Older Adults, Long-term Survivors, and Life-term Survivors in the Ryan White HIV/AIDS Program

By: Ranier Simons, ADAP Blog Guest Contributor

The lived experience of aging can be challenging. Those aging while living with HIV experience additional challenges as compared to the general population. According to the Centers for Disease Control & Prevention (CDC), in 2021, over 53 percent of people living with HIV/AIDS (PLWHA) were 50 years old or older.[1] In 2022, 48.2 percent of the 560,000 clients served by the Ryan White HIV/AIDS Program (RWHAP) were aged 50 or older.[2] As such, Health Resources & Services Administration (HRSA) recently issued a letter to RWHAP colleagues to not only bring awareness of the aging issues they should be addressing but also provide guidance and resources to help them more effectively serve the complex needs of aging PLWHA.

Photo Source: TargetHIV

As David “Jax” Kelly, President of Let’s Kick ASS (AIDS Survivor Syndrome) Palm Springs and Founder & CEO of the Aging and HIV Institute, points out, “The community aging with HIV consists of two distinct groups long-term survivors who have been living with HIV prior to 1995, and those who are over 50 and have been living with HIV after the discovery of the "cocktail" – antiretroviral medications that changed HIV/AIDS to a chronic condition rather than a diagnosis of imminent death.” According to Kelly, this aging cohort has specific medical, psychosocial, and support needs. The fact that more PLWHA are living longer increases the urgency of bolstering the infrastructure of HIV aging services.

Just like the general population, aging PLWHA experience age-related medical issues. However, older PLWHA have a higher prevalence of non-HIV comorbidities.[3] Thus, managing multiple morbidities and polypharmacy is a challenge.[3] Numerous medical issues mean treatment with multiple medications. The difficulty of navigating the medical aspects of multiple maladies is compounded by having to monitor drug-drug interactions of non-HIV-related medications with antiretroviral therapies. In addition to prescription drugs, older PLWHA may be taking over-the-counter medicines like pain relievers and supplements.[4] Studies also show that PLWHA develop age-related non-HIV medical issues earlier than the aging general population.[5] Some of the non-HIV-related conditions with higher prevalence among PLWHA are hypertension, kidney disease, dyslipidemia, and anemia.[5] One of the possible causes of higher rates of comorbidities is the side effects of long-term ART experienced by long-term survivors. 

Aging PLWHA also have specific psychosocial needs. According to Kelly, “Long-term survivors who experienced the trauma of the AIDS plague years when life expectancy was sometimes merely a few months are experiencing another wave of loss that may trigger survivor's guilt.” Social isolation is also an issue.[6] It is a challenge for the general population, but it can be extra challenging for PLWHA; especially those who may be LGBTQ. Aging PLWHA who happen to be LGBTQ have sometimes lost friends and people they consider chosen families. Due to ageism, sexism, racism, and homophobia, they live in self-isolation and are isolated, given that society does not place any priorities on ensuring their comfortable existence. 

Depression from physical and social isolation is not the only serious mental challenge aging PLWHA struggle with. Aging, in general, can sometimes bring on a bit of mental decline. However, cognitive impairment due to HIV-associated neurocognitive disorder (HAND) is also a known complication of HIV.[7] HAND can cause difficulty with concentration and memory, irritability, and motor skills issues.[7] In late, untreated stages, it can cause dementia. Psychosocial challenges and mental decline not only result in poor mental health but are barriers to maintaining medication adherence or achieving a high level of personal care.

Support is an area where much improvement is needed. The aging PLWHA population is diverse. People in their 50s, 60s, 70s, and up have different and dynamic needs. HIV care and geriatric care are siloed and not well coordinated. A technical expert panel put together by HRSA reported that in the U.S., primary care practitioners are not skilled in geriatric care, and geriatric practitioners are not skilled in HIV care.[8] It is imperative to have coordinated care efforts that are efficient, effective, and sustainable to encompass all the needs of aging PLWHA. 

Photo Source: HRSA | Flickr

Additionally, there are shortages of geriatricians, and many primary care practitioners don’t have the time to adequately address the needs of and perform the screenings needed for aging PLWHA.[8] HIV stigma and ageism, unfortunately, exist in the medical environment as well. Many clinicians, especially younger professionals, underestimate the mental and cognitive abilities of older PLWHA and don’t view them as sexual beings. Lacking knowledge and training of what it means to age with HIV results in not performing necessary medical screenings, overlooking thorough holistic needs assessments, and even inadequate tracking of health outcomes.

HRSA understands the interdisciplinary, multifaceted approach needed to effectively serve aging PLWHA. That is why the “Dear Colleague” letter was written. The letter references many tools and knowledge sources for RWHAP recipients to utilize. 

