The Last Clean Snapshot: What the CDC's 2024 HIV Data Tells Us About What Comes Next

The Centers for Disease Control and Prevention (CDC) released its National HIV Prevention and Care Objectives: 2026 Update on May 18, 2026, presenting the most recent national picture of the U.S. HIV care continuum. Among the roughly 38,434 people aged 13 and older diagnosed with HIV in 2024, 83.1% were linked to care within one month. Among the 1,103,895 people living with diagnosed HIV at year-end 2024, 77% received some care, 56% were retained in care, and 69% achieved viral suppression. The data are provisional, reflecting reports through December 2025 with a standard 12-month reporting delay per National HIV Surveillance System protocols.

The CDC's own summary notes these data "highlight the need for continued efforts to meet national HIV prevention and care goals." That is the agency saying out loud what every advocate already knows. The 2024 numbers are the last clean snapshot before a converging set of federal and state policy decisions begins reshaping what the next continuum-of-care report will show.

Where the System Is Failing People

The CDC data identifies precisely where the care continuum loses people, and the disparities are not subtle.

At diagnosis, 7.8% of people received a stage 0 classification, the marker of very early detection, with the highest rates among people aged 13–24 (11.2%) and American Indian/Alaska Native people (14.1%). On the other end, 21.7% received a stage 3 (AIDS) classification at diagnosis, reflecting late-stage disease and missed testing opportunities. Late diagnoses were concentrated among people aged 65 and older (35.5%), Asian and Native Hawaiian/Pacific Islander people (25.6% each), and people with HIV attributed to heterosexual contact (25.1%).

Linkage to care within one month ran at 83.1% overall, lowest among Black/African American people (80.8%), people with HIV attributed to injection drug use (80.2%), and people living in the South at the time of diagnosis (81.5%).

The retention figures are where the system's structural fragility becomes most visible. Of people living with diagnosed HIV, 77.0% received some care during 2024, but only 56% met the threshold for retention. That 21-point gap is the difference between a single lab visit and the sustained engagement that produces viral suppression. Viral suppression itself reached 68.5% nationally, with the lowest rates among people with HIV attributed to injection drug use (57.2%), Native Hawaiian/Pacific Islander people (63.9%), people aged 65 and older (65.8%), residents of the Northeast (66.7%), and women (67.8%). Six-month viral suppression after diagnosis hit 71.1% overall, dropping to 57.9% among people with HIV attributed to injection drug use and 69.2% among people diagnosed in the South.

These are not statistical curiosities. The populations at the bottom of each chart are the same populations most exposed to the safety-net erosion now underway.

Reading the Baseline Correctly

Before drawing conclusions from these numbers, we have to be honest about what produced them. The 2024 data does not reflect a steady state. It reflects a system already absorbing serious strain.

AIDS Drug Assistance Programs (ADAPs) served 257,644 people in 2024 across 49 reporting jurisdictions, representing roughly 23% of all people living with diagnosed HIV in the United States. ADAPs achieved an 87% viral suppression rate among clients served, eighteen points above the national rate, within a client population where 65% live at or below 200% of the Federal Poverty Level. That suppression rate is what targeted public health infrastructure produces when it functions. It was also achieved while ADAPs absorbed a 30% surge in new enrollments during the post-COVID Medicaid unwinding, and while inflation-adjusted federal ADAP appropriations declined 31% since 2005.

The 2024 baseline is what an under-resourced safety net can deliver on its best day. The resources are about to thin further.

What's Already Moving

The policy environment shifting around these numbers is not theoretical. It is on the calendar.

Federal funding. The FY26 Labor, Health and Human Services appropriations bill, finalized in February 2026, rejected approximately $2 billion in proposed cuts and preserved Ryan White at $2.6 billion, the Ending the HIV Epidemic initiative at $165 million, and CDC HIV/Viral Hepatitis/STD/TB Prevention at $1.384 billion. The Minority HIV/AIDS Fund was cut by $4 million. As the American Academy of HIV Medicine noted, flat funding will not achieve the goals set out in the Ending the HIV Epidemic plan or address recent transmission outbreaks. A floor is not a plan.

State ADAP retrenchment. Twenty-three states (including DC) have implemented or are considering ADAP cost-containment measures per NASTAD data. Florida reduced ADAP eligibility from 400% to 130% of the Federal Poverty Level on March 1, 2026, and removed Biktarvy, which accounts for 52% of the U.S. antiretroviral market, from its formulary. State legislation in mid-March restored $31 million through HB 697, recovering eligibility for over 11,000 people, but the underlying fiscal pressure remains. Arkansas, Louisiana, and New Jersey report considering waiting lists, a measure not used in over a decade.

Coverage and housing. H.R. 1's Medicaid cuts and work requirements threaten coverage for 42% of Medicaid enrollees with HIV. Enhanced ACA premium tax credits expired, producing an estimated 114% premium increase for subsidized enrollees and benchmark premium increases of 26% nationally, with 33% in Florida and 35% in Texas. The President's FY27 budget proposed eliminating HOPWA, the Housing Opportunities for Persons with AIDS program, funded at $529 million in FY26. On May 20, 2026, the House Appropriations Committee released its FY27 Transportation, Housing and Urban Development bill flat-funding HOPWA at $529 million, a reversal from the House's prior posture. Holding the line against elimination matters. Flat funding also does not house anyone new in a year when rents and homelessness are both climbing.

Each disparity in the CDC data maps onto a population now losing safety-net protection. Northeast residents with the lowest viral suppression face mounting Medicaid pressure. Southern residents and Black people with the lowest linkage rates are losing ACA tax credits in states where premiums rose most. People with HIV attributed to injection drug use, who post the lowest suppression rates across every cut of the data, face continued federal funding restrictions on sterile syringes despite the public health evidence supporting harm reduction.

Tools Ahead of the Rails

The clinical pipeline is running well ahead of the delivery system. CROI 2026 confirmed the efficacy of twice-yearly injectable lenacapavir for PrEP at 0.07 per 100 person-years incidence in PURPOSE 1 and 0.11 in PURPOSE 2. The VOLITION study showed 85% of treatment-naive adults opted to switch from daily pills to bimonthly long-acting cabotegravir/rilpivirine, with 95% maintaining suppression. Yet injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of total PrEP use globally, and 38% of ADAPs report difficulty implementing long-acting injectables and provider-administered drugs. The populations falling furthest behind in the CDC data are the same populations least likely to access these options today.

Defending the Baseline

The 2024 data identifies what needs protecting. Specific action remains available to the actors with authority.

Congress should increase the federal ADAP earmark to reflect documented enrollment growth and pursue Ryan White HIV/AIDS Program reauthorization, lapsed since 2013. Congress should reinstate and make permanent the enhanced ACA premium tax credits and require safety-net impact assessments in future drug pricing legislation. Congress should preserve HOPWA at no less than $529 million through conference and final passage of FY27 THUD appropriations. State Medicaid programs and ADAPs should design formularies that follow federal HIV treatment guidelines and reject prior authorization and step therapy on antiretrovirals. The Department of Health and Human Services and CDC should protect community-led surveillance and demographic data collection. We cannot close gaps we refuse to measure. Payers and ADAPs should expand coverage for long-acting prevention and treatment options and remove administrative barriers that delay access.

