Real-World Data Yields Promise for DoxyPEP

By: Ranier Simons, ADAP Blog Guest Contributor

Sexually transmitted diseases (STIs) are serious, highly communicable diseases that, left unchecked, can cause serious harm and even be life-threatening. Some, such as HIV, are incurable. Others can be disfiguring, cause sterility, or even brain damage and congenital abnormalities. (NIH, 2017). Three of the most common curable STIs are syphilis, chlamydia, and gonorrhea. In the U.S., over 2.4 million cases of syphilis, gonorrhea, and chlamydia combined were diagnosed and reported in 2023. (Press, 2024). A recent treatment innovation being adopted in the fight against STIs is doxycycline post-exposure prophylaxis, commonly referred to as doxyPEP. Clinical trials have shown promising results, and recent data shows the promise of its effectiveness in real-world populations of sexual networks.

Photo Source: Chicago Department of Public Health

DoxyPEP is the administration of 200 mg of doxycycline within 24 hours of unprotected sex. (Lou, 2025). Two previous clinical trials, the DOXY/PEP study in the U.S. and the DOXYVAC study out of France, indicate that DoxyPEP is effective for STI prevention. However, the sample sizes of the studies were small, and it is necessary to investigate the effectiveness of the intervention on larger populations out in the real world. The DOXY/PEP study contained 501 participants, and the DOXYVAC study included 556. (Molina, 2024; Susman, 2022). Two recent studies indicate the high efficacy of more extensive population-level doxyPEP implementation. One study was conducted in San Francisco, and the other studied populations in Northern California.

The study out of San Francisco was a population-level interrupted time series analysis of STI cases of men who have sex with men (MSM) and transgender women before and after the city issued citywide doxyPEP guidelines in 2022. (Sankaran, 2025) During the study period, there were 6694 cases of chlamydia, 9603 cases of gonorrhea, and 2121 cases of early syphilis. The study's objective was to observe the percentage differences between STI-modeled projected infections and observed STI rates after citywide doxyPEP was initiated. By the end of the study period, chlamydia cases had decreased -49.64% and early syphilis cases by -51.39% compared to projected case levels. However, there was an increase in gonorrhea cases compared with projections.

The Northern California study was a retrospective cohort examination of adult Kaiser Permanente Northern California (KPNC) members who were given HIV PrEP from November 1, 2022, through December 31, 2023. (Trager, 2025) In the study of 11,551 subjects, 2253 were dispensed doxyPEP. The primary outcome of the study was the examination of quarterly rates of STI positivity. Among those on doxyPEP, quarterly chlamydia positivity decreased from 9.6% before doxyPEP administration to 2.0% after. Gonorrhea positivity decreased from 10.2% to 9.0%. Syphilis positivity lowered from 1.7% to 0.3%. Rates remained stable among those who were not utilizing doxyPEP.

The CDC has officially recommended the use of doxyPEP for STI prevention for MSM and transgender women since June of 2024. (Lou, 2025). Counseling for doxyPEP is especially encouraged for members of this population who have had at least one STI infection in the past year. Notably, doxyPEP has had questionable efficacy related to gonorrhea. In the San Franciso study, there was an increase in gonorrhea cases. The Kaiser Permanente study showed lower rates of gonorrhea positivity in rectal and urethral site infections with an increase in pharyngeal gonorrhea rates. These findings support the hypothesis that pharyngeal tissues could be a reservoir of gonorrheal antibacterial resistance and the possibility of increased risk of gonorrheal antibacterial resistance overall.

These aforementioned studies indicate that doxyPEP is potentially an efficacious modality of STI prevention not just in clinical studies but also out in the real world. However, larger, more targeted studies must be conducted on wide populations to gain a deeper understanding. The San Francisco and Kaiser Permanente studies only show a correlation and not a causal relationship between doxyPEP and lowered STI rates because the studies are observational. Regardless, doxyPEP is making a significant dent in STI transmissions and only time will reveal its true efficacy and possibility of antibiotic resistance risk.

Photo Source: San Francisco City Clinic

[1] NIH. (2017). Why are sexually transmitted diseases (STDs) and sexually transmitted infections (STIs) of particular concern for pregnant women? Retrieved from  https://www.nichd.nih.gov/health/topics/stds/conditioninfo/concern#:~:text=STIs%20during%20pregnancy%20can%20also%20cause:&text=Miscarriage%20(fetal%20loss%20before%2020,Health%20complications%20in%20the%20mother

[2] Lou, N. (2025, January 6). DoxyPEP Rollout Tied to Dent in STI Epidemic in the Real World. Medpagetoday.com; MedpageToday. Retrieved from https://www.medpagetoday.com/infectiousdisease/stds/113668

[3] Molina, J.-M. (2024). Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 × 2 factorial design. Lancet. Infectious Diseases/˜the œLancet. Infectious Diseases. https://doi.org/10.1016/s1473-3099(24)00236-6

[4] Press, A. (2024, November 13). STI Epidemic Slows as New Syphilis and Gonorrhea Cases Fall in the U.S. Medpagetoday.com; MedpageToday. Retrieved from https://www.medpagetoday.com/infectiousdisease/stds/112879

[5] Sankaran, M., Glidden, D. V., Kohn, R. P., Nguyen, T. Q., Bacon, O., Buchbinder, S. P., Gandhi, M., Havlir, D. V., Liebi, C., Luetkemeyer, A. F., Nguyen, J. Q., Roman, J., Scott, H., Torres, T. S., & Cohen, S. E. (2025). Doxycycline Postexposure Prophylaxis and Sexually Transmitted Infection Trends. JAMA Internal Medicine. Retrieved from  https://doi.org/10.1001/jamainternmed.2024.7178

[6] Susman, E. (2022, July 29). Post-Exposure Doxycycline Reduces STIs. Medpagetoday.com; MedpageToday. https://www.medpagetoday.com/meetingcoverage/iac/99983

[7] Traeger, M. W., Leyden, W. A., Volk, J. E., Silverberg, M. J., Horberg, M. A., Davis, T. L., Mayer, K. H., Krakower, D. S., Young, J. G., Jenness, S. M., & Marcus, J. L. (2025). Doxycycline Postexposure Prophylaxis and Bacterial Sexually Transmitted Infections Among Individuals Using HIV Preexposure Prophylaxis. JAMA Internal Medicine. Retrieved from https://doi.org/10.1001/jamainternmed.2024.7186

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. 

