Reflections from an HIV Advocate's Journey: Jonathan J. Pena

By: Jonathan J. Pena, senior in social work, North Carolina State University

Eckhart Tolle once wrote, “Acceptance looks like a passive state, but in reality it brings something entirely new into this world. That peace, a subtle energy vibration, is consciousness.”

I have traveled down many roads, like countless others, that greeted me with familiar faces who welcomed, guided, and loved me. Over time, however, the lights that illuminated these stretches of road started to dim when the darkness in the crevices of my pain and self-doubt began to grow. I traveled many miles addicted to crystal meth, distain and shame over my HIV-positive diagnosis, and with nameless strangers as a lost soul because I was always traveling but never arriving.

Today with almost four years of sobriety and the acceptance of my HIV status, I still travel down roads but now they are filled with purpose, opportunity and advocacy. In the beginning, acceptance for me did feel like a “passive state” because it was something that I couldn’t immediately measure when I was expecting a more obvious guided marker of direction. I realized that there was a value in representing myself from the standpoint of where I was in life in that current moment, which was as a non-traditional student in NYC. I was enrolled in a speech class where I decided to raise awareness about the stigma surrounding the word “clean” and in the process disclosed my own status to my classmates and professor. I felt empowered, liberated and at peace. Shortly after, I attended my first ADAP Advocacy Association conference in 2015, which greatly expanded my understanding of the challenges that HIV-positive communities can face but it also exposed me to all of the wonderful people who are involved and in the trenches fighting for change.

My time in NYC came to an end and I found myself in Raleigh, North Carolina where I was accepted in North Carolina State University. Here my journey in HIV advocacy continues. Once accepted into NCSU, I changed my major from psychology to social work and became a member of the Professional Association of Social Workers in HIV/AIDS in 2017. Also in 2017, I wrote my first blog for the ADAP Advocacy Association titled “Finding Emotional & Physical Health in Sobriety” - which goes into more detail on my journey towards self-discovery. These stepping-stones lead me to an amazing summer internship in 2018, with the ADAP Advocacy Association, where I authored a white policy paper titled, “Improving Access to Care Among Formerly Incarcerated Populations with HIV/AIDS under the AIDS Drug Assistance Program (ADAP)”. This experience was invaluable not only for the insight on how underserved this population is but also the enormous value and role that current information plays when agencies are striving to bridge the gap in accessibility while being innovative in their delivery process. So, where am I now and what have I learned?

I am senior and entering my last semester of my undergrad at NCSU. I am inline and applying for an advance standing Masters in Social Work program beginning summer of 2020. My acceptance journey has had a profound influence on my academics, how I navigate the world, and how I developed a deeper understanding of who I am. I am complicated, in all sense of the word because I am never just one thing and thus can never be defined by any singular narration. I’ve accepted this along with everything I have expressed, felt, and done but I have also grounded myself in a higher level of consciousness that guides me.  I am worth more so therefore I do more, for myself and in the near future for others in a greater capacity. There will always be a need for advocacy because I understand that its road is often paved with dim flickering lights and we as advocates, social service providers, and community healers accept the call to action that is pivotal in helping to keep those light on.



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.

Now a chronic disease, HIV is turning gray

By: Jeffrey R. Lewis

On June 5, 1981, a new public health threat reared its ugly head in the United States: five cases of Pneumocystiscarinii pneumonia (“PCP”) were reported by the Centers for Disease Control & Prevention (“CDC”) in its Morbidity & Mortality Weekly Report (“MMWR”) (CDC, 2001). What was first identified as gay-related immune deficiency, or GRID (Altman, 1982), would later be labeled by scientists as the Acquired Immunodeficiency Syndrome (“AIDS”).  Some years later, it was determined the human immunodeficiency virus (“HIV”) caused AIDS, and it started the dark legacy behind HIV/AIDS.

Photo Source: NAMES Project

This legacy lives on. Since 1982, an estimated 692,790 Americans have died of HIV-related illnesses (Cichocki, 2019). Fortunately, things are changing. Major advances in the care and treatment available to people living with HIV-infection means that they are living longer. In other words, HIV is turning gray!

In the United States today, young adults with HIV-infection who adhere to their antiretroviral (“ARV”) treatment maintain lower viral loads and living longer. Many such patients are expected to mirror the life expectancy of someone in the general population, which is around 78 years (Preidt, 2017). The advent of the highly active antiretroviral therapies (“HAART”) has turned HIV/AIDS from a death sentence to a manageable, chronic illness similar to diabetes, epilepsy, or cardiovascular disease (WHO, 2017). This stands in stark contrast to the early days of the AIDS epidemic (before there was even an HIV-specific test), when life expectancy was often only 1 or 2 years (Quora, 2017).

Several years ago, Prudential Financial Inc. became the first major life insurance company to offer life insurance products to people living with HIV-infection. Although Prudential has discontinued its life insurance products for people with this disease, multiple other companies are now offering policies to people with HIV (LIB, 2019), further suggesting that HIV is viewed as a chronic rather than a fatal, illness.

There are many socio-economic variables contributing to life expectancy, but modern HIV treatment plays a significant role (Preidt, 2017) in extending life. This underscores the need to afford people with HIV the opportunity to access timely, appropriate HIV care and treatment, regardless of their ability to pay for it. Public safety-net assistance, such as the AIDS Drug Assistance Program (“ADAP”) and Medicaid, deserve the ongoing support of our nation’s leaders, along with robust federal funding and liberalized state drug formularies. Anything less does a true disservice to those who stand to lose their lives to this epidemic.

From a historical perspective, we should recall that the partnerships forged between advocacy groups, government agencies, and industry changed the medical, scientific, and political landscape…for the better! Despite initial distrust among stakeholders, slowly, this partnership inched us toward stemming the tidal wave of AIDS-related deaths among family, friends, neighbors, and colleagues (Arnold, 2019).

Fast forward to 2016, when half of the people living with HIV-infection are aged 50 and older (CDC, 2019). What once seemed unthinkable is now more common. According to the CDC, in 2016, an estimated 327,000 people aged 55 and older were living with HIV. Significant majorities of them had received some care (69%), were retained in care (56%), or were virally suppressed (60%). That isn’t to suggest the epidemic is over, because that same year, there were 10,944 deaths among people in the United States aged 50 and older with diagnosed HIV (CDC, 2019).

The demographics behind HIV continue to shift. By next year, as many as 65-70% of people living with HIV-infection will be age 50 or older (Birnstengel, 2019). That is, an estimated 660,000 of  1.1 million women, men, and transgender people living with HIV/AIDS will be over age 50 (Anderson, 2018). Similar to the general population, older patients in this cohort are changing the face of healthcare. We should be doing more to address their needs.

As the face of the epidemic has aged, so have the challenges facing people living with HIV-infection. For many long-term survivors, the evolution of this epidemic has been mentally and emotionally taxing. After all, they watched so many people around them lose their battles to AIDS, only to be left wondering: why did I survive?

For those patients who lived through the dark days of the epidemic, it has also taken its toll on their bodies. AIDS-defining illnesses among people aging with HIV have been replaced with HIV-associated non-AIDS conditions. Common are cardiovascular disease, lung disease, certain cancers, dementia, and liver disease (HIV.gov, 2019). Aging with HIV is also presenting unique health changes for older women living with HIV.

As aging with HIV slowly gains notoriety, some troubling trends are emerging. Co-morbidities among long-term survivors typically associated with people in their 60s and 70s are striking two decades earlier. This phenomenon is most likely linked to the immune system inflammation caused by the virus (POZ, 2019).

The increased likelihood of co-morbidities is ominous. According to AIDSinfo.gov, “People with HIV are more likely to have type 2 diabetes than people without HIV. Additionally, some HIV medicines may increase the risk of type 2 diabetes in people with HIV” (2019). HIV-infected patients are at higher risk (61%) of cardiovascular disease compared to the general population (Triant, 2013). And among patients with lower CD4 counts, their prevalence for developing HIV-associated dementia (7%-27%) increases during the later stages of infection (Huang, 2018). These co-morbidities represent only a few faced by this graying population.

