State Payors Make Advancements in Coverage of HIV Long-Acting Injectable Treatments

By: Marcus J. Hopkins, ADAP 340B Consultant

As of June 2025, 47 state AIDS Drug Assistance Programs (ADAPs) and all state Medicaid programs offer coverage for Cabenuva (cabotegravir; rilpivirine), a long-acting injectable (LAI) for the treatment of HIV/AIDS. This represents a significant change from 2023, when ADAP Advocacy found that just 40 state ADAP and 39 state Medicaid programs offered coverage for Cabenuva.

According to the National Alliance of State and Territorial AIDS Directors (NASTAD), only four state ADAP programs—Louisiana, Missouri, South Dakota, and Texas—do not currently offer coverage for Cabenuva. However, last month the Texas Legislature approved $338 billion two-year spending plan with funds to support Long-Acting Injectables (LAIs) for the Texas AIDS Drug Assistance Program (Figure 1).

Figure 1 – Long-Acting Injectable Coverage Map – Cabenuva – ADAP Coverage by State, June 2025

In addition to 47 state ADAPs offering coverage for Cabenuva, all state Medicaid programs currently provide coverage through either their fee-for-service Medicaid program or one of their Managed Care Organizations (MCOs; Figure 2). Medicaid coverage of Cabenuva, along with coverage provided by commercial insurance plans, is more difficult to quantify, as many plans may include coverage as a medical benefit rather than a pharmacy benefit. Finding information about drugs covered as medical benefits often requires searching through dozens, if not hundreds, of plan documents.

This was the case when researching Medicaid Preferred Drug Lists (PDLs). When ADAP Advocacy was unable to find direct confirmation of coverage for Cabenuva, it relied upon Long-Acting Agent Resource Center’s Cabenuva Coverage Map, a project of the American Academy of HIV Medicine (https://hivlaa.org/map/), to provide coverage information. Coverage information for the following 11 states was gleaned using this resource: Colorado, Georgia, Indiana, Iowa, Kansas, Kentucky, Montana, Nebraska, South Carolina, South Dakota, and Wisconsin.

Figure 2 – Long-Acting Injectable Coverage Map – Cabenuva – Medicaid Coverage by State, June 2025

ADAP Advocacy, under the direction of its 13-member ADAP Long-Acting Injectables Patient Advisory Committee, first began tracking ADAP and Medicaid coverage of Cabenuva, along with other LAIs to prevent or treat HIV in 2023 (Hopkins, 2023), when it was discovered that several state Medicaid programs were offering coverage of Cabenuva—first approved for monthly treatment in 2021, with a secondary approval for bi-monthly injections in 2022 (ViiV Healthcare, 2022)—in name only, with many states placing virtually insurmountable prior authorization (PA) requirements between patients and their life-saving medications. The formulary research into drug coverage and PA requirements led ADAP Advocacy to conduct original quantitative and qualitative patient-side research on sentiments and attitudes toward long-acting agents.

Key findings from ADAP Advocacy's research include:

• The majority of respondents to the Treatment Survey (52.3%) indicated that they would prefer receiving LAI medication to treat their HIV over a daily pill-based regimen; In the Prevention Survey, the majority of respondents (71.4%) indicated they would prefer an LAI over a daily pill-based regimen to prevent HIV.
• The vast majority of respondents to the Treatment Survey (87.8%) indicated being aware of Cabenuva as an LAI to treat HIV. Of those respondents who learned about the existence of LAI medications through this survey, half (50%) reported being open to discussing them with a medical provider; Just over half of respondents to the Prevention Survey (58.4%) indicated being aware of Apretude for use as LAI PrEP. More than four out of every ten respondents (42.2%) who learned about the existence of Apretude through this survey reported being open to discussing it with a medical provider;
• A majority of respondents to the Treatment Survey (87.7%) indicated having no issues finding information about LAI medications. Of those respondents who did have trouble finding information (12.3%), most respondents had trouble finding information about insurance coverage (78.6%), prior authorization requirements (78.6%), and the cost they would have to pay to access LAIs (71.4%);
• Insurance coverage barriers impacted respondents’ ability to pursue LAIs, with more than 1 in 4 survey respondents (27%) reporting this barrier in the Treatment and Prevention surveys. In the case of PrEP, a majority of those experiencing this (66%) indicated that the barriers to access were so cumbersome that they decided Apretude was not right for them.

In addition to coverage for Cabenuva, ADAP Advocacy also found that:

• 2 state ADAP programs (MA & MN) and 40 state Medicaid programs offer coverage for Apretude as Pre-Exposure Prophylaxis (PrEP);
• 43 state ADAP and 42 state Medicaid programs provide coverage for Sunlenca as HIV salvage therapy; and,
• 50 state ADAP and 32 state Medicaid programs provide coverage for Trogarzo as HIV salvage therapy.

Coverage for LAI drugs is of ever-increasing importance for People Living with HIV/AIDS (PLWHA) as long-acting agents may help to increase medication adherence and reduce the risk of creating multi-drug-resistant strains of the HIV virus. ADAP Advocacy will continue to monitor coverage of LAIs and provide updates when significant changes are made.

[1] Hopkins, M. J. (2023, July 20). The state of long-acting injectable Medicaid coverage. Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2023/07/the-state-of-long-acting-injectable.html

[2] ViiV Healthcare. (2022, January). ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/viiv-healthcare-announces-fda-approval-of-cabenuva-for-use-every-two-months/

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.    

Fireside Chat Retreat in Minneapolis, MN Tackles Inflation Reduction Act's Adverse Impact on Patient Care

By: Brandon M. Macsata, CEO, ADAP Advocacy & Ranier Simons, ADAP Blog Guest Contributor

ADAP Advocacy hosted its Health Fireside Chat retreat in Minneapolis, Minnesota, among key stakeholder groups to discuss the adverse impact on patient care being caused by the Inflation Reduction Act (IRA). The Health Fireside Chat was held from Thursday, June 12th, to Saturday, June 14th. An analysis of the IRA's drug price controls—including its pill penalty provisions, challenges community pharmacies are facing, more restrictive drug formularies increasing, non-medical switching, and patients absorbing greater costs due to shifts from co-pays to co-insurance—were all evaluated and discussed by the 24 diverse stakeholders.