The Numbers We Are Choosing

The 2027 continuum-of-care report will reflect decisions being made right now, in state capitals enforcing ADAP cuts, in Congress drafting FY27 appropriations, in the implementation of H.R. 1, in what data the federal government continues to collect. Ending the HIV Epidemic remains possible at every level of analysis. So does walking backward from 69% viral suppression. The CDC has published the map of who is most at risk. Every actor with policy authority can read it. What shows up in the 2027 release will reflect what they chose to do with that information.

When the Target Is SSRIs, the Risk Is the Six Protected Classes

On May 4, 2026, Health Secretary Robert F. Kennedy Jr. closed a daylong Make America Healthy Again (MAHA) Institute summit on mental health and overmedicalization by announcing a federal initiative to reduce the use of selective serotonin reuptake inhibitors (SSRIs). The package includes new Centers for Medicare & Medicaid Services (CMS) reimbursement codes for clinicians who help patients taper off antidepressants, forthcoming Substance Abuse and Mental Health Services Administration (SAMHSA) training modules, a technical expert panel to develop deprescribing clinical guidelines, and a "Dear Colleague" letter to providers urging non-pharmacologic alternatives. No major medical organizations participated in the summit. Kennedy described the goal as ending "unnecessary dependence on medication" and returning control to patients. For readers familiar with how Medicare Part D's six protected classes (6PC) have been contested over the past two decades, the announcement reads less as a discrete clinical reform than as a foothold.

What Was Announced, and What the Evidence Says

The administration's framing rests on contested and, in some cases, fabricated premises. Kennedy has claimed, without evidence, that SSRIs are partly responsible for school shootings, a claim he first advanced during his confirmation hearings and repeated at the May 4 summit. He has also stated that SSRIs are harder to quit than heroin. The withdrawal evidence is more measured: a 2019 British study reported 56% of patients experienced withdrawal symptoms, while a 2024 placebo-controlled German analysis found roughly one in six experienced withdrawal effects and about 3% described them as severe. Roughly 16.6% of U.S. adults currently take an SSRI, and the American Psychiatric Association (APA) considers SSRIs a first-line, evidence-based treatment for depression.

The APA called the administration's framing an "oversimplification" that "ignores the larger reality" of access barriers to mental health care. Dr. J. John Mann of the New York State Psychiatric Institute was more direct, telling Reuters that "restricting use of these medications is not justifiable medically". The American Foundation for Suicide Prevention emphasized that decades of clinical, population-level, and health-system data show judicious antidepressant use reduces suicide risk overall.

Some elements of the initiative are defensible. Better tapering support, stronger informed consent, and broader access to talk therapy reflect long-standing clinical recommendations. The concern lies in what surrounds those elements.

A Reported Exploration of a Ban

Four days after the summit, Reuters reported that two sources familiar with internal discussions said HHS officials had explored whether the agency could ban specific drugs within the SSRI class in the week before Kennedy's announcement. HHS spokesman Andrew Nixon denied the discussions had occurred. The Food and Drug Administration (FDA) does not have authority to unilaterally ban approved medications absent new safety evidence, and manufacturers can refuse withdrawal requests, as Amgen did with Tavneos in April 2026. The reporting does not establish that a ban is imminent. It does establish that the agency's internal direction outpaces its public posture.

What the 2004 Black Box Warning Should Teach Us

Federal messaging about antidepressant risk has a documented track record of producing harm. The FDA's 2003 and 2004 advisories, followed by the October 2004 boxed warning on pediatric antidepressants and its 2007 extension to young adults, were based on a meta-analysis never designed to measure suicidality and that recorded no completed suicides. Subsequent research by Stephen Soumerai and Christine Lu found that rates of depression diagnosis, clinical visits, and antidepressant prescribing dropped by roughly one-third, while youth suicide attempts and deaths rose. No study has demonstrated that the warnings improved mental health outcomes. The lesson: federal rhetoric that vilifies a class of medications drives patients away from care, and the patients who disengage are often those at highest risk.

Why This Reaches the Six Protected Classes

Antidepressants are one of six therapeutic classes that Part D plans must cover "all or substantially all" drugs within. The other five are anticonvulsants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. The policy was established through CMS guidance in 2005, codified by the Medicare Improvements for Patients and Providers Act in 2008, and reinforced by the Affordable Care Act in 2010. It exists because Congress recognized that insurers, left to their own design, would engage in adverse selection against the sickest enrollees.

The 6PC have been targeted before. In January 2014, CMS proposed removing protected status from antidepressants, antipsychotics, and immunosuppressants. The proposal was rescinded within two months after opposition from patient groups, providers, manufacturers, and lawmakers. In May 2018, the first Trump administration's "American Patients First" Blueprint signaled renewed interest in weakening 6PC protections. In January 2021, the CMS Innovation Center released a Part D Payment Modernization Model Request for Applications that would have allowed participating plans to bypass the 6PC requirement for five classes starting in 2022, and for antiretrovirals starting in 2023. The HIV Health Care Access Working Group, of which CANN is a member, warned that restricting antiretrovirals would produce disruptions to care, decreased rates of viral suppression, increased rates of new infections, and more drug resistant strains of HIV. The Biden administration rescinded those changes.

People living with HIV (PLWH) have an immediate stake in this fight. Co-occurring serious mental illness and substance use disorders are common among PLWH, and the same statutory architecture that guarantees access to antiretrovirals also guarantees access to antidepressants and antipsychotics. Erosion of that architecture for one class establishes precedent for the others. A 2024 Health Affairs analysis from Weill Cornell Medicine estimated that removing protected class regulation could have reduced prescription drug spending by approximately $47 billion between 2011 and 2019, a figure that will be cited by anyone seeking to revisit the policy. The savings argument is not hypothetical, and it is not new. What they fail to factor into the equation (or willfully ignore), is that those saved dollars equal lost treatment access for real patients. There is always a cost, this one would be human.

The Pattern Around the Initiative

The SSRI initiative is not arriving into a stable regulatory environment. Since January 2025, HHS has eliminated the Administration for Community Living, the only federal agency dedicated to community living and civil rights for disabled and older Americans. HHS Office for Civil Rights staffing was cut and half of its regional offices closed. On May 12, 2025, the administration paused 2024 final rules requiring insurers to disclose how they restrict mental health claims under the Mental Health Parity and Addiction Equity Act. H.R. 1, signed July 4, 2025, imposed Medicaid work requirements and reduced Medicaid funding by more than $1 trillion over a decade. The Leadership Conference Health Care Task Force described the cumulative effect as a "wholesale assault on public health."

A campaign to reduce SSRI use, taken on its own, would warrant clinical debate. Layered onto this regulatory environment, it warrants vigilance.

What Advocates Should Watch and Do

Several specific actions matter now. First, monitor SAMHSA's forthcoming prescribing trend data and the deprescribing clinical guidelines expected this summer. The language used to justify reduced antidepressant utilization can be repurposed against other protected classes, particularly antipsychotics, which share co-prescribing patterns with antiretrovirals among PLWH with serious mental illness. Second, watch CMS for any Part D rulemaking or demonstration authority that quietly modifies formulary requirements. The 2021 Payment Modernization Model was rescinded because a broad coalition of cancer, HIV, mental health, and disability advocates spoke with one voice; that coalition infrastructure should be reactivated and ready. Third, engage in any HHS comment period touching deprescribing guidance, formulary design, or utilization management. Fourth, document and report plan-level changes affecting antidepressant or antiretroviral access, including new prior authorization requirements or step therapy protocols. Fifth, communicate clearly with patients that current treatments remain covered and that medical decisions belong with them and their clinicians. The chilling effect documented after the 2004 black box warning was driven by media coverage, not by any actual loss of access. We can blunt that effect by keeping accurate information in front of the communities we serve.

