A New Single-Tablet Option for HIV's "Forgotten Population" Could Change Lives. Will Policy Let It?

With contributions from David "Jax" Kelly, JD, MPH, MBA

Editor's Note: David "Jax" Kelly, JD, MPH, MBA, is the Founder, President, and CEO of the Aging and HIV Institute and President of Let's Kick ASS Palm Springs (AIDS Survivor Syndrome). The Aging and HIV Institute works at the intersection of aging policy, HIV, and health equity, focusing on strengthening how aging systems recognize and respond to people aging with HIV. The organization analyzes policy language, governance structures, and planning processes to ensure that people living with HIV are explicitly included in the frameworks that guide aging services. The kind of policy and systems work described in this article depends on organizations like the Aging and HIV Institute having the resources to stay at the table. If you believe older adults living with HIV deserve a seat in the rooms where aging policy is shaped, consider making a contribution at AgingandHIV.org.

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For nearly two decades, single-tablet regimens have been the standard of care in HIV treatment. One pill, once a day, to maintain viral suppression. For most people living with HIV, that promise became reality years ago. But for tens of thousands of people in the United States and many more worldwide, it never did.

These are people whose treatment histories stretch back to the earliest years of the epidemic, when the drugs available were less effective and far harder on the body. Many developed resistance to multiple classes of antiretrovirals over the course of decades on treatment. Others cannot tolerate components of existing single-pill options, or face drug-drug interactions with the medications they take for conditions that come with aging. The result is a population still managing complex regimens of multiple pills, multiple times a day, while the rest of HIV treatment has moved on without them.

As Dr. Chloe Orkin, Clinical Professor of Infection and Inequities at Queen Mary University of London and lead investigator of the ARTISTRY-1 trial, told NPR in March 2026: "They're like a forgotten population."

Now, new data suggest that may be about to change. On February 25, 2026, The Lancet published the Phase 3 results of the ARTISTRY-1 trial, which tested a new once-daily single-tablet regimen combining bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor. The combination, made by Gilead Sciences, was presented as a late-breaker at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) 2026 in Denver. The results are strong. The question now is whether the people who need this pill the most will actually be able to get it.

The ARTISTRY-1 Trial: What the Data Show

The ARTISTRY-1 trial enrolled 557 people with HIV across 90 sites in 15 countries, all virologically suppressed on complex multi-tablet regimens, and randomized 2:1 to switch to the bictegravir/lenacapavir (BIC/LEN) single-tablet regimen or continue their existing complex regimen. The study population reflects exactly who this pill was designed for: the oldest cohort enrolled in a registrational HIV treatment program to date, with a median age of 60, a median of 28 years on antiretroviral therapy (ART), and 81% on complex regimens due to drug resistance. At baseline, participants were taking a median of three antiretroviral pills per day (range 2 to 11), 39% were dosing twice daily, and 54% had two or more comorbidities including dyslipidemia (68%), hypertension (50%), and hyperglycemia or diabetes (24%).

At Week 48, only 0.8% of participants on BIC/LEN had HIV-1 RNA at or above 50 copies/mL, compared to 1.1% on the complex regimen, meeting noninferiority. No emergent resistance was detected. Switching to BIC/LEN also improved fasting lipid parameters in a population where over half carried two or more cardiovascular risk factors, and participants reported a mean 7-point increase in treatment satisfaction while those on complex regimens reported no change. A separate Phase 3 trial, ARTISTRY-2, presented alongside at CROI 2026, showed BIC/LEN was also noninferior to Biktarvy, a guideline-recommended first-line single-tablet regimen. Gilead plans to file for U.S. Food and Drug Administration (FDA) approval "in the near future," with a potential launch in the second half of 2026. Bictegravir/lenacapavir in combination is investigational and not yet approved anywhere globally.

Who This Pill Is Really For: Long-Term Survivors Aging into Medicare

The clinical data are compelling. But this story requires context beyond the trial results.

The people who stand to benefit most from BIC/LEN are disproportionately older adults now covered by Medicare. Over half of people living with HIV in the United States are now age 50 or older, according to the Centers for Disease Control and Prevention (CDC). The number of traditional Medicare beneficiaries with HIV has more than doubled since the mid-1990s, rising from roughly 42,500 in 1997 to over 103,000 in 2020, and this count does not include those enrolled in Medicare Advantage plans. Medicare is the second largest source of federal financing for HIV care, accounting for 39% of federal spending on HIV care and treatment.

For these older adults, treatment complexity carries consequences well beyond inconvenience. Research published in AIDS and Behavior found that among nearly 48,627 people with HIV in the Medicare program, only about 53% achieved optimal ART adherence. More than one in four had treatment gaps of at least 30 days, and 10% discontinued treatment entirely. A Health Affairsanalysis of Medicare claims data found that Medicare beneficiaries with HIV who were not receiving ART incurred 95.4% higher total spending than those without HIV, driven by higher rates of hospitalizations, emergency department visits, and spending on mental health and other chronic conditions. Beneficiaries who filled ART prescriptions consistently for 12 months, by contrast, had similar risk-adjusted Parts A and B spending to people without HIV. The data make a clear case: keeping people on treatment and adherent saves both lives and money. Treatment simplification is a direct lever for achieving that.

"Medicare provides essential coverage, but it was not originally designed with the long-term trajectory of HIV in mind," said Jax Kelly, JD, MPH, MBA, Founder, President, and CEO of the Aging and HIV Institute. "When I speak with long-term survivors, many tell me they feel grateful for Medicare coverage but still find the system difficult to navigate when it comes to specialized HIV care and medications." The day-to-day burden, Kelly noted, is logistical and financial as much as it is medical: "For someone on a fixed income, managing a complicated regimen alongside Medicare coverage rules can become stressful very quickly."

Kelly's perspective is shaped by years of work at the intersection of HIV and aging, including through the Aging and HIV Institute and Let's Kick ASS Palm Springs. "From my work, I see how important it is that scientific advances translate into real improvements in people's lives," he said. "As more people with HIV age into Medicare, we need policies that recognize the intersection of HIV, aging, and chronic disease management. Without that coordination, people can fall through gaps even when effective treatments exist."

Federal research from HRSA has echoed this concern, finding that older people with HIV have significantly higher rates of depression, chronic kidney disease, COPD, hypertension, diabetes, and other conditions compared to those without HIV, and calling for better coordination between HIV services and geriatric services, including training for medical professionals on the intersecting challenges of aging and HIV.

The Access Question: Will Formulary Barriers Block the Path?

If BIC/LEN receives FDA approval, the question of access will be immediate, especially for people on Medicare.

Medicare Part D plans are required to cover all approved antiretrovirals as one of the six protected drug classes. That is a meaningful safeguard. But coverage does not equal access. People with HIV on Medicare still face prior authorization requirements, specialty tier copays, and formulary placement decisions that vary from plan to plan. An IQVIA analysisof Medicare Part D formulary controls across five chronic therapeutic areas found that more than half of patients were initially denied coverage when trying to fill a new prescription. Among those who could not overcome a rejection within a year, 68% to 80% never started any treatment in that therapeutic area. While this study did not focus specifically on HIV, the pattern of formulary-driven treatment delays and abandonment should concern anyone watching how a new HIV therapy might move through the Medicare system.

"Historically, when new HIV medications enter the market, there can be a lag before Medicare Part D plans fully incorporate them into formularies," Kelly noted. "Sometimes they are placed on higher specialty tiers or require prior authorization before patients can access them."

The broader policy environment compounds this concern. Biktarvy, the most widely prescribed HIV medication in the U.S., was recently selected for the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA), the first HIV medication included. At the same time, we have watched Florida's ADAP crisis unfold, with thousands of people losing access to medications after the state slashed eligibility thresholds. These are reminders that even widely used and well-established HIV therapies can become subject to pricing pressures and funding instability. A new medication entering this environment will face the same forces, and advocates should be watching closely from day one.

Beyond the Pill Burden: What Treatment Simplification Really Means

There is an aspect of this conversation that the clinical trial data cannot fully capture. For long-term survivors who have spent decades on complex regimens because of drug resistance, treatment simplification is about more than reducing the number of pills. It touches questions of stigma, identity, and belonging that have defined the experience of aging with HIV.

When the Undetectable = Untransmittable (U=U) message gained traction, it was a turning point for many people living with HIV. The science was clear: people who achieve and maintain viral suppression cannot sexually transmit the virus. But some long-term survivors could not fully participate in that promise because their complex regimens, while keeping them alive, did not always achieve stable suppression, or because decades of earlier treatment had left them with resistance profiles that made sustained undetectability harder to reach.

"When the U=U message took hold several years ago, it transformed how people think about HIV and transmission," Kelly said. "But some long-term survivors told me they felt left behind because they had never been able to reach an undetectable viral load after decades on earlier generations of treatment. A therapy that helps more people achieve viral suppression could mean more than convenience. It could help erase a stigma that some long-term survivors have lived with for much of their lives."

Research among older adults living with HIV in South Carolina published in the Journal of the Association of Nurses in AIDS Care found mixed views on U=U, with some participants expressing outright skepticism. For older adults already facing the double stigma of HIV-related stigma and ageism, the psychological weight of being on a complex regimen while others take a single pill is real. An effective new single-tablet option, if accessible, could begin to close that gap.

What Needs to Happen Now

The ARTISTRY-1 and ARTISTRY-2 data make a clear case for BIC/LEN as a treatment option. Gilead plans to seek FDA approval. Now the work shifts from the lab to the systems that determine whether people can actually get what the science has produced.

The Centers for Medicare & Medicaid Services (CMS) must ensure rapid and equitable formulary inclusion upon FDA approval. The agency should monitor Part D plan placement of BIC/LEN and act to prevent specialty tier assignment or excessive prior authorization requirements that would delay access for Medicare beneficiaries with HIV. Protected drug class status means nothing if the practical barriers to filling a prescription make access unworkable for people on fixed incomes managing multiple chronic conditions.

Federal and state policymakers must invest in integrating HIV care with aging services. HIV care and aging services operate in separate policy silos, with the Ryan White program, Medicare, and the Older Americans Act aging network each governed by different rules and funding streams. HRSA has called for increased integration, including training for medical professionals on multi-morbidity and polypharmacy in aging HIV populations. Older adults with HIV should not have to serve as their own case managers across fragmented systems. We need concrete movement on bridging them.

Advocates and community organizations must center older adults and long-term survivors in the conversation about treatment access. Too often, the voices of people who have been living with HIV the longest are absent from policy discussions about the medications they depend on. Community-based organizations, peer networks, and aging services providers should work together to ensure that this population is visible and heard, both in formal comment processes and in the broader public discourse around HIV treatment. The American Society on Aging's practical guide for making the aging network HIV-inclusive, published in December 2025, offers a concrete framework for this kind of cross-sector engagement.

We need to treat stigma as a policy issue, not a footnote. The work of education, outreach, and community building for older adults living with HIV has to accompany any new treatment advance. A pill that could bring more people to viral suppression has the potential to reduce the stigma that long-term survivors have carried for decades, but that potential only materializes if we pair it with targeted U=U education for older adults, provider training on the psychosocial dimensions of aging with HIV, and sustained investment in peer support networks. Science alone does not erase stigma. People do.

The long-term survivors who lived through the worst of the epidemic have been on treatment for close to three decades. They took the drugs that didn't work well, weathered the side effects of regimens that were the best available at the time, and developed the resistance profiles that locked them out of the simpler options that followed. As Kelly said: "New treatments are incredibly important, but they must be paired with policies that ensure older adults living with HIV can actually access them and benefit from them."

The science is closing the treatment gap for this overlooked population. Our policy systems and our communities must do the same.

The False Economy of Rationing Life

Across the country, states are making a choice. Faced with budget shortfalls driven by flat federal funding, the expiration of enhanced ACA premium tax credits, and the downstream wreckage of H.R. 1's nearly $800 billion in Medicaid cuts, they are choosing to solve their fiscal problems by restricting access to the medications that keep people living with HIV alive and stop the virus from spreading. Eighteen states have implemented cost-containment measureson their AIDS Drug Assistance Programs, with five more considering changes. Florida slashed ADAP eligibility from 400% to 130% of the federal poverty level on March 1, cutting off more than 12,000 people and removing Biktarvy, which accounts for 52% of the U.S. ARV market, from its formulary. Louisiana is considering HB927, legislation that would repeal the state's long-standing statutory protections against prior authorization and step therapy for antiretrovirals in Medicaid.

The pressures are real. ADAP enrollment surged 30% from 2022 to 2024 as states shed Medicaid enrollees after the pandemic. NASTAD's February 2026 ADAP Watch reports 19 ADAPs forecast deficits for the upcoming fiscal year. When adjusted for inflation, ADAP appropriations have declined 31% since 2005, with the FY2025 appropriation carrying roughly the same purchasing power as FY1999 levels. Nobody disputes the math. What we dispute, forcefully and on the evidence, is the response.

Utilization Management on ARVs Is Clinically Indefensible

Step therapy requires a patient to "fail" a medication before accessing the one their provider has already determined is best for them. In HIV treatment, failure means the virus has replicated in the presence of inadequate drug levels and potentially developed resistance, rendering the entire associated drug class less effective or ineffective. For someone on PrEP, "failing" a regimen means they have seroconverted and acquired HIV, possibly with resistance that limits their treatment options from day one. Prior authorization creates gaps in access while paperwork is processed. Drug resistance can develop within several weeks of stopping ART, as some components of a combination regimen remain in the body longer than others, leaving HIV exposed to one or two drugs instead of a full suppressive regimen. CD4+ cell counts can decline by up to 100 cells/mm³ within weeks of interruption. The SMART trial demonstrated that episodic ART interruption was associated with increased risk of opportunistic disease and death, findings so conclusive the strategy was abandoned entirely.

The CMS Medicare Part D Manual specifically notes that utilization management tools like PA and step therapy are generally not employed in best-practice formulary models for HIV/AIDS drugs. The American Academy of HIV Medicine issued a white paper with a single recommendation: HIV medications should be exempt from prior authorization requirements. As of 2019, 14 states had enacted laws prohibiting at least some UM techniques for ARVs. The broader health policy world is arriving at the same conclusion about PA generally: a January 2026 KFF Health Tracking Poll found that four in ten people with chronic conditions say prior authorization is their single biggest healthcare burden beyond costs, and KFF President Drew Altman has openly questioned whether its short-term cost control benefits are worth the costs to patients in an already overburdened system. If the mainstream is questioning PA broadly, the case for applying it to ARVs, where the clinical stakes include drug resistance, viral transmission, and death, does not exist.

The Math Doesn't Work, and the Motive Is Worse

Here is where we need to stop treating this conversation as though it is happening in good faith.

The stated rationale for stripping UM protections from ARVs is cost containment. But anyone who has watched private insurance markets operate over the past two decades recognizes what utilization management on high-cost drug classes actually produces: leverage. Private payers have used UM as a negotiating tool for years, threatening to restrict formulary access unless manufacturers offer deeper discounts. The people whose treatment gets disrupted in the process are the collateral damage that makes the threat credible.

CANN has been warning for years that as state Medicaid programs face mounting budget pressure, the temptation to adopt this same playbook would grow. That is exactly what is unfolding. When states impose PA and step therapy on antiretrovirals, the practical effect extends well beyond cost management. It creates a bargaining position where patient access to life-saving medication becomes a concession to be traded for supplemental rebates from manufacturers. This is the private payer model of healthcare as revenue generation imported into public health programs responsible for managing a communicable disease. It transforms the health of people living with HIV into a bargaining chip, and it represents a fundamental betrayal of what public health programs exist to do.

The people whose medications get delayed, whose viral loads rebound, whose resistance profiles narrow while prior authorizations are processed are not an unfortunate side effect of this model. They are the leverage. That is not healthcare. It is government treating public health as a profit center.

The economics don't support it either. Every new infection from someone with a detectable viral load carries an estimated lifetime medical cost of $326,500, with the cost avoided by preventing that infection estimated at $229,800. More recent analyses from HIVMA put average lifetime expenditures between $500,000 and more than $1.2 million. A Precision Health Economics analysis estimated that allowing UM on Part D antiretrovirals alone could result in over 6,750 new HIV infections. Whatever supplemental rebate a state might extract by threatening formulary restrictions will be dwarfed by the downstream costs. And in a U.S. cohort studied between 2021 and 2023, 28% of people with HIV experienced a treatment interruption of 90 days or more, with those affected disproportionately women, Black, dealing with substance use, and less likely to have commercial insurance. These barriers concentrate harm on the people who are already most structurally vulnerable.

We Have Already Watched This Fail

We don't need to theorize. We watched it happen with Hepatitis C. For years, state Medicaid programs and MCOs imposed PA, step therapy, sobriety requirements, and prescriber restrictions on curative direct-acting agents for HCV. People were denied treatment while their disease progressed. By the end of 2025, 34 jurisdictions had removed PA requirements for most Medicaid HCV patients, reflecting the national consensus that those restrictions never served patients or budgets. Louisiana itself now receives an "A" grade for HCV Medicaid access. As CANN's letter to Vice Chair McMahen on HB927 notes, the bill proposes substantially similar risks to HIV medication access as those once imposed on HCV, in a state that passed model PrEP and PEP legislation in 2024 that these same UM tools would undermine.

What Must Happen

Florida's own legislature proved these cuts are not inevitable when it passed HB 697 in mid-March with $31 million to restore ADAP eligibility for over 11,000 people. Bipartisan, responsive, and proof that different choices are available when the political will exists.

States must fight for adequate federal ADAP funding, which has been flat-funded since FY2014 while program costs have grown relentlessly. They must leverage 340B rebates and supplemental funding rather than cutting the people the programs exist to serve. They must design Medicaid formularies to ensure access following federal HIV treatment guidelines, not undermine them. And their federal legislators should realize that if we can fund the Department of Defense at a trillion dollars a year, we can surely pay to keep people from dying from AIDS.

There is no clinical necessity for removing ARV protections. Doing so will not balance budgets. It will create drug resistance, increase transmission, push people into more expensive care settings, and compound the harms of H.R. 1's Medicaid budget cuts and work requirements, which threaten coverage for 42% of Medicaid enrollees with HIV. At every level of analysis, this approach fails. What it succeeds at is transferring the cost of federal policy failures onto the bodies of people living with HIV, and that is not fiscal responsibility. It is abandonment dressed in budget drag.

The Quiet Pay Cut: Rising Health Insurance Costs Are Eroding Worker Compensation

The average annual family premium for employer-sponsored health insurance reached $26,993 in 2025, according to KFF's (Kaiser Family Foundation) annual benchmark survey of employers. Workers contribute $6,850 of that cost out of their paychecks. Family premiums rose 6% this year, continuing a pattern of 6 to 7% annual increases over the past three years, outpacing both general inflation (2.7%) and wage growth (4%). Costs are expected to accelerate: Aon estimates that employer coverage will surge approximately 9.5% in 2026, the largest single-year increase in at least 15 years. About 154 million Americans under 65 depend on employer-sponsored coverage, making this a compensation crisis hiding in plain sight.