Photo Source: Getty Images

The IRA discussion was designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:

• Meg Beaven, Senior Director, Rational 360
• Ninya Bostic,  National Policy & Advocacy Director, Johnson & Johnson
• Grant Cale, Senior Director, Alliance Development Lead, U.S. Policy and Government Affairs, Bristol Myers Squibb
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Jeffery S. Crowley, Director of the Center for HIV and Infectious Disease Policy at the O’Neill Institute
• Olivier Viel, Associate Director, Policy and Government Affairs, Merck
• Jazlyn Gallego, Policy and Advocacy Manager, Cancer Support Community
• Max Grechko, Associate Director, Strategic Alliances and Issue Advocacy, Novartis
• Rick Guasco, Editor-in-Chief, Positively Aware
• Connie Jorstad, Director of Government Relations, ViiV Healthcare
• Patrick Ingram, Implementation Project Manager, Midwest AETC
• Kristy Kibler, CEO, Lupus Colorado
• Amanda Kornegay, Owner, Kornegay Consulting, LLC
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Paramedic Crew Chief & Patient Advocate
• Brandon M. Mascata, CEO, ADAP Advocacy
• Heidi Mesik, Senior Director, PhRMA
• Michiel Peters, Head of Advocacy Initiatives, Global Coalition on Aging
• Kalvin Pugh, Director of State Policy, 340B, Community Access National Network
• Ranier Simons, Consultant, ADAP Advocacy
• Jason Sterne, Director, Policy Advocacy and Alliances, Gilead
• Scott Suckow, Senior Consultant, Perry Communications Group
• Matt Toresco, CEO, Archo Advocacy
• Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency

To level set and provide background for discussions, attendees are sent suggested readings in advance. The following are just a few from the thorough list provided for this session:

• The Inflation Reduction Act (IRA): Impact on Medication Pricing, Spending, Affordability, and Access – Analysis by Pioneer Institute
• Independent Pharmacies Reluctant to Stock Drugs in Medicare Negotiation Program, New Survey Shows – Survey by the National Community Pharmacy Association
• Executive Summary: Impact of the IRA on Patient Access & Discovery of Small Molecule Drugs – Report by the Global Coalition on Aging
• CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing – Blog by Travis Manint, Community Access National Network
• How the IRA's Part B Coinsurance Inflation Adjustments Can Raise Seniors' Drug Costs – Analysis by Dr. Adam Fein, Drug Channels Institute

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat.

The overarching theme of the discussions was how varying aspects of issues, directly or indirectly related to the IRA, can affect patients and their access to medical care. Drug pricing was a significant thread throughout the gathering. Participants expressed a consensus that the pricing of pharmaceuticals is a complex system involving many players, with patients often being stuck in the middle or positioned at the bottom. High prescription drug expenditures are partially the result of multiple bad actors making profits at the expense of the masses who need drugs for their care. The discussion largely mirrored the conclusions reached by Kenneth E. Thorpe in his June 2024 piece in Health Affairs, "Penny Wise And Pound Foolish: IRA Impact On Chronic Disease Costs In Medicare."

In-depth dialogue occurred surrounding the IRA's effects on independent, community pharmacies. These pharmacies, in particular, routinely operate within thin margins or sometimes at a loss. Due to issues such as under-reimbursement, many pharmacies are already closing. The IRA’s Maximum Fair Price (MFP) key provision for Medicare drug price negotiation has the potential to harm pharmacies further. The MFP could negatively impact pharmacies by lowering reimbursement rates, further causing financial strain. Discourse revealed that many independent pharmacies are quietly already stating they will not be stocking many of the medications subject to the MFP because they cannot afford to. Independent pharmacies are the lifeblood of communities where larger pharmacies are not present. Closing due to financial strain would rob citizens of auxiliary services and preventative care services, in addition to drug access.

Photo Source: National Community Pharmacy Association

The conflict involving pharmacy benefit managers (PBMs) and their pharmacies was also discussed. There has been an uptick in state legislation aimed at preventing PBMs from owning and operating pharmacies in the states where they do business. Vertical integration is a problem as it allows pharmacy steering and predatory independent pharmacy contracting. When PBMs own and operate pharmacies, they manipulate pricing to their advantage, steering patients to their networks at higher costs. They also offer independent pharmacies less favorable contracts, lower reimbursements, and higher fees, among other disadvantages. Attendees gleaned from the discourse that vertical integration is considered self-dealing, which is a form of fraud. It is not ethical for a health plan to own a pharmacy, just as it is not ethical for a PBM to own one.

Moreover, under the IRA, if pharmacies choose not to participate in the MFP under the Medicare Drug Price Negotiation program, they are, in essence, excluded from participating in Medicare Part D for the drugs in question. Independent pharmacies are not in favor of the new IRA mechanism because their cash flow would be split between reimbursement from CMS and refunds from drug manufacturers to make up the difference. Pharmacies would have to suffer delays in cash flow waiting to be made whole, with the possibility of not being made whole at all. The conversation specifically acknowledged that CMS is acting as a payer without any understanding of care delivery for multiple disease states.

During the period spent discussing strategy and solutions, the underlying focus was on messaging. The concern was how to effectively convey the right message to the public and into the marketplace. Some attendees suggested that the pharmaceutical industry should be more proactive in generating opposition to the current administration. It was acknowledged that “big pharma” has taken steps, especially through extending relationships with advocacy groups. However, there remains a notion that the pharmaceutical industry needs to embrace the concept that “dead people do not buy medications.” This means that they should embrace concerted efforts to protect patients and patient access, not just from a position of altruism but as a sensible business strategy. The reality is, as Dr. Adam J. Fein of the Drug Channels Institute has pointed out, "a growing number of Part B drugs now have inflation-adjusted coinsurance rates that are rising, not falling...[and] in many cases, the rate dips temporarily before snapping back to the standard 20%." It begs the question: Are patients paying more?

Photo Source: Drug Channels Institute

Discussions of messaging also zeroed in on patient perception. The issues surrounding the IRA and its various aspects are complex, even for those well-versed in the issue. Attendees emphasized the importance of engaging patients by creating messaging that is simple yet resonates with their humanity in ways they understand. The price is being conflated with out-of-pocket costs, and messaging needs to highlight how the IRA can increase out-of-pocket costs for patients.

The Cancer Support Community (CSC) has developed patient-centered principles to help guide its advocacy work, which is available online. These patient-centered principles are also included in CSC's sign-on letter on the EPIC Act, to which ADAP Advocacy also signed.

With so many of the IRA's targeted drug price controls falling on chronic health conditions and rare diseases, such as cancer and HIV, they have the potential to fuel already exacerbated health disparities among medically underserved communities. The sole focus on "price" largely ignores the money saved by treating these conditions with life-altering and life-saving therapeutics. Sadly, proponents of these anti-patient drug price controls—including several groups financed by Arnold Ventures' special interests efforts pushing harmful state drug affordability boards, or PDABs—leverage potentially harmful metrics. Among them is the dehumanizing quality-adjusted life years (QALYs). 

Suggestions included campaign-style messaging that utilizes both traditional and non-traditional media to educate patients by making the message more personal. Presenting the public with stories that explain how specific policies directly affect aspects of their daily lives is a way to empower patients and transform the patient community into a voting bloc. Populist patient-centered messaging and actions promote community building to engage policymakers as well as empower citizens. 

