Evidence Suggest Long-Acting Injectables Game Changer for Adherence

By: Ranier Simons, ADAP Blog Guest Contributor

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) approved Cabenuva, the first injectable drug combination for HIV.[2,5] GSK recently released results from clinical trial data indicating Cabenuva works better than daily pills for patients with adherence challenges.[1,4,5,6]

Photo Source: Pharmalive

Cabenuva is a two-injection regimen of cabotegravir and rilpivirine administered either once a month or once every two months.[7] This month, GSK released data from the LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study comparing the efficacy of Cabenuva in contrast with daily pill regimens regarding adherence.[1] 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.[1] Once they were virally suppressed, they were randomly selected to receive Cabenuva injections every four weeks or continue with daily pill therapy.[1] 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.[1]

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.” 

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.[2,3]

Photo Source: NIAID

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.”

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.[2] 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.[2] This means that less than half of PLWH in the U.S. would qualify for Cabenuva. 

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.[5] 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.[2]

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.[2] Shipping doses of emergency medication is not viable for people with unstable housing or living situations where receiving medication is not optimal.

Photo Source: HIV.gov

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.[8]

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.

[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/

[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

[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

[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

[5] Bernstein, L. (2021, January 22). FDA approves breakthrough injectable HIV medication. Retrieved from FDA approves breakthrough injectable HIV medication

[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

[7] VIIV Healthcare. (2024, January). Cabenuva. Retrieved from https://www.cabenuva.com/  

[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

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. 

Prior Authorization: A Growing Headache for Patients

By: Ranier Simons, ADAP Blog Guest Contributor

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. 

Photo Source: Salon (Getty Images/FG Trade)

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.

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).[9] 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.[6]

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.[1] 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.[7] 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.

Photo Source: American Medical Association

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. 

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.

The District of Columbia passed Bill 25-124, which became ACT 25-301 in November 2023.[5] 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.[5] 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.[5] For standard requests, it specifies a response within three business days by electronic portal or five business days by mail, fax, or telephone.[5]

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.[10] 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.[10] 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.[10]

Photo Source: American Medical Association

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.[6] 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.[6,8] 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.”

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.[3,7] Delays in patient care can result in avoidable poor patient health outcomes and exacerbation of disease states.[2,3,4] 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.

[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

[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/

[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

[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.

[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

[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/

[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

[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

[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

[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

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. 

NHBS-Trans Sheds Light on HIV Prevalence Among Transwomen in the United States

By: Ranier Simons, ADAP Blog Guest Contributor

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.[1,2,3]

Photo Source: CDC

The CDC developed a surveillance system named National HIV Behavioral Surveillance Among Transgender Women (NHBS-Trans).[1] 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.[1] 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.

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.[2,4] 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.[2,4]

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.[4] 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.[3,4] 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.

Photo Source: iStock | Rights Purchased

Participants who were on Medicaid in states where Medicaid did not cover gender-affirming care were twice as likely to have difficulty finding employment.[3] 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.[4] 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.[5] 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.

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.[4] 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.

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.

[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

[2] 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

[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

[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.

[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/

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. 

Feds Tell States to Cover Hep C Medications, Regardless of Substance Use

By: Ranier Simons, ADAP Blog Guest Contributor

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.[1,2] 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.”[1] 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. 

Photo Source: U.S. Department of Justice

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).[3] 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.”[5]

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).”[4] There was no scientifically evidence-based reasoning for the restriction. 

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.[4] 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.[4] 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.[4]

Photo Source: Arkansas Medical Society

The DOJ utilized the ADA in 2020 to reach a settlement with Massachusetts General Hospital.[6] 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.[6] 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.[6] 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.[6] 

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.”[7] 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.”[7] 

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.

[1] 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.

[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

[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

[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

[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

[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/

[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

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. 

Nicolas Overfield’s Avoidable Tragedy is a Symbolic Failure of Justice

By: Ranier Simons, ADAP Blog Guest Contributor

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.[1]

Photo Source: Los Angeles Times | Overfield family

In February 2022, Nicholas Overfield was arrested and detained at El Dorado County Jail for failure to appear in court.[2] Upon his arrest, he informed the police that he was HIV positive and required his HIV medication daily to keep his HIV controlled.[2] His medication was present at this home, and his mother gave his medication to the police before they took him away.[2] 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.[2] 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.[2]

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.[4] Mandisa Moore-O’Neal, Executive Director of the Center for HIV Law and Policy (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.” 

It is well-documented that many inmates in jails and prisons receive substandard medical care.[3,5,6]. 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. 

Photo Source: PBS News Hour

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.[2] 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.[2]

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 Appalachian Learning Initiative (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.” 

This makes it hard to gather information since they are characteristically lax in reporting their data. A deep-diving Reuters 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.[3] 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.[3]

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.[3] 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. 

Photo Source: The Lancet | Copyright © 2016 Sakhorn

The largest jail healthcare companies are Wellpath Holdings Inc., NaphCare Inc., Corizon, PrimeCare Medical Inc., and Armor Correctional Health Services Inc.[3] 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.[3]

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.

[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/

[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

[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/

[4] Estelle v. Gamble, 429 U.S. 97, 102 (1976).

[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/

[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

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.