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The repealed Maryland statute was discriminatory regarding HIV status and race.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.  

United States' HIV Viral Suppression Complemented by State AIDS Drug Assistance Programs

By: Ranier Simons, ADAP Blog Guest Contributor

Population health decisions should always be evidence-based and informed by quality data. State AIDS Drug Assistance Programs (ADAPs), funded by the Ryan White HIV/AIDS Program (RWHAP), provide access to HIV antiretrovirals and other related prescription medications to low-income people living with HIV/AIDS (PLWHA) who are uninsured or underinsured. They also offer other support services that bolster PLWHA’s ability to manage HIV care. Without regard to its inherent value, the Trump Administration's FY2026 budget proposal calls for cuts to the RWHAP, which could adversely affect patients served by ADAPs. A recent study of longitudinal data proves that ADAPs are efficacious and valuable, deserving of more funding, not less (McManus, 2025). 

Photo Source: MedRxIV

A recent study, led by Dr. Kathleen McManus of the University of Virginia School of Medicine, evaluates how ADAPs have contributed to the United States' viral suppression rates from 2015 to 2022. The findings show that ADAPs are effective and their viral suppression outcomes are better than those of PLWHA, who do not receive ADAP-funded services. 

The retrospective longitudinal study explored ADAP participants’ viral suppression (VS) and viral load (VL) data compared to the PLWHA overall population from 2015 to 2022. The state-level data covered all 50 states and the District of Columbia, sourced from the National Alliance of State and Territorial AIDS Directors (NASTAD) National RWHAP Part B and ADAP Monitoring Project Annual Reports and the Centers of Disease Control and Prevention’s (CDC) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) AtlasPlus (McManus, 2025). All jurisdictions for each year of the study were considered, only including data for a jurisdiction when the NASTAD and CDC data for any given year were both complete. Establishing set guidelines for data inclusion strengthened the validity of the findings.

Photo Source: NASTAD

Over the study period, there were some years where various jurisdictions were not included due to missing data. Overall, 81.9% to 96.4% of the population of PLWHA were included. From 2015 to 2022, the estimated number of PLWHA in the U.S. grew from 942,988 to 1,092,023. The number of ADAP clients from the overall population for each year ranged from 146,879 to 220,839, or 65.5% to 96.9%, respectively (McManus, 2025). 

The VS rate for PLWHA overall ranged from 60% to 66.3%. However, the VS rate for non-ADAP participants ranged from 53.2% to 59.4% compared to 81.2% to 91.4% for ADAP clients. This indicates that viral suppression was significantly higher among those served by state ADAPs. This finding is significant given that for the entire study period, ADAP clients were underrepresented among those eligible for assessment (McManus, 2025). In other words, the proportion of PLWHA ADAP clients overall was always higher than the proportion eligible for VS assessment. Additionally, for all the study years, the proportion of PLWHA who were ADAP clients was greater than the proportion of PLWHA who were ADAP clients with detectable VL. Notably, in 2020 and 2022, the proportion of ADAP clients was only 5.7%, although ADAP clients comprised 23.9% and 21.0%, respectively, for both years (McManus, 2025).

Consistently, ADAP clients comprised one-third (~33%) of all virally suppressed PLWHA nationwide while representing only 21.0% to 24.4% of the total PLWHA population (McManus, 2025). This data illuminates that ADAPs result in higher VS rates than the VS rates of the general population of PLWHA. The cost of HIV antiretroviral medications is not decreasing (McCann et. al, 2020). Moreover, PLWHAs live longer; thus, there is an increasing demand for assistance from ADAPs (McManus et al., 2013). It is not in the best interest of public health nor fiscal responsibility to cut funding to ADAP programs.

Photo Source: HRSA

It would be wiser to increase funding and establish policies that expand and innovate using RWHAP and ADAP funds. Viral suppression increases with ADAP-supported health insurance (McManus et. al, 2019). Supporting expanded ADAP enrollment efforts in addition to ADAP-covered premiums would expand access compared to the costs of providing medication directly for those without any insurance. Cutting RWHAP funds and subsequently ADAP funding would result in the loss of medication and care access for many PLWHA. Disruptions in medication and care access would decrease VS rates and potentially increase transmission rates and poor health outcomes. One CDC study showed that 63% of new HIV transmissions resulted from 34% of PLWHA who were aware of their status but were not virally suppressed (Li et. al, 2016). 

Achieving viral suppression is the most effective way to prevent HIV transmission. “Undetectable = Untransmittable” (U=U) is one of the most essential tenets of HIV treatment and prevention. U=U is possible because of the lifesaving and life-changing medications that ADAPs can provide. Federal funding for ADAPs has remained flat for years, especially for southern states (Nunn, 2014). Cutting funding would be detrimental to state ADAPs across the board. The study, headed by Dr. McManus, should be a data-rich wake-up call for policymakers aiming to reduce funding.