A Call to Serve: Patient Advocates Must Step-Up During T2

By: Brandon M. Macsata, CEO, ADAP Advocacy

In December 2024, ADAP Advocacy hosted its final Health Fireside Chat of the year as part of a broader Health Policy Retreat held in collaboration with the Community Access National Network. Despite hopes that the country's better angels would be reflected at the ballot box, both organizations had been preparing for what once seemed impossible: Trump Two (T2). POSITIVELY AWARE captured the sentiments shared by members of several national and state-level HIV advocacy and policy organizations from across the country prior to the Election. But now the rubber meets the road...

ADAP Advocacy CEO Brandon M. Macsata on The Morning Meeting, 12/09/24

At the Health Fireside Chat, political commentator Mark Halperin, editor-in-chief of 2WAY Interactive and host of The Morning Meeting podcast, pointedly dished out some straight talk about how patient advocates need to view the election as a call to serve. During the 2024 presidential election, Halperin scooped that President Joe Biden was dropping out of the presidential race days before the news broke, as well as three weeks prior to the election sounding the alarm that the Harris-Walz campaign was in big trouble in the swing states' suburbs. Agreeing to disagree in a few areas, most attendees in the room understood the merits of the advice being given by a political insider.

In fact, Halperin's message echoed the words of the late Bill Arnold (former President & CEO of the Community Access National Network and former founder and board co-chair of the ADAP Advocacy Association): leave your personal politics at the door! Halperin challenged the patient advocates and other stakeholders in the room to fight for a seat at the preverbal table. Ironically, it sounds awfully similar to The Denver Principles and the "Nothing About Us Without Us" principle!

To that end, ADAP Advocacy is returning some of its targeted advocacy efforts back to the very roots of the organization's founding some seventeen years ago...GRASSROOTS, that is. Back in 2010 during the height of the ADAP Crisis that landed over 1,300 people living with HIV/AIDS in thirteen states on waiting lists under the State AIDS Drug Assistance Program (ADAP), including a couple reported deaths, ADAP Advocacy helped to galvanize state grassroots networks to raise awareness and demand action by lawmakers. It is time to re-activate these state grassroots networks to push back against those dark forces seeking to gut the social safety-net, spread misinformation about science and vaccine efficacy, and perpetuate hate and stigma against marginalized communities...many of whom are disproportionately impacted by HIV.

ADAP Advocacy CEO Brandon M. Macsata at Florida town hall in 2010

Patient advocates are encouraged to contact ADAP Advocacy at info@adapadvocacy and indicate which state they're residing in, and how they might help with advocacy efforts. Aside from targeting federal lawmakers with constituent visits to better educate them, there will be plenty of opportunity for patient advocates to influence their state legislatures on many HIV-related issues.

Additionally, ADAP Advocacy leverages patient advocates and other public health stakeholders to serve on numerous patient advisory committees. This is a call to serve!

• ADAP State Drug Formulary Patient Advisory Committee

RE: Drug Formularies

Committee Chair: Rev. Alexander Garbera (Connecticut)

ADAP Advocacy works to improve access to timely, appropriate care and treatment for people living with HIV/AIDS being served by the State AIDS Drug Assistance Programs (ADAPs) under the Ryan White HIV/AIDS Program, including promoting robust drug formularies to best serve the needs of clients. Whenever feasible, ADAP Advocacy strongly supports "open" drug formularies. Approximately 20 seats need to be filled for this committee.

Learn more about the ADAP State Drug Formulary Patient Advisory Committee.

• ADAP Long-Acting Injectables Patient Advisory Committee

RE: Long-Acting Injectables

Committee Chair: Joey Wynn (Florida)

ADAP Advocacy strives to identify best practices on how to improve patient access to long-acting injectable therapies for the treatment of (and prevention of) HIV/AIDS. As general guidelines, they would be designed to help State AIDS Drug Assistance Programs (ADAPs), and other relevant payers, remove the barriers to accessing injectable HIV-related therapies, as well as other non-ARV, health-related injectable therapies. Three seats need to be filled for this committee.

Learn more about the ADAP Long-Acting Injectables Patient Advisory Committee.

• Ryan White Grantee 340B Patient Advisory Committee

RE: 340B Drug Pricing Program

Committee Chair: Guy Anthony

ADAP Advocacy ensures the voice of people living with HIV/AIDS shall always be at the table and the center of the discussion, including on how supports and services are financed under the Ryan White HIV/AIDS Program. To that end, reforming the 340B Drug Pricing Program is of paramount concern by returning the program to its original legislative intent: putting the patient first. Two seats need to be filled for this committee.

Learn more about the Ryan White Grantee 340B Patient Advisory Committee.

ADAP Advocacy has long prided itself on using its Values Statements to define its advocacy work. Among these values, that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion. Patient advocates must step-up during T2, so join the fight!

Photo Source: shutterstock.com

Fireside Chat Retreat in Washington, DC Tackles Pressing Public Health Issues

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

ADAP Advocacy hosted its Health Fireside Chat retreat in Washington, DC, as part of a broader health policy retreat convened collaboratively with the Community Access National Network (CANN) and its Industry Advisory Group. Board members from both organizations, as well as respective consultants and funders, assembled to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened on Friday, December 6th. The 27 diverse stakeholders discussed Trump Two, one-party rule returning to the nation’s capital, Inflation Reduction Act, 340B Drug Pricing Program, Prescription Drug Affordability Boards (PDABs), AIDS Drug Assistance Program’s drug formularies, and long-acting injectables. 

Photo Source: Getty Images

The Health Fireside Chat kicked off with a political recap from political commentator Mark Halperin, editor-in-chief - 2WAY Interactive. During the 2024 presidential election, Halperin had scooped that President Joe Biden was dropping out of the presidential race days before the news broke, as well as three weeks prior to the election sounding the alarm that the Harris-Walz campaign was in big trouble in the swing states' suburbs. 

Halperin shared his perspectives on what a second Trump Administration might look like, both from a potentially positive viewpoint, as well as a not-so-positive one. He offered some predictions on the Cabinet nominations, again noting where some could serve as potential change agents to improve public health – but also emphasized the unpredictability behind some of those same nominees if confirmed by the U.S. Senate. Halperin offered strong advice on the need to “get in the room” for the important conversations, which he argued won’t happen by merely attacking the incoming administration. Despite the extremes of both parties gaining more power, he offered examples whereby the “center” still holds a lot of weight over the legislative process to do good. Halperin took questions about what Trump Two and the GOP-led Congress might do for HIV, sharing even more advice on how to navigate those waters.