Going forward, discussions also emphasized the importance of finding ways to navigate within the confines of the challenging current administration, as its operations are adversarial, unpredictable, and unprecedented. The consensus indicated that an effective way to do this is to make “new friends.” This means engaging with untapped entities, such as labor unions, insurance commissions, Ryan White service providers, and disability groups. Many entities that potentially could be drastically affected by the IRA and other issues are unaware of their risk of adverse outcomes. Forging new avenues of communication with groups like these is a way to create infrastructure that can effect change.

Woven throughout the day's policy analysis was recognition that patient advocacy groups need to push back harder against the fallacy that their advocacy efforts aren't genuine simply because they accept financial support from drug manufacturers. Ongoing attempts to discredit patient advocacy by faux news outlets, such as the 340B Report, ignore the realities that patients and drug manufacturers often have shared interests, and that the financial support provided by industry acknowledges those values. It is also disingenuous to have patients living with chronic health conditions and rare diseases be faulted by paternalistic critics who aren't patients themselves.

ADAP Advocacy would like to publicly acknowledge and thank Jen Laws, Heidi Mesik, Michiel Peters, Jazlyn Gallego, and Matt Toresco for co-facilitating this critically important discussion.

Additional Fireside Chats are planned for 2025 in Atlanta (September).

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.

New Study Yields Insights to Women Living with HIV/AIDS, and Viral Suppression

By: Ranier Simons, ADAP Blog Guest Contributor

The goal of HIV antiretroviral therapy (ART) is viral suppression. Viral suppression is reducing the level of HIV in the blood to an undetectable status. Viral suppression is achieved through strict adherence to antiretroviral therapy (ART) regimens in their various forms. Insufficient adherence can result in increased viral loads or even virological drug resistance. As advances in ART continue, it is essential to determine the level of adherence considered sufficient for viral suppression. In a perfect world, all people living with HIV/AIDS would have 100 percent adherence to treatment regimens, meaning that they never missed a dose. That is not realistic. Thus, consensus in medical science views 95% as a high level of adherence. Even 95% adherence is not achievable for many people living with HIV/AIDS (PLWHA). Because data show that viral suppression can be achieved with adherence of less than 95% using newer medications, scientists are investigating the levels of adherence required for this outcome. A recent Canadian study examined viral suppression and treatment adherence among women, taking into account the unique characteristics of many women’s lived experiences (Mokaddam et al., 2025).

Photo Source: HIVinfo | NIH

Presently, ART is lifelong. Thus, effective treatment requires consistent and ongoing adherence. Women living with HIV/AIDS (WLWHA) have unique social, biological, and other categories of lived experience that result in unique challenges to ART adherence (Ogden et al., 2004). Canadian researchers performed a longitudinal study of WLWHA because 2020 data showed women lagged behind men concerning the Joint United Nations Programme on HIV/AIDS target for HIV care. The target is 95-95-95, meaning 95% of all PLWHA should be aware of their status, 95% of those diagnosed should be on effective therapy, and 95% of those on ART should have viral suppression (Mokaddam et al., 2025). PLWHA Data from 2020 shows men at target levels of 90%–87%–96% and women at 88%–85%–90% (Mokaddam et al., 2025). 

The Canadian study utilized data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS), a community-based, prospective cohort study. The CHIWOS study was conducted in three waves from 2013 to 2018. The recent Canadian study executed a longitudinal analysis of self-reported survey data, including socioeconomic data, health history including HIV and ART, substance abuse, and even history of violence and abuse (Mokaddam et al., 2025). The researchers specifically included subjects only if they reported utilizing a regimen consisting of an antiretroviral backbone with a third agent. The ‘backbone’ consists of two nucleoside reverse transcriptase inhibitors (NRTIs). The backbone is then combined with a third medication chosen from several classes, including non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), or integrase strand transfer inhibitors (INSTIs) (HIV.Gov, n.d.). The researchers made this distinction as a standard for inclusion to rule out other forms of ART that may be prescribed due to previous drug resistance or other drug interactions and conditions to lower the possibility of confounding factors affecting adherence.

Photo Source: HIV.gov

The cross-sectional analysis of the third wave of participants revealed that overall, 95.5% reported viral suppression, and 76.2% of participants had an ART adherence level of ≥ 95% (Mokaddam et al., 2025). Of those reporting ≥95% adherence, 97% of those achieved viral suppression. Other levels of reported adherence were associated with different viral suppression percentages. Respondents who reported 85-89% adherence had a viral suppression of 78.6%, those with 75-79% adherence had a viral suppression of 75%, and those with less than 65% reported a viral suppression of 76.5% (Mokaddam et al., 2025). Those reporting 90-94% adherence to ART had a viral suppression level of 97.2%, similar to that of those with ≥95% adherence. There were no differences in the odds of participants reporting viral suppression across the various medications used as a third agent to the ART backbone. Approximately 27.2% were on a first-generation INSTI, 34.0% on a second-generation INSTI, 22.9% on a NNRTI, and 15.9% were on a PI (Mokaddam et al., 2025). 

This Canadian study suggests that the odds of achieving viral suppression with adherence rates of 90% or less are significantly lower than those with adherence rates of 95% or higher. Several studies have indicated that viral suppression can be achieved with adherence levels of 75% to 80%. Interestingly, the study observed an increase in the utilization of INSTIs as a third agent, specifically dolutegravir, over the course of the waves between 2013 and 2018 (Mokaddam et al., 2025). The use of dolutegravir increased the odds of virologic suppression (VS) across varying levels of adherence.

WLWHA have unique issues to deal with that affect their ability to maintain treatment adherence. Medication access, living situations, women-specific health conditions, and many other factors influence the ability to engage in care. It is imperative to continue exploring the impact of their lived experience on their ability to maintain adherence, coupled with the development of ART that is more forgiving in terms of the levels of adherence required to maintain viral suppression. This data is vital for women as well as PLWHA as a whole.

[1] Mokaddam, M., Kronfli, N., Sheehan, N. L., Reyes, A. G., Dubuc, D., Loutfy, M., Kaida, A., & De Pokomandy, A. (2025). Antiretroviral therapy use, self‐reported adherence, and viral suppression among women living with HIV in Canada. HIV Medicine. https://doi.org/10.1111/hiv.70034. Retrieved from https://onlinelibrary.wiley.com/doi/10.1111/hiv.70034

[2] NIH Office of AIDS Research (HIV.Gov). (n.d.). HIV/AIDS Glossary: Backbone. Retrieved from https://clinicalinfo.hiv.gov/en/glossary/backbone

[3] Ogden, L., Ogden, J., Mthembu, P., & Williamson, N. (2004). Impact of HIV on women internationally. Emerging infectious diseases, 10(11), 2032–2033. https://doi.org/10.3201/eid1011.040624_01. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC3329028/

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.   

