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. 

What is 100-100-100?

By: Ranier Simons, ADAP Blog Guest Contributor

The ongoing Covid-19 pandemic is a glaring reminder of the importance of the global efforts to address other epidemics and pandemics. After over 30 years of such efforts, worldwide there has been success with polio. Wild poliovirus was virtually extinct in 2020 with only about 140 cases remaining.[1] However, two serious remaining global disease crises are HIV/AIDS and Hepatitis C (HCV).

In 2020, it was estimated that there were 37.7 million people living with HIV/AIDS, and an estimated 58 million people with chronic Hepatitis C.[2][3] The strongest two-pronged approach to fight both is testing and treatment. In 2014, UNAIDS, the Joint United Nations Programme on HIV/AIDS, came up with a target known as 90-90-90. The goal was to have 90% of all persons living with HIV/AIDS aware of their status, 90% of all diagnosed on sustained antiretroviral treatment, and for 90% of those on treatment to have an undetectable viral load by 2020. 

The WHO, World Health Organization, proposed a similar target for HCV in 2016. They pledged to globally eliminate HCV by 2030. This elimination included a target of 80% those with HCV to be in treatment, a 90% reduction in new infections, and a 65% reduction in liver-associated deaths as a result of hepatitis C.[4] 

Photo Source: UNAIDS

The 90-90-90 goal was not met in 2020 and it is not likely that HCV will be eradicated by 2030. Were the goals too ambitious or was there something missing in the execution of the efforts? 

The focus has always been on testing and treatment. It is of the utmost importance to have widespread testing to identify those that need treatment in order to get them into treatment. However, what had previously been missing was discourse on barriers to testing and treatment. In 2021, the UNAIDS Global AIDS Strategy acknowledged the existence of structural barriers to HIV and HCV testing and services. 

The challenge has been that solving the problem of these hurdles has not been included in the system of testing and treatment. The structural hurdle of lack of fulfilment of basic needs should be a systemic part of treatment. Human nature prioritizes stable shelter, food, and safety over seeking out testing and adherence to treatment regimens.

This is especially true in the population of people who inject drugs (PWID). Intravenous drug users are 29% more at risk to contract HIV and 40% of new HCV infections worldwide.[5]

Photo Source: Yahoo!

In response to understanding the importance of including the effective meeting of basic needs as part of disease prevention, a new target, 100-100-100 is being discussed in global health circles. It is initially being considered through the lens of PWID regarding HIV and HCV. The goal is to have stable housing for 100% of PWID who have housing instability, offering substance abuse treatment to 100% of PWID that desire treatment, and giving 100% of PWID access to harm reduction services.

Stable housing means safe and consistent shelter. It means having a stable place to eat and prepare meals. Having stable housing provides a place for self-care and identity.  Stress is lowered when one has a safe stable place to live as well allowing focus on other needs. A sense of community results from stable housing as well. When groups of PWID have stable housing, they can create a sense of belonging and care for each other communally. 

Having a stable place to live and rest also facilitates successful substance abuse treatment. Taking away stressors of basic survival allows a person to redirect their energies towards bettering their lives. Coupled with substance abuse treatment is harm reduction. Harm reduction services come in many forms.[6] Most importantly it is acknowledging the complicated etiology of drug use. It is the realization that drug use does happen, and it is necessary to help people along the continuum of complete abstinence from drug use to the other end of safer and “responsible” drug use starting at whichever stage PWID find themselves.

Reaching this 100-100-100 goal, along with aggressive strides toward testing and treatment, is the growing discourse that is providing hope towards the eradication of HIV and HCV. Removing the inequalities of lack of basic needs will help not just PWID but the greater population at large living with HIV and HCV as well.

[1] Kaiser Family Foundation. (2021, Oct 29). The U.S. Government and global polio efforts. Retrieved from https://www.kff.org/global-health-policy/fact-sheet/the-u-s-government-and-global-polio-efforts/
[2] UNIADS. Global HIV and AIDS statistics fact sheet. Retrieved from https://www.unaids.org/en/resources/fact-sheet
[3] World Health Organization. (2021, Jul 27). Hepatitis C. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
[4] World Health Organization. (‎2016)‎. Global health sector strategy on viral hepatitis 2016-2021. Towards ending viral hepatitis. World Health Organization. Retrieved from https://apps.who.int/iris/handle/10665/246177
[5] UNAIDS. (2017, Jan 1) 90–90–90: an ambitious treatment target to help end the AIDs epidemic. Retrieved from https://www.unaids.org/en/resources/documents/2017/90-90-90
[6] Principles of harm reduction. National Harm Reduction Coalition. Retrieved from https://harmreduction.org/about-us/principles-of-harm-reduction/ 

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.

Veterans Linkage to Care: Perspectives on HIV, Viral Hep, Opioids & Mental Health

By: Jonathan J. Pena, MSW, Licensed Clinical Social Work Associate (LCSWA)

*** Reprinted with permission from the Community Access National Network (CANN) ***

Approximately 8 percent of the U.S. population are Veterans, numbering over 18 million Americans with most of them being males and older than nonveterans. But those demographics will change in the coming years, with significant increases in ranks among women and minorities (Schultz, 2017). As a society, we tend to view these men and women formerly in uniform as larger than life figures capable of overcoming almost any odds. The reality, however, is there are numerous ongoing public health challenges faced by Veterans in this country once discharged from the military – among them HIV, Hepatitis C, opioid dependence, and mental health conditions. As a society, don't we owe it to them to provide the most timely, appropriate linkages to care and treatment?

To view the full opinion piece, infographic and video, go to: https://www.hiv-hcv-watch.com/blog/veterans-linkage-to-care.

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.

Co-Infection: HIV & Hepatitis C Therapies Under State AIDS Drug Assistance Programs

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

According to amfAR, The Foundation for AIDS Research, there are an estimated 1.2 million people living with HIV/AIDS in the United States, with as many as 150,000 unaware of their status.[1] The U.S. Centers for Disease Control & Prevention (CDC) estimates one percent of the adult population, or nearly 2.4 million Americans, are living with Hepatitis C (HCV).[2] The intersection between these dual epidemics continues to place significant strain on the nation's public health system. In 2009, approximately one in five of the HIV-infected adults who were tested for past or present HCV infection tested positive.[3] It is unknown how the ongoing Covid-19 pandemic is influencing HIV/HCV co-infection.