Mark Halperin discusses political landscape and health policy

The day-long strategy session 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:

• Guy Anthony, President & Founder, Black, Gifted & Whole Foundation
• Donna Christensen, former Member of Congress
• Erin Darling, Associate Vice Pres. & Counsel, Federal Policy, Merck
• Amy Dempster, Director, Issue Advocacy and Alliances, Genentech
• Robert Dorsey, Chief of Staff, DC Department of Small & Local Business Development
• Alexander Garbera, Member, New Haven Mayor’s Task Force on AIDS, City of New Haven, CT
• Dusty Garner, Patient Advocate
• Patrick Ingram, Implementation Project Manager, Midwest AETC
• Ashley John, Director, Issue Advocacy, Novartis
• Lisa Johnson-Lett, Peer Support Specialist, AIDS Alabama
• Amanda Kornegay, President, Kornegay Consulting
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Patient Advocate
• Brandon M. Macsata, CEO, ADAP Advocacy
• Travis Manint, Policy Consultant, Community Access National Network
• Maria Mejia, Patient Advocate
• Judith Montenegro, Program Director, Latino Commission on AIDS
• Theresa Nowlin, Patient Advocate
• Kassy Perry, President & CEO, Perry Communications Group
• Amanda Pratter, Director, Policy Advocacy, Gilead Sciences
• Kalvin Pugh, Policy Consultant, Community Access National Network
• Josh Roll, Director, Strategic Alliances & Issue Advocacy, Bristol Myers Squibb
• Ranier Simons, Policy Consultant, Community Access National Network
• Cindy Snyder, Retired
• David Spears, Creatives Consultant, ADAP Advocacy
• Jennifer Vaughan, Patient Advocate
• Joey Wynn, Grants & Contract Manager, Holy Cross Hospital

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

This particular Fireside chat did not have its standard format of specific formal presentations followed by discussion. It was more free flowing, consisting of an exchange of ideas surrounding many sub-topics and all surrounding public policy strategies. One of the most important threads of discourse was navigating policy and advocacy work in dealing with the incoming Trump Administration. A significant concern is figuring out how to manage hostile spaces in order to effect needed change.

The reality is that Trump is the president-elect. Moreover, albeit narrow, Republicans do have majority control across the board. This potentially makes it harder to achieve policy and advocacy goals because effecting change requires being in the room at the table when things are being done. A prevailing sentiment is that those rooms and tables are not welcome to racially and ethnically diverse, sexually diverse, and vulnerable communities that traditionally are adversely affected by and targeted by right-wing conservative ideology and policies. Yet, on some issues, Republican interests could be better aligned with patient interests on things like access to therapies (i.e., right-to-try), or reforming the abuses by big hospital systems and mega service providers under the 340B Drug Pricing Program.

An important focus of group discourse surrounded staying true to marginalized communities while speaking truth to power. The consensus is “wins” can be scored in unfriendly spaces by focusing on common ground, and in doing so doesn’t negate the deeply rooted concerns in other policy or political areas. As the late Bill Arnold often argued, “In this space, you have to leave your personal politics at the door if you’re going to achieve anything meaningful.” One example that was cited was the success in harm reduction policies by the North Carolina Harm Reduction in the Tarheel State.

Photo Source: JazzHR.com

Similarly, it is essential to not leave certain groups behind when broader community discussions are happening around legislation. It is necessary for advocates to figure out how to strategically call out grievances without compromising opportunities to access the players required to effect change. Sometimes, it is a matter of identifying the appropriate messenger for a specific audience. This does not mean the sociologically identified middle-aged white woman or cis-gendered heterosexual white male must be the vehicle to get a seat at every table. It does mean it’s wise to navigate relationships and understand the parties involved to determine the best messengers for different steps of strategic processes. The group had strong consensus that more women of color need to be invited to these proverbial tables. If for nothing else, t requires trust between the messengers and the communities they represent. The most effective messengers for an issue may not always look like or have the lived experience of some of the people for which they are representing. Thus, trust must be built in that they are effectively representing the needs and interests of affected communities when messengers are operating in hostile spaces. Humanizing issues with policymakers is a way to work through the muck and mire of ideological toxicity.

Another significant portion of this Fireside Chat discourse revolved around federal versus state issues. ADAP Advocacy collaborates with CANN to effect change on state and federal matters, as both have specific inroads of expertise. It is increasingly likely that more issues will be impacted at the state level more so than at the federal level. For example, there is a lot 340B-related activity and PDAB (Prescription Drug Affordability Board) legislation occurring on the state level. On the federal level, PEPFAR, Ending the HIV Epidemic, and the possibility of a Ryan White reauthorization are several issues of concern. There is strong evidence to suggest that the new incoming Republican majority in Congress plans to take a hard look at all the sunset programmatic laws as a way to achieve "savings" in the federal budget.

CANN shared a recently released video on PDABs, and how these boards are embarking on inadvertently creating a service delivery crisis for patients living with HIV. The video can be viewed online, here. Additionally, ADAP Advocacy shared a sneak peek of its new patient-centric advocacy tool highlighting why the 340B Program needs reform. Some discussion centered around California's Proposition 34, and embracing what voters achieved to bring better accountability and transparency to the 340B program. 

Photo Source: CANN

HIV is the tip of the spear that opens the door to conversation that makes room for navigating other community issues. Group discourse emphasized the need to strengthen the “Grassroots-to-Capitol Hill” pipeline of advocacy and influence. It was deemed necessary to enhance communication among major advocacy organizations such that there is a commonality of messaging on major issues when Capitol Hill interests inquire for guidance about community concerns. Additionally, it is necessary to identify members, such as some in the House, who can be ‘allies’ knowingly or unknowingly, to help influence the influencers to target things in a bipartisan manner to move the needle in favor of vulnerable and marginalized communities. Most importantly, it is imperative to open their eyes to how positively affecting change for these communities is beneficial to the general population as well.

ADAP Advocacy’s Health Fireside Chats are deeply rooted in the diverse voices who contribute valuable insight from various spaces of their expertise and lived experiences, all focused on the same issue of effecting positive change. In addition to lively and productive group discussion, individual spontaneous conversations occur between people who would otherwise not be in the same room. Virtual meetings are effective and have their place. However, there are times when the power and value of being physically present is undeniable.

Additional Fireside Chats are planned for 2025.

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

Anti-LGBTQ Laws are Propagating as Violence, Undermining Transgender Health

By: Ranier Simons, ADAP Blog Guest Contributor

As 2024 ends there is the painful reality that Donald J. Trump is returning to The White House, and with him promises of rolling back protections for LGBTQ people…and in some cases, even denying them care. The anxiety and fear are very authentic, and there is real world evidence of how discriminatory policies adversely impact already marginalized communities. One glowing example is how HIV prevention is undermined by LGBTQ-related attacks (legislation) and violence!

