CBO Data Proves Hospital Systems Exploit 340B Drug Program for Billions

The Congressional Budget Office has delivered a damning federal validation of what CANN and other patient advocates have been arguing for years: the 340B Drug Pricing Program has become a $44 billion hospital exploitation scheme. The September 9 report confirms that large health systems are systematically gaming the program to capture massive profits while reducing charity care and consolidating away from the vulnerable communities they claim to serve.

The CBO's findings demolish the hospital industry's primary defense of 340B expansion: that growth reflects rising drug costs rather than system manipulation. The program expanded 565% from $6.6 billion in 2010 to $43.9 billion in 2021, with federal economists confirming that two-thirds of this growth stems from covered entity and third-party behaviors, not pharmaceutical price inflation. As CANN CEO Jen Laws noted, "It is a HELL of a thing that CBO found program growth is driven more by how hospitals and middlemen game the system than by the 'rising drug costs' hospitals always blame."

The implications extend far beyond 340B reform to fundamental questions about healthcare market structure and the accountability of tax-exempt institutions capturing billions in public benefits as “profit” while abandoning charity care and drowning patients in medical debt in the process.

How Hospitals Weaponize 340B for Anti-Competitive Consolidation

The CBO analysis reveals the precise mechanisms through which hospitals transform 340B discounts into acquisition capital. Hospital outpatient departments and satellite clinics control 87% of total 340B spending, providing massive cash flows that traditional community providers cannot match when competing for physician practices or specialty services.

Cancer drugs represent 41% of all 340B spending at approximately $18 billion annually, creating particularly lucrative acquisition targets. When hospitals acquire independent oncology practices, they can immediately capture 340B discounts on existing patient treatments while expanding their geographic footprint. This explains why 70.1% of buyer hospitals in mergers and acquisitions from 2016-2024 were 340B covered entities, compared to just 59.9% of hospitals nationally.

The regulatory framework enables this exploitation through geographic eligibility rules that allow hospitals to extend 340B benefits to satellite facilities serving affluent populations, provided they maintain connection to a qualifying parent institution. Off-site outpatient clinics participating in 340B exploded from 6,100 in 2013 to 27,700 by 2021, with many located in wealthy suburbs far from the low-income communities that justify program participation.

Contract pharmacy arrangements provide additional consolidation leverage, growing 2,400% from approximately 1,000 locations in 2010 to 32,069 by 2025. Hospitals negotiate exclusive arrangements with pharmacy chains, effectively controlling medication access across entire markets while extracting profits from every prescription filled by their "340B-eligible" patients, regardless of the patient's income or insurance status.

Laws captured the patient harm precisely: "hospital systems are exploiting cancer patients to drive revenue that would otherwise be considered 'profit' and further anti-competitive behaviors to the detriment of patient access." The mechanism creates a feedback loop where 340B profits fund acquisitions that eliminate competition, enabling hospitals to raise prices and reduce services while maintaining program eligibility despite providing declining levels of actual charity care.

The Charity Care Shell Game Exposes Regulatory Failure

Hospital claims about using 340B savings to support vulnerable populations collapse under scrutiny of actual charity care data. The Government Accountability Office's 2018 report documented that 340B hospitals experienced "steady decline in both charity care and uncompensated care" during the period of explosive program growth, revealing a fundamental disconnect between rhetoric and practice.

The regulatory structure enables this deception through definitional ambiguity. Hospitals routinely conflate charity care, which involves writing off debt with no patient obligation, with uncompensated care, which includes bad debt that hospitals aggressively collect through lawsuits and wage garnishments. As CANN has emphasized, "charity care is care provided at no cost or debt to the patient. Moving forward, we must not confuse, conflate, or combine generalized uncompensated care with charity care."

Johns Hopkins Hospital demonstrates how prestigious 340B institutions exploit this definitional confusion. The hospital filed more than 2,400 lawsuits against patients since 2009, with cases increasing from 20 in 2009 to 535 in 2016. Despite obtaining wage garnishments in more than 400 cases for a median amount of only $1,438, Johns Hopkins simultaneously received $36 million more in state charity care support than it actually provided.

This pattern reflects systematic regulatory failure rather than isolated incidents. A 2018 GAO survey found that 57% of 340B hospitals do not provide discounted drug prices to low-income, uninsured people at their contract pharmacies. The Health Resources and Services Administration (HRSA) lacks enforcement mechanisms to ensure program benefits reach intended populations, creating an accountability vacuum that hospitals exploit with impunity.

The policy implications prove profound. Medical debt grew from $81 billion in 2016 to $140 billion in 2019 during massive 340B expansion, precisely when enhanced hospital resources should have reduced financial barriers to care. A Pioneer Institute study found Massachusetts General Hospital's charity care dropped from 3.8% to 1% of patient revenue between 2013 and 2020, even as 340B profits increased substantially.

State Legislation Creates Compliance Theater That Benefits Hospitals

The proliferation of conflicting state 340B laws represents a masterclass in regulatory capture. Seven states enacted contract pharmacy protection laws in 2025 alone, joining eight states with similar 2024 legislation. These laws create administrative complexity that large hospital systems navigate easily while imposing crushing compliance burdens on community health centers and rural clinics.

The policy design reveals sophisticated lobbying influence. Hospital-backed legislation focuses on procedural requirements and reporting obligations that sound patient-protective but actually entrench existing power structures. Meanwhile, substantive reforms addressing charity care requirements, geographic restrictions, or patient benefit mandates remain absent from most state proposals.

One rural federally qualified health center reported 60% erosion in 340B savings resulting in a loss of $531,720 per year, forcing closure of oral health centers serving low-income patients. Large hospital systems with dedicated compliance departments experience no similar hardships, instead benefiting from reduced competition as smaller providers struggle with regulatory complexity.

Federal courts have begun recognizing this manipulation. West Virginia's S.B. 325 was blocked in December 2024when Judge Thomas E. Johnston ruled it "stands as an obstacle to achieving the federal objective of preventing fraud in the 340B Program." The emerging circuit split creates additional uncertainty that benefits well-resourced hospitals while harming smaller safety-net providers unable to navigate conflicting legal requirements.

Even supportive officials recognize the limitations. Utah Governor Spencer Cox allowed his state's legislation to become law without signature, explicitly stating the bill "does not go far enough to ensure cost savings experienced by 340B covered entities are passed onto patients." This acknowledgment exposes the fundamental inadequacy of state-level approaches to addressing federal program failures.

ACCESS Act Addresses Root Causes, Not Just Symptoms

The recently reintroduced 340B ACCESS Act represents the first comprehensive federal response to CBO-confirmed abuses. As CANN stated in its press release, "The 340B ACCESS Act is an excellent starting place to reform the 340B program. The legislation, in deep alignment with currently proposed federal rules, puts patients in the driver's seat for the first time since the program was established in 1992."

The legislation addresses structural incentives that enable hospital exploitation through hospital transparency requirements and administrative fee limits that target the accountability vacuum in current regulations. The bill's provisions for "reducing patient out-of-pocket costs through sliding fee scale drug discounts" directly address the patient access barriers created by current hospital practices.

Crucially, the ACCESS Act would "ensure PBMs appropriately reimburse on 340B drugs" and limit "third-party administrator fees," addressing the middleman extraction that enables massive profit-taking from vulnerable patient populations. The legislation also addresses gaps in the Ryan White Program's 318 grants that created the issues highlighted in the Sagebrush lawsuit, where manufacturers challenge STI clinic eligibility for 340B participation.

The legislation is far from perfect, including a six-month limitation on telehealth provisions that may harm people seeking outpatient methadone services and legitimate PrEP clinics. However, as CANN's Kalvin Pugh noted, "The 340B ACCESS Act is a critical start to putting patient need over hospital greed and finally bringing the program back to its original intent”

Federal Action Required to Restore Program Integrity

The CBO report eliminates any remaining doubt about 340B's transformation from safety-net support to hospital profit extraction scheme. The data confirms what patient advocates have documented: hospitals systematically reduce charity care while using 340B revenue to finance anti-competitive consolidation that harms the communities supposedly being served.

State legislative responses have failed because they address symptoms rather than causes. The ACCESS Act offers comprehensive federal reform that could restore program integrity by ensuring 340B savings benefit patients rather than hospital shareholders. Without such intervention, the program will continue enriching hospital systems while people living with HIV lose access to Ryan White clinics, cancer patients face treatment delays due to provider consolidation, and rural communities watch their last remaining healthcare options disappear despite billions in program funding ostensibly flowing to support them.

The choice facing policymakers is clear: prioritize patient need over hospital greed through meaningful federal reform, or continue enabling a system that betrays every principle underlying the 340B program's original mission.

The CDC's Ideological Takeover

The systematic dismantling of scientific leadership at the Centers for Disease Control and Prevention (CDC) under Health Secretary Robert F. Kennedy Jr. represents more than bureaucratic reshuffling. The firing of CDC Director Susan Monarez after just three weeks in office, followed by the resignation of four senior officials in protest, suggests we have reached a point of no return: the subordination of scientific evidence to predetermined ideological conclusions. This transformation threatens decades of progress in disease prevention and raises a troubling question for public health advocates: have we abandoned scientific rigor for the comfort of confirmation bias?

The numbers tell a story of institutional collapse. Since April 2025, the CDC has lost nearly 2,400 employees, representing 20% of the agency's workforce. More than 1,000 HHS workers have signed letters demanding Kennedy's resignation. When Monarez refused to "rubber-stamp unscientific, reckless directives and fire dedicated health experts," according to her legal team, she chose protecting public health over political expediency, and was terminated for that choice.

The Architecture of Predetermined Conclusions

History suggests Kennedy's approach follows a troubling pattern: conclusions first, “evidence” later. In June 2025, Kennedy fired all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP), replacing them with vaccine skeptics and anti-vaccine activists. Among his appointments is David Geier, a discredited proponent of the long-debunked vaccine-autism connection who lost his medical license for practicing without proper credentials.

The ideological nature of Kennedy's decision-making became even clearer when STAT reported that Monarez had submitted a confidential reform plan that closely mirrored Kennedy's subsequent proposals for CDC modernization. Her July 20 memo called for upgraded infrastructure, workforce investments, enhanced disease surveillance, and stronger firewalls against political influence—priorities Kennedy later claimed as his own in his Wall Street Journal defense. Yet Kennedy fired her anyway, not for opposing reform, but for refusing his ultimatum to "approve all recommendations from the vaccine advisory committee" and "fire top CDC officials." The revelation exposes Kennedy's public rationale about "replacing leaders who resisted reform" as fundamentally dishonest.

This pattern of predetermined conclusions reached its most explicit expression during a Cabinet meeting when Kennedy promised to reveal in September "interventions that are clearly, almost certainly causing autism," with Trump speculating that "something artificial" must be the cause. Announcing conclusions before conducting research represents the antithesis of scientific inquiry and is nothing more than predetermined outcomes masquerading as hypothesis testing.

Dr. Demetre Daskalakis, former director of the National Center for Immunization and Respiratory Diseases who resigned in protest, captured the gravity of this shift: "I only see harm coming. I may be wrong, but based on what I'm seeing, based on what I've heard with the new members of the Advisory Committee for Immunization Practices, or ACIP, they're really moving in an ideological direction where they want to see the undoing of vaccination."

The Human Cost of Ideological Public Health

The dismantling of CDC expertise creates cascading consequences that disproportionately impact vulnerable populations. The agency's budget has been cut nearly in half, from $9.1 billion to $4.2 billion. Chronic disease prevention funding, which provided $16-20 million per state annually, faces elimination. The agency now has 750 fewer "ready responders" available for health emergencies.

For people living with HIV and other vulnerable populations, these cuts represent a direct assault on health equity. The CDC's HIV surveillance systems, prevention programs, and outbreak response capabilities depend on the institutional knowledge and scientific expertise that Kennedy has systematically eliminated. When flu sample submissions from abroad decreased by 70% due to the administration's withdrawal from the World Health Organization, the United States lost crucial early warning systems for pandemic preparedness.

Dr. Debra Houry, the former chief medical officer who resigned, warned that "we are not ready for emerging health threats, and it's only getting worse." Rural communities and people with chronic conditions—populations already facing significant health disparities—will bear the greatest burden of this institutional collapse.

Bipartisan Alarm and the Need for Oversight

The crisis has prompted rare bipartisan concern from lawmakers. Sen. Bill Cassidy (R-LA), who provided a crucial vote for Kennedy's confirmation, called for the postponement of the September ACIP meeting, stating that "any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership." Sen. Susan Collins (R-ME) found "no basis" for Monarez's removal.

The tension within Republican ranks became evident in a public Twitter exchange between Cassidy and Sen. Rand Paul (R-KY), where Cassidy pointedly noted that "MAHA starts with preventing vaccine preventable diseases." The comment raises a fundamental question: is Secretary Kennedy aware of this starting point for his own Make America Healthy Again agenda? Paul's defense of Kennedy's vaccine skepticism highlights the fracture between evidence-based public health Republicans and those embracing anti-vaccine ideology.

Even more telling, nine former CDC directors spanning both Republican and Democratic administrations condemned Kennedy's actions as "unlike anything we had ever seen at the agency and unlike anything our country had ever experienced." When career public servants who have served under multiple administrations express such unified alarm, the threat to institutional integrity cannot be dismissed as partisan politics.

The American Medical Association issued a statement expressing deep concern about CDC's destabilization at "a challenging moment for public health," while the American Nurses Association warned that the changes "could potentially pose a direct risk to the safety and security of our nation."

The Broader Questions: Science vs. "Vibes" in Public Health Policy

The CDC crisis illuminates a broader erosion of evidence-based decision-making in public health policy. When scientific conclusions are predetermined and evidence is selectively marshaled to support ideological positions, we abandon the fundamental principles that underpin effective public health practice.