For PLWH and the organizations that support them, the connection to Ending the HIV Epidemic is direct. Viral suppression depends on uninterrupted access to the right antiretroviral regimen for each patient, and that access depends on the statutory protections that the 6PC framework provides.

What Comes Next

The SSRI initiative may proceed entirely within the bounds of clinical policy. The deprescribing codes may improve care. The training modules may help clinicians who have long lacked tapering expertise. The protected classes may remain untouched. None of that is guaranteed, and the past eighteen months of HHS reorganization give us no reason to assume the most benign interpretation. What we can do is read the policy direction accurately, engage the regulatory process the way our coalitions have engaged it before, and keep the communities we serve informed. The six protected classes have survived three administrations' attempts to weaken them. Keeping them protected is ongoing work.

The Policy Stack: How SAMHSA, the White House, and Louisiana Are Rewriting Drug and Homelessness Response

On April 24, 2026, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a Dear Colleague letter that withdraws federal funding eligibility from fentanyl test strips, sterile water, saline, ascorbic acid, sterile syringes, safer smoking supplies, and overdose hotlines. Signed by Principal Deputy Assistant Secretary Christopher Carroll, the letter operationalizes the July 2025 Executive Order directing the agency to defund what the order termed "so-called harm reduction" programs. This action arrives as Louisiana's House Bill 211 advances toward the state Senate, threatening fines and imprisonment for unauthorized public camping. Together, these federal and state moves construct a coordinated policy framework that abandons decades of evidence on what prevents HIV and HCV transmission, reduces overdose mortality, and connects people who use drugs to treatment.

For people living with HIV and HCV, people who inject drugs, and people experiencing homelessness, these are not parallel debates. They are the same policy question, asked at different levels of government.

What the Updated Guidance Actually Removes

The April 2026 letter preserves SAMHSA funding for naloxone and nalmefene, medication lock boxes, sharps disposal, wound care, FDA-approved home testing kits for HIV and viral hepatitis, navigation to PrEP and PEP, and condom distribution. It eliminates funding for fentanyl, xylazine, and medetomidine test strips intended for use by people who use drugs, alongside syringes, safer smoking supplies, sterile water, saline, ascorbic acid, and overdose hotlines that provide a remote companion to people while using.

This represents a significant retreat from the July 2025 SAMHSA guidance, which had preserved test strips even as it shifted the agency's overall framing. STAT News notes that the test strip policy reverses a position the federal government held since 2021. The carve-out permitting test strip purchases for law enforcement, emergency medical services, and healthcare professionals captures the structural problem: test strips work because they reach people before an overdose, not after. Each strip costs roughly one dollar. Rachel Winograd, who oversees Missouri's central warehouse for overdose prevention supplies, confirmed her usual order for 80,000 test strips on the afternoon the SAMHSA letter arrived in her inbox.

A second letter issued the same day warns grantees against medication-only treatment for opioid use disorder, encouraging clinicians to review continued use of methadone or buprenorphine "at least annually." As STAT observed, current standards of care do not support withholding medication from patients who decline psychosocial services, and the ASAM guideline the letter cites contradicts that framing.

The Evidence the Policy Discards

Syringe services programs (SSPs) are among the most studied public health interventions of the past three decades. A meta-analysis of more than 6,000 patients found a 58% HIV transmission risk reduction among SSP participants. High-coverage programs reduced HCV transmission by 52% in one UK meta-analysis and by 76% in a Cochrane review of nearly 2,500 patients. New York City saw a 29% reduction in HCV prevalence among people who inject drugs after SSP introduction. The economic case is equally clear: full harm reduction averts approximately 70 HCV treatments per 1,000 people who inject drugs, translating to roughly $2 million to $6.7 million in annual savings per 1,000 people based on direct-acting antiviral pricing.

The connection to current epidemiology is direct. HCV infections in the United States increased 124% between 2013 and 2020, largely driven by injection opioid use, and over 75% of overdose deaths in 2023 involved fentanyl. A meta-analysis published in Viruses demonstrated that combined harm reduction with medications for opioid use disorder reduced HCV transmission nearly fourfold compared to limited or absent access. The Department of Veterans Affairs, in its December 2025 analysis referenced in CANN's previous coverage, described SSPs as one of the most effective public health interventions ever devised, with reductions in new HIV and HCV cases of up to 67% and a five-fold increase in the likelihood of achieving abstinence among participants.

The evidence base is not contested in the medical literature. It is contested in federal policy.

The Executive Order's Architecture of Enforcement

The April 2026 SAMHSA letter does not stand alone. Section 4(a)(i) of Executive Order 14321, signed July 24, 2025, directed HHS to ensure SAMHSA grants "do not fund" harm reduction or safe consumption efforts. Section 3 instructs the Attorney General, HHS, HUD, and the Department of Transportation to prioritize discretionary grants for jurisdictions that enforce prohibitions on urban camping, loitering, and squatting, and that move people with mental health conditions or substance use disorder into treatment through civil commitment.

The order's foundational claims warrant examination. It asserts that the "overwhelming majority" of unhoused people are addicted to drugs or have a mental health condition. The data tell a different story: roughly one-third of people experiencing homelessness have a substance use disorder, and roughly one-third have a mental health condition. Penn LDI's Dennis Culhane has observed that housing affordability is the primary explanatory variable in modeling homelessness rates by city or county, and that 84% of households in shelters do not receive Housing First or rental assistance to exit homelessness. The Department of Veterans Affairs implementation of Housing First reduced veteran homelessness by 55%, and the administration has not modified that program.

A federal appeals court ruled on March 31, 2026 that HUD's attempt to cap permanent housing spending at 30% of grants was unlawful, describing the policy as a slapdash imposition of political whims. The administration must now go to Congress to alter that framework.

Louisiana HB 211: The Cascade in Practice

Louisiana's House Bill 211, authored by Representative Debbie Villio, criminalizes unauthorized public camping with fines up to $500 and six months imprisonment for a first conviction, escalating to $1,000 and one to two years with hard labor for subsequent convictions. The bill passed the Louisiana House in April 2026 and awaits action in the Senate Judiciary C Committee.

State officials have acknowledged that supporting the bill could improve Louisiana's standing with the Trump administration when discretionary federal grants are awarded. This is the EO's incentive structure functioning as designed. The downstream context matters: Louisiana has the nation's highest poverty rate and the highest incarceration rate in the Western world. About 60% of Louisiana's unhoused population is Black despite the state being 30% Black. Roughly one in three Louisiana households are extremely low income, and the National Low Income Housing Coalition estimates a shortage of more than 100,000 affordable homes for those families. New Orleans Councilmember Lesli Harris compared the bill to internment camps and warned it would produce no lasting housing or services.

The Homelessness Court program created by HB 211 allows participants to have charges dismissed upon successful completion, but defendants may be required to pay for treatment costs, with courts authorized to mandate unpaid labor when payment is impossible. Pastor Jeremy Babineaux, quoted in KPLC's coverage, asked the question that the bill's text does not answer: how do unhoused people pay fines and program fees when they cannot afford housing in the first place?

