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.

DoxyPEP's Impact: New Evidence Shows Promise and Challenges in STI Prevention

After nearly two decades of rising sexually transmitted infection (STI) rates in the United States, the Centers for Disease Control & Prevention (CDC) 2023 surveillance report reveals a welcome shift: overall STI rates dropped by 1.8% from 2022 to 2023. Gonorrhea cases declined by 7% for the second straight year, and primary and secondary syphilis fell by 10%—marking the first significant decrease in more than two decades. While these figures offer cautious optimism, questions remain about how best to sustain momentum, especially amid ongoing concerns about antimicrobial resistance and unequal access to prevention resources.

One potentially transformative intervention gaining traction is doxycycline post-exposure prophylaxis (doxyPEP). The CDC’s 2024 guidelines recommend doxyPEP for gay, bisexual, and other men who have sex with men (MSM), as well as transgender women, who have experienced a bacterial STI in the past year. Although clinical trials showed promising efficacy against chlamydia and syphilis, real-world data underscore nuanced challenges related to resistance, health disparities, and local healthcare capacity.

The Changing Landscape of STI Prevention

Several initiatives set the stage for the recent slowdown in STI rates. The American Rescue Plan Act of 2021 provided funding to strengthen the disease intervention specialist workforce, bolstering capacity for targeted contact tracing and clinical follow-up. These efforts were amplified by new CDC recommendations that formalized doxyPEP for specific high-risk groups.

San Francisco became an early adopter of doxyPEP guidelines in October 2022, leveraging its established HIV prevention infrastructure and community partnerships. Early clinical trial data had shown marked drops in chlamydia and syphilis, prompting local officials to adopt prophylactic antibiotic use despite concerns over potential misuse and growing gonococcal resistance. Their experience would soon be mirrored and examined in other healthcare settings.

Real-World Evidence: San Francisco and Kaiser Permanente

Two new studies illuminate the impact of doxyPEP beyond controlled clinical environments. The first, conducted by the San Francisco Department of Public Health, examined STI rates before and after the city’s 2022 adoption of doxyPEP guidelines. Investigators reported a 49.6% drop in chlamydia and a 51.4% decline in early syphilis compared to what forecasts had predicted. Three sentinel STI clinics observed that 19.5% of eligible gay, bisexual, and other men who have sex with men, as well as transgender women, initiated doxyPEP—a relatively high uptake for a new intervention.

A complementary Kaiser Permanente Northern California study included more than 11,000 participants already on HIV pre-exposure prophylaxis (PrEP). Those who added doxyPEP to their prevention repertoire saw chlamydia rates fall from 9.6% to 2.0% every quarter, while syphilis rates declined from 1.7% to 0.3%. These improvements closely mirrored prior clinical trial data, underscoring doxyPEP’s real-world effectiveness in high-risk populations.

However, the two studies diverged in their findings on gonorrhea. San Francisco observed a 25.6% increase in gonorrhea cases among the doxyPEP group, while Kaiser Permanente achieved a modest 12% reduction. Even in the latter setting, the intervention had varying efficacy based on infection site, with minimal impact on pharyngeal gonorrhea. Researchers attribute these discrepancies to existing tetracycline resistance patterns, which can range from 20% in U.S. gonorrhea strains to over 50% in certain regions globally.

Key Challenges to Implementation

1. Antimicrobial Resistance

Chief among concerns is the capacity of gonorrhea and other pathogens to develop resistance to tetracyclines. A modeling study in The Lancet warns that if doxyPEP achieves very high uptake—around 90%—it could lose effectiveness within just 1.6 years. More moderate adoption might prolong utility but still faces the ever-present risk that gonococcal strains could quickly evolve. The tension between scaling up prophylaxis to curb infections and preserving antibiotic utility for the long term remains a core dilemma for public health agencies.

2. Limited Healthcare Infrastructure

Successfully rolling out doxyPEP also requires robust clinical infrastructures. San Francisco’s early adoption relied on specialized STI clinics, disease intervention specialists, and strong community engagement. Such resources are scarce in many rural areas and underresourced urban centers, where STI burdens are often high. Without targeted funding and workforce development, these regions may fail to realize the potential benefits of prophylaxis. This gap underscores why a one-size-fits-all strategy for doxyPEP is unlikely to work uniformly nationwide.

3. Cost and Insurance Access

The Kaiser Permanente experience highlighted how commercial insurance coverage can determine doxyPEP uptake. Though Kaiser found no racial or ethnic disparities in its cohort, the ability to pay for routine tests and antibiotics remains a significant hurdle for many. Nearly half of all new STIs affect patients aged 15–24, a demographic often lacking stable insurance. Safety-net providers, such as community clinics and public health agencies, will need additional resources to prevent cost barriers from fueling inequities in STI prevention.

Addressing Health Equity

Disparities in STI burden persist despite national declines. CDC data show that Black communities—though comprising just 12.6% of the population—face roughly a third of all reported STIs, and American Indian and Alaska Native populations have the highest rates of syphilis. These patterns reflect structural inequities, from healthcare access to economic stability. DoxyPEP, if expanded, could either narrow or widen these gaps, depending on implementation strategies.

For example, the San Francisco Department of Public Health’s success relied on partnerships with community-based organizations that serve LGBTQ+ populations, bilingual outreach, and peer educators who could directly address stigma. Similar culturally tailored approaches will be crucial elsewhere. Nationally, any prophylaxis effort must acknowledge social determinants of health, from limited insurance coverage to historical medical mistrust, as central issues in achieving equitable outcomes.

Policy Recommendations

Meeting these challenges head-on requires collaboration among federal agencies, healthcare systems, and local organizations. Four policy domains stand out:

1. Robust Surveillance and Resistance Tracking

   • Establish or enhance regional testing to promptly detect shifts in gonococcal resistance.

   • Standardize reporting on doxyPEP uptake, stratifying data by race, ethnicity, and insurance status to monitor equity.

2. Integrated Healthcare Delivery

   • Incorporate doxyPEP into existing HIV PrEP programs, leveraging shared clinical workflows for ongoing STI screening.

   • Provide decision-support tools to guide providers in identifying those most likely to benefit from prophylaxis and in understanding local resistance rates.

3. Financing and Insurance Coverage

   • Secure coverage mandates or subsidies so that the costs of antibiotics and regular STI tests do not fall disproportionately on those most at risk.

   • Offer grants or incentives for safety-net clinics to scale up prevention services, including patient education and follow-up testing.

4. Antimicrobial Stewardship and Patient Education

   • Develop guidelines for targeted doxyPEP use to minimize unnecessary exposure—especially for gonorrhea, given its evolving resistance.

