Strengthening Caregiving Infrastructure is Fundamental to a Healthy American Society

John’s Hopkins defines a caregiver as a person who tends to the needs or concerns of a person with short- or long-term limitations due to illness, injury, or disability. On June 24, 2025, PBS will air a documentary on the multifaceted landscape of caregiving executive produced by Bradley Cooper and narrated by Uzo Aduba. The documentary explores the history of various aspects of caregiving in the United States, with a focus on the lived experiences of care providers, particularly family caregivers who provide care in the home. The documentary is timely, given how caregiver support could be affected by the present-day potential changes to Medicaid and other healthcare funding changes. The caregiving continuum spans from birth to the end of life, yet the caregiving infrastructure in the United States is insufficient.

Caregiving in the United States is both paid and unpaid, provided by professionals and laypeople. Caregiving encompasses a wide range of services, including daycare, preschools, in-home care, nursing homes, and more. Notably, according to 2020 data from AARP, around 53 million Americans give unpaid care in the home. This level of effort is by necessity, not by choice. Paying for private care services is prohibitively expensive, and loved ones prefer those in need to be in the surroundings of their own homes, living through long-term health challenges, as opposed to institutions. Home surroundings are especially desired regarding end-of-life issues.

The current U.S. healthcare infrastructure is not sufficient to meet the needs of caregivers and those they care for. Nursing homes are where some individuals with long-term significant care needs find themselves because they don’t have any family to take care of them or their family is ill-equipped to meet their needs. While Medicaid will pay 100 percent of the costs of nursing homes, the logistics of the coverage is problematic.

Medicaid coverage of nursing home care requires specific financial and health conditional requirements. In general, the financial eligibility criteria mean that a person in need must have very little in assets. If a patient does not qualify for Medicaid financially, they essentially have to spend down all their assets until they reach the required level of poverty. Additionally, in some states, the state will go after possession of a patient’s home if there is a home in their name at the end of their life. It’s referred to as Medicaid estate recovery, where a lien is placed on the home to recover some of the funds spent on long-term institutional care.

This is damaging, as it undermines the home's ability to remain in the family as a means of generational wealth. Moreover, if relatives are living in the house, they lose their place of domicile. Medicare, on the other hand, does not pay for any long-term care, such as nursing homes. Medicare will only pay for short-term care, documented medically necessary care in skilled nursing facilities such as rehabilitation homes after someone has been inpatient in a hospital. Patients who have significant care needs but do not require a level of care demanding enough to meet Medicaid criteria or do not qualify for Medicaid financially have to be cared for at home.

Having been a multi-year primary caregiver of my mother, who dealt with multiple healthcare issues, I understand first-hand the demands of being an at-home caregiver. I was not trained to be a caregiver. I was unaware of resources available to help me care for her, nor were hospitals or outpatient clinics any significant help in navigating her increasing needs from year to year. When it got to the point where she couldn’t walk, feed herself, get out of bed to relieve herself, bathe, or groom, the responsibility fell upon me as her only child.

I had to navigate taking care of all of her physical and medical needs while trying to financially support myself and attempt to flesh out a modicum of normalcy in my life. Although I was fortunate to work from home, it was challenging to balance my demanding data analysis position with her care needs. It was painful to hear her calling out for me while I was in the middle of a meeting or presentation, whether those I was interfacing with could hear her or not. I was not concerned if someone heard her faintly from down the hall during virtual meetings. It was painful because I always let her know when I had meetings scheduled so I could take care of her needs preemptively before the events. Thus, hearing her call out for me meant that it was a serious, urgent need, knowing that she always felt like she was being a burden and tried not to disturb me unless she urgently needed to.

Her financial situation did not qualify her for Medicaid, especially given her retirement and social security benefits. She had Medicare, which was partially paid for through her employer as part of her retirement benefits. While Medicare paid for her medications, it did not cover care needs related to day-to-day living. Medicare would not pay for a nurse or trained care individual to come in daily or several times a week to give her a proper bath once she could no longer bathe herself, thoroughly make sure her private areas were cleaned adequately after bodily functions, make sure all her bodily skin folds were powdered and dressed, and so much more. For example, I knew that any time she relieved herself of solid waste while bedridden, that meant one to two hours of time it would take me to properly get her taken care of as she couldn’t help me move her body to tend to her needs.

After I talked in depth with her primary care doctor, Medicare agreed to pay for a basic home hospital bed that allowed me to raise her up to make her comfortable and raise her legs when necessary. Medicare paid for a lower extremity lymphedema pump air compression recovery boot system for her swollen legs that sometimes developed sores, which I had to dress and clean. She was overweight, in addition to being unable to mobilize herself. Thus, after petitioning a doctor who attended to her after one of many inpatient stays, Medicare paid to rent a Hoyer lift so that I was able to lift her to change the bed or help put her on stretchers at times I had to call EMS. Although Medicare paid for renting these items after many rounds of begging and discussions, they would not pay for someone to come in and help me utilize the tools.

I had to learn how to use them on my own. The only time Medicare paid for anyone to come into the home was when some of her leg wounds and bed sores exacerbated to the point of justifying once-a-week home health visits to take care of them. Most importantly, those visits were only temporary. Once they had healed to the point where she was evaluated as not requiring weekly paid care, the visits stopped. I had to learn the involved processes from the home health nurses and how to administer care on my own. They would even order extra supplies to send to our home so that Medicare would cover them, rather than my mother and I having to buy them ourselves.

The aforementioned is only a small part of the realities of being an at-home caregiver. However, it is a window into the kind of support that caregivers and patients need. There need to be payment innovations that provide funding for things like home care beyond temporary skilled nursing needs. When patients with significant needs are discharged back into their homes after inpatient stays, there needs to be robust networks of after-discharge support that include inquiring about the needs of caregivers and those they care for.

Chronic condition care often requires numerous durable medical goods and disposable medical products that Medicare and private insurance do not cover. A system that helped caregivers with some of the financial burden of those needs would prevent families from financial ruin. For example, since my mother was bedridden, she obtained a device called a Pure Wick system that was a means to relieve urination without the complications of skin breakdown from wetting adult diapers. We had to pay out of pocket for the single-use catheters used for the device, which cost $150 per month in addition to all of the other many care products used on a daily basis.

There are many reasons why people end up in a long-term home care situation. There needs to be infrastructure in place at the local level to fill the gaps and meet needs financially, emotionally, and physically. Presently, a company like Trualta has the right idea. It is an online platform that provides caregivers with access to various training, support, and a way to interact with other caregivers.

However, vast improvements in government infrastructure are needed to effectively remedy home health care needs. The current potential detrimental changes to Medicaid and Medicare present an exacerbation of the status quo instead of a solution. Only 10 states have any means of compensation for family caregivers, and just 13 have paid family and medical leave. Caregiving is not a private issue to be lived through in darkness and silence. Ensuring a robust and stable caregiving continuum from birth until the end of life is the only way to ensure an economically stable and medically healthy society.

CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing

The Centers for Medicare and Medicaid Services (CMS) released its draft guidance for the Medicare Drug Price Negotiation Program in May 2025, offering operational improvements like using Wholesale Acquisition Cost (WAC) for standardized refund calculations. Yet beneath these technical refinements lies a critical policy failure: CMS's refusal to mandate federal claims modifiers for affected transactions and contradictory programs. This decision creates a regulatory vacuum that enables systematic duplicate discounts worth billions annually while sidelining patient experiences.

By abdicating responsibility for duplicate discount prevention and suggesting retrospective payment models that could strain smaller entities, CMS has created an environment where unscrupulous actors can exploit loopholes as state laws increasingly block the transparency mechanisms needed for program integrity. The contrast is stark—CMS requires mandatory "TB" modifiers for Part B inflation rebates but makes them voluntary for Maximum Fair Price (MFP) effectuation, creating an inconsistent regulatory framework that undermines program integrity.

"CMS had an easy answer right in front of them," says Jen Laws, CEO of the Community Access National Network (CANN). "Claims modifiers are an already existing tool within the scope of Medicare claims and instead agency officials opted to offer more than 220 pages worth of justifying why they won't mandate the information and not one page was dedicated to appreciating how such a fragmented approach might harm patients. The only mention we got was off handed references about maybe listening to patient advocacy organizations - which didn't go so well for us during the initial listening sessions of drug selection. Honestly, it's all entirely baffling."

The Mechanics of Duplicate Discounts and Why Modifiers Matter

Without clear claims identification, the same drug unit may receive multiple discounts—340B pricing plus Medicare rebates or Medicaid rebates—creating billions in inappropriate financial flows. Federal law (42 USC 256b(a)(5)(A)(i)) explicitly prohibits duplicate discounts between 340B and Medicaid rebates on the same drug unit, yet enforcement remains weak. While this might seem fine, no specified benefit is required to flow to patients and these factors incentivize ever increasing, uncontrolled costs within the healthcare ecosystem.

The scope of this problem is staggering. IQVIA estimates $20-25 billion in duplicate discounts annually across the industry. A Government Accountability Office (GAO) audit found that 25% of audited 340B programs had duplicate discount errors, with 264 of 429 cases caused by inaccuracies in the Medicaid Exclusion File system (MEF) itself. For context, some states seeking to prohibit claims modifier requirements cite use of the MEF—these inaccuracies and resulting duplicate discounts highlight the flaws of this approach.

The exploitation extends beyond duplicate discounts. Contract pharmacy fees extract over $1 billion annually from the 340B ecosystem, with CVS's third-party administrator (TPA) operation alone collecting over $350 million in fees over a few years according to Senate HELP Committee inquiry.

"Statutorily prohibited duplicate discounts are one of the many ways the 340B program is exploited as a profit-making tool by large hospital systems and for-profit contract pharmacies," explains Kalvin Pugh, State 340B Policy Director at CANN. "A simple claims modifier would ensure that this guidance prevented continued abuse and taken a step forward in much-needed accountability."

Despite misleading statements to the contrary, claims modifiers do not risk patient privacy. Claims modifiers function as digital markers using de-identified information to tag individual claims as 340B, similar to Medicare claims, enabling automated systems to exclude them from other rebate calculations. Without this technical infrastructure, PBMs can attempt "illicit rebate grabs" on 340B drugs, and covered entities can divert Medicaid rebates that should be reinvested in state programs directly to their own entities. These exploitations drive up the overall cost of medication and care for patients, either directly by profiteering off of patients and not passing on those discounts or by way of increased private insurance premiums as justified by increased billing across the healthcare ecosystem.

State Medicaid Programs Bear the Cost of Federal Inaction

The absence of mandatory claims modifiers enables duplicate discounts that drain state Medicaid rebate programs of billions annually, forcing difficult choices between expanding access and protecting limited state resources. While the pending Reconciliation Bill making its way through the Senate includes provisions to prohibit 340B spread pricing in Medicaid programs—as was seen in the December 2024 Continuing Resolution prior to it being gutted—efficient and effective compliance requires a claims modifier.

A Health Management Associates study found that 9 states position that manufacturers should seek recoupment from providers rather than reducing state rebate payments. The Texas experience illustrates the real-world consequences—when the Texas Legislature considered legislation that would have expanded 340B contract pharmacy use without oversight or revenue-sharing requirements, the fiscal note projected the state's HIV Medication Program would become 'insolvent by 2027' with an estimated $72 million shortfall over a multiyear period. This demonstrates how policy changes affecting 340B identification can directly threaten state programs serving vulnerable populations, while some states implemented comprehensive carve-out policies removing all 340B drugs from managed care to avoid such complications entirely.

"State programs will lose out on numerous rebates by offering the option to use the often lower 340B discount instead of the Medicaid price," Pugh explains. "This will strain state resources and put vulnerable impoverished communities at risk of losing access to lifesaving healthcare and medications."

In non-fee-for-service states, choosing the 340B rate over the Medicaid rate diverts rebate value away from Medicaid program reinvestment, effectively divesting from state programs that serve vulnerable populations. This interaction between 340B and Medicaid creates perverse incentives that undermine both programs' effectiveness.

CMS's Abdication of Responsibility Creates a Regulatory Vacuum

By declaring it "will not, at this time, assume responsibility for deduplicating discounts", CMS has created a regulatory vacuum that enables bad actors while burdening manufacturers and providers with piecemeal solutions.

The consequences of this abdication are far-reaching. At least 12 states have enacted laws restricting 340B claims modifier requirements or data sharing. CMS provides limited oversight of state Medicaid duplicate discount prevention efforts, leaving this responsibility to states, which are not always sufficiently funded or staffed to meet this responsibility. The Indiana situation exemplifies this chaos—former state officials filed a "whistleblower" lawsuit alleging "tens, likely hundreds" of millions of dollars of Medicaid fraud by hospital systems and managed care entities (PBMs by any other name), partly due to inadequate state oversight.

According to insights from interviews with former and current Medicaid directors and pharmaceutical policy experts in 14 states, the Health Resources and Services Administration (HRSA) has been faulted with inconsistent and weak enforcement of 340B duplicate discounts due to lack of data transparency. The GAO review found that only 4 of 13 covered entities had accurate descriptions of state Medicaid policies.

"While CMS might be about to assume some of HRSA's responsibilities with regard to 340B, it seems the agency is prepared to repeat HRSA's abdication of responsibility," Laws notes. "The IRA's interaction with 340B under this draft guidance systematizes the absolute headache covered entities, manufacturers, and patients already have with one program and just...duplicates it."

Retrospective Payment Models Threaten Safety-Net Provider Viability

The shift from prospective 340B discounts to retrospective payment models could create existential cash flow threats for smaller safety-net providers who lack working capital to absorb payment delays. While the draft guidance offers a rubric for manufacturers to assess entity financial sustainability and requires manufacturers to enact individualized action plans, this approach is clumsy and not foolproof, nor does the guidance suggest how smaller entities might efficiently comply with a patchwork of manufacturer assessment tools.

The financial reality for true safety-net providers is bleak. Nearly 45% of rural hospitals operate with negative margins, making 340B savings vital for maintaining operations. 93% of rural hospitals report relying on 340B savings to help keep their doors open. However, rural hospitals average only $2.2 million in annual 340B savings, compared to $11.8 million for all hospitals. Compliance costs range from $100,000 to $200,000 annually, regardless of hospital size, posing a significant burden on these facilities.

The timing requirements compound these challenges. The 14-day MFP payment window plus manufacturer 45-day lookback requirements create complex compliance deadlines that smaller entities may struggle to meet.

CMS also fails to contemplate the natural and expected outcome of confusing and potentially conflicting billing for patients. People already face challenges determining actual payments due when engaging in critical care for chronic and complex health conditions. Bills may come slow or arrive with differing amounts due based upon claims adjudication. A complex retrospective payment process as suggested by CMS will only further exacerbate this issue.

Technical Infrastructure: Why Modifiers Are the Solution

Claims modifiers represent proven, existing technical infrastructure that could solve the identification problem with minimal additional burden on providers already using similar systems. Think of claims modifiers as digital tags—simple two-digit codes that healthcare providers already add to insurance claims to provide additional information about services without changing the fundamental billing process. The "TB" modifier became the universal 340B identifier for all covered entities when billing Medicare Part B starting January 1, 2025.

The key point is that this infrastructure already exists for Medicare—extending similar requirements to the Medicare Drug Price Negotiation Program would simply apply proven technology consistently across federal programs rather than creating new systems. Furthermore, False Claims Act liability creates potential fines up to $10,000 per incorrect Medicare entry, ensuring accuracy and proper use of these digital markers.

The Path Forward Requires Federal Leadership

The public comment period for CMS's draft guidance closes on June 26, 2025, representing a critical opportunity for stakeholders to advocate for mandatory modifiers.

"We had some high hopes for a more thoughtful and, frankly, direct approach to our already fractured healthcare system with this guidance," Laws reflects. "The draft, as it is, is a mess. Mandating a claims modifier is a direct and elegant answer that would require far less wasted ink. Despite this Administration's claims to the contrary, here we are watching draft guidance unfold that will perpetuate a system prone to fraud and abuse. And patients? Our experiences in the middle of all of this? We're an afterthought. It's just completely unacceptable. The only way systems meet patient needs is by starting with us. This is not that and CANN is prepared to be loud and clear about that fact."

A mandatory federal claims modifier can provide the systematic solution needed to protect safety-net providers and ensure program integrity. Technical fixes aren't enough—comprehensive policy reform is needed. The stakes are too high, and the patients we serve deserve better than regulatory half-measures that enable exploitation while threatening the safety net they depend on for survival.

RFK Jr's Budget Testimony Reveals Concerning Vision for America's Healthcare Safety Net

In a pair of contentious congressional hearings last week, U.D. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. defended the Trump Administration's proposed fiscal year 2026 budget for HHS—a plan that would slash the department's discretionary funding by 26%, amounting to approximately $33 billion in cuts. These hearings before the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Appropriations Committee provided the most comprehensive look yet at the administration's vision for reshaping America's healthcare system and safety net programs.

Secretary Kennedy's testimony, frequently punctuated by tense exchanges with lawmakers, outlined a fundamental restructuring of the federal government's role in healthcare under the banner of "Making America Healthy Again" (MAHA). The vision embraces dramatic cost reductions justified as eliminating "waste" and "bureaucracy," but the evidence suggests these changes would significantly impact access to healthcare for millions of Americans, particularly those living with chronic conditions and those from marginalized communities.

The Magnitude of Proposed Cuts

The scale of proposed reductions across HHS agencies is staggering, particularly for federal research and public health programs. The National Institutes of Health (NIH) faces an $18 billion reduction, nearly 40% of its current budget. The Centers for Disease Control and Prevention (CDC) would see cuts of approximately $4 billion. Multiple agencies would be eliminated entirely, including the Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA), Administration for Strategic Preparedness and Response (ASPR), and the Administration for Community Living (ACL).

During his testimony, Kennedy framed these changes as necessary consolidations rather than eliminations: "We had nine separate offices of women's health. When we consolidate them Democrats say we're eliminating them. We're not. We're still appropriating the $3.7 billion," Kennedy told House lawmakers. He further justified the reductions by claiming that "my department grew by 38% over the last four years. I would say that's great if Americans got healthier, but they didn't. They got worse."

But the budget document itself tells a different story. The proposed restructuring would move many functions to a new "Administration for a Healthy America" (AHA) while explicitly cutting total funding. For example, the Low Income Home Energy Assistance Program (LIHEAP), which provides critical utility assistance to low-income Americans, would be eliminated entirely based on the rationale that "states have policies preventing utility disconnection for low-income households, effectively making LIHEAP a pass-through benefitting utilities in the Northeast," according to the budget proposal.

Impact on Health Coverage and Access

Perhaps most concerning are the projected impacts on health insurance coverage. The proposed budget works in tandem with the reconciliation bill currently working its way through Congress, which would impose significant changes to Medicaid and the Affordable Care Act (ACA) Marketplaces.

According to the Congressional Budget Office (CBO), these changes could increase the number of people without health insurance by 8.6 million, with the total rising to 13.7 million when combined with the expected expiration of the ACA's enhanced premium tax credits. A Kaiser Family Foundation (KFF) analysis projects that the uninsured rate would increase by 5 percentage points or more in Florida, Louisiana, Georgia, Mississippi, and Washington, with 30 states and the District of Columbia seeing increases of at least 3 percentage points.

When Senator Bernie Sanders asked Kennedy about the reconciliation bill's potential to eliminate health insurance for 13.7 million Americans, Kennedy acknowledged that people would lose coverage but characterized the cuts as "eliminations of waste, abuse and fraud." Yet when pressed for specifics, the Secretary could not provide details on several programs affected, including funding delays for Head Start, impacts on clinical trials, and cuts to childhood lead poisoning prevention.

The Mirage of Medicaid Work Requirements

Central to both the budget proposal and the reconciliation bill is the implementation of Medicaid work requirements. Under these provisions, certain Medicaid recipients would need to work at least 20 hours per week to maintain their coverage. Proponents, including Kennedy, argue this would reduce dependency and promote employment.

However, extensive research contradicts these claims. According to Congressional Budget Office's own analysis, Medicaid work requirements "would have a negligible effect on employment status or hours worked by people who would be subject to the work requirements." This aligns with the real-world experience from Arkansas—the only state to fully implement such requirements—where more than 18,000 people lost coverage while employment rates remained unchanged.

The evidence shows that most Medicaid recipients who can work already do. A KFF analysis found that 92% of Medicaid adults under age 65 are either working (64%), caring for family members (12%), dealing with illness or disability (10%), or attending school (7%). Only 8% report being retired, unable to find work, or not working for another reason.

Moreover, a recent Commonwealth Fund study projects that implementing nationwide Medicaid work requirements would have devastating economic consequences. Between 4.6 million and 5.2 million adults could lose Medicaid coverage in 2026, cutting federal funding to states by $33 billion to $46 billion in the first year. This would trigger a $43 billion to $59 billion reduction in economic activity, a loss of 322,000 to 449,000 jobs nationwide, and a $3.2 billion to $4.4 billion reduction in state and local tax revenues.

"Our findings demonstrate a paradox of Medicaid work requirement policies: rather than bolstering employment—as claimed by proponents—they could actually reduce employment and people's earnings," the study's authors conclude. These economic impacts would extend beyond just expansion states, affecting all states due to interconnected economies.

Transparency and Public Input Concerns

Beyond specific policy proposals, the administration's approach to transparency and public input has raised alarm. In March 2025, HHS rescinded the Richardson Waiver, which had been in place since 1971 and required public comment periods for certain HHS actions. Senator Ron Wyden characterized this move as a shift from "radical transparency" to "radical secrecy," saying Kennedy has "shut the gates, locking out doctors, patient advocates, and everyday Americans from weighing in on the chaotic disruption of America's healthcare."