Photo Credit: iStock (rights purchased)

What we do know is people living with HIV-infection face a higher risk of long-term liver failure as a result of co-infection with HCV. In fact, HCV-related liver failure has become the leading non-AIDS-related cause of death among people living with HIV-infection in the United States – and as such, treating HCV is of paramount importance.[4]

HIV/HCV co-infection remains a growing and evolving epidemic. Advances in HIV medication since the introduction of highly-active anti-retroviral therapy in 1996 has increased a detection of sexually transmitted HCV infection. Dating back to 2011, sexual transmission of HCV is becoming a growing concern amongst men-who-have-sex-with-men (MSM).[5] 

The HIV/HCV Co-Infection Watch — a program of the Community Access National Network (CANN) — delivers relevant information from a “patient-centric” perspective on access to care and treatment. The three primary groups best suited for this information include patients, healthcare providers, and community-based AIDS Service Organizations.

Of particular importance to the ADAP Advocacy Association are the patients who frequently rely on coverage provided by state- and federally-funded programs – such as the AIDS Drugs Assistance Program (ADAP). According to the National Alliance of State & Territorial AIDS Directors (NASTAD), "While ARVs represent 95% of all CY2018 ADAP drug expenditures, 0.4% and 1% were expended on hepatitis B and C treatment, respectively."[6]

Dating back to the passage of the Affordable Care Act, NASTAD has detailed the availability of testing, care and treatment for individuals who are mono-infected with HCV and co-infected with HCV and HIV, in light of newly available curative treatments for HCV.[7]  NASTAD has also made available an interactive map highlighting the important work of health department HIV and viral hepatitis programs.

Additionally, CANN's HIV/HCV Co-Infection Watch includes detailed information on States whose ADAP drug formularies cover HCV therapies. Summarized Jen Laws, Project Director for the HIV/HCV Co-Infection Watch, “For purposes of our monitoring, coverage is broken down into ten categories - Basic Coverage, Sovaldi, Harvoni, Zepatier, Epclusa, Vosevi, Mavyret, Pegasys, Harvoni (generic), and Epclusa (generic). This will be expanded as newer treatment options become available."

Photo Source: HIV/HCV Co-Infection Watch

While 47 of the country's 56 state and territorial ADAPs provide some form of HCV coverage, only 44 provide coverage for direct acting agents matching with the standards of care provided for by American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. The quarterly report monitors for changes in HCV medication coverage. Most recently published in April 2021, it notes several changes with regard to HCV treatment coverage among ADAPs, primarily as a result of budget impacts due to COVID-19. For example, Texas's program has ceased coverage of any HCV therapies except for Epclusa (brand only), and Georgia's ADAP has stopped paying for all HCV therapies, while maintaining them as drugs on the formulary.

Laws further reflected, "Program information can be challenging to navigate and the Watch is an invaluable as a tool to help patients navigate what's available to help them, when they need it." Laws added, "As far as HCV treatment coverage, given the significant rate of HCV coinfection with HIV, it's unfortunate to see some ADAPs treat access to and coverage of HCV medications as optional or fail to adopt medication coverage in alignment with standards of care because we know treating the medical needs of PLWH holistically leads to a higher rate of positive health outcomes."

The HIV/HCV Co-Infection Watch list-serve sign-up form is available online: https://www.tiicann.org/signup_listserv.php.

[1] amfAR, The Foundation for AIDS Research (June 2020). Statistics: United States. Retrieved online at https://www.amfar.org/about-hiv-and-aids/facts-and-stats/statistics--united-states/#:~:text=An%20estimated%201.1%20million%20people%20in%20the%20United,15%25%20of%20those%20don’t%20know%20they%20are%20infected.

[2] Centers for Disease Control & Prevention (2018, November 18). CDC Estimates Nearly 2.4 Million Americans Living with Hepatitis C. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/nchhstp/newsroom/2018/hepatitis-c-prevalence-estimates-press-release.html. 

[3] Centers for Disease Control & Prevention (2020, September 21). People Coinfected with HIV and Viral Hepatitis. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/hepatitis/populations/hiv.htm. 

[4] Community Access National Network (April 2021). HIV/HCV Co-Infection Watch – About. Retrieved online at https://www.hiv-hcv-watch.com/about.

[5] U.S. Centers for Disease Control & Prevention, MMWR Vol. 60 No.28, July 22, 2011.

[6] National Alliance of State & Territorial AIDS Directors (2020, August 10). NATIONAL RYAN WHITE HIV/AIDS PROGRAM (RWHAP) PART B AND ADAP MONITORING PROJECT: 2020 ANNUAL REPORT. Retrieved online at https://www.nastad.org/PartBADAPreport.

[7] National Alliance of State & Territorial AIDS Directors (2014, December 4). Access to Care and Treatment for HCV Mono-Infection and HIV/HCV Co-Infection. Retrieved online at https://www.nastad.org/sites/default/files/resources/docs/HCV-HIV-Care-Access-Webinar-December-2014.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.

I Benefit from HIV Co-pay Assistance Programs; CMS Wants to Change That

By: Guy Anthony, President/CEO, Black, Gifted & Whole Foundation, and Board Member, ADAP Advocacy Association

I found myself both shocked and appalled when reviewing the latest Notice of Benefit and Payment Parameters (NBPP) for 2021 issued by the Centers for Medicare and Medicaid Services (CMS) recently. The proposed NBPP, which is released annually, attempts to exclude manufacturer coupons from being counted towards a patient's annual deductible on cost-sharing.

As someone that has been living with HIV for over a decade, and a direct beneficiary of the drug manufacturer co-pay assistance program, I have an intimate understanding of the far-reaching and potentially devastating effects this decision could have on those in the HIV and HCV community.

Photo Source: Sermo

How Many People Will Be Affected by the Changes?

Over one million people in the U.S. live with HIV and over three million live with chronic HCV. Those who have these conditions come from all walks of life. They're certainly not limited to the LGBTQIA+ community. However, those from disadvantaged backgrounds are much more likely to have the disease than those that hail from affluent socioeconomic backgrounds.

According to the Centers for Disease Control and Prevention (CDC), HIV prevalence in U.S. poverty areas matches those of countries designated as having a generalized HIV epidemic such as Burundi, Ethiopia, and Haiti. What's more, HIV prevalence rates in urban poverty areas are inversely related to annual household income – the lower the income, the higher the HIV prevalence rate.

In other words, the poorer you are, the more at risk you are of contracting the disease. Furthermore, due to the nature of chronic diseases such as HIV, those living with these conditions find it much harder to secure long-term work due to issues surrounding immunodeficiency. This is something I have experienced myself, and employment with HIV is not easy to maintain.

Since a great deal of HIV and HCV cases are found in lower-income households, these changes are going to have a dramatic impact on a considerable proportion of those one million-plus people living with the condition.

