, transportation, and other social support services is necessary for creating a more equitable and effective HCV response.

The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing many of these challenges. The plan's key elements include a subscription-based payment model for medications, investment in rapid point-of-care testing, and increased federal support for community-based healthcare infrastructure and provider training. However, as CANN CEO Jen Laws emphasizes, successful implementation requires more than just affordable drugs. The plan must prioritize reinvestment of cost savings into public health systems, support community-based testing and integrated treatment models, and address logistical barriers to care. Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would further strengthen the plan's foundation.

Conclusion

While significant progress has been made in expanding HCV treatment access, the fight to eliminate HCV as a public health threat demands a sustained and multifaceted effort. The Biden Administration's proposed plan offers a promising roadmap, but its success hinges on congressional budget approval and addressing the systemic barriers that continue to impede progress.

To effectively combat HCV, we must move beyond a narrow focus on medication access and embrace a holistic approach that prioritizes harm reduction, addresses social determinants of health, and ensures equitable access to care for all. CANN’s latest HIV/HCV Co-Infection Watch report provides a valuable resource for understanding the current landscape of HCV treatment access and harm reduction programs across the United States, empowering advocates and communities to push for meaningful change. Together, we can translate the promise of a cure into a reality for all Americans affected by HCV.

Together TakeMeHome: One Year of Progress, Challenges Ahead

A newly published report from the Centers for Disease Control & Prevention (CDC) offers promising initial results from the first year of Together TakeMeHome (TTMH), a groundbreaking program that provides free HIV self-tests by mail to people across the U.S., including Puerto Rico, making it the largest HIV self-testing program in the nation's history. This direct-to-consumer approach aims to address persistent gaps in HIV testing coverage and reach those who have not engaged with traditional testing services, particularly within priority populations disproportionately affected by HIV.

The report reveals that TTMH has already exceeded expectations, distributing 443,813 tests to 219,360 people in its first year, far surpassing its initial goal of distributing 200,000 tests annually. Significantly, 24.1% of TTMH users reported never having previously received HIV testing, demonstrating the program's success in reaching those who may face barriers to traditional testing methods.  This success builds upon the growing recognition of HIV self-testing (HIVST) as a valuable tool in the global effort to increase testing rates and achieve earlier diagnoses. The World Health Organization recommends HIVST as an additional approach to HIV testing services, recognizing its potential to overcome common barriers such as stigma, privacy concerns, cost, and lack of access to clinics.

Successes of TTMH and the Benefits of HIVST

The initial data from TTMH not only highlights the program's impressive reach but also provides valuable insights into its effectiveness in engaging priority populations and identifying new diagnoses. The report shows that 67.9% of TTMH users identify as members of groups disproportionately affected by HIV, including gay and bisexual men, Black women, and transgender women. This targeted reach is particularly important given that these communities often face greater barriers to accessing traditional testing services. Furthermore, the program's success in utilizing dating apps as a primary outreach platform, with nearly 70% of orders originating from these sources, demonstrates its ability to connect with people in online spaces where they feel comfortable. While comprehensive data on new HIV diagnoses among all TTMH users is not yet available, initial findings suggest that the program is successfully identifying people who are unaware of their HIV status. Among a subset of participants who completed a follow-up survey and had not previously reported an HIV diagnosis, 1.9% received a reactive result on their self-test.

These promising results are consistent with the broader benefits of HIVST demonstrated by research on other programs. For example, the eSTAMP study, a randomized clinical trial published in JAMA Internal Medicine, found that participants who received HIV self-tests were significantly more likely to test for HIV at least three times during the trial compared to a control group. Significantly, eSTAMP participants reported 34 newly identified transmissions among members of their social networks who used the study self-tests, highlighting the potential for HIVST to extend its reach beyond the initial user. The TakeMeHome program demonstrated that HIVST can be delivered at a reasonable cost, identifying 18 confirmed new HIV diagnoses in its first year at a cost of $9440 per diagnosis. This cost falls within the range of $3500 to $36,300 per diagnosis reported for traditional HIV testing methods implemented in various healthcare and non-healthcare settings. Moreover, research on the eSTAMP trial, a similar HIVST program, suggests that such programs can be cost-saving in the long run due to their potential to avert new transmissions and reduce lifetime HIV treatment costs. A scoping review published in Patient Preference and Adherence further supports the value of HIVST, finding that it is generally preferred over traditional testing methods due to its convenience, privacy, and the control it affords users.