Photo Source: Le Monde

The concept of infrastructure does not always connote a physical embodiment of something. Infrastructure also encompasses societal structures, including culturally pervasive attitudes and legal policies. The problematic domestic and global infrastructure adversely affecting the lives of LGBTQ people is harmful to their well-being on many levels, including HIV prevention. The societal infrastructure set against LGBTQ contains aspects of physical violence as well as anti-LGBTQ legislation. The rate of violence perpetrated against LGBTQ in general, in addition to specific Transgender violence, is higher than the heterosexual general population.[1] Transgender violence and anti-LGTBQ laws and policies impede HIV prevention efforts, resulting in avoidable individual and public health adverse outcomes.

Over 500 anti-LGBTQ bills were introduced in the United States in 2023, almost tripling in number from 2022 to 2023.[2] This legislation is multi-focused, including attacks on health care, civil rights, public accommodations, and even education.[2] A recent study from the UNC Gillings School of Global Public Health found that there is a clear interconnection between discriminatory anti-LGBTQ legislation and HIV prevention.[3] Anti-LGBTQ legislation and policies adversely affect HIV prevention by increasing stigma and decreasing health care access.[3]

Photo Source: FiveThirtyEight

Many of the laws target transgender people and youth specifically, including efforts to deny gender-affirming care. This includes laws to prohibit the changing of gender or sex on identification or medical records. Some laws are purposed to ban the discussion of LGBTQ issues in schools. Regardless of the focus, the legislation contributes to LGBTQ stigma that even occurs in health settings.[4] This is due to a history of pathologizing LGBTQ identity, behavior, and desire in medicine.[4] Two-thirds of LGBTQ adults have experienced discrimination in the past year compared to four in ten non-LGBTQ adults.[4] The stigma fueled by anti-LGBTQ legislation is dehumanizing. It adversely affects the self-worth of individuals affected, which contributes to discouraging positive health-seeking behaviors and influences treatment when it is obtained.

Testing and PrEP use are significant tenets of HIV prevention. The UNC study showed that PrEP use was lower in states with more anti-LGBTQ legislation activity. Youth living in states with fewer anti-LGBTQ policies or counties with majorities of Democratic voters had higher levels of PrEP use. This positive increase in PrEP use was compounded for youth who lived in both a more progressive state and county.[4] Approximately 7.6% of U.S. adults identify as LGBTQ in 2024, and that number is increasing. Regular testing is a part of PrEP adherence. When stigma negatively affects access to testing, it simultaneously weakens the ability to maintain PrEP adherence even if PrEP is available.

Anti-LGBTQ laws are propagating concurrently as violence, specifically against transgender individuals, is an issue. One study out of San Diego, for example, showed that there were 229 documented cases of fatal violence against transgender women in the United States between 2013 and 2021.[5] The bulk of these cases, 78%, were Black victims, which included Afro-Latinas. Over half of these occurred in the South, followed in prevalence by the Midwest. This also reflects the number of recent anti-LGBTQ bills, with most being introduced in the South and the Midwest.[6] As of November 19, 2024, the Human Rights Campaign reports 372 transgender and gender-expansive victims of fatal violence from 2013 to the present.[7] These fatalities are only the reported ones. The actual numbers are estimated to be higher.

Prevention of violence against transgender people is a public health issue. Anti-LGBTQ policies and laws amplify the insecurity of daily existence that transgender individuals face. Adversity in dealing with daily survival is compounded by discrimination and lack of access to health care. Globally, on average, approximately 2/3 of transgender individuals are aware of their HIV status.[8] Also globally, the percentage of transgender individuals who avoid HIV testing due to discrimination and stigma is estimated to range from 47% to 73%. Additionally, those who have experienced discrimination in a healthcare setting are three times more likely to avoid seeking out healthcare than transgender people who have not experienced it.[8]

Photo Source: CDC

Social attitudes, the reality of violence, and anti-LGBT laws, including criminalization based on gender identity, contribute to the isolation of transgender people. Regardless of whether the isolation is externally or internally propagated, it adversely affects their mental health. Transgender individuals’ continuous exposure to harassment, bias, and discrimination contributes to poor mental health.[6] Poor mental health leads to things such as substance abuse and other detrimental patterns of behavior, which are barriers to effective HIV prevention, which includes medication adherence for transgender individuals living with HIV. 

Approximately one million people identify as transgender in the U.S., with 9.2% of those living with HIV. In addition to intravenous drug use, unsafe injection practices while injecting hormones can contribute to the increased likelihood of HIV transmission.[7] Sexual violence against transgender individuals also contributes to HIV transmission, especially since it is mainly unreported, and the victims do not seek out medical attention. Additionally, transgender people face housing and employment discrimination, which exacerbates challenges with maintaining proactive health maintenance, including HIV prevention.[7]

The adverse impact of HIV prevention challenges among people who identify as LGBTQ because of anti-LGBTQ laws and policies is significant. It is imperative to repeal toxic legislation and create beneficial policies that strengthen infrastructure to support HIV prevention and care. Legal protections and proactive policies will help fight against stigma and systemic structural barriers.

[1] Truman, J. L., Morgan, R. E., & U.S. Department of Justice, Office of Justice Programs, Bureau of Justice Statistics. (2022). Violent Victimization by sexual orientation and gender Identity, 2017–2020. In Statistical Brief. https://bjs.ojp.gov/content/pub/pdf/vvsogi1720.pdf

[2] Choi, A. (2024, January 22). Record number of anti-LGBTQ bills were introduced in 2023. Retrieved from https://www.cnn.com/politics/anti-lgbtq-plus-state-bill-rights-dg/index.html

[3] Kelly, N. K., Ranapurwala, S. I., Pence, B. W., Hightow-Weidman, L. B., Slaughter-Acey, J., French, A. L., Hosek, S., & Pettifor, A. E. (2024). The relationship between anti-LGBTQ legislation and HIV prevention among sexual and gender minoritized youth. AIDS (London, England), 38(10), 1543–1552. https://doi.org/10.1097/QAD.0000000000003926

[4] Dawson, L., Kates, J., Montero, A., and Kirzinger, A. (2024, September 30). LGBTQ Health Policy. Retrieved from https://www.kff.org/health-policy-101-lgbtq-health-policy/

[5] Halliwell, P., Blumenthal, J., Kennedy, R., Lahn, L., & Smith, L. R. (2024). Characterizing the prevalence and perpetrators of documented fatal violence against Black transgender women in the United States (2013–2021). Violence Against Women. https://doi.org/10.1177/10778012241289425 

[6] ACLU. (2024). Mapping Attacks on LGBTQ Rights in U.S. State Legislatures in 2024. Retrieved from https://www.aclu.org/legislative-attacks-on-lgbtq-rights-2024

[7] HRC. (2014, November 19). The Epidemic of Violence Against the Transgender & Gender-Expansive Community in the U.S. Retrieved from https://reports.hrc.org/an-epidemic-of-violence-2024#epidemic-numbers

[8] UNAIDS. (2021). HIV and Transgender and Other Gender-Diverse People: Human Rights Fact Sheet Series. Retrieved from https://www.unaids.org/sites/default/files/media_asset/04-hiv-human-rights-factsheet-transgender-gender-diverse_en.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. 