How Does Co-Pay Assistance Help Those with HIV?

As you know, those with chronic conditions such as HIV and HCV have had the financial burden of the disease reduced thanks to co-pay assistance programs provided by drug manufacturers in conjunction with additional support from the AIDS Drug Assistance Program (ADAP). Co-pay assistance ensures that financially-challenged individuals can receive the drugs they need to live with the disease.

Everyone living with HIV and HCV knows and appreciates how important these programs are to the community. I've long advocated as part of my awareness campaigns that co-pay assistance and ADAP are pretty much the reason why HIV is no longer a death sentence, since many patients can better "afford" to stay alive. But this move to exclude manufacturers coupons by the CMS is going to hit those who need financial relief the most.

What is the Likely Fallout from These Proposed Changes?

The most immediate ramification will come in the form of reduced medication adherence. Suddenly those that enjoyed financial relief will have to deal with the impact of high deductibles and high cost-sharing expenses. Most individuals living with HIV and HCV need to take at least two antiretroviral drugs every single day. It doesn't matter who you are; anyone can see that these changes will force some people to choose between money and medication. It makes me sick that we live in a country that people with chronic conditions such as HIV might not be able to get access to necessary drugs, as prescribed by their doctor, as a result of a lack of financial means.

I know of individuals who potentially face a situation of not being able to afford the medication they need to live a normal life. One of those people happens to be me. It seems that the constitutional right to life and liberty has been thrown out the window. I think this has a lot to do with the continued stigmatization of conditions such as HIV and HCV. I am no less of a person because I have HIV, no one chooses to have this disease, so why have the rights of individuals within this community being gradually eroded?

Photo Source: Novartis

Help Us to Creat Change!

The CMS proposal to exclude manufacturer coupons would have genuinely concerning effects on the affordability of many medications within the regimens of HIV and HCV patients, including myself. In many cases, those living with these diseases will have to bear the financial burden as a result. For some, that burden will be too much.

As is the case for a lot of situations in life, it's going to be those without sufficient means that are going to find themselves the most adversely affected.

We need your help to stop this becoming a reality. Please contact your member of Congress and ask them to help stop this from happening to our community.

References:

• Denning, MD, MPH, Paul, and Elizabeth DiNenno PhD (2019, December 11). Communities in Crisis: Is There a Generalized HIV Epidemic in Impoverished Urban Areas of the United States? Centers for Disease Control & Prevention. Retrieved online at https://www.cdc.gov/hiv/group/poverty.html.
• McManus, K. A., Engelhard, C. L., & Dillingham, R. (2013). Current challenges to the United states' AIDS drug assistance program and possible implications of the affordable care act. AIDS research and treatment, 2013, 350169. https://doi.org/10.1155/2013/350169

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.

2019 HealthHCV State of HCV Health National Survey!

By: Brian Hujdich, Executive Director, HealthHIV

HealthHCV is fielding the 2019 HealthHCV State of HCV Care National Survey(TM). This annual survey reaches providers nationwide, including hepatologists, gastroenterologists, infectious disease specialists, HIV care providers, primary care providers, and others screening for and/or treating hepatitis-C. The 2019 survey, developed with input from viral hepatitis advocacy groups, payers, and HCV care providers, builds on the findings from HealthHCV’s inaugural Report on the State of HCV Care, based on a survey of almost 200 prescribing providers involved in HCV care. The inaugural survey formed some of the first data points regarding the provision of HCV care and treatment in the U.S.

While advances in HCV cure therapy have led to improved survival rates for patients with cirrhosis, reduced health care costs, and a reduced need for liver cancer surveillance, a more comprehensive approach to HCV care is needed to curb the epidemic, especially as the opioid crisis continues to fuel increases in new infections.

The State of HCV Care is integral to understanding and improving current HCV care and prevention efforts, as well as shaping advocacy and policy needs. There are currently few efforts to collect information on hepatitis C (HCV) care and treatment in the U.S., and these survey results serve as some of the first national data points regarding provision of HCV care. The data collected from this survey provides an opportunity for those on the front lines of HCV care to cite challenges and barriers to providing necessary services. This year’s survey will evaluate the latest impacts on HCV screening practices, treatment access and reimbursement, barriers to care, provider training needs, and integration and coordination of HCV services with behavioral health and substance use treatment.  

Your feedback is critical to shape national HCV advocacy, education, and training in 2019 and beyond that contribute to ending the HCV epidemic! In order to take the survey please press HERE.

About HealthHCV: HealthHCV’s unique role in evaluating national provider needs helped shape a robust suite of current education offerings on HCV, including the 20x20 Initiative: Increasing HCV Screening and Linkage to Care by 2020 and Addressing the Evolving Opioid and HCV Epidemics Through Community Engagement and Education.




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.

CANN Hosts 3rd Annual Community Roundtable on Correctional Hepatitis

By: Marcus J. Hopkins, Policy Consultant

Reprinted with Permission from the Community Access National Network (CANN)

On Wednesday, April 17th, the Community Access National Network (CANN) hosted its 3rdAnnual Community Roundtable on Viral Hepatitis in Correctional Settings at the Pharmaceutical Research and Manufacturers of America (PhRMA) headquarters in Washington, DC. Their panel included three presenters: yours truly, along with Wayne  Turner (Senior Attorney at the National Health Law Program), and Todd Schwartz (National Account Director at Gilead Sciences, Inc.). Each presented touched on some facet of the myriad issues faced by inmates living in state correctional facilities, as well as various research efforts, funding mechanisms, and opportunities for improvement.

I presented on viral hepatitis in Correctional Settings, during which I focused on CANN’s two-year research effort focusing on HIV, Hepatitis B (HBV), and Hepatitis C (HCV) testing protocols in state prisons, as well as the declining per inmate cost of HCV treatments, and the state of HCV-related Class-Action lawsuits winding their ways through various courts.

Since 2017, I have been reaching out to Department of Corrections (DOCs) in every state and the District of Columbia on behalf of both CANN and the ADAP Advocacy Association to determine what are the state protocols for testing: Is testing compulsory (required), upon request, or based upon clinical criteria, is it conducted during or after the intake process, can inmates refuse to be tested, and is testing offered using an Opt-In (“informed consent”) or an Opt-Out (“informed refusal”) model of delivery. This research represents only a handful of national efforts to identify state correctional testing protocols and to determine whether or not these protocols will help the U.S. towards reaching its established goals of reaching elimination of HIV and HCV (both by 2030).

