tag:blogger.com,1999:blog-51390513486300035102024-03-19T01:44:11.955-04:00AIDS Drug Assistance ProgramThis blog focuses on the federal commitment to fully fund the AIDS Drug Assistance Program (ADAP) for people living with HIV/AIDS.ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.comBlogger476125tag:blogger.com,1999:blog-5139051348630003510.post-11123321048569257652024-03-14T05:52:00.003-04:002024-03-14T06:13:52.042-04:00CROI 2024 Highlights: Conference on Retroviruses and Opportunistic Infections<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>The fight against HIV and other viruses like HCV and SARS-CoV-2 is a worldwide team effort. That is why the <a href="https://www.croiconference.org" target="_blank"><span style="color: #3d85c6;">Conference on Retroviruses and Opportunistic Infections</span></a> (CROI) convened from March 3rd through March 6th, 2024 in Denver, Colorado. Since 1993, CROI has brought together scientists, clinical scientists, and epidemiologists to present original groundbreaking research and collaborate to advance the treatment and prevention of HIV and other viral infections and opportunistic diseases.<span style="font-size: xx-small;">[8]</span> CROI is one the first places research showing the effectiveness of triple-drug therapy for HIV was shared. It was also one of the first places where the results of the SMART study were shared, which proved that early treatment of HIV provides the best outcomes.<span style="font-size: xx-small;">[8]</span> This year, 4,000 attendees gathered at CROI. Participants presented a multitude of novel and emerging therapies and studies. What follows are just a few notable highlights.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggqTxwTPhqut5-nm1nuJbtzxinCYIk0hbJcDGxXsMn7DX2EInVLqfoOgjVwT4x_ecJNFwhemCER4FNKr6afcy3sT59XZ3uwNEyBDDDbeGpJfqjysnFxRlh21RFmik6wkDoS6Cd1uTNt2CTVQix9R3HriSAy6RsEXBhCTTRroSWiMVh51U_1uAui3htOUY/s545/CROI-LOGO2.png" style="margin-left: auto; margin-right: auto;"><img alt="CROI 2024" border="0" data-original-height="545" data-original-width="395" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEggqTxwTPhqut5-nm1nuJbtzxinCYIk0hbJcDGxXsMn7DX2EInVLqfoOgjVwT4x_ecJNFwhemCER4FNKr6afcy3sT59XZ3uwNEyBDDDbeGpJfqjysnFxRlh21RFmik6wkDoS6Cd1uTNt2CTVQix9R3HriSAy6RsEXBhCTTRroSWiMVh51U_1uAui3htOUY/w290-h400/CROI-LOGO2.png" width="290" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: CROI</span></td></tr></tbody></table><p><b>Long-Acting Injectables Blaze Forward</b></p><p>GSK’s long-acting injectable, cabotegravir, has already shifted the antiretroviral therapy (ART) paradigm. Coupled with rilpivirine, it is one-half of Cabenuva, the first complete ART injectable approved by the U.S. Food & Drug Administration (FDA). Cabenuva allows people who live with HIV (PLWH) to change from taking daily pills to the Cabenuva injection monthly or every two months. Studies have proven it is effective for those who have medication adherence challenges. It also presents an option for PLWH who wish to make medication management a less intrusive part of their lives.</p><p>ViiV Healthcare, the HIV-focused subsidiary of GSK, presented data from a clinical trial for a revolutionary new ultra-long-acting cabotegravir at CROI.<span style="font-size: xx-small;">[7]</span> The new formulation has a higher concentration and double the half-life, potentially allowing it to be dosed every four months instead of every two.<span style="font-size: xx-small;">[7]</span> Further clinical trials will be conducted to explore the use of the new formulation of cabotegravir as PrEP and as a treatment for PLWH. GSK’s goal is to have the first long-acting injectable for HIV prevention on the market by 2026 and for HIV treatment by 2027. The company also aims for an annual long-acting injectable by the first part of the 2030s.</p><p><b>DoxyPEP for STIs</b></p><p>DoxyPEP stands for doxycycline post-exposure prophylaxis. It is the practice of taking 200mg of oral doxycycline within 24 to 72 hours of condomless sex. Clinical trials have shown that DoxyPEP is effective in reducing the incidence of bacterial STIs such as syphilis and chlamydia. Results of Doxy PEP clinical studies of reducing STIs have been so promising that the CDC proposed guidelines for DoxyPEP usage in October 2022. However, those guidelines are not finalized.<span style="font-size: xx-small;">[1]</span> </p><p>Infectious disease professionals at CROI presented new data regarding DoxyPEP usage out in the real world among populations of people, mainly cisgender MSM and transgender women. Previous data was from clinical trials in contrast with new data that examined the results of DoxyPEP uptake in over 3,700 clients of sexual health clinics across San Francisco. Usage resulted in a 58% reduction in bacterial STI cases overall, a 67% reduction in chlamydia, and a 78% reduction in syphilis cases.<span style="font-size: xx-small;">[2]</span> The real-world data indicated that when offered, there was a demand for DoxyPEP, and people consistently integrated it into their sexual health routine. As the Centers for Disease Control & Prevention (CDC) finalizes formal guidelines, DoxyPEP may potentially be solidified as another viable form of population wide STI prophylaxis.</p><p><b>Weekly Oral Antiretroviral Therapy</b></p><p>Long-acting injectable HIV therapy is not an optimal treatment modality for everyone. Nevertheless, other options for medication adherence that do not involve a daily regimen are needed for optimal health outcomes. At CROI, Gilead Sciences and Merck presented data from a clinical trial for a possible weekly oral antiretroviral therapy (ART) solution.</p><p>The solution is a weekly dosage of Gilead’s Sunlenca (lenacapavir), and an experimental drug named islatravir from Merck. <span style="font-size: xx-small;">[3,4]</span> The phase 2 trial compared 104 patients taking daily Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets) with a group taking the weekly oral lenacapavir with islatravir. Data indicated that 94.2% of subjects taking the lenacapavir/islatravir combination maintained their viral suppression compared to 92.3% of the Biktarvy group.<span style="font-size: xx-small;">[3,4]</span> The study will continue for another 48 weeks as open-label. This means that the study is no longer randomized. Both the medical professionals and the subjects know precisely what they are being given. There is no placebo. Studies move forward to open-label from randomized controlled studies once a high level of efficacy is proven and high benchmarks of defined endpoints are reached. </p><p><b>Protecting Pregnant Women from HIV Infection</b></p><p>Research has shown there are physiological changes in the female body that cause a threefold increase in the risk of contracting HIV while pregnant.<span style="font-size: xx-small;">[5]</span> This is especially troubling for countries where HIV is at an endemic level. Medications for HIV treatment and prevention are powerful, and it is crucial to find safe pharmaceuticals that will not harm the mother or the developing fetus.</p><p>At CROI, data from a multi-country (South Africa, Uganda, and Zimbabwe) clinical study presented safe options. A monthly flexible vaginal ring containing dapivirine as well as oral daily tenofovir disoproxil fumarate/emtricitabine PrEP (Truvada) were shown to be safe for use for pregnant women. The dapivirine vaginal ring is established in some African countries to be used as HIV prevention for cisgender women who are not pregnant. Truvada has already been proven to be safe for pregnant HIV-positive mothers to use.</p><p>The study was a randomized trial where pregnant women aged 18-40 used the dapivirine ring or received the oral PrEP up until delivery or for 41 weeks and six days, depending on which came first.<span style="font-size: xx-small;">[6]</span> Only 1% experienced stillbirth or miscarriage, 95% of the women’s pregnancies went to term, and 4% of the births were premature.<span style="font-size: xx-small;">[6]</span> Most importantly, none of the women contracted HIV. The results indicate that both the ring and Truvada are safe for pregnant mothers and their unborn fetuses to protect them from infection.</p><p>CROI continues to be a catalyst for pushing HIV and other infectious disease research forward. Scientific communities meet there, spurring the most qualified and passionate minds to collaborate and innovate. Whenever a cure for HIV is found, it would not be surprising if someone at a future session of CROI first presents it.</p><p><span style="font-size: xx-small;">[</span><span style="font-size: xx-small;">1] DiMarco DE, Urban MA, Fine SM, et al. Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections [Internet]. Baltimore (MD): Johns Hopkins University; 2023 Sep. Available from: https://www.ncbi.nlm.nih.gov/books/NBK597440/</span></p><p><span style="font-size: xx-small;">[2] Carstens, A. (2024, March 6). DoxyPEP aces first real-world test. Retrieved from https://www.thebodypro.com/article/croi-2024-doxypep-real-world-clinical-data</span></p><p><span style="font-size: xx-small;">[3] Clinical Trials Arena. (2024, March 7). Gilead-Merck’s combination therapy maintains HIV suppression in trial. Retrieved from https://www.clinicaltrialsarena.com/news/gilead-merck-hiv-trial/?cf-view</span></p><p><span style="font-size: xx-small;">[4] Taylor, P. (2024, March 7). Gilead and MSD say weekly oral therapy controls HIV. Retrieved from https://pharmaphorum.com/news/gilead-and-msd-say-weekly-oral-therapy-controls-hiv</span></p><p><span style="font-size: xx-small;">[5] Salzman, S. (2018, March 9).New study shows women's HIV risk triples during pregnancy, quadruples postpartum. Retrieved from https://www.thebodypro.com/article/new-study-shows-womens-hiv-risk-triples-during-pre</span></p><p><span style="font-size: xx-small;">[6] HIV.gov. (2024, March 5). Vaginal ring and oral Pre-Exposure Prophylaxis found safe for HIV prevention throughout pregnancy. Retrieved from https://www.hiv.gov/blog/vaginal-ring-and-oral-pre-exposure-prophylaxis-found-safe-for-hiv-prevention-throughout-pregnancy</span></p><p><span style="font-size: xx-small;">[7] Reuters. (2024, March 5). GSK's new HIV drug formula could support longer dosing intervals. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-new-hiv-drug-formula-could-support-longer-dosing-intervals-2024-03-04/</span></p><p><span style="font-size: xx-small;">[8] CROI Foundation. (2024). General information about CROI. Retrieved from https://www.croiconference.org/about/</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-13705983964417443242024-03-07T05:44:00.003-05:002024-03-07T05:44:31.102-05:00Through Her Tears, Compassion, and Hope, Hydeia Loren Broadbent Changed the Narrative on HIV/AIDS<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Hydeia Loren Broadbent came into this world on June 14, 1984, and the sun set on her life on February 20, 2024.<span style="font-size: xx-small;">[1]</span> Having been born with HIV, she literally spent her entire life as an advocate for HIV/AIDS prevention and awareness. Hydeia was diagnosed with HIV at a time when HIV was a death sentence, before the advent of the antiviral medications available today, and when HIV/AIDS stigma and fear ran high due to the unknown. As a child, the doctors predicted she would only have a life span of a few years, yet Hydeia defied their odds and lived 39 full, powerful years dedicating her life to making change.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjX-Qbs9reHOl6ZtVhpY0Hs_5tph1MtGmByLzvpg1JEy0kq4f9DRpHthVx8C2vYT_4JQ77BrueW56UsVM2GpmMX-Nce_ijlhg3hcadvKXkixJ3Q-NBWsvV0Jumfz49IJHjnQUihl5E-CnGTMEDnZMJFRDR1ar45v9eFEeKXznDWgjVk3qGdt5_zAbr97s0/s400/Hydeia-1.png" style="margin-left: auto; margin-right: auto;"><img alt="Hydiea Broadbent appearing on Oprha in 1996" border="0" data-original-height="312" data-original-width="400" height="313" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjX-Qbs9reHOl6ZtVhpY0Hs_5tph1MtGmByLzvpg1JEy0kq4f9DRpHthVx8C2vYT_4JQ77BrueW56UsVM2GpmMX-Nce_ijlhg3hcadvKXkixJ3Q-NBWsvV0Jumfz49IJHjnQUihl5E-CnGTMEDnZMJFRDR1ar45v9eFEeKXznDWgjVk3qGdt5_zAbr97s0/w400-h313/Hydeia-1.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: hydeiabroadbent.com</span></td></tr></tbody></table><p>Normalcy and compassion were what Hydeia desired and were the messages she promulgated. When she was seven years old, during a Nickelodeon news special, she told Earvin “Magic” Johnson, “I want people to know that we’re just normal people.”<span style="font-size: xx-small;">[4]</span> HIV/AIDS carried a dark stigma during Hydeia’s earliest years as it was viewed as an intravenous drug user and gay men’s disease. Before Hydeia’s journey, Ryan White had to legally fight for the right to attend public schools in Indiana, far away from Hydeia’s home of Las Vegas, Nevada, before he died in 1990. Even though she was able to start public school, she endured travesties and abuses no child should have had to process. One time in kindergarten, a teacher aware of her HIV status sprayed Clorox bleach on her when she sneezed.<span style="font-size: xx-small;">[2]</span> After that incident, Hydeia was homeschooled with tutors until she started junior high school.<span style="font-size: xx-small;">[2]</span></p><p>Hydeia was born with HIV in 1984 but was not diagnosed until the age of three. She was adopted at six weeks of age before HIV testing was normalized. Hydeia’s birth mother was denied custody due to drug addiction, hence Hydeia ended up in the adoptive system.<span style="font-size: xx-small;">[2]</span> Hydeia’s adoptive parents had her tested when they were notified by health officials her birth mother had given birth to another child that she and the child were HIV positive. By age five, Hydeia’s condition had progressed to AIDS. She was one of the first pediatric patients treated with AZT. Rubgie Lucas, an infectious disease investigator in Clark County, where Vegas is located, remembered Hydeia stating, "We had to learn how to treat her because the adult medication was too strong."<span style="font-size: xx-small;">[3]</span> Anthony S. Fauci remembers treating Hydeia at the National Institutes of Health (NIH). Regarding her life, he stated, “her accomplishments are substantial.”<span style="font-size: xx-small;">[2]</span></p><p>Hydeia touched many lives both domestically and internationally. She traveled around the world spreading awareness about HIV/AIDS, advocating for treatment and care, and promoting prevention through abstinence and safer sex practices. She is well known for her activism and high-profile public speaking moments, such as when she was on the Oprah Winfrey Show at age 11. Her passion and mission also gave her a platform on shows such as Good Morning America and 20/20.<span style="font-size: xx-small;">[5] </span>Hydeia was featured in many publications such as <i>The New York Times</i>, <i>People</i>, <i>National Geographic</i>, <i>Ebony</i>, <i>POZ</i>, and was even on the cover of <i>TV Guide</i>.<span style="font-size: xx-small;">[5]</span> Her knowledge, poise, and personable nature opened doors for many speaking engagements. She spoke to audiences singularly and as a part of panels at institutions such as Morehouse School of Medicine, Duke University, and UCLA. In 2006, Hydeia was a speaker at the International AIDS Conference.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7jiCqT8E0UDAM7SYkB0Xz0vgmPrz4nMVwsyhKCKnu35dXJzed1XfALcJz0h1e7cc3cb-avirIhZOXTe5JBgs9ba5lhm3mEt7LhUMyNZdgpw1BF0Q2_jzXrGIyhoCfo1PgHAzeHO-QDIDxD7XRulEH6PPT2fZeRC0TsxCKsD8KUu8MWtPNgBbhd1VnQlk/s1266/Screenshot%202024-03-07%20at%205.42.51%E2%80%AFAM.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Hydeia Broadbent" border="0" data-original-height="840" data-original-width="1266" height="265" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7jiCqT8E0UDAM7SYkB0Xz0vgmPrz4nMVwsyhKCKnu35dXJzed1XfALcJz0h1e7cc3cb-avirIhZOXTe5JBgs9ba5lhm3mEt7LhUMyNZdgpw1BF0Q2_jzXrGIyhoCfo1PgHAzeHO-QDIDxD7XRulEH6PPT2fZeRC0TsxCKsD8KUu8MWtPNgBbhd1VnQlk/w400-h265/Screenshot%202024-03-07%20at%205.42.51%E2%80%AFAM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: <span style="caret-color: rgb(153, 153, 153);">hydeiabroadbent.com</span></span></td></tr></tbody></table><p>Hydeia gave of herself selflessly while simultaneously dealing with her own humanity. As she spoke to the world as a child, she still dealt with serious health issues such as blood infections, brain fungus, and heart issues. While navigating the demands of being a very public figure, she had to deal with her personal life. She expressed how hard it was to date given her diagnosis yet was optimistic about finding love and being married one day. During her teen years, at the height of her speaking and advocacy, she dealt with depression and perfection anxiety to the point of resenting being such a public figure and speaking to the world. She stated during an episode of Where Are They Now on Oprah’s OWN network that she had to find her inner peace.</p><p>In 39 years, Hydeia experienced more life than most people could handle or even comprehend, no matter how long they lived. She experienced HIV/AIDS from the very beginning before there were many treatments through the advent of antiviral drug cocktails. Her life and message touched millions internationally. Hydeia represented children born with HIV, was the face of African American women living with HIV and was a pioneer who forged her way just like Ryan White. She was once quoted as saying, “…with all that we know about the virus, it is clear to me that contracting HIV/AIDS today is a choice, and we can’t allow anyone the power to make that choice for us!”. Hydeia’s legacy is a life fulfilled and a continuing burning torch of compassion and hope to continue to be passed along until we one day conquer HIV/AIDS.</p><p><span style="font-size: xx-small;">[1] Schilken, C. (2024, February 2022). Hydeia Broadbent, who teamed up with Magic Johnson in HIV/AIDS fight, dies at 39. Retrieved from https://www.msn.com/en-us/health/other/hydeia-broadbent-who-teamed-up-with-magic-johnson-in-hivaids-fight-dies-at-39/ar-BB1iJLdt?ocid=socialshare</span></p><p><span style="font-size: xx-small;">[2] Langer, E. (2024, February 23). Hydeia Broadbent, young activist for HIV/AIDS awareness, dies at 39. Retrieved from http://www.washingtonpost.com/obituaries/2024/02/23/hydeia-broadbent-hiv-aids-dead/</span></p><p><span style="font-size: xx-small;">[3] Nomura, A. (2024, February 27). Retired county disease investigator reflects on late HIV/AIDS activist from Las Vegas. Retrieved from https://www.msn.com/en-us/health/other/retired-county-disease-investigator-reflects-on-late-hivaids-activist-from-las-vegas/ar-BB1j04HL?ocid=socialshare</span></p><p><span style="font-size: xx-small;">[4] Kornelis, C. (2024, February 23). Hydeia Broadbent, Who Helped Change the Conversation About HIV/AIDS, Dies at 39. Retrieved from https://www.msn.com/en-us/health/other/hydeia-broadbent-who-helped-change-the-conversation-about-hivaids-dies-at-39/ar-BB1iMwJU?ocid=socialshare</span></p><p><span style="font-size: xx-small;">[5] BounceTV. (2020). Community Activist Award 2020 Trumpet Award Bio. Retrieved from https://www.trumpetawards.com/award-honoree/hydeia-broadbent/1184/#:~:text=Broadbent%20is%20also%20considered%20a,Award%20and%20an%20Essence%20Award.</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-28332795075890202732024-02-29T06:31:00.018-05:002024-02-29T11:16:14.287-05:00Evidence Suggest Long-Acting Injectables Game Changer for Adherence<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Adherence to medication is one of the most important tenets of antiretroviral therapy (ART) for people living with HIV (PLWH). Adherence is taking the appropriate medications in the proper dosages on the correct schedule. Reaching an undetectable viral load requires strict adherence, with which many PLWH have difficulty for various reasons. The recent innovation of long-acting injectables (LAI) is an attempt to strengthen adherence for PLWH who have difficulty with pill regimens. In January 2021, the U.S. Food & Drug Administration (FDA) <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv" target="_blank"><span style="color: #3d85c6;">approved Cabenuva</span></a>, the first injectable drug combination for HIV.<span style="font-size: xx-small;">[2,5]</span> GSK recently released results from clinical trial data indicating Cabenuva works better than daily pills for patients with adherence challenges.<span style="font-size: xx-small;">[1,4,5,6]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlyri7oXumQ7xfZfYVzUC5rGP9T1WAbihmO4OKYfvBsp-_jKZY4BxeFNV5iksNx23VM_uZcHckAb9vxHouJEuC48oj8Npk1i6TqcsSDooLcaS_3zDLZvTWG-uUPuC_qOGB2X7HWQCnqHgMcIjWEzmx8OzEK1d1Pf4FiXIm1Uy8R7E9ZaUUsZso0ryRjvg/s1030/Cabenuva_Vials_and_Packaging_Closed.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Cabenuva" border="0" data-original-height="1030" data-original-width="1030" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlyri7oXumQ7xfZfYVzUC5rGP9T1WAbihmO4OKYfvBsp-_jKZY4BxeFNV5iksNx23VM_uZcHckAb9vxHouJEuC48oj8Npk1i6TqcsSDooLcaS_3zDLZvTWG-uUPuC_qOGB2X7HWQCnqHgMcIjWEzmx8OzEK1d1Pf4FiXIm1Uy8R7E9ZaUUsZso0ryRjvg/w400-h400/Cabenuva_Vials_and_Packaging_Closed.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Pharmalive</span></td></tr></tbody></table><p>Cabenuva is a two-injection regimen of cabotegravir and rilpivirine administered either once a month or once every two months.<span style="font-size: xx-small;">[7]</span> This month, GSK released data from the <a href="https://www.nih.gov/news-events/news-releases/nih-trial-evaluates-long-acting-hiv-medication-unable-adhere-strict-daily-regimens" target="_blank"><span style="color: #3d85c6;">LATITUDE</span></a> (Long-Acting Therapy to Improve Treatment Success in Daily Life) study comparing the efficacy of Cabenuva in contrast with daily pill regimens regarding adherence.<span style="font-size: xx-small;">[1]</span> The screened participants were verified as having challenges with ART adherence. They were initially given a three-drug oral ART regimen, receiving comprehensive and incentivized adherence support.<span style="font-size: xx-small;">[1]</span> Once they were virally suppressed, they were randomly selected to receive Cabenuva injections every four weeks or continue with daily pill therapy.<span style="font-size: xx-small;">[1]</span> The strong evidence of superior efficacy of Cabenuva over daily pill therapy led the Data Safety Monitoring Board (DSMB) for Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) to recommend removal of the randomization and offer all participants the option to take Cabenuva.<span style="font-size: xx-small;">[1]</span></p><p>This new development is an optimistic win in the fight against HIV. Joey Wynn, activist and chair of the ADAP Long-Acting Injectables Patient Advisory Committee, states, “Although definitely not for everyone, this is the next phase of evolution in HIV therapy. Injections allow us to get on with our lives and not be weighed down with the daily burden of taking pills.” </p><p>There are many reasons daily pill therapy adherence is a challenge for some. Psychologically, taking daily pills is a reminder of disease that is too much for some to handle. There are people with developmental challenges who can't keep up a daily regimen. Stigma and privacy are adherence challenges for PLWH in living situations that are not safe or supportive, where the discovery of medication bottles is not ideal or dangerous.<span style="font-size: xx-small;">[2,3]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg2x1dJgdlZynimAnGfwm3nTneNyfzd8G9jJ50NyFYWVtD3O4tSf0fLXloR8tLU6y95z2u3R46yHGGDiI5bHjOGideqoAMDVzR2S_L82kK-ohRtLOFVqXPE6_EQ7HQ82cm62oplBGoslMnj5EZxEWglVoxDTZl5SVChoNonHqOU5ETL5hIkCUA3N__j_zg/s1157/20190509-dailymedsbox.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Weekly Pill Planner" border="0" data-original-height="825" data-original-width="1157" height="285" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg2x1dJgdlZynimAnGfwm3nTneNyfzd8G9jJ50NyFYWVtD3O4tSf0fLXloR8tLU6y95z2u3R46yHGGDiI5bHjOGideqoAMDVzR2S_L82kK-ohRtLOFVqXPE6_EQ7HQ82cm62oplBGoslMnj5EZxEWglVoxDTZl5SVChoNonHqOU5ETL5hIkCUA3N__j_zg/w400-h285/20190509-dailymedsbox.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: NIAID</span></td></tr></tbody></table><p>As Riley Johnson, project manager for ADAP Advocacy's Long-Acting Injectables Project, points out, “LAIs can mean consistent medication instead of having meds lost or stolen and having to navigate bureaucratic hoops to pursue replacement.”</p><p>While very promising, Cabenuva does have hurdles to its implementation. Presently, there are three main criteria to be eligible for Cabenuva. It is only approved for PLWH who are virally suppressed, have documented absence of resistance to either cabotegravir or rilpivirine, and have no prior antiretroviral treatment failures.<span style="font-size: xx-small;">[2]</span> Viral suppression requires adherence to oral medication, which is the challenge LAIs were created to remedy. In 2019, the Centers for Disease Control & Prevention (CDC) estimated that only 56.8% of PLWH were virally suppressed or undetectable.<span style="font-size: xx-small;">[2]</span> This means that less than half of PLWH in the U.S. would qualify for Cabenuva. </p><p>Just as with pill regimens, cost is also a hurdle for widespread adoption. The wholesale acquisition cost of the initial/loading dose is $5,940, and monthly/maintenance injections are $3,960.<span style="font-size: xx-small;">[5]</span> Insurance companies must approve Cabenuva before patients can begin therapy. This is an access issue for those who do not have medical insurance. It is also an access issue for those with insurance because some insurance companies do not have an official classification of Cabenuva as a pharmaceutical or healthcare benefit. Thus, even though ViiV Healthcare has a payment assistance program for those who have commercial insurance, the lack of clarity of benefit status means ambiguity in which costs will be billed to patients and which to insurance companies.<span style="font-size: xx-small;">[2]</span></p><p>Studies have shown that multiple social determinants of health affect many patients' ability to maintain adherence regarding pill regimens. The same challenges apply to Cabenuva. Cabenuva must be administered in a healthcare setting by a health professional. Even though the visits would only be monthly or bi-monthly, that still poses a challenge for PLWH who lack reliable and affordable transportation. While pill forms of the medications are available for emergency doses if a patient misses an injection, on-time injections of Cabenuva are imperative to ensure resistance to either of the components does not occur.<span style="font-size: xx-small;">[2]</span> Shipping doses of emergency medication is not viable for people with unstable housing or living situations where receiving medication is not optimal.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXWTWYsun_1B6LXDwihWLJIyTTM6hb9kUmzaP3barsG-NpxHZ6iknYfxKikxSRlb6jQ_1iLlWxGGxTiEPV2miUjypvIgyILxeyT9IP0maY6v9qSqgmB9T8Nr6NPR8AUen0t5QOqu4b_YWEwJbw7O1nZRakx5Fva7oipw66f21_Wd1BqrLPUTdVYTmqYrI/s800/Adherence-800.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Adherence" border="0" data-original-height="387" data-original-width="800" height="194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXWTWYsun_1B6LXDwihWLJIyTTM6hb9kUmzaP3barsG-NpxHZ6iknYfxKikxSRlb6jQ_1iLlWxGGxTiEPV2miUjypvIgyILxeyT9IP0maY6v9qSqgmB9T8Nr6NPR8AUen0t5QOqu4b_YWEwJbw7O1nZRakx5Fva7oipw66f21_Wd1BqrLPUTdVYTmqYrI/w400-h194/Adherence-800.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: HIV.gov</span></td></tr></tbody></table><p>Widespread adoption of Cabenuva also requires providers to adopt changes. Currently, with HIV healthcare, patients on established therapy only see their infectious disease doctors once or twice a year, and the responsibility of pill treatment adherence is on the patient. With Cabenuva injections, the facility's operational flow is disrupted since the injections require more frequent visits. Additionally, responsibility is added to the medical practices by ensuring patients do not miss their injection appointments and following up with them when they do. Moreover, practitioners must be trained in the z-track injection technique required for the intramuscular injection and have proper refrigeration equipment to store the Cabenuva between 2°C and 8°C.<span style="font-size: xx-small;">[8]</span></p><p>The recent data from the Cabenuva trial is a promising step in the right direction, though not without its challenges. Joey Wynn adds, “Understandably, there are issues of access for those on private insurance, clinic flow issues, and limited distribution shortages, meaning advocates need to demand improved pipeline delivery from the manufacturer so people can get what they need/want/require with less difficulties.” Riley Johnson adds, “no degree of adherence is possible if the medication is not available or accessible.” To ensure the success of the LAI landscape, policy and holistic community support will be required to keep up with the advances of science.</p><p><span style="font-size: xx-small;">[1] GSK. (2024, February 21). Press release: LATITUDE phase III interim trial data indicates ViiV Healthcare’s long-acting injectable HIV treatment Cabenuva (cabotegravir + rilpivirine) has superior efficacy compared to daily therapy in individuals living with HIV who have adherence challenges. Retrieved from https://www.gsk.com/en-gb/media/press-releases/latitude-phase-iii-interim-trial-data-indicates-cabenuva-has-superior-efficacy-compared-to-daily-therapy/</span></p><p><span style="font-size: xx-small;">[2] Pinto, R. M., Hall, E., & Tomlin, R. (2023). Injectable Long-Acting Cabotegravir-Rilpivirine Therapy for People Living With HIV/AIDS: Addressing Implementation Barriers From the Start. The Journal of the Association of Nurses in AIDS Care: JANAC, 34(2), 216–220. https://doi.org/10.1097/JNC.0000000000000386</span></p><p><span style="font-size: xx-small;">[3] Simoni, J. M., Tapia, K., Lee, S. J., Graham, S. M., Beima-Sofie, K., Mohamed, Z. H., Christodoulou, J., Ho, R., & Collier, A. C. (2020). A Conjoint Analysis of the Acceptability of Targeted Long-Acting Injectable Antiretroviral Therapy Among Persons Living with HIV in the U.S. AIDS and Behavior, 24(4), 1226–1236. https://doi.org/10.1007/s10461-019-02701-7</span></p><p><span style="font-size: xx-small;">[4] Hart, R. (2024, February 21). First long-acting injectable HIV treatment works better than daily pills for some patients, GSK says. Retrieved from https://www.msn.com/en-us/health/other/first-long-acting-injectable-hiv-treatment-works-better-than-daily-pills-for-some-patients-gsk-says/ar-BB1iDCzR?ocid=socialshare</span></p><p><span style="font-size: xx-small;">[5] Bernstein, L. (2021, January 22). FDA approves breakthrough injectable HIV medication. Retrieved from FDA approves breakthrough injectable HIV medication</span></p><p><span style="font-size: xx-small;">[6] Liu, A. (2024, February 21).GSK’s long-acting HIV med Cabenuva beats daily therapy in patients who've faced adherence hurdles. Retrieved from https://www.fiercepharma.com/pharma/cabenuva-trial-modified-gsks-long-acting-hiv-med-beat-daily-therapy-patients-adherence</span></p><p><span style="font-size: xx-small;">[7] VIIV Healthcare. (2024, January). Cabenuva. Retrieved from https://www.cabenuva.com/ </span></p><p><span style="font-size: xx-small;">[8] De Vito, A., Botta, A., Berruti, M., Castelli, V., Lai, V., Cassol, C., Lanari, A., Stella, G., Shallvari, A., Bezenchek, A., & Di Biagio, A. (2022). Could Long-Acting Cabotegravir-Rilpivirine Be the Future for All People Living with HIV? Response Based on Genotype Resistance Test from a Multicenter Italian Cohort. Journal of personalized medicine, 12(2), 188. https://doi.org/10.3390/jpm12020188</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-28220113069573645402024-02-22T09:16:00.003-05:002024-02-22T20:05:55.924-05:00Prior Authorization: A Growing Headache for Patients<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Amidst all the complicated machinations of the U.S. healthcare system, the ultimate focus should be the patient's best interests. Unfortunately, many barriers interfere with physicians and patients working together for the most optimal outcomes. One of those pervasive barriers is prior authorization. Prior authorization (PA) is when insurers require healthcare providers to obtain pre-approval for things such as services, procedures, durable medical goods, and medications. The pre-approval is required before insurance companies will agree to pay for a requested intervention. Insurance industry messaging claims that prior approvals are in the best interests of patients to make sure that inappropriate care is not needlessly utilized, thus saving them money, lowering healthcare system expenditures, and ensuring only the most effective options for care are chosen by physicians. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXc-kt0LUu1YCmKItgBOiZ1PH0klpfaOnV7Hbk_uIcKjkbKhegYaHeeLpmF1WfMt0wUcjBOhXDZkKZVFFhIEqLGIAi3T8t2aq1sQf0yzNgIHStpkoaF2cJd0ZRvy44KvsJZu6Fu722h5m0qwNOhMhCVr2tfqAvRDflHnVq-BuB25dhen3FWiOeRE4HaBE/s894/Screenshot%202024-02-22%20at%209.10.52%E2%80%AFAM.png" style="margin-left: auto; margin-right: auto;"><img alt="Frustrated physician with head in hands." border="0" data-original-height="376" data-original-width="894" height="169" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXc-kt0LUu1YCmKItgBOiZ1PH0klpfaOnV7Hbk_uIcKjkbKhegYaHeeLpmF1WfMt0wUcjBOhXDZkKZVFFhIEqLGIAi3T8t2aq1sQf0yzNgIHStpkoaF2cJd0ZRvy44KvsJZu6Fu722h5m0qwNOhMhCVr2tfqAvRDflHnVq-BuB25dhen3FWiOeRE4HaBE/w400-h169/Screenshot%202024-02-22%20at%209.10.52%E2%80%AFAM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Salon (Getty Images/FG Trade)</span></td></tr></tbody></table><p>However, PAs are not in patients' best interests but are a method of cost control or cost-cutting to save insurers money. Jen Laws, CEO of Community Access National Network, states, “Taking a note from auto carriers, payers have been utilizing prior authorization as a bet that most folks don't have time, energy, or navigation experience enough to fight for the care patients rightly need. It's delay and deny on the bet that patients will give up." PAs have detrimental effects on patient health outcomes, interfere with the patient-physician relationship, unduly burden physicians, and ultimately generate more healthcare spending, because of medical interventions needed because of the poor patient outcomes they can cause.</p><p>For several years, many groups have been fighting for prior authorization reform. Recently, in a step in the right direction, the Centers for Medicare and Medicaid Services (CMS) released their Final Prior Authorization and Interoperability Rule (CMS-0057-F).<span style="font-size: xx-small;">[9]</span> Even though it is a win for patients and providers, it is not enough. As such, legislatures nationwide are working on state-level legislative remedies to the prior authorization problem. Some states have already passed more stringent measures, and others have bills in process.<span style="font-size: xx-small;">[6]</span></p><p>The new rule has many details, but there are some notable highlights. A significant problem with the prior authorization process is the excessive time burden placed on medical providers.<span style="font-size: xx-small;">[1]</span> According to a 2022 American Medical Association (AMA) survey, physicians and their staff spend an average of about 14 hours, roughly two business days per week, completing around 45 PAs per physician.