When questioned about specific programs being cut, Kennedy repeatedly cited a court order preventing him from discussing reorganization details. Yet this didn't stop him from defending the broader vision of massive structural change, leaving lawmakers and the public with limited ability to assess the full impact of the proposals.

Implications for Patients and Advocates

For people living with chronic conditions, including HIV, hepatitis, and other serious illnesses, the proposed changes would create multiple barriers to care. Reduced funding for research could slow the development of new treatments. Medicaid work requirements could jeopardize coverage for those whose conditions make consistent employment difficult but who don't qualify for disability exemptions. Cuts to public health programs would impact prevention efforts, disease surveillance, and outbreak response capabilities.

Rural communities face particular risks, with hospital closures likely to accelerate. A recent report found that 742 rural hospitals are already at risk of closing, with over 300 classified as being at "immediate risk." Cuts to Medicaid funding would further destabilize these essential providers.

Advocates must understand that while Secretary Kennedy has stated that appropriated funds will be spent as directed by Congress, the administration's budget proposal reveals its long-term vision for drastically reducing the federal government's role in healthcare. This makes engagement with congressional representatives, particularly those on appropriations committees, absolutely critical in the coming months.

The administration's budget proposal represents a fundamental reshaping of America's healthcare safety net that would leave millions of Americans with less access to care, despite evidence that key proposals like Medicaid work requirements fail to achieve their stated goals and may actually harm state economies and healthcare systems. As policymakers debate these changes, the voices of patients and advocates must be centered to ensure that vulnerable populations are not left behind in the pursuit of government efficiency.

Antibiotic Crisis: Hope Amid Institutional Decline

The fight against antimicrobial resistance (AMR) in sexually transmitted infections (STIs) stands at a critical crossroads. Despite a slight decline in U.S. STI rates in 2023, resistance to antibiotics continues to rise globally, particularly for gonorrhea. This creates a paradox: while we're seeing promising new treatments advancing toward approval, recent political decisions have dramatically weakened our ability to track resistance patterns. Meanwhile, funding and policy support for developing new antibiotics remain inadequate. This crisis demands urgent attention as resistant infections spread faster than new treatments can be developed, with serious implications for public health and patient care.

The Growing Threat of Antibiotic-Resistant STIs

For people living with chronic conditions or compromised immune systems, antibiotic-resistant STIs aren't just a public health statistic—they represent a serious and growing threat to wellbeing. While the Centers for Disease Control and Prevention (CDC) reported fewer gonorrhea cases in the U.S. last year, the global picture is far more concerning.

Gonorrhea is becoming increasingly resistant to our last effective treatments. In Southeast Asia, the World Health Organization (WHO) identified a three-fold increase in extensively drug-resistant gonorrhea strains in Cambodia between 2022 and 2023. These hard-to-treat infections now make up over 12% of cases in the region.

What does this mean for patients? When first-line treatments fail, people face longer infectious periods, more complex and expensive treatments, and greater risk of complications. For people living with HIV or hepatitis C, these resistant infections can further compromise health and complicate disease management.

Breakthrough Treatments on the Horizon

Despite the grim outlook, two novel antibiotics represent genuine breakthroughs in the fight against resistant STIs after decades without new gonorrhea treatments.

Zoliflodacin, developed through a Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics partnership, completed the largest Phase 3 trial ever conducted for gonorrhea, with promising results. While its 91% cure rate appears slightly lower than the current standard's 96%, zoliflodacin's significance lies in its novel mechanism of action against resistant strains and its oral administration route. As resistant gonorrhea increasingly requires injectable treatments, an effective oral option represents a major advance for both accessibility and patient care.

Equally promising is gepotidacin, developed by GSK and already FDA-approved for urinary tract infections as of March 2025. This novel antibiotic showed a 92.6% success rate against gonorrhea through its unique dual-targeting mechanism that inhibits two critical bacterial enzymes, making it effective against resistant strains. GSK plans to submit for the gonorrhea indication later in 2025.

These developments showcase complementary partnership models: GARDP's non-profit approach ensures zoliflodacin's availability in low-income countries, while gepotidacin demonstrates successful public-private partnership between GSK and BARDA. Despite these advances, the WHO reports the broader antibiotic pipeline remains critically thin, with only 12 truly innovative antibiotics among 32 in development, and just 4 targeting the most critical pathogens.

Political Decisions Undermining Public Health

In a dangerous contradiction, just as resistance is rising and new treatments are on the horizon, political decisions have severely weakened our ability to monitor and respond to these threats.

Since early 2025, the current administration has eliminated approximately 20,000 jobs across health agencies and proposed cutting the HHS budget by about 26% ($127 billion).

The impact on STI programs has been particularly severe. The Washington Post reported that all 27 scientists at the only U.S. facility capable of tracking hepatitis outbreaks were fired. Additionally, 77 CDC staff members working on STI prevention were let go, including 49 experts embedded in state health departments who provided critical support to local efforts.

Most alarming for people at risk of STIs is the closure of the specialized lab that tests gonorrhea samples for antibiotic resistance. This lab was our early warning system—without it, doctors and patients won't know which antibiotics still work until treatment failures start mounting.

Prevention Strategies: Interrupting Transmission Chains

While developing new antibiotics is critical, prevention remains essential. Doxycycline Post-Exposure Prophylaxis (DoxyPEP) has emerged as an effective tool for breaking transmission chains. The CDC now recommends that men who have sex with men and transgender women with a history of bacterial STIs use DoxyPEP after sexual encounters.

Real-world data from San Francisco showed significant declines in chlamydia and syphilis among those using DoxyPEP, though gonorrhea reductions were less dramatic. While some concerns exist about the potential for DoxyPEP to contribute to broader antibiotic resistance, current evidence suggests this approach can effectively reduce STI transmission in high-risk groups—a crucial tool while we wait for new treatments.

The Funding Gap and Market Failure

The fundamental problem in antibiotic development is an economic one: the market doesn't adequately reward the creation of new antibiotics, especially those held in reserve to combat resistance.

The experiences of both zoliflodacin and gepotidacin highlight this challenge. Zoliflodacin required non-profit involvement through GARDP to advance through clinical trials, while gepotidacin needed significant government funding through BARDA. As Henry Skinner of the AMR Action Fund notes, "The funds needed to support this ecosystem, particularly in late-stage development, won't be there in a couple of years unless something unanticipated happens."

The AMR Action Fund, backed by pharmaceutical companies, aims to invest $1 billion to bring 2-4 new antibiotics to patients by 2030. The Fund has deployed over $100 million in capital to companies developing promising antimicrobials. However, experts recognize this as a stopgap measure rather than a solution to the underlying market failure.

A more sustainable approach is proposed in the PASTEUR Act, which has been introduced in multiple congressional sessions without passing. This legislation would create subscription contracts with developers of critical antimicrobials, ensuring financial returns regardless of how sparingly the drugs are used—essentially paying for access rather than volume.

This "Netflix model" for antibiotics would help align public health needs with market incentives. However, despite bipartisan support, the Act faces an uncertain future in the current political climate of budget cutting and deregulation.

Disproportionate Impact on Vulnerable Communities

Antimicrobial resistance operates within complex syndemics, where multiple health conditions interact and amplify each other within populations experiencing social inequities. People living with HIV stand at the intersection of these overlapping epidemics.

Research shows people living with HIV have higher rates of drug-resistant gonorrhea co-infection, each condition worsening the other. This syndemic intensifies with hepatitis C—a Department of Veterans Affairs study found 37% of people with HIV were also HCV-positive, with significantly higher rates of mental health issues and substance use disorders among these co-infected patients.

Among people who inject drugs with HIV, HCV rates reach up to 71% in some settings, according to a global review. These aren't coincidental occurrences—structural factors create environments where these epidemics cluster and interact.

The dismantling of surveillance infrastructure creates a dangerous blind spot in tracking these syndemics. Without specialized CDC labs monitoring resistant gonorrhea, we've lost our early warning system for emerging resistance patterns in vulnerable communities. Simultaneously, new restrictions on health equity research effectively discourage scientists from studying social factors that increase vulnerability to antimicrobial resistance.

A Patient-Centered Path Forward

From a patient and advocate perspective, five key policy areas require immediate attention:

1. Restore critical infrastructure. The dismantling of STI surveillance labs has left both patients and providers flying blind. Congress must fund restoration of these capabilities and hold administration officials accountable so we can track resistance patterns, update treatment guidelines, and support state and local health departments.

2. Support innovative development models. The GARDP partnership for zoliflodacin and the GSK-BARDA collaboration that produced gepotidacin demonstrate effective approaches to antibiotic development. These models—balancing commercial viability with public health needs—warrant expanded funding and replication.

3. Implement pull incentives. The PASTEUR Act would create a subscription-based model rewarding companies for developing critically-needed antibiotics without encouraging overuse, aligning market incentives with public health priorities.

4. Strengthen integrated care models. People at highest risk of resistant infections often face multiple health challenges. HIV, HCV, and STI services should be integrated to address overlapping needs, following the Ryan White HIV/AIDS Program's comprehensive care model.

5. Expand prevention strategies. While new treatments are essential, preventing infections reduces suffering and limits resistance. Expanded access to DoxyPEP, increased STI screening in high-risk populations, and vaccine research represent critical prevention strategies.

The antimicrobial resistance crisis in STIs reveals a stunning act of self-sabotage: just as scientific innovation finally delivers promising new treatments like zoliflodacin and gepotidacin, the misguided decimation of public health infrastructure has crippled our ability to track and respond to resistant infections. This isn't poor timing—it's the cavalier dismemberment of critical surveillance systems by ill-equipped partisans wielding policy chainsaws with no regard for consequences. The resulting wreckage threatens to undo decades of progress against STIs, particularly for communities already navigating systemic barriers to care.

The path forward demands both hope and principled outrage. Patients and advocates must forcefully reject further cuts to public health infrastructure, demand immediate restoration of STI surveillance capabilities, and hold elected officials accountable for the consequences of their decisions. We must insist on passage of the PASTEUR Act to fix the broken economics of antibiotic development while ensuring that promising science reaches those who need it most, not just those with wealth, power, and access.

The High Cost of Middlemen Medicine

For millions of Americans, the promises of modern medicine are starting to sound a lot like a scam. Despite breakthrough treatments and historic R&D investments, every year more and more people can’t actually afford the medications that could save or improve their lives. They’re stuck navigating a labyrinth of AI-powered insurance denials, sky-high out-of-pocket costs, and middlemen who profit precisely because access is so difficult.

The numbers don’t lie. In 2024, Americans spent $98 billion out-of-pocket on prescription drugs—a 25% increase over five years, according to research from the IQVIA Institute. This burden falls hardest on people with chronic illnesses, who are often forced to choose between staying alive and staying solvent.

The Growing Burden of Out-of-Pocket Costs vs. Net Drug Prices

Here lies one of the most troubling contradictions in our prescription drug system: while patients are paying more, manufacturers' net prices have grown at dramatically lower rates. According to IQVIA data, protected brand drug net prices increased by merely 0.1% in 2024, following several years of flat or negative growth. Meanwhile, out-of-pocket costs for patients have risen substantially, with the aggregate burden growing 25% since 2019.

This widening gap between patient costs and manufacturer net prices points directly to a dysfunctional system where middlemen capture an increasing share of value. For brand-name medications—often the only options for certain conditions—commercially insured patients saw their costs rise from $20.02 to $25.07 over five years, while cash-paying patients now face average costs of $130.18 per prescription based.

The difference between list prices (what insurers use to calculate patient cost-sharing) and net prices (what manufacturers actually receive after rebates and discounts) has grown to approximately 52% across all medicines. In diabetes treatments, this gap is particularly stark—net prices are 77.5% below list prices, yet patients pay cost-sharing based on those inflated list prices rather than the heavily discounted prices their insurers actually pay.

The burden of these costs falls heavily on specific populations. Nearly half (46%) of insured Americans report that if diagnosed with a chronic illness or experiencing a major medical event, their out-of-pocket costs would be either "expensive" or "more than they could afford." This concern rises to 59% among Black Americans and 57% among those with government insurance.

PBMs: Profiting at Patients' Expense

The growing disparity between net prices and patient costs can be traced directly to the rise of Pharmacy Benefit Managers (PBMs), who have positioned themselves as essential intermediaries in the prescription drug supply chain. These entities manage prescription drug benefits for health insurers, self-insured employers, and government programs, negotiating with drug manufacturers and pharmacies while setting the terms for patient access.

The PBM market is highly concentrated, with three major companies—CVS Caremark, Express Scripts, and OptumRx—controlling approximately 80% of the market. Their business practices raise serious concerns about whose interests they truly serve.

A particularly troubling practice is how PBMs handle manufacturer rebates. While PBMs negotiate substantial discounts from drug manufacturers—sometimes exceeding 70% of a drug's list price—these savings rarely benefit patients directly. Instead, PBMs often retain a portion of these rebates and pass the remainder to insurers, who may use them to lower premiums slightly across all enrollees rather than reducing costs for the patients actually taking the medications.

According to Federal Trade Commission findings, the "Big 3 PBMs" marked up numerous specialty generic drugs by hundreds or thousands of percent, generating "more than $7.3 billion in revenue from dispensing drugs in excess of estimated acquisition costs from 2017-2022" as documented in Congressional testimony. This practice known as "spread pricing"—charging plan sponsors more than they pay pharmacies for the same drug and pocketing the difference—has drawn increasing scrutiny from regulators and lawmakers.

The public strongly supports reform in this area. Research from the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Patient Experience Survey found that 64% of insured Americans strongly support "cracking down on abusive practices by PBMs and health plans like inappropriate fail first (step therapy) and prior authorization." Additionally, 63% strongly support requiring health insurers and PBMs to pass on any rebates or discounts they receive from pharmaceutical companies to patients at the pharmacy counter.

Insurance Barriers: When Coverage Doesn't Mean Access

Beyond cost concerns, insured Americans face substantial barriers to accessing prescribed medications. In the past year, 41% of people taking prescription drugs encountered at least one insurance-imposed barrier to accessing their medication.

The most common obstacles include:

• Prior authorization requirements (22%)

• Formulary exclusion (21%)

• Quantity limits (10%)

• "Fail first" (step therapy) policies (9%)

These barriers have real consequences. Across all payer types, 27% of written prescriptions go unfilled due to a combination of payer rejections and patient abandonment. In Medicaid, this figure rises to 34%, with a significant portion due to prior authorization rejections according to IQVIA research.

The problem is even more pronounced for newer medications. For novel drugs launched in 2022 and 2023, a staggering 56% of new prescriptions went unfilled, with only 29% of patients with chronic conditions remaining on these medications after one year. Among the reasons cited, insurance barriers were the primary factor, with 39% of prescriptions for these drugs rejected by all payers.

The Fleecing of 340B

The 340B Drug Pricing Program was created to help safety-net providers "stretch scarce federal resources" for vulnerable populations, requiring pharmaceutical manufacturers to provide substantial discounts to qualifying healthcare organizations. The program has grown dramatically, reaching $66 billion in total purchases in 2023 according to Drug Channels analysis. What's driven this growth is the explosive expansion of contract pharmacy arrangements—from about 1,300 in 2010 to over 33,000 pharmacy locations today—transforming what was intended as targeted assistance into a revenue source for hospitals and pharmacies, with questionable benefit to vulnerable patients.

In response to perceived abuses, approximately 37 drug manufacturers have imposed restrictions on their participation, specifically limiting 340B pricing through contract pharmacies. The concern is justified: a 2022 analysis by the Alliance for Integrity and Reform of 340B found that many 340B hospitals provide less charity care than non-340B hospitals, despite their safety-net designation as reported in Becker's Hospital Review. Meanwhile, nonprofit hospital systems pursue debt collection against patients who should have qualified for charity care under the hospitals' own policies, according to ProPublica's reporting.

Public sentiment strongly favors reform, with 70% of Americans supporting "requiring hospitals to be more transparent about prescription medicine markups" and 57% supporting requirements that hospitals use 340B discounts to help low-income patients access needed medicines. While manufacturers have responded by limiting distribution to contract pharmacies, patient advocates push for reforms requiring 340B savings to directly benefit vulnerable patients through reduced medication costs or expanded services. Any meaningful reform must address this fundamental disconnect between the program's intent and its current operation.

Recent Policy Developments: Promise or Posturing?

In April 2025, President Trump signed yet another executive order titled "Lowering Drug Prices By Once Again Putting Americans First," which included provisions aimed at reforming the Medicare Drug Price Negotiation Program, improving transparency into PBM fee disclosure, and addressing anti-competitive behavior by drug manufacturers.

However, experts caution that executive orders have limited impact without legislative or regulatory action. As Ted Okon, executive director of the Community Oncology Alliance, noted: "Just so everybody understands the executive order, it doesn't have any authority. It's not statute...but I think it's very much a game plan of what is being signaled to the Congress, and if the Congress doesn't do it, HHS."

The executive order largely focuses on studies and recommendations rather than immediate action. For example, it directs the Secretary of Labor to "propose regulations" on PBM transparency and calls for "joint public listening sessions" on anti-competitive behavior by pharmaceutical manufacturers, with concrete reforms left for future consideration.

What Real Reform Looks Like

If policymakers are serious about fixing this mess, they need to stop nibbling around the edges and go after the structural rot:

1. Rebate pass-through: If PBMs get a discount, patients should benefit—not just insurers.

2. Ban spread pricing in all insurance markets. If it’s wrong in Medicaid, it’s wrong everywhere.

3. Delink PBM profits from drug list prices, so there’s no financial incentive to inflate costs.

4. Limit prior auths and step therapy, especially for chronic and life-threatening conditions.

5. Hold 340B entities accountable for how they use discounts to serve vulnerable patients.

6. Cap out-of-pocket costs for everyone, with special protections for those with chronic conditions.

These aren’t radical ideas. They’re popular, they’re practical, and they’re long overdue. 94% of insured Americans believe policymakers have a responsibility to protect access to affordable care. And 93% say insurance should work for everyone—not just the healthy, wealthy, or well-connected.

Enough Excuses. Patients Deserve Better.

The current system isn’t failing—it’s succeeding exactly as designed. Middlemen make billions. Insurers avoid risk. Hospital systems exploit safety-net programs for profit while vulnerable patients go without. And patients? They’re left panhandling through GoFundMes, skipping doses, or giving up entirely.

This isn’t just an affordability crisis. It’s a moral one. We know how to fix it. The question is whether we have the political will to stop protecting profit margins and start protecting people.

Mapping Injustice: Redlining's Legacy in HIV Treatment Delays

A new study from Tulane University reveals how discriminatory housing policies from decades ago continue to shape HIV care outcomes today. Published in JAMA Internal Medicine, the research shows that people living with HIV (PLWH) in historically redlined neighborhoods face 15% longer delays in achieving viral suppression compared to counterparts in non-redlined areas—193 days versus 164 days. These delays impact both patient health outcomes and broader public health efforts to prevent HIV transmission.

The Lasting Legacy of Redlining

Redlining—the practice where mortgage lenders marked certain areas with red lines to deny loans based on race or ethnicity—was officially abolished in 1968. Yet its consequences persist in the built environment, healthcare infrastructure, and social conditions that determine health outcomes.

The Tulane study analyzed 1,132 newly diagnosed patients in New Orleans between 2011 and 2019. Of these patients, 62% resided in formerly redlined neighborhoods. Most were men between ages 25-44 years, and despite New Orleans having a majority Black population, the study found a higher concentration of Black residents in redlined areas than in non-redlined ones.

The findings validate what many healthcare advocates have long observed: geography profoundly influences health. As senior author Scott Batey noted, "The association between redlining and health outcomes is not a new concept, but applying this lens specifically to HIV was novel." Even where gentrification has occurred, treatment delays remain—indicating that historical marginalization creates barriers that investment alone cannot remove.

Interconnected Barriers to HIV Care

What explains these persistent treatment delays? The answer lies in multiple overlapping structural barriers that create a healthcare access quagmire for PLWH in redlined communities.

Pharmacy Deserts

One-third of neighborhoods in major U.S. cities qualify as pharmacy deserts, with predominantly Black and Latino neighborhoods disproportionately affected. In Los Angeles, for example, one-third of all Black and Latino neighborhoods were pharmacy deserts, particularly concentrated in South Central LA neighborhoods.

For PLWH, this means not just longer travel times for medication but reduced access to HIV prevention resources and testing services. Pharmacies serve as crucial health access points—they provide HIV prevention tools like PrEP, conduct HIV testing, and offer medication counseling essential for treatment adherence. When pharmacies close or never open in certain neighborhoods, these services disappear too.

Medicare Part D and Medicaid plans often exclude independent pharmacies serving these communities, forcing PLWH to travel even farther for care. These policies function as a form of structural racism that requires historically marginalized populations to overcome additional barriers to access life-saving medications.

Provider Network Inadequacy

Healthcare provider shortages plague formerly redlined areas. Current federal network adequacy standards fail to ensure sufficient HIV care providers in these communities. Provider directories frequently overstate physician availability, and narrow insurance networks often include less than one-fourth of available providers.

Studies show that adults with Medicaid or Marketplace coverage are more likely than those with Medicare or employer-sponsored insurance to report network problems. This is especially concerning as approximately 40% of people living with HIV (PLWH) rely on Medicaid for their healthcare coverage. For PLWH, this translates to longer wait times, fewer options for culturally competent care, and reduced provider continuity—all factors that influence treatment adherence and viral suppression rates.

Time/distance standards for network adequacy ignore the reality that residents often rely on limited public transportation, making even "acceptable" distances functionally unreachable. A mile can feel like thirty when bus service is limited, transfers are required, or service ends before evening clinic hours conclude.

