CDC Releases New Information About People Living With HIV/AIDS

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

The Centers for Disease Control and Prevention (CDC) released its latest update to the Behavioral and Clinical Characteristics of Persons with Diagnosed HIV Infection in September 2026. These data represent findings from people living with HIV/AIDS (PLWHA) collected in 2024, and could point to significant trouble ahead for PLWHA (CDC, 2026).

Source: CDC

Key Findings and Discussion:

While 80% of respondents were prescribed antiretroviral therapy (ART) to treat their HIV, only 63% reported taking every dose as prescribed. Among those who missed doses, 22.7% missed doses for 1 to 2 days, 10.2% for 3 to 5 days, 1.5% for 6 to 10 days, and 2.3% for 11 or more days. The most commonly reported reasons for not taking medications included:

• Forgetting to take them (69.1%)
• Changes in daily routines or travel (42.3%)
• Falling asleep early or oversleeping (38.4%)
• Feeling depressed or overwhelmed (21%)
• Problems getting prescriptions or refilling medications (18.5%)
• The person didn’t feel like taking them (14.1%)
• Alcohol or drug use (10.3%)
• Problems paying for medications (6.9%)
• In the hospital or too sick to take medications (6.6%)
• Difficulties with medication side effects (5.8%)

When disaggregated by sex, Female respondents were slightly more likely to be adherent to treatment (66.2%), while 62.5% of Males reported being adherent.

When disaggregated by race, Multiracial Americans were the least likely to be treatment adherent (59.5%), followed by Black Americans (62%), Hispanic/Latine Americans (63.1%), and White Americans (65.6%). Asian Americans had the highest rate of treatment adherence, at 70.6%.

When disaggregated by age, adults aged 50+ were most likely to be treatment adherent (69.9%), followed by those aged 40-49 (58.3%) and those aged 18-29 (53.6%). Adults aged 30-39 were the least adherent, at 50.6%.

These data are particularly problematic, as failure to adhere to treatment regimens can result in the mutation of the virus to become resistant to specific ARTs or drug classes, making HIV harder to treat and limiting future treatment options. Additionally, nonadherence to ART regimens can leave the virus unsuppressed, increasing the likelihood of transmitting it to others (HIV dot Gov, 2026).

Source: Marley Drug

How to Improve Treatment Adherence

The HIV treatment landscape has changed significantly over the past twenty years. While treating HIV once required patients to take and keep track of multiple pills a day (or daily injections), single-pill oral regimens became the norm in the 2010s, and now, we have long-acting injectable (LAI) medications that can be delivered monthly or every other month.

A recent study published in The New England Journal of Medicine found that patients treated with LAIs were significantly less likely to experience regimen failure (n = 29; 19%) than patients taking a standard oral regimen (n = 55; 36%). While most regimen failures in the standard group resulted from virologic failure (58.2%), treatment discontinuation or abandonment caused regimen failure in the LAI group (82.6%). At the 48-week mark, regimen failure was 22.8% in the LAI group and 41.2% in the standard oral regimen group, indicating that LAIs are a key component to improve treatment adherence and virologic suppression (Rana et al., 2026)

ADAP Advocacy’s own research found that 52.3% of patients who responded to a 2024 survey would prefer LAI treatment regimens over oral regimens (Johnson et al., 2024).

Source: ADAP Advocacy

Quality of Life and HIV

Additional findings of the MMP found that structural challenges continue to negatively impact PLWHA, with respondents reporting hunger or food insecurity (22%), unstable housing or homelessness (20%), and unemployment (15%) as being primary drivers of poor physical, mental, and emotional health. Moreover, many PLWHA reported unmet needs for ancillary services that could improve living conditions and well-being, including access to dental care (24%), meal or food service assistance (15%), and stable sheltering or housing services (15%).

Trouble Ahead

The real concern in these data is not the data themselves, but that they were gathered before the Trump Administration took wrecking balls to nearly every aspect of public health provision and services. With state ADAP programs facing increasing budgetary shortfalls that could result in constriction of state programs (Hopkins, 2026), the forthcoming Medicaid implosion that the Trump Administration and its allies in Congress forced through in the One Big Beautiful Bill Act (Hopkins, 2025), and exploding costs of living related to the ongoing war against Iran and nonsensical tariffs, including skyrocketing costs of fuel, diesel, food, goods, and services (Wile & Murphy, 2026; Zahn, 2026), PLWHA are going to be squeezed more than ever. The reality is that patients living with HIV are going to be significantly worse off financially and are likely to face significantly higher barriers to accessing not only HIV care and treatment, but basic necessities, like food, shelter, and transportation.

