Florida, Once Again, Imperils the Lives of People Living with HIV/AIDS

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The state of Florida is in the process of revamping [deconstructing] its state’s AIDS Drug Assistance Program (ADAP) to exclude nearly half of its current enrollees. That plan hit a roadblock when the Florida Department of Health ignored the state statutes governing administrative procedure, which opened it to an administrative action filed by the AIDS Healthcare Foundation (AHF). The state withdrew its proposal but plans to proceed with it…this time, actually following the rules. It represents a temporary win, but much work remains to be done to protect Floridians living with HIV/AIDS reliant on the program. The Florida Legislature appears to be taking steps to address the crisis, as both the House and Senate budget proposals call for additional funding for the drug assistance program. The Senate's budget proposal includes $118 million, while the House's plan offers only $68 million, which represents about half of the funding needed.

How This Started

The emails started circulating on January 7th, 2026 (see Figure 1):

Figure 1 - Email from an ASO

“ADAP will reduce its [Federal Poverty Level (FPL)] eligibility from 400% to 100%.”

“[Co-pay] assistance will only be provided to participants who meet the new eligibility criteria.”

“ADAP-funded insurance coverage will be discontinued.”

“Only generic medications will be covered.”

And the panic began.

State and national organizations across the country immediately began to both panic and organize:

How can we best support patients who will lose access to their medications, as well as organizations that may face closure as a result of these changes?

The State of Florida Confirms Its Plans

By Thursday, January 8th, 2026, the state of Florida clarified its plans:

Dear Colleagues,

As you are probably aware, ADAP will be moving to a financially sustainable model to benefit the largest population of ADAP clients. We will continue to support the current model (direct dispense, CVS Caremark and insurance) for a two month period to ensure ADAP clients have ample time to seek insurance and medication assistance, if no longer eligible to receive ADAP services through the department. Following this transition period, we will move to direct medication dispensing, capping the eligible federal poverty level at 130%, as well as implementing ADAP formulary changes starting March 1, 2026.

Regarding the formulary changes, Biktarvy will be removed and Descovy will be restricted to only those with renal insufficiency (CrCl <60). All other current ART medications including Tivicay will be available. However, we will monitor cost closely and adjust if needed. A few actions to consider:

• Upon follow up visits, transition to new ART regimen such as Tivicay plus Truvada, other Truvada-based or NRTI-based regimen in combination with integrase inhibitors, or alternative class outside of integrase inhibitors. Please refer to the treatment guidelines: Initiation of Antiretroviral Therapy | NIH.
• For patients on those Biktarvy or Descovy, ensure they have adequate medication until their next clinical visit prior to March 1st.
• For Descovy, providers are required to document the reason: due to CrCl <60 or renal insufficiency on the prescription note section.

Will keep you posted on any additional changes. As always, please reach out if you have any questions.

{Source: U. Choe, personal communication, January 06, 2026}.

So, What Happened?

Florida’s controversial Surgeon General, Joseph Ladapo, stated that the cuts were necessary to prevent a “…projected $120 million shortfall” (Shepard, 2026), but state and national advocates are asking whether or not taxpayer dollars have been illegally diverted or misappropriated (Adamczeski, 2026), pointing to a recent investigation that uncovered the DeSantis Administration’s diversion of $35 million in taxpayer dollars to wage campaigns against two ballot initiatives that would have legalized recreational marijuana use (Amendment 3) and overturned the six-week abortion ban passed by the state legislature (Amendment 4; Mower et al., 2025).

What Happened Next?

Shortly after these announcements, ADAP Advocacy remained publicly quiet, but behind the scenes, it was working on two fronts to help alleviate growing concern. One route has political ties to the governor, while the other option involves potential litigation. That is all the organization has been authorized to say at this time.

AHF almost immediately filed an administrative legal action, arguing that the state of Florida failed to comply with mandatory public rulemaking processes that require it to publish a “Notice of Proposed Rule” (NPR).

Publishing an NPR starts a mandatory 21-day procedural clock during which the public may submit written comments, requests for public hearings, workshop requests, and “lower-cost regulatory alternatives” (LCRAs).

The state of Florida issued this NPR on Wednesday, February 11th.

What This Would Mean for People Living with HIV/AIDS in Florida

The “cost-containment” measures announced by the Florida Department of Health are each, by themselves, draconian cuts that would have devastating negative impacts on People Living with HIV/AIDS (PLWHA) in the state.

In its NPR, Florida proposes the following changes to the program:

Lowering the Income Eligibility Threshold from 400% of the FPL to 130% of the FPL:

In 2023, there were an estimated 123,279 PLWHA in the state of Florida, of whom 36,834 (29.9%) were enrolled in Florida’s state ADAP program (National Alliance of State and Territorial AIDS Directors, 2025).

Should Florida move ahead with its plan to lower its income eligibility cap to 130%—roughly $20,345 / year for an individual—potentially up to half of patients currently enrolled (between 16,000-20,000 PLWHA) would be disenrolled (Figure 2).

Figure 2 – Florida State ADAP Enrollees by Percentage of the Federal Poverty Level, 2024

Photo Source: ADAP Advocacy

For context, capping income eligibility at 130% would make Florida one of just 4 state ADAPs with income eligibility caps below 300% of the FPL, along with Utah (250%), Texas, and Oklahoma (both 200%; ADAP Advocacy, 2025).

Significant and Potentially Deadly Changes to the ADAP Formulary:

ADAP rules currently require that ADAP formularies include at least one medication from each class of core antivirals. The NPR issued by the state of Florida eliminates this language altogether.

Patients who remain eligible for ADAP would face significant restrictions on the medications they can take. As detailed in the email from the Florida Department of Health, the most popular and commonly prescribed medication to treat HIV/AIDS, Biktarvy, will be removed from the formulary.

Biktarvy, a single-pill oral regimen made by Gilead Sciences, is taken by over 430,000 people living with HIV in the United States (Gilead Sciences, 2026), or 35.8% of PLWHA.

By removing Biktarvy from the ADAP formulary, the Florida state government will be forcing impacted patients to transition off of the medications that are the standard of care to older, less effective multi-pill regimens in order to “contain costs.”

While this initial statement has been removed from the NPR, AHF has advised state advocates that the Florida Department of Health is separately attempting to restrict access to Biktarvy and Descovy through an informal policy outside the rulemaking process.

Dismantling the Health Insurance Premium Plus and Marketplace Premium Assistance framework:

Additionally, Florida’s plan includes discontinuing health insurance continuation payments for ADAP clients. Insurance continuation is a process that allows state ADAPs to pay for various aspects of private health insurance coverage, including those plans made available to patients on the Health Insurance Marketplace under the Affordable Care Act, and the vast majority of state ADAPs participate in some form of insurance continuation purchasing, be that through premium assistance, paying deductibles, and/or paying co-pays (Figures 3-5).

Figure 3 – State ADAP Programs That Pay Private/Marketplace Insurance Premiums, 2023

Photo Source: ADAP Advocacy

Figure 4 – State ADAP Programs That Pay Private/Marketplace Insurance Deductibles, 2023

Photo Source: ADAP Advocacy

Figure 5 – State ADAP Programs That Pay Private/Marketplace Insurance Co-Pays, 2023

Photo Source: ADAP Advocacy

In the recently filed NPR, Florida significantly narrows this framework by limiting the program to medication co-pay and deductible assistance through a limited number of contracted pharmacies.

Eliminating Part A information sharing in an effort to implement artificial administrative barriers:

Another change announced in the NPR is the removal of Ryan White Part A programs from the definition of who can issue a “Notice of Eligibility” (NOE), and the elimination of the provision that allowed Part A NOEs to satisfy ADAP (Part B) eligibility requirements.

