Goliath vs. Goliath—How the 340B Devil’s Bargain Might Self-Destruct

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

Mount Sinai Health Systems (New York, NY), the University of Kansas Hospital Authority (Kansas City, KS), and the University of Michigan Hospitals and Health Centers (Ann Arbor, MI) are suing CVS Health for failing to properly reimburse them for drugs purchased and dispensed under the massive 340B Drug Pricing Program, claiming under-reimbursement to the tune of nearly $250 million over a period of five years (Hut, 2026).

Source: Forbes | Getty

The suits, filed in three separate courts, argue that CVS, which serves as a contract pharmacy for all three health systems, accuses CVS Health and its subsidiaries of retaining illegally large shares of 340B revenues generated and failing to remit them to the covered entities that generated the sales. The plaintiffs are seeking triple damages under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act and seek injunctions enjoining CVS from continuing the business practices in question (Halleman, 2026).

In addition to the three initial suits, Henry Ford Health (Detroit, MI) sued CVS on July 16, alleging 340B revenue diversions amounting to more than $29 million, requesting the courts force CVS to disgorge any profits retained from the alleged diversion scheme and reinstate the pharmacy services CVS terminated with the health system in April—a termination that Henry Ford argues was in retaliation for its attempt to audit their arrangement with CVS (Jeffries, 2026a).

Source: Henry Ford Health

And then, a fifth hospital, Froedtert Memorial Lutheran Hospital (Milwaukee, WI), sued CVS Health on August 20th, alleging diversions amounting to $18 million between 2020 and 2025. When Froedtert attempted to audit CVS on March 2nd, 2026, CVS refused the request and terminated the hospital’s pharmacy services. This suit alleges breach of contract, fraud, violations of the Wisconsin Deceptive Trade Practice Act, and civil RICO violations, and it also seeks triple damages, reinstatement of the pharmacy services agreement, and disgorgement of profits derived from the scheme (Jeffries, 2026b).

CVS Health has been in the spotlight in 2026, after a particularly damaging congressional hearing in which Representative Alexandria Ocasio-Cortez (D-NY-14) all but accused CVS Health CEO David Joyner of operating an illegal monopoly.

During the January 22nd, 2026, hearing, Ocasio-Cortez highlighted what former CVS Health CEO Karen Lynch referred to as its “captive strategy,” in which CVS provides services to patients through its health insurance company, Aetna, and its primary care clinic, Oak Street Health, fills prescriptions through CVS, operates a Pharmacy Benefit Manager (PBM), CVS Caremark, and develops biosimilar medications through its Dublin, Ireland-based drug manufacturer, Cordavis (Hopkins, 2026).

Source: Rep. Alexandria Ocasio-Cortez

In response, CEO David Joyner stated, “No, I wouldn't agree that it's market concentration. I would suggest it's a model that works really well for the consumer.”

These suits against CVS Health bring to the fore one of the primary complaints against PBMs and contract pharmacy arrangements: if CVS (or any contract pharmacy or PBM) is surreptitiously or illegally hoarding 340B revenues, those are funds not being used to benefit patients. Maybe an amicus brief might be in order here?

To be certain, ADAP Advocacy has consistently called out many hospital systems for failing to properly use 340B revenues to benefit patients. In this case, five large health systems are going up against an equally large, and arguably more publicly bruised, company.

And we’re anxiously awaiting the outcomes...

Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website. 

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

References:

[1] Halleman, S. (2026, May 22). Hospitals sue CVS for allegedly siphoning $250M in 340B funds. Newton, MA: Healthcare Dive. News. https://www.healthcaredive.com/news/hospitals-file-340b-lawsuit-cvs-health/820959/

[2] Hopkins, M. J. (2026, January 29). Congress Shines Spotlight on Health Insurance Companies' Squeeze on Patients. Washington, DC: ADAP Advocacy: ADAP Blog. https://adapadvocacyassociation.blogspot.com/2026/01/congress-shines-spotlight-on-health.html

[3] Hut, N. (2026, May 27). 340B lawsuits against CVS allege $250M in underpaid hospital reimbursement. Downers Grove, IL: Healthcare Financial Management Association. https://www.hfma.org/payment-reimbursement-and-managed-care/cvs-340b-lawsuits-hospital-reimbursement/

[4] Jeffires, E. (2026a, July 22). Henry Ford Health sues CVS, alleges 340B pricing scheme. Chicago, IL: Becker’s Hospital Review: Legal & Regulatory Issues. https://www.beckershospitalreview.com/legal-regulatory-issues/henry-ford-health-sues-cvs-alleges-340b-pricing-scheme/

[5] Jeffries, E. (2026b, August 31). Milwaukee hospital sues CVS over $18M in alleged 340B diversion. Chicago, IL: Becker’s Hospital Review: Legal & Regulatory Issues. https://www.beckershospitalreview.com/pharmacy/milwaukee-hospital-sues-cvs-over-18m-in-alleged-340b-diversion/

HIV Vaccine Tests in Primates Point to the Potential for Future Developments

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

Research published in Nature found that germline-targeting vaccines administered in primates were the first to generate high numbers of ‘broadly neutralizing ' virus-fighting antibodies against HIV (Steichen et al., 2026).