First and foremost, the letter reminds them that it is acceptable to use RWHAP funds to support aging PLWHA across various HRSA RWHAP core medical and support service categories.[2] However, HRSA is aware that there are some needs aging PLWHA have that RWHAP funds cannot directly address. For example, long-term care is not an allowable expense through RWHAP. To that end, HRSA refers RWHAP colleagues to connect with the Administration for Community Living’s (ACL) aging network grantees.[2] These community centers offer many services to help address holistic needs, such as transportation, housing, caregiver support, insurance counseling, and nutrition services.[2]

HRSA also provides reference and training materials to inform RWHAP recipients on ways to improve service delivery and structure their organizations. These are available through TargetHIV.org and the RWHAP AIDS Education and Training Center (AETC) Program’s National Coordinating Resource Center website.[2] A couple of these reference guides are: ‘Incorporating New Elements of Care’ and ‘Putting Together the Best Healthcare Team.’ Those two guides help identify screen assessments, screenings, and social needs of aging PLWHA, as well as guidance on how to effectively staff teams and build capacity.[9]

HRSA’s commitment to support the RWHAP is truly beneficial to the success of the programming. Tez Anderson, President & Founder, Let’s Kick ASS (AIDS Survivor Syndrome), expressed these sentiments regarding HRSA’s efforts: “As an advocate and someone living with HIV for over 40 years, I’m pleased HRSA is shining a light on the Ryan White Cares services available for the large and diverse cohort of older adults living with HIV and long-term survivors. As a group, we all have unique needs, and the priority must be to improve our quality of life. For those of us who have lived over half our lives with HIV, we agree living longer is a fantastic achievement, but living better is where hope lives.”

[1] NIH Office of AIDS Research. (2024, March 12). HIV and Older People. Retrieved from https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-older-people

[2] Cheever, L. (2024, August 16). Dear Colleague Letter on Older Adults, Long-term Survivors, and Life-term Survivors in the Ryan White HIV/AIDS Program. Retrieved from https://paetc.org/resources/dear-colleague-letter-on-older-adults-long-term-survivors-and-life-term-survivors-in-the-ryan-white-hiv-aids-program/

[3] Kong, A. M., Pozen, A., Anastos, K., Kelvin, E. A., & Nash, D. (2019). Non-HIV Comorbid Conditions and Polypharmacy Among People Living with HIV Age 65 or Older Compared with HIV-Negative Individuals Aged 65 or Older in the United States: A Retrospective Claims-Based Analysis. AIDS patient care and STDs, 33(3), 93–103. https://doi.org/10.1089/apc.2018.0190

[4] NIH Office of AIDS Research. (2019, December 18). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-hiv-and-older

[5] Schouten, J., Wit, F. W., Stolte, I. G., Kootstra, N. A., van der Valk, M., Geerlings, S. E., Prins, M., Reiss, P., & AGEhIV Cohort Study Group (2014). Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, 59(12), 1787–1797. https://doi.org/10.1093/cid/ciu701

[6] HRSA. (n.d.) Optimizing HIV Care for People Aging with HIV:  Incorporating New Elements of Care Reference Guide for Aging with HIV. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/aging-guide-new-elements.pdf

[7] Eggers, C., Arendt, G., Hahn, K., Husstedt, I. W., Maschke, M., Neuen-Jacob, E., Obermann, M., Rosenkranz, T., Schielke, E., Straube, E., & German Association of Neuro-AIDS und Neuro-Infectiology (DGNANI) (2017). HIV-1-associated neurocognitive disorder: epidemiology, pathogenesis, diagnosis, and treatment. Journal of Neurology, 264(8), 1715–1727. https://doi.org/10.1007/s00415-017-8503-2

[8] HRSA. (n.d.). Addressing the Health Care and Social Support Needs of People Aging with HIV: Technical Expert Panel Executive Summary. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/resources/hrsa-aging-tep-summary.pdf

[9] HRSA. (2022, February). Clinical Care Guidelines and Resources. Retrieved from https://ryanwhite.hrsa.gov/grants/clinical-care-guidelines-resources

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.  

HRSA Offers Guidance on Doxy-PEP to Stem the Tide of Rising STIs Among PLWHAs

By: Ranier Simons, ADAP Blog Guest Contributor

According to the Centers for Disease Control & Prevention (CDC), there were 2.5 million reported cases of gonorrhea, chlamydia, and syphilis in the United States in 2022.[1] The rates of sexually transmitted diseases (STIs) have been increasing globally, which is of particular concern for people living with HIV/AIDS (PLWHA). One strategy that is proving highly successful in combatting the spread of STIs is Doxy-PEP (post exposure prophylaxis).

Photo Source: The Washington Post

The presence of HIV in the body can, in some cases, make it harder to treat STIs.[2] Additionally, an STI can increase the HIV viral load in PLWHA who are not on treatment regimens.[3] For those with good antiretroviral adherence, an STI is not likely to change someone from undetectable to detectable. However, the numerous harms STIs inflict on the body make it essential to reduce STIs' impact on PLWHA. The Health Resources & Services Administration (HRSA) recently issued a letter to Ryan White HIV/AIDS Program (RWHAP) colleagues emphasizing their role in lowering the risk of STIs for PLWHA, as well as awareness of new clinical guidelines on the use of doxy PEP in preventing bacterial STIs.[4]