Despite ambitious plans to End the Epidemic by 2030, our public health system needs to adapt to these new challenges. Older HIV patients struggle to cope with many obstacles, among them mental health problems, homelessness, and co-morbidities, daily.

The modern marvels behind HAART have done little to help these long-term survivors with the co-occurring mental health conditions that often plague them, such as the guilt associated with survival when so many others have died, depression, anxiety, or the loneliness that many endure. Tez Anderson, a longtime AIDS activist, has dubbed this condition “AIDS Survivor Syndrome” (Anderson, 2016).

Anderson summarized how many long-term survivors feel about the epidemic: “The people and agencies providing our care is more focused on the future, while older adults are regarded as relics of a bygone era. Our lives are defined by mass causalities, enormous loss, caretaking, illness, and ensuing trauma. We hear little about the astounding resilience of the first generation of people with HIV/AIDS. We do not think of individuals living with this virus for 20 and 30-plus years as the pioneers of the AIDS epidemic. We are survivors of the worst epidemic in history. Alas, too often we are just thought of as old” (Anderson, 2018).

Research has shown that anxiety, cognitive or mood disorders, and depression are common among people living with HIV-infection, yet fewer than one-half of the cases get recognized clinically (Williamson, 2019). Among patients who are dually diagnosed with HIV and depression, as many as eight in 10 are not receiving psychosocial care (Williamson, 2019).

Photo Source: HIV.gov

We have an opportunity to integrate HIV/AIDS service programs and mental health care, which would improve the overall health and outcomes of these patients. Long Term Survivors Awareness Day, which is now recognized nationally on June 5th of each year, represents a good first step in raising the awareness to make the needed changes.

There is a strong linkage between worsening health status and unstable housing status (Macsata, 2017), yet there remains a disproportionate number of people living with HIV/AIDS in care who are homeless or living in marginalized housing environments (NCH, 2009). It is even more concerning because unstable housing status often leads patients to under-utilize the care and treatment needed to achieve viral suppression (Milloy, 2013).

Earlier this year, the San Francisco Chronicle ran, “Aging onto the Street,” highlighting the urgency behind homelessness and its growing impact on people aged 50 and over. According to the Chronicle’s reporting, among survey respondents older than 50 who participated in a recent study, more than 40 percent had experienced homelessness for the first time after turning 50. The piece also features 62-year-old Michelle Myers, who is homeless, HIV-positive, and newly diagnosed with cancer (Fagan, 2019).

I’ve always been moved by the journey experienced by my friend and colleague, Wanda Brendle-Moss, from Winston-Salem, NC. Wanda, who is a registered nurse who cared for AIDS patients during the early days, when some front-line healthcare staff refused to do so, in 2009 found herself HIV-positive and living in her car. Wanda persevered with assistance from family, friends, and a rural AIDS Service Organization. Not everyone has been so fortunate, however.

While gone are the days of local obituaries sprinkled with announcements of another friend or neighbor lost to AIDS, their struggles remain visible on the faces of the many people who remain with us. The face of the epidemic ages before us. It is our societal obligation to help these long-term survivors – whether it is through expanded mental health services, or making affordable housing more readily available, or finding clinicians to treat their emerging co-morbidities. HIV may be graying, but that doesn’t mean we should allow these patients to be forgotten.

And, our ultimate focus should be on the creation of a community-based long term care system that is blind to disabilities, focused on patient-centered care, and a sliding fee scale to ensure that people who can afford to pay more do, and others are not penalized.

The need is great and growing.  The time for real legislative action is now.

Editor's Note: Jeffrey Lewis is the President and CEO of Legacy Health Endowment in Turlock, Ca. The views expressed our his own. He can be reached at jeffrey@legacyhealthendowment.org.

References:

• AIDSinfo.gov (2019, October 18). HIV and Diabetes. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/22/59/hiv-and-diabetes.
• Altman, Lawrence K. (1982, May 11). NEW HOMOSEXUAL DISORDER WORRIES HEALTH OFFICIALS. The New York Times. Retrieved online at https://www.nytimes.com/1982/05/11/science/new-homosexual-disorder-worries-health-officials.html.
• Anderson, Tez (2016, August 8). What is AIDS Survivor Syndrome? And Why You Need to Know. LetsKickASS. Retrieved online at https://letskickass.hiv/what-is-aids-survivor-syndrome-dc0560e58ff0.
• Anderson, Tez (2018, September 6). Older Adults with HIV: The Forgotten Majority. The ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2018/09/older-adults-with-hiv-forgotten-majority.html.
• Arnold, William E. (2019). National ADAP Working Group. Community Access National Network.
• Avert (2019, September 26). GROWING OLDER AND AGEING WITH HIV. Retrieved online at https://www.avert.org/living-with-hiv/health-wellbeing/growing-older-ageing.
• Birnstengel, Grace (2019, July 5). Dual Stigma: HIV Positive and Over 50. Next Avenue. Retrieved online at https://www.nextavenue.org/stigma-hiv-positive-and-over-50/.
• Centers for Disease Control & Prevention (2019, November 12). HIV and Older Americans. Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Retrieved online at https://www.cdc.gov/hiv/group/age/olderamericans/index.html.
• Cichocki, RN, Mark (2019, August 21). How Many People Have Died of HIV? Despite a reversal in AIDS deaths, challenges remain. Very Well Health. Retrieved online at https://www.verywellhealth.com/how-many-people-have-died-of-aids-48721.
• Fagan, Kevin (2019, March 8). Aging onto the street. San Francisco Chronicle. Retrieved online at https://www.sfchronicle.com/bayarea/article/Aging-onto-the-street-Nearly-half-of-older-13668900.php.
• “First Report of AIDS” (2001). Morbidity & Mortality Weekly Report 50 (21): 1 June 2001. Retrieved online at https://www.cdc.gov/mmwr/PDF/wk/mm5021.pdf.
• Huang, Juebin, MD (March 2018). HIV-Associated Dementia. Merck. Retrieved online at https://www.merckmanuals.com/professional/neurologic-disorders/delirium-and-dementia/hiv-associated-dementia.
• Life Insurance Blog (2019, October 11). HIV Life Insurance with Prudential. Retrieved online at https://www.lifeinsuranceblog.net/hiv-life-insurance-with-prudential/.
• Macsata, Brandon M. (2017, June 8). Linkages to Care - Housing is Healthcare: Linking Stable Housing & Medication Adherence. The ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2017/06/linkages-to-care-housing-is-healthcare.html.
• HIV.gov (2019, September 19). Aging with HIV – Growing Older with HIV. U.S. Department of Health & Human Services. Retrieved online at https://www.hiv.gov/hiv-basics/living-well-with-hiv/taking-care-of-yourself/aging-with-hiv.
• Milloy, M. J., Marshall, B. D., Montaner, J., & Wood, E. (2012). Housing status and the health of people living with HIV/AIDS. Current HIV/AIDS reports, 9(4), 364–374. doi:10.1007/s11904-012-0137-5. Retrieved online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3693560/.
• National Coalition for the Homeless (2009). HIV/AIDS and Homelessness. Retrieved online at http://www.nationalhomeless.org/factsheets/hiv.html.
• POZ Magazine (2019, July 19). Aging and HIV. Retrieved online at https://www.poz.com/basics/hiv-basics/hiv-aging.
• Preidt, Robert (2017, May 10). HIV Life Expectancy Nears Normal With Treatment – Still small, but persistent gaps for some groups with HIV, global health expert says. WebMD. Retrieved online at https://www.webmd.com/hiv-aids/news/20170510/life-expectancy-with-hiv-nears-normal-with-treatment#1.
• Quora (2017). What is the life expectancy of a person diagnosed with HIV in 1982? Retrieved online at https://www.quora.com/What-is-the-life-expectancy-of-a-person-diagnosed-with-HIV-in-1982.
• Triant V. A. (2013). Cardiovascular disease and HIV infection. Current HIV/AIDS reports, 10(3), 199–206. doi:10.1007/s11904-013-0168-6. Retrieved online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964878/.
• World Health Organization (2017). HIV: from a devastating epidemic to a manageable chronic disease. Ten years in public health 2007-2017. Retrieved online at https://www.who.int/publications/10-year-review/hiv/en/.