   • Emphasize correct usage and follow-up testing in patient education to ensure prophylaxis remains effective and that potential side effects are promptly reported.

Looking Ahead: Balancing Innovation and Stewardship

DoxyPEP’s success in specific cohorts highlights how targeted prophylaxis can substantially reduce chlamydia and syphilis infections. However, higher gonococcal resistance in some locales points to the need for continual surveillance and swift policy adjustments. Achieving a balance between curbing acute STI outbreaks and safeguarding long-term antibiotic effectiveness will require:

• Adaptive Guidelines: Quickly revising prescribing recommendations if local data reveal resistance spikes.

• Equitable Implementation: Ensuring consistent uptake in historically underserved communities, rather than concentrating benefits among those with robust insurance.

• Global Collaboration: Sharing best practices and emerging data to keep pace with evolving gonococcal strains and develop new therapeutic agents or vaccines.

Conclusion

The modest national declines in STI rates are a reminder that with strategic investments and coordinated interventions, progress is possible. DoxyPEP stands out as a promising addition to the prevention toolbox—particularly for chlamydia and syphilis—when backed by sufficient testing, monitoring, and community outreach. Yet the specter of antimicrobial resistance, along with ongoing disparities in healthcare access, underscores that a single biomedical solution must be carefully managed.

Findings from San Francisco and Kaiser Permanente prove doxyPEP can effectively reduce STI incidence in real-world settings. Whether it remains a durable tool will depend on collective commitment: policymakers must fund surveillance and outreach, clinicians must practice stewardship, and communities must engage to ensure equitable access. If implemented wisely, doxyPEP could shape a future where the burden of STIs—and the inequalities that fuel them—diminish, showcasing how targeted prevention strategies can enhance public health without jeopardizing our arsenal of antibiotics.

When Algorithms Deny Care: The Insurance Industry's AI War Against Patients

The assassination of UnitedHealthcare CEO Brian Thompson in December 2024 laid bare a healthcare crisis where insurance companies use artificial intelligence to systematically deny care while posting record profits. Federal data shows UnitedHealthcare, which covers 49 million Americans, denied nearly one-third of all in-network claims in 2022 - the highest rate among major insurers.

This reflects an industry-wide strategy that insurance scholar Jay Feinman calls "delay, deny, defend" - now supercharged by AI. These systems automatically deny claims, delay payment, and force sick people to defend their right to care through complex appeals. A Commonwealth Fund survey found 45% of working-age adults with insurance faced denied coverage for services they believed should be covered.

The consequences are devastating. As documented cases show, these automated denial systems routinely override physician recommendations for essential care, creating a system where algorithms, not doctors, decide who receives treatment. For those who do appeal, insurers approve at least some form of care about half the time. This creates a perverse incentive structure where insurers can deny claims broadly, knowing most people will not fight back. For the people trapped in this system, the stakes could not be higher - this is quite literally a matter of life and death.

The Rise of AI in Claims Processing

Health insurers have increasingly turned to AI systems to automate claims processing and denials, fundamentally changing how coverage decisions are made. A ProPublica investigation revealed that Cigna's PXDX system allows its doctors to deny claims without reviewing patient files, processing roughly 300,000 denials in just two months. "We literally click and submit. It takes all of 1.2 seconds to do 50 at a time," a former Cigna doctor reported.

The scope of automated denials extends beyond Cigna. UnitedHealth Group's NaviHealth uses an AI tool called "nH Predict" to determine length-of-stay recommendations for people in rehabilitation facilities. According to STAT News, this system generates precise predictions about recovery timelines and discharge dates without accounting for people's individual circumstances or their doctors' medical judgment. While NaviHealth claims its algorithm is merely a "guide" for discharge planning, its marketing materials boast about "significantly reducing costs specific to unnecessary care."

Only about 1% of denied claims are appealed, despite high rates of denials being overturned when challenged. This creates a system where insurers can use AI to broadly deny claims, knowing most people will not contest the decisions. The practice raises serious ethical concerns about algorithmic decision-making in healthcare, especially when such systems prioritize cost savings over medical necessity and doctor recommendations.

Impact on Patient Care

The human cost of AI-driven claim denials reveals a systemic strategy of "delay, deny, defend" that puts profits over patients. STAT News reports the case of Frances Walter, an 85-year-old with a shattered shoulder and pain medication allergies, whose story exemplifies the cruel efficiency of algorithmic denial systems. NaviHealth's algorithm predicted she would recover in 16.6 days, prompting her insurer to cut off payment despite medical notes showing she could not dress herself, use the bathroom independently, or operate a walker. She was forced to spend her life savings and enroll in Medicaid to continue necessary rehabilitation.

Walter's case is not unique. Despite her medical team's objections, UnitedHealthcare terminated her coverage based solely on an algorithm's prediction. Her appeal was denied twice, and when she finally received an administrative hearing, UnitedHealthcare didn't even send a representative - yet the judge still sided with the company. Walter's case reveals how the system is stacked against patients: insurers can deny care with a keystroke, forcing people to navigate a complex appeals process while their health deteriorates.

The fundamental doctor-patient relationship is being undermined as healthcare facilities face increasing pressure to align their treatment recommendations with algorithmic predictions. The Commonwealth Fund found that 60% of people who face denials experience delayed care, with half reporting their health problems worsened while waiting for insurance approval. Behind each statistic are countless stories like Walter's - people suffering while fighting faceless algorithms for their right to medical care.

The AI Arms Race in Healthcare Claims

Healthcare providers are fighting back against automated denials by deploying their own AI tools. New startups like Claimable and FightHealthInsurance.com help patients and providers challenge insurer denials, with Claimable achieving an 85% success rate in overturning denials. Care New England reduced authorization-related denials by 55% using AI assistance.

While these counter-measures show promise, they highlight a perverse reality: healthcare providers must now divert critical resources away from patient care to wage algorithmic warfare against insurance companies. The Mayo Clinic has cut 30 full-time positions and spent $700,000 on AI tools simply to fight denials. As Dr. Robert Wachter of UCSF notes, "You have automatic conflict. Their AI will deny our AI, and we'll go back and forth."

This technological arms race exemplifies how far the American healthcare system has strayed from its purpose. Instead of focusing on patient care, providers must invest millions in AI tools to combat insurers' automated denial systems - resources that could be spent on direct patient care, medical research, or improving healthcare delivery. The emergence of these counter-measures, while potentially helpful for providers and patients seeking care, highlights fundamental flaws in our healthcare system that require policy solutions, not just technological fixes.