Source: Nature

This vaccine, a collaboration between La Jolla Institute for Immunology and Scripps Research, works by trying to find rare naïve B cells (white blood cells, also called lymphocytes), and using a series of booster shots to get them to produce “broadly neutralizing antibodies” (bnAbs). Using 24 rhesus macaques split into four groups of six, Steichen et al. produced bnAb lineages in at least 50% of the animals, with individual antibodies reaching up to 67% of the neutralization breadth of the human BG18 antibody.

This practice, commonly referred to as “germline targeting,” essentially preempts the vaccine virus by creating antibodies that could provide between 50% and 90% protection against HIV transmission.

And “could” is the primary word here:

While Steichen et al. attempted to find these rare B cells and get them to produce the desired antibodies, they did not actually test the efficacy of these antibodies in any scientific, clinical, or real-world setting. This means that, while this is an exciting scientific breakthrough, there is little evidence that any near-term vaccines will be developed using this process, in no small part because successfully identifying and targeting these very rare B cells (which are, admittedly, rarer in humans than rhesus macaques) is both incredibly difficult and very much a trial-and-error process that seems to be reliant upon individual animal genetics.

Exciting news, to be certain.

Source: CDC

In many ways, however, Pre-Exposure Prophylaxis (PrEP) provides similar prevention efficacy, with Yeztugo (Gilead Sciences) showing up to 100% efficacy in biological females in one trial and 96% in a second, primarily male drug-trial cohort (Patel et al., 2025).

While PrEP is not a vaccine regimen, it does provide excellent protection against the acquisition of HIV! 

The development of an HIV vaccine presents significant challenges due to the virus's rapid mutations, its ability to integrate into the host's DNA, and its mechanisms for evading the immune response. Conventional vaccines function by training the immune system to identify consistent pathogen features. In contrast, HIV employs strategies that counter this approach. Although research from the La Jolla Institute demonstrates potential, it remains, under specific circumstances, the most recent effort aimed at eradicating HIV.

Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website. 

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

References:

[1] Patel, R. R., Hoover, K. W., Lale, A., Cabrales, J., Byrd, K. M., & Kourtis, A. P. (2025, September 18). Clinical Recommendation for the Use of Injectable Lenacapavir as HIV Preexposure Prophylaxis — United States, 2025. MMWR, 74(35), 541-540 https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm

[2] Steichen, J. M., Madden, P. J., Flynn, C. T., Phulera, S., Shil, M., Kalyuzhniy, O., Liguori, A., Kifude, C., Sewall, L. M., Cottrell, C. A., Ma, K. M., Baboo, S., Diedrich, J. K., McKenney, K., deCamp, A. C., Carnathan, D. G., Phung, I., Ramezani-Rad, P., Marina-Zárate, E., Freeman, B., … Schief, W. R. (2026, June 30). Vaccination elicits HIV broadly neutralizing antibodies in primates. Nature, 656, 723-733. https://doi.org/10.1038/s41586-026-10837-5

Are Medicaid Work Requirements an Attempt to Destroy America’s Social Safety Nets?

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

On January 1st, 2027, Americans enrolled in state Medicaid programs will be required by federal law to work, enroll in half-time education, complete community service hours, or participate in a work program for 80 hours per month in order to maintain coverage (Centers for Medicare and Medicaid Services, 2026). While some exemptions exist, advocates worry that qualifying for those exemptions, reporting work or volunteer hours, and maintaining coverage will result in unacceptable coverage lapses for roughly 600,000 Americans (Altman, 2024).

Source: McCourt School of Public Policy at Georgetown University

Make no mistake:

Work requirements for social safety programs are not designed to root out waste, fraud, or abuse; that has left many advocates asking if they are fundamentally and purposefully designed to create such high administrative burdens that poor Americans are forced off of the programs those implementing the work requirements openly hope to destroy (Ives-Rublee & Musheno, 2025).

Moreover, more than half of current Medicaid enrollees are unaware that work requirements are being implemented, despite state and federal efforts to inform them, and just over one-quarter of enrollees report hearing about them but were unsure of the details (Olsen, 2026).

And who, frankly, can blame them for being unaware?

Because of the nature of the Medicaid program—federally funded, but administered at the state level—getting a good grasp on what requirements are going to be implemented and where.