<span style="font-size: xx-small;">[7]</span> Historically, much of the PA process is manual, requiring long phone calls and forms to be filled out, faxed, or sent through postal mail. The CMS rule helps with this by requiring insurers to support an electronic prior authorization process that is embedded in the physician’s electronic health records. This streamlines the process and helps with automation since the electronic health record is a centralized place where physicians do much of their work. Patients regularly see their physician typing things like notes and prescription requests in the examination room during their visits.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7pb8g8YFYZBdlhVNOiSHYiRM3RIcVROpbt3Er350QSJ6qcsoQRSsf68JmpzkXYtwcPQ0I_BytNP29bl7edw5dSPBYYyFXaEu1RA6x6sCJjrMjMrlPziv8vIchBzExkr7Z5tPcTedtiVnba2WZzWFSrqiFgw4IEm0GqeekRWqxrL3231qRvkO3qxSeJL0/s1296/Screenshot%202024-02-22%20at%209.13.05%E2%80%AFAM.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Chart showing care delays associated with PA." border="0" data-original-height="1078" data-original-width="1296" height="333" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7pb8g8YFYZBdlhVNOiSHYiRM3RIcVROpbt3Er350QSJ6qcsoQRSsf68JmpzkXYtwcPQ0I_BytNP29bl7edw5dSPBYYyFXaEu1RA6x6sCJjrMjMrlPziv8vIchBzExkr7Z5tPcTedtiVnba2WZzWFSrqiFgw4IEm0GqeekRWqxrL3231qRvkO3qxSeJL0/w400-h333/Screenshot%202024-02-22%20at%209.13.05%E2%80%AFAM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: American Medical Association</span></td></tr></tbody></table><p>Another remedy the new CMS rule delivers is transparency. When PAs are often denied, physicians and patients don’t know why since the insurers don’t give clear reasoning. They respond with opaque responses such as deeming a requested medical intervention as ‘medically unnecessary’. The new rule requires insurers to give very specific reasons for denial. This will not only enable providers to refute and appeal denials more effectively but can result in more accountability of insurers. Having to provide precise reasoning will result in insurers being more cautious with denials. CMS furthers transparency requirements by requiring metrics reporting. The new rule requires insurers to publicly report their actions such as how often they approve and deny PAs, how long they take to make decisions, as well as the frequency of denials and approvals by medical ailment category. This will enable patients to be informed consumers as they shop for insurance coverage. </p><p>The new CMS rule has many positive details but also limitations. The ruling does not pertain to prescription drugs. The ruling also only applies to government-regulated health plans such as Medicaid, CHIP, Medicaid managed care plans, and plans on the healthcare exchange. The electronic PA requirement goes into effect in 2027, and the metric reporting goes into effect in 2026. To create more substantial changes, some states have already passed PA reform legislation, and many others are working on it. The District of Columbia has already passed legislation with some of the same aspects as the CMS ruling, but also goes further.</p><p>The District of Columbia passed Bill 25-124, which became ACT 25-301 in November 2023.<span style="font-size: xx-small;">[5]</span> The act has an electronic PA requirement in the same manner as the CMS rule. It requires all review entities to accept and respond to PA requests using their NCPDP SCRIPT Standard ePA transaction by January 1, 2024.<span style="font-size: xx-small;">[5]</span> The D.C. Act goes beyond the CMS ruling regarding required timeframes for PA decisions. The CMS ruling requires review entities to respond within 72 hours for expedited urgent care PA requests and within seven days for standard requests. The D.C. Act requires review entities to respond within 24 hours with approval or denial of urgent care PA requests.<span style="font-size: xx-small;">[5]</span> For standard requests, it specifies a response within three business days by electronic portal or five business days by mail, fax, or telephone.<span style="font-size: xx-small;">[5]</span></p><p>North Carolina is one of the states with pending PA legislation. Its details also contain some requirements that are more stringent than those of CMS. Like the D.C. Act, one highlight is its timetable for review response specification. For non-urgent healthcare services PA requests, an insurer must decide within 48 hours of obtaining all required information and within 24 hours for urgent care requests.<span style="font-size: xx-small;">[10]</span> The North Carolina bill also contains transparency language. Suppose the reviewing entity of an insurer questions the medical necessity of a physician’s PA request. In that case, it must notify the provider within five business days of the date of the request.<span style="font-size: xx-small;">[10]</span> Also, before issuing a PA denial, the insurer must allow the affected provider to discuss the need for the medical service on the telephone directly with the medical doctor who will be responsible for the review determination.<span style="font-size: xx-small;">[10]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgwGFWA8Z3thJ9vP5DXsiBmDfdCiX_UBYaYxTAalpzsNVEypvxpDUyT_9wcpc1FlwTaYlWgM3LmnnMjEkKYyEEYXQKYSVPMTDYm4DdYokYQcZDfEBCiUhveMYdhur4A4B9H4tYGjcTuVPcf7X_agwysixCnKoyZpKQc5E7NJvRGZL53qbMTDznHWVSpdvc/s1280/PA-Maze.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Prior Authorization maze with physician in it." border="0" data-original-height="720" data-original-width="1280" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgwGFWA8Z3thJ9vP5DXsiBmDfdCiX_UBYaYxTAalpzsNVEypvxpDUyT_9wcpc1FlwTaYlWgM3LmnnMjEkKYyEEYXQKYSVPMTDYm4DdYokYQcZDfEBCiUhveMYdhur4A4B9H4tYGjcTuVPcf7X_agwysixCnKoyZpKQc5E7NJvRGZL53qbMTDznHWVSpdvc/w400-h225/PA-Maze.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: American Medical Association</span></td></tr></tbody></table><p>Current and developing state legislation model suggestions supported by the AMA. One of those is “gold carding”. Five states have already passed gold carding legislation: Louisiana, Michigan, Texas, Vermont, and West Virginia.<span style="font-size: xx-small;">[6]</span> In gold carding, six months of a medical practice or provider’s prior authorizations are reviewed. If 90% of the requests are approved, then that practice or provider is not subject to any PA requirements for six months.<span style="font-size: xx-small;">[6,8]</span> Maintaining those statistics would be required to maintain the privilege. While on the surface, it seems to be a good way to reduce the volume of PAs, thus reducing administrative time waste, it has a downside. As Jen Laws points out, “Gold carding can come with the incentive for payors to become even more aggressive in their PA and other UM (utilization management) practices because it rests on the idea that a provider can "prove" they don't need review. The best way around that is to merely get more aggressive with UM, moving the goalpost to an unattainable standard.”</p><p>The adverse effects of prior authorizations are well documented. They cause physician burnout, interfere with the patient-provider relationship, and cause delays in patient care.<span style="font-size: xx-small;">[3,7]</span> Delays in patient care can result in avoidable poor patient health outcomes and exacerbation of disease states.<span style="font-size: xx-small;">[2,3,4]</span> In diseases such as cancer, timely and very personalized treatment can be a matter of life and death. Physicians make very informed decisions about their patients’ medical care. When physicians make evidence-based treatment determinations for their patient's best health, they should not be undermined by profit-centric cost-cutting measures that are not based on proper consideration of current medical data. Pushing forward to ensure transparency and accountability is critical. It will take continued federal and state efforts to create a healthcare landscape that genuinely has the patient at its center.</p><p><span style="font-size: xx-small;">[1] Medical Ecconomics. (2023, August 4). 2023 Physician Report: The latest physician salary, productivity and malpractice cost data. Retrieved from https://www.medicaleconomics.com/view/2023-physician-report-the-latest-physician-salary-productivity-and-malpractice-cost-data?slide=18</span></p><p><span style="font-size: xx-small;">[2] Sausser, L. (2023, December 2023). Cancer patients face frightening delays in treatment approvals. Retrieved from https://kffhealthnews.org/news/article/cancer-patients-prior-authorization-treatment-delays/</span></p><p><span style="font-size: xx-small;">[3] Merrill, J. R., Flitcroft, M. A., Miller, T., Beichner, B., Clarke, C. N., Maduekwe, U. N., Wang, T. S., Dream, S., Christians, K. K., Gamblin, T. C., Evans, D. B., & Kothari, A. N. (2023). Patterns of Unnecessary Insurer Prior Authorization Denials in a Complex Surgical Oncology Practice. The Journal of surgical research, 288, 269–274. https://doi.org/10.1016/j.jss.2023.03.013</span></p><p><span style="font-size: xx-small;">[4] Miller, T. (2023, November 7). Big insurance met its match when it turned down a top trial lawyer's request for cancer treatment. Retrieved from https://www.propublica.org/article/blue-cross-proton-therapy-cancer-lawyer-denial#:~:text=Blue%20Cross%20and%20Blue%20Shield%20denied%20payment%20for%20the%20proton,he%20was%20ready%20to%20fight.</span></p><p><span style="font-size: xx-small;">[5] Council of the District of Columbia. (2023, November 15). D.C. ACT 25-301 Prior Authorization Reform Amendment Act. Retrieved from https://lims.dccouncil.gov/downloads/LIMS/52301/Signed_Act/B25-0124-Signed_Act.pdf?Id=180462</span></p><p><span style="font-size: xx-small;">[6] Sable-Smith, B. (2024, February 12). States target health insurers' 'prior authorization' red tape. Retrieved from https://kffhealthnews.org/news/article/states-health-insurers-prior-authorization-legislation-gold-carding/</span></p><p><span style="font-size: xx-small;">[7] American Medical Association. (2023). 2022 AMA prior authorization (PA) physician survey. Retrieved from https://www.ama-assn.org/system/files/prior-authorization-survey.pdf</span></p><p><span style="font-size: xx-small;">[8] American Medical Association. (2024, January 24). Advocacy in action: Fixing prior authorization. Retrieved from https://www.ama-assn.org/practice-management/prior-authorization/advocacy-action-fixing-prior-authorization</span></p><p><span style="font-size: xx-small;">[9] Centers for Medicare and Medicaid Services. (2024, January 17). CMS Finalizes rule to expand access to health information and improve the prior authorization process. Retrieved from https://www.cms.gov/newsroom/press-releases/cms-finalizes-rule-expand-access-health-information-and-improve-prior-authorization-process</span></p><p><span style="font-size: xx-small;">[10] North Carolina General Assembly. House Bill 649 - Ensure Timely/Clinically Sound Utiliz. Review. Retrieved from https://www.ncleg.gov/Sessions/2023/Bills/House/PDF/H649v0.pdf</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-30698785107032550582024-02-15T07:07:00.001-05:002024-02-22T09:02:03.098-05:00NHBS-Trans Sheds Light on HIV Prevalence Among Transwomen in the United States<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Transgender women have disproportionately higher rates of HIV. It Is estimated that 14% of transwomen in the United States are living with HIV. Numerous studies exist examining HIV in various populations and subgroups. However, data on the mechanisms of HIV in the transgender community is lacking. The Centers for Disease Control & Prevention (CDC) uses data to determine who is most at risk for HIV, and that data comes from healthcare providers. Unfortunately, for a long time, there was no mandate for providers to count transgender patients. Historically, transgender women were categorized as gay and bisexual men, although they have vastly different needs. The 2015 update to the National HIV/AIDS Strategy prioritized data collection for trans people, and its mandate went into effect in 2018. Recently, the CDC released data from a systematic biobehavioral study conducted to examine HIV risk factors among transwomen.<span style="font-size: xx-small;">[1,2,3]</span></p><p></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiqYGPi4sIScliDpZXhYuP_THy_58JlU0dX84icaWIDf00oCIQaw43Lco7Qj66D2nIvV9l-Dm1OJ8ekUHfyL0yPoHF5ZBgI0x3V21GPTvzayRuUQtTDYwpPurCZpgfwGMh8IDG-m6zuoDEPHymIywCZt0jHdZsLqnO6GfcsmECNHBVwnWBMXJbomq3QpTs/s1516/Screenshot%202024-02-13%20at%208.23.01%E2%80%AFPM.png" style="margin-left: auto; margin-right: auto;"><img alt="HIV Prevalence Among Transgender Women in the United States" border="0" data-original-height="764" data-original-width="1516" height="201" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiqYGPi4sIScliDpZXhYuP_THy_58JlU0dX84icaWIDf00oCIQaw43Lco7Qj66D2nIvV9l-Dm1OJ8ekUHfyL0yPoHF5ZBgI0x3V21GPTvzayRuUQtTDYwpPurCZpgfwGMh8IDG-m6zuoDEPHymIywCZt0jHdZsLqnO6GfcsmECNHBVwnWBMXJbomq3QpTs/w400-h201/Screenshot%202024-02-13%20at%208.23.01%E2%80%AFPM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: CDC</span></td></tr></tbody></table><p></p><p>The CDC developed a surveillance system named <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826683/" target="_blank"><span style="color: #3d85c6;">National HIV Behavioral Surveillance Among Transgender Women</span></a> (NHBS-Trans).<span style="font-size: xx-small;">[1]</span> The purpose was to gather data specific to transgender women regarding HIV prevention, risk factors, testing services, and other social determinants affecting HIV treatment and overall health. From 2019 to 2020, the study gathered data from 1,609 transgender women from seven U.S. urban areas: Atlanta, Los Angeles, New Orleans, New York City, Philadelphia, San Francisco, and Seattle.<span style="font-size: xx-small;">[1]</span> Trained interviewers administered anonymous questionnaires utilizing computer tablets and offered free blood rapid HIV testing. The participants were selected through respondent-driven sampling. This means that after an initial seed group of participants was identified through a referral from a community-based organization, they were asked to go out into their communities and recruit others. The study revealed that many factors contribute to the high rate of HIV among transwomen, with discrimination being one of the leading causes.</p><p>Approximately 42% of the study participants tested positive for HIV. Among the black subjects, 62% were living with HIV, 35% of the Hispanic and Latino participants, and 17% of the white participants.<span style="font-size: xx-small;">[2,4]</span> The study data showed that the disproportionately high rate of HIV was due to factors such as lack of access to PrEP, discrimination in employment and healthcare access, homelessness, and even violence and harassment.<span style="font-size: xx-small;">[2,4]</span></p><p>Among all the participants, 17% had no health insurance, 7% had not visited a health provider in the past year leading up to the study, and 63% had household incomes at or below the poverty level. Additionally, 42% had experienced homelessness in the previous 12 months leading up to the study, 17% had been incarcerated, and 34% had received money or drugs in exchange for sex.<span style="font-size: xx-small;">[4]</span> Employment discrimination was intertwined with a lack of healthcare access. People usually get healthcare coverage through their employment. Over 32% of the participants reported having great difficulty finding employment, with 10% stating they had been fired due to being transgender.<span style="font-size: xx-small;">[3,4]</span> Without employment, many were without healthcare insurance. Lack of health insurance results in no access or poor access to HIV care and treatment, lack of access to PrEP, and lack of access to gender-affirming care.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFVrOTgSWIDUwqfCTKeSyl7E_UnJH7elPGIBkwZ_zLd7InNCfdEWCCPb_RNGc5V8k0wCmD0Ia-OuSUCQb4hpSLLu0zE2XLiADn3VK3FTzoSoHPKtWtx-rJDipZSmGo4f4ojGj9ZT_YzTKxYVpWfECDz5LsP5zkoOMPoA-awrwCAnHRKr-RalBRvFFO42I/s1254/iStock-157735844.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Protesters holding signs that read, Trans Rights are Human Rights" border="0" data-original-height="836" data-original-width="1254" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFVrOTgSWIDUwqfCTKeSyl7E_UnJH7elPGIBkwZ_zLd7InNCfdEWCCPb_RNGc5V8k0wCmD0Ia-OuSUCQb4hpSLLu0zE2XLiADn3VK3FTzoSoHPKtWtx-rJDipZSmGo4f4ojGj9ZT_YzTKxYVpWfECDz5LsP5zkoOMPoA-awrwCAnHRKr-RalBRvFFO42I/w400-h266/iStock-157735844.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: iStock | Rights Purchased</span></td></tr></tbody></table><p>Participants who were on Medicaid in states where Medicaid did not cover gender-affirming care were twice as likely to have difficulty finding employment.<span style="font-size: xx-small;">[3]</span> Lack of employment leads to homelessness and housing instability. Moreover, difficulty finding employment leads some transgender women into sex work for survival, which is a high-risk factor for HIV transmission as well as an avenue into possible incarceration.<span style="font-size: xx-small;">[4]</span> Lack of gender-affirming care also adversely affects HIV treatment and prevention. Studies have shown that transgender women receiving gender-affirming care are less likely to contract and transmit HIV.<span style="font-size: xx-small;">[5]</span> This is due to the health education they receive with the care. Additionally, meeting the basic needs of identity allows transgender women to focus on other aspects of their health. Without gender-affirming healthcare, some transgender women take non-prescription hormones, which are potentially damaging to their health. Improper dosages, poor quality of medication, and lack of medical guidance can result in additional poor health outcomes. Moreover, some participants reported not seeking out PrEP or being inconsistent with their medicines out of fear of drug interactions with their hormone therapy. The study highlights the need to couple gender-affirming care with HIV prevention and treatment.</p><p>The study also revealed data regarding abuse and harassment. Approximately 54% of the transgender women in the study reported verbal abuse or harassment because of their identity, with 27% reporting physical abuse.<span style="font-size: xx-small;">[4]</span> Of those reporting physical abuse, 15% reported the abuse from a sexual or intimate partner. Lack of social support and healthy surroundings adds to the mental stress and instability of the lives of these transgender women, which can also lead to illicit drug use as a way to cope. Eighteen percent of the participants had suicidal thoughts. Seven percent had previously made plans, and 4% had attempted suicide.</p><p>The study is not genuinely national since the sampling is from specific urban environments. However, it does highlight the dire need for more research to gather robust data regarding transgender women and HIV. Potentially, data can influence policymakers to create policies to facilitate beneficial access to HIV and gender-affirming care that improves their lives and respects their identities. It is essential to provide safe spaces where transgender women can receive culturally competent care coupled with access to medically sound interventions, prevention, and treatment specific to their needs. Policy intervention is also needed to remove transgender discrimination regarding employment and housing.</p><p><span style="font-size: xx-small;">[1] Kanny D, Lee K, Olansky E, et al. Overview and Methodology of the National HIV Behavioral Surveillance Among Transgender Women — Seven Urban Areas, United States, 2019–2020. MMWR Suppl 2024;73(Suppl-1):1–8. DOI: http://dx.doi.org/10.15585/mmwr.su7301a1</span></p><p><span style="font-size: xx-small;">[2]</span><span style="font-size: x-small;"> Adamczeski, R. (2024, January 28). Transgender women have a higher risk of HIV infections. A new CDC report reveals why. Retrieved from https://www.advocate.com/news/transgender-women-hiv-infections-discrimination</span></p><p><span style="font-size: xx-small;">[3] Adamczeski, R. (2024, January 29). The real reason trans women have high HIV rates. Retrieved from https://www.hivplusmag.com/transgender/trans-women-high-hiv-rates</span></p><p><span style="font-size: x-small;">[4] Centers for Disease Control and Prevention. HIV Infection, Risk, Prevention, and Testing Behaviors Among Transgender Women—National HIV Behavioral Surveillance, 7 U.S. Cities, 2019–2020. HIV Surveillance Special Report 27. Retrieved from http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published April 2021.</span></p><p><span style="font-size: xx-small;">[5] Owen, G. (2023, April 28th). Surprising study indicates trans women in gender-affirming care contract HIV less often. Retrieved from https://www.lgbtqnation.com/2023/04/surprising-study-indicates-trans-women-in-gender-affirming-care-contract-hiv-less-often/</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-87468803145031809302024-02-08T05:44:00.000-05:002024-02-08T05:44:37.045-05:00Feds Tell States to Cover Hep C Medications, Regardless of Substance Use<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>The right to health is a human right recognized in many international human rights documents, such as the 1966 International Covenant on Economic, Social, and Cultural Rights and the World Health Organization’s (WHO) Constitution.<span style="font-size: xx-small;">[1,2]</span> According to the WHO, “Countries have a legal obligation to develop and implement legislation and policies that guarantee universal access to quality health services and address the root causes of health disparities, including poverty, stigma and discrimination.”<span style="font-size: xx-small;">[1]</span> To that end, in recent history, the United States Departments of Justice (DOJ) and Health and Human Services (HHS) have found it necessary to intervene in order to protect citizens’ right to health. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjmFMZGxMzNU732j2Wh9wrt0_j3_gAlWdf-UUly02SGUUuLG1KDRMRwDOkH8k4Hd4v8yMlfEnWkN-wpFW_8OuLwtdqWFbIHcTIYhLOMZam4oEnDTpxrUfCQOS2Uc-wHP8p2RV_qmJIDX8aGfUUztS_t2L8COGMIod34B6CPajoktApl1D7dJ6dH7AO-s5w/s1200/DOJ%20Logo.jpg" style="margin-left: auto; margin-right: auto;"><img alt="U.S. Department of Justice" border="0" data-original-height="799" data-original-width="1200" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjmFMZGxMzNU732j2Wh9wrt0_j3_gAlWdf-UUly02SGUUuLG1KDRMRwDOkH8k4Hd4v8yMlfEnWkN-wpFW_8OuLwtdqWFbIHcTIYhLOMZam4oEnDTpxrUfCQOS2Uc-wHP8p2RV_qmJIDX8aGfUUztS_t2L8COGMIod34B6CPajoktApl1D7dJ6dH7AO-s5w/w400-h266/DOJ%20Logo.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: U.S. Department of Justice</span></td></tr></tbody></table><p>The DOJ Civil Rights Division issued a letter to state Medicaid administrators on January 24, 2024, reminding them of their obligation to ensure that their programs allow people who have both Substance Use Disorder (SUD) and Hepatitis C (HCV) to access direct-acting antivirals (DAAs).<span style="font-size: xx-small;">[3]</span> In the letter, the DOJ and HHS reiterate Medicaid agencies are required to grant this access under the Americans with Disabilities Act (ADA). Under the Act, states cannot discriminate against people with disabilities, which includes SUD. SUD qualifies as a disability because it “substantially limits one or more major life activities and interferes with the operation of key bodily functions.”<span style="font-size: xx-small;">[5]</span></p><p>In 2022, the DOJ reached a settlement agreement with Alabama Medicaid after an investigation of its Medicaid policy. It was denying access to DAAs for people who had consumed drugs or alcohol six months prior to starting treatment and denying payment if they used any drugs during their treatment. The DOJ accused Alabama Medicaid of “imposing non-medically indicated sobriety restrictions for HCV treatment, in violation of the Americans with Disabilities Act (ADA).”<span style="font-size: xx-small;">[4]</span> There was no scientifically evidence-based reasoning for the restriction. </p><p>Alabama Medicaid agreed to multiple stipulations and reporting requirements as part of the settlement. They were required to reverse their sobriety policy for HCV treatment and agree not to create any further restrictions, such as requirements for drug or alcohol counseling.<span style="font-size: xx-small;">[4]</span> Additionally, Alabama Medicaid had to notify Medicaid providers of the change and inform the Alabama Board of Medical Examiners and the Alabama Department of Public Health.<span style="font-size: xx-small;">[4]</span> One notable requirement was notification of all Medicaid recipients of the change, thus informing them of their rights. Interestingly, in the settlement, Alabama Medicaid denied any acknowledgment of any violation of the ADA but framed their cooperation as an amicable negotiated resolution to the matter.<span style="font-size: xx-small;">[4]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiF9ST-44SwaeY__o8XUfgk-Z2FzxFDzyTLiiqDGqzAEPhjsZtm-bcIEGtxQBMrQBbkzmogpzd7O6r2v14d8NU5d7j1xSxBknqgv_Y5SEsYOIarHa0Vo3tcd-C8G_Bz5wV7r_4FH25qJJ8pu700-fly9yW8qaaWwT8PjGtj0rwi4T_16fPrVJzEn5b1z98/s1759/Substance-Use-Disorder-graphic-e1580152397952.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Substance Use Disorder" border="0" data-original-height="1351" data-original-width="1759" height="308" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiF9ST-44SwaeY__o8XUfgk-Z2FzxFDzyTLiiqDGqzAEPhjsZtm-bcIEGtxQBMrQBbkzmogpzd7O6r2v14d8NU5d7j1xSxBknqgv_Y5SEsYOIarHa0Vo3tcd-C8G_Bz5wV7r_4FH25qJJ8pu700-fly9yW8qaaWwT8PjGtj0rwi4T_16fPrVJzEn5b1z98/w400-h308/Substance-Use-Disorder-graphic-e1580152397952.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Arkansas Medical Society</span></td></tr></tbody></table><p>The DOJ utilized the ADA in 2020 to reach a settlement with Massachusetts General Hospital.<span style="font-size: xx-small;">[6]</span> Massachusetts General Hospital denied a cystic fibrosis patient access to be listed on the lung transplant list because he was taking suboxone, a drug used to treat dependence on opioids. The cystic fibrosis damaged his lungs so severely that he needed a lung transplant to live. As part of the settlement, Massachusetts General Hospital paid $170,000 to the patient and $80,000 to his mother.<span style="font-size: xx-small;">[6]</span> The hospital additionally agreed to give ADA training to its staff and end its discriminatory policy. The patient ended up receiving a lung transplant at the University of Pennsylvania.<span style="font-size: xx-small;">[6]</span> Selma Medical, Charwell Operating Nursing Facility, Athena Health Care Systems, Alliance Health, New England Orthopedic Surgeons, and King’s Daughters Medical Center are other providers that reached settlements with the DOJ after violating the ADA by denying healthcare to patients taking medication for SUD.<span style="font-size: xx-small;">[6]</span> </p><p>Utilizing the ADA to ensure health protections for people with SUD is a robust tool. However, under the ADA, protections against discrimination only extend to “a person in recovery who is no longer engaging in the current illegal use of drugs.”<span style="font-size: xx-small;">[7]</span> Protections from being denied healthcare services is an exception or ‘carve-out’: “A person who is currently engaging in the illegal use of drugs can’t be denied healthcare or rehabilitation services because of their current use if they would otherwise qualify for these services.”<span style="font-size: xx-small;">[7]</span> </p><p>That is why the letter issued by the DOJ and HHS is important. Amplifying attention to the matter is a way to prevent harm before it happens since widespread understanding of the exception is lacking policy-wise and programmatically. Although people with SUD have rights, having to fight for their rights when denied care results in treatment delays and poor health outcomes. It is better to address and change policy before issues occur. The letter is guidance and an indication to entities that the DOJ can and will actively seek remedy against infractions. Optimistically, the threat of litigation is enough of a deterrent for entities to examine and modify their policies.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">World Health Organization. (2023, December 1). Human rights. Retrieved from https://www.who.int/news-room/fact-sheets/detail/human-rights-and-health#:~:text=The%20right%20to%20health%20and,of%20physical%20and%20mental%20health.</span></p><p><span style="font-size: xx-small;">[2] Office of the United Nations High Commissioner for Human Rights. n.b. The Right to Health. Retrieved from https://www.ohchr.org/sites/default/files/Documents/Publications/Factsheet31.pdf</span></p><p><span style="font-size: xx-small;">[3] Department of Justice. (2024, January). Letter to State Medicaid Administrators. Retrieved from https://www.justice.gov/d9/2024-01/dear_colleague_letter-state_medicaid_coverage_for_people_with_hcv_and_sud.pdf</span></p><p><span style="font-size: xx-small;">[4] Settlement Agreement between the United States of America and the State of Alabama's Medicaid Agency. (2022, December 5). Retrieved from https://www.justice.gov/opa/press-release/file/1555501/download</span></p><p><span style="font-size: xx-small;">[5] U.S. Department of Justice Civil Rights Divison. (2022, April 5). The ADA and Opioid Use Disorder: Combating Discrimination Against People in Treatment or Recovery. Retrieved from https://www.ada.gov/resources/opioid-use-disorder/#2-does-an-individual-in-treatment-or-recovery-from-opioid-use-disorder-have-a-disability-under-the-ada</span></p><p><span style="font-size: xx-small;">[6] Rahim, H. (2023, Decemeber 26). Does the ADA protect people with substance use disorder from health care discrimination? Retrieved from https://blog.petrieflom.law.harvard.edu/2023/12/26/the-ada-as-protection-from-health-care-discrimination-towards-persons-with-substance-use-disorder/</span></p><p><span style="font-size: xx-small;">[7] ADA National Network. (2020). The Americans With Disabilities Act, Addiction, and Recovery for State and Local Governments. Retrieved from https://adata.org/factsheet/ada-addiction-and-recovery-and-government</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-22711381455399082412024-02-01T05:51:00.001-05:002024-02-01T06:16:10.744-05:00Nicolas Overfield’s Avoidable Tragedy is a Symbolic Failure of Justice<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Access to timely, appropriate care is required for a high quality of life and optimal healthcare outcomes. Vulnerable populations face many challenges to proper care, especially people who are living with HIV (PLWH). Incarcerated PLWH endure compounded harm. The same people who are disproportionately represented in jails and prisons are also disproportionately represented by HIV. Recently reported in the media is the story of a young man, Nicholas Overfield, who lost his life because he was denied his HIV medication while in jail.<span style="font-size: xx-small;">[1]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlS1C9uXjsx5oNDj0HonRLn44bDkPJ7wA61D2q8iy3ObTmLtOYn6tDf66BD96L15cTU6ZKoUbLp5J3-MG12AiarN2_IFgFIaQ1v0oT5N7ylcQ36mf32FjRn3QwmC8uBB-Ac0P9atAEeKHMM9B_M6XMnUOoUDbYEWcalMJehLNnQFZsNEO5JMrEjKkJD70/s1156/Screenshot%202024-01-31%20at%208.12.14%E2%80%AFPM.png" style="margin-left: auto; margin-right: auto;"><img alt="Nicholas Overfield is shown with his mother, Lesley Overfield. She is suing El Dorado County and Wellpath Community Care, a company that contracts with governments to provide medical treatment in correctional facilities. (Overfield family)" border="0" data-original-height="1116" data-original-width="1156" height="386" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlS1C9uXjsx5oNDj0HonRLn44bDkPJ7wA61D2q8iy3ObTmLtOYn6tDf66BD96L15cTU6ZKoUbLp5J3-MG12AiarN2_IFgFIaQ1v0oT5N7ylcQ36mf32FjRn3QwmC8uBB-Ac0P9atAEeKHMM9B_M6XMnUOoUDbYEWcalMJehLNnQFZsNEO5JMrEjKkJD70/w400-h386/Screenshot%202024-01-31%20at%208.12.14%E2%80%AFPM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Los Angeles Times | Overfield family</span></td></tr></tbody></table><p>In February 2022, Nicholas Overfield was arrested and detained at El Dorado County Jail for failure to appear in court.<span style="font-size: xx-small;">[2]</span> Upon his arrest, he informed the police that he was HIV positive and required his HIV medication daily to keep his HIV controlled.<span style="font-size: xx-small;">[2]</span> His medication was present at this home, and his mother gave his medication to the police before they took him away.<span style="font-size: xx-small;">[2]</span> On April 22, 2022, Nicholas’ mother visited him, and he was brought to her in a wheelchair because he was too weak to walk and was unable to speak.<span style="font-size: xx-small;">[2]</span> The following day, his mother confronted a jail nurse demanding the medical care that he needed, and he subsequently ended up being rushed to the hospital that same night, requiring emergent care. After being hospitalized, he was placed into hospice care and died on June 21, 2022.<span style="font-size: xx-small;">[2]</span></p><p>Under the Eight Amendment of the U.S. Constitution, prisoners have a right to receive medical care, especially for serious medical issues, regardless of whether they are housed in a local, state, or federal jail or prison.<span style="font-size: xx-small;">[4]</span> Mandisa Moore-O’Neal, Executive Director of the <a href="https://www.hivlawandpolicy.org" target="_blank"><span style="color: #3d85c6;">Center for HIV Law and Policy</span></a> (CHLP), explains, “It is a fundamental duty to provide the necessary healthcare to those under your care and control, and yet jails and prisons across the country find so many ways to circumvent or all around avoid that duty.” </p><p>It is well-documented that many inmates in jails and prisons receive substandard medical care.<span style="font-size: xx-small;">[3,5,6]</span>. About 19% of inmates haven’t had a single health-related doctor visit since incarceration. The disjointed and weak infrastructure of incarceration health is especially life-threatening for people with chronic health conditions such as HIV. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwL0hqEmcSaQPhJC2y8tsBs4uAAlCB0GTOKw_8D46XXGzIzhnwAaKO7MPPn0Waxx2GLrL9TKv5J6QAUh_VAPjCcX3YACpo5r4mouL51ODSUeKXyX4bL_ENXz6s2NGhV8i5nykGqtCWG1Kmn2OJdNdIeW8S_MHAQYbYcJK1mxHiZy17pDiwFjUpOxr1WPw/s1200/medicalneglect.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Sign that reads, "Medical neglect is cruel and unusual"" border="0" data-original-height="800" data-original-width="1200" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwL0hqEmcSaQPhJC2y8tsBs4uAAlCB0GTOKw_8D46XXGzIzhnwAaKO7MPPn0Waxx2GLrL9TKv5J6QAUh_VAPjCcX3YACpo5r4mouL51ODSUeKXyX4bL_ENXz6s2NGhV8i5nykGqtCWG1Kmn2OJdNdIeW8S_MHAQYbYcJK1mxHiZy17pDiwFjUpOxr1WPw/w400-h266/medicalneglect.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: PBS News Hour</span></td></tr></tbody></table><p>Incarcerated PLWH frequently have long delays in receiving medication, spotty administration of medication, or complete omission. This can result in drug resistance, which can make a person even sicker. In the case of Nicolas Overfield, because he was denied his medication, he progressed to AIDS.