AI Bias: Amplifying Healthcare Inequities

The potential for AI systems to perpetuate and intensify existing healthcare disparities is deeply concerning. A comprehensive JAMA Network Open study examining insurance claim denials revealed that at-risk populations experience significantly higher denial rates.

The research found:

• Low-income patients had 43% higher odds of claim denials compared to high-income patients

• Patients with high school education or less experienced denial rates of 1.79%, versus 1.14% for college-educated patients

• Racial and ethnic minorities faced disproportionate denial rates:

  • Asian patients: 2.72% denial rate

  • Hispanic patients: 2.44% denial rate

  • Non-Hispanic Black patients: 2.04% denial rate

  • Non-Hispanic White patients: 1.13% denial rate

The National Association of Insurance Commissioners (NAIC) Consumer Representatives report warns that AI tools, often trained on historically biased datasets, can "exacerbate existing bias and discrimination, particularly for marginalized and disenfranchised communities."

These systemic biases stem from persistent underrepresentation in clinical research datasets, which means AI algorithms learn and perpetuate historical inequities. The result is a feedback loop where technological "efficiency" becomes a mechanism for deepening healthcare disparities.

Legislative Response and Regulatory Oversight

While California's Physicians Make Decisions Act and new Centers for Medicare & Medicaid Services (CMS) rules represent progress in regulating AI in healthcare claims, the NAIC warns that current oversight remains inadequate. California's law prohibits insurers from using AI algorithms as the sole basis for denying medically necessary claims and establishes strict processing deadlines: five business days for standard cases, 72 hours for urgent cases, and 30 days for retrospective reviews.

At the federal level, CMS now requires Medicare Advantage plans to base coverage decisions on individual circumstances rather than algorithmic predictions. As of January 2024, coverage denials must be reviewed by physicians with relevant expertise, and plans must follow original Medicare coverage criteria. CMS Deputy Administrator Meena Seshamani promises audits and enforcement actions, including civil penalties and enrollment suspensions for non-compliance.

The insurance industry opposes these safeguards. UnitedHealthcare's Medicare CEO Tim Noel argues that restricting "utilization management tools would markedly deviate from Congress' intent." But as the NAIC emphasizes, meaningful transparency requires more than superficial disclosures - insurers must document and justify their AI systems' decision-making criteria, training data, and potential biases. Most critically, human clinicians with relevant expertise must maintain true decision-making authority, not just rubber-stamp algorithmic recommendations.

Recommendations for Action

The NAIC framework provides a roadmap for protecting patients while ensuring appropriate oversight of AI in healthcare claims. Key priorities for federal and state regulators:

• Require comprehensive disclosure of AI systems' training data, decision criteria, and known limitations

• Mandate documentation of physician recommendation overrides with clinical justification

• Implement regular independent audits focused on denial patterns affecting marginalized communities

• Establish clear accountability and substantial penalties when AI denials cause patient harm

• Create expedited appeal processes for urgent care needs

Healthcare providers should:

• Document all cases where AI denials conflict with clinical judgment

• Track patient impacts from inappropriate denials, including worsened health outcomes

• Report systematic discrimination in algorithmic denials

• Support patient appeals with detailed clinical documentation

• Share denial pattern data with regulators and policymakers

The solutions cannot rely solely on technological counter-measures. As the NAIC emphasizes, "The time to act is now."

Conclusion

The AI-driven denial of care represents more than a technological problem - it's a fundamental breach of the healthcare system's ethical foundations. By prioritizing algorithmic efficiency over human medical judgment, insurers have transformed life-saving care into a battlefield where profit algorithms determine patient survival.

Meaningful change requires a multi-pronged approach: robust regulatory oversight, technological accountability, and a recommitment to patient-centered care. We cannot allow artificial intelligence to become an instrument of systemic denial, transforming healthcare from a human right into an algorithmic privilege.

Patients, providers, and policymakers must unite to demand transparency, challenge discriminatory systems, and restore the primacy of human medical expertise. The stakes are too high to accept a future where lines of code determine who receives care and who is left behind. Our healthcare system must be rebuilt around a simple, non-negotiable principle: medical decisions should serve patients, not corporate balance sheets.

Jen’s Half Cents: On Prognostication and Pragmatism

Much has been made over the 2024 election results and the expected two, if not four, years that we’ve already begun to enter.

On the day this blog publishes, those results will be certified by the 119th Congress. Despite expected heavy snow fall, by law, there is no discretion on the day and time in which certification of the electoral college must occur.

And, I suppose, this is an apt metaphor for how much of the American public might be feeling about our upcoming political experience. If Scott Gottlieb’s recent Washington Post column about the bird flu threat is any indication, this feeling is certainly the air hanging heavy over the heads of public health and healthcare policy experts and advocates nationwide, regardless of their subject matter focus or political alignment. To say the least, much prognostication has occurred in the last two months.

For a brief but pointed background, the 118th Congress had the opportunity to close out the session with broadly popular ideas via a continuing funding resolution (often referred to as a “CR”). Included was a prohibition on managed care organization spread pricing and 340B Program abuses in Medicaid, significant PBM reform, several child cancer bills, and more. Not all provisions were wildly popular - the “third rail” of American politics, a Congress pay raise, was also included. Importantly, of the “good” pieces of the now-dead CR, several were items the incoming President had championed less than 48 hours prior to his most noted advisors taking to their social media platform of choice and riling a ready public. A good but imperfect bill, which would have returned more than $5 billion to the American public and government, died in a spectacle that even just two years prior would have been unimaginable.

Many and notable elected Representatives have referenced Voltaire’s infamous “Le mieux est l’ennemi du bien” (“The best is the enemy of good” or “Can’t let perfect be the enemy of good”) in negotiating critical legislation during a tightly divided government. There is a pragmatism to this wisdom that conflicts with ideological opposition to “compromise”. The logic goes “if you start from a place of compromise, you’re always going to lose",” or “Compromise means you’re giving up on meeting your ideals” and both of those things are absolutely true in terms of short-term investments. They are necessary truths in a country of an estimated 334.9 million souls, all with deeply held, even if sometimes morally repugnant, ideals. That does not change the necessity of pragmatism to achieve functionality. “Burn it all down” - the Purge, if you will - will only ever serve those already with the means to survive and thrive; it’s us peasant left to fight for our lives, after all.

That does not mean we should not strive to achieve our Promise as a country. Rather, it means that every step we take will also always be someone else’s “increment”, not matter how big or small and that the nature of “progress” is taking steps.