One of the most significant advantages of HIVST is its ability to combat stigma, a persistent barrier to HIV testing. As noted in the Journal of Public Health Management and Practice, "Many men who have sex with men (MSM) prefer to test for HIV in privacy rather than at clinical settings or testing sites." This preference for privacy is particularly relevant for marginalized communities who may face discrimination or judgment in traditional healthcare settings. HIVST empowers people to learn their status in a safe and confidential environment. The HIV.gov blog succinctly captures this empowerment, stating that "HIV self-testing enables a person to learn their HIV status by placing control directly into the hands of users. With HIV self-tests, people can discreetly and conveniently test themselves in private, bypassing the potential discomfort or discrimination they might face in traditional settings."

Addressing the Needs of Diverse Populations

While promising, TTMH and other HIVST programs must acknowledge that HIV does not affect all communities equally. Disparities in HIV testing rates and outcomes persist, requiring tailored strategies to ensure equitable access to HIVST. For example, testing rates vary across racial and ethnic groups, with Asian people and Native Hawaiian and Pacific Islanders reporting lower rates than some other communities of color.

People who inject drugs (PWID) and those in rural communities face unique barriers to HIV testing. Research suggests that while PWID are willing to utilize at-home testing, structural barriers, such as stigma and limited access to healthcare, result in lower test completion rates. Similarly, rural communities often lack sufficient HIV prevention and testing infrastructure, and residents may face transportation challenges. To address these issues, we must partner with relevant organizations, offer alternative delivery methods, provide clear instructions and support, increase funding for rural programs, and collaborate with rural providers to promote HIVST.

Furthermore, recognizing the intersections of race/ethnicity, gender identity, and immigration status is crucial. Black and Hispanic immigrants face lower testing rates than their U.S.-born counterparts, even with known risk factors. Fear of deportation, fueled by policies like the "public charge" rule, can deter Latinx immigrants from seeking testing. Undocumented African immigrants face similar challenges, compounded by HIV-related stigma within their communities. HIVST programs must partner with organizations serving these populations, provide clear information about confidentiality and its separation from immigration enforcement, and offer culturally appropriate support.

Transgender people, especially transgender women of color, experience disproportionately high rates of HIV. HIVST can offer a more private and affirming option, but programs must be trans-inclusive and address anticipated stigma, which can be a significant barrier to testing. Similarly, people engaged in sex work often face stigma and marginalization, hindering access to healthcare. Outreach efforts should prioritize building trust, ensuring confidentiality, and partnering with organizations that serve this population.

Addressing the unique needs of diverse populations is essential for HIVST programs to achieve health equity and ensure that everyone has the tools they need to know their status and engage in appropriate care and prevention.

Strengthening Linkage to Care

While HIVST programs like TTMH are effective in expanding access to testing and identifying new diagnoses, their true impact hinges on ensuring that people who test reactive are seamlessly connected to appropriate care and support services. As highlighted in my previous blog post, there is a significant gap in linkage to care following HIVST. This gap is concerning, as timely linkage to care is essential for initiating treatment, improving health outcomes, and reducing the risk of onward transmission.

Unfortunately, we lack specific data on linkage to care outcomes for the TTMH program. However, the program website does provide information on the resources available to users who test reactive. These resources include referrals to local testing sites for confirmatory testing, contact information for HIV care providers, and links to support services. While these resources are valuable, they may not be sufficient to ensure that all people who test reactive are successfully linked to care.

To strengthen linkage to care for TTMH and other HIVST programs, we need a more robust and proactive approach. This includes implementing strategies such as:

• Telehealth Follow-Up: Offering telehealth consultations for post-test counseling, linkage to care, and ongoing support can help address logistical barriers and provide immediate access to guidance.

• Partnerships with Local Providers: Establishing formal partnerships with HIV testing sites, clinics, and community-based organizations can streamline referrals and ensure that people have a clear pathway to care.

• Peer Navigation: Utilizing peer navigators who have lived experience with HIV can provide invaluable support and guidance to people navigating the complexities of the care system. Peer navigators can offer emotional support, assist with appointment scheduling, and help address any barriers to accessing care.

• Data Collection and Monitoring: Implementing comprehensive data collection and monitoring systems to track linkage to care outcomes is essential for identifying gaps and areas for improvement. This data can help programs tailor their services to better meet the needs of their users.

By investing in these strategies, we can bridge the gap in linkage to care after HIVST and ensure that everyone who tests reactive receives the timely and comprehensive care they deserve.