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.

FDA Approves New Injectable Naloxone

By: Marcus J. Hopkins, Policy Consultant

The U.S. Food & Drug Administration (FDA) has approved a new injectable form of naloxone hydrochloride – an antagonist used to reverse the effects of an opioid (House, 2019).
India-based Aurobindo Pharma, Ltd. received approval for its injectable naloxone in early November 2019 from the FDA at a time when certain areas of the U.S. – primarily those located in areas where opioid-related drug overdoses are high – are facing shortages of naloxone (Sharpless, 2019).

Photo Source: NPR

Injectable naloxone, as per FDA requirements, require a prescription for distribution in most states, although some states and pharmacies have suspended that requirement (Marsh, 2018). It is also more difficult for people to administer than the nasal spray version, Narcan, which retails at an average retail price of $140.48 (GoodRX, n.d.). The FDA did, however, approve a generic version of the nasal spray from Israel-based Teva Pharmaceutical Industries, Ltd. in May 2019 (Ducharme, 2019), although Teva has not yet announced their pricing on the generic, nor a street date for its release.

The U.S. continues to see annual increases in drug overdose deaths overwhelmingly driven by opioid-related overdose deaths, primarily heroin and fentanyl, a synthetic opioid drug that has increasingly been finding its way into supplies of heroin, counterfeit prescription drugs, and supplies of other illicit drugs such as methamphetamine. The states with the highest rates of drug overdose deaths – West Virginia, Ohio, Pennsylvania, and Kentucky in particular – have large swaths of the states where there is a convergence of opioid overdose deaths, Injection Drug Use (IDU), infectious disease spread via IDU, and a lack of easy access to medical and healthcare services.

As a result of the increasing rates and incidence of overdose deaths, states and municipalities have responded by authorizing (and in some cases, requiring) that state employees be trained and begin carrying naloxone in their places of employment, including local and state offices, schools, and state buildings. These requirements are put in place in anticipation that, given the widespread rate of opioid addiction, someone may overdose in these buildings at some time and require naloxone administration in an attempt to save their lives.

References:

• Ducharme, J. (2019, April 19). The FDA Just Approved the First Generic Nasal Spray to Reverse Opioid Overdoses. New York City, NY: Time USA, LLC.: Time: Health: Drugs. Retrieved from: https://time.com/5574107/fda-generic-naloxone-nasal-spray/
• GoodRx. (n.d.). Narcan. Santa Monica, CA: GoodRx. Retrieved from: https://www.goodrx.com/narcan
• House, D. W. (2019, November 06). FDA OKs Aurobindo's naloxone for opioid overdose. Ra’anana, Israel. Seeking Alpha: Healthcare. Retrieved from: https://seekingalpha.com/news/3515511-fda-oks-aurobindos-naloxone-opioid-overdos
• Marsh, T. (2018, June 04). Here’s How to Get Naloxone, the Opioid Overdose Antidote, Without a Prescription. Santa Monica, CA: GoodRx: Blog. Retrieved from: https://www.goodrx.com/blog/heres-how-to-get-naloxone-the-opioid-overdose-antidote-without-a-prescription
• Sharpless, N. E. (2019, September 20). Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths. Rockville, MD: U.S Food & Drug Administration: News & Events: FDA Newsroom: Press Announcements. Retrieved from: https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose

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.

Web Pharmacy Sites Offered Antibiotics Cancer & HIV Treatments Along with Counterfeit Opioids

By: Shabbir J. Safdar, Executive Director, The Partnership for Safe Medicines

Reprinted with permission from The Partnership for Safe Medicines

On September 30th, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) issued a joint warning to four online networks that were operating a total of ten fake online pharmacy websites. While all four networks were offering misbranded/counterfeit opioid medications such as tramadol and Soma for sale without a prescription, three of the online networks had marketplaces offering misbranded medications to treat a kaleidoscope of ailments, such as allergies, cancer, smoking, asthma, and infection.

Photo Source: PSM

The websites operated by Euphoria Healthcare included the sites tapentadol.us, and genericwellness.com.  An Internet archive search of Generic Wellness’ prescription medication offerings shows that this illegal online pharmacy was selling misbranded “generic” versions of Sofosbuvir (Hepatitis C), Bactrim and Suprax (antibacterial treatments),  Amoxil, Cipro, and Zithromax (antibiotics), Zyrtec, Flonase spray, and Clarinex (allergy), and the hair loss treatment Propecia, among many other essential medications.

Generic Wellness claimed on their site “We are well known online pharmacy for selling FDA approved high quality generic medicines all over the world.” This statement cannot be true, since the FDA specifically warned them for selling non-FDA approved medications.

The ‘About us:’ section of the Generic Wellness site goes even further, stating: “Thus we sell over 100 generic products which are manufactured under government certified standards and meet the highest Food and Drug Administration (FDA) and World Health Organization (WHO) standards and requirements. Therefore all the generic medications available in our website are equivalent to the branded ones in comparison to its reliability and safety.”

The JMC Pharmacy Group also offered what they claimed were FDA approved medications as well.  An Internet Archive search of their GM Pharmacy also known as Got Milk Pharmacy and Global Order Trade Medicine International Licensed Pharmacy showed they were selling non-FDA approved versions of Lipitor (cholesterol), Zithromax and other antibiotics, Truvada (HIV), and birth control pills. Images from the website included an opened box of codeine phosphate cough syrup bottles taken in the front seat of a car, bags of so-called Adderall pills in plastic sandwich bags on a kitchen counter, and crumbled bars of counterfeit Xanax labeled, “Brand Xanax Onax bar 2mg  Niravam, Alprazolam $120,00 – Strong.” Most disturbingly this internet site labeled as a pharmacy advertises admits their oxycodones are counterfeit and expect their users to abuse them intravenously or by snorting. The description beneath the so-called Oxycodone 30MG pills says the are “pressed with Fentanyl 0.8 MG which is equal 100MG OXY as active substance. The product has accurately dosed [ no hot spot ] it can be used IV / oral / smoke / snort.”

 The Meds4U network primarily sold painkillers via their site USPainkillers.  However they also offered Viagra and Cialis (ED medication) along with a dangerous prescription-only weight loss medication (Phentermine) that must be taken with medical supervision. Information on the Got Milk site concerning the location of the pharmacy or “About Us” descriptions were limited or non-existent.

As the joint FDA/DEA warning noted about these websites: “Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe. Additionally, several of these websites offer opioids online without a prescription, posing significant risks to patients.”



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.

Transportation Assistance Survey from the PAN Foundation

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The Patient Access Network (PAN) Foundation launched a transportation assistance pilot program earlier this year, called Treatment Transport. Through Treatment Transport, eligible patients received a stipend towards Lyft rides to doctors' appointments and to the pharmacy.

Click here to learn more about PAN's Treatment Transport FAQs.

Photo Source: U.S. News & World Report

 The Treatment Transport pilot program has ended, and PAN is seeking to gauge interest in expanding it in 2020. Please let PAN know your thoughts in this survey, which should take 5-7 minutes to complete. We hope you will respond by December 6, 2019.

Complete the PAN survey online at https://www.surveymonkey.com/r/WBWSJ2Z.

For additional information, please contact Amy Niles, Vice President, External Relations, PAN Foundation at aniles@panfoundation.org.



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.

Molecular HIV surveillance: public health tool or weapon?

By: Jeffrey R. Lewis

There is a longstanding, inherent value in the assurance of privacy in our healthcare system. Among other things, it is the keystone of the physician-patient relationship (Holman, 2017); it improves treatment adherence (Heath, 2017); and it has been proven to promote better health outcomes (2013). An ambitious new initiative to combat HIV/AIDS in the United States, however, employs technology that places patients’ privacy protections at risk.