ViiV's Positive Perspectives Research Provides Insights to Patient-Provider Relationships

By: Ranier Simons, ADAP Blog Guest Contributor

The doctor-patient relationship is the cornerstone of healthcare. Patients cannot fully benefit from the many advances in medical science without a solid relationship with their provider, where they feel listened to and cared for. The relationship has been defined as “a consensual relationship in which the patient knowingly seeks the physician’s assistance and in which the physician knowingly accepts the person as a patient” (Chipedza et al., 2015). Mutual trust and vulnerability are required, especially regarding people who are living with HIV/AIDS (PLWHA). ViiV Healthcare recently released data from the third wave of its Positive Perspectives Research study (PP3), which examines the lived experiences of PLWHA globally. This wave of inquiry is heavily focused on improving health outcomes by digging into the interactions between PLWHA and their healthcare providers.

Photo Source: GoodTherapy

The current wave, PP3, will eventually include 3,000 participants. The newly released data is a result of the first 698 participants representing 16 countries, including the United States, United Kingdom, and Canada (Lutton, 2025). Eventually, it will cover 29 countries. Wave One surveyed 1,111 PLWHA and 250 of their partners, covering nine countries. Wave 2 involved 2,389 PLWHA covering 25 countries (ViiV, Press Release 2025). All the waves investigate various themes surrounding the lived experiences of PLWHA. PP3 aims to further define and raise the voices of PLWHA to improve healthcare outcomes by informing healthcare providers and other stakeholders of the realities of how PLWHA navigate their care and day-to-day lives.

Early PP3 data suggest an overarching theme of communication issues between PLWHA and their healthcare providers. The early findings indicate that there are strong levels of trust in PLWHA’s patient-provider relationships. Approximately 80% of those currently surveyed reported trusting their healthcare provider. (Lutton, 2025). However, while the trust is solid, there are reported weaknesses in areas such as patients' practical understanding of information and their inclusion in care decisions.

Photo Source: Doctor Patient Relationship

Although a high level of trust has been reported, 47.5% of PLWHA surveyed feel that their healthcare providers do not effectively listen to them, and 39.7% reported that they were not included in the choice of their antiretroviral regimen (ART) (ViiV, 2025). Successful HIV health outcomes are holistic, involving more than just a focus on viral suppression. Patients need to be able to fully express their values, preferences, and individual life circumstances to their healthcare providers. Empathy is associated with patient satisfaction and treatment adherence (James, 2023). When healthcare professionals truly listen, they can better understand how their patients interact with life, which is often vastly different from their own lives and familiar ways of thinking.

Part of ART selection is based on patients’ specific virological needs. However, there are nuances of selection that are influenced by patient preference when patients are fully informed of all their options. The preliminary study results indicated that 53% of patients were worried about long-term effects of ART (ViiV Press Release, 2025). ART comes in many different combinations of drugs with the potential for short-term and long-term side effects. Approximately 53% of respondents had ART-related weight gain as a side effect concern. It is essential for healthcare professionals to engage in transparent discussions about the aspects of different drug combinations, empowering patients to make informed decisions rather than leaving them to accept the physical manifestations of regimens that are unilaterally imposed upon them. Patients’ ability to be consistent with their regimen is also a consideration in education about all modalities, such as long-acting injectables. Approximately 43.2% of the current respondent group stated a disdain for daily medication because it was a daily reminder of their HIV status (ViiV Press Release, 2025). When patients feel fully included in their care, they are more likely to adhere to their medication schedule.

Photo Source: Patient Voices

A notable early revelation of the study is that the concept of undetectable equals untransmittable, or “U=U”, is not fully embraced or understood. Medical science has proven that PLWHA cannot transmit the HIV virus when they have reached and maintained an undetectable viral load. However, only 58% of respondents truly believed it. Approximately 93.7% knew U=U, but low uptake of it as a belief system means that many PLWHA are not empowered to fully live their lives without the guilt and stigma of embracing their relationships and sexual expression. Moreover, only 31.1% of patients were able to explain the concept of U=U to other people (ViiV Press Release, 2025). It is essential for healthcare providers to thoroughly educate PLWHA on the science behind U=U, enabling them to advocate for themselves and combat stigma within their social networks.

Wave three of the Patient Perspectives study is only partially complete. The goal of 3,000 participants will yield a more comprehensive picture of the patient-doctor relationship, providing healthcare professionals with an informed understanding of its strengths and weaknesses. Understanding what is being done well in comparison to areas needing improvement will enable providers to make effective changes to the status quo. Health literacy is influenced by socioeconomic status, age, racial and ethnic factors, and educational levels (Dawson-Rose et al., 2016). Once fully completed, PP3 will inform healthcare providers on how to facilitate improvements in patients’ health literacy, as well as bolster care professionals’ ability to step outside their own spheres of understanding into an empathetic place of true patient communication.

[1] Chipidza, F. E., Wallwork, R. S., & Stern, T. A. (2015). Impact of the Doctor-Patient Relationship. The primary care companion for CNS disorders, 17(5), 10.4088/PCC.15f01840. https://doi.org/10.4088/PCC.15f01840

[2] Dawson-Rose, C., Cuca, Y. P., Webel, A. R., Solís Báez, S. S., Holzemer, W. L., Rivero-Méndez, M., Eller, L. S., Reid, P., Johnson, M. O., Kemppainen, J., Reyes, D., Nokes, K., Nicholas, P. K., Matshediso, E., Mogobe, K. D., Sabone, M. B., Ntsayagae, E. I., Shaibu, S., Corless, I. B., … Lindgren, T. (2016). Building Trust and relationships between patients and providers: An essential complement to health literacy in HIV care. Journal of the Association of Nurses in AIDS Care, 27(5), 574–584. https://doi.org/10.1016/j.jana.2016.03.001

[3] James, T. (2023, January 12). Building Empathy into the Stucture of Health Care. Retrieved from https://postgraduateeducation.hms.harvard.edu/trends-medicine/building-empathy-structure-health-care#:~:text=Studies%20demonstrate%20how%20empathy%20improves,they%20feel%20heard%20and%20understood.

[4] ViiV Healthcare. (May 2025). Positive Perspectives Research. Retrieved from https://viivhealthcare.com/hiv-community-engagement/positive-perspectives-research/#:~:text=Wave%203%20survey

[5] ViiV Press Release. (2025, May 27). ViiV Healthcare Positive Perspectives 3 Study Finds Widespread Communication Barriers: Half of People Living with HIV Feel Unheard by Healthcare Providers Despite High Trust. Retrieved from https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/may/positive-perspectives-survey/

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.   

Closing the Book on Maryland's HIV Criminalization Law

By: Ranier Simons, ADAP Blog Guest Contributor

Science and equity slowly continue to push policy forward. On May 21, 2025, Maryland became the fifth state to decriminalize HIV. In February 2025, Maryland Senate Bill 356 and House Bill 39 passed in their respective chambers. On May 21, Governor Wes Moore signed the legislation into law with the official name, ‘The Carlton R. Smith Act’. Carlton R. Smith was an activist, long-term HIV survivor, and advocate championing Baltimore LGBTA and HIV services (Bishop, 2024; Medina, 2024). He passed away in May 2024, and as an active proponent of this legislation, it was fitting to name it after him. The effective date of the legislation is October 1, 2025. 