Hospital Consolidation

The acceleration of hospital consolidation has further eroded healthcare infrastructure in vulnerable communities. When acquiring systems take over local hospitals, they frequently close specialized services, forcing patients to travel further for care.

"The unfortunate reality is that more than 25 years of market-driven health facility consolidation has really left too many communities across the U.S. without timely access to needed care," experts note. This especially impacts residents of redlined neighborhoods, who often must navigate complex transportation systems to reach consolidated healthcare facilities.

Research shows hospitals without nearby competitors charge prices 12.5% higher than those in competitive markets—a financial burden that falls heavily on communities already struggling with economic disadvantage. As of 2017, 19% of markets—representing 11.2 million U.S. residents—were served by only one hospital system, creating healthcare monopolies that exacerbate access disparities.

Political Context: New Threats to Health Equity Research

Political attacks on health equity initiatives now compound these structural barriers. Recent executive orders targeting Diversity, Equity, and Inclusion (DEI) programs across federal agencies threaten vital HIV research and services.

The U.S Department of Health and Human Services (HHS) faces proposed budget cuts from $121 billion to $80 billion in discretionary funding, cutting precisely the prevention-focused health initiatives designed to address disparities. Healthcare researchers report increasing censorship pressures around health disparity research, particularly when using terminology associated with equity.

One cancer researcher noted the chilling effect: "We aren't sure what we can say in our grants. I very freely — before — wrote about disparities and equity in my grants." This uncertainty threatens the very research needed to understand and address HIV treatment delays in historically redlined communities.

Federal agencies have removed HIV-related content from websites, especially materials serving transgender populations. Reports indicate hundreds of HIV-related web pages were removed following executive orders targeting "gender ideology" and "DEI." When pages were restored, they often lacked reference to transgender people, creating significant gaps in data and care recommendations for key populations.

The threat extends to global HIV prevention efforts, with pauses on foreign aid affecting PEPFAR implementation and leaving vital medication and services in limbo. These disruptions threaten to reverse hard-won progress in controlling the HIV epidemic both domestically and globally.

From Analysis to Action

Understanding redlining's impact on HIV treatment access demands more than recognition—it requires targeted policy responses:

1. Strengthen pharmacy access in underserved areas by incentivizing pharmacy establishment and requiring Medicaid and Medicare Part D plans to include independent pharmacies serving marginalized communities. State pharmacy boards should consider pharmacy access when reviewing new applications and closures.

2. Reform PBM practices to eliminate patient steering by prohibiting PBM-owned specialty pharmacies from exclusively dispensing HIV medications. Research shows that patient steering to mail-order or specific chain pharmacies disrupts established care relationships and reduces medication adherence, particularly affecting PLWH in historically redlined areas who rely on community pharmacies for wrap-around services.

3. Reform network adequacy standards to ensure sufficient culturally-competent providers in historically redlined neighborhoods. Standards must account for transportation realities and penalize narrow networks that exclude critical HIV care providers. Secret shopper surveys should validate actual appointment availability beyond paper compliance.

4. Mandate PBM transparency and fair reimbursement to prevent discriminatory practices forcing community pharmacies in redlined neighborhoods to close. State legislation should require PBMs to disclose all revenue streams, prohibit retroactive fee clawbacks, and establish minimum reimbursement rates based on acquisition cost plus a fair dispensing fee.

5. Enhance antitrust enforcement to prevent further hospital consolidation, reducing access points in vulnerable communities. When mergers occur, mandate maintenance of essential services in historically underserved areas and require community benefits agreements that address historical inequities.

6. Protect and expand community-based HIV programs that provide testing, prevention education, and linkage to care services directly within affected neighborhoods. This includes mobile testing units, community health worker programs, and faith-based outreach initiatives.

7. Prioritize long-acting injectable antiretrovirals as a solution for areas with limited pharmacy access, reducing adherence challenges for people facing transportation barriers. Delivery models should include provision through mobile clinics and community-based organizations.

8. Defend health equity research funding against political attacks that threaten to undermine our understanding of how structural racism impacts health outcomes. Ensure that Institutional Review Boards (IRBs) and research institutions protect researchers examining health disparities.

Moving Forward

The link between historical redlining and HIV treatment delays reveals how structural inequities become embodied in health outcomes. This connection demands that policymakers, healthcare systems, and advocates recognize that achieving HIV treatment equity requires addressing the legacy of discriminatory housing policies.

As Dr. Batey notes, "If we can make services more accessible and get people virally suppressed sooner, the impact on the HIV epidemic can be quite significant." This requires defending existing health equity initiatives and developing new approaches that confront the structural barriers in historically redlined communities.

The one-month treatment delay identified in the Tulane study translates to real health consequences for PLWH and increased transmission risk within communities. Moving from awareness to action means investing in healthcare infrastructure that overcomes geography as destiny, creating systems where treatment access doesn't depend on neighborhood history.

In an era of political attacks on health equity initiatives, this research underscores why structural analysis matters. Without understanding how policies like redlining continue to shape healthcare access, we risk addressing symptoms while ignoring causes. Achieving HIV treatment equity demands both acknowledging historical injustice and implementing structural change—starting with the communities where barriers remain highest.

Leaked HHS Budget: Critical HIV Services Face Deep Cuts

A recently leaked budget document from the Department of Health and Human Services (HHS) has revealed the Trump Administration's plans for sweeping cuts that would fundamentally reshape federal health programs. The 64-page "pre-decisional" budget proposal, first reported by The Washington Post, outlines a severe reduction in HHS discretionary spending from $121 billion to approximately $80 billion—a 33% cut. This proposal provides the first comprehensive look at the administration's vision for restructuring the nation's health infrastructure, including the creation of a new Administration for a Healthy America (AHA) while eliminating or consolidating many established agencies that form the backbone of our public health system. The proposed changes would profoundly impact HIV/AIDS programs, viral hepatitis services, substance use disorder treatment, and access to care for vulnerable populations, potentially reversing decades of progress in public health.

The Scale of Proposed Cuts

The magnitude of cuts outlined in the leaked budget document would fundamentally transform the federal health infrastructure in ways not seen in decades. The National Institutes of Health (NIH), America's premier biomedical research institution, would see its budget slashed by 42%—from $47 billion to just $27 billion. This dramatic reduction would be accompanied by a plan to reorganize NIH's 27 institutes and centers into just eight, eliminating some entirely while consolidating others into broader entities with less specialized focus.

Similarly devastating, the Centers for Disease Control and Prevention (CDC) faces a proposed 44% budget reduction, from $9.2 billion to approximately $5.2 billion. The document indicates the CDC would be refocused primarily on "emerging and infectious disease surveillance, outbreak investigations, preparedness and response, and maintaining the Nation's public health infrastructure."

Even more concerning, several agencies would be eliminated entirely as independent entities, including the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Administration for Strategic Preparedness and Response (ASPR), and the Administration for Community Living (ACL). While some programs from these agencies would transfer to the proposed Administration for a Healthy America (AHA), many would be eliminated outright. As the leaked document itself states: "Many difficult decisions were necessary to reach the funding level provided in this passback."

Impact on HIV/AIDS Infrastructure

The proposed budget would effectively dismantle decades of federal HIV prevention and treatment infrastructure, threatening to reverse significant progress made toward ending the epidemic. Most alarming is the complete elimination of the CDC's Division of HIV Prevention (DHP), which has been the cornerstone of the nation's HIV prevention efforts. According to POZ, the division passes 89% of its funding directly to state and local HIV programs, with states like Alabama and Mississippi depending on it for up to 100% of their HIV prevention efforts.

The budget also eliminates the Ending the HIV Epidemic (EHE) initiative, which was launched during Trump's first administration and has produced a 21% reduction in new HIV transmissions within targeted jurisdictions. This initiative represented a rare bipartisan commitment to addressing the HIV epidemic through increased testing, prevention, and treatment resources.

The Ryan White HIV/AIDS Program, which provides essential care and treatment to over 550,000 people living with HIV who are uninsured or underinsured, would see significant cuts. The KFF analysis reveals that while core funding for grants to cities, states, and the AIDS Drug Assistance Program (ADAP) would be maintained, the budget eliminates support for dental services, AIDS Education and Training Centers, and demonstration programs.

Additionally, the Minority AIDS Initiative, which addresses the disproportionate impact of HIV on racial and ethnic minorities, would be eliminated entirely. This comes at a time when Black and Latino communities continue to face disproportionate HIV rates and could worsen existing health disparities.

"The scale of what is being lost is staggering," POZ reports. "According to recent analysis from amfAR, a 100% reduction in DHP funding will lead to 143,486 new HIV infections by 2030, 14,676 additional AIDS related deaths, and $60.3 billion in additional lifetime health care costs."

The proposal would move remaining HIV/AIDS programs under the new Administration for a Healthy America with reduced funding and an unclear structure, raising serious questions about program coordination and effectiveness going forward.

Viral Hepatitis, STIs, and Related Programs

The leaked budget proposal takes aim at viral hepatitis, sexually transmitted infections (STIs), and tuberculosis programs by consolidating their funding into a single, smaller grant program. According to POZ, "a proposal in the new budget to turn other CDC funding for viral hepatitis, STDs, and TB into block grants masks devastating funding losses as 'flexibility to address local needs.'" In reality, this consolidation would reduce overall funding by approximately $500 million, severely limiting the capacity to prevent and respond to outbreaks of these conditions.

Particularly concerning is the elimination of CDC's Global Health Center and the agency's critical STD laboratory, which MedPage Today confirms was shuttered during the recent mass layoffs. These cuts would dismantle essential testing infrastructure at a time when sexually transmitted infections are at record highs nationwide. The consolidation approach significantly weakens the specialized responses needed for these distinct but interconnected public health challenges, potentially allowing localized outbreaks to develop into broader public health crises without the targeted interventions currently in place.

Mental Health and Substance Use Disorder Services

The proposed budget calls for the complete elimination of the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency dedicated to addressing mental health and substance use conditions. The impact of this elimination would be compounded by severe cuts to services: Mental Health Services would see a 25% reduction, Substance Use Treatment funding would drop by approximately 13%, and most alarmingly, Substance Use Prevention would be nearly eliminated with a staggering 92% cut.

The proposal would eliminate 17 mental health programs and 23 substance use prevention and treatment programs. Harm reduction services, which are critical in preventing overdose deaths and the transmission of infectious diseases such as hepatitis C virus (HCV), are particularly targeted for cuts. The proposed budget would also end the Certified Community Behavioral Health Clinic program, which provides 24-hour crisis services regardless of patients' ability to pay.

As STAT News reports, "We continue to face a mental health and addictions crisis, and the need for effective federal leadership is more important than ever." These cuts come at a time when more than one in four people will experience a mental health or substance use problem, and over 209,000 Americans die annually from alcohol, suicide, and drug overdoses.

Rural Health and Access to Care

Rural communities would bear a disproportionate burden from the proposed budget cuts through the elimination of numerous programs specifically designed to support rural healthcare infrastructure. As detailed in the leaked document, the budget would eliminate State Offices of Rural Health, which coordinate statewide efforts to improve healthcare delivery in rural areas. The Washington Post reports that rural hospital flexibility grants, rural residency development programs, and at-risk rural hospitals program grants would all face elimination or significant cuts.

Additionally, critical telehealth funding would be eliminated at a time when remote healthcare services have become essential lifelines for rural populations. These programs have historically enjoyed strong bipartisan support due to their critical role in maintaining healthcare access for the approximately 60 million Americans living in rural areas.

Alan Morgan, CEO of the National Rural Health Association said, "Those are essential to ensuring access to care for rural Americans and critical to keeping rural hospitals open. If that would come to fruition it would be absolute shocking news, because these programs have had such bipartisan support."

The Advisory Board notes that these cuts would exacerbate the already fragile state of rural healthcare, where over 150 rural hospitals have closed since 2010, leaving many communities without access to emergency and essential medical services.

340B Program and Healthcare Costs

Amid the sweeping cuts to safety-net programs, the leaked budget also proposes significant changes to the 340B Drug Pricing Program, which provides discounted medications to hospitals and clinics serving vulnerable populations. HFES reports that the administration is "seeking new authority to regulate 'all aspects of the 340B Program'" and would require covered entities to report on their use of 340B savings.

According to Health Exec, the proposal would require facilities to "charge no more than the actual cost of acquiring and dispensing drugs to low-income patients." While greater transparency might be beneficial, these changes—combined with cuts to other safety-net programs—could restrict access to affordable medications for people living with HIV, hepatitis, and other chronic conditions who rely on safety-net providers participating in the 340B program.

Conclusion

Unlike during Trump's first term when Congress often rejected deep cuts to health agencies, the current political landscape offers much less hope for meaningful congressional pushback. Under the GOP-controlled Congress, recent reports show Republicans largely falling in line behind Trump's initiatives, with Reuters reporting that the president is "testing the U.S. Constitution's system of checks and balances" while congressional Republicans demonstrate "staunch support." This legislative acquiescence has extended to health policy, with little effective opposition to the administration's sweeping restructuring of federal health agencies.

Further complicating advocacy efforts, HHS Secretary Robert F. Kennedy Jr. has eliminated a key avenue for public input by rescinding a 54-year-old policy that required public comment periods for rules on grants, benefits, and other health programs. This change, which came despite Kennedy's promises of "radical transparency," allows HHS to implement major policy changes without seeking feedback from affected communities, healthcare providers, or advocacy organizations.

In this environment, traditional advocacy approaches must evolve. In the absence of congressional intervention, our energy may be better spent:

1. Forming coalitions between patient groups, healthcare providers, private business, and public health organizations to amplify impact

2. Considering support for legal challenges to health policy changes implemented without adequate review

3. Carefully documenting and publicizing the real-world impacts of cuts to HIV services and other critical programs

4. Engaging with state officials who may have flexibility in implementing federal changes

5. Making use of remaining public comment opportunities when available, with a focus on evidence-based arguments

The proposed dismantling of federal HIV infrastructure represents an existential threat to decades of progress. While the political headwinds are strong, our collective advocacy efforts remain essential to protecting the health services that millions of Americans depend on.

System Failure: Inside the Collapse of HIV Data Protections

The privacy frameworks that protect people living with HIV—built over decades through advocacy, legislation, and the lived consequences of stigma and surveillance—are now on the brink of collapse. Recent reporting from WIRED reveals that "much of the IT and cybersecurity infrastructure underpinning the nation’s health system is in danger of a possible collapse" following deep staffing cuts at the U.S. Department of Health and Human Services (HHS). Agency insiders warn that "within the next couple of weeks, everything regarding IT and cyber at the department will start to reach a point of no return operationally."

These reductions—orchestrated under the banner of "efficiency"—have eliminated the technical expertise necessary to maintain the very systems designed to protect patient information while enabling effective public health response. What took decades of careful negotiation to build could unravel in weeks.

A History of Mistrust and What It Built

In response to early AIDS panic and political scapegoating, HIV reporting systems were designed to protect privacy while still enabling public health surveillance. States initially resisted name-based reporting, opting instead for coded identifiers. These systems directly resulted from community resistance to the idea that a centralized government entity would hold a list of PLWH. By the late 1990s, the Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA) had settled into a delicate dance: collect enough data to direct resources without breaking trust with the communities most impacted.

The Ryan White HIV/AIDS Program (RWHAP), created in 1990, is a reflection of this balance. Providers are required to report client-level data annually through the Ryan White Services Report (RSR), but it must be de-identified. Each grantee—whether a city, state, clinic, or community-based organization—must report separately, even if they serve the same client. This redundancy is intentional. It's how we avoid co-mingling funds and how we ensure that data is not aggregated in a way that risks patient re-identification. It’s messy, yes. But it’s designed to protect people, not just count them.

Why It’s So Complicated

At a structural level, RWHAP is segregated by design. Part A grantees are typically cities, Part B is for states, Part C goes to clinics, and Part D supports programs for women, infants, children, and youth. Each grantee and subgrantee reports separately. A person receiving services from a city-funded housing program and a clinic-funded medical program will appear in two different reports. They’ll be encrypted, anonymized, and counted twice—because each program needs its own audit trail. This is not a flaw. It’s a firewall.

It’s also one of the biggest complaints from providers. Clinics and case managers spend untold hours cleaning and submitting the same data to multiple entities for different grants every year. State agencies complain about the burden. But buried underneath the frustration is the reality: these walls are what keep private information from being aggregated, shared, and potentially exposed (or worse, used to target).

Molecular Surveillance and the Reemergence of Privacy Concerns

Parallel to the RSR reporting, the CDC continues to manage HIV surveillance through diagnostic reports, lab data, and increasingly, molecular surveillance—using genomic data from viral samples to track clusters and potential outbreaks. These systems operate independently from care-based reporting systems like the RSR. They’re not supposed to overlap. That’s on purpose.

Molecular surveillance is a powerful tool. It can detect transmission networks, identify gaps in care, and help allocate resources. But it also raises serious privacy concerns. People have no ability to opt out of having their viral sequence data analyzed. Community advocates have raised alarms about how this data could be misused—especially in states with HIV criminalization laws or where public health trust is already low.

When properly separated from care systems, surveillance data can inform public health strategy without endangering patient privacy. But the more these systems are tampered with, neglected, or mismanaged, the greater the risk of privacy breaches and data misuse.

The DOGE Playbook: Gutting Public Health from Within

None of this works without infrastructure. And right now, that infrastructure is being hollowed out.

On April 1, the Department of Health and Human Services (HHS) laid off roughly 10,000 employees—about 25% of its workforce. That includes entire IT teams, cybersecurity experts, and staff responsible for maintaining the systems that house Ryan White and surveillance data. As WIRED reported, these cuts have left HHS systems teetering on the edge of collapse.

The layoffs were orchestrated by the Department of Government Efficiency (DOGE), a Musk-backed initiative with a mandate to slash spending and "modernize" systems. In reality, DOGE operatives have cut critical personnel and attempted to rebuild complex legacy systems—like Social Security's COBOL codebase—without the necessary expertise. As NPR reported, DOGE staff have also sought sweeping access to sensitive federal data, raising serious concerns about the security and ethical use of health information.

A retired Social Security Administration (SSA) official warned that in such a chaotic environment, "others could take pictures of the data, transfer it… and even feed it into AI programs." Given Musk's development of "Grok," concerns have been raised that government health data might be used to "supercharge" his AI without appropriate consent or oversight.

The value of this data—especially when aggregated across systems like HHS, SSA, Veterans Affairs, and the Internal Revenue Service—is enormous. On the black market, a single comprehensive medical record can command up to $1,000 depending on its depth and linkages to other data sets. For commercial AI training, the value is even greater—not in resale, but in the predictive and market power that comes from large, high-quality datasets. If private companies were paying for this kind of dataset, it would cost billions. Musk may be getting it for free—with no consent, no oversight, and no consequences.

Meanwhile, at USAID, funding portals were shut off. Grantees couldn’t access or draw down funds. Even after systems came back online, no one was there to process payments. The same scenario is now playing out at HHS. Grantees have reported delays, missed communications, and uncertainty about reporting requirements—because the people who used to run the systems have been fired.

What's at Stake: Beyond Data Points

The crisis we're witnessing isn't merely technical—it threatens the foundation of HIV services in America. When data systems fail, grants cannot be properly administered. When grants are disrupted, services are compromised. And when privacy protections collapse, people living with HIV may avoid care rather than risk unwanted disclosure of their status.

We've been here before. In the early days of the epidemic, mistrust of government systems drove people away from testing and treatment. The privacy frameworks built into today's reporting systems were designed specifically to overcome that mistrust, enabling effective public health response while respecting human dignity.

A Call for Immediate Action

To address this growing crisis, we need action at multiple levels:

1. Congress must exercise oversight over DOGE's activities by requiring transparent reporting on HHS staffing changes and their operational impacts, and by establishing strict limits on data access and audit trails to ensure administrative accountability.

2. HHS must rapidly rehire technical expertise with the institutional knowledge needed to maintain these complex systems before contracts expire and systems fail.

3. Advocacy organizations should demand clear guardrails on any use of healthcare data, particularly regarding AI applications, including explicit prohibitions on repurposing data collected for public health for commercial training without consent or compensation.

4. HRSA must immediately address the continuity of the RSR and other reporting systems to ensure grant requirements don't become impossible to meet due to system failures.

But let’s be clear: none of this is a call to keep broken systems frozen in time. Public health data infrastructure can—and should—be modernized. There is real opportunity to streamline reporting, reduce administrative burden, and build tools that serve patients more effectively. But modernization must be done carefully, collaboratively, and with privacy at the center—not with a chainsaw in one hand and a Silicon Valley slogan in the other.

The “move fast and break things” ethos may work for social media startups, but it has no place in systems that safeguard the lives and identities of people living with HIV. What we’re witnessing is not innovation—it’s ideological demolition. The goal isn’t better care or stronger systems. It’s control, profit, and a reckless dismantling of public trust.

The myth that federal IT systems are merely bloated bureaucracies in need of disruption ignores their critical role in protecting sensitive information. Our public health data infrastructure has been built layer by layer, through hard-fought battles over privacy, accountability, and service delivery. Dismantling these systems doesn’t represent modernization—it threatens to erase decades of progress in building frameworks that enable effective care while respecting the rights of people living with HIV.

The privacy architectures designed in response to the early AIDS crisis weren’t just policy innovations—they were survival mechanisms for communities under threat. We cannot afford to let them collapse through neglect, arrogance, or privatized pillaging. The stakes—for millions of Americans receiving care through these programs—couldn't be higher.