This shift toward policy by "vibes" rather than evidence gains particular momentum from social media influencer culture and the wellness industry, a $6.3 trillion global market that dwarfs pharmaceuticals' $1.65 trillion. Research from the Center for Countering Digital Hate reveals that Kennedy belongs to the "Disinformation Dozen" - 12 individuals responsible for 65% of anti-vaccine content on major platforms. These “wellness” influencers, with millions of collective followers, promote alternative health products while spreading vaccine misinformation that platforms fail to control despite documented public health harms.

The regulatory disparity amplifies this problem. While pharmaceutical drugs require 10-15 years of clinical trials costing billions, dietary supplements face no pre-market approval requirements under the 1994 Dietary Supplement Health and Education Act. This creates an ecosystem where unsubstantiated wellness claims flourish on social media while rigorously tested medical interventions face increasing skepticism from audiences primed by influencer misinformation.

The pattern extends beyond vaccines to encompass the entire architecture of public health surveillance and response. When Kennedy restricts COVID-19 vaccine access based on ideology rather than epidemiological evidence, when he eliminates chronic disease programs without data supporting their ineffectiveness, when he replaces career scientists with political appointees lacking relevant expertise, he transforms public health agencies into instruments of social engineering rather than evidence-based medicine.

One current CDC employee described this as "the beginning of the end of objective science." The consequences extend far beyond CDC headquarters in Atlanta—they reach into every community clinic serving people living with HIV, every state health department tracking disease outbreaks, every family seeking evidence-based guidance about their health decisions.

The Stakes for Health Equity and Patient Access

The response from state governments illustrates the severity of the federal abdication. California, Oregon, and Washington announced the formation of a West Coast Health Alliance to "uphold scientific integrity in public health as Trump destroys CDC's credibility." When states feel compelled to create alternative public health infrastructure, the federal system - and its leadership - have fundamentally failed.

While some states move to protect science-based public health, others are abandoning it entirely. On the same day the West Coast Health Alliance was announced, Florida declared plans to become the first state to end all vaccine mandates, including for schoolchildren. The stark contrast—three states forming an alliance to preserve scientific integrity while another dismantles evidence-based protections—illustrates how Kennedy's assault on federal public health expertise is fracturing the nation's disease prevention infrastructure.

The elimination of scientific expertise at the CDC represents a direct threat to health equity and evidence-based patient care. For advocates working to expand access to HIV prevention and treatment, for policymakers crafting evidence-based health legislation, for people relying on public health guidance to make informed decisions about their care, the stakes could not be higher.

Congress must exercise its oversight authority to protect the institutional integrity that underpins effective public health practice. This responsibility transcends partisan politics—it represents a fundamental obligation to ensure that public health decisions are grounded in scientific evidence rather than ideological predetermination. The alternative is a public health system that serves political ends rather than human health, where predetermined conclusions masquerade as scientific inquiry, and where the most vulnerable populations pay the highest price for our collective abandonment of evidence-based decision-making.

Federal Antitrust Retreat Threatens Patient Access

President Trump's August 13, 2025 revocation of Biden's Executive Order 14036 creates a federal healthcare competition enforcement vacuum that threatens to accelerate consolidation-driven cost increases and access barriers for people living with chronic conditions, even as bipartisan pharmacy benefit manager (PBM) reform momentum paradoxically continues and states scramble to fill regulatory gaps through expanded oversight programs.

The timing proved strategic, if not coordinated. UnitedHealth completed its $3.3 billion Amedisys acquisition one day after the revocation. The simple four-sentence order contained no specific rationale beyond dismantling "burdensome" Biden regulations, yet its implications reshape healthcare markets fundamentally. Industry analysts immediately anticipated a "more favorable consolidation landscape" following the revocation.

Biden's Competition Legacy

Executive Order 14036, signed July 9, 2021, directed 72 competition-promoting initiatives across federal agencies, explicitly targeting hospital mergers that left rural communities "without good options for convenient and affordable healthcare service." The Federal Trade Commission (FTC) challenged four hospital mergers during Biden's first two years compared to fewer than one per year under the previous administration.

The order catalyzed enforcement mechanisms beyond merger challenges. The FTC withdrew outdated healthcare policy statements, calling them "no longer reflective of market realities," while the DOJ established its Task Force on Health Care Monopolies and Collusion. Most significantly, the FTC's PBM investigation produced reports documenting how the Big Three PBMs extracted $7.3 billion in excess revenue from specialty drug markups between 2017-2022.

Sixty-three percent of specialty generic drugs dispensed by PBM-affiliated pharmacies were marked up more than 100% over acquisition costs. For people living with HIV, this meant $521 million in excess revenue extracted from essential medications alone.

The UnitedHealth Monopoly Machine

UnitedHealth's vertical integration exemplifies the consolidation risks that relaxed enforcement enables. The company now employs over 70,000 physicians through its Optum Health subsidiary, making it the largest physician employer in the United States. As Dr. Glaucomflecken's satirical healthcare commentary notes: "Why reimburse doctors when you can own them."

UnitedHealth operates across insurance (UnitedHealthcare), PBM services (OptumRx), and provider services (Optum), allowing the company to control every aspect of patient care while maximizing profit at each step. The Change Healthcare cyberattack demonstrated these consolidation vulnerabilities, affecting half of all U.S. medical claims processing and leaving people living with HIV facing $2,000 balance bills when Patient Assistance Programs couldn't be processed. Independent pharmacies faced severe financial strain as they couldn't process claims or receive reimbursements, forcing many to consider closing while UnitedHealth's own pharmacies remained operational.

The commentary's prediction proves prescient: "Just imagine every interaction you have with the U.S. healthcare system throughout your life all owned and operated by United Healthcare." From ambulance services to hospital stays to prescription fills, vertical integration eliminates market competition while creating systemic vulnerabilities that drive up cost, reduce quality, and limit patient access to essential care.

The PBM Paradox: Aggressive Reform Amid Broader Deregulation

Trump's healthcare policy creates unusual dynamics where consolidation enforcement broadly weakens while PBM scrutiny intensifies. His May 12, 2025 "Most Favored Nation" executive order declared "We're going to totally cut out the famous middleman," claiming potential savings of 30-80% on drug costs. This aggressive anti-PBM stance contrasts sharply with the permissive approach toward hospital consolidation.

The FTC's September 2024 lawsuit against CVS Caremark, Express Scripts, and OptumRx for artificially inflating insulin prices continues despite the executive order revocation. FTC Chair Andrew Ferguson reversed his initial recusal in April 2025 to maintain quorum, with evidentiary hearings scheduled for February 2026.

States are simultaneously pursuing PBM reforms, though facing industry pushback. Arkansas enacted the nation's first-in-the-nation law prohibiting companies that own PBMs from also operating pharmacies. However, CVS and Express Scripts successfully challenged the law in federal court, with Judge Brian Miller ruling it "appears to overtly discriminate against plaintiffs as out-of-state companies."

Meanwhile, congressional momentum for PBM reform has been building over several years across party lines. The House Energy and Commerce Committee previously held hearings titled "Reining in PBMs Will Drive Competition and Lower Costs," while the bipartisan Pharmacy Benefit Manager Reform Act has been reintroduced. Spring 2025 legislative updates show continued bipartisan interest in PBM transparency and reform measures, though comprehensive legislation faces the typical challenges of a closely divided Congress.

Filling the Federal Enforcement Gap

With federal antitrust enforcement retreating, some states are rapidly expanding healthcare oversight programs. These initiatives represent a fundamental shift in competition policy, moving from federal leadership to a patchwork of state-level enforcement.

California leads through its Office of Health Care Affordability, which can block healthcare transactions that threaten affordability or access. Since April 2024, the office reviewed 26 transactions, approving 96% with conditions that protect consumers. California's healthcare spending targets of 3.5% for 2025-2026, decreasing to 3% by 2029, create enforceable benchmarks. Starting in 2026, the state can impose financial penalties on health systems that exceed cost growth limits.

New York Governor Hochul's FY 2026 budget proposes strengthening the state's ability to scrutinize healthcare deals before they close. The 60-day pre-closing notification requirement with potential 180-day delays gives regulators time to assess whether mergers will harm patients.

Massachusetts demonstrates mature oversight through its Health Policy Commission, which completed substantial market impact findings for the Dana-Farber/Beth Israel merger and required Mass General Brigham's first-ever Performance Improvement Plan when the health system exceeded cost growth benchmarks.

The state-level enforcement patchwork creates geographic disparities in patient protection. People living with chronic conditions may find robust protections in California or New York while facing minimal oversight in states without comprehensive programs. This creates particular challenges for multistate health systems that can shift operations to less regulated jurisdictions or structure transactions to avoid state oversight entirely.

Merging Toward Disaster

Accelerated healthcare consolidation creates documented barriers to access and affordability for people living with HIV and chronic conditions. Hospital mergers historically increase prices 6-18% in consolidated markets while reducing specialized service lines. The Hartford HealthCare lawsuit revealed pricing disparities of $3,800 for colonoscopies compared to $1,400 at competing hospitals.

Private equity ownership compounds these risks through systematic cost-cutting that prioritizes profits over patient care. Sen. Chris Murphy's report on Prospect Medical Holdings documented how private equity-backed facilities experienced supply shortages so severe that patients were "sometimes left on the operating table while staff scrambled" for basic equipment. Nurses and technicians reported personally buying food for patients to prevent hunger after the company stopped paying vendors.

Healthcare consolidation also drives intentional understaffing crises that compromise patient safety. Hospital Corporation of America, despite $7 billion in profits, maintains staffing ratios 30% lower than national averages while allocating $8 billion to stock buybacks. This profit-over-patients approach contributed to preventable tragedies like Rep. Eddie Bernice Johnson's death from an infection caused by medical neglect at an understaffed facility.

The revocation of Executive Order 14036 marks a decisive federal retreat from aggressive healthcare competition enforcement while states emerge as primary competition enforcers through oversight programs that may prove more durable than federal initiatives. For people managing HIV and chronic conditions, this enforcement vacuum creates compounded access barriers. Accelerated provider consolidation, private equity exploitation, narrowed networks, and increased costs threaten the specialized care relationships that we depend on. Healthcare advocates must pivot to intensive state-level engagement while supporting targeted federal initiatives like PBM reform that maintain bipartisan support. The strategic timing of major transactions immediately following the revocation demonstrates industry confidence in this permissive environment. Sustained advocacy pressure remains essential to protect patient access and care quality as healthcare markets consolidate with minimal oversight.

Most Favored Nation, Least Favored Patients

President Trump's May 12th executive order establishing Most Favored Nation (MFN) pricing for prescription drugs promises dramatic savings. Still, it threatens to dismantle America's position as the global leader in medical innovation while importing discriminatory healthcare rationing through the back door. While the Administration claims the policy could generate $85.5 billion in Medicare savings over seven years, the evidence reveals a devil's bargain that risks sacrificing immediate access to life-saving and life-improving medications and the medical breakthroughs that keep America first in line for life-saving treatments.

Congress just allocated $75 billion in extra funding for ICE to detain and deport brown people while simultaneously implementing policies that could paralyze medical research. It seems Washington has unlimited money to remove people from the country, but life-saving drug innovation must be rationed through foreign price controls. This isn't limited to Republicans—Democrats tried similar price controls in 2019.

The executive order directs the U.S. Department of Health and Human Services to implement pricing tied to "the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita." Unlike Trump's blocked 2020 attempt, this version establishes a two-phase approach: voluntary compliance within 30 days, followed by escalating enforcement, including regulatory rulemaking, drug importation authorization, and even potential FDA approval revocations. So far, not much has been disclosed by the Administration or manufacturers as to how that process is going.

To casual observers, this may sound appealing on its surface. Americans do pay more for prescription drugs than patients in other developed countries in terms of gross costs. But MFN pricing operates as a Trojan horse that would fundamentally reshape American pharmaceutical markets while potentially circumventing federal prohibitions on quality-adjusted life year (QALY) metrics that systematically discriminate against vulnerable populations. Additionally, U.S. investments in pharmaceutical innovation help fund global access to medications in underserved countries—a moral leadership role we abandon when we adopt foreign rationing schemes.

The QALY Trap: How International Pricing Imports Discrimination

Countries used as MFN benchmarks systematically employ Quality-Adjusted Life Year (QALY) and similar assessments to determine drug coverage and pricing, creating an indirect pathway for importing these controversial metrics into U.S. healthcare despite explicit federal prohibitions. QALYs attempt to measure treatment value by calculating both quantity and quality of life gained, but they assign numerical scores to different health states—effectively putting a price tag on human life based on perceived disability or illness.

Consider two people needing treatment: Person A without a chronic condition and Person B living with cystic fibrosis. Under QALY calculations, because Person B may not achieve the same "quality" of life after treatment as Person A, treatment for Person B is automatically deemed "less valuable" than treatment for Person A—especially for therapies targeting chronic conditions. All under the frame of "cost-effectiveness."

The United Kingdom's National Institute for Health and Care Excellence (NICE) employs "cost-effectiveness" thresholds of £20,000-30,000 per QALY gained, meaning treatments costing more than roughly $25,000-$37,000 per "quality-adjusted" year of life are typically rejected. Canada's Agency for Drugs and Technologies in Health (CADTH) reduced its threshold to CAD$50,000 per QALY in late 2020. Australia's Pharmaceutical Benefits Advisory Committee (PBAC) routinely rejects drugs exceeding AUD$76,000 per QALY. When MFN pricing imports these countries' low drug prices, it inherently imports the discriminatory QALY calculations that produced them.