The Hidden Pay Cut

Every dollar an employer spends on health insurance premiums is a dollar unavailable for wages. This is well-established economics, and the scale of it is staggering. A January 2024 study published in JAMA Network Openfound that from 1988 to 2019, the mean cumulative lost earnings associated with growth in health insurance premiums was $125,340 per family, nearly 5% of total earnings over that 32-year period. If employer-sponsored insurance costs had remained at the same proportion of the 1988 compensation package, the median family with employer coverage could have earned $8,774 more in annual wages by 2019.

This cost falls hardest on the people who can least afford it. The same JAMA Network Open study found that by 2019, health care premiums consumed 19.8% of compensation for Hispanic families and 19.2% for non-Hispanic Black families with employer-sponsored insurance, compared to 13.8% for non-Hispanic White families. At the 20th percentile of earnings, premiums consumed 28.5% of compensation, compared to just 3.9% at the 95th percentile. Because most employers do not adjust premium contributions by income, rising health insurance costs function as a regressive tax on lower-wage workers, widening racial and economic inequality through a mechanism that rarely gets the attention it deserves.

Fresh data from the Federal Reserve Bank of New York confirms this dynamic is accelerating. In February 2026 regional business surveys, firms reported health insurance cost increases averaging more than 13%. Those same firms reported that absent the cost increases, they would have raised wages by roughly an additional percentage point, representing a 20% drag on wage growth. To put the numbers in perspective: the average annual premium for employer-sponsored family coverage is now roughly equivalent to the full-time annual wage of a worker earning $15 per hour.

When Workers Bear the Burden

As premiums climb, employers pass costs along through higher deductibles and out-of-pocket expenses. The average single-coverage deductible in 2025 stands at $1,886, up 17% over five years, according to the KFF 2025 Employer Health Benefits Survey. Workers at small firms face average deductibles of $2,631, and more than half of covered workers at those firms now face deductibles of at least $2,000. Nearly three-quarters (72%) of covered workers face out-of-pocket maximums above $3,000, with one in five facing maximums above $6,000.

The consequences are measurable and immediate. A March 2026 Employee Benefit Research Institute (EBRI) survey found that four in ten privately insured adults reported higher healthcare costs in the past year. Among those, roughly a third had trouble covering their bills, and a quarter reduced retirement contributions. People are delaying and avoiding care because of cost. As EBRI director Paul Fronstin noted, affordability now shapes both access to care and longer-term financial security.

For people living with HIV and other chronic conditions, delayed care carries compounding risks. Interrupted treatment, missed appointments, and medication non-adherence can undermine viral suppression and lead to worse health outcomes, higher long-term costs, and greater strain on the healthcare system.

What's Driving the Increase

Employers point to multiple converging cost drivers. Among large firms in the KFF survey, 36% say prescription drug prices contributed "a great deal" to higher premiums in recent years, followed by the prevalence of chronic disease (30%), higher utilization of services (26%), and hospital prices (22%). GLP-1 medications for weight loss have become a particular flashpoint: among the biggest employers covering these drugs, 59% say utilization exceeded expectations and two-thirds report a significant impact on prescription drug spending.

The problem for employers is that their usual playbook is running out of room. Strategies like changing plan designs and managing vendors more tightly are likely to shave only two or three percentage points from the average increase, according to Aon. When costs are rising 9.5%, that arithmetic does not work, and 64% of CFOs and CEOs say an 8 to 10% cost increase is the threshold for making significant changes to their coverage offerings. Those changes typically mean workers pay more.

The Small Business and Nonprofit Squeeze

Small businesses face an even sharper version of this crisis. Half of the nation's smallest employers do not offer health insurance at all, and those that do are struggling to hold on. Rachel Bernier-Green, who started the financial consulting firm EJ Consortium in Chicago in 2023, began offering health benefits to her six workers in 2025. By the time premiums spiked, she was forced to drop coverage entirely. In the nonprofit sector, where mission-driven organizations serve communities affected by chronic conditions and health disparities, this dynamic is particularly concerning.

At the Community Access National Network (CANN), we take a different approach. "Given the work that we do, it is critical in actualizing our values — our goals for the rest of the patient community — to ensure our employees are well-covered and able to realize their full compensation value," said Darnell Lewis, CANN Board Chair. "This means providing our employees with high-quality, low deductible, low co-pay / co-insurance, and low maximum out of pocket health insurance coverage with 100% of the monthly premium assumed by CANN for all employees. We also recognize the need for ensuring our employees' families are well covered, which is why we covered 50% of dependent premiums for the same quality of coverage. We are actively modeling the best practices in compensation and coverage that we urge the rest of the non-profit sector and all businesses to adopt."

Too many nonprofits treat employee benefits as an afterthought. When an organization's mission centers on health access and health equity, the benefits it provides its own people should reflect that mission. Taking care of the people who do the work is a core organizational value, and it is a standard the sector should rise to meet.

PBM Reform: A Policy Opening

A significant share of premium growth traces back to prescription drug costs, and 2026 has brought the most meaningful federal action on pharmacy benefit manager (PBM) reform in decades. Three converging actions deserve attention. On January 29, 2026, the U.S. Department of Labor (DOL) proposed a rule requiring PBMs to disclose rebates, spread pricing, and pharmacy claw-backs to plan fiduciaries of self-insured group health plans, covering approximately 90 million Americans. Days later, the 2026 Consolidated Appropriations Act (CAA) was signed into law on February 3, requiring 100% rebate pass-through for Employee Retirement Income Security Act (ERISA) plans and delinking PBM compensation from drug prices in Medicare Part D beginning in 2028. On February 4, the Federal Trade Commission (FTC) settled with Express Scripts, requiring elimination of spread pricing and point-of-sale rebate pass-through in its standard offerings by January 2027, while litigation continues against Caremark Rx and OptumRx.

These reforms target an opaque layer of the drug supply chain that has long driven up costs for plans and the people they cover. For people living with HIV, where antiretroviral therapy is both lifesaving and lifelong, PBM practices affect formulary design, out-of-pocket costs, and pharmacy access in direct and material ways. Comments on the DOL proposed rule are due March 31, 2026, and patient advocates, employers, and labor organizations should submit them.

Where Employer and Labor Interests Align

Rising premiums represent one of the clearest points of alignment between employers and labor. Unions have historically secured better health benefits for members. Bureau of Labor Statistics data show that 96% of union workers have access to medical care benefits compared to 69% of non-union workers, with lower premium contributions and lower deductibles. Some unions have gone further, partnering with employers to address the root causes of cost growth. A Boston hotel workers' union built provider networks excluding the highest-cost hospitals and offered no-deductible plans at premiums one-tenth the national average, with emergency room use dropping significantly in the first year. In New Jersey, public-sector unions used a PBM "reverse auction" model that secured a contract 10% below projections and saved $1.5 billion over three years.

These examples demonstrate that cost containment does not have to mean cost-shifting. Unions, as both purchasers and users of health benefits, are positioned to push for reforms that target provider prices and supply-chain opacity rather than asking workers to accept higher deductibles and thinner coverage.

What We Can Do

The policy window is open. Here is where we need action:

Policymakers should strengthen PBM transparency reforms, ensure the DOL proposed rule includes robust enforcement mechanisms, and monitor implementation of the 2026 CAA provisions. State-level cost commissions and hospital price transparency initiatives deserve expanded support.

Employers should review PBM contracts now, well before the CAA requirements take effect for plan years beginning January 1, 2029. Coalition purchasing strategies and value-based plan designs that target price rather than utilization offer more sustainable paths than continuing to shift costs to workers.

Advocates and labor organizations should submit comments on the DOL proposed rule before the March 31 deadline. We should push for extending commercial drug pricing reforms and advocate for policies that address the underlying drivers of premium growth.

The math here is straightforward: rising health insurance costs reduce wages, deepen inequality, and force people to delay or forgo care. For those of us working in patient advocacy, health equity, and public health, this should be a unifying cause. We all share an interest in a system where comprehensive coverage is the standard, not the exception.

CROI 2026: The Tools Are Here. The Infrastructure Is Not.

The 33rd Conference on Retroviruses and Opportunistic Infections (CROI) convened February 22nd – 25th in Denver under extraordinary tension between a pipeline of HIV prevention, treatment, and potential cure tools that could reshape the epidemic's trajectory, and a global funding crisis actively dismantling the infrastructure required to deliver any of it. As Conference Chair Nicolas Chomont of the Université de Montréal stated in the Opening Session, "we share a responsibility to defend and sustain funding for international HIV programs and research." That charge framed every session that followed.

The Funding Crisis: New Data on the Damage

The consequences of disruptions to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the dissolution of the United States Agency for International Development (USAID), and National Institutes of Health (NIH) cuts are no longer hypothetical. The CROI session "Sleepless in Denver" presented the first systematic evidence of the damage. Ellen Brazier's survey data from the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium found that across 32 countries, 47% of clinics reported disruptions in HIV services, with similar rates of disruption to medication availability, laboratory services, and clinic operations. In KwaZulu-Natal, South Africa, Lindsey Filiatreau reported that 39% of clinics experienced disruptions affecting an estimated 830,000 people living with HIV.

The damage is not confined overseas. Aaron Richterman presented data from a rapid survey across three U.S. states showing that 47% of clinics reported HIV service disruptions, including medication shortages. He also demonstrated how cuts to the Supplemental Nutrition Assistance Program (SNAP), the country's largest targeted anti-poverty program serving more than 42 million Americans, directly undermine treatment outcomes. During the 2025 government shutdown, ART adherence among people living with HIV who receive SNAP benefits dropped to as low as 40%. The connection between food security and viral suppression is well established; cutting one predictably undermines the other. As Filiatreau put it, "These things [HIV services]… can be taken away overnight, but they can't be rebuilt overnight."

Prevention: An Expanding Toolkit, a Widening Access Gap

Against this backdrop, CROI delivered a prevention portfolio that is broader and stronger than at any previous conference. Final results from the PURPOSE 1 and PURPOSE 2 trials confirmed the efficacy of twice-yearly injectable lenacapavir for pre-exposure prophylaxis (PrEP). In PURPOSE 1, which enrolled cisgender adolescent and young women in sub-Saharan Africa, HIV incidence among lenacapavir recipients was 0.07 per 100 person-years, compared to 1.98 for oral emtricitabine/tenofovir alafenamide (F/TAF) and 1.94 for emtricitabine/tenofovir disoproxil fumarate (F/TDF), with only two seroconversions among more than 2,000 participants. PURPOSE 2, enrolling men who have sex with men and gender diverse people, showed HIV incidence of 0.11 per 100 person-years for lenacapavir versus 0.92 for F/TDF, with three seroconversions among 2,179 participants.

The five total seroconversions across both studies received considerable attention, with four showing lenacapavir-associated resistance mutations that researchers believe developed during PrEP rather than being transmitted. Research into why these breakthroughs occurred is ongoing. As Gilead's Stephanie Cox stated, "We don't know why these occurred… I think the efficacy is very high." San Francisco AIDS Foundation (SFAF) Medical Director Hyman Scott, MD, MPH, added context: "The breakthrough infections are important to evaluate but are extremely rare among the thousands of study participants."

The Prévenir study's final eight-year results from France reinforced that both daily and on-demand oral PrEP are safe and effective, with overall HIV incidence of 0.11 per 100 person-years across more than 3,200 users and 13,000 person-years of follow-up. Switching between daily and on-demand use was the norm rather than the exception, with 59% of daily users changing to on-demand at least once, and 52% doing the reverse. This carries a clear message for implementation: people need flexibility, and rigid one-size prescribing undermines persistence.

The prevention pipeline continues to expand. Merck's once-monthly oral PrEP candidate MK-8527 selected an 11 mg dose maintaining protective drug levels in at least 95% of participants, with Phase 3 EXPrESSIVE trials now enrolling. Gilead's PURPOSE 365 study, testing once-yearly lenacapavir for PrEP, is being designed. The SEARCH study showed that community health workers paired with digital tools reduced HIV incidence by 70% in rural populations, a reminder that prevention tools work best when embedded in community-driven delivery.

The problem is reach. Andrew Hill highlighted that only 2.3 million people are currently on oral PrEP, far below UNAIDS targets, and that injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of total PrEP use, respectively. We have a growing menu of prevention tools. Getting them to the people who need them is where the system breaks down.

Treatment: More Options, Longer Intervals, Patient Choice

The treatment pipeline at CROI 2026 moved toward a central goal: giving people living with HIV more choices that fit their lives. Merck presented late-breaking data from three Phase 3 trials of doravirine/islatravir (DOR/ISL), the first ever once-daily, non-INSTI two-drug regimen. In treatment-naive adults, DOR/ISL demonstrated non-inferiority to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), with 91.8% achieving viral suppression at Week 48 compared to 90.6%, including participants with high viral loads and low CD4 counts. The U.S. Food and Drug Administration (FDA) has set an action date of April 28, 2026 for the DOR/ISL application. For people aging with HIV who manage multiple comorbidities, a two-drug, non-INSTI regimen addresses a real clinical gap. Research presented at this same conference linked the widely used INSTI dolutegravir to neuropsychiatric effects, including blocking a brain enzyme essential for memory and emotional regulation, with one study halted for ethical reasons after participants experienced worsening symptoms. For people navigating tolerability concerns, toxicity issues, or polypharmacy, having a non-INSTI alternative with fewer active agents matters.

Gilead's ARTISTRY-1 and ARTISTRY-2 trials demonstrated that a bictegravir/lenacapavir (BIC/LEN) single-tablet regimen can maintain viral suppression for people switching from complex multi-tablet regimens (96% at 48 weeks in ARTISTRY-1) or from Biktarvy (93.5% in ARTISTRY-2). For people who have been on complex regimens for years due to resistance histories, this potential simplification addresses a real quality-of-life gap. Gilead plans to submit these results to regulatory authorities.

Long-acting injectables continued their forward march. In ViiV Healthcare's EMBRACE study, lotivibart (a broadly neutralizing antibody, or bNAb) given as an IV infusion every four months plus monthly cabotegravir maintained viral suppression in 94% of participants at 12 months. Part 2 of EMBRACE, testing lotivibart infusions every six months, is now fully enrolled. ViiV also presented early data on VH-184, a third-generation integrase inhibitor with potential twice-yearly dosing, and VH-499, a capsid inhibitor supporting twice-yearly intervals. The VOLITION study showed that 85% of treatment-naive adults opted to switch from daily pills to bimonthly long-acting cabotegravir/rilpivirine (CAB+RPV LA), with 95% maintaining suppression. Data like VOLITION's 85% opt-in rate reinforce what the HIV community has long argued: when people living with HIV are offered options that fit their lives, they take them. Payers, formulary committees, and ADAP programs should take note. Treatment is not one-size-fits-all, and coverage shouldn’t treat it as such.

Community activist Shari Margolese put it plainly at CROI's final Community Breakfast Club: "As a community we need to get much angrier about the fact that we can't get access to the drugs." Francois Venter of Ezintsha in South Africa warned that without action, "we might be sitting here again in 10 years' time" celebrating breakthroughs that never reach communities.

Cure, Comorbidities, and the Equity Question

On the cure front, the RIO trial's Phase B results offered genuine encouragement. Among the 28 people who received a placebo in Phase A and were then given bNAbs teropavimab and zinlirvimab, 54% had prolonged viral remission after stopping antiretroviral therapy (ART), with two still off treatment after more than a year. Because ART was stopped six months after the bNAb infusions, these results point to an immunological "vaccinal effect" rather than direct viral suppression. A cure remains distant, but these are the kinds of incremental, well-designed steps that build the evidence base forward.

CROI also highlighted the growing urgency of managing comorbidities in aging populations living with HIV. The POPPY study found that depression affects 32.4% of people living with HIV over 50, linked to inflammatory markers rather than psychosocial factors alone. A study of over 1,500 men showed that the combination of age 65 and over, HIV, and metabolic syndrome produced significantly worse cognitive impairment than any factor alone. Metabolic syndrome is the modifiable factor in that triad, which means clinicians and patients can act on it now. CROI data on GLP-1 receptor agonists like semaglutide point toward a potential tool for doing so: in a study of people living with HIV-associated lipohypertrophy, semaglutide produced a 19% reduction in total body fat, a 31% decrease in visceral adipose tissue, and a nearly 50% drop in C-reactive protein, a key inflammatory marker. Separate data presented at the conference found that semaglutide did not worsen depression in people living with HIV, and that people with moderate or severe depression at baseline actually showed improvements. These findings warrant dedicated research into how GLP-1 therapies can address the long-term health consequences of chronic inflammation and aging with HIV. If the evidence continues to support their role, GLP-1 receptor agonists should be evaluated for inclusion in the HIV standard of care, with appropriate insurance and program coverage to match.

The equity question came into sharp focus with data from the ENCORE cohort. Black trans women in the U.S. had an HIV incidence of 15.5 per 1,000 person-years, compared to 1.4 for White trans women. Poverty, houselessness, and lack of insurance were significant drivers, and only 4% of trans women in the cohort used long-acting injectable PrEP. Dr. Sari Reisner of the University of Michigan warned that the current administration's erasure of gender identity data from federally funded datasets will make it harder to monitor disparities and determine what works. We cannot close gaps we refuse to measure, and they know that.

What Comes Next

CROI 2026 produced a clear picture: we have tools that can change the course of the HIV epidemic, and the systems required to deliver them are being actively undermined. The path forward requires specific action. We must defend and restore funding for PEPFAR, NIH, and the global HIV infrastructure that makes science reach people. State ADAP programs and payers must expand coverage for long-acting prevention and treatment options and remove administrative barriers that delay access. To do that, they need to be adequately funded. PrEP implementation must embrace the full range of validated modalities, from daily oral to on-demand to injectable to monthly oral, with flexibility built into delivery. Care for people aging with HIV must shift toward whole-person approaches that integrate cognitive screening, metabolic risk management, and mental health support alongside viral suppression. And we must protect the community-led surveillance and data collection that allows us to see and respond to disparities, especially for trans and gender-diverse communities.

Wes Sundquist of the University of Utah, who helped develop the science behind lenacapavir, reflected at CROI on the decades-long journey that produced this tool. He warned that while the field now has "a really powerful new tool in the arsenal," forces are blocking its use. "It will be a human tragedy," he said, "if we don't overcome those." The science has done its part. The rest is a question of political will, policy design, and whether we as a community can sustain the pressure long enough for these tools to reach the people who need them.

ADAPs Work. Federal Policy Is Defunding Them on Accident.