Mixed Signals: Trump's Drug Policy Undermines Its Own Goals

Last week, STAT News obtained the Trump administration's new drug policy statement, revealing a contradictory approach to the addiction crisis. The three-page "Statement of Drug Policy Priorities" combines harsh criminal penalties with support for addiction treatment, medication-based approaches, and even fentanyl test strips — harm reduction tools actively opposed during Trump's first term.

While pledging the "harshest available penalties" for those selling drugs causing overdose deaths, it also advocates increasing naloxone availability and supporting medications for opioid use disorder. This policy emerges as overdose deaths have begun declining under the Biden administration's public health approach, with fatal overdoses dropping 14.5% over the last year, though still claiming approximately 96,000 American lives annually.

The policy's implementation faces a significant obstacle: days before its release, the administration began massive layoffs across health agencies responsible for addiction response and data collection.

Understanding the New Policy Document

The Trump Administration's drug policy document sets out six key priorities: reducing overdose fatalities, securing the global drug supply chain, stopping drug flow across borders, preventing drug use before it starts, providing treatment leading to long-term recovery, and using data to inform strategy.

While the previous Trump administration actively opposed fentanyl test strips, with one official even writing a blog post cautioning against the "temptation to develop seemingly quick solutions," this new document specifically states that the administration will "encourage state and local jurisdictions to increase the availability of drug test strips and naloxone to mitigate the impact of deadly drugs on communities across the country."

The document also uses terminology like "medications for opioid use disorder" rather than "medication-assisted treatment," reflecting evolution in the addiction medicine field's preferred language. However, these statements appear alongside more forceful enforcement-focused language about bringing distributors to "justice" and pursuing "harshest available penalties" against those who sell fentanyl resulting in overdose deaths.

This policy juxtaposition reflects an ongoing tension within U.S. drug policy between public health and criminal justice approaches—a tension that has persisted through multiple administrations regardless of political party.

RFK Jr.'s Privileged Recovery Shapes Policy

Health Secretary Robert F. Kennedy Jr.'s substance use history significantly influences his policy perspective. Kennedy has been open about his 14-year struggle with heroin beginning at age 15, crediting his recovery to faith and 12-step programs — approaches now informing his recommendations.

Kennedy's advocacy for "wellness farms" where "American kids can reconnect to America's soil" reflects his personal journey but ignores that his wealth and status provided treatment access unavailable to most Americans facing addiction. Despite his history, Kennedy has shown skepticism toward evidence-based medical treatments, suggesting government should provide "a bottom" for people who use drugs — essentially favoring coerced treatment over voluntary healthcare pathways.

Enforcement vs. Treatment: Unbalanced Priorities

The administration heavily emphasizes enforcement over treatment. During the campaign, Trump promised to crack down on fentanyl smugglers, secure the border, and execute drug dealers. This mentality appears in the policy document's focus on "harshest available penalties" and "disrupting the supply chain."

Border czar Tom Homan has even threatened military action against Mexican cartels, stating the administration will use "the full might of the United States special operations to take them out." Drug policy researcher Jonathan Caulkins called such military action "the worst idea anyone has ever had," noting illegal supply chains easily rebuild after enforcement actions.

Meanwhile, evidence suggests the Biden Administration's public health approach contributed to the recent 14.5% drop in overdose deaths through expanded access to medications like buprenorphine and naloxone—interventions with stronger evidence of effectiveness than enforcement-only approaches.

Workforce Cuts Undermine Data Commitment

The administration's commitment to data-driven policy faces immediate challenges. On April 1, the U.S. Department of Health and Human Services (HHS) began layoffs cutting approximately 10,000 positions—25% of the department's workforce. Among those laid off was the entire team responsible for the National Survey on Drug Use and Health, a 50-year-old survey providing crucial data on substance use patterns.

Senior leaders at agencies critical to addiction response were let go or reassigned, including Substance Abuse and Mental Health Services Administration (SAMHSA)'s Office of Recovery staff, which had developed strategies to reduce overdose deaths. This dismantling of expertise contradicts the policy's stated goals of prioritizing "continuous collection and analysis of accurate, timely, and relevant data."

Medicaid Cuts Threaten Treatment Access

The most glaring contradiction is the proposed $880 billion cut to Medicaid over the next decade. Medicaid is the largest payer for addiction treatment in America, covering approximately 35% of all people treated for opioid use disorder, with over 1.82 million people receiving treatment through the program.

In New Hampshire, 82% of Medicaid enrollees with opioid use disorder receive medication-assisted treatment. Studies show Medicaid enrollees receiving buprenorphine are more likely to become employed, have shorter job searches, and earn more than those not receiving treatment.

The proposed cuts would severely undermine treatment access. Data from the Kaiser Family Foundation shows spending for Medicaid enrollees with substance use disorders is twice as high as for those without—about $1,200 versus $550 per month—making them particularly vulnerable to coverage reductions.

Leadership Without Expertise

The nomination of Sara Carter to lead the Office of National Drug Control Policy (ONDCP) further illustrates the disconnect between stated priorities and implementation. Carter, a Fox News contributor with no background in drug policy, public health, or government, would coordinate the nation's response to substance use disorders.

This contrasts sharply with her predecessor, Dr. Rahul Gupta, a physician and former health commissioner with extensive public health experience. Project 2025, a policy blueprint embraced by the administration, advocates for reducing ONDCP's influence by transferring its grant programs to other departments.

Harm Reduction Under Threat

Despite its surprising shift to support fentanyl test strips—tools that can detect the presence of fentanyl in other substances and were explicitly opposed by the previous Trump Administration—the policy document notably avoids using the term "harm reduction." This telling omission reflects ongoing ideological resistance to comprehensive harm reduction strategies.

The document's limited endorsement of test strips and naloxone creates uncertainty for organizations like OnPoint NYC, which has reversed over 1,700 overdoses since 2021 through more comprehensive supervised consumption services. The first Trump administration actively opposed such services, with the Department of Justice suing to prevent a site from opening in Philadelphia.

The current policy's silence on supervised consumption, coupled with Kennedy's "tough love" approach, suggests harm reduction organizations may face increased legal challenges despite clear evidence that such services save lives without increasing drug use or crime in surrounding communities. This selective adoption of certain harm reduction tools while potentially undermining broader evidence-based approaches highlights the administration's fundamentally punitive orientation to substance use.

Same War, Different Rhetoric

The Trump administration's drug policy represents a mixed approach, pairing traditional "war on drugs" enforcement strategies with acknowledgment of some evidence-based interventions. Its support for fentanyl test strips and recognition of medications for opioid use disorder marks a meaningful evolution from the previous administration's stance, potentially saving lives if implemented properly.

However, this progress exists alongside troubling contradictions: promising data-driven strategies while firing the researchers who collect data; advocating for treatment while proposing deep Medicaid cuts that would devastate access; and endorsing overdose prevention while appointing leadership without relevant expertise. This disconnect between words and implementation capacity raises serious concerns.

Since 1971, America has spent well over a trillion dollars on enforcement-first drug policies that have filled prisons without reducing substance use disorders. The results speak for themselves: overdose deaths have continued to climb for decades, with entrenched racial disparities in enforcement and inadequate treatment resources in many communities.

The inclusion of fentanyl test strips and medication support represents a positive step, but cannot overcome fundamental structural barriers created by workforce reductions and funding cuts. After decades of evidence showing what works—and what doesn't—in addressing substance use disorders, we need policies that match rhetoric with resources. Only time will tell whether this administration can reconcile its contradictory approaches to deliver meaningful improvements in America's response to addiction.

Are Federal Spending Cuts Endangering America's Most Vulnerable

CANN continues to monitor the restructuring of federal health agencies and the impacts of funding cuts on public health programs nationwide. This article is part of our developing coverage.

Two infants in Louisiana recently died from whooping cough—the first such deaths in the state since 2018. This tragedy comes amid a twelve-fold increase in whooping cough cases, from just 11 in 2023 to 149 in 2024, with 110 already recorded in the first three months of 2025 alone. These deaths occurred shortly after a February 13th decision by the Louisiana Surgeon General to end all vaccine promotion and outreach events statewide—the same day Robert F. Kennedy Jr. was confirmed to lead the U.S. Department of Health and Human Services (HHS).

These preventable deaths are the direct consequence of an intensifying assault on America's public health infrastructure, as the Trump Administration executes an $11.4 billion clawback of COVID relief funds from state health departments while simultaneously gutting federal health agencies through mass layoffs. The consequences of these dangerous, ideologically-driven policies are unfolding across the country and, as public health experts predicted, people are dying.

A System Already at the Breaking Point

Before these cuts, state and local health departments were already operating in a perpetual state of crisis. Years of chronic underfunding and staffing shortages had left America's public health system dangerously fragile and ill-equipped to handle emerging health threats.

In Utah, 70-90% of the state's public health funding comes from the federal government. Local health departments, particularly in rural and underserved areas, often function with minimal staff and resources, stretching their capacity to its limits to fulfill basic functions.

"This is going to be a major dent in our ability to be prepared for whatever new threat might come," warned Connecticut Health Commissioner Manisha Juthani. Philip Huang, Dallas County Health director, pointed out that even modest cuts can have outsized impacts on smaller departments: "It may not be in the millions, but these are really small health departments that have very few staff, very little capacity. And then if you hit those, then it starts to really impact their ability to respond."

The $11.4 Billion Clawback: A Devastating Blow

On March 25, 2025, the Centers for Disease Control and Prevention (CDC) announced it was pulling back $11.4 billion in COVID-19 funding previously allocated to state and local health departments across the nation. The announcement came without warning, leaving health officials scrambling to assess impacts on critical programs and staff.

The administration's justification was blunt and misleading: "The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago," said HHS Director of Communications Andrew Nixon in a statement to NBC News. This characterization fundamentally misrepresents how these funds were being used.

While the grants were initially authorized for pandemic response, they had evolved to support core public health functions: tracking infectious disease outbreaks, monitoring wastewater for early detection of disease spread, supporting community health workers in underserved areas, addressing health disparities, and maintaining vaccination programs for multiple preventable diseases.

The financial impact on states is severe: Texas faces the loss of $877 million, Florida $482 million, and North Carolina $100 million in cuts affecting immunization efforts and infectious disease monitoring. In Kentucky, $34 million in already-committed funds are now inaccessible, despite previous federal guarantees those funds would be available through March 2026.

Minnesota's Department of Health has issued layoff notices to 170 workers and rescinded offers to 20 new hires in response to losing $220 million in federal funding. This has resulted in slower responses to infectious disease outbreaks with fewer lab technicians and public health investigators.

The HHS Bloodbath: Dismantling Decades of Expertise

On April 1, 2025, HHS began executing the largest mass layoff in its history—eliminating 20,000 positions (10,000 through direct layoffs and another 10,000 through early retirement and voluntary separation offers).

The manner of these dismissals was particularly callous. According to the Associated Press, "Some staffers began getting termination notices in their work inboxes at 5 a.m., while others found out their jobs had been eliminated after standing in long lines outside offices to see if their badges still worked." Some workers who received layoff notices were directed to contact an EEO official who had died months earlier.

As the layoffs commenced, HHS Secretary Robert F. Kennedy Jr. tweeted triumphantly, "The revolution begins today!" When confronted by a fired HHS employee asking about the impact on people with disabilities, Senator Jim Banks responded, "You probably deserved it," then called the worker "a clown" as elevator doors closed.

Critical CDC and HIV Programs Decimated

MedPage Today reports that the hardest-hit areas of the CDC included centers focused on injuries, global health, chronic disease prevention, and infectious diseases including HIV, hepatitis, STIs, and tuberculosis. Directors of at least three major CDC centers were reassigned or placed on administrative leave.

The cuts strategically targeted offices serving vulnerable populations. The Administration for Community Living, which coordinates programs like Meals on Wheels, saw approximately 40% of its staff eliminated. The Office of Minority Health was largely dismantled, and entire offices were eliminated, including the Office of Science and Data Policy and Freedom of Information Act offices at the CDC.

The HIV+Hepatitis Policy Institute's Carl Schmid warned that the elimination of HHS's Office of Infectious Disease and HIV Policy would have lasting consequences:

"The expertise of the staff, along with their decades of leadership, has now been destroyed and cannot be replaced. We will feel the impacts of these decisions for years to come and it will certainly, sadly, translate into an increase in new HIV infections and higher medical costs."

These cuts follow the forced resignation of Dr. Peter Marks, the FDA's top vaccine safety official, who had resisted Kennedy's vaccine misinformation. In his departure letter, Marks wrote that "truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies."

Louisiana: Where Anti-Vaccine Policy Has Already Claimed Lives

Louisiana offers a foreboding preview of what happens when ideology trumps evidence-based public health practice. On February 13, 2025, Louisiana Surgeon General Dr. Ralph Abraham issued a directive ending all vaccine promotion and outreach events by the state health department.

Jennifer Herricks of Louisiana Families for Vaccines warned: "And the consequences of lower vaccination rates? More illness. More hospitalizations. More deaths." Tragically, her prediction has already come true for two Louisiana families who lost their babies to a vaccine preventable disease.

The memo came despite Louisiana experiencing its worst whooping cough outbreak in over a decade. Manning Family Children's Hospital in New Orleans has been admitting 1-2 children weekly for whooping cough, with cases statewide skyrocketing from 11 in 2023 to 149 in 2024.

By February 20—less than a week after the vaccine promotion ban—news outlets reported the first infant death from whooping cough. A second soon followed. Yet the health department did not officially confirm these deaths until March 28, more than a month later. In that belated announcement, Abraham did acknowledge that "vaccines are the best way to protect against infections, especially for babies," but this came after the vaccine preventable deaths had already occurred.

Vaccine Science Under Attack

During an American Public Health Association panel on vaccine science, Dr. Paul Offit of the Children's Hospital of Philadelphia compared the dismantling of public health agencies to an invasion "by a foreign nation" whose interest "is to destroy public health agencies." He emphasized that the HHS cuts will cause a significant loss of institutional knowledge vital for future public health emergencies.

Offit noted that NIH-funded research on mRNA technology "probably saved roughly 3 million lives" during the COVID pandemic. The dismantling of vaccine expertise comes amid a resurgence of vaccine-preventable diseases, with two deaths already reported in the measles outbreak affecting several states.

Public Health Leaders Unite in Opposition

Over 100 of the nation's most respected public health leaders—including former HHS Secretaries, CDC Directors, and state health officials—have issued an open letter urging Congress to halt the Trump administration's dismantling of public health infrastructure.

The letter, organized by For Our Health, warns: "This is a moment of profound danger for public health. The dismantling of CDC is not just an internal agency matter—it will leave states, communities and American families without the support they need to protect themselves from disease, misinformation and chronic illness."

Broader Impacts: New Threats for PLWH and Vulnerable Populations

For people living with HIV and other immunocompromised conditions, the dismantling of public health infrastructure creates particularly dangerous vulnerabilities. The elimination of the HHS Office of Infectious Disease and HIV Policy removes coordination for HIV programs across federal agencies.

With the Health Resources and Services Administration (HRSA) facing staffing reductions, coordination of HIV prevention and treatment programs could be compromised. These structural changes risk undermining the health infrastructure that people living with HIV depend on for essential care.

The closure of wastewater surveillance programs eliminates a key early warning system for HIV cluster detection, while the decimation of health equity programs removes vital supports for marginalized communities disproportionately affected by HIV.

Breaking: Judge Blocks Funding Cuts as HHS Backtracks

In a significant development, U.S. District Judge Mary McElroy announced on April 3 she would issue a temporary restraining order blocking the Trump administration's $11.4 billion funding cuts to state health departments. During the hearing, McElroy stated that the 23 states and District of Columbia that filed the lawsuit "make a case, a strong case, for the fact that they will succeed on the merits."

This judicial intervention represents a critical, if temporary, reprieve for state health departments already reeling from layoffs and program cancellations. New York Attorney General Letitia James responded to the ruling by tweeting: "We're going to continue our lawsuit and fight to ensure states can provide the medical services Americans need."

Simultaneously, Secretary Kennedy has begun backtracking on the sweeping cuts, claiming it was "always the plan" to reinstate certain employees and programs after terminating them. Kennedy acknowledged that "personnel that should not have been cut were cut" and said some would be reinstated, including a CDC program that monitors blood lead levels in children.

This claim contradicts the chaotic, across-the-board nature of the cuts that eliminated entire divisions and critical public health functions. Kennedy's assertion that "we're going to do 80% cuts, but 20% of those are going to have to be reinstalled, because we'll make mistakes" reveals a reckless approach to public health administration where critical programs and expertise are eliminated first, with potential consequences evaluated only after damage is done.

These developments suggest mounting pressure against the administration's public health cuts is beginning to have an effect, reinforcing the importance of continued advocacy and legal challenges.

The Fight to Preserve Public Health: What Comes Next

The combined impact of the COVID funding clawback and HHS restructuring represents an unprecedented assault on America's public health infrastructure. Twenty-three state attorneys general have already filed legal challenges against the funding cuts, arguing they exceed executive authority and violate appropriations law.

Recent election results suggest the administration's approach to public health may be backfiring politically. In Wisconsin's Supreme Court race, liberal candidate Susan Crawford defeated her conservative opponent despite record spending by DOGE architect Elon Musk. Meanwhile, special elections in Florida districts that Trump won by 30 points saw Republican margins cut in half.

This political landscape creates an opening for effective advocacy. Congressional representatives, particularly those in vulnerable districts, may be increasingly receptive to constituent concerns about public health funding. The moment calls for coordinated action: contact your representatives to demand oversight hearings and funding restoration; document and report public health impacts in your community; and support organizations working to preserve essential health services.

The preventable deaths we're witnessing are the predictable consequence of policies that prioritize ideology over scientific evidence and public health. Our collective advocacy can make the difference between a temporary setback and lasting damage to our nation's public health infrastructure.

PDAB Chicanery: How Drug Affordability Boards Are Undermining Public Engagement

Prescription Drug Affordability Boards (PDABs) across the country are playing a dangerous game with public engagement—one where they keep changing the rules and moving the goalposts. From inadequate notice periods to last-minute document releases, these boards are creating barriers that echo troubling federal trends, effectively sidelining the very people who have the most at stake: patients.

These state-level games mirror concerning federal developments, most notably the rescinding of the Richardson Waiver by U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr. This action removed a 50-year precedent requiring public input on HHS rules—effectively telling patients and advocates their opinions aren't welcome at the policy table.

As these transparency rollbacks continue, people who rely on medications face increasing uncertainty about their access to life-sustaining treatments—while boards claim to represent their interests through processes that actively exclude them.

Maryland PDAB: How to Follow the Letter of the Law While Breaking Its Spirit

Maryland's Prescription Drug Affordability Board offers a master class in technical compliance that functionally blocks meaningful public participation. Their recent meeting preparation tactics exemplify how these boards can check procedural boxes while effectively sidelining patient voices.

On March 18, 2025, the Maryland PDAB posted a revised agenda for their upcoming March 24 meeting. This might seem unremarkable until you realize the public comment deadline was March 19—giving stakeholders exactly one day to review, analyze, and formulate responses to complex pharmaceutical policy documents. The revised agenda wasn't a minor update either. It contained material differences from the previous version, including a comprehensive cost review dossier for Farxiga, a medication critical for many people with diabetes and heart failure.

As CANN's letter to the board noted, "Posting the updated agenda with associated meeting materials the day before the deadline for comment is not a good faith effort in garnering public trust, nor does it display value in public input." The Maryland PDAB's approach creates a veneer of public engagement while practically guaranteeing that meaningful input will be minimal.

This pattern suggests the board views public comment as a procedural hurdle rather than a valuable source of insight. By technically fulfilling their obligation to post materials before the comment deadline (even if by mere hours), they've found a convenient loophole that undermines the very transparency standards that public notice requirements are designed to uphold.

The Maryland case isn't an anomaly. It's a symptom of a growing tendency to treat public engagement as an inconvenient formality rather than a crucial component of sound healthcare policy development.

The Federal Parallel: HHS and the Richardson Waiver

The state-level PDAB maneuvers don't exist in a vacuum. They mirror a troubling federal precedent set by HHS Secretary Robert F. Kennedy, Jr., who recently rescinded the Richardson Waiver—a decision that effectively slams the door on patient advocacy at the federal level.

The Richardson Waiver has a 50-year history. Established in 1971, it required HHS to subject matters relating to "public property, loans, grants, benefits, or contracts" to the American Procedures Act's notice and comment rulemaking guidelines. This waiver was created specifically to ensure public voices would be heard on matters that directly affect their health and well-being.

Now, that protection is gone. The new HHS rule claims the waiver "impose[s] costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department's flexibility to adapt quickly to legal and policy mandates." This bureaucratic language translates to a simple message: we don't care what you think.

God forbid they remember who they work for.

And the impact is far-reaching. While Medicare remains protected under separate provisions of the Medicare Act, critical programs like Medicaid, SAMHSA, and the Administration for Children and Families now operate without mandated public comment periods. Legal experts note this could allow for swift implementation of controversial measures like Medicaid work requirements without going through normal rulemaking processes.

The timing is particularly ironic given the Office of Management and Budget's recent guidance letter emphasizing the importance of "broadening public participation and community engagement" and making it "easier for the American people to share their knowledge, needs, ideas, and lived experiences to improve how government works for and with them."

This federal retreat from transparency sets a dangerous tone that state-level boards appear eager to follow.

Other State PDAB Examples: Oregon and Colorado's Concerning Patterns

Maryland isn't alone in its questionable approach to public engagement. Oregon's PDAB recently decided to include Odefsey—an antiretroviral medication for people living with HIV—on its list for cost control exploration, contradicting previous discussions to protect these medications. While they claim they might reconsider based on affordability research, this flip-flop creates unnecessary anxiety for people who depend on these treatments.