The discrimination is measurable. Between 2014-2018, zero rare disease treatments reviewed by the Institute for Clinical and Economic Review (ICER) received "high value" ratings under standard QALY thresholds. Canada required price reductions exceeding 70 percent for 71 percent of orphan drug approvals to meet "cost-effectiveness" standards. The United Kingdom systematically rejected multiple cancer drugs based purely on QALY calculations, prompting the creation of the Cancer Drugs Fund specifically to bypass NICE's thresholds.

A 2022 National Institute of Allergy and Infectious Disease-funded, ICER "cost-effectiveness" review explicitly utilizing QALYs concluded that breakthrough long-acting injectable HIV prevention "limits the additional price society should be willing to pay" because of pre-existing oral regimens. The value of increased adherence and reduced HIV transmissions, under this conclusion, was simply not worth the cost to "society."

As the Disability Rights Education & Defense Fund explains, "The QALY equation relies on a baseline of 'perfect health' that is calculated by society's conception of health and functioning." People with disabilities are automatically assigned lower quality-of-life scores, regardless of their lived experiences. The breakthrough cystic fibrosis treatment Trikafta, which significantly extends lives, is undervalued by QALY calculations because cystic fibrosis involves the functional “limitation” of “only” ensuring patients with cystic fibrosis will remain out of the hospital, not return to full lung function.

Current U.S. law explicitly prohibits federal programs from using QALYs in coverage decisions. The Affordable Care Act forbids Medicare from using QALYs or "similar measures that discount the value of a life because of a person's disability." Yet MFN pricing effectively endorses discriminatory "cost-effectiveness" standards because importing prices from countries like the United Kingdom and Canada inherently imports the QALY-based decisions that generated those prices.

These metrics harm access today, not just in the future. Trikafta was selected by Colorado's Prescription Drug Affordability Board (PDAB) for "affordability review" last year. Only after more than a year of patient advocacy, industry data input, and provider testimony about the medication's effectiveness did the Board deem the drug "not-unaffordable"—despite not defining what “affordability” means or for whom. If the Board had determined the medication “unaffordable,” it could have then imposed a reimbursement cap – essentially reducing what plans, not patients, would pay for it and harming the financial stability of actors up and down the supply chain. Patients rightfully shared concerns about losing access under what amounts to political appointees saying, "your medication isn't worth paying for."

Back in Colorado, Trikafta patient Amanda Boone testified to the Board about her fear of losing the ability to be a mom to her child, returning to ongoing hospital stays, and the physical and mental health costs of living with cystic fibrosis before the life-altering medication. She was firey, brought to tears, and ultimately silenced by the Board for her honesty. Today, the Board is still considering data about medications driven by similar backdoor QALY insertions and by ICER’s Harvard equivalent, PORTAL – all funded by the state of Colorado.

QALYs and the mechanism of importing them, by way of MFN, aren’t just a future threat. They’re a threat on access to medications that exist today.

Human life is not a value equation that can be calculated by an analyst, actuary, or worse, a politician. In a time when populist rhetoric increasingly dehumanizes people across gender, race, and sexual identity, we cannot allow healthcare policy to embed systematic discrimination against people with disabilities, chronic conditions, or terminal illnesses. The intersections of humanity most burdened by diseases like HIV and hepatitis C deserve better than rationing schemes disguised as cost savings.

Innovation Exodus: The Cost of Being Second

MFN pricing threatens America's position as the global innovation leader in ways that extend far beyond budget calculations. National Bureau of Economic Research analysis demonstrates that cutting drug prices by 40-50% leads to 30-60% fewer R&D projects in early-stage development. With only three out of 10 pharmaceutical products generating returns exceeding average R&D costs of $802 million, aggressive pricing pressures could eliminate the margins that make drug development viable.

The historical precedent is sobering. European R&D investment exceeded U.S. levels by 24 percent in 1986, but after implementing price controls, European R&D fell to 15 percent below U.S. investment by 2004. By 2020, 47 percent of global new treatments originated from the United States versus 22 percent from Europe—a complete reversal from 25 years earlier.

The damage is already starting. Venture capital investment dropped from $36.7 billion in 2022 to $29.9 billion in 2023, and 166 of 785 U.S. venture-backed companies with drugs in development have not raised capital since 2021. Companies like Alnylam have already halted Phase 3 trials for Stargardt disease, explicitly citing pricing policy pressures as the reason.

What happens when the next breakthrough HIV cure emerges from Chinese research facilities while American companies struggle under price controls? What happens when Europeans develop the next generation of mRNA vaccines while U.S. biotech funding dries up?

Here's the reality: Europe won't catch up. Neither will China. No other country is prepared to step into the innovation gap the United States represents. There's no telling if or when any other country might be willing to make the types of investments we do today. Cutting off the funding source won't magically drive down today's costs—it will simply lead to fewer cures, more deaths, and more illnesses tomorrow. Fewer cancer cures, fewer investments in curing Alzheimer's, a world where we're further from our health goals, not closer.

We maintain the most critical advantage in the world: developing the most effective, safest medicines and being first in line for medical breakthroughs. MFN pricing gambles away that advantage for questionable savings.

Real Solutions: Fixing the Actual Problems

If President Trump genuinely wants to lower prices for consumers, he should target the obvious culprits driving up costs through market manipulation rather than importing foreign price controls and the threats to patients that come with them. Ohio demonstrated the path forward by eliminating CVS Caremark and OptumRx from Medicaid and creating a single state pharmacy benefit manager with pass-through pricing. The result: $140 million in savings over two years while actually paying pharmacies more. Kentucky achieved $282.7 million in savings between 2021-2022 through its single PBM model.

The scope of pharmacy benefit manager abuse is staggering. Federal Trade Commission findings reveal that PBMs generated $7.3 billion in excess revenue from specialty drug markups between 2017-2022, marking up some generic cancer drugs by almost 250 times acquisition cost. Major PBM formularies excluded 1,156 unique prescription medicines in 2022—a 961 percent increase since 2014—affecting an estimated 275,000 patients who required medication switches.

Real reform means addressing PBM spread pricing that allows middlemen to pocket the difference between what they pay pharmacies and charge insurers. It means demanding transparency from hospital systems that have consolidated into monopolies driving up costs while reducing services. It means eliminating 340B abuse where hospitals generate billions in profits while patients see no benefit. And it means holding insurance company executives accountable with real consequences when they systematically deny legitimate claims.

These solutions exist and work. Ohio saved $140 million. Kentucky saved $283 million. West Virginia cut insurance rate increases in half. None required importing discriminatory rationing schemes.

Choose Progress, Not Populism

MFN pricing offers a false choice between astronomical drug costs and innovation collapse, when the real choice is between gutting American medical leadership or fixing the broken systems that actually drive up costs. We can pursue aggressive reforms without sacrificing our position as the country where breakthrough treatments emerge first.

With 30 million Americans living with rare diseases depending on continued innovation and 95 percent of approximately 7,000 rare diseases still lacking treatments, we cannot afford policies that prioritize short-term budget savings over long-term survival. America's healthcare system needs reform, but MFN pricing represents a dangerous gamble that could leave us second in line when the next cancer breakthrough or HIV cure emerges. That's a risk no American should have to take.

HRSA Tightens STI Clinic 340B Rules Amid Industry Lawsuit

The Health Resources and Services Administration (HRSA) proposed sweeping documentation requirements for sexually transmitted infection (STI) clinics in the 340B Drug Pricing Program on August 7, 2025, responding to pharmaceutical industry litigation that challenges how these safety-net providers qualify for discounted medications. The proposed changes would require STI and tuberculosis (TB) grantees to provide formal grant documentation during registration and recertification, marking a significant shift from current self-attestation practices as drugmakers intensify legal challenges to the program's scope.

The timing of these changes is significant. Congenital syphilis cases reached 3,882 in 2023 - the highest level since 1994 - while pharmaceutical companies Amgen, Eli Lilly, and UCB pursue litigation arguing that many STI clinics receiving only "in-kind" support like condoms and educational materials rather than direct cash grants should be ineligible for the program. The proposed documentation requirements emerge as HRSA faces pressure to tighten program oversight while maintaining access to discounted medications for safety-net providers serving communities most affected by rising STI rates.

Legal Pressure Drives Regulatory Response

The pharmaceutical industry's legal challenge against STI clinic 340B eligibility intensified in December 2024 when Amgen, Eli Lilly, and UCB filed suit against the U.S. Department of Health & Human Services (HHS), arguing that many STI clinics improperly qualify for the program. The manufacturers contend that clinics use 340B drugs for non-STI conditions, engage in prohibited drug diversion, and that entities receiving only "in-kind" contributions like condoms and educational materials rather than cash grants lack the statutory requirement of receiving federal "funds."

The lawsuit targets the ambiguity in Section 318 of the Public Health Service Act, which authorizes STI prevention funding but lacks clear definition of qualifying support. Most Section 318 grants involve state health departments distributing in-kind resources rather than direct cash transfers. The companies specifically challenge Nevada-based Sagebrush Health Services, where discounts totaled $27 million since 2022 across the three manufacturers. They allege Sagebrush subdivisions "use 340B drugs for purposes other than STI prevention and treatment" and "engage in diversion" by reselling discounted drugs improperly.

When Chief Judge James E. Boasberg refused to dismiss the claims on August 4, 2025, the litigation gained momentum. The manufacturers seek court declarations invalidating all 340B registrations for subgrantees using discounted drugs for non-STI purposes or receiving only in-kind support, potentially eliminating hundreds of safety-net providers from the program.

This threatens numerous county health departments and Ryan White HIV/AIDS Program participants that have operated under in-kind funding arrangements for decades. Provider advocates emphasize these grants are essential for clinic operations, enabling them to leverage limited federal resources into comprehensive sexual health services through 340B savings.

Documentation Requirements Target Program Integrity

HRSA's August 7, 2025, Federal Register notice proposes fundamental changes to how STI and tuberculosis grantees demonstrate 340B eligibility, requiring supporting documentation for the first time during initial registration and recertification processes. The new requirements mandate that entities provide federal grant notices of award identifying the grantor, grant number, funding period, and recipient information. At the same time, subgrantees must submit executed written subrecipient agreements detailing names, addresses, grant numbers, and specific terms of support.

This represents a significant departure from the current system, where STI and TB grantees could register based solely on self-attestation of their grant status. HRSA estimates the documentation requirements will increase registration burden from 1.0 to 1.25 hours per entity, affecting 341 STI/TB clinic registrations annually and 6,412 entities during annual recertification cycles.

Kalvin Pugh, CANN's Director of State Policy, 340B, views the proposed changes as progress toward needed reform. "This notice of recertification is additional momentum in the calls for greater transparency and accountability needed in the 340B Drug Pricing program to ensure it serves communities as it was intended, which are often the same communities that face disproportionate rates of STIs," Pugh said. "It will be a delicate balancing act to ensure that organizations are in compliance with 340B's intent, while ensuring that access to these vital treatments is not interrupted."

Public Health Stakes During STI Crisis

The timing of these regulatory changes coincides with an unprecedented public health crisis that has reached epidemic levels in states like Mississippi. The state now has STI rates of approximately 1,200 per 100,000 residents, ranking third nationally for syphilis cases, fifth for gonorrhea, and second for chlamydia. Mississippi's congenital syphilis crisis exemplifies the national emergency, with cases spiking 1,000% from just 10 cases in 2016 to 110 cases in 2022. Nationally, congenital syphilis cases have increased by 340% from 2019 to 2023, with the Centers for infection Control and Prevention emphasizing that 90% of these cases could have been prevented with timely testing and treatment.

The epidemic disproportionately affects communities of color, with rising rates particularly concentrated among people aged 14-24. STI clinics participating in 340B use program savings to provide free or reduced-cost treatments for uninsured patients, fund wraparound services including transportation and case management, and support community outreach and testing initiatives. Dr. Kayla Stover, professor and vice chair of pharmacy practice at The University of Mississippi, highlighted syphilis's particularly insidious nature, noting that "each of those stages has symptoms that could be mistaken for something else," earning it the designation as "The Great Imitator."

Deja Abdul-Haqq, director of the nonprofit My Brother's Keeper, pointed to systemic barriers in accessing prevention tools, observing that "the information regarding the solution to these issues usually gets to the Black communities late." She emphasized the potential of newer prevention medications like Doxy-PEP, noting that congenital syphilis cases could be dramatically reduced if "all of these mothers that were exposed to syphilis during sex would have gotten Doxy-PEP within 72 hours."

The potential loss of 340B eligibility for STI clinics would eliminate crucial cost savings precisely when public health officials are combating rising syphilis rates among pregnant people and working to prevent a resurgence of HIV transmission through expanded PrEP access programs.

Balancing Oversight and Access

HRSA's proposed documentation requirements represent a measured response to legitimate program integrity concerns while attempting to preserve essential safety-net access during a critical public health crisis. The enhanced oversight measures address years of Government Accountability Office (GAO) criticism and pharmaceutical industry pressure, acknowledging that some level of increased administrative burden is justified to ensure program resources reach genuinely eligible entities.

However, the broader legal challenges to STI clinic participation could force closures of safety-net providers precisely when public health needs demand expanded access to prevention and treatment services. Office of Pharmacy Affairs (OPA) Director Chantelle Britton acknowledged the ongoing uncertainty in July 2025, telling conference attendees to "stay tuned as these cases work through the courts."

The controversy over in-kind versus cash grant funding exposes fundamental ambiguities in the 340B statute that courts alone cannot resolve. The public comment period extends through October 6, 2025, giving stakeholders an opportunity to weigh in on how these changes will affect program operations and patient access. Whether the 340B program can continue stretching scarce federal resources while ensuring pharmaceutical manufacturers provide required discounts to genuine safety-net providers will depend on how policymakers resolve these competing demands during a worsening STI epidemic affecting the communities these clinics serve.