For the uninitiated, Part A of the Ryan White Cares Act funds grants to Eligible Metropolitan Areas (EMAs) and Transitional Grant Areas (TGAs)—areas of the country with populations of at least 50,000 people that have seen between 1,000 and 2,000 AIDS diagnoses in the most recent five years.

Florida’s proposed change would require every Part A client to qualify separately for ADAP services, resulting in additional paperwork and administrative costs that increase the risk of lapses in coverage, administrative delays, and missed doses or treatment abandonment. Because of the nature of the HIV virus, missed doses or abandoning treatment can result in the mutation of the virus, creating drug-resistant strains. Lapsed treatment also assures that viral suppression will evaporate, increasing the risk of outbreaks of a multi-drug resistant strain of HIV.

Administrative burdens are a common tool used by public (in this case, the state of Florida) and private (e.g., insurance companies) payers to increase the likelihood that otherwise eligible program applicants will abandon application and/or renewal processes.

For example, in 2021, in an effort to artificially reduce its ADAP enrollment numbers, the state of Texas began requiring enrollees to recertify their eligibility in person. This was when the COVID-19 pandemic was still killing thousands of Americans each day, making this requirement potentially deadly to a patient population at severe risk of developing potentially deadly opportunistic infections, solely to serve the state’s goal of decreasing the number of enrollees to “save money.”

Limiting the types of documents acceptable for income verification:

In addition to these changes, the state of Florida is further creating administrative barriers by limiting the types of documents that can be used to verify income eligibility. This change would limit the documents available for use to W-2s, tax returns, pay stubs, unemployment documents, and Medicaid award letters.

This creates a barrier for gig workers (e.g., DoorDash drivers, Uber drivers, contractors), people paid directly in cash, and others with informal financial support by preventing them from submitting Form 1099s, contracts, or other income documents.

Changing program language to eliminate prioritization criteria, waitlist rules, and notice requirements:

Another change introduced in Florida’s NPR would revise the standard language about all program enrollment and services being subject to the availability of funds to exclude additional language that detailed prioritization criteria, rules related to the creation of a waitlist, or notice to enrollees that their coverage may or will be eliminated should funds be reduced or unavailable.

This essentially means the state can simply cease services without providing enrollees with sufficient notice to seek alternative patient assistance.

What Can Advocates Do?

The AIDS Healthcare Foundation has recommended that individuals and organizations follow the following strategy:

Figure 6 – What You Should Do Right Now

Photo Source: AHF

{Source: AIDS Healthcare Foundation, 2026}

Individuals may also directly contact their legislators using the resources below:

To find your representative in the Florida House of Representatives:

https://www.flhouse.gov/FindYourRepresentative

To find your representative in the Florida Senate:

https://www.flsenate.gov/Senators/Find

This Friday (February 20th) at 9 am ET, advocates can join a HIV Patient Access and Advocacy Strategy Convening, hosted by The AIDS Institute. 

In the meantime, ADAP Advocacy announced this week that it is rescinding its three-year travel ban to the state of Florida. This travel ban applied to ADAP board members, staff, consultants, and scholarship-funded patient advocates and precluded hosting any patient advocacy events, such as Fireside Chats, in Florida.

The severity of potential outcomes for PLWHA in the state of Florida “…warrant[s] our change in strategy,” said ADAP Advocacy CEO Brandon M. Macsata. ADAP Advocacy will continue to monitor this situation and will report any additional information as it becomes available.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Adamczeski, R. (2026, January 20). Ron DeSantis will have 'blood on his hands' if HIV funding isn't restored, Democratic chair says. Los Angeles, CA: The Advocate: Politics. https://www.advocate.com/politics/florida-desantis-hiv-medication-funding

[2] ADAP Advocacy. (2025). ADAP Directory. Nags Head, NC: ADAP Advocacy. https://adap.directory/directory

[3] Gilead Sciences. (2026). Biktarvy. Foster City, CA: Gilead Sciences: Biktarvy: About Biktarvy. https://www.biktarvy.com/about-biktarvy

[4] Mower, L., Glorioso, A., & Garcia, J. (2026, January 19). DeSantis admin diverted child welfare and medical funds for consultants, ads. Miami, FL: Miami Herald: News: Florida Politics. https://www.miamiherald.com/news/politics-government/state-politics/article313630394.html

[5] National Alliance of State and Territorial AIDS Directors. (2025). 2025 Annual Report. Washington, DC: NASTAD. https://nastad.org/2025-rwhap-part-b-adap-monitoring-report

[6] Shepard, S. (2026, January 21). New Florida AIDS drug rules may leave 15,000 without HIV treatment options, Democrats say. West Palm Beach, FL: CBS 12: News: Local. https://cbs12.com/news/local/floridas-revised-hiv-treatment-eligibility-raises-questions-from-democratic-lawmakers-south-florida-news-ryan-white-aids-drug-assistance-program-adap-reps-lois-frankel-debbie-wasserman-schultz-and-sheila-cherfilusmccormick-zoom-meeting-january-21-2026

Why Modifying Protected Drug Classes Creates a Slippery Slope for Patients Living with HIV

By: Scott Bertani, Director of Advocacy at HealthHIV

As a Person living with HIV who was diagnosed in Denver in the mid-1990s, during a period when treatment options were limited and access was fragile (to say the least), I relied on the Denver Blue Card for my care and access to medications and, during particularly precarious periods, on donation houses and informal community networks to stay alive when formal systems fell short. I lost many friends during those years, and I remember clearly what it meant to live before truly effective HIV antiretroviral therapy existed. The Colorado Department of Health Care Policy and Financing’s (HCPF)  consideration of modifying protected drug classes and allowing the use of prior authorization for select drugs threatens to undermine that progress.

Photo Source: Manatt | January 27, 2026

In 1996, when protease inhibitors first came online, they did more than change treatment guidelines—they saved people who would not have been alive the following month. The shift was so profound that one of our local bars, Proteus, was euphemistically renamed by many of us as "Protease," reflecting how seismic that moment felt within the community. 

Back then, cherished friends and bar owners—many connected through BJ’s and the Carousel Ball—helped establish the Tavern Guild as a way to formalize what BJ’s, Mike’s on Broadway, Charlie’s, Blush & Blu, and similar LGBTQ-safe spaces had long done informally—strengthen access to community-based resources, collective buying power, mutual aid, and care. Their work reinforced what many of us already knew from lived experience: progress in HIV has never been driven by medicine alone, but by the constant interaction between clinical innovation, policy decisions, and community infrastructure. That history—contemporary with the Denver Principles—shapes how I read Policy Action 6: not as an abstract cost-containment proposal, but as a set of decisions that land on real people whose health, stability, and longevity depend on continuity of care. It’s why—I feel—that the Colorado Department of Health Care Policy and Financing’s (HCPF) consideration of modifying protected drug classes and allowing prior authorization for select HIV drugs risks reintroducing access barriers we have long since left behind.

(With that, I relinquish the soapbox and turn to Colorado’s HCPF proposed Policy Action 6—grounded in lived-experience and the principle that has guided HIV policy and advocacy for decades: "Nothing about us, without us").

Across HIV prevention and care, we see the same pattern repeat: funding debates occur in one lane, policy design in another, implementation somewhere else, and the consequences show up downstream with patients, providers, and communities. The uncomfortable question is who ultimately absorbs the cost—both quantitatively and qualitatively—when that chain breaks. 