Where the Syndemics Compound

Harm reduction defunding does not happen in a vacuum. Encampment sweeps, civil commitment mandates, and treatment-first housing conditions interact with the loss of test strips, sterile supplies, and overdose hotlines to produce harms that exceed the sum of their parts. For people who inject drugs and live with or are at risk for HIV or HCV, the result is a policy environment that systematically severs the connections that public health depends on.

Sweeps and criminalization disrupt continuity of care in concrete, documented ways. Research compiled by the National Alliance to End Homelessness finds that enforcement actions cause loss or destruction of legal documents, medical equipment, prescriptions, and personal effects, while displacing people from the locations where outreach workers and providers know to find them. People moved from one public area to another lose contact with street medicine teams, syringe services, and the case managers who help them apply for Medicaid or get on antiretroviral therapy. Those connections are how the Ending the HIV Epidemic and HCV Elimination plans actually reach the populations that drive ongoing transmission.

The economics are not subtle. Chronic homelessness costs taxpayers approximately $31,000 per person per year under enforcement-driven approaches, while permanent supportive housing with case management costs roughly $10,000 per year. The U.S. Interagency Council on Homelessness has documented that anti-homeless enforcement can cost three times more than housing the same people. Housing First programs, when compared to treatment-first models, reduce homelessness by 88% and, among people living with HIV, decrease emergency department visits by 41%, hospitalizations by 36%, and mortality by 37% within two years, according to research summarized in the AMA Journal of Ethics.

The convergence is what makes the compounding harm difficult to undo. A person who loses access to sterile syringes is more likely to acquire HCV. A person whose encampment is swept loses the ID required to enroll in Medicaid coverage for direct-acting antivirals. A person facing civil commitment or a camping conviction acquires a record that disqualifies them from future housing applications. Each link in the chain, individually defensible to its proponents, produces a population less reachable by the public health system than it was a year ago.

Specific Actions for Advocates

The federal policy framework can be challenged at multiple points. The April 2026 SAMHSA guidance is administrative, not statutory, and Congress retains appropriations authority. The FY2026 Labor-HHS package, as we previously reported, already includes structural protections requiring advance notice before HHS reorganizations and grant terminations. The FY2027 cycle is the next opportunity to direct SAMHSA on allowable harm reduction expenses and to push back on the medication-only treatment framing in the second April 24 letter.

For people working in HIV and HCV care, the most immediate action is documentation. State health departments and Ryan White grantees should be tracking, in real time, the gaps that emerge as SAMHSA-funded programs lose access to test strips and sterile supplies. Quantifying lost services and projected transmission impacts gives appropriators and oversight committees the data they need to act. Sharing that documentation with state public health officials, congressional staff, and the press converts administrative changes into a public record.

For Louisiana readers, HB 211 sits before the Senate Judiciary C Committee. The cost-effectiveness data is unambiguous, and the bill's own structure invites scrutiny: a program that requires payment from people who cannot afford housing, with unpaid labor as the alternative, will not produce the rehabilitative outcomes its sponsors claim. Constituent contact with committee members, paired with testimony from clinicians and people with lived experience, is the most direct lever. The state's existing crisis with HIV transmission and HCV in rural and Delta communities makes the public health case immediate.

At the federal level, Representative Rashida Tlaib's Unhoused Persons Bill of Rights, reintroduced April 30, 2026, calls on HHS to declare the unhoused crisis a public health emergency and proposes universal housing vouchers, expanded rental assistance, and non-carceral approaches to unsheltered homelessness. The resolution will not pass the current Congress, but its cosponsors are the policymakers most likely to move incremental protections through appropriations and oversight.

The Pridgen et al. review published in Harm Reduction Journal in June 2025 outlines additional federal and state actions worth pursuing: amending 21 U.S.C. 863 to decriminalize syringes and drug-checking equipment; protecting Medicaid coverage of PrEP in light of the Braidwood litigation; expanding scope of practice for nurse practitioners and physician assistants to prescribe PrEP; and opposing Medicaid lockouts based on substance use. None of these require the current administration's cooperation. All of them require sustained engagement from the advocacy community.

The Cost of Choosing Ideology Over Evidence

The federal government has, simultaneously, committed to ending the HIV epidemic, eliminating hepatitis C as a public health threat, and reducing overdose mortality. Yet, achieving any of those goals requires reaching the populations whose injection drug use, housing instability, and disconnection from systems of care drive ongoing transmission and death. The April 24, 2026 SAMHSA guidance, the July 2025 Executive Order, and state bills like Louisiana HB 211 move in the opposite direction. They withdraw the tools that connect public health systems to the people they are meant to serve, and they create incentives for jurisdictions to use enforcement against the populations the federal government has committed to helping.

The evidence on syringe services programs, fentanyl test strips, Housing First, and medications for opioid use disorder is not preliminary. It spans decades, multiple meta-analyses, and the operational experience of the Department of Veterans Affairs, which the current administration has chosen to leave intact. The contradiction is the policy.

For us, the path forward is to keep the evidence in front of the people making decisions: appropriators, state legislators, Medicaid directors, hospital systems, and the press. Public health goals like ending the HIV epidemic and HCV elimination are not abstract aspirations. They depend on specific tools, specific funding streams, and specific connections to the populations most at risk. Each test strip removed, each encampment swept, each treatment-first mandate imposed represents a measurable cost to those goals.

Patients deserve policy grounded in what works. The administrative and legislative actions of the past nine months have moved in a different direction. We have the data, the clinical experience, and the cost analyses to make the case for course correction. The work now is to make that case loudly enough, often enough, and to the people with the authority to act.

When Oversight Fails: Iowa's $22 Million Contract Pharmacy Scandal and the Structural Fragility of ADAP Financing

On March 6, 2026, the Iowa Department of Health and Human Services filed a nine-page complaint in Polk County District Court alleging that NuCara Specialty Pharmacy failed to remit more than $22 million in 340B program income generated through the state's AIDS Drug Assistance Program (ADAP). According to the filing, NuCara missed eight months of required monthly payments between October 2024 and January 2026, then used those funds to pay unrelated creditors. Iowa terminated the contract the same day it sued. Three days later, on March 9, the state implemented an ADAP waiting list of 1,106 people, the first such waitlist reported to NASTAD in more than a decade.

The Iowa story differs in important ways from Florida's earlier ADAP crisis. Florida's eligibility cuts and formulary restrictions were political choices made under questionable budget claims and without stakeholder engagement. Iowa's failure is structural: a single contract pharmacy relationship spanning 28 years, an oversight architecture incapable of detecting eight months of missed payments in real time, and a federal financing model that has quietly become majority-dependent on rebate revenue states cannot reliably audit. Both crises produce the same outcome for people living with HIV, but they require different policy responses, and conflating them obscures the specific reforms Iowa now demands.

How the Money Was Supposed to Work

The mechanics matter, because they explain the scope of the loss. Under Iowa's contract with NuCara, the pharmacy ordered medications on behalf of the state at the 340B discounted ceiling price. When clients had third-party insurance, NuCara billed insurers at the standard, non-discounted rate, generating "program income" from the spread. NuCara was permitted to retain a $75 dispensing fee per claim and was required to remit the remaining program income to Iowa HHS each month for reinvestment in the program. The lawsuit alleges that NuCara instead "improperly used those 340B savings to pay other creditors" and "no longer has the capital necessary to pay Iowa HHS the program income required under the Contract." A pending acquisition by OneroRX offers no relief; according to the state, OneroRX does not intend to assume NuCara's liabilities.