The Kaiser Family Foundation (KFF) has created a relatively comprehensive dashboard to track the implementation of the Medicaid changes enacted by the One Big, Beautiful Bill Act (OBBBA). The dashboard can be accessed using the following link:

• Tracking Implementation of the 2025 Reconciliation Law Medicaid Work Requirements

Source: Kaiser Family Foundation

With those issues established, let’s take some time to review what has advocates so concerned:

Medicaid Work Requirement Exemptions

The Centers for Medicare and Medicaid Services (CMS) has released some guidance regarding exemptions to the upcoming work requirements, listing the following categories of people as being exempt:

• Former foster care youth;
• American Indians and Alaska Natives; 
• Parents, guardians, caretaker relatives, or family caregivers of a dependent child 13 years of age and under, or a disabled individual;
• Veterans with a total disability rating;
• Medically frail or otherwise have special medical needs that significantly impair their ability to comply with the requirement;
• Meet the TANF work requirements or are a member of a household receiving SNAP benefits and are not exempt from the SNAP work requirements;
• Participants in a drug or alcohol rehabilitation or treatment program;
• Inmates of a public institution; and
• Pregnant or eligible for postpartum coverage in their state.

States may also opt to provide additional short-term exemptions for hardship, including those who are:

• Receiving certain medical services such as inpatient hospital or nursing facility services; 
• Residing in a county in which there is an emergency or disaster declared by the President;
• Residing in a county with a high unemployment rate; or
• Traveling outside of their community for an extended period of time for medical services for a serious or complex medical condition for themselves or their dependent (CMS, 2026)

According to The Commonwealth Fund:

H.R. 1’s criteria for medical frailty almost exactly parallel the Alternative Benefit Plan (ABP) definition. Both definitions must at least include people who meet Social Security Administration (SSA) disability criteria or have a substance use disorder, “disabling” mental disorder, “serious or complex” medical condition, or physical, intellectual, or developmental disability that “significantly impairs” their ability to perform an activity of daily living (Musumeci et al., 2025).

Source: The Commonwealth Fund

As Musumeci et al. clarify, the SSA eligibility criteria do not incorporate the most recent developments in medicine or knowledge about disability, and those living with chronic conditions, including diabetes, heart failure, and lung disease, do not currently qualify as being “disabled” by the SSA, even though such chronic ailments can be wholly debilitating.

Tim Horn, Director of Medication Access at the National Alliance of State and Territorial AIDS Directors (NASTAD), openly stated at ADAP Advocacy’s recent Fireside Chat in Pittsburgh, Pennsylvania, that there are no exemptions for people living with HIV/AIDS (PLWHA), and that there is little clarity from states regarding whether or not self-attestation will continue to qualify as “proof of work.”

ADAP Advocacy always believes, but does not expect, that the Trump Administration should create specific exemptions for people living with chronic illnesses. The reality, however, is that we have come to expect only the worst from an administration whose members are openly hostile to the poor, the sick, the old, and the frail! 

Disclaimer: All funders of the ADAP Advocacy Association are publicly listed on our website. 

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

References:

[1] Altman, D. (2024, December 17). Making Sense of Medicaid Work Requirements. Menlo Park, CA: KFF. https://www.kff.org/from-drew-altman/making-sense-of-medicaid-work-requirements/

[2] Centers for Medicare and Medicaid Services. (2027, June 01). Medicaid Community Engagement Requirement for Certain Individuals Interim Final Rule with Comment Period [CMS-2454-IFC]. Baltimore, MD: United States Department of Health and Human Services: Centers for Medicare and Medicaid Services: Newsroom: Fact Sheets. https://www.cms.gov/newsroom/fact-sheets/medicaid-community-engagement-requirement-certain-individuals-interim-final-rule-comment-period-cms

[3] Ives-Rublee, M. & Musheno, K. (2025, July 03). The Truth About the One Big Beautiful Bill Act’s Cuts to Medicaid and Medicare. Washington, DC: Center for American Progress: Article. https://www.americanprogress.org/article/the-truth-about-the-one-big-beautiful-bill-acts-cuts-to-medicaid-and-medicare/

[4] Musumeci, M., Rao, P., Crays, A., & Shachar, C. (2025, December 18). How Medical Frailty Exemption Policies Can Offer a Lifeline to People with Disabilities and Chronic Illnesses When Medicaid Work Requirements Are Implemented. New York, NY: The Commonwealth Fund: https://www.commonwealthfund.org/blog/2025/how-medical-frailty-exemption-policies-can-offer-lifeline-people-disabilities-and-chronic

[5] Olsen, E. (2026, June 08). Over half of Medicaid enrollees say they’re unaware of upcoming work requirements. Newton, MA: Healthcare Dive: News. https://www.healthcaredive.com/news/over-half-medicaid-enrollees-unaware-work-requirements-health-management-academy-survey/822228/