Doxy-PEP is the administration of 200 mg of doxycycline within 24-72 hours of condomless anal, vaginal, or oral sex and should not exceed a maximum of 200mg in any 24hr period.[5] Studies have shown that Doxy-PEP reduces syphilis and chlamydia infections by more than 70% and gonococcal infections by approximately 50%.[5]

Men who have sex with men (MSM) and transgender women (TGW) have been identified as groups disproportionately affected by STIs. Thus, CDC guidelines recommend that medical professionals target MSM and TGW who have had a bacterial STI in the past twelve months to offer education and counseling on the benefits of Doxy-PEP. After counseling and education, if desired, providers should provide prescriptions for Doxy-PEP to be self-administered.[5]

Photo Source: The PrEP Clinic

HRSA’s letter specifically encourages RWHAP recipients to adopt the CDC guidelines and integrate Doxy-PEP into their protocols and clinical programs. The letter also urges state AIDS Drug Assistance Programs (ADAPs) to add Doxy-PEP to their drug formularies to facilitate equitable access and coverage for their eligible populations. In case they are unaware, HRSA reminds RWHAP colleagues that purchasing Doxy-PEP is an allowable cost. “RWHAP Parts A, C, and D recipients may contribute RWHAP funds to ADAPs to purchase medications and/or health care coverage and medication cost sharing for ADAP-eligible clients.”[4]

Proper administration of Doxy-PEP requires STI testing every three to six months, as well as evaluation of the appropriateness of continued utilization of doxy PEP.[5] Increasing the number of those utilizing the antibiotic intervention will also increase the instances of contact with care professionals. Increased contact means more opportunities for strengthening linkages to care and exploration of other points of need. One of the main goals of RWHAP is to improve the health outcomes of PLWHA. Adoption of Doxy-PEP practices and protocols would be another tool to add to comprehensive whole-person care along with established practices such as harm-reduction and risk-reduction counseling, facilitating access to PrEP, and regular STI testing.

Photo Source: The PrEP Clinic

Notably, HRSA’s letter highlighted the RWHAP Part F's AIDS Education and Training Center (AETC) Program and the RWHAP Part F Special Projects of National Significance Addressing STIs: “Ask. Test. Treat. Repeat.” Initiative.[6,7] Both programs provide training and information on the proper implementation of Doxy-PEP and ways to adopt and normalize routine testing of STIs. This letter from HRSAs HIV/AIDS Bureau is more than just an F.Y.I. It is a tangible outreach of support for RWHAP colleagues. 

Ryan White-funded organizations work tirelessly to stretch federal dollars to improve the health and well-being of the vulnerable populations of PLWHA they serve. Clear guidance on Doxy-PEP and the proliferation of educational resources directly acknowledges that the federal government is an active partner with and sees and embraces the efforts of RWHAP recipients.

[1] CDC. (2024, January 30). CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority. Retrieved from https://www.cdc.gov/std/statistics/2022/default.htm

[2] U.S. Department of Health & Human Services. (2024, June 27). Sexually Transmitted Infections. Retrieved from https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/sexually-transmitted-diseases#:~:text=Many%20STIs%20do%20not%20have,if%20you're%20sexually%20active.

[3] Stanford, A. (2023, September). Undetectable viral load and HIV transmission. Retrieved from https://www.aidsmap.com/about-hiv/undetectable-viral-load-and-hiv-transmission

[4] HRSA. (2024, July 31). Letter to Ryan White HIV/AIDS Program Colleagues. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hab-doxy-pep-clinical-guideline-bacterial-sti-prevention.pdf

[5] CDC. (2024, June 6). CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. Retrieved from https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm

[6] AIDS Education and Training Center Program. https://aidsetc.org/topic/sexually-transmitted-infections

[7] TargeyHIV.org. (2024). Addressing STIs: Ask. Test. Treat. Repeat. https://targethiv.org/intervention/addressing-stis-ask-test-treat-repeat?utm_source=bpURL

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.  

340B Program Cash Cow for Covered Entities and Their CEOs, Report Finds

By: Brandon M. Macsata, CEO, ADAP Advocacy; Marcus J. Hopkins, Executive Director, Appalachian Learning Initiative

In 2023, ADAP Advocacy, along with the Community Access National Network (CANN), launched a project to examine the potential impacts of the 340B Drug Pricing Program (340B Program) on the annual revenues, chief executive salaries, and charity care expenditures of covered entities. Specifically, we sought to examine whether eligibility for the 340B program was correlated with statistically significant increases in annual revenues and whether executive compensation for company presidents and Chief Executive Officers (CEOs) for all covered entity types and charity care provision for hospital entities saw commensurate increases. The report – “The 340B Drug Pricing Program and its Potential Impacts on Annual Revenues, Executive Compensation, and Charity Care Provision in Eligible Covered Entities” – found that annual revenues increased by an average of 824.32%, and executive compensation increased by an average of 231.51%.