Data Shows Lenacapavir's Long-Lasting Efficacy

By: Ranier Simons, ADAP Blog Guest Contributor

The road to successful drug development is a long one. The approval of a new drug is a result of rigorous science and various phases of clinical trials in humans to prove its safety and efficacy. However, once a drug is approved and entered standard practice, the road does not end there. It is necessary to continue clinical trials to support a drug’s ongoing usage and emphasize its strengths and weaknesses. That is why recent data concerning lenacapavir is so encouraging. Data shows that its efficacy is long-lasting.[1]

Photo Source: NATAP

Lenacapavir’s continuing success was presented in October at the IDWeek annual meeting in Los Angeles. IDWeek is an annual international conference of healthcare professionals working with infectious diseases. At the conference, individuals such as researchers, clinicians, and public health officials, including those involved with treating HIV patients, collaborate and learn.[1] Third-year results of the CAPELLA study were presented, indicating long-term viral suppression achieved by those remaining in the study.[2]

The CAPELLA study led to lenacapavir being approved for use in the United States.[3] Under the brand name Sunlenca, lenacapavir is used to treat people who have multi-drug resistance to HIV antiretroviral medications. People living with HIV who have failed drug regimens are in a precarious situation, being unable to effectively control their HIV and achieve viral suppression. Lenacapavir is a subcutaneous infection administered twice a year in addition to an optimized regimen of other antiviral HIV medications. The CAPELLA clinical trial proved the efficacy of lenacapavir. The suppression shown in year two of the study continues in year three.

From year two to year three, viral suppression remained high, and there have been no treatment failures, which are defined as loss of viral suppression. Additionally, the CD4 counts of the participants continue to rise. Most importantly, no new cases of lenacapavir resistance have been seen. Earlier in the study, there were about 14 cases of lenacapavir-associated resistance.[2] This was attributed to issues such as non-adherence and an ineffective optimized background regimen (OBR). Lenacapavir is taken in addition to other antiviral medication. For lenacapavir to succeed, patients must maintain an effective OBR that works with their bodies. A patient’s OBR is based on their treatment history and other clinical test results involving resistance and pharmacological concerns. The best chance of success with any drug added to a failed regimen is an effective OBR.[4]

Photo Source: aidsmap

The significance of the success of lenacapavir is that it is a long-acting injectable that is only administered twice a year. There are two other medications approved to help those living with multi-drug HIV resistance: fostemsavir and ibalizumab. However, fostemasavir is a twice-daily oral pill, and ibalizumab is an injection given every two weeks.[5] The twice-daily pill has more potential for adverse drug interactions, and both two medications are more demanding in terms of the logistics of treatment adherence. Requiring a patient to keep up with two additional daily pills in a multi-drug regimen or maintaining visits to receive a bi-weekly injection is more prone to non-adherence compared to a semi-annual injection like lenacapavir.

As the CAPELLA study continues, the hope is that the results continue to be favorable. Having an effective and convenient treatment for those living with multi-drug resistance is imperative. Ongoing success with lenacapavir will also support efforts to research and invest in future long-term injectable therapies. As more long-term injectable therapies arise, their success will prove their utility to the insurance industry. Hopefully, this will result in funding innovation to enable widespread access to those in need of these life-saving drugs.

[1] Laub, G. (2024, November 20). Sustained Viral Suppression in Multidrug-Resistant HIV With Lenacapavir at 3 Years. Retrieved fromhttps://www.medpagetoday.com/meetingcoverage/idweekvideopearls/113019

[2] Mascolini, M. (2024, October 20). Lenacapavir Sustains HIV Control and Keeps Boosting CD4s Through 3 Years. Retrieved from https://www.natap.org/2024/IDWeek/IDWeek_06.htm

[3] Segal-Maurer, S., DeJesus, E., Stellbrink, H.-J., Castagna, A., Richmond, G. J., Sinclair, G. I., Siripassorn, K., Ruane, P. J., Berhe, M., Wang, H., Margot, N. A., Dvory-Sobol, H., Hyland, R. H., Brainard, D. M., Rhee, M. S., Baeten, J. M., & Molina, J.-M. (2022). Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. New England Journal of Medicine, 386(19), 1793–1803. https://doi.org/10.1056/nejmoa2115542

[4] CLinical Info HIV.GOV. (n.d.) HIV/AIDS Glossary: Optimized Background Therapy. Retrieved from https://clinicalinfo.hiv.gov/en/glossary/optimized-background-therapy-obt

[5] Cluck, D. B., Chastain, D. B., Murray, M., Durham, S. H., Chahine, E. B., Derrick, C., Dumond, J. B., Hester, E. K., Jeter, S. B., Johnson, M. D., Kilcrease, C., Kufel, W. D., Kwong, J., Ladak, A. F., Patel, N., Pérez, S. E., Poe, J. B., Bolch, C., Thomas, I., & Asiago‐Reddy, E. (2024). Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment‐experienced and/or have multidrug‐resistant HIV‐1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy. Pharmacotherapy the Journal of Human Pharmacology and Drug Therapy, 44(5), 360–382. https://doi.org/10.1002/phar.2914

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. 

Voters Put Guardrails on 340B Program, Also Aiding Reform Efforts to Ebb Abuse

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

Judges aren’t the only ones putting guardrails on the 340B Drug Pricing Program. On November 5th, 2024, voters in the state of California passed Proposition 34 (Prop 34), enacting the Protect Patients Now Act (2024; PPNA) by a margin of 50.9% to 49.1% (California Secretary of State, 2024c). The PPNA, which goes into effect on January 1st, 2025, requires covered entities who receive revenues through the 340B drug pricing program to “…spend at least 98 percent of their net revenues generated in this state through the discount prescription drug program on direct patient care” (CSOS, 2024b).

Photo Source: The Real Deal

The issue of using 340B-related revenues for purposes other than their original intent has been one that has stoked calls for reform, particularly considering ADAP Advocacy’s 2024 report highlighting how 340B-eligible covered entities—particularly hospitals—have seen significant increases in revenue accompanied by significant decreases in at-cost charity care provision. Overall, hospitals receiving 340B revenues saw average revenues increases of 217% after becoming eligible for the 340B Program while decreasing charity care provision as a percentage of annual revenues by an average of 15%. HIV organizations saw revenue increases averaging 2,095% after becoming eligible for the 340B program (Hopkins, Macsata, & Laws, 2024).