President Trump’s “End the Epidemic by 2030” (EtE) initiative focuses on the 46 (out of 3,000) counties in the United States that account for more than half of new HIV infections. The Administration's plan also provides the opportunity to evaluate the ongoing rise in sexually transmitted diseases, which include worrying trends reported by the U.S. Centers for Disease Control and Prevention (CDC). Examples of the rise of STDs include  a 19% increase in Chlamydia, 63% increase in Gonorrhea, and 71% increase in Syphilis (CDC, 2019).

It is through this initiative that HIV stakeholders are getting an important glimpse into a potentially useful, but troubling, new tool being used by our public health infrastructure – namely, molecular HIV surveillance.

Photo Source: CDC

Molecular HIV surveillance involves data collection and sharing between healthcare practitioners and public health departments to track individual treatment resistance, as well as trends in HIV infections. It also leverages cluster detection to identify new infections of “people normally out of reach to public health” (McClelland, 2019). This information is shared with the CDC, which in turn uses the data to determine funding allocations for state and local health departments combating HIV (CDC, 2017). But at what cost to patients already living with HIV?

What’s troubling is that there is no informed consent by patients for data collected using individuals’ blood samples. State and local health departments report de-identified data to the CDC, but there are obvious patient privacy concerns.

Major health data breaches have become a problem in recent years. In 2016, patients enrolled in California’s AIDS Drug Assistance Program (“ADAP”) (Gorman, 2018); in 2017, patients served by CVS Pharmacy under Ohio’s ADAP  (Hassan, 2018), and Aetna patients in Pennsylvania  (Gordan, 2018), all had their privacy violated. It is not outside the realm of possibility that a data breach could also happen on a larger scale, exposing people living with HIV to further stigma.

Photo Source: Insurance Journal

Although the CDC’s data collection is governed by federal guidelines which intend to protect the privacy of individuals, for those living in the shadows of the nation’s long, dark history of HIV-related stigma, these provide little comfort. The fact remains that negative attitudes toward HIV/AIDS persist.

According to the Kaiser Family Foundation, nearly one in five Americans are somewhat or very uncomfortable working with someone who is living with HIV. One in five Americans is also somewhat or very uncomfortable having a close friendship with someone who is living with HIV. And a staggering two out of five Americans report being somewhat or very uncomfortable sharing a living space with someone who is living with HIV (Kirzinger, 2019). These attitudes are from current data -  not from the early 1980s!

Because molecular HIV surveillance identifies where clusters of people living with HIV reside, there are concerns that it will further fuel HIV-related stigma, which is already high and continues to grow. Worse, patient advocacy groups and legal scholars fear the potential exists for more unfair criminal prosecutions under outdated state HIV criminalization laws that allow prosecution of those who fail to disclose their HIV status.

The CDC has defended the use of this strategy, claiming it is “important to identify growing clusters of recent and rapid transmission to intervene to interrupt transmission” (Oster, 2017). According to their data through December 2015, such clusters have surfaced in each region of the United States, with 1,923 clusters identified, ranging in size from 2-22 cases (Oster, 2017).

Some of these clusters have gained national attention, namely ones in Scott County, Indiana, and San Antonio, Texas. The former resulted in more than 200 diagnoses of new HIV infections, whereas the latter helped to identify a cluster of 24 Latino gay and bisexual men (O’Neill Institute, 2019). What is often overlooked in the discussion over both of these clusters is whether and how syringe exchange programs could have effectively prevented many new infections.

To fully understand why public identification of these clusters is problematic, one must view the current situation in the context of its potential legal implications. Draconian HIV-specific criminalization laws still exist in 34 states; another 24 states have used general criminal statutes against people living with HIV for “HIV exposure” or non-disclosure of HIV status (CHLP, 2019). These laws relegate people living with HIV to second-class citizenship for numerous reasons. According to the Center for HIV Law and Policy, state HIV criminalization laws “criminalize non-disclosure of HIV status or exposure of a third party to HIV; make exceptions to confidentiality and privacy rights of people living with HIV; provide for sentence enhancements for people living with HIV convicted of underlying crimes such as prostitution and solicitation; and require sex offender registration for people living with HIV” (CHLP, 2019).

Lambda Legal,  considered the leading advocacy organization for the LGBTQ community, takes it a step further in characterizing the harm done by state HIV criminalization laws, speculating that these laws harm public health by creating disincentives for people to get tested for HIV and  prevent others who are HIV-positive from seeking care and treatment. Lambda argues that “information from healthcare providers is often used to prosecute,” which undermines the keystone of the physician-patient relationship (Lambda Legal, 2013).

Photo Source: SERO

It isn’t hard to imagine a worst-case scenario in which molecular HIV surveillance data makes its way into a courtroom and contributes to the “unjust prosecutions” (Lambda Legal, 2013), or into the court of public opinion to “stigmatize and oppress” people living with HIV (Lambda Legal, 2013). While molecular HIV surveillance alone cannot be used in court to establish HIV transmission (Schneider, 2019), it can be used as evidence, and that alone should cause considerable concern.

People living with HIV see very little difference between molecular HIV surveillance as an effective “tool” fighting the epidemic and HIV criminalization. They see it more as  a weapon aimed at further isolating, stigmatizing, and punishing people living with HIV. We should be listening to them rather than trying to reassure them.

In our quest to eradicate HIV/AIDS in the United States (and across the globe), it is important to keep the ongoing struggle in perspective. As we pursue new approaches toward ending the epidemic – including leveraging new technologies that can pinpoint HIV clusters and link more people to care – we must not become over-zealous and ignore the very real concerns expressed over molecular HIV surveillance by our family, friends, colleagues, neighbors, and even strangers living with HIV.

HIV-positive people should be afforded the very same privacy protections as their HIV-negative counterparts. That is what this community expect, deserves, and should be guaranteed.

Editor's Note: Mr. Lewis has worked on issues impacting the HIV/AIDS community for many years. The views expressed our his own. He can be reached at jeffreyrobertlewis@gmail.com.

References:

• Centers for Disease Control & Prevention (2017). Surveillance Overview. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/hiv/statistics/surveillance/index.html. 
• Centers for Disease Control & Prevention (2019). Sexually Transmitted Disease Surveillance 2018. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/std/stats18/default.htm. 
• Center for HIV Law and Policy (March 2019). HIV Criminalization in the United States: A Sourcebook on State and Federal HIV Criminal Law and Practice (Third Edition). Retrieved online at http://www.hivlawandpolicy.org/sourcebook. 
• Eustace-McMillan, Loni (1999, December 17). Protecting Private Medical Information: Liability for Unauthorized Disclosure. University of Houston Law Center. Retrieved online at https://www.law.uh.edu/healthlaw/perspectives/Privacy/991217Protecting.html. 
• Gorman, Anna (2018, April 6). Former California State Contractor Sued Over Breach Of HIV Patient Privacy. California Healthline. Retrieved online at https://californiahealthline.org/news/former-california-state-contractor-sued-over-breach-of-hiv-patient-privacy/. 
• Gordon, Elena (2018, January 17). Aetna Agrees To Pay $17 Million In HIV Privacy Breach. NPR. Retrieved online at https://www.npr.org/sections/health-shots/2018/01/17/572312972/aetna-agrees-to-pay-17-million-in-hiv-privacy-breach. 
• Hassan, Carma (2018, April 1). Lawsuit claims CVS unintentionally revealed HIV status of 6,000 customers. CNN. Retrieved online at https://www.cnn.com/2018/04/01/health/cvs-lawsuit-hiv-status-customers/index.html. 
• Heath, Sara (2017, August 22). 5 Ways to Improve Medication Adherence in Chronic Care Patients; Providers need to uncover the patient barriers to help improve medication adherence in chronically sick patients. Patient Engagement Hit. Retrieved online at https://patientengagementhit.com/news/5-ways-to-improve-medication-adherence-in-chronic-care-patients. 
• Holman, Tayla (2017, June 27). How to Build Patient Trust to Improve the Doctor-Patient Relationship. Dignity Health. Retrieved online at https://www.dignityhealth.org/articles/how-to-build-patient-trust-to-improve-the-doctor-patient-relationship. 
• Kempner, Martha (2019, March 4). New Study Triggers Concerns Over Use of Molecular HIV Surveillance. TheBodyPro. Retrieved online at https://www.thebodypro.com/article/concerns-over-use-of-molecular-hiv-surveillance. 
• Kirzinger, Ashley, Lunna Lopes, Bryan Wu, and Mollyann Brodie (2019, March 26). KFF Health Tracking Poll – March 2019: Public Opinion on the Domestic HIV Epidemic, Affordable Care Act, and Medicare-for-all. Kaiser Family Foundation. Retrieved online at https://www.kff.org/health-reform/poll-finding/kff-health-tracking-poll-march-2019/. 
• Lambda Legal (2013, December 13). 15 Ways HIV Criminalization Laws Harm Us All. Retrieved online at https://www.lambdalegal.org/publications/15-ways-hiv-criminalization-laws-harm-us-all. 
• Macsata, Brandon M. (2019, May 2) The ADAP Blog. When State & Local Public Health "Policies" Fuel HIV Stigma. ADAP Advocacy Association. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/05/when-state-local-public-health-policies.html. 
• McClelland, Alexander, Adrian Gula, and Marilou Gagnon (2019, February 10). The rise of molecular HIV surveillance: implications on consent and criminalization. Critical Public Health. Retrieved online at https://www.tandfonline.com/doi/citedby/10.1080/09581596.2019.1582755?scroll=top&needAccess=true. 
• Mesika, Robert (2012, July). The Ethics of HIV Criminalization. ETHICAL INQUIRY: JULY 2012. International Center for Ethics, Justice and Public Life. Retrieved online at https://www.brandeis.edu/ethics/ethicalinquiry/2012/July.html. 
• O’Neill Institute for National & Global Health Law (2019, Augsut). Quick Take: Using Cluster Detection to End the HIV Epidemic. Georgetown Law. Retrieved online at https://oneill.law.georgetown.edu/wp-content/uploads/Quick-Take_HIV-Cluster-Detection_August-2019.pdf. 
• Oster, M.D., Alexa, et. al. (2017, March 24). National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Use of molecular surveillance data to identify clusters of recent and rapid HIV transmission. U.S. Centers for Disease Control & Prevention. Retrieved online at https://www.seaetc.com/wp-content/uploads/2017/01/Use-of-Molecular-Surveillance-Data-to-Identify-Alexandra-Oster.pdf. 
• Schneider, Jacon (2019, September 12). Is HIV Molecular Surveillance Worth The Risk? The Center for HIV Law & Policy. Retrieved online at http://www.hivlawandpolicy.org/fine-print-blog/hiv-molecular-surveillance-worth-risk. 
• Serenko*, Natalia, and Lida Fan (2013). Patients’ perceptions of privacy and their outcomes in healthcare. Int. J. Behavioural and Healthcare Research, Vol. 4, No. 2. Retrieved online at http://aserenko.com/IJBHR_Serenko_Fan.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.

Reflections from an HIV Advocate's Journey: Mark Janes

By: Mark Janes, California Advocate

My journey with HIV began in 1995, and I still remember the first time I discussed AIDS publicly, in a Speech Communication class I was attending, in 1997. The final segment was to be a Persuasion speech, and I decided to speak in favor of expanding resources for the prevention of, and more support for those living with, AIDS. My first line was, My name is Mark Janes, and I am a person living with AIDS.” I went on to discuss why prevention was money well spent, research our best hope, and why those who have it deserve support and compassion.

I had numerous struggles with opportunistic infections, including chemo for Kaposi’s Sarcoma, which was relatively mild in me, but not entirely invisible. I agreed to be involved in numerous drug trials, some of which were truly hard (like eight large capsules at a time), and at least one of which is now listed as an allergen on my chart. I remember the summer of 2002 receiving a call from my HIV pharmacist, offering a trial for a drug then called T-20, that was injected twice daily. Six months of that finally gave me viral control. The day that blood was drawn was March 3, 2003.

My re-entry into the world of HIV support and advocacy began on Facebook; I was poking around in a few HIV Groups there, when a woman by the name “Maria HIV” asked me if I would be willing to help her admin a new Group she’d started, “International Group for people with HIV/AIDS, and the people who love us.” At that time it had maybe 400 members; it currently has around 14,000 and is among the largest of its kind on Facebook. I soon found myself answering all sorts of questions from around the globe, and have learned many valuable lessons both from Maria Mejia and from the Group as a collective.

It was Eddie Hamilton who suggested that I apply to attend the ADAP Advocacy Association’s annual Conference in Washington, DC. I did so, and was approved for a partial scholarship; my parents paid for my airfare. It was the first time I’d flown since 1999, and an extraordinary welcome back: Virgin America Flight 1, from San Francisco to Washington National; a World War II Honor Flight- veterans going to see the newly-completed memorial. The flight left on time and arrived a few minutes early. The vets were treated like royalty and the rest of us weren’t forgotten. The plane was showered by the airport fire trucks on arrival. But the best was yet to come: I was paired with Bob Skinner, who is both a strong advocate and a really good man in general. I learned a lot, and grew a lot, that first time. It made me more effective online.

The following year I attended AIDSWatch, and actually met my Congressman; he was gracious enough to give us a couple minutes of his time. That September I attended USCA, and had a impromptu teaching moment with the TSA as I was going through security at Washington National. The agent told me he “felt something loose on my upper thigh” and that secondary screening was needed. We went into a small room, I pulled my pants down, and showed him the loose skin, “From just under a decade of injecting Fuzeon twice a day, to treat HIV.”

I hear from people newly diagnosed from all around the globe on an almost daily basis. I do my best to offer advice that is as accurate as possible, and I also believe it’s important that our representatives in Congress are aware of our existence and what our needs are. Simply put, no government tries to just dump money on random items; there needs to be a call, a demand, for resources. I still believe that people speaking out and asserting their needs, is part of living in a nation like the United States, and my main issue is HIV.

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.

New Study Demonstrates Value of Tesamorelin for Non-Alcoholic Fatty Liver Disease

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association since its inception has advocated for more open drug formularies under the AIDS Drug Assistance Program ("ADAP") because they promote greater access to care and treatment for people living with HIV/AIDS. By omitting therapies that are approved by the U.S. Food & Drug Administration ("FDA") for the treatment of HIV-infection and related co-morbidities, some State ADAPs are being counter-productive to the needs of the people they're intended to serve. One example is the unfair limitation often put on the drug tesamorelin for the treatment of lipodystrophy. A new study published online in The Lancet shows promise for non-alcoholic fatty liver disease, and as such it might finally change some opinions about adding it to drug formularies.

Photo Source: Drugs.com

Current restrictions on the use of tesamorelin do a disservice to the needs of people living with HIV/AIDS, and diagnosed with HIV-related abnormal accumulation of visceral adipose tissue (VAT) by concluding that the potential discontinued use of tesamorelin and its “expense” is limited its use. Yet, research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments - something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

Some states, such as Massachusetts, have long recognized the value of tesamorelin - not only within its ADAP drug formulary, but by also mandating treatment for HIV-related lipodystrophy for private insurance. The Massachusetts model was largely based on the FDA's findings: “The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy. The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”[1]

The new study - "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" - yielded positive results, such as demonstrating tesamorelin can reduce liver fat and prevent scarring of the liver.[2]

According to the study, "Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD."[3]

The study's findings concluded:

"61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of −4·1% (95% CI −7·6 to −0·7, p=0·018), corresponding to a −37% (95% CI −67 to −7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localized injection site complaints than those in the placebo group, though none were judged to be serious."[4]

These findings bode well for people living with HIV/AIDS, especially as it relates to co-morbidities such as cardiovascular and type 2 diabetes risks. Now it is time for more State ADAPs to take notice.