<span style="font-size: xx-small;">[2] </span>His lack of proper care in jail also resulted in the failure of his body to fight off the encephalitis varicella-zoster virus that he contracted while incarcerated, which also contributed to his physical decline.<span style="font-size: xx-small;">[2]</span></p><p>Nicolas Overfield’s situation spotlights one of the contributing factors to poor prison healthcare, which is the outsourcing of prison healthcare to private contractors. Marcus J. Hopkins, founder & executive director of the <a href="https://www.appli.org" target="_blank"><span style="color: #3d85c6;">Appalachian Learning Initiative</span></a> (AAPLI), explains, “One of the biggest issues with carceral healthcare provision is that most of it occurs behind a wall of secrecy. As with most services, healthcare provision has been contracted out to private companies, such as Corizon and Wellcare, who use trade secrets laws—specifically the provisions that protect the negotiation of services and prices—to shield the exact services they provide.” </p><p>This makes it hard to gather information since they are characteristically lax in reporting their data. A deep-diving <i>Reuters</i> study of over 500 jails revealed that from 2016-2018, jails relying on one of the five leading jail healthcare contractors had higher death rates than facilities where medical services are run by government agencies.<span style="font-size: xx-small;">[3]</span> Often, some facilities, especially those in smaller jurisdictions with tighter budgets, will hire private contractors for ease of managing health services and to save money.<span style="font-size: xx-small;">[3]</span></p><p>Unfortunately, the means by which some private contractors save money is by denying care, such as not sending inmates to hospitals when care is needed. The contracts these private providers have sometimes do not have proper standards, staffing requirements, and protocols stipulating protocols for health monitoring and hospitalizations.<span style="font-size: xx-small;">[3]</span> When inmates, especially those with chronic and mental health conditions, do not receive care, it is not only dangerous for their well-being but also the well-being of other inmates and staff. Inmates with documented mental health issues can be a danger to themselves and others when they are not effectively monitored and kept on their medications. Additionally, when inmates are not treated and screened for sexually transmitted diseases, diseases spread. Eventually, people in jails and prisons are released back into society. This is a danger to public health at large, releasing people with undocumented and uncontrolled diseases or ailments. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjftEpHI3Eoen76zUBlL5TyNqB6rOyWP_XAVSjOTZ75mGBdbh0sfZDW5t-iPcOJRbS7X7jbQmLkCWc6i9Z49_5U6oA6kQfucPZ5I_m_NuuvS0I3Jh9YY0rKCKgn75Haw7UcwBZutdIa7S-aqTVOZ5Q_aiwAtVTCnJrof6a0B6aoQZH8VUQHH8a1Ok7cQ8M/s505/handsthrucell.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Hand inside prison bars" border="0" data-original-height="343" data-original-width="505" height="271" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjftEpHI3Eoen76zUBlL5TyNqB6rOyWP_XAVSjOTZ75mGBdbh0sfZDW5t-iPcOJRbS7X7jbQmLkCWc6i9Z49_5U6oA6kQfucPZ5I_m_NuuvS0I3Jh9YY0rKCKgn75Haw7UcwBZutdIa7S-aqTVOZ5Q_aiwAtVTCnJrof6a0B6aoQZH8VUQHH8a1Ok7cQ8M/w400-h271/handsthrucell.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: The Lancet | Copyright © 2016 Sakhorn</span></td></tr></tbody></table><p>The largest jail healthcare companies are Wellpath Holdings Inc., NaphCare Inc., Corizon, PrimeCare Medical Inc., and Armor Correctional Health Services Inc.<span style="font-size: xx-small;">[3]</span> Wellpath is the company in charge of the jail where Nicolas Overfield was a pre-trial detainee. Not only is Wellpath private, but it is owned by a private equity firm, which would indicate that it has a targeted interest in saving money and making a profit.[3] Some private jail health contractors state that the levels of healthcare challenges of incarcerated populations are why they have higher death rates. However, studies have shown that when you control for the differences in the health of the overall population as compared to the general population, private prisons still have more deaths.<span style="font-size: xx-small;">[3]</span></p><p>Nicolas Overfield’s avoidable tragedy is a symbolic failure of justice. Ms. Moore-O’Neal expressed, “his incarceration sheds some light on the injustice that is our criminal legal system. The fact that he was even in jail because of a February 2022 arrest for failure to appear in court should have all of us appalled and ready to overhaul this entire system.” Many people like Nicolas Overfield sit in jails and suffer harm and neglect, sometimes fatally before they even make it to trial. Failure to provide constitutionally adequate medical care is not only a legal issue but a human rights issue.</p><p><span style="font-size: xx-small;">[1] Kandel, J. (2024, January 19). ‘A shocking failure’: Inmate died after jail medical staff denied him HIV medication for months, lawsuit alleges. Retrieved from https://lawandcrime.com/lawsuit/a-shocking-failure-inmate-died-after-jail-medical-staff-denied-him-hiv-medication-for-months-lawsuit-alleges/</span></p><p><span style="font-size: xx-small;">[2] Complaint for Damages OVERFIELD v. WELLPATH, et al. (2024, January 16). Retrieved from https://s3.documentcloud.org/documents/24369518/overfield-v-wellpath-complaint.pdf</span></p><p><span style="font-size: xx-small;">[3] Szep, J., Parker, N., Eisler, P., Smith, G. (2020, October 26). Special Report: U.S. jails are outsourcing medical care — and the death toll is rising. Retrieved from https://www.reuters.com/article/idUSL1N2HG0MD/</span></p><p><span style="font-size: xx-small;">[4] Estelle v. Gamble, 429 U.S. 97, 102 (1976).</span></p><p><span style="font-size: xx-small;">[5] Levins, H. (2023, March 6). Reviewing The Flaws of U.S. Prisons and Jails’ Health Care System. Retrieved from https://ldi.upenn.edu/our-work/research-updates/the-flaws-of-u-s-prisons-and-jails-health-care-system/</span></p><p><span style="font-size: xx-small;">[6] Wang, L. (2022, June). Chronic Punishment: The unmet health needs of people in state prisons. Retrieved from https://www.prisonpolicy.org/reports/chronicpunishment.html#insurance</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-48047488568114219632024-01-25T05:58:00.000-05:002024-01-25T05:58:59.824-05:00For People Living with HIV, Why Covid-19 Still Matters<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Even though the COVID-19 pandemic emergency designation is no longer in effect, COVID-19 remains a very present public health issue. Research continues to unearth and examine its mechanisms and effects on the body. Understanding COVID-19 is vital for people living with HIV (PLWH) because co-infection with HIV has different consequences than for those who are HIV-negative. Studies continue to reveal the results of the interactions of HIV and COVID-19 and the realities of long Covid.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfoF9t6qQBmhcHknW6f6Z8xg8CvtWm-QC_mEyiSNoo79ApeGZ69vW1nRZIAHvll62nL3Y7Pxc8RehMFkl9QUCFJ8HuAcFHyaD8LsX_yBCL2NfReqAWmiGV9UIBTKqb5RLnvBfAk05IGsdHgt5dBBH5X3Tq5ghJPXWlhb8KV02HVU4EXwvrd4_3Yz0v9Uc/s1200/cdc-hiv-basics-covid19-1200x1200.png" style="margin-left: auto; margin-right: auto;"><img alt="Living with HIV and Covid-19" border="0" data-original-height="1200" data-original-width="1200" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfoF9t6qQBmhcHknW6f6Z8xg8CvtWm-QC_mEyiSNoo79ApeGZ69vW1nRZIAHvll62nL3Y7Pxc8RehMFkl9QUCFJ8HuAcFHyaD8LsX_yBCL2NfReqAWmiGV9UIBTKqb5RLnvBfAk05IGsdHgt5dBBH5X3Tq5ghJPXWlhb8KV02HVU4EXwvrd4_3Yz0v9Uc/w400-h400/cdc-hiv-basics-covid19-1200x1200.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: HIV.gov</span></td></tr></tbody></table><p>A significant difference discovered regarding HIV and COVID-19 is that PLWH are at a higher risk of being reinfected with COVID-19 after an initial bout. The Centers for Disease Control & Prevention (CDC) and the Chicago Department of Public Health studied 453,000 Chicago residents who contracted COVID-19. They found that 5.2% of HIV-negative people experienced reinfection, while the reinfection rate of PLWH was 6.7%.<span style="font-size: xx-small;">[1]</span> Additionally, data showed that PLWH had higher primary vaccination plus booster rates than the general population at 31.8% and 27%, respectively.<span style="font-size: xx-small;">[1]</span> This supports the hypothesis that HIV infection is a reinfection risk causal factor.</p><p>Increased risk of developing long Covid is another reality of the intersection of HIV and COVID-19. Long Covid is defined as a range of over 200 symptoms that linger or appear after an acute episode of Covid-19.<span style="font-size: xx-small;">[3,6]</span> This wide range of symptoms can last months or years. Frequently reported symptoms of long covid include cognitive impairment (brain fog), incessant fatigue, loss of smell, muscle pain, shortness of breath, post-exertional malaise (inability to recover after exercise), and postural orthostatic tachycardia syndrome (POTS).<span style="font-size: xx-small;">[2,3,4]</span> POTS is a relatively new term to describe a condition that has previously gone without a name. It is an issue with the autonomic nervous system that can cause fainting, rapid heartbeat, and dizziness.<span style="font-size: xx-small;">[5]</span> Additionally, research presented at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI), shows that not only are PLWH more likely to have persistent long Covid symptoms but have an increased risk of developing new diseases such as diabetes, heart disease, and cancer.<span style="font-size: xx-small;">[2,7]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEieeMWv9qryOOUm_poM8Lz-YsLqY2P_bTSAOXIw653D026n9jLbyGrO2i4q_QQq-QV3a_mnxpfq2uqslZjDpzBBBuA1TvsFb80zmECqXNck83OVAx4iXueQguwSeWtyLuICeVTbh3OpAl5Zj2hpACSIpZ5FNF5wBxHEd8LEdr2YfE6ypXNnNhJgXovYx84/s1568/Screenshot%202024-01-23%20at%208.32.24%E2%80%AFPM.png" style="margin-left: auto; margin-right: auto;"><img alt="Long Covid and HIV" border="0" data-original-height="814" data-original-width="1568" height="208" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEieeMWv9qryOOUm_poM8Lz-YsLqY2P_bTSAOXIw653D026n9jLbyGrO2i4q_QQq-QV3a_mnxpfq2uqslZjDpzBBBuA1TvsFb80zmECqXNck83OVAx4iXueQguwSeWtyLuICeVTbh3OpAl5Zj2hpACSIpZ5FNF5wBxHEd8LEdr2YfE6ypXNnNhJgXovYx84/w400-h208/Screenshot%202024-01-23%20at%208.32.24%E2%80%AFPM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Michael Peluso, MD | IAS 2023</span></td></tr></tbody></table><p>Some possible causes of long Covid symptoms are inflammation, persistent SARS-CoV-2 infection, reactivation of existing pathogens, immune responses that don’t return to normal after acute infection, and "leaky gut" condition.<span style="font-size: xx-small;">[2]</span> HIV is already known to cause microbial translocation, known as leaky gut. This means weakened intestinal wall permeability allows bacteria and their toxins into the bloodstream, causing disease. Since studies are showing that long Covid symptoms may be due to the SARS-CoV-2 virus causing loss of gut wall integrity, having HIV compounds that condition.<span style="font-size: xx-small;">[3]</span> Research has also proven that PLWH have higher levels of chronic inflammation, which could compound the inflammation caused by Sars-CoV-2 that raises risks of long Covid.<span style="font-size: xx-small;">[3]</span> PLWH have increased susceptibility to vascular disease and endothelial dysfunction.<span style="font-size: xx-small;">[8]</span> This can worsen long Covid related clotting and heart problems.<span style="font-size: xx-small;">[2,8]</span></p><p>Continuing research is necessary to investigate all the nuances of HIV and Sars-CoV-2 infection. Most notably, it is essential to delineate how long Covid amidst PLWH differs from the general population. At present, it is imperative that PLWH continue to follow medical guidelines concerning staying up to date with COVID-19 vaccinations and remaining consistent in treating comorbid conditions. Research shows that vaccination does reduce the severity of long Covid symptoms, even though it is true that PLWH may experience long Covid at a higher rate than the general population.<span style="font-size: xx-small;">[2,3]</span> Additionally, it is crucial that PLWH are included in clinical trials investigating treatments for long Covid symptoms.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">Kekatos.M. *2923, October 18). People with HIV at higher risk of COVID reinfection: CDC. Retrieved from https://abcnews.go.com/Health/people-hiv-higher-risk-covid-reinfection-cdc/story?id=104035803</span></p><p><span style="font-size: xx-small;">[2] Highleyman, L. (2024, January 17). Are people with HIV at greater risk for long COVID. Retrieved from https://www.poz.com/article/people-hiv-greater-risk-long-covid</span></p><p><span style="font-size: xx-small;">[3] Alcorn, K. (@023, June 13).More evidence that long COVID is more common in people with HIV. Retrieved from https://www.aidsmap.com/news/jun-2023/more-evidence-long-covid-more-common-people-hiv</span></p><p><span style="font-size: xx-small;">[4] Davis, H., Assaf, G., McCorkell, L., Wei, H., Low, R., Re’em, Y., Redfield, S., Austin, J. P., & Akrami, A. (2021). Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine, 38, 101019. https://doi.org/10.1016/j.eclinm.2021.101019</span></p><p><span style="font-size: xx-small;">[5] Morris, A. (2023, February 23). A condition called POTS rose after covid, but patients can’t find care. Retrieved from https://www.washingtonpost.com/wellness/2023/02/27/pots-heart-fainting-long-covid/ </span></p><p><span style="font-size: xx-small;">[6] Davis, H., Assaf, G., McCorkell, L., Wei, H., Low, R., Re’em, Y., Redfield, S., Austin, J. P., & Akrami, A. (2021b). Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine, 38, 101019. https://doi.org/10.1016/j.eclinm.2021.101019</span></p><p><span style="font-size: xx-small;">[7] Yendewa, G. A., Perez, J. A., Patil, N., & McComsey, G. A. (2022). HIV Infection is Associated with Higher Risk of Post-Acute Sequelae of SARS-CoV-2 (PASC) However Vaccination is Protective. Social Science Research Network. https://doi.org/10.2139/ssrn.4276609</span></p><p><span style="font-size: xx-small;">[8] Peluso, Michael J.a; Antar, Annukka A.R.b. Long COVID in people living with HIV. Current Opinion in HIV and AIDS 18(3):p 126-134, May 2023. | DOI: 10.1097/COH.0000000000000789</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-9626476106992996212024-01-18T06:23:00.003-05:002024-01-18T07:22:19.742-05:00FDA Failure: Why Agency's Approval of Floridian Drug Importation Plan Fails Patients on Both Sides of the Border<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>The U.S. Food & Drug Administration (FDA) has started the year off in the news cycle under controversy. The beleaguered federal agency <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program" target="_blank"><span style="color: #3d85c6;">announced on January 5th</span></a> its authorization of Florida’s flawed drug importation program.<span style="font-size: xx-small;">[1]</span> Under section 804 of the Food, Drug, and Cosmetic Act (FD&C Act), the FDA created a pathway for states to import certain prescription medications from Canada.<span style="font-size: xx-small;">[2]</span> A state must submit a section 804 importation program proposal (SIP) to the FDA, which fulfills all requirements specified by the FD&C Act and FDA regulations delineated under the Code of Federal Regulations Title 21 Part 251 (21 C.F.R. part 251).<span style="font-size: xx-small;">[3]</span> Drug prices in Canada are significantly lower than those in the United States, but rooted in a myriad of reasons. The goal, in theory, is to lower the costs of drugs for the consumer by purchasing them at lower prices from Canada. However, Florida’s SIP does not provide lower costs for consumers, threatens the safety of the United States' drug supply, and could cause harm to Canadians. Moreover, in its current approved iteration, Florida’s plan is an acute threat to people living with HIV (PLWH) since many of the proposed drugs for import are HIV treatments. For that reason, ADAP Advocacy was the very first patient advocacy organization to <a href="https://www.adapadvocacy.org/pdf-docs/2024_ADAP_Press_FDA_Florida_Drug_Importation_01-05-24.pdf" target="_blank"><span style="color: #3d85c6;">question the FDA's decision</span></a> after it was made public.</p><div style="text-align: center;"><a href="https://twitter.com/adapadvocacy/status/1743339508521697403" target="_blank"><img alt="ADAP Advocacy Blasts @US_FDA on Florida's Drug Importation Approval - Federal agency's approval of the risky drug importation plan potentially puts the health of people living with HIV at risk https://adapadvocacy.org/pressroom.html #DrugImportation #CounterfeitDrugs #Florida" border="0" data-original-height="380" data-original-width="1202" height="126" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi3f_YqkvU6oa2a6P_WiAz8BfifykouaYRmE_0Ll3Bkh2oCi5FuD94h9MQJ1i7UNGPKzYm4n8UA5srQeTA3BJqQYWykDlspl8e7JHcwm-PQZtsgwZ-F9um0O0UCiuuZbdH-x5btcDfNzKRhKqyjtjIbk6RaWSVGxD98g42ZZLR7-2Ghj8gTIiFI-yIsDKE/w400-h126/Screenshot%202024-01-17%20at%208.07.17%E2%80%AFAM.png" width="400" /></a></div><p>All of the FDA and FD&C Act rules for the importation of prescription drugs from Canada exist to support one central overarching tenet: to significantly reduce the cost of drugs to the American consumer without imposing additional risk to public health and safety. Florida’s plan does not fulfill that tenet. According to Florida’s SIP, the drugs purchased are for those receiving care through the Florida Agency for Healthcare Administration and its Medicaid managed care plans, Agency for Persons with Disabilities (APD), Department of Children and Families (DCF) mental health treatment facilities, Department of Corrections (DOC), and the Department of Health (DOH) county health departments.<span style="font-size: xx-small;">[4]</span> Those served by these entities are a small subset of the overall Floridan population. Additionally, those receiving prescription drugs through these programs already have access to them at very deep discounts and, in some cases, for free. Any resulting cost savings would benefit state drug spending expenditures, not Floridian consumers.</p><p>Cost savings or cost containment is also a challenge due to the logistics required to properly execute the importation program. The section 804 importation program rules require many steps to help ensure the safety of imported medications. One of these critical steps is testing. Testing of every batch of imported medicines is required to verify authenticity, degradation inquiry, and purity to rule out contamination and more.<span style="font-size: xx-small;">[2,3,5]</span> Testing is expensive and requires the usage of FDA-acceptable testing laboratories. Florida plans to use two testing facilities, one mainly functioning as a backup. One is in Detroit, Michigan, and the other is in Fairfield, New Jersey.<span style="font-size: xx-small;">[4]</span> There is only one FDA-approved U.S. Customs and Border Protection (CBP)port of entry for eligible imported drugs, which is in Detroit.<span style="font-size: xx-small;">[4]</span> Thus, there are costs associated with temperature-controlled transport of medications to testing facilities.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXOx-o8zIiRUe4OoDwZ2YAgK1cQw51ob4Wh3XToAKjkVZmkhrpi-hyG3OWkTpNB4G9tbT2HsN_uCdzoe1zfXraPsTm7uOkuArx21GXz0m_k1HKTLFXhSCVkGVnSQosxxrVxh5v-0PyOCNQhokPnF-KbRn7rP9SCfKy5miwVGRdYUBQV3K05fQIkYnfacs/s1024/FDAimage.jpg" style="margin-left: auto; margin-right: auto;"><img alt="U.S. Food & Drug Administration headquarters" border="0" data-original-height="576" data-original-width="1024" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXOx-o8zIiRUe4OoDwZ2YAgK1cQw51ob4Wh3XToAKjkVZmkhrpi-hyG3OWkTpNB4G9tbT2HsN_uCdzoe1zfXraPsTm7uOkuArx21GXz0m_k1HKTLFXhSCVkGVnSQosxxrVxh5v-0PyOCNQhokPnF-KbRn7rP9SCfKy5miwVGRdYUBQV3K05fQIkYnfacs/w400-h225/FDAimage.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: US Times Mirror</span></td></tr></tbody></table><p>The costs are just a fraction of the multitude of costly logistical details on both sides of the Canadian border required to implement Florida’s importation plan. The state has a $38 million contract with a logistics company for the administration and operation of the program.<span style="font-size: xx-small;">[6]</span> This cost is in addition to paying for the drugs purchased under the program. Not only are most Floridians not receiving any consumer relief from prescription drug costs, but as taxpayers, their money is paying for the program. Research by Dr. Kristina M.L. Acri revealed that costs associated with conducting proper testing of imported drugs cancel out any potential savings.<span style="font-size: xx-small;">[7]</span></p><p>The logistics of implementing the program is also part of why it has the potential to add risk to public health and safety. Section 804 and the FDA regulations stipulate extensive and detailed requirements such as reporting on the origin of medications and their manufacturing, the documentation of the controlled chain of custody of drug batches, verifying that all Canadian suppliers receive drugs from FDA-approved manufacturers, and even requiring a detailed system for notification and retrieving drugs that have been recalled. Proper execution requires many moving parts and geographical locations, providing multiple points of possible compromise. The massive implementation will also result in subcontracting for various aspects, posing another potentially disastrous failure that can result in counterfeit medications, lowered efficacy of drugs due to improper storage or transport, or even adulterated or tampered medications. Moreover, Canada does not have a track and trace system like the United States; thus, there is no solid way to verify true transparency back to a non-US manufacturer.<span style="font-size: xx-small;">[8]</span></p><p>On the other side of harm is the damage Florida’s drug importation program could potentially be due to the Canadian system. <a href="https://adapadvocacy.org/boardofdirectors.html#lf" target="_blank"><span style="color: #3d85c6;">Lyne Fortin, B.Pharm, MBA</span></a>, who serves on ADAP Advocacy's board of directors, offered her insights from the Canadian perspective: "In recent years, 1 in 5 approved prescription drugs in Canada have been in out-of-stock situations, creating already enormous pressure on the public Canadian Healthcare which continues to introduce regulatory safeguards against US drug importation initiatives. The recent FDA decision, however, paving the way for such a program in Florida dangerously compounds the risks and severity of potential drug shortages for Canadians. Florida alone represents half of the entire Canadian population. HIV being a chronic, life-threatening infectious condition where U=U, the importance of secured supply and drug integrity are even more heightened. When patients on both sides of the border bear all the risks against the pursuit of unvalidated economic benefits, flags should be raised to balance short-sighted wishful thinking policies."</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiC5FuEblaoWeACFuKMIOIwPdz_Eajaq0GUi-yAvstYMB8upzSioLCdvWxt_L1DjEpWr_hTo1q8ssSOSjzNLfyHIX-giIp4ZJARPk_wxLOM4A9QwBF4PPcm0hYDq6VgQgQzMhzOpBgZ2kbm12HLCGvauZAwelfRPOsJ8dlI-Ij7L_cl2klzJJJ_u8nztfQ/s932/us-canada-rx-pills.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Two pills with one symbolized by U.S. flag and other with Canadian flag" border="0" data-original-height="535" data-original-width="932" height="230" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiC5FuEblaoWeACFuKMIOIwPdz_Eajaq0GUi-yAvstYMB8upzSioLCdvWxt_L1DjEpWr_hTo1q8ssSOSjzNLfyHIX-giIp4ZJARPk_wxLOM4A9QwBF4PPcm0hYDq6VgQgQzMhzOpBgZ2kbm12HLCGvauZAwelfRPOsJ8dlI-Ij7L_cl2klzJJJ_u8nztfQ/w400-h230/us-canada-rx-pills.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: AARP</span></td></tr></tbody></table><p>On January 8th, Health Canada, Canada's version of the FDA, released a statement in response to the FDA decision. “Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the United States, including those identified in Florida's bulk importation plan or any other state's future importation programs.”<span style="font-size: xx-small;">[9]</span> Canada is effectively legislatively blocking the bulk exportation of drugs. Essentially, no wholesaler in their legitimate supply chain can ship to the United States, and FDA regulations do not allow imported drugs outside of the legitimate supply chain. Additionally, manufacturers that sell their patented medications in both United States. and Canadian markets will not sell extra supplies to Canada just to potentially buffer increased demand due to exportation. Thus, if any exportation occurred, it would be from the supply meant explicitly for Canada, directly shorting their coffers. Canadians, in general, <a href="https://www.nbcnews.com/health/health-news/canada-outrage-florida-cheaper-prescription-drugs-rcna133363" target="_blank"><span style="color: #3d85c6;">aren't too happy</span></a> with the news either!</p><p>In addition to the aforementioned problems associated with the Florida bulk importation program, it poses a targeted threat to PLWH. Of the fourteen initial drugs listed for procurement in the Florida SIP, ten are HIV treatment medications. In recent years, there have been issues with counterfeit HIV medications. Gilead Sciences was the victim of a notable scheme. Over a two-year period, criminals sold over $250 million of counterfeit bottles of their HIV drugs including Descovy, Genvoya and Biktarvy.<span style="font-size: xx-small;">[10]</span> Anything that can threaten the already fragile supply chain of HIV medication, such as drug importation, is a detriment to both U.S. and Canadian public health.</p><p>The FDA’s approval of Florida’s SIP is just the first step and one hill the state must climb to actually see any medicine in hand from this program, much less any savings. Additionally, given that Canada is not supportive of the venture, Florida does not have a Canadian supply to tap. Ultimately, the more significant issue is that importation does not solve the United States problem of high prescription drug prices.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">FDA. (2024, January 5). News Release: FDA Authorizes Florida's Drug Importation Program. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program</span></p><p><span style="font-size: xx-small;">[2] FDA. (2024, January 5). Importation program under section 804 of the FD&C Act. Retrieved from https://www.fda.gov/about-fda/reports/importation-program-under-section-804-fdc-act</span></p><p><span style="font-size: xx-small;">[3] National Archives and Records Administration. (2024, January 10). Code of Federal Regulations: Part 251 - Section 804 Importation Program. Retrieved from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-251</span></p><p><span style="font-size: xx-small;">[4] State of Florida. (2023, October 20). The State of Florida’s Section 804 Importation Program (SIP) Proposal for the Importation of Prescription Drugs from Canada. Retrieved from https://www.safemedicines.org/wp-content/uploads/2019/09/01-Florida-SIP-Proposal-Oct-2023.pdf</span></p><p><span style="font-size: xx-small;">[5] FDA. (2024, January 5). Letter of Authorization for Florida’s Section 804 Importation Program. Retrieved from https://www.fda.gov/media/175237/download?attachment</span></p><p><span style="font-size: xx-small;">[6] State of Florida Agency for Health Care Administration. (December 29, 2020) Standard Contract. Retrieved from https://www.safemedicines.org/wp-content/uploads/2024/01/CN-680000-ME214.pdf</span></p><p><span style="font-size: xx-small;">[7] Lybecker, K. M. (2020). State pharmaceutical importation programmes: an analysis of the cost‐effectiveness. Journal of Pharmaceutical Health Services Research, 11(2), 117–126. https://doi.org/10.1111/jphs.12349</span></p><p><span style="font-size: xx-small;">[8] The Partnership for Safe Medicines. (2023). Canada doesn't have Track and Trace. Retrieved from https://www.safemedicines.org/wp-content/uploads/2019/09/Track-and-Trace-final.docx.pdf</span></p><p><span style="font-size: xx-small;">[9] Health Canada. (2024, January 8). Statement from Health Canada on FDA decision on Florida bulk drug importation plan. Retrieved from https://www.canada.ca/en/health-canada/news/2024/01/statement-from-health-canada-on-fda-decision-on-florida-bulk-drug-importation-plan.html</span></p><p><span style="font-size: xx-small;">[10] Reuters. (2022, September 28). Gilead widens battle against alleged counterfeit HIV drug ring. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/gilead-widens-battle-against-alleged-counterfeit-hiv-drug-ring-2022-09-29/</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-7055976272591141922024-01-11T09:08:00.003-05:002024-01-11T09:17:39.287-05:00Harm Reduction Key to HIV Prevention<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Harm reduction is defined as “a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use.”<span style="font-size: xx-small;">[1]</span> Adverse outcomes of drug use include the spread of transmissible infectious diseases, such as HIV and Hepatitis C, as well as overdose, injury, and death. Effective harm reduction is compassionate and meets people where they are in their journey of drug use.<span style="font-size: xx-small;">[2]</span> Evidence-based harm reduction does not require the populations being served to stop their drug use.<span style="font-size: xx-small;">[1]</span> The goal is to enable them to deal with their addiction safely, work towards reducing their drug dependence, and educate and guide users into treatment options as they desire. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEic2mh9TdslzUbxb51K5HbvOaoP15Znd44wrNivmGscjjqUT0Tt4mefCXsauwUCVqEpH3cy3gUro-xIzG4Z415As5D0EMxBhjZzoiNZ6QJEuZ0x6m5TuZuwxXfA84BgI1otAFQwx4rnQ2p8aXToXZGYwx8HBJ1MEmAx-no9VENLAehjNGtWcAxL2Oa0VDg/s1080/Harm-Reduction.png" style="margin-left: auto; margin-right: auto;"><img alt="Why Harm Reduction Works" border="0" data-original-height="1080" data-original-width="1080" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEic2mh9TdslzUbxb51K5HbvOaoP15Znd44wrNivmGscjjqUT0Tt4mefCXsauwUCVqEpH3cy3gUro-xIzG4Z415As5D0EMxBhjZzoiNZ6QJEuZ0x6m5TuZuwxXfA84BgI1otAFQwx4rnQ2p8aXToXZGYwx8HBJ1MEmAx-no9VENLAehjNGtWcAxL2Oa0VDg/w400-h400/Harm-Reduction.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: New Hampshire Harm Reduction Coalition</span></td></tr></tbody></table><p>Removing barriers to tools and assistance is an integral part of harm reduction. Organizations engaged in harm reduction are community-based, engaging directly with people who use illicit drugs. Harm reduction tools include needle exchange programs, safer-sex kits, home testing kits for viral hepatitis and HIV, substance testing kits such as fentanyl test strips, and even naloxone kits to prevent drug overdose.<span style="font-size: xx-small;">[2]</span> The population in direst need of harm reduction services does not frequent traditional healthcare centers. When available in the community, harm-reduction organizations usually have limited hours and are poorly funded.</p><p>One innovative way to effectively lower the barrier to access harm reduction services is neighborhood vending machines. In December of 2023, in Cincinnati, Ohio, the Hamilton County Health Department installed two life-saving harm reduction vending machines on the streets where people need them.<span style="font-size: xx-small;">[3]</span> One is located at a downtown Fire Station, and another is located in an alley near a NeighborHub Integrated Health Clinic. NeighborHub Health is a Federally Qualified Health Center (FQHC) exclusively focused on providing integrated medical and behavioral care to those who are homeless and/or living with HIV/AIDS.</p><p>These vending machines contain naloxone spray, fentanyl test strips, and condoms. Naloxone spray is used to treat suspected opioid overdoses. Fentanyl test strips empower substance abusers to know if the drugs they are using contain the deadly drug fentanyl in order to prevent death and overdoses. They are small strips of paper that can detect fentanyl in many different kinds and forms of drugs, whether they are injectable, powder, or pills.<span style="font-size: xx-small;">[4]</span> Condoms are provided to prevent the spread of HIV and other infectious diseases. Substance abuse has been shown to result in people engaging in riskier sexual behavior. Thus, providing condoms along with harm-reduction supplies is a means of accessible, holistic public health intervention. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvmUnHJvb9mJ9EM8J6H-mg9TfNjx_YwxpPKSc6M-90pHNRtuXA4LoVce7K3fQi49GKN8dWdhPEV4bmaB0jaI4OH1yjpFi8_VZzXq5a9I1bTOSW9yO87jhxWc7vUMIQmpG8bZoLz8jo7x6GuUDDbM7Pgpy38RdtsZsrzVCL5ilQjenJGh4fxmUHCymzDMo/s1242/Vending.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Harm Reduction vending machine" border="0" data-original-height="932" data-original-width="1242" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvmUnHJvb9mJ9EM8J6H-mg9TfNjx_YwxpPKSc6M-90pHNRtuXA4LoVce7K3fQi49GKN8dWdhPEV4bmaB0jaI4OH1yjpFi8_VZzXq5a9I1bTOSW9yO87jhxWc7vUMIQmpG8bZoLz8jo7x6GuUDDbM7Pgpy38RdtsZsrzVCL5ilQjenJGh4fxmUHCymzDMo/w400-h300/Vending.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Yahoo News</span></td></tr></tbody></table><p>These two vending machines are additions to Ohio's first harm reduction machine, which was installed in Northside, a community in Cincinnati, in 2021. Caracole, a nonprofit HIV/AIDS organization in Cincinnati, operates and placed the machine outside of its office. This machine contains injection kits for safer drug injections, kits for safer substance smoking, safe sex kits, pregnancy tests, naloxone, bandages, and even containers with which to carry needles and syringes until they can be safely disposed of.<span style="font-size: xx-small;">[5]</span></p><p>Vending machines are examples of no-contact harm reduction. The vending machines are accessible 24/7 and do not require face-to-face contact. The supplies are free and are accessible via a code obtained by calling a special confidential number, which connects to a trained person who obtains non-identifying information and gives a code. Having on-contact harm reduction resources available on the street with 24/7 access increases accessibility. Some of those in need are uncomfortable with going into centers that may have the supplies or may be unable to get to them during hours of operation. Additionally, no-contact accessibility means that people can get what they need at all hours without judgment or fear of arrest such as sex workers and transient unhoused dealing with substance abuse.</p><p>A study published in the <i>Journal of the American Pharmacists Association</i> proved that the Caracole vending machine resulted in increased accessibility of harm reduction products and services and was associated with a lower countywide incidence of unintentional overdose death and HIV.<span style="font-size: xx-small;">[6]</span> This is important to note since harm-reduction efforts in Hamilton County started in 2014 in response to increased HIV cases. In 2014, the Cincinnati Exchange Project dispensed sterile syringes to drug users to protect them from HIV and Hepatitis C. Vending machines are a practical addition to harm reduction strategies already in use, such as mobile health vans that travel to neighborhoods also providing safer drug use supplies, safe-sex supplies and information concerning healthcare services and treatment.