NASTAD released its 2026 National Ryan White HIV/AIDS Program (RWHAP) Part B AIDS Drug Assistance Program (ADAP) Monitoring Project Annual Report this month, and the numbers tell two stories at once. In 2024, state and territorial ADAPs served 257,644 people living with HIV across 49 reporting jurisdictions, achieving an 87% viral suppression rate among clients served. That figure significantly outpaces the estimated 67% suppression rate among all people living with diagnosed HIV in the United States, and it was achieved within a population where 65% of clients live at or below 200% of the Federal Poverty Level (FPL). By any clinical measure, ADAPs are delivering.

The second story is fiscal. Drug rebates generated through the 340B Drug Pricing Program now constitute 52% of total ADAP budgets, dwarfing the federal ADAP earmark at just 29%. A $2.7 billion safety net serving nearly one-quarter of all people living with diagnosed HIV in the country is now majority-funded by a revenue source that multiple federal policy changes are actively eroding. And demand is about to surge.

The Unwinding as Stress Test

The post-COVID Medicaid unwinding that began in April 2023 showed us what happens when coverage shifts push low-income people living with HIV off their insurance. ADAPs absorbed a 30% increase in new client enrollments and an 11% increase in total enrollment compared to 2022. Across 40 jurisdictions with comparable data, prescription drug spending grew 17% in two years, from $1.31 billion to $1.54 billion. Some states faced localized shocks: Pennsylvania's drug costs rose 82%, Arizona's nearly tripled. A JAMA Health Forum study confirmed that more than 25 million people nationally had Medicaid terminated during unwinding, with coverage losses concentrated among younger, healthier adults most likely to fall out of care when coverage disappears.

The system held. But the unwinding was a stress test, not the main event.

The Rebate Dependency Trap

Congressional appropriations for RWHAP Part B totaled $1.41 billion in FY2024, with ADAP-specific funding essentially flat. States have bridged the gap through 340B rebate revenue. In FY2019, 73% of rebates were applied to ADAP budgets; by FY2024, that figure reached 86%. Programs are retaining nearly every rebate dollar generated, and it still barely meets demand.

The Inflation Reduction Act (IRA) creates an unintended problem here. Its Medicare Part D reforms cap annual out-of-pocket drug costs at $2,000 in 2025 and $2,100 in 2026, which genuinely benefits Medicare beneficiaries. But ADAPs generate "partial-pay rebates" on cost-sharing payments made on behalf of clients enrolled in Medicare Part D. Lower cost-sharing means lower rebate revenue. The IRA's Medicare Drug Price Negotiation Program is likely to further compress the pricing benchmarks driving rebate calculations. The third negotiation round, announced in January 2026, selected Biktarvy for negotiated pricing effective in 2028. Biktarvy is the most widely prescribed single-tablet HIV regimen in the country and cost Medicare approximately $3.9 billion for 101,000 beneficiaries in the most recent measurement period. A negotiated reduction in Biktarvy's Medicare price could directly lower the "best price" benchmark that determines ADAP rebate revenue on the very drug that anchors most clients' treatment.

Layer on the PBM reform provisions signed into law in February 2026 requiring 100% rebate pass-through in Medicare Part D starting in 2028, plus manufacturer restrictions on 340B contract pharmacies that 54% of ADAPs report are creating payment challenges, and the picture is clear: the revenue stream funding more than half the HIV safety net is being squeezed from multiple directions, all at once, and the pressure is increasing.

Each of these policies may have merit on its own terms. But none were designed with a safety net impact assessment in mind, and the cumulative downstream effect on ADAP financing is significant and remains unaddressed.

The Demand Surge

While revenue contracts, demand is set to spike. H.R. 1, signed July 4, 2025, enacts the largest Medicaid cuts in the program's history. The Congressional Budget Office (CBO) estimates $911 billion in federal Medicaid spending reductions over a decade. KFF notes that more than 10.3 million people are likely to lose Medicaid. A Center for American Progress analysis found the bill's approximately $1 trillion in Medicaid cuts is roughly matched by approximately $1 trillion in tax reductions directed to the top 1% of earners. The priorities embedded in that budget math deserve scrutiny, to put it mildly.

And then the enhanced ACA premium tax credits expired at the end of 2025 without extension. Approximately 22 million people received those credits last year, and the average recipient has seen premiums more than double. The Urban Institute estimates roughly 5 million people may drop coverage and go uninsured, with the impact falling disproportionately on Black and low-income communities in metro areas like Houston and Atlanta, per the Economic Policy Institute. When the CBPP tallies all coverage losses, the total reaches roughly 15 million people newly uninsured by 2034.

For people living with HIV, these numbers carry specific weight. Medicaid is the single largest source of coverage for adults living with HIV at an estimated 40%, with 42% of those enrollees qualifying through the ACA expansion pathway H.R. 1's work requirements directly target. People living with HIV also rely on ACA Marketplace plans at higher rates than the general population; at least 40,000 ADAP clients were enrolled in Marketplace plans as of 2023. KFF estimates the premium tax credit expiration alone will cost state ADAPs an estimated $83.7 million in additional premium costs, with ADAPs in non-expansion states facing the steepest increases. If ADAPs cannot absorb those costs, KFF outlines the consequences: reduced income eligibility, restricted formularies, increased utilization management, and the possible return of waiting lists for the first time since 2012.

We don't have to speculate about what this looks like. On January 8, 2026, the Florida Department of Health announced sweeping changes to its ADAP, effective March 1: slashing income eligibility from 400% FPL to 130% FPL, eliminating insurance premium assistance, and removing Biktarvy from the formulary. NASTAD estimates more than 16,000 people will lose ADAP coverage. Florida cited rising premiums and the premium tax credit expiration, yet has not released an ADAP budget in over a year and bypassed the stakeholder engagement required under federal Ryan White guidelines. Every structural vulnerability the NASTAD report identifies played out in a single state in a matter of weeks.

What We Should Be Doing

The NASTAD report warns that H.R. 1 and the premium tax credit expiration threaten to "unravel the coverage gains" it documents. ADAPs serve 23% of all people living with diagnosed HIV. The Ending the HIV Epidemic (EHE) initiative depends on sustained viral suppression, which depends on treatment access, which depends on these programs remaining solvent. The data demands specific action. Short of reversing the policies of H.R. 1 and actually insuring poor people as a just and moral society might choose to do, several targeted measures could prevent the worst outcomes.

Congress should increase the federal ADAP earmark to reflect documented enrollment growth and the surge H.R. 1 will drive, and pursue RWHAP reauthorization to replace the year-to-year appropriations the program has relied on since its authorization lapsed in 2013. Flat funding in the face of 30% enrollment growth is a policy choice with consequences measured in lives.

Congress should reinstate and make permanent the enhanced ACA premium tax credits. For people already navigating the social determinants of health that create barriers to care, losing insurance coverage removes one of the few reliable pathways to sustained treatment access and viral suppression. Future drug pricing legislation should include safety net impact assessments to identify and offset downstream revenue effects on programs like ADAPs before those effects become crises.

States need targeted investment in ADAP administrative infrastructure to manage the coming enrollment wave. 60% of ADAPs already report maintaining client eligibility as challenging and 38% report difficulties implementing long-acting injectables and provider-administered drugs. The 30% enrollment surge during unwinding stretched existing capacity. What H.R. 1 delivers will be larger and longer-lasting.

The 2026 NASTAD report documents a system that works. An 87% viral suppression rate among a low-income population, achieved through sophisticated fiscal management and a decades-long commitment to keeping people in care, is a public health accomplishment we should be protecting. The question is whether we will defend the infrastructure that makes it possible, or let it collapse under the weight of policy decisions that were never designed to account for it.

Warren and Hawley Want to Break Up Big Medicine. Here's What the Bill Actually Does.

On February 10, 2026, Sen. Elizabeth Warren (D-Mass.) and Sen. Josh Hawley (R-Mo.) introduced the Break Up Big Medicine Act, a bipartisan bill that would force the structural separation of healthcare conglomerates that simultaneously own insurance companies, pharmacy benefit managers (PBMs), pharmacies, physician practices, and drug wholesalers. The political pairing is unusual: a progressive Democrat and a populist Republican, finding common ground on the idea that a handful of corporate giants have rigged the healthcare supply chain in their own favor. The bill arrives as both parties scramble to address healthcare affordability ahead of the 2026 midterm elections, and just days after President Trump signed an appropriations package containing new PBM transparency rules and issued executive orders directing agencies to "reevaluate the role of middlemen" in prescription drug pricing. The political will to confront healthcare consolidation is clearly building. The question is whether this bill meets the moment.

What the Bill Does

The Break Up Big Medicine Act draws its inspiration from the Glass-Steagall Act of 1933, which separated commercial and investment banking after the financial system's collapse during the Great Depression. Applied to healthcare, the principle is the same: entities that are supposed to be bargaining competitively with one another should not be owned by the same parent company.

The bill establishes two core prohibitions. First, it bars any person or entity from simultaneously owning or controlling a medical provider or management services organization (MSO) and an insurance company or PBM. Second, it bars common ownership of a provider or MSO and a prescription drug or medical device wholesaler. Companies in violation would have one year to divest. Those who miss divestiture milestones would face automatic penalties, including 10% of profits transferred into escrow on a monthly basis and, eventually, a court-appointed divestiture trustee with authority to force asset sales. Revenue from seized profits would be deposited into a fund created by the Federal Trade Commission (FTC) and distributed to serve the healthcare needs of harmed communities.

An MSO is an entity that contracts with a medical provider to furnish administrative and business services such as payroll, payer contracting, billing and collection, coding, IT, and patient scheduling. While MSOs do not technically practice medicine, they have become the primary vehicle through which corporate entities, including insurers and private equity firms, exert operational control over physician practices without appearing on paper as the owner. The bill's explicit inclusion of MSOs is a recognition that corporate control of healthcare delivery does not require direct ownership; it can be achieved through the back office.

The enforcement architecture is broad. The FTC, the Department of Justice (DOJ) Antitrust Division, the Department of Health and Human Services (HHS) Inspector General, state attorneys general, and private citizens can all bring civil actions. The private right of action provision allows treble damages (a legal remedy where a court triples the amount of actual, compensatory damages awarded to a prevailing plaintiff), attorney's fees, and equitable relief. The FTC and DOJ would also retain forward-looking authority to review and block future transactions that would re-create the prohibited conflicts of interest.

The bill's definition of "provider" is notably expansive: it includes pharmacies (both in-patient and outpatient), physician practices, ambulatory surgery centers, urgent care centers, post-acute care facilities, home-health providers, and hospitals. This means the legislation reaches well beyond PBM-owned pharmacies to encompass the full range of insurer-owned care delivery.

The Problem It Targets

The scale of vertical integration in U.S. healthcare is difficult to overstate. Three PBMs, CVS Caremark, Express Scripts, and OptumRx, manage nearly 80% of prescription drug claims for roughly 270 million people. Each is owned by a company that also operates a health insurance plan, physician offices, and pharmacies. Three drug wholesalers control 98% of U.S. drug distribution. As of 2023, UnitedHealth Group, through its Optum subsidiary, controls approximately 10% of all American physicians, making it the single largest employer of doctors in the country. Nearly 80% of physicians now work for a corporate parent, and since 2019, nearly 4,000 independent pharmacies have closed.

The evidence on what this consolidation does to costs and quality is damning. RAND Corporation testimony to the U.S. House of Representatives found that vertical integration of hospitals or health systems with physician practices does not lower spending and does not improve quality of care. Instead, it shifts care to higher-cost settings and increases payment rates through greater negotiating power. Hospital-physician vertical integration has been associated with 10 to 14% price increases for physician services. A Commonwealth Fund analysis found vertical consolidation associated with 14% higher physician prices and 10-20% higher total spending per patient.

The FTC itself has found that vertically integrated PBMs have both the ability and incentive to steer business to their own affiliated pharmacies, reducing competition and increasing prescription drug costs. PBMs engage in spread pricing, charging health plans more for a drug than they reimburse pharmacies and keeping the difference, while simultaneously reducing reimbursements to independent pharmacies to drive them out of business.

The conflicts run deeper. As Wendell Potter detailed in Healthcare Uncovered, the joint ownership of insurance companies, PBMs, provider organizations, and pharmacies allows parent companies to game the Affordable Care Act's (ACA's) medical loss ratio (MLR) requirement. The ACA mandates that insurers spend 80-85% of premium dollars on medical care. When an insurer owns the PBM, the provider group, or the pharmacy, it can count internal payments to those entities as "medical care" for MLR purposes, even though those payments are self-dealing. This accounting maneuver converts premium dollars to profits at a rate Congress never intended.

Antitrust enforcement has proven inadequate to the task. From 2000 to 2020, only 13 mergers out of 1,164 were challenged by the FTC. As Erin Fuse Brown, professor at Brown University's School of Public Health, noted during a recent KFF Health Wonk Shop panel, antitrust enforcement has largely looked the other way on vertical consolidation, and even when agencies have attempted to bring cases, they have struggled to convince courts that vertical mergers pose a competitive risk.

The Promise for Patients and Providers

If enacted, the bill could address several of the structural conflicts of interest that drive up costs and limit patient choice. Forced separation of PBMs from their affiliated pharmacies could create a more level playing field for independent pharmacies, which currently compete against entities that also control their reimbursement rates. For people living with chronic conditions who rely on specialty medications, the current system means that the company deciding what drug is covered, how much the patient pays, and which pharmacy fills the prescription can be the same company. Breaking those links could open real competition in both pricing and access.

The bill would also force the divestiture of insurer-owned physician practices, a development that could restore meaningful clinical autonomy for physicians and potentially slow the trend of care being steered toward affiliated, higher-cost settings. Consolidation has already narrowed provider choice for patients across the country. Hospital consolidation from 1998 to 2021 resulted in 1,887 mergers and reduced the number of hospitals nationwide by about 25%. The GAO reported that rural hospital closures force residents to travel roughly 20 miles farther for common inpatient services and about 40 miles farther for less common services. When consolidated systems close facilities or eliminate services that rarely turn a profit, such as maternity wards, primary care clinics, and emergency departments, patients in underserved and rural communities face fewer doctors, longer wait times, and greater distances to travel for care. For low-income patients who may lack access to paid time off, reliable transportation, or affordable child care, those distances can mean the difference between receiving care and going without. Reducing the financial incentive for insurers to steer patients exclusively to affiliated providers could, over time, help preserve a broader range of care options in the communities that need them most.

The bill's expansive definition of "provider" and its inclusion of MSOs is significant: it closes the backdoor through which corporate entities use management services agreements to exert de facto control over physician practices without technically owning them. The private right of action with treble damages gives patients and affected parties a meaningful tool to hold companies accountable, something traditional antitrust enforcement has failed to do at scale.

The Pitfalls

The bill's ambition is also its vulnerability. A one-year divestiture timeline for restructuring trillion-dollar companies like UnitedHealth Group, CVS Health, and Cigna is aggressive by any measure. The logistics of unwinding these conglomerates, separating data systems, reassigning contracts, re-establishing independent management structures, present real operational risk. Corey Katz, a partner at Bates White Economic Consulting, cautioned during the KFF panel that policymakers should be careful of unintended consequences because the linkages in these systems are complex, and breaking them can produce adverse outcomes that were not anticipated. He pointed to the Haven joint venture between JP Morgan, Amazon, and Berkshire Hathaway, which sought to make healthcare more efficient and collapsed within five years, as evidence that restructuring healthcare delivery is harder than it appears.

Industry has already signaled opposition. CVS Health Group president David Joyner pushed back on the characterization of the system as market concentration at a House hearing in January, describing the integrated model as one that "works really well for the consumer." Evidence would seem to suggest otherwise, but Mr. Joyner is certainly welcome to his opinion.

The bill also has notable gaps. It does not address hospital-to-hospital horizontal mergers, which remain a primary driver of higher prices in local markets. It does not address private equity acquisitions of physician practices, which a GAO analysis found can lead to 4-16% increases in commercial insurance spending depending on the specialty. And it does not address the payment system incentives, particularly the persistent site-of-care payment differentials where Medicare pays two to four times more for identical outpatient procedures performed in a hospital setting versus a physician's office, that create the financial motivation for consolidation in the first place. Fuse Brown acknowledged that structural separation is a "blunt instrument" but argued that we have reached the point where antitrust tools have proven insufficient and bolder approaches are warranted.

What This Means for People Living with Chronic Conditions

For people living with HIV and other chronic conditions, pharmacy access is a persistent concern. The current vertically integrated system can dictate which pharmacy fills a prescription, what drugs appear on a formulary, and what a patient pays out of pocket. PBM-driven patient steering limits access to specialty pharmacies and 340B providers that play a critical role in serving people who are most affected by healthcare costs. Consolidation also disproportionately impacts communities of color, who, as the Commonwealth Fund noted, are more likely to face medical debt, are more vulnerable to increased costs, and are more likely to bear the brunt of the often cruel business practices that consolidation enables.

Separating PBMs from their captive pharmacies could expand real pharmacy choice for patients. But poorly managed divestiture could also temporarily destabilize specialty pharmacy networks or disrupt care coordination for people who depend on uninterrupted medication access. The details of how divestiture is structured and monitored will matter as much as the principle behind it.

Looking Forward

The Break Up Big Medicine Act faces long odds in a divided Congress. But its bipartisan sponsorship reflects a genuine shift in the political calculus around healthcare consolidation, one that cuts across party lines and ideological camps. Whether or not the bill advances, it establishes a policy framework that advocates, policymakers, and the public can build on.

We should watch closely for how recently enacted PBM transparency rules interact with these structural proposals, how state-level merger review and health equity impact assessments continue to evolve, and whether the FTC and DOJ use existing authority to pursue vertical consolidation cases more aggressively. We should also urge our elected representatives to support the bill and, critically, to demand that any restructuring of the healthcare system be evaluated for its impact on patient access, affordability, and health equity. Structural separation is a necessary conversation. Making sure the people most affected by consolidation are centered in that conversation is our responsibility.

Third Wave of Medicare Drug Price Negotiation Adds More Potential Peril

The  Centers for Medicare & Medicaid Services (CMS) recently announced its selections for the third cycle of drug price negotiations. For this iteration, not only is it the first time Medicare Part B drugs are on the list, but it is also the first time an infectious disease drug is on the list. The infectious disease drug selected is Biktarvy, a widely used HIV antiretroviral. The decision to start including Part B drugs has many stakeholders concerned, given the distinctly different nature of administration and reimbursement in comparison to Part D drugs. The inclusion of an infectious disease drug, specifically, Biktarvy, is significant because the previous focus was on non-infectious chronic conditions. Including HIV-antiviral drugs and other infectious disease treatments is concerning, given the potential for adverse effects on access.