__________
[1] U.S. Food & Drug Administration (2010, November 10). FDA approves Egrifta to treat Lipodystrophy in HIV patients. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/news/889/fda-approves-egrifta-to-treat-lipodystrophy-in-hiv-patients---november-10--2010.
[2] Brokaw, Sommer (2019, October 15). NIH: Drug reverses liver fat, slows fibrosis in HIV-positive people. UPI. Retrieved online at https://www.upi.com/Health_News/2019/10/15/NIH-Drug-reverses-liver-fat-slows-fibrosis-in-HIV-positive-people/8621571156412/?sl=3.
[3] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.
[4] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.

Medicare's Low-Income Subsidy Program

By: Amy Niles, Vice President, External Relations, Patient Access Network (PAN) Foundation

Access to medically necessary healthcare is critical for successful patient outcomes, yet access is often impeded or blocked entirely by high deductibles, co-pays and coinsurance. These out- of-pocket (OOP) costs hit low-income seniors especially hard. For economically vulnerable Medicare beneficiaries and people with disabilities, the Low-Income Subsidy (LIS) program is a critical safety net that helps cover OOP costs for prescription drugs. The PAN Foundation's Issue Brief describes the LIS program, how it helps low-income seniors and people with disabilities, and what more can be done to ensure that OOP drug costs do not prevent these beneficiaries from getting the treatment they need.

WHAT IS THE LIS PROGRAM AND WHO IS ELIGIBLE?

All Medicare beneficiaries are eligible for prescription drug coverage through Medicare Part D drug plans. Medicare beneficiaries with low incomes and very few assets (e.g. bank accounts, stocks, bonds, etc.) as well as some people with disabilities may qualify for the LIS program, which helps cover OOP prescription drug costs. Also called “Extra Help,” the LIS program shields economically vulnerable and disabled beneficiaries from high OOP drug costs by helping them pay for monthly premiums, annual deductibles and co-payments for prescription medications obtained through Medicare prescription drug programs.[1]

The LIS program is divided into two parts: the “Full LIS program” and the “Partial LIS program,” and they differ based on who is eligible, how people enroll, and how much support the program provides for OOP drug costs.

To learn more about the LIS program, download the PAN Foundation's Issue Brief 11 - Medicare’s Low-Income Subsidy Program.

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.

DHHS Reports That Majority Of Data Breaches Expose Non-Health-Related Data

By: Marcus J. Hopkins, Policy Consultant

The U.S. Department of Health and Human Services released on September 23rd, 2019, a report in the Annals of Internal Medicine that found that the majority of information accessed in the over 1,500 protected health information (PHI) breaches reported over the last decade has been sensitive demographic information (e.g. – driver’s license number and Social Security Numbers – SSNs) and financial information including billing and payment information (Hlavinka, 2019). Only 2% of data breaches were found to expose sensitive medical information, such has HIV status, cancer diagnoses, or substance abuse, but 65% of these breaches exposed general medical or clinical information (Hlavinka).

According to the findings, over half of data breaches reported to HHS could be attributed to healthcare providers’ personal mistakes or negligence. This could include anything from failing to encrypt laptops, to using “CC” instead of “BCC” when E-mailing patients (Hlavinka).

Photo Source: evidencesolutions.com

HHS proposed regulatory, in March 2019, that would modernize the way that health information is shared by implementing certain provisions of the 21st Century Cures Act, including increasing the amount of data that is entered and shared electronically. The fundamental tradeoff of this modernization, however, is that health data will naturally become more susceptible to exposure. This last point is increasingly concerning considering the recent increase in so-called “Ransomware” cyber-attacks against public computer systems. Campbell County Health in Gillette, Wyoming, was hit, this month, with one such cyber-attack affecting all 1,500 of the systems computers, including the E-mail server, which resulted in the CCH having to divert patients from ERs starting on September 20th, 2019, as well as cancelling many exams, procedures, and new patient admissions (Landi, 2019).

Healthcare systems remain one of the largest targets of hackers, and while ransomware attacks, themselves, do not access private information, instead denying access to information, the potential exists for hackers to jump from denying access to exposing sensitive data if ransoms are not paid.

These data presented by HHS come on the heels of a recent settlement announcement in the state of Ohio between state AIDS Drug Assistance Program (ADAP) clients and CVS Health, the company contracted to provide prescription drug benefits, after a CVS mailer to OHDAP (Ohio’s ADAP program) clients in an envelope that clearly announced clients’ HIV status (Hopkins, 2017). In our August 2017 coverage of this issue, one of the plaintiffs, Eddie Hamilton, head of the ADAP Educational Initiative, shared with us the envelope he received (unredacted) which clearly listed his ID number as: “PM 6402 HIV”.

“In our case, CVS used our Ryan White CAREWare numbers as their subscriber numbers,” Hamilton told me. “It has our birthdates embedded in that URN (Unique Record Number), which is not HIPAA compliant. So, not only was our HIV status on the mailer, but our names, addresses, and birthdates all visible to anyone who looked at the envelope. I do not think that the Health Resources and Services Administration (HRSA) is even aware that those numbers are being used for public consumption.”

The CVS settlement, which has yet to receive approval from a judge, agrees to pay out $4.4 million to settle the class-action lawsuit filed in June 2018 by the roughly 4,500 patients impacted. Under the settlement, each recipient of the mailer would receive a minimum of $400, those who can show they suffered non-financial harm can get as much as $2,500, and those who can prove they suffered financial harm can receive up to $10,000. The lawyers representing the plaintiffs may receive up to $1.46 million – over a third of the overall reward (Anderson, 2019).

Photo Source: UpGuard

The agreement language, itself, include some troubling clauses, such as clause 10.19 which reads:

"10.19 Non-Disparagement. The Parties and their counsel agree that neither the fact that Caremark entered into this Settlement Agreement nor its terms shall at any time, directly or indirectly, be used to disparage Caremark’s administration of OhDAP. For purposes of this Section, the term “disparage” shall mean to make comments or statements that would adversely affect the business or professional reputation of Caremark. Nothing in this Paragraph or any other Paragraph of the Agreement, precludes the Parties or their Counsel from (a) referring to public information about the above-captioned litigation, Settlement, or other publicly available documents; (b) responding to any subpoena, legal process or request for information from any governmental authority; (c) testifying truthfully under oath pursuant to any lawful court order or subpoena; or (d) pursuing any legal right they may have against each other. Nothing in this paragraph or any other paragraph of this Agreement precludes Counsel for Plaintiffs from making statements regarding signatories to this Agreement in the context of pursuing a claim or lawsuit. Nothing in this paragraph or any other paragraph of the Agreement shall be construed to restrict the right to practice in violation of applicable Rules of Professional Conduct."

Non-Disparagement clauses are frequently used as tools to prevent those who agree to settle from going public with their personal stories, particularly in the event that they come to feel that the amount they received in the settlement is not sufficient to cover their injury.

In addition to the Non-Disparagement clause, the settlement includes no admission of guilt – a common practice in settlement agreements. This, to my way of thinking, is unconscionable. CVS’ negligence in this matter had the potential to result in long-lasting impacts, both personally and financially, for those whose statuses were exposed in their mailers. That no party involved in the decision to use “HIV” in the member ID numbers – not OHDAP, not the Ohio Department of Health, and certainly not CVS Caremark – is willing to admit to wrongdoing despite clearly having done wrong is worthy of disparagement.

The reality of living in the 21st Century is that, the further along we go, the more information about us is going to be accessible to others. Data breaches have always occurred and oftentimes, it can be the result of a simple mistake. The question then becomes, “How much security are we willing to sacrifice in the name of expedience?”

Personally, because I’m very vocal and open about my status and personally invite any hacker to try to use my SSN to gain access to credit (best of luck, suckers! The joke’s on you [Marcus goes to cry over his poor credit rating]), as well as the fact that I have a tendency to relocate pretty frequently, I prefer the ease of data mobility. Others, however, are not so open, and for them, the risk of exposure – while, according to the HHS data, is slim – presents a far more daunting choice.