Photo Source: CHLP

The act repeals the previous law, which consisted of two concise sections: 

• (a) An individual who has the human immunodeficiency virus may not knowingly transfer or attempt to transfer the human immunodeficiency virus to another individual. 
• (b) A person who violates the provisions of this section is guilty of a misdemeanor and, on conviction, is subject to a fine not exceeding $2,500 or imprisonment not exceeding 3 years or both.

HIV criminalization means criminalizing living with HIV by criminalizing behavior that is not commonly criminalized when a person is HIV-negative. It also means adding enhanced punitive actions for a crime to those living with HIV convicted of a crime, more than the punishment if HIV was not involved (CHLP, 2025 May). The Maryland legislation was inherently problematic because it did not specify the means of transmission, did not require actual, verified transmission of the virus, and did not require any proof of intent. It merely needed someone to ‘knowingly’ expose another person to HIV (Cisneros et al., 2024). Additionally, it carved out HIV from general health statutes surrounding the spreading of other communicable diseases, adding a misdemeanor, monetary fine, and a maximum three-year imprisonment term (Cisneros et al., 2024).

The repealed Maryland statute was discriminatory regarding HIV status and race. From 2020-2022, enforcement of HIV criminalization laws was heavily concentrated in predominantly Black counties: 32% of the state's cases were in Baltimore City, 19% in Montgomery County, and 18% in Prince George’s County (Cisneros et al., 2024). Additionally, Black Marylanders were only 30% of the state's population and 71% of PLWHA, but they accounted for 82% of all HIV-related cases (Cisneros et al., 2024).

The Maryland statute ignored scientific evidence, which shows that a person with an undetectable viral load cannot transmit the virus. It also did not give any weight to a person living with HIV who disclosed their status or received consent from the other party (Cisneros et al., 2024). Thus, the latitude of defining actions as ‘knowledgeable exposure’ was predatorily wide.

Photo Source: The 19th

According to the Center for HIV Law and Policy (CHLP), in the United States, 32 states currently have HIV-specific criminalization laws, and 28 have HIV-related criminal penalty enhancements (CHLP, 2025 February). Additionally, some states have general statute criminal laws that allow HIV to be prosecuted in terms of assault with a deadly weapon or reckless endangerment. These laws are fundamentally not evidence-based because HIV cannot be transmitted through spitting, biting, fighting, or throwing bodily fluids. Outdated laws contribute to the stigma and reinforce opinions that contradict current medical science. 

In March of this year, North Dakota also got rid of its HIV criminalization laws. Before repeal, N.D. Cent. Code § 12.1-20-17 stated that PLWHA could be prosecuted for having sex if they did not disclose their status, even if the activity was low risk or posed no risk at all, such as with oral sex. The penalties for conviction were up to 20 years in prison and a Class A felony conviction. Additionally, people who shared syringes or needles without proper sterilization could have been prosecuted even without intent to transmit or any verified actual infection, as well as qualify for the same maximum 20-year imprisonment penalty and felony classification.

HIV criminalization laws do not benefit or improve public health or safety. In fact, HIV criminalization laws make people fearful of getting tested, seeking care, or even disclosing when undetectable and in treatment. It is imperative to continue to educate legislators as well as the public. It is unacceptable to allow these laws to keep PLWHA tangled in the justice system unduly, demoralize their existence, and continue to marginalize and disenfranchise racial and sexual minoritized groups.

[1] Bishop, K. (2024, June 6). Remembering Carlton Smith. Retrieved from https://chasebrexton.org/blog/remembering-carlton-smith

[2] Center For HIV Law and Policy (CHLP). (2025, February). Mapping HIV Criminalization Laws in the U.S., CHLP (2025). Retrieved from https://www.hivlawandpolicy.org/maps#:~:text=In%20the%20United%20States%2C%2032,knowledge%20of%20their%20HIV%20status.

[3] Center For HIV Law and Policy (CHLP). (2025, May 20). Maryland Repeals HIV Criminalization Law. Retrieved from https://hivlawandpolicy.org/news/maryland-repeals-hiv-criminalization-law

[4] Cisneros, N., Tentindo, W., Sears, B., Macklin, M., Bendana, D. (2024, January). Enforcement of HIV Criminalization in Maryland. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/HIV-Criminalization-MD-Jan-2024.pdf

[5] Medina, J. (2024, June 24). The Life and Work of Carlton Smith. Retrieved from https://www.freestate-justice.org/the-life-and-work-of-carlton-smith

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.   

Is Trump's Executive Order on Most Favored Nations Drug Pricing a Wet Noodle?

By: Ranier Simons, ADAP Blog Guest Contributor, and Marcus J. Hopkins, ADAP 340B Consultant

The Trump Administration’s policies continue to generate uncertainty and disarray in most sectors of the economy in the United States, especially healthcare. On May 12, 2025, another executive order aimed at “reducing prescription drug costs” was signed. The President issued Executive Order (EO) 14297, ‘Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients’, with the false claim that prescription drug and pharmaceutical prices will be reduced, almost immediately, by 30% to 80%. In actuality, the EO is vague, flawed, and has the potential to do damage to many areas within the healthcare ecosystem. The EO was presented as a strong-armed mandate to effect swift change to the status quo. However, STAT’s Matthew Herper reported, "As pharmaceutical investors see it, he stomped loudly and wielded a wet noodle" (Herper, 2025).

Photo Source: The White House

The premise of the EO is that the status quo of what the United States pays for prescription drugs compared to other developed foreign markets is unfair; thus, the imbalance needs to be corrected. The narrative presented is that drug manufacturers are taking advantage of American consumers and the government by charging the United States exorbitant prices for drugs to offset the low prices other foreign governments demand for the same drugs. A direct quote from section one of the EO states, “Drug manufacturers, rather than seeking to equalize evident price discrimination, agree to other countries’ demands for low prices, and simultaneously fight against the ability for public and private payers in the United States to negotiate the best prices for patients.”

According to the nonprofit RAND Corporation, a nonpartisan research organization, the United States pays almost three times what approximately 33 other comparatively developed nations pay for the same prescription drugs (Mulcahy, Schwam & Lovejoy, 2024). However, RAND Corporation’s 'apples to apples' findings ignore numerous factors that separate the United States from the other developed nations, thus calling into question the simplified comparison.