As of March 2019, all but seven states either responded to inquiries or had the protocols publicly posted on their respective states’ DOC websites (only 14 states, including two that responded, publicly post their testing protocols). Our findings determined that, while most states (n=34) do a good job of making HIV testing compulsory, only 11 states require HBV testing, and only 22 require HCV testing (Hopkins, 2019).

What is concerning about these findings is that, in Arizona, Alaska, Florida, Kentucky, Maine, and Massachusetts – all areas of the country where Injection Drug Use (IDU) is high, HIV testing is performed only upon request.

For HBV, the testing landscape is, for lack of a better word, “bleak.” Despite having a commercially available vaccine for HBV since 1981 (and recombinant vaccines since 1986), only 50 million adults and 70 million babies in America have received at least one dose of the vaccine since 1982 – roughly 37% of the American population (Immunization Action Coalition, 2017). Because, HBV is transmissible via sexual contact, as well as by IDU, the vaccination recommendations are considerably broad, but because the disease was so rare, physicians in more rural parts of the nation never bothered to vaccinate many Americans. As a result, the U.S. is seeing an increase in new HBV infections in places where the virus was largely absent. With only 11 states requiring HBV testing in state prisons, inmates face a greater risk of encountering this entirely avoidable, yet incurable disease.

For HCV, as the rates of new infections continue to climb, in all ten of the states with the highest rates of new infections, testing is either not compulsory, or there are no protocol data made available.

You can find my report at the following link: Viral Hepatitis in Correctional Settings.

Wayne Turner, Senior Attorney at the National Health Law Program (NHLP), presented on the various ways state Medicaid programs can and cannot be utilized to help cover to cost of treating incarcerated individuals. He discussed the various intricacies of how the Medicaid program defines “inmate” and “incarceration,” as well as issues surrounding eligibility during and after incarceration, linkage to Medicaid during the reentry process, and how Medicaid is structured.

You can find Mr. Turner’s report at the following link: Medicaid, Incarcerated Persons, and Hepatitis C Treatment.

Todd Schwarz, National Account Director at Gilead Sciences, Inc., provided us with an overview of the corrections system, Gilead’s efforts to help with education, HIV and HCV resource location services, education efforts, and statistics related to new infections and prevalence rates within the state correctional healthcare systems.

You can find Mr. Schwartz’s presentation at the following link: Community Roundtable on Linkages to Care for Incarcerated Citizens Living with Hepatitis C – Gilead Focus on Hepatitis C in Corrections.

Contact CANN to learn more.

References:

• Hopkins, M.J. (2019, April 17). Viral Hepatitis in Correctional Settings. Washington, DC: Community Access National Network. Retrieved from: http://www.tiicann.org/urls/2019_CANN_Presentation_1_Hepatitis_Corrections_04-17-19_HOPKINS.pdf
• Immunization Action Coalition. (2017, December). Hepatitis B: Questions and Answers. St. Paul, MN: Immunization Action Coalition: Handouts: Vaccine Index: Hepatitis B. Retrieved from: http://www.immunize.org/catg.d/p4205.pdf
• Schwartz, T. (2019, April 17). Community Roundtable on Linkages to Care for Incarcerated Citizens Living with Hepatitis C – Gilead Focus on Hepatitis C in Corrections. Foster City, CA: Gilead Sciences, Inc. Retrieved from: http://www.tiicann.org/urls/2019_CANN_Presentation_3_Hepatitis_Corrections_04-17-19_SCHWARTZ.pdf
• Turner, W. (2019, April 17). Medicaid, incarcerated persons, and hepatitis C treatment. Washington, DC: National Health Law Program. Retrieved from: http://www.tiicann.org/urls/2019_CANN_Presentation_2_Hepatitis_Corrections_04-17-19_TURNER.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.

NASTAD Releases Updated 2019 ADAP Formulary Database

By: Tim Horn, Director, Medication Access and Pricing, NASTAD

The National Alliance of State & Territorial AIDS Directors ("NASTAD") has released an updated 2019 Online AIDS Drug Assistance Program ("ADAP") Formulary Database ("the Database"), which may be accessed via the accompanying User’s Guide. The Database provides an online, searchable, publicly available resource detailing state-by-state ADAP coverage of medications both individually and by drug class including HIV antiretroviral (ARV) treatments, “A1” Opportunistic Infections (A1 "OI") medications, treatments for hepatitis B and C, mental health and substance use treatment medications, and various vaccines and laboratory tests and includes ADAP formulary coverage for all 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands as of December 31, 2018.

 Key findings from the updated 2019 ADAP Formulary Database include:

• 11 ADAPs have “open formularies” in which all FDA-approved medications are included, excluding designated exceptions
• 42 ADAPs cover one or more hepatitis B treatment medication
• 41 ADAPs cover one or more hepatitis C treatment medication
• 39 ADAPs cover one or more of the curative direct acting antiviral ("DAA") hepatitis C ("HCV") treatment medications
• 27 cover daclatasvir (Daklinza)
• 35 cover elbasvir and grazoprevir (Zepatier)
• 36 cover glecaprevir and pibrentasvir (Mavyret)
• 33 cover ledipasvir and sofosbuvir (Harvoni)
• 30 cover sofosbuvir (Sovaldi)
• 31 cover sofosbuvir, velpatasvir (Epclusa)
• 22 cover sofosbuvir, velpatasvir, and voxilaprevir (Vosevi)
• 48 ADAPs cover one or more of the most frequently prescribed mental health treatment medications
• 30 ADAPs cover one or more substance use treatment medication

NASTAD thanks state ADAP coordinators who provided the important data that comprises the ADAP Formulary Database. Questions regarding the Database may be directed to Amanda Bowes, Manager, Health Care Access.

HIV Patients Co-Infected With HCV Face Higher Mortality Rates

Guest Blog By: Marcus J. Hopkins, Consultant, Community Access National Network (CANN)

Reprinted with Permission from the Community Access National Network

A ten-year follow-up study has found that people living with HIV who are co-infected with Hepatitis C (HCV) face an increased risk of mortality by 4.3%, even when receiving treatment for HIV (Bender, 2018). The same study found that treatment with HCV Direct-Acting Antivirals (DAAs) resulted in a lower risk of mortality than those whose HCV went untreated, but that the harm caused by HCV still resulted in increased risk.

Photo Source: medscape.com

One of the primary consequences of untreated HCV infections is damage to the liver – damage that is no immediately repair itself once the virus is successfully treated. Liver fibrosis – scarring of the liver that prevents the organ from properly functioning – is not healed by HCV treatment, and depending upon the severity of the scarring, the liver may never completely regenerate. Those whose livers are cirrhotic – those with late-stage liver scarring – will likely never fully recover optimum liver function and may become dependent upon other prescription medications and dietary restrictions to aid in liver functions such detoxifying substances in the body, purifying blood, and making vital nutrients (Welch, 2017).