</p><p>Harm reduction, in its various forms, is drug overdose and injury prevention, as well as HIV and infectious disease prevention. It should be supported in public policy to innovate and increase funding for modalities already in place, to educate the public and health professionals who sometimes demonize harm reduction efforts due to misinformation, and for research to create new pathways. Harm reduction acknowledges the dignity and humanity of those in need, improves public health outcomes, and can supportively lead people into substance abuse treatment and cessation.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">Sue, K., & Fiellin, D. A. (2021). Bringing Harm Reduction into Health Policy — Combating the Overdose Crisis. The New England Journal of Medicine, 384(19), 1781–1783. https://doi.org/10.1056/nejmp2103274</span></p><p><span style="font-size: xx-small;">[2] SAMHSA.(2023). Harm Reduction. Retrieved from https://www.samhsa.gov/find-help/harm-reduction</span></p><p><span style="font-size: xx-small;">[3] DeMio, T., Kim, R. (2024, January 3). Drugs, sex and harm reduction: New vending machines could reduce spread of HIV. Retrieved from https://news.yahoo.com/drugs-sex-harm-reduction-vending-033416611.html</span></p><p><span style="font-size: xx-small;">[4] CDC. (2022, September 30). Fentanyl Test Strips: A Harm Reduction Strategy. Retrieved from https://www.cdc.gov/stopoverdose/fentanyl/fentanyl-test-strips.html</span></p><p><span style="font-size: xx-small;">[5] DeMio, T. (2021, March 8). Ohio's first harm reduction vending machine helps promote safer sex, safer smoking, safer injection. Retrieved from https://www.cincinnati.com/story/news/2021/03/08/vending-machine-safer-sex-drug-use-supplies-overdose-hiv-prevention-ohio/4592675001/</span></p><p><span style="font-size: xx-small;">[6] Arendt, D. (2023). Expanding the accessibility of harm reduction services in the United States: Measuring the impact of an automated harm reduction dispensing machine. Journal of the American Pharmacists Association, 63(1), 309–316. https://doi.org/10.1016/j.japh.2022.10.027</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-9146238779741391132024-01-04T11:39:00.004-05:002024-01-05T08:48:54.698-05:00Our Commitment to Transparency, 2023<p><i>By: Brandon M. Macsata, CEO, ADAP Advocacy</i></p><p>One of the most important foundational values embodied in the advocacy done by ADAP Advocacy are the partnerships with <i>all</i> stakeholders working to end the HIV epidemic in the United States. Look no further than our mission's support statement: "<i>ADAP Advocacy works with advocates, community, health care, government, patients, pharmaceutical companies and other stakeholders to raise awareness, offer patient educational programs, and foster greater community collaboration.</i>" Equally important is our commitment to transparency. We need more transparency in public policy, as well as public health. As an organization, ADAP Advocacy takes great pride in the partnerships we've formed over the years, and as such we make no apologies for the financial support afforded to fund our efforts. The 340B Drug Pricing Program provides ample evidence of what happens when there is a <i>lack</i> of transparency. Highlighting our values statements and our commitment to transparency goes hand-in-hand with our unwavering conviction that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1YcBPaait9qGFWZKfzJWs55bZLPIGegaKc-cgpEx51MGUlD3ICMZnWHRL-UK-KT1OiWrVXsa8iYkXwuxilUNsZUo5UIFO6VFPjovgW-uuL-dOA8rHLQDCZpeUPvWYOPFQZK_mihhSYD9AANvS2oMU7KeQ_6zCF4WteN6_4rWloySWh2IY97nNCXoslLA/s1254/iStock-1221303443.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Blocks showing the words, Trust / Truth" border="0" data-original-height="836" data-original-width="1254" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1YcBPaait9qGFWZKfzJWs55bZLPIGegaKc-cgpEx51MGUlD3ICMZnWHRL-UK-KT1OiWrVXsa8iYkXwuxilUNsZUo5UIFO6VFPjovgW-uuL-dOA8rHLQDCZpeUPvWYOPFQZK_mihhSYD9AANvS2oMU7KeQ_6zCF4WteN6_4rWloySWh2IY97nNCXoslLA/w400-h266/iStock-1221303443.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Rights Purchased via iStock</span></td></tr></tbody></table><p>Since our <a href="https://adapadvocacyassociation.blogspot.com/2021/12/our-commitment-to-transparency-2021.html" target="_blank"><span style="color: #3d85c6;">last transparency report in 2021</span></a>, not much has changed. ADAP Advocacy still receives no taxpayer funding. We received no funding from the Ryan White HIV/AIDS Program, Medicaid, Medicare, HOPWA, or Veterans Affairs. Additionally, we receive no revenue from the lucrative 340B Program. All of our revenue is generated from individuals, corporations, foundations, and nonprofit organizations. Check out our <a href="https://www.guidestar.org/profile/26-0482120" target="_blank"><span style="color: #3d85c6;">Silver Transparency profile on Guidestar</span></a>.</p><p>ADAP Advocacy has increasingly been engaging patient advocates on why reforming the 340B Program is in their best interests. The lack of accountability in the program and the near-zero transparency among the program's covered entities is mind-boggling, and that is an understatement. Our advocacy has led us to ask simple questions about where is all the money going, and who is actually being served who otherwise might not have received needed services and supports. Those efforts prompted us to <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_Press_340B_Revenue_Executive_Compensation_Charity_Care_Medical_Debt_10-31-23.pdf" target="_blank"><span style="color: #3d85c6;">examine the intersection</span></a> between growing 340B revenues, increasing executive compensation, declining hospital charity care, and the explosion of the medical debt in this country. Upon releasing some of the examination's top-line findings, what would happen next epitomized the problems faced by those of us trying to put patients <i>before</i> providers.</p><p>Ever dealt with the media? They always have their angle, and it’s expected with interviews. But ya go into it with a smile, <i>right</i>? </p><p>What followed with this so-called news "<a href="https://340breport.com/340b-program-may-lead-to-lower-charity-care-says-drug-industry-backed-aids-group/" target="_blank"><span style="color: #3d85c6;">story</span></a>" about our 340B examination resulted in nothing more than a classic "take down" piece from a publication financed by pro-hospital groups and well-financed lobbyists fueling anti-patient reforms! Despite the reporter being told our 340B examination was funded by general revenue dollars, his story attempted to still taint the findings with a "guilt by association" because drug manufacturers are among our advocacy partners and funders. <i><b>Editor's Note:</b> Since 2007, not once has a drug manufacturer attempted to attach strings or any quid pro quo to its funding either instructing us to support or oppose a single federal public policy initiative. Not once!</i></p><p>What’s funny is how our work was labeled as “drug industry backed” yet no mention of the hospital back or mega service provider backed opposition groups noted in the article. The woman questioning my intentions in the so-called news story has received a NINETY PERCENT (90%) increase in executive compensation since being name CEO in 2015. The reporter failed to mention that important factoid. I wonder how patients feel about that 90% pay raise or the disconnect between exploding 340B revenues and rise in CEO compensation, and patients still struggling. There is a darn good reason why on World AIDS Day, ADAP Advocacy <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_Press_World_AIDS_Day_12-01-23.pdf" target="_blank"><span style="color: #3d85c6;">sounded the alarm</span></a> on the medical debt crisis facing consumers – including people living with HIV/AIDS (PLWHA).</p><p>A much more detailed summary of the 340B examination was provided by Marcus J. Hopkins, who serves on ADAP Advocacy's Ryan White Grantee 340B Patient Advisory Committee and conducted the data analysis. Upon Hopkins penning his guest blog, <a href="https://adapadvocacyassociation.blogspot.com/2023/11/340b-covered-entities-revenue-witnessed.html" target="_blank"><i><span style="color: #3d85c6;">340B Covered Entities’ Revenue Witnessed Huge Executive Compensation Increases, Alarming Charity Care Decreases</span></i></a>, he was instructed by me to include the following transparency statement on me:</p><p><i><span style="color: #666666;"></span></i></p><blockquote><i><span style="color: #666666;">"At the request of ADAP Advocacy’s CEO, Brandon M. Macsata, to demonstrate transparency, we’re sharing some information about compensation paid to his firm, Purple Strategy Group, Inc. (PSG). PSG is paid a monthly management fee, which covers the work Brandon does on administrative, accounting, governance, marketing, and programs. The monthly fee is $8,000 per month, which has remained at that level since 2013 without an increase. Based on budget and net revenue year-end numbers, Brandon is also eligible to receive a performance bonus up to $6,500. Additionally, Brandon gives back to the organization annually, with his annual financial contributions ranging between $2,500 and $15,000+. No fringe benefits are paid, since Brandon is a 1099 contractor and not an employee. He is eligible to receive additional compensation for special projects that fall outside the scope of work, although most years there are no such projects."</span></i></blockquote><p></p><p>Transparency is about not only talking the talk, but walking the walk. Ironically, upon further review of said publication, any reporting focused on 340B Program reform efforts gets labeled as “drug industry backed” in the story headline or opening paragraph. There doesn't appear to be a firewall between its "news" division and its advertisers, sadly enough.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg7RS776OhaUQyv4AYFzA8S_0uvpINIrdkbIdka8AmajnsIX8Pe2YGH3zX6kHGuLSF3QwkI9j1FRD4rqLuXNzhiyXawaKW4ooEBvpDdyFhpb-QBLYWaXyR4BKciAZwW3kx4N9BzCosSZGBkG1-M96gTsOThlsoIKOTTVn0PVO97mQC64mlp5wUCdsxJySM/s1448/iStock-1194349001.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Corporate Philanthropy" border="0" data-original-height="724" data-original-width="1448" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg7RS776OhaUQyv4AYFzA8S_0uvpINIrdkbIdka8AmajnsIX8Pe2YGH3zX6kHGuLSF3QwkI9j1FRD4rqLuXNzhiyXawaKW4ooEBvpDdyFhpb-QBLYWaXyR4BKciAZwW3kx4N9BzCosSZGBkG1-M96gTsOThlsoIKOTTVn0PVO97mQC64mlp5wUCdsxJySM/w400-h200/iStock-1194349001.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Rights Purchased via iStock</span></td></tr></tbody></table><p>In 2023, our revenue, as it will be reported to the Internal Revenue Service, was $359,226.70, derived from numerous sources <span style="font-family: "helvetica"; font-size: 12px;">—</span> including corporate partnerships, event sponsorships, program sponsorships, scholarship fund donations (<i>ranging from $5.00 to $5,000.00</i>), third-party donors (<i>i.e., PayPal Giving Fund</i>), and miscellaneous donations. Approximately 75% (<i>in 2022, it was 82%</i>) were membership dues received from pharmaceutical manufacturers. That means nearly one-fourth of our membership funding (25%) came from <u>non</u>-industry partners. Among organizational donors to our restricted Scholarship Fund, 45% of the funding was derived from pharmaceutical manufacturers and 55% from <u>non</u>-industry partners. For our flagship ADAP Directory sponsorships, approximately 77% was support from pharmaceutical manufacturers and 23% from <u>non</u>-industry partners. Among registration fees, only 22% came from pharmaceutical manufacturers and 78% from <u>non</u>-industry partners. We also received several thousand dollars from individual donations, supporting either our general mission or specifically supporting our restricted Scholarship Fund. Our organization strives every single year to achieve greater funding diversification because it is consistent with a sound business model. Some years we do better than others.</p><p>Our ongoing 340B Project was funded entirely by pharmaceutical manufacturers, including AbbVie, Bristol-Myers Squibb, Genentech, Gilead Sciences, Johnson & Johnson Health Systems (Janssen Pharmaceuticals), Merck, and Novartis. Their support has never been a deeply held secret. And it is worth noting, again, our 340B examination on 340B revenues, executive compensation, charity care, and medical debt was funded by general revenues and not the 340B Project, although moving forward that will change. Another ongoing project financed entirely by pharmaceutical manufacturers is our Long-Acting Injectables Project with support from Gilead Sciences, Merck, and ViiV Healthcare.</p><p>That said with respect to general revenues (memberships, scholarship fund, directory sponsorships), our top five pharmaceutical funders this year were Merck (20.66), Gilead Sciences (18.08%), Janssen Pharmaceuticals (15.50%), ViiV Healthcare (12.91%), and Napo Pharmaceuticals (1.00%). Our top five non-industry funders were Magellan Rx Management (7.75%), Ramsell Corporation (7.75%), Walgreens (5.17%), Community Access National Network (2.58%), and the Partnership for Safe Medicines (1.00%). We generated financial support from nineteen (19) corporate entities.</p><p>In totality, our corporate donors included AbbVie, AIDS Alabama, Bender Consulting Services, Bristol-Myers Squibb, Community Access National Network, Genentech, Gilead Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson, Magellan Rx Management, Maxor National Pharmacy Services Company, MedData Services, Merck, Napo Pharmaceuticals, Novartis, Partnership for Safe Medicines, Patient Access Network Foundation, Patient Advocate Foundation, Pharmaceutical Research and Manufacturers of America, Ramsell Corporation, ScriptGuideRx, ViiV Healthcare, and Walgreens.<br /><br />Our top individual donor was yours truly. In 2023, I personally donated $1,355.00 to the organization (an amount less than previous years because I directed more of my personal donations to help the nonprofit nursery school where my son attends). All donations made to our scholarship fund are restricted in nature, and as such can only be used toward funding scholarships for people living with HIV/AIDS and/or their advocates.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhVN6xJCoFHLAZs_TrnyY_olq3Cm1jmXdGfQLWfWwRalTig6VJ5o42skfncO6MUP6Ii-WV4abdsjqY6t07xfBK8-OmssKf-M5iQT80CC5E_I2YemvUHMhmXxDdZaLcJHCCFIVlNrh-QYmY-LXC05xaufhyphenhyphen4GFADaE9gOm_Vvc5K9LbfsN_y6o05SAKP17U/s1681/iStock-1755803668.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Group of diverse crowd holding up heart shaped images" border="0" data-original-height="623" data-original-width="1681" height="149" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhVN6xJCoFHLAZs_TrnyY_olq3Cm1jmXdGfQLWfWwRalTig6VJ5o42skfncO6MUP6Ii-WV4abdsjqY6t07xfBK8-OmssKf-M5iQT80CC5E_I2YemvUHMhmXxDdZaLcJHCCFIVlNrh-QYmY-LXC05xaufhyphenhyphen4GFADaE9gOm_Vvc5K9LbfsN_y6o05SAKP17U/w400-h149/iStock-1755803668.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Rights Purchased via iStock</span></td></tr></tbody></table><p>ADAP Advocacy remains deeply committed to improving access to care for PLWHA. Every decision we make is made through the lens of the patient. When those interests align with the pharmaceutical industry, then so be it. In doing so, we're also not afraid to <a href="https://www.positivelyaware.com/articles/340b-hypocrisy" target="_blank"><span style="color: #3d85c6;">call out the hypocrisy</span></a> behind the naysayers who question our intentions.</p><p>According to a survey Network for Good conducted among 3,000 donors, <a href="https://www.networkforgood.com/resource/7-reasons-why-donors-give/" target="_blank"><span style="color: #3d85c6;">there are 7 reasons why donors give (and 1 reason they don’t)</span></a>. While the aforementioned survey solicited feedback from individuals, there are consistent ‘ideological sorting' motivations for giving among corporate donors and political donors. Donors give money to align themselves with causes they already support, and not the dogmatic 'vote-buying' hypotheses. There is plenty of research in this area, too.</p><p>It is important to remember that there is an <a href="https://adapadvocacyassociation.blogspot.com/2018/08/an-inherent-value-in-advocacy.html" target="_blank"><span style="color: #3d85c6;">inherent value in advocacy partnerships</span></a>. We remain unapologetically pleased with the relationships we've built over the last 17 years since the organization's founding in 2007. We're thankful for the support from industry, and equally thankful for the support from our non-industry partners...which includes some individuals who give as little as five bucks!</p><p><i>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.</i></p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-2553827372821060192023-12-14T06:15:00.003-05:002023-12-14T10:21:06.328-05:00Americans with Disabilities Act Negates Tennessee HIV Criminalization Statute<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Christmas has come early in Tennessee. December 2023 began with a victory in the fight against HIV criminalization in the Volunteer State. As a result of complaints filed by the Center for HIV Law and Policy (CHLP), the U.S. Department of Justice found that Tennessee’s enforcement of its aggravated prostitution statute violates the Americans with Disabilities Act (ADA) by specifically targeting people living with HIV (PLWHA). CHLP hailed the decision, "<a href="https://www.hivlawandpolicy.org/news/news-release-chlp-made-call-and-doj-answered" target="_blank"><span style="color: #3d85c6;">CHLP Made the Call and the DOJ Answered</span></a>."</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_tbqLSV3Vkk794ofarvJs2KUwh7vNHHd8LAGQqN-AIGtxWEC3fxCcerdQyJbG7FUVyVRbJYKOTrDaVenT5iKNJe4ZYB75koTe2fRTC_kNFlYgZTmDLRBj_QDCtyZz0Ua7fnIF27pzveFZRr04-w0h9hL3Yxb28-E_E35G04EWQUdn2UOUxxHE4DjBD-g/s620/Screenshot%202023-12-13%20at%206.21.13%E2%80%AFAM.png" style="margin-left: 1em; margin-right: 1em;"><img alt="Center for HIV Law & Policy" border="0" data-original-height="200" data-original-width="620" height="129" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj_tbqLSV3Vkk794ofarvJs2KUwh7vNHHd8LAGQqN-AIGtxWEC3fxCcerdQyJbG7FUVyVRbJYKOTrDaVenT5iKNJe4ZYB75koTe2fRTC_kNFlYgZTmDLRBj_QDCtyZz0Ua7fnIF27pzveFZRr04-w0h9hL3Yxb28-E_E35G04EWQUdn2UOUxxHE4DjBD-g/w400-h129/Screenshot%202023-12-13%20at%206.21.13%E2%80%AFAM.png" width="400" /></a></div><p>According to the Centers for Disease Control & Prevention (CDC), 35 states currently have laws that criminalize HIV exposure, which fall into several categories. They are either HIV-specific laws regarding actions that can potentially result in HIV exposure, sexually transmitted disease (STD) or communicable disease exposure laws that could include HIV, general criminal statutes that could be used to define actions that could possibly cause HIV or STD exposure, or laws that enhance sentences for certain crimes when committed by PLWHA.<span style="font-size: xx-small;">[1]</span> Tennessee’s aggravated prostitution statute falls into the sentence enhancement category.</p><p>Tennessee enacted its aggravated prostitution statute in 1991. Prostitution in the state, in general, is only a misdemeanor crime. However, the aggravated prostitution statute converts it to a Class C Felony if the person convicted is HIV positive. Conviction of a Class C felony means the possibility of imprisonment from three to fifteen years and up to a $10,000 fine.<span style="font-size: xx-small;">[2]</span> Conviction of prostitution by someone without HIV is only a Class B misdemeanor, which could result in up to only six months in jail and up to a $500 fine.<span style="font-size: xx-small;">[2]</span> Additionally, aggravated prostitution convictions require registering with the Tennessee Bureau of Investigations as a sex offender. </p><p>To add insult to injury, in 2010, aggravated prostitution was reclassified as a violent sexual offense. This means that those convicted must stay on the sexual offender registry (SOR) for life. Previously, they were able to petition to be removed after ten years.<span style="font-size: xx-small;">[2]</span> Moreover, an aggravated prostitution conviction makes one ineligible for judicial diversion. Judicial diversion is when first-time offenders are allowed to enter what equates to a conditional guilty plea. If they plead guilty and fulfill the conditions of a court-defined special probation period, their charges are dismissed, and their records are expunged.<span style="font-size: xx-small;">[2]</span></p><p>The Americans with Disabilities Act defines HIV/AIDS as a disability because it can significantly hinder life activities. PLWHA are protected whether they are symptomatic or not, and those protection were reaffirmed in <i><a href="https://www.hivlawandpolicy.org/resources/bragdon-v-abbott-524-us-624-1998-majority-opinion" target="_blank"><span style="color: #3d85c6;">Bragdon v. Abbott</span></a></i>, 524 U.S. 624 (1998). Protection under the ADA means guaranteed “equal opportunity for individuals with disabilities in public accommodations, employment, transportation, State and local government services, and telecommunications…also protects persons who are discriminated against because they have a record of or are regarded as having HIV, or they have a known association or relationship with an individual who has HIV”.<span style="font-size: xx-small;">[3]</span> All of those guarantees are denied to those convicted under the aggravated prostitution statute, which subjects those convicted to undue hardship in many aspects of their lives.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://www.poz.com/article/hiv-criminalization-poster" target="_blank"><img alt="HIV Criminalization Map" border="0" data-original-height="338" data-original-width="708" height="191" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvJCCCKYOfvzaOfQKNid-a5gjzGB_s8ZNqOa87jw-V8lytCzB8qBTJpKSRmU7nizrIkif7O5Csa_awANaXLRXQLj6FRmJjsmtBBNN8VZthzq2xFva0q75qWFAQLSvmLcKlTp-gnKyLXaxPzM9DBVDf6WkHqsQVEjtWKQ44X7mWOH_uAjDYOX9-n8KSaM0/w400-h191/HIV%20Criminalization%20Map.jpg" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://www.poz.com/article/hiv-criminalization-poster" target="_blank">Photo Source: POZ Magazine</a></td></tr></tbody></table><p>Being on the sexual offender registry significantly affects where people can live, work, or be present in public. You may not work or live within 1,000 feet of any school, childcare facility, public park, or playground.<span style="font-size: xx-small;">[2]</span> Simply being on the premises of these areas is also prohibited unless you have an express reason for being there, such as being the parent of a child at a specific place. An individual on the SOR cannot take their child to a public park to play. However, they can retrieve their child from school only if they give written notice to the school in advance that they are a registered sex offender.<span style="font-size: xx-small;">[2]</span> The SOR denies people the ability to spend time with children in their families. One example is a grandparent who is on the SOR and cannot spend time alone or babysit their grandchild because they are prohibited from being alone with minors.</p><p>A lifetime registry on the SOR facilitates long-term discrimination and even homelessness. Landlords run background checks and frequently won't rent to anyone on the SOR. Once on the SOR, a person’s personal information becomes publicly available. The publicly searchable Tennessee Bureau of Investigations (TBI) SOR website lists all sorts of data such as photos, ages, names, addresses, parole information, school and work addresses, unrelated criminal history, and more. Furthermore, the website enables visitors to click on the statutes for which one has been convicted. Thus, seeing that someone is convicted under the aggravated prostitution statute means public exposure of their HIV status. This leaves a person vulnerable to hate crimes, housing and employment discrimination, and mental stress from living with their life on display.</p><p>The DOJ investigation revealed that Shelby County in Tennessee had the highest enforcement rate of the aggravated prostitution statute. In 2022, Shelby County was the residence of 74% of people on the SOR for aggravated prostitution while housing only 13% of the state’s population.<span style="font-size: xx-small;">[2]</span> Also, over 90% of those aggravated prostitution arrests were Black, with a large number being Black women, both cisgender and transgender.<span style="font-size: xx-small;">[2]</span> The SOR further oppresses marginalized individuals financially. Many of those convicted are low-income, making the annual $150 mandatory fee for being listed on the SOR a hardship. Additionally, being on the SOR requires reporting in person four times a year to update registration.<span style="font-size: xx-small;">[2]</span> Failure to do so results in a violation, which could result in jail time.</p><p>DOJ detailed multiple legal remedies to the ADA violations to both the state government and specifically the Shelby County District Attorney General’s Office (SCDAG). The list for the SCDAG includes stopping the enforcement of the statute, including probation violations related to violations of SOR reporting requirements, creating a protocol for vacating aggravated prostitution convictions, and educating all SCDAG attorneys about HIV and the nondiscrimination requirements of Title II of the ADA.<span style="font-size: xx-small;">[2]</span> </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://www.cdc.gov/hiv/policies/law/states/exposure.html" target="_blank"><img alt="Criminalized or controlled actions in HIV/AIDS criminalization laws" border="0" data-original-height="618" data-original-width="1185" height="209" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLeM7gEGvJ0RpUV5fQzuiTvRKCC5mA2n7WpMFwctXMzj4lCbijrpITKdFvWKjpbEWjrUWvkmZtz_Ut3fv5XpKIfy9NTVDktl7suI87e_PoIREqc20WiCBH_H6oPdF06cNt9yQpYSlVdHIphjrQ8mvfkerI5CSdKTWXEq3FeKM9mLcsdkeyr1dWNQk0PJw/w400-h209/criminalized-actions-for-hiv-crime-03-2023-large.jpg" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://www.cdc.gov/hiv/policies/law/states/exposure.html" target="_blank">Photo Source: CDC</a></td></tr></tbody></table><p>For the state, DOJ’s recommendations include ceasing the enforcement of the statute, using the TBI to remove people on the SOR who are there solely due to aggravated prostitution convictions, expunging all state records showing that those with aggravated prostitution convictions were ever on the SOR, and paying compensatory damages (SOR fees, court costs and fines, bonds, etc.) to those who were victims of the statute.<span style="font-size: xx-small;">[2,5]</span> One very notable recommendation to the state is to notify all those who have been removed from the SOR and whose references to their convictions have been removed.<span style="font-size: xx-small;">[2]</span> Not only is it legally empowering to have documentation in hand, but it is also mentally empowering to have confirmation of reclaiming control over one’s life.</p><p>The aggravated prostitution law is predatory to vulnerable populations and is not based on science, according to our government's highest law enforcement institution. It is draconian, according to advocates. Since 1991, advances in antiretroviral therapy have come a long way and it has opened the door to "<a href="https://www.cdc.gov/hiv/clinicians/treatment-care/treatment-as-prevention.html" target="_blank"><span style="color: #3d85c6;">treatment as prevention</span></a>" (TasP) and "<a href="https://www.cdc.gov/hiv/risk/art/evidence-of-hiv-treatment.html" target="_blank"><span style="color: #3d85c6;">undetectable equals untransmittable</span></a>" (U=U). Laws need to reflect these advances.</p><p>S. Mandisa Moore-O’Neal, CHLP Executive Director, states, “The implications of the DOJ’s findings are far-reaching. This not only puts the state of Tennessee on notice that this is a serious issue, but it also serves as notice to other states with similar HIV criminal statutes.”<span style="font-size: xx-small;">[4]</span> Regarding the future continuation of the fight against HIV criminalization, she also says, “This is also an opportunity for other state coalitions organizing and educating around HIV criminalization to leverage these findings with lawmakers. When many state budgets are already tight, the possibility of new and often costly litigation may be the impetus to change these laws.”<span style="font-size: xx-small;">[4]</span></p><p>Jen Laws, President & CEO of the Community Access National Network applauded the decision, "This is an excellent development in implementing the ADA and affording protections to people living with HIV. We owe a debt of gratitude to our friends at CHLP for exploring this legal argument. DOJ's Civil Rights Division has room to expand on this work in other areas affecting people living with HIV and the legal system. From enforcement of medication access for incarcerated and jailed persons to enforcement of these same protections in family courts, our people face discrimination when interacting with our legal system and that needs to change."</p><p>In today’s political climate, many lawmakers either do not care about the adverse effects flawed laws have on marginalized communities or feel the consequences of the laws are somehow deserved due to their personal ideologies. Challenging the aggravated prostitution law by showing how it violates the ADA is a perfect example and blueprint of how to fight legalized oppression by using legal statutes that cannot be ignored. When one cannot change the system, it’s empowering to find ways to use the existing system to one’s advantage. Chalk-up a big win for CHLP...<i>and</i> PLWHA in Tennessee.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">Health Resources and Services Administration. (2023, September). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Dat</span><span style="font-size: xx-small;">1) Centers for Disease Control. (2023). HIV and STD Criminalization Laws. Retrieved from https://www.cdc.gov/hiv/policies/law/states/exposure.html#:~:text=As%20of%202022%2C%2035%20states,categorized%20them%20into%20four%20categories.</span></p><p><span style="font-size: xx-small;">[2] U.S. Department of Justice Civil Rights Division. (2023, December 1). The United States’ Findings and Conclusions Based on its Investigation of the State of Tennessee and the Shelby County District Attorney General’s Office under Title II of the Americans with Disabilities Act, DJ No. 204-70-85. Retrieved from https://www.justice.gov/d9/2023-12/2023.11.30_tn_hiv_lof_final.pdf</span></p><p><span style="font-size: xx-small;">[3] U.S. Department of Justice Civil Rights Division. (2023). Protecting the rights of persons living with HIV/AIDS. Retrieved from https://archive.ada.gov/hiv/ada_hiv_brochure.html</span></p><p><span style="font-size: xx-small;">[4] Center for HIV Law and Policy. (2023, December 1). News Release: CHLP Made the call and the DOJ answered. Retrieved from https://www.hivlawandpolicy.org/news/news-release-chlp-made-call-and-doj-answered</span></p><p><span style="font-size: xx-small;">[5] Kruesi, K. (2023, December 1). Tennessee’s penalties for HIV-positive people are discriminatory, Justice Department says. Retrieved from https://apnews.com/article/justice-department-hiv-tennessee-6cda4a9170dfbe46bd8d8f6af91f76cd</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-80260928686246519992023-12-07T08:51:00.001-05:002023-12-08T09:39:11.862-05:00Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Effective population health monitoring, program evaluation, and decision-making requires quality data. To that end, in September 2023, the Division of Policy and Data, HIV/AIDS Bureau (HAB) under the Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services published the <a href="https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-adap-data-report-2021.pdf" target="_blank"><span style="color: #3d85c6;">Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report</span></a>.<span style="font-size: xx-small;">[1]</span> The current iteration of this annual publication covers the years 2017 through 2021. The client-level data includes information such as demographics, socioeconomic status/factors, and service utilization.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDKngXge2ao4rJkskIsTWR4rnBPj6j4ery2GqiQWzcfSltWbziBec5-6xbbfAgb3R9yr3iJxCPRcFcqAbZxNz298n3x8NDVudROcjz0NeZK7wLIWngtPg6bBL6s1lNJxQ9HFeTa4zoODZD6tNnxhxqMemqFtzBYji_-Pel8cfNPiAEoK6rUyttVhxY1L0/s619/HRSA-agency-logo_FINAL.jpg" style="margin-left: 1em; margin-right: 1em;"><img alt="Health Resources and Services Administration" border="0" data-original-height="203" data-original-width="619" height="131" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDKngXge2ao4rJkskIsTWR4rnBPj6j4ery2GqiQWzcfSltWbziBec5-6xbbfAgb3R9yr3iJxCPRcFcqAbZxNz298n3x8NDVudROcjz0NeZK7wLIWngtPg6bBL6s1lNJxQ9HFeTa4zoODZD6tNnxhxqMemqFtzBYji_-Pel8cfNPiAEoK6rUyttVhxY1L0/w400-h131/HRSA-agency-logo_FINAL.jpg" width="400" /></a></div><p>ADAPs are in each of the 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and six U.S. territories, receiving funding from Part B of the Ryan White HIV/AIDS Program (RWHAP). Eligibility for ADAP services requires one to have a diagnosis of HIV, be of low income, defined as a percentage of the federal income poverty level, and meet residency requirements based on a particular state’s ADAP structure. The report includes a multitude of metrics grouped by age, race/ethnicity, gender, federal poverty level, and healthcare coverage status. What follows is an overview of some of the data. To view the report in its entirety, please click <a href="https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-adap-data-report-2021.pdf" target="_blank"><span style="color: #3d85c6;">here</span></a>.</p><p>According to the report, clients served numbers are on an upward trend. From 2017 to 2021, the client base grew from 268,174 to 289,289. These numbers describe those who specifically receive ADAP services and do not include clients who only receive non-ADAP RWHAP direct health care and support services. However, some ADAP clients partake of those services as well. Increasing yearly numbers indicate that ADAP programs are needed, and ongoing funding is necessary. Additionally, research shows that ADAP programs are cost-effective, and policies that stifle them are detrimental to the health and well-being of those dependent upon them and society overall.