References:

• Anderson, Maia. (2019, September 13). CVS to pay $4.4M settlement over inadvertent HIV disclosure of 4,500 patients. Chicago, IL: Becker’s Healthcare: Becker’s Hospital Review: Pharmacy. Retrieved from: https://www.beckershospitalreview.com/pharmacy/cvs-to-pay-4-4m-settlement-over-inadvertent-hiv-disclosure-of-6-000-patients.html
• Hlavinka, E. (2019, September 23). Health Data Breaches Give Up SSN, Not HIV Status - Just 2% involved sensitive medical information. New York, NY: MedPage Today, LLC: MedPage Today: Public Health & Policy: Practice Management. Retrieved from: https://www.medpagetoday.com/publichealthpolicy/practicemanagement/82332
• Hopkins, M.J. (2017, August 28). HIPAA: Healthcare mailers violate privacy rights of people living with HIV. Washington, DC: Community Access National Network: HEAL Blog. Retrieved from: https://communityaccessnationalnetwork.wordpress.com/2017/08/28/1498/
• Landi, H. (2019, September 23). Wyoming health system hit with ransomware attack, diverts ER patients and cancels services. Framingham, MA: Questex, LLC: Fierce Healthcare: Tech. Retrieved from: https://www.fiercehealthcare.com/tech/campbell-county-health-wyoming-hit-ransomware-attack-diverts-er-patients

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 Releases Inaugural Ryan White Patient-Level Report

By: Marcus J. Hopkins, Policy Consultant

The Health Resources and Services Administration (HRSA) – the U.S. government organization responsible for overseeing the Ryan White HIV/AIDS Program and the AIDS Drug Assistance Program (ADAP) – released its first report focused on providing client-level demographic data and how ADAP-funded services were used from 2014-2017 (Cheever, 2019).

The finding of this new annual report found that ADAP served 268,174 clients in 2017, 77.7% of whom were Male, 21.1% Female, and 1.2% Transgender. The data also indicate that over 2/3 of ADAP clients are from racial/ethnic minority populations – 39.5% African American, 25.4% Hispanic/Latinx, and less than 2% each are Asian, American Indian/Native Alaskan, Native Hawaiian/Pacific Islander, and persons identifying as multiracial – and that these racial/ethnic demographics have remained largely unchanged since 2014 (HRSA, 2019).

The data also found that racial/ethnic minority clients tend to be younger than White clients, with 56.9% of White clients being aged 50 years or older, compared with nearly 2/3 of Black and Hispanic/Latinx clients being under the age of 50. This holds consistent with HIV infection rates – the majority of new HIV infections in 2017 occurred in patients aged 20-39, with a majority of new infections occurring in African Americans and Hispanic/Latinx infection numbers coming in 3rd-highest (Centers for Disease Control and Prevention, 2019).

In addition to racial/ethnic demographic information, the report also found that more than 38.6% of ADAP clients had no health care coverage in 2017, down from 44.4% in 2014. This may be a result of state Ryan White programs being authorized by HRSA to use ADAP funds to purchase health insurance (“insurance continuation”) for clients, as well as to pay co-pays and premiums.

The most troubling data found that racial/ethnic minorities were more likely than white clients to be living at or below 100% of the Federal Poverty Level (FPL), with 51.8% of Hispanic/Latinx meeting this criteria, 49.5% American Indians/Alaska Natives, 48.3% of African Americans, 45.8% of Multiracial clients, 40.5% of Native Hawaiians/Pacific Islanders, 35.7% of Asians, and 33.7% of White clients. These data comport with long-held evidence that the people most likely to become infected or living with HIV, particularly among minorities, are those in lower income brackets.

Photo Source: njdc.info

Another concerning data point found that only one in five (20.4%) of ADAP clients received medication co-pay/deductible assistance in 2017, compared to just 12.3% in 2014. This is troubling because, even though HRSA has authorized funds to be used to purchase health insurance from clients, the vast majority were not utilizing this option which would allow them to access other healthcare services for which the Ryan White program could feasibly pay. Many of these services are already covered in urban areas under Ryan White Part A, but in more rural areas, like many Southern states where the majority of new HIV infections occur, access to Ryan White clinics is far more limited. Purchasing health insurance for clients opens far more options, in terms of places to go to receive healthcare services.

I look forward to seeing the 2018 report, once more data are available, as these reports will be an invaluable tool for tracking how Ryan White funds are utilized in the coming years.

References:

• Centers for Disease Control and Prevention. (2019, April 12). Statistics Overview – Diagnoses of HIV Infection, by Age. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention: Division of HIV/AIDS Prevention: HIV: Statistics Center. Retrieved from: https://www.cdc.gov/hiv/statistics/overview/index.html#targetText=Prevalence%20is%20the%20number%20of,infections%20had%20not%20been%20diagnosed.&targetText=CDC.
• Cheever, L. (2019, September 18). HRSA Releases Inaugural Report of Ryan White HIV/AIDS Program AIDS Drug Assistance Program Client-Level Data. Washington, DC: United States Department of Health and Human Services: Office of HIV/AIDS and Infectious Disease Policy. Retrieved from: https://www.hiv.gov/blog/hrsa-releases-inaugural-report-ryan-white-hivaids-program-aids-drug-assistance-program-client?utm_source=twitter&utm_medium=social&utm_campaign=blog
• Health Resources and Services Administration. (2019, September). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report 2017. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: Data: Data Reports and Slide Decks. Retrieved from: https://hab.hrsa.gov/sites/default/files/hab/data/datareports/2017-hrsa-adr-data-report.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.

Reflections from an HIV Advocate's Journey: LaDonna Boyens

By: LaDonna Boyens, Super Advocate

I am a super advocate, because if advocacy is speaking from one's truth, then my advocacy journey has and will be ongoing. Even at 52 years old, I experience growing pains. In my HIV advocacy journey there is so much to be done to help PLWHA and there are only so many hours in a day, in a week, etc., but if we are honest with ourselves, we live it as long as we live. I could give you facts as a testimony and give you lots of statistics, but truth be told I want you to learn with me. Advocacy is my life, to stand up for what I truly believe is right and fair, and be a voice for the voiceless.

My mom use to tell me I have a big mouth and my family is so proud that I am using my power for good and not evil (hence the "super advocate" statement). It truly is a calling that you need to walk and accept it with HIV-related STIGMA holding so people back, I just want you to know not to let a diagnosis keep you down or to live in a broken state-of-mind.  I am here waiting to embrace you, as are so many others. I am HIV positive and to tell the truth, I am different, but for me I love being different and making a difference.

Over the years, my advocacy journey has allowed me to work with Philadelphia FIGHT to help connect others to community resources. I have been involved with the Positive Women's Network (PWN), because women need a collective voice in our fight against the epidemic. And I've attended several national conferences hosted by the ADAP Advocacy Association in Washington, DC. Each experience has opened me to new colleagues, and new advocacy tools.

There has been so many leaders and soldiers that aren't with us in the physical anymore so I truly let those that are still here know how important they are to me and others. Sometimes personality gets in the way of the work including mine, but I remind myself, it is bigger than my hurt feelings or my bruised ego and continue to let people know we are HIV/AIDS diagnosed we count, we matter, and we are still here. The fight still remains so I want to encourage you to remain. Don't quit, hang in there when you get weary of doing good, do a little more, roll up your sleeves and go at it again and I will be there with you.  We are not victims! We are victorious!  If you can be anything please be kind! As advocates we will be the change makers of tomorrow. So my request is that you invest in us today.




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..

HIV/AIDS Fireside Chat Retreat in Virginia Tackles Pressing Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Richmond, Virginia among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS. The Fireside Chat took place on Thursday, September 12th, and Friday, September 13th. Medicaid Expansion, Ryan White HIV/AIDS Program ("RWHAP"), and Patient Assistance Programs (PAPs) were dissected by 23 diverse leaders in the fight against the HIV/AIDS epidemic.