The compensation of healthcare executives has been a topic of growing concern and worker outrage, particularly since the COVID-19 pandemic demonstrated both the irreplaceable value of and the poor compensation of healthcare workers (Saini, Garber, & Brownlee, 2022). Research from the North Carolina State Health Plan for Teachers and State Employees, Rice University’s Baker School for Public Policy, and Johns Hopkins University’s Bloomberg School of Public Health found that CEO pay has climbed significantly in the state of North Carolina while nurse pay has largely stagnated (North Carolina State Health Plan for Teachers and State Employees, 2023). This, their report posits, is because hospital CEO salaries are largely based upon their abilities to increase hospital revenues while simultaneously cutting costs in ways that both threaten patient safety and decrease the affordability of care (Scott, 2023).

In 2021, in the midst of the COVID-19 pandemic, former Democratic Congressman Tim Ryan (Ohio 13), expressed what most American workers and patients struggling to pay their medical bills feel:

“In the late ‘70s, a CEO made 35x the worker; today, it’s 300-400x the worker.”
(Forbes Breaking News, 2021)

Photo Source: Forbes Breaking News

In fewer places is this truer than in the healthcare industry. According to the U.S. Bureau of Labor Statistics, Licensed Practical and Licensed Vocational Nurse salaries average $59,730/year, while Registered Nurses average $86,070/year (U.S. BLS, 2024). Comparatively, the average CEO compensation for the 38 hospitals we examined was $1,141,973.29—180.1% higher than an LPN and 172% higher than an RN.

The explosive growth in the 340B Program has been painstakingly documented over the years by Dr. Adam Fein with Drug Channels. In September 2023, Drug Channels’ headline read, EXCLUSIVE: The 340B Program Reached $54 Billion in 2022—Up 22% vs. 2021. Fein, whose well-known call sign is “I ♥ DATA”, noted the following: “Every 340B covered entity type experienced double-digit growth, despite drug prices that grew more slowly than overall inflation.”

This process involved identifying different covered entities, checking the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs Information System (OPAIS) to determine the dates when each entity became eligible for the 340B program, and then using ProPublica’s Nonprofit Explorer to access publicly available federal 990 filings for each of the covered entities, looking at filings for the year prior to eligibility, the year after eligibility, five years after, ten years after, and the most recent year on record.

It is first important to define what ADAP Advocacy’s findings do and do not suggest:

1. ADAP Advocacy’s findings make no implications of impropriety against any of the entities whose filings were examined. Rather, the research was designed to determine whether or not eligibility for the 340B drug rebate program had any positive or negative impacts, either directly or indirectly, on annual revenues, on executive compensation, and, for hospital entities, whether or not increases or decreases in annual revenues were met with comparable increases or decreases in the percentage of charity care provided to lower-income patients.

2. ADAP Advocacy’s research makes no claims about the use, misuse, or abuse of 340B revenues by any covered entities.

3. ADAP Advocacy’s research does not claim that increases in executive compensation are the result of any impropriety; simply that those increases have occurred.

From these filings, we gathered the following information:

• Total Annual Revenue
• Annual CEO/President Compensation in U.S. Dollars
• CEO Compensation as a Percentage of Annual Revenue (i.e., what percentage of revenues were spent on CEO compensation)
• Annual Charity Care Expenditures in U.S. Dollars (for hospital entities, only)
• Charity Care Expenditures as a Percentage of Annual Revenue (i.e., how much of annual revenues are spent on the provision of charity care)

We then measured the following:

• Percentage Change in Annual Revenues from Pre-340B to Present
• Percentage Change in Annual Executive Compensation from Pre-340B to Present
• Percentage Change in Annual Charity Care as a Percentage of Annual Revenues from Pre-340B to Present
• Average Change in Annual Revenues Across Entity Types (excluding the highest and lowest outliers)
• Average Change in Annual Executive Compensation Across Entity Types (excluding the highest and lowest outliers)
• Average Change in Annual Charity Care as a Percentage of Annual Revenues Across Entity Types (excluding the highest and lowest outliers)

We examine a total of 69 covered entities, including 24 HIV Care Providers, 38 Hospitals, and 7 Other types of entities, including Federally Qualified Health Centers (FQHCs) and Comprehensive Healthcare Centers (CHCs). Our key findings include:

• Annual revenues increased by an average of 824.32% across all entity types:
• HIV Care Entities saw an average increase of 2,094.88%
• Hospitals saw an average increase of 217.09%
• Other Entity Types saw an average increase of 1,312.59%

• Executive compensation increased by an average of 231.51% across all entity types:
• HIV Care Entity executives saw an average increase in annual compensation of 282.57%
• Hospital executives saw an average increase of 206.10%
• Executives at other entities saw an average increase of 187.16%

• Charity Care as a percentage of annual revenues decreased across all hospital entity types by 14.79%

Increases in Annual Revenues

ADAP Advocacy’s findings suggest that the types of entities that the largest increases in revenues after gaining eligibility for the 340B drug rebate program tend to be those providing HIV care. This may be because of the high list prices of HIV medications which, when the rebates are supplied to HIV care providers for the difference between the list prices and the purchase prices, may result in significant revenues (Figure 1). These 340B revenues may account for a percentage of those revenue increases, though other revenue streams and the acquisition of additional locations with pharmacies may account for them, as well. 