HRSA's 340B Pilot Tests What Already Works While Ignoring What Doesn't

On July 31, 2025, the Health Resources and Services Administration (HRSA) announced a voluntary 340B Rebate Model Pilot Program. Starting January 1, 2026, the pilot could apply to 10 drugs subject to Medicare price negotiation, allowing manufacturers to provide post-purchase rebates instead of upfront discounts. To be fair, in terms of actual financial impact for covered entities this may end up being a distinction without a difference because of the draft guidance offered by the Centers for Medicare and Medicaid Services (CMS) in June 2025 regarding “retrospective” payment processes. While HRSA Administrator Tom Engels framed this as addressing "concerns we have received from both covered entities and manufacturers," the pilot creates statutory violations that threaten program integrity and neglects the fact that the model has already been proven in AIDS Drug Assistance Programs (ADAPs).

The timing and design of this pilot raise fundamental questions about HRSA's priorities. Instead of addressing well-documented concerns regarding 340B program exploitation by large hospital systems at the expense of market competition and patient benefit, the agency is testing a model that already functions successfully elsewhere, while potentially accommodating institutional resistance to transparency and accountability.

The ADAP Gold Standard: Proof Already Exists

The most compelling argument against this pilot lies in its redundancy. ADAPs, administered in every U.S. state and territory, have operated successfully under rebate models for nearly the entire history of the 340B program. These programs demonstrate that rebate mechanisms can be effective, transparent, and fully compliant with statutory protections while enhancing program integrity and protecting patient access.

ADAPs represent the gold standard of 340B implementation, proving that rebate systems can safeguard against duplicate discounts and maintain access without upfront pricing. These programs show that prospective discounts are not the only viable approach to ensuring people living with HIV and other patients, especially those with chronic, complex, or disabling health conditions, receive necessary medications at affordable prices.

The success of ADAP rebate models over decades makes HRSA's pilot approach particularly puzzling and, frankly, wasteful. Rather than conducting an unnecessary pilot, the agency could focus resources on codifying a permanent rebate-based structure informed by ADAP experience for medications subject to the 340B program. The evidence base for rebate models already exists and has been tested at scale across every state and territory.

Voluntary Participation: Ensuring Failure

The pilot's voluntary nature for covered entities virtually guarantees inadequate data collection. Given widespread complaints from covered entities about rebate models, maintaining current distribution mechanisms while making rebate engagement optional will likely lead to minimal participation, as covered entities object to a rebate model. This voluntary structure benefits hospital systems' interests while undermining the pilot's evaluative potential.

Without mandatory participation, particularly among large covered entities serving substantial patient populations, the pilot cannot correctly evaluate the rebate model's impact on administrative burden and processes. The voluntary design ensures the pilot will be unable to test the viability of rebate models as scalable solutions, effectively wasting resources while providing political cover for maintaining the status quo - all while not delivering data on exactly “how” patients are served.

As ever, the casual observer on this issue cannot be surprised that the model lacks any requirement for covered entities to disclose details on 340B revenue use, completely obscuring the necessary distinctions between patient interests and covered entity interests served by the program.

Hospital Resistance: Cash Flow or Compliance?

The opposition to rebate models from large hospital systems reveals more about their operational priorities than legitimate patient access concerns. 340B Health, a special interest group representing safety-net hospitals, claims that rebate models would force disproportionate share hospitals to front an average of more than $72 million while waiting for rebates, "straining their ability to deliver critical care services." It’s worth noting that the proposed rebate model requires manufacturers to fulfill rebate claims within 10 days for medications subject to Medicare drug price negotiation and, under the draft guidance offered by CMS in June, these same manufacturers would be allowed a retrospective payment window of 14 days under Medicare claims. There is not a world of difference here, despite the clamoring of objectors.

Additionally, the framing from certain covered entities obscures the reality that these entities operate with substantial revenues, often far exceeding the entire federal awards provided to all state ADAPs combined. The concerns about transitioning from discount to rebate reflect, at most, a change in cash flow timing, not in total financial benefit.

More fundamentally, legitimate covered entities should have no substantive concerns with rebate models. If covered entities are not exploiting the program, the same dollars are simply moving later in the claims process - not being withheld or denied arbitrarily. Hospital systems arguing that oversight, transparency, or delayed benefit somehow threatens access are effectively admitting that their financial benefit may not align with actual patient care delivery or statutory obligations that prohibit duplicate discounts.

The intensity of hospital opposition raises important questions about program integrity. The pushback from certain covered entities, in the absence of evidence that legitimate claims would be denied, suggests potential concerns about whether current claims could withstand scrutiny under heightened transparency requirements.

Statutory Violations by Design

The pilot's most egregious flaw lies in its explicit violation of federal law. While applying only to Medicare-negotiated drugs, the pilot excludes Medicaid duplicate discount protections under the rebates section. This represents a fundamental violation of the 340B statute, which requires an explicit prohibition on duplicate discounts across other programs.

This design flaw is not merely technical. Preventing manufacturers from identifying duplicate Medicaid rebates not only conflicts with the law but invites large-scale exploitation of federal and state resources - the very issue that has generated many existing concerns about the 340B program. The pilot essentially directs regulatory loopholes that undermine program integrity rather than strengthening it.

The exclusion of Medicaid duplicate discount prevention represents a concerning (and quite possibly illegal) accommodation to covered entities that should welcome, rather than resist, measures preventing duplicate discounts.

Accommodation Over Accountability

The pilot's design reveals a troubling pattern of accommodating institutional resistance rather than enforcing program integrity. Hospital systems have consistently opposed measures that increase transparency or accountability in 340B operations. The American Hospital Association expressed concern that the pilot "authorizes a significant departure from how the 340B program has successfully operated for decades and sets a dangerous precedent." But duplicating the proven model offered by ADAPs is certainly not a “departure”, rather it’s an explicit effort to return the program to its original intent using best practices already known to the ecosystem.

However, the 340B program's current operation has generated widespread concerns about exploitation by large hospital systems that capture savings without demonstrable patient benefit. The program was designed to help safety-net providers stretch scarce resources to serve vulnerable populations, not to generate revenue streams for large hospital systems.

Covered entities that operate in good faith should welcome clarity, transparency, and compliance for the benefit of the patients they serve. Those who object to the mere possibility of statutory enforcement only reinforce concerns about potential misuse of program benefits intended for vulnerable patients.

It’s Time For Comprehensive Reform

Rather than conducting an unnecessary pilot that accommodates hospital resistance, HRSA should focus on building a permanent, comprehensive rebate framework that reflects real-world success, centers patient access and affordability, and enforces statutory accountability across all payers.

This framework should draw from the ADAP experience, which has demonstrated that rebate models can and do work effectively when implemented adequately with statutory clarity and with the explicit purpose and result of meeting patient needs. The pilot's current design - voluntary participation, statutory violations, and accommodation of institutional resistance - suggests HRSA is willing to waste valuable resources and time rather than accept and adopt the obvious answer before it.

While this is a good step, in the right direction, it is simply not enough to deliver on the promises of the program’s intent - promises patients deserve to see fulfilled.

Comprehensive reform remains essential. Such reforms should focus on improving patient access while enforcing the transparency and accountability that large hospital systems have consistently resisted. When institutional behavior persistently resists oversight designed to protect vulnerable populations, the solution is increased accountability, not accommodation through poorly designed policies that weaken statutory protections.

The Plan to Kill the World's Most Successful AIDS Program

The President's Emergency Plan for AIDS Relief (PEPFAR) stands at a critical juncture, having narrowly escaped a $400 million funding cut in July 2025 only to face a more existential threat: the Trump administration's quiet plan to fundamentally transform the world's most successful HIV/AIDS program. Leaked planning documents reveal an administration intent on dismantling PEPFAR as a public health initiative and reconstituting it as a disease surveillance and commercial enterprise platform. This transformation exemplifies the dangerous politicization of evidence-based health programs that threatens to reverse decades of progress and abandon millions of people living with HIV worldwide.

A Plan Revealed

While Congress celebrated blocking the proposed $400 million cut, leaked State Department documents obtained by The New York Times reveal a more comprehensive plan to end PEPFAR as we know it. The documents propose a 42% reduction in PEPFAR's current $4.7 billion budget and envision countries transitioning away from U.S. assistance within two to eight years. Countries closest to epidemic control—Botswana, Namibia, South Africa, and Vietnam—would see complete U.S. withdrawal within two years.

The proposed transformation fundamentally alters PEPFAR's mission. Rather than providing medicines and services to treat and prevent HIV, the program would focus on "bilateral relationships" centered on detecting disease outbreaks that could threaten the United States and creating "new markets for American drugs and technologies." The documents explicitly frame the transition as "the premier example of the U.S. commitment to prioritizing trade over aid, opportunity over dependency and investment over assistance."

The Human Cost of Disruption

The human consequences of PEPFAR's disruption are already measurable and devastating. In Mozambique, researchers found that viral suppression among children receiving HIV treatment dropped 43% between February 2024 and February 2025, directly attributed to PEPFAR disruptions. South Africa has closed 12 specialized HIV clinics and seen over 8,000 health workers in its national HIV program lose their jobs.

Enid Kyomuhendo, a sex worker in Kampala, Uganda, described her experience when her clinic closed just days after she needed her antiretroviral refill: "I got so worried. I started taking alcohol. I was thinking that anytime I am going to die. It became this life of hopelessness." After two months without medication, she developed a dark, itchy rash and now worries about drug resistance—a preventable complication that could worsen her condition.

Modeling studies project even more severe consequences. A 90-day PEPFAR funding pause could result in over 100,000 excess HIV-related deaths over a year in sub-Saharan Africa alone. More than 75,000 adults and children are estimated to have already died because of the effective shutdown that began less than six months ago.

The Politicization of Public Health

PEPFAR's current crisis reflects a broader politicization of public health programs that historically enjoyed bipartisan support. The program's 2024 reauthorization became entangled in abortion rights debates, resulting in an unprecedented one-year extension instead of the traditional five-year renewal. Representative Michael McCaul (R-Texas) captured the frustration: "I'm disappointed. Honestly, I was looking forward to marking up a five-year reauthorization, and now I'm in this abortion debate." McCaul also noted that "a lot of the Freedom Caucus guys would not want to give aid to Africa."

The evangelical community's response proves particularly revealing. Despite PEPFAR's alignment with pro-life principles and its prevention of millions of deaths, white evangelical leaders have remained largely silent about the program's dismantling. As one conservative pastor noted: "If a Democratic administration were doing this—callously, illegally, and completely unnecessarily destroying a cause prayed for, advocated for, designed by, and in many cases carried out by evangelical believers—I struggle to believe that the response would be any less immediate and strident than if they were to mandate states to permit abortion."

This selective moral outrage demonstrates how partisan loyalty can override stated principles, even when millions of lives hang in the balance.

The Innovation Paradox

The timing of PEPFAR's crisis creates a particularly cruel irony. Just as revolutionary prevention tools become available, the administration has restricted prevention programming to pregnant and breastfeeding women only, cutting off access for sex workers, men who have sex with men, and people in serodiscordant relationships.

In June 2025, the FDA approved lenacapavir, a twice-yearly injectable that proved 100% effective in preventing HIV among women and 96% effective among gay and bisexual men in clinical trials. This breakthrough represents the most significant advance in HIV prevention since pre-exposure prophylaxis became available, offering a discreet, long-acting option that could overcome adherence challenges.

Yet PEPFAR's disruption threatens access to this transformative intervention. The Global Fund and Gilead Sciences have committed to providing 2 million doses over three years, but this represents a fraction of global need. PEPFAR was expected to fund approximately half of the initial procurement, but the program's uncertain future has left this commitment in doubt.

Reform Proposals and Alternative Paths

Various stakeholders have proposed different approaches to PEPFAR's future, recognizing that some transition planning is necessary while arguing against the administration's rushed timeline. Duke University researchers have outlined reform proposals that could reduce program costs by 20% over five years while maintaining essential services and planning sustainable transitions.

The Center for Strategic and International Studies has called for a realistic five-year transition plan that would include binding bilateral compacts with clear milestones, graduated timelines based on country capacity, and maintained surge capacity for outbreak response.

However, the administration's leaked documents assume timelines that health experts consider unrealistic. Dr. Mwanza wa Mwanza, who has worked in senior roles in Zambia's HIV program for nearly a decade, noted that "three years, it's really a very short period for a heavy program like the H.I.V. program in Zambia—it's impossible."

Protecting Evidence-Based Public Health

PEPFAR's crisis extends beyond HIV/AIDS policy to represent a fundamental test of whether evidence-based public health programs can survive political weaponization. The program's documented success—26 million lives saved, nearly 8 million babies born HIV-free, and significant contributions to global health security—should make its preservation a nonpartisan priority.

Yet the administration's approach suggests that ideological considerations and commercial interests now outweigh public health evidence in policy decisions. This precedent threatens not only HIV/AIDS programs but the entire framework of global health cooperation that has made possible advances in pandemic prevention, disease elimination, and health security.

Congress retains the power to protect PEPFAR through appropriations and oversight, but sustained advocacy will be necessary to maintain political support. We must demand that policymakers prioritize evidence over ideology and recognize that global health programs serve both humanitarian and strategic American interests.

The fight for PEPFAR represents a broader struggle for the soul of American public health policy. Whether evidence-based programs can survive political polarization will determine not only the fate of millions of people living with HIV worldwide but also America's capacity to lead effective responses to future health crises.

Enhanced Premium Tax Credits Face Political Crossroads as Coverage Crisis Looms

The enhanced premium tax credits that have made Affordable Care Act (ACA) marketplace coverage affordable for millions of Americans face an uncertain future as political divisions within the Republican Party intensify. With these subsidies set to expire on December 31, 2025, and insurers proposing median premium increases of 15% for 2026—the steepest in over five years—people living with HIV (PLWH) and other chronic conditions find themselves caught in a manufactured crisis that threatens to undermine decades of progress toward treatment accessibility.