While we should have been preparing for this for a while, many of us were caught flat-footed by the wholesale destruction being wrought by the Trump Administration. Hopefully, we will be able to course correct enough to avoid the majority of the devastation many are predicting.

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] Centers for Disease Control and Prevention. (2026, September 10). Behavioral and Clinical Characteristics of Persons with Diagnosed HIV Infection. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention: Division of HIV Prevention: HIV Data: Medical Monitoring Project. https://www.cdc.gov/hiv-data/mmp/behavioral-clinical-characteristics-pwh.html

[2] HIV dot Gov. (2026, September 24). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. Rockville, MD: United States Department of Health and Human Services: Office of Infectious Disease and HIV/AIDS Policy: HIV dot Gov: Clinical Info: Guidelines. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/interruption-antiretroviral-therapy

[3] Hopkins, M. J. (2025, July 30). Preparing for One Big Beautiful Disaster. Washington, DC: PlusInc: Blog. https://www.plusinc.org/blog/one-big-beautiful-disaster

[4] Hopkins, M. J. (2026, September 24). ADAP: A House of Cards Waiting to Fall. Nags Head, NC: ADAP Advocacy: ADAP Blog. https://adapadvocacyassociation.blogspot.com/2026/09/a-house-of-cards-waiting-to-fall.html

[5] Johnson, R. D., Hopkins, M. J., Laws, J., & Macsata, B. M. (2024). HIV Long-Acting Injectables: Patient access considerations for injectable HIV therapies and injectable HIV Pre-Exposure Prophylaxis. Nags Head, NC: ADAP Advocacy. https://www.adapadvocacy.org/s/2024_ADAP_Project_Long_Acting_Injectables_Final_Report_062524-wgxy.pdf

[6] Rana, A. I., Zheng, L., Castillo-Mancilla, J., Bao, Y., Sieczkarski, S., Brooks, K. M., Lake, J. E., Fichtenbaum, C., Heath, S. L., Belaunzaran-Zamudio, P. F., Klingman, K., Fox, L., Morton, T., Stirratt, M., Li, J. Z., Acosta, E. P., Venuto, C., Galárraga, O., Shoptaw, S., Wohl, D., … ACTG A5359 LATITUDE Trial Team. (2026). Cabotegravir plus Rilpivirine for Persons with HIV and Adherence Challenges. The New England journal of medicine, 394(9), 858–871. https://doi.org/10.1056/NEJMoa2508228

[7] Wile, R. & Murphy, J. (2026, September 23). The U.S. economy before and after the Iran war, in five charts. New York, NY: NBC News: Business: Economy. https://www.nbcnews.com/business/economy/us-economy-iran-war-five-charts-rcna598412

[8] Zahn, M. (2026, August 25). Tariffs will cost US households over $1,000 a year, Yale Budget Lab says. Burbank, CA: ABC: ABC News: Business. https://abcnews.com/Business/tariffs-cost-us-households-1000-year-yale-budget/story?id=135945432

ADAP: A House of Cards Waiting to Fall

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

Did you know that Federal funding for the AIDS Drug Assistance Program (ADAP) accounted for just 29% of the 2024 national ADAP budget? Did you know that Congress has not appropriated any new money for the ADAP budget in over a decade?

It’s true!

Source: KFF

According to the National Alliance of State and Territorial AIDS Directors (NASTAD), federal appropriations for ADAP account for a vanishingly small percentage of the national ADAP budget (NASTAD, 2026).

Since the establishment of the Ryan White HIV/AIDS Program in 1990, Congress has appropriated funds specifically to address the provision of medications to treat HIV/AIDS for patients who might otherwise be unable to afford them. But the spending power of those federal dollars has fallen significantly over the past twenty years.

In Fiscal Year 2004, federal appropriations accounted for 61%, state-level funding for 19%, and drug rebates for 12%.

Fast forward to 2024—the most recent year for which data are available—and that funding model is fundamentally different:

In FY2024, drug rebates accounted for 52%, federal funding for 29%, and state-level funding for just 4%.