Figure 1 - HIV Organizations with the Largest Increases in Annual Revenues After Receiving Eligibility for the 340B Drug Rebate Program 

Photo Source: ADAP Advocacy

While hospital revenues saw comparatively modest increases, this may be because many of those hospitals already had annual revenues in the hundreds-of-millions of dollars, whereas many of the HIV organizations began with revenues in the lower millions (Figure 2). Essentially, while hospitals still see increases in revenues in the multiple millions of dollars, they tend to start with far greater annual revenues than HIV care organizations making the increases in revenue proportionally smaller.

Figure 2 - Hospitals with the Largest Increases in Executive Compensation After Receiving Eligibility for the 340B Drug Rebate Program 

Photo Source: ADAP Advocacy

While increases in 340B revenues—and consequently increases in 340B revenues as a percentage of total revenues—significantly bolster the ability of HIV care providers to provide services to patients, where more clarity is needed across every entity type is in exactly how, where, and on what those 340B dollars are spent.

The 340B regulatory and enforcement landscape is such that, aside from certain types of entities being required to report the amount of 340B revenues in a specific filing period, HRSA has failed to provide specific guidelines concerning allowable expenditures using those dollars or where those dollars are reinvested (Mulligan, 2021). While the legislation itself only requires certain entity types, including HIV care providers, to spend 340B revenues according to the stipulations of their grants, hospitals are not required to utilize those revenues in any specific way or in any specific jurisdiction. This may result in expenditures that, while not technically in violation of the statutory requirements, would be largely perceived as violating the spirit of the statute. An example of this would be for a hospital system to generate 340B revenue at a Disproportionate Share Hospital—one that serves a disproportionately large share of lower-income patients and receives payments from the Centers for Medicaid and Medicare Services (CMS) to cover the cost of providing care to uninsured patients—and then utilizing those revenues by building new facilities, upgrading existing facilities, or expanding services in areas that serve primarily higher-income populations.

Increases in Executive Compensation

When examining the compensation of covered entities’ presidents and CEOs, ADAP Advocacy found that their compensation increased by an average of 231.51% across all entity types, with executives at HIV care organizations seeing the highest increases in compensation, in terms of a percentage of growth, at an average of 282.57%. Two organizations—Equitas Health, Inc. and CAN Community Health—saw CEO compensation increase by 1,380.79% and 1,088.94%, respectively (Figure 3). These increases resulted in both CEOs receiving more than $1 million dollars in compensation, significantly higher than any of the other 22 HIV care organizations we examined.

Figure 3 – HIV Organizations with the Largest Increases in Executive Compensation After Receiving Eligibility for the 340B Drug Rebate Program

Photo Source: ADAP Advocacy

By comparison, executive compensation rose at the hospitals ADAP Advocacy examined by an average of 206.10%, with the highest increases in compensation occurring at Yale New Haven Hospital and Sutter Valley Hospitals, at 1,421.15% and 1,133.42%, respectively (Figure 4). The primary differences in executive compensation levels between HIV care organizations and hospitals is that the starting size of the compensation packages are vastly different. All of the HIV care executives began with salaries below $200,000/year, while only one hospital executive’s salary started below $200,000. In fact, 25 of the 38 hospitals we examined (65.8%) had starting executive salaries above $500,000.

Figure 4 – Hospital Organizations with the Largest Increases in Executive Compensation After Receiving Eligibility for the 340B Drug Rebate Program

Photo Source: ADAP Advocacy

Decreasing Charity Care Provision

Perhaps the most stunning findings to come out of ADAP Advocacy’s research are the significant decreases in the provision of charity care or uncompensated care by hospitals at cost as a percentage of annual revenues. Of the 38 hospitals whose 990s ADAP Advocacy examined, just 9 (23.7%) reported increases in the amount of charity care they provided as a percentage of annual revenues. Of the five hospitals that saw the largest decreases in charity care, three—Cabell-Huntington Hospital, Pleasant Valley Hospitals, and Charleston Area Medical Center—are located in West Virginia, one of the most impoverished states in the nation (Figure 5). This is particularly concerning due to the fact that more than 1 out of every 4 West Virginians (28.1%) earns less than 150% of the Federal Poverty Level (American Community Survey, 2023).

Figure 5 - Decreases in the Provision of Charity Care as a Percentage of Annual Revenue in Hospitals After Receiving Eligibility for the 340B Drug Rebate Program

Photo Source: ADAP Advocacy

This raises a significant concern regarding the utilization of 340B revenues in hospitals: if the purpose of the program is to increase patient access to medications and treatments, shouldn’t the provision of charity care at cost be one of the primary mechanisms for doing so? Unfortunately, because there is no transparency regarding 340B revenues, either in the generation or spending of them, neither HRSA nor patients are able to hold hospitals accountable.

Perhaps the most salient statement about the rules regarding hospitals and 340B is this: 

“The number one rule of 340B is that there are no rules.”