Cost growth is a legitimate concern. It has long been debated across ecosystems affecting HIV treatment—by Prescription Drug Affordability Boards; Medicaid and provider and therapeutics committees; Medicare benefit designers; AIDS Drug Assistance Programs (ADAPs); the Affordable Care Act Marketplace; employer-sponsored coverage; and others. In response, states and payers have operationalized those concerns through cost-containment mechanisms such as formulary redesign, eligibility adjustments, and increased scrutiny of high-cost antiretroviral therapies, particularly widely used single-tablet regimens that account for a significant share of HIV drug spending, as reflected in recent IPAY 2028 actions under the Inflation Reduction Act.

Policy Action 6 emerges from this same cost-growth context. However, reintroducing prior authorization and step therapy for communicable disease medications—especially HIV drugs—introduces predictable treatment delays and administrative barriers that undermine adherence and viral suppression. Any savings analysis, including evidence-based spending and utilization patterns, should therefore account for downstream clinical and system costs, not just pharmacy spending and rebate leverage.

Photo Source: PharmacyTimes.com | Image Credit: © piter2121

In practice, utilization management often shifts costs out of the pharmacy benefit and into care coordination, emergency coverage, and re-engagement efforts. Those costs do not disappear; they reappear elsewhere in the system and are shouldered by Ryan White providers, safety-net clinics, and public health programs. In those settings, administrative delays, regimen uncertainty, and coverage churn undermine stability before it is ever achieved. That disruption is managed by Title XIX targeted case management, Ryan White medical case management and non-medical supportive services, and Part C clinic staff and administrators. This list is not exhaustive and is rarely reimbursed at a level that reflects improved health outcomes.

While Policy Action 6 is framed as a measured return to utilization management that would apply prospectively after July 2027 and preserve continuity for patients deemed "stable," the greatest disruption from prior authorization and step therapy occurs upstream—during initiation or rapid starts, regimen switches and re-initiation, and early treatment.

As a result, these programs must devote—often divert—additional staff time to care coordination, enrollment troubleshooting, and compliance management. That operational burden adds strain through burnout, retention challenges, and reduced workforce readiness, particularly when churn occurs at both the reimbursement level and the policy level, including through federal and HRSA requirements.

Cost containment is vital to the implementation of a healthy Colorado, including for people enrolled in public assistance programs, as the Department of Health affirms. However, rebate strategies that rely on utilization management function by introducing administrative hurdles—not by changing clinical care—and those hurdles directly affect whether people remain on treatment and stay virally suppressed.

In many ways, this is a Palisade peaches–to–Rocky Ford cantaloupe comparison: both are nutritious, but the differences are wide, not narrow—much like lifelong HIV medication management in the real world. Short-term utilization metrics do not account for resistance history, hepatitis B co-infection, or clinically meaningful differences across integrase strand transfer inhibitor (INSTI) classes, including the higher resistance barriers and durability of second-generation INSTIs compared with earlier agents. Nor do they reflect the realities of aging with HIV, including low CD4 nadirs and the long-term durability of immune recovery. When treatment decisions intersect with comorbidities and acute stressors—such as COVID-19, influenza, or measles—disruptions over decades of care can compound treatment fatigue, adherence challenges, and cumulative harm in ways utilization controls are not designed to absorb.

Colorado's statutory framework already reflects this concern. Section 10-16-152 paused prior authorization and step therapy for HIV medications and required a study—explicitly including qualitative patient and provider experience—before any policy reversal. That structure recognizes that access, treatment stability, and adherence are central to cost-effective HIV care, and that utilization management assumptions should be tested rather than presumed.

Washington's experience provides a relevant real-world test of the same assumptions underlying Policy Action 6, including the expectation that utilization management can be reintroduced without destabilizing treatment or shifting costs downstream. Through a legislatively directed budget proviso, Washington required the Health Care Authority (HCA) to remove prior authorization for all FDA-approved HIV antiviral drugs under Apple Health beginning January 1, 2023, and to report annually on utilization, expenditures, and regimen switching. That proviso—adopted in SB 5092, section 118.6.a—also prompted the convening of the HIV Medication Access Workgroup (HMAW).

Through the HMAW process, stakeholders consistently documented that prior authorization, step therapy, and regimen disruption introduced administrative friction that delayed access, destabilized effective treatment, and increased churn within Medicaid HIV care. Participants emphasized that utilization management strategies intended to favor lower-cost or multi-tablet regimens did not operate in isolation, but shifted costs downstream to Ryan White providers, safety-net clinics, and public health systems tasked with mitigating treatment interruptions and re-engaging patients. In this context, "continued access" often existed on paper while continuity of care eroded in practice.

Photo Source: ADAP Advocacy | iStock Rights Purchased

As required by the proviso, HCA published its 2024 legislative report on HIV antiviral drugs, analyzing utilization, expenditures, and available health outcomes data following the removal of prior authorization. Viral load data were available for approximately 42 percent of Apple Health clients receiving HIV treatment in 2022—more than 3,000 individuals—representing a substantial real-world Medicaid population. While HCA appropriately cautioned that this subset cannot be assumed to represent all clients, it did not characterize the data as unreliable or dismiss observed differences across regimen types.

Within this cohort, patients initiating treatment on single-tablet regimens demonstrated higher rates of viral suppression than those starting on multi-tablet regimens or switching regimens. Although insufficient to establish causality, these findings establish directionality and challenge the assumption that regimen form and administrative disruption are clinically neutral—particularly in Medicaid settings shaped by utilization management, coverage churn, and administrative delay.

Preventing a single HIV infection avoids hundreds of thousands of dollars in lifetime medical costs, with some estimates exceeding one million dollars depending on treatment scenarios. Given these well-established costs, policy decisions that risk even modest reductions in adherence or viral suppression should not be evaluated solely on short-term pharmacy spending or rebate leverage.

Notably, Washington ultimately codified the policy direction reflected in the proviso and stakeholder findings. In 2025, the Legislature enacted SB 5577, requiring Medicaid coverage of all FDA-approved HIV antiviral drugs without prior authorization or step therapy for both fee-for-service and managed care enrollees, effective July 1, 2025. This statutory action reflects a legislative determination that, for HIV treatment, utilization management introduces unacceptable risk to treatment stability and system sustainability.

The lack of complete outcomes data argues for caution, not for reinstating prior authorization and step therapy based on projected savings alone. Policy Action 6 assumes these controls can be reintroduced for HIV drugs without disrupting care or shifting costs outside the pharmacy benefit—an assumption that has not been supported by real-world experience. That assumption is not only incorrect, but—I feel—potentially harmful for Persons living with HIV in Colorado.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Martin, K. (2025, August 06). The 340B Drug Pricing Program: How It Works and Why It’s Controversial. Commonwealth Fund. https://doi.org/10.26099/210h-wv98

[2] Rojas, Dutch. (2025, January 29). The Charity That Pays Like Wall Street. The Rojas Report. https://dutchrojas.substack.com/p/the-charity-that-pays-like-wall-street?utm_campaign=email-post&r=3z1yhv&utm_source=substack&utm_medium=email

Are 340B Covered Entities Sacrificing Affordable Care for Executive Compensation?

By: Brandon M. Macsata, CEO, ADAP Advocacy, Guy Anthony, Chair, ADAP Advocacy 340B Patient Advisory Committee, and Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The 340B Drug Pricing Program was founded on a straightforward accountability agreement: in return for significant discounts on outpatient medications, safety-net providers would “stretch scarce federal resources” to make healthcare more accessible and affordable for those most in need. However, as eligibility for the 340B Program has broadened and revenues have soared, a pressing concern has emerged: are some covered entities diverting a patient-focused initiative to fund executive compensation (CEO compensation at hospitals increased by an average of 197.2%, while compensation for CEOs at organizations that provide care for patients living with HIV/AIDS increased by 219.9%) rather than reducing costs, expanding services, and supporting vulnerable communities?