According to a presentation delivered by NASTAD’s Tim Horn at ADAP Advocacy’s recent Health Fireside Chat in Pittsburgh, Pennsylvania, federal funding for the AIDS Drug Assistance Program has been stalled at ~$900 million annually for a program that costs $2.7 billion (Macsata & Hopkins, 2026).

And now, yet another crisis has landed itself in ADAP's proverbial lap. After 13 years, people living with HIV/AIDS in two states are once again being denied access to care and treatment because ADAP is running out of money. According to NASTAD’s ADAP Watch, Iowa and Utah have ADAP waiting lists.

Source: NASTAD

How did we get here?

Put plainly, ADAP has been largely forgotten by federal and state legislators, in much the same way that many people seem to have forgotten that HIV/AIDS still exists. Unless someone is in front of them banging the drum that people are still being diagnosed and living with HIV/AIDS, it’s out of sight, out of mind.

In many ways, the reluctance of HIV advocacy organizations to actively and vocally push for increases to the ADAP earmark comes from a place of fear: fear that, by reminding legislators that HIV/AIDS exists, it places HIV funding at risk of further funding cuts.

And that fear isn’t without merit; since resuming office in January 2025, Donald Trump’s administration has actively worked to dismantle and defund HIV services at home and abroad.

In 2025, the Trump Administration:

• Issued a stop-work order that froze all programming and services for the President’s Emergency Plan for AIDS Relief (PEPFAR), which halted all work in the field, including the provision of antiretroviral therapy (ART);
• Issued a limited waiver for PEPFAR that allowed only ‘life-saving HIV services,” which excluded most HIV prevention services;
• Dissolved the USAID program that administered the PEPFAR program;
• Canceled funding for hundreds of programs that included HIV activities (KFF, 2026)

Source: STAT | Getty Images

Beyond pulling the rug out from under PEPFAR, the Trump Administration has gone further by announcing it will not renew $46 million in funding for Community-Based Organizations (CBOs) to provide HIV testing, linkage to care, referrals to pre- and post-exposure drug treatment, and outbreak response (Cohen, 2026). Instead, those funds will be redirected to state and local health departments—an effort to control how the funds are used and who they reach, avoiding funding for “Diversity, Equity, and Inclusion.”

The President’s 2027 budget also proposed eliminating $800 million from the Centers for Disease Control and Prevention’s HIV prevention funding (Cohen, 2026). Additionally, it proposed the elimination of the Housing Opportunities for People with AIDS (HOPWA) program—which serves over 100,000 households annually (Bennett & Hannon, n.d.).

In context, those cuts, whether they’re actual or proposed, paint an even bleaker picture of the state of ADAPs at the federal level. Even though more clients are enrolling and healthcare costs are climbing, federal funding for ADAPs hasn't really grown over the past decade. This means ADAPs have the same purchasing power as they did in 1999, once inflation is accounted for. HIV advocacy needs to remind Congress of the inherent value of this program.

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] Bennett, R. & Hannon, B. (n.d.) Housing Opportunities for Persons with AIDS (HOPWA). National Low Income Housing Coalition. https://nlihc.org/sites/default/files/AG-2025/4-135_Housing-Opportunities-for-Persons-with-Aids-HOPWA.pdf

[2] Cohen, A. (2026, July 20). Trump administration puts kibosh on HIV prevention funding. Washington, DC: Roll Call: Policy. https://rollcall.com/2026/07/20/trump-administration-puts-kibosh-on-hiv-prevention-funding/

[3] KFF. (2026, August 06). The Trump Administration’s Foreign Aid Review: Status of PEPFAR. San Francisco, CA: KFF: Global Health Policy. https://www.kff.org/global-health-policy/the-trump-administrations-foreign-aid-review-status-of-pepfar/

[4] Macsata, B. M. & Hopkins, M. J. (2026, August 20). Fireside Chat Retreat in Pittsburgh, PA Tackles Emerging Crisis Facing AIDS Drug Assistance Programs. Washington, DC: ADAP Advocacy: ADAP Blog. https://adapadvocacyassociation.blogspot.com/2026/08/fireside-chat-retreat-in-pittsburgh-pa.html

[5] National Alliance of State and Territorial AIDS Directors. (2026a). 2026 National Ryan White HIV/AIDS Program Part B ADAP Monitoring Project Annual Report: Stabilizing the Safety Net: Stewardship and Outcomes in a Volatile Landscape. Washington, DC: National Alliance of State and Territorial AIDS Directors. https://nastad.org/2026-rwhap-part-b-adap-monitoring-report

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/

When a Free Trip to the Cayman Islands is an Illegal Drug Smuggling Scheme

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

The Fourth Circuit Court of Appeals recently upheld a decision in Gilead Sciences, Inc. v. Meritain Health, a lawsuit in which Gilead Sciences—makers of several HIV medications, including the most commonly prescribed medication, Biktarvy—accused Meritain Health, ProAct Inc., Rx Valet, Affordable Rx Meds, and Fetih Eczanesi (a Turkish pharmacy) of illegally importing foreign versions of their brand-name drugs not approved by the U.S. Food and Drug Administration (FDA) (Lee et al., 2026).

Photo Source: U.S. Court of Appeals for the Fourth Circuit

ADAP Advocacy, which was among a group of patient advocacy organizations filing an amicus brief in support of Gilead's claim, released a press statement lauding this decision, with CEO Brandon M. Macsata stating, “Risky decisions by profit-driven alternative funding programs should never be allowed to put patients at risk by circumventing laws designed to protect our nation’s drug supply chain, all to save a buck.” 

After a Maryland patient living with HIV received a Turkish version of Biktarvy in the mail through his employer-sponsored health insurance, Gilead investigated and found that Meritain Health facilitated the illegal importation of the drug in order to save money on the purchase prices of drugs (Gilead Sciences, Inc. v. Meritain Health, Inc. et al).

While the substance of the suit lies in the illegal importation of drugs sold by Gilead Sciences in other countries—specifically Türkiye—at the heart of the issue is a more systemic problem:

Americans and American companies pay more for medications than any other country on the planet, and everyone, from patients to insurers to pharmacies, is looking for ways to get around those prices.

For patients, that looks like importing medications from other countries via sketchy websites and black-market physical sites.

For insurance companies providing employer-sponsored health insurance plans, this looks like offering “Alternative Funding Programs” (AFPs), which seek to lower costs for employer-sponsored health plans, often by illegally importing medications from overseas or sending patients on medical-tourism vacations to access cheaper medications (Zamost et al., 2025).

Photo Source: ADAP Advocacy

The former model of illegal drug importation was the case in Gilead v. Meritain et al., but the bigger issue remains:

If medication costs are too high for both patients and payors, they will absolutely ignore the warnings and do what they think they have to do.

For patients who don’t know better or think they have no other options, it’s understandable. For corporations that absolutely know the laws and are looking for ways to skirt them to decrease costs and increase profits, it’s unacceptable.

The primary issue many advocates and pharmaceutical companies have with drug importation is that the supply chain does not undergo FDA screening and verification processes to ensure medications are authentic and safe for patients. By bypassing these processes, patients open themselves to ingesting counterfeit drugs that may not contain the ingredients needed to treat their diseases or may be ingesting substances that could kill them.

When patients make these choices for themselves, especially after being informed about the risks of importation, they accept those risks. They are free to make that choice.

With AFPs, those choices are made for the patients.

In one example reported by CNBC, a patient’s employer offered him an all-expenses-paid trip to the Cayman Islands and the Bahamas to retrieve the medication he needed to treat his multiple sclerosis (MS). PriceMD, a Florida-based company, offered to send them out of the country on a vacation to get his medication, rather than pay the $2,159 per week it costs in the U.S. ($112,268/year). PriceMD found that it was significantly cheaper to send him and his wife on vacation to obtain his medications than to pay U.S. prices (Zamost et al., 2025).

PriceMD’s model is an extreme one. But the risks are very real.

Photo Source: CNBC

The Partnership for Safe Medicines (PSM), which has long warned about the dangers of drug importation and was among the first to sound the alarm over AFPs, promptly applauded the court's decision. In a statement, PSM's executive director Shabbir Imber Safdar said: "The appeals court's decision in Gilead Sciences v. Meritain Health is unambiguous: you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine. Track-and-trace is a cornerstone of why the U.S. drug supply chain is the safest in the world, and it is not optional" (PSM, 2026).

For most AFPs, the model involves illegally importing medications from foreign countries in order to avoid those costs.

There are some advocates who argue that concerns about drug importation are overblown. Gabriel Levitt, Founder of Prescription Justice, argues that opponents of drug importation “…wrongly conflate the importation of lower-cost drugs with counterfeit drugs and rogue online pharmacies and perpetuate the notion that the FDA remains the world’s regulatory “gold standard” in drug safety and that any drug without FDA approval or outside the US drug supply chain is unsafe” (Levitt, 2024).

Unfortunately, those arguments usually rely on hyperbole and "catchy" anti-big pharma messaging to side-step the genuine concerns over drug importation and the risky AFP-sponsored tactics. ADAP Advocacy agrees that the FDA is the gold standard, but it also recognizes that it could do more.

This is why better framing is needed, especially when news in the United States is filled with examples of the FDA failing to properly inspect food (Semuels, 2025), drugs (Cenziper & Rose, 2025), and baby formula (Fletcher et al., 2026).

If we argue that the FDA is the “gold standard,” it would help if the FDA were actually doing its job. Its failure undermines the very basis of the consumer safety argument.

In the meantime, we’re counting Gilead’s victory in this case as a win for patient safety! 

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] Cenziper, D. & Rose, M. (2025, December 22). The FDA Often Doesn’t Test Generic Drugs for Quality Concerns, So ProPublica Did. New York, NY: ProPublica: RxRoulette. https://www.propublica.org/article/fda-generic-drug-testing

[2] Fletcher, L., Nejman, A., & Aaron, N. (2026, August 21). After 2 infant formula botulism outbreaks, families ask if warning signs were missed. Los Angeles, CA: ABC 7 News. https://wjla.com/features/i-team/two-infant-formula-botulism-outbreaks-warning-signs-foodborne-illness-fda-cdc-byheart-whole-nutrition

[3] Gilead Sciences, Inc. v. Meritain Health, Inc. et al. (4th Cir. 2026). https://www.safemedicines.org/wp-content/uploads/2026/08/Gilead-v.-Meritain-appeals-court-decision.pdf

[4] Lee, M., Tortorelli, P., & Zamost, S. (2026, August 14). Court rules companies can’t import Gilead medications from overseas in blow to AFP health programs. Englewood Cliffs, NJ: CNBC: Health and Science. https://www.cnbc.com/2026/08/14/court-ruling-gilead-medications-overseas-afps.html

[5] Levitt, G. (2024). Enough Excuses on Drug Importation: A New Transnational Paradigm for FDA Regulation and Lower US Drug Prices. Brooklyn Journal of International Law, 49(1), 286-329. https://brooklynworks.brooklaw.edu/bjil/vol49/iss1/8

[6] Semuels, A. (2025, April 08). Food Safety Was Slipping in the U.S. Then Came Mass Layoffs. New York, NY: Time Magazine: https://time.com/7275746/food-safety-fda-layoffs/

[7] Zamost, S., Tortorelli, P., & Lee, M. (2025, November 13). Cheaper medicines, free beach trips: U.S. health plans tap prescriptions that feds say are illegal. Englewood Cliffs, NJ: CNBC: Health and Science. https://www.cnbc.com/2025/11/13/employer-health-plans-afp-prescriptions-feds-illegal.html

Fireside Chat Retreat in Pittsburgh, PA Tackles Emerging Crisis Facing AIDS Drug Assistance Programs

By: Brandon M. Macsata, CEO, ADAP Advocacy & Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

ADAP Advocacy hosted its Health Fireside Chat retreat in Pittsburgh, Pennsylvania, with key stakeholder groups to discuss the adverse impact on patient care caused by the emerging financial crisis facing state AIDS Drug Assistance Programs (ADAP). The Health Fireside Chat was held on Friday, August 14th, and convened as part of its grassroots advocacy campaign, 'ADAP Saves Lives: End the Wait', in response to the resurfacing of ADAP waiting lists—now affecting over 1,000 clients. Nearly two dozen diverse health policy stakeholders attended the event.

Photo Source: Getty Images

The ADAP Crisis discussion —including waiting lists in two states, cost containment measures in over one dozen states, a summary of the fiscal health and stress of the programs nationwide, and patient fears over not having access to their medications—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:

• Kate Abel, Merck
• Michelle Anderson, Narrative Power Institute LLC (ADAP Advocacy consultant)
• Guy Anthony, Black, Gifted & Whole Foundation (ADAP Advocacy Board Co-Chair)
• Scott Bertani, HealthHIV
• Duane Binion, True T Pittsburgh
• Erin Bradshaw, Patient Advocate Foundation
• Jeffrey S. Crowley, O’Neill Institute
• Jose De Marco, ACT UP Philadelphia
• Moira Foster, Pennsylvania Department of Health, Division of HIV Health
• John Haines, Pennsylvania Department of Health, ADAP
• Kathie Hiers, AIDS Alabama (retired)
• Marcus J. Hopkins, Appalachian Learning Initiative (ADAP Advocacy consultant)
• Tim Horn, NASTAD
• Amanda Kornegay, Kornegay Consulting LLC (ADAP Advocacy consultant)
• Stephanie Knupsky, PWN Pennsylvania
• Brandon M. Macsata, ADAP Advocacy
• Tom McDaniels, HIV-HEP Policy Institute
• Judith Montenegro, Latino Commission on AIDS
• Steve Novia, ViiV Healthcare
• Michiel Peters, Global Coalition on Aging
• David Spears, Magic Box LLC (ADAP Advocacy consultant)
  
  

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:

• ADAP Watch – July 2026
  This report tracks the fiscal health of AIDS Drug Assistance Programs across 43 reporting jurisdictions. It shows 15 ADAPs projecting budget deficits, 23 reporting balanced budgets, 5 anticipating surpluses, and active waiting lists in Iowa and Utah.
  Source: National Alliance of State & Territorial AIDS Directors
  
  
• ADAP Crisis Threatens Access to Lifesaving HIV Care
  This Quick Take warns that the AIDS Drug Assistance Program (ADAP), a foundational part of the HIV care safety net, is under growing strain.
  Source: O’Neill Institute | Georgetown Law
  
  
• Merck Announces New Agreement with ADAP Crisis Task Force to Improve Access and Care for People Living with HIV
  Agreement will help state ADAP programs provide access to IDVYNSO™ (doravirine/islatravir) for eligible individuals.
  Source: Merck
  
  
• Thousands Of Americans Are Set To Lose Access To HIV Medication And Care
  [Podcast: 42-Minute Listen]
  Source: NPR
  
  
• The ADAP “Perfect Storm” Returns; Over 1,000 Patients Being Denied Care
  What’s old is new, again!
  Source: ADAP Advocacy

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

The Health Fireside Chat focused on the issues facing the nation's state AIDS Drug Assistance Programs (ADAP), with special attention to how the funding paradigm has shifted over the past 20 years.

Photo Source: ADAP Advocacy

[Tim Horn, right, and Steve Novis, left]

Tim Horn, Director of Medication Access at the National Alliance of State and Territorial AIDS Directors (NASTAD), led the discussion and presented data from state ADAPs to NASTAD for calendar year 2025. While these data won't be published until 2027, Horn explained that they point to trouble ahead:

• Enrollment in state ADAP has increased, likely due to a combination of the introduction of the Ending the HIV Epidemic (EHE) program and the ending of the Medicaid Continuous Enrollment provision introduced during the COVID-19 pandemic to ensure that patients were not disenrolled
• Per-client drug expenditures have increased 1.5% annually from 2019 to 2025
• Per-client insurance premium expenditures have increased 8.3% annually from 2019 to 2025, and increased by 22% from Quarter 1 2025 to Quarter 1 2026. Double-digit increases are expected again in 2027
• Despite a decrease in enrollment from 2024 to 2025, costs increased in prescription drug costs (2.6%), premium expenditure (17.1%), and total core expenditures (3.0%)
• From 2019 to 2025, per-client costs increased 9.6%, and per-client insurance premiums increased 61.3%. Total spending increased 55.7%

Horn also explained that the ~$75 million in ADAP Emergency Funds have remained stagnant for several years, but the number of state ADAPs applying has increased from an average of ~8 states each year to 34, making that $75 million significantly less impactful.

Additionally, federal ADAP funding has remained unchanged at $900 million per year since 2014, even as the program costs $2.4 billion annually. Most state ADAPs cover that difference through 340B Drug Pricing Program rebates, which now account for 52% of ADAP budgets.

This reliance on rebate funding places state ADAPs in the precarious position of relying upon private industries to essentially fund a government program.

Of significant concern to Horn is the fact that there is no specific carveout for Persons Living with HIV/AIDS (PLWHA) in the Medicaid work requirements imposed by the federal government, meaning that PLWHA who are currently enrolled in state Medicaid programs may be kicked off of Medicaid for being unable to work or overcome the significant administrative (paperwork) burden placed upon them in order to prove that they are meeting the work requirements.