The selection of Part B drugs is significant because those are medications that cannot be self-administered. These drugs are often administered in a clinical setting, such as an infusion center, hospital outpatient department, or physician's office, or, in certain circumstances, in a home setting by authorized personnel. Part B drugs often include cancer chemotherapy, immunosuppressants, and some vaccines. Entyvio, Orencia, Cosentyx, Cimzia, Xolair, and non-cosmetic Botox are the drugs clearly delineated as Part B-qualified on the third cycle list. The aforementioned drugs treat conditions including Crohn’s disease, ulcerative colitis, plaque psoriasis, asthma, and ankylosing spondylitis. These are potentially debilitating conditions that patients depend on for an acceptable quality of life.

Many physician-administered Part B drugs are purchased by practices via a ‘buy-and-bill’ system. This is when physicians buy, store, and administer the medications directly and then bill Medicare. Presently, physicians are reimbursed on the Average Sales Price (ASP) plus an additional 6% fee. The Maximum Fair Price (MFP) drug negotiation structure means that reimbursement would be limited to the negotiated price. Thus, physicians would be at a higher financial risk of having to purchase medications at acquisition prices higher than the MFP reimbursement rate. In theory, the CMS guidance is supposed to require manufacturers to offer physician-administered drugs to practices at the MFP. However, Part B drugs are not privy to the rebates and PBM negotiations that Part D drugs are.

Therefore, the cost differential between acquisition prices and MFP is higher. If the lack of enforcement results in physicians purchasing drugs at acquisition prices well above MFP reimbursement, then they are financially at a loss. If practices then have to wait on the proposed Medicare Transaction Facilitator (MTF) to recoup full reimbursement from manufacturers, they are financially floating a fiscal deficit. In this case, time is literally money, which adversely affects practices’ ability to function and provide care. Moreover, physicians would have to manage the purchasing of inventory of the same drugs at non-MFP commercial prices for their non-Medicare patients. This not only increases the administrative burden but also the up-front financial risk.

The selection of Biktarvy for the drug negotiation list generates a nuanced, different subset of concerns. HIV medications are generally covered under Medicare Part B. A notable exception is provider-administered HIV pre-exposure prophylaxis (PrEP) drugs for prevention that are covered with no cost-sharing, thus zero dollar deductibles or copays, as long as it is for prevention and not treatment. HIV treatment medications, such as Biktarvy, under Part D are subject to deductibles, copays, and coinsurance based on the particular plan, such as Medicare Advantage. Starting in 2025, Part D includes a $2,000 annual cap on out-of-pocket drug spending. Additionally, antiretrovirals are among the six protected classes that Medicare plans are required to cover regardless of the drug formulary.

Medicare Part D patients cannot use patient assistance programs (PAPs), such as ‘copay coupon cards’ for medications like Biktarvy. However, they are eligible for financial assistance through AIDS Drug Assistance Programs (ADAPs), State Pharmaceutical Assistance Programs (SPAPs), charitable organizations, and the Medicare Low-Income Subsidy (LIS/Extra Help). Notably, over 70% of HIV patients on Medicare are enrolled in the LIS program for financial support in obtaining their medications. Thus, setting an MFP for Biktarvy would not lower the out-of-pocket cost for the medication since cost-sharing is a direct product of plan design. The only savings potentially generated would be for the federal government.

HIV is a unique infectious and chronic disease. Successful treatment is very individualized and has specific requirements based on biological factors. HIV treatment involves the consideration of comorbidities, immune system status, contraindications, the likelihood of successful adherence, and more. It is not a chronic disease in which multiple medications are immediately interchangeable or can be readily swapped out for something that appears ‘cheaper’ on the surface. There is also a distinct difference between a treatment and a regimen.  Biktarvy is a single-pill treatment consisting of several drugs. It is less cumbersome in terms of adherence than multiple-tablet regimens (MTRs), in which several medications are taken in single-drug-ingredient form.

Biktarvy is the only 1A DHHS-recommended single-tablet regimen (STR) that does not have viral load restrictions, does not require HBV testing, and has no resistance testing requirements. The 1A DHHS recommendation indicates the highest strength of recommendation based on the highest quality of evidence from clinical trials and other research. Studies across Medicare, commercial, and managed Medicare populations show consistently higher persistence on Biktarvy compared to other DHHS 1A-recommended regimens. Higher persistence indicates fewer medication switches, suggesting patient satisfaction and adequate disease control.

Moreover, direct-comparison studies show that Biktarvy has significantly lower total costs than dolutegravir and multi-tablet regimens, despite its higher price, due to better control and patient outcomes. (Note: these studies did not include Dovato as they were done before its widespread usage). Cost is not limited to the initial drug price. Costs include advanced medical care as a result of other ineffective regimens due to drug characteristics, barriers to adherence, or even the development of resistance. Biktarvy is also overwhelmingly recommended for initial rapid-start  HIV therapy. Rapid initiation of treatment is the ideal path to successful treatment and ultimately an undetectable viral load. This is especially important given that in the Medicare-aged community, when undiagnosed transmission is discovered, it is at a later stage of disease progression, where more immune system damage has been done. Therefore, evidence-based, consistent, effective, and reliable therapy is essential.

Ongoing data already indicate that the Medicare Drug Price Negotiation program poses significant risks to patient access, pharmacy stability, and adverse disturbances to provider services. HIV and the medical conditions most often represented in Part B coverage are all conditions that are debilitating, without vast amounts of treatment options. Most importantly, HIV is an infectious disease that is forward-promoting, meaning that its control is a matter of public health. Undetectable viral load means untransmittable disease. Adding these drugs to the third wave of negotiations risks the well-being of vulnerable patients, pharmacies, and the healthcare provider ecosystem. Ultimately, the only benefactor of any real savings would be the federal government.

The Great American Recovery Needs More Than a Slogan

On February 2, 2026, Health and Human Services Secretary Robert F. Kennedy Jr. took the stage at SAMHSA's Prevention Day to announce a $100 million pilot program addressing homelessness and addiction, alongside a meaningful expansion of medication access for families affected by opioid use disorder. In the same speech, Kennedy characterized harm reduction as a "non-effective intervention" that "enabled future drug use." The contradiction captures the current state of American addiction policy: genuine progress on biomedical treatment access undermined by ideological rejection of the evidence-based strategies needed to keep people alive long enough to access that treatment.

The scope of the crisis is not in dispute. According to the White House fact sheet accompanying the Great American Recovery Initiative, 48.4 million Americans, or 16.8% of the population, live with substance use disorder. Nearly eight in ten did not receive treatment in 2024. These numbers should focus policymakers on removing every barrier between people and care. Instead, the administration is simultaneously expanding some pathways while actively dismantling others.

The Biomedical Frontier

One area of genuine scientific promise involves glucagon-like peptide-1 (GLP-1) receptor agonists, medications originally developed for diabetes and obesity that are showing unexpected potential for treating addiction. These drugs target the brain's mesolimbic reward pathways, and emerging research indicates they may modulate the dopamine neurotransmission involved in addictive behaviors.

The implications are significant. As the British Journal of Pharmacology notes, no FDA or EMA-approved medications currently exist for cocaine or stimulant use disorders. This treatment gap disproportionately affects marginalized communities, including LGBTQ populations where methamphetamine use remains a significant concern intersecting with HIV and HCV transmission.

Early evidence is encouraging. A large observational study using the VA database found that people with alcohol use disorder who used GLP-1 medications had a 50% lower rate of alcohol bingeing compared to those not on the medications. People with opioid use disorder on these medications had a 40% lower rate of overdose. Clinical trials are now underway for multiple substance use disorders, including a trial specifically enrolling people with both cocaine use disorder and HIV.

"This research is very important because alcohol and drug addiction are major causes of illness and death, yet there are still only a few effective treatment options," Dr. Lorenzo Leggio of the National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism noted in October 2025.

The critical question is access. As Penn Medicine researchers have observed, "many who struggle with addiction are multiply marginalized, making access to these medications a potential concern." The VA study data came largely from older white males, and robust research across demographics remains necessary. Breakthrough treatments mean little if the people who need them most cannot obtain them.

Meaningful Progress

Credit where due: the administration has taken concrete steps to expand medication access for opioid use disorder. On February 2, the Administration for Children and Families announced that buprenorphine, methadone, and naltrexone now qualify as prevention services eligible for Title IV-E funding. States and tribes can receive a 50% federal match to provide these medications to parents when children are at imminent risk of entering foster care. The policy reflects sound reasoning: keeping families together through effective treatment generally serves children better than separation.

The December 2025 reauthorization of the SUPPORT Act extended substance use disorder programs through fiscal year 2030 after the original legislation had languished since its 2023 expiration. The bill passed with strong bipartisan support, 366-57 in the House and by unanimous consent in the Senate.

There is also useful historical precedent from the first Trump administration. In May 2020, HHS Office for Civil Rights Director Roger Severino secured an agreement with West Virginia establishing that people in recovery using medication-assisted treatment are entitled to ADA protections. "People in recovery from opioid use disorder should never be stigmatized for seeking appropriate medical treatment that can save their lives," Severino stated at the time. That principle should guide current policy.

Where Policy Contradicts Evidence

Against these advances stands a pattern of actions that undermine the stated goal of connecting people with treatment.

The Substance Abuse and Mental Health Services Administration has lost approximately one-third of its roughly 900 employees over the past year. In January 2026, the administration briefly cancelled nearly $2 billion in SAMHSA grants before bipartisan backlash forced a reversal within 24 hours. Providers report an environment where planning for the future feels impossible.

The administration proposed folding SAMHSA into a new "Administration for a Healthy America." Congress rejected this in the FY2026 LHHS appropriations package and added structural protections requiring 60 days' advance notice before HHS reorganizations affecting CDC functions and three days' notice before grant terminations. These guardrails exist because they proved necessary.

On harm reduction, the gap between evidence and policy is particularly troubling. The July 2025 executive order "Ending Crime and Disorder on America's Streets" directed SAMHSA to defund "so-called harm reduction" programs. A subsequent SAMHSA letter drew an explicit line between acceptable overdose reversal tools like naloxone and the "ideological concept of harm reduction."

This framing ignores the government's own evidence. In December 2025, the VA published an analysis of its harm reduction programs describing syringe services programs as "one of the most effective public health interventions ever devised." The data: SSPs decrease new HIV and HCV infections by up to 67%, increase the likelihood of achieving abstinence five-fold, and "do not enable or increase drug use, nor do they cause increases in crime."

The FY2026 appropriations bill maintains Section 525, the longstanding prohibition on using federal funds for sterile needles or syringes outside narrow outbreak exceptions. Report language frames harm reduction through an abstinence-first lens, treating harm reduction and recovery as opposing forces when the evidence shows they are complementary. Meeting people where they are is how you eventually connect them with treatment.

The Syndemic Reality

These policy contradictions have real consequences for communities facing intersecting epidemics. Syringe services programs are foundational infrastructure for preventing HIV and HCV transmission among people who inject drugs. Cutting STI prevention funding by $10 million while syphilis and congenital syphilis remain at historically high levels makes no public health sense.

The approach to homelessness reveals similar contradictions. The July 2025 executive order abandons Housing First, the evidence-based model that prioritizes stable housing as a foundation for recovery. In its place, the order directs agencies to prioritize jurisdictions that enforce bans on urban camping, loitering, and open-air drug use when awarding federal grants. It encourages states to expand involuntary civil commitment and conditions housing assistance on participation in behavioral health treatment. The Bipartisan Policy Center notes this approach may invite Fair Housing Act lawsuits, since conditioning housing on treatment could constitute discrimination against people with disabilities, including those with substance use disorder.

HHS’s $100 million STREETS Initiative operates within this enforcement-first framework. Kennedy described the model as finding people on the street and moving them "from crisis to detox treatment to housing to employment." Housing comes after treatment compliance, not before. The National Alliance to End Homelessness has been direct in its assessment: "Deinstitutionalization did not cause homelessness, and re-institutionalization will not solve it."

The 2024 Point-in-Time count recorded over 770,000 people experiencing homelessness, an 18% increase from the previous year and the largest annual jump ever recorded. Those most affected include people with mental illness or substance use disorder, LGBTQ youth, and veterans, as Harvard's Howard Koh has noted. A $100 million pilot serving eight cities cannot address a crisis of this scale, particularly when the broader policy framework criminalizes the people it claims to help.

Access barriers to existing treatments compound the problem. The Cato Institute reports that 80% of U.S. counties have no opioid treatment programs, and only 600,000 of the 8 million people meeting criteria for opioid use disorder received methadone in 2024. The bipartisan Modernizing Opioid Treatment Access Act would have enabled primary care prescribing of methadone; it was not reintroduced in the current Congress.

The Path Forward

The promise of emerging treatments like GLP-1 agonists cannot be realized without the infrastructure to deliver them. A breakthrough medication for stimulant use disorder means nothing to someone cycling between encampments and emergency rooms because Housing First was abandoned in favor of treatment mandates they cannot access. Flat funding for SAMHSA, restrictions on harm reduction, and criminalization of homelessness create gaps that no medication can bridge.

"If we want to create a world where there's opioid recovery, we need to also offer affordable housing and access to affordable food and improved access to health care," Dr. Sadie Elisseou of Harvard told Behavioral Health Business. This syndemic framing should guide policy. It currently does not.

The administration cannot simultaneously expand medication access, gut the agency responsible for treatment infrastructure, restrict the harm reduction programs that keep people alive and connected to care, and criminalize the circumstances of those most in need of help. These policies do not form a coherent strategy. They form a contradiction.

Congress rejected the administration's most extreme proposals through the passage of the L-HHS funding package, but holding ground is not progress. Advocates should monitor SAMHSA implementation closely, push for evidence-based harm reduction funding that aligns with the VA's proven model, defend Housing First against ideological attack, and ensure that new treatments reach marginalized communities rather than only those with private insurance and stable housing.

The tools to address substance use disorder exist. What remains absent is a policy framework that treats people who use drugs as deserving of care rather than punishment. Until that changes, the Great American Recovery will remain a slogan, not a strategy.

Congress Rejects HIV Cuts, But Flat Funding Won't End the Epidemic

As of this writing, the FY2026 Labor, Health and Human Services appropriations bill awaits final passage. The Senate is expected to pass the package Friday night, with the House voting Monday evening. A brief partial shutdown through the weekend appears unavoidable. The following analysis assumes the legislation passes as currently written.

After a year of proposed cuts that created significant uncertainty for HIV programs and the communities they serve, Congress has negotiated a spending package that maintains current funding levels while falling short of what ending the epidemic requires. The bill, released January 20, 2026, rejects over $1.7 billion in proposed cuts and preserves funding for Ryan White, the Ending the HIV Epidemic initiative, and CDC prevention programs. It also includes the first major pharmacy benefit manager (PBM) reforms in Medicare Part D in nearly two decades, a development with significant implications for patient access to HIV and hepatitis C medications.

Yet flat funding cannot meet growing demands, particularly as long-acting therapeutics promise to transform HIV prevention and care for those who need them most. In an environment where maintaining the status quo requires extraordinary effort, advocates must reckon with an uncomfortable truth: the status quo is not enough to end the epidemic.

What Was at Stake

The path to this appropriations package has been fraught, to say the least. In May 2025, the Trump administration proposed $31.3 billion in cuts to the Department of Health and Human Services, including a 40% reduction to NIH and the consolidation of its 27 institutes into eight. The proposal called for eliminating HIV prevention programs entirely and restructuring HHS agencies, including folding SAMHSA (Substance Abuse and Mental Health Services Administration) into a new "Administration for a Healthy America."

The House Appropriations Committee's September 2025 bill embraced much of this vision. It provided zero funding for CDC HIV prevention programs, proposed cutting the Ryan White HIV/AIDS Program by 20%, and would have eliminated the Ending the HIV Epidemic initiative completely. CDC funding faced a nearly 20% reduction overall.

The final package represents a decisive rejection of these proposals. Congress preserved the Ryan White HIV/AIDS Program at $2.6 billion, maintained the Ending the HIV Epidemic initiative at $165 million, and funded CDC HIV/AIDS, Viral Hepatitis, STDs, and TB Prevention at $1.384 billion. The Minority HIV/AIDS Fund received $56 million. The bill closely tracks the bipartisan Senate proposal that advanced from committee in July 2025, a predictable outcome given the Senate's historical role as a moderating force on appropriations. The Administration's proposed cuts and the House bill were never likely to survive a bicameral process intact, but their existence created uncertainty that disrupted planning and strained already stretched public health infrastructure throughout the year.

Flat Funding Is Not Progress

Preserving current funding levels is not the same as meeting current needs. The American Academy of HIV Medicinedescribed the bill as presenting "a mixed picture for domestic HIV programs," noting that level funding will not achieve the goals set forth in the Ending the HIV Epidemic plan launched during the first Trump administration or address a rise in HIV transmission outbreaks as we’ve seen in Maine and New York.

The timing makes this particularly frustrating. Long-acting injectable treatments and prevention options are transforming what is possible in HIV care. Lenacapavir for PrEP offers twice-yearly dosing. Long-acting cabotegravir and rilpivirine provide monthly or bimonthly treatment options for people who struggle with daily pills or face adherence barriers. These innovations could reach people who have historically fallen through the cracks of our prevention and treatment infrastructure, but scaling them requires investment that flat funding cannot provide.

Prevention initiatives, workforce development, training programs, and the rollout of new innovations are particularly vulnerable under current funding levels. Without targeted investment, long-acting options will remain inaccessible to people in Medicaid-dependent, rural, and underserved areas. The tools exist to end HIV as a public health threat. The political will to fund their deployment does not.

Within the broader infectious disease category, the bill sends mixed signals. Viral hepatitis prevention received a $3 million increase to $46 million, one of the few areas to see any growth. STI prevention, by contrast, took a $10 million cut to $164 million. While provisional 2024 data shows overall STI cases declining for the third consecutive year, reported syphilis cases and congenital syphilis remain at historically high levels, with continued increases in some demographics. Cutting prevention funding while these disparities persist is shortsighted.

Harm Reduction: Evidence Ignored

The bill's approach to harm reduction reveals a troubling gap between public health evidence and legislative ideology. Section 525 maintains the longstanding prohibition on using federal funds to purchase sterile needles or syringes, with a narrow exception for jurisdictions experiencing or at risk for HIV or hepatitis outbreaks. This reactive approach undermines prevention and contradicts the government's own evidence base.

The VA, in a December 2025 analysis of its harm reduction programs, described syringe services programs as "one of the most effective public health interventions ever devised," noting they decrease new HIV and HCV infections by up to 67% and increase the likelihood of achieving abstinence five-fold. The VA further emphasized that these programs "do not enable or increase drug use, nor do they cause increases in crime."