Shortly before the year turned, Jimmy Carter died. An unquestionably Good Man whose legacy as a President was, at best, challenging. Carter was not necessarily known as a “favorite” among his Presidential peers. Anchored to his ethics, the Peanut Farmer shattered some of the secrecy of the Presidency and championed ethical progress above all else, while building a stronger, more collaborative executive branch. Less a cornerstone of his legacy in terms of “pop” culture, Carter’s mark on how Americans experience healthcare and public health access can only be accounted as indelible. The 39th President of the United States is rightly credited for shaping the debates we have in healthcare today - for the better. From wanting broad access in a private-public program for every resident of this country to recognizing a need to ensure that access did not amount to a blank check for hospitals to readily recognizing that access meant rural and mental providers via community health centers, Carter did not blink at the necessity of pragmatic reforms. Indeed, beyond renaming the Department of Health, education, and Welfare to the agency we know today as Health and Human Services, Carter established one of the most essential regulatory and bodies in healthcare - the Health Care Financing Administration or, as it’s known today, the Centers for Medicare and Medicaid Services (CMS).

He was…thoughtful.

And so, rather than prognosticating about what bills we will and will not, or how often they’ll get yanked because of a whim as strong and reliable as a limp noodle, I would like to open 2025 encouraging our readers, friends, and colleagues to consider what “pragmatism” might look like as we work to defend access to care, HIV programs, health and human rights, and our neighbors more deeply affected by prejudices and inequity than ourselves.

In Times of Uncertainty, Remember Your Values

Last week, the boards for Community Access National Network and ADAP Advocacy met with various partners and our respective staff and consultants to discuss the future. As with all things around prognostication, our collective crystal balls are hazy and the future remains uncertain, but not without opportunity.

I want to recognize the tension and fear many of our community members are facing and will continue to face…the tangible harms some of us will realize in the years to come. I also want to acknowledge that those fears come from harms many of us have felt in years prior.

In reflecting on the meeting, I felt rooted in a simple fact, one I hope to come back to many times as we navigate the waters ahead: In times of uncertainty, we must find ourselves as deeply tied to our values as ever. Our actions must reflect those values individually and collectively. To each organization’s board members who righteously reminded the group of these things: thank you.

The policy landscape of 2025 and the future thereafter is likely to be rife with new and old challenges. Decisions from the United States Supreme Court will increase the healthcare ecosystem’s penchant for litigation, which will leave certain policy-making in the hands of judicial officers rather than policy experts. How much? We’re going to learn. And, frankly, this is true even outside of healthcare as a sector of advocacy. All advocacy organizations will grapple with the notion of regulatory changes that can be held to a jury trial and where agency deference is limited. This does not mean advocacy no longer has a role between corporate interests and attorneys. Rather it means advocacy must focus on compelling arguments and investing in relationships with public interest firms to ensure the public’s true interests, rather than the government’s or corporate interests, are centered in arguments and outcomes. In many ways, this operational assessment is not different from rule-making and regulatory engagement.

To that end, this is also not the first time advocacy, HIV-advocacy specifically, has faced a necessity to consider our non-partisan and bipartisan origins. Collectively and within our institutional and historical knowledge, we know how to identify allies of all stripes. We know how to align ourselves on narrow policy and program issues while also not endorsing harmful policy from the same people with whom we find those narrow alliances.

At the end (and beginning) of the day, certain truths remain:

• We come from a long history of advocacy with the passion of activists whose legacies we must honor.

• We have the expertise this moment demands and we must ensure that expertise is extended to newer partners.

• HIV exists and thrives in social environments of stigma and privilege. Much of the health equity fight can find roots and advancements in HIV.

• Ending the HIV Epidemic in the United States will require returning public trust in science and investment abroad. Health equity does not end at our borders.

• Other health crises will arise as we continue this fight.

• All policy matters - elevating HIV as a critical symptom of tertiary policy issues is both noble and effective. To that end, finding a balance in an organization’s primary mission and tertiary issues can be challenging.

• Our communities are exhausted. As advocacy organizations, we have a duty to our served constituents to not “ring bells” which do not yet need to be rung. As we struggle with our capacity limitations, we must also recognize the emotional capacity limitations of those we advocate on behalf of.

• The time has already arrived to invest in the next generation of advocacy leadership. Legacy advocacy organizations must invest in succession planning and our funding sources must be willing to take risks in these investments as well. We will not change the current state of our shared stories by doing things as we have always done them. It’s time to step into the future together.

In all fairness, I want to close out this year sharing some significant investments CANN has made. CANN has been on a “growth” track for the last three years. Our funding has increased, our number of funders has increased, and our presence in state-based advocacy has increased. Some of funding partners and new community partners are not specifically involved in HIV advocacy, they do however, recognize the intersection of our shared interests in healthcare and public health policy. Their willingness to invest in CANN and take those risks is well and truly appreciated. Additionally, ensuring the “national” in our name is not limited to federal advocacy is deeply important to anchoring into our values. We do, of course, continue to advocate on federal issues and expect to expand on federal work in 2025.

CANN’s growth also includes bringing on new consultants. We have historically prioritized identifying patient community members who have an entrepreneurial spirit, passion for policy, and a thriving desire to improve the world around them as potential talent to draw from, regardless of formal education. Our singular recognition in these priorities is that in order to improve patient-community lives, policy solutions must originate from patients themselves.

In 2024, we welcomed Travis Manint as our permanent blogger and he will be taking on some additional administrative responsibilities in helping CANN maintain our quality of work product as we grow. Ranier Simons also joined CANN in a more full-time capacity tackling the pressing issues of state-based Prescription Drug Affordability Boards (PDABs) and their threat to the Ryan White program, other safety-net providers, independent pharmacies, and vulnerable patients, including people living with HIV or other potentially disabling health conditions. Ranier has also spearheaded developing work on Pharmacy Benefit Manager (PBM) reform and PBM oversight and investigative activities on both the federal and state levels. Ensuring government bodies are fully aware of the unique aspects of the healthcare ecosystem and supply chain is a core activity for us. We also welcomed Kalvin Pugh to the team as our state-based 340B policy specialist. Kalvin is already off to a strong start representing patient interests via testimony in Michigan and updating data on CANN’s 340B Action Center. We remain well-served by our business consultant, Brandon M. Macsata, and have sincerely enjoyed the event coordination services provided by Amanda Kornegay. Dave Mickler, Sergio Gomez, and David Spears have readily worked to ensure CANN’s website, infographics, and educational videos represent CANN’s “best side”. Lastly, and certainly not least, the team at Perry Communications has made deep investments in helping CANN’s message and priorities land in front of the right eyes - patients and policymakers alike.