This issue is one that receives far less attention than it deserves and is part of why there is so much opposition against including Fibrosis Scoring in treatment determinations. While it may seem financially prudent in the short-term to limit treatment of HCV to those who are “sick enough” to be treated, the long-term negative health impacts of liver scarring are far costlier in the long-term. For those living with HIV, liver function is of critical concern as that is where most HIV medications are metabolized. If liver function is impaired, the drugs may not properly metabolize, making the treatment of HIV less effective.

References:

• Bender, K. (2018, October 23). HCV Increases Mortality of People with HIV Despite Antiretroviral Treatment. Cranbury, NJ: Intellisphere, LLC: MD Magazine. Retrieved from: https://www.mdmag.com/medical-news/hcv-increases-mortality-of-people-with-hiv-despite-antiretroviral-treatment

• Welch, C.M. (2017, August 16). Hepatitis C Treatment and Cirrhosis. Hep Mag. Retrieved from: https://www.hepmag.com/blog/hepatitis-c-treatment-cirrhosis

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.

3rd Annual National Monitoring Report on HIV/HCV Co-Infection

By: Marcus J. Hopkins, Consultant, Community Access National Network

The Community Access National Network (CANN) will be hosting its 3rd Annual National Monitoring Report on HIV/HCV Co-Infection on Wednesday, September 19th, beginning at 2:00 p.m. EST. This annual report provides valuable information on the state of Hepatitis C (HCV) treatment coverage, harm reduction measures to prevent transmission of HIV and HCV, and, new to this year, a brief focus on HIV and HCV testing and treatment for individuals currently incarcerated and post-incarceration.

Returning this year are yours truly (as the Project Director for the HIV/HCV Co-Infection Watch and Medicaid Watch), and Amanda Bowes, Manager on the National Alliance for State and Territorial AIDS Directors’ (NASTAD) Health Care Access Team. New presenters for 2018 include Ayesha Azam, Senior Director of Medical Affairs at the Patient Access Network (PAN) Foundation, and Jack Rollins, Senior Policy Analyst at the National Association of Medicaid Directors.

At last year’s National Monitoring Report, I focused on the increase in coverage options for both the Ryan White and Medicaid programs, showing how treatment options have expanded across the country since 2015 (when the HIV/HCV Co-Infection Watch began). Mrs. Bowes provided more detailed information available about coverage, as well as NASTAD’s efforts to expand coverage for Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) within the nation’s AIDS Drug Assistance Programs (ADAPs).

This year’s event is sponsored by the ADAP Advocacy Association, Gilead Sciences, Merck, Quest Diagnostics, Walgreens, and the Pharmaceutical Research and Manufacturers of America (PhRMA).

The 3rdAnnual National Monitoring Report on HIV/HCV Co-Infection can be attended either in person at PhRMA Headquarters in Washington, DC, or remotely for non-DC residents. Registration is free and can be done online. While registration is free, there is limited seating for those attending in person and advanced registration is required to attend.

Learn more at http://www.tiicann.org/events.html#091918cr.


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.

Linkages to Care During Post-Incarceration

By: Jonathan J. Pena, intern, ADAP Advocacy Association, and rising junior in social work, North Carolina State University

The ADAP Advocacy Association late last year announced its Correctional Health Project, which aims to raise awareness about issues confronting formerly incarcerated populations living with HIV/AIDS (and/or Hepatitis C) who also access care and treatment (or whom could benefit from such care and treatment) under the AIDS Drug Assistance Program ("ADAP"), as well as provide useful resources and tools to the communities serving them. A subsequent blog also focused on the issue. While this approach is an effort to sharpen the scope and need for access to care and treatment for HIV-infection (and/or HCV) among formally incarcerated populations, it is equally important to widen to the lens just for a minute in order to see where we stand globally on the issue of incarceration.

Incarceration rates are highest in the United States out of any country, which translates to 910 per 100,000 adults.[1] When you factor in the 1.2 million people living with HIV in the U.S, a sixth of this population are entering prisons and jails and also transitioning back into their communities.[2] This sets the stage for an enormous request to address the needs of these populations so that the public health system may begin to seal the cracks that they fall through by utilizing accurate assessments and combining it with proactive case management in order to link them to care.

Programs do exist, such as State ADAPs, which are designed to assist these individuals. But the most recent National ADAP Monitoring Project demonstrates that ADAPs are assisting some of these individuals, it is also clear more can be done to assist them. The National AIDS Strategy also provides some guidance to help formerly incarcerated populations achieve viral suppression.

Viral suppression is crucial for HIV-positive ex-offenders during post-incarceration but the challenges that they face can seem monstrous and when faced with so many immediate competing needs like housing, food and transportation, continuity of viral suppression may fall by the waste side. Very often the linkage to care is lost for these populations due to poor discharge planning and thus limited access to quality based community programs. As a result the natural onset of vulnerability that is placed on an HIV-positive ex-offender is amplified when re-entering their communities that the possibility for them to engage in risky behavior like drug use, and transactional unprotect sex to maintain goods increases. These negative affects of poor discharge planning not only hurts the ex-offender but also hurts those within their community with other possible new cases of infection if they are not adherent to their medication.

Photo Source: SERO

Download SERO's "Staying Strong Inside"

Jails and prison systems are such dynamic institutions that they face additional compounding challenges to providing heath services other than HIV. With such a revolving door, these institutions have to tackle issues like addiction and mental illness. However, what seems to be alarming is the rate of HCV infections. A team of researchers at the National Drug and Alcohol Research Centre at the University of New South Wales in Sydney pooled together a series of data from 196 countries spanning from 2005 through 2015 that aimed at determining the number of inmates with HIV, hepatitis B virus, hepatitis C virus, and TB. This data indicated that out of 10 million inmates, HCV ranked at the top with 15.1% of infections and with HIV estimated at 3.8% of infections.[3]

As the ADAP Advocacy Association's Correctional Health Project continues to take shape, it is important to convey some of the needs driving our interest behind it. Important community resources will be made available in a few months.