The appropriations bill ignores this evidence. Report language frames harm reduction through an abstinence-first lens, elevating the administration's efforts to "prioritize prevention, treatment, and long-term recovery." This framing treats harm reduction and recovery as opposing forces when the evidence shows they are complementary. Meeting people where they are is essential to eventually connecting them with treatment. Restricting proven interventions on ideological grounds costs lives.

The bill does maintain substance use disorder treatment funding, with SAMHSA receiving $7.44 billion (a $65 million increase), State Opioid Response Grants at $1.6 billion, and CARA First Responder Training at $59 million. These investments matter. But they would matter more if paired with evidence-based harm reduction that keeps people alive long enough to access treatment.

PBM Reform: A Genuine Win With Implementation Risks

The inclusion of pharmacy benefit manager reforms represents a genuine policy achievement and the first major PBM reform in Medicare Part D in nearly 20 years. For people living with HIV and hepatitis C who depend on specialty medications, these provisions could meaningfully improve access and reduce costs.

The reforms target the opaque practices that have allowed PBMs to profit at the expense of patients and plan sponsors. Beginning in 2028, PBM compensation in Medicare Part D will be delinked from drug list prices, eliminating the perverse incentive to favor higher-priced medications. PBMs will be required to pass through 100% of manufacturer rebates and fees to plan sponsors. The bill bans spread pricing in Medicaid, where PBMs have profited by charging plans more than they reimburse pharmacies. CMS receives $188 million for implementation and new authority to define and enforce "reasonable and relevant" contract terms between Part D plans and pharmacies.

The transparency provisions are equally significant. PBMs must report pricing information, including all rebates negotiated with manufacturers, directly to plan sponsors and HHS. For PBMs with affiliated mail-order or specialty pharmacies, the bill requires disclosure of any benefit design parameters that steer prescriptions to those pharmacies. This addresses a core concern: vertically integrated PBMs using formulary placement and prior authorization requirements to drive volume to their own pharmacies at the expense of patient choice and community pharmacy access.

For people living with HIV, the stakes are concrete. Specialty HIV medications flow through PBM-controlled channels that have historically lacked transparency around rebates, formulary decisions, and pharmacy reimbursement. The reforms create mechanisms to challenge contract terms that effectively exclude community pharmacies or impose unreasonable administrative burdens. The appeals process for pharmacies to dispute terms that fail the "reasonable and relevant" standard could prove particularly important for independent and specialty pharmacies serving HIV populations.

The risk, as always, lies in implementation and industry adaptation. PBMs have proven adept at restructuring their business practices to maintain margins when regulations target specific revenue streams. The provisions take effect in 2028 for Medicare and 2029 for pharmacy contract standards, giving industry ample time to identify workarounds. Advocates should watch for attempts to shift costs to patients through benefit design changes, or to game the "reasonable and relevant" standard through contract terms that are technically compliant but practically exclusionary. The history of PBM regulation is a history of regulatory arbitrage, and vigilance will be required to ensure these reforms deliver their intended benefits.

Structural Protections and Access Provisions

Beyond funding levels, the bill includes important structural provisions. It rejects the administration's proposed HHS restructuring and requires the Secretary to provide detailed justification to Congress at least 60 days before any reorganization affecting CDC functions. Grant terminations now require three days' advance notice to appropriations committees. These guardrails matter in an environment where administrative action has disrupted programs faster than legislative oversight can respond.

The package extends Medicare telehealth waivers through December 31, 2027, maintains community health center funding at $4.6 billion plus bridge funding, and delays Medicaid disproportionate share hospital cuts until September 2028. These provisions support healthcare access in underserved communities where HIV and viral hepatitis programs depend on functioning safety-net infrastructure.

The Work Ahead

Assuming the bill passes as expected, funding appropriated is not funding effectively deployed. The same administration that proposed eliminating these programs will now oversee their implementation. How HHS manages grant administration, staffing, and program guidance will determine whether level funding translates into maintained services or quiet erosion. The bill's requirements for advance notice on grant terminations and reorganization plans provide some guardrails, but vigilance will be required.

The United States has the tools to end HIV as a public health threat. Long-acting prevention and treatment options could reach people who daily pills cannot. Harm reduction keeps people alive and connected to care. Ryan White and the EHE initiative provide the programmatic infrastructure. What we lack is the political will to fund these efforts at the scale required and the moral clarity to implement evidence-based policy over ideological preference.

Flat funding is not progress. It is a holding pattern in an environment where holding ground required effort. The work ahead is ensuring these programs are implemented effectively while continuing to push for the investment these programs actually need. The fight for adequate funding, evidence-based policy, and equitable access continues.

Florida's ADAP Cuts Put 16,000 People Living with HIV at Risk

On January 8, 2026, the Florida Department of Health (DOH) sent an email to healthcare partners announcing sweeping changes to the state's AIDS Drug Assistance Program (ADAP), effective March 1, 2026. In the days that followed, thousands of Floridians living with HIV received letters informing them that their access to life-saving medications and insurance coverage would be drastically curtailed in less than two months. The announcement came with minimal warning and no prior engagement with the affected community, marking an alarming departure from decades of collaborative public health practice and threatening to unravel progress made toward Ending the HIV Epidemic.

What Florida Is Doing

The changes are significant in scope. Florida DOH is reducing ADAP income eligibility for uninsured clients from 400% of the Federal Poverty Level (FPL) down to 130% FPL, which translates to an annual income of approximately $20,345 for a single person. The state is eliminating insurance premium assistance, which previously helped people maintain coverage through the Affordable Care Act (ACA) marketplace. Florida is also removing Biktarvy, the most widely prescribed single-tablet HIV regimen, from the ADAP formulary while restricting Descovy to people with renal insufficiency.

According to the National Alliance of State and Territorial AIDS Directors (NASTAD), Florida ADAP served 32,248 clients in 2024, with 40% at or below 100% FPL, 10% between 101–138% FPL, and 50% between 138–400% FPL. With a cutoff at 130% FPL, NASTAD estimates that more than 16,000 people will lose ADAP coverage. The administration has offered a different estimate. At a January 14, 2026 Florida Senate Appropriations Committee hearing, Florida Surgeon General Joseph Ladapo estimated approximately 10,000 people would be affected.

The numbers matter less than the underlying reality: half of all Floridians currently relying on ADAP for uninterrupted access to HIV treatment face immediate risk of treatment disruption based on an administrative eligibility change, not clinical need.

The Stated Rationale and Its Problems

DOH has framed the changes as necessary to prevent a projected $120 million budget shortfall, attributing the crisis to rising health care insurance premiums and the expiration of enhanced ACA premium tax credits at the end of 2025. The federal government shutdown in October 2025, during which Republicans and Democrats fought over the impending expiration of these tax credits, did lead to their lapse on December 31. Florida, with nearly 4.5 million people receiving marketplace insurance and roughly 31% of ADAP clients enrolled in marketplace plans, faces genuine financial pressure.

What DOH has not provided is transparency around its budget calculations. At the Senate hearing, David Poole, who oversaw Florida's AIDS program from 1993 to 2005, pointed out that the state transparency website shows $120 million in rebate revenues from the prior year. Testimony from a former consumer representative to the Florida DOH ADAP Advisory Workgroup indicated that information shared with stakeholders suggests the expanded tax credits had minimal impact on the program, with insurance premiums increasing only about $150 per client annually. The state has not publicly released an ADAP budget in more than a year, according to Malcolm Ried of the U.S. People Living with HIV Caucus.

When Senator Carlos Guillermo Smith asked Kendall Kelly, director of policy and budget under Governor DeSantis, about the state's authority to make such dramatic cuts to a federally funded program, Kelly referenced a potential $700 million shortfall for the health department overall but could not provide specifics about federal funding changes. No other state has made such drastic changes to its ADAP program this year. Pennsylvania, facing similar budget pressures, reduced its eligibility from 500% to 350% FPL—a far more measured response.

The Clinical and Public Health Stakes

Treatment interruption for a person living with HIV is a clinical risk, not an administrative inconvenience. When antiretroviral therapy (ART) is interrupted, viral rebound occurs, drug resistance can develop, viral suppression is lost, and the risk of onward transmission increases. The science is clear: consistent treatment keeps people healthy and prevents new transmissions. This principle underlies the entire Ending the HIV Epidemic (EHE) initiative, which targets sustained viral suppression as one of its four core strategies.

Dr. Paul Arons, the former Medical Director of the state HIV/AIDS program from 1989 to 2007, testified that asking a person with HIV whose treatment is working to change regimens for non-medical reasons is a traumatic request. According to the U.S. Department of Health and Human Services (HHS), 89.6% of clients enrolled in the Ryan White HIV/AIDS Program achieved viral suppression as of fiscal year 2025. HIV medications have among the highest adherence rates of any chronic disease treatment. Disrupting that success for opaque and questionable budget claims defies logic and evidence-based practice.

The formulary changes compound the harm. Biktarvy is prescribed to 60% of Florida ADAP clients. The state has offered no transition plan, no guidance on which generics will replace it, and a warning that additional formulary restrictions may follow. The International Association of Providers of AIDS Care (IAPAC) has called this approach drug rationing under the banner of cost control.

A Failure of Process

Federal Ryan White legislation and HRSA HIV/AIDS Bureau (HAB) guidance require states to engage stakeholders, including people living with HIV, in program planning and to explore cost-saving measures before implementing cost-cutting measures like eligibility reductions or formulary restrictions. The ADAP Manual from HRSA HAB distinguishes between cost-saving measures (improving efficiency, expanding health care coverage, maximizing rebate collection) and cost-cutting measures (restricting enrollment or benefits). Waiting lists are described as a last resort.

Florida DOH bypassed this framework entirely. The eligibility level for Florida's ADAP program is established in regulation, requiring a public regulatory process to change. No such process was undertaken before this announcement. The announcement came with less than two months notice, days before the ACA open enrollment period ended, and without prior consultation with advisory workgroups or community partners. Testimony at the January 14 Senate hearing revealed that stakeholders learned of the changes only days earlier and were never brought in to discuss cost containment measures.

The timing compounds the harm. Florida's plan to cancel premium assistance was announced just days before the end of ACA open enrollment. ADAP enrollees had selected plans approved by the program, often with higher premiums, because ADAP covered the cost. Canceling those subsidies as of March 1 leaves people locked into plans they cannot afford with no ability to change their enrollment.

The abrupt nature of the announcement left people living with HIV scrambling. "This is deeply personal for me—not only do I rely on this coverage to stay virally suppressed, but I also need it to manage other health issues as I age with HIV," Kamaria Laffrey, Co-Executive Director of The SERO Project and a Florida resident, told Positively Aware. "With no warning and no transparency, this feels like a random and unjustified attack on people simply trying to live."

The lack of transparency extends to notification. Some people will not receive termination letters because they did not consent to mailings at home. County health departments, according to testimony, have not received guidance on tracking these clients. The two-month transition window is unrealistic for navigating alternative coverage in a fragmented insurance market, particularly after open enrollment has closed.

Historical Echo

This situation carries echoes of an earlier Florida crisis. In the early 2010s, following the 2008 recession, Florida maintained the largest ADAP waiting list in the nation, with thousands of people waiting months to access medications. Advocates fought to implement cost containment measures and stabilize the program. The state eventually recovered, but the lessons of that period—the importance of transparency, stakeholder engagement, and exploring alternatives before cutting eligibility—appear to have been forgotten.

What Happens Next

The policy implications extend beyond Florida. Because all state ADAPs rely on the same federal funding streams, what happens in one state signals possibilities for others. IAPAC has urged clinicians in states with similar political and fiscal dynamics to engage their representatives proactively. The Save HIV Funding campaign has noted that the Florida changes come alongside broader health system destabilization, including Medicaid cuts and disruptions to federal HIV programs, creating a compounding effect.

At the state level, Chair Jay Trumbull of the Senate Appropriations Committee indicated the issue would likely be negotiated during budget talks. Surgeon General Ladapo acknowledged the situation could become a crisis without intervention and suggested funding approaches that might not be onerous. Yet DOH has not requested additional state funds, despite Florida holding $17 billion in reserves.

What Needs to Happen

The immediate need is a complete halt to the March 1 implementation while finances are fully reviewed and medically sound alternatives are developed. Florida must release transparent budget data, engage stakeholders as required by federal law, and explore the full range of cost-saving measures before resorting to eligibility cuts and formulary restrictions.

For advocates and policymakers watching this unfold, the Florida crisis offers a clear lesson: when states treat HIV programs as budget line items rather than public health infrastructure, people fall out of care, viral suppression declines, and new transmissions occur. The economic argument for maintaining access is well-established: keeping people in care and virally suppressed prevents costly emergency interventions, hospitalizations, and new transmissions that carry their own long-term treatment costs.

Florida has the resources, the federal funding framework, and the clinical expertise to maintain a functional ADAP program. What it lacks, at this moment, is the political will to use them or the moral grounding to not sacrifice the most vulnerable. The cost of that failure will be measured in preventable illness, unnecessary suffering, and setbacks to the national goal of Ending the HIV Epidemic. We cannot let that happen.

Equipping Patients with Tools to Reclaim the Promise of 340B

The 340B Drug Pricing Program was created with a clear and compelling purpose: to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”s. For decades, the program has played an important role in supporting access to medications for people living with chronic and life-threatening conditions, including HIV, by providing medications at a steep discount to safety-net providers tasked with fulfilling the program’s statutory intent

But today, that clear and compelling purpose has been thwarted, the safety net with its growing wear and tear from years of abuse and margin-motivated cuts have created the moment we find ourselves in. 

Today, instead of consistently benefiting patients, the program has increasingly become a financial engine for large hospital systems and for-profit entities—often with no transparency or accountability to demonstrate how savings are being used to improve patient care. With continued misguided state-level legislation, and without meaningful federal reform, 340B risks drifting even further away from its legislative intent and deeper into a system that prioritizes padded pockets over patient outcomes.

Program Growth —Without Guardrails

Since its creation in 1992, 340B has grown dramatically in size and complexity. Covered entities have expanded, contract pharmacy arrangements have multiplied, and revenue tied to discounted drugs has surged into the tens of billions of dollars annually.

Yet the statute itself remains narrowly focused: 340B was never intended to be a profit center. Congress designed it to benefit patients, not to subsidize hospital consolidation, executive compensation, or unrelated capital expansion.

Today, patients are frequently left with pressing questions: Why are my drug costs still increasing at the pharmacy counter?  “Why isn’t 340B being used to make my meds cheaper for me?” Why do patients receiving care at 340B hospitals still encounter medical debt, often sent to aggressive collection agencies, and face access challenges?

The uncomfortable truth is that there are too many loopholes that are being exploited, no federal requirement for hospitals to pass savings directly to patients—or even to report how those savings are used. This lack of transparency allows patient benefit to become optional rather than required.

State-level efforts to address 340B challenges have created a patchwork of laws that deepen confusion and conflict, particularly with other federal policies like the Inflation Reduction Act (IRA). These fragmented approaches fail to address the core issue: the absence of clear federal standards that define patient benefit, accountability, and program integrity.

The harsher truth? State-Level Legislation has not improved patient outcomes. Recent data from IQVIA demonstrates that access to medications, nor medication abandonment rates have improved in states that have passed contract pharmacy expansion. These truths reveal that patchwork state laws cannot fix a federal problem.

Federal reform is essential to: recenter patients as the primary beneficiaries of 340B, establish transparency and reporting requirements tied to patient outcomes, prevent misuse by for-profit entities operating under the guise of safety-net care, and ensure any program growth aligns with access, affordability, and equity—not consolidation.  Without reform, patients will continue to be excluded from decisions made in their name, while the program’s credibility—and long-term sustainability—remains at risk. There are solutions on the table including the recently introduced ACCESS Act but it remains stagnant in the halls of congress. 

Patients Must Have a Real, Meaningful Seat at the Table

The reality is the federal government is slow at enacting reform, and one of the most glaring gaps in the 340B debate at all levels is the absence of patient voices. Policymakers hear regularly from well-monied interests like hospitals, pharmaceutical manufacturers, and pharmacies—but far too rarely from the people the program was meant to serve.

Patients deserve more than rhetoric. They deserve real tools to engage, educate, and advocate.

That’s why we at Community Access National Network (CANN) are expanding the 340B Patient Advocacy Toolbox—adding to our growing collection of resources designed to empower patients and community advocates with the knowledge and language needed to participate meaningfully in policy conversations.

Adding to our existing infographics, state legislation tracking, and state fact sheets we are adding: 

• Policy Brief: Conflicts Between State 340B Laws & Proposed Federal Reforms

• A comprehensive guide to the conflicts between state legislation and 340B ACCESS Act (HR 5256), the SUSTAIN 340B discussion draft, the 340B Rebate Model Pilot introduced by the Health Resources & Services Administration (HRSA), downstream effects of drug pricing provisions within the Inflation Reduction Act (IRA), and Medicare Part D’s as-of-current “voluntary” claims submissions form.

• Accompanying this brief are two infographics that highlight the prohibitions states have enacted, and the conflicts that arise between these state-level laws and these proposed federal reforms. 

• Policy Brief: State 340B Mandates Do Not Improve Patient Access/Cost

• An insightful, IQVIA data-driven look at the impact of state-level mandates, their impact on patient access and medication abandonment rates following the enactment of these laws. 

All of CANN’s 340B tools are rooted in a simple belief: informed patients are powerful advocates. By equipping patients with these tools, CANN is working to shift the 340B conversation away from institutional protectionism and toward patient-driven reform.

The Road Ahead

As state legislative efforts continue, the future of 340B depends on whether policymakers are willing to listen to patients and act with clarity and courage. CANN is committed to ensuring that patient voices are not just included—but prioritized.

By advocating for federal reform and equipping patients with the tools to engage, CANN is committed to reclaiming the promise of 340B and realign it with its original mission: putting patients first.

Patients should not have to guess whether they benefit from a program designed in their name.

Because safety-net programs only work when the safety net actually reaches the people it was built for.

ACA Subsidies in Limbo: What the Senate Framework Means for Patients

The enhanced Affordable Care Act (ACA) premium tax credits expired on January 1, 2026, and millions of Americans are now facing the consequences. According to the Kaiser Family Foundation, subsidized enrollees are seeing their out-of-pocket premium payments increase by an average of 114%. For a single mother in social work like Katelin Provost, that means watching her monthly premium jump from $85 to nearly $750, a ninefold increase that forces an impossible choice between her own coverage and her daughter's.

This is the reality for more than 20 million Americans who benefited from the enhanced subsidies first enacted in 2021 as a COVID-19 pandemic response. The Wall Street Journal reports that roughly four in ten ACA enrollees had been paying nothing toward their premiums under the enhanced credits—more than double the share in 2020. That era ended last week, and Congress is now scrambling to respond amid growing political pressure and the specter of another government shutdown deadline on January 30.