When I accepted the position of CEO of CANN, I emphasized a deep desire to ensure our partners and community can feel proud of work - that we can and do readily honor Bill Arnold’s legacy while also stepping up to and meeting today’s needs. It is with the sweat equity of these truly remarkable human beings that I am as confident that CANN will continue to meet this priority. Speaking for myself, I am proud of the team CANN has brought together - every person - and the work we’ve brought forward this year

In a season of uncertainty, the entire CANN team, from our board members to our staff and consultants, helps us all remain committed to our values.

Healthcare in the Lame Duck

Lawmakers have returned to Washington for what many observers predict will be a subdued lame duck session. With former President Donald Trump set to return to the White House in January 2025 and Republicans poised to control both chambers of Congress in the new session, the current Democratic-led Congress faces tough decisions about which healthcare priorities can realistically advance before the year ends. Given these shifting dynamics and a continuing resolution set to expire on December 20th, many healthcare stakeholders are closely watching to see if a handful of critical policies—ranging from Medicare telehealth extensions to community health center funding—will receive even short-term relief.

Multiple programs tied to patient access and affordability are slated to expire on December 31, 2024. These include expanded Medicare telehealth flexibilities, community health center (CHC) funding, and measures preventing Medicaid Disproportionate Share Hospital (DSH) payment reductions. Efforts to stabilize Medicare physician payments, address pharmacy benefit manager (PBM) practices, and implement site-neutral payment reforms are also on the table. However, the political uncertainty, combined with constrained legislative days and an incoming administration that may set different healthcare priorities, create a complex landscape for deciding which items are addressed before the new year.

The Broader Political Context

The upcoming change in leadership is already influencing legislative calculations. Republicans, who will soon have unified control in 2025, may choose to defer major reforms or costly extensions until they can shape policy more extensively under the incoming Trump Administration. Analysts suggest that lawmakers will likely focus on minimal, must-pass measures to keep essential programs afloat while leaving more sweeping changes to the next Congress.

Several sources point to a “lamer-than-usual” lame duck session, with meaningful healthcare legislation potentially limited to urgent deadlines. The December 20th government funding cutoff provides a possible vehicle for limited healthcare fixes. Short-term extensions—buying mere months, rather than years—are a likely reality. During this time, people living with chronic conditions, those receiving services at safety-net providers, and people living in rural areas risk seeing uncertainty in care continuity if Congress cannot secure even interim solutions.

The incoming administration’s planned appointments to health agencies and global health leadership changes could realign federal priorities. While the previous administration’s approach emphasized a strong response to public health emergencies, the incoming leadership has signaled greater skepticism toward traditional vaccine policies and may focus less on infectious disease prevention, shifting attention toward other areas of healthcare. As a result, the current Congress may feel pressure to secure patient protections now, anticipating policy moves in 2025 that could reduce certain resources or alter public health strategies.

Must-Pass Healthcare Extensions: Preserving Patient Access Before 2025

Medicare Telehealth Flexibilities

One of the most urgent healthcare priorities involves extending Medicare telehealth flexibilities set to expire on December 31st. Initially expanded during the COVID-19 public health emergency, these provisions have allowed Medicare beneficiaries—including those in rural and underserved communities—to receive certain types of care without the geographic and site restrictions that once applied. The expansion has played a significant role in maintaining continuity of care, especially for behavioral health and chronic disease management services. A House Energy & Commerce Committee proposal would extend these provisions for two years, enabling policymakers to gather more data on telehealth’s cost and quality impact.

A permanent expansion faces a cost barrier. While telehealth enjoys bipartisan support, the price tag remains a challenge to achieving a long-term fix. Thus, a short-term extension appears the most likely outcome. If Congress allows the telehealth provisions to lapse, people who have integrated virtual visits into their healthcare routines—particularly for managing conditions such as HIV—might lose access to services they have come to rely on. This would create new hurdles for maintaining adherence to treatment regimens and managing ongoing care.

Medicare Physician Payment Stabilization

Another pressing issue involves Medicare physician payment rates. Under the current trajectory, doctors face a 2.83% pay cut in 2025—a continuation of multiple consecutive years of reimbursement reductions. Physician groups and bipartisan coalitions in Congress support a Medicare payment stabilization bill that would offset these reductions. Yet cost considerations and the search for budgetary offsets loom large.

Some policymakers view site-neutral payment reforms—discussed later—as a potential “pay-for” to fund these physician payment patches. The prospect of linking physician payment relief with spending cuts elsewhere may shape what Congress accomplishes now. Without a temporary fix, physicians in rural and lower-resource areas might limit the number of Medicare beneficiaries they see, potentially shrinking access to care just as winter months and other public health challenges approach.

Community Health Centers and Safety-Net Providers

CHCs, serving roughly 31 million people, face potential disruptions if their funding authorization expires at year’s end. According to George Washington University research, CHCs often operate on thin margins and rely heavily on federal support. Any gap in funding could mean reduced primary care services, delayed hiring or retention of medical staff, and less capacity to serve people who rely on these centers as their primary healthcare access point.

Medicaid DSH payments, which help hospitals serving people with lower incomes and those living in poverty, also face cuts. Without legislative action, an $8 billion reduction in DSH payments could take effect. Advocacy groups and hospital associations warn that this could erode crucial parts of the healthcare safety net, limiting services at facilities that care for populations disproportionately affected by chronic conditions and economic instability.

The lame duck session provides a narrow window to secure short-term extensions, preserving CHC and Medicaid DSH programs into early 2025. Lawmakers must balance competing priorities, including the need for cost offsets, making it uncertain whether robust, multi-year reauthorizations are possible. With Republicans waiting to implement their policy vision next year, the likely outcome may be modest stopgaps rather than a long-term solution.

Uncertainty for Other Key Programs: Ryan White and PEPFAR

Beyond the well-known year-end deadlines, advocates are also paying attention to larger federal programs that were previously reauthorized but now continue largely through appropriations. The Ryan White HIV/AIDS Program and the President’s Emergency Plan for AIDS Relief (PEPFAR) have historically enjoyed bipartisan support, delivering life-saving care, treatment, and prevention services for people living with HIV in the U.S. and abroad. However, as the next Congress and Administration look to reduce spending, longstanding programs that rely on continued federal investment but lack recent formal reauthorization could come under scrutiny.

Advocates fear that with a new majority eager to trim budgets and revisit healthcare spending priorities, both Ryan White and PEPFAR could face more critical examination. While no immediate action on these programs is expected in the lame duck session, their future stability may depend on how the incoming leadership chooses to address them in the months ahead. This uncertainty raises concerns in public health communities that rely on these programs to maintain progress in HIV prevention, treatment retention, and global health collaborations.