Photo Source: Getty Images

The Fireside Chat included moderated white-board style discussion sessions on the following issues:

• Medicaid Expansion: Implications for Access to Care & Service Delivery for PLWHA in Virginia — moderated by Dr. Kathleen A. McManus, Department of Medicine,University of Virginia
• Ryan White Program: Impact to Service Delivery under Trump's Plan to Eliminate AIDS by 2030 — moderated by Jeffrey S. Crowley, O'Neill Institute for National and Global Health Law, Georgetown Law
• Access to Care: How Patient Advocacy Groups & Patient Assistance Programs Fill Treatment Gaps for PLWHA — moderated by Alan Richardson, Patient Advocate Foundation

The discussion sessions were designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Fireside Chat. The following represents the attendees:

• Carnelle Adkins, Lead Case Manager, Capital Area Health Network
• William E. Arnold, President & CEO, Community Access National Network (CANN)
• Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
• Dawn Patillo Exum, Director, Public Policy, MERCK
• Kathie Hiers, President & CEO, AIDS Alabama
• Lynea Hogan, Virginia Consumer Advocate
• Lisa Johnson-Lett, Treatment Adherence Specialist /Peer Educator, AIDS Alabama
• Diana Jordan, Director of Disease Prevention, Virginia Department of Health
• Darnell Lewis, Local Coordinator ACCELERATE, TCC Group
• Brandon M. Macsata, CEO, ADAP Advocacy Association
• Kathleen McManus, Physician, University of Virginia
• John Minneci, Regional Account Executive, ViiV HealthCare
• Herminia Nieves, Assistant Director of Medication Access, Virginia Department of Health
• Theresa Nowlin, Massachusetts Consumer Advocate
• Juan Pierce, Virginia Consumer Advocate
• Alan Richardson, Executive Vice President of Strategic Patient Solutions, Patient Advocate Foundation
• Josh Robbins, Owner, BNA Talent Group & The BRANDagement
• Kimberly Scott, Director of HIV Care Services, Virginia Department of Health
• Matt Sheffield, Director, Government Affairs, Thera Technologies
• Robert Skinner, President & CEO, Valley AIDS Information Network
• LaWanda Wilkerson, North Carolina Consumer Advocate
• Marcus Wilson, National Policy & Advocacy Director, Johnson & Johnson
• Jennifer Zoerkler, Executive Director, VHO

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

Medicaid Expansion:

Dr, Kathleen McManus summarized how Medicaid expansion under the Affordable Care Act has played a major role in the uninsured rate declining from 18% to 14% among people living with HIV/AIDS. In Medicaid expansion states the decline was event more visible, down from 14% to only 7% (with Ryan White clients classified as uninsured clients). In Virginia, for example, Medicaid eligibility was one of the most restrictive programs in the nation.

That said, barriers remain under Medicaid expansion. Sometimes more restrictions exist under Medicaid, such as closed drug formularies (often times more restrictive than ADAP drug formularies), mail-order pharmacy requirements, or providers being out-of-network. The ongoing challenges also remain with insurance carriers dropping plans under the ACA's marketplace. Some potential strategies to combat challenges created by the uncertain insurance market included state health departments leveraging existing relationships with insurance carriers, as well as increasing peer-to-peer education. The National Alliance of State & Territorial AIDS Directors ("NASTAD") has made available several important resources to help state health departments and Ryan White Programs navigate the Medicaid expansion landscape.

Medicaid expansion in Virginia has raised some important questions, including transitions for existing ADAP clients, access to care with Medicaid Managed Care Organizations, and upcoming Medicaid work requirements. “The Graying of HIV” was central throughout the Medicaid expansion discussion.

The following materials were shared with retreat attendees:

• Kaiser Family Foundation: Medicaid and HIV
• The Body: What Medicaid Work Requirements Might Mean for People With HIV
• Daily Press: It will be years before Virginia Medicaid program makes people work, and Republicans aren’t happy (May 22, 2019)
• HIV/AIDS Bureau Policy: Clarifications Regarding the Use of Ryan White HIV/AIDS Program Funds for Health Care Coverage Premium and Cost Sharing Assistance

The ADAP Advocacy Association would like to publicly acknowledge and thank Kathleen for facilitating this important discussion.

Ryan White Program:

The Ryan White HIV/AIDS Program was discussed as a follow-up to the Michigan Fireside Chat, mainly as it relates to the Administration's plan to End the Epidemic by 2030 (EtE) initiative. As a foundational point for this discussion, some important facts were shared on why is the Ryan White Program needed if people with HIV have health insurance coverage, especially its role in leading the way in getting people with HIV virally suppressed by ensuring stable access to HIV primary care and medication, along with critical support services. Some of the issues touched upon included the impact of the uneven Medicaid expansion landscape from state-to-state, ADAP-funded insurance premium assistance, and mental health.

The EtE's targeted approach focuses on 46 counties in the United States, which account for over half of the new infections (there are over 3,000 counties nationwide). It was widely recognized that the plan does include a significant down payment to fund the initiative, but concerns linger over the ongoing assault on the Affordable Care Act. The Administration's plan also provided the opportunity to evaluate the ongoing rise in sexually transmitted diseases, which include worrying trends (22% increase in Chlamydia, 67% increase in Gonorrhea, and 80% increase in Syphilis). Additionally, PrEP was discussed as a way to improve population-level outcomes.

Photo Source: CDC

Finally, there was considerable discussion over the emerging controversy surrounding the use of cluster detection to pinpoint HIV hotspots. Whereas many health departments and public health professionals applaud using cluster detection (described as a tool), many patient advocates and people living with HIV/AIDS are increasingly alarmed over it. Emerging concerns include privacy, stigma, and criminalization.

The following materials were shared with retreat attendees:

• What is ‘Ending the HIV Epidemic: A Plan for America’?
• HRSA Congressional Justification, FY 2020: See Ryan White Program section, pages 228-265
• ACHIEVING SUFFICIENT SCALE OF PrEP USE IS CRITICAL TO ENDING THE HIV EPIDEMIC
• THE US STI CRISIS
• USING CLUSTER DETECTION TO END THE HIV EPIDEMIC

The ADAP Advocacy Association would like to publicly acknowledge and thank Jeffrey for facilitating this important discussion.

Patient Assistance Programs:

Earlier this year the Patient Advocate Foundation ("PAF") blogged about Navigating the Costs of HIV Care – Conversations, Resources & Patient Experience, which summarized two online survey assessments of patients to identify root causes of financial toxicity including preferences towards cost conversations, degree and sources of financial stress. These surveys provided an important backdrop of this discussion about patient assistance programs ("PAPs").

The complexity of the nation's healthcare system and safety net programs often create "gaps" and the potential for patients to fall through them, thus losing access to timely, appropriate care and treatment. PAPs often provide the necessary resources to fill many of the care and treatment gaps. Some of the programs discussed included co-payment relief programs, case management services, and patient navigator programs.

Photo Source: PAF

Questions asked included what are manufacturer free drug programs and how do they operate, what are Coupon Cards and how do they work, and what is the difference between a manufacturer free drug program and charitable co-pay programs? Aside from the services provided by PAF, other patient resources offered by different organizations were also discussed, including the PAN Foundation, NeedyMeds, and PhRMA.

The following materials were shared with retreat attendees:

• Who Provides Patient and Health Advocacy?
• Ten Key Skill Sets of Health Care Advocates
• How a Patient Advocate Helps You Navigate the Medical System
• Patient advocates’ role expands to meet healthcare’s increasingly complex demands
• Patient Advocacy for Beginners
• HIV, AIDS & Prevention CareLine
• Hepatitis C CareLine

The ADAP Advocacy Association would like to publicly acknowledge and thank Alan for facilitating this important discussion.

Additionally, a special thank you is extended to Diana Jordan, Kimberly Scott and the entire Virginia Department of Health for their assistance during our stay in Richmond, VA.

Additional 2019 Fireside Chats are planned in New York, New York.