The stakes extend far beyond healthcare economics. For middle-income people living with HIV who earn too much to qualify for Ryan White services but depend on subsidized marketplace coverage, the convergence of expiring tax credits and soaring premiums represents a direct threat to viral suppression and community-wide prevention efforts. As Republican leaders grapple with internal divisions over extending these pandemic-era benefits, the August 2025 deadline for insurers to finalize rates creates an urgent timeline for Congressional action.

Market Instability Signals Deeper Systemic Problems

ACA marketplace insurers across 19 states and the District of Columbia are requesting their largest premium increases since 2018, with 105 insurers proposing a median 15% increase—more than double the 7% median increase for 2025. These proposals reflect multiple interconnected pressures that disproportionately impact people managing chronic conditions requiring continuous care.

The distribution of proposed increases reveals the severity of market instability. While 32 insurers are requesting increases between 10-15%, another 24 are seeking 15-20% increases, and 20 insurers want increases exceeding 20%. Critically, no insurers have requested rate decreases for 2026, signaling unanimous expectations of higher costs across the marketplace.

State-by-state variations compound these challenges. Colorado leads with a 28.4% average increase, with insurers attributing at least 8% specifically to uncertainty surrounding enhanced premium tax credit expiration. Arkansas follows at 26.2%, Tennessee at 24.2%, and Illinois at 23.4%. These increases reflect not just underlying healthcare cost inflation running at 8% annually, but also insurers' strategic responses to anticipated market disruption.

Insurers are building approximately 4% additional premium increases specifically to cover the expected impact of enhanced tax credit expiration. This reflects their anticipation that healthier enrollees will abandon the marketplace due to unaffordability, leaving behind a sicker, more expensive risk pool that necessitates even higher premiums in subsequent years.

The 75% Premium Shock Threatens Treatment Continuity

The expiration of enhanced premium tax credits will cause out-of-pocket premiums to increase by over 75% for the 93% of marketplace enrollees who currently receive subsidies. For people living with HIV, this creates an acute crisis given the intersection of their income levels, geographic distribution, and healthcare needs.

The enhanced credits currently save the average marketplace enrollee $705 annually, representing a 44% reduction in premium costs. However, their most significant impact has been eliminating the "subsidy cliff" that previously cut off all assistance at 400% of the federal poverty level. The 1.5 million people currently enrolled above this threshold would lose all subsidies entirely, reverting to full premium payments that many cannot afford.

For a 45-year-old person living with HIV earning $65,000 annually—just above many states' Ryan White eligibility limits—annual premiums would jump from $5,525 to $6,466, an increase of $941. For older enrollees, the impact becomes even more severe, with a 60-year-old couple earning $82,000 seeing monthly premiums skyrocket from $581 to $2,111, representing an annual increase of $18,400.

Geographic disparities compound these challenges. Wyoming enrollees would see 195% premium increases averaging $1,872 annually, while rural premiums already run 10% higher than urban areas. For people living with HIV, who are disproportionately concentrated in the South where many states haven't expanded Medicaid, these geographic disparities create additional barriers to affordable coverage.

HIV Care Economics Underscore Coverage Urgency

The unique healthcare needs of people living with HIV underscore why affordable insurance coverage remains essential for the community. Annual HIV medication costs range from $36,000 to $48,000 for standard antiretroviral therapy regimens, with complete annual healthcare expenses averaging $30,000 per person. These medications account for 60% of total HIV care costs, creating an unforgiving financial equation for those facing coverage loss.

Research demonstrates a direct, quantifiable relationship between insurance affordability and health outcomes critical for people living with HIV. Each $1,000 increase in out-of-pocket costs correlates with decreased medication adherence, while those with continuous insurance coverage show 3.2 times higher antiretroviral adherence rates compared to the uninsured. This relationship directly impacts viral suppression, which prevents both disease progression and transmission to others.

Current insurance patterns reveal the precarious coverage situation for many people living with HIV. While 40% rely on Medicaid and 35% have private insurance, 11% remain uninsured. Geographic disparities compound the challenge—52% of new HIV diagnoses occur in the South, where many states haven't expanded Medicaid and marketplace premiums run highest.

Republican Division Creates Policy Uncertainty

Republican leaders face growing internal pressure to extend enhanced premium tax credits as Trump's pollster warns that the GOP will pay a "political penalty" in the 2026 election if the funding expires. The warning carries particular weight given that 56% of ACA enrollees live in Republican congressional districts, making coverage losses a direct threat to GOP electoral prospects.

The political dynamics reveal significant fractures within the party. Rep. Brian Fitzpatrick (R-Pa.), representing a swing district, advocates for continuing the credits to avoid price increases, while Sen. Mike Rounds (R-S.D.) supports extension despite representing a deep-red state. Even Sen. Tommy Tuberville (R-Ala.), running for governor, calls on his party to consider an extension, though he expresses concern about costs.

However, conservative opposition remains fierce. Rep. Andy Harris (R-Md.), chair of the House Freedom Caucus, wants the funding to end, calling it unaffordable Covid-era policy. Rep. Chip Roy (R-Texas) dismisses extension efforts as a "nonstarter," while Sen. Ron Johnson (R-Wis.) flatly opposes preserving the subsidies.

The $335 billion ten-year cost of permanent extension creates a significant hurdle for fiscally conservative Republicans. Sen. Thom Tillis (R-N.C.), an early proponent of continuing the funds, suggests modifications may be necessary "to get Republicans on board," while House Speaker Mike Johnson (R-La.) keeps options open, saying the issue is "on the radar" but hasn't come up yet.

Ryan White Program Cannot Fill Coverage Gap

The Ryan White HIV/AIDS Program, designed as a safety net for low-income people living with HIV, typically limits eligibility to those earning 400-500% of the federal poverty level, varying by state. This creates a critical coverage gap for middle-income people who earn too much for Ryan White services but cannot afford unsubsidized marketplace premiums.

The enhanced premium tax credits have successfully bridged this gap for an estimated 50,000 Ryan White clients who received marketplace premium assistance by 2014, a number that has grown significantly since. These people typically fall in the 150-400% federal poverty level range, using Ryan White for premium assistance, copay help, and wraparound services while relying on ACA plans for comprehensive coverage beyond HIV-specific care.

The program's "payer of last resort" status means it cannot serve as primary insurance, making affordable marketplace coverage essential for non-HIV medical needs. Without marketplace coverage, Ryan White programs alone cannot provide comprehensive healthcare access for people living with HIV.

Policies for Sustainable Solutions

The convergence of enhanced tax credit expiration and massive premium increases demands immediate Congressional action to prevent a preventable public health crisis. Policymakers must recognize that insurance affordability directly impacts HIV treatment adherence and viral suppression—factors that prevent transmission and save lives.

Congress should extend enhanced premium tax credits through at least 2027 to provide market stability while developing longer-term reforms. This extension must maintain the elimination of the subsidy cliff at 400% of federal poverty level, ensuring continued coverage for middle-income people living with HIV who fall outside Ryan White eligibility.

State policymakers should strengthen coordination between Ryan White programs and marketplace enrollment, following successful models in California and New York. This includes streamlining enrollment processes, improving data sharing between programs, and ensuring comprehensive support for people transitioning between coverage sources.

The Urgency of Action

As insurers face their August 2025 deadline to finalize rates based on uncertain Congressional action, the window for preventing coverage catastrophe narrows rapidly. Congressional Budget Office projections show marketplace enrollment dropping from 22.8 million to 18.9 million in 2026 alone, with continued declines to 15.4 million by 2030 if enhanced credits expire.

For people living with HIV who have achieved viral suppression through consistent treatment access, January 1, 2026 represents a politically manufactured crisis that threatens both individual health outcomes and community-wide prevention efforts built on treatment as prevention. The precision of this policy failure specifically targets middle-income Americans who work, pay taxes, and contribute to their communities, yet find themselves earning just enough to be abandoned by both safety net programs and affordable insurance markets.

The stakes transcend healthcare policy, touching fundamental questions about American commitments to public health, health equity, and the value we place on treatment accessibility. With Republican polling data showing broad support for continuing these credits and electoral consequences looming in competitive districts, the political incentives align with public health imperatives. Whether Congressional Republicans recognize this convergence and act accordingly will determine whether decades of progress toward HIV treatment accessibility survives the current political moment.

Medicaid loses billions as 340B program expansion collides with state budgets

The 340B Drug Pricing Program diverted $6.5 billion in rebates away from Medicaid in 2024, with state governments shouldering $2.3 billion of these losses, according to a July 2025 study by the Berkeley Research Group (BGR). This financial hemorrhaging stems from a fundamental design flaw where federal duplicate discount prohibitions create perverse incentives that simultaneously drain state healthcare budgets while enabling systematic exploitation of taxpayer-funded programs.

The study, commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), represents the first comprehensive state-by-state analysis of how the 340B program's expansion into managed care environments undermines Medicaid's drug rebate collections. While the pharmaceutical industry's funding raises legitimate questions about methodology and framing, the underlying financial mechanics reveal a critical policy failure that demands immediate federal intervention.

The managed care loophole: How billions slip through regulatory gaps

The crux of the problem lies in the structural incompatibility between the 340B program's provider-based discount model and Medicaid's claims-based rebate system. Federal law prohibits manufacturers from providing both a 340B discount and a Medicaid rebate on the same drug unit—a sensible protection against duplicate discounts that becomes problematic when applied across different payment systems.

In fee-for-service Medicaid, this works as intended. Federal regulations under 42 CFR 447.512(b) require states to reimburse pharmacies at the actual acquisition cost, which is the discounted 340B price plus a dispensing fee. Lost rebate revenue gets offset by reduced reimbursement, maintaining fiscal neutrality.

Managed care environments tell a completely different story. The BRG analysis found that "managed care plans generally do not reduce reimbursement for 340B drugs—and in some cases are statutorily prohibited from doing so—the loss in rebate revenue from 340B expansion is not offset and drives up the net cost of prescription drug coverage for states and the federal government." Managed care organizations negotiate rates that typically exceed the discounted 340B price, with covered entities and contract pharmacies capturing the difference as revenue. At the same time, states forfeit manufacturer rebates without corresponding savings.

This distinction matters because managed care now dominates Medicaid delivery, covering approximately 72% of beneficiaries. The scale of this shift has transformed what was once a manageable tracking challenge in fee-for-service environments into a massive revenue diversion that states struggle to monitor, let alone prevent.

State-by-state devastation reveals policy choices and fiscal impact

The geographic distribution of losses illuminates how state policy decisions shape financial outcomes. Pennsylvania faces the steepest hit, with $634.8 million in total ineligible rebates, translating to a direct state budget impact of $265.3 million after accounting for federal matching funds. Illinois follows with a total of $544.3 million ($238.4 million state share), while Massachusetts sees a total of $433.5 million ($189.9 million state share).

These figures represent real money that could fund healthcare access, improve provider reimbursement, or provide budget relief for cash-strapped state programs. For context, Pennsylvania's $265 million loss exceeds the entire annual budget of many state health departments.

Notably, fifteen states appear as "N/A" in the analysis, indicating their Medicaid program structures prevent these specific costs. The BRG methodology "accounts for the 340B/Medicaid policies specific to each state," suggesting these states have implemented carve-out policies or other structural protections that eliminate managed care 340B dispensing to Medicaid beneficiaries.

California and New York exemplify this approach, having transitioned prescription drug coverage out of managed care partly due to 340B program costs. While these carve-outs protect rebate revenue, they require states to directly manage pharmaceutical benefits—a complex undertaking that smaller states may lack the resources to implement effectively.

Secondary market distortions compound direct fiscal harm

The BRG study acknowledges that rebate losses represent only part of the 340B program's broader impact on Medicaid spending. The analysis notes: "Our analysis does not account for other pathways through which the 340B program may be contributing to increased spending in Medicaid. The 340B program has been associated with a shift in care toward hospitals, for example—generally a higher-cost setting."

This observation aligns with research showing that 340B eligibility incentivizes provider consolidation and shifts in care settings. A 2018 Health Services Research study found that the 340B program has a significant impact on cancer care site selection and spending in Medicare, while a 2016 Milliman analysis documented how cost drivers shift across different care settings. When hospitals acquire physician practices or expand outpatient departments to capture 340B revenue, patient care migrates from lower-cost settings to higher-cost hospital environments. For Medicaid programs operating under global budgets or facing legislative pressure to control spending, these cost shifts compound the rebate revenue losses documented in the BRG analysis.

The study also references evidence that "340B covered entities tend to use more and/or more costly drugs for their patients, potentially because 340B drug margin (the difference between acquisition cost and reimbursement) is often greater for more expensive medicines." A 2015 Government Accountability Office (GAO) report found that financial incentives were used to prescribe 340B drugs at participating hospitals. A 2022 Milliman analysis of commercial outpatient drug spending at 340B hospitals and a 2025 Journal of Health Economics study on physician agency in 340B expansion document these utilization patterns. This dynamic creates perverse incentives where financial considerations may influence prescribing patterns, driving up both drug costs and Medicaid expenditures beyond the direct rebate losses.

Federal regulatory abdication enables systematic exploitation

The scope of revenue diversion revealed in the BRG study reflects broader failures in federal oversight and program integrity. A 2020 GAO report found that 25% of audited 340B programs had duplicate discount errors, with 264 of 429 cases caused by inaccuracies in the Medicaid Exclusion File system itself—the very mechanism supposed to prevent these problems.

More troubling, GAO found that only 4 of 13 covered entities had accurate descriptions of state Medicaid policies, suggesting systematic confusion about compliance requirements. When the federal oversight agency's own tracking system contains errors and covered entities lack a basic understanding of duplicate discount rules, billions in revenue diversions become inevitable.