The California Chronic Care Coalition's (CCCC) President and CEO, Elizabeth Helms, explained her organization's support of Prop 34 prior to the election to The Sacramento Observer, "We are patient-centric. We care that people are able to access the care that they need, including their medications, seeing physicians. And when we see that not happening, or we start hearing it from the field that (people are) having problems, (people) can’t do this, (people) can’t afford this, (people) can’t get timely care; you know, (people are) having to choose food over medicine or all these other things. Proposition 34 is important. Especially to people who need care, who can’t get it” (Henderson, 2018).

The text of Prop 34 was very specific in its justification for passing the amendment:

...some safety net health care providers have manipulated the program to receive enormous markups on the discounted prescription drugs they receive and then stick taxpayers with the added cost. Instead of using this massive windfall to help patients, the worst offenders have used their fortunes to purchase luxury coastal condominiums, wasted hundreds of millions of dollars on failed political campaigns, put elected politicians on their payrolls, and acquired low-income multifamily housing complexes that are operated as slums (CSOS, 2024b).

Proposition 34 has many layers. It is an attempt to codify the current statewide negotiation of Medi-Cal drug prices in addition to being a roadmap to prevent potentially bad actors from abusing net revenues received from the 340B Program. In 2019, Governor Gavin Newsome issued Executive Order N-01-19, which required the California Department of Health Care Services (DHCS) to migrate all Medi-Cal pharmacy services from managed care (MC) to fee-for-service (FFS) (Dept. of Health Care Services, n.d.). In addition to strengthening the state’s negotiation buying power, the order standardizes pharmacy benefits throughout the entire state, and greatly improves access to Medi-Cal beneficiaries by creating a pharmacy network that includes approximately 94% of the state’s pharmacies (Dept. of Health Care Services, n.d.). Proposition 34 seeks to “permanently authorize the Medi-Cal Rx program so that its expanded patient access and continued access and cost-savings can be continued in perpetuity.”(Secretary of State, 2024). Executive orders are not permanent and can be revoked, legally challenged as being unlawful, or ended by a changing political guard. Codifying the order will ensure it lives even after the Governor is no longer in office.

Proposition 34 strikes against the exploitation of the 340B Program by requiring, what it describes as prescription drug price manipulators, to spend at least 98% of revenues generated from participation in the program on direct patient care. As part of the oversight to enforce this requirement, the entities must submit annual reports detailing their statewide and nationwide gross and net revenues obtained from the 340B Program, as well as details on how the program revenues were spent (Secretary of State, 2024).  Non-compliance results in license revocation and a ban from obtaining operating licenses for ten years. Additionally, tax exempt status is revoked for ten years, and an entity is rendered ineligible for state and local grants and contracts for ten years (Secretary of State, 2024). Moreover the proposition grants several state departments the authority to standardize the specifics of the accounting reporting requirements (Secretary of State, 2024). This ensures that entities cannot obscure their numbers.

The controversy that has surrounded Proposition 34 is due to its very specific definition of ‘prescription price manipulator’. The proposition describes such an entity as one the fulfills all of the following requirements: it utilizes the 340B Program to obtain medication, has spent more than $100 million on non-direct patient care activities during any ten-year period, and is currently or has a history of owning and operating highly dangerous multifamily dwellings (Secretary of State, 2024). Additionally, said entity meets one of the following criteria: has had a license to provide healthcare services, has currently or formerly contracted with the Centers for Medicare and Medicaid Services (CMS) as a Medicare special needs plan, or presently or in the past has had a license to operate as a clinic or a pharmacy”(Secretary of State, 2024). While there are many entities who improperly utilize 340B funding, only one group seems to embody the proposition’s multifaceted assignment of characteristics – AIDS Healthcare Foundation (AHF).

AHF has faced significant scrutiny for its activities over the past three decades, particularly in states where voters are able to vote directly on laws, such as Prop 34. Most recently, AHF has come under fire for its 2017 purchase of the Madison in Los Angeles’ Skid Row for use as part of its venture into providing housing services for lower-income people. A 2023 investigation by The Los Angeles Times reported that tenants:

“…live[d] in squalid conditions with dozens under the threat of eviction. Roaches and bedbugs infest rooms. Electricity, heating and plumbing systems fail. Elevators malfunction. Code enforcement and public health complaints at foundation buildings are more than three times higher than those owned by other Skid Row nonprofits. Meanwhile, the foundation has evicted tenants over debts of just a few hundred dollars, eviction records show, while suing nearly 70 others for back rent in small claims court (Dillon, Smith, & Oreskes, 2023).”

Photo Source: The Los Angeles Times

These incidents, which resulted in a class action suit on behalf of AHF’s tenants being filed in 2020 and settled in September of this year (Wagner, 2024), along with various other lawsuits that AHF has settled over the past six years, provide the examples specifically mentioned in the Prop 34 text, above. AHF, for its part, came out vocally against Prop 34 in language that was included in the CSOS’s Quick Reference Guide:

Prop. 34—The Revenge Initiative. California Apartment Association, representing billionaire corporate landlords, doesn't care about patients. Their sole purpose is silencing AIDS Healthcare Foundation, the sponsor of the rent control initiative. 34 weaponizes the ballot, is a threat to democracy, and opens the door to attacks on any non-profit (CSOS, 2024a).

While Prop 34’s language obliquely seems to target AHF, generally speaking any alleged misuse of 340B revenues in ways that do not directly improve patients’ access to healthcare services and medication is an issue that ADAP Advocacy has reported on for over a decade. While AHF qualifies for the 340B Drug Pricing Program as a HIV healthcare provider, other types of covered entities—providers and pharmacies that qualify to purchase medications at significant discounts, dispense them to outpatients, and receive revenues in the form of rebates for the difference between the purchase price and the list price—including major hospitals and hospital systems, are facing calls to be more forthcoming with information about the amount they receive in 340B revenues and how those revenues are spent.

Summarized ADAP Advocacy's CEO, Brandon M. Macsata, "Matthew 26:52's proverb, 'Live by the sword, die by the sword', best characterizes what happened in California on November 5th. For the last decade, AHF has routinely played Russian roulette with ballot initiatives to advance its interests in California and Ohio, even ones that had nothing to do with healthcare. Ironically, even though their ballot initiative strategy is marked by loss after loss, in the end they got beat at their own game."