Policy Enhancements

The successes of the TTMH program underscore the transformative potential of HIVST to expand access to testing, reach those who have traditionally been left behind, and combat stigma. To fully realize this potential and solidify HIVST as a cornerstone of the Ending the HIV Epidemic (EHE) initiative, we must advocate for policies that support its long-term sustainability, equitable reach, and seamless integration with other health services. This includes:

• Increased Funding: Sustained and increased funding for TTMH and similar HIVST programs is paramount to ensuring their continued operation, expansion, and ability to reach diverse communities.

• Targeted Outreach: Developing and implementing tailored outreach strategies for PWID, rural communities, BIPOC, and other marginalized groups, is essential for addressing the unique barriers they face and promoting equitable access to HIVST.

• Public Awareness Campaigns: Comprehensive public awareness campaigns are needed to promote HIVST, address stigma surrounding HIV testing and status, and educate the public on the importance of knowing their HIV status.

• Integration with Other Services: Integrating HIVST with other health services, such as STI testing and treatment, PrEP, and primary care, can create a more holistic and patient-centered approach to sexual health, facilitating access to a broader range of prevention and care services.

The EHE initiative, launched in 2019, aims to reduce new HIV transmissions in the U.S. by 90% by 2030. HIV testing is a critical first step in achieving this goal. As the CDC aptly states, "The COVID-19 pandemic has shown how critical HIV self-testing services are to sustaining momentum to end the HIV epidemic." TTMH has demonstrated that HIVST can effectively reach those who have not engaged with traditional testing services, combat stigma, and identify new diagnoses.

We must continue to advocate for policies and programs that support HIVST and ensure that everyone, regardless of their background or circumstances, has access to convenient, confidential, and empowering testing options. Together, we can make HIV testing a routine part of healthcare, reduce new transmissions, and move closer to ending the HIV epidemic in the U.S.

Equitable Access to Long-Acting HIV Treatment

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

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

The Promise of LAIs

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

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

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

Evidence of Effectiveness

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

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

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

Impact on the HIV Epidemic

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

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

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

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

The Cost Conundrum

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

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

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

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

A Holistic Cost-Benefit Analysis

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

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

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

Intangible Benefits

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

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

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

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

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

Ethical Considerations

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

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

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

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

Addressing Barriers and Implementing Solutions

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

Policy Recommendations for ADAPs

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

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

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

Provider Education and Training

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

Ongoing education initiatives should focus on:

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

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

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

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

Patient Advocacy and Support

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

PLWH and community organizations can play a powerful role by:

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

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

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

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

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

Conclusion

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

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

ADA & HIV Legal Protections

The fight for disability rights has been long and arduous, marked by significant milestones and persistent challenges. For people living with HIV (PLWH), this struggle intersects with ongoing battles against stigma, misinformation, and discrimination. While legislation like the Americans with Disabilities Act (ADA) has provided important protections, achieving true equality and inclusion demands vigilance and robust, consistent enforcement.

Systemic barriers often obstruct PLWH from educational opportunities and professional fulfillment. Take Robin Dugas, a cosmetology student in Arkansas. Despite being fully qualified, she was denied her license by the Arkansas Board of Cosmetology solely because she disclosed her HIV-positive status. This blatant discrimination, challenged by Dugas and the ACLU, exemplifies the ingrained stigma PLWH continue to face.

The ADA guarantees equal opportunity and prohibits discrimination against people with disabilities, including PLWH, recognizing that HIV, even in asymptomatic stages, can limit major life activities. However, as Dugas' case shows, legal protections alone don't ensure lived equality. PLWH still face stigma and discrimination, especially in healthcare, employment, and access to services.

The emergence of HIV in the 1980s led to widespread fear, misinformation, and discrimination, affecting marginalized communities and resulting in societal rejection, job loss, and denial of healthcare.

In response, the ADA was passed in 1990, marking a turning point against HIV discrimination by recognizing people with HIV as having a disability. This ensures their right to equal opportunities in employment, public accommodations, housing, essential services, and as we have seen recently, the justice system. The ADA’s impact was solidified in the Supreme Court case Bragdon v. Abbott (1998), where the Court ruled that even asymptomatic HIV qualifies as a disability. This decision underscored that discrimination based on HIV status is unlawful and affirmed the rights of PLWH.

The ADA as a Tool for Change

The ADA requires ongoing interpretation, enforcement, and adaptation. Recently, the U.S. Department of Health and Human Services (HHS) updated Section 504 of the Rehabilitation Act to strengthen protections against disability discrimination, particularly relevant to PLWH. Research shows that healthcare professionals sometimes harbor biases against PLWH, leading to a lower standard of care and poor health outcomes. The updated rule directly combats this by explicitly prohibiting discrimination in medical treatment decisions based on biases, stereotypes, or judgments about the value of life based on disability. Healthcare providers cannot deny, delay, or provide lower quality care to PLWH simply because of their HIV status.