The House Vote: Forcing the Issue

Last Thursday, the House passed a three-year extension of the enhanced subsidies, a bill that has no chance of becoming law in its current form. The Senate rejected an identical measure in December. So why hold the vote?

The answer lies in a procedural rebellion that caught House leadership off guard. Four swing-district Republicans—Reps. Mike Lawler of New York and Robert Bresnahan, Brian Fitzpatrick, and Ryan Mackenzie of Pennsylvania—signed a Democratic discharge petition to force the vote over Speaker Mike Johnson's objections. Last Wednesday, nine Republicans joined Democrats on a procedural motion to advance the bill.

These centrist Republicans are calculating political survival. As Rep. Fitzpatrick told The Hill, "Everyone's lamenting discharge petitions. There's an easy way to fix that: Put bills on the floor that have majority support. It's not hard." The vote serves a strategic purpose: it creates a legislative vehicle the Senate can amend and sends a clear signal that inaction carries electoral consequences in November's midterms.

The Senate Framework Takes Shape

While the House engages in political theater, a bipartisan Senate group led by Sens. Bernie Moreno (R-Ohio) and Susan Collins (R-Maine) has been negotiating a compromise. According to Politico, legislative text could be ready as early as today.

The emerging framework includes a two-year extension of enhanced subsidies with several Republican-demanded reforms. The Wall Street Journal outlines the key elements: an income cap excluding households earning more than 700% of the federal poverty level (approximately $225,000 for a family of four), a requirement that enrollees pay at least $5 per month toward their coverage, and $100,000 fines on insurers who sign up "phantom enrollees" without their knowledge. In the second year, enrollees would have the option to direct their subsidy funds into a pre-funded health savings account instead of having them flow to insurance companies.

The framework also reportedly includes measures to directly fund cost-sharing reductions (CSRs), which could generate significant savings. The Committee for a Responsible Federal Budget estimates that direct CSR funding would reduce deficits by over $50 billion over a decade while lowering silver plan premiums by 10% to 20%. This would end the practice of "silver loading," where insurers inflate silver plan premiums to compensate for CSR costs the federal government stopped paying in 2017.

Sen. Moreno told NPR, "We're in the red zone. But that does not mean a touchdown. It could mean a 95-yard fumble."

The Barriers to a Deal

Two sticking points threaten to derail negotiations: abortion coverage and the elimination of $0 premium plans.

On abortion, Republicans want explicit language preventing subsidies from flowing to plans that cover the procedure. Democrats counter that current law already addresses this concern—ACA plans that cover abortion must charge enrollees a separate $1 per month, segregating federal funds from abortion services. Sen. Ron Wyden (D-Ore.) warned Fox News, "I am not going to open the door to Hyde, given what happens and what has been seen historically when you do that. If you open the door, it will get drafty in a hurry."

President Trump complicated matters when he told House Republicans to be "flexible on Hyde," drawing pushback from conservatives. Sen. Moreno has since indicated the framework does not change current abortion policy, calling the issue "peripheral" to the core negotiations.

The second obstacle carries more direct implications for patient access. The proposed $5 monthly minimum premium—designed as an anti-fraud measure—would eliminate $0 premium plans that currently cover millions of low-income enrollees. Sen. Wyden called this a "rate hike" affecting 8 million people. Sen. Jeanne Shaheen (D-N.H.) noted, "Data shows that you lose a lot of people at the lowest income levels when you do that."

This concern is grounded in evidence. The NIH Clinical Guidelines on Antiretroviral Therapy are direct: "Out-of-pocket costs for people with HIV can be prohibitive, creating a barrier to the initiation and continuation of ART. Cost sharing results in higher rates of people not initiating ART, prescription abandonment at the pharmacy, decreased adherence, and more frequent drug discontinuation." The guidelines note that in 2022, the CDC's Medication Monitoring Project found that among people with HIV who had stopped taking antiretroviral therapy, 34% reported that money or insurance problems contributed to stopping treatment. For people managing chronic conditions requiring consistent care, even modest cost-sharing can disrupt treatment continuity with serious downstream consequences for both personal health and public health goals.

Why This Matters for People Living with Chronic Conditions

The evidence on cost-sharing and health outcomes should inform how we evaluate any compromise. The Commonwealth Fund's 2023 Health Care Affordability Survey found that 37% of marketplace enrollees reported delaying or skipping needed care due to cost in the prior 12 months. Among those who delayed care, 61% said a health problem got worse as a result. One-third of marketplace enrollees reported paying off medical debt.

These affordability challenges fall disproportionately on certain communities. The Center on Budget and Policy Priorities notes that 23% of Black enrollees and 18% of Hispanic enrollees in private insurance reported problems paying medical bills, compared to 15% of white enrollees.

For people living with HIV, coverage continuity directly affects health outcomes. The NIH Clinical Guidelines emphasize that "health insurance and prescription drug coverage can directly affect clinical outcomes for people with HIV; changes to coverage can result in lapses in viral suppression and should be anticipated as best possible." The guidelines specifically warn that disengagement from care occurs more frequently during transitions in coverage, including when people switch insurance plans or experience changes in employment status. With wholesale acquisition costs for commonly prescribed single-tablet antiretroviral regimens ranging from approximately $2,800 to $4,700 per month, the stakes of coverage disruption are substantial.

As CANN's December analysis detailed, New York City's 2024 HIV surveillance data showed diagnoses rising for the fourth consecutive year, with 86% of new diagnoses among Black or Latino people and 48% of those interviewed lacking health insurance. The Ryan White HIV/AIDS Program and AIDS Drug Assistance Programs (ADAPs) provide critical safety net support, but these programs work best when complementing stable insurance coverage rather than substituting for it.

The KFF analysis of proposed Medicaid cost-sharing requirements offers a window into what happens when cost barriers are introduced for vulnerable populations. Under a maximum cost-sharing scenario, Medicaid expansion enrollees with three or more chronic conditions could face average annual costs of $1,248—potentially exceeding the 5% of income cap for those at 100% of the federal poverty level.

What Comes Next

Any Senate deal requires 60 votes to overcome a filibuster, meaning at least seven Democrats must join all 53 Republicans, or significant bipartisan support must materialize. Sen. Moreno has indicated he needs 35 Republican senators on board to feel confident in the level of GOP support. Senate Majority Leader John Thune has said any deal must get a "big vote" among Republicans.

The political calendar adds pressure. The January 30 government funding deadline looms, and neither party has appetite for another shutdown after last fall's 43-day standoff. An extended open enrollment period would likely accompany any deal, giving people who dropped coverage due to premium spikes a chance to re-enroll.

For advocates, the coming days demand close attention. The specific legislative text—particularly provisions around minimum premiums, income verification, and any changes to covered services—will determine whether a compromise actually improves access or introduces new barriers. Contact your Senators to emphasize that affordability must remain central to any reform. Monitor for the final text expected early next week. And prepare to help community members navigate an extended enrollment period if one materializes.

The enhanced subsidies enabled record ACA enrollment of 25.2 million in early 2025, according to KFF data. What happens in Congress over the next two weeks will determine whether that progress holds or unravels, and whether the people who depend on affordable coverage can continue accessing the care they need.

The Only Thing That Stays The Same… Welcome to 2026

I want to personally thank those of you who joined me in finishing the sentence that is this week’s blog title.

For CANN and many of our colleagues and partners, 2025 was indeed the year of significant change. From government institutions being shook to their core—a near unprecedented challenge to our societal agreements on “fact”—to our dedication to issues and community through education and growth, who we are today is not who we were on January 1, 2025. And, despite what reflection of harder and more stressful moments might tell us, that change is not necessarily a bad thing.

2026 greets CANN, as an organization, with our own evolution: even as we seek to evolve the policy landscape and our partners to be patient-focused in an ever-increasingly tangible way.

CANN’s growth means permanent work for some of our contractors, allowing for incredible investments in three astounding individuals and their continued development as trend setters and thought leaders. Along with conversion to employee status, Ranier and Kalvin’s roles are expanding to leverage their state-based successes and networks to include federal policy education and advocacy. Travis’s expanded position will find him focused on ensuring CANN’s image is uniform, polished, and properly presented to the world at large. Our friends at Perry Communications are continuing as collaborators in shaping the advocacy ecosystem as patient-driven without fear or favor to the influences impacting access to care.

Our community investments are also growing and evolving in exciting ways. Later this year, CANN will share details on our re-vamped Community Roundtable events and how the “PDAB Summit” will transform into a broader conversation on patient access, drug pricing, and necessary reform and regulation. This discourse will offer real solutions that serve patients rather than simply catering to the next round of shady middlemen or market manipulating investors.

Growth and change is never all easy. The nature of evolution often demands the…unfamiliar.

After twelve years of service to CANN, Brandon Macsata will be moving on to focus on his work with ADAP Advocacy and PlusInc. After coming on to assist CANN’s founder, Bill Arnold, with restructuring the organization in 2014, Brandon continued to shepherd the organization through Bill’s death, including recommending me to the Board as successor CEO. Brandon’s contributions to CANN are immeasurable and we’re grateful for his care in helping us get to here.

This year is CANN’s 30th anniversary and much like any person turning thirty years old, we’ve been steadily evaluating our role, our knowledge, and our power to positively effect change. In 2025, we issued four $10,000, low-barrier advocacy grants to state-based and national partner organizations working on our shared issues from different perspectives. These organizations, Lupus Colorado, Aging and HIV Institute, Pharmacists United for Truth and Transparency, and Epilepsy Alliance of Louisiana, share our mission to define the issues impacting patient access to care across all health conditions and regardless of a patient’s socio-economic status, race, sex or gender, religion, geography, or their health history. We learned from these organizations about services they offer, treatment development pipelines, perspectives on navigating care coverage across programs, challenges in keeping local pharmacy doors open, and how providers, even in schools, can refuse to administer life-saving medication to a child experiencing a seizure simply because they are uncomfortable with the medication determined to be the standard of care. We shared our perspectives on messaging and leveraged our experience in HIV exceptionalism to navigate policy change and demand equitable care for our shared communities.

Because the reality is that HIV is losing its exceptional nature in the policy realm. While our programs remain alive—and, frankly, as of yet still funded—our support systems and our integration into broader, more generalized care as a manner of ensuring actual access for people living with HIV (those systems and changes for which we’ve advocated), are under threat by short-sighted, single-issue discussions. Advocacy organizations who have collected money over the years without innovation or growth will continue to labor without producing results and at the expense of true change-makers. Those who expect to proceed according to their own status quo, mired in bureaucracy, the successes of the past, and without authentic coalition-building will atrophy. Again, that’s authentic coalition-building: as I’ve shared over the years, “we must find friends”. And I don’t mean transactional friends (i.e., “If you sign this letter, I’ll sign yours”), but rather real relationships built in a slower manner that develops attachment without expectation of specific action, and instead deep enough care to show up when a call is made.

This goes beyond our community partners. Our industry partners are facing much the same conversation about the therapeutic areas they invest in and their alliances with advocates. What does it mean to be more than funders? What does it look like to fundamentally transform the patient advocacy ecosystem through stabilizing investments? What does it mean to support incubator models of advocacy? How does this impact or otherwise become integrated into a company’s business model? The answers to these questions are not static and they are far beyond any quarterly stockholder assessment, and our partners know this.

Advocates, for our parts, must be responsive to a rapidly-changing environment where those most confident in their proposed “solutions” are only having half the conversation on a single-issue within a larger web of issues, networked in a complex chain reaction of impacts. The consequences of policymakers—state and federal—suffering from “tunnel vision” or engaging in cheap, inaccurate, and deceptive talking points are manifesting in readily foreseeable conflicts making their way through expensive and unnecessary legal battles at the expense of tax dollars and patient quality and affordability of care.

We can do better than this. As HIV advocates, we know how to leverage historical challenges into future successes. We know how to seek out the unforeseeable and to respond to clever callousness. We have an obligation to share this knowledge and empower partners across the country to achieve what we have and, in doing so, to save our own investments from today’s threats.

2026 requires a paradigm shift from institutional comfort to nimble, responsive, powerful advocacy.

The changes 2025 brought us will be the continued challenges of 2026. To which the answer must be “We can.” (…CANN)

How Lupus Colorado and CANN Built an Advocacy Powerhouse

Some partnerships start with a formal strategy session. Ours began with a simple realization. People living with lupus and people living with HIV or viral hepatitis face many of the same obstacles when they try to get the care they need. Once we recognized that shared landscape, the connection between Lupus Colorado and the Community Access National Network (CANN) started to feel not only natural, but necessary.

CANN’s mission is to define, promote, and improve access to healthcare services and supports for people living with HIV and people living with viral hepatitis. The focus is on keeping care affordable and within reach for people no matter where they live, what they earn, or how they are insured. As soon as we spent time together, it was clear how much that mission speaks to the lived reality of people living with lupus. Many in our community depend on the same safety net programs, the same specialty pharmacies, and the same policies that protect medication access for people with chronic conditions nationwide.

Once we began sharing stories, the overlap came into full view. We heard about people living with lupus who rely on the 340B Drug Pricing Program to keep their treatment affordable. We heard about people managing both lupus and other long term conditions who face the same hurdles that people living with HIV or hepatitis encounter when insurance rules change or formularies shift. We also heard how uncertainty about programs like the 340B Program or state efforts to set Upper Payment Limits through bodies like the Colorado Prescription Drug Affordability Board creates stress and confusion for everyone who counts on steady access to treatment. The policy language may sound technical, but the effects show up in daily life. That shared experience became the spark that brought our organizations together.

Lupus Colorado eventually became a kind of testing ground for patient engagement around these issues. When debates surrounding 340B and the state board intensified, we invited our community to learn more and speak up. People living with lupus stepped forward with thoughtful questions about what these changes might mean for their medications and their stability. They shared stories about years spent finding the right treatments. They talked about the worry that comes with not knowing whether a familiar pharmacy or discount program will still be available. Their honesty helped shape a clearer picture of what access really means for people with chronic conditions.

CANN supported this work by offering context, training, and a strong national network. Their experience showed us how these local conversations fit into broader public health goals, including ongoing efforts to build sustainable systems for people living with HIV and long term strategies for hepatitis C elimination. They also helped amplify our stories by connecting them to advocates, policymakers, and public health leaders who are working to protect and expand medication access nationwide.

As we continued working together, the partnership grew into something that felt like friendship and, at times, even family. It surprised all of us how quickly Louisiana and Colorado began to feel connected through shared purpose and shared energy. This work is deeply personal, and when good people come together with the belief that collaboration, not competition, brings out our strongest work, something close to magic begins to take shape. My curiosity and strategic thinking blended naturally with Jen’s mentorship and policy insight. Kalvin and Ranier added necessary context for any variety of issues we shared and even accompanied me to some meetings to ensure Lupus Colorado's interests were well-defined for our audience. Together we created a combination that strengthened every effort that followed.

This collaboration also changed how advocacy feels for many people. Instead of seeing policy as something decided far away, our community began to see it as something they can influence. When people speak about their lives, policymakers listen differently. The technical language becomes human. The stakes become easier to understand. And the entire conversation shifts toward solutions that protect access rather than limit it.

The partnership between Lupus Colorado and CANN has shown us that when organizations connect around shared purpose, everyone benefits. We bring different histories and different areas of expertise, but we are united by our commitment to ensure that people living with chronic conditions can access the care they need without fear or financial hardship. Our collaboration continues to strengthen advocacy networks, uplift patient voices, and support progress toward public health goals that matter to all of us.

Most of all, this partnership reminds us that no one faces this journey alone. When communities work together, even unlikely collaborations can grow into something powerful enough to spark change.

Policy Failures, Not Fate: Inside 2025’s Health-Care Unraveling

As 2025 draws to a close, the American healthcare safety net finds itself fraying at multiple seams simultaneously. The enhanced Affordable Care Act (ACA) premium tax credits are set to expire on December 31, threatening to more than double out-of-pocket premiums for 24 million Americans. HIV care infrastructure has been deteriorating for months through administrative obstruction, and new data shows progress on ending the epidemic has stalled. State-level drug pricing experiments continue advancing on unsound foundations while federal policy casts an uncertain shadow over pharmaceutical access.

These crises share a common thread: they result from policy choices, not external forces. The Kaiser Family Foundation (KFF) estimates that average ACA out-of-pocket premium payments will increase by 114% if enhanced subsidies expire. New York City's latest surveillance data shows HIV diagnoses rising for the fourth consecutive year. The interconnected nature of these programs means each failure amplifies the others, and the decisions Congress makes in the coming days, and how states respond in the coming months, will determine whether 2026 brings stabilization or acceleration of these access crises.

The ACA Subsidy Showdown

As of this writing, the Senate is scheduled to vote on Thursday, December 11th, on the future of enhanced premium tax credits, and according to Politico, “all proposals appear doomed.” Senate Minority Leader, Chuck Schumer, announced Democrats will push a “clean” three-year extension: "This is the bill, a clean three-year extension of ACA tax credits, that Democrats will bring to the floor of the Senate for a vote next Thursday, and every single Democrat will support it. Republicans have one week to decide where they stand."

The measure requires 60 votes to overcome a filibuster, meaning 13 Republicans would need to cross the aisle. That support is not expected to materialize, as Republicans remain fractured between those who prefer inaction, those insisting on conservative overhaul, and those worried about the political consequences of rising premiums amid the quickly coming midterm fights.

President Trump was poised to release a framework last month extending the subsidies temporarily with income caps at 700% of the federal poverty level and minimum premium requirements. He backed down after some Republican lawmakers insisted any extension restrict ACA plans from covering abortions and include more conservative changes. Majority Leader John Thune acknowledged the abortion issue is "a difficult and challenging one on both sides." The Hydr amendment already forbids federal funds being used to subsidize abortions.

Several competing Republican proposals have emerged, though each carries significant implications for cost and access. Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bill Cassidy (R-La.) wants to redirect enhanced subsidies to health savings accounts tied to bronze-level plans with higher deductibles. The approach would shift costs from premiums to out-of-pocket expenses rather than reduce them, and HSA rules, as they currently stand, prohibit using funds to pay premiums. For people with chronic or complex health conditions requiring consistent care, high-deductible plans create significant barriers: annual HIV medication costs alone range from $36,000 to $48,000, and KFF research shows each $1,000 increase in out-of-pocket costs correlates with decreased medication adherence.

Sen. Rick Scott (R-Fla.) has proposed "Trump Health Freedom Accounts" that could be used to pay premiums, though funding levels and eligibility thresholds remain unclear. Sen. Josh Hawley (R-Mo.) has floated allowing people to deduct up to $25,000 in medical expenses from their taxes, but as a deduction rather than a credit, this approach disproportionately benefits higher earners and does nothing at the point of purchase for people who cannot afford premiums upfront.