Iowa's structural exposure to this kind of failure was unusually concentrated. According to NASTAD's 2025 RWHAP Part B ADAP Monitoring Project Annual Report, Iowa's total FY2023 ADAP budget was $12,996,461, with the federal ADAP Earmark contributing just $1,917,626. ADAP rebates allocated to the broader Part B program reached $12,070,445 in FY2023, up from $7,098,397 in FY2022, a 70% year-over-year increase in rebate dependency. Iowa's recorded state general revenue contribution to ADAP was $0. When NuCara stopped remitting program income, Iowa's ADAP had no state-funded redundancy to absorb the loss. The $22 million now in dispute exceeds Iowa's entire FY2023 ADAP budget.

This concentration is not Iowa's alone. Drug rebates generated through 340B now constitute 52% of total ADAP budgets nationally, with the federal ADAP earmark covering only 29%. Federal ADAP appropriations have remained flat in nominal dollars since FY2014, meaning purchasing power has declined 31% since 2005. The rebate-and-program-income revenue stream has quietly become load-bearing infrastructure for HIV treatment access in this country, and Iowa just demonstrated what happens when that infrastructure has a single point of failure.

The Oversight Vacuum

The federal architecture was not designed to detect this kind of contract pharmacy failure quickly, and Government Accountability Office (GAO) testimony delivered to the Senate HELP Committee in October 2025 had already laid out why. Director Michelle Rosenberg's statement documented that HRSA has implemented only five of 20 GAO recommendations to improve 340B oversight, with 15 remaining unaddressed. The agency does not require covered entities to register contract pharmacies for each individual site, leaving HRSA without complete data on contract pharmacy arrangements nationally. HRSA's guidance to covered entities "lacks specificity as it relates to the scope and frequency" of contract pharmacy oversight, and GAO found that some covered entities "performed minimal contract pharmacy oversight" as a result.

The audit footprint is also vanishingly small relative to program scale. HRSA conducts roughly 200 audits of covered entities per year against a covered entity site footprint that grew from about 20,000 in 2013 to more than 55,000 by 2023. HRSA has told Congress repeatedly, across more than a decade of budget requests, that it lacks the regulatory authority to enforce many of the recommendations GAO has flagged. Iowa was operating within a federal oversight system that GAO itself has documented as insufficient. The eight-month detection lag was not surprising. It was predictable.

A Legislator, a Bill, and a Conflict of Interest

The Iowa case carries a political dimension worth naming directly. Iowa Rep. Brett Barker (R) has served as NuCara's vice president of operations since 2012. He also served on the Iowa Board of Pharmacy from May 2017 to December 2021. In January 2026, weeks before the lawsuit was filed, Barker introduced legislation that would prohibit drug manufacturers from restricting the delivery of 340B discounted drugs to contract pharmacies, a policy change that would directly benefit contract pharmacy financial interests including NuCara's. Barker has stated he had no operational knowledge of the matters in the lawsuit and that they involved "departments and actions entirely separate from my work."

Whether Barker had operational knowledge is a question for the litigation. The structural concern for advocates and policymakers is broader and material regardless of how the case resolves: contract pharmacy interests have direct legislative representation in Iowa, the patient-facing safeguards on 340B revenue do not, and the state has no disclosure framework that surfaces this kind of conflict before legislation moves. This pattern is replicated in many statehouses, and it shapes which 340B reforms gain traction and which stall.

Why This Matters Beyond Iowa

The April 2026 ADAP Watch places the Iowa scandal within a system already under enormous and mounting pressure. Nineteen ADAPs report a budget deficit for the current Ryan White HIV/AIDS Program (RWHAP) Part B fiscal year ending March 31, 2027, with Iowa among the nine reporting significant deficits of 5% or greater. Two ADAPs now have active waiting lists (Iowa at 1,106 and Utah at 10), two operate under maximum client caps, and KFF analysis published March 2 documents that 18 states have already adopted cost-cutting changes to ADAPs with five more considering them. The top reported drivers of these deficits include rising per-client drug costs, increasing premium costs, expiration of enhanced premium tax credits, increased client enrollment, and decreased 340B rebate revenue.

The demand pressure is also accelerating. The post-COVID Medicaid unwinding pushed a 30% increase in new ADAP enrollments and an 11% increase in total enrollment compared to 2022. H.R. 1, signed July 4, 2025, is projected to drive an additional surge as more than 10.3 million people lose Medicaid. Iowa's experience is the warning shot. As demand surges and rebate revenue compresses simultaneously, more states are one operational failure away from a waitlist of their own.

What Reform Should Look Like

The temptation in moments like this is to treat the Iowa scandal as a contracting failure, fix the contract, and move on. That response misses the systemic risk the case exposes. Reform needs to address the federal oversight architecture, the state-level operational gaps, and the conflict-of-interest framework that lets contract pharmacy financial interests shape 340B legislation without disclosure. We should be specific about what each level of government should do.

At the federal level, Congress should grant HRSA explicit rulemaking authority over the 340B program. The agency has requested this authority for more than a decade, and the absence of it is the proximate reason 15 of 20 GAO recommendations remain unimplemented. Rulemaking authority should include the power to require site-level contract pharmacy registration, mandatory program income reporting from contract pharmacies serving covered entities, and enforceable corrective action plans following audits. Congress should also increase the federal ADAP earmark to reflect documented enrollment growth and reduce the structural overdependence on rebate revenue that now constitutes 52% of total ADAP budgets. A safety net program majority-funded by a revenue source no federal agency reliably tracks is a safety net engineered for this kind of failure.

At the state level, ADAPs should require monthly attestation and independent audit of contract pharmacy program income remittance. An eight-month detection lag is unacceptable when the funds at stake support life-sustaining medication for people living with HIV. State health departments should also reassess single-vendor dependencies. Iowa's 28-year relationship with NuCara is not unusual in ADAP procurement practice, but the Iowa case demonstrates that contract longevity is not a substitute for ongoing operational scrutiny. Where feasible, ADAPs should diversify contract pharmacy arrangements to eliminate single points of failure, and HRSA's HIV/AIDS Bureau should issue updated guidance encouraging this practice.

State legislatures should adopt conflict-of-interest disclosure requirements for legislators with operational or executive roles at 340B covered entities, contract pharmacies, or third-party administrators. The Iowa case illustrates why this matters. Contract pharmacy interests routinely shape state-level 340B legislation, and patients have no comparable seat at the table. Disclosure does not resolve the underlying tension, but it surfaces it for voters, advocates, and other legislators in time to inform debate.

Patient advocates should also continue pressing for a clear federal definition of "patient benefit" tied to reporting requirements, as CANN's 340B Policy Director has argued in prior analysis. The 340B program was designed to stretch federal resources to reach more eligible patients, not to function as an opaque revenue stream for intermediaries. The recently introduced ACCESS Act and the SUSTAIN 340B discussion draft offer frameworks worth pressure-testing in Congress, and the Iowa case provides a concrete example of why federal standards cannot wait.

