Thursday, August 27, 2020

An America on the Precipice of a COVID-19 Disaster

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor

For those of us who grew up in the 1980s and ‘90s, one of the biggest concerns about having sex was the fear of contracting HIV. But, it wasn’t just having sex we were afraid of, in the beginning – it was pretty much every activity.

In the beginning years, we didn’t really know how it was contracted. Was it airborne? If we didn’t wear masks and essentially biohazard suits in hospital rooms, were we going to get it and end up just like “them” – the “others” who fell victim to the devastation of the AIDS epidemic sweeping across the country and taking no prisoners?

We didn’t know not know how it was spread; we didn’t know how to treat it. Every other week, we heard rumors of a cure; of some expensive treatment in Mexico, or Brazil, or Germany that could cure AIDS, but the U.S. government just didn’t want us to know. Desperate people weren’t given hope; they were given expiration dates.

I was just a kid, growing up in the middle of the HIV epidemic of the 1980s and ‘90s, and, to this day, I remember being terrified of the images we saw on television and in every magazine. Worse still, I remember being pissed off at the thought that our federal government sat back and did virtually nothing; said virtually nothing. Although AIDS was identified in 1981 (at GRID – Gay-Related Immune Deficiency), then-President Ronald Reagan never publicly mentioned the word until a press conference in September 1985, a full four years too late, and many dollars too short.

When the COVID-19 pandemic first made its way to the United States, people who had lived through the AIDS epidemic of the ‘80s and ‘90s began making comparisons between HIV and COVID-19. Those comments were almost immediately shouted down by those who were offended by the comparison, insisting that it made light of people living with HIV. Those of us who saw and commented on the parallels were castigated for our poor taste and lack of empathy.

Donald J. Trump
Photo Source: IBTimes UK

Turns out, we were right.

The spread of the COVID-19 pandemic throughout the U.S. mirrors that of the HIV epidemic in many ways:

  • We were, and still are, plagued (as it were) by uncertainty about how the disease is spread, contained, and treated; 
  • A certain segment of Americans is pinning the blame on a vulnerable minority population for “causing” or “creating” the disease, and discriminating and, at times, literally bashing people whom they blame for bringing it here (read: “China Virus” or “Wuhan Flu”);
  • We have a White House occupant who is neither willing, nor able to admit the severity of the pandemic, and is focused more on his own venality and “ratings” than on the lives of the Americans he was stupidly elected to represent;
  • We have an endless supply of snake oil salesmen peddling fake cures, fake preventative devices, and frankly shitty “medical” advice to a population that is both frightened, and super-credulous;
  • We have a patchwork approach to dealing with the virus, in no small part because we have all but gutted our public health systems in none-urban areas;
  • We have an overworked, underpaid, and increasingly frustrated and disheartened frontline medical staff that hasn’t seen a break since March, and gets to watch idiots wander around in public without masks, like nothing is going to happen to them;

The similarities between the two epidemics exists in no small part because, as with the HIV epidemic, our federal government has been led to failure by an incompetent administration, hellbent on hamstringing medical professionals and proffering false hope of a quick turnaround, optimism that we’re turning a corner, and outright lies, when what the American people need is honesty, instead of a lying carnival barker.

It isn’t just HIV survivors who see these parallels – epidemiologists have recognized this pattern of failure in America’s healthcare system and governance:

"If you put a map of the HIV epidemic over a map of the worst coronavirus hotspots, they look almost identical,” said Jared Baeten, the vice dