340B: Are Patients at the Table or on the Menu? Reflections on the HELP Committee Hearing on 340B

It was a busy few weeks for 340B in the nation’s capitol, on Thursday October 30th, The Health and Human Resources Administration (HRSA) announced it had approved nine drugs for its Rebate Model Pilot. Last Thursday October 23rd, the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Committee convened a full-committee hearing titled “The 340B Program: Examining Its Growth and Impact on Patients” to examine the rapid expansion of the 340B program and its implications for patients and taxpayers alike. For those who are working toward a reformed 340B program, this was a crucial moment: the program was created to help low-income and uninsured patients, yet representation at the witness table provided the glaring reminder, when we are not at the table, we are on the menu. 

Good Intentions

The hearing was convened last Thursday following a broad investigative effort led by Louisiana Senator Bill Cassidy, M.D., Chairman of the HELP Committee, whose majority-staff report released in April 2025 laid bare serious transparency and oversight concerns in the 340B program, and the recent Congressional Budget Office’s report on the growth of the 340B program.  At the hearing, Senators from both parties expressed strong support for reform of the program. Senators called for more transparency regarding how 340B revenues are used and how the program has grown far beyond its original intent. Chairman Cassidy’s opening remarks underscored the tension: “It’s a well-intentioned program … but people judge you by your actions, not your intentions.” He pointed to findings that as 340B has grown, so have health care costs. 

Longstanding Issues Raised

The hearing began with a table of witnesses deemed as experts on the program’s inner workings and challenges: Michelle Rosenberg, U.S. Government Accountability Office, Aditi Sen, Ph.D., Congressional Budget Office, and William B. Feldman, MD, DPhil, MPH, University of California. All three witnesses' testimony reflected on the program's explosive growth, the challenges faced in 340B’s impact on spending at the federal level, its financial impact on state Medicaid programs, and the need for modern reform of legislation to bring it into the 21st century. In between partisan shots for screen time, witnesses and Senators highlighted:

• Lack of transparency: The April report found that some large hospital systems generated hundreds of millions of dollars through 340B, yet could not clearly demonstrate that savings were passed directly to patients. 

• Program growth beyond original intent: The 340B program, established in 1992 to help safety-net providers stretch federal resources and serve more eligible patients, has grown to cover over 60,000 participating entities. That scale raises questions about whether the program still reflects its original purpose.

• Cost-shifting and unintended consequences: The Senators flagged that the Congressional Budget Office found that 340B’s expansion “encourages behaviors … that tend to increase federal spending.”

• Disconnect between revenue and patient benefit: The investigative report suggests that in many cases 340B revenue is being used for facility capital improvements or general operations rather than directly reducing out-of-pocket burdens for low‐income patients.

• Contract pharmacy and administrative complexities: The role of contract pharmacies and third‐party administrators (TPAs) was called out for potential erosion of intended benefit, and the investigation recommends more scrutiny. 

The Missing Witness

For all the laudable questioning of the program’s mechanics, what was striking at the hearing was the absence of direct patient voices. While policy makers, hospital executives, pharmacies and manufacturers were discussed, one would look in vain for the witness table to include someone whose story is the core rationale for 340B — a low-income patient trying to access a drug or services that otherwise would be out-of-reach.

This gap in experience in witnesses matters deeply:

• Patients are the raison d’être of 340B. The statute allows eligible providers to purchase outpatient drugs at a discounted rate so they “reach more eligible patients and provide more comprehensive services.”  If we cannot hear from those very patients, we risk losing sight of whether the program is delivering on its intent.

• Policy without lived experience lacks accountability. Reforms that focus exclusively on revenue flows, auditing, definitions and transparency can overlook whether the end result is better access, lower cost, fewer barriers. The missing patient perspective means we lack insight into whether the “front-line” outcomes are improving.

• Reform risks being mechanical, not human. If hearings remain focused on numbers (how many providers, how many dollars, what audits) and not on the personal hardship of people for whom drug access matters, then reform may fix the mechanics—not the mission.

While the hearing continued its focus to the numbers instead of patients, the need for transparency in light of various reports including the North Carolina Treasurer's report, the growing evidence of abuse such as Bon Secours Mercy Health, and how for-profit corporations have continued to siphon the 340B program’s value from it’s intended purpose, it made apparent the partisan divide of the issues, but the agreement that this program has lost it’s way and needs to be meaningfully reformed to ensure that the support of scarce federal resources this program provides is vital to the safety net. 

Looking Forward

Thursday’s hearing was a meaningful spotlight on a program ready for reform—but it should not be the headline byline. The real story needs to be: how is 340B reaching patients, how are those patients faring? Reform should not just scrutinize how many dollars 340B moves; it must ask: How many patients paid less? How many accessed care they previously could not? And how many were left behind because the program has shifted focus away from them?

As we continue to experience the circus that is 340B policy in the coming weeks and months, we must insist that patient voices are at the table, not just provider executives and lobbyists. We must craft measurable guardrails that ensure 340B savings are not invisible dollars but tangible patient impact. And we must be unafraid to hold stakeholders accountable when the data show a disconnect between program growth and patient benefit. The 340B program is at a crossroads. Last week’s HELP Committee’s hearing signals that change is coming. We must focus that change so it works for the people, not just the institutions—and ensure we bring patient voices from the margins into the center of the conversation so it works for the people, not just the institutions—and ensure we bring patient voices from the margins into the center of the conversation.

Clade I Mpox Emerges as Public Health Capacity Collapses

Between October 14 and October 17, 2025, three California residents were confirmed with Clade I mpox, all requiring hospitalization, none vaccinated, none with international travel history. These represent the first known cases of community transmission of Clade I within the United States. The strain demonstrates case fatality rates of 3-10.6% compared to less than 0.2% for the Clade II virus that spread in 2022. All three cases occurred in Southern California. Health officials have found no epidemiological connections between them.

This was predictable. In May 2023, the Community Access National Network (CANN) cautioned against premature declarations of victory over mpox, warned that insufficient vaccine coverage among marginalized communities risked endemic transmission, and urged public health agencies to take community reports seriously rather than "paternalistically denying the potential or possibility of new outbreaks or breakthrough cases." Two and a half years later, the infrastructure to respond to those warnings has been systematically dismantled precisely when the more dangerous strain has arrived.

What We Failed to Build

Only 21-23% of at-risk populations nationally have received the full two-dose JYNNEOS vaccine series. This means 66-78% remain unvaccinated against a virus now spreading domestically. Even California, ranked third nationally with 43% of at-risk populations fully vaccinated, leaves more than half of vulnerable people unprotected. None of the three confirmed Clade I cases had been vaccinated.

The racial disparities are unchanged from 2022. As of April 2023, 77.9% of Black people in vaccine-eligible populations remained unvaccinated, despite experiencing mpox incidence 5.8 times higher than White people during the August 2022 peak. The vaccination-to-case ratio during the 2022 outbreak tells the story precisely: for every mpox case in a White male, 43 White males were vaccinated. For Black males, 9 were vaccinated per case. For Hispanic males, 17 per case.

JYNNEOS was added to CDC immunization schedules in October 2023. Most health plans have been required to cover vaccination without cost-sharing since January 1, 2025. Access improved. Utilization did not. Dr. Peter Chin-Hong of UCSF explained the gap: "They might have gotten the first shot back in 2022 when everyone was afraid, and people knew a lot of people who had it." As mpox faded from headlines, vaccination rates declined. Series completion rates remain at 64.5% in California. The consequence is massive population vulnerability to a virus significantly more dangerous than the 2022 strain, spreading now in the communities with the lowest vaccination coverage.

What We Are Dismantling

The federal government shutdown that began October 1, 2025, continues through October 22, now the second-longest in modern U.S. history. Only 37% of CDC staff continue working. Disease surveillance analysis has halted for certain diseases. Guidance to state and local health departments has been suspended. Communication lines are severely limited.

On October 10, approximately 600 CDC workers were cut when 1,300 employees received Reduction in Force (RIF) notices. These targeted staff in infectious disease programs, Laboratory Leadership Service, the CDC Library, chronic disease programs, global health initiatives, and health statistics. The entire CDC Washington Office was eliminated, destroying the agency's Congressional liaison capacity. Dr. John Brooks, former CDC Division of HIV Prevention official, explained the significance: "CDC has worked directly with Congress for decades to help constituents by providing data, expertise and insight when needed. These firings mean Congress no longer has a means of direct access to the agency it funds when it needs information or briefings."

This followed March 2025 HHS restructuring under Secretary Robert F. Kennedy Jr. that eliminated approximately 3,000 CDC positions, a 25% workforce reduction. The Morbidity and Mortality Weekly Report (MMWR) failed to publish for the first time in its 60-year history. Dr. Karen Remley, former CDC official and Virginia health commissioner, described the practical impact: "Sometimes that help might be sending some people to help you investigate this. Sometimes that might be talking to somebody who's the world's expert on a specific type of infection or exposure. Now, there's nobody to answer the phone."

The California Department of Public Health acknowledged: "The department continues to work with available staff at CDC, but the recent federal government shutdown and other actions at the federal level have added a layer of uncertainty to the current work environment." Joseph Osmundson, Clinical Associate Professor of Biology at NYU, stated it plainly: "The infrastructure we built during the 2022 outbreak has just been eviscerated. The very things we need to understand if we have a problem now, and if we will have a problem in the future, are being systematically dismantled."

What We Refused to Fix

Provider knowledge gaps documented in 2022 persist unchanged. A Johns Hopkins study analyzing 1,024 mpox tests across different clinical settings found anogenital examination performed in only 44.5% of emergency department visits and 40.4% of primary care visits, compared to 82.4% in infectious disease clinics. An HIV activist in New York's Hell's Kitchen reported in early 2023: "A number of my friends, as well as myself, if I'm being honest, have reported that their physicians are both unaware that reinfection with MPV [MPOX Virus] is possible and that infections can still occur in people who have been fully vaccinated, and as a result of their knowledge gap are refusing to test MPV lesions."

Spanish-language materials were not available until August 2022, three months into the outbreak. Technology-dependent scheduling systems requiring monitoring of health department social media accounts favored digitally connected populations. Uninsured patients were vaccinated significantly later than privately insured patients, 83 days versus 41 days. Three years later, these barriers remain unaddressed.

The vaccination disparities - 77.9% of Black people unvaccinated, 9 vaccinated per case compared to 43 per case for White people - reflect structural access failures compounded by medical mistrust rooted in documented sterilization programs, non-consensual experimentation, and systemic racism in healthcare delivery. As CANN documented in 2022, these historical harms manifest in current provider interactions: "Moral judgments are made, stories get told, patients are admonished and made to feel ashamed. The impacts of these behaviors, both short-term and long-term, can lead to patients refusing to seek testing or treatment." The barriers are known. The solutions are known. We have chosen not to implement them.

What Works and What We Abandoned

Community-based vaccination programs work. CDC's Mpox Vaccine Equity Pilot Program launched in September 2022 received 35 vaccination project proposals, with 22 completed projects administering 25,675 vaccine doses at targeted locations including Pride events and sexual health clinics. The program partnered with community-based organizations serving gay, bisexual, and other men who have sex with men and transgender people, used trusted messengers, and eliminated eligibility documentation barriers. It was proven effective. It was never scaled to address the 66-78% of at-risk populations who remain unvaccinated.

No real-world effectiveness data exists for JYNNEOS against Clade I. The vaccine is expected to provide protection based on its mechanism and animal studies showing 100% protective efficacy against death. But antibody levels wane significantly 6-12 months post-vaccination, dropping to levels at 12 months comparable to peak single-dose levels. Whether booster doses might be needed remains unresolved. CDC currently does not recommend third doses.

Epidemiological models suggest vaccination coverage above 50% is needed to prevent mpox outbreaks in high-risk populations. California's 43% falls short. Most states are far below that threshold. As CANN wrote in 2023: "If we are ever going to eradicate MPV in the United States, we are going to have to do a significantly better job of getting vaccine supplies to those most likely to be impacted and do a better job of overcoming the cultural and hesitancy barriers that exist in those communities."

The recommendations are unchanged because the problems are unchanged. Increase investments in mobile, pop-up, and community-based healthcare delivery. Provide culturally competent care that meets people where they are. Address provider knowledge gaps through comprehensive education. Eliminate technology-dependent barriers to vaccine access. Collect complete demographic data to track and address disparities. Hold health departments accountable for being "responsive, creative, and careful as community members and advocates identify potential cases and outbreaks."

The Choice We Face

These are early days of this outbreak. But the October 2025 California cases represent something no other country has reported: Clade I mpox transmission without international travel links. Sweden, United Kingdom, Germany, Thailand, Australia all successfully prevented community transmission when they detected imported cases through rapid surveillance, contact tracing, and adequate public health capacity. No wider community transmission occurred in any of these countries.

The California cases emerged during a 22-day federal shutdown, with CDC operating at 37% staffing. State health departments report "nobody to answer the phone" when they need federal expertise. Whether this degraded capacity contributed to these cases spreading undetected, or whether it will hamper efforts to contain them, remains to be seen.

Whether California can contain these three cases depends on rapidly closing vaccination gaps in communities with lowest coverage and highest risk, restoring adequate federal public health capacity to support state and local response, and implementing the equity-centered strategies that worked in 2022 but were never sustained. The infrastructure to accomplish these goals did exist.

Three cases with no identified connections between them and no clear source of transmission suggests either multiple introductions or undetected spread. The systems that failed to prevent these cases being the first domestic transmissions must now prove they can contain them. The question is whether they still have the capacity to do so.

The Debt We Owe: How Miss Major Griffin-Gracy Showed Us What Solidarity Means

Miss Major Griffin-Gracy died on October 13, 2025, at her home in Little Rock, Arkansas, surrounded by family and the chosen community she spent 78 years building. Her death comes as America, and more pointedly, America’s LGBTQ community faces a question we have answered badly before: when solidarity becomes inconvenient, do we protect our most vulnerable, or leave them behind?

When Trans Women Saved Gay Men

In the early 1980s, when mothers and fathers refused to enter hospital rooms where their gay sons were dying, when disease transmission was a mystery, and the government stayed silent, Miss Major did what she always did: she organized.

She founded Angels of Care, mobilizing trans women in New York, San Diego, San Francisco, and Los Angeles to care for dying gay men. Many of the them were sex workers with no medical training, stepping into the void left by government inaction and familial abandonment. "No one wanted to take care of those gay guys when they first got AIDS," she later said. "And a lot of my transgender women stepped up to the plate to do it."

It wasn’t charity, it was survival. Mutual aid. Trans women needed work in a society that offered them none. Gay men needed someone willing to touch them without fear. Miss Major built a community-based health network on the principle she learned from fellow organizer Frank “Big Black” Smith in the 1970s: you don’t leave anyone behind.

By the 1990s, she was driving San Francisco’s first mobile needle-exchange van, bringing harm-reduction services directly to people who had nowhere else to turn. At the Tenderloin AIDS Resource Center, she founded GiGi’s Place: a drop-in site with a refrigerator for HIV meds that needed cold storage and washing machines so unhoused people could clean their clothes. Her colleague Yoseñio Lewis called these “small interventions that removed major barriers to care.”

When her partner, Joe Bob Michael, died of AIDS in 1995, her resolve only deepened. “The best trait an organizer can have is to listen,” she said decades later, “and to listen closely to what the people want…find out what it is they need.”

That ethic could not be more relevant today. Structural discrimination and systemic neglect have created conditions where Black trans women face HIV rates 26 times higher than other Black Americans, and trans women overall experience 42% HIV prevalence, not because of who they are, but because of who society excludes. Barriers to care, job discrimination that forces many into survival sex work, and incarceration that disrupts treatment continue to drive these disparities. Despite 92% awareness of PrEP, only 32% of eligible trans women have recently used it, a gap born of access barriers, not ignorance.

In 2025, as structural cuts unravel the safety nets meant to protect the same communities Miss Major once organized, those with the least access and the greatest burden of disease again bear the weight as the L, G, and B reap the benefits of privilege and attempt to discard those they deem “problematic” to their politics. Her method - meeting people where they are, removing practical barriers, and listening first - remains a blueprint for survival when institutions fail and care becomes a collective act. Forty years later, the people she fought alongside still face epidemic-level HIV rates as funding collapses around them. The trans women who cared for gay men when no one else would are still waiting for the community to return the favor.

Stonewall's Inconvenient Truths

The historical record shows that trans women and drag queens were on the front lines of resistance when police raided the Stonewall Inn on June 28, 1969. On the second night of rioting, Marsha P. Johnson climbed a lamppost and dropped a heavy bag onto a police car, shattering the windshield. Miss Major was knocked unconscious by police and thrown in jail. Sylvia Rivera, though her presence that first night remains disputed by historians, became a fierce advocate for trans rights immediately following Stonewall, co-founding Street Transvestite Action Revolutionaries with Johnson in 1970.

At the first Pride parade in 1970, organizers asked trans people to march in the back, but they refused. "The trans community said, 'Hell no, we won't go.' We fought for this as much as you did, or even started it," said Victoria Cruz, who was there. "And we just mingled throughout the crowd." By 1973, organizers barred drag queens including Johnson and Rivera from speaking at the Christopher Street Liberation Day Rally, claiming they would give the movement a "bad name." Rivera grabbed the microphone anyway during a speech by lesbian feminist Jean O'Leary that was critical of drag queens. The mostly white, cisgender crowd booed as she shouted: "I have been beaten. I have had my nose broken. I have been thrown in jail. I have lost my job. I have lost my apartment for gay liberation and you all treat me this way?"

Before her death in 2002, Rivera said: "I gave them their Pride, but they have not given me mine."

The pattern repeated in 2007 when Representative Barney Frank introduced an Employment Non-Discrimination Act explicitly excluding gender identity protections, arguing there weren't enough votes for trans-inclusive legislation. The Human Rights Campaign endorsed this strategic abandonment. Over 400 organizations formed United ENDA in opposition, but the message was sent: when political calculus demands it, trans people are expendable.

Miss Major was characteristically direct about this long history of exclusion. "The shame of it was that after it [Stonewall] happened, most of the Black girls that had been involved in it, we got whitewashed out of it," she told SF Weekly. "The gay and lesbian community just took it over and acted not only as if we did not exist, but that we weren't even there."

She was equally clear about the cost of these betrayals: "If these are my allies, well, I'll take my chance with my enemies because at least my enemies might have enough decency to stab me in the front."

In January 2025, the Trump Administration removed the word "transgender" from the Stonewall National Monument website, literally erasing trans contributions to the history trans women created. The erasure continues.

The Bodies Piling Up

This is not an abstract debate about political strategy. Real people are dying while our community calculates costs.

In 2025, 965 anti-trans bills have been filed across 49 states plus 81 federal bills. Twenty-seven states have banned gender-affirming care affecting approximately 120,400 transgender youth - 40% of all trans youth in America. Six states classify providing such care as a felony punishable by up to 20 years in prison.

The Trevor Project documented a 72% increase in suicide attempts in states with restrictive policies compared to states without such laws. Already, 46% of LGBTQ+ youth seriously considered suicide in the past year. The day after the 2024 election, the Trevor Project's crisis services saw a 700% volume increase, with 40% of contacts from trans and nonbinary youth.

In 2024, at least 36 trans people were murdered, with 50% being Black trans women despite Black people representing just 13% of the population. The youngest victim was Pauly Likens, murdered at age 14 in Pennsylvania. In U.S. data, trans people face nearly double the mortality rate of non-trans peers, and some estimates place their median life expectancy about 7 years shorter.

Republicans spent $215 million on anti-trans television advertisements during the 2024 election cycle, with Trump's campaign alone spending $95 million in the final two weeks - more than on housing, immigration, and the economy combined. Yet polling consistently showed 80% of Americans agreed both parties "should spend less time talking about transgender issues." Trans people represent roughly 0.5% of adults and 1.4% of teenagers, yet became scapegoats for a conservative movement seeking cultural wedge issues.

Some Democrats have responded to this onslaught by going quiet on trans rights, calculating that defending trans people was politically costly. The bodies keep piling up regardless of political strategy. Twenty-nine percent of trans people live in poverty compared to 16% of the general population. Forty-seven percent have been fired, not hired, or denied promotion for being trans. Forty-seven percent of Black trans people have been incarcerated at some point, compared to 16% of all trans people.

Miss Major spent her final months despite declining health traveling to let young trans people "see and touch me. I'm alive. There aren't that many Black girls still alive. Let them know that they can get here too."

She kept fighting because she understood what some in our community seem to have forgotten: "You can't throw anybody under the bus. You can't leave anybody behind," she insisted. "It has to include all of us, or it's not going to work."

The question facing the LGBTQ+ community is whether we believe her. Trans women cared for gay men when we were dying of AIDS. They fought at Stonewall while others watched from windows. They built our movement while we pushed them to the margins. Now they're dying, from suicide, from violence, from AIDS related complications, while we debate whether defending them is politically expedient.

Miss Major would ask what she always asked: What kind of community are we? Are we one that protects its most vulnerable members, or do we abandon them when solidarity becomes inconvenient? Her mantra echoes as both eulogy and call to action: “I'm still fucking here. We're still fucking here.” The debt remains unpaid.

Collateral Damage: How Shutdown Politics Abandons Survivors at the Margins

October is Domestic Violence Awareness Month - but in 2025, awareness is no longer enough. Across the United States, people living with HIV (PLWH), hepatitis C (HCV), and substance-use disorders (SUD) are facing a convergence of crises where intimate partner violence (IPV) amplifies every barrier to care. At the same time, the U.S. Department of Justice’s grant programs - lifelines that help survivors achieve viral suppression, complete HCV treatment, and sustain recovery - are being systematically dismantled after three decades of bipartisan progress.

The numbers tell a story every HIV provider knows. One in four people living with HIV (26.3%) has experienced intimate partner violence. When abusive partners prevent medication adherence, sabotage appointments, or create chaos that interrupts treatment, survivors show 36 percent lower odds of achieving viral suppression than those without IPV histories. Women carry a disproportionate burden, but men with IPV history face nearly triple the HIV prevalence of men without, and transgender people report lifetime IPV rates between 31 and 50 percent while experiencing 66 times higher HIV prevalence than the general population.

For HCV, the overlap is even tighter. Sixty-eight percent of women who inject drugs have HCV, and 40 to 60 percent of domestic-violence cases involve substance use. These aren’t parallel epidemics - they’re feedback loops. Violence undermines treatment; HIV or HCV status becomes a weapon of control; trauma drives relapse. Each condition magnifies the others, and when federal support for survivor-centered programs collapses, the entire structure of prevention and recovery begins to unravel.

The Bidirectional Syndemic

The relationship between intimate partner violence and HIV is both brutally direct and insidiously complex. Women in abusive relationships face a 48% higher likelihood of HIV infection than those in non-abusive relationships. Abusive partners often sabotage safer-sex practices - research shows that condom negotiation attempts frequently trigger coercion or violence. Among people living with HIV, 24% of women experience abuse after disclosing their status, and those reporting recent gender-based violence are significantly less consistent in condom use. Gay men report 26% lifetime IPV prevalence, underscoring that control operates across gender and orientation.

The link to hepatitis C exposes another layer of risk. In relationships where both partners inject drugs, power imbalances determine who controls access, dosing, and the act of injection itself. Partners with more control may withhold drugs to induce withdrawal or insist on injecting the other, reinforcing dependence and exposure. Violence-related bleeding raises the odds of HCV infection 5.5-fold, what researchers call “a previously unrecognized mechanism for HCV transmission.” Among women who inject drugs, 60% report receptive syringe sharing, a behavior shaped by depression and low self-esteem resulting from abuse.

Trauma also drives substance use itself. Eighty percent of women in drug treatment report lifetime sexual or physical assault. Reductions in PTSD severity correspond to four-fold decreases in substance use, while the reverse is rarely true - reinforcing the self-medication model in which survivors use substances to cope with violence.

This syndemic runs both ways. HIV, HCV, and substance-use disorders not only result from domestic violence - they also increase vulnerability to it. Nearly one-third of people living with HIV experience violence following serodisclosure, including coercion, control, and financial or sexual exploitation. Nearly one-third of survivors report that partners deliberately withheld essential medication, from HIV antiretrovirals to HCV or opioid-use-disorder treatments, weaponizing care itself as a means of control.

When Laws Become Weapons

HIV criminalization laws in 32 states create a deadly double bind for domestic violence survivors. Enacted largely between 1986 and 2000 - before modern antiretroviral therapy and long before the U=U consensus - these statutes criminalize potential exposure regardless of actual transmission, condom use, or viral suppression.

Twenty-four states require disclosure of HIV status before any sexual activity. Penalties range from 3 to 10 years in prison, extending to 25 or more in some states. At least five mandate sex-offender registration for HIV-related convictions.

The control dynamic is devastatingly simple. Disclosure can trigger violence - studies show 18% to 80% of women living with HIV experience violence after disclosing their status - yet non-disclosure remains a felony. Abusers exploit this legal trap, threatening to report partners to police or weaponizing the risk of decades-long sentences and sex offender registration as blackmail.

Research from Canada illustrates the toll: one-fifth of women living with HIV said criminalization laws increased violence in their relationships. The perverse outcomes are clear. In one documented case, a woman reported her partner for abuse, only to be charged herself after he alleged non-disclosure during a single encounter, despite a four-year relationship in which she had disclosed her status.

The 2025 Federal Funding Crisis

Hours after the government shut down on October 1, 2025, the Trump Administration furloughed staff in the Department of Justice’s grant-making offices, halting support for organizations that serve victims of domestic violence and other violent crimes. Officials cited the shutdown as the cause, but former staffers told Politico it didn’t have to be this way - these programs had operated during past shutdowns with existing funds.

“Their own contingency plan says that they have funds. So it’s a choice to say, ‘We want this to hurt,’” said Marnie Shiels, who worked 24 years in the Office on Violence Against Women (OVW). “I can’t know for sure what they’re thinking, but I very much fear that it is about a political motivation of wanting to get rid of this issue, get rid of this office, get rid of the staff.”

The furloughs followed a year of escalating disruptions. In February, OVW abruptly removed all eight fiscal-year 2025 funding notices, including a $40 million transitional-housing program that had served hundreds of survivors for nearly two decades. In April, the Department of Justice terminated more than 360 grants, cutting roughly $500 million in remaining funds and affecting hundreds of sub-awards for violence prevention, victim services, mental-health treatment, and reentry programs.

When new opportunities appeared in May, they came with expanded “out-of-scope” rules that barred activities “framing domestic violence or sexual assault as systemic social-justice issues.” The language aligned with a January 2025 executive order, “Defending Women from Gender Ideology Extremism,” and a subsequent directive ordering agencies to remove “gender ideology” from contracts, websites, and correspondence. PEN America later documented more than 350 banned words, including gender, women, trans, LGBTQ+, diversity, and disability - effectively erasing the terminology needed to describe many of the populations these programs serve.

The effects reach beyond domestic-violence services. NIH canceled dozens of HIV-related research grants in March; five CDC HIV-prevention branches were dissolved; and hepatitis funding was cut by $77 million. Proposed reductions to the Ryan White HIV/AIDS Program total $239 million.

For organizations serving survivors living with HIV, hepatitis C, or substance-use disorders, these converging cuts are existential - removing both their funding streams and, in some cases, their ability to even describe who they serve. Shiels noted that leadership had “said that they want federal employees to feel ‘trauma,’” and recalled the president’s remark that “a little fight with the wife shouldn’t be a crime.” The contrast, she said, “shows they don’t understand or care about these issues.”

The Office on Violence Against Women - created in 1995 and made independent in 2004 - has awarded more than $4.7 billion in grants since its inception, including $684 million across 880 awards in FY 2024. That bipartisan infrastructure recognized what decades of data confirm: 55 percent of women living with HIV have experienced intimate-partner violence, a link directly associated with lower care engagement, higher viral loads, and worse health outcomes.

Now, the systems built to protect those lives hang by a thread.

What We Must Do Now

The convergence of domestic violence, HIV, hepatitis C, and substance use disorders is not theoretical - it’s the reality providers see every day. Survivors’ viral loads rebound when housing instability forces them back to abusive partners. Hepatitis C treatment stalls when the only culturally competent program loses its grant. Trauma-informed care disappears, and relapse follows. The nation’s Ending the HIV Epidemic and hepatitis C elimination goals cannot succeed while survivors are forced to choose between safety and survival.

Rebuilding that safety net demands more than temporary fixes. The Department of Justice must reopen its grant-making offices - shutdown or not - and restore continuity for organizations on the front lines. Congress must fully fund these programs and eliminate restrictions that prevent them from even naming the people they serve. States must modernize or repeal HIV criminalization laws that trap survivors in violent relationships under the guise of public health.

A syndemic is not fate; it is a policy choice repeated, ignored, and justified until it becomes another fading bruise on a battered cheek. The systems we built to keep people alive are being dismantled in plain sight - not through neglect, but intent. And when government decides that survival itself is partisan, silence becomes complicity.

Healthcare Infrastructure Crisis Compounds America's STI Epidemic

The Centers for Disease Control and Prevention's (CDC) September 2025 release of provisional 2024 STI surveillance data offers proof that public health interventions work: more than 2.2 million cases of chlamydia, gonorrhea, and syphilis represent a 9% decline from 2023, the third consecutive year of decreases. Primary and secondary syphilis dropped 22%, chlamydia fell 8%, and gonorrhea declined 10%. "The overall U.S. STI burden remains substantial, but signs of progress continue," noted Dr. Bradley Stoner, Director of CDC's Division of STI Prevention.

Yet congenital syphilis increased 2% to nearly 4,000 cases in 2024, continuing a 700% climb since 2012 that resulted in 279 stillbirths and infant deaths in 2023 alone. CDC analysis shows 88% of these cases were preventable with timely testing and treatment. This divergence—overall rates declining while the most vulnerable populations remain unreached—reveals a deeper crisis: we are systematically dismantling the healthcare infrastructure necessary to sustain these gains precisely when evidence demonstrates what works.

The Systematic Dismantling

The erosion of STI prevention capacity unfolded across three stages. It started with CDC's Division of STI Prevention losing 40% of its purchasing power since 2003 through chronic underfunding, while local health departments shed 20% of workforce capacity from 2008 to 2019. A Harvard study documented that nearly 50% of state and local public health employees left their jobs between 2017 and 2021. Decades of flat or declining budgets hollowed out the workforce that conducts contact tracing, provides testing and treatment, and links patients to care.

In June 2023, the Fiscal Responsibility Act eliminated $1.3 billion in CDC funding specifically intended to expand Disease Intervention Specialist capacity, with states like Nevada losing over 75% of their STI prevention budgets. These cuts targeted the 2,200 people nationwide who conduct partner services and contact tracing that prevent transmission chains. The 2024 data showing declining rates was collected during this period, demonstrating what the system could achieve even as Congress pulled resources.

Then in March 2025, the Trump Administration terminated $11.4 billion in pandemic-era grants. Under HHS Secretary Robert F. Kennedy Jr., the department eliminated 31% of its workforce. The President's proposed FY 2026 budget cuts CDC funding by 53% compared to FY 2024. A George Washington University analysis projects 42,000 eliminated jobs nationwide, with states losing hundreds of millions in funding. The Administration also withheld Title X grants from 23 states, threatening 200 Planned Parenthood clinics serving 2.8 million people annually. Utah's sole Title X recipient lost $2.8 million, forcing closure of clinics that served 26,000 patients.

The consequences are materializing. Penobscot County, Maine, faces the largest HIV outbreak in state history—28 new cases over two years, seven times typical rates, nearly all among people who use drugs and are homeless. The outbreak emerged after supply shortages forced closure of the region's largest syringe services program, then accelerated following February 2025 clearing of the city's largest homeless encampment. Broome County, New York, reported in September 2025 that new HIV diagnoses among people with injection drug use history exceed the previous four years combined. The 2015 Scott County, Indiana HIV outbreak that infected over 200 people occurred after public health funding cuts eliminated syringe access. We know what happens when we strip prevention infrastructure. We are choosing to repeat it.

Interconnected System Failures

The public health workforce collapse intersects with physical infrastructure deterioration to compound access barriers. American hospitals carry $390 billion in deferred maintenance, with 50% of health systems managing buildings over 50 years old. Deteriorating facilities cannot maintain proper medication storage, provide adequate clinic space for confidential counseling, or support infection prevention protocols that 80% of hospitals lack sufficient staff to implement.

Infrastructure failures drive facility closures that eliminate access entirely. Over 100 rural hospitals closed from 2013 to 2020, forcing residents to travel 20 miles farther for common services and 40 miles farther for specialized care. Deferred maintenance becomes a death spiral: aging infrastructure drives up operating costs, reducing resources for patient care, making facilities financially unsustainable. The closures concentrate in rural areas and communities serving predominantly low-income populations and people of color - the same populations bearing the highest STI burdens. Meanwhile, as we reported in our article titled, “CBO Data Proves Hospital Systems Exploit 340B Drug Program for Billions,” when hospitals do invest in facilities, they target affluent white neighborhoods.

A Center for Economic and Policy Research analysis documents that hospitals serving communities of color receive systematically less infrastructure investment. Hospital occupancy rates are 11 percentage points higher than pre-pandemic, driven by a 16% reduction in staffed beds. Overcrowded, understaffed, aging facilities cannot deliver consistent prenatal screening to prevent congenital syphilis.

Medication access compounds these failures. Pfizer's April 2023 Bicillin L-A shortage, ongoing through 2025 with July 2025 recalls further limiting supply, eliminates the only CDC-recommended treatment for syphilis in pregnancy. A November 2023 survey found 68% of health departments stated the shortage would directly increase syphilis rates. Among 2022 congenital syphilis cases, 37.9% of birth parents received no prenatal care whatsoever.

Who Bears the Cost

Geographic and economic barriers determine who suffers these system failures. Thirty-five percent of U.S. counties are maternity care deserts with no birthing facility or obstetric clinician, affecting 2.3 million people of reproductive age. Patients in these areas face twice the uninsured rates, 13% increased preterm birth risk, and average drive times of 38 minutes versus 16 minutes nationally. These are the predictable results of decades of policy choices that prioritized cost containment over access.

Racial disparities reveal who we are willing to sacrifice. Black populations account for 32.4% of all chlamydia, gonorrhea, and primary/secondary syphilis cases despite comprising 12.6% of the population, experiencing gonorrhea at 7.7 times the rate of White populations. American Indian and Alaska Native infants face congenital syphilis rates 75 times higher than Asian families, with maternal syphilis among American Indian and Alaska Native mothers increasing 783% from 2016 to 2022. Mississippi data shows African American infants account for 71.1% of congenital syphilis cases while representing 43.3% of the general population, with 92.6% of cases among Medicaid recipients.

CDC acknowledges explicitly: "Differences by race and/or Hispanic ethnicity cannot be understood without consideration of long-standing structural contributors that are not adequately captured in case notification data such as systemic racism, challenges with healthcare access, and disparities in social determinants of health." Eight percent of Americans—27.1 million people—lack insurance coverage, with 1.5 million in the Medicaid coverage gap in ten non-expansion states, over 60% people of color.

The 2% increase in congenital syphilis amid overall STI declines tells us exactly who cannot access care: pregnant people, disproportionately Black and brown, in maternity care deserts, served by overwhelmed safety-net systems, facing medication shortages, unable to reach closing clinics. This is the distribution of harm we accept when we defund infrastructure.

The Choice Before Us

The 2024 data was collected before March 2025 grant terminations fully materialized, before spring clinic closures accelerated, before proposed 53% CDC budget cuts take effect. The encouraging trends reflect a system already deteriorating through chronic underfunding and workforce elimination. They do not reflect what comes next if current trajectories continue.

We have evidence. Disease Intervention Specialists, syringe services programs, prenatal screening, Bicillin access, Title X clinics—these interventions work. The 22% drop in primary and secondary syphilis demonstrates it. The HIV outbreak in Maine after syringe program closure demonstrates the cost of abandonment. The congenital syphilis crisis demonstrates who pays when we moralize instead of invest.

This is not a resource constraint. It is a priority choice. We can reverse the 2025 funding cuts and restore public health workforce capacity. We can address the $390 billion hospital infrastructure deficit with focus on facilities serving communities of color. We can secure medication supply chains through domestic manufacturing and emergency stockpiles. We can eliminate maternity care deserts and expand Medicaid in ten remaining states. We can fund what works.

The 2024 data proves progress is possible. The 2025 policy choices determine whether it endures or whether we return to climbing rates, preventable infant deaths, and widening disparities. Tough budget choices may be required. But the health and survival of pregnant people and their babies should not be on the chopping block. We know what works. The question is whether we value those lives enough to fund it.

The Great European Drug Drought: What MFN Means for America

As CANN and ADAP Advocacy shared in a joint statement against Connecticut's HB 6870, we warned legislators against "the base, ethical and economic cheapness of sacrificing tomorrow's lives for today's pennies." The European pharmaceutical access crisis provides concrete evidence of what America could experience under Most Favored Nation (MFN) price negotiations, where patients wait up to 989 days for approved treatments while pharmaceutical innovation migrates to Asia.

The data from Europe reveals a system in distress: only 29% of innovative medicines are fully available through EU reimbursement, down from 42% five years ago. This decline translates into life-threatening delays for patients, with those in Malta waiting nearly three years for new treatments while Germans wait four months, creating a geographic lottery where your passport determines your access to life-saving care.

Engineering a Pharmaceutical Desert

European International Reference Pricing mechanisms create precisely the downward spiral that current MFN executive orders would import to America. Twenty-six of 28 EU states use reference pricing systems, where countries systematically reference each other's prices in an interconnected web that drives pharmaceutical companies out of markets entirely.

The cascade effect reveals how a single policy decision triggers global consequences. Belgium references prices in the Netherlands, Germany, France, and the UK, taking the average to set maximum reimbursement rates. When Lithuania references Belgium's price and negotiates an even lower rate, those reductions automatically flow back through every system that references Lithuanian pricing, and round and round it goes. Research demonstrates that a 10% price reduction in Switzerland forces dozens of countries that reference Swiss prices to demand similar cuts, creating €495.2 million in additional global losses from that single initial reduction.

This interconnected pricing web forces pharmaceutical companies into difficult strategic positions that directly harm patients. For example, when a breakthrough hepatitis C cure could command €50,000+ per treatment in wealthy countries like Germany and France, but Poland negotiates for €15,000, companies face a choice: launch in Poland and watch Germany demand the same low price, or delay the Polish launch to protect higher-value markets. Pharmaceutical companies are compelled to act in the interest of their shareholders, and patients with hepatitis C develop cirrhosis or die waiting while companies and governments play pricing chess across borders.

Countries systematically exploit this system through 'free-riding' behavior, with wealthier nations deliberately referencing poorer countries' prices to secure discounts below their economic capacity. Nations reference varying numbers of other countries when setting drug prices, from as few as four countries (Netherlands) to all other EU countries (Belgium), creating a complex web where no country wants to be the highest price in anyone else's reference basket. One consequence of these pricing games is less investment: studies demonstrate that a 10% price drop in the EU correlates with a 14% decrease in venture capital biomedical funding, showing how European pricing policies directly undermine global pharmaceutical development.

Michiel Peters from the Global Coalition on Aging, who brings EU policy experience to his current advocacy role, warned in our interview that this system creates inevitable consequences: "What you're likely to see is just a smaller total amount of money going into biopharmaceutical research leading to a smaller pipeline of drugs in the future." European governments treat breakthrough medicines as commodities rather than recognizing their unique value, systematically destroying the economic foundation that makes pharmaceutical innovation possible.