The following is an overview prepared by ADAP Advocacy on how the mechanisms of the EO describe solutions to the problem, including relevant notes:

1. Ordering the Secretary of Commerce to identify “foreign nations freeloading”—a catch-all term that will attempt to identify any “act, policy, or practice” that may be “unreasonable or discriminatory” or that “may impair United States national security and that has the effect of forcing Americans to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value.” (Editor's Note): This process is unlikely to consider that almost all these developed nations do not use the free-market for-profit healthcare model used by the United States, but have implemented a Universal or Single-Payer healthcare model. This means that there is one organized purchaser of these medications. If pharmaceutical companies wish to sell their products in those countries, they can either agree to the terms that those nations specify for the drugs or refrain from selling their drugs there. Meanwhile, in the United States, a patient's price for a drug can vary significantly from patient to patient, depending on their insurer. This means that every single payor (except for Medicare) must negotiate with pharmaceutical companies to determine what price they will pay, and those negotiations are protected by “trade secrets” laws that shield the entire process from consumers and most lawmakers.
2. Enabling direct-to-consumer sales of drugs from pharmaceutical companies to patients. This is an interesting proposal that can potentially eliminate several middlemen from the existing domestic drug procurement and purchasing system. (Editor's Note): Currently, by the time a patient actually purchases a medication from their pharmacist, it has already passed through at least two middlemen—drug wholesaling companies and pharmacy benefit managers (PBMs)—and each middleman is attempting to make a profit. This means that, even if the starting acquisition cost of a medication is $20/bottle, to make a profit, the wholesaler will mark up the cost to $22/bottle, which will require the pharmacy to mark up the cost to $24/bottle…but then, for the PBM to make a profit, they will pocket a percentage of the reimbursement to the pharmacy, which will necessitate increasing the price to $26/bottle in order for the pharmacy to make a profit.
3. By allowing pharmaceutical companies to sell their drugs directly to patients, the Trump Administration could potentially decrease consumer costs, but risks putting pharmacies out of business or creating a model where pharmaceutical companies could purchase pharmacies outright and increase their profits while putting local and community pharmacies out of business.
4. Enabling “Most-Favored-Nation Pricing” (MFN) by instituting price controls through administrative rulemaking. This would allow the Secretary of the U.S. Department of Health and Human Services (HHS) to request that pharmaceutical manufacturers come to the table with the federal government to agree upon a maximum price that they can charge for medications in the United States. This would first be done voluntarily…with the threat of involuntary price controls and the removal of drug approval by the U.S. Food and Drug Administration (FDA).

Photo Source: Market.us Media

If pharmaceutical companies don’t agree to the terms set forth by this administration, the various Department Secretaries are empowered to:

a.) Propose a rulemaking plan that would “impose most-favored-nation pricing;”

b.) Allow drug importation from foreign countries (a position which ADAP Advocacy vehemently opposes);

c.) “Review” potential actions that could be taken to prevent the exporting of drugs to other countries (i.e., forbid U.S.-based manufacturers from exporting drugs);

d.) Review and modify approvals granted for drugs, which would force drug manufacturers to take their medications off the market—a punitive move that is likely illegal (Payne & Silverman, 2025); and

e.) “…address global freeloading and price discrimination against Americans.”

On its face value, the EO is hazy and does not explain much of its implementation. The overall theme is ‘facilitate, study, and propose’. There are several essential questions the EO leaves unanswered:

• How will HHS determine “Most-Favored-Nation” pricing?

• Which classes and how many drugs will be included in this pricing?

• Will this only apply to drugs purchased by Medicaid, Medicare, and Veterans Affairs, or will this apply to commercial insurers and the uninsured, as well? (Franco, 2025)

Most importantly, much of what the President desires to do requires cross-agency cooperative Congressional legislative action (Payne & Silverman, 2025). Nothing in the EO represents actionable endeavors that will reduce drug prices for Americans in the immediate future. For example, the EO directs HHS to set target prices for negotiations with drug manufacturers in the next 30 days. If, after an unspecified time, drug manufacturers have not voluntarily made “significant progress,” that is when rulemaking will begin to force MFN pricing.

Politics surely makes for strange bedfellows. Congressional Democrats were quick to embrace this latest EO – evidenced by Representative Ro Khanna, who represents California's 17th congressional district, introducing legislation to codify MFN into law. Sen. Bernie Sanders, one of the pharmaceutical industry’s greatest detractors, called on Republicans to support federal legislation mirroring the EO. It is unlikely any Republican would support an effort to impose price controls on pharmaceutical products.

Photo Source: X

The top two Republican Senators, Senate Majority Leader (SD) and Senate GOP Whip John Barrasso (WY), have already expressed skepticism about an MFN pricing model. Wall Street didn't seem too alarmed by its prospects, either. POLITICO's headline read, "Wall Street shrugs at Trump’s most-favored order," in an article that featured colorful responses from investment groups. Still, some organizations remain on the fence (Gardner & Lin, 2025).

The reality is that the MFN approach to "fixing" healthcare costs associated with prescription drugs ignores the complexities of the healthcare ecosystem. Moreover, instituting MFN pricing would be financially devastating to drug manufacturers. It would result in a drastic revenue reduction in tandem with the Trump Administration’s recently threatened pharmaceutical tariffs (Reed, 2025). It is not sustainable for pharmaceutical companies to lower domestic prices to the levels of the lowest foreign countries. In speaking with the Wall Street Journal, Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota College of Pharmacy stated, “The first thing we have to realize is if another country’s getting a drug at one-tenth of the price that we are, we’re not going to get all of our drugs at one-tenth of the price we’re paying now” (Hopkins & Loftus, 2025). 

For example, instituting an international pricing model for Medicaid would cost drug manufacturers an estimated $1 trillion over the span of a decade (Hopkins & Loftus, 2025). Drug companies would have to raise the prices that other countries are paying for drugs. Coincidentally, the President stated that other countries will have to pay more for drugs to expressly pay their ‘fair share’ for innovation and development (Hopkins & Loftus, 2025). Thus, the administration aims to disrupt the global pharmaceutical market. Convincing other countries to modify and increase their expenditures drastically does not appear plausible.

MFN pricing also threatens programs like the 340B Drug Pricing Program, given that it would drastically reduce rebates. Reducing 340B funding would adversely affect providers and covered entities that serve vulnerable populations (Lopez, 2025). This change would have a devastating impact on the State AIDS Drug Assistance Programs (ADAP). There could also be unintended consequences for the Medicaid Drug Rebate program, as MFN pricing would reduce federal matching Medicaid dollars. Dangerously, the MFN idea tangentially invites using quality-adjusted life years, or QALY, to make pricing decisions. While outlawed in the United States, many foreign governments use QALYs, which are discriminatory methodologies that devalue the lives of vulnerable populations. These measures also ignore the lived experiences of diverse racial and ethnic groups (Lopez, 2025).

Photo Source: STAT News

PlusInc, a nonprofit dedicated to health equity, has demonstrated how QALYs fuel health disparities. In a recent analysis, PlusInc argued, "If the math behind QALYs seems obtuse, you’re not alone—one of the primary criticisms of the QALY is that the methodology behind determining how a QALY is measured is predicated upon a lot of assumptions that may or may not hold true across every community. Some recognized experts who have studied QALYs have expressed concern over their impact on health equity."