Additionally, this update mandates accessibility for websites and mobile applications and works to ensure equal access for people with disabilities, including providing sign language interpreters and accessible medical diagnostic equipment, such as exam tables and mammography machines.

These updates enhance the legal framework to hold healthcare providers accountable for discriminatory practices and empower patients to advocate for their rights. As HHS Office of Civil Rights Director Melanie Fontes Rainer stated, “By removing barriers to healthcare and social services, this rule advances justice for people with disabilities who have for too long been subject to discrimination.”

Persistent Challenges: Evidence of Ongoing HIV Discrimination

Despite ADA protections, many PLWH still face discrimination. Recent cases and public health data highlight the need for robust ADA enforcement, education, and state-level policy reforms.

A 2021 UNAIDS fact sheet showed that in 7 out of 11 countries surveyed, 21% of PLWH were denied healthcare in the past year, and over 50% experienced job loss due to HIV-related discrimination. These findings highlight the global scope of the problem.

The ViiV Healthcare Positive Perspectives survey (Wave 1) found that 39% of respondents experienced institutional stigma, including denial of jobs, visas, health services, or education. Nearly a quarter worried that their HIV status would negatively impact their relationship with their primary care provider.

These data emphasize the need for interventions addressing HIV stigma and discrimination, particularly those intersecting with race, gender identity, and socioeconomic status. Legal protections like the ADA are essential but must be supported by enforcement, public education, and efforts to dismantle systemic barriers. Indeed, the necessity of robust enforcement and education becomes apparent when examining real-world incidents where these protections falter.

Case Study: Tractor Supply Company

In 2024, Tractor Supply Company settled a lawsuit filed by the Equal Employment Opportunity Commission (EEOC) for $75,000 on behalf of a Mississippi woman with HIV. The manager disclosed her HIV status to coworkers and then fired her after she complained about the resulting harassment. The woman endured verbal abuse and discriminatory treatment from colleagues fearing HIV transmission. The EEOC argued that Tractor Supply failed to protect her from a hostile work environment and retaliated against her for reporting the discrimination.

Marsha Rucker, a regional attorney for the EEOC, stated, “Tractor Supply Company created and maintained a hostile work environment for this employee by publicizing her private medical information and then failing to address the harassment this generated. Rather than protect this employee from harassment, the company fired her.” This case highlights the vulnerability of PLWH to workplace discrimination, even with clear legal protections.

Case Study: Tennessee’s Aggravated Prostitution Law

The criminal justice system can also be used as a tool of discrimination. The lawsuit OutMemphis v. Lee, brought by OutMemphis, the ACLU, and the Transgender Law Center, challenges Tennessee’s aggravated prostitution statute under the ADA and the U.S. Constitution. This ongoing case highlights how such laws disproportionately target and punish PLWH, effectively barring them from various social, employment, and housing opportunities due to the requirement to register as sex offenders.

Parallel to this, the Center for HIV Law and Policy (CHLP) submitted complaints to the Department of Justice (DOJ) which launched its own investigation, focusing on the discriminatory enforcement of the aggravated prostitution statute in Shelby County. The DOJ’s investigation found that the state and the Shelby County District Attorney’s Office violated Title II of the ADA by subjecting people living with HIV to harsher criminal penalties solely because of their HIV status.

When asked about the strategy to challenge the aggravated prostitution statute, Jada Hicks, staff attorney with CHLP’s Positive Justice Project explained, “if a person is accused of being a sex worker… that's a misdemeanor charge. If they then find out that they're HIV positive, it's a felony. That's it. That's all it takes. That is the most clear violation of the ADA that I can think of. It’s the perfect example of how you can violate the ADA based on someone's health status.”

The impact of this legal challenge has been profound, resulting in a landmark settlement agreement and a major win in the fight against HIV criminalization. This case marked the first time the ADA has been successfully used to challenge and dismantle such a law. Sean McCormick, a staff attorney at CHLP, highlighted the significance of this achievement: "This really reflects a tremendous milestone in this fight to use the ADA to attack HIV criminalization [as it] represents the first tangible, concrete change to laws, policies, practices that promote and enable HIV criminalization." There are currently 10 other states with similar aggravated prostitution laws that could be impacted by the Tennessee case, underscoring the broader potential for reform and the importance of strategic advocacy to address these unjust laws on a national scale.