Corporate Flight Accelerates Under Pricing Pressure

The reference pricing spiral has triggered an unprecedented corporate exodus from European markets, with major pharmaceutical companies choosing public confrontation over traditional behind-the-scenes negotiations. This shift has been accelerated by Trump Administration threats to implement MFN pricing that would tie U.S. prices to European levels, creating additional pressure for companies to establish pricing precedents that protect their American revenue streams.

Take, for instance, Bristol Myers Squibb's September 2025 announcement. The company declared it would launch Cobenfy at full U.S. pricing ($22,200 annually) in the UK, explicitly threatening to "walk away" if UK authorities refused to recognize the value of the first novel schizophrenia treatment in 70 years. This represents a fundamental shift from accepting European pricing terms to demanding recognition of the value of innovative treatments.

The UK's deteriorating investment climate illustrates how pricing pressures create economically unsustainable market conditions. Under the Voluntary Pricing Agreement, pharmaceutical companies must pay rebates to the NHS when industry sales exceed predetermined growth rates. These repayment rates have escalated beyond reason, from just 5.1% of revenue in 2021 to 26.5% in 2023. Companies must now return more than a quarter of their UK revenue to the government, making market participation economically untenable. Both AbbVie and Eli Lilly withdrew from the agreement entirely in January 2023, with Eli Lilly stating the scheme "has harmed innovation, with costs spiraling out of control."

The cumulative effect is a pharmaceutical industry in retreat. Novartis CEO Vas Narasimhan warned that "30 to 40 percent of cancer drugs are delayed or not launched on the European market at all," with this proportion expected to increase as pricing pressures intensify. The UK has fallen from 4th to 98th place in overall pharmaceutical trade balance since 2010, reflecting the systematic hollowing out of European pharmaceutical markets under aggressive pricing policies.

The Cost of Withheld Access

Behind these policy failures are people whose lives depend on accessing breakthrough treatments, but who find themselves trapped in bureaucratic systems that prioritize budget control over medical necessity. Take Estonian cancer patient Kadri Tennosaar for example. She required €20,000 for three months of Enhertu treatment for metastatic breast cancer. Despite the European Medicines Agency (EMA) approving Enhertu in January 2021, Estonia's government refused reimbursement, forcing her to seek treatment through charity. Her situation illustrates how European "universal healthcare" systems systematically exclude the treatments patients need most.

Romania has developed an even more troubling solution: systematic reliance on court orders for cancer treatment access. Over 1,000 people received medications through legal action in 2023, with courts consistently ruling in favor of patients seeking approved treatments. This judicial intervention effectively acknowledges that Romania's formal reimbursement system fails to provide medically necessary care, forcing dying patients into litigation to access drugs their doctors have prescribed and European regulators have approved.

The system's fundamental contradictions become clear when European patients living under universal healthcare systems resort to American-style fundraising for medical care. As Peters observed in our interview, "European patients will still start a GoFundMe to get an innovative treatment in the US because…if you're dying of a rare disease you're not going to wait 600 days." That 600-day figure represents the average time from regulatory approval to patient availability across EU countries. That’s nearly three years for treatments already deemed safe and effective by European regulators. For patients with aggressive cancers or degenerative diseases, these delays often mean death.

America's IRA Lessons Preview MFN's Future

The Inflation Reduction Act's differential treatment of small molecules versus biologics provides real-time evidence of how pricing policies reshape innovation incentives, offering a preview of MFN's likely effects. Investment in small molecules has declined 70% since September 2021, with the University of Chicago projecting this will result in 188 fewer small molecule treatments over 20 years, leading to 116 million life-years lost.

Small molecules remain particularly critical for neurological diseases like Alzheimer's and Parkinson's, which require blood-brain barrier penetration that biologics cannot achieve. The National Pharmaceutical Council found that 77% of investors report the IRA's "pill penalty" creates a disincentive for small molecule investing, with venture capital flowing overwhelmingly toward biologics. This shift away from small molecules threatens entire categories of medical innovation precisely when aging populations need breakthrough treatments for neurological conditions most.

Meanwhile, China has emerged as the global innovation leader. China's pharmaceutical contribution to the global R&D pipeline has increased from 4% in 2013 to 28% in 2023, surpassing Europe and ranking second only to the United States. From 2019-2023, China led globally with 256 new drug approvals, ahead of the US (243) and EU (191). The funding patterns confirm this shift. China accounts for over 75% of all biotech VC/PE funding in Asia-Pacific since 2019, with late-stage expansion rounds increasing 1.5x from 2019-2024. This demonstrates the systematic migration of pharmaceutical investment toward Asian markets as Western pricing policies make innovation economically unviable in traditional centers of drug development.

MFN: Importing Europe's Failures Through Executive Order

Current MFN executive orders, which have attracted bipartisan Congressional support, would import these European failures directly into American Medicare and Medicaid programs. The fundamental premise, that forcing pharmaceutical companies to accept European prices will reduce costs without affecting innovation, ignores overwhelming evidence of investment withdrawal and patient access failures across Europe.

The United States market accounts for 64% to 78% of worldwide pharmaceutical profits, making the European model economically impossible to replicate without devastating consequences for future drug development. As our previous analysis pointed out, "Europe won't catch up. Neither will China. No other country is prepared to step into the innovation gap the United States represents." Eliminating American profit margins means eliminating the economic foundation that funds global pharmaceutical research.

The projected consequences align with European experience. The CMS Office of the Actuary projected that 9%-19% of drugs would be inaccessible under the 2020 MFN proposal because manufacturers would not sell products at MFN prices, with the American Society of Clinical Oncology's analysis indicating that up to 19% of Medicare beneficiaries would lose access to care. These projections mirror current European realities, where patients routinely face treatment delays, denials, and geographic access barriers under government-controlled pricing systems.

Innovation is Access

For people living with HIV, cancer, rare diseases, and other life-threatening conditions, access to novel treatments represents the difference between survival and suffering. European pricing policies demonstrate that short-term cost savings achieved through price controls create long-term access barriers that cost far more in human suffering and economic burden than the original pharmaceutical investments.

The European experience reveals a brutal truth: government-controlled pricing systematically eliminates the treatments patients need most. Estonian cancer patients rely on charity. Romanian patients require court orders. European patients start GoFundMe campaigns to access treatments readily available in America. These policies have transformed medical innovation into a geographic lottery where your passport determines your survival prospects.

U.S. MFN policies follow the same flawed logic, promising immediate savings while systematically destroying the economic foundation that makes future cures possible. The 70% collapse in small molecule research since the IRA, combined with China's emergence as the global innovation leader, proves that pricing policies have consequences extending far beyond budget spreadsheets into the fundamental question of which countries will develop tomorrow's treatments, if they are developed at all.