Mike Eging, who leads the Rare Access Action Project (RAAP), summarized many of the concerns being expressed about the proposal: "Many rare products are developed through family foundations set up by patients and families to seek therapies to treat not just loved ones, but also their patient communities. Others are discovered by passionate scientists in universities, or through emerging smaller companies with only one or two products in development. These efforts can lead to therapies, some of which are never launched overseas due to price controls and regulatory hurdles. Or, they require partnerships with larger companies to navigate an expensive launch in Europe, at a price they no longer control. Further, some emerging rare companies never launch in Europe due to these challenges. Application of MFN to rare products could have a chilling effect on investment in these situations and across the rare disease in general. Rare medicines were exempted from the first iteration of this policy. We hope that continues."

EO 14297 is rife with vagaries but has the potential to do more harm than good. Threatening pharmaceutical revenues could reduce investment in developing needed therapies (Lopez, 2025). Legally, as it stands, the government would not be able to set prices outside of the Medicare program. Mandating the pricing of commercial, privately owned companies would require acts of Congress that would take lots of time and litigation (Jacobson, 2025). Patients could lose medication access due to a complex system response to adversarial price negotiations. Disrupting foreign markets could adversely affect international relations.

The ongoing debate over drug pricing in the United States is essential to the overall healthcare conversation. However, the EO does not present a foreseeable effective path for improving the status quo. In agreement with the EO’s objective of more equitably sharing research and development costs across countries, a Lily spokesperson expertly summarized the challenge stating, “an MFN approach is not the answer to help patient affordability; instead, lower prices for consumers in the United States can only happen if intermediaries take less for themselves” (Hopkins & Loftus, 2025). For these reasons, it is hard to understand why any patient advocacy organization could find itself supporting this approach.

[1] 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

[2] Gardner, L., Lin, D. (2025, May 13). Wall Street shrugs at Trump’s most-favored order. Retrieved from https://www.politico.com/newsletters/prescription-pulse/2025/05/13/wall-street-shrugs-at-trumps-most-favored-order-00342967

[3] Herper, M. (2025, May 13). To understand why investors rejoiced at Trump’s attack on drug firms, think like a pharma CEO. Retrieved from https://www.statnews.com/2025/05/13/trump-drug-pricing-plan-analysis/

[4] Hopkins, J., Loftus, P. (2025, May 12). Drugmakers Avoid Worst-Case Pricing Scenario for Now. Retrieve from https://www.wsj.com/health/pharma/trump-drug-price-plan-pharmaceutical-companies-217f809b?st=UrWWgU&reflink=desktopwebshare_permalink

[5] Lopez, T. (2025, May 14). Most Favored Nation vs. Human Sustainability: How Federal Price Controls Fight Biology—and Americans Lose. Retrieved from https://nmqf.org/resource-library/most-favored-nation-vs-human-sustainability-how-federal-price-controls-fight-biology-and-americans-lose/

[6] Mulcahy, A., Schwam, D., Lovejoy, S. (2024, February 1). International Prescription Drug Price Comparisons: Estimates Using 2022 Data. Retrieved from https://www.rand.org/pubs/research_reports/RRA788-3.html

[7] Jacobson, L. (2025, May 14). Donald Trump exaggerates speed, certainty of prescription drug price reductions. Retrieved fromhttps://www.politifact.com/factchecks/2025/may/14/donald-trump/prescription-drug-price-cut-executive-order/

[8] Payne, D. & Silverman, E. (2025, May 12). Our biggest burning questions on Trump’s order to bring down drug prices. Retrieved from https://www.statnews.com/2025/05/12/trump-executive-order-drug-prices-analysts-five-questions-agency-authority-court-challenges/

[9] Reed, T. (2025, May 7). Pharma shipments surge as Trump tariff threat looms. Retrieved from https://www.axios.com/2025/05/07/tariffs-imports-drugs-pharmaceuticals

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.   

Sen. Cassidy Shines Spotlight on 340B Program, Furthering Calls for Reform

By: Ranier Simons, ADAP Blog Guest Contributor, and Marcus J. Hopkins, ADAP 340B Consultant

So far in 2025, state legislatures nationwide witnessed a flurry of legislation on the 340B Drug Pricing Program. Just over one hundred 340B-related bills were introduced in this legislative session (Ingmire, 2025). A handful can be characterized as genuine reform efforts. Still, most are “gimmes” to the powerful hospital lobby, designed to expand the program without any guardrails or guarantees that patients will benefit. Billions of dollars and ultimately patients’ welfare are at stake, which is why Senator Bill Cassidy recently released a report on the 340B Program. The report, focused on stronger accountability and transparency, culminates a year-long inquiry by the powerful Senate Health, Education, Labor, and Pensions (HELP) Committee. The report echoes the growing chorus calling for long-overdue reforms.

Sen. Bill Cassidy | Photo Source: End Points News

Aside from special interests representing the reform denialists, reactions to the report’s findings have been cheered and represent momentum toward something finally being done to return the program to its legislative intent. Senator Cassidy states, “This investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients. Congress needs to act to bring much-needed reform to the 340B Program” (HELP, 2025).

The 30-year-old 340B program has ballooned more than 600% since 2000, with over 60,000 participating covered entities (Olsen, 2025). The program was created to enable providers, known as ‘covered entities’ (CE), serving large populations of low-income individuals to purchase brand-name and generic medications at a considerable discount and use the savings to provide increased care to patients and lower their costs. Presently, the designation of CE encompasses six different categories of hospitals and ten categories of non-hospital entities (340B, n.d.). Drug manufacturers have to offer the drugs at a discount under the 340B program as a condition of participating in the Medicare Drug Rebate Program. 

As a result of the growing number of participants, many stakeholders are alarmed because the program seems not to result in increased care and lowered costs for low-income and uninsured patients as initially intended. Senator Cassidy’s investigation comprised information requests of eight of the most prominent 340B participants from several categories: two hospital-covered entities, two FQHCs, two contract pharmacies, and two drug makers (Muoio, 2025). What follows is an overview analysis of the Cassidy Report.

Photo Source: Senate HELP Committee

The investigation found that:

• Neither Bon Secours Mercy Health (Richmond Community Hospital in Richmond, VA) nor the Cleveland Clinic (Cleveland, OH)—the two hospital systems examined by Senator Cassidy’s office—pass on 340B savings directly to patients. Both hospital systems stated that the 340B legislation does not require them to do so. While both systems have sliding scale payment programs for patients based upon their annual incomes as a percentage of the Federal Poverty Level (FPL) that allow patients to pay smaller percentages of the costs of services, both systems responded that they are not required to pass “dollar-for-dollar” savings on to patients.

• Neither Bon Secours nor the Cleveland Clinic accounts for 340B revenues or savings in their operating budgets. Both reported sentiments that “340B revenues are revenues like any other” and did not feel obligated to allocate or earmark 340B revenues for specific purposes. Instead, both hospitals treat those revenues as part of general funds and that they can be used for any purpose they see fit. This sentiment aligns with sentiments expressed by other hospital systems in previous congressional hearings.