This shift in Medicaid policy is likely to result in PLWHA falling back on state ADAPs as they are disenrolled from Medicaid, further straining already limited budgets.

Horn also highlighted that the shift to purchasing health insurance for clients, once heralded as a significant cost-saving measure for state ADAPs compared with the direct purchasing model, is becoming less cost-effective as premiums, deductibles, and co-pays increase.

After Horn's initial presentation, attendees discussed their myriad concerns about the state of ADAP and access to HIV care. Stephanie Knupsky of Positive Women's Network PA summed it up best:

"I am scared. I listen to [Tim Horn's data] and all I can think about is how it feels like our voices are being suffocated."

Fear, in fact, was one of the primary sentiments expressed at the Pittsburgh FSC. How was the fear summarized during the day's discussions? 

• Fear that the Trump Administration and MAGA Republicans are purposely trying to destroy social safety net programs like Medicaid, SNAP, and ADAP;

• Fear that Black and Brown Americans are being specifically slandered and targeted in an attempt to instill so much fear in them that they stop attempting to enroll in these programs;

• Fear that immigration policies are going to result in even worse health outcomes for non-White populations;

• Fear that patients will fall out of care and services;

• Fear that the loss of access to HIV medications could result in the emergence of multidrug-resistant strains of the HIV virus;

• Fear that the loss of the current generation of HIV advocates and activists has left younger replacements insufficiently trained and prepared to pick up the mantle when they have retired or passed away.

Some patient advocacy organizations, such as HealthHIV, ACT UP Philly, and AIDS Alabama, offered additional historical perspectives from the last ADAP Crisis. It was noted that the Positive Women's Network (PWN) was in its infancy during the last go-around, but today it stands in a much stronger position to help shape the public debate.

Photo Source: ADAP Advocacy

[Scott Bertani, right, Brandon M. Macsata, center, Marcus J. Hopkins, left]

ADAP Advocacy shared details about the re-activation of its grassroots advocacy campaign, "ADAP Saves Lives: End the Wait," including the airing of its new digital public service announcement (PSA). The latest PSA builds on the landmark PSA – which aired on 210 media outlets from February 21, 2011 to April 3, 2011.

The newly released PSA features Texas-based HIV-positive advocate Michelle Anderson, who was among the advocates included in the 2011 PSA. It can be viewed online here: https://www.youtube.com/watch?v=jxt-RuYqWE8.

Additionally, ADAP Advocacy announced the launch of its new grassroots advocacy hub, available online here: https://www.adapadvocacy.org/adap-saves-lives. Presently, it showcases the two states with waiting lists, Iowa and Utah, as well as four other states being monitored by the organization. Those states include Florida, Illinois, Pennsylvania, and Texas. The grassroots advocacy hub will add more resources and tools to help patient advocates in those states, and the broader advocacy campaign is also building out state advocacy teams.

For advocates in Pennsylvania, representatives from ACT UP Philly and PWN Pennsylvania shared updates on their work, and much of the conversation focused on improving coordination among the groups. ADAP Advocacy pushed the narrative that all the bubbling fear among PLWHA needed to be channeled into advocacy, as it was during the previous ADAP Crisis.

Not all sentiments were fearful, however. One of the comments most frequently made by attendees was how surprised they were that ADAP Advocacy chose to bring a Fireside Chat event to Pittsburgh:

"So often, we have to travel elsewhere to attend these meetings. Everyone goes to Philadelphia, which might as well be another planet compared to the rest of Pennsylvania. We need more of these kinds of meetings in Pittsburgh."

And this is the clarion call for advocacy organizations:

So often, we focus on hosting events in large cities—New York, San Francisco, Atlanta, Chicago, Boston, Washington, DC—because they are easier and more convenient to reach by transportation.

This tendency reflects arguably the greatest disparity in public health:

The worst health outcomes in the U.S. rarely occur in our nation's major cities; instead, they lie in smaller cities, rural areas, and geographically isolated regions.

While we regularly speak of rural hospital closures and a lack of access to quality healthcare services in underserved areas, we rarely host meetings and conferences there. This inevitably excludes the patient voices we most need to hear, as they cannot afford to travel to those major cities without significant financial and time outlays. It's food for thought, as organizations plan these events.

Additional Health Fireside Chats are planned for 2026.

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.