Europe's pharmaceutical desert offers a preview of America's future under MFN: innovation migrating eastward, patients waiting years for approved treatments, and governments prioritizing short-term savings over long-term survival. America faces a hard choice: maintain our position as the country where breakthrough treatments emerge and are accessed first, or follow Europe's path toward innovation rationing and access lotteries. That future remains avoidable, but only if we choose innovation over rationing, access over austerity, and tomorrow's cures over today's pennies.

September Shutdown Could Cripple Open Enrollment as HIV Patients Face Coverage Crisis

Congress faces a September 30th government funding deadline that could shut down federal agencies just as Americans prepare to experience unprecedented healthcare premium increases during the November open enrollment period. The seven-week stopgap funding bill released by House Republicans would only extend government operations through November 21st, creating the possibility of multiple shutdowns right as people living with HIV and millions of others discover that their healthcare costs will increase dramatically for 2026.

The timing creates a perfect storm of healthcare disruption. Enhanced ACA subsidies expire December 31, 2025, but insurers have already built the expected 75% premium increases into their 2026 rates. When open enrollment begins November 1, Americans shopping for coverage will immediately see these massive premium spikes, creating intense political pressure on Congress just as government funding battles reach their peak.

For people living with HIV who rely on ACA marketplace plans, this convergence threatens treatment continuity at the worst possible moment. Many earn too much to qualify for Ryan White HIV/AIDS Program services but depend on enhanced subsidies to make coverage affordable. The prospect of 75% premium increases forces impossible choices between maintaining viral suppression and financial stability.

Premium Sticker Shock Meets Shutdown-Threatened Infrastructure

Insurers nationwide have proposed a median premium increase of 18% for 2026, more than double last year's 7% median increase. The majority explicitly cite the expected expiration of enhanced premium tax credits as driving rates an additional 4 percentage points higher than they would otherwise charge.

Average out-of-pocket premium payments will increase by more than 75% when enhanced subsidies expire, translating to roughly $700 more annually for the typical family. People earning between 100% and 150% of the federal poverty level would see their average premiums rise from $0 to $387 per year. In Maryland, carriers requested 17.1% increases, but rates would drop to 7.9% if Congress extends enhanced subsidies, illustrating the immediate financial impact of political inaction.

These massive increases hit Americans during November open enrollment while government infrastructure faces shutdown disruption. The September 30 deadline threatens systems needed for November 1 enrollment, and even the Republican stopgap bill expires November 21 during the critical enrollment period.

Healthcare.gov and state marketplaces require functioning federal systems to process applications and verify income for subsidy eligibility. Historical shutdown impacts show services degrade rapidly during funding lapses. The timing compounds administrative challenges from the Trump administration's Marketplace Integrity and Affordability Rule, requiring people in $0 premium plans to verify eligibility or face minimum $5 monthly charges starting in 2026.

Insurers cannot adjust these rates after open enrollment begins. Blue Cross Blue Shield of Vermont warns that healthier members will leave at a disproportionately higher rate than those with significant healthcare needs, worsening the risk pool. This death spiral dynamic makes immediate Congressional action an absolute necessity, both politically and practically, as Americans navigate premium increases while government systems fail to function.

Political Standoff Intensifies as Healthcare Costs Hit Constituents

Traditional shutdown politics change fundamentally when constituents experience immediate healthcare cost increases during an election cycle. Senate Minority Leader Chuck Schumer argues Democrats hold a stronger position because Republicans face blame for both the shutdown and healthcare cost increases their policies created.

House Speaker Mike Johnson insists ACA subsidy negotiations belong in December when they expire, calling them "a December policy debate and decision, not a September funding matter." This ignores the practical reality that Americans need certainty when making coverage decisions during November open enrollment. Families cannot wait until December to learn whether their January 2026 premiums will be affordable.

The electoral pressure becomes intense when 22 million Americans face premium increases. TD Cowen's analysis notes that "many Congressional Republicans are also eager to extend these subsidies for fear of health insurance sticker shock in advance of the November 2026 midterms." Only Senator John Fetterman has indicated willingness to vote for Republican funding without healthcare provisions, suggesting Democrats maintain unity while Republicans need Democratic cooperation they have refused to seek.

The Trump Administration compounds uncertainty through potential "pocket rescissions" that could cancel federal funding without Congressional approval. Budget Director Russell Vought defended this controversial tactic, noting "the money evaporates at the end of the fiscal year." This raises constitutional questions about Congressional spending authority and creates a trust crisis for Democrats who fear GOP leaders could agree to healthcare provisions in negotiations only to have the Administration cancel funding through rescissions after a continuing resolution passes. Lawmakers must consider both immediate shutdown impacts and the Administration's demonstrated willingness to bypass Congress on funding decisions.

State and Local Healthcare Programs Face Immediate Funding Disruption

Government shutdowns immediately disrupt state and local healthcare programs through suspended grant payments and federal workforce reductions. During shutdowns, 45% of HHS staff are furloughed, including personnel who process grants to state health departments and community organizations providing HIV services. The 2013 shutdown left 477 grant payment requests totaling $165 million unpaid while programs continued operating on dwindling reserves.

State health departments must issue stop work orders to community organizations when Ryan White grant payments cease during shutdowns. State AIDS Drug Assistance Programs face immediate medication supply crises as federal funding stops flowing to programs serving 265,000 low-income Americans with HIV medications. Unlike programs with multi-year appropriations, these discretionary programs lose payment authority immediately when government shuts down.

Community health centers serving 32.5 million Americans operate on margins where federal grants constitute 11-18% of revenue. Recent funding disruptions provide a preview of shutdown impacts: Virginia's 16 of 31 federally qualified health centers lost federal funding access, forcing three Richmond facilities to close entirely. Centers typically maintain 100 days to six months of reserves, making extended shutdowns particularly devastating.

The Women, Infants, and Children program loses funding within days of shutdown, cutting services to 6.3 million participants including 39% of all U.S. infants. State health departments lack reserves to float these federal programs, forcing immediate service reductions that disproportionately impact communities already facing healthcare access barriers.

Healthcare Access Cannot Wait for Political Theater

People living with HIV and other chronic conditions cannot afford treatment interruptions while Congress debates funding priorities. Those caught between Ryan White eligibility limits and unaffordable marketplace premiums face a healthcare access crisis manufactured by political inaction.

Healthcare advocates must demand that any continuing resolution include immediate extension of enhanced ACA subsidies through 2026. Congressional Republicans who claim to support these subsidies must prove their commitment by including them in September funding legislation, not promising future action that may never materialize.

State and local health officials should prepare contingency plans for potential grant payment disruptions while advocating with their Congressional delegations about immediate shutdown impacts on essential services. Community health centers and organizations serving people living with HIV need to communicate directly with patients about potential service disruptions and alternative care options.

Congress must choose between responsible governance that prioritizes patient care or political theater that forces impossible choices between treatment adherence and financial survival. For people living with HIV and millions of others depending on stable healthcare access, the time for action could not be shorter.

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.