[1] Li, Z., Purcell, D., Sansom, S., Hayes, D., Hall, H. (2016). Vital Signs: HIV Transmission Along the Continuum of Care - United States. MMWR Morb Mortal Wkly Rep. 2019;68(11):267-272. doi:10.15585/mmwr.mm6811e1.  

[2] McCann, N., Horn, T., Hyle, E., Walensky, R. (2020, February 3).HIV Antiretroviral Therapy Costs in the United States, 2012-2018. JAMA Intern Med. 2020;180(4):601–603. doi:10.1001/jamainternmed.2019.7108. Retrieved from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2759735#:~:text=School%2C%20Boston%2C%20Massachusetts-,JAMA%20Intern%20Med.,3

[3] McManus, K., Christensen, B., Nagraj, V., Furl, R., Yerkes, L., Swindells, S., Weissman, S., Rhodes, A., Targonski, P., Rogawski McQuade, E., & Dillingham, R. (2019). Evidence From a Multistate Cohort: Enrollment in Affordable Care Act Qualified Health Plans’ Association With Viral Suppression. Clinical Infectious Diseases, 71(10), 2572–2580. https://doi.org/10.1093/cid/ciz1123. Retrieved from https://academic.oup.com/cid/article/71/10/2572/5627781

[4] McManus, K., Engelhard, C., & Dillingham, R. (2013). Current challenges to the United States' AIDS drug assistance program and possible implications of the Affordable Care Act. AIDS research and treatment, 2013, 350169. https://doi.org/10.1155/2013/350169. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC3614023/#:~:text=The%20demand%20for%20ADAP%20support,goals%3B%20and%20the%20recession%20continues.

[5] McManus, K., Killelea, A., Rogers, E., Liu, F., Horn, T., Steen, A., Keim-Malpass, J., Hamp, A., & Rogawski McQuade, E. (2025). State AIDS Drug Assistance Programs’ Contribution to the United States’ Viral Suppression, 2015-2022. https://doi.org/10.1101/2025.04.04.25325288. Retrieved from https://www.medrxiv.org/content/10.1101/2025.04.04.25325288v1.full.pdf

[6] Nunn, A. (2014, May). The Southern Epidemic: Are the South’s cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs,  to function effectively in this region? Retrieved from https://www.adapadvocacy.org/pdf-docs/2014_aaa_WP_The_Southern_Epidemic_05-15-14.pdf

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. 

Trump's Executive Order on Drug Prices Includes Both Good and Bad Ideas

By: Ranier Simons, ADAP Blog Guest Contributor

On April 15, 2025, President Donald J. Trump signed Executive Order 14273: Lowering Drug Prices by Once Again Putting Americans First (Exec. Order No. 14273, 2025). The executive order is meant to delineate actions the Administration will take as solutions to lower prescription drug prices for Americans. The executive order’s actions include changes to the Medicare Drug Price Negotiation Program, drug importation, and addressing the activity of Pharmaceutical Benefit Managers (PBMs). The various provisions of the order are to be enacted on staggered timetables of 60, 180, and 365 days from the issuance of the order. The specificity of the various provisions varies. Yet, it is prudent to examine the major themes.

Photo Source: AP Photo/Alex Brandon

The most detailed section of the executive order is Section Three: Improving upon the Inflation Reduction Act (Exec. Order No. 14273, 2025). This section addresses the Administration's perceived flaws in the Medicare Prescription Drug Negotiation Program (MPDNP). The President describes the MPDNP as too complex and expensive, feels it caused changes to the Medicare Part D program that were detrimental to seniors, and distorts innovation by creating a “pill penalty” between large and small molecule drugs.

The “pill penalty” concerns the period allowed before a small-molecule or large-molecule drug is eligible for price negotiation. The MDPNP law identifies high-cost prescription drugs, whether brand name or biological, without generic or biosimilar equivalents, as eligible for negotiation (Cubanski & Neuman, 2025). This effectively means that small-molecule drugs would be affected by Medicare negotiated prices 9 years following their FDA approval, in contrast to 13 years for biologics. Small-molecule drugs are synthetic drugs that are chemically synthesized, while biologics are extracted from living organisms. Small-molecule drugs are typically administered in pill form or non-sterile liquid (Pantheon, 2025). Most biologics are available in injectable or intravenously administered forms, have special requirements to maintain stability, and are more complex and much more expensive to produce than small-molecule drugs (Caris, 2025).

Photo Source: YouTube / Seniors 4 Better Care

The executive order aims to increase small-molecule drug eligibility for price control to match that of the biologic drugs. The sentiment is that the discrepancy is a disincentive for investment in developing lower-cost small-molecule drugs, which are cheaper and used by a larger population than biologics (Exec. Order No. 14273, 2025). Biologics are typically used to treat things such as rare diseases or cancer. The possible outcome is that Medicare spending could increase. If this change were applied to the drugs that have already been selected in the first and second rounds of Medicare negotiations, half of the chosen medications, which equate to total gross Medicare Part D spending of $61 billion out of $91 billion, would not have qualified (Cubanski & Neuman, 2025). Some stakeholders are concerned that the change would result in higher prices and premiums for Medicare Part D recipients. The executive order mentions that other actions would be taken to prevent adverse price increases without specificity.