Where other 340B entity types have reporting requirements, hospitals have none; where other entities are required to use funds in compliance with certain restrictions, hospitals have no such restrictions; where other entities actively risk losing their 340B eligibility for failing to comply with HRSA’s 340B requirements, hospitals face no such risk. Moreover, hospitals, their lobbyists, and their executives have openly opposed all efforts to reform the 340B program, including a 2023 bill—H. R. 3290—that proposed relatively modest changes to the program that would require transparency about revenues generated by covered entities (Southwick, 2023).

HIV care providers are equally likely to oppose 340B reform. In a statement released in September 2022, Ryan White Clinics for 340B Access (RWC-340B)—a national 501(c)(4) organization composed of over 60 organizations across 24 states that advocates against 340B reform efforts—argued that opinion pieces and “so-called ‘studies’” criticizing the 340B program in 2022 were authored almost exclusively by persons with “...have financial ties to the pharmaceutical industry, calling into question the objectivity and integrity of their work” (RWC-340B, 2022). The arguments against 340B reform from HIV care organizations tend to be grounded in the idea that any changes to the program are likely to fundamentally destroy their ability to provide services to PLWHA by reducing the size of the program and increasing scrutiny of how those revenues are reinvested to improve patient access to and utilization of care. They additionally contend that efforts to reform the 340B program are funded by pharmaceutical manufacturers that are statutorily required to participate in the program, and that anyone who receives funding from those companies is biased in favor of increasing pharmaceutical company profits.

The arguments against 340B reform pose a set of interesting questions:

• Is there room for targeted 340B reforms that focus on increasing regulations, transparency, and reporting requirements for specific types of covered entities?
• How should potential reforms be structured in order to ensure that patients reliant upon social safety net programs like the Ryan White Part B program and who receive healthcare services at Ryan White clinics are not negatively impacted?
• What are the potential downstream impacts of reforms that would specifically define how 340B revenues may be used, and which entities will be most likely to face negative impacts?
• Aside from regulatory reforms, what changes are required to grant enforcement power and regulatory oversight to HRSA that would allow them to discipline entities that fail to comply with existing 340B regulations and any other requirements that may be enacted through the reform process.

As with most issues related to the healthcare system in the United States, the answers to these questions and issues are rarely simple. Any efforts to reform programs or the healthcare system itself to benefit patients is met with stern opposition from providers who rely on certain revenue streams, payors who rely on cost containment measures to ensure profitability, and manufacturers who depend on complex reimbursement and the for-profit healthcare model to support both profitability and purported innovation. One significant change in the patient’s favor may result in the destabilization or wholesale destruction of one or more pillars of an overly complex, profit-driven model that impacts one-sixth of the American economy.

With those considerations in mind, it is important that any efforts to reform the 340B program look at the totality of impacts across all covered entity types and make reforms that will increase and improve patient access to care and treatment, rein in bad actors who abuse the 340B system, and ensure that good actors are able to access 340B revenues without increase their regulatory and reporting burdens.

This report reminds us why patients keep asking, "340B: What About Me?"

Disclosure: Phase I of this report was funded by general revenues. A complete listing of funders is available online, here. Phase II of this report was funded by revenues from its Ryan White Grantee 340B Project. This 340B Project is funded by the following corporate entities: Bristol-Myers Squibb, Genentech, Gilead Sciences, Johnson & Johnson Health Systems (Janssen Pharmaceuticals), Merck, Novartis, PhRMA, and ViiV Healthcare. The report explicitly states that ADAP Advocacy exercised full control over the implementation strategy, design, and data analysis, independent of funder influence. This independence is crucial for maintaining the objectivity and credibility of the research.

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.

Fraudsters are Using Grindr to Buy HIV Meds

By: Brandon M. Macsata, CEO, ADAP Advocacy; Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines

Earlier this year, ADAP Advocacy, in collaboration with the Partnership for Safe Medicines (PSM),  issued an important safety alert warning Grindr's users to stop selling their HIV and other medications on the popular gay dating App. Medicine buyback schemes falsely claim to be "Buyers Clubs" making medicine available to people who cannot afford them. In reality criminals buy medicine, and sometimes empty bottles, from patients and sell them at a discount to unsuspecting pharmacies who dispense it to patient victims. The safety alert urged Grindr's users to be more mindful of patient safety.

Photo Source: ADAP Advocacy

Grindr, as well as potentially other dating Apps, are being used as a platform for fake user profiles operating under counterfeit drug rings to buy prescription medications. This seemingly innocent practice is not only illegal, but it is jeopardizing the drug supply chain and putting the health of patients at risk for health complications, severe illness, and even death. It often targets high-cost drugs – because the potential profit spread is higher – often associated with the treatment of cancer, diabetes, and HIV (and others).

This is not a theoretical patient danger: over the past five years, hundreds of millions of dollars of HIV medicine has been diverted and counterfeited in the drug supply this way, resulting in some patients getting fake medicines. 

ADAP Advocacy and PSM potentially uncovered one such counterfeit drug ring in New Orleans Parish earlier this year and immediately alerted both the U.S. Food & Drug Administration, as well as Gilead Sciences. Earlier this year, Gilead Sciences uncovered a criminal enterprise centered in Florida distributing over $230 million of counterfeit drugs, some of which were their HIV antiretroviral medications.