PBM Reform and Drug Pricing: A Fleeting Opportunity?

Pharmacy Benefit Managers have drawn increasing scrutiny from Congress for pricing practices that, according to some analyses, drive up medication costs and limit access to necessary prescriptions. There has been a rare display of bipartisan interest in addressing PBM transparency. The House-passed Lower Costs, More Transparency Act—referenced by Mercer—offers a framework for imposing new reporting requirements on PBMs and prohibiting certain practices like spread pricing in Medicaid.

Recent Federal Trade Commission (FTC) actions against the largest PBMs underscore these concerns. The FTC’s administrative complaint alleges that PBM rebating structures inflate medication costs, impairing access to more affordable alternatives. Policymakers, patient advocates, and public health officials have pointed out that PBM practices may particularly affect people living with HIV and other chronic conditions, who depend on stable access to medications. Restrictions like mandatory mail-order pharmacy rules can disrupt continuity of care, especially for those who require regular medication management.

Still, significant PBM reforms may not pass during the lame duck session. Republicans may prefer to tackle drug pricing and PBM oversight under their upcoming majority, potentially shaping legislation more to their liking. If any PBM-related measures pass now, they will likely serve as incremental changes or as offsets for other healthcare priorities rather than representing the comprehensive reform that some lawmakers and patient advocates seek.

Site-Neutral Payment Reforms: A Budgetary Lever

One of the most closely watched and potentially transformative policy changes up for discussion involves site-neutral payment reforms. Current Medicare regulations often allow higher reimbursements for services delivered at off-campus hospital outpatient departments compared to physician offices or ambulatory surgical centers. Hospitals justify these higher rates based on overhead and regulatory requirements, but policymakers, backed by advisors like the Medicare Payment Advisory Commission (MedPAC), have increasingly called for aligning payments across settings to reduce unnecessary spending.

According to Modern Healthcare reporting, robust site-neutral legislation could save over $100 billion over ten years. This makes the policy attractive as a funding mechanism—lawmakers can use those savings to pay for other priorities like extending telehealth, stabilizing Medicare physician payments, or preserving safety-net funding.

In previous Congresses, only modest site-neutral measures advanced. However, the political environment has changed. Analysts note that with a unified Republican government in 2025, policymakers may be more inclined to pass significant site-neutral reforms to secure long-term savings. During the lame duck session, a narrow measure included in the bipartisan Lower Costs, More Transparency Act—requiring site-neutral payments for certain drug administration services—could move forward as a pay-for. This smaller step might pave the way for broader reforms next year.

Hospitals, supported by the American Hospital Association, strongly oppose site-neutral policies, arguing these cuts would limit their ability to provide comprehensive services. Some advocates worry that reducing hospital outpatient department payments could disproportionately affect rural and underserved areas, threatening access to care if hospitals respond by consolidating or reducing less profitable services. Congress must weigh these concerns against the promise of substantial cost savings. Whether any notable site-neutral measures pass now or wait until next year remains uncertain.

The Upcoming Administration: Implications for Public Health Priorities

By early 2025, incoming administration appointees will shape federal healthcare priorities. As PBS NewsHour reports, the Administration’s picks signal possible skepticism toward established vaccine policies and a shift in public health approach, potentially reducing the emphasis on infectious disease prevention that guided previous eras. Meanwhile, experts warn that changes could weaken U.S. influence on global health initiatives.

This shifting focus could impact ongoing campaigns to address HIV and other chronic or communicable conditions. Without consistent federal direction and robust support, gains made under established programs may not be sustained. Advocates hope that at least some lame duck extensions can preserve the foundation of existing programs—like telehealth and CHCs—helping insulate vulnerable communities from policy swings that may come with new leadership.

Programs like Ryan White and PEPFAR, which have maintained strong bipartisan support in the past, could face new scrutiny in an environment where budget discipline and re-examining unreauthorized programs take center stage, potentially embroiling these critical pillars of HIV care and prevention in broader spending debates.

Navigating Short-Term Extensions and Long-Term Implications

Analysts predict a restrained legislative approach during the lame duck, with lawmakers likely settling for short-term solutions to avert immediate disruptions rather than enacting comprehensive reforms. This approach may feel unsatisfying to those seeking lasting certainty, but it can prevent sudden gaps in coverage and services while buying time to reassess priorities in 2025.

For example, a brief funding extension for CHCs or a short-term continuation of telehealth flexibilities could prevent abrupt care disruptions. Telehealth has already proven critical for expanding access to behavioral health services, and federal agencies have now taken further steps to preserve this access. The U.S. Drug Enforcement Administration (DEA) and U.S. Department of Health and Human Services (HHS) recently extended telemedicine flexibilities for prescribing Schedule II-V controlled substances through the end of 2025. This marks the third extension of pandemic-era policies that allow practitioners to prescribe controlled medications—such as suboxone (used in opioid use disorder treatment)—via telemedicine without an in-person evaluation. Retaining these flexibilities, even if temporary, helps sustain harm reduction efforts and essential treatment access for those managing substance use disorders.

A modest Medicare physician payment patch could also preserve provider participation while deeper structural reforms are debated. On the revenue side, modest site-neutral tweaks may generate savings to fund these stopgaps without forcing lawmakers to finalize wide-ranging changes immediately.

Meanwhile, Democrats have floated extending Affordable Care Act subsidies in a potential year-end health deal that also includes telehealth extensions and incremental improvements in physician reimbursements. Such proposals face uncertainty as Republicans prepare to take full control in 2025, but even short-term deals could maintain coverage gains and service expansions that benefit people managing chronic conditions and those relying on affordable insurance options.

Given the incoming administration’s focus on spending and efficiency, it may be prudent for stakeholders to identify areas where reducing waste, redundancy, or abuse is possible—particularly within large, long-standing programs. Offering proactive solutions aligned with fiscal priorities, while demonstrating that essential services remain intact, could help preserve support for programs like Ryan White. This approach allows advocates to show policymakers that sustained funding can go hand-in-hand with accountability and cost-effectiveness, paving the way for more secure, long-term access to critical healthcare services.

Actions for Advocates and Public Health Officials

1. Engage Legislators Before December 20th:

   With deadlines looming, advocates can communicate the importance of even short-term extensions for telehealth, CHC funding, and Medicare physician payment stabilization. Stressing the immediate impact of allowing these programs to expire can help secure stopgap measures.