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[1]  The Lancet HIV. (2017, November 27). Predictors of linkage to HIV care and  suppression after release from jails and prison: a retrospective cohort study. Retrieved from: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(17)30209-6/fulltext?code=lancet-site
[2] The Lancet HIV. (2017, November 27). Predictors of linkage to HIV care and  suppression after release from jails and prison: a retrospective cohort study. Retrieved from: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(17)30209-6/fulltext?code=lancet-site
[3] HIVandHepatitis. (2016, September 07). AIDS 2016: Neglect of Infectious Disease in Prisons Highlighted at Conference. Retrieved from: http://www.hivandhepatitis.com/hiv-epidemiology/5845-aids-2016-neglect-of-infectious-disease-in-prisons-highlighted-at-conference

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

HIV/AIDS Fireside Chat Retreat in Tampa Tackles Pressing Issues

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

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Tampa, FL among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS and/or viral hepatitis. The Fireside Chat took place on Thursday, May 17th, and Friday, May 18th. Although there was no fireplace in the room, there was plenty of heat generated by the fiery give-and-take.

Photo Source: Getty Images

The Fireside Chat included a series of three moderated white-board style discussions about the following issues:

• 340B Drug Pricing Program
• Opioid Epidemic & Impact on HIV
• Ryan White Program & Underserved Communities

Each of the white board discussions was facilitated by a recognized content expert followed by an in-depth dialogue among the retreat attendees. The discussions certainly couldn't be characterized as a Kumbaya, since vastly different perspectives were seated in the room. Rather the discussions were designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Fireside Chat.

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

340B Drug Pricing Program:

The discussion on the 340B Drug Pricing Program was facilitated by Jeffrey R. Lewis, President & CEO of the Legacy Health Endowment based in Turlock, CA. Lewis also serves as co-chair of the newly-minted national commission taking a thorough and candid review of the 340B Drug Pricing Program, and making specific recommendations to Congress on how and in what ways the program should be strengthened. The discussion focused on why the program is important to the Ryan White Program and other covered entities, such as hemophiliac clinics and community health centers. Also discussed were the “tough choices” to reform the program, as well as the “opportunities” to expand the program (i.e., Corrections), and why?

The following materials were shared with retreat attendees:

• Overview of the 340B Drug Pricing Program, by the Medicare Payment Advisory Commission (MedPAC)
• Consequences of the 340B Drug Pricing Program, by Sunita Desai, Ph.D., and J. Michael McWilliams, M.D., Ph.D.
• Market Distortions from the 340B Drug Pricing Program, by Adam J. Fein, PhD
• The Ugly Co-Pay Surprise, infographic by the Alliance for Patient Access
• Community Access National Network Tackles Challenges Facing the 340B Drug Pricing Program 

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

Opioid Epidemic & Impact on HIV:

The discussion about the ongoing intersection between the opioid epidemic and HIV was facilitated by David Fawcett PhD, LCSW. It focused on opioids among at-risk populations, but also the growing crystal methamphetamine use. Also discussed were health disparities and access to care, and harm reduction strategies — such as Syringe Exchange Programs ("SEPs") and medication assisted programs.

The following materials were shared with retreat attendees:

• Opioid Fact Sheet, by David Fawcett, Ph.D., LCSW
• Meth, the Other Epidemic, Poses a Real Risk for HIV, by Dr. David Fawcett
• Body & Soul: Combatting the Dual Epidemic of HIV-Infection and Substance Abuse, webinar with Dr. David Fawcett)

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

Ryan White Program & Underserved Communities (i.e., women, LGBT, formerly incarcerated, undocumented immigrants, etc.):

The discussion about underserved communities served (or potentially served) by the Ryan White Program was facilitated by Jeffrey S. Crowley, Program Director at the O'Neill Institute for National and Global Health Law, Georgetown University Law Center. It focused on the existing structure of the Ryan White Program and the program's essential roles, as well as evidence for the program’s success. Important questions raised included what are structural changes that could help the program to seize current or future opportunities to increase engagement in care and viral suppression, and should the program consider new roles (i.e. financing and delivering PrEP or financing HCV treatment for mono-infected individuals), among others.

The following materials were shared with retreat attendees:

• Protecting and Advancing HIV Public Health Gains During Health System Reform, by Jeffrey S. Crowley, Sean Bland, and Connie Garner
• HIV Prevention: Assessing Our Progress and Charting a Future Direction, by Jeffrey S. Crowley and Sean E. Bland
• Healthcare Coverage for HIV Provider Visits Before and After Implementation of the Affordable Care Act, Barry SA et al
• Affordable Care Act Qualified Health Plan Coverage: Association With Improved HIV Viral Suppression for AIDS Drug Assistance Program Clients in a Medicaid Nonexpansion State, by McManus KA et al
• Editorial Commentary: Affordable Care Act, Medicaid Expansion … or Not: Ryan White Care Act Remains Essential for Access and Equity, by Eaton EF and Mugavero MJ

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

Additional Fireside Chats are planned in 2018.

Infographics Serve as Powerful HIV Advocacy Tools

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

"Infographics are a powerful way of communicating information since they combine data and visual images – left brain and right brain – thereby making it easier to digest, remember and share information."[1]

Infographics are widely recognized as an important and powerful educational tool. In fact, online marketing has increasingly become saturated with infographics on a wide array of topics, including public health. Countless books, periodicals and blogs have been dedicated to this subject. According to the Wharton School of Business, infographics are more engaging and convincing because "presenters who used visual language were perceived by audiences as more effective than those not using visuals."[2] Thus, infographics can also serve as powerful HIV advocacy tools.

Photo Source: missdetails.com

AIDSinfo has made available an online library for their infographics. They include infographics on treatment options, prevention strategies, and general information about living with HIV.

HIV advocates would be well-served to leverage these infographics (and others) as visual advocacy tools, especially when meeting with policymakers at the federal, state and local levels. Infographics are an excellent way to condense a complex issue into a simple message. The ADAP Advocacy Association, in fact, has published numerous infographics and made them available to stakeholders. In April 2017, an infographic on transgender health was published on Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program.

The Centers for Disease Control & Prevention ("CDC") also offers many HIV-related infographics. CDC infographics and posters include various topics related to HIV including African Americans, Continuum of Care, Gay and Bisexual Men, HIV Testing, Latinos, Pre-Exposure Prophylaxis ("PrEP"), Women, and Youth. The AIDS Education & Training Center Program ("AETCP") has an robust library of these visual presentations on their website.

Last year, two powerful infographics complemented the 2017 National ADAP Monitoring Report when it was released by the National Alliance of State & Territorial AIDS Directors ("NASTAD"). One infographic, Key Characteristics of Ten ADAPs With Highest Rates of Viral Suppression, gives an analysis on ADAPs with the highest rates of viral suppression. The other one, Ryan White Part B and ADAP Partnership to Bolster Health Outcomes, gives an analysis on the Ryan White Part B and ADAP partnership. Anyone who has read NASTAD's annual report know how much data is shared in it, so these infographics provide an amazing snapshot.