The Centers for Medicare & Medicaid Services (CMS) "provides limited oversight of state Medicaid duplicate discount prevention efforts, leaving this responsibility to states, which are not always sufficiently funded or staffed to meet this responsibility," according to the BRG analysis. This abdication of federal responsibility creates a regulatory vacuum where systematic revenue diversions can occur without detection or accountability.

As we documented in our June 2025 analysis, CMS's refusal to mandate federal claims modifiers in its Medicare Drug Price Negotiation Program guidance exemplifies this regulatory failure. Claims modifiers represent existing, proven technology that could enable automated duplicate discount prevention, yet CMS has chosen to perpetuate complex, error-prone manual processes that enable continued exploitation.

Context of federal cuts amplifies the crisis

The timing of these revelations proves particularly concerning given broader federal policy changes affecting safety-net healthcare financing. As detailed in our July 2025 analysis of the One Big Beautiful Bill Act, proposed Medicaid cuts threaten to force 200,000 people living with HIV off coverage while simultaneously reducing Ryan White HIV/AIDS Program capacity to serve as a safety net.

When federal cuts increase provider dependence on 340B revenue precisely as that revenue diverts billions from state Medicaid programs, the result is a death spiral for safety-net financing. States lose revenue they need to maintain Medicaid access while providers chase 340B margins to replace vanishing federal funding. People living with HIV and other vulnerable populations get caught in the middle as both funding streams face pressure.

This dynamic transforms the 340B program from a targeted safety-net support into a massive wealth transfer from taxpayer-funded Medicaid programs to hospital systems and contract pharmacy networks. The BRG study's $6.5 billion figure likely represents a conservative estimate given the secondary spending effects and ongoing program expansion.

Immediate federal intervention required

Immediate federal action to implement mandatory claims identification systems and comprehensive program transparency is urgently needed. Claims modifiers represent proven technology already used in Medicare that could enable real-time duplicate discount prevention without disrupting legitimate 340B access for safety-net providers.

States cannot solve this problem unilaterally. The interstate nature of managed care organizations, the federal structure of both 340B and Medicaid programs, and the technical complexity of pharmaceutical supply chains require coordinated federal leadership. Every day of continued regulatory inaction enables millions more in revenue diversions while undermining both program integrity and taxpayer confidence.

The 340B program serves legitimate safety-net functions, but systematic exploitation of regulatory gaps threatens its long-term viability while imposing unsustainable costs on state budgets. Federal agencies must choose between meaningful reform that preserves legitimate access while preventing abuse, or continued abdication that enables billion-dollar revenue diversions until political pressure forces more drastic interventions. For the vulnerable populations depending on both 340B providers and Medicaid access, the stakes of this choice could not be higher.

The Coming HIV Care Crisis

The One Big Beautiful Bill Act (OBBBA)'s reduction of Medicaid expansion eligibility from 138% to 100% of the federal poverty level (FPL) creates an unprecedented crisis for HIV care in the United States, threatening to force approximately 200,000 people living with HIV off coverage while simultaneously undermining the Ryan White HIV/AIDS Program's capacity to serve as an adequate safety net, ultimately jeopardizing decades of progress toward ending the HIV epidemic and disproportionately harming communities of color and rural populations who already face significant barriers to care.

A Crisis at the Intersection of Policy and Survival

The One Big Beautiful Bill Act, signed into law on July 4, 2025, represents, according to the National Alliance of State and Territorial AIDS Directors (NASTAD), a moment when "AIDS Drug Assistance Programs (ADAPs) stand at a critical precipice." Let us not mince words: this legislation systematically dismantles the interconnected safety net that has enabled the United States to achieve the highest rates of viral suppression in the history of the epidemic.

The math, like those who passed this legislation, is cruel and unforgiving. With 40% of non-elderly adults living with HIV relying on Medicaid for coverage—nearly three times the rate of the general population—this eligibility reduction targets precisely the demographic most dependent on public health insurance. The Congressional Budget Office (CBO) projects that 7.8 million people will lose Medicaid coverage overall, with advocacy organizations estimating that approximately 200,000 people living with HIV will be among those stripped of coverage.

The timing creates a perfect storm. As NASTAD warns, "enhanced premium tax credits associated with Marketplace plans are set to expire later this year." At the same time, state health departments face "drastic budget cuts and reductions in force because of federal agency cuts." This convergence of federal policy changes threatens to create what NASTAD calls "sharp increases in the number of uninsured people with low incomes," precisely when the safety net programs designed to catch them are facing their own funding constraints.

The Medicaid Foundation: Why This Coverage Matters

The reduction from 138% to 100% of the federal poverty level specifically targets the income bracket where HIV prevalence is highest. Research demonstrates that 42% of Medicaid enrollees with HIV gained coverage through the Affordable Care Act's expansion, with this figure rising to 51% in expansion states. More than a mere statistical abstraction, it represents hundreds of thousands of people living with HIV (PLWH) who gained access to consistent, comprehensive healthcare for the first time.

The financial implications reveal the complexity of HIV care. Average Medicaid spending reaches $24,000 per HIV enrollee compared to $9,000 for non-HIV enrollees, reflecting the intensive medical management required for effective HIV treatment. When coverage disappears, these costs don't vanish—they shift to an already overwhelmed safety net or go unmet entirely, leading to treatment interruptions that increase viral loads and HIV transmission risk.

State-level analyses paint an even grimmer picture. Louisiana and Virginia face 21% spending cuts over the 10-year period, while Southern states that bear 52% of new HIV diagnoses despite comprising only 38% of the population will see disproportionate impacts. The legislation includes five major provisions that collectively cut $896 billion from Medicaid: work requirements, repealing Biden-era eligibility rules, provider tax restrictions, state-directed payment limits, and increased eligibility redeterminations.

The Ryan White Program: Last Resort, Impossible Math

The Ryan White HIV/AIDS Program operates on a fundamentally different model than Medicaid—one that makes absorbing massive coverage losses mathematically impossible. With $2.6 billion in discretionary funding requiring annual Congressional appropriations, the program lacks Medicaid's entitlement structure that automatically expands to meet growing needs.

The program's current client base reveals the scale of the challenge. Ryan White already serves over 576,000 clients annually, representing more than half of all diagnosed HIV cases. Critically, 39% of Ryan White clients have Medicaid as their primary payer, meaning they use Ryan White for wraparound services Medicaid doesn't cover. When these people lose Medicaid, Ryan White must suddenly cover their entire care costs—an impossibility given current funding constraints.

NASTAD's analysis warns this would "shift unsustainable burdens to the Ryan White HIV/AIDS Program," potentially forcing jurisdictions to reintroduce AIDS Drug Assistance Program (ADAP) waitlists not seen since the early 2010s. The program's "payer of last resort" status means it legally must serve anyone without other coverage options, creating an unfunded mandate when Medicaid disappears.

Historical evidence demonstrates the program's existing capacity limitations. From 2017-2019, 58.7% of uninsured persons had unmet needs for HIV ancillary care services, yet the program achieved 90.6% viral suppression rates among clients in 2023—a testament to its effectiveness when adequately resourced.

The proposed FY 2026 budget compounds this crisis by cutting Ryan White funding to $2.5 billion while eliminating Part F entirely. Part F includes AIDS Education and Training Centers that reached 56,383 health professionals last year, representing a critical workforce development component that would disappear precisely when demand for HIV care is expected to surge.

Healthcare Infrastructure Under Siege

Federally Qualified Health Centers (FQHC), serving as the backbone of HIV care in underserved communities, face an existential crisis. With Medicaid comprising 43% of FQHC revenue, the reconciliation bill threatens the fundamental business model of these safety-net providers. FQHCs currently operate on razor-thin margins approaching negative 2.2%, with 42% reporting 90 days or less cash on hand.

The rural healthcare crisis intensifies these challenges. Over 700 rural hospitals face closure risk—representing one-third of all rural hospitals—with 171 having shut down since 2005. The bill's $25 billion rural transformation fund provides only 43% of what experts calculate is needed to offset Medicaid cuts.

For HIV care, this means losing critical access points in areas already designated as priority jurisdictions for the Ending the HIV Epidemic (EHE) initiative. Research demonstrates that FQHCs in the rural South could reduce median drive time to HIV care from 50 to 10 minutes—but only if they remain financially viable. When Medicaid patients lose coverage, FQHCs must still serve them as uninsured patients by law, creating additional uncompensated care costs the facilities cannot absorb.

The 340B Program: Hidden Financial Hemorrhaging

The removal of Pharmacy Benefit Manager (PBM) spread pricing prohibitions represents a significant blow to 340B savings that HIV programs depend on for sustainability. The 340B program generated $38 billion in discounts in 2020 alone, with Ryan White clinics using these savings to serve an additional 43,000 people living with HIV.

Without spread pricing protections, PBMs can continue diverting these savings through discriminatory practices. States have documented massive overcharges: Ohio lost $224.8 million in one year, Pennsylvania $605 million over four years, and Maryland $72 million annually to spread pricing schemes. For HIV programs already operating on minimal margins, these losses represent the difference between serving patients, implementing waitlists, or shutting down altogether.

The policy intersection becomes particularly cruel when considering substance use services. While the OBBBA protects substance use disorder services from cost-sharing requirements—a "modest but important win" according to county officials—the broader context undermines these protections. Research shows 23.94% of people with HIV need treatment for alcohol or substance use, with people who inject drugs facing 30 times higher HIV risk than non-users.

Geographic and Demographic Devastation

The reconciliation bill's impacts fall hardest on communities already bearing disproportionate HIV burdens. Black and Hispanic/Latino people account for 64% of all people with HIV while representing only 31% of the population. These communities have higher Medicaid coverage rates due to lower incomes and higher disability rates, making them particularly vulnerable to coverage losses.

Southern states face a catastrophic combination of high HIV prevalence, limited state resources, and political resistance to mitigation strategies. The region accounts for 52% of new diagnoses, and includes many non-expansion states where 66% of HIV-positive adults rely on disability-related Medicaid pathways.

Nine states have trigger laws automatically ending Medicaid expansion if federal matching rates drop, creating immediate coverage cliffs. The intersection of geography, race, and poverty creates concentrated zones where HIV care infrastructure may collapse entirely, reversing decades of progress in communities that have historically faced the greatest barriers to care.

Clearly, This Isn’t About Fiscal Responsibility

The legislation represents fiscal malpractice when considering the long-term costs of new HIV transmissions. Each new HIV infection creates $501,000 in lifetime healthcare costs, while achieving 72% viral suppression would cost $120 billion over 20 years. The math is unambiguous: preventing new infections through sustained treatment is far more cost-effective than treating them after they occur.

The HIV community's response demonstrates the severity of the threat. Over 113 organizations relaunched the #SaveHIVFunding campaign, while the Partnership to End HIV, STI, and Hepatitis Epidemics united major organizations in opposition, emphasizing that "healthcare is not a reward for paperwork—it is a human right."

As NASTAD's analysis concludes, "When one of these pillars weakens, the others feel the shock waves"—and this bill doesn't just weaken pillars, it demolishes them. Without immediate action to reverse these cuts, the United States will witness a preventable reversal of decades of progress in HIV care, measured not in budget savings but in lives lost to a disease we know how to treat.

War-Torn Ukraine Beats U.S. on Integrated Addiction Care

At Strizhavka Detention Center in central Ukraine, vending machines dispense clean syringes to inmates while Russian missiles target infrastructure just hours away. It's a remarkable scene: a country under active invasion operates one of the world's most progressive harm reduction networks, achieving an 81% reduction in AIDS mortality since 2010 and zero new HIV infections in prisons with needle exchange programs. Meanwhile, the United States continues to trap vulnerable patients in a fragmented maze of disconnected systems that increases costs, worsens outcomes, and reflects a fundamental failure of political will to prioritize evidence-based care coordination over institutional preservation and stigma-driven policy making.

Ukraine has mastered what public health experts call syndemic response—addressing the interconnected epidemics of substance use disorders, HIV, hepatitis C, and tuberculosis through innovative, integrated solutions. In war-torn Ukraine, where Russian missiles regularly destroy infrastructure, a person with opioid addiction can access methadone through any pharmacy with a prescription and receive 30-day take-home supplies during crisis periods. In Louisiana, that same person might spend months navigating separate systems for addiction treatment, HIV care, and basic healthcare—if they can access treatment at all. While Ukraine maintains comprehensive services under active invasion, Louisiana saw drug overdose deaths quintuple from 401 to 2,376 between 2017 and 2022. This divergence reveals a fundamental truth: healthcare fragmentation represents a policy choice, not an inevitability.

Ukraine's Integrated Model: Coordination Under Fire

Ukraine operates Europe's most comprehensive harm reduction network, serving 250,000+ vulnerable people through coordinated government-civil society partnerships. The system's architecture connects HIV testing, hepatitis C screening, opioid substitution therapy (OST), and substance use disorder treatment into one seamless framework coordinated by the Alliance for Public Health Ukraine.

Beyond Strizhavka, the integration model extends across the country's correctional system. The Free Zone organization now operates similar programs in 56 Ukrainian prisons, a radical departure from punitive approaches that have defined American corrections. Ukraine trains incarcerated people as peer counselors, with 77 certified social workers among more than 400 inmates trained through the program.

Mobile testing units exemplify the wraparound approach. Inside vans parked outside Kyiv methadone clinics, social workers help clients test themselves while offering take-home tests for partners—a simple intervention that dramatically expands testing reach. One client, Mykolai, can earn small payments for testing and receive cards to distribute to friends, slowly building a self-sustaining testing network that operates independently of formal healthcare systems.

War forced remarkable adaptations that reveal the system's flexibility. Solar panels now power clinics to ensure uninterrupted service during blackouts. The HelpNOW digital platform coordinates care for 30,000+ displaced Ukrainians across 52 countries, ensuring treatment continuity despite massive population displacement. As one incarcerated person described the transformation, "civilization came to this place" through these integrated services.