Neither of these proposals address the systemic issues driving up the costs of premiums, like pharmacy benefit managers (PBMs) vertically integrated with their own solely owned pharmacies or the plan that are supposedly contracting with them. Directly, PBMs are setting their own prices to justify higher costs across the board with limited to no transparency or accountability. Changing which hands money comes from would not change this dynamic but it could potentially make it harder to track the source of these cost pressures.

A bipartisan group of 35 House members released a two-year extension proposal retaining enhanced subsidies for people earning up to 600% of the poverty level, with reduced amounts up to ten times the poverty level. But only about 15 Republicans have signed on, far short of the majority-of-the-majority threshold typically required for leadership to allow a floor vote. "I have 40,000 people in my district who rely on this health care and doing nothing to prevent a spike in their premiums is wrong," said Rep. Jen Kiggans (R-Va.), who won reelection last year by less than four percentage points.

The real-world consequences are already materializing. Blue Cross Blue Shield of Michigan reports a 20% spike in call center volume from members facing premium increases. KFF polling found that 58% of ACA enrollees said they couldn't afford a $300 annual increase without significant disruption to their household finances. Yet 72% of Republican ACA enrollees favor extending the enhanced subsidies, as do the same share of MAGA supporters with marketplace coverage.

HIV Programs: Rising Cases Meet Proposed Cuts

As we documented in November, the HIV care system experienced systematic disruption throughout 2025 through administrative obstruction and funding delays, independent of any congressional budget action. The question now is what 2026 holds, and early signals are troubling.

New York City's annual HIV surveillance report, released last week, showed 1,791 new HIV diagnoses in 2024, representing a 5.4% increase from 2023. This follows a 6.9% increase from 2022 to 2023, meaning new diagnoses have increased or remained stable for four consecutive years. Acting Health Commissioner Dr. Michelle Morse noted that "this progress has stalled as new diagnoses have increased or remained stable for the fourth year in a row while lifesaving federal funding for ending the epidemic is in jeopardy."

The federal threat is concrete: New York City would lose more than $41 million for HIV research, treatment, education and services if the proposed closure of the Centers for Disease Control and Prevention's (CDC) Division of HIV Prevention is approved. Nationally, the House Appropriations Committee's FY2026 bill would eliminate approximately $1 billion in CDC HIV prevention funding and cut the Ryan White HIV/AIDS Program by $525 million.

Members of the Presidential Advisory Council on HIV and AIDS (PACHA) released a letter last week urging the White House and Congress to protect funding, warning that "without continued investment, progress toward ending the HIV epidemic will stall, cases will increase again, and the health of Americans will suffer." Multiple PACHA members told ABC News the council has not met this year, raising questions about its ability to carry out its advisory role. The White House dismissed the council as "a largely symbolic body" engaged in "another useless PR exercise."

The NYC data underscores who bears the consequences of policy failures: 86% of people newly diagnosed with HIV in 2024 were Black or Latino, with 42% living in high-poverty neighborhoods. Among those interviewed by the health department, 48% lacked health insurance.

340B and PBM Reform: Rare Bipartisan Ground

Amid partisan gridlock on coverage questions, 340B Drug Pricing Program and pharmacy benefit manager (PBM) reform showed rare bipartisan momentum in 2025. The October HELP Committee hearing on 340B produced unusual agreement across party lines, with Chairman Cassidy noting that "340B should be about making drugs more affordable, not a line item on an investor call."

CBO's September 2025 analysis confirmed what patient advocates have argued for years: the program expanded 565% from $6.6 billion in 2010 to $43.9 billion in 2021, with two-thirds of this growth stemming from covered entity and third-party behaviors rather than pharmaceutical price inflation. The recently reintroduced 340B ACCESS Act represents the first comprehensive federal response to these documented abuses.

CANN's Director of 340B Policy Kalvin Pugh anticipates reform momentum will continue: "Next year begins several HRSA changes to 340B. I anticipate continued movement in Congress to try to realign the now second largest drug discount program to its original intent. I also anticipate continued efforts on the state level as large hospital systems and other margin motivated players will look for other ways to extract value from 340B."

On PBMs, the Federal Trade Commission's January 2025 interim staff report documented that PBM-affiliated pharmacies extracted over $7.3 billion in revenue above estimated acquisition costs on 51 specialty generic drugs between 2017-2022. The report's unanimous approval by FTC commissioners reflected the undeniable nature of these practices, yet the failure to enact meaningful federal PBM reform demonstrated that industry lobbying power remains formidable.

Support for these reforms has existed for some years and has been growing but has thus far stalled. How much these reforms will remain prioritized in a midterm election year, again, remains a question.

State Experiments and Federal Shadows

State Prescription Drug Affordability Boards (PDABs) continued their problematic trajectory in 2025. Colorado and Maryland, the two states furthest along in setting Upper Payment Limits (UPLs), are basing their limits on federal Maximum Fair Price (MFP) without conducting thorough cost-benefit analyses or assessing potential adverse system outcomes.

CANN's Drug Pricing Policy Director Ranier Simons offered a pointed assessment: "As 2025 comes to a close, PDABs remain expensive experiments built upon unsound foundations with nebulous projections of incalculable benefits. As state PDABs and other entities lean into equally untenable federal actions the outlook for positive change in 2026 is not promising."

Simons additionally warned that while the appetite for PDABs may be fading, it is likely to be replaced by legislative bully behavior or legislatures attempting to pass direct MFP bills, foregoing the facade of the Boards themselves.

The federal Most Favored Nation (MFN) executive order signed in May 2025 has since evolved into TrumpRx, a direct-to-consumer website set to launch in 2026. The administration has announced deals with five manufacturers, including Pfizer, AstraZeneca, and Novo Nordisk, touting discounts averaging 50% and reaching as high as 85%. The framing as "MFN pricing" is generous. TrumpRx functions as a cash-pay portal where consumers bypass insurance to purchase directly from manufacturers. The 92% of Americans with health insurance likely won't benefit, since purchases don't count toward deductibles or out-of-pocket maximums, and insured consumers often pay less through their pharmacy benefit. I-MAK CEO Tahir Amin called it "political theater" that won't deliver "substantial savings for the government or patients," noting that pharmaceutical stocks rose after the announcements. The specific terms of manufacturer deals remain confidential, making it impossible to verify whether "MFN prices" for Medicaid will actually be lower than the rebated prices Medicaid already receives under existing federal law. Medicaid is already guaranteed the lowest market cost on medications under the “best price” rule.

As we analyzed in August, true MFN pricing tied to international benchmarks risks importing discriminatory QALY-based frameworks. TrumpRx sidesteps that concern by avoiding genuine price regulation altogether.

Utilization Management: The Quiet Expansion

While coverage debates dominate headlines, a less visible threat to medication access is accelerating: the expansion of utilization management (UM) tools by both public and private payers. The U.S. drug utilization management market reached $39.82 billion in 2024 and is projected to more than double to $82.07 billion by 2034.

The Inflation Reduction Act's Part D benefit redesign creates new incentives for expanded UM. With Part D plans now responsible for 60% of costs in the catastrophic phase (up from 15% in 2023), plans face financial pressure to restrict access through step therapy, fill limits, and prior authorization requirements. The Medicare Payment Advisory Commission found that Part D and Medicare Advantage plans now apply some form of utilization management to more than half of drugs on their formularies. In June, a coalition of 60 patient advocacy organizations wrote to CMS Administrator Dr. Mehmet Oz warning that "restrictive cost-control measures can delay or prevent beneficiaries from accessing necessary treatments."

CMS is currently engaged in investigations on Medicare Advantage Plans abusing UM practices to deny care. Because these abuses are so well-know, the agency's proposal to adopt these practices for traditional Medicare might seem hypocritical, if not foretelling.

Payers are increasingly deploying AI to automate these decisions. A Bain & Company survey found that approximately 80% of payers now have an AI strategy in place or in development, with prior authorization automation among the top use cases. Industry analysts frame this as reducing "administrative gridlock," but the concern for patients is that automation makes it easier to deny care at scale. A 2024 American Medical Association survey found that 93% of physicians reported prior authorization led to delays in necessary care, and 82% said the process can lead patients to abandon their recommended treatment. For people managing HIV, cancer, and other chronic conditions, automated denials represent a new front in the fight for treatment access that demands sustained advocacy attention in 2026.

The Crossroads of 2026

The policy decisions of the coming days will shape healthcare access for years. Lawmakers increasingly view January 30, the next government funding deadline, as the real cutoff for a healthcare deal if Thursday's vote fails. If ACA subsidies expire, KFF projects marketplace enrollment dropping from 22.8 million to 18.9 million in 2026 alone.

Looking further ahead, Medicaid work requirements under H.R. 1 take effect January 2027, requiring adults ages 19-64 to complete 80 hours monthly of approved activities to maintain coverage. Planning for that implementation begins now.

GOP strategist Jason Cabel Roe captured the political bind: "This is an issue we've been railing on for how many years? And now, all of a sudden, we have to deal with it, and there are no good proposals right now to get us out of this. If we don't fix it now, we risk letting Democrats fix it later, and we're not going to like that fix."

Whether Congress finds pragmatic solutions or continues partisan paralysis will determine whether 2026 brings relief or deepening crisis for the millions of Americans whose healthcare access hangs in the balance.

World AIDS Day: The Resistance of Resilience

Every year since 1988 people around the planet come together on the first of December to recognize World AIDS Day. In years past we have taken pause to honor those whom we have lost and celebrate the progress made in the global HIV response.

In 2025, it is nearly impossible to focus on anything but the challenges that threaten to unravel that progress. It arrives at a time of shifting political winds, renewed debates about public health funding, and increasing threats to the systems and supports that people living with HIV rely on every day.

Yet if there is one constant in the HIV movement, it is resilience.

For more than four decades, the HIV community has endured cycles of crisis and recovery. We have faced indifference, stigma, scarcity, and political backlash. And still—through mutual aid, activism, and unshakeable hope—we have rebuilt again and again. This year, with potential federal and state cuts on the horizon, that resilience is not just inspiring, it is essential.

At this moment, the United States stands at a crossroads.

For more than 20 years, the President’s Emergency Plan for AIDS Relief (PEPFAR) has been one of the most successful global health initiatives in history. It has saved an estimated 25 million lives, strengthened fragile health systems, and brought the world closer than ever to controlling the HIV epidemic. USAID has been central to this effort—building clinical capacity, partnering with community-led organizations, expanding access to prevention, and ensuring that millions stay connected to lifesaving treatment.

The current political divide, funding uncertainty, and stalled reauthorization efforts have created a dangerous vacuum. PEPFAR-supported clinics have reported staffing gaps, reduced community outreach, disruptions in treatment continuity, and delays in expanding services to key populations. These cracks—if allowed to widen—threaten decades of hard-won progress.

The message is clear: Treatment access is not guaranteed. Progress is reversible. Lives are at stake.

The uncertainty about the future of our movement does not end outside of the borders of this country. Here, at home, the dismantling of the foundations we have built our successes upon resembles the current state of the east wing. 

Policy decisions made in statehouses and on Capitol Hill have life-or-death consequences. Reductions to HIV prevention, care, housing, and treatment programs don’t simply trim budgets; they unravel the fragile ecosystems that keep people alive. Cuts disproportionately impact Black, Brown, LGBTQ+, and rural communities—people who already face higher barriers to care and greater exposure to stigma.

But we have never waited for political permission to do what is needed.

History shows us that progress in HIV policy is rarely linear. Budgets rise, then fall, with the optional attention of charity. Political champions emerge, then fade with the regularity opportunism offers. But the HIV response moves forward because the community keeps pushing forward. When lawmakers scale back, communities scale up. We see advocates testifying at hearings, organizations expanding peer-led services, and networks of people living with HIV stepping into leadership. We see researchers, healthcare providers, and activists working together to protect progress that took decades to build. 

This ability to adapt—to find new paths when old ones are blocked—is one of our greatest strengths.

When the early epidemic was met with silence, people living with HIV built their own networks of care. When treatments were inaccessible, advocates demanded—and won—more equitable access. When global leadership faltered, activists and partner nations strengthened PEPFAR and the Global Fund, saving millions of lives. When stigma has surged, communities have countered it with truth, visibility, and love.

This year’s uncertainties are not new terrain. The community has always been its own engine of progress.

Every political cycle brings the chance for renewed commitments…renewed inspiration. Funding threats today can become new opportunities tomorrow—but only if we keep momentum alive.

World AIDS Day reminds us, even during challenging times, that we must steadfastly defend the essential programs that provide medications, testing, prevention, housing, and supportive services. Once an HIV safety net is compromised, rebuilding it becomes multitudes more costly and emotionally taxing.

It also calls us to elevate the voices of those communities that are most impacted.  Resilience as it is strongest when those most impacted are centered. Policies crafted with meaningful, empowered involvement from people living with HIV are more equitable, more effective, and more enduring.

Finally it calls us to believe that hard times are temporary. When leadership changes—or when public health once again becomes a national priority—the HIV community will be ready with solutions, partnerships, and a long-term vision rooted in justice.

Resilience is not passive. It is planning, persistence, and refusing to let setbacks define the future.

The progress we’ve made— undetectable becoming untransmittable, vastly improved treatments, longer and healthier lives—is too valuable to lose. The HIV community, and its allies aren’t asking for miracles. We are demanding what we have always deserved: dignity, care, evidence-based policy, and sustained investment in human life.

On this World AIDS Day, we honor the fortitude that carried us this far, and we recommit to the work ahead. No matter how the political winds blow, we will continue fighting for a world where every person living with HIV has the access, resources, respect, and rights they need to thrive.

I urge you to take a moment and remember who we are, because the resilience to rebuild is not just our story—it is our most valuable strategy.

I Didn’t Plan for Advocacy or Gratitude, Yet Here They Are

Thanksgiving has always been a bit of a mixed bag for me, not in a tragic or dramatic way, but in that specific way you get when you grow up loving the holiday and growing up in the church. I’ve always enjoyed the food, the chaos, the family, the ritual of it all. But the season also came with this subtle expectation to perform gratitude, like the “giving thanks” moment could quietly morph into a post–Bible study prayer circle if you weren’t careful. Not disingenuous, just… a little showier than felt right to me and Jesus. And maybe that’s why, as I look back now, I’ve realized nothing about the road that brought me into advocacy is neat, polished, or suitable for a holiday centerpiece. It’s messy. Imperfect. Deeply human.

If I trace the line back to where it all began, the ink is more Rorschach blot than paint-by-numbers. I didn’t grow up dreaming of writing about HIV policy or public health or anything remotely adult and sensible. I grew up absorbing the quiet and not-so-quiet messages that who I was needed correcting. And to be fair, I didn’t just sit there and take it. I came out of the closet young for the time, ran headfirst into freedom, and made choices that would make Freud say, “see what I mean?”

But those early church scripts are stubborn. They cling like glitter after vacation Bible school. So in my twenties I did what far too many queer kids raised in pews eventually do: I marched myself right back into the sanctuary and tried to pray myself straight. Ten years of shrinking, contorting, and spiritual self-flagellation in the name of being “acceptable.” When I finally came up for air, gasping and blinking, trying to remember what it was like to breathe again, the universe had a plot twist waiting for me.

“Sir, your test results are in. We need to see you in our office.” The nice lady from the Wake County Health Department had no idea I’d been laid off from my job the day before, that her timing would land like a comedic beat in a very dark sitcom. Better get that COBRA coverage, hunny. In reality, the voice I heard when I was diagnosed with HIV in 2013 wasn’t the clinician’s. It was the church. “See, [insert slur]? You deserved this.” Not God. Not my mother. Not anyone who actually loved me. Just that old, well-worn shame cassette clicking into place like it had been waiting years for its solo. Shame doesn’t need facts. It doesn’t need context. It just needs a crack in the door. It can take a moment of pure biology and twist it into prophecy.

I wish I could say I rose to the occasion right away, but life isn’t linear or cinematic. There was no orchestral swell, no title card reading The Turning Point. The years after my diagnosis were a blur of contradictions. Some spiraling, yes, but also a lot of functioning. A lot of over-functioning, honestly. Working nonstop. Achieving. Pouring every unresolved fragment of identity and trauma into my career like it was mortar holding me together. I got married. I excelled. I tried to be “good enough,” whatever that meant. Worthy. Whole. Not broken. Oh, the stigma of it all. Oh, the pain we carry.

So when COVID hit and work evaporated overnight, it wasn’t just a job loss. It was an identity collapse. The marriage, which had long been more about me playing savior than building a partnership, blew apart next. Everything I’d built in the name of being acceptable crumbled at once. And when I let a man put a needle in my arm for the first time, it wasn’t rebellion or thrill-seeking. It was because I genuinely believed I had nothing left to live for.

And then, because life is bizarre and occasionally merciful, I met Jen. You may know him as CANN’s CEO. I knew him first as “Jen,” the guy I met through a mutual friend at a time when I wasn’t exactly giving “promising candidate” energy. Somehow, in the middle of my scrambled-brain era, he saw something I had long since stopped recognizing. He believed in me when I didn’t trust my own wiring.

So when he asked me to write for CANN in September 2023, it wasn’t about being rescued. It was about being reminded. There was still something in me worth tapping into. Something I’d buried but not lost. Even through the fog, I could feel it: I wasn’t finished. Not by a long shot.

And then I looked around at the moment I was walking into and thought: You’ve got to be kidding me.

Public health under political attack. HIV programs being destabilized and dismantled. Cuts that would undo decades of progress. LGBTQ+ people being treated like legislative piñatas. Clinics forced to scale back services while they wait for grants that used to arrive on time. Providers trying to keep people in care while the system beneath them is being quietly hollowed out. Everyone exhausted, angry, anxious.

This is when I show up? Now? When everything is on fire?

A hell of a time to get into advocacy.

But maybe that’s the point. You don’t get to choose the moment you’re needed. You only get to decide whether you’re going to show up, shaky knees, frayed edges, all of it.

My gratitude this Thanksgiving won’t be found on a Pinterest board. It’s not arranged on a charcuterie board with rosemary sprigs. It’s the gritty kind, the kind that comes from knowing how close I came to disappearing. The kind born from surviving things I absolutely should not have survived. I didn’t get here because I was virtuous or inspiring. I got here because people threw me ropes when I was sinking, and because I had access so many people don’t. Access to meds, to care, to community, to plain dumb luck. Privilege wrapped in trauma wrapped in stubborn persistence. I think about that every day.

That’s why the work isn’t abstract to me. When I write about funding cuts or bureaucratic sabotage, I’m not theorizing. I know what it feels like when systems fail. I know how shame can warp a diagnosis into a death sentence. I know what happens when care depends on luck, or geography.