The long and short of it is YES.

Since 2023, ADAP Advocacy, in collaboration with the Appalachian Learning Initiative (APPLI) and the Community Access National Network, has audited Form 990 federal filings with the Internal Revenue Service, which have uncovered troubling trends. It involved a multi-year audit of 170 organizations eligible to participate in the 340B Program as “covered entities”—non-profit healthcare providers of various types who qualify to purchase certain outpatient prescription drugs at significantly lower prices, sell them to lower-income and poor patients, and receive rebates from pharmaceutical companies for the difference between the list price of those drugs and the purchase price (Figure 1). 

The program’s financial gains are increasingly benefiting executive leadership rather than bedside care. We believe that a program designed to stretch scarce resources shouldn’t be stretching paychecks faster than it stretches care.

What we’ve discovered has been astonishing.

Across 170 covered entities audited (all averages exclude outliers):

• Annual revenues after the first year of eligibility increased from the year prior to receiving eligibility by an average of 12.2%, while annual CEO compensation increased by an average of 28.9%.
• From the year prior to eligibility to the most recent 990s on file, annual revenues increased by an average of 609.5%, while annual CEO compensation increased by an average of 221.3%.
• CEO compensation at hospitals increased by an average of 197.2%, while compensation for CEOs at organizations that provide care for patients living with HIV/AIDS increased by 219.9%. Similarly, at other types of organizations, including (but not limited to) Federally Qualified Health Centers, Consolidated Health Centers, and STD clinics, CEO compensation increased by an average of 230.4%.

All data from ADAP Advocacy’s findings are available online at https://340bmap.org.

Figure 1 – The Complex Ecosystem of 340B Drug Pricing

Photo Source: Martin, 2025

What differentiates HIV care providers who run AIDS Drug Assistance Programs (ADAPs) under the Ryan White HIV/AIDS Program is that ADAP providers are required to report detailed records about the amounts of 340B revenue they receive and how those revenues are used. Many of these ADAPs also operate under a rebate model rather than the upfront payments used by nearly all other covered entities participating in the program. They’ve successfully used these rebates to expand access to care and treatment, while remaining accountable. 

Essentially, they’re required to show their work.

Hospitals, however, are not required to provide any public-facing information about their 340B drug sales, revenues, or how those revenues are used, which has repeatedly led to those revenues—statutorily required to be used to improve the access and affordability of healthcare services for poor patients—being misappropriated for other purposes, including the opening or acquisition of new facilities (known as “child sites”) in affluent neighborhoods where profits will be higher, unnecessary, decorative construction inside hospitals, to increase CEO and other executives’ salaries, and other purposes.

In fact, 10 of the 104 hospitals we audited saw CEO compensation increase by 500% or more from the year prior to their eligibility for the 340B program to their most recent filings, with one hospital increasing its CEO compensation by 2,803.8% in just 16 years.

It is symbolic of a larger trend within the hospital ecosystem, as eloquently noted by Dutch Rojas in a recent Substack post in The Rojas Report: The Charity That Pays Like Wall Street. Supplemental Executive Retirement Plans, or SERPs, are "how nonprofit hospitals pay their executives more than Wall Street pays its bankers" (Rojas, 2025).

Meanwhile, the United States faces a critical national nursing shortage that will leave American citizens at significant risk. This shortage will increase as a result of recent moves by the Trump Administration to declassify nursing as a “professional” degree, thus making it more difficult for aspiring nurses to receive student loans. And all of this while CEOs—who virtually never engage with actual patients or provide any sort of healthcare service—are able to demand salaries so high that most Americans cannot conceive of the number, and nobody blinks an eye.

We argue that 340B dollars, regardless of the covered entity eligible to receive them, should be directly tied to improving patient access and affordability. One way to improve services, for example, would be to use those funds to hire more nurses. Or increase the pay of the existing nurses. Alternatively, keep rural hospitals open rather than closing and consolidating them.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Martin, K. (2025, August 06). The 340B Drug Pricing Program: How It Works and Why It’s Controversial. Commonwealth Fund. https://doi.org/10.26099/210h-wv98

[2] Rojas, Dutch. (2025, January 29). The Charity That Pays Like Wall Street. The Rojas Report. https://dutchrojas.substack.com/p/the-charity-that-pays-like-wall-street?utm_campaign=email-post&r=3z1yhv&utm_source=substack&utm_medium=email

Congress Shines Spotlight on Health Insurance Companies' Squeeze on Patients

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The CEOs of four major insurance companies—UnitedHealth Group, CVS Health, Elevance Health, and Cigna—testified before the House Committees on Energy and Commerce and Ways and Means on Thursday, January 22nd, 2026. It went poorly for them.

Photo Source: Kent Nishumara | Bloomberg | Getty Images

It is rare in the Year of Our Lord Two-Thousand, and Twenty-Six, for congressional enemies to join the same team when questioning witnesses, but health insurance companies seem to be one of the few industries left where bipartisan enmity is shared. And with good reason.

UnitedHealth Group, CVS Health, Elevance Health, and Cigna’s most recent financial reports indicate annual revenue growth ranging from 7.8% (CVS) to 12% (UnitedHealth & Elevance), continuing the pattern of insurers delivering for shareholders, but failing to deliver for patients.

In a statement issued after the two hearings concluded, Brandon M. Macsata, CEO of ADAP Advocacy, stated:

Patients in America are facing unprecedented increases in premiums, deductibles, and co-payments, while insurance giants make out like bandits. After Congress allowed the enhanced premium subsidies enacted during the COVID-19 pandemic to expire, marketplace benchmark premiums increased by an average of 21.7%, compared with the 2% annual increases seen from 2020 through 2025. Meanwhile, premiums increased between 6% to 7% in the employer-sponsored insurance market. These marketplace premium increases are both unconscionable and discriminatory, as they specifically target the patients who most need insurance.

These premium hikes are likely to have an outsized effect on People Living with HIV/AIDS, as most state AIDS Drug Assistance Programs assist enrollees through insurance continuation and premium and co-pay assistance.

But the issue runs deeper than premiums—one of the key moments from these hearings included an exchange between Representative Alexandria Ocasio-Cortez (D-NY-14) and CVS Health CEO, David Joyner:

Rep. Ocasio-Cortez correctly identified, explained, and excoriated Joyner for what CVS Health Group refers to as their “captive strategy.”

Photo Source: Rep. Alexandria Ocasio-Cortez | YouTube

CVS Health Group not only owns CVS pharmacies, but also owns:

• Aetna
• The health insurance company providing insurance to over 36 million Americans (Aetna, 2026)
• Oak Street Health
• A system of primary care clinics serving over 350,000 people across 27 states (Oak St. Health, 2025)
• CVS Caremark
• A Pharmacy Benefit Manager (PBM) that negotiates prices for prescription medications, processing nearly 30% of all prescriptions in a given year for more than 110 million plan members in the United States (CVS Caremark, 2026); and,
• Cordavis
• A Dublin, Ireland-based drug maker that works with existing drug manufacturers to commercialize and/or co-produce biosimilar medications for the U.S. (CVS Health, 2023)

When asked whether this collection of companies constituted “market concentration,” Joyner responded:

No, I wouldn't agree that it's market concentration. I would suggest it's a model that works really well for the consumer” (Rep. AOC, 2026).

This response, so glibly delivered, is not unique; rather, it is typical of major corporations like Microsoft, Google, Meta (formerly Facebook), and Amazon, which control multiple companies within the same sector.

It all boils down to this argument:

“This isn’t a monopoly! No! It’s just…vertical integration! It’s what’s best for consumers!”

What they’re really saying is, “It’s what’s best for shareholders and my bank account.”