In apparent backlash to these legal actions, Tennessee passed an amendment that expands the offense of aggravated rape to include cases where the defendant, knowing they are infected with HIV, commits rape and transmits the virus to the victim. This amendment, enacted in May of 2024, reflects ongoing legislative efforts that may further stigmatize and criminalize PLWH, highlighting the need for vigilant advocacy and legal challenges.

McCormick reflects on the role of HIV criminalization laws in oppressing marginalized groups, "the Tennessee experience with aggravated prostitution really speaks to the way that HIV criminalization continues to oppress marginalized folks... these laws are used as a way to target marginalized communities, particularly black trans and cisgender sex workers."

Hicks adds, "People who sit at the intersection of multiple identities are at an increased risk of interacting with the criminal legal system. For instance, if you're black, trans, inject drugs, and you're an immigrant, it's just increasing your chances of having an interaction with the carceral system."

This case serves as a potent example of how the ADA can be utilized to challenge similar laws in other states. As McCormick points out, "The most obvious translation is other states with very similar sentences and sentence enhancements for people who are convicted of aggravated prostitution." CHLP is actively working with advocates in states like Ohio and Pennsylvania to replicate the success achieved in Tennessee.

The Need for State-Level Reform

While federal laws like the ADA provide crucial protections for PLWH, as we have seen, state-level laws remain inconsistent and often inadequate. This patchwork of protections creates confusion and vulnerability, as PLWH may face different consequences depending on their state. Outdated HIV criminalization laws and sentence enhancements are still on the books in 30 states, highlighting the ongoing need for state-level advocacy and reform.

Realities Facing PLWH:

• Indiana: Indiana has HIV-specific criminal statutes that classify nondisclosure of HIV status to sexual partners, needle-sharing partners, or exposure to bodily fluids as felonies or misdemeanors. These laws discourage HIV testing and disclosure, perpetuating stigma and discrimination. Additionally, these statutes do not account for modern medical understanding of HIV transmission, leading to potentially unjust legal consequences.

• Tennessee: Despite removing aggravated prostitution as a "violent sex offense" requiring sex offender registration, Tennessee maintains the aggravated prostitution offense. This law penalizes PLWH harshly for consensual sex work, disproportionately affecting those who are already marginalized by race, gender identity, poverty and other intersectional social determinants.

• Louisiana: Louisiana's HIV-specific laws are particularly concerning. The state's broadly written statute criminalizes "intentional" exposure to HIV through sexual contact, even without transmission risk. The law's failure to define "intent" leaves interpretation to law enforcement and prosecutors, discouraging open communication about HIV status and leading to potential prosecutions without intent to harm. No actual transmission is required for conviction, meaning PLWH can be prosecuted for behaviors like spitting, biting, or consensual sex with a condom. The Center for HIV Law and Policy's analysis highlights how Louisiana courts have interpreted "sexual contact" broadly, allowing subjective enforcement and encompassing acts with no risk of HIV transmission.

The journey toward equality for people living with HIV (PLWH) has seen notable achievements, such as the protections offered by the Americans with Disabilities Act (ADA), yet it remains hindered by ongoing stigma and discrimination. Despite legal safeguards like the ADA, real-world equality requires consistent enforcement and proactive advocacy.

Discrimination in healthcare, employment, and through punitive laws like Tennessee’s aggravated prostitution statute highlights the significant challenges PLWH face. These laws disproportionately affect those at the intersection of multiple marginalized identities, making the vigorous application of the ADA across states crucial. The updated Section 504 of the Rehabilitation Act by the U.S. Department of Health and Human Services (HHS) is a step forward, ensuring that biases in healthcare and other services do not undermine the rights of PLWH.

Looking ahead, it's essential to support litigation efforts, push for legislative reforms, and educate the public to dismantle systemic barriers. Organizations like the ACLU and CHLP play a critical role in this fight, but broader community engagement is vital for sustained change.

By enhancing ADA protections and advocating for their robust enforcement, we can transform societal attitudes and ensure that all individuals with HIV live dignified lives, free from prejudice. For more information, visit the Americans with Disabilities Act homepage and the Center for HIV Law and Policy.

Equitable and Data-Driven Viral Hepatitis Quality Measures

Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.

Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.

OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.

The Landscape of Disparities and the Need for Action

The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."

These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."

Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.

Analyzing the Proposed Measures

At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.

This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.

The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.

Data Considerations

The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.

Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.

Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.

Collaborative Action

The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.

The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."

Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.

Conclusion

OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.

Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.

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.