2. Highlight Evidence and Outcomes:

   Data-driven arguments can persuade legislators that certain policies merit continued investment. For example, demonstrating that telehealth has improved access in rural areas or that CHCs reduce costly emergency department visits can make a compelling case for sustained support.

3. Prepare for 2025 Debates:

   The new Congress will likely reassess programs ranging from telehealth expansions to broader HIV initiatives like Ryan White and PEPFAR. Advocates should cultivate coalitions and gather patient stories now, ensuring they can respond effectively to future proposals that may challenge established healthcare priorities. By proactively preparing data and first-person accounts, stakeholders can better influence upcoming debates.

4. Monitor Agency Leadership and Policy Shifts:

   Staying informed about new federal health agency leaders and their public statements helps anticipate changes in priorities. Understanding where the Administration might diverge from past practice can help advocates and providers design strategies to maintain access and care quality—even if federal emphasis shifts away from certain public health initiatives.

Conclusion

December 2024 places the U.S. healthcare landscape at a turning point. The lame duck session unfolds under a cloud of political transition, with an incoming administration and unified Republican control set to reshape policy debates. Lawmakers face a stacked agenda of expiring programs and urgent healthcare needs but may opt only for minimal extensions that maintain the status quo for now.

Decisions made in these final weeks of 2024—from temporary telehealth fixes to short-term CHC funding—will determine how seamlessly care continues into the new year. As Congress weighs sites of service, physician reimbursements, PBM practices, and the future of critical programs like Ryan White and PEPFAR, advocates must remain engaged. The approaching shift in power and priorities adds urgency to even the smallest policy wins now, as they may offer a critical foundation to protect patient access and maintain progress on significant public health initiatives in a potentially more challenging political climate.

New CDC Data Shows Progress on STI and Overdose Prevention

New data from the Centers for Disease Control and Prevention (CDC) marks the first significant declines in both sexually transmitted infections (STIs) and drug overdose deaths after nearly two decades of consistent increases. According to CDC's 2023 STI surveillance report, STI rates have decreased by 1.8% from 2022 to 2023, while provisional data through June 2024 indicates a 14.5% decline in national overdose deaths compared to the previous year. These improvements highlight the impact of recent targeted public health interventions, but significant barriers remain, especially in underserved populations and high-burden regions. The incoming Trump Administration's approach to public health funding raises concerns about the stability of these gains, as political shifts can lead to funding uncertainties and program disruptions.

A Closer Look at the STI Data

The CDC's 2023 STI surveillance report reveals encouraging improvements across several key metrics. Gonorrhea cases declined by 7.2%, falling below pre-pandemic levels, and primary and secondary (P&S) syphilis cases decreased by 10.2%, marking the first substantial decline in over two decades. Perhaps most notably, the rate of congenital syphilis increase slowed significantly to 3% compared to previous annual increases of up to 30%.

Despite these positive trends, persistent disparities continue to be a significant concern. Young people aged 15-24 years account for 48.2% of all reported STI cases, although they represent only 25% of the sexually active population. Gay, bisexual, and other men who have sex with men (MSM) remain disproportionately affected, making up 32.7% of all P&S syphilis cases in 2023. Racial and ethnic disparities are also evident, with Black and American Indian/Alaska Native populations experiencing significantly higher rates of all measured STIs compared to other groups.

Geographic disparities further complicate the picture. The South and West regions of the United States report the highest STI rates, with limited testing accessibility and healthcare infrastructure contributing to these regional differences. Targeted prevention measures in high-burden regions will be critical to further reducing these disparities and sustaining progress.

Progress in Overdose Prevention

CDC provisional data through June 2024 indicates a significant decline of 14.5% in national drug overdose deaths compared to the previous year. Forty-five states report decreases in overdose deaths, with North Carolina, Nebraska, and West Virginia showing the most notable reductions of 30%, 23%, and 19%, respectively. However, five Western states continue to report increases, highlighting ongoing geographic disparities in overdose prevention effectiveness.

One of the key factors contributing to these improvements is the expanded access to naloxone, particularly after its approval for over-the-counter use in March 2023. Increased naloxone availability, paired with interventions to reduce solitary drug use, is estimated to have the potential to reduce overdose deaths by up to 37.4%.

Despite this progress, access to overdose prevention services remains inconsistent. Rural areas, especially in the Western United States, face unique challenges due to limited availability of treatment options and prevention tools. This calls for more targeted interventions to bridge the gap between urban and rural areas.

Federal Investments and Policy Shifts

Recent federal funding initiatives signal a strategic shift towards integrated prevention approaches. The Biden Administration's $65.7 million prevention and treatment package, announced in August 2024, emphasizes coordinated responses to overlapping public health challenges, including STIs and substance use disorders. Of this, $27.5 million is specifically allocated for substance use prevention services across states, local governments, and tribal communities.

Additional investments include the U.S. Department of Health & Human Services’ (HHS) Minority HIV/AIDS Fund's $4.8 million support for initiatives targeting doxycycline post-exposure prophylaxis (doxy PEP) and point-of-care testing for HIV and syphilis in 13 jurisdictions. These efforts focus on regions identified as having high unmet needs, aiming to reduce barriers to STI prevention and treatment, particularly for marginalized populations.

However, funding sustainability remains an ongoing challenge, especially with the uncertainty introduced by the changing political landscape and the potential for shifts in federal priorities under the new administration. The 2023 rescission of $400 million in disease intervention specialist funds has forced staff reductions across state health departments, compromising the ability to provide essential contact tracing, partner services, and community outreach. While the Senate Appropriations Committee has proposed a $2 million increase for STI prevention programs, it falls significantly short of offsetting previous cuts, posing a substantial risk to the gains made in recent years.

Barriers to Sustained Progress

Despite progress, systemic barriers threaten the sustainability of current improvements in STI and overdose prevention. Key challenges include limited workforce capacity, geographic disparities in access to care, and medical supply chain issues.

Workforce Capacity and Geographic Barriers

The loss of $400 million in disease intervention specialist funding has significantly impacted state-level prevention efforts, leading to workforce reductions across health departments and limiting their capacity to provide necessary prevention services. The impacts of these workforce reductions are most acutely felt in the South and West regions, where both STI and overdose rates remain highest.

Healthcare delivery infrastructure also presents notable barriers. In rural and underserved communities, access to testing and prevention services remains a critical issue. Without targeted investment in these areas, disparities in healthcare access will persist, undermining the broader public health goals of reducing STI and overdose rates.