It is unclear from the Prop 34 text whether or not the prop’s sponsors intended for other types of covered entities to be subject to the law, as hospitals and other types of covered entities are not required under federal law to report 340B revenues in their annual tax filings. The text of Prop 34 requires any “prescription drug price manipulators” that hold tax exempt status, a pharmacy license, a health care service plan license, or a clinic license to comply with the PPNA. In order to comply with the PPNA, covered entities must submit an annual detailed accounting of both its California statewide and nationwide gross and net 340B revenues for the prior year. If an entity falls out of compliance, they are subject to the following penalties:

(a) Any and all California pharmacy licenses, health care service plan licenses, or clinic licenses held by the prescription drug price manipulator shall be permanently revoked. 

(b) The prescription drug price manipulator shall be prohibited from applying for, or obtaining or possessing, a California pharmacy license, health care service plan license, or clinic license for a period of 10 years.

(c) Any person serving as an owner, chief executive officer, chief financial officer, chief administrative officer, chief operating officer, president, or any other similar position exercising significant influence or control over the prescription drug price manipulator at the time the violation of Section 14124.44 occurred shall be prohibited from serving as an owner, officer, director, or employee of a California licensed pharmacy for a period of 10 years.

(d) The prescription drug price manipulator shall lose, and no longer be eligible for, tax-exempt status in the State of California […] and shall instead be subject to the Revenue and Taxation Code and other state laws as a taxable organization. The prescription drug price manipulator shall be prohibited from reapplying for, or again being granted, tax-exempt status in this state for a period of 10 years.

(e) The prescription drug price manipulator shall be ineligible to receive any new or renewed state or local grants or contracts for a period of 10 years (CSOS, 2024b).

The big question in all of this well be whether or not any of this can—or rather, will—be enforced. While the California proposition system provides voters with great opportunities to directly impact the laws under which they live and work, bring a proposition to the ballot is an expensive exercise that is always funded (and opposed) by large financial interests.

Photo Source: The Sacramento Bee

In addition to opposition by AHF, Prop 34 was opposed by the National Organization for Women, Consumer Watchdog, Coalition for Economic Survival, CA Democratic Parry Renters Council, Dolores Huerta Foundation, Unite HERE Local 11, and the Monterey County Renters United (No on 34, 2024). In the effort of full disclosure, ADAP Advocacy was one of the organizations that came out in favor of Prop 34, as well as 25 other organizations and 12 news organizations (Yes on Prop 34, 2024).

Jen Laws, President and CEO of the Community Access National Network (CANN) reflected, "CANN supported Prop 34 because it aligned with the original intent of the 340B statute – serving patients. 340B revenues should never be used to further political initiatives or programs that leave patients behind with regard to comprehensive care."

The PPNA will, if fully enforced, be one of the broadest and strictest state-level attempts to overhaul and regulate how 340B revenues are used. ADAP Advocacy will continue to monitor the impacts of Prop 34 as it is implemented.

References:

Cadelago, C. (2023, August 30). California proposal would sideline a prolific ballot measure player. Politico: News. https://www.politico.com/news/2023/08/30/california-proposal-ballot-measure-00113475

California Secretary of State. (2024a). Quick Reference Guide, Prop 34. California Secretary of State: California General Election. https://voterguide.sos.ca.gov/quick-reference-guide/34.htm

California Secretary of State. (2024b, November 05). General Election Voter Information Guide - Proposition 34 Text of Proposed Laws. California Secretary of State: California General Election. https://vig.cdn.sos.ca.gov/2024/general/pdf/prop34-text-proposed-laws.pdf

California Secretary of State. (2024c, November 10). State Ballot Measures - Statewide Results. California Secretary of State: California General Election. https://electionresults.sos.ca.gov/returns/ballot-measures

Dillon, L., Smith, D., & Oreskes, B. (2023, November 16). Inside the world's largest AIDS charity's troubled move into homeless housing. Los Angeles Times. https://www.yahoo.com/news/inside-worlds-largest-aids-charitys-110010062.html

Department of Health Care Services. (n.d). Medi-Cal Rx. Retrieved from https://www.dhcs.ca.gov/provgovpart/pharmacy/Pages/Medi-CalRX.aspx

Henderson, Edward (2024, September 18). On Your November Ballot: Prop 34 Aims to Expand Medi-Cal Prescription Drug Funding — With Restrictions. CBM Newswire - The Sacramento Observer. https://sacobserver.com/2024/09/on-your-november-ballot-prop-34-aims-to-expand-medi-cal-prescription-drug-funding-with-restrictions/

Hopkins, M. J., Macsata, B. M., & Laws, J. (2024, July). The 340B Drug Rebate Program and its potential impacts on annual revenues, executive compensation, and charity care provision in eligible covered entities. Nags Head, NC: ADAP Advocacy. https://www.adapadvocacy.org/pdf-docs/2024_ADAP_RW_340B_Project_Asset_6_ExecComp_FInal_Report_06-05-24.pdf

Secretary of State. (2024). Text of Proposed Laws. Retrieved from https://vig.cdn.sos.ca.gov/2024/general/pdf/prop34-text-proposed-laws.pdf

Wagner, D. (2024, September 16). AIDS Healthcare settles. The Brief: News. https://laist.com/brief/news/housing-homelessness/los-angeles-aids-healthcare-foundation-michael-weinstein-madison-hotel-settlement-rent-control-proposition-prop-33

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. 

Courts Put Guardrails on 340B Program, Aiding Reform Efforts to Ebb Abuse

By: Ranier Simons, ADAP Blog Guest Contributor

Since 1992, the 340B Drug Pricing Program has enabled eligible health care providers, referred to as covered entities, “to stretch scarce federal resources to reach more eligible patients or provide more comprehensive services.”[1] One of the most notable characteristics of the program is that it is not funded by the government. Since it requires drug manufacturers to sell medications to eligible entities at steep discounts, in essence, it is a legally mandated reallocation of financial resources from private industry to providers. As such, abuses of the program are especially egregious. The vast growth of the 340B Program over time has led to increased abuses in it as big hospital systems and mega service providers sought to enhance their profits over serving vulnerable patient populations. A tug-of-war among varied interests has generated many legal challenges in attempts at 340B reform. Recently, the pharmaceutical industry has achieved wins in its favor.