Colorado's PDAB situation is particularly egregious. Since 2023, CANN has repeatedly requested that the board consult with the state health department about rebate impacts on public health infrastructure and patient affordability—concerns echoed by the former SDAP director and PDAB members themselves.

Yet Colorado PDAB staff have consistently avoided conducting a proper fiscal impact analysis, bluntly stating "We won't be doing that" when asked directly. This refusal persisted even as formal rulemaking began, which triggers statutory requirements for analyses under Colorado's Administrative Procedure Act.

The board has repeatedly postponed its first rulemaking hearing, effectively delaying compliance with transparency requirements. Meanwhile, the Joint Budget Committee has begun questioning the PDAB's financial accountability, receiving only partial responses about consultant costs and litigation expenses.

Most concerning is the disconnect between PDAB actions and demonstrated patient benefits. A 2024 analysis of Oregon's similar program showed states would need additional funds to maintain programs under an upper payment limit system—with no meaningful patient affordability improvements identified.

Patient Impact: Why This Matters

Behind the procedural games and policy maneuvers are real people whose lives hang in the balance. The Colorado PDAB's actions exemplify how these bureaucratic decisions create genuine fear and uncertainty for people with rare diseases and conditions requiring specialized medications.

Twelve-year-old Avery Kluck lives with Aicardi syndrome and faces life-threatening seizures that have been intensifying. Her doctors recommended Sabril, a powerful anticonvulsant costing up to $10,000 per month—a medication on Colorado's PDAB radar for potential price controls.

"We're to a point now where her seizures are getting more violent, and this is our last resort," explains Heather Kluck, Avery's mother. "And now I'm finding out she may not have access to it." The family faces an impossible choice between starting a medication that might become unavailable or watching their daughter suffer.

This uncertainty isn't theoretical. At least one pharmaceutical company has already threatened to pull drugs from Colorado if price caps are imposed. For medications like Sabril, which are dangerous to discontinue abruptly, such market exits could be catastrophic.

People living with cystic fibrosis also had to mobilize to prevent Colorado's PDAB from declaring Trikafta "unaffordable," with one parent describing the experience as "torturous for our family" and another stating: "It's an experiment, and it's really gross that they're doing it on people who are really sick."

The irony is painful: boards created to increase medication access may end up restricting it for those who need it most.

Conclusion

These boards, created under the guise of helping patients afford medications, are operating in ways that actively silence patient voices. From Maryland's last-minute document dumps to Colorado's refusal to conduct impact analyses and Oregon's policy reversals on critical medications, these boards are erecting barriers that exclude the very people who will bear the consequences of their decisions.

The problems run deeper than procedural failures. The fundamental approach of PDABs—attempting to control drug prices without adequately assessing impacts on patient access—risks creating catastrophic unintended consequences for people who depend on specialized medications. Avery Kluck and others living with rare conditions don't have the luxury of waiting while boards experiment with price controls that might make their life-saving treatments unavailable.

The pattern is clear: from the federal level with RFK Jr.'s dismantling of public comment protections to state PDABs playing administrative games, we're witnessing a coordinated retreat from meaningful public engagement in healthcare policy. This isn't just bad governance—it's dangerous for patients.

States should seriously reconsider whether PDABs serve any legitimate purpose beyond political theater. At minimum, stakeholders across the healthcare spectrum must demand that these boards either implement truly transparent, patient-centered processes or acknowledge they cannot fulfill their stated mission without causing harm to the very people they claim to help.

A Public Health Crisis in the Making

In recent years, the United States has made substantial progress in combating the HIV epidemic through increased access to treatment, prevention programs, and support services. These advancements have been largely driven by federal funding initiatives, such as the Ryan White HIV/AIDS Program (Ryan White), the Ending the HIV Epidemic (EHE) initiative, and the proper use of the 340B Drug Pricing Program. However, proposed cuts to HIV prevention funding at the federal level pose a significant threat to undoing decades of progress and could have devastating public health consequences.

On March 18th, the Wall Street Journal reported the Trump Administration’s plan to “reorganize” certain programs within the Center for Disease Control and Prevention (CDC). The reports of sources stated that the plan included existing HIV prevention programs and their allocated funding. Reports of the directive were to return to 2019 levels of funding, reduction of 10% of funding and workforce, and potentially move programs under HRSA while keeping surveillance at CDC. 

​The Trump Administration's proposed significant reductions in HIV prevention funding and workforce have profound implications for both domestic public health programs, mirroring concerns around cuts to USAID, affecting global public health. These cuts threaten to reverse decades of progress in combating the HIV epidemic, leading to increased infections, compromised healthcare systems, and heightened economic burdens.

HIV prevention programs support activities across other areas of infectious disease monitoring, prevention, and treatment, including STI, Viral Hepatitis, Tuberculosis, and Substance Use programs. Prevention programs further support treatment programs with testing, screening activities, and linkage to care upon reactive tests.

Federal HIV programs provide essential services to individuals living with or at risk for HIV, particularly those from marginalized communities who may lack access to private healthcare. Programs like Ryan White ensure access to life-saving antiretroviral therapy (ART), which not only improves individual health outcomes but, as we’ve learned in the past decade, also prevents HIV transmission when individuals remain undetectable. Ryan White programs are housed within the Health Resources and Services Administration (HRSA), which also handles other treatment delivery programs. Additionally, CDCl’s HIV prevention programs and PrEP initiatives have expanded awareness and increased access to the prevention toolbox that reduces new infections.

This serves as a move widely seen as counter to one of the Trump Administration’s most high-profile first-term priorities. The EHE initiative, launched in 2019, aims to reduce new infections by 90% by 2030. Achieving this ambitious target requires sustained and increased investment. In support of these efforts and to help vulnerable patients re-engage and sustain their care, in FY 2024, HRSA awarded EHE grantees approximately $147,000,000 to link people with HIV who are either newly diagnosed or are diagnosed but currently not in care to essential HIV care and treatment and support services, as well as to provide workforce training and technical assistance, leading to 35,724 new diagnoses in 2022. The design of these dollars recognizes the role of people already living with HIV as “prevention warriors” by providing resources to stop chains of transmission.

However, HRSA’s awards operate differently than those programs housed at and funded by the CDC. The Administration's proposal to eliminate some or all federal funding for domestic HIV prevention programs is particularly alarming. This move would dismantle the CDC’s HIV prevention division, effectively halting federally funded prevention efforts for communities where HIV transmission is high and seeking to serve the needs of people vulnerable to HIV acquisition, as opposed to those who have already been diagnosed. Such reductions could undo decades of progress in combating the epidemic.

CANN President & CEO Jen Laws argued: “Moving prevention programs to HRSA, dividing up surveillance and programmatic activities, is a non-starter. HRSA is already under water, by their own admission, in terms of capacity and reports by the Government Accountability Office has outlined necessary oversight of existing programs being less than optimal, thus showing this type of suggestion isn’t a serious one.” “I don't think anyone can disagree that certain efficiencies must be made - duplicative reporting requirements across multiple grants is absolutely a burden on our service providers. But I think folks who might see a HRSA shift as hopeful are being a bit…hopeful. Moving HIV prevention programs to HRSA likely means opening the door to grouping prevention and treatment programs together, without an expanded budget or workforce, and very truly risks a sector shift to prevention only and abandoning people already living with HIV altogether.”

Historically, reductions in prevention funding have led to decreased HIV testing rates and diminished awareness of prevention methods, including mother-to-child transmission prevention, later-stage diagnoses, and reduced linkage to care rate for people who have seroconverted by have not yet been diagnosed. This not only jeopardizes individual health but also facilitates unchecked transmissions of HIV within communities.

The CDC spends about $1 billion a year on domestic HIV prevention, most of it funneled to the states to help with local efforts. The goal of increasing PrEP coverage to 50% according to the CDC’s Monitoring National HIV Prevention Goals by using data from the National HIV Surveillance System (NHSS) had increased from 13.6% at the launch of EHE to 36% in 2022, and a total of 1,736,850 CDC-funded HIV tests were conducted in 2021.

The EHE initiative and CDC have provided much-needed resources to regions most impacted by the domestic HIV epidemic. In 2022, testing was provided to diagnose 19,822 in the disproportionately burdened South, along with the Northeast (5,080), Midwest (4,903), West (7,858), and U.S. territories and freely associated states (380). The CDC provided $495,904,554 in prevention awards in 2024 to state and county health departments and their partners. 

Threats of $700 million to $1 billion in HIV prevention funding being cut are not just a dollar amount; they have significant economic repercussions. This would impact state and city health departments, STI clinics, non-profit organizations that provide testing and treatment services, and thousands of individuals who have dedicated their lives and careers to ending this epidemic. These individuals would face the risk of job losses, health insurance coverage, and widespread devastation to the workforce. This move would also eliminate large swaths of 340B revenue sources - expanding the economic impact

Moreover, budget cuts have previously resulted in significant staffing reductions within local health departments. Notably, 43% of departments experiencing funding cuts reported decreases in HIV, sexually transmitted infections (STI), and viral hepatitis program staffing levels. Such workforce reductions hinder the capacity to deliver essential services, further exacerbating the public health crisis. ​

Without proper funding, many individuals will experience interruptions in care and prevention, leading to late diagnosis, drug resistance, opportunistic infections, and AIDS-related complications. The decline in accessible HIV care and prevention could result in higher mortality rates, disproportionately affecting the most vulnerable regions across the country.  In 2022, numbers and percentages of HIV-related deaths were as follows: Northeast—570 (13%), Midwest—430 (10%),  South—2,379 (56%), West—766 (18%), U.S. territories and freely associated states—98 (2%). 

The Trump Administration's reductions in HIV prevention funding and workforce pose significant threats to both domestic and global health. The potential increase in HIV infections, coupled with strained healthcare systems and escalating economic costs, underscores the critical need for sustained investment in HIV prevention and treatment programs.

Reducing this funding would put millions of Americans at risk, disproportionately affecting Black, Latino, LGBTQ+, and low-income communities, especially those across the South, who already face very real obstacles to healthcare. Every dollar invested in HIV prevention and treatment saves lives and reduces future healthcare costs. Treatment and prevention programs operate like a train on tracks, separate and distinct pieces that need one another to reach a destination - remove one of those pieces, and the goal is entirely unattainable. If we want to continue making progress, the Trump Administration must recognize that reducing funding now is a short-sighted decision that will result in lives lost and financial losses in the future. Federal HIV prevention funding and programs are more than just a budget line item—it is a lifeline for millions of people. Cutting it would set us back decades and put lives at risk.

HIV Long-Acting Injectables Face Policy Hurdles After CROI 2025

Amid the political turmoil and public health uncertainties of 2025, a remarkable scientific success story continues to unfold. The Conference on Retroviruses and Opportunistic Infections (CROI 2025) showcased significant advancements in HIV long-acting injectables for prevention and treatment—with new formulations requiring as few as one intervention per year. These latest innovations build on the promise of existing long-acting therapies while dramatically extending their duration and effectiveness.

These advancements represent more than scientific achievements; they're testaments to the HIV community's persistent demand for better options. After decades of daily pills, these innovations offer liberation from medication schedules, reduced visibility for those who face stigma, and new hope for those who struggle with adherence. The HIV community has always adapted and persevered, and these breakthroughs are the latest chapter in that ongoing story of resilience.

Yet, as we celebrate these scientific milestones, we face a familiar challenge: ensuring innovations translate into accessible care for all who need it. While researchers present promising data in conference halls, Republican-led attempts to slash Medicaid funding and legal challenges to preventive care coverage threaten to limit who benefits from these breakthroughs. It's a jarring disconnect between scientific progress and political reality that the HIV community knows all too well.

Still, if history has taught us anything, it's that the HIV community has never backed down from a fight for access. So we'll toast to the science, roll up our sleeves, and get to work on the policy—because breakthrough treatments mean little if they're out of reach for those who need them most.

Scientific Breakthroughs in HIV Prevention

The most notable announcement from CROI 2025 was Gilead's presentation of first clinical data for once-yearly lenacapavir formulations for HIV prevention. The Phase 1 study data showed that both intramuscular formulations maintained plasma concentrations well above protective thresholds for a full year, with median trough concentrations at Week 52 significantly higher than those observed with twice-yearly lenacapavir at Week 26.

This represents a substantial advance beyond current options like daily oral PrEP and bimonthly injectable cabotegravir, potentially reducing interventions to just once annually. The PURPOSE trials have already demonstrated the impressive efficacy of lenacapavir, with PURPOSE 1 showing 100% protection in women in South Africa and Uganda, and PURPOSE 2 finding a 96% lower acquisition rate compared to background incidence across diverse populations.

Advancements in Long-Acting HIV Treatment

Treatment options for people living with HIV are seeing similar progress. The combination of lenacapavir with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab maintained viral suppression in 96% of participants at Week 26, comparable to daily oral treatment. This regimen, which gained FDA Breakthrough Therapy Designation in January 2025, could offer a complete twice-yearly treatment option.

ViiV Healthcare's EMBRACE study of N6LS, administered every four months with monthly cabotegravir, showed similarly high rates of viral suppression. A UCSF study further confirmed the value of long-acting injectables, with 98% viral suppression after 48 weeks among patients who previously struggled with oral medication.

Diverse Patient Preferences

Research confirms that preferences for HIV treatment vary significantly. A recent study identified three distinct preference groups: those preferring implants (29%), those preferring long-acting oral or injectable options (35%), and those preferring daily or long-acting oral treatments (36%). These preferences correlated with factors like age, education, injection aversion, and adherence to current therapy.

This heterogeneity underscores that "the failure of current daily oral ART to achieve viral suppression for all people living with HIV has shown that there is no one-size-fits-all in HIV care." Offering a range of options will be essential to address diverse needs and preferences, potentially improving both adherence and outcomes.

Access Barriers and Coverage Challenges

Despite the promising scientific advances in long-acting treatment and prevention therapies, significant structural barriers threaten to limit their reach to the communities that need them most. The complex distribution and administration requirements for these medications create unique challenges not seen with oral HIV medications.

According to data from NASTAD, the Wholesale Acquisition Cost (WAC) for Apretude (cabotegravir for PrEP) is $3,700 per dosing kit, translating to approximately $22,200 annually for maintenance doses, or about $25,900 for the first year with initiation doses. This cost, while lower than the $40,000 often cited for Cabenuva (the treatment version), remains substantially higher than generic oral PrEP. Unlike oral medications, these injectable options also require additional costs for clinic visits and administration fees, further complicating access.

For people relying on AIDS Drug Assistance Programs (ADAPs), coverage remains inconsistent. According to the International Association of Providers of AIDS Care (IAPAC), six states (Missouri, Kentucky, Louisiana, Oklahoma, Texas, and South Dakota) and some U.S. territories do not cover injectable HIV medications through their ADAP programs. Even in states that do provide coverage, the distribution system for these medications differs significantly from oral medications. As NASTAD explains, long-acting injectables are distributed through "buy-and-bill," "white bagging," or "clear bagging" mechanisms involving specialty distributors or pharmacies rather than traditional retail pharmacies, creating additional logistical barriers.

While the Biden Administration issued updated guidance in October 2024 requiring health insurers to cover all three FDA-approved forms of PrEP without cost-sharing, this mandate faces legal challenges. The Supreme Court has agreed to hear a lawsuit challenging the Affordable Care Act's preventive services provision, with arguments commencing in spring 2025 and a decision expected by July. This case could potentially eliminate the requirement for insurance plans to cover preventive services like PrEP without cost-sharing.

These access challenges disproportionately affect those at highest risk for HIV. Despite the recommendations for PrEP that now include newer formulations, PrEP uptake remains unequal. The Centers for Disease Control and Prevention (CDC) has estimated that the proportion of persons with indications for PrEP who received it was 60.5% among White persons vs 7.9% in Black persons and 13.8% in Hispanic/Latino persons. Without policy intervention to address these barriers, the remarkable scientific progress in HIV prevention and treatment risks benefiting only those with privileged access to healthcare while leaving behind the communities with the greatest need.

Political Context and Threats to Progress

The current political landscape presents additional challenges to expanding access to long-acting injectables for HIV treatment and prevention. The Republican-led Congress is considering plans to cut Medicaid by potentially $880 billion or more to help pay for tax cuts, according to a Kaiser Family Foundation report. Such reductions would likely impact access to these innovative but costly treatments.

At the international level, the Trump administration's pause on PEPFAR-funded prevention services threatens to reverse progress in global HIV prevention efforts. As Jirair Ratevosian writes in his CROI analysis, "The Trump administration now faces a choice: either let PEPFAR's legacy crumble or seize this opportunity to lead the next phase of HIV prevention."

It's worth noting that Medicaid enrollees across the political spectrum express concerns about potential program cuts. KFF focus groups found that "both Trump and Harris voters valued their Medicaid coverage and the access to health care services, mental health services, and medications for themselves and their children it provides." Participants described losing Medicaid as potentially "devastating" and likely to lead to serious consequences for their physical and mental health.

Bridging the Gap

To ensure equitable access to these breakthrough HIV prevention and treatment options, several policy approaches should be considered:

1. Strengthen CMS Guidance on Long-Acting Injectables: The Centers for Medicare & Medicaid Services should update its informational bulletins on HIV prevention and care delivery to reflect the latest advancements in longer-acting therapies and issue specific policy guidance on Medicaid's role in supporting PrEP uptake and persistence.

2. Defend Preventive Service Coverage: Advocacy efforts should focus on defending the ACA's preventive services mandate as the Supreme Court considers challenges to this provision.

3. Expand ADAP Coverage: State ADAP programs that do not currently cover long-acting injectables should be encouraged to add these medications to their formularies, potentially with additional federal support to offset costs.

4. Engage in Value Assessment: Payers, including Medicaid and Medicare, should evaluate the long-term clinical and economic benefits of these options, including reduced transmission, improved quality of life, and potentially fewer hospitalizations due to better adherence.

Conclusion

The scientific advancements presented at CROI 2025 offer unprecedented opportunities to transform HIV prevention and treatment. Once-yearly prevention therapies and twice-yearly treatment regimens could dramatically improve adherence, reduce transmission, and enhance quality of life for millions of people living with or at risk for HIV.

However, without concerted policy action to address access barriers, these innovations risk becoming available only to those with privileged access to healthcare, potentially widening rather than narrowing health disparities. As long-acting HIV therapies move closer to widespread availability, advocates, policymakers, healthcare providers, and industry partners must work together to ensure that these scientific breakthroughs translate into public health impact for all communities affected by HIV.

The gap between what's scientifically possible and what's accessible represents both a policy failure and a moral challenge. Bridging this gap requires political will, innovative financing approaches, and a commitment to health equity that matches the remarkable scientific progress we've witnessed.

Patients Still at Risk: The State of Copay Accumulator Adjustment Policies in 2025

For people living with chronic and serious conditions like HIV, viral hepatitis, or cancer, specialty medications are often the only option for managing their health. However, the high cost of these medications—even for those with insurance—has prompted many to seek assistance from third-party programs to cover copayments and coinsurance. These lifelines are being threatened by health insurance company practices known as "copay accumulator adjustment policies" (CAAPs).

A newly released report from The AIDS Institute (TAI) reveals that more than 40% of individual health plans reviewed for 2025 include CAAPs, which prevent assistance funds from counting toward enrollees' annual deductibles or out-of-pocket maximums. This practice forces patients to pay twice for the same medication—once through the assistance program and again out of pocket—creating substantial financial barriers to necessary treatments.

"Copay accumulator adjustment policies discriminate against people living with chronic illness, interrupting their access to needed treatment and threatening their health," notes Rachel Klein, Deputy Executive Director of The AIDS Institute in their 2025 press release.

The 2025 TAI National Copay Report: A State-by-State Analysis

The AIDS Institute's comprehensive analysis reveals a troubling picture of copay accumulator policies across the United States. Their review of individual market health plans in all 50 states and D.C. found that in 39 states, at least one insurer maintains a CAAP, with vast differences in prevalence from state to state.

The report grades states based on the percentage of plans implementing these policies. Ten states received failing "F" grades, indicating that 75-100% of their available plans include CAAPs: Florida, Idaho, Iowa, Missouri, Montana, Pennsylvania, South Carolina, Utah, Wisconsin, and Wyoming. At the other end of the spectrum, 11 states, Washington D.C., and Puerto Rico received "A" grades for having zero plans with CAAPs, ensuring patients receive the full benefit of copay assistance.

Perhaps most concerning is the finding that in 11 states (Colorado, Delaware, Georgia, Illinois, Louisiana, North Carolina, Oklahoma, Oregon, Tennessee, Texas, and Washington), at least one insurer continues to include CAAPs "in apparent violation of state law," according to the TAI report. This suggests a significant enforcement gap, with state insurance departments failing to ensure compliance with existing patient protections.

The report also highlights how difficult it is for patients to determine whether their plan includes these policies. Across all states, 18 plans failed to provide policy documents online during open enrollment, forcing prospective enrollees to make lengthy phone calls to learn about copay policies. Unsurprisingly, 13 of these 18 plans that required phone calls have copay accumulator policies.

The Human Impact of Copay Accumulator Policies

Behind the statistics are real people facing impossible choices due to these policies. According to the TAI report, the annual out-of-pocket maximum in 2025 is $9,200 for individuals and $18,400 for families—amounts that exceed what most Americans have in savings. Research cited in the report found that when out-of-pocket costs reach just $75-$125, over 40% of patients leave their prescriptions at the pharmacy counter. When costs hit $250, more than 70% of patients walk away without their medications.