Louisiana as U.S. Fragmentation Case Study

Louisiana exemplifies how U.S. system fragmentation creates insurmountable barriers for vulnerable patients despite having what advocates describe as "one of the best coordination of care situations across the country." The state serves 22,920 people living with HIV across a fragmented regional system where Ryan White programs operate across Regions 3-9 for Part B funds, with separate Part A grants for Greater New Orleans and Baton Rouge, and Parts C and D funded at local clinic and community organization levels.

This multi-layered approach creates coordination nightmares where patients must navigate different systems depending on their geographic location and specific service needs. The fragmentation's impact is clear, as CANN CEO Jen Laws explains: "One of our biggest barriers in this country is that the segregation of our programs do not encourage engagement in care. Indeed, they create such administrative burden on the patient alone that people fall out of care all the time. When someone goes to a space they're supposed to trust, the 'experts' managing their care, with a problem and get told to run around more and more and more, trust disintegrates. Getting the care you need shouldn't be a full-time job.”

The human cost manifests in stories like Jessica Baudean and Terry Asevado, methadone patients who face extraordinary barriers to daily treatment access. Baudean, who is disabled and lives in Avondale, must rely on Medicaid transportation when available or have Asevado push her wheelchair 1.4 miles to the nearest bus stop, then spend an hour taking two buses to reach the only clinic on the city's East Bank authorized to dispense their medication. If they arrive even a minute past noon, they miss their dose. If they miss a dose, they may be denied the next one—a punitive approach that penalizes the very disability and transportation barriers the system creates. When Asevado was arrested in Jefferson Parish, Baudean described her partner's inevitable suffering: "Poor Terry, I know he's still going to be sick right now." The Jefferson Parish Sheriff's Office lacks coordination with local methadone clinics despite federal regulations permitting continued treatment, forcing people in custody into painful and dangerous withdrawal.

Nationally, only 39% of Ryan White clients have Medicaid as their primary payer, indicating massive gaps in coverage coordination. Research reveals that fragmented care costs $4,542 more annually per patient—$10,396 versus $5,854 for coordinated systems. Patients face duplicative eligibility verification, inconsistent prior authorization requirements, and limited data sharing between systems, with 73% of insured adults performing administrative healthcare tasks annually.

For returning citizens—formerly incarcerated people—the barriers multiply exponentially. Despite HIV prevalence among incarcerated populations being three times the general population rate, only 18.9% of criminal justice-involved people with substance use disorders receive treatment. Among those released from Texas prisons, just 5% maintain medication continuity within two months, creating catastrophic treatment disruptions precisely when continuity matters most.

Political Backlash and Current Threats

Even traditionally supportive states are retreating from harm reduction while federal policy accelerates toward punitive approaches. Oregon's House Bill 4002 reinstated criminal penalties with up to six months jail time for possession, largely repealing its pioneering decriminalization measure. California voters passed Proposition 36, rolling back criminal justice reforms despite opposition from harm reduction advocates.

Federal policy under the Trump administration has dramatically accelerated this retreat. The Department of Health and Human Services (HHS) announced $11.4 billion cuts to addiction and mental health programs, while the Substance Abuse and Mental Health Services Administration (SAMHSA) faces $1 billion in immediate cuts with 20,000 planned staff reductions. The 2026 budget proposal explicitly criticizes harm reduction, stating SAMHSA grants "funded dangerous activities billed as 'harm reduction.'"

This political momentum contradicts public opinion. Bipartisan polling shows 79% support for medication-assisted treatment and 64% for overdose prevention centers. However, partisan breakdown reveals deep divides that complicate political feasibility, with Democrats supporting overdose prevention centers by 67 points but Republicans by only 2 points.

The resistance reflects deeper currents of moralizing medical conditions like substance use disorders and HIV—a toxic legacy of moral majority politics that treats addiction as moral failing rather than health condition. This moralization couples with America's fetishization of policing and punishment, creating an undercurrent of ill will toward helping people dealing with these issues. Congressional dynamics offer little hope for reversal. House Republicans proposed the provocatively named "Crack is Whack Act" to explicitly ban safe consumption sites nationwide, while the federal "crackhouse statute" continues blocking evidence-based interventions. This political landscape creates a paradox: public health crises that should unite communities instead become wedges for division when filtered through moral judgment rather than medical evidence.

Systemic Barriers and Misaligned Incentives

U.S. healthcare fragmentation persists through structural design flaws embedded in historical decisions that separated substance use treatment from mainstream medicine. This separation created what researchers describe as "insular fields with inadequate communication, coordination, and collaboration." Multiple funding streams—federal, state, and local government (42%), Medicaid (21%), Medicare (5%)—operate under different rules with incompatible requirements.

Financial incentives actively maintain fragmentation. Fee-for-service payment models reimburse discrete services rather than coordinated care, with administrative burden consuming 50% of physician time. Technology failures compound human ones: despite decades of electronic health record adoption, 48% of hospitals share data with other organizations but receive nothing in return.

Worse yet, provider stigma compounds structural barriers. Systematic reviews document that 20-51% of healthcare professionals hold negative attitudes toward people with substance use disorders. Privacy regulations like 42 CFR Part 2—federal rules that create stricter confidentiality protections for substance use treatment records than standard medical records—create additional barriers to integration by requiring separate consent processes and record systems for substance use treatment, despite 2024 reforms aimed at improving coordination.

The Moral Test of Healthcare Policy

Ukraine's wartime harm reduction success exposes American policy failures as choices, not inevitabilities. A country under active invasion maintains better care coordination than the world's wealthiest nation during peacetime. This contrast reveals how political will, not resources, determines outcomes.

Successful integration models do exist within the United States. Vermont's Hub and Spoke model achieves the nation's highest opioid use disorder treatment capacity—10.56 people in treatment per 1,000 population. Nine regional "Hub" clinics provide specialized services while 87+ "Spoke" sites in primary care settings offer office-based treatment, ensuring appropriate care levels while maximizing capacity.

Breaking this deadlock requires acknowledging that healthcare fragmentation reflects deeper societal decisions about who deserves care. Yet even modest reform efforts face existential threats as Congressional Republicans advance unprecedented cuts to programs serving the most vulnerable Americans. The proposed $1.1 trillion in Medicaid reductions would devastate services for 71 million people, prompting callous dismissals from GOP leaders like Senator Mitch McConnell, who told worried colleagues that voters will "get over it" when they lose healthcare coverage. Iowa Senator Joni Ernst doubled down on this cruelty, telling constituents concerned about Medicaid cuts that "we all are going to die" and posting a sarcastic apology video filmed in a cemetery. These responses reveal the moral bankruptcy underlying American healthcare politics—treating life-sustaining programs as political footballs while dismissing the human consequences with shocking indifference.

Ukraine has shown that even under the most challenging circumstances imaginable, integrated care saves lives and money. American policymakers have no excuse for maintaining systems that force vulnerable patients to navigate bureaucratic mazes while their health deteriorates, especially when the alternative being offered is abandoning them entirely through devastating cuts that prioritize tax breaks for the wealthy over basic human dignity.

How Pharma Can Turn Advocates Into Allies

Governor Ned Lamont's recent visit to ViiV Healthcare's Branford research facility highlighted a missed opportunity that extends far beyond Connecticut's biotech sector. While Gov. Lamont toured laboratories where researchers develop long-acting injectable HIV prevention drugs, the scene raised a compelling question: What if pharmaceutical companies routinely invited advocacy leaders—not just politicians—behind the scenes for plant tours, CEO roundtables, and genuine engagement with the science that drives their work?

This moment arrives at a critical juncture for disease advocacy organizations across therapeutic areas. As federal funding faces unprecedented cuts and advocacy groups struggle for sustainability, the pharmaceutical industry's evolution from traditional grant-maker to authentic community partner offers a transformative model that could reshape how companies support grassroots organizations serving people living with HIV, hepatitis C, lupus, rare diseases, and countless other conditions.

Federal Funding Collapse Creates Cross-Disease Crisis

The Trump Administration's systematic dismantling of federal health programs creates funding gaps that affect advocacy organizations across all disease states. The Centers for Disease Control and Prevention (CDC)'s HIV Prevention Division faces nearly $1 billion in cuts, while the National Institutes of Health (NIH) confronts a 40% reduction in its $3.3 billion HIV research portfolio. Over 200 HIV/AIDS research grants have been terminated since January 2025.

These cuts reverberate beyond HIV advocacy. Chronic disease programs, rare disease research initiatives, and community health grants face similar reductions, leaving advocacy organizations across therapeutic areas scrambling for alternative funding sources. Los Angeles County's 39 HIV organizations received contract termination notices affecting $19 million in CDC funding, a harbinger of what advocacy groups in oncology, autoimmune diseases, and rare conditions could expect.

Industry's $100 Million Evolution

Pharmaceutical companies have been pioneering investments that transcend traditional grant-making, demonstrating innovation in community partnerships that becomes critical as federal funding disappears. ViiV Healthcare's $7.8 million Fund Our Futures pledge, announced in November 2024, exemplifies this shift through their AMP Grant Initiative, where 13 organizations distribute funds to activate over 150 grassroots projects—the first time a pharmaceutical company has empowered communities to make their own funding decisions.

Gilead Sciences leads with $24 million through their Zeroing In program and an additional $12.6 million Setting the P.A.C.E. Initiative serving Black women and girls. Merck's $7 million HIV Care Connect initiative addresses social determinants of health over five years.

These programs demonstrate authentic partnership through direct C-suite executive participation in community dialogues, real influence for community advisory boards on corporate decision-making, and holistic approaches addressing social determinants beyond strict “medical” needs.

A Hard Look at the Two-Tier Funding System

The funding divide between established and grassroots advocacy organizations is stark. amfAR has raised nearly $950 million since 1985, including over $17 million at their 2024 Cannes Gala alone, while the National Minority AIDS Council operates on $5-7 million annually with executive compensation exceeding $400,000.

The reality for smaller organizations is far different. Kristy Kibler, CEO of Lupus Colorado, details the issue: "Small, state level patient groups are drowning in too many programs created to generate funding and need to be more bold in asking for operational support. We can not continue to ask patients and their families to keep these orgs financially afloat."

Warren Alexander O'Meara-Dates, Founder/CEO of The 6:52 Project Foundation, echoes these challenges from the HIV advocacy space: "Without name recognition and measured outcomes for programs, pharma companies often times do not align themselves with us. Additionally, the strict guidelines set in application processes, tend to eliminate our ability to qualify for and/or apply for support."

Pharmaceutical companies contribute to this disparity through their funding patterns. "They often support the two national orgs who do not invest locally or pass along any of that funding which leaves little room in their budgets to support our state level work," Kristy explains. Meanwhile, staffing instability devastates smaller organizations: "We have had two partners eliminate their advocacy teams and leave us without even a contact at their company."

This creates self-reinforcing cycles where established organizations possess infrastructure for complex grant applications and institutional relationships that survive personnel turnover. AIDS United's average grant size of $36,522 often represents a lifeline for smaller entities, but similar micro-funding challenges affect almost all small and upstart advocacy organizations.

Innovation Models Ready for Cross-Disease Application

Sophisticated engagement strategies pioneered in HIV advocacy provide blueprints for other disease areas. European Community Advisory Board meetings bring advocates directly into dialogue with pharmaceutical executives, where community members have real influence on drug development and safety protocols. Bristol Myers Squibb's Global Patient Outreach structure integrates patient voice into all business decisions—a model that spans their oncology and other therapeutic portfolios.

Executive engagement has become central to these partnerships. Carmen Villar, Gilead's VP of ESG and Corporate Citizenship, leads direct dialogue sessions with community leaders, while ViiV executives participate in European advisory meetings where advocates shape corporate strategy. This direct access allows advocacy organizations to influence corporate policies, research priorities, and community investment strategies in real time.

Experiential Investment Over Transactional Charity

The pharmaceutical industry has an unprecedented opportunity to model transformative advocacy investment across all disease states. Rather than simply writing checks, companies should create meaningful engagement opportunities that build advocacy capacity and strengthen community-industry relationships.

Plant tours and research facility visits represent one powerful model. Kristy from Lupus Colorado articulates what advocacy leaders want: "I would want to know what barriers the trials are facing, specifically in the lupus community. It would be helpful to get some education on how their drugs work and why they are novel so that we can help generate excitement and hope in our patients."

Warren from The 6:52 Project emphasizes the importance of understanding pharmaceutical development processes: "What process does new product development go through from concept to market sales. Therein, I would like to learn how much community input is involved during the process."

The value extends beyond education to building trust and credibility. Warren notes that "having access to c-suite executives would benefit my organization because it would allow us to share stories of success and barriers serving marginalized communities in rural areas. Doing so would shape better relationship building with community such that trust of pharma and their intentions could be increased."

Beyond plant tours, pharmaceutical companies can leverage advocacy organizations as strategic resources. "Using us as a resource for trial participants, connection with their sales reps to help us open doors into provider space, co-branded marketing materials," Kristy suggests. Warren emphasizes the credibility factor: "Credibility partnering with a major corporation increases validity of programming offerings for smaller organizations like mine."

The most transformative opportunity lies in giving advocacy organizations real influence over corporate strategy from the beginning. Warren advocates for "including my expertise in developing products for community from conception" rather than "waiting until later in the process." This represents a fundamental shift from charitable giving to authentic partnership.

Forward-thinking pharmaceutical companies should establish advocacy advisory boards that include smaller, state-level organizations across therapeutic areas, not just established national groups. Launch executive mentorship programs pairing pharmaceutical executives with advocacy leaders. Create structured programs bringing advocacy leaders to research facilities and executive meetings. Provide operational support that moves beyond program-specific grants to unrestricted funding that builds organizational capacity.