In response to the Florida fraudsters, ADAP Advocacy and PSM aired a public service announcement sharing some important steps patients can take to combat counterfeit drugs. Additionally, PSM hosted an online briefing focused on recent breaches in the United States drug supply chain that put patients living with HIV at risk.

If you see people trying to buy medicine on dating apps, please report them to us.

• REPORT FRAUDSTERS by filling out this webform
• By emailing us at report@safemedicines.org
• By texting us at (415) 367-0067.

Additional collaboration on patient safety in the fight against counterfeit drug rings is warranted in this space. Download the safety alert, here.

Photo Source: ADAP Advocacy

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.

Facing HIV Health Disparities in Latino Communities

By: Ranier Simons, ADAP Blog Guest Contributor

While overall HIV rates in the United States have been in decline, HIV is still a present and impactful issue. This is especially true for communities that experience a higher impact of HIV-related health disparities. One of these groups is the Latino community. The Latino community is second to the Black community about bearing the HIV burden. Several challenges converge in maintaining HIV’s disproportionate impact on the Latino community, including racism, stigma, language barriers, and access. In recently reported data for 2022 by the Centers for Disease Control & Prevention (CDC) the Latino community was about 18 percent of the U.S. population, but represented 33 percent of new HIV diagnoses.[1]

Photo Source: Baton Rouge AIDS Society

According to PlusInc, which addresses health disparities in the United States, HIV disproportionately impacts Black and Hispanic/Latino Americans (according to 2019 data). PlusInc’s HIV health disparities statement notes:

"While Black and Hispanic/Latino make up just 13.4% and 18.5% of the U.S. population, respectively, Black Americans account for 40.3% and Hispanic/Latino Americans account for 24.7% of the total population of Persons Living with HIV/AIDS (PLWHA). Additionally, this disparity extends to the incidence, with 42% of new HIV diagnoses occurring in Black Americans and 27.8% in Hispanic/Latino Americans. According to the Centers for Disease Control and Prevention (CDC), 26% of new HIV diagnoses were among Black gay and bisexual Men who have Sex with Men (MSM), 23% were among Hispanic/Latino gay and bisexual MSM, and 45% among gay and bisexual MSM under the age of 35."

Access is a significant issue contributing to HIV challenges among Latinos. Latinos are the most underinsured/uninsured ethnic group in the United States.[2] Approximately 19 percent did not have health insurance in 2023, in contrast to 5.8 percent of White Americans and 8.6 percent of Black Americans.[3] Lack of health insurance means reduced access to HIV treatment and prevention, reduced or lack of primary healthcare services, or comorbidity management. Only 84 percent of the Latino community is aware of their HIV status, compared to 87 percent of the general population.[4] Of Latinos living with HIV who know their status, in 2021, only 72 percent received some kind of HIV care, 54 percent consistently remained in care, and only 64 percent were virally suppressed.[5]

Many Latinos are underinsured or uninsured due to financial barriers, language barriers, occupation, and even immigration status. In 2022, One-third of Latinos without health insurance were undocumented, and 37.7 percent were dependent upon Medicaid.[6] Some Latinos struggle to understand the healthcare system, and others do not seek out healthcare due to fear of deportation because of their immigration status. In states where they may be eligible for Medicaid, some Latinos in the process of acquiring citizenship are hesitant to apply out of fear of being deemed a public charge. However, only one-tenth of one percent of deportations result from public charge determinations.[6] Moreover, although ACA Medicaid expansion enables more adults to be covered, ten states have not expanded Medicaid, including Texas, Florida, and Georgia, which have large numbers of uninsured Latino residents.[6]

Photo Source: Axios

Two specific HIV care access challenges affecting the Latino community are PrEP and long-acting injectables. In 2021, Latinos represented 17 percent of PrEP users and 27 percent of new HIV diagnoses.[7] While PrEP could drastically improve outcomes, access barriers are high. Additionally, many Latinos living with HIV could greatly benefit from long-acting injectable treatments, such as Cabenuva, which would ameliorate adherence issues. However, it is expensive, and thus, paying for it out of pocket is impossible. Moreover, getting it covered in public assistance programs is also a challenge.

There are states, such as Texas, that do not carry Cabenuva on their drug formulary under the AIDS Drug Assistance Program (ADAP). Steven Vargas, Texas HIV advocate and long-term survivor, argues, “What I really want is for our Texas ADAP to be brought to its full potential in easing the burden of HIV on Texans.” 

Vargas offers some novel ideas to help Latinos in need, as well as all Texans access Cabenuva. One way would be for Texas to expand Medicaid since Cabenuva is covered by Medicaid. Another option would be to utilize state ADAP funds to purchase insurance for those in need. Unfortunately, presently, in Texas, that is not possible due to exaggerated concerns about costs and solvency. A policy proposal Vargas suggested involves the federal agency, Health Resources & Services Administration (HRSA). He suggests that the agency “...create a policy clarification mandating non-Medicaid expansion states to use ADAP funds to purchase health insurance for HIV-positive individuals. This would ensure more equitable access to healthcare and align with efforts to end the HIV epidemic in these intransigent states. Without such measures, the current inequities will persist, and achieving the goal of ending the HIV epidemic will remain out of reach.”