Photo Source: PharmaLive | Biospace

In May of this year, D.C. Circuit Court of Appeals ruled in favor of Novartis and United Therapeutics. Both companies separately sued the Health Resources and Services Administration (HRSA), which is the federal agency charged with overseeing the program. HRSA sent oversight enforcement letters stating the pharmaceutical manufacturers were in violation of the 340B statute because they imposed new restrictions on covered entities and limited their number of contract pharmacies.[2] The manufacturers had issued conditions on the usage of contract pharmacies 340B qualified entities utilized to purchase drugs they sold. Some of the conditions included requiring covered entities with in-house pharmacies to use those pharmacies to dispense 340B drugs and limiting entities without in-house pharmacies to only one contract pharmacy.[2]

HRSA claimed that the 340B statute allowed covered entities to utilize an unlimited number of contract pharmacies; thus, drug manufacturers were mandated to ship 340B drugs to wherever entities wanted. They issued enforcement letters threatening civil monetary penalties due to non-compliance.[2] The D.C. Circuit consolidated both companies' cases and ruled that the 340B statute did not explicitly forbid manufacturers from imposing conditions on the distribution of covered drugs to covered entities.[2] Additionally, the court quashed HRSA’s enforcement letters, stating that they were arbitrary and capricious under the Administrative Procedure Act (APA).[2] Thus, the manufacturers can continue to impose conditions.

Pharmaceutical companies have instituted conditions on contract pharmacies as one way to fight against abuses of the 340B program. Mounting evidence has demonstrated too many bad actors are taking advantage of the program, increasing profit instead of using the proceeds to benefit patients. Some hospitals have purchased 340B drugs and then sold them at full price or more to affluent, fully insured patients as well as uninsured patients.[3] This harms uninsured and vulnerable populations, cutting access when they cannot afford the pricing instead of helping those the program was meant to help. Another abuse is entities prescribing higher-cost medications when effective lower-cost drugs are available for the sole purpose of maximizing profit from the 340B discount spread.[4] Abuses like these are possible because the law in its present state does not specify drug discounts remain reserved only for those who are needy.[3] This is why manufacturers are trying to limit distribution to entities and pharmacies directly benefiting needy patients.

Photo Source: Fierce Healthcare

There is fierce opposition to the growing chorus calling for reforms to the 340B Program, that is actually anti-reform. Those fighting against 340B reform posit that those in support of 340B reform are attempting to gut the program and save themselves money by reducing the number of drugs they are discounting. The reality is the anti-reform movement is more concerned over what is seemingly an unlimited ATM with few strings attached, if any. For example, the American Hospital Association wrote a letter against H.R. 8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act.[5] The act does several things, including creating updated eligibility requirements ensuring that authentic safety-net providers serving needy, underserved populations are the only entities benefiting from the program. It also establishes that federal grantees and their contract pharmacies must provide affordability assistance policies that ensure patients are not denied access to 340B medicines based on their ability to pay.[6]

The well-resourced forces who are against 340B reform are against it because reform prevents them from utilizing the 340B Program revenues as cash flows to expand services, acquire practices, and engage in other ventures that are not focused on safety-net population medical care. In June of this year, a study conducted as a combined effort of Appalachian Learning Initiative, ADAP Advocacy, and Community Access National Network highlights how large organizations use 340B funds.[7] The full text of the report can be found, here. 

One of the most notable findings involves CEO compensation. The study examined data on the entities studied, showing changes in activity before and after obtaining 340B eligibility. It was found that executive compensation increased by an average of 231.51%, and the provision of charity care as a percentage of annual hospital revenues decreased by 14.79%.[7] Additionally, they found that the overall yearly revenues of the entities studied increased by an average of 824.32%.[7] This would indicate that as revenues increased, the level of spending on charity care decreased. Charity care is not the only avenue available to covered entities to support their poor and underserved populations. However, if the purpose of the 340B program is to generate revenues to help those in need, one would expect to see an increase in charity care.

Photo Source: Drug Channels Institute | iStock Photos

The recent court ruling by the D.C. Court of Appeals, and other ones, is finally putting some guardrails on the 340B Program, which has ballooned to a record $66.3 billion in 2023.[8] In his recent analysis of the program’s growth, Dr. Adam J. Fein with the Drug Channels Institute summarized, “Lobbyists claim that manufacturers’ 340B contract pharmacy changes are 'stripping billions of dollars from the healthcare safety net.' But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.”[8]

Whether it's using 340B eligibility to expand into financially prosperous communities for profit, structuring operations to maintain the bare minimum share of low-income patients required for 340B qualification, or other questionable actions, there is a demonstrated need for 340B reform.[9] The recent wins in the name of 340B reform achieved by pharmaceutical companies are steps in the right direction. Nevertheless, it is imperative that ongoing reform efforts reach a harmonious balance of weeding out bad actors, stabilizing the finances of covered entities acting in the best interests of their patient populations, and ensuring that pharmaceutical companies can continue to contribute without worrying about adverse effects to their operational finances.

[1] Health Resources & Services Administration. (2021). 340B drug pricing program. Retrieved from https://www.hrsa.gov/opa/index.html

[2] Grimm, D., Hethcoat, G., Trunk, S. (2024, June 27). The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court. Retrieved from https://www.jdsupra.com/legalnews/the-340b-saga-continued-hrsa-states-and-9025687/

[3] Center for Medicine in the Public Interest. (2022, September 12). New Report Demonstrates How Hospitals, Pharmacies & PBMs Exploit the Federal 340B Drug Program to the Harm of Disadvantaged Patients

[4] Pitts, P., Popovian, R. (2022, September). 340B and the Warped Rhetoric of Healthcare Compassion. Retrieved from https://www.fdli.org/2022/09/340b-and-the-warped-rhetoric-of-healthcare-compassion/

[5] Hughes, S. (2024, July 26). AHA Comments Opposing the 340B ACCESS Act (H.R. 8574). Retrieved from https://www.aha.org/lettercomment/2024-07-26-aha-comments-opposing-340b-access-act-hr-8574

[6] ASAP340B. (2024, May 28). ASAP 340B Applauds Introduction of the 340B ACCESS Act. Retrieved from  https://www.asap340b.org/post/asap-340b-applauds-introduction-of-the-340b-access-act

[7] Hopkins, M. J., Macsata, B. M., & Laws, J. (2024, July). The 340B Drug Rebate Program and its potential impacts on annual revenues, executive compensation, and charity care provision in eligible covered entities. Nags Head, NC: ADAP Advocacy.

[8] Fein, Ph.D, Adam J. (2024, October 22) The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions. Drug Channels. Retrieved from https://www.drugchannels.net/2024/10/the-340b-program-reached-66-billion-in.html

[9] DiGiorgio, A. M., & Winegarden, W. (2024). Reforming 340B to Serve the Interests of Patients, Not Institutions. JAMA Health Forum, 5(7), e241356–e241356. https://doi.org/10.1001/jamahealthforum.2024.1356

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.