• Of the two Federally Qualified Health Centers (FQHCs) examined by Senator Cassidy’s office, both Sun River Health and Yakima Valley Farm Workers Clinic generated a majority of their 340B revenues from a single class of drugs—HIV/AIDS medications, which accounted for more than 54% of their 340B revenues at Sun Valley, and drugs to treat diabetes, which accounted for nearly 45% of 340B revenues at Yakima.

• Both FQHCs leveraged their 340B revenues to provide significant discounts on medications dispensed to patients whose incomes fell below 200% of the FPL.

• CVS Health and Walgreens, the two contract pharmacies and third-party administrations examined by Senator Cassidy’s office, initially refused to provide the documents requested by the office and only did so after extended negotiations.

• Both companies charge significant and increasing fees related to the provision of pharmacy dispensing and 340B third-party administrator (TPA) services. The covered entities that contract with them indicated that these increasing fees are straining their resources.

• The pharmaceutical companies that provide billions of dollars in discounts to covered entities under the 340B Program have significant concerns about the integrity of the program, with Eli Lilly and Amgen both arguing that the lack of transparency that currently exists with most covered entity types allows for covered entities, contract pharmacies, and third-party administrators to too easily manipulate, misuse, and abuse a program that was designed to increase access to care.

• Both Eli Lilly and Amgen reported significant increases in sales to contract pharmacies, rather than hospitals and grantees.

Photo Source: ADAP Advocacy

The Cassidy Report comes as ADAP Advocacy launched its national advocacy campaign, calling for reforms to the 340B Program. The campaign was kicked off with a new commercial that asks the question, Is the 340B Drug Pricing Program the Next 'Too Big to Fail'? The commercial will air in the greater metropolitan DC market while Congress is in session, and it provides plenty of fodder for lawmakers to appreciate the need to move on the report.

Ultimately, Senator Cassidy’s office recommended five changes to the 340B Program:

• Requiring covered entities to provide detailed annual reporting on how 340B revenue is used to ensure direct savings for patients, providing a more transparent link between program savings and patient benefit;

• Addressing potential logistical challenges caused by increased administrative complexity, leading to burdens that may impede patients from benefiting from the program;

• Investigating the types of financial benefits contract pharmacies and TPAs receive for administering the 340B Program to ensure that increasing fees do not disadvantage covered entities and patients;

• Requiring transparency and data reporting for entities supporting participants in the 340B Program (i.e., contract pharmacies and TPAs); and

• Providing clear guidelines to ensure that the manufacturer discounts actually benefit 340 B-eligible patients, including examining legislative changes to the definition of eligible patients.

Advocacy groups such as ADAP Advocacy, Community Access National Network, and The Alliance to Save America's 340B Program (ASAP 340B) are supportive. Cassidy’s report findings align with the work of ADAP Advocacy’s 340B Patient Advisory Committee over the last two years. In a press release, Brandon M. Macsata, CEO of ADAP Advocacy, summarized: “In 2019, ADAP Advocacy endorsed the Community Access National Network 340B Commission’s final report calling for long-overdue accountability and transparency standards to improve the 340B Program, among them clearly defining who are 340B patients, and how 340B covered entities should utilize their 340B savings to improve patient access to care and services. Senator Cassidy has laid a path to reform this vital program, and ADAP Advocacy looks forward to working with him on this important issue.” 

ASAP 340B issued a statement in support of Senator Cassidy’s work. In the release, Thomas Johnson, Executive Director of ASAP 340B, states, “This report details how large hospital systems, PBMs, and corporate middlemen take advantage of the program – it is clear the time for meaningful reform is now. We strongly urge Congress to enact legislation that realigns the 340B program in the interest of true safety-net providers and the patients and communities they serve.”

Conversely, and not surprisingly, there were some opposing viewpoints from hospital stakeholders. For example, 340B Health, a lobbying group representing over 1500 hospitals and health systems in the 340B program, expressed concern about the report. In a statement, 340B Health stated it had “concerns with several aspects of the report that may not fully reflect the purpose or implementation of 340B” (Muoio, 2025). Maureen Testoni, 340B Health’s president and CEO, also emphasized that the language of the 340B statute names ‘cost of operations’ reductions as one of the program's primary goals. She implied that using 340B savings to fund capital improvements and community benefits was a way to benefit low-income patients (Muoio, 2025). However, that sentiment is one of the concerns heralded by proponents in favor of 340B reform. Passing savings on to patients and improving their care is the impetus behind the 340B program. Capital improvements do not benefit patients directly, especially when improvements involve facilities that do not serve needy communities.

Photo Source: Drug Channels Institute

Leading biopharmaceutical experts, critical of the reform denialists' claims that the program isn't warped, pointed to the Cassidy Report to highlight glaring problems that only seem to be getting worse. For example, Adam J. Fein, Ph.D., with the Drug Channels Institute, published an analysis: "Follow the 340B Dollar: Senator Cassidy Exposes How CVS Health and Walgreens Profit as 340B Contract Pharmacies." Likewise, Matt Toresco pointed to the report, asking: "340B: Safety Net or Profit Engine?"

Although Senator Cassidy’s report involves a small sample of 340B entities, it is still an informed and enlightening cross-section of the 340B landscape and the needs for reform. Urging Congressional 340B reform actions can help bolster state legislative actions addressing the misuse of the program in hopes of refocusing the benefit on patients. Some covered entities effectively pass savings on to patients; however, many do not. Senator Cassidy has a long history of being active in healthcare reform, and this report is a salient foundation for continued efforts.

[1] 340B Health. (n.d.) 340B Drug Pricing Program Overview. Retrieved fromhttps://www.340bhealth.org/members/340b-program/overview/#:~:text=The%20340B%20ceiling%20price%20is,over%2Dthe%2Dcounter%20drugs.

[2] Ingmire, B, (2025, May 1). The Evolving Landscape of 340B Drug Pricing Laws. Retrieved from https://www.multistate.us/insider/2025/5/1/the-evolving-landscape-of-340b-drug-pricing-laws

[3] Muoio, D. (2025, April 24). Cassidy calls for 340B reform, increased oversight of hospitals, contract pharmacies. Retrieved from https://www.fiercehealthcare.com/regulatory/sen-cassidy-releases-340b-report-recommending-greater-transparency-oversight-hospitals    

[4] Olsen, E. (2025, April 28).Top Republican calls for 340B reform in long-awaited investigation. Retrieved from https://www.biopharmadive.com/news/bill-cassidy-help-committee-340B-reform-investigation/746405/

[5] U.S. Senate Committee on Health, Education, Labor and Pensions (HELP). (2025, April 24). Chair Cassidy Releases Report on 340B Reform, Calls for Congressional Action. Retrieved from https://www.help.senate.gov/rep/newsroom/press/chair-cassidy-releases-report-on-340b-reform-calls-for-congressional-action

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.