The convergence of federal funding cuts and industry innovation creates a critical window for establishing alternative advocacy funding ecosystems. Companies that pioneer experiential investment models across disease states will strengthen their community relationships and position themselves as leaders in sustainable public health advocacy.

Imagine a pharmaceutical industry that recognizes the untapped potential in scrappy, nimble advocacy organizations led by people who understand their communities' needs intimately. These creative advocates—like Kristy in Colorado working directly with lupus patients, or Warren serving marginalized communities in rural areas—bring innovation, agility, and authentic community connections that larger legacy organizations often lack. They deserve more than the leftover funding after national organizations take their share.

The pharmaceutical industry has the opportunity to empower and equip these advocates not just with financial resources, but with knowledge, access, and genuine partnership. When companies invest time in plant tours, executive mentorship, and collaborative strategy sessions with smaller advocacy organizations, they tap into a reservoir of community insight and innovative approaches that could transform how medicine reaches the people who need it most. The scrappy organizations working closest to affected communities often have the boldest ideas and the strongest commitment to change—they simply need industry partners willing to see past the polished grant applications of established organizations to recognize the potential of authentic grassroots advocacy.

This moment demands more than transactional charity. It calls for industry to reimagine community investment as true partnership with the advocates who know their communities best.

RFK Jr.’s Administration for a Healthy America is Not Healthy

RFK Jr.’s paradigm for reimagining the pathway to improve population health in the United States includes the creation of what he calls the Administration for a Healthy America (AHA). He has issued a mandate to solve chronic disease issues that he views as essential. Implementation of the AHA would consolidate many existing agencies and lines of funding to increase efficiency. However, there is no benefit to consolidation if it means stripping away resources, including finances and personnel, without fiscal reinvestment and infrastructure replacement.

The AHA absorbs multiple entities under one umbrella. Agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA), the Office of the Assistant Secretary for Health (OASH), and the National Institute of Environmental Health Sciences (NIEHS) would cease to exist and their functions would be absorbed into the new AHA entity. While there is some benefit to government reorganization and streamlining of funding and communication silos, the pathway set by AHA appears to eliminate the benefits of the current entities in favor of a nebulous description of chronic disease prevention.

RFK Jr. champions the fight against the causes of chronic disease across the nation. However, the specifics of his foci do not logically follow data. Approximately six out of 10 Americans live with one chronic disease, while four in ten have two or more. While extolling the virtues of eradicating chronic disease, actions by the U.S. Department of Health & Human Services (HHS)would abolish the Centers for Disease Control & Prevention’s (CDC) National Center for Chronic Disease Prevention and Health Promotion in its present form. In budget documents, AHA is referred to as “the primary federal agency committed to transforming the health of all Americans by addressing the root causes of chronic disease, promoting preventive care, advancing mental health and substance use services, and increasing access to a healthy environment and foods.” Yet the priorities of what are being viewed as pertinent chronic disease issues are what concern many stakeholders.

Kennedy continues to push the narrative that too much money and focus is spent on infectious disease inquiry at the expense of chronic diseases. However, the data show that this is not true. Receiving $8.1 billion, infectious diseases landed at ninth on the list of NIH-funded research subjects in 2024. Comparatively, brain disorders received $8.1 billion, and Cancer received almost the same as the entirety of infectious diseases. One cannot reallocate a resource focus from infectious disease to chronic disease because it is not a matter of one being more important than the other.

Infectious diseases and chronic diseases are inextricably linked to each other. Limiting infectious disease research would exacerbate chronic disease states, as communicable diseases play a crucial role in their development. For example, ongoing research suggests infections from things like herpes, syphilis, and pneumonia contribute to the development of neurological issues like Alzheimer’s. Moreover, HIV research has been integral in the advancement of treatments and understanding of chronic diseases. HIV research has led to a deeper understanding of the immune system. Knowledge concerning how the body identifies and targets infected cells is derived from HIV research. Lentiviruses function in a similar way to HIV, which led scientists to use lentiviruses in gene therapy to treat maladies such as blood cancers. The infectious Epstein-Barr virus has been associated with lymphoma, lupus, and multiple sclerosis.

Dismantling the current infrastructure to consolidate and reform under the AHA umbrella may be a setback because knowledgeable staff with valuable expertise and networks have already been laid off through reductions in force (RIFs). Recreating effective teams does not happen overnight and cannot be reconstituted with RFK Jr’s proposed reductions in funding. Additionally, chronic disease research, assessment, and prevention require analysis of data acquired through proper surveillance. Jerome Adams, surgeon general during Trump’s first administration, is quoted as stating, “Surveillance capabilities are crucial for identifying emerging health issues, directing resources efficiently, and evaluating the effectiveness of existing policies…Without robust data and surveillance systems, we cannot accurately assess whether we are truly making America healthier.”

The AHA agenda aims to investigate the “true” root causes of chronic diseases. However, a dearth of quality research already exists. Additionally, factors like obesity and environmental exposure have been proven to be causal factors of chronic disease. However, those issues have etiologies related to conditions such as socioeconomic status. Unfortunately, JFK Jr and the Trump Administration have described research in health disparities and health equity as lacking scientific merit and purpose. This is unfortunate when research of this nature is effective. A study that investigated disproportionate levels of mortality from COVID-19 among minorities resulted in improved efforts that led to a reduction of the racial gaps in vaccination rates, saving lives.

RFK Jr. has done nothing to generate trust in his vision or demonstrate the ability to make sound public health decisions. He recently released a health commission report on children’s chronic issues that was touted as gold-standard science. Instead, experts have proven many of the studies referenced in the report were mischaracterized, were of dubious merit, some having touted messaging that has already been debunked by evidence-based science, and seven studies referenced were fraudulent, having been complete fabrications. This behavior is further complicated by Kennedy's description of established peer-reviewed medical journals, such as The Lancet and the New England Journal, as corrupt. As an alternative, he expressed the possibility of creating government-run journals.

Divesting from infectious disease control and prevention will assuredly increase our chronic illness burden. Focusing efforts on chronic disease topics that are not significant factors in the most pressing public health needs diverts discourse and resources from issues that truly matter, ultimately harming the population. As JFK Jr.’s budgetary plans continue to develop, it is imperative to continually ask questions that shine a light on the opaque nature of his messaging and desired implementation.

Equal Health Policy is Queer Liberation

The month of June is recognized globally as Pride Month for the LGBTQ+ community. Set in motion at Stonewall and in my home of Kansas City where organizers of the movement met in 1966. It is a time to recognize those who have come before us, the progress we have made, and the continued commitment to live and love freely, authentically, and visibility.

The fight for equality has never been without its legislative setbacks, The Defense of Marriage Act, Don’t Ask, Don't Tell, and California’s Proposition 8. In recent years, a disturbing trend has emerged across the United States and beyond: a wave of legislation that directly targets the LGBTQ+ community—particularly transgender individuals—under the guise of public health, education, or religious freedom. While often framed as matters of morality or parental rights, these laws have very real and dangerous consequences for the health and well-being of our communities. The political weaponization of identity not only marginalizes communities but creates systemic barriers to healthcare access, exacerbating existing disparities such as houselessness, substance misuse, and mental health. 

“In an era where queer lives are being legislated out of public existence and public health is being gutted for political theater, allyship means more than rainbow logos—it means resistance. It means leveraging your voice, your access, and your platforms to push back loudly, not later.” - Travis Manint, Director of Communication Community Access National Network

The Legislative Landscape: An Escalating Crisis

From bills banning gender-affirming care for youth, anti-DEI initiatives, and restricting LGBTQ-inclusive education, to efforts allowing providers to deny care based on religious beliefs, the legal attacks on LGBTQ health are mounting. In 2024 alone, hundreds of anti-LGBTQ bills were introduced across state legislatures—many of them passing into law.

Additionally, the suggestion of any cuts to HIV funding, including prevention, takes many back  to times in our history when the Regan administration turned their backs on our community, and allowed an entire generation to be wiped out, citing moral panic as a reason to deny federal funding.  

These measures are not benign. When transgender youth are denied access to hormone therapy or counseling, their mental health suffers, and a community more likely to consider suicide When schools are forbidden from discussing LGBTQ topics, students lose access to information that affirms their identities. And when healthcare providers can legally refuse to treat LGBTQ patients, trust in the healthcare system erodes. Each policy sends the wrong message: you do not belong, and you are not safe here.

The Health Consequences of Discrimination

LGBTQ youth experience houselessness at a rate far higher than their peers, with some studies indicating they are 120% more likely to experience it. While only 7% of the overall youth population identifies as LGBTQ, they comprise up to 40% of homeless youth. This disparity is particularly pronounced for transgender and nonbinary youth, with some research suggesting they experience houselessness at even higher rates. Houselessness is not limited to LGBTQIA+ youth, Sexual minority adults are twice as likely as the general population to have experienced homelessness in their lifetime. 

Substance misuse is highly prevalent among LGBTQ+ persons, data on the rates of substance abuse in gay and transgender populations are sparse, it is estimated that between 20 percent to 30 percent of gay and transgender people abuse substances, compared to about 9 percent of the general population, yet affirming treatment centers for our community continue to be scarce. In 2021, over half of LGBTQ youth (56%) used alcohol in the last year, including 47% of LGBTQ youth under the age of 21. Over one in three LGBTQ youth (34%) used marijuana in the last year, including 29% of LGBTQ youth under the age of 21. One in 10 (11%) LGBTQ youth reported having used a prescription drug that was not prescribed to them in the last year, and this rate was the same for those under and over the age of 21. The stress that comes from daily battles with discrimination and stigma is a principle driver of these higher rates of substance use, as gay and transgender people turn to tobacco, alcohol, and other substances as a way to cope with these challenges.

Research has consistently shown that LGBTQ individuals face disproportionately high rates of mental health conditions, substance use, and chronic illness—not because of their identities, but because of the stigma and discrimination they face. According to the CDC, LGBTQ youth are more than four times as likely to attempt suicide compared to their non-LGBTQ peers. Transgender individuals face elevated risks of depression, anxiety, and suicidal ideation, especially when denied gender-affirming care. According to the Trevor Project 39% of LGBTQ+ young people seriously considered attempting suicide in the past year — including 46% of transgender and nonbinary young people.  

Policy plays a pivotal role in either perpetuating or addressing these health disparities. Restrictive laws not only block access to care but foster environments of fear, alienation, and trauma. Conversely, affirming policies—such as nondiscrimination protections, inclusive data collection, and funding for LGBTQ+-specific services—create pathways to health equity.

LGBTQ+ Health Must Be a Policy Priority

Healthcare policy should be a tool for protection, not persecution. We must hold legislators accountable when they propose or support bills that endanger LGBTQ+ lives under the guise of “protecting children” or “religious liberty.” At the same time, we must uplift and support policies that affirm identity, improve access, and invest in LGBTQ+ health. Prioritizing LGBTQ+ health is not a matter of inclusion—it’s a matter of survival. Our laws should reflect the values of dignity, equity, and compassion. 

In an environment where our very existence is being attacked in legislative sessions, it is time we draw from our history, become voices, not victims, and for our allies to stay engaged. It is our turn to make history, demanding better of our lawmakers. Because at the end of the day affirming, culturally competent, equitable LGBTQ+ healthcare is Queer liberation.

Strengthening Caregiving Infrastructure is Fundamental to a Healthy American Society

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing

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

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

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

The Mechanics of Duplicate Discounts and Why Modifiers Matter

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

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

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

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

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

State Medicaid Programs Bear the Cost of Federal Inaction

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

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

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

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

CMS's Abdication of Responsibility Creates a Regulatory Vacuum

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

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

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

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

Retrospective Payment Models Threaten Safety-Net Provider Viability

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

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

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

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

Technical Infrastructure: Why Modifiers Are the Solution

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

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

The Path Forward Requires Federal Leadership

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

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

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

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

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

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

The Magnitude of Proposed Cuts

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

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

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

Impact on Health Coverage and Access

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

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

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

The Mirage of Medicaid Work Requirements

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

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

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

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

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

Transparency and Public Input Concerns

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

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

Implications for Patients and Advocates

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

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

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

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

Antibiotic Crisis: Hope Amid Institutional Decline

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

The Growing Threat of Antibiotic-Resistant STIs

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

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

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

Breakthrough Treatments on the Horizon

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

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

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

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

Political Decisions Undermining Public Health

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

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

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

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

Prevention Strategies: Interrupting Transmission Chains

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

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

The Funding Gap and Market Failure

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

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

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

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

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

Disproportionate Impact on Vulnerable Communities

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

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

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

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

A Patient-Centered Path Forward

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

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

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

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

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

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

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

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

The High Cost of Middlemen Medicine

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

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

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

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

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

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

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

PBMs: Profiting at Patients' Expense

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

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

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

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

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

Insurance Barriers: When Coverage Doesn't Mean Access

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

The most common obstacles include:

• Prior authorization requirements (22%)

• Formulary exclusion (21%)

• Quantity limits (10%)

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

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

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

The Fleecing of 340B

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

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

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

Recent Policy Developments: Promise or Posturing?

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

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

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

What Real Reform Looks Like

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

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

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

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

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

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

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

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

Enough Excuses. Patients Deserve Better.

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

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

Mapping Injustice: Redlining's Legacy in HIV Treatment Delays

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

The Lasting Legacy of Redlining

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

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

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

Interconnected Barriers to HIV Care

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

Pharmacy Deserts

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

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

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

Provider Network Inadequacy

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

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

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

Hospital Consolidation

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

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

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

Political Context: New Threats to Health Equity Research

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

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

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

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

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

From Analysis to Action

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

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

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

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

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

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

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

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

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

Moving Forward

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

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

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

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