Supply Chain Vulnerabilities

Another critical challenge lies in supply chain vulnerabilities, particularly for key medications like Bicillin L-A, which is the only approved treatment for congenital syphilis. Shortages in Bicillin L-A have complicated the treatment of congenital syphilis, which already poses a substantial burden on maternal health services. The 2023 STI surveillance report highlights 3,882 reported congenital syphilis cases, including 279 stillbirths and infant deaths, emphasizing the urgent need for stable access to treatment.

Funding Instability

Funding instability continues to undermine long-term progress. The inconsistent nature of prevention program funding—often reliant on short-term grants—makes it challenging for state health departments to maintain consistent services and infrastructure. Transitioning to sustainable funding models that support long-term planning and implementation is crucial if gains are to be maintained and expanded.

Path Forward: Scaling Effective Models and Sustainable Funding

To build on recent successes in reducing STI and overdose rates, it is essential to strengthen and expand effective prevention models, address healthcare access disparities, and secure sustainable funding sources. Below are recommendations to ensure continued progress:

1. Transition to Sustainable Funding Mechanisms

Federal and state funding for STI and overdose prevention programs must transition from sporadic grants to more reliable, sustained funding streams. The restoration of the $400 million disease intervention specialist funding should be prioritized to rebuild essential workforce capacity. Without a stable financial foundation, health departments will struggle to maintain prevention programs and respond effectively to emerging challenges.

2. Expand Proven Prevention Models Nationally

Programs such as CDC's PS-24-0003, which supports HIV prevention in sexual health clinics, and PS-23-0011, which expands services in high-burden communities, have demonstrated effectiveness in improving health outcomes. Scaling these models to a national level, with an emphasis on high-burden regions, will help ensure that the successes seen in certain areas can be replicated more broadly.

3. Strengthen Healthcare Access in Underserved Areas

Addressing geographic disparities requires focused efforts to expand healthcare access in rural and underserved communities. Efforts should include increasing the availability of rapid testing, supporting mobile health units, strengthening telemedicine infrastructure, and investing in the development of local healthcare workforces. Such measures will help bridge the gaps in access and contribute to reducing the unequal burden of STIs and overdose deaths across regions.

4. Address Supply Chain Issues for Essential Medications

To mitigate the impact of medication shortages, federal policy must prioritize securing stable supply chains for essential treatments like Bicillin L-A. This might include incentives for domestic production or other strategies to ensure a consistent supply of critical medications.

5. Enhance Data Collection and Integration

Modernizing data collection and surveillance systems will enhance the ability to track health outcomes and guide resource allocation. Improved integration between public health and healthcare systems can facilitate more timely and effective responses, reduce duplicative efforts, and enhance the overall efficiency of prevention programs.

Moving Towards Sustainable Progress

Recent data showing reductions in STI and overdose rates demonstrate the positive impact of well-targeted public health interventions. However, sustaining and expanding upon this progress requires systematic policy changes and sustained commitment to prevention infrastructure. Addressing systemic barriers—including funding instability, geographic and racial disparities, workforce limitations, and supply chain challenges—will be crucial to achieving long-term success. By scaling effective programs, ensuring equitable access to healthcare services, and committing to long-term funding, there is potential not only to maintain recent gains but to significantly move towards reducing the incidence of STIs and overdose deaths nationwide.

World AIDS Day: Together, Forward.

Every December 1st, World AIDS Day serves as a time for reflection, honoring those we’ve lost to HIV/AIDS, and recommitting to the work ahead. This year, the Office of National AIDS Policy unveiled the theme “Collective Action: Sustain and Accelerate HIV Progress” on October 4th. However, by November 5th, many of us were questioning how we can sustain and, let alone accelerate, our efforts following the general election and the resulting uncertainty.

For most, World AIDS Day is an annual event. But for some of us, every day is World AIDS Day.

Since my diagnosis in 2016, this day has been deeply personal—a time for introspection. It’s a day to recognize and honor those who came before me, those who fought for better lives for themselves and their communities. I feel immense gratitude for their sacrifices. While this day often presents an opportunity to celebrate our progress, it can be challenging to celebrate when that progress remains unequal. It’s even harder to celebrate knowing the uncertainty that looms after the recent election.

Over the past few weeks, I’ve had extensive conversations with individuals in my community who are grappling with fear and anxiety about the unknown. This fear is valid. Concerns about access to gender-affirming care, uphill challenges in the public health sector, and worries for immigrants are all real. The incoming Administration has already indicated plans to target marginalized communities, dismantle essential programs and departments, and undermine critical initiatives. While campaign promises often fall short, they can sow seeds of doubt and concern about what lies ahead.

Just days after the election, I attended a meeting of the U.S. People Living with HIV Caucus. These meetings are among my favorites, always inspiring, and filled with legends of advocacy—many of whom have been at the forefront of this fight since the early days of the AIDS crisis. 

Space was allocated for meeting attendees to express their emotions regarding the election and the future. Many expressed sadness and distress about the outcome. I’m often quiet in these meetings, I feel like a small child in a room full of grown-ups. After listening to others’ perspectives, I decided to raise my hand. I spoke about my concerns for LGBTQ+ youth and the communities disproportionately affected by HIV. Despite my concerns, I expressed a sense of resolve.

Following the 2016 election, I, like many others, felt lost, and angry. Struggling to find purpose, I reached out to the local LGBTQ+ center to volunteer. I discovered that building community, learning to love, and leaning on one another provided hope amidst uncertainty.

Much has transpired in the eight years since then. Many of us who engaged during that time have continued to advocate for various issues. I’ve reminded myself and others that while we may face unknown and challenging days ahead, we have consistently fought for a better world regardless of who is in power. This has equipped us with two crucial tools for navigating an uncertain future: experience and community.

Throughout history, communities have come together to counteract the harms inflicted by those in power. Including the Gay Liberation Front, ACTUP, and the civil rights movement. Those who are knowledgeable about our collective history are better prepared to prevent it from repeating or at least minimize the damage. The knowledge of our rich history of transforming the tide gives me the most significant asset in this moment: hope.

Back in November, I posed a question: are we ready to answer the call of this moment? I don’t believe that question is any less relevant today. We never knew what that call would entail, yet here we are. This year, on World AIDS Day, and likely every day for the next four years, I hold onto the words my friend Jen Laws shared with us shortly after the election: “We are not called to this work because it is easy; we are called to this work because it is necessary.”

While we face an uncertain path ahead, we have the blueprints from our history, and the support of our communities to guide us. We must approach each day, one at a time, while clinging to hope with unwavering determination. Not because things will be easy, but because it is our inherent calling to look forward, to work collectively to not only sustain but also to shape the future of our country, and the world. It would be an ultimate disgrace to let our friends, family, and elders succumb to a plague, and for us to abandon our mission at this moment.