To understand how CAAPs affect patients financially, consider this example of two scenarios for a patient taking a medication costing $1,680 monthly with an annual copay assistance limit of $7,200:

Without a CAAP, the patient's assistance helps meet their deductible and cover coinsurance until July, when assistance runs out. The patient then pays $1,350 out-of-pocket to reach their annual maximum, and the insurer collects $8,550 total.

With a CAAP, the same amount of assistance is used up by June, but none of it counts toward the patient's deductible or out-of-pocket maximum. The patient must then pay $7,960 out-of-pocket—nearly six times more—while the insurer collects $15,160 total, almost double what they would collect without the CAAP.

"These policies undermine important patient protections enacted in the Affordable Care Act (ACA) and make it more difficult for people trying to manage a chronic illness to afford medicine they need," the report states.

Federal Regulation and Legal Battles

The federal regulatory landscape governing copay accumulator policies has been marked by contradiction and uncertainty. In 2019, the Department of Health and Human Services (HHS) finalized the 2020 Notice of Benefit and Payment Parameters (NBPP), which significantly restricted the use of copay accumulator adjustment policies, only permitting them for brand-name drugs with available and medically appropriate generic equivalents.

However, before this patient-friendly rule could take effect, HHS announced it would not implement the provision. In 2020, the agency reversed course entirely with the 2021 NBPP, which allowed insurers and PBMs to adopt CAAPs for all prescription drugs regardless of whether generics were available, as long as state law permitted such practices.

This regulatory whiplash prompted legal action from patient advocates. According to the TAI report, a U.S. District Court for the District of Columbia ruled in late 2023 that HHS could not allow insurers and PBMs to decide whether manufacturer copay assistance must count toward an enrollee's cost-sharing limit. The court declared that insurers must follow the more protective 2020 rule until HHS issues new regulations.

Despite this ruling, HHS has so far declined to enforce the 2020 rule, instead announcing plans to update the cost-sharing rule with new language. This enforcement gap means many insurance plans continue to include CAAPs in 2025, leaving patients exposed to potential financial harm.

State-Level Progress and Challenges

While federal action stalls, states have become the primary battleground for protecting patients from copay accumulator policies. To date, 21 states, the District of Columbia, and Puerto Rico have enacted laws restricting the use of CAAPs.

Nine states and Puerto Rico have adopted comprehensive protections requiring insurers to count all copay assistance toward patients' deductibles and out-of-pocket limits: Connecticut, Delaware, Illinois, Louisiana, New Mexico, New York, Oklahoma, Virginia, and West Virginia. Twelve more states and DC have enacted laws that prohibit CAAPs for drugs without generic alternatives while allowing insurers to exclude assistance for brand-name drugs when generics are available.

Despite this progress, implementation challenges remain significant. The TAI report found that in 11 states with existing laws, at least one insurer continues to include CAAP language in apparent violation of state law. This finding underscores that "laws and regulations are meaningless unless properly enforced."

State efforts to regulate CAAPs are part of a broader trend of PBM reform at the state level. During the 2024 legislative sessions alone, 33 bills related to PBM regulation were enacted in 20 states, addressing issues from spread pricing to patient steering.

A critical limitation is that state laws only apply to health insurance plans regulated at the state level—typically individual and small group plans. This leaves a protection gap for the majority of Americans who receive coverage through large employer plans, which are regulated at the federal level. According to the TAI report, the current state laws only protect an estimated 26 million people, representing just 19% of those enrolled in commercial health insurance plans nationwide.

Congressional Action and Setbacks

Despite broad bipartisan support for addressing PBM practices including copay accumulators, federal legislative efforts have repeatedly fallen short. The Help Ensure Lower Patient (HELP) Copays Act, which would require insurers and PBMs to count copay assistance toward patients' annual cost-sharing requirements, garnered more than 150 cosponsors in the previous Congress but never came to a vote.

The most recent setback came in December 2024, when PBM reform provisions were stripped from a bipartisan Continuing Resolution that would have funded the government. According to Chain Drug Review, the measure collapsed after President-elect Trump and his allies expressed concerns about the scope of the bill, leading to a stripped-down version that excluded most extraneous provisions, including PBM reform.

In February 2025, Senators Chuck Grassley and Maria Cantwell reintroduced two bipartisan bills aimed at increasing PBM transparency and accountability. While neither bill directly addresses copay accumulator policies, they signal ongoing bipartisan interest in PBM reform.

The New Administration's Position and FTC Scrutiny

The Trump administration has signaled that PBM reform will be a priority. At a December 2024 press conference, Trump stated: "We are going to knock out the middleman." Health and Human Services Secretary Robert F. Kennedy Jr. echoed this during his confirmation hearing: "Trump is absolutely committed to fixing the PBMs. Trump wants to get the excess profits away from the PBMs and send it back to primary care, to patients in this country."

This political momentum builds on the Federal Trade Commission's ongoing investigation of PBM practices. As we covered in a previous CANN blog post, the FTC's January 2025 report provided substantial evidence of PBMs marking up specialty drugs—including HIV medications—by hundreds or thousands of percent, generating billions in excess revenue. The report's unanimous approval by all five FTC commissioners adds significant weight to arguments for comprehensive reform.

Next Steps

The 2025 TAI National Copay Report confirms that despite progress in some states, copay accumulator adjustment policies continue to threaten access to essential medications for people living with chronic conditions. The patchwork of state laws, inconsistent enforcement, and limitations of existing federal regulations leave millions of Americans vulnerable to financial harm when seeking necessary treatment.

Several actions are needed to address this ongoing challenge:

For policymakers:

• Congress should pass comprehensive federal legislation like the HELP Copays Act to ensure all patients, including those with employer-sponsored insurance, are protected from copay accumulator policies.

• State insurance commissioners must prioritize enforcement of existing laws that restrict CAAPs, closing the implementation gap identified in the TAI report.

For patient advocates:

• Focus advocacy efforts on states with "F" grades in the TAI report, where the greatest number of patients are at risk.

• Document and report instances where insurers violate state laws restricting CAAPs to appropriate regulatory authorities.

• Build coalitions that include both patient groups and pharmacy advocates to strengthen the case for reform.

For patients:

• Check whether your state has laws protecting against CAAPs and understand how your specific insurance plan handles copay assistance.

• When selecting insurance plans, directly ask customer service representatives about copay accumulator policies if this information is not clearly stated in plan documents.

• If denied the ability to count assistance toward your deductible, appeal the decision and report potential violations to your state insurance department.

As Congress continues to flirt with PBM reform, the FTC intensifies its scrutiny, and the new administration signals interest in "knocking out the middleman," a rare window of opportunity exists to finally address these harmful policies. The key will be translating bipartisan rhetoric and mounting evidence into concrete action that protects all patients, regardless of where they live or how they receive their health insurance. Without such action, millions of people living with chronic conditions will continue to face financial barriers to the medications they need to survive and thrive.

America's Vaccination Problem

Politics Trump Public Health

The United States is confronting a serious resurgence of vaccine-preventable diseases, exemplified by the measles outbreak in Texas and New Mexico that has now infected over 124 people and claimed the life of an unvaccinated child. This crisis coincides with multiple failures in public health leadership and unprecedented political interference in evidence-based practice.

Recent Centers for Disease Control and Prevention (CDC) analysis reveals that the percentage of children with a vaccine-hesitant parent varies dramatically by vaccine type — from 56% for COVID-19 vaccines to 12% for routine childhood vaccines. This growing hesitancy has created dangerous gaps in community protection across the country.

In a rapid succession of alarming developments within a single week, we've witnessed a new confirmed measles case in Kentucky from an international traveler, Health and Human Services (HHS) Secretary Robert F. Kennedy (RFK) Jr.'s cancellation of a multimillion-dollar project to develop an oral COVID-19 vaccine, and the FDA's abrupt cancellation of a critical advisory committee meeting on next season's flu vaccine formulation. During his first cabinet meeting appearance, Kennedy incorrectly stated there had been two measles deaths (there was one) and downplayed the outbreak as "not unusual" — a claim physicians immediately contradicted.

This confluence of declining vaccination rates, active disease outbreaks, and systematic dismantling of public health infrastructure represents a crisis entirely of our own making. It’s 2025 and children are dying from diseases we've known how to prevent for decades, not because of scientific limitations, but because of a collective failure to prioritize evidence over ideology.

A Dismantling in Real Time

At the February 27 cabinet meeting, HHS Secretary Kennedy made several troubling statements about the ongoing measles outbreak. "Measles outbreaks are not unusual," Kennedy claimed, an assertion quickly refuted by medical experts.

"Classifying it as 'not unusual' would be inaccurate," said Dr. Christina Johns, a pediatric emergency physician. "Usually an outbreak is in the order of a handful, not over 100 people that we have seen recently with this latest outbreak in West Texas."

Dr. Philip Huang, director of Dallas County Health and Human Services, was more direct: "This is not usual. Fortunately, it's not usual, and it's been because of the effectiveness of the vaccine."

Kennedy's statement that two people had died from measles was also incorrect – Texas officials confirmed there has been one death, an unvaccinated school-aged child. His claim that patients were hospitalized "mainly for quarantine" was astonishingly false. Local health officials reported that most patients required treatment for serious respiratory issues, including supplemental oxygen and IV fluids.

Meanwhile, in just his first two weeks in office, Kennedy has taken several actions that threaten to undermine vaccine development and public health guidance:

1. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for March was abruptly canceled. This annual meeting is crucial for selecting the strains to be included in next season's flu vaccines. A wise move in the middle of the worst flu season in 15 years. Norman Baylor, former director of the FDA's Office of Vaccine Research and Review, told NBC News: "I'm quite shocked. The VRBPAC is critical for making the decision on strain selection for the next influenza vaccine season."

2. Kennedy halted a $460 million contract with Vaxart to develop a new COVID-19 vaccine in pill form, just days before 10,000 people were scheduled to begin clinical trials.

3. Just days earlier, Kennedy indefinitely postponed a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), which helps determine vaccine recommendations for states and insurers.

Dr. Paul Offit, a member of VRBPAC and vaccine expert at Children's Hospital of Philadelphia, expressed his dismay: "I feel like the world is upside down. We aren't doing the things we need to do to protect ourselves."

Evidence of Vaccine Success Amid Political Attacks

In striking irony, the CDC Morbidity and Mortality Weekly Report (MMWR) just published new data demonstrating the remarkable success of the human papillomavirus (HPV) vaccination program in preventing cervical cancer. During 2008–2022, cervical precancer incidence decreased 79% among screened women aged 20–24 years, the age group most likely to have been vaccinated. Higher-grade precancer incidence decreased 80% in the same group.

This success story illustrates what effective vaccination programs can achieve when supported by consistent policy and healthcare provider recommendations. The HPV vaccine has prevented countless future cancers in a generation of young people, with similar potential for other vaccines when politics doesn't interfere with public health.

The contrast between this evidence of vaccine success and the current administration's assault on public health infrastructure could not be more glaring. At the very moment when scientific data confirms vaccines' life-saving impact, political appointees are systematically dismantling the systems designed to implement and monitor vaccination programs.

The False Promise of "Informed Consent"

Kennedy has justified halting vaccine promotion by claiming he wants future campaigns to focus on "informed consent" instead. However, experts warn this framing misrepresents the concept and creates dangerous misperceptions about vaccines (which, to be fair, would make it right in RFK Jr.’s wheelhouse—if only that were the actual job description).

Mark Navin, Lainie Friedman Ross, and Jason A. Wasserman explained in STAT News: "True 'informed consent' requires an understanding of how people process information about risks, and public health must promote collective benefits rather than focus entirely on individual autonomy."

Simply listing potential vaccine side effects without context creates predictable cognitive biases, similar to hearing about a shark attack and becoming afraid to swim despite the infinitesimal risk. As these experts note, "It is more like handing someone a list of everything that could go wrong on an airplane without mentioning that flying is far safer than driving."

The CDC's canceled 'Wild to Mild' campaign appropriately conveyed what matters most: vaccines' ability to turn severe, potentially deadly disease cases into manageable, mild illnesses—reducing hospitalizations, complications, and deaths. Replacing this messaging with uncontextualized risk information isn't enhancing informed consent — it's promoting fear and hesitancy.

The Expanding Measles Threat

Measles is making a dangerous comeback. The Kentucky Department of Health confirmed its first case since 2023 in an adult who recently traveled internationally. While contagious, the individual visited a Planet Fitness gym, potentially exposing others—a not-so-subtle reminder that wiping down equipment is more than just good manners.

This case adds to outbreaks in nine states, including Texas, New Mexico, Alaska, Georgia, New Jersey, New York, and Rhode Island. The most severe remains in West Texas’ Gaines County, where nearly 14% of schoolchildren have religious exemptions from required vaccinations.

On February 26, an unvaccinated child in that Texas community became the first U.S. measles fatality since 2015 and the first pediatric death since 2003. Before vaccines, measles killed 400 to 500 Americans annually.

These outbreaks are particularly tragic given that the MMR vaccine is exceptionally safe and effective. Two doses provide 97% protection against a disease that, without vaccination, would infect nearly every child by age 15. Among 10,000 measles cases, 10 to 30 children will die, 2,000 will require hospitalization, and over 1,500 will suffer serious complications, some with lifelong consequences.

By contrast, severe vaccine side effects are extraordinarily rare—fewer than four in 10,000 people experience fever-related seizures, blood clotting issues, or allergic reactions. As beloved children’s author Roald Dahl wrote after losing his daughter Olivia to measles encephalitis in 1962: "I think it is almost a crime to allow your child to go unimmunized."

Roald Dahl and the open letter he wrote in 1986, encouraging parents to vaccinate their children against measles. (Credit: Ronald Dumont/Daily Express/Getty Images)

Declining Vaccination Rates

Vaccination rates for measles and other preventable diseases have been trending downward, creating dangerous gaps in community protection. According to research from the Center for American Progress, kindergarten MMR vaccination rates have fallen below the critical 95% threshold needed for herd immunity. Since the 2019-20 school year, coverage has dropped from 95% to approximately 93% nationwide, leaving over 250,000 children vulnerable to infection.

This decline is even more concerning at the state level. Thirty-nine states saw vaccination rates fall below the 95% threshold in the 2023-24 school year, an increase from 28 states during the 2019-20 school year. Overall, less than 93% of kindergarten children were up to date on their state-required vaccines in 2023-24, compared with 95% four years earlier.

COVID-19 and influenza vaccination rates show similar concerning trends. According to the CDC's vaccination tracking data, only 23.1% of adults have received the 2024-25 COVID vaccine, while 45.3% have received the seasonal flu vaccine. For adults 65 and older, these rates are somewhat higher but still insufficient – 44.4% for COVID and 70.2% for flu.

A 2022 modeling study estimated that over 9.1 million children (13.1%) in the United States are currently susceptible to measles infection. If pandemic-level vaccination declines persist without catch-up efforts, that number could rise to over 15 million children (21.7%), significantly increasing the risk of larger and more frequent outbreaks.

When Vaccines Become Political Identifiers

Vaccine-preventable diseases disproportionately impact vulnerable communities. Flu vaccination rates vary significantly by race, with 49% of White adults vaccinated, compared to 42% of Black adults and 35% of Hispanic adults. These disparities stem from access barriers, medical mistrust, and inconsistent provider recommendations.

The politicization of vaccines exacerbates these challenges. Support for school vaccine mandates has dropped from 82% in 2019 to 70% in 2023, driven by a sharp decline among Republicans (79% to 57%), while Democratic support remains stable at 85-88%. Similar trends appear among White evangelical Protestants, where support for school vaccine requirements fell from 77% to 58%. This geographic clustering of under-vaccinated populations fuels outbreaks—exactly what’s unfolding in West Texas.

Partisan divides extend beyond COVID-19. Republicans report lower annual flu vaccination rates than Democrats (41% vs. 56%), and among those fully vaccinated against COVID-19, Democrats are nearly three times as likely to have received a recent booster (32% vs. 12%). Vaccine hesitancy also correlates with education levels, further compounding risks in communities with both lower socioeconomic status and conservative political leanings.

Addressing these disparities requires public health strategies that acknowledge political polarization while working beyond it. Culturally tailored messaging, trusted community voices, and policies that eliminate access barriers are essential to counteract the social and ideological forces shaping vaccine decisions today.

State-Level Assaults: Louisiana's Ban on Vaccine Promotion

Federal attacks on vaccine policy are now playing out at the state level. In February 2025, the Louisiana Department of Health announced it would no longer promote mass vaccination through health fairs or media campaigns—a directive from Surgeon General Dr. Ralph Abraham that drew immediate backlash from the medical community.

Nine state medical organizations, including the Louisiana State Medical Society, issued a joint letter condemning the move: "Immunizations should not be politicized. Healthcare should not be politicized. Public health should not be politicized. Your relationship with your physician should not be politicized."

Dr. Vincent Shaw, president of the Louisiana Academy of Family Physicians, called the opposition unprecedented and warned that halting vaccine promotion could bring back diseases he's "only seen in textbooks, like measles and rubella." Meanwhile, Abraham has misrepresented his credentials, falsely identifying as a board-certified family medicine physician—raising serious concerns about the expertise guiding public health policy.

The consequences are already surfacing. Dr. Mikki Bouquet, a Baton Rouge pediatrician, reports growing parental skepticism about routine vaccinations. "Now parents are asking which vaccines are really necessary. That's absurd—it’s like asking which vitamin matters most. You need them all."

Even Republican Senator Bill Cassidy, despite voting to confirm RFK Jr. as HHS Secretary, has criticized the policy, warning that cutting vaccine outreach ignores the reality of parents' lives.

This shift underscores a troubling trend: political ideology overriding evidence-based public health, with the most vulnerable populations poised to suffer the consequences.

The Fight for Evidence-Based Solutions

This past week has marked a dangerous escalation of political interference in public health. The cancellation of vaccine advisory meetings, the halting of innovative vaccine development, and the downplaying of a deadly measles outbreak signal a fundamental shift away from science-based policy.

Healthcare professionals can no longer afford to stay on the sidelines. Beyond their clinical roles, they must become active policy advocates by:

1. Contacting state and federal representatives to oppose policies that undermine vaccination

2. Engaging with professional organizations to develop unified advocacy efforts

3. Providing expert testimony at legislative hearings on vaccine-related bills

4. Writing op-eds and speaking to media about vaccine safety and efficacy

5. Countering misinformation as trusted community voices

6. Supporting candidates who prioritize evidence-based public health policies

Medical organizations must also wield their influence more effectively. The recent joint statement from nine Louisiana medical groups demonstrates the power of unified action, while hospital systems—often major employers—hold political capital that should be used to safeguard public health infrastructure.

Community advocates play a critical role, too. Parents, faith leaders, and business owners can amplify vaccine messaging and reinforce public health norms. Even conservatives who support science-based medicine must speak out. As Senator Bill Cassidy’s rebuke of Louisiana’s vaccine policy shows, principled advocacy can transcend partisan divides when children's health is at stake.

The choice is clear: we either defend decades of vaccination progress or risk a return to the preventable suffering of the pre-vaccine era. Healthcare providers willing to advocate beyond clinic walls will determine which path we take.

Influenza, and Bird Flu, and TB, Oh My!

The United States is currently experiencing its worst flu season in 15 years, with the Centers for Disease Control and Prevention (CDC) reporting at least 29 million cases - the highest number since the 2009-2010 season. This surge in seasonal influenza coincides with an expanding outbreak of H5N1 avian influenza that has now infected 67 people across multiple states, marking the first sustained transmission of bird flu to humans in the U.S.

Against this backdrop of escalating disease threats, the federal public health infrastructure faces unprecedented disruption. On January 20, 2025, the Trump Administration ordered an immediate halt to external communications from federal health agencies, including the CDC's primary vehicle for disseminating critical public health information - the Morbidity and Mortality Weekly Report (MMWR).

The timing is… concerning. As noted by Stephanie Psaki, former U.S. coordinator for global health security, these restrictions come as public health officials also grapple with outbreaks of Marburg virus in Tanzania and Ebola in Uganda. The convergence of multiple disease threats with diminished public health response capabilities creates dangerous gaps in our ability to detect, track, and contain emerging outbreaks.

Public Health Infrastructure In Disarray

The dismantling of federal public health systems has proceeded with striking speed. On January 21, 2025, acting Health and Human Services (HHS) Secretary Dorothy Fink issued a directive halting all external communications from federal health agencies, requiring presidential appointee review of any document intended for publication. By January 31, federal health agencies had removed over 8,000 webpages from public access - including mission-critical resources like HIV prevention guidelines and clinical trial diversity databases. Though U.S. District Judge John Bates ordered the CDC and Food and Drug Administration (FDA) to restore these resources on February 11, ruling their removal likely violated federal law, the disruption to public health operations remains significant. As one federal health official noted, "It was a double waste for us because we took them offline, put some of them back, edited others and now are putting it back again."

The administration's intervention in the CDC's Morbidity and Mortality Weekly Report signals an even deeper assault on scientific independence. This cornerstone publication has served as the primary vehicle for disseminating public health information and recommendations since 1952, continuing without interruption even during government shutdowns - until now. Multiple federal health officials report that Trump Administration appointees have taken direct control over the journal's content, dictating coverage priorities and withholding completed studies about the expanding bird flu outbreak - including critical research about transmission patterns that could help prevent further spread.

As former CDC director Tom Frieden notes, "MMWR is the voice of science." The journal ranks among the most-cited health publications globally, with health officials, clinicians, and researchers relying on its studies for disease treatment and prevention guidance. The current interference represents a tectonic shift in how public health data and science are controlled and disseminated in the United States.