Stigma is another barrier from a policy, healthcare, and cultural perspective. Vargas points out, “Stigma is an overarching and deeply entrenched challenge significantly hindering Hispanic/Latino engagement in HIV services. Local efforts to increase community awareness and knowledge about HIV prevention and treatment are not prioritized and buried beneath the weight of stigmatizing edicts from our Governor and Texas Legislature.” A 2022 study shows that 11 percent of Latinos living with HIV reported encountering discrimination in a healthcare setting at least three times in a 12-month period.[5]

Photo Source: The Hill

Cultural stigmas and norms are also high barriers to improved HIV outcomes as well. Latino men who have sex with men accounted for the highest number of new HIV diagnoses in 2022. There is a sizeable Catholic influence in Latino culture. Thus, discussing sex and sexual health is not a widely socially acceptable norm, especially if one is gay. There is also the existence of marianismo and machismo. Marianismo is the idea that women should be subservient to men even in sexual encounters, including not wearing a condom if that is what the man desires. Machismo is the ideal that men should be masculine, dominant, and virile.[8] Social pressures and stigma cause many to be fearful of seeking out care and live secretly with their status if, they are positive. This could result in increased transmission by allowing social norms to influence decision-making when it comes to sexual health and partner selection.

Reducing the impact of HIV in the Latino community will require interventions from both policy and community perspectives. The Latino community is not monolithic. Thus, there is a need for stigma intervention that explicitly targets different groups, such as youth groups, church groups, and parent groups. One such national campaign is Celebro Mi Salud (I Celebrate My Health).[9] It is designed to normalize HIV and encourage people living with HIV to seek out care and stay in care. Policy interventions would include means to strengthen collaboration between communities and local governments. There needs to be more culturally competent and bi-lingual healthcare providers as well as those involved with helping Latinos in need navigate the challenges of poverty, food insecurity, homelessness, and immigration.

There is no single simple solution. Addressing the impact of HIV requires making people whole. A holistic approach means helping Latinos in need navigate the challenges of poverty, food insecurity, homelessness, and immigration, as well as healthcare. Providing stability with the basic needs of life facilitates making personal health a priority instead of an afterthought.

[1] CDC. (2024, May). Estimated HIV incidence and prevalence in the United States, 2018–2022. HIV Surveillance Supplemental Report 2024;29(No. 1). Retrieved from https://www.cdc.gov/hiv-data/nhss/estimated-hiv-incidence-and-prevalence.html

[2] Guilamo-Ramos, V., Thimm-Kaiser, M., Benzekri, A., Chacón, G., López, O. R., Scaccabarrozzi, L., & Rios, E. (2020). The Invisible U.S. Hispanic/Latino HIV Crisis: Addressing Gaps in the National Response. American journal of public health, 110(1), 27–31. https://doi.org/10.2105/AJPH.2019.305309

[3] Vankar, P. (2024, July 10). Percentage of people in the U.S. without health insurance by ethnicity 2010-2023. Retrieved from https://www.statista.com/statistics/200970/percentage-of-americans-without-health-insurance-by-race-ethnicity/#:~:text=Percentage%20of%20people%20in%20the,insurance%20by%20ethnicity%202010%2D2023&text=In%202023%2C%20approximately%20nineteen%20percent,national%20average%20was%209.1%20percent.

[4] Helmer, J. (2024, June 2). HIV/AIDS in Hispanic and Latino Populations. Retrieved from https://www.webmd.com/hiv-aids/hiv-aids-hispanic-latino-populations

[5] The Body. (2024, April 30). How HIV Impacts Latinos in the U.S. Retrieved from https://www.thebody.com/health/hiv-aids-latinx

[6] Smith, C. (2024, April 22). Hispanics make up nearly half the nation's uninsured. Retrieved from https://www.governing.com/health/hispanics-make-up-nearly-half-the-nations-uninsured

[7] AIDSVU. (2022, July 29). AIDSVu Releases New Data Showing Significant Inequities in PrEP Use Among Black and Hispanic Americans. Retrieved from https://aidsvu.org/news-updates/prep-use-race-ethnicity-launch-22/

[8] Nuñez, A., González, P., Talavera, G. A., Sanchez-Johnsen, L., Roesch, S. C., Davis, S. M., Arguelles, W., Womack, V. Y., Ostrovsky, N. W., Ojeda, L., Penedo, F. J., & Gallo, L. C. (2016). Machismo, Marianismo, and Negative Cognitive-Emotional Factors: Findings From the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study. Journal of Latina/o psychology, 4(4), 202–217. https://doi.org/10.1037/lat0000050

[9] HIV.GOV. 2022. Celebrao Mi Salud. Retrieved from https://www.hiv.gov/es/respuesta-federal/campanas/celebro-mi-salud

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.