<span style="font-size: xx-small;">[2]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihw3Phnrf_LoTgDVm5qD85L6EeC16zcaYLdjKlDE6W9dRGRrmCQhPON-t6MQ_CaAmkHkfrOpxtlqONauGUXOZzCCsJJmx4j4GXWYcCiPPZ0z3XxxYzGXYpYSJ3FDh6lrvu3kpPOhfYy_aysT0mIHJS0BWUhZ-vGJg_JM0tp4N9XOP53YHSgnvg9bg3mps/s910/nastad%20graphic.JPG" style="margin-left: auto; margin-right: auto;"><img alt="ADAP Clients Served, by Program Type" border="0" data-original-height="515" data-original-width="910" height="226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihw3Phnrf_LoTgDVm5qD85L6EeC16zcaYLdjKlDE6W9dRGRrmCQhPON-t6MQ_CaAmkHkfrOpxtlqONauGUXOZzCCsJJmx4j4GXWYcCiPPZ0z3XxxYzGXYpYSJ3FDh6lrvu3kpPOhfYy_aysT0mIHJS0BWUhZ-vGJg_JM0tp4N9XOP53YHSgnvg9bg3mps/w400-h226/nastad%20graphic.JPG" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: NASTAD</span></td></tr></tbody></table><p>A few gender-related observations stand out as well. Most of the ADAP clients are male. In 2021, 78.6% were cis-gender male. This percentage and the overall gender ratio of male, female, and transgender patients served has remained consistent over the 2017-2021 timeframe. In 2021, the data shows a difference in poverty based on gender. There were more cis-gender female/transgender female ADAP clients than cis-gender male/transgender males living at or below 100% of the federal poverty level, though as a whole, half of all ADAP clients were below. The comparison was 54.1% cis-gender female and 65.6% transgender female in contrast to 44.7% cis-gender male and 51.4% transgender male. Gender differences were also noted in the status of healthcare coverage. In 2021, 36.5% of ADAP clients were entirely without health care insurance coverage. However, of that subgroup, 36.6% were male, and 34.95 were female. The numbers for transgender clients were higher, with 49.8% of transgender males and 51.2% of transgender females lacking any healthcare coverage. Complete lack of coverage means they did not even have Medicaid.</p><p>The report indicated a few standout metrics regarding race as well. The majority of ADAP clients are non-White. In 2021, seven out of ten were racial or ethnic minorities, with white clients comprising 30% of the client total. A further breakdown of the racial data indicates that in 2021 over half, 55%, of female ADAP clients were African American. By comparison, 24.1% were Hispanic/Latina, 18.1% were White, and less than 2% identified as Asian, mixed-race, American Indian/Alaska Native or Native Hawaiian/Pacific Islander. In contrast, 33.6% of male clients were African American, 33.3% were White, and 29.9% were Hispanic/Latino. A very notable racially varied metric involved age. Ethnic/minority ADAP clients are younger than White clients. In 2021, 62.1% of white clients were 50 years of age or older. This contrasts with the statistics of 39.9% being African American, 48.9% being American Indian/Alaska Native, 38.6% Hispanic/Latino, and 36.0% Asian. </p><p>The observations are just a few of the many data points described in the report. Continued reporting of this nature is necessary for accountability in terms of the billions spent on ADAP each year and to continue to improve the services and the lives of those dependent on ADAP services. Whether examining the breakdown of various service utilization or how the distribution of services differs based on geographical region, continuing to create a robust repository of data is the best way to improve the health outcomes of the vulnerable ADAP population.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">Health Resources and Services Administration. (2023, September). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report 2021. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-adap-data-report-2021.pdf</span></p><p><span style="font-size: xx-small;">[2] McManus, K. A., Strumpf, A., Killelea, A., Horn, T., Hamp, A., & Keim-Malpass, J. (2022). Economic benefits of the United States' AIDS drug assistance Program: A systematic review of cost analyses to guide research and policy priorities. Preventive medicine reports, 29, 101969. https://doi.org/10.1016/j.pmedr.2022.101969</span></p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-6156864794307750832023-11-30T07:28:00.000-05:002023-11-30T07:28:34.156-05:00Provider ‘Smash and Grab’ Tactics Fueling Medical Debt, Hurting Patients<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>In the United States, healthcare is one universal expense incurred by everyone, regardless of their station in life. Approximately 100 million people in this country, including 41% of adults, have some sort of medical debt.<span style="font-size: xx-small;">[1]</span> Some people can manage it, but many struggle. As a result of medical debt, people have had to cut spending on food and necessities, deplete savings, delay purchasing a home, work multiple jobs, or even declare bankruptcy.<span style="font-size: xx-small;">[1]</span></p><p></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNbbJaTfR_0UWnZfWbf8rjfMIQi5l2Qo664ZLRbuaj7jSYlZfnOsN4uZFmeuYDrbND1M_NNtHCJ8MohQg-7FNhygzxQW8dq-RDK__TJH7-k17LW_U-WiFrwKrIlqUSKUj8TYr49b8NuH6YEfCkOacQa9eZfF18ewA7uNa4hHJA3YSkaX17_2bVIL2GYoc/s1255/iStock-535162543.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Hospital Bill with 'PAST DUE' notice" border="0" data-original-height="835" data-original-width="1255" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNbbJaTfR_0UWnZfWbf8rjfMIQi5l2Qo664ZLRbuaj7jSYlZfnOsN4uZFmeuYDrbND1M_NNtHCJ8MohQg-7FNhygzxQW8dq-RDK__TJH7-k17LW_U-WiFrwKrIlqUSKUj8TYr49b8NuH6YEfCkOacQa9eZfF18ewA7uNa4hHJA3YSkaX17_2bVIL2GYoc/w400-h266/iStock-535162543.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: iStock (purchased)</span></td></tr></tbody></table><p></p><p>Most of the medical debt is <i>actually</i> <b>hospital debt</b>, and that debt is owed to large hospitals, not small private practices. In the United States, there are two different types of hospitals: for-profit and nonprofit. There are 5,139 community hospitals, with 1,228 being for-profit, 951 being state and local government-run hospitals, and 2,960 being non-governmental nonprofit health facilities.<span style="font-size: xx-small;">[2]</span> For-profit hospitals are business-oriented and owned by investors and shareholders; thus, they are focused on making money for their stakeholders. Nonprofit hospitals are not beholden to any shareholders or investors. In theory, their profits are to be reinvested into the hospitals for their operations. Additionally, nonprofit hospitals are tax-exempt and required to provide more community health services and serve patients regardless of whether they can afford care. Unfortunately, some nonprofit hospitals are the <i>worst</i> offenders when it comes to saddling patients with debt.</p><p>Nonprofit hospitals do not pay <i>any</i> federal and state income, property, or sales taxes and receive other tax breaks.<span style="font-size: xx-small;">[2]</span> In 2020, the nation’s nonprofit hospitals received an estimated $28 billion in tax benefits, accounting for 44% of their net income.<span style="font-size: xx-small;">[3]</span> In return for the tax benefits, the federal government requires nonprofit hospitals to provide community benefits such as charity care. Charity care is providing services to low-income people for free or at significantly reduced rates.<span style="font-size: xx-small;">[3]</span> The Affordable Care Act (ACA) also mandates that they must maintain a transparent and available financial assistance program and refrain from taking “extraordinary collection actions” against patients eligible for charity care.<span style="font-size: xx-small;">[4]</span> The reality of some of the largest nonprofit hospitals is a travesty of the concept of charity care.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQQDpALBTHd7WjWt6KVlI7ufnGO-YWvyFpn9YBGLsivHFblFnGh_yUDYFTgq2U__aniFz11uieMPHPnSgrqKl4dZMi_9pJ1YA42cSpxtxxroRr_oSDselBlzysdpOjFlTV3ZIbCXnc6cT5VvdzQeClzenFVevNwEm9l-rk3ExW7rjSEOz7YUJ5mMlzfUA/s600/profitovercharitycare2012.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Profits Over Charity Care" border="0" data-original-height="457" data-original-width="600" height="305" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQQDpALBTHd7WjWt6KVlI7ufnGO-YWvyFpn9YBGLsivHFblFnGh_yUDYFTgq2U__aniFz11uieMPHPnSgrqKl4dZMi_9pJ1YA42cSpxtxxroRr_oSDselBlzysdpOjFlTV3ZIbCXnc6cT5VvdzQeClzenFVevNwEm9l-rk3ExW7rjSEOz7YUJ5mMlzfUA/w400-h305/profitovercharitycare2012.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: National Nurses United</span></td></tr></tbody></table><p><b>Some nonprofit hospitals aggressively pursue patients over their bills.</b> They garnish paychecks and sell patient accounts to collection agencies (debt buyers) that harass and intimidate. Lawsuits are filed against patients for outstanding balances. Some of them are filed against people who qualify for charity care. These lawsuits attach legal fees and late payment interest, multiplying the original outstanding debt amounts. Moreover, some hospitals pursue family members for a patient’s medical debts and even place property liens on patients’ homes. Many do not find out about property liens until a relative has passed. Property liens lower the value of homes and adversely affect the transference of intergenerational wealth.</p><p>Federal tax law mandates that nonprofit hospitals spend some of their revenues as community benefit and defines the kind of spending that qualifies but does not stipulate the amount. Charity care is just one of the defined categories of spend. In 2020, nonprofit hospitals had approximately $28 billion in tax exemptions but provided <i>only</i> $16 billion in free or discounted services through charity care.<span style="font-size: xx-small;">[5]</span> </p><p>U.S. Senator Bernie Sanders, chair of the Senate Committee on Health, Education, Labor & Pensions (HELP), filed a <a href="https://www.sanders.senate.gov/wp-content/uploads/Executive-Charity-HELP-Committee-Majority-Staff-Report-Final.pdf" target="_blank"><span style="color: #3d85c6;">congressional report</span></a> on nonprofit hospitals and their tax exemptions. The committee examined 16 of the largest nonprofit health systems in the U.S., finding that they spent less than 60% of the estimated value of their tax breaks on charity care.<span style="font-size: xx-small;">[6]</span> The 16 hospital chains examined took in more than 3$ billion in annual revenue. Twelve of the 16 chains dedicated less than two percent of their total revenue to charity care, with 6 of those 12 having less than 1% of their total revenue dedicated to charity care.<span style="font-size: xx-small;">[3]</span> Between 2012 and 2019, nonprofit hospitals increased their average operating profit by more than 36% and almost doubled their cash reserves. In the same timeframe, charity care spending dropped from only $6.7 million to $6.4 million.<span style="font-size: xx-small;">[3]</span> Ironically, in 2021, of the 16 nonprofit hospital chains in the report, the average CEO compensation was $8 million, with a collective total of more than $140 million.<span style="font-size: xx-small;">[3]</span></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiE3AdF3p_tl8rcmOTWBkAgbbX9zTV3RaLj7UunBLJBcpF0qHpf3lAniYtg4hJVbcBl8V5yI8GTmgOBsCh4QFM3xLYwg9uad_4FRMibvt7gqbxao-sUImTsN5-ZLaseWSpK1tysfcAbq3bMTQv0E18JhJqd680pN2QKs6w7CsT2zK2GX1-6ZClsquG1Wvk/s999/ScreenshotCharity.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Witness testifying before Congressional Committee" border="0" data-original-height="530" data-original-width="999" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiE3AdF3p_tl8rcmOTWBkAgbbX9zTV3RaLj7UunBLJBcpF0qHpf3lAniYtg4hJVbcBl8V5yI8GTmgOBsCh4QFM3xLYwg9uad_4FRMibvt7gqbxao-sUImTsN5-ZLaseWSpK1tysfcAbq3bMTQv0E18JhJqd680pN2QKs6w7CsT2zK2GX1-6ZClsquG1Wvk/w400-h213/ScreenshotCharity.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: WRAL</span></td></tr></tbody></table><p><i>Editor's Note: <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_Press_340B_Revenue_Executive_Compensation_Charity_Care_Medical_Debt_10-31-23.pdf" target="_blank"><span style="color: #3d85c6;">ADAP Advocacy recently called into question 340B Drug Discount Program practices with an examination focused on growing 340B revenues, increasing executive compensation, declining charity care, and the exploding medical debt.</span></a></i></p><p>Sen. Sanders feels that Congress should specifically define the level of charity care and financial assistance required of nonprofit hospitals. One suggestion is that tax breaks be limited to the amount of charity care provided. Additionally, Sanders feels that hospital financial assistance programs should have defined standards. For example, some of the hospitals do not transparently explain, advertise, or actively facilitate entering qualified patients into the programs. Instead, some hospital systems, such as Atrium in North Carolina, steer patients towards loans to pay their outstanding bills that sometimes have interest rates as high as 13%.<span style="font-size: xx-small;">[7]</span></p><p>Hospital groups pushed back against the analyses by Sen. Sanders, but they also tend to oppose any accountability or transparency reforms.. The American Hospital Association states that nonprofit hospitals' community benefit is comprehensive and encompasses more than just charity care. It says that community benefit includes research, medical innovation, absorbing underpayments from Medicaid, health education, and housing assistance.<span style="font-size: xx-small;">[6,8]</span> That sentiment is misleading and flawed. For example, a good deal of research is funded by taxpayers’ dollars.</p><p>Jen Laws, President & CEO of the Community Access National Network (CANN), isn't buying the AHA's argument. According to Laws, financial assistance and community benefit are different line items on the Internal Revenue Service's Form 990 for a reason. In fact, CANN has been quite vocal on the need for <a href="https://www.tiicann.org/340b_action-center.html" target="_blank"><span style="color: #3d85c6;">reforms to programs</span></a> designed to help indigent patients, yet are falling short of that intended goal.</p><p>According to Laws, community assumption is a "good faith" definition, but loopholes surrounding hospital-related nonprofit status tax rules inevitably can lead to bad faith in this space, or even abuse. He believes the overwhelming body of evidence surrounding the decline in hospital charity care is in direct opposition of the IRS' intention, namely providing a benefit to needy persons, families, and communities.</p><p>Laws said, "For example, our government, namely the IRS, hasn't updated 'community benefit' rules in decades and many no longer apply, like having an open Emergency Room. This gets to the core of CANN's position - honesty is not part of that muddy language. And we need to be frank about that lack of honesty."</p><p>It is crucial that community benefit standards are revamped with a focus on charity care that directly benefits those in need. In some states, the difference between the amount of funds spent on charity care and the total tax exemptions the nonprofit hospitals receive is greater than the recorded debts listed on patients' credit reports.<span style="font-size: xx-small;">[3]</span> Change must come so that needy patients' lives are no longer ruined by being sued by hospitals for outstanding balances as low as $500 or less that they can’t afford to pay.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">Levey,N. (2022, June 16). 100 Million people in America are saddled with health care debt. Retrieved from https://kffhealthnews.org/news/article/diagnosis-debt-investigation-100-million-americans-hidden-medical-debt/</span></p><p><span style="font-size: xx-small;">[2] Modi, J. (2023, March 21). Nonprofit vs. for-profit hospitals: what’s the difference? Retrieved from https://www.buzzrx.com/blog/nonprofit-vs-for-profit-hospitals-whats-the-difference</span></p><p><span style="font-size: xx-small;">[3] United States Senate Health, Education, Labor, and Pensions Committee. (2023, October 10). Mahority Staff Report: Major Nonprofit Hospitals Take Advantage of Tax Breaks and Prioritize CEO Pay Over Helping Patients Afford Medical Care. Retrieved from https://www.sanders.senate.gov/wp-content/uploads/Executive-Charity-HELP-Committee-Majority-Staff-Report-Final.pdf</span></p><p><span style="font-size: xx-small;">[4] 26 U.S.C 501(r)(4), (6); Internal Revenue Serv, Billing and Collections – Section 501(r)(6) (Jul. 13, 2023), https://www.irs.gov/charities-non-profits/billing-and-collections-section-501r6. </span></p><p><span style="font-size: xx-small;">[5] Miller, A., Hawryluk,M. (2023, July 11). As Nonprofit hospitals reap big tax breaks, states scrutinize their required charity spending. Retrieved from https://kffhealthnews.org/news/article/nonprofit-hospitals-tax-breaks-community-benefit/</span></p><p><span style="font-size: xx-small;">[6] Wilkerson,J. (2023, October 10). Bernie Sanders bashes nonprofit hospitals over their tax breaks. Retrieved from https://www.statnews.com/2023/10/10/bernie-sanders-nonprofit-hospitals/</span></p><p><span style="font-size: xx-small;">[7] Levey,N. (2023, August 16). North Carolina hospitals have sued thousands of their patients, a new report finds. Retrieved from https://kffhealthnews.org/news/article/north-carolina-hospitals-patient-debt-lawsuits/</span></p><p><span style="font-size: xx-small;">[8] American Hospital Association. (2023, October). Tax-exempt hospitals provided nearly $130 billion in total benefits to their communities. Retrieved from https://www.aha.org/system/files/media/file/2023/10/Results-from-2020-Tax-Exempt-Hospitals-Schedule-H-Community-Benefit-Reports.pdf</span></p><div><i>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.</i> </div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-7717294914371844842023-11-24T07:00:00.000-05:002023-11-24T07:07:48.497-05:00Stigmas Impact on ART Medication Adherence among Young Transgender Women & HIV-Positive MSM<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>One of the most essential tenets of antiretroviral therapy (ART) is adherence. Consistent administration of HIV medication is the route to well-controlled HIV disease and ultimately undetectable status. Lack of adherence prevents viral suppression, resulting in advanced disease states, can result in medication resistance, and contributes to transmission. A myriad of challenges causes key populations of people living with HIV/AIDS (PLWHA) to experience ineffective adherence. A recent report on a study conducted in several countries of Africa reveals a lack of adherence among key populations of young people due to intersectional stigma. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnE0IETlVcFgy51ZjU7aGsAbHqH1H5YqVSjfgUlFtfqm_zHMead75QrC6EeZuNgGoDgL6gRerQ_zWkxgPG63Xn4w1X-ieHsF1BArsASwD959NaLH6lYGLjrHiB5bmplRi9dZdGyCXXfVNwqXkmTFz70BP_954ziG_O-gc7_trZmGIQmtleCiaWaK52Ek/s1200/power-of-education-to-end-HIV-discrimination-c-i_am_zews-Shutterstock.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Young adults talking in a group setting" border="0" data-original-height="628" data-original-width="1200" height="209" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnE0IETlVcFgy51ZjU7aGsAbHqH1H5YqVSjfgUlFtfqm_zHMead75QrC6EeZuNgGoDgL6gRerQ_zWkxgPG63Xn4w1X-ieHsF1BArsASwD959NaLH6lYGLjrHiB5bmplRi9dZdGyCXXfVNwqXkmTFz70BP_954ziG_O-gc7_trZmGIQmtleCiaWaK52Ek/w400-h209/power-of-education-to-end-HIV-discrimination-c-i_am_zews-Shutterstock.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: UNESCO</span></td></tr></tbody></table><p>The Health Economics and AIDS Research Division (HEARD) of the University of KwaZulu, Kamuzu University of Health Sciences in Malawi, the University of Zambia, and the University of Zimbabwe collaborated for a three-year research project to examine how various stigmas influence anti-retroviral therapy (ART) medication adherence in young transgender women and HIV-positive men who sex with men (MSM).[1] The study of 156 participants consisted of interviews and surveys. The purpose is to explore the experiences of intersectional stigma, develop a conceptual change model, design an intervention to improve ART adherence based on the model, and document results to create guidelines for improvement of the status quo in the South African Development Community Region.<span style="font-size: xx-small;">[1]</span> Overall, fear of the study population’s HIV status being revealed and depression from dealing with the social stigma attached to their sexual and gender minority status results in poor medication adherence. </p><p>Fear of discovery amidst the study population was nuanced. Some participants skipped doses of their medication because their living arrangements did not allow them privacy to take care of their health. They feared their medication being discovered in their belongings or being seen taking medication. Some of the participants lived in communities with social stigma of PLWHA. These young people feared their family or friends discovering their HIV status. Others feared discovery by their relationship partners. They feared their partners would desert them upon discovery of their status. In this case, skipping medication means poor health outcomes for themselves and possible transmission to their partners. Some participants even reported HIV stigma within the LGBTQ community, which they felt would make it harder for them to find partners.<span style="font-size: xx-small;">[1]</span></p><p>Others dealt with a different fear. Some of the participants lived in communities where there was increasing normalization of more acceptance of PLWHA. However, in these communities, there is still a negative stigma towards homosexuality, and in some cases, it is criminal. For the youth who were already known to be homosexual, they feared discovery of their HIV status because these communities saw it as a punishment for their sexuality. Thus, they skipped medication often or did not seek out regular treatment in medical facilities for fear of being treated poorly for being HIV positive and homosexual. </p><p>For both the transgender women participants and the MSM, social stigma due to their sexual and gender identity caused mental health issues that contributed to a lack of treatment adherence.<span style="font-size: xx-small;">[1]</span> They reported being looked upon with disdain and sometimes verbal or physical violence; navigating society as proverbial ‘black sheep’ caused depression and even suicidal ideation that made it challenging to be consistent with the self-care of ART adherence.<span style="font-size: xx-small;">[1,2]</span> This was especially true for those who reported alcohol and substance abuse as a way of coping. It’s a well-documented fact that substance abuse results in poor medication adherence. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8EfZv051aeCYT0rhnwS6NX2MdaRHi5_2fDN1B_sE-Gt4RxgimbdTM21VyCKV0eskVCwpSyit6gD_ArBVow5h2cSqQ1_saJhVgSuasO1LN5E-CSO0BsZ7f7fVMhye6sNv9KSKOYwRHkby-ZJD6AaGstuKehUQ9SCO4RwDf2g_x6VKl2e84FPBiWEZb1p0/s670/HIV_group.jpg" style="margin-left: auto; margin-right: auto;"><img alt="AIDS activists protesting" border="0" data-original-height="437" data-original-width="670" height="261" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8EfZv051aeCYT0rhnwS6NX2MdaRHi5_2fDN1B_sE-Gt4RxgimbdTM21VyCKV0eskVCwpSyit6gD_ArBVow5h2cSqQ1_saJhVgSuasO1LN5E-CSO0BsZ7f7fVMhye6sNv9KSKOYwRHkby-ZJD6AaGstuKehUQ9SCO4RwDf2g_x6VKl2e84FPBiWEZb1p0/w400-h261/HIV_group.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: The Lancet</span></td></tr></tbody></table><p>The research project is ongoing and in the stages of synthesizing intervention concepts. The discussion of the data has spawned several priorities. One priority is finding safe avenues of adequate care regarding HIV treatment. There need to be safe spaces to receive care and medication. Additionally, mental health resources for these young people are required. It is imperative to create safe spaces to talk about what is going on in their lives and how to cope. They need mental health professionals as well as safe peer group spaces to interact and support each other. Researchers also emphasized the importance of including the experiences and perceptions of front-line healthcare providers. The study cannot change external factors such as cultural prejudices and unfair criminalization. However, creating safe healthcare pipelines and infrastructure for psycho-social support will hopefully improve ART adherence and quality of life for the young sexual and gender minorities of Zimbabwe, Zambia, and Malawi.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">SADC. (2023, April). Regional Symposium Report. Retrieved from https://www.heard.org.za/wp-content/uploads/2023/06/SADC-Symposium-Report_final.pdf</span></p><p><span style="font-size: xx-small;">[2] Govender, K., Nyamaruze, P. (2023, September 25). Young people with sexual or gender diversity are at higher risk of stopping their HIV treatment, research finds. Retrieved from https://medicalxpress.com/news/2023-09-young-people-sexual-gender-diversity.html</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-53833315114451326592023-11-16T05:38:00.000-05:002023-11-16T05:38:24.229-05:00HIV Self-Testing: Opportunities and Challenges<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>In the fight to eradicate HIV in the United States, testing is a fundamental and indispensable tool. Testing is the gateway to treatment and prevention. It is the only way to identify those who are HIV-positive, not only to get them into timely, appropriate care and treatment but also prevent transmission to others with <a href="https://preventionaccess.org/resources/" target="_blank"><span style="color: #3d85c6;">Undetectable equals Untransmissible</span></a> (“U=U”). Unfortunately, about 13% of people in the United States living with HIV/AIDS (PLWHA) are unaware of their status.<span style="font-size: xx-small;">[1]</span> Whereas HIV self-testing has helped to overcome this barrier, it hasn’t been without its own challenges.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdkrQBkZAkg1792Wwhdu564FwWYHPq8U4fGNGWHAyz-UbsbVBsC_Ix_wyuJqcQJ1BmBfYa1hbff9aOgi5NAu5qI8MAsGn0x5eScX_tSRHldTCDFrctvV4FgYZlucci65Tep5xpsxs_3dEmF2TY2jWYVDSL7-8k3Oplwkc5hn-f3tn-eWPmTtS9fjafcDg/s4700/2020-cde-waidsday-infographic-3-eng0.jpg" style="margin-left: auto; margin-right: auto;"><img alt="What is HIV Self-Testing" border="0" data-original-height="4700" data-original-width="2000" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjdkrQBkZAkg1792Wwhdu564FwWYHPq8U4fGNGWHAyz-UbsbVBsC_Ix_wyuJqcQJ1BmBfYa1hbff9aOgi5NAu5qI8MAsGn0x5eScX_tSRHldTCDFrctvV4FgYZlucci65Tep5xpsxs_3dEmF2TY2jWYVDSL7-8k3Oplwkc5hn-f3tn-eWPmTtS9fjafcDg/w170-h400/2020-cde-waidsday-infographic-3-eng0.jpg" width="170" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: PAHO</span></td></tr></tbody></table><p>Many people do not test for a myriad of reasons. Some do not have access to testing facilities due to transportation issues or lack of availability in their area. Stigma and fear hinder others. Presently, some still fear being seen in a testing clinic by people in their community, while others fear receiving a positive result. Cost is a barrier to those who lack healthcare insurance and do not have access to free clinics. To increase HIV testing, medical science has developed exceptionally effective HIV self-testing. It has been an invaluable tool.</p><p>HIV-self testing, in the past, required painful finger pricking to draw blood. Now, there are oral self-testing kits, such as OraQuick, that only require swabbing of the mouth and gums. Self-testing kits are much more affordable than going into doctor's offices for bloodwork. They also allow people to test in the privacy of their own homes and ensure their confidentiality. Moreover, some organizations provide free testing kits for those who can’t afford to purchase the over-the-counter ones.</p><p>As beneficial as HIV self-testing kits are in attempting to normalize testing, especially in high-risk groups, there are downsides. Testing in private means that there are people who will be alone when they receive a positive result. Self-tests, such as OraQuick, provide a 24-hour hotline for people to use for support and guidance concerning a positive or negative result. However, for some, that is not enough. A positive result's psychological gravity could be too overwhelming for someone to handle alone speaking with a support person over the phone. Studies have shown that PLWHA are 100 times more likely to commit suicide than the general population.<span style="font-size: xx-small;">[2,3]</span> In a clinical setting, trained support professionals are available to help navigate a positive diagnosis. Moreover, a support hotline number is not guaranteed to be utilized. There’s the risk that people will deal with the diagnosis in a vacuum.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiBXIEdt4SWxRcf-6tHvkv1sK-3JAVHN-95Pbpyy5qp1aEZHioYqA-udXepb_7l142WMFS44gaNk5pUR29QcKt2tuICEen9zHWtz-UW4JPnxGhi8nWvjq5OgfRTM6zr_ZtJJfPt3noVdXtor99dNV74nSLbWcsLERXWGFdl0KzG8IwZkWNt5HS20S6n-gg/s1020/OraQuick-OTC-Full-Kit-1600x900.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="OraQuick HIV Self-Test Kit" border="0" data-original-height="574" data-original-width="1020" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiBXIEdt4SWxRcf-6tHvkv1sK-3JAVHN-95Pbpyy5qp1aEZHioYqA-udXepb_7l142WMFS44gaNk5pUR29QcKt2tuICEen9zHWtz-UW4JPnxGhi8nWvjq5OgfRTM6zr_ZtJJfPt3noVdXtor99dNV74nSLbWcsLERXWGFdl0KzG8IwZkWNt5HS20S6n-gg/w400-h225/OraQuick-OTC-Full-Kit-1600x900.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: U.S. Food & Drug Administration</span></td></tr></tbody></table><p>Self-testing also does not always result in people seeking treatment. Doctors recommend people confirm a positive self-test with clinical bloodwork. This is to verify the result and facilitate the swift initiation of an antiviral medication regimen. Studies show that some people do not seek out and initiate HIV treatment after a positive test result.<span style="font-size: xx-small;">[4]</span> This can result in poor health outcomes from progression into later stages of HIV disease. Additionally, lack of treatment can result in additional virus transmission to others.</p><p>Self-testing also has potential adverse effects on those testing negative. Research shows that self-testing does not facilitate behavior modification in those who test negative. For example, data indicates that self-testing increases incidences of condomless anal sex among men who have sex with men (MSM).<span style="font-size: xx-small;">[4]</span> Receiving a negative test result in a clinical setting provides the opportunity for discussion on ways to stay negative. This can include behavior modification as well as initiation of PrEP. </p><p>HIV self-testing reduces linkage to care by about 17%.<span style="font-size: xx-small;">[5]</span> The lack of linkages to care not only impacts patients and their own healthcare, but also the community at large. In the U=U era of fighting the HIV epidemic, linkages to care are of paramount importance.</p><p>Therefore, it needs to remain a part of wide-ranging prevention efforts and needs targeted additional support. Self-tests can result in more people being tested; however, uncovering the population of unknown positive individuals cannot be the sole focus. Stimulating additional positive outcomes from self-testing will require innovation to bolster support.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">U.S. Department of Health and Human Services. (2023, October 3). U.S. Statistics. Retrieved from https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics/</span></p><p><span style="font-size: xx-small;">[2] Wilder, T. (2021, October 8). The suicide rate for people with HIV is 100 times higher than the general population. The need for mental health care is urgent. Retrieved from https://www.thebodypro.com/article/suicide-rate-people-with-hiv-100-times-higher-than-general-population</span></p><p><span style="font-size: xx-small;">[3] Cairns, G. (2021, August 11). The hardest outcome of all: HIV and suicide. Retrieved from https://www.aidsmap.com/news/aug-2021/hardest-outcome-all-hiv-and-suicide</span></p><p><span style="font-size: xx-small;">[4] Adeagbo, O., Badru, O., Lucho, E. (2023, October 2). HIV self-test kits are meant to empower those at risk − but they don’t necessarily lead to starting HIV treatment or prevention. Retrieved from https://theconversation.com/hiv-self-test-kits-are-meant-to-empower-those-at-risk-but-they-dont-necessarily-lead-to-starting-hiv-treatment-or-prevention-213726</span></p><p><span style="font-size: xx-small;">[5] Witzel, T. C., Eshun-Wilson, I., Jamil, M. S., Tilouche, N., Figueroa, C., Johnson, C. C., Reid, D., Baggaley, R., Siegfried, N., Burns, F. M., Rodger, A. J., & Weatherburn, P. (2020). Comparing the effects of HIV self-testing to standard HIV testing for key populations: a systematic review and meta-analysis. BMC medicine, 18(1), 381. https://doi.org/10.1186/s12916-020-01835-z</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-54767392968145562372023-11-09T06:53:00.000-05:002023-11-09T06:53:01.971-05:00US District Court Sides with Patient Groups on Co-Pay Accumulators<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>An important legal decision produced a financial win for patients on medication affordability. On September 29, 2023, U.S. District Court Judge John D. Bates struck down a federal rule left over from the Trump Administration that previously allowed broad use of copay accumulators by insurance companies, which shifted more cost-sharing to patients. For a detailed explanation of copay accumulators, please view a previous ADAP Advocacy blog post on the subject <a href="https://adapadvocacyassociation.blogspot.com/2022/03/profiting-from-misery-because-they-can.html" target="_blank"><span style="color: #3d85c6;">here</span></a>. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEht7YmTUpbBCWAWHbYRVgWekLbNQBu0Z-kJV5m5VspEE7XUV5-g6keHLHtZKtYNpKEnxoUUD1Aymz-Rnngbyjp7cZtMSaPpvEMDFA_lFhzZYyO4Yu8GwINlpDbzURyrbLlWmINJn8TB57FiMlZxCMMJ8_v7SOQP3X3b95MrDNTy20XUhSo42T0cFEaCnEk/s1000/Copay-Accumulators-Blog-Post-Graphic.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Understanding Copay Accumulators" border="0" data-original-height="624" data-original-width="1000" height="250" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEht7YmTUpbBCWAWHbYRVgWekLbNQBu0Z-kJV5m5VspEE7XUV5-g6keHLHtZKtYNpKEnxoUUD1Aymz-Rnngbyjp7cZtMSaPpvEMDFA_lFhzZYyO4Yu8GwINlpDbzURyrbLlWmINJn8TB57FiMlZxCMMJ8_v7SOQP3X3b95MrDNTy20XUhSo42T0cFEaCnEk/w400-h250/Copay-Accumulators-Blog-Post-Graphic.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: National Infusion Center Association</span></td></tr></tbody></table><p>Copay accumulators, in essence, allow insurers to ‘double-dip’, maximizing profits while increasing financial burdens for patients. The accumulators allow insurers to refrain from applying drug manufacturer copay assistance payments to patients’ deductibles and out-of-pocket costs. Under copay accumulator policies, insurers pay less for medications by prolonging the cost-sharing time period before they are responsible for 100 percent of a medication’s cost.</p><p>The Trump-era rule is officially known as the U.S. Department of Health and Human Services (HHS) Notice of Benefit and Payment Parameters for 2021 (NBPP).<span style="font-size: xx-small;">[1]</span> The <a href="https://hivhep.org" target="_blank"><span style="color: #3d85c6;">HIV+Hepatitis Policy Institute</span></a>, <a href="https://nationalhealthcouncil.org/member/national-diabetes-volunteer-leadership-council/" target="_blank"><span style="color: #3d85c6;">Diabetes Leadership Council</span></a>, <a href="https://www.diabetespac.org" target="_blank"><span style="color: #3d85c6;">Diabetes Patient Advocacy Coalition</span></a>, and three patients sued HHS over the rule. The win means that insurance companies must now abide by the federal rule that controlled 2020 health plans. Thus, copay accumulator programs are only allowed to be used for brand-name drugs that have generic equivalents.