Section Eight: Reevaluating the Role of Middlemen hints at addressing issues surrounding PBMs (Exec. Order No. 14273, 2025). The order instructs a multi-department investigation to create recommendations “…on how best to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices”. The White House fact sheet released in tandem with the executive order also explains that the order will address the influence of middlemen and promote open competition (White House, 2025). While PBM reform initiatives are occurring in multiple states, recent actions of the Administration do not support the expressed desire for PBM reform. 

The Federal Trade Commission (FTC) is actively involved in a lawsuit against the three largest PBMs concerning their activities that allowed them to take in millions in profits at the expense of patients regarding high-priced insulin drugs. The FTC has also released a second report highlighting how PBMs have grossly marked up and manipulated generic drugs. Yet, the President fired two FTC commissioners in March (Godoy, 2025). This resulted in the FTC’s general counsel issuing an administrative stay in the case since there are no Commissioners available to adjudicate the case. 

Photo Source: AIS Health

Additionally, newly released draft legislation created by the House Judiciary Committee, in essence, removes federal antitrust enforcement powers from the FTC and consolidates them under the DOJ (Fuchs & McCarthy, 2025). The DOJ prosecutes the law, while the FTC, as an administrative body, has functions such as writing rules, enforcing laws, and conducting market studies. The Administration's actions favor its desire to bring about deregulation, which is not in alignment with PBM reform. The theme of deregulation is evidenced in the carefully worded verbiage of Section Two of the executive order, which states, “It is the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at lower costs to American patients and taxpayers” (Exec. Order No. 14273, 2025).

Another notable section of the executive order is Section Ten: Increasing Prescription Drug Importation to Lower Prices (Exec. Order No. 14273, 2025). This section, in part, states it “shall take steps to streamline and improve the Importation Program under section 804 of the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality.” A breadth of data indicates that drug importation as a means to lower prescription drug costs is not a viable tool. 

The nature of the drug supply and the drug supply chain indicate that there is not enough of a drug supply to acquire medications from a country like Canada, which is frequently referenced as a source for cheaper medications. Most importantly, drug importation lends itself to infiltration by bad actors that can introduce counterfeit, improperly handled, and low-efficacy drugs into the supply chain. Dangerous counterfeit drugs already exist in the U.S. drug supply. Bulk importation is a flawed idea since it would source medications from other countries outside the U.S. safe drug tracking system, which are not subject to our strict regulations and oversight. Moreover, Canada has explicitly stated, "Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future” (Partnership for Safe Medicines, 2022). Florida, the only state with an FDA-approved drug importation plan, has already spent $50 million on a warehouse and over $24 million on an importer (Galewitz, 2024). It has not imported any drugs or saved any money.

The aforementioned sections are just a few of the fourteen sections listed in the executive order. Those sections describe more direct actions, indicating actionable changes. The other sections can be characterized as promises to investigate concerns, with the desired output being reports explaining the solution. Indeed, the high price of drugs is a problem worthy of intervention. However, the implementation of much of the order is unclear, as are the end products of what it nebulously implies. Time will indicate if the executive order results in benefits, falls short with no effect, or worse yet, creates more problems.

[1] Caris Life Sciences. (2025). Difference Between Small Molecule and Large Molecule Drugs. Retrieved from https://www.carislifesciences.com/difference-between-small-molecule-and-large-molecule-drugs/  

[2] Cubanski, J, Neuman, T. (2025, April 16). The Effect of Delaying the Selection of Small Molecule Drugs for Medicare Drug Price Negotiation. Retrieved from https://www.kff.org/policy-watch/the-effect-of-delaying-the-selection-of-small-molecule-drugs-for-medicare-drug-price-negotiation/

[3] Exec. Order No. 14273, F.R. 90 (2025, April 15). Lowering Drug Prices by Once Again Putting Americans First. Retrieved from https://www.federalregister.gov/documents/2025/04/18/2025-06837/lowering-drug-prices-by-once-again-putting-americans-first

[4] Fuchs, H., McCarthy, M. (2025, April 29). Trump could gain vast new deregulatory and antitrust powers under GOP megabill plans. Retrieved from https://www.politico.com/news/2025/04/29/trump-executive-powers-reins-act-ftc-antitrust-00317105

[5] Galewitz, P. (2024, November 20). Florida Gov. DeSantis' Canadian drug import plan goes nowhere after FDA approval. Retrieved from https://www.cbsnews.com/news/florida-desantis-fda-canadian-drug-imports/

[6] Godoy, J. (2025, March 19). Trump fires both Democratic commissioners at FTC. Retrieved from https://www.reuters.com/world/us/trump-fires-both-democratic-commissioners-ftc-sources-say-2025-03-18/

[7] The Partnership for Safe Medicines. (2022). Drug importation endangers U.S. patients. Retrieved from https://www.safemedicines.org/importation-page

[8] The White House. (2025, April 15). Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices. Retrieved from https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices/

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.