And this work, as infuriating as it is, lets me fight back. For myself. For my people. For the folks who didn’t get the lifelines I did, who missed the right friend or the right doctor or the right skin tone. I get to push against systems built to confuse and exhaust people. I get to challenge the ridiculous fiction that some lives deserve less and that some people are worth more.

And strangely, I’m even grateful that advocacy requires actual humanity. Not rage-tweet humanity. Real humanity. The kind that asks you to hold onto your heart even when you’d rather slam a door. It’s easy to fight enemies. It’s harder, and far more necessary, to fight for justice while refusing to lose yourself.

Hope feels irresponsible these days. Believing in institutions feels like bad budgeting. But here I am. Here we are. Somehow still choosing to show up.

I’m grateful, not neatly, not saintly, but honestly.

Grateful to still be alive.

Grateful to have crawled out of the wreckage and found something worth rebuilding.

Grateful for every rope thrown my way, even the ones I didn’t think I deserved.

Grateful that CANN took a chance on me, the recovering, rewiring, not-exactly-LinkedIn-ready version of me, and said, “Yeah, this guy has something worth hearing.”

Grateful that I get to use every broken, complicated, hard-won piece of my story to help someone else carry theirs.

And I’m grateful, truly, that I get to show up in this exact moment, look around at the mess, and still say: I’m here. I’m ready. Let’s fight.

The HIV Care System Is Breaking Before Congress Even Cuts It

In October 2025, the Emergency HIV Clinical Response Task Force surveyed 526 HIV clinicians across the United States. Seventy percent reported service disruptions affecting their patients, with the Midwest and South hit hardest at 77% and 71%. Gender-affirming care topped the list of disrupted services at 33%, followed by housing support at 26% and PrEP or PEP access at 25%. Transgender people and immigrants bore the heaviest impact, with 41% and 38% of clinicians reporting these populations were most affected.

These numbers tell an important story, but not the one many headlines suggest. The disruptions in this survey are not the result of Congressional budget cuts to HIV programs. No legislation has eliminated Ryan White HIV/AIDS Program funding or CDC prevention dollars. Instead, they stem from administrative actions, grant recissions, and bureaucratic obstruction that destabilized HIV services months before Congress debated any cuts at all.

That distinction matters. It reveals how vulnerable the HIV care infrastructure has become, and how much worse things could get if proposed eliminations of HIV programs and broader healthcare funding cuts move forward.

The Administrative Stranglehold

The current disruptions trace directly to Office of Management and Budget Director Russell Vought’s systematic manipulation of the federal budget process. Before joining the Trump administration, Vought outlined these tactics in Project 2025, describing how “apportioned funding” could “ensure consistency with the President’s agenda.” He has executed this strategy with surgical precision.

Rather than releasing appropriated funds to agencies like the Centers for Disease Control and Prevention (CDC) in standard apportionments, Vought shifted to monthly releases requiring Department of Government Efficiency (DOGE) review for every grant award. By August 2025, the CDC’s center for HIV and tuberculosis prevention had spent $167 million less than historical averages, the Ryan White Program underspent by $105 million, and mental health funds at the Substance Abuse and Mental Health Services Administration lagged by more than $860 million.

The money exists. Congress appropriated it. Administrative roadblocks are what prevent it from reaching clinics, health departments, and community organizations.

The human cost is visible in provider reports. When funding delays hit in July 2025, 81 HIV organizations wrote to HHS Secretary Robert F. Kennedy Jr. warning that “with every day of delayed FY2025 funding release, the delivery of essential HIV services is compromised.” Clinics laid off case managers, reduced clinician hours, closed sites, and scaled back hotlines. The funds eventually arrived about a month later, but the damage—to staff capacity, patient trust, and continuity of care—was done.

At St. John AIDS outreach ministry in New Orleans, program director Tamachia Davenport faced a choice: cut staff or cut supplies when CDC funds did not arrive on time. To keep staff from fleeing to more stable jobs, she stopped buying condoms the organization distributes to prevent sexually transmitted infections—despite Louisiana’s already high rates of HIV, chlamydia, and gonorrhea, and the fact that condoms cost far less than treating any of them.

One CDC official summarized the view from inside: “Everyone’s inbox is full of letters from grant recipients asking, ‘How do we proceed?’ We just say, ‘Please wait.’”

Robert Gordon, a public policy specialist at Georgetown University and former assistant finance secretary at HHS, described the strategy plainly: “This is a sophisticated strategy to cause money to lapse and then say, ‘If they can’t spend it, they don’t need it.’”

The Unlegislated Threat

While administrative actions create the current disruptions, proposed legislation in Congress represents a qualitatively different threat.

In September 2025, the House Appropriations Committee released its FY2026 funding bill eliminating all CDC HIV prevention funding—approximately $1 billion—and cutting the Ryan White HIV/AIDS Program by $525 million, or 20%.

The bill does not merely trim budgets. It eliminates program components entirely. Ryan White Part F, including AIDS Education and Training Centers, the Dental Reimbursement Program, and the Minority AIDS Initiative, would disappear. The $220 million for the Ending the HIV Epidemic initiative would be eliminated. Direct grants to more than 400 HIV clinics providing care and treatment through Ryan White Parts C and D would end.

Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, summed up the stakes: “This is not a bill for making America healthy again, but a disastrous bill that will reignite HIV in the United States.”

The Senate tells a different story. In July 2025, the Senate Appropriations Committee advanced a bipartisan bill that maintains flat funding for all parts of the Ryan White Program ($2.57 billion), level funding at $220 million for Ending the HIV Epidemic, and flat funding for CDC HIV prevention. The contrast could not be clearer.

Researchers at Johns Hopkins Medicine modeled what would happen if federal funding for Ryan White ended. Their study in the Annals of Internal Medicine projects 75,436 additional HIV infections through 2030, a 49% increase. As senior author, Dr. Todd Fojo noted, effective treatment is the most powerful form of HIV prevention.

No final FY2026 budget has been enacted. The government is operating under a continuing resolution, and the gap between House and Senate proposals is unresolved. But the threat is not hypothetical, and the clinician survey’s forward-looking data reflects it: 72% anticipate moderate or significant service disruptions in the next 6–12 months, rising to 77% for the following 12–18 months.

The Broader Ecosystem Under Siege

The clinician survey captures disruptions to direct HIV services, but not the compounding pressures from Medicaid restructuring that threaten both coverage for people living with HIV and the financial stability of AIDS service organizations.

The One Big Beautiful Bill Act, signed July 4, 2025, reduces Medicaid expansion eligibility from 138% to 100% of the federal poverty level, affecting an estimated 200,000 people with HIV. This is not a marginal tweak: 40% of non-elderly adults with HIV rely on Medicaid, nearly three times the rate of the general population. Starting in 2027, adults ages 19–64, captured under the Affordable Care Act’s Medicaid expansion, must complete 80 hours per month of approved activities to maintain coverage, and semi-annual eligibility redeterminations will replace annual reviews, injecting churn into programs where uninterrupted access to antiretroviral therapy is a clinical requirement, not a luxury.

Program eligibility recertification as an administrative burden on patients and otherwise a deterrent to staying enrolled in a program is something Ryan White clients are exceedingly familiar with. Recall, in 2021, under a Policy Clarification Notice (PCN 21-02), historical 6-month recertification requirements were relaxed in order to facilitate keeping eligible clients in care and not losing patients to care because of paperwork burdens. Medicaid work requirements as described in HR1 are the exact opposite of this best practice.

Taken under another lens, many AIDS service organizations converted to Federally Qualified Health Center (FQHC) status after the Affordable Care Act to serve newly insured patients and stabilize revenue. Medicaid comprises 43% of FQHC revenue. The OBBBA cuts into this income through provider tax caps that ratchet down over time and by capping state-directed payments at 100% of Medicare rates in expansion states. At the same time, the Congressional Budget Office projects 7.8 million people will lose Medicaid coverage overall. Enhanced ACA premium tax credits expire at the end of 2025, and so far Congress has not extended them.

As Davenport of St. John AIDS outreach told KFF Health News, “A lot of us are having to rob Peter to pay Paul.” But what happens when Peter gets defunded? Maybe the “Good Christians” in the halls of Congress can tell us.

Another angle of “robbing Peter”, is state expansion of 340B by way of allowing Medicaid providers to opt for any given claim under the 340B program, rather than forcing the claim through Medicaid. In these scenarios, the provider benefits the most from 340B discounts while robbing the state’s Medicaid program of possible Medicaid Drug rebates because no single claim may receive both. One report tied this Medicaid divestment to the tune of $1.2 billion annually. A novel consideration might be stabilization of Medicaid programs and payments by way of disallowing the option of 340B claims and requiring those claims be passed through a state Medicaid program. Maximizing Medicaid’s re-investment opportunity stabilizes both state budgets and the payment ecosystem for qualified healthcare entities.

Ground Truth: What’s Happening Now

Local decisions layered on top of federal obstruction are already shutting people out of care. Institutional brain trust and community trust in those same institutions is easy to lose and hard to recover.

In Mecklenburg County, North Carolina, the public health department laid off six workers, including half its disease investigators, when HIV prevention and surveillance grants expired at the end of May with no information about future funding. The grants were restored a month later, but only half the positions were refilled. “So now we’re behind, and cases are still being reported every day that have to be investigated,” said director Raynard Washington.

In Dallas County, Texas, public health director Philip Huang waits for nearly 30% of the promised award for emergency preparedness with no timeline or clarity, making basic staffing decisions feel like a gamble.

Breanne Armbrust, executive director of Richmond’s Neighborhood Resource Center, summed up the cumulative burden on patients: “They’re already sick or in need of care and asking them to do one more thing when their acuity levels might be high is too much, and it’s unreasonable.”

The Warning We Cannot Ignore

The clinician survey documents disruptions caused by administrative obstruction at a time when HIV programs still technically have appropriated funding. It is a snapshot of a system that is already unstable.

If the House FY2026 proposal eliminating CDC prevention funding and cutting Ryan White by $525 million becomes law, these disruptions will not simply “increase,” they could scale into system failure. Each new HIV infection carries an estimated at least $501,000 in lifetime healthcare costs. The Ryan White Program in 2023 achieved a 90.6% viral suppression rate among 576,000 clients. These programs work. Dismantling them would reverse decades of progress in a matter of years.

The workforce crisis compounds the threat. The United States needs 1,500 additional HIV specialists to reach 90-90-90 benchmarks. The South already has only 8 providers per 1,000 people with HIV, compared with 11 nationally. Counties that have reached at least one 90-90-90 target have 13 providers per 1,000. Eliminating AIDS Education and Training Centers, as the House bill proposes, would deepen that shortage just as demand for services intensifies.

None of this is theoretical. Administrative sabotage is already cutting off care people depend on to stay healthy, alive, and connected to treatment. Layer a legislative funding strike on top of a system this fragile, and the outcome is entirely predictable: preventable infections, preventable deaths, and preventable suffering concentrated among people already pushed to the margins.

Federal Policy Changes Threaten to Overwhelm ADAPs

Established in 1987, AIDS Drug Assistance Programs (ADAPs) were the first federally supported initiative to help states purchase AZT (zidovudine), then the only approved antiretroviral drug available for people living with HIV (PLWH). When Congress enacted the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act in 1990, ADAPs were formally incorporated into what would become the Ryan White HIV/AIDS Program. Nearly forty years later, these programs remain the backbone of HIV treatment access in the United States, supporting medication coverage for those without affordable insurance options and sustaining the nation’s viral suppression gains.

That foundation is now under strain. A series of converging federal policy changes threatens to unravel the safety net that ensures continued access to lifesaving HIV treatment.

The One Big Beautiful Bill Act, enacted July 4, 2025, combined with the expiration of enhanced ACA Premium Tax Credits on December 31, 2025, and proposed federal funding reductions for Fiscal Year 2026, have created what NASTAD describes as "an unprecedented fiscal storm." The Congressional Budget Office estimates that H.R. 1, combined with the end of enhanced Premium Tax Credits, will leave 14.2 million more Americans uninsured by 2034. Another 750,000 to 1.8 million Marketplace enrollees are projected to lose coverage under the 2025 Marketplace Integrity Rule.

For ADAPs, the timing could not be worse. NASTAD data show ADAP enrollment increased 8 percent between 2019 and 2023, with new enrollment rising 28 percent and prescription drug expenditures up 10 percent. Program administrators are already managing cost growth, changing insurance landscapes, and expanding client need. The convergence of these federal shifts represents not a single budget gap, but a cumulative structural failure that could overwhelm the system responsible for sustaining treatment access for more than 270,000 people nationwide.

When the Safety Net Last Failed

The last major ADAP funding crisis, in 2010 and 2011, offers a clear warning. During that period, national ADAP waitlists grew from 2,937 to 9,217 people within twelve months, even after an emergency $25 million federal allocation. The consequences were immediate and measurable. Three deaths in South Carolina among people waiting for medication became a national call to action. Congress responded by reprogramming Ryan White funding and authorizing additional emergency allocations between 2010 and 2013, and waitlists were fully eliminated by 2017.

The difference today is scale and complexity. The current threat is not a temporary funding shortfall but a sequence of federal policy changes that simultaneously reduce insurance coverage, restrict Medicaid access, and diminish the resources available to offset those losses. Each component amplifies the pressure on ADAPs, narrowing every available safety valve.

The lessons from 2010 remain relevant. When the safety net fails, the consequences are measured not in spreadsheets but in treatment interruptions, declining viral suppression rates, and preventable deaths. Without urgent federal and state intervention, ADAPs face conditions that could produce a repeat of that crisis, magnified by broader systemic strain and political indifference.

Medicaid Work Requirements: Paperwork as Policy Weapon

H.R. 1 introduces the largest reduction to Medicaid in U.S. history, with nearly $1 trillion in cuts projected from 2025 through 2034. Beginning January 1, 2027, most Medicaid expansion adults will be required to document at least 80 hours of “qualifying activities” each month to maintain coverage. The Congressional Budget Office estimates that these provisions will result in 4.8 million more people losing coverage by 2034.

Research shows that two out of three enrollees who lose Medicaid under work requirement policies are already employed or qualify for exemptions. The result is not an increase in employment but a rise in administrative loss of coverage.

Arkansas’s 2018 work requirement experiment illustrates what lies ahead. More than 18,000 people lost coveragewithin months, primarily due to confusion and difficulties with the state’s online reporting system. Employment rates did not increase.

Nationally, about 10 percent of Medicaid renewals currently result in “procedural disenrollment,” meaning people lose coverage for paperwork reasons despite remaining eligible. H.R. 1 worsens this by requiring Medicaid enrollees to renew eligibility every six months instead of annually, doubling the opportunities for administrative failure.

For people living with HIV, Medicaid is a primary source of healthcare coverage. Nationally, approximately 40 percent of people receiving HIV care are enrolled in Medicaid. These provisions directly threaten treatment continuity by increasing administrative barriers and coverage interruptions. The legislation also reduces retroactive eligibility from three months to one or two months, raising costs for ADAPs that depend on retroactive reimbursement for medications dispensed while coverage applications are pending.

The Marketplace Affordability Cliff

The expiration of enhanced ACA Premium Tax Credits will create an affordability crisis for people living with HIV who earn too much to qualify for Ryan White services but depend on subsidized marketplace plans. KFF estimates that marketplace enrollees will see average premium payments more than double in 2026, increasing by 114 percent from $888 annually to $1,904. Approximately 1.5 million people earning above 400 percent of the federal poverty level will lose all subsidies entirely.

A larger share of people living with HIV receive marketplace coverage than the general population. For a 45-year-old in Miami-Dade County earning $38,000, annual premiums would rise by $1,699, from $117 to $259 per month. Given that antiretroviral therapy typically costs $36,000 to $48,000 annually and total healthcare expenses average $30,000, marketplace affordability is critical to maintaining viral suppression.

Insurers are building in additional premium increases of roughly four percent in anticipation of the subsidy expiration, assuming healthier enrollees will drop coverage and leave behind a sicker risk pool. Average Healthcare.gov plan premiums are projected to rise 26 percent for 2026. The Congressional Budget Office projects that the uninsured population will grow by 2.2 million people in 2026 alone without an extension of the tax credits, eventually reaching 4.2 million.

Federal Funding Cuts Compound the Crisis

While coverage losses increase, federal budget proposals for FY2026 would eliminate the very programs that support ADAPs and coordinated HIV care. The White House budget proposes a $74 million reduction to the Ryan White HIV/AIDS Program, lowering total funding to $2.5 billion by eliminating Part F programs that include the AIDS Education and Training Centers, dental programs, and Special Projects of National Significance.

The House Appropriations Committee proposes deeper reductions, eliminating $525 million in Ryan White funding, or roughly 20 percent of the program’s total. These cuts would affect more than 400 HIV clinics that provide medication, case management, and medical care nationwide.

The House proposal also eliminates the entire $1 billion budget for CDC HIV prevention, including $220 million for the Ending the HIV Epidemic initiative. The HIV+Hepatitis Policy Institute describes this as “not a bill for making America healthy again, but a disastrous bill that will reignite HIV in the United States.” The Foundation for AIDS Research projects that ending prevention funding alone could lead to 144,000 new HIV diagnoses, 15,000 deaths, and $60.3 billion in healthcare costs by 2030.

The Senate Appropriations Committee rejected these reductions by a bipartisan vote of 26–3, maintaining existing levels for domestic HIV prevention programs. This outcome offers temporary stability, but reconciliation between House and Senate versions remains uncertain.

Immediate Actions Required

The NASTAD analysis warns that the convergence of federal coverage losses and funding reductions could force ADAPs into crisis conditions reminiscent of 2010. While states can employ fiscal management strategies to delay the impact, the core solutions lie in federal policy.

Congress must extend enhanced Premium Tax Credits through at least 2027 to stabilize the individual marketplace and prevent subsidy loss for people living with HIV who rely on private coverage. Lawmakers should reject proposed eliminations of Ryan White Part F and CDC HIV prevention funding, which have produced measurable long-term savings by reducing new infections and sustaining treatment continuity. Maintaining these investments is far less costly than responding to the resurgence of uncontrolled HIV transmission.

States also play a central role. Strengthening coordination between Ryan White programs, ADAPs, and marketplace enrollment systems, as demonstrated in California and New York, can mitigate insurance disruptions and preserve treatment adherence during policy transitions.

NASTAD emphasizes that continuity of care must remain the guiding principle throughout any period of programmatic change. Ensuring uninterrupted access to medication, case management, and communication between providers and clients is critical to maintaining public trust and preventing viral rebound.

The intersection of these federal policies represents a defining test for HIV care in the United States. The ADAP crisis of 2010 showed that delay has a human cost measured in treatment lapses and preventable deaths. Policymakers again face a choice between sustaining a proven safety net or repeating the mistakes that history has already documented.

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.