<span style="font-size: xx-small;">[1]</span> According to a report issued by IQVIA, manufacturer copay assistance in 2022 was almost $19 billion.<span style="font-size: xx-small;">[2]</span> This means insurers previously received billions in payments provided by manufacturers in addition to the overage they were predatorily siphoning directly from patients. </p><p>The flawed federal rule allowed insurance companies to arbitrarily decide if copay assistance programs were considered a type of cost-sharing. This was based on contradictory interpretations of the law and problematic ambiguities of its language. Copay assistance should indeed be regarded as cost-sharing, given the rule states cost-sharing is “any expenditure required by or on behalf of an enrollee.”<span style="font-size: xx-small;">[1]</span> Striking down the rule removes any ambiguity mandating that patients can go back to applying copay assistance payments towards deductibles and out-of-pocket maximums, thus significantly lowering their financial burden for high-cost medications.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgyBcsMz1OuKNh6oyHNFYb_ophJaJp3Pjp4eahh43V-TPt8d6fLHh-lO4vvvnAe8SMS3nQcLulGMLmXur_xx8-wzuUcnfKaKBlO1yQn64s4aQceRwmr4DLHOMwC2LRU-mqM2c_33Eyr4eCFgR0e_TXGs-W8qDh-uw3y9o-Wl4J6hTJfTt551uXz9CwYMSw/s2500/accumlators%20harm%20patients.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Copay Accumulators Harm Patients" border="0" data-original-height="1771" data-original-width="2500" height="284" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgyBcsMz1OuKNh6oyHNFYb_ophJaJp3Pjp4eahh43V-TPt8d6fLHh-lO4vvvnAe8SMS3nQcLulGMLmXur_xx8-wzuUcnfKaKBlO1yQn64s4aQceRwmr4DLHOMwC2LRU-mqM2c_33Eyr4eCFgR0e_TXGs-W8qDh-uw3y9o-Wl4J6hTJfTt551uXz9CwYMSw/w400-h284/accumlators%20harm%20patients.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: National Bleeding Disorders Foundation</span></td></tr></tbody></table><p>Health insurance policy and drug benefit design can be a bridge or a barrier to effective and optimal access to life-saving medications. High out-of-pocket costs for patients often result in medicine abandonment, poor medication adherence, or even failure to initiate necessary treatment.<span style="font-size: xx-small;">[3]</span> Patients affected by copay accumulators are 1.5 times less likely to fill their prescriptions than those in high-deductible plans.<span style="font-size: xx-small;">[4]</span></p><p>The legal decision is a significant win. However, it must be aggressively and effectively enforced. The representatives of HHS attempted to use convoluted and flawed arguments to explain why copay accumulators were good for patients and how they somehow forced manufacturers to lower prices. The judge refuted their arguments, but he remanded to HHS in the event it should decide to offer new arguments concerning the legality of copay accumulators under the Affordable Care Act.<span style="font-size: xx-small;">[1]</span> Swift and sweeping enforcement can ensure there is no delay in patients' financial relief. Languid implementation of the ruling will continue to harm patients while providing time for continued attempts to construct arguments in favor of the accumulators.</p><p><span style="font-size: xx-small;">[1] </span><span style="font-size: xx-small;">HIV + HEP Policy Institute. (2023, October 2). Court strikes down HHS rule that allowed insurers to not count copay assistance. Retrieved from https://hivhep.org/press-releases/court-strikes-down-hhs-rule-that-allowed-insurers-to-not-count-copay-assistance/ </span></p><p><span style="font-size: xx-small;">[2] IQVIA Institute For Human Data Science. (2023). The Use of Medicines in the U.S. 2022: Usage and Spending Trends and Outlook to 2026. Retrieved from https://www.statnews.com/wp-content/uploads/2023/10/iqvia-institute-the-use-of-medicines-in-the-us-2022-1.pdf</span></p><p><span style="font-size: xx-small;">[3] Simons, R. (2023, May 18). Affordable Care Act marketplace plans and drug benefit design. Retrieved from https://adapadvocacyassociation.blogspot.com/2023/05/affordable-care-act-marketplace-plans.html</span></p><p><span style="font-size: xx-small;">[4] Silverman, E. (2023, October 3). Court strikes down Trump-era rule that allowed health insurers to broadly use copay accumulators. Retrieved from https://www.statnews.com/pharmalot/2023/10/02/trump-biden-hhs-copay-insurance-accumulator/</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-90533155164032227602023-11-02T09:52:00.001-04:002024-01-04T11:05:30.148-05:00340B Covered Entities’ Revenue Witnessed Huge Executive Compensation Increases, Alarming Charity Care Decreases<p><i>By: <a href="https://www.linkedin.com/in/mjhopkins81/" target="_blank"><span style="color: #3d85c6;">Marcus J. Hopkins</span></a>, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)</i></p><p></p><p></p><p>Research conducted by ADAP Advocacy, as part of its ongoing 340B Project, and its newly minted Ryan White Grantee 340B Patient Advisory Committee found executive compensation increased significantly at 340B Covered Entities after they became eligible for 340B drug rebates as a source of revenue. In the same period, hospitals receiving 340B rebates almost uniformly saw nearly universal decreases in the percentage of charity care they provided as a percentage of revenues.</p><p>Read the ADAP Advocacy press release, <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_Press_340B_Revenue_Executive_Compensation_Charity_Care_Medical_Debt_10-31-23.pdf" target="_blank"><span style="color: #3d85c6;">here</span></a>.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVzKl2mccfhCOjotg15B_ODdHHj6Im8V_sfkggGmtFhREBfM-uvSKCyob_0L9ySqtCiRj4kQ8XyQyomPKZGMWXeR0bwi3AD7VLnt0TNaWTy7odIt8DgbehtDolGvFf2YEa7BLBh7Z3aq4BDo027Z30CegfJ-il5NKwUSj3psM8SE_9xvsI2zuAZ3cB-y8/s617/340B%20Final%20Report.jpg" style="margin-left: auto; margin-right: auto;"><img alt="340B in a pill" border="0" data-original-height="578" data-original-width="617" height="375" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgVzKl2mccfhCOjotg15B_ODdHHj6Im8V_sfkggGmtFhREBfM-uvSKCyob_0L9ySqtCiRj4kQ8XyQyomPKZGMWXeR0bwi3AD7VLnt0TNaWTy7odIt8DgbehtDolGvFf2YEa7BLBh7Z3aq4BDo027Z30CegfJ-il5NKwUSj3psM8SE_9xvsI2zuAZ3cB-y8/w400-h375/340B%20Final%20Report.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: CANN</span></td></tr></tbody></table><p>ADAP Advocacy examined total annual revenues for select Covered Entities participating in the 340B Drug Pricing Program—including executive compensation (only Chief Executive Officers, or CEOs)—charity care totals, and charity care as a percentage of annual revenues. The analysis identified trends across 340B Covered Entities, breaking them into two groups: hospitals and non-hospital grantees. It compares the year before each organization was deemed 340B eligible, one year after, five years after, ten years after, and the most recent year on file.</p><p>Across the non-hospital grantees, executive compensation increased at an average rate of 391.3%. When excluding outliers, that average was 320.2%. Across the hospitals, CEO compensation increased at an average rate of 224.9%, including outliers, and 186.8% when accounting for outliers.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1r7gEdE9JkuM2XCyihZ-qAOjgzKhd8F9cfgzgsP4N3vJyUCiDMY9CrFIfVh9dbTQ-p8CKb3HT0ifCb7HgRxRtDVKyk0OrPKHg1sc83umoPLpI46n8hHACkvSezlv1z5SpVexU7ItpxZwOwR4APEQoX62rHRxzepL7cuGvfmYQU2hXvOYadt4LMYK_d4c/s1000/shutterstock_24430747.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Man in suit with $100 bills in his dress suit pocket" border="0" data-original-height="667" data-original-width="1000" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi1r7gEdE9JkuM2XCyihZ-qAOjgzKhd8F9cfgzgsP4N3vJyUCiDMY9CrFIfVh9dbTQ-p8CKb3HT0ifCb7HgRxRtDVKyk0OrPKHg1sc83umoPLpI46n8hHACkvSezlv1z5SpVexU7ItpxZwOwR4APEQoX62rHRxzepL7cuGvfmYQU2hXvOYadt4LMYK_d4c/w400-h266/shutterstock_24430747.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Vistage.com</span></td></tr></tbody></table><p>Of the hospitals examined, just three hospitals—Ascension’s St. Francis, Bon Secours’ St. Francis Xavier Hospital, and Wellstar’s Piedmont Athens Regional Medical Center—increased the charity care they provided as a percentage of overall revenues by 114.9%, 86.7%, and 13.2%, respectively. An additional two hospitals provided no charity care information. Overall, charity care as a percentage of revenues <b><u>decreased</u></b> across all hospitals at an average rate of 29.7%. When accounting for outliers, the average decrease was 36%.</p><p>These decreases in charity care as a percentage of total revenue come at a time when there are mixed reports about the number of Americans and households with medical debt in the United States. Different agencies and outlets report vastly different perspectives and analyses of medical debt, highlighting the need for more clarity and transparency about how medical debt is calculated and counted.</p><p>According to the <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/02/14/fact-sheet-new-data-show-8-2-million-fewer-americans-struggling-with-medical-debt-under-the-biden-harris-administration/#:~:text=Today%2C%20the%20Consumer%20Financial%20Protection,the%20first%20quarter%20of%202022." target="_blank"><span style="color: #3d85c6;">Biden Administration</span></a>, the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. They attribute this decrease to streamlining by the Department of Veterans Affairs (VA) to improve access to medical debt relief for veterans with lower incomes, the purchasing and forgiveness of medical deb from hospitals and other sources using funds from the American Recovery Plan (ARP) by individual municipalities and counties, and the development of a new credit score that excludes medical debt.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxzG32rR2bn2W6oM89MkXVN2_STqgmPZBu1EAZykjIqgJlCBOkxM0o9zC-U3-J-6D819mnLXQeo8-bxoqFtgKGOBKbXZDFphc-srx_4f824gYQ4uMDY_U8elEZ30Tdx1R0KQF9hyphenhyphenXlxwPVHtolQnlbaqLa_QlW2LLSPJgz2QKxi_6RlQsCiw6NWjV_IM8/s474/medical-debt.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Medical Debt" border="0" data-original-height="316" data-original-width="474" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxzG32rR2bn2W6oM89MkXVN2_STqgmPZBu1EAZykjIqgJlCBOkxM0o9zC-U3-J-6D819mnLXQeo8-bxoqFtgKGOBKbXZDFphc-srx_4f824gYQ4uMDY_U8elEZ30Tdx1R0KQF9hyphenhyphenXlxwPVHtolQnlbaqLa_QlW2LLSPJgz2QKxi_6RlQsCiw6NWjV_IM8/w400-h266/medical-debt.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: National Foundation for Credit Counseling</span></td></tr></tbody></table><p>Conversely, a <a href="https://s3.amazonaws.com/files.consumerfinance.gov/f/documents/cfpb_medical-debt-burden-in-the-united-states_report_2022-03.pdf" target="_blank"><span style="color: #3d85c6;">report</span></a> released by the Consumer Financial Protection Bureau in 2022 found that there was roughly $88 billion in medical debt on consumer credit reports. Since that report, credit agencies have voluntarily removed debts of less than $500, debts less than a year old, or those that have been marked as ‘Paid’ (<a href="https://www.politico.com/news/2023/09/07/state-lawmakers-america-medical-debt-00114330" target="_blank"><span style="color: #3d85c6;">Goldberg, 2023</span></a>). Additionally, <a href="https://www.kff.org/report-section/kff-health-care-debt-survey-main-findings/" target="_blank"><span style="color: #3d85c6;">Kaiser Family Foundation</span></a> (KFF) found that one out of every ten adults has medical debt and that the amount owed is at least $195 billion. </p><p>According to Goldberg’s article in <i>Politico</i>, the real issue is that total medical debt is impossible to quantify in the United States “…because it hits people in incalculable ways.” Medical debt doesn’t always take on the form of debt sent to collections that will be reported on credit reports:</p><p></p><ul style="text-align: left;"><li>Patients may be actively paying on debts owed, meaning that the only people aware of the medical debt are the holder and the patient.</li><li>Patients may have paid medical debts using credit cards or personal loans, which again, so long as the patient remains current on their payments, would not be reflected on credit reports.</li><li>Patients may have borrowed from family or friends and are repaying them.</li></ul><p></p><p>These represent just a few of the potential scenarios that make the true total of medical debt impossible to quantify.</p><p>What is clear when looking at <a href="https://apps.urban.org/features/debt-interactive-map/?type=medical&variable=medcoll" target="_blank"><span style="color: #3d85c6;">maps of households with medical debt</span></a> released by the Urban Institute is that the communities where the percentage of households with medical debt in collection are largely located in the American South, including almost every county in West Virginia and South Carolina, as well as a plurality of counties in Oklahoma, North Carolina, and Texas. It is therefore important to evaluate which hospitals serving those communities are living up to their obligations of using 340B funds to improve patient care and access to care and treatment.</p><p><b><i>Editor’s Note:</i></b> At the request of ADAP Advocacy’s CEO, Brandon M. Macsata, to demonstrate transparency, we’re sharing some information about compensation paid to his firm, Purple Strategy Group, Inc. (PSG). PSG is paid a monthly management fee, which covers the work Brandon does on administrative, accounting, governance, marketing, and programs. The monthly fee is $8,000 per month, which has remained at that level since 2013 without an increase. Based on budget and net revenue year-end numbers, Brandon is also eligible to receive a performance bonus up to $6,500. Additionally, Brandon gives back to the organization annually, with his annual financial contributions ranging between $2,500 and $15,000+. No fringe benefits are paid, since Brandon is a 1099 contractor and not an employee. He is eligible to receive additional compensation for special projects that fall outside the scope of work, although most years there are no such projects.</p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-9321238101152770502023-10-26T06:17:00.007-04:002023-10-26T06:29:54.463-04:00A Growing Problem, which is Potentially Contributing to Overdose Deaths<p><i>By: <a href="https://www.linkedin.com/in/mjhopkins81/" target="_blank"><span style="color: #3d85c6;">Marcus J. Hopkins</span></a>, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)</i></p><p></p><p></p><p>In September 2023, alarming data on overdose deaths was published in the Morbidity and Mortality Weekly Report (MMWR). In response, ADAP Advocacy and the Partnership for Safe Medicines (PSM) issued a press release, <i><a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_Press_CDC_Counterfeit_Pill_Deaths_09-13-23.pdf" target="_blank"><span style="color: #3d85c6;">ADAP Advocacy Calls for More Awareness on Counterfeit Medicines</span></a></i>, calling attention to an increase in the infiltration of counterfeit medications into both the legitimate pharmaceutical marketplace and the illicit drug markets. “Unlike counterfeit opioid pills which often kill instantly, counterfeit HIV medications will victimize patients silently and slowly. Treatment failure, with a whole host of health events, will be the only clue a patient and their physician will notice,” stated Brandon Macsata, ADAP Advocacy’s CEO.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTMYIV3poZYTJ6CocxZdqpoYVVFoTXBIP2RY48LtCTK2cX3LEw8u0J67GR7v1Mnj2uwvdzbD64D1Jw0S5EyXAKmH3S9up-aIc30YXcEKhUXz4IR-j5YuURI4ZGjXk4DRRPU_2YMJgypSHC2PEZozVcTEQpHictBsZB3yC7OoU9nx2QWxYyS8G09bXWctg/s600/MMWR.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Morbidity and Mortality Weekly Report" border="0" data-original-height="300" data-original-width="600" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTMYIV3poZYTJ6CocxZdqpoYVVFoTXBIP2RY48LtCTK2cX3LEw8u0J67GR7v1Mnj2uwvdzbD64D1Jw0S5EyXAKmH3S9up-aIc30YXcEKhUXz4IR-j5YuURI4ZGjXk4DRRPU_2YMJgypSHC2PEZozVcTEQpHictBsZB3yC7OoU9nx2QWxYyS8G09bXWctg/w400-h200/MMWR.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: HHS</span></td></tr></tbody></table><p>There have been two recent very high-profile examples of counterfeit drugs entering the marketplace: Janssen’s Symtuza (darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide) and Gilead’s Biktarvy (bictegravir/ emtricitabine/ tenofovir alafenamide) and Descovy (emtricitabine/ tenofovir alafenamide).</p><p>The Janssen case came to light on December 24th, 2020, when the company released a statement <a href="https://www.fda.gov/media/144858/download" target="_blank"><span style="color: #3d85c6;">warning patients, providers, and pharmacists</span></a> that counterfeit versions of their highly effective HIV drug, Symtuza, had entered the consumer market through pharmacies that had purchased their drugs from distributors that were not authorized by Janssen. In an effort to alert consumers, Janssen began distributing information to providers, patients, and pharmacists with pictures and descriptions of authentic Symtuza pills and informing providers and pharmacists to reach out to patients to alert them to be on the lookout for counterfeits.</p><p>Similarly, Gilead Sciences <a href="https://www.gilead.com/news-and-press/company-statements/gilead-warns-of-counterfeit-hiv-medication-being-distributed-in-the-united-states" target="_blank"><span style="color: #3d85c6;">announced</span></a> on August 5th, 2021, that counterfeit versions of Biktarvy and Descovy had made their way to pharmacy shelves, again via unauthorized distributors, and again provided images of authentic pills and packaging to allow patients to better identify counterfeit products.</p><p>Both companies responded in similar ways—attempting to educate the consumer population about authentic products while simultaneously working to address unauthorized distributors. Gilead went further in 2022 by <a href="https://www.gilead.com/news-and-press/company-statements/gilead-announces-actions-to-remove-counterfeit-hiv-medications-from-us-supply-chain" target="_blank"><span style="color: #3d85c6;">announcing</span></a> that they were working to identify and sue two individuals responsible for leading and orchestrating the scheme. Their <a href="https://www.gilead.com/news-and-press/company-statements/gilead-continues-efforts-to-halt-the-distribution-of-counterfeit-hiv-medications-and-protect-patient-safety#:~:text=Gilead%20initiated%20this%20litigation%20in,solely%20to%20sell%20counterfeit%20medications." target="_blank"><span style="color: #3d85c6;">investigation</span></a> found that these two individuals had directed the initial sale through suppliers created solely to sell counterfeit products. Further action was taken when an asset freeze order was unsealed revealing that 50 defendants were added to the suit. Janssen followed shortly after by announcing its own <a href="https://www.fiercepharma.com/pharma/johnson-johnson-follows-gilead-suit-its-own-pursuing-sellers-counterfeit-versions-its-hiv" target="_blank"><span style="color: #3d85c6;">lawsuit</span></a>.</p><p>And then, there’s the illicit drug market…</p><p>A September 1st, 2023, MMWR <a href="https://www.cdc.gov/mmwr/volumes/72/wr/mm7235a3.htm" target="_blank"><span style="color: #3d85c6;">found evidence</span></a> that the evidence of overdose deaths resulting from counterfeit pills increased from 2.0% in July-September 2019 to 4.7% in October-December 2021. Fentanyl was the only drug involved in 41.4% of deaths with evidence of counterfeit pill use and 19.5% of deaths without evidence.</p><p>The issue, here, isn’t that patients are purchasing counterfeit prescription drugs from pharmacies, but that they’re purchasing them from illicit sources (e.g., illicit drug dealers). And yet, these are still counterfeit versions of legitimate pharmaceutical drugs, each designed to look roughly identical to their authentic counterparts—in these cases, primarily oxycodone (the generic version of OxyContin, a powerful and highly addictive pain medication) and alprazolam (the generic version of Xanax, a drug used primarily to treat anxiety or panic attacks, and one of the most addictive benzodiazepine medications on the market).</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVHMbzoBwm6xLbHcairhObivwX7TQorqV8cahwLtR4RzJgj-oDCt4ZMJokGFDV9dPEmda1qkmy19wVt6awoRdyo-V-ibM45hh0yJNrogm-AjFh-sTZKG8fKHL6_qKW6a57mL4yKEz4-yWLQY5b-uAFGBxJrdMR1hkbhMGeSEJwKbcA6O-E-wl6deVJGLU/s428/Counterfeit%20Pills.png" style="margin-left: auto; margin-right: auto;"><img alt="Fake Oxy" border="0" data-original-height="428" data-original-width="384" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjVHMbzoBwm6xLbHcairhObivwX7TQorqV8cahwLtR4RzJgj-oDCt4ZMJokGFDV9dPEmda1qkmy19wVt6awoRdyo-V-ibM45hh0yJNrogm-AjFh-sTZKG8fKHL6_qKW6a57mL4yKEz4-yWLQY5b-uAFGBxJrdMR1hkbhMGeSEJwKbcA6O-E-wl6deVJGLU/w359-h400/Counterfeit%20Pills.png" width="359" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Drug Enforcement Administration</span></td></tr></tbody></table><p>Unlike HIV or specialty medications that have very specific, patented designs, both oxycodone and alprazolam have generic equivalents that can make spotting counterfeit versions more difficult. In September 2021, the U.S. Department of Justice's Drug Enforcement Administration (DEA) put out a <a href="https://www.dea.gov/sites/default/files/2021-09/DEA_Fact_Sheet-Counterfeit_Pills.pdf" target="_blank"><span style="color: #3d85c6;">fact sheet</span></a> with an image showing the similarities between authentic and counterfeit oxycodone, and the reality is that, unless someone is actively examining each pill they take, the differences are hard to spot. At first glance, the counterfeit version looks like it’s more authentic than the real M30 tablet because the markings are clearer and easier to read.</p><p>A bigger concern, here, is that the pills that are shown to have the highest likelihood of being counterfeited are ones to which people may be highly addicted, making them less likely to check pills for authenticity, rather than to just take the pills, either orally or via smoking, the most common non-ingestion drug use route among deaths with evidence of counterfeit drug use (39.5%). This can be exceptionally dangerous, particularly among younger people who are less likely to have experience identifying and avoiding counterfeit drugs. Moreover, those with severe addictions may be driven more by the need to satiate their need than any concerns about potential overdose risks.</p><p>Two of the findings from the MMWR report were that overdose deaths with evidence of counterfeit pill use were significantly more likely to occur among young people, with 57.1% of said overdoses occurring in people aged younger than 35 and were more often to occur in Hispanic or Latino populations (18.7%). If these young people are anything like I was in my twenties, they’re not likely to check the provenance of their drugs, rather than just take them.</p><p>Additionally, this increase in overdoses impacts a region that has traditionally seen relatively few fentanyl-based overdose deaths compared to the South, Midwest, and New England: the West (<a href="https://www.npr.org/2023/09/06/1197954655/drug-overdose-deaths-counterfeit-prescription-pills" target="_blank"><span style="color: #3d85c6;">Hernandez, 2023</span></a>). When looking at states in the West, the rate of overdose deaths with evidence of counterfeit pill use surged from 4.7% to 14.7% in the time period examined. Researchers indicate that the type of heroin prevalent in the West—black tar heroin—is difficult to mix with white powder fentanyl, which has made it less likely to be found in Western states. Counterfeit medications, however, make it easier to introduce fentanyl into the market.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnAjrJufNVorOsgFycNyfoNWrVg-bG-j5UPbO9wWxd6z33Nh66q5h8z6ePvulzGKVFJ4ErjWb8rXwVQ3qna_hUgw3z8_8z9TPe_KIL8cD8J2arVOjKsH_Uxcz1M2pG0blVytwYBvfz07PEl3G7UNe0kMt_x5BSJNvbnq0Tih8aU0vlaAdn8MquNR5pOSI/s1430/Overdose%20Death%20Increases%20Chart.png" style="margin-left: auto; margin-right: auto;"><img alt="Drug Overdose Deaths with Evidence of Counterfeit Pill Use — United States, July 2019–December 2021" border="0" data-original-height="916" data-original-width="1430" height="256" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnAjrJufNVorOsgFycNyfoNWrVg-bG-j5UPbO9wWxd6z33Nh66q5h8z6ePvulzGKVFJ4ErjWb8rXwVQ3qna_hUgw3z8_8z9TPe_KIL8cD8J2arVOjKsH_Uxcz1M2pG0blVytwYBvfz07PEl3G7UNe0kMt_x5BSJNvbnq0Tih8aU0vlaAdn8MquNR5pOSI/w400-h256/Overdose%20Death%20Increases%20Chart.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: CDC</span></td></tr></tbody></table><p>Note. Retrieved from <a href="https://www.cdc.gov/mmwr/volumes/72/wr/mm7235a3.htm" target="_blank"><span style="color: #3d85c6;">O’Donnell et al., 2023</span></a>.</p><p>Outside of the United States, it was announced on October 24th, 2023, that <a href="https://www.reuters.com/world/europe/several-people-taken-hospital-austria-after-taking-suspected-fake-ozempic-2023-10-24/" target="_blank"><span style="color: #3d85c6;">several people living in Austria were hospitalized</span></a> after using suspected counterfeits of the blockbuster diabetes and weight loss drug Ozempic (semaglutide). Ozempic, made by Danish company Novo Nordisk, has been shown to drastically improve weight loss outcomes and was approved by the U.S. Food & Drug Administration (FDA) for that purpose under the brand name Wegovy. The drug’s popularity for weight loss purposes has exacerbated supply chain issues, causing worldwide shortages of the drug for patients living with diabetes. Counterfeiters are recognizing these shortages as an opportunity to bring fake versions of the injector pens to the market packaged in official boxes. Authorities in Germany and Britain have been investigating cases where a wholesaler in Austria sold these counterfeits to Germany and to two additional wholesalers in Britain. Here in the United States, similar reports of counterfeit Ozempic were <a href="https://nabp.pharmacy/news/blog/regulatory_news/counterfeit-ozempic-found-in-us-retail-pharmacy/" target="_blank"><span style="color: #3d85c6;">reported</span></a> in August 2023.</p><p>What makes counterfeit pills so dangerous is that people have come to trust in the security of pills. We assume that medications in pill form are guaranteed to be safe, even when we purchase them from illicit sellers, and we do so because we’ve been told by numerous agencies that they are safe, from the FDA who approves them to the manufacturers, providers, and pharmacists who sell them. We also assume, when we buy pills from illicit sources, that they have procured those pills from legitimate sources and are just reselling them. When counterfeit pills enter the market, whether credible-looking fakes of specialty medications or convincing fakes of generic drugs, patients begin to lose trust in the system that fails them…assuming they’re still alive to lose that faith..</p><p><i>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.</i></p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-72093918064020127822023-10-19T06:04:00.001-04:002023-10-19T06:28:33.355-04:002023 Ryan White HIV/AIDS Program Biennial Report Now Available<p><i>By: Health Resources and Services Administration’s HIV/AIDS Bureau</i></p><p></p><p></p><p>The Health Resources and Services Administration’s (HRSA) HIV/AIDS Bureau (HAB) is excited to share that the 2023 Ryan White HIV/AIDS Program Highlights biennial report is now available.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhDGKQVhANinpmUrtM7e0Y4f6x8RtPJtUIw8kCIx_WmqVBqX3jTDVUP_l7u3d3_jUs5d03FFQRwgDNTEFFxr1kM0Lx_G9dFHaUqJqXXeivGIrltm30WxY7bzMilFKKGsq-nR_L6wJnPj0aiihmN8BLEWZRkz_25BLWzys3fagTquqqsO_iOjuOuYYapIg0/s619/HRSA-agency-logo_FINAL.jpg" style="margin-left: 1em; margin-right: 1em;"><img alt="HRSA" border="0" data-original-height="203" data-original-width="619" height="131" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhDGKQVhANinpmUrtM7e0Y4f6x8RtPJtUIw8kCIx_WmqVBqX3jTDVUP_l7u3d3_jUs5d03FFQRwgDNTEFFxr1kM0Lx_G9dFHaUqJqXXeivGIrltm30WxY7bzMilFKKGsq-nR_L6wJnPj0aiihmN8BLEWZRkz_25BLWzys3fagTquqqsO_iOjuOuYYapIg0/w400-h131/HRSA-agency-logo_FINAL.jpg" width="400" /></a></div><p>To highlight innovative models of HIV care and treatment that Ryan White HIV/AIDS Program and HAB Ending the HIV Epidemic in the United States (EHE) initiative recipients implement in communities across the country, HRSA HAB publishes a report every two years. These reports provide an update of Ryan White HIV/AIDS Program and HAB EHE efforts to improve health outcomes for people with HIV and document the successes and challenges of recipients.</p><p>Titled <a href="https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/hrsa-biennial-report-2023.pdf" target="_blank"><span style="color: #3d85c6;">Harnessing the Power of Community Engagement and Innovation to End the HIV Epidemic: 2023 Ryan White HIV/AIDS Program Highlights</span></a>, the 2023 biennial report features seven Ryan White HIV/AIDS Program and HAB EHE recipients who have implemented effective strategies and syndemic approaches to HIV care by addressing health disparities and engaging the HIV community in the planning and implementation of programs. The seven recipients have focused on partnering with service providers to deliver innovative programs to priority populations, conducting outreach to youth, offering housing services, providing mpox vaccine distribution, facilitating peer-led engagement of transgender women, and integrating oral health services and dental training. These and other HRSA RWHAP recipients provide inspiration for leveraging community engagement and innovation to end the HIV epidemic in the United States.</p><p>Please note Harnessing the Power of Community Engagement and Innovation to End the HIV Epidemic: 2023 Ryan White HIV/AIDS Program Highlights is not copyrighted. Readers are free to duplicate and use all or part of the information contained in this publication; however, photographs require permission to be reproduced. For suggested citation, please see page ii in the report.</p><p>To read the 2023 report and previous biennial reports, please visit: <a href="https://ryanwhite.hrsa.gov/data/biennial-reports"><span style="color: #3d85c6;">https://ryanwhite.hrsa.gov/data/biennial-reports</span></a>.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh6VRq9G0cBDu9Rlbe1rXhXJekMiiH0Nxz1crlo_jGHWkVPdDFm95eT5xZAPF12WFOpanIW9m15SuJCLl0qyAFTyN3turud1OQ1QOlW3t9OXhk2gAzE2JHLy3O592cxNy48wLxWc2dSFu7DsqB-gxSQIYATf71TkAToKGZJ24YGWsFvTzt5In75uMEE3CE/s1342/Screenshot%202023-10-17%20at%203.11.14%E2%80%AFPM.png" style="margin-left: 1em; margin-right: 1em;"><img alt="Harnessing the Power of Community Engagement and Innovation to End the HIV Epidemic: 2023 Ryan White HIV/AIDS Program Highlights" border="0" data-original-height="1342" data-original-width="1036" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh6VRq9G0cBDu9Rlbe1rXhXJekMiiH0Nxz1crlo_jGHWkVPdDFm95eT5xZAPF12WFOpanIW9m15SuJCLl0qyAFTyN3turud1OQ1QOlW3t9OXhk2gAzE2JHLy3O592cxNy48wLxWc2dSFu7DsqB-gxSQIYATf71TkAToKGZJ24YGWsFvTzt5In75uMEE3CE/w309-h400/Screenshot%202023-10-17%20at%203.11.14%E2%80%AFPM.png" width="309" /></a></div><p><i>Editor's Note: Laura Cheever and Heather Hauck from the HIV/AIDS Bureau shared this update on October 17th via email to Ryan White HIV/AIDS Program Colleagues. No editorial analysis or comment has been provided by ADAP Advocacy.</i></p><p><i>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.</i></p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-13295826680023767822023-10-12T06:25:00.008-04:002023-10-12T06:26:58.903-04:00When You’re Still Sick: Living with Long-COVID and HIV<p><i>By: <a href="https://www.linkedin.com/in/mjhopkins81/" target="_blank"><span style="color: #3d85c6;">Marcus J. Hopkins</span></a>, ADAP Blog Guest Contributor, and Founder & Executive Director of the Appalachian Learning Initiative (APPLI)</i></p><p></p><p></p><p>Recently release research in <i>The Lancet</i> has found that, in addition to Long COVID, other respiratory ailments (Acute Respiratory Infections, or ARIs), such as colds, flus, and pneumonias, are associated with a wide range of long-term symptoms more than four weeks after the acute infection (<a href="https://doi.org/10.1016/j.eclinm.2023.102251" target="_blank"><span style="color: #3d85c6;">Vivaldi, Pfeffer, Talaei, Basera, Shaheen, & Martineau, 2023</span></a>).</p><p>This article was sent to me by Brandon M. Macsata, CEO of ADAP Advocacy, after graciously allowing me to cancel my attendance at the most recent Health Fireside Chat in Philadelphia due to a respiratory ailment.</p><p>“I read this article and said, ‘Hmmm…sounds like Marcus.’”</p><p>And it did.</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIRnpt455zI6Y68oJK9bhdzi8o61VInX1Yx5ACmibohaXdjrhsyAe-8acwExQ0BvtDYn-zn-98T4bFe17Xt5paEU_nw9O4XXLbqML_PtbuvpJuWmntaDJ0dWF8hyphenhyphen5H1Gijf9HImIZe0VF1IAsfah_09P7eZT5KMMCEhyaHxM_ZKNH9GdONnp4l5PNK3Sw/s1080/When%20You're%20Still%20Sick%20(10-11-23).png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Silhouette hunched over out of breath, standing in front of stairs" border="0" data-original-height="1080" data-original-width="1080" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIRnpt455zI6Y68oJK9bhdzi8o61VInX1Yx5ACmibohaXdjrhsyAe-8acwExQ0BvtDYn-zn-98T4bFe17Xt5paEU_nw9O4XXLbqML_PtbuvpJuWmntaDJ0dWF8hyphenhyphen5H1Gijf9HImIZe0VF1IAsfah_09P7eZT5KMMCEhyaHxM_ZKNH9GdONnp4l5PNK3Sw/w400-h400/When%20You're%20Still%20Sick%20(10-11-23).png" width="400" /></a></div><p>On July 14th, 2023, I attended an outdoor ABBA tribute band concert with my mother and stepfather, but left early because I was feeling sick. I got home, and within twelve hours, I could barely breathe and moving was a chore. The following Monday, I tested myself for COVID, and got a negative result, so I thought, “Okay…must just be a summer cold.”</p><p>And then, it lingered.</p><p>By August, I’d spent most of July sleeping ~12 hours a day, between sleeping at night and intermittent naps throughout the day. My waking hours were spent coughing for so long I would literally lose consciousness from the lack of oxygen and come to a few moments later to find myself slumped over in bed and disoriented.</p><p>I had to push back several deadlines with clients, and when I reached out to my Primary Care Physician (PCP, who is also my Infectious Disease, ID, doctor), they recommended I go to Urgent Care for testing, where I was given a breathing treatment while they tested me for fourteen different respiratory ailments, from multiple strains of COVID to flu to tuberculosis, took X-Rays of my lungs, and sent me home with an inhaler, a strong antibiotic, and instructions to rest.</p><p>Another week went by, and there were no changes. Finally, my ID doc agreed to see me, where I was put through another battery of tests to see if non-ARI issues were to blame for my symptoms, including thyroid function, testosterone levels, prostate-specific antigen (PSA) levels, lung function, toxoplasmosis (from my eight cats), and virtually every other disorder or disease that are common for People Living with HIV/AIDS (PLWHA). After several hours, I left with a steroidal inhaler, a new statin drug, and additional orders to rest.</p><p>Another month went by, and my symptoms continued. </p><p>It’s been three months since my initial illness, and still, I find myself regularly out of breath, physically exhausted from simple tasks such as walking down the stairs or into the kitchen, and suffering from neverending bouts of intestinal issues. Ultimately, they determined I must have initially had a negative reaction to receiving a second Shingrix vaccine on July 12th—a claim that seemed plausible, but still unlikely.