While Trump's first administration sought to influence public health messaging during the COVID-19 pandemic through selective pressure on specific reports, his second administration has taken direct editorial control over the entire infrastructure of public health communication and surveillance. This shift from attempting to shape the narrative to controlling the flow of scientific information itself represents a fundamental threat to public health practice and undermines the ability to detect, track, and respond to disease outbreaks.

Impact on Disease Surveillance

The impact of these system disruptions on disease surveillance became clear when the CDC finally released its delayed study of H5N1 infections among veterinarians. The research, conducted in September 2024 but held from publication until February 2025, revealed that three out of 150 cattle veterinarians tested positive for H5N1 antibodies despite having no known contact with infected animals. More concerning, one veterinarian practiced exclusively in Georgia and South Carolina - states with no previously reported cases of H5N1 in dairy cattle.

These findings expose serious gaps in our surveillance capabilities. As Lauren Sauer, professor at the University of Nebraska Medical Center College of Public Health, explains, "Any detection of asymptomatic or mild cases in this study just tells me we're missing cases." None of the infected veterinarians reported respiratory symptoms or conjunctivitis, suggesting that focusing surveillance only on symptomatic cases substantially underestimates the true spread of the virus.

Unfortunately, surveillance problems are likely to get worse with the removal of demographic data collection capabilities from federal health agencies, crippling our ability to identify and address emerging disease patterns across different populations. When researchers cannot track where problems exist or evaluate which solutions work, targeted interventions become impossible to develop or assess.

The dairy industry illustrates these compounding challenges. Recent research shows that tracking human infections has been persistently difficult throughout the bird flu outbreak, with health agencies having limited authority to conduct disease surveillance on farms and workers often reluctant to get tested. Current restrictions on data collection and analysis magnify these existing barriers.

Time matters in disease surveillance. When we cannot accurately track disease spread or identify emerging patterns, we lose the ability to implement timely interventions that could prevent broader transmission. It’s a dangerous cycle where reduced surveillance leads to delayed responses, allowing outbreaks to expand unchecked before detection.

Consequences In The Field

Healthcare providers face mounting challenges in responding to multiple disease threats amidst systemic disruptions to public health infrastructure. While the CDC's recent health advisory provides guidance on expedited influenza A subtyping for hospitalized patients to identify potential H5N1 cases, the broader erosion of public health systems and communications channels complicates coordinated response efforts.

The impact of these systemic weaknesses is evident in Kansas, where the state faces one of the largest tuberculosis outbreaks ever recorded in the United States. The power granted to public health officials at both state and federal levels has been sharply curtailed, limiting officials' ability to mandate tests, isolation, or closures due to infectious disease. “You can think of TB outbreaks like a canary in the coalmine of our public health infrastructure,” said David Dowdy, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health.

“What causes them to happen is a weakening of our public health infrastructure.”

Healthcare facilities struggle to adapt while managing mounting disease pressures. Many hospitals have implemented temporary visitor restrictions in response to rising influenza cases, but without coordinated federal guidance, each facility must develop its own protocols. The resulting patchwork of inconsistent response measures places additional burden on already strained healthcare workers and creates confusion for patients and families seeking care across different facilities.

The loss of access to regularly updated and trustworthy federal guidelines and surveillance data forces healthcare providers to make critical decisions about testing, treatment, and infection control with incomplete information. This compromises not only their ability to provide optimal care but also undermines efforts to prevent disease spread within healthcare settings and the broader community.

A Record Flu Season

The current flu season illustrates how quickly policy decisions translate into public health outcomes. With 370,000 hospitalizations and 16,000 deaths so far, seasonal flu has overtaken COVID-19 in both metrics for the first time since the pandemic began. For the first time since the 2017-2018 season, the CDC has classified this as a high-severity season for all age groups.

The toll on children has been particularly severe, with 68 pediatric deaths reported and rising cases of serious neurological complications. These deaths are especially tragic given that influenza vaccination significantly reduces flu-related mortality across all age groups, cutting death rates by up to four times among vaccinated people.

The severity of this flu season cannot be separated from the broader erosion of trust in public health institutions and preventive measures. As Dr. Anice Lowen explains, influenza viruses follow predictable patterns that inform vaccine development and public health responses. When trust in these institutions is undermined and fewer people seek vaccination or follow prevention guidelines, it creates a cycle where reduced prevention leads to increased transmission, straining healthcare systems and potentially fostering even greater distrust in public health measures.

The political and policy implications extend beyond the federal chaos. In Louisiana, for example, health officials have been explicitly forbidden from promoting or advertising COVID, influenza, or mpox vaccines - a directive that strikes at the core mission of public health. As we face multiple concurrent disease threats, maintaining public confidence in science-based interventions becomes increasingly critical for protecting public health.

Critical Questions for Public Health

The dismantling of public health infrastructure through systematic defunding, deregulation, and politicization raises fundamental questions about the future of disease prevention and control in the United States. As the Trump Administration installs anti-vaccine activist Robert F. Kennedy Jr. at the helm of Health and Human Services, while simultaneously threatening to withhold federal funding from schools with COVID-19 vaccine requirements, we confront a sobering reality: federal public health leadership can no longer be relied upon as a consistent source of evidence-based guidance and response coordination.

The impact of this leadership void is already evident. The Department of Government Efficiency (DOGE) continues to remove experienced staff from critical positions across federal health agencies, creating dangerous gaps in expertise. Even when forced to reverse course - as with the United States Department of Agriculture’s (USDA) attempt to fire and then re-hire staff working on the bird flu response - the disruption to public health operations remains significant.

The transformation of public health into a political battleground makes scientific evidence and established prevention measures casualties of ideology. When political appointees amplify medical misinformation or withhold and reframe public health data to fit political narratives, they erode trust in the very institutions designed to protect population health.

As federal and state public health infrastructure faces unprecedented disruption, the public health community must grapple with several pressing questions:

How can state and local health departments maintain effective disease surveillance when federal systems prove unreliable?

What mechanisms can healthcare facilities develop to share data and clinical guidance without depending on federal channels?

Which legal frameworks best protect scientific integrity and public access to health data? While recent court orders have restored some removed resources, deeper questions remain about safeguarding public health information from political interference.

How can public health practitioners rebuild trust in science-based interventions when prevention measures become political battlegrounds? The record-breaking flu season highlights the human cost when evidence-based recommendations face systematic undermining.

What role should professional organizations and academic institutions play in maintaining disease surveillance and response capabilities? As federal expertise drains, alternative networks may need to fill critical gaps.

These questions reflect fundamental challenges to public health practice in the United States. When political pressure shapes which data gets collected, analyzed and shared, it compromises our ability to detect and respond to disease threats. The most vulnerable communities often bear the heaviest burden of these systemic failures.

The path forward requires careful examination of how public health systems can adapt while upholding scientific integrity and protecting population health. As multiple outbreaks strain our fractured infrastructure, finding answers to these questions becomes increasingly urgent.

Dismantling of Health Equity Research

A federal judge has ordered the Trump Administration to restore thousands of public health websites and datasets that were abruptly taken offline January 31, 2025. But the ruling, while important, addresses only the most visible aspect of a deeper transformation taking place in American public health research.

The order requires immediate restoration of critical resources like the Centers for Disease Control and Prevention’s (CDC) Youth Risk Behavior Survey, which has tracked adolescent health trends for over 30 years, and AtlasPlus, which provides essential HIV surveillance data. Yet even as some datasets begin to return, fundamental questions remain about their integrity and future usefulness.

New restrictions on research language and funding are reshaping how health disparities can be studied, documented, and addressed. At the National Science Foundation (NSF), grant proposals are now screened for over 70 terms related to equity and inclusion. Similar constraints are being implemented across federal health agencies, controlling not just what data exists, but how it can be analyzed and applied.

We've seen this strategy before. For over 20 years, the Dickey Amendment effectively halted federal research on gun violence - not through outright prohibition, but by using funding restrictions to make the research politically toxic. Today's policies follow the same playbook, using indirect means to reshape what questions researchers can ask and what problems they can study.

The implications for public health - and patient care - could echo for decades to come.

The Architecture of Erasure

The Trump administration's data purge made headlines, but the less visible transformation of research funding mechanisms will have far greater long-term impact. Under new NSF guidelines, grant proposals containing terms like "health disparities," "barriers to care," or "systemic inequities" trigger automatic review. These aren't outright bans - they're strategic barriers designed to make certain types of research more difficult to fund and publish.

Similar restrictions are being implemented across federal health agencies. The National Institutes of Health (NIH) and CDC must now screen research proposals for language that could be interpreted as promoting "gender ideology" or diversity initiatives. Even if researchers secure funding, their ability to frame findings around equity and access faces new constraints.

This reshapes research at every level. A study on maternal health outcomes might be funded if it focuses on individual behaviors, but not if it examines how systemic barriers affect Black maternal mortality. Mental health research could explore "personal resilience" but not structural obstacles to care access. Over time, these restrictions don't just limit what can be studied - they fundamentally alter how health challenges are understood and addressed.

The mechanism is subtle but effective. When researchers know their work will be flagged for examining disparities or structural inequities, many will self-censor to protect their funding. As one CDC scientist told Science magazine, "No federal employee was willing to risk his or her career or the agency's funding to find out" exactly where the new boundaries lie. This kind of suppression doesn't require explicit bans - just the implicit threat of losing resources.

For health systems dependent on federal grants, these restrictions create impossible choices. How can a hospital justify funding for language access programs if they can't document disparities in care? How can public health departments address racial gaps in health outcomes if they can't name those gaps in their grant applications? The system is being redesigned not just to ignore inequity, but to make studying it professionally toxic.

Learning from History: The Dickey Amendment's Legacy

The strategic use of funding restrictions to suppress research isn't new. In 1996, Congress passed the Dickey Amendment, which prohibited the CDC from using funds to "advocate or promote gun control." While this didn't explicitly ban gun violence research, Congress simultaneously slashed CDC's budget by the exact amount previously spent studying firearms - sending an unmistakable message about the political cost of pursuing such research.

The impact was immediate and long-lasting. For over 20 years, federal agencies avoided gun violence research entirely, creating a massive knowledge gap during a period when America's gun violence epidemic dramatically worsened. Even former Representative Jay Dickey, the amendment's author, later expressed regret, stating "I wish I had not been so reactionary."

When Congress finally restored partial funding in 2020, the research community's response was dramatic. The CDC and NIH awarded $149.5 million for firearms research from 2020-2022, leading to a 90% increase in clinical trials and an 86% increase in research publications. But two decades of lost research had already shaped a generation of health policy - or rather, the lack thereof.

Today's restrictions on health equity research follow a similar pattern. While the court has ordered data restoration, new language restrictions and funding mechanisms create powerful disincentives for studying health disparities. Like the Dickey Amendment, these policies don't need to explicitly ban research - they just need to make it politically and professionally risky enough that researchers and institutions avoid it altogether.

The parallels are striking: both policies use indirect means to achieve political goals, both rely on funding threats rather than outright bans, and both are likely to create long-term gaps in critical public health knowledge. However, today's restrictions on health equity research have potentially broader implications - they affect how we understand and address disparities across our entire healthcare system. The knowledge gaps we create today could take decades to fill, leaving us unable to effectively study or address systemic barriers to care.

Beyond Data: How Research Shapes Care

What happens when we can't study disparities in healthcare? The impact cascades through the entire system - from how research is funded, to who is selected for clinical trials, to what guidelines are written, to how providers make decisions, and ultimately, to whether patients receive appropriate care.

Consider HIV surveillance and prevention. The CDC's AtlasPlus tool wasn't just a database - it was the primary mechanism for tracking outbreaks and targeting prevention resources where they were needed most. Without this real-time mapping capability, public health officials lose their ability to respond quickly to emerging hotspots or evaluate which interventions are working. This particularly impacts PrEP outreach in Black and Latino communities, where research has shown targeted, culturally-responsive programs are most effective.

The restrictions on studying maternal health disparities are equally concerning. We know that Black women are three times more likely to die from pregnancy-related causes than white women. But without the ability to study why these deaths occur or evaluate which interventions help, maternal mortality review committees cannot make evidence-based recommendations for prevention. The data might show us who is dying, but research restrictions mean we can't effectively study how to save them.

Language access in healthcare settings presents another critical challenge. When 60% of healthcare workers report witnessing discrimination against non-English speakers, we need research to understand where translation services are most urgently needed and which interpretation models work best. But with terms like "culturally responsive" now flagged in federal grant proposals, who will study these issues? How will hospitals justify funding for language access programs if they can't document their impact?

jThe Youth Risk Behavior Survey's 30-year dataset on adolescent mental health has been essential for developing school-based interventions and suicide prevention strategies. Even if this data is restored, new restrictions on studying LGBTQ+ youth mental health could leave healthcare providers unable to identify which prevention strategies actually work for this high-risk population.

These aren't just academic concerns. When research is restricted, health systems lose their ability to identify problems, evaluate solutions, and implement evidence-based changes. The result? Providers make decisions without complete information, institutions lack data to justify needed programs, and patients - especially those already facing systemic barriers - suffer the consequences.

The Road Ahead

Despite the federal court order to restore health agency websites, serious questions remain about both compliance and data integrity. While some datasets have returned online, many lack essential documentation needed for analysis. The administration's response has been defiant, with Vice President Vance suggesting that "judges aren't allowed to control the executive's legitimate power."

Even if full compliance is achieved, researchers face a transformed landscape across all federal agencies. Under new government-wide directives, research proposals at the NSF, NIH, CDC, and other federal agencies must undergo scrutiny for language related to diversity, equity, inclusion, and accessibility (DEI/A). The impact extends far beyond health research - with similar restrictions at the Departments of Education, Housing and Urban Development, and other federal agencies, our ability to study and address systemic inequities across all social determinants of health is severely compromised.

The impacts extend beyond federal agencies. State health departments and research institutions rely on federal frameworks for standardization and analysis. When these systems are dismantled or restricted, it affects health surveillance and research at every level. Hospitals and clinics dependent on federal grants must align their programs with new guidelines or risk losing funding - even if that means ignoring documented disparities in their communities.

For patients, especially those already facing barriers to care, these changes could have profound consequences that don’t stay in academic journals. They play out in hospitals, emergency rooms, and community health clinics—in real people’s lives. They determine who gets care, who gets ignored, and who is left to suffer without accountability. For people living with HIV—particularly transgender women of color, who already face some of the highest levels of stigma and systemic barriers to care—these policies do more than entrench existing inequities. They manufacture new ones.

This is the reality we face: a healthcare system where evidence of disparities exists but cannot be named, where inequities persist but cannot be studied, and where patients suffer but their experiences cannot be documented in ways that drive change. In this climate, who will take the risk of researching these disparities at all?

Conclusion

These restrictions are not just an attack on data collection—they are an attack on the ability of marginalized communities to fight for their own survival. The ability to name a problem, to document its scope, to prove its harm—this is what drives change in public health. Put another way, it is a deliberate strategy to strip communities of the proof they need to demand better.

The Dickey Amendment's legacy shows us how research censorship can shape public health outcomes for generations. Twenty years of suppressed gun violence research contributed to policies based on politics rather than evidence and led to the worst gun violence epidemic of any developed country. Today's restrictions on health equity research risk creating similar knowledge gaps across every aspect of our healthcare system.

Research doesn't just generate statistics - it provides the evidence needed to develop effective interventions and drive meaningful change. Without the ability to study health disparities or document systemic barriers to care, healthcare providers lose essential tools for improving patient outcomes. When we can no longer collect data showing where problems exist or evaluate which solutions work, we risk perpetuating preventable suffering in communities that already face the greatest challenges accessing care.

The restoration of federal health websites is an important first step. But unless we also protect researchers' ability to study disparities, document inequities, and evaluate solutions, we risk creating gaps in public health knowledge that could take decades to fill. The consequences of these strategic policy decisions will be measured not just in datasets lost, but in human suffering and headstone counts.

Flying Blind: Public Health Without Population Data

On January 31, 2025, federal health agencies began removing thousands of webpages and datasets from public access in response to executive orders from the Trump Administration targeting "gender ideology" and diversity, equity, and inclusion initiatives. By February 1, over 8,000 federal webpages and 450 government domains had gone dark, including critical public health resources from the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Food and Drug Administration (FDA).

Immunologist and microbiologist Dr. Andrea Love, Executive Director of the American Lyme Disease Foundation, minced no words regarding the executive actions: "If you weren't clear: a President ordering a Federal health and disease agency to delete pages on its website is a public health crisis." The scope of removed content spans decades of population health data, from the 40-year-old Youth Risk Behavior Surveillance System to current HIV surveillance statistics. Many pages that have returned now display banners warning of further modifications, creating uncertainty around the future availability and integrity of federal health data.

This sudden removal of public health information echoes similar challenges faced during the early COVID-19 response, when limited access to comprehensive population data hampered the ability to identify and address emerging health disparities. As we examine the current situation, the key question becomes: How can evidence-based public health function without access to the very data that drives decision-making and ensures equitable health outcomes?

Scale of Impact

The removal of federal health datasets represents an unprecedented disruption to public health surveillance and research capabilities. According to KFF analysis, key resources taken offline include:

The CDC's Youth Risk Behavior Surveillance System, which for 40 years has tracked critical health indicators among high school students. This dataset has been instrumental in identifying emerging health crises, including the rise in youth mental health challenges and substance use patterns.

CDC's AtlasPlus tool, containing nearly 20 years of surveillance data for HIV, viral hepatitis, sexually transmitted infections, and tuberculosis, is no longer accessible. This platform has been essential for tracking disease trends and designing targeted prevention strategies.

The Social Vulnerability Index and Environmental Justice Index - critical tools for identifying communities at heightened risk during public health emergencies and environmental disasters - have also been removed. These resources help public health officials allocate resources effectively during crises and natural disasters.

Public health researchers report that the loss of demographic data collection and analysis capabilities particularly impacts their ability to identify and address health disparities.

As Dr. Jennifer Nuzzo, director of the Pandemic Center at Brown University School of Public Health notes, "Health equity is basically all of public health."

The ability to analyze health outcomes across different populations is fundamental to developing effective interventions and ensuring equitable access to care.

The CDC's healthcare provider resources have also been affected, including treatment guidelines for sexually transmitted infections and HIV prevention protocols. This loss of clinical guidance materials creates immediate challenges for healthcare providers working to deliver evidence-based care.

Beyond individual datasets, this wholesale removal of public health information disrupts the interconnected nature of federal health data systems. Many of these resources inform each other, creating compounding effects when multiple datasets become unavailable simultaneously.

Research and Care Delivery Impact

The removal of federal health data creates immediate challenges for both research and clinical care delivery. The Infectious Diseases Society of America (IDSA) warned that removing HIV and LGBTQ+ related resources from CDC websites "creates a dangerous gap in scientific information and data to monitor and respond to disease outbreaks."

This impact is particularly acute in STI prevention and treatment. Including gender and demographic data in research helps identify populations at elevated risk for infections like syphilis, which has reached its highest levels in 50 years. Without this data, developing targeted interventions becomes significantly more challenging.

For HIV prevention specifically, the loss of CDC's AtlasPlus tool removes access to critical surveillance data that guides prevention and treatment strategies. Healthcare providers report that missing CDC clinical guidance on HIV testing and PrEP prescribing creates uncertainty in delivering evidence-based care.

David Harvey, executive director of the National Coalition of STD Directors, emphasizes the immediate clinical impact: "Doctors in every community in America rely on the STI treatment guidelines to know what tests to run, to know what antibiotic will work on which infection, and how to avoid worsening antibiotic resistance. These are the guidelines for treating congenital syphilis, for preventing HIV from spreading, and for keeping regular people healthy every time they go to the doctor."

The loss of demographic data collection capabilities also threatens to undermine decades of progress in understanding and addressing health disparities. Research requiring analysis of health outcomes across different populations may face delays or compromised results without access to comprehensive federal datasets.

This disruption extends beyond immediate clinical care to impact long-term research projects and clinical trials. FDA guidance documents about ensuring diverse representation in clinical studies are no longer accessible, potentially affecting the development of new treatments and their applicability across different populations.

Historical Context and Implications

The current removal of federal health data follows concerning precedent. During the COVID-19 pandemic, similar actions to restrict access to public health data hampered effective response. In July 2020, hospital COVID-19 data reporting was moved from CDC control to a private contractor, leading to significant gaps in data access and accuracy that impeded pandemic response.

As Harvard epidemiologist Nancy Krieger notes, "There's been a history in this country recently of trying to make data disappear, as if that makes problems disappear... But the problems don't disappear, and the suffering gets worse."

This observation proved accurate during COVID-19, when limited access to comprehensive demographic data delayed recognition of disparate impacts on communities of color.

Early COVID-19 response efforts were hampered by insufficient data about how the virus affected different populations. This information gap contributed to delayed identification of emerging hotspots and slowed targeted intervention efforts. The result was preventable disparities in COVID-19 outcomes, particularly among Black, Hispanic, and Native American communities.

Today's wholesale removal of federal health data risks recreating similar blind spots across multiple public health challenges. Without demographic data to identify disparities and guide interventions, public health officials lose the ability to effectively target resources and measure outcomes. As Dr. Jennifer Nuzzo emphasizes, this data is "really important for us to answer the essential question of public health, which is, Who is being affected and how do we best target our limited resources?"

Legal Response and Policy Challenges

On February 4, 2025, Doctors for America filed suit against multiple federal agencies including the Office of Personnel Management (OPM), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS).

The lawsuit challenges two key actions: OPM's directive requiring agencies to remove webpages and datasets, and the subsequent removal of critical health information by CDC, FDA, and HHS. The complaint argues these actions violated both the Administrative Procedure Act and the Paperwork Reduction Act of 1995 (PRA).