Increasingly viral hepatitis is an emerging issue, as more people living with HIV/AIDS are also co-infected with Hepatitis C ("HCV"). The Community Access National Network ("CANN") has used infographics to tackle complex issues surrounding HCV. Among them are their infographics on HCV and Health Law In U.S. Incarceration Settings (2017), and Hepatitis C Therapies Covered by the AIDS Drug Assistance Programs (2015).

Effective grassroots communication and lobbying by HIV advocates can help to influence a position or outcome on a particular issue. Being sensitive to time constraints of policymakers is important, which makes using infographics even more important. The advocates who get the most value from infographics are those that see them as part of a wider strategy to support grassroots efforts at the federal, state, and local levels.

Photo Source: Ragan.com

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[1] Aleksejeva, Nika (2015, September 6). The Power of Infographics: Why, What and How. Infogram. Retrieved from https://infogram.com/blog/the-power-of-infographics-why-what-and-how/.
[2] Long, Jonathan (2014, September 23). The Power of Visual Content [Infographic]. Market Domination Media®. Retrieved from https://www.marketdominationmedia.com/power-visual-content-infographic/.

ADAP Open Drug Formulary Programs Improve Access to Care & Treatment; So why are there so few?

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

Each State AIDS Drug Assistance Program ("ADAP") is unique in that "it decides which medications will be included in its drug formulary, and how those medications will be distributed to eligible consumers."[1] It clearly presents a conundrum between payers and consumers. Ask any payer of health benefits, and controlling costs is probably paramount to them. Ask any consumer of health benefits, and most important is the unrestricted access to all the supports, services and/or therapies that should be afforded to them. Therein is the divide between closed and open drug formulary programs, including ADAP.

(Editor's Note: This blog is not intended to be an endorsement of any product made by any pharmaceutical company but rather acknowledge the unique health needs experienced by people living with HIV/AIDS, as they attempt to access care and treatment that is appropriate, culturally competent, and timely)

Photo Source: COMP Blog

In March 2015, Managed Healthcare Executive published an article, Closed formularies hold the line on costs, which accurately summed up the challenges faced by health plans. Though health plans are quite different from State AIDS Drug Assistance Programs, in general, they nonetheless do share an important thing in common. They often employ cost containment strategies in an effort to not only control costs, but also ensure plan sustainability. It provides little comfort, however, for consumers living with chronic health conditions, such as HIV/AIDS, who require access to numerous drug therapies.

According to the National Alliance of State & Territorial AIDS Directors ("NASTAD"), only approximately one in five (1:5) ADAPs employ an open drug formulary program. The Online AIDS Drug Assistance Program Formulary Database (2018 version) reports the following states offer open drug formularies: Illinois, Iowa, Massachusetts, Minnesota, Nebraska, New Hampshire, New Jersey, Ohio, Oregon, and Washington State. Only Washington State reports no drug exclusions under its open drug formulary program.[2]

To be fair, ADAPs aren't unique in this area. ADAPs mirror private health plans (and many other public health plans) in that they have closed drug formularies. Yet, open drug formulary programs are advantageous to consumers because they provide additional coverage for medications. So why are there so few?

The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) dictates that "each ADAP must cover at least one drug from each class of HIV antiretroviral medications ("ARVs") on their ADAP formulary. RWHAP funds may only be used to purchase FDA-approved medications."[3] Otherwise, State ADAPs are pretty much left to their own fruition on which ARVs to include on their formularies, as well as non-ARV medications to treat other conditions and medication side effects.

Eddie Hamilton, founder of the Ohio-based ADAP Educational Initiative, summarized his support for open drug formulary programs:

“One of the leading barriers to care is the lack of access to the non-ARV medications for various reasons, such as co-pays or non-covered medications. Open formularies enhance ARV regimen compliance as it enables people living with HIV/AIDS to deal with the various side effects and co-morbidities associated with HIV. While the Ryan White program covers mostly HIV related services, it is counter-intuitive to fix only one medical issue while leaving other potential life threatening medical issues that would be preventable on the table. One may have a undetectable viral load but succumb to a heart attack because of the lack of access to a statin!”

It is disheartening when people living with HIV/AIDS are denied access to numerous non-ARV medications, especially when the medications could treat a litany of other health-related conditions. Some of the conditions commonly identified by consumers are lipodystrophy, diarrhea, hormone therapy, and co-infection with Hepatitis C ("HCV").

For example, HIV-related lipodystrophy remains an important health issue confronted by consumers yet often it is characterized by payers as cosmetic. Research has shown that between 20% and 30% of HIV-positive patients are experiencing excess visceral adipose tissue ("VAT"). For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments — something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

An ADAP Blog posted in late 2016 highlighted the success by Massachusetts in expanding treatment options for people living with HIV-associated lipodystrophy. The Treat Lipodystrophy Coalition fought tirelessly for the law to require insurance coverage for treatment of a debilitating and disfiguring side effect of HIV medications. Patients living with HIV-associated lipodystrophy are now demanding the same is done with public payers, such as ADAP and Medicaid.[4]

Photo Source: Treat Lipodystrophy Coalition

Carl Sciortino, executive director for the AIDS Action Committee, and former representative in the Massachusetts Legislature who introduced the aforementioned legislation, then summarized the effort to expand treatment access: "Some of our long-term survivors carrying the physical scars of earlier life-saving treatments have been denied the dignity and medical treatment they are entitled to for far too long. Lipodystrophy affects our veterans, and as a country we have effectively turned our backs on their need to treat their epidemic-inflicted wounds. I'm proud of our step forward in providing insurance coverage in Massachusetts, and I'm grateful for any interest it sparks in providing care to people living with HIV across the country."[5]

Tesamorelin (common brand name: Egrifta) is the only FDA-approved therapy to combat HIV-related lipodystrophy. Yet, as of December 31, 2017, only 11 ADAPs reported that they do include Tesamorelin on their drug formularies, including: Colorado, District of Columbia, Illinois, Louisiana, Massachusetts, New Hampshire, New Jersey, North Carolina, North Dakota, South Carolina, and Washington. Thanks to the ADAP Crisis Task Force, that soon could be changing after a discounted drug pricing agreement for ADAPs was reached with the drug's manufacturer.