Over in the House Ways and Means Committee, Representative Greg Murphy (R-NC-03) stated unequivocally:

You have put profits above patients. And you have put profits above those who care for patients. You have squarely abused your position of authority to deliver healthcare to patients in this country (Parduhn, 2026).

Photo Source: WalletInvestor.com

Paul Markovich, CEO of the non-profit parent company that owns California Blues’ largest plan, was also present for these hearings, and spared no words in criticizing the American healthcare system:

Our healthcare system is bankrupting and failing us. I’ve come to the conclusion that the system will not fix itself. The healthcare system needs some tough love and clear direction, and the American government is in the best position to provide both (Parduhn, 2026).

Markovich truly hit the nail on the head here. The American healthcare system isn’t so much a system as it is a patchwork collection of profit-driven corporations, all of whom know that they have a captive market:

• Drug manufacturers actively navigate the U.S. patent system to extend patents beyond their initial time period, secure numerous patents to cover the same product, use secondary patents to cover dosage changes, formulation changes (e.g., capsule to tablet), and even delivery methods (e.g., adding dosage counters to inhalers; Tu & Rutschman, 2025). Critics argue that these practices allow manufacturers to maintain control over the available treatment market, justify price increases, and maximize profits.
• Health insurance companies actively utilize formulary management to deny access to life-saving medications either by excluding them from their formularies outright, creating labyrinthine prior authorization processes to access them, or forcing patients to switch to medications they deem as being “similar,” but which have not been actively prescribed as they are no longer the standard of care (Giebenhain, 2017).
• PBMs act as intermediaries between individual or group pharmacies, insurance companies, pharmaceutical companies, and drug wholesalers, each of which is attempting to either save money or make a profit by (Mattingly II et al., 2023):
• Designing formularies (i.e., determining which medications are available to patients)
• Managing drug utilization (e.g., creating prior authorization requirements, including step-therapy, supply limits, and/or tiering medications based on their list prices or utilization)
• Negotiating purchasing prices between pharmacies, wholesalers, and drug manufacturers
• Forming pharmacy networks that lock patients into purchasing covered medications at specific locations (e.g., speciality pharmacies)
• Providing mail-order pharmacy services

PBMs have come under consistent criticism over the past twenty years for creating market conditions that have limited competition. By 2023, 3 PBMs accounted for 79% of prescription drug claims in the U.S., and just 6 PBMs handle 96%. CVS Caremark accounted for 33% of all prescription drug claims, followed by Express Scripts (24%) and OptumRx (22%; Mattingly II et al., 2023).

Corporate profits soar; shareholders get paid; patients suffer.

This is the plight of the American Patient: getting left behind with more and more medical debt. Meanwhile, American life expectancy lags behind that of comparable nations (Sharfstein et al., 2024), even as we’re told we have “the best healthcare system in the world.”

Paul Markovich was right: the U.S. government is in the best position to fix the U.S. healthcare system. In all likelihood, however, it lacks the political will.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Aetna. (2026). About Us. Hartford, CT: CVS Health Group: Aetna: About Us. https://www.aetna.com/medicare/footers/about-us.html

[2] CVS Caremark. (2026). About Us. Woonsocket, RI: CVS Health Group: CVS Caremark: About Us. https://business.caremark.com/about-us.html

[3] CVS Health. (2023, August 23). CVS Health launches Cordavis. Woonsocket, RI: CVS Health Group: New: PBM. https://www.cvshealth.com/news/pbm/cvs-health-launches-cordavis.html

[4] Giebenhain, K. (2017, June). Dirty Laundry: Drug Formulary Exclusions. AMA Journal of Ethics, 19(6): 629-630. https://doi.org/10.1001/journalofethics.2017.19.6.imhl1-1706

[5] Mattingly II, T. J., Hyman, D. A., & Bai, G. (2023, November 03). Pharmacy Benefit Managers: History, Business Practices, Economics, and Policy. JAMA Health Forum, 4(11): e233804. https://doi.org/10.1001/jamahealthforum.2023.3804

[6] Oak Street Health. (2025, May). The Gold Standard of Advanced Primary Care for Medicare Beneficiaries. Chicago, IL: CVS Health Group: Oak Street Health. https://www.cvshealth.com/content/dam/enterprise/cvs-enterprise/pdfs/2025/Oak-Street-White-Paper-2025-v2.pdf

[7] Parduhn, R. P. (2026, January 23). Insurance CEOs’ no good, very bad day on the Hill. Newton, MA: Informa TechTarget: Industry Dive: Healthcare Dive: News. https://www.healthcaredive.com/news/health-insurance-ceos-house-hearings-affordability/810269/

[8] Representative Alexandria Ocasio-Cortez [RepAOC]. (2026, January 22). Rep. AOC Calls Out CVS Health’s Corporate Strategy to Monopolize Patient Care  [Video]. YouTube. https://www.youtube.com/watch?v=ayNKCNhoD7w

[9] Sharfstein, J., Gemmill, A., Appel, L., Angell, S., Saloner, B., Horwitz, J., Villareal, S., Alvarez, K., & Ehsant, J. (2024, December). A Tale of Two Countries: The Life Expectancy Gap Between the United States and the United Kingdom. Baltimore, MD: Johns Hopkins University: Johns Hopkins Bloomberg School of Public Health. https://americanhealth.jhu.edu/sites/default/files/2025-02/2024 Life Expectancy Report.pdf

[10] Tu, S. S. & Rutschman, A. S. (2025, November 14). Mapping Intellectual Property Abuses in the Pharmaceutical Field. JAMA Health Forum, 6(11): e254938. http://doi.org/10.1001/jamahealthforum.2025.4938

Trump Administration Applauds Itself for Rx Access Agreements, But Will They Help Patients?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

In May 2025, President Donald J. Trump signed an executive order requiring, among other things, that pharmaceutical companies lower the prices of certain drugs to align with those charged in other comparably developed nations (e.g., most of Europe; Simons & Hopkins, 2025). Those companies that failed to comply with this order would be subject to administrative retaliation that imposes what the Trump Administration is calling “Most-Favored Nation” (MFN) pricing.

Photo Source: The White House

ADAP Advocacy covered this executive order last May, bringing several questions to the fore:

1. How will the U.S. Department of Health and Human Services (HHS) determine what the MFN price is for medications?
2. Which classes of medications and how many will be included in this pricing scheme?
3. Will these pricing agreements apply only to drugs purchased through public insurance programs, such as Medicaid, Medicare, and the Veterans Affairs (VA), or will these pricing agreements apply to drugs purchased using commercial insurance? (Franco, 2025)

In 2026, the Trump Administration’s "negotiations-at-gunpoint" approach has borne some fruit. The Trump Administration released a fact sheet late last year indicating that pricing and manufacturing agreements had been reached with 9 drug manufacturers (The White House, 2025). The details are available in the list below, which outlines each manufacturer’s agreement.

As with the executive order itself, the majority of the details of each manufacturer’s agreement with the Trump Administration are proprietary. What is striking about many of these deals is that the drugs sold direct-to-consumer are already off-patent, have cheaper biosimilars, or are no longer actively prescribed.

The latter is true for many of the medications used to treat HIV that will sold directly to patients, including Reyataz (Briston Myers Squibb; atazanavir), an oral protease inhibitor medication that was commonly used in combination with other medications, including Norvir (ritonavir; used to slow down the breakdown of Reyataz) and a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI), such as Truvada (emtricitabine/tenofovir disoproxil fumarate).

Other drugs, such as Humira (Amgen), have multiple biosimilar options available at lower prices than Amgen's direct-to-patient pricing. Of greater concern is the possibility that these lower prices are merely stopgap measures that will remain in place only as long as the Trump Administration remains in office.