</p><p>And then, Brandon sent me <i>The Lancet</i> article.</p><p>These symptoms I am still experiencing align perfectly with those described in <i>The Lancet</i>. Patients who had Non-COVID ARIs were more likely than COVID patients to report certain symptoms, including diarrhea, sleep problems, and coughing. They were also likely to report muscle or joint pain, difficulty concentrating, and lightheadedness or dizziness (Figure 1):</p><p><b>Figure 1.</b></p><p><i>Regularly Reported Symptoms by Patients Dependent Upon Infection Status</i></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi000JmpXZYP-Lcu24csiPhghIa8GULdgaPGB3MGAPOISL4ovKIni7a-Npxi6RvmkqbWoEjCPC9iqFBWKR1X6NWVqSkiKG6dPkiSngrRjjfZ9rOKm5YYXdfJ3vmbh2TA7Wfr1sK4TMqdviMlXA4ImxiqO4_2GO2BtriGHN0i3_BusFHptR4lspILx0Q7Hs/s1036/Screenshot%202023-10-11%20at%2017.37.32.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Graph showing variance in symptoms" border="0" data-original-height="658" data-original-width="1036" height="254" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi000JmpXZYP-Lcu24csiPhghIa8GULdgaPGB3MGAPOISL4ovKIni7a-Npxi6RvmkqbWoEjCPC9iqFBWKR1X6NWVqSkiKG6dPkiSngrRjjfZ9rOKm5YYXdfJ3vmbh2TA7Wfr1sK4TMqdviMlXA4ImxiqO4_2GO2BtriGHN0i3_BusFHptR4lspILx0Q7Hs/w400-h254/Screenshot%202023-10-11%20at%2017.37.32.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: The Lancet</span></td></tr></tbody></table><p>While this research does not definitively answer the underlying question, “What the Hell is Wrong with Typhoid Marcus,” it <i>does</i> provide me with another piece of information to send to my ID specialist for consideration.</p><p>One of the most humiliating parts of living with a chronic condition, like HIV/AIDS, is having to navigate the various conversations we must have with any number of parties to explain our health issues without opening ourselves up to unwanted or undue levels of scrutiny. Some of the conversational barriers we must overcome include:</p><p></p><ol style="text-align: left;"><li>How do we communicate our symptoms to our healthcare providers without coming across as a hypochondriac?</li><ul><li>Will our providers believe us? (This concern is particularly felt by persons of color or of trans experience)</li><li>Will additional tests or examinations provide us with definitive answers?</li></ul><li>How do we communicate our health issues with our employers or clients without risking our employment or incomes?</li><ul><li>Will our employers or clients be understanding of our health challenges and willing to extend deadlines so that we are able to meet them?</li><li>Will our employers or clients consider these delays unacceptable and terminate our employment or contracts? If so, is there any recourse?</li></ul><li>How do we communicate our health issues to friends and loved ones?</li><ul><li>Will our friends understand that we may not have the capacity or ability to respond to their inquiries about our health?</li><li>Will our family members understand that we may not have the energy or ability to live up to familial obligations?</li><li>Will anyone be able or willing to help us pick up the slack, in terms of chores, daily tasks, or caring for dependents?</li></ul></ol><p></p><p>When it comes to our incomes, how will we navigate the very real possibility that our incomes will suffer if we’re physically unable to work? Will we be able to make rent? For PLWHA, is there an immediate support system in place that can quickly respond to our needs as they relate to utility and housing costs, given the dysfunction that typifies the Housing Opportunities for Persons with HIV/AIDS (HOPWA) program?</p><p>Luckily, my clients have been largely understanding and accommodating, in no small part because I, personally, am an open book when it comes to my health. Other PLWHA may have neither the luxury of being open about their health issues nor the interest in telling others about their health. This is another area where PLWHA must navigate what level of disclosure is right for them, if any at all.</p><p>So, here we are.</p><p>I am slated to fly to Washington, DC, next week to attend an in-person meeting, and…if I’m being honest, I’m not certain whether or not I will have the energy to do so.</p><p>This places me in the very frustrating position of having to explain to the organizer that I will have to attend virtually, even though I confirmed my in-person attendance in July…before all of this started.</p><p>Hopefully, I’ll be able to return to some semblance of normal health sooner, rather than later. In the meantime, I’ll keep using my inhaler and resting.</p><p>References:</p><p>Vivaldi, G., Pfeffer, P.E., Talaei, M., Basera, T.J., Shaheen, S.O., & Martineau, A.R. (2023, October 06). Long-term symptom profiles after COVID-19 vs other acute respiratory infections: an analysis of data from the COVIDENCE UK study. The Lancet. https://doi.org/10.1016/j.eclinm.2023.102251.</p><p><i>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.</i></p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-79199336512149925762023-10-05T07:40:00.003-04:002023-10-06T10:09:05.352-04:00Fireside Chat Retreat in Philadelphia, PA Tackles Pressing Public Health Issues<p><i>By: <a href="https://www.linkedin.com/in/brandonmacsata/" target="_blank"><span style="color: #3d85c6;">Brandon M. Macsata</span></a>, CEO, ADAP Advocacy</i><br /><br />ADAP Advocacy hosted its "Health Fireside Chat" retreat in Philadelphia, Pennsylvania among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened Thursday, September 21st through Saturday, September 23rd. The growing threat to public health from the spread of medical misinformation and disinformation, reforming the 340B Drug Pricing Program to better serve patients rather than providers, and the effective implementation of longer-acting HIV treatment and prevention programs were evaluated and discussed by the 20 diverse stakeholders.<br /></p><p>The Fireside Chat's “ice breaker” activity included some fun and games at Dave & Buster's with their pool tables, video games, carnival challenges, and virtual reality. Attendees enjoyed some bonding and laughter before collectively rolling up their sleeves and taking a deep dive into the policy discussions.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiuCFcZBJpyzl20WrsGlnRURx5a6QhKhvhRaQGWhbK-CZ8FkmADzwP2MokDlAdoAgQoD-NK6RInuFCLpcO_3-cIhH86RvLw8CD8IDy8qwc-SFIjHcaxmpP-HB-uN053GeATmdFsmeT9-ug/s1600/fdr-hero.jpg" style="margin-left: auto; margin-right: auto;"><img alt="FDR Fireside Chat" border="0" data-original-height="617" data-original-width="1100" height="179" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiuCFcZBJpyzl20WrsGlnRURx5a6QhKhvhRaQGWhbK-CZ8FkmADzwP2MokDlAdoAgQoD-NK6RInuFCLpcO_3-cIhH86RvLw8CD8IDy8qwc-SFIjHcaxmpP-HB-uN053GeATmdFsmeT9-ug/s320/fdr-hero.jpg" title="" width="320" /></a></td></tr><tr><td class="tr-caption" style="font-size: 12.8px;">Photo Source: Getty Images</td></tr></tbody></table><p>The Health Fireside Chat included moderated white-board style discussion sessions on the following issues:</p><ul><li><b>Public Health Alert: Medical Misinformation Can be Dangerous to Your Health </b>— <i>moderated by Rick Guasco, Acting Editor-in-Chief and Creative Director at Positively Aware</i></li><li><b>340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions? </b>— <i>moderated by Tim Horn, Director, Medication Access at NASTAD</i></li><li><b>Long Acting Injectables: Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation </b>— <i>moderated by Jeffrey Crowley, Distinguished Scholar/Program Director, Infectious Disease Initiatives at the O'Neill Institute/Georgetown Law</i></li></ul><p>The discussion sessions were designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:<br /></p><div class="MsoNormal" style="font-family: Cambria; margin: 0in 0in 0.0001pt;"></div><ul><li><b>Ninya Bostic</b>, National Policy and Advocacy Director, IDV, Johnson & Johnson</li><li><b>Jeffrey S. Crowley</b>, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law</li><li><b>Theresa Daugherty</b>, Patient Advocate</li><li><b>David Gana</b>, Patient Advocate</li><li><b>Alexander Garbera</b>, Co-Chair, New Haven Mayor’s Task Force on AIDS, City of New Haven, CT</li><li><b>Dusty Garner</b>, Patient Advocate</li><li><b>Rick Guasco</b>, Acting Editor-in-Chief and Creative Director at <i>Positively Aware</i></li><li><b>Tim Horn</b>, Director, Medication Access at NASTAD</li><li><b>Riley Johnson</b>, Founder, RAD Remedy</li><li><b>Thomas Johnson</b>, Executive Director, Alliance to Save America’s 340B Program</li><li><b>Jen Laws</b>, President & CEO, Community Access National Network</li><li><b>Darnell Lewis</b>, Program Coordinator, RAO Community Health</li><li><b>Brandon M. Macsata</b>, CEO, ADAP Advocacy</li><li><b>J. Maurice McCants-Pearsall,</b> Government Relations Director (Southeast), ViiV Healthcare</li><li><b>Aisha McKenzie</b>, Patient Advocate</li><li><b>Warren O’Meara-Dates</b>, Founder & CEO, The 6:52 Project Foundation</li><li><b>Brian Smith</b>, Alliance Development and Strategic Advocacy</li><li><b>Matt Toresco</b>, CEO & CPO, Archo Advocacy LLC & Elavay</li><li><b>Stacey L. Worthy</b>, Director, Healthcare Policy & Strategy, Johnson & Johnson</li><li><b>Joey Wynn</b>, Chairman, Florida HIV/AIDS Advocacy Network</li></ul><p>The Covid-19 pandemic is still ongoing. Covid-19 cases and hospitalizations are both on the rise again, according to data by the Centers for Disease Control & Prevention (CDC) With that in mind, ADAP Advocacy implemented strong Covid-19 safety protocols for the Health Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and <i>optional</i> masks during the sessions (which some attendees exercised <i>without</i> feeling shunned).</p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMhfTdAhFGwE6l-yHttaT0HSrGjSaEVy2YSvXZng4yWLizkDqUwTWz2q7K877mJcMJaAZnO886rl7GIdqZ7bPlbHL6ZogeTUItzP8Ioo34ToXKyydXBsPBsl_lpj-Elb537rmt5x5CqN22_iLDrAU9Zbj61klG01esUrLmfpiUts-PxUK3LtmUixfvRNE/s498/ADAP%20Health%20Fireside%20Chat%20Logo%20Horz%20Update.png" style="margin-left: 1em; margin-right: 1em;"><img alt="Health Fireside Chat" border="0" data-original-height="160" data-original-width="498" height="129" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMhfTdAhFGwE6l-yHttaT0HSrGjSaEVy2YSvXZng4yWLizkDqUwTWz2q7K877mJcMJaAZnO886rl7GIdqZ7bPlbHL6ZogeTUItzP8Ioo34ToXKyydXBsPBsl_lpj-Elb537rmt5x5CqN22_iLDrAU9Zbj61klG01esUrLmfpiUts-PxUK3LtmUixfvRNE/w400-h129/ADAP%20Health%20Fireside%20Chat%20Logo%20Horz%20Update.png" width="400" /></a></div><br /><p>ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat.</p><p></p><p><b><u>Medical Misinformation</u></b>:<br /></p><div>The first policy session, “<b>Public Health Alert: Medical Misinformation Can be Dangerous to Your Health</b>”, lead by the <i>Positively Aware Magazine’s</i> Rick Guasco, challenged guests to evaluate their own role in potentially sharing medical misinformation without even knowing it. Guasco highlighted that everyone can do something about misinformation, starting with being cognizant of how people can potentially spread it. A little information is a dangerous thing. Medical misinformation is information that is false, inaccurate, or misleading. A little misinformation can become the building block of lies and ignorance. As such, medical disinformation is misinformation with a purpose. According to the Kaiser Family Foundation's recent poll, <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-health-misinformation-tracking-poll-pilot/?utm_campaign=KFF-2023-Polling-Surveys&utm_source=hs_email&utm_medium=email&utm_content=271243276&_hsenc=p2ANqtz-8uVuqZ0D0d1zt243KX-Iw-MySaTZkbQbEMWUYjFEuzp1P4-AH8ocNqL8FQTqCRpE8B4sUhXUj_0hDHZxyCqRD3IqKp4g" target="_blank"><span style="color: #3d85c6;">most Americans encounter health misinformation, and most aren’t sure whether it’s true or false local TV</span></a>.</div><div><br /></div><div>Drawing on KFF's Misinformation Pilot Poll, KFF released three follow-up reports examining exposure to, and belief in, health misinformation among <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/addressing-misinformation-among-black-adults-snapshot-from-the-kff-health-misinformation-tracking-poll-pilot/?utm_campaign=KFF-2023-Polling-Surveys&utm_medium=email&_hsmi=274453581&_hsenc=p2ANqtz-9os9cdzqS-WkbZP2JyNQR6c8UvAQ0SU2NNYQ_ToRKfdUTje3N3dTnnj7ndNq_ej4Z1imIPbVblSpsBhy7kXhS9PMznMw&utm_content=274453581&utm_source=hs_email" target="_blank"><span style="color: #3d85c6;">Black adults</span></a>, <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/addressing-misinformation-among-hispanic-adults-snapshot-from-the-kff-health-misinformation-tracking-poll-pilot/?utm_campaign=KFF-2023-Polling-Surveys&utm_medium=email&_hsmi=274453581&_hsenc=p2ANqtz--B-UQ1V-FdAFZqvCmxKEAV0aqoFuJV41SuFxUimDYSDqagsKSo6ke3Y3MfJwfc7K_eXpVvL9LyQ3kLfMCWbzpIJZcDpQ&utm_content=274453581&utm_source=hs_email" target="_blank"><span style="color: #3d85c6;">Hispanic adults</span></a>, and <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/addressing-misinformation-in-rural-communities-snapshot-from-the-kff-health-misinformation-tracking-poll-pilot/?utm_campaign=KFF-2023-Polling-Surveys&utm_medium=email&_hsmi=274453581&_hsenc=p2ANqtz-9JELcE30JyNyqVgrreIuXi56wC4PcG5UidHMgZazvOg9ZsL0IXkbxa5t4eqNajEyk5tQJAGhk-VXa_FsCbcWHG0Qmjhg&utm_content=274453581&utm_source=hs_email" target="_blank"><span style="color: #3d85c6;">rural communities</span></a>.</div><div><br /></div><div>Guasco shared what he viewed as the best three ways to combat medical misinformation and disinformation. They included 1) promoting the truth by proactively talking about health literacy, 2) <i>pre-</i>bunking fake medical news by putting counter-arguments out in anticipation, and 3) <i>de-</i>bunking fake medical news, but it is more difficult because it is harder to change minds once the misinformation and disinformation is spread. Significant conversation centered around lingering medical mistrust in the Black community after the Tuskegee Airmen experiments. Rev. Alexander Garbera offered an excellent quote to summarize how to combat the dangers associated with medical misinformation and disinformation: "Combat fear with empathy."</div><div><br /></div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEit2-_UwviGXCAj6u0tRpMGnyLHYWI_2ODwIePFxMQcEozx3kFf_BU50xA07TA30tmPaXRENrTuuYB9wHfurccPGXt3GpEAHKBp5sds2HeM1Vd8x5v2Hq6DoEIvEn2qFKmB6CCgW-Gz2lxujhIWWVuG7UiGVBhu012WCte8hHmFnpBQu5qjMo8Y_uw0fz8/s1920/Medical-Fake-News.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Fake News" border="0" data-original-height="1280" data-original-width="1920" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEit2-_UwviGXCAj6u0tRpMGnyLHYWI_2ODwIePFxMQcEozx3kFf_BU50xA07TA30tmPaXRENrTuuYB9wHfurccPGXt3GpEAHKBp5sds2HeM1Vd8x5v2Hq6DoEIvEn2qFKmB6CCgW-Gz2lxujhIWWVuG7UiGVBhu012WCte8hHmFnpBQu5qjMo8Y_uw0fz8/w400-h266/Medical-Fake-News.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Florida International University</span></td></tr></tbody></table><br /><div>The following materials were shared with retreat attendees:</div><div><ul><li><a href="https://www.medpagetoday.com/special-reports/features/101224" target="_blank"><span style="color: #3d85c6;">Ex-JAMA Chief: Cut the Hype, Spin in Published Studies — Howard Bauchner, MD, says researchers want to report accurately, but "they too have their biases"</span></a> via <i>MedPage Today</i></li><li><a href="http://washingtonpost.com/health/2023/07/26/covid-misinformation-doctor-discipline/" target="_blank"><span style="color: #3d85c6;">Doctors who put lives at risk with covid misinformation rarely punished</span></a> via <i>The Washington Post</i></li><li><a href="https://www.youtube.com/watch?v=dvJQyaJX4po" target="_blank"><span style="color: #3d85c6;">Abortion health information</span></a> via <i>National Library of Science</i></li><li><a href="https://www.croiwebcasts.org/s/2023croi/SYMPOSIUM-09" target="_blank"><span style="color: #3d85c6;">Science Communication in the Age of Misinformation</span></a> via CROI 2023</li></ul></div><p></p><p></p><p>ADAP Advocacy would like to publicly acknowledge and thank Rick Guasco for facilitating this important discussion.<br /><br /><b><u>340B Drug Discount Program</u>:</b><br /></p><p>As a backdrop to the discussion over the 340B Drug Discount Program, an <a href="https://www.positivelyaware.com/articles/340b-hypocrisy" target="_blank"><span style="color: #3d85c6;">opinion piece</span></a> dropped calling out the hypocrisy behind the forces fighting reform. NASTAD's Tim Horn kicked-off the discussion with an overview of the program, including an analysis on how 340B intersects with the Ryan White HIV/AIDS Program, including State AIDS Drug Assistance Programs (ADAP). In that, some challenges were addressed – such as explosive program growth, lack of transparency, and calls for more oversight. There was particular focus on ADAPs and their specific programmatic use of the 340B dollars exclusively for patient care, and that in many ways it represents the "gold standard" among Covered Entities participating in the program. The discussion also centered around some of the pros and cons associated with ongoing reform proposals; they included contract pharmacy restrictions, discriminatory reimbursement laws, and possible federal legislation (e.g., <a href="https://www.asap340b.org" target="_blank"><span style="color: #3d85c6;">ASAP 340B</span></a>). The conversation touched the rising medical debt crisis in the United State (of which, most medical debt is actually hospital-associated debt), declining charity care among hospitals, as well as the adverse impact on patients via provider consolidation. Ongoing scrutiny over the lack of transparency in the program continues to grow, evidenced by the <a href="https://www.thune.senate.gov/public/index.cfm/press-releases?ID=117909BA-5601-44F0-8A9D-C9E1ADE72185" target="_blank"><span style="color: #3d85c6;">Request for Information</span></a> (RFI) issued by a group of bipartisan senators, including Senator John Thune (R-SD), Senator Debbie Stabenow (D-MI), Senator Shelley Moore Capito (R-WV), Senator Tammy Baldwin (D-WI), Senator Jerry Moran (R-KS), and Senator Benjamin Cardin (D-MD). Read the joint statement by ADAP Advocacy and CANN, <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_CANN_Public_Comment_Senate_RFI_340B_07-24-23.pdf" target="_blank"><span style="color: #3d85c6;">here</span></a>.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://www.positivelyaware.com/articles/340b-hypocrisy" target="_blank"><img border="0" data-original-height="888" data-original-width="1410" height="253" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKlbcWYs9EEEoa4ciY-RINr7aRx9_e2fjugCG5K0q-J13L21DlXoCwjmWT4MPUQeAqaboCG3cJ3mFHqzXnWDXY5_fxPPW3P3d7_VZBiUQS3eyS3lzEbRbGDq3IyyX0TDL8_heV-xLKpioLpIi3nW3n55DYspRlvFkCbfaMgJSoYY07SRJV51f9fn3neNo/w400-h253/Screenshot%202023-10-04%20at%201.14.53%20PM.png" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://www.positivelyaware.com/articles/340b-hypocrisy" target="_blank"><span style="color: #999999;">Photo Source: Positively Aware</span></a></td></tr></tbody></table><p>The following materials were shared with retreat attendees:</p><p></p><ul><li><a href="https://nastad.org/sites/default/files/2022-12/PDF-ACTF-Fact-Sheet-December-2022.pdf" target="_blank"><span style="color: #3d85c6;">ADAP Crisis Task Force Fact Sheet</span></a> via NASTAD</li><li><a href="https://www.asap340b.org/_files/ugd/b11210_318c9f05aca84d17abef9296659a86b8.pdf" target="_blank"><span style="color: #3d85c6;">Principles for Ensuring the 340B Program Benefits Patients and True Safety-Net Providers</span></a> via ASAP 340B</li><li><a href="https://www.asap340b.org/_files/ugd/b11210_cd632275426e47a1a1b9c06863ae4dbc.pdf" target="_blank"><span style="color: #3d85c6;">Creating Long-Overdue Clarity Around Patient Definition in the 340B Program</span></a> via ASAP 340B</li><li><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2737308" target="_blank"><span style="color: #3d85c6;">Estimated Changes in Manufacturer and Health Care Organization Revenue Following List Price Reductions for Hepatitis C Treatments</span></a> via <i>JAMA Network</i></li><li><a href="https://jamanetwork.com/journals/jama/article-abstract/2808049" target="_blank"><span style="color: #3d85c6;">340B-Where Do We Go From Here?</span></a> via <i>JAMA Network</i> </li><li><a href="https://rwc340b.org/wp-content/uploads/2023/07/Pharmaceutical-Manufacturer-340B-Price-Restriction-Policies-and-Exemptions-Summary-Updated-7.7.23.pdf" target="_blank"><span style="color: #3d85c6;">Pharmaceutical Manufacturer 340B Price Restriction Policies and Exemptions Summary. Ryan White Clinics for 340B Access</span></a> via RWC340B</li><li><a href="HIV Prevention and the 340B Drug Pricing Program" target="_blank"><span style="color: #3d85c6;">HIV Prevention and the 340B Drug Pricing Program</span></a> via <i>The New England Journal of Medicine</i></li><li><a href="https://www.iqvia.com/form-pages/general?redirectUrl=%2f-%2fmedia%2fiqvia%2fpdfs%2fus%2fwhite-paper%2f2023%2f340b-drug-discount-program-exceeds-usd-100b-in-2022.pdf&title=340B+Drug+Discount+Program+Exceeds+USD+100B+in+2022" target="_blank"><span style="color: #3d85c6;">The 340B Drug Discount Program Exceeds #100B in 2022</span></a> via IQVIA</li><li><a href="https://www.ncsddc.org/resource/340b-and-ending-the-epidemics/" target="_blank"><span style="color: #3d85c6;">340B and Ending the Epidemics</span></a> via National Coalition of STD Directors</li><li><a href="https://www.nachc.org/wp-content/uploads/2022/06/NACHC-340B-Health-Center-Report_-June-2022-.pdf" target="_blank"><span style="color: #3d85c6;">340B: A Critical Program for Health Centers</span></a> via National Association of Community Health Centers</li><li><a href="https://nastad.org/sites/default/files/2023-06/PDF-340B-Syndemic-Approach-Fact-Sheet.pdf" target="_blank"><span style="color: #3d85c6;">A Syndemic Approach to STD 340B Correctional Facility Partnerships for Health Department Prevention Programs</span></a> via NASTAD</li><li><a href="https://nastad.org/resources/best-practices-shared-adap-and-340b-drug-pricing-program-clients" target="_blank"><span style="color: #3d85c6;">Best Practices for Shared ADAP and Other 340B Covered Entity Clients</span></a> via NASTAD</li><li><a href="https://www.ajmc.com/view/association-of-340b-contract-pharmacy-growth-with-county-level-characteristics" target="_blank"><span style="color: #3d85c6;">Association of 340B Contract Pharmacy Growth with County-Level Characteristics</span></a> via <i>American Journal of Managed Care</i></li><li><a href="https://www.nytimes.com/2022/09/24/health/bon-secours-mercy-health-profit-poor-neighborhood.html" target="_blank"><span style="color: #3d85c6;">How a Hospital Chain Used a Poor Neighborhood to Turn Huge Profits</span></a> via <i>The New York Times</i></li></ul><div>ADAP Advocacy would like to publicly acknowledge and thank Tim Horn for facilitating this important discussion.<br /></div><p></p><div><i><b>Editor's Note:</b> The ADAP Advocacy Association has offered opinions on 340B over the last several years, including <a href="https://adapadvocacyassociation.blogspot.com/2022/04/industrys-changes-to-340b-drug-discount.html" target="_blank"><span style="color: #3d85c6;">Industry’s Changes to 340B Drug Discount Program</span></a> (April 2022), <a href="https://adapadvocacyassociation.blogspot.com/2020/01/340b-reply-hazy-try-again.html" target="_blank"><span style="color: #3d85c6;">340B – Reply Hazy, Try Again</span></a> (January 2020), <a href="https://adapadvocacyassociation.blogspot.com/2019/03/the-federal-340b-program-call-to-order.html" target="_blank"><span style="color: #3d85c6;">The Federal 340B Program: A Call to Order</span></a> (March 2019), and <a href="https://adapadvocacyassociation.blogspot.com/2017/03/340b-program-dont-throw-baby-out-with.html" target="_blank"><span style="color: #3d85c6;">340B Program: Don't Throw the Baby Out with the Bathwater</span></a> (March 2017)</i></div><p><b><u>Long-Acting Injectables</u>:</b></p><p>The O'Neill Institute for National and Global Health Law recently published a brief, Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation. The O'Neill Institute summarized long-acting injectables:</p><p></p><blockquote><i><span style="color: #666666;">"Scientific advancements resulting from our long-term national commitment to HIV research have begun producing new products both for HIV treatment and prevention that do not require daily dosing. The first standalone longer-acting (LA) FDA-approved products are delivered by intramuscular injection every 1-2 months, but future products may require far less frequent injections or could come in other forms such as small implants under the skin or oral medications. These products represent exciting advances because they give users more options to stay engaged in the HIV treatment or prevention continuum. While many patients and providers speak of how transformative these products can be, access to these products is limited and a myriad of barriers prevent individuals from accessing them. Deliberate policy actions are needed to ensure that these innovations do not bypass the individuals and communities that stand to benefit the most from them."</span></i></blockquote><p></p><p><a href="https://oneill.law.georgetown.edu/publications/brief-effective-implementation-of-longer-acting-hiv-treatment-and-prep-requires-delivery-system-innovation/" target="_blank"><span style="color: #3d85c6;">Read the brief and its related materials</span></a>. </p><p>Jeffrey S. Crowley led this important discussion. While early in the implementation of these products, several barriers have arisen that must be overcome. Among these are:</p><p></p><ol style="text-align: left;"><li>Adapting our current clinics and health care programs to allow for greater scale;</li><li>Overcoming insurance and financing barriers to access;</li><li>Addressing regulatory and financing barriers to new delivery models, such as greater use of pharmacies, mobile clinics, or self-administration; and,</li><li>Ensuring that innovations in HIV services delivery reduces rather than increases equity.</li></ol><p></p><div>Some perspective was also shared on the work done by the O'Neill Institute in this area. Dusty Garner offered his perspective on some of the challenges he has encountered accessing his LAI treatment. Additionally, several members of the ADAP Advocacy's <a href="https://www.adapadvocacy.org/pdf-docs/2022_ADAP_Press_Policy_HIV_Long_Acting_Agents_08-29-22.pdf" target="_blank"><span style="color: #3d85c6;">ADAP Injectables Advisory Committee</span></a>, including Jen Laws, Riley Johnson, and Warren O-Dates, offered their perspectives on LAIs and the challenges being faced by patients.</div><div><br /></div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiepJviPfJNHVrHlZBmb9YEneJ1bWhdgsoAWs_vg-3nFzGP2Lq0o1_Zw5DPMPKLTznldRbr8oubMKhyS_IPI0mDsTULHNf6L7Qo6YyZsHa-fmOeaxsJilwqCvKlplnImm1QtEGyS_6NIb1B4Uwy1wtY2YhKp1146U8EwODCaqHlxANwmhyphenhyphenQtX9hpqzwp5I/s840/longacting%20retroviral%20image.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Long-Acting Injectables" border="0" data-original-height="463" data-original-width="840" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiepJviPfJNHVrHlZBmb9YEneJ1bWhdgsoAWs_vg-3nFzGP2Lq0o1_Zw5DPMPKLTznldRbr8oubMKhyS_IPI0mDsTULHNf6L7Qo6YyZsHa-fmOeaxsJilwqCvKlplnImm1QtEGyS_6NIb1B4Uwy1wtY2YhKp1146U8EwODCaqHlxANwmhyphenhyphenQtX9hpqzwp5I/w400-h220/longacting%20retroviral%20image.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: European AIDS Treatment Group</span></td></tr></tbody></table><br /><div>The following materials were shared with retreat attendees: </div><ul><li><a href="https://oneill.law.georgetown.edu/wp-content/uploads/2023/05/ONL_BI_24_Delivery_System_P3.pdf" target="_blank"><span style="color: #3d85c6;">Big Ideas Brief: Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation</span></a> via O'Neill Institute</li><li><a href="https://oneill.law.georgetown.edu/wp-content/uploads/2022/07/ONL_HIV_LA_Payer_Landscape.pdf" target="_blank"><span style="color: #3d85c6;">Quick Take: Equitable Access to New HIV Treatment and Prevention Options is Needed Across Payers</span></a> via O'Neill Institute</li><li><a href="https://oneill.law.georgetown.edu/wp-content/uploads/2022/07/ONL_HIV_LA_Overview.pdf" target="_blank"><span style="color: #3d85c6;">Quick Take: New Options for HIV Treatment and Prevention are Here</span></a> via O'Neill Institute</li><li><a href="https://nastad.org/sites/default/files/2022-04/PDF_Cabenuva_ADAP_NASTAD_March%202022.pdf" target="_blank"><span style="color: #3d85c6;">Cabenuva (cabotegravir & rilpivirine extended-release injections) Considerations for AIDS Drug Assistance Programs</span></a> via NASTAD</li><li><a href="https://www.treatmentactiongroup.org/wp-content/uploads/2023/07/pipeline_ARV_2023_final.pdf" target="_blank"><span style="color: #3d85c6;">Pipeline Report 2023</span></a> via Treatment Action Group</li><li><a href="https://avac.org/event/long-acting-injectable-cabotegravir-for-prep-understanding-results-of-hptn-083-084-and-key-areas-for-advocacy/" target="_blank"><span style="color: #3d85c6;">Long-Acting Injectable Cabotegravir for PrEP: Understanding Results of HPTN 083 & 084 and key areas for advocacy</span></a> via AVAC</li><li><a href="https://avac.org/event/long-acting-injectables-antiretrovirals-for-treatment-and-prevention/" target="_blank"><span style="color: #3d85c6;">Long-Acting Injectables Antiretrovirals for Treatment and Prevention</span></a> via AVAC</li></ul><p>ADAP Advocacy would like to publicly acknowledge and thank Jeffrey S. Crowley for facilitating this important discussion.<br /><br />Additional Fireside Chats are planned for 2023 in New Orleans, Louisiana.</p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-84073200339275180162023-09-28T06:17:00.005-04:002023-09-28T06:44:07.383-04:00Tell HIV Stigma: Stay in Your Lane<p><i>By: <a href="https://www.linkedin.com/in/brandonmacsata/" target="_blank"><span style="color: #3d85c6;">Brandon M. Macsata</span></a>, CEO, ADAP Advocacy Association</i></p><p><b><span style="font-size: x-small;">****Important Support Resources Included****</span></b></p><p>Recently, I posted some commentary on my personal Twitter handle (<a href="https://twitter.com/Purple_Strategy/status/1702652992447447225" target="_blank"><span style="color: #3d85c6;">@Purple_Strategy</span></a>) noting an observed <i>uptick</i> in HIV stigma in the gay dating world. Gay dating apps are notorious for it. Likely, it isn't limited to the dating space, evidenced by a recent <a href="https://glaad.org/endhivstigma/2023/" target="_blank"><span style="color: #3d85c6;">report</span></a> issued by GLAAD, as well as subsequent commentary in private conversations and social shares highlighting examples of HIV stigma. It is <i>very</i> rare for me to interject my personal life's situations into ADAP Advocacy's daily advocacy and public policy activities, but it is vitally important to combat such stigma whenever possible. Frankly, HIV stigma has no place in my life and thus it needs to <i>stay</i> in its lane.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhINHLOXKt_lzC_y8bOadGFyNsV4c4qijY9c4W_vi3FwQRWrK6oybxh8kXmArWU2jVz1ub9BvkEj8SvXxS2Z5bYniSAEw6p5n359XxVhMIEY-9yVT1_31p4kbf6Sy3O5sM_d05MU5uUbzptc1NYhd1pmynumye7dVgrkoAGo4s9Iz-U3Nfwx96a02bY47k/s1512/IMG_5631.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Tweet: "Lately, I can say from my experience in the gay dating world there is also an uptick in guys uncomfortable dating poz guys. 3:5 last few guys I was talking to all abruptly ended our chatting / dating once I disclosed."" border="0" data-original-height="1512" data-original-width="1170" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhINHLOXKt_lzC_y8bOadGFyNsV4c4qijY9c4W_vi3FwQRWrK6oybxh8kXmArWU2jVz1ub9BvkEj8SvXxS2Z5bYniSAEw6p5n359XxVhMIEY-9yVT1_31p4kbf6Sy3O5sM_d05MU5uUbzptc1NYhd1pmynumye7dVgrkoAGo4s9Iz-U3Nfwx96a02bY47k/w310-h400/IMG_5631.jpeg" width="310" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><p>I'm a Taurus; we're pretty confident. I'm Italian; we're tough as nails. You hit me; I hit you ten times harder. But not everyone is like me. These recent dating rejections surrounding my status (undetectable, since 2004) weren't the first experiences with HIV stigma, and I know they won't be the last of them. But I can honestly say that I've taken them with a grain of salt. And now, U=U (undetectable equals untrabnsmittable) and fine work being done by <a href="https://preventionaccess.com" target="_blank"><span style="color: #3d85c6;">Prevention Access Campaign</span></a> and <a href="https://www.uequalsuplus.org" target="_blank"><span style="color: #3d85c6;">U=U plus</span></a> has changed the national conversation.</p><p>BUT! Not everyone is a stubborn bull like me. I've had countless conversations with friends and colleagues, whereby their personal "run-ins" with HIV stigma really hurt them. It hurt their feelings, self-confidence, pride, and dare I even say, their self-worth. It has always bothered me on a very deep level seeing them struggle to cope with the ugliness that is HIV stigma.</p><p>Fighting HIV stigma won't come easily. According to GLAAD's 2023 State of HIV Stigma Report, only half of the respondents indicated they're "knowledgable" about HIV. Whereas GenX is considered most "knowledgable" about HIV, still one in four don't fall into that designation. What is most troubling is the trend line is going in the wrong direction on the general publics' comfortability interacting with people living with HIV—especially among certain professionals such as barbers or hair stylists, and teachers. Interacting with co-workers living with HIV is now problematic for 1:3 respondents.