The Patient Stake

The 1,106 Iowans now on an ADAP waiting list did not create this failure. They did not negotiate a 28-year single-vendor contract, did not write the federal statute that left HRSA without enforcement authority, and did not introduce legislation that would expand the financial interests of the company that allegedly mishandled their program income. They are simply trying to access HIV treatment, and the architecture built to support that access has now demonstrated a failure mode that other states are structurally exposed to.

The Ending the HIV Epidemic initiative depends on sustained viral suppression, which depends on consistent treatment access, which depends on programs like Iowa's remaining solvent and operationally sound. The reforms outlined here are not abstract. They are the conditions under which a national strategy launched in 2019 can actually succeed. We have the data, we have the GAO recommendations, and we now have a $22 million case study showing what happens when those recommendations sit on a shelf. What we need is the political will to act before more patients find themselves without medication and sitting on a waiting list, praying for someone to do the right thing.

The Recipe for Change: From Surviving Appointments to Changing Policy

For a long time, I thought advocacy meant surviving the next appointment.

I thought it meant learning how to explain my pain better, how to prepare for another referral visit, how to justify why I was missing work, school, or pieces of my life to something I didn't even understand for so long, while it was reduced to just part of "being a woman." Like many patients with endometriosis, I spent years fighting to be believed before I ever understood how much of that fight was never actually about me — it was about the system itself. That realization changed everything.

Endometriosis is often treated like an isolated women's reproductive issue, but it is one of the clearest examples of systemic failure in the 21st century. Delayed diagnosis, insurance denials, medical gaslighting, lack of ADA recognition, and repeated surgical barriers are not separate problems. They are connected outcomes of the same design failure.

Cases like Virginia OBGYN Dr. Perwaiz from 2021, who was sentenced for needlessly operating on dozens of women, are often discussed as individual scandals. However, they reveal something much larger — when patients are repeatedly dismissed, overtreated, undertreated, or financially trapped, we are not looking at exceptions. We are looking at a pattern. That pattern is expensive.

In the United States alone, endometriosis carries an estimated annual economic burden of $69 to $86 billion. Patients lose an average of 11 hours of productivity every week, with more than six hours from workplace productivity and nearly five from household responsibilities. That means reduced income, missed promotions, family strain, disability use, and careers reshaped by a disease that many providers still misunderstand. Endometriosis does not just take time away from work. It takes time away from living. That is where policy enters, and that is the part most people do not realize.

Congress may not perform surgery, but Congress influences whether research gets funded. NIH shapes how the disease is defined and studied. HHS drives oversight and accountability. CMS determines reimbursement structures that decide whether trained specialists can remain accessible. CPT coding through the AMA shapes how complex excision surgery is valued. FDA pathways matter when diagnostics and treatment development are still being built on outdated definitions. Then we have ACOG, which is responsible for surgical and treatment guidelines.

This is where advocacy becomes a civics lesson.

Through the American End of Endo Project, we teach people that advocacy means understanding where decisions are made and how to plug in. Our advocacy workshop says it best — advocacy means knowing who is in the kitchen, what they are cooking, and where you can add your ingredients to make the biggest impact. We walk patients through the three branches of government, how a bill becomes law, how appropriations language works, and why constituents matter. We show them how to find their lawmakers, identify committee assignments, understand representative priorities, and make a clear, direct ask. We also share how to use their lived experience to tie it all together.

Most people assume policy work belongs to lobbyists or large organizations. But some of the most meaningful movements happen because ordinary patients decide to keep showing up.

This past year, our AEEP "Oceans 4" team worked together to help contribute to federal appropriations language recognizing endometriosis as a chronic, systemic, inflammatory disease — not simply a reproductive disorder. That language encourages the NIH to use an updated, evidence-based definition aligned with current scientific understanding and to move research away from outdated narratives that have harmed patients for decades. No lobbyists. No big corporate backing. Just lived experience, and persistence. That is exactly what it was.

What looks like one paragraph in federal report language was actually months of calls, follow-ups, research, relationship-building, and learning how to communicate inside rooms never built for patient voices. It meant learning which offices mattered, which committee staff shaped decisions, and how appropriations in one place could springboard conversations with HHS, CMS, and broader federal accountability. That is the unique part of this process.

People often ask how I keep all the moving parts straight, and honestly, the answer is that advocacy becomes less overwhelming when you stop seeing it as random and start seeing it as systems working together, like a giant machine. One meeting leads to another. One appropriations request opens a door to reimbursement reform. One state conversation on PBM transparency connects to broader affordability reform. One workshop creates ten new advocates who now know how to speak to their own legislators. That ripple effect matters.

I saw this clearly during roundtable discussions on PBM transparency and patient affordability this March in Denver. Conversations focused heavily on cost, but I brought in the nuance that patients are still being prescribed treatments based on outdated and even falsified data. Too many people are pushed into repeated hormonal suppression, unnecessary hysterectomies, or endless "band-aid" medication cycles because the healthcare system has not caught up to the evidence. The response in the room was simple — things just need to catch up.

Patients do not live in policy timelines. They live in bodies that are expected to function a certain way.

When a six-hour excision surgery performed by a highly trained specialist is reimbursed similarly to a short procedure done by someone without disease-specific training, that is a structural failure. When insurance companies refuse to recognize surgical complexity, patients are forced into out-of-network care, massive financial loss, or dangerous delays. That is why CMS billing reform and CPT coding reforms matter so much. This is also why the battle is not won and has really just begun.

The appropriations language created a foundation, but there is still work ahead — CMS and CPT coding reform, continued HHS collaboration, FDA pathways for diagnostics and treatment development, and broader agency engagement across the federal landscape. We now have abbreviated agencies mapped and active areas of action to pursue. Genuine collaboration creates movement. That is what success looks like in advocacy. Not a single victory, but a structure being built.

For me, the shift happened when I stopped asking, "How do I survive this appointment?" and started asking, "Who controls the system creating this outcome?"

That changed everything.

Sometimes advocacy looks like legislation. Sometimes it looks like a congressional workbook with references. Sometimes it looks like a workshop teaching Civics 101 to patients who never realized they belonged in those rooms. Because they do.

Real change happens when communities rise up. Every story told, every meeting held, and every voice added creates pressure that systems cannot ignore. Endometriosis is not a niche issue. It is a public health issue, an economic issue, and a human issue. It certainly constitutes a public health crisis at this time.

Once patients understand where they can add their seasonings to the ribeye steak to make the most impact — everything starts to change.

Building Stronger Communities, Together: Reflections from Our Patient Affordability Roundtable

Editor's Note: This article was originally published on April 10, 2026, by Lupus Colorado and is republished here with permission. The Patient Affordability Roundtable discussed in this piece was hosted in partnership with Community Access National Network. Lupus Colorado, led by CEO Kristy Kibler, works to improve the lives of people affected by lupus through advocacy, education, and support services across Colorado. Their work on patient affordability, community building, and state-level policy advocacy strengthens the broader chronic disease patient community that CANN serves. To learn more about Lupus Colorado or donate to support their work, visit LupusColorado.org.

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Patient advocates and community organization leaders from across the country convene at the Patient Affordability Roundtable, hosted by Lupus Colorado in partnership with Community Access National Network.

At Lupus Colorado, we know that real progress happens when people come together, share openly, and commit to lifting one another up. That spirit was fully alive at our recent Patient Affordability Roundtable, hosted in partnership with Community Access National Network. This gathering brought together a powerful group of advocates and organizations, including End of Endo Project, Mamas Facing Forward, Chronically Informed, ACT NOW, CF United, Chronic Care Collaborative, Michigan Lupus Foundation, National Bleeding Disorders Foundation- CO and Colorado Patients Taking Action.