Photo Source: Houston Public Media | Win McNamee | Getty Images

While the optics of lower drug prices through forced “voluntary” negotiations look great on paper, most of these agreements come with three-year exemptions from tariffs imposed by the Trump Administration, which are currently facing a pending Supreme Court ruling on the legality of those tariffs under the International Emergency Economic Powers Act (IEEPA; Chung, 2026).

Should those tariffs be overturned by the Supreme Court or by a future president, drug manufacturers will have little incentive to honor many of the provisions of their respective deals, particularly U.S.-based manufacturing and research and development investments.

Further still, the opacity of these agreements, as well as HHS's determination of what “MFN” pricing is for individual drugs, means there remains little transparency into the drug pricing process. What’s to stop manufacturers from drastically increasing list prices to offset the “discounts” offered (Buntz, 2026)?

Finally, how many Americans will actually be able to access and afford these medications hinges on whether they have public (e.g., Medicaid, Medicare, VA) or commercial insurance (e.g., employer-sponsored, marketplace). While each manufacturer was voluntarily forced to sell medications on TrumpRx.gov, there is still no “TrumpRx”—the website is a placeholder site that promises “the lowest prescription drug prices in America,” but no details or actual drugs are listed. Instead, visitors are “graced” with a scowling (and AI-edited) photo of the president.

Photo Source: TrumpRx

The reality, here, is that Trump’s increasingly unpopular brand, as well as his long-documented failures to make good on the vast majority of his promises, are likely to drive away consumers, rather than convincing them to put their faith in anything with his name on it. But that’s the way of the day in our Trumpian dystopia: a power-hungry madman obsessed with branding everything with his name, like some heifer at the O.K. Corral.

In the short term, state Medicaid programs are the likeliest to benefit, as nearly every manufacturer has agreed to sell their medications to those programs at prices comparable to other developed nations (Lim, 2026). That will save states money, but most Medicaid patients already pay very low prices for most medications, meaning that the savings here are mostly to state governments rather than patients.

For direct-to-patient purchasing, while many patients may choose this route rather than enrolling in commercial insurance, for those who receive federal subsidies to offset monthly premiums, the complexity and secrecy of the U.S. healthcare system make it virtually impossible to determine whether patients will actually save money by skipping the middlemen.

ADAP Advocacy will continue to monitor MFN pricing and how that might impact people living with HIV/AIDS.

Drug Manufacturer MFN Agreement Outlines:

• Amgen
• Amgen will expand its direct-to-patient program, AmgenNow™, to include Aimovig® (migraine treatment) and Amjevita® (biosimilar to Humira to treat autoimmune conditions), at a discounted monthly price of $299. This expands the available drugs, which also includes Repatha® (cholesterol-lowering medication) at a monthly price of $239 (Amgen, 2025).
• Bristol Myers Squibb (BMS)
• BMS agreed to make Eliquis® (blood thinning medication) available to Medicare for free starting January 1st, 2026.
• Agreed to donate 7 tons of Eliquis to fill the U.S. Strategic Active Pharmaceutical Ingredient Reserve (SAPIR).
• Agreed to launch new medications with “…a more balanced pricing approach across developed nations”.
• Agreed to enable direct-to-patient access for cash-paying patients for Sotyktu® (plaque psoriasis), Zeposia® (relapsing multiple sclerosis and ulcerative colitis), Reyataz® (HIV), Baraclude® (Hepatitis B), Orencia® SC (autoimmune conditions).
• Each of these drugs will be sold at approximately 80% off the current list price through TrumpRx.gov (BMS, 2025).
• Boehringer Ingelheim
• Boehringer will offer medications directly to consumers through TrumpRx.gov
• Will sell Jentadueto (Type-2 Diabetes) for $55.
• Will invest $10 billion through 2028 to expand pharmaceutical research and development (R&D) and manufacturing operations in the U.S.
• Includes $1b specifically earmarked for capital expenditures (Boehringer Ingelheim, 2025).
• Genentech
• Genentech will provide medications to state Medicaid programs at prices comparable to other developed nations.
• Will allow certain drugs, including Xofluza (inflluenza) through TrumpRx.gov and through its recently established direct-to-patient program.
• Commits to increasing U.S. manufacturing, infrastructure, and R&D (Genentech, 2025).
• Gilead Sciences
• Gilead will offer discounts on certain existing medications, including those used to treat HIV, Hepatitis C, Hepatitis B, and COVID-19, for state Medicaid programs.
• Agreed to price future medications “…at parity” with other key developed nations.
• Will launch a direct-to-patient program for Epclusa® (Hepatitis C) at a discounted cash price that can be accessed through TrumpRx.gov (Gilead Sciences, 2025).
• GSK (formerly GlaxoSmithKline) / ViiV
• GSK will lower the prices of certain medications to state Medicaid programs, including most of its respiratory drug portfolio.
• GSK will also make most of its inhaled medications and other products available through a direct-to-patient program (TrumpRx.gov) at savings up to 66%.
• Will provide SAPIR with a reserve of albuterol (active ingredient in many inhalers used to treat asthma and chronic obstructive pulmonary disorder [COPD]; GSK, 2025).
• Merck
• Merck will provide direct-to-patient access to Januvia (Type-2 Diabetes), Janumet (Type-2 Diabetes), and Janumet XR through TrumpRx.gov.
• This will be expanded to include enlicitide decanoate, an investigational drug currently being developed to lower cholesterol, once it has received approval from the U.S. Food and Drug Administration (FDA; Merck, 2025).
• Novartis
• Novartis agreed to launch future medications at prices comparable with other developed nations.
• Will build direct-to-patient platforms for Mayzent (multiple sclerosis), Rydapt (acute myeloid leukemia and rare blood disorders), and Tabrecta (metastatic non-small cell lung cancer) through TrumpRx.gov.
• Will apply to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model announced by the Trump Administration in November 2025 (HHS, 2025) aimed at improving access to medications through state Medicaid programs.
• Will support efforts to “…address the global imbalance in investment in pharmaceutical innovation” (Novartis, 2025).
• Sanofi
• Sanofi agreed to ensure that state Medicaid programs can access Sanofi medications at the same prices as other developed nations.
• Will reduce prices by an average of 61% for certain medications used to treat diabetes, cardiovascular and neurological conditions, and cancer.
• Will offer direct-to-patient access for certain drugs through TrumpRx.gov.
• Will implement a “…more balanced approach” on pricing in other nations.
• Agreed to increase investments in upgrading existing manufacturing facilities and expand manufacturing partnerships (Sanofi, 2025).