One of the most common side effects causing angst for people living with HIV/AIDS is diarrhea. It is a widely held opinion that HIV-related diarrhea is a thing of the past with the advent of the newer ARVs. The "runs" impact long-term survivors quite often, according to a patient survey released in December 2017.[6]

Josh Robbins, Founder of the HIV Scoop, isn't known for being shy, and as such he become a vocal spokesman on how this common HIV-related side effect personally impacted his life. His advocacy on the issue has given hope to others like him. Robbins characterized the struggle as follows:

“Before I found the drug to help normalize my gastro issues related to living with HIV, I was at a crossroads with HIV treatment. Everyone preached the importance of adherence to ARVs and staying in care, but I was exhausted of the process because of diarrhea and me not finding relief from it or support medically. When I saw the information on the drug, I knew I wanted to give it a try. What could I lose as I tried everything else? After starting it, there wasn’t a magic moment that I knew it was working for me—but I did notice that I didn’t dread taking my ARVs anymore and I stopped missing doses because they made me feel bloated and the diarrhea was brutal. All of that slowed down to where I don’t even think about it anymore. Can I give all the credit to this drug? Maybe not, but I can say that I finally feel normal in my stomach, I don’t spend tons of time in the bathroom anymore, and I’m finally adherent to my HIV meds. At least for me, this drug makes my journey living undetectable possible, because it normalized my gastro issues. So, yea, this drug changed my journey living with HIV.”

The medication in reference is Mytesi. Unfortunately, currently only 22 State ADAP drug formulary programs cover Mytesi, and as such people living with HIV/AIDS suffering from diarrhea are forced to rely on less potent over-the-counter therapies. These therapies often provide little or no relief. Once again, thanks to the ADAP Crisis Task Force, that soon could be changing after a discounted drug pricing agreement for ADAPs was reached with the drug's manufacturer.[7]

Evidence suggests that HIV-infections disproportionately impact the transgender communities.[8] In its recent issue brief on transgender health, NASTAD acknowledged the need to adopt a holistic approach to providing health services to this underserved population. The issue brief reads, in part, "...it is imperative that ADAPs ensure that their interventions are informed by a robust understanding of the unique personal, societal, and structural barriers that impede access to care and treatment for transgender people."[9]

The Centers for Disease Control & Prevention (CDC) has documented the unique needs set facing the transgender communities in the United States. CDC data suggests there is a need for gender-variant, culturally competent awareness and guidelines designed to better serve this underserved community enrolled in public health programs, as well as those persons eligible, but not enrolled (including ADAP).[10]

The CDC concluded, “Insensitivity to transgender identity can be a barrier for those who are diagnosed with HIV and seek quality treatment and care services. Research shows transgender women with diagnosed HIV infection are less likely to be on antiretroviral therapy (ART) or achieve viral suppression. Furthermore, few health care providers receive adequate training or are knowledgeable about transgender health issues and their unique needs.”[11]

Furthermore, NASTAD echoed this concern in its issue brief, making a compelling case for open drug formulary programs that are more liberalized to serve transgender consumers: "ADAP formulary composition presents another opportunity to promote trans- inclusive care and treatment. Beyond the provision of ARVs, ADAPs play a critical role in supporting the availability of medications for many co-occurring needs of PLWH, including transgender transition-related medications."[12]

As of December 31, 2015, unfortunately only 16 ADAPs covered one or more FDA-approved transgender transition-related medications on their formulary.[13]

According to Marcus J. Hopkins, Project Director of the Community Access National Network's HIV/HCV Co-Infection Watch, there are 43 State ADAPs offering some form of coverage for HCV treatment. Of those programs, 36 have expanded their HCV coverage to include the regimens that serve as the current Standard of Care (SOC) for Hepatitis C treatment. Eight (8) programs offer only Basic Coverage and 13 programs offer No Coverage. Three (3) territories – American Samoa, Marshall Islands, and Northern Mariana Islands – are not accounted for in this data.

HCV is a common co-infection in people with HIV/AIDS. An estimated 200,000-300,000 people in the United States are co-infected with both HIV and HCV infections. Experts believe that about 25% of Americans with HIV also have HCV; conversely some 10% of people with HCV are thought to also have HIV.

In most states, people living with HIV/AIDS are well served by their ADAP but that doesn't mean consumers should settle on the status quo. According to Jen Laws, an independent policy consultant and an ADAP Advocacy Association board member, expanding the efficacy of the State AIDS Drug Assistance Programs requires both modernization in systems and expansive formularies to meet the health needs of target populations; from heart disease and diabetes to gender confirming hormone replacement therapies, ADAPs can help us close the gaps in care clients face else where and realize the true potential of the programs in working to end HIV.

Laws argued, "Today, we understand comprehensive approaches to chronic health needs result in greater client adherence and positive overall health outcomes, directly impacting efficacy of HIV specific treatment. We know meeting target population health needs is a necessary step in combating the epidemic, especially in an environment where these same populations are unlikely to get their health needs met in traditional markets. In the age of treatment as prevention, ADAPs have a unique opportunity to function at the corner of both prevention and patient care."

Related articles of potential interest:

• Don't Take VAT, sponsored by Theratechnologies
• Keep Your Pants On, sponsored by Napo Pharmaceuticals
• Talking to your Doctor About Symptoms, online survey of patients living with HIV conducted Oct 25-Nov 6, 2017, sponsored by Napo Pharmaceuticals
• TRANSGENDER HEALTH: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program: Model Policy for Ryan White/ADAPs Serving Transgender Clients, published in April 2017 by the ADAP Advocacy Association
• INFOGRAPHIC: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS under the AIDS Drug Assistance Program, published in April 2017 by the ADAP Advocacy Association
• CROSSROADS: ADAP CONSIDERATIONS FOR TRANSGENDER HEALTH, published in August 2016 by the National Alliance of State & Territorial AIDS Directors
• HIV/HCV Co-Infection Watch – March 2018, published in March 2018 by the Community Access National Network

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[1] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from https://hab.hrsa.gov/about-ryan-white-hivaids-program/part-b-aids-drug-assistance-program.
[2] National Alliance of State & Territorial AIDS Directors (2018, February 1); 2018 ADAP Formulary Database; National Alliance of State & Territorial AIDS Directors (NASTAD). Retrieved from https://www.nastad.org/adap-formulary-database.
[3] Health Resources & Services Administration (2017, October). Part B: AIDS Drug Assistance Program. U.S. Department of Health & Human Services. Retrieved from https://hab.hrsa.gov/about-ryan-white-hivaids-program/part-b-aids-drug-assistance-program.
[4] Macsata, Brandon M. (2016, October 28). ADAP Blog. Why HIV Medical Treatment Guidelines Matter. ADAP Advocacy Association. Retrieved from http://adapadvocacyassociation.blogspot.com/2016/10/why-hiv-medical-treatment-guidelines.html.
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