Centering Community as a Strategy

One of the most meaningful threads throughout the roundtable was a deep and intentional conversation about community building, not just as a value, but as a strategy for change.

We had the opportunity to dig deeper into what it truly takes to build and sustain a strong, effective community. At Lupus Colorado, we see every day that investing in people drives lasting change. Our ongoing collaboration with partners like ACT NOW, CF United, and Chronic Care Collaborative reflects a shared commitment to trust, connection, and leadership that strengthens the entire ecosystem. When we intentionally support one another and follow through on that investment, individuals step forward not just to participate, but to lead, advocate, and create meaningful change for their communities.

That insight carried throughout the conversation. Community is not built overnight. It is cultivated through consistency, care, and a willingness to grow together.

A Deeper Look at Affordability and Who It Impacts

Building on that foundation, the group explored one of the most important questions in our work: how we define affordability.

Too often, systems are designed around averages, what works for a typical patient. But in our communities, especially among those living with complex, chronic conditions like lupus, there is no such thing as typical.

We discussed the distinction between common and complex patient experiences and how policies that appear effective on paper can fall short when applied to real lives. This conversation reinforced a shared understanding that affordability must reflect lived experience, not simplified models.

Learning Across State Lines

These conversations naturally expanded into a broader exchange of ideas across states.

While each state operates within its own policy landscape, many of the challenges we face are deeply aligned. From patient protections to reimbursement policy and affordability frameworks, participants shared both barriers and promising approaches.

There is real momentum in learning from one another. Every insight shared strengthens our collective ability to advocate more effectively and to bring forward solutions that are grounded in both policy and lived experience.

Policy Conversations That Matter

With that shared understanding, the roundtable created space for focused, solutions-oriented policy discussion.

We explored key issues including PDAB reform, concerns related to QALYs, PBM loopholes, and fiduciary responsibility, along with the importance of rebate pass through, stronger patient protections, and oversight of Alternative Funding Programs to ensure patients are not unintentionally burdened. The conversation also emphasized the importance of building informed legislative champions who can advance patient-centered solutions.

Honoring the Patient Voice

Equally important was an honest conversation about the human side of advocacy.

For many individuals, participating in the legislative process means revisiting deeply personal experiences. We acknowledged the reality of re-traumatization and the responsibility we share to create spaces that are not only impactful, but also supportive.

Advocacy should empower, not exhaust. As a community, we are committed to elevating patient voices in ways that also protect and support those who share their stories.

Moving Forward, Together

What emerged from this convening was more than a list of challenges. It was a shared sense of direction and a renewed commitment to working together.

We move forward with stronger relationships, new ideas, and deeper alignment around how to create meaningful change. By continuing to invest in our community, elevate patient voices, and collaborate with partners across the country, we are building a future where access, affordability, and dignity are not aspirations, but expectations.

Together, we are shaping systems that work better, care deeper, and reach further. And that is where real progress begins.

The Story of Us: How Celebrity Voices Have Shaped HIV Advocacy for Four Decades

On April 1, Taylor Swift dropped a surprise music video for her song "Elizabeth Taylor," directing streaming royalties to the Elizabeth Taylor AIDS Foundation (ETAF). Two weeks earlier, on March 18, stars from six Real Housewives franchises descended on Capitol Hill to press lawmakers on the thousands of Americans at risk of losing access to HIV medications. Three days before that, the Elton John AIDS Foundation's (EJAF) annual Oscar viewing party raised $10.6 million for the fight against HIV. And last week, Time reports that Ciara has re-recorded her hit "1, 2 Step" for Gilead's "One2PrEP" campaign to raise awareness about pre-exposure prophylaxis (PrEP), including a twice-yearly injectable that reduces the risk of HIV by 96% to 100%.

That is a lot of celebrity firepower pointed at HIV in a very short window. And the timing matters, because the policy ground beneath people living with HIV is shifting fast.

According to KFF data cited by The 19th, 18 states plus Washington, D.C. have already cut AIDS Drug Assistance Programs (ADAPs), and 12 more are weighing further reductions. Federal funding for these programs has remained flat since 2014. Florida has slashed ADAP eligibility from 400% to 130% of the federal poverty level, a move expected to cut more than 10,000 people from the program. The state also plans to stop covering Biktarvy, the most widely prescribed antiretroviral medication in the country. Medicaid cuts signed into law have compounded the pressure: roughly 4 in 10 people living with HIV rely on Medicaid. And as Lindsey Dawson, director of LGBTQ health policy at KFF, told The 19th: drugs have gotten more expensive, more people living with HIV are relying on Ryan White, and the funding has not kept pace.

So when NeNe Leakes, Erika Jayne, Phaedra Parks, Melissa Gorga, Candiace Dillard Bassett, Marysol Patton, and Luann de Lesseps show up to Washington to talk about PrEP access and ADAP cuts alongside lawmakers including Senators Tammy Baldwin and Cory Booker, that is a megaphone being handed to a message that desperately needs one. Dillard Bassett, who worked in the White House during the Obama administration, put the stakes plainly: "The science to end HIV already exists." The challenge, she said, is making sure everyone has access.

Some voices in the advocacy community have grumbled about celebrity involvement in HIV work. The criticism is familiar: they could do more, say more, give more. Maybe. But this critique has a short memory, and the historical record is worth revisiting.

The Blueprint

In the summer of 1985, Elizabeth Taylor was trying to organize the first major celebrity AIDS fundraiser in Hollywood. Studio heads who had profited millions from her films refused to take her calls. Friends declined invitations. As Taylor biographer Kate Andersen Brower has documented, Taylor was told repeatedly to stay away. The industry was, in Taylor's own words, "turning its back on what it considered a gay disease." She would later recall the moment of resolve: "I finally thought to myself, Bitch, do something yourself."

The thing that changed the calculation was Rock Hudson's public AIDS diagnosis in July 1985. His disclosure mobilized Hollywood and forced the Commitment to Life dinner to move to a larger ballroom. The event raised $1.3 million for AIDS Project Los Angeles. Within two months of Hudson's announcement, Congress approved a significant increase in AIDS research funding. And President Reagan, who had mentioned AIDS publicly for the first time only two days before that dinner, did not deliver a formal address on the crisis until May 1987.

Taylor went on to co-found the American Foundation for AIDS Research (amfAR) in 1985 and establish ETAF in 1991, a foundation structured so that 100% of every donation goes directly to the cause. She testified before Congress three times in support of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. Over the last 25 years of her life, she is credited with raising over $100 million for HIV/AIDS-related causes. As researchers Noland, Goodale, Marshall, and Schlecht documented in their 2009 study in the Journal of Health & Mass Communication, Taylor emerged as "the leading celebrity voice and arguably the dominant HIV advocate at a time when there was a political vacuum in HIV leadership."

She did not fill that vacuum alone. Magic Johnson's 1991 disclosure that he was HIV-positive generated 259 AIDS-focused news stories in a single week and caused calls to AIDS hotlines to more than double overnight. As a heterosexual African-American athlete, Johnson broadened the public's understanding of who HIV affects. The red ribbon debuted at the 1991 Tony Awards as a symbol of solidarity, driven by the theater community that had been devastated by the epidemic. Princess Diana's 1987 handshake with an AIDS patient, without gloves, challenged the panic around casual contact at a time when hospital workers were leaving meals outside patients' doors. Elton John, who has said he should have died in the 1980s alongside friends like Freddie Mercury and Rock Hudson, founded EJAF in 1992. The foundation has since raised more than $650 million across 3,100 projects in 102 countries.

Why This Pattern Holds

The data on celebrity impact in HIV awareness is clear. When Charlie Sheen publicly spoke about his HIV status in 2015, the American Psychological Association documented a 265% increase in HIV-related news coverage and 1.25 million searches for HIV, condoms, testing, and symptoms on the same day. As Noland et al. concluded in their generational analysis: celebrities serve as "vehicles and embodiments of concern that act as proxies for their various audiences" and "maintain the primacy of a crucial issue in otherwise fickle media and political spheres."

Ronald Bayer, an expert on AIDS history at the Columbia University Mailman School of Public Health, has also been careful to note that celebrity advocacy has always been a complement to grassroots work, not a substitute. The activists built the movement. The celebrities amplified it to audiences that grassroots organizing alone could not reach.

That dynamic is playing out again right now. The "Housewives on the Hill" event, organized by MISTR, a telemedicine PrEP provider, put cameras and reporters in rooms where lawmakers were hearing directly about the ADAP crisis. Marysol Patton, an original cast member of The Real Housewives of Miami, connected the policy to its human cost in her home state: "When programs like ADAP are weakened, working-class people can't access this treatment." Florida ranks third in the nation for HIV diagnoses.

At the EJAF Oscar viewing party, Sheryl Lee Ralph, a producer on the documentary anthology Unexpected about Black women living with HIV, told Variety that upticks in diagnoses among women of color across the South demand attention, and that many women still have no idea PrEP is available to them. Women accounted for 1 in 5 new HIV diagnoses in the United States in 2022, and new diagnoses occur disproportionately among Black women.

As Fran Drescher put it at the same event: "If you have celebrity and you have social reach, if you don't use it, you're wasting it."

Something Worth Sitting With

We spend a lot of time in this space covering threats: funding cuts, Medicaid erosion, the hollowing out of public health infrastructure. Those fights are real and they are ongoing. But in the span of three weeks this spring, a cross-section of famous people used their platforms to put HIV back in front of millions of people who may not read policy briefs or follow ADAP eligibility changes. They directed money to organizations doing direct-service work. They sat in rooms with lawmakers and talked about PrEP access and Ryan White funding.

Could they do more? Sure. That question applies to all of us. But Elizabeth Taylor started this work in 1985 by simply refusing to be silent when silence was the norm. Forty-one years later, that same impulse is still producing results. The science to end HIV exists. The tools, from antiretroviral therapy to twice-yearly PrEP injections, are here. What we need now is the political will and public attention to make access universal. And any platform, any voice, any audience willing to carry that message forward is one we should welcome.

When Public Health Becomes Profit over Patients

Public health programs like 340B are designed with a clear and urgent purpose: to improve community health, expand access to care, and protect the most vulnerable among us. Whether it’s ensuring access to lifesaving medications, funding prevention initiatives, or supporting safety-net providers, these programs exist because the private market alone has historically failed to meet the needs of all patients equitably.

Yet increasingly, we are seeing a disturbing shift—public health programs are being leveraged, reshaped, and in some cases outright commandeered to serve as revenue streams for for-profit entities. This public health piracy threatens not only the integrity of these programs, but also the patients they were built to serve.

The Original Intent: Patients First

Programs like 340B, Medicaid, Medicare, and drug pricing initiatives were created to close gaps in care, not to create new profit centers. Their structure reflects a social contract: public dollars are invested to achieve public good. That includes expanding access, reducing disparities, and improving outcomes for communities that have long been underserved.

When these programs are used as vehicles for profit maximization, their core mission becomes diluted. Dollars that should be directed toward patient care, support services, and community health infrastructure are instead diverted into complex financial arrangements, administrative overhead, or shareholder returns.

The Rise of Revenue Optimization Strategies

In recent years, strategies by for-profit entities have emerged that allow them to extract value from public programs in ways that were never intended. 

These include:

• Exploiting reimbursement structures to maximize margins rather than improve care delivery

• Using intermediaries and contract arrangements that obscure where funds are actually going

• Shifting focus from patient benefit to financial performance metrics. 

• Leveraging regulatory gaps to operate in gray areas without clear accountability

• While these strategies may be legal, they raise serious ethical and policy concerns. Legality should not be confused with legitimacy—particularly when public health is at stake.

Evidence from Minnesota’s 340B Reporting Initiative

Minnesota’s 340B Covered Entity Report, established to bring transparency to the program, provides critical insight into how 340B revenues are actually distributed. The findings raise serious concerns:

• Significant diversion of funds to middlemen: Payments to contract pharmacies and third-party administrators exceeded $120 million, representing roughly 16–20% of gross 340B revenues.

• Negative financial outcomes for true safety-net providers: Approximately 10% of federal grantees reported negative net 340B revenue after paying fees to contract pharmacies and vendors.

• Less than 2% of 340B net revenues were allocated to federal grantee entities

• Disproportionate gains for large hospital systems: Minnesota providers generated at least $630 million in 340B revenue, with the largest hospital systems capturing the majority of those profits.

These findings illustrate a troubling reality: the 340B program, like many public programs is increasingly functioning as a revenue-generating mechanism for large health systems and corporate intermediaries, rather than a targeted support system for vulnerable patients.

The Impact on Patients and Communities

When public health programs are treated as revenue generators, patients often bear the consequences:

• Reduced access to affordable medications or services, despite programs designed to lower costs

• Fragmented care delivery, as financial incentives drive decision-making

• Erosion of trust in health systems and public institutions

• Widening health disparities, particularly for marginalized populations

At its worst, this dynamic creates a system where the appearance of support exists, but the substance fails the test.

The Accountability Gap

One of the biggest challenges is the lack of transparency and accountability in how funds from public programs are used. Without clear reporting requirements or enforceable standards tied to patient benefit, it becomes difficult to ensure that these programs are fulfilling their intended purpose.

Public dollars should come with public accountability. That means:

• Defining and measuring “patient benefit” in concrete terms

• Requiring transparent reporting on how funds are used

• Ensuring oversight mechanisms that prioritize patient outcomes over financial returns

• Aligning incentives so that doing well financially requires doing right by patients

• Reclaiming the Purpose of Public Health Programs

The solution is not to eliminate partnerships with private entities—these collaborations can be valuable when structured appropriately. But the terms of engagement must be clear: public programs should never be repurposed primarily as revenue engines.

Instead, policymakers, advocates, and stakeholders must work together to:

• Recenter programs on patient outcomes and community impact

• Close loopholes that enable exploitation

• Strengthen guardrails to ensure funds are used as intended

• Elevate patient voices in decision-making processes

At a time when public health challenges are growing more complex—from chronic disease to emerging infectious threats—we cannot afford to let mission drift undermine our most important tools.

Public health programs are not commodities. They are commitments—to equity, to access, and to the fundamental belief that health is a public good. Protecting that vision requires vigilance, transparency, and a willingness to confront uncomfortable truths about how these programs are being misused today. Because when public health becomes a profit strategy, it is patients who ultimately pay the price.

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.