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhUa83delrCYECQVsAltlft9JDBAAA9sndX23r5FtPNJzXJDkvkjRdnwS0qvQDZ0JfBbLoC979oskhtI0o79Gk-svaGJdrmAxd0651iOIVwMp8zfCayQbUmVigbHypkVi25gW_XEs9wHXiIQboKgNQo-BzPnc3qMk0BzifO0NDcuxK3E9aeFDt6eiLou78/s1534/Screenshot%202023-09-27%20at%207.37.08%20PM.png" style="margin-left: auto; margin-right: auto;"><img alt="Americans’ discomfort interacting with those living with HIV increased vs. 2022 for interactions with hairstylists, teacher and co-worker. Professions where we have been separated from each other due to COVID. The South has higher discomfort levels in these areas than other regions of the country. A majority of Americans believe a stigma around HIV still exists This number has remained stable year over year. More Americans believe the false claim that HIV mostly impacts LGBTQ people Anyone can contract HIV, regardless of sexual orientation or gender identity. Yet, more Americans this year believe the fasle claim that HIV mostly impacts LGBTQ poeple, calling for the need for more awareness, education, and stories of poeple living with HIV thriving, and living long, healthy lives. Significant decreases year over year that everyone should be tested for HIV in their lifetime According to the Centers for Disease Control and Prevention nearly 40% of new HIV infections are transmitted by people who don’t know they have the virus. GLAAD’s Invisible People report examined the impacts of COVID-19 on prevention, testing and treatment in the United States. In it, we detail how HIV testing rates were greatly reduced during the stay-at-home order period in 2020. Annual wellness visits declined during COVID Research showed delays and deferments of care during COVID, particularly among African Americans and people with chronic health conditions. As annual health screenings resume post-COVID, it’s possible Americans are prioritizing other screenings and testing as opposed to HIV testing. It’s important to keep the focus and awareness on testing as another important measure of prevention. Annual wellness visits declined during COVID COVID-19 impact on HIV cure/treatment Relatedly, regarding cure and treatment, our research shows more than 4 in 10 Americans believe COVID has stalled advancements. COVID-19 impact on HIV cure-treatment U.S. HIV and STD Criminalization Laws 2022 Accoding to the CDC, there are currently 35 states that criminalize HIV exposure. After more than 40 years of HIV research and significant biomedical advancements to treat and prevent HIV transmission, many state laws are now outdated and do note reflect our current understanding of HIV. 80% of Americans agree with criminalizing non-disclosure HIV status This further stigmatizes and discriminates against people living with HIV. Accessibility of information and education on HIV is key Having easily accessible information on HIV and methods of HIV prevention taught in schools is of high importance to Americans. These numbers have remained high year over year, pointing to a knowledge gap and a desire to have more readily available information on HIV in communities and schools. Methodology The 2023 State of HIV Stigma Study was conducted through an online survey in February 2023 among a sample of 2,533 U.S. adults 18+. The sample was sourced and aggregated through CINT, who has the world’s largest consumer network for digital survey-based research. The Table of Contents Introduction from Sarah Kate Ellis Key Findings Stable knowledge of HIV year over year Continued understanding of PreP benefits Gen X is the most knowledgeable about HIV Headline here about age of diagnosis in 2020 More Americans have seen stories about real people living with HIV in media this year TV and movies are the biggest platforms for seeing stories about people living with HIV Comfortability interacting with people living with HIV has changed year over year in a few professions A majority of Americans believe a stigma around HIV still exists More Americans belive the false claim that HIV mostly impacts LGBTQ people Significant decreases year over year that everyone should be tested for HIV in their lifetime Annual wellness visits declined during COVID-19 COVID-19 impact on HIV cure and treatment U.S. HIV and STD Criminalization Laws 2022 80% of Americans agree with criminalizing non-disclosure HIV status Accessibility of information and education on HIV is key Methodology Download the full publication in PDF format. To view last year’s 2022 State of HIV Stigma Study click here. To view the 2021 State of HIV Stigma Study click here. To view the 2020 State of HIV Stigma Study click here. Prev PREVIOUS PUBLICATION Advertising Visibility Index 2023 NEXT PUBLICATION 2023 Studio Responsibility Index Next MORE PUBLICATIONS 2023 Studio Responsibility Index September 14, 2023 Read More 2023 State of HIV Stigma Report September 6, 2023 Read More Advertising Visibility Index 2023 June 20, 2023 Read More Social Media Safety Index 2023 June 15, 2023 Read More Book Bans – A Guide for Community Response and Action June 6, 2023 Read More Accelerating Acceptance 2023 June 1, 2023 Read More View All SHARE THIS OUR PICKS “Schitt’s Creek’s” Emily Hampshire Competes on Celebrity Jeopardy to Raise Money for GLAAD! September 26, 2023 Unregistered LGBTQ Voters–We Need You September 19, 2023 HeadCount is Leading National Voter Registration Day Across the Nation September 15, 2023 States, Right to Read Advocates, and Organizations Drive Efforts to Counteract Book Bans September 15, 2023 TOPICS Topics FOLLOW US Facebook Twitter Instagram YouTube LinkedIn TikTok DON'T MISS GLAAD & S.E.A.T. Organize a Media Training with LGBTQ Advocates in Houston For GLAAD Media Institute Alum Kevin Anderson, interviews with journalists have become increasingly prevalent in… Read More Five LGBTQ Veterans Take a Stand Against the Legacy of “Don’t Ask Don’t Tell” August 15, 2023 eharmony Releases Major LGBTQ-inclusive Updates to Platform in Collaboration with GLAAD August 15, 2023 Summer Updates and Actions to Take For Local and National LGBTQ Rights August 9, 2023 Join GLAAD and take action for acceptance. SIGN UP" border="0" data-original-height="838" data-original-width="1534" height="219" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhUa83delrCYECQVsAltlft9JDBAAA9sndX23r5FtPNJzXJDkvkjRdnwS0qvQDZ0JfBbLoC979oskhtI0o79Gk-svaGJdrmAxd0651iOIVwMp8zfCayQbUmVigbHypkVi25gW_XEs9wHXiIQboKgNQo-BzPnc3qMk0BzifO0NDcuxK3E9aeFDt6eiLou78/w400-h219/Screenshot%202023-09-27%20at%207.37.08%20PM.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: GLAAD, 2023</span></td></tr></tbody></table><p>It is 2023, and we're still dealing with 1993 attitudes (pre-<a href="https://www.ncbi.nlm.nih.gov/books/NBK554533/" target="_blank"><span style="color: #3d85c6;">HAART</span></a>). I truly believe that there is plenty of fight left in all of us. I also believe that we are in this fight together, so I felt compelled to share some helpful resources available to my fellow POZ folks who might be coping with HIV stigma:</p><p></p><ul style="text-align: left;"><li><a href="https://preventionaccess.org/resources/" target="_blank"><span style="color: #3d85c6;">Prevention Access Campaign - U=U Resource Center</span></a></li><li><a href="https://www.cdc.gov/hiv/basics/hiv-stigma/index.html" target="_blank"><span style="color: #3d85c6;">CDC - Facts About HIV Stigma and Discrimination</span></a></li><li><a href="https://www.cdc.gov/stophivtogether/hiv-stigma/ways-to-stop.html" target="_blank"><span style="color: #3d85c6;">CDC - Ways to Stop HIV Stigma and Discrimination</span></a></li><li><a href="https://www.cdc.gov/stophivtogether/hiv-stigma/stigma-scenarios.html" target="_blank"><span style="color: #3d85c6;">CDC - Stigma Scenarios: Support in Action</span></a></li><li><a href="https://www.hiv.gov/hiv-basics/overview/making-a-difference/standing-up-to-stigma/" target="_blank"><span style="color: #3d85c6;">HIV.gov - Standing Up to Stigma</span></a></li><li><a href="https://glaad.org/endhivstigma/2023/" target="_blank"><span style="color: #3d85c6;">GLAAD - 2023 State of HIV Stigma Report</span></a></li><li><a href="https://www.healthline.com/health/hiv-aids/hiv-stigma" target="_blank"><span style="color: #3d85c6;">Healthline - How We Start Erasing the Stigma Around HIV</span></a></li><li><a href="https://www.hivlawandpolicy.org/issues/stigma" target="_blank"><span style="color: #3d85c6;">Center for HIV Law & Policy - Stigma</span></a></li><li><a href="https://www.seroproject.com/united-states-resources-and-groups/" target="_blank"><span style="color: #3d85c6;">SERO Project - United States Resources and Groups</span></a></li><li><span style="color: #3d85c6;"><a href="https://transgenderlawcenter.org/get-help/" target="_blank"><span style="color: #3d85c6;">Transgender Law Center - Legal Information Helpdesk</span></a></span></li><li><a href="https://www.adaywithhiv.com/home2/" target="_blank"><span style="color: #3d85c6;">Positively Aware - A Day with HIV</span></a></li><li><span style="color: #3d85c6;">Greater than HIV - Real People. Real Stories.</span></li><li><a href="https://twitter.com/imstillJosh" target="_blank"><span style="color: #3d85c6;">ImstillJosh - Twitter</span></a></li><li><a href="https://www.tiktok.com/@marninathequeen" target="_blank"><span style="color: #3d85c6;">MarninaTheQueen - TikTok</span></a> </li><li><a href="https://www.youtube.com/@Pozleigh/videos" target="_blank"><span style="color: #3d85c6;">PozLeigh - YouTube Channel</span></a></li></ul><p></p><p><span style="font-size: x-small;">(email <a href="mailto:info@adapadvocacy.org" target="_blank">info@adapadvocacy.org</a> if you wish to recommend a resource be added above)</span></p><p>Life is hard enough without having to confront stigma, simply over sero status. HIV stigma says more about the people dishing it out, and less about defining who you are. We have the tools to keep HIV stigma in its lane. There are over a million of us POZ folks in the United States, so remember that you're not alone and there are resources available!</p><div><i>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.</i></div>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-8043126611582275032023-09-21T10:04:00.001-04:002023-09-22T09:04:37.353-04:00340B Hypocrisy: The Inconvenient Truth Behind Why We Need to Reform This Vital Safety Net Program<p><i>By: Brandon M. Macsata, CEO, ADAP Advocacy</i><br /><i> Jen Laws, President & CEO, Community Access National Network</i></p><p>The <a href="https://www.hrsa.gov/opa" target="_blank"><span style="color: #3d85c6;">340B Drug Pricing Program</span></a> (“340B”) is probably one of the most transformative public health programs providing lifesaving supports and services to people living with HIV in the United States, second only to the <a href="https://www.hrsa.gov/about/organization/bureaus/hab" target="_blank"><span style="color: #3d85c6;">Ryan White HIV/AIDS Program</span></a> (“RWHAP”). As such, rigorous debate about the future of the program is not only healthy, but it is also paramount to its success. As patients (and patient advocates), it is our responsibility to demand accountability, transparency, and stability. There is universal agreement about the vital role 340B plays in improving access to healthcare. But for many – including ADAP Advocacy and the Community Access National Network – we contend that the program could be doing more…and <i>better!</i> The focus of the program should be on the patients, and not the Covered Entities, medical or service providers, or any other business enterprises making lots of money off it. That is the inconvenient truth behind <i>why</i> we need to reform this vital safety net program.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilHCLVWEUyMUBsdC3CO53DzmAXi3Q2evHDqsqKirVk2-ynBjJg8w221tXjwe-g-_9MdryTsXiVVF1-1_QrJQ6_Cog5MwUabcFZ_1T9WScSji9D-zrMsfQTt67nTI-a8gzwQWsfratK4-U-DpHsniFtoKciij8l-cNNSJ4XSZkR2PL7J4ZVUpRmMjEGT1U/s617/340B%20Final%20Report.jpg" style="margin-left: auto; margin-right: auto;"><img alt="340B" border="0" data-original-height="578" data-original-width="617" height="375" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilHCLVWEUyMUBsdC3CO53DzmAXi3Q2evHDqsqKirVk2-ynBjJg8w221tXjwe-g-_9MdryTsXiVVF1-1_QrJQ6_Cog5MwUabcFZ_1T9WScSji9D-zrMsfQTt67nTI-a8gzwQWsfratK4-U-DpHsniFtoKciij8l-cNNSJ4XSZkR2PL7J4ZVUpRmMjEGT1U/w400-h375/340B%20Final%20Report.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: CANN</span></td></tr></tbody></table><p>Section 340B of the <a href="https://www.govinfo.gov/content/pkg/COMPS-8773/pdf/COMPS-8773.pdf" target="_blank"><span style="color: #3d85c6;">Public Health Service Act</span></a> (PHSA) is a Drug Pricing Program established by the <a href="https://www.hrsa.gov/opa/program-requirements/public-law-102-585" target="_blank"><span style="color: #3d85c6;">Veterans Health Care Act</span></a> of 1992. That year, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients; if pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, then they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple. Drug manufacturers could have a guaranteed income from participation in the Medicaid program and Covered Entities could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates and discounts affording certain healthcare providers a way to fund much needed care to patients who could not otherwise afford it. </p><p></p><blockquote><span style="color: #666666;"><i><span style="font-size: medium;">“…to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”</span></i> </span></blockquote><blockquote><i><span style="color: #666666; font-size: medium;">H.R. Rep. No. 102-384(II), at 12 (1992)</span></i></blockquote><p></p><p><b><i>THAT</i></b> is the legislative intent behind 340B. <b><i>THAT</i></b> is where some of us want to return 340B’s focus. <b><i>THAT</i></b> is why reform is coming!</p><p>Ironically, critics of the 340B reform movement – often motivated by self-preservation and protecting their ever-expanding budget and geographic footprint – are quick to attack the idea of the need for reforms. Sadly, they’re also quick to turn their criticism into personal attacks, including questioning the intentions, morals, and character of the people supporting reform. They charge, using Inspector Clouseau “gotcha” style rhetoric, that we’re in the “pockets” of the drug manufacturers because we accept their money to help with our patient advocacy and education (yet there is no “gotcha”, since this information is quite publicly available on our websites, annual tax returns, Guidestar, as well as frequent public commentary). </p><p>Isn’t it funny how the “gotcha” mentality cannot accept the obvious, that maybe our interests align with the drug manufacturers because it is in the <i>best interest of the patients</i>. Drug manufacturers make products patients want and need. Ensuring funding flows in a way that expands patient access to medications does indeed benefit both patients and the drug manufacturers. It should be noted, this criticism tends to also neglect mentioning the interests of the entities challenging reform: anti-competitive consolidation among <a href="https://thehill.com/opinion/healthcare/3857923-health-care-cronyism-is-fueling-hospital-consolidation-and-rising-medical-costs/" target="_blank"><span style="color: #3d85c6;">hospitals</span></a> and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9206190/" target="_blank"><span style="color: #3d85c6;">pharmacies</span></a> (leaving whole areas without services), <a href="https://www.modernhealthcare.com/payment/drugmakers-340b-sales-pbms-pharmacy-benefit-managers-caremark-express-scripts-optumrx" target="_blank"><span style="color: #3d85c6;">increasing profits</span></a>, <a href="https://ftw.usatoday.com/lists/miami-is-reportedly-using-medical-profits-to-hire-a-new-football-coach-which-made-the-internet-properly-irate" target="_blank"><span style="color: #3d85c6;">paying for salaries unrelated to healthcare</span></a>, and increasing administrative salaries are all excellent examples of why we’re left asking “Who is actually benefiting from this program?”</p><p>The truth of the matter is, aside from a growing list of patients, patient advocacy organizations, and drug manufacturers, there is a growing chorus calling for reform. Academia wants it (<a href="https://www.nejm.org/doi/full/10.1056/NEJMp2303245?query=featured_secondary" target="_blank"><span style="color: #3d85c6;">NEJM</span></a>, <a href="https://ldi.upenn.edu/our-work/research-updates/how-a-federal-policy-for-pharmacoequity-keeps-falling-short/" target="_blank"><span style="color: #3d85c6;">Penn LDI</span></a>, <a href="https://healthpolicy.usc.edu/article/federal-340b-drug-pricing-policies-need-reform-to-realize-potential/" target="_blank"><span style="color: #3d85c6;">USC Schaeffer</span></a>), economists want it (<a href="https://www.ajmc.com/view/association-of-340b-contract-pharmacy-growth-with-county-level-characteristics" target="_blank"><span style="color: #3d85c6;">Nikpay</span></a>, <a href="https://www.ajmc.com/view/association-of-340b-contract-pharmacy-growth-with-county-level-characteristics" target="_blank"><span style="color: #3d85c6;">Gracia</span></a>), national trade associations want it (<a href="https://340breport.com/nachc-hill-day-document-calls-for-340b-reform-and-offers-guiding-principles-key-hill-staffer-joins-organization/" target="_blank"><span style="color: #3d85c6;">NACHC</span></a>, <a href="https://www.ntu.org/publications/detail/340b-program-must-be-reformed-to-achieve-its-intended-purpose" target="_blank"><span style="color: #3d85c6;">NTU</span></a>), policy think tanks want it (<a href="https://cmpi.org/in-the-news/new-report-demonstrates-how-hospitals-pharmacies-pbms-exploit-the-federal-340b-drug-program-to-the-harm-of-disadvantaged-patients" target="_blank"><span style="color: #3d85c6;">CMPI</span></a>, <a href="https://afro.com/rev-al-sharpton-calls-for-stronger-congressional-oversight-over-hospital-pharmaceutical-program/" target="_blank"><span style="color: #3d85c6;">NAN</span></a>), and even multiple news media outlets are suggesting it (<a href="https://www.forbes.com/sites/waynewinegarden/2021/12/12/comprehensive-regulatory-reform-from-the-bottom-up-the-case-of-340b/?sh=bb2f18b65785" target="_blank"><span style="color: #3d85c6;">Forbes</span></a>, <a href="https://www.nytimes.com/2022/09/24/health/bon-secours-mercy-health-profit-poor-neighborhood.html" target="_blank"><span style="color: #3d85c6;">NYT</span></a>, <a href="https://www.wsj.com/articles/340b-drug-discounts-hospitals-low-income-federal-program-11671553899#comments_sector" target="_blank"><span style="color: #3d85c6;">WSJ</span></a>). Local activists are also increasingly fed-up with what they’re witnessing (<a href="https://www.daytondailynews.com/ideas-voices/voices-low-income-and-uninsured-patients-pay-the-price-for-corporate-hospital-loopholes-and-executive-bonuses/PETYREBCENGQPDTHAPHSKLO7L4/" target="_blank"><span style="color: #3d85c6;">Dinkins</span></a>, <a href="https://www-nola-com.cdn.ampproject.org/c/s/www.nola.com/opinions/letters/letters-government-must-address-equity-in-health-care/article_480142d0-e907-11ed-9ae6-afc1af44207f.amp.html" target="_blank"><span style="color: #3d85c6;">Feldman</span></a>, <a href="https://richmondobserver.com/opinion/opinion-340b-program-needs-more-oversight.html" target="_blank"><span style="color: #3d85c6;">Winstead</span></a>).</p><p>Dr. Diane Nugent, Founder & Medical Director of the Center for Inherited Blood Disorders, recently noted an <a href="https://timesofsandiego.com/author/diane-nugent/" target="_blank"><span style="color: #3d85c6;">opinion piece</span></a> in the <i>Times of San Diego</i>, “A September 2022 analysis by the <a href="https://communityoncology.org" target="_blank"><span style="color: #3d85c6;">Community Oncology Alliance</span></a> revealed that some hospitals participating in 340B price leading oncology medications nearly five times more than the price they paid. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions.”</p><p>But speaking of deep pockets, isn’t it also an inconvenient truth that the very folks fighting reform, and fighting improving the program so patients can benefit more directly from it, are the same folks financed by big hospital systems, and mega service providers abusing 340B intent?</p><p>A question often asked by advocates learning about 340B: “So, exactly how much money are we talking about here?”</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgR5W_jO3m2oUrWUPSH8kSyi9f_nPgpJBnqWENE3srgROD-0UYR9SpptJG8vyzEXLZ_DikeSCDzqLcxdZSwtRrwMfFXwsTKYykhKzkJTYW7BiB8iPivSpdHjPaCFwxUirVRH278L-pQHftu-lROKwhVbfhHSLc2qMHJlbtYdFoOklRw0S-pC0bjJRfZub0/s414/$100B.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="$100 Billion" border="0" data-original-height="414" data-original-width="414" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgR5W_jO3m2oUrWUPSH8kSyi9f_nPgpJBnqWENE3srgROD-0UYR9SpptJG8vyzEXLZ_DikeSCDzqLcxdZSwtRrwMfFXwsTKYykhKzkJTYW7BiB8iPivSpdHjPaCFwxUirVRH278L-pQHftu-lROKwhVbfhHSLc2qMHJlbtYdFoOklRw0S-pC0bjJRfZub0/w400-h400/$100B.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Business 2 Community</span></td></tr></tbody></table><p>Well, we don’t really know…<i>sort of</i>. For Federal Grantees covered under 340B, their grant contracts require accounting of 340B rebates as part of their programmatic revenues. Those revenues are required to be re-invested in the program, which generated the income. This level of transparency is pretty much a “gold standard” that other Covered Entities (<i>less maybe hemophiliac centers</i>) in the 340B space are required to meet. That’s part of why we, and other advocates, are calling on minimum reporting requirements for hospitals, contract pharmacies, and pharmacy benefit managers (insurers covering medications) to begin providing some <a href="https://www.statnews.com/2022/10/26/after-30-years-of-340b-time-for-data-honest-conversation/" target="_blank"><span style="color: #3d85c6;">data</span></a>. Clearing up the murkiness, if you will. What we do know is drug manufacturers reported more than <a href="https://phrma.org/Blog/340B-program-reaches-100-billion-in-sales-while-patients-are-left-behind#:~:text=Recent%20data%20from%20IQVIA%20shows,good%20thing%20for%20vulnerable%20patients." target="_blank"><span style="color: #3d85c6;"><i>$100 BILLION</i></span></a> in 340B-related sales last year.</p><p>That’s concerning especially because “charity care” is <a href="https://www.chiefhealthcareexecutive.com/view/report-contends-340b-hospitals-aren-t-providing-enough-charity-care" target="_blank"><span style="color: #3d85c6;">declining</span></a> and medical debt is a <a href="https://www.kff.org/health-costs/issue-brief/the-burden-of-medical-debt-in-the-united-states/" target="_blank"><span style="color: #3d85c6;">growing</span></a> issue for more and more patients and their families. The Affordable Care Act mandated “charity care”, or “financial assistance”, to be offered by non-profit hospitals seeking to qualify as 340B entities but did not place any definitions behind the mandate, including any “floor” of how much charity care a hospital has to offer. </p><p>Now, in all rhetoric opposing <i><u>any</u></i> type of transparency in 340B, hospitals tend to conflate their “uncompensated care” and “unreimbursed care” or “off-sets” for public health programs – these don’t necessarily reflect any “charity” being provided to patients. These things should be separated when considering what benefit hospitals provide a community. And under that lens, things get kind of ugly with far too many of the 340B hospitals reporting providing less than 1% of their operating costs as charity. When reviewing how much hospitals write off in bad debt, or going after patients who can’t afford care, often far exceeding those charity care levels, we’re left asking if the “non-profit” designation is really a declaration of concentrating “profits” by way of salaries to top executives rather than formal shareholders?</p><p>That bad debt shows up for patients as medical debt. And we need to be very specific here: according to the <a href="https://www.urban.org/research/publication/most-adults-past-due-medical-debt-owe-money-hospitals" target="_blank"><span style="color: #3d85c6;">Urban Institute</span></a>, some 72% of patients with medical debt owe some or all of that debt to hospitals. Meaning, what we call medical debt is really hospital debt. The situation is unarguably bad. This year alone the Los Angeles County Office of Public Health issued a <a href="http://publichealth.lacounty.gov/hccp/MedicalDebt/" target="_blank"><span style="color: #3d85c6;">report</span></a> outlining for policymakers the role and responsibility hospitals have in driving medical debt and how increasing charity care might stem this problem. </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgX1JFt-J6e5MX7N5ZGQzfemvVvAzyh7mNn6uM9J_1-hhHnBBm0209zEZDU13yW5mRiAO4AOzbN6tN29IAf0URlCtNowM_qhgfwqedy7fGJPqwmhX-B_K4MpjgPshExPZCDBMV5FqmKjM79-abSJli-ZRoE5mmx7NGflL75RHiiajKhSz_itUCbSFuc8cY/s700/Medical-Debt.jpeg" style="margin-left: auto; margin-right: auto;"><img alt="Medical Debt" border="0" data-original-height="467" data-original-width="700" height="266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgX1JFt-J6e5MX7N5ZGQzfemvVvAzyh7mNn6uM9J_1-hhHnBBm0209zEZDU13yW5mRiAO4AOzbN6tN29IAf0URlCtNowM_qhgfwqedy7fGJPqwmhX-B_K4MpjgPshExPZCDBMV5FqmKjM79-abSJli-ZRoE5mmx7NGflL75RHiiajKhSz_itUCbSFuc8cY/w400-h266/Medical-Debt.jpeg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: Business Insider</span></td></tr></tbody></table><p>As patients, and frankly as patient advocates who represent thousands like us, medical debt isn’t an issue that can be swept under the carpet. Entire communities avoid necessary care to protect their financial interests. We’ve personally watched our friends open GoFundMe accounts to cover medical expenses. We’ve helped our loved one’s cover food and light bills to not miss a medical bill. We also well recognize how negative credit reporting from medical debt can hurt people from getting rental housing or a car loan, or even simple necessities. And when thinking about how much we don’t know about what’s behind that $100 billion price tag, the fact that patients face these concerns on the regular is <i>pretty obscene</i>.</p><p>We do know there are plenty of good actors in the 340B space. Particularly, Federal Grantee Covered Entities, like Ryan White Clinics and AIDS Drug Assistance Programs (ADAPs). And we know they’re <i>generally</i> great actors because of that transparency in reporting and the oversight offered by their grant contracts. Ultimately, we’re not necessarily asking for a whole lot more than that for literally everyone else who stands to make a buck in the chain between drug manufacturers and patients. Indeed, that trust on Federal Grantees, particularly Ryan White Clinics and ADAPs, is part of why drug manufacturers restricting 340B sales held a carve out for these Federal Grantees. (To be fair and without much public fanfare, years ago, we – as in ADAP Advocacy and CANN – <a href="https://www.adapadvocacy.org/urls/2020_ADAP_Letter_Industry_340B_RW_10-01-20_CANN.pdf" target="_blank"><span style="color: #3d85c6;">helped to negotiate these carve-outs</span></a> as part of our advocacy. Our relationship with drug manufacturers isn’t a one-way street as detractors might try and sell you on. </p><p>$100 billion is a lot of money! Is it too much to ask, “Why aren’t patients benefiting more directly from this ever-growing healthcare program?” Facts show that 340B revenues are soaring year after year, yet against the grim backdrop of consistently declining charity care in the impoverished communities needing the most help. To make matters worse, rising medical debt is crushing families. Patients deserve better. People living with HIV who depend on the RWHAP and 340B deserve better! And <b><i>THAT</i></b> is why we need reform.</p><p>Read our policy reform suggestions <a href="https://www.adapadvocacy.org/pdf-docs/2023_ADAP_CANN_Public_Comment_Senate_RFI_340B_07-24-23.pdf" target="_blank"><span style="color: #3d85c6;">here</span></a>.</p><p><i>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.</i></p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0tag:blogger.com,1999:blog-5139051348630003510.post-33279924217087400562023-09-14T09:00:00.006-04:002023-09-14T16:01:35.678-04:00New Study Dissects Efficacy of Lenacapavir<p><i>By: <a href="https://www.linkedin.com/in/raniersimons/" target="_blank"><span style="color: #3d85c6;">Ranier Simons</span></a>, ADAP Blog Guest Contributor</i></p><p></p><p></p><p>Lenacapavir, a novel HIV treatment medication, again appears in the medical news cycle. A recent article in <i>Medical Express</i>, ‘FDA approves treatment for multi-drug resistant HIV,’ was published on September 1st.<span style="font-size: xx-small;">[1]</span> The article title would lead the reader to think the drug was just approved. However, the U.S Food and Drug Administration (FDA) initially approved lenacapavir in December of 2022.<span style="font-size: xx-small;">[2]</span> Gilead Sciences released the medication under the name Sunlenca. Please view the previous ADAP Advocacy discussion of Sunlenca and its background <a href="https://adapadvocacyassociation.blogspot.com/2023/01/fda-approves-promising-new-injectable.html" target="_blank"><span style="color: #3d85c6;">here</span></a>. So, what happened?</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTK_IBf1-UL9GMz8KrCCBZUDcMuiQCPM2JUdC8Wd8573krkrYNN4MgbIarMp80yNClmtnTUzq8gOarn5Ecf-q65ddJI-ojhi7nym3B_9F_0Pl2U__pmYb06ZXbSpPBGaNrJJLl6bb3BN6Z5vHMtCoO7QIF7-7f7VlHzyh-IIWTDXp5grvuKr5pUT38KJs/s2674/lenacapavir%20action.png" style="margin-left: auto; margin-right: auto;"><img alt="Lenacapavir" border="0" data-original-height="1488" data-original-width="2674" height="223" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjTK_IBf1-UL9GMz8KrCCBZUDcMuiQCPM2JUdC8Wd8573krkrYNN4MgbIarMp80yNClmtnTUzq8gOarn5Ecf-q65ddJI-ojhi7nym3B_9F_0Pl2U__pmYb06ZXbSpPBGaNrJJLl6bb3BN6Z5vHMtCoO7QIF7-7f7VlHzyh-IIWTDXp5grvuKr5pUT38KJs/w400-h223/lenacapavir%20action.png" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: sunlencahcp.com</span></td></tr></tbody></table><p>The impetus for the recent article is newly reported data regarding lenacapavir’s ongoing clinical trials. The August 2023 issue of <i>The Lancet</i> included the story, 'HIV presents an article where researchers discuss week 52 results of the phase 2/3 trial',<span style="font-size: xx-small;">[3]</span> which discusses the study's results. But just as important is examining the study’s design.</p><p>The ongoing clinical trial of lenacapavir is also known as the Capella study, ClinicalTrials.gov number <a href="https://clinicaltrials.gov/study/NCT04150068" target="_blank"><span style="color: #3d85c6;">NCT04150068</span></a>. There are 72 subjects divided into two cohorts. Previous data had been reported for evaluations performed at 26 weeks. In Cohort 1, 36 subjects were randomly assigned oral lenacapavir or placebo on days 1,2, and 8 in addition to simultaneously continuing their failing antiretroviral therapy for 14 days. On day 15, those in the lenacapavir group began subcutaneous lenacapavir once every six months (26 weeks) in addition to an optimized background therapy. On day 15, the placebo group began oral lenacapavir plus an optimized background therapy for one week, then switched to subcutaneous lenacapavir once every six months.<span style="font-size: xx-small;">[3]</span></p><p>The primary efficacy endpoint was the percentage of patients that had a decrease in the HIV-1 viral load of at least 0.5log10 copies/ml by day 15. In the lenacapavir group, that endpoint was seen in 88% of the patients while in only 17% of the placebo group.<span style="font-size: xx-small;">[4]</span> In Cohort 2, 36 subjects were given an optimized background regimen on day 1 along with oral lenacapavir on days 1,2, and 8, switching to subcutaneous lenacapavir once every six months (26 weeks) starting on day 15.</p><p>A secondary efficacy endpoint involved viral load. The endpoint was a viral load of less than 50 copies per/ml or a viral load of less than 200 copies per/ml. In cohort 1, at 26 weeks, a viral load of 50 copies per/ml was seen in 81% (29 of 36), and a viral load of less than 200 copies was seen in 89% (32 of 36).<span style="font-size: xx-small;">[4]</span> In cohort 2, less than 50 copies per/ml was observed in 83% (30 of 36); and less than 200 copies in 86% (31 of 36).<span style="font-size: xx-small;">[4]</span> The recent report in Lancet: HIV reports data at the 52-week point. At week 52, 83% (30 of 36) subjects in cohort 1 had HIV-1 RNA of less than 50 copies per mL, and 86% (31 of 36 ) had HIV-1 RNA of less than 200 copies per mL.<span style="font-size: xx-small;">[3]</span> For cohort 2 at 52 weeks, 72% (26 of 36) had less than 50 copies per/ml, and 78% (28 of 36) had less than 200 copies per/ml.</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0TZAgRMrHwMRb3CPyMmQ280O03Fa4mVGs-4iHXLmxufV2XlYPx7JtVXU9yWcwK1Osz84qVN6QFaEUNsCncaXk0x7nISPsMWmO43RLYkr6w09frb7PxStWpF8bnquiTKGaqek7ehum4dxK-NJdO094PJR20B03fKsUyB3hzNp4ka7Uc876MBt_epInK7A/s840/longacting%20retroviral%20image.jpg" style="margin-left: auto; margin-right: auto;"><img alt="Long-Acting Antiretrovirals" border="0" data-original-height="463" data-original-width="840" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0TZAgRMrHwMRb3CPyMmQ280O03Fa4mVGs-4iHXLmxufV2XlYPx7JtVXU9yWcwK1Osz84qVN6QFaEUNsCncaXk0x7nISPsMWmO43RLYkr6w09frb7PxStWpF8bnquiTKGaqek7ehum4dxK-NJdO094PJR20B03fKsUyB3hzNp4ka7Uc876MBt_epInK7A/w400-h220/longacting%20retroviral%20image.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="color: #999999;">Photo Source: European AIDS Treatment Group</span></td></tr></tbody></table><p>The overall theme is that the results at 52 weeks support the efficacy of lenacapavir injections every six months for those with multi-drug resistance to retrovirals. Consistent viral suppression was met, and therapeutic drug levels were maintained in the blood between injections. Most importantly, since lenacapavir is to be used with other medications, the injections do not increase pill burden or complicate daily regimens. </p><p>Although the results are promising, there are reasons to research much further before expanding lenacapavir for other uses, such as prevention. The cohort size was very small, at 72 participants. That is partly due to the requirements of the subjects. The participants had to have documented resistance to at least two drugs from at least three of the four major antiretroviral classes in addition to having advanced HIV disease. Additionally, while the data showed no significant safety issues, people living with HIV are known to have hypersensitivity issues with drug reactions. The CAPELLA clinical trial, along with CALIBRATE, a different lenacapavir clinical trial, together only have a total of 229 subjects.<span style="font-size: xx-small;">[5]</span></p><p>Much larger cohorts need to be examined in order to have comprehensive cross-sectional data to explore gender, age, and ethnicity differences. The complex variances of combination antiviral regimens of multi-drug resistant patients are also a significant concern. Once further lenacapavir research is conducted, the path of its utilization will be more apparent. It could even possibly become paired with another complete long-acting drug, creating an easy-to-use twice-yearly injection for all patients, whether multi-drug resistant or not.<span style="font-size: xx-small;">[5]</span></p><p><span style="font-size: xx-small;">[1] Rivera, Viviana. (2023, September 1). FDA approves treatment for multi-drug resistant HIV. Retrieved from https://medicalxpress.com/news/2023-09-fda-treatment-multi-drug-resistant-hiv.html</span></p><p><span style="font-size: xx-small;"><span>[2] </span><span>FDA Press Release (2022, December 22). FDA Approves New HIV Drug for Adults with Limited Treatment Options. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options</span></span></p><p><span style="font-size: xx-small;">[3] Ogbuagu, O., Segal-Maurer, S., Ratanasuwan, W., Avihingsanon, A., Brinson, C., Workowski, K. A., Antinori, A., Yazdanpanah, Y., Trottier, B., Wang, H., Margot, N., Dvory-Sobol, H., Rhee, M. S., Baeten, J. M., Molina, J., DeJesus, E., Richmond, G., Berhe, M., Ruane, P., . . . Rassool, M. (2023). Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. The Lancet HIV, 10(8), e497–e505. https://doi.org/10.1016/s2352-3018(23)00113-3</span></p><p><span style="font-size: xx-small;">[4] </span><span style="font-size: xx-small;">Segal-Maurer, S., DeJesus, E., Stellbrink, H., Castagna, A., Richmond, G., Sinclair, G., Siripassorn, K., Ruane, P., Berhe, M., Wang, H., Margot, N., Dvory-Sobol, H., Hyland, R. H., Brainard, D. M., Rhee, M. S., Baeten, J. M., & Molina, J. (2022). Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. The New England Journal of Medicine, 386(19), 1793–1803. https://doi.org/10.1056/nejmoa2115542</span></p><p><span style="font-size: xx-small;">[5] SHarris, M. (2023). Lenacapavir: an attractive option, but proceed with caution. The Lancet HIV, 10(8), e486–e487. https://doi.org/10.1016/s2352-3018(23)00170-4</span></p><p><i>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.</i> </p>ADAP Advocacyhttp://www.blogger.com/profile/12953388477622949653noreply@blogger.com0