Under the PRA, federal agencies must "ensure that the public has timely and equitable access to the agency's public information" and "provide adequate notice when initiating, substantially modifying, or terminating significant information dissemination products." The complaint alleges agencies failed to provide required notice before removing vital health information and datasets.

The legal challenge emphasizes the fundamental role these datasets play in public health. According to the filing, "The removal of the webpages and datasets creates a dangerous gap in the scientific data available to monitor and respond to disease outbreaks, deprives physicians of resources that guide clinical practice, and takes away key resources for communicating and engaging with patients."

Nine out of twelve public health researchers on CDC's advisory board signed a letter to the agency's acting director seeking explanation for the data removal. These scientists expect to face consequences for speaking out but emphasize the critical nature of maintaining public access to health data.

Data Preservation Efforts

As federal health datasets disappeared, researchers and institutions launched rapid preservation efforts. Harvard University organized its first "datathon" to archive website content through the Wayback Machine, while other academic institutions worked to preserve datasets locally.

The Kaiser Family Foundation reports having downloaded significant portions of CDC data prior to removal. While some CDC data files have been restored, they currently lack essential documentation like questionnaires and codebooks needed for analysis.

For healthcare providers needing immediate access to clinical guidelines, medical associations are working to provide archived copies of treatment protocols. The Infectious Disease Society of America and HIV Medicine Association are coordinating with members to ensure continued access to critical clinical resources.

State health departments maintain some parallel data collection systems that may help fill gaps in federal surveillance. However, these systems often rely on federal frameworks for standardization and analysis, potentially limiting their utility as standalone resources.

These preservation efforts, while necessary, cannot fully replace the coordinated federal data infrastructure needed for comprehensive public health surveillance and research.

Recommendations

Healthcare providers and public health officials should consider these immediate steps to ensure continued access to vital health information:

Data Access and Preservation

• Download and securely store copies of restored CDC datasets, including documentation

• Maintain offline copies of current clinical guidelines and protocols

• Establish relationships with academic institutions archiving federal health data

Alternative Data Sources

• Connect with state and local health departments to access regional surveillance data

• Utilize medical society and professional organization resources for clinical guidance

• Consider participating in alternative data collection networks being established by research institutions

Advocacy Actions

• Support ongoing legal efforts to restore data access

• Document specific impacts of data loss on care delivery and research

• Engage with professional organizations coordinating preservation efforts

Future Planning

• Develop contingency plans for maintaining essential health surveillance

• Build redundant data collection systems where feasible

• Strengthen partnerships with academic and nonprofit research organizations

These steps cannot fully replace federal health data infrastructure but may help maintain critical public health functions while broader access issues are resolved.

Massive Medicaid Cuts Could Threaten Healthcare Access for Millions

House Republicans are seizing control of both congressional chambers with an ambitious—and deeply concerning—plan to slash 2.3 trillion dollars in Medicaid spending over the next decade. In practice, this amounts to a 31% reduction of the program’s projected federal budget, according to the latest Kaiser Family Foundation (KFF) research. Such sweeping cuts place the more than 72 million Americans who rely on Medicaid in a precarious position, one that’s about much more than line items in a budget.

For people living with HIV (PLWH), the stakes are even higher. Analyses from KFF show Medicaid is the single largest insurer for non-elderly PLWH in the U.S., covering 40% of that population (compared to just 15% of non-elderly adults overall). In FY 2022 alone, federal Medicaid spending on HIV care reached $13 billion, with states contributing $5.4 billion on top. If Republicans follow through on this plan—framed as a way to offset the costs of extending Trump-era tax cuts—it could fundamentally reshape Medicaid, potentially shutting out millions of vulnerable patients who depend on its comprehensive healthcare services.

“Budget hawks love to target public health coverage,” says Jen Laws, CEO of Community Access National Network (CANN). “But the problem is—these programs are largely popular. It’s easy to say ‘cut Medicaid, it’s too expensive,’ right up until people realize they’re cutting care from their own neighbors, relatives, or even themselves. That becomes much harder to navigate.”

As Congress begins deliberating, it’s crucial we understand the scope of these proposed changes—and what they really mean for healthcare access. Below, we examine the biggest potential cuts, the likely fallout for PLWH, and how states and advocates might respond.

The Scope of Proposed Cuts

House Republicans have laid out multiple options for Medicaid reductions that would, if implemented, dramatically change how the program operates. Documents obtained by Axios detail the core proposals:

1. Per Capita Caps on Federal Spending

   • This approach would allot states a fixed dollar amount per enrollee, rather than matching a percentage of state spending. It’s projected to reduce federal outlays by a staggering $918 billion.

2. Lowered Federal Match Rate for ACA Expansion

   • Under current law, the federal government covers 90% of costs for expansion populations. Reducing that match could save $690 billion, but states would either have to find additional funding or roll back coverage. Georgetown University’s Center for Children and Families points out that at least nine states have so-called “trigger laws” that would immediately end Medicaid expansion if federal funds decrease.

3. Restrictions on Provider Taxes

   • Currently, 49 states (all except Alaska) use provider taxes to help fund their share of Medicaid. Under the new plan, capping or eliminating these taxes could slash another $175 billion in federal matching dollars, per Modern Healthcare. This would deal yet another blow to states already scrambling to manage shortfalls from other proposed Medicaid cuts.

4. Work Requirements

   • Proposed work requirements would likely reduce Medicaid spending by $120 billion, but they also risk creating significant coverage gaps. Data from Georgia’s limited program expansion shows that despite 240,000 people being eligible, only 5,500 have enrolled, largely due to red tape and stringent reporting rules (as is the point, one would assume).

These changes coincide with a broader Republican push to extend Trump-era tax cuts that are set to expire at the end of 2025. According to KFF, such a massive reduction in Medicaid funding would force states into agonizing choices: raise taxes, cut benefits or eligibility, or slash provider payments. The ripple effects—from enrollees losing coverage to hospitals losing funding—would be felt nationwide.

Impact on HIV Care Access

For people living with HIV, Medicaid is a lifeline. It provides comprehensive coverage for treatments and medications that keep viral loads in check and reduce transmission risk. According to KFF, the average per-capita spending for PLWH in Medicaid is $13,725, more than triple that of the general Medicaid population ($3,087). This reflects the more complex and intensive nature of HIV-related healthcare needs—especially as nearly half of PLWH enrolled in Medicaid face co-occurring mental health or substance use disorders.

Proposed cuts in federal matching rates could be devastating for states that expanded Medicaid under the ACA. Georgetown’s research suggests many expansion states would consider dropping coverage altogether if the federal share falls below 90%. For PLWH, that would mean losing consistent access to antiretroviral therapy—a move that risks patient health outcomes and undermines national efforts to End The Epidemic.

Meanwhile, work requirements can easily create disruptions in coverage. While 41% of Medicaid enrollees with HIV qualify through disability pathways (versus 11% in the general Medicaid population), others do not—and could find it difficult to maintain strict reporting, particularly if they’re already juggling medical appointments, mental health support, and other stressors. Breaks in treatment, even if temporary, can drive up viral loads and raise transmission rates.

State-Level Implementation Challenges

If the Republican blueprint moves forward, states will carry much of the burden—and we’ve already seen how smaller-scale restrictions can backfire.

• Georgia’s Pathways to Coverage

  • Billed as a work requirement program, it’s enrolled a paltry 5,500 people out of an estimated 240,000 who might qualify. According to the Center on Budget and Policy Priorities (CBPP), nearly half who tried to enroll were derailed by administrative red tape.

• Idaho’s Medicaid Expansion Repeal Bill

  • Legislators claim dropping expansion would save $110 million a year, but Idaho Capital Sun reporting indicates these estimates overlook higher uncompensated care costs and increased strain on county indigent services. That’s aside from the blow to rural hospitals already operating on razor-thin margins.

In many states, providers are sounding the alarm. Modern Healthcare reports that aggressive Medicaid cuts often trigger service reductions or outright hospital closures, particularly in rural communities. This doesn’t just impact Medicaid recipients—it threatens the entire local healthcare ecosystem.

Political and Practical Barriers

Passing massive Medicaid cuts—even under Republican control—may not be smooth sailing. The House majority is razor-thin—and getting thinner with every confirmation hearing—and the Senate offers little cushion. Winning near-unanimous GOP support is a tall order given Medicaid’s popularity and the economic havoc cuts could unleash in members’ home districts.

Healthcare industry players are also mobilizing. Hospitals, in particular, are warning that reduced Medicaid funding could be a death knell for already strained facilities—echoing the outcry from the 2017 attempts to repeal the ACA. Even some conservative legislators with medical backgrounds acknowledge the fragile balance. Rep. Dr. Greg Murphy (R-N.C.) notes he’s wary of undermining critical funding streams in regions he knows personally as a former hospital chief of staff.

Voter sentiment adds another layer. Polling data finds 81% of registered voters oppose Medicaid cuts. Politicians ignoring such broad support risk serious backlash, particularly if cutbacks lead to tangible community harm.

Recommendations and Action Steps

1. Engage State Legislators

   • As budget pressures trickle down, governors and state lawmakers decide how to fill funding gaps. Demonstrating Medicaid’s value—especially for PLWH and patients with complex medical needs—can help stave off drastic rollbacks.

2. Compile and Share Data

   • Hard numbers on how Medicaid boosts public health and supports local economies are powerful. For instance, data on antiretroviral drug spending and hospital closures averted can paint a clear picture of the stakes.

3. Explore Alternatives

   • Rather than flat-out reducing eligibility or coverage, policymakers could invest in value-based care or address core drivers of healthcare costs. It’s about controlling costs thoughtfully rather than shifting them to low-income patients.

4. Stay Involved in Policy Development

   • Because these cuts are complex to implement, there may be opportunities for partial carve-outs or exemptions—if advocates and community groups remain at the table.

Conclusion

Medicaid covers one in five Americans, making it a cornerstone of the nation’s healthcare landscape. With House Republicans proposing deep cuts to offset tax breaks, the question is whether Congress—and voters—will accept a plan that inevitably leaves millions at risk. For PLWH, in particular, the stakes range from basic medication access to broader public health efforts to keep viral loads down and to curb transmission.

Right now, we have an opening to influence how these proposals evolve. Sharing clear data, elevating personal stories, and pressing officials at every level can help preserve the critical supports Medicaid provides. Because ultimately, this isn’t just about budgets—it’s about preserving the health and dignity of countless people who rely on the nation’s largest public health insurance program.

FTC Exposes PBM Price Gouging of Specialty Generic Drugs

The Federal Trade Commission's (FTC) second interim staff report confirms what patient advocates have long suspected: the three largest pharmacy benefit managers (PBM)—CVS Caremark, Express Scripts, and OptumRx—are systematically price-gouging specialty generic drugs, putting profits over patient access to life-saving medications. The report documents how these PBMs abuse their market power to generate billions in excess revenue at the expense of people who rely on these medications to survive.

This comprehensive analysis examines 51 specialty generic drugs—a significant expansion from the two drugs analyzed in the FTC's July 2024 report. The findings are damning: PBM-affiliated pharmacies extracted over $7.3 billion in revenue above estimated acquisition costs for these medications between 2017-2022, with this excess revenue growing at a staggering 42% annual rate. This is not market efficiency—it's profiteering.

The report's unanimous approval by FTC commissioners, including incoming Chair Andrew Ferguson, reflects the undeniable nature of these abusive practices. The evidence shows PBMs are deliberately inflating costs for medications that treat HIV, cancer, multiple sclerosis, and other serious conditions, creating unnecessary barriers to care while padding their own profits. For those of us fighting to protect access to care, this report provides irrefutable evidence that PBM reform cannot wait. The breadth and depth of documented abuses demand immediate action to stop practices that threaten both patient health outcomes and public health goals.

Key Findings: Systematic Price Gouging and Patient Steering

The FTC's analysis exposes a deliberate pattern of excessive markups on specialty generic medications that would be illegal in most other industries. A staggering 63% of specialty generic drugs dispensed by PBM-affiliated pharmacies for commercial health plan members were marked up more than 100% over acquisition costs between 2020 and 2022. Even more egregious, PBMs marked up 22% of these medications by more than 1,000%—an indefensible practice when dealing with life-saving medications.

These markups weren't random—they targeted critical medications across multiple therapeutic categories where patients have few alternatives:

• Cancer treatments: $3.3 billion in excess revenue (44% of total)

• Multiple sclerosis medications: $1.8 billion (25%)

• Transplant medications: $824 million (11%)

• HIV medications: $521 million (8%)

• Pulmonary hypertension treatments: $432 million (7%)

The investigation also uncovered clear evidence of patient steering. While PBM-affiliated pharmacies filled 44% of commercial specialty generic prescriptions overall during 2020-2022, they commandeered 72% of prescriptions for drugs marked up more than $1,000 per prescription. This disparity reveals how PBMs systematically funnel high-profit prescriptions to their own pharmacies.

Beyond these markup practices, PBMs extracted an additional $1.4 billion through spread pricing—billing plan sponsors more than they reimburse pharmacies for medications. Most of this spread pricing revenue (97%) came from commercial prescriptions filled at unaffiliated pharmacies—a clear demonstration of how PBMs exploit their market position to profit from competing pharmacies while simultaneously steering patients to their own dispensing operations. This dual strategy of profiting from independent pharmacies while actively working to put them out of business reveals the anti-competitive impact of vertical integration in the pharmacy sector.

These practices have become central to PBM business models. Operating income from PBM-affiliated pharmacy dispensing of these specialty generic drugs accounted for 12% of their parent healthcare conglomerates' relevant business segment operating income in 2021, up from less than 8% just two years earlier. The top 10 specialty generic drugs alone represented nearly 11% of this operating income.

This isn't a case of a few isolated pricing anomalies. The FTC's analysis reveals a systematic campaign to extract maximum profit from medications people need to survive. These practices have become a major profit center for vertically integrated PBMs, deliberately trading patient access for corporate profits.

The Human Cost: Exploiting HIV Care Access

The FTC's findings expose how PBMs are actively undermining decades of progress in HIV care and prevention. PBMs extracted $521 million in excess revenue from HIV medications alone—representing 8% of total excess revenue despite these drugs comprising a smaller portion of prescriptions. This targeted exploitation of HIV medications reveals a calculated strategy to profit from a vulnerable population.

The FTC report documents troubling markup patterns affecting every level of HIV treatment. Take lamivudine (generic Epivir) as an example - PBM-affiliated pharmacies marked up this essential medication by 168-197% compared to acquisition costs. This level of markup isn't unique to lamivudine but represents a systematic practice affecting the full spectrum of HIV medications, from single-drug therapies to combination treatments. For people living with HIV who often require multiple medications as part of their treatment regimen, these markups create compounding barriers to care access.

Beyond the pricing abuse, PBM steering practices actively disrupt HIV care by forcing people living with HIV away from specialized pharmacies that understand their needs. These community pharmacies provide essential services that PBM-owned pharmacies often fail to match:

• Experienced HIV medication counseling

• Critical adherence support

• Care coordination with HIV specialists

• Navigation of assistance programs

• Culturally competent care

For Medicare Part D beneficiaries living with HIV, the situation is particularly egregious. Despite "any willing pharmacy" protections meant to preserve patient choice, PBMs use discriminatory reimbursement practices to force independent pharmacies to either accept unsustainable payment rates or abandon their patients. This deliberately undermines pharmacies serving communities most impacted by HIV.

PrEP Profiteering

The FTC report reveals perhaps the most cynical PBM practice yet: marking up generic PrEP by over 1,000% above acquisition costs. This price gouging of HIV prevention medication directly sabotages public health efforts to end the HIV epidemic. In an era when expanding PrEP access is critical to preventing HIV transmission, PBMs are creating artificial barriers to a medication that should be becoming more affordable through generic availability.

While the Affordable Care Act requires most private insurance plans to cover PrEP without cost-sharing (for now), PBM markup practices drive up overall healthcare costs through inflated plan sponsor payments. This leads to higher premiums that can make insurance itself unaffordable for many people who need PrEP coverage.

The forced migration to PBM-owned pharmacies compounds the damage by separating people from community pharmacies that have developed comprehensive PrEP care programs. These specialized pharmacies don't just dispense medication - they provide an integrated set of essential services including regular HIV testing, STI screening coordination, adherence support and counseling, benefits navigation, and ongoing coordination with healthcare providers. PBM-owned pharmacies typically lack these specialized services, creating gaps in PrEP care that can affect both initiation and adherence. By disrupting these established care relationships, PBM steering practices threaten the comprehensive support system that helps keep people engaged in PrEP care. The FTC's findings prove that PBM practices are actively working against HIV prevention goals by creating unnecessary barriers to PrEP access and fragmenting PrEP care delivery.

Political Landscape: Reform Momentum Meets Industry Resistance

The unanimous FTC commissioner support for the second interim report, including incoming FTC Chair Andrew Ferguson's concurring statement, reflects the undeniable nature of PBM abuses. President Trump's rhetoric about "knocking out the middleman" suggests potential executive branch support for reform, but previous promises of action on drug pricing require skeptical assessment.

The December 2024 failure of comprehensive PBM reform legislation reveals the industry's continued influence over the legislative process. Despite bipartisan support, PBMs and their allies successfully stripped crucial reforms from the federal funding bill that would have:

• Required pass-through of all rebates to Medicare sponsors and group health plans

• Prohibited excessive billing of Medicaid programs

• Mandated transparency in drug spending practices

• Protected patient choice in pharmacy selection

Current legislative proposals like the PBM Act, introduced by Senators Warren and Hawley, target the fundamental problem of vertical integration by prohibiting joint ownership of PBMs and pharmacies. This structural approach directly addresses the conflicts of interest documented in the FTC report.

While narrow Republican majorities in Congress create opportunities for bipartisan action, the PBM industry's demonstrated ability to derail reform efforts demands sustained advocacy pressure. The challenge isn't finding solutions—it's overcoming industry resistance to implementing them.

State-Level Response: Why Price Controls Miss the Mark

The FTC's detailed analysis of PBM practices provides compelling evidence for why Prescription Drug Affordability Boards (PDABs) are fundamentally misaligned with addressing drug affordability issues. The report documents that PBM-affiliated pharmacies generated over $7.3 billion in revenue above estimated acquisition costs on specialty generic drugs—a problem that stems from markup practices and vertical integration rather than base drug prices.

Take, for example, the pulmonary hypertension drug tadalafil (generic Adcirca). The FTC found that in 2022, while pharmacies purchased the drug at an average cost of $27, PBMs marked it up by $2,079, resulting in a reimbursement rate of $2,106 for a 30-day supply—a markup exceeding 7,700%. A PDAB focusing on upper payment limits would fail to address these markup practices or the steering mechanisms that drive prescriptions to PBM-affiliated pharmacies where such markups occur.

Similarly, the report's findings on multiple sclerosis medications illustrate the inadequacy of the PDAB approach. For dimethyl fumarate (generic Tecfidera), PBMs marked up the drug by $3,753 over its $177 acquisition cost—a 2,100% increase. This markup occurred through PBM practices that PDABs have no authority to regulate or control.

The FTC's analysis of spread pricing further undermines the PDAB model. PBMs generated approximately $1.4 billion through spread pricing on these specialty generic drugs, with 97% coming from commercial claims. PDABs, focused on manufacturer prices rather than PBM practices, would do nothing to address this significant source of cost inflation.

Moreover, PDABs could exacerbate existing market distortions. The report documents that PBM-affiliated pharmacies already handle 72% of prescriptions for drugs marked up more than $1,000 per prescription, despite filling only 44% of commercial specialty generic prescriptions overall. Adding PDAB-imposed price controls could result in pharmacy under-reimbursement. This would be financially detrimental, disproportionately so for independent pharmacies, resulting in pharmacy closures. Pharmacy closures would only increase the market concentration of PBM-affiliated pharmacies. Additionally, a PDAB-imposed Upper Payment Limit (UPL) could lead a PBM to enforce utilization management policies which would increase practitioners' administrative burden.

The evidence demands solutions that directly address PBM pricing practices, vertical integration, and market consolidation—not ineffective state-level price control boards that may actually strengthen PBMs' market position while failing to protect patient interests.

The Path Forward: Ending PBM Abuse

The FTC's comprehensive report demands immediate legislative action to dismantle PBM practices that systematically undermine patient care and inflate healthcare costs. Based on the documented evidence, reform must target three critical areas:

Dismantling Anti-Patient Practices

• Prohibit PBMs from forcing patients into proprietary pharmacy networks

• Ban exclusionary network designs that restrict patient choice

• Eliminate spread pricing mechanisms

• Terminate retroactive pharmacy reimbursement clawbacks

• Prevent prescription steering practices that disrupt established care relationships

Establishing Real Accountability

• Create federal oversight with clear investigative and enforcement powers

• Mandate comprehensive transparency in PBM revenue streams

• Implement rigorous contract review processes for health plans

• Develop meaningful penalties for violations that harm patient care

Protecting Specialized Care

• Guarantee patient pharmacy selection autonomy

• Preserve continuity of care for chronic condition management

• Safeguard community pharmacies providing specialized services

• Ensure access to providers with deep therapeutic expertise

• Protect pharmacies serving vulnerable and marginalized communities

The FTC's findings provide irrefutable evidence of systematic abuse. Ineffective approaches like Prescription Drug Affordability Boards (PDABs) and industry self-regulation have failed. Federal legislation with clear enforcement mechanisms is the only path to stopping these harmful practices and protecting patient access to care.

Healthcare advocates must sustain pressure on Congress and the new administration to implement comprehensive reforms. The time for incremental compromises has passed. We need decisive action to end PBM practices that prioritize corporate profits over patient health.