In addition to these companies, the Administration has entered into pricing and manufacturing agreements with:

• AbbVie
• AbbVie agreed to spending $100 billion in U.S. R&D and other capital investments over the next decade.
• Will provide “low prices” to state Medicaid programs.
• Will provide direct-to-consumer access to Humira (rheumatoid arthritis), Alphagan (glaucoma or ocular hypertension), Combigan (glaucoma or ocular hypertension), and Synthroid (hyperthyroidism) through TrumpRx.gov (Fidler, 2026).
• AstraZeneca
• AstraZeneca will provide direct-to-consumer sales to eligible patients with chronic diseases at a discount of up to 80% off list prices through TrumpRx.gov.
• Will invest $50 billion in manufacturing and R&D through 2030, 50% of which is expected to be generated in the U.S. (AstraZeneca, 2025).
• .ohnson & Johnson (J&J)
• J&J will provide direct-to-patient access through TrumpRx.gov.
• Will “…[enable] American patients to access medicines at comparable prices to other developed countries”.
• Will provide state Medicaid programs with access to medications at prices comparable to other developed nations.
• Announced two new U.S. manufacturing facilities in Pennsylvania and North Carolina (J&J, 2026).
• Eli Lilly
• Eli Lilly and Company will provide Medicare beneficiaries with Zepbound (weight management GLP-1 medication) and orforglipron, an investigational oral GLP-1 drug awaiting FDA approval, for no more than $50/month.
• State Medicaid programs will also be able to access these medications at reduced prices (prices not stated).
• Will enable self-paying (cash-paying) patients to access Zepbound at its lowest dose for $299, with additional doses up to $449 through direct-to-patient access, representing a $50 savings.
• Patients refilling their multi-dose pens will pay no more than $449.
• Will provide direct-to-patient orforglipron at the lowest dose for $149, with additional doses up to $399.
• Nota bene – the scope of this agreement DOES NOT include commercial pricing.
• Will add Emgality (migraines and cluster headaches), Trulicity (Type-2 Diabetes), and Mounjaro (specific to Type-2 Diabetes) to direct-to-patient channels at 50-60% off current list prices.
• Will continue to offer insulin to patients for no more than $35/month, whether a patient is commercially insured or uninsured (Eli Lilly, 2025).
• Pfizer
• Pfizer agreed to implement measures to ensure Americans receive “…comparable drug prices to those available in other developed countries,” and will price new medications at parity with other developed markets.
• Will participate in direct-to-patient sales through TrumpRx.gov, allowing Americans to purchase primary care treatments and specialty drugs at an average discount of 50% and at discounts of up to 85%.
• Committed to investing an additional $70 billion in the U.S. for R&D and capital projects over the next few years (Pfizer, 2025).

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Amgen. (2025, December 19). Amgen takes action with the U.S. government to lower the cost of medicines for American patients. Thousand Oaks, CA: Amgen: Newsroom: Press Releases. https://www.amgen.com/newsroom/press-releases/2025/12/amgen-takes-action-with-the-u-s--government-to-lower-the-cost-of-medicines-for-american-patients

[2] AstraZeneca. (2025, October 10). AstraZeneca announces historic agreement with US Government to lower the cost of medicines for American patients. Cambridge, UK: AstraZeneca: Media Centre: Press Releases. https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-announces-historic-agreement-with-us-government-to-lower-the-cost-of-medicines-for-american-patients.html

[3] Boehringer Ingelheim. (2025, December 19). Boehringer Ingelheim announces broad agreement with the U.S. Government to lower the cost of medicines for American patients and expand its U.S. footprint. Ridgefield, CT: Boehringer Ingelheim: US: Media: Press Releases. https://www.boehringer-ingelheim.com/us/media/press-releases/boehringer-ingelheim-announces-agreement-us-government

[4] Bristol Myers Squibb. (2025, December 19). Bristol Myers Squibb Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans. Princeton, NJ: Bristol Myers Squibb: News: Corporate/Financial News. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Agreement-with-U-S--Government-to-Improve-Affordability-and-Access-to-Critical-Medicines-for-Americans/default.aspx

[5] Buntz, B. (2026, January 02). Drug companies sign “Most Favored Nation” deals, then raise prices anyway. Cleveland, OH: WTWH Media LLC: Drug Discovery & Development. https://www.drugdiscoverytrends.com/drug-companies-sign-most-favored-nation-deals-then-raise-prices-anyway/

[6] Chung, A. (2026, January 09). Supreme Court plans rulings for January 14 as Trump's tariffs remain undecided. London, UK: Reuters: Legal: Government. https://www.reuters.com/legal/government/supreme-court-set-issue-rulings-trump-awaits-fate-tariffs-2026-01-09/

[7] Eli Lilly and Company. (2025, November 06). Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans. Indianapolis, IN: Eli Lilly and Company: News Releases. News Release Details. https://investor.lilly.com/news-releases/news-release-details/lilly-and-us-government-agree-expand-access-obesity-medicines

[8] Fidler, B. (2026, January 13). AbbVie pledges $100B to US production in drug pricing deal with Trump. Newton, MA: Industry Dive: Biopharma Dive: News. https://www.biopharmadive.com/news/abbvie-drug-price-deal-trump-most-favored-nation/809441/

[9] Franco, M. A. (2025, May 14). Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know. Holland & Knight: Insights. Retrieved from https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing

[10] Genentech. (2025, December 19). Genentech Announces Agreement With U.S. Government. South San Francisco, CA: Genentech: Media: Press Releases. https://www.gene.com/media/press-releases/15094/2025-12-19/genentech-announces-agreement-with-us-go

[11] Gilead Sciences. (2025, December 19). Gilead and U.S. Government Enter Agreement to Lower Costs of Medicines for Americans. Foster City, CA: Gilead Sciences: News: News Releases. https://www.gilead.com/news/news-details/2025/gilead-and-u-s--government-enter-agreement-to-lower-costs-of-medicines-for-americans

[12] GSK. (2025, December 19). GSK enters agreement with U.S. government to lower drug prices and expand access to respiratory medicines for millions of Americans. London, UK: GSK: Media: Press Release Archive. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-with-us-government-to-lower-drug-prices-and-expand-access-to-respiratory-medicines-for-millions-of-americans/

[13] Johnson & Johnson. (2026, January 08). Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments. New Brunswick, NJ: Johnson & Johnson: Media Center: Press Releases. https://www.jnj.com/media-center/press-releases/johnson-johnson-reaches-agreement-with-u-s-government-to-improve-access-to-medicines-and-lower-costs-for-millions-of-americans-delivers-on-u-s-manufacturing-and-innovation-investments

[14] Lim, D. (2026, January 04). Trump’s drug-pricing deals won’t benefit most Americans today. They could over time. Politico: News. https://www.politico.com/news/2026/01/04/trumps-drug-pricing-deals-wont-benefit-most-americans-today-that-could-over-time-00706529?cid=Connatix

[15] Merck. (2025, December 19). Merck Reaches Agreement With U.S. Government to Expand Access to Medicines and Lower Costs for Americans. Rahway, NJ: Merck: Media: News Releases. https://www.merck.com/news/merck-reaches-agreement-with-u-s-government-to-expand-access-to-medicines-and-lower-costs-for-americans/

[16] Novartis. (2025, December 19). Novartis and US government reach agreement on lowering drug prices in the US. Basel, CH: News. https://www.novartis.com/news/media-releases/novartis-and-us-government-reach-agreement-lowering-drug-prices-us

[17] Pfizer. (2025, September 30). Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients. New York, NY: News: Press Release. Press Release Details. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reaches-landmark-agreement-us-government-lower-drug

[18] Sanofi. (2025, December 19). Press Release: Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation. Paris, FR: Sanofi: English: Media Room: Press Releases. https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-19-19-21-43-3208697

[19] Simons, R. & Hopkins, M. J. (2025, May 22). Is Trump's executive order on Most Favored Nations drug pricing a wet noodle? Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2025/05/is-trumps-executive-order-on-most.html

[20] United States Department of Health and Human Services. (2025, November 06). CMS Announces New Drug Payment Model to Strengthen Medicaid and Better Serve Vulnerable Americans. Washington, DC: United States Department of Health and Human Services: Press Room. https://www.hhs.gov/press-room/cms-announces-new-drug-payment-model-to-better-serve-vulnerable-americans.html

[21] White House, The. (2025, December 19). Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing Most-Favored-Nation Pricing to American Patients. Washington, DC: The White House: Fact Sheets. https://www.whitehouse.gov/fact-sheets/2025/12/fact-sheet-president-donald-j-trump-announces-largest-developments-to-date-in-bringing-most-favored-nation-pricing-to-american-patients/

Trump Administration Pushes Two New Rebate Models, But Will They Help Patients?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The Centers for Medicare and Medicaid Services (CMS) has released information about a new proposed mandatory pricing model—the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model—that would assess the inflation rebate amounts paid for certain medications covered under Medicare Part D using a benchmark derived from international pricing information rather than using current domestic benchmarks (CMS, 2025).

Photo Source: CMS

The GUARD model is one of two pricing models being proposed by the Trump Administration—the other being the Global Benchmark for Efficient Drug Pricing (GLOBE), which would assess inflation rebates for drugs covered under Medicare Part B.

In both models, the Trump Administration plans to use modeling to employ drug “rebate models,” which are payment models ostensibly intended to lower the cost of medications by having drug manufacturers return a percentage of the purchase price to the buyers. These rebates are generally negotiated behind closed doors between payors, including pharmacy benefit managers (PBMs), insurers, and government programs, with drug manufacturers. Once those rebate amounts are set, drug manufacturers remit rebate payments to payors only after the drugs have been purchased and dispensed (SmithRx, 2025).

CMS's GUARD Model would attempt to reduce Medicare drug spending by tying prices to international benchmarks and collecting rebates from manufacturers when prices exceed those. 

Rebates, such as the proposed 340B Drug Pricing Program rebate model, can be an effective means of introducing cost savings into health care systems and indirectly helping patients, because they bring added transparency. In the case of the GUARD Model, they can also disadvantage patients. That is because the rebated price is not known at the time that the patient is dispensed the medication. Accordingly, out-of-pocket costs are calculated based on the higher "list" prices of drugs, forcing patients to pay more in deductibles, coinsurance, and copayments at the pharmacy counter.

In essence, the wider health care system may benefit from a rebate, but the patient may see no reduction in their costs. The 340B rebates differ from GUARD/GLOBE in that 340B rebates are specifically designed to be passed onto the consumer in the form of increased investment in/access to/savings for healthcare services. GUARD/GLOBE rebates are specifically designed to go to payors, with no requirements whatsoever that those revenues be reinvested or savings passed on.

Drug rebate models have been in place in the U.S. since the 1990s, with the creation of the Medicaid Prescription Drug Rebate Program (MDRP) under the Omnibus Reconciliation Act. They are also actively used in at least 31 European countries, including Italy, Portugal, Spain, France, Germany, and the United Kingdom (Vogler et al., 2012).

Photo Source: ADAP Advocacy | iStock

The primary rationale behind these rebate models is that requiring manufacturers to pay rebates to payors incentivizes drug manufacturers to keep drug prices lower. While this might be true in nations where this is a single payor, such as those listed above, rebate models in the U.S. have objectively poorer outcomes.

Recent research from the Leonard D. Schaeffer Institute for Public Policy & Government Service out of the University of Southern California found that, on average, every $1 increase in rebates was associated with $1.17 increase in list prices, particularly for single-source drugs—a Food and Drug Administration (FDA)-approved medication available from only one manufacturer, often lacking a generic equivalent, and specifically the types of drugs that will be evaluated under both the GUARD and GLOBE models being proposed (Sood et al, 2020).

Another study examined rebates for 444 unique branded medications and found that, while drug manufacturers may increase list prices in order to offer larger rebates to payors, consumers—particularly those lacking health insurance coverage—experienced statistically significant increases in out-of-pocket costs for those medications (Yeung et al., 2021).

Decades of research confirm what people living with HIV/AIDS already know: out-of-pocket costs lead to skipped doses, delayed refills, or complete abandonment of prescriptions. 

Public health data from the Centers for Disease Control show that a significant share of people living with HIV/AIDS (PLWHA) report cost-related non-adherence. A 2019 study found that 7% of PLWHA in the U.S. reported non-adherence to prescribed dosing due to cost-related concerns, with another 4% reporting skipping doses, 4% reporting taking less medicine, and 6% reporting delaying medication purchases (Beer et al., 2019).

Sadly, PLWHA facing affordability challenges may delay or abandon medications because they are unable to afford out-of-pocket costs.  These cost-saving behaviors are directly associated with lower rates of viral suppression, poorer health outcomes, and increased strain on the healthcare system.

Research has also demonstrated that very small cost-sharing amounts can have outsized effects. Studies examining HIV prevention and treatment medications have found that prescription abandonment rates rise sharply when out-of-pocket costs increase from $0 to even $10 (Dean et al., 2024). Persistence on therapy drops as costs rise—a finding that should concern everyone.

Photo Source: ADAP Advocacy | iStock

Put simply, when patients pay more, adherence suffers, and people's health suffers.

In order for rebates to truly result in lower costs for consumers, the U.S. would need to do away entirely with our multi-payor healthcare model, which requires different payors (both for-profit and government-based) each have to enter into pricing and rebate negotiations with drug manufacturers to set prices and rebate amounts.

Pressure campaigns are effective only when pressure is applied from all sides. While drug manufacturers are unlikely to abandon a revenue cash cow like the Medicare program, they still have non-Medicare-enrolled consumers onto whom they can push increased drug prices with few to no negative outcomes. Consumers have come to not only accept but also expect medication price inflation, especially when there are few, if any, viable comparable alternative therapies available to them.

What the GUARD and GLOBE programs are intended to do is force manufacturers to provide higher rebates for medications that CMS deems “too expensive.” This, they posit, will result in lower drug costs for seniors and those non-seniors who rely on Medicare for drug coverage. The reality is that those consumers will likely realize few, if any, net savings from these programs, so long as there are multiple payors willing to pay whatever price is needed to move medications to their customers.

Although the GUARD proposal may seem promising to some, it does not require that these rebates be automatically passed on to patients in the form of lower out-of-pocket costs. That central problem needs to be addressed before the proposal is finalized and implemented.

The proposal states that it hopes that lower GUARD prices will benefit patients. The proposal says that "[i]t is possible that in response to the alternative payments]" GUARD creates manufacturers might "reduce their net price" in an effort to reduce the GUARD Model rebate payments. If so, then there might be some chance that patients would benefit from the GUARD prices. 

But the "possibility" that GUARD "might" help patients at the pharmacy counter just is not good enough. ADAP Advocacy plans to submit public comment in response to these proposals that address the patient perspective.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Beer, L., Tie, Y., Weiser, J., & Shouse, R. L. (2019, December 13). Nonadherence to Any Prescribed Medication Due to Costs Among Adults with HIV Infection — United States, 2016–2017. Morbidity and Mortality Weekly Report, 68(49): 1,129-1,133 http://dx.doi.org/10.15585/mmwr.mm6849a1

[2] Centers for Medicare and Medicaid Services. (2025, December 29). GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Model. United States Department of Health and Human Services: Centers for Medicare and Medicaid Services: Priorities: Overview: Innovation Models. https://www.cms.gov/priorities/innovation/innovation-models/guard

[3] Dean, L. T., Nunn, A. S., Chang, H. Y., Bakre, S., Goedel, W. C., Dawit, R., Saberi, P., Chan, P. A., & Doshi, J. A. (2024). Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis. Health affairs (Project Hope), 43(1), 36–45. https://doi.org/10.1377/hlthaff.2023.00808

[4] SmithRx. (2025, March 21). How Drug Rebates Influence Prescription Costs for Employers. San Francisco, CA: SmithRx. https://smithrx.com/blog/how-drug-rebates-influence-prescription-costs-for-employers

[5] Sood, N., Ribero, R., Ryan, M., & Van Nuys, K. (2020, February 11). The Association Between Drug Rebates and List Prices. Los Angeles, CA: University of Southern California: Leonard D. Schaeffer Institute for Public Policy & Government Service. https://schaeffer.usc.edu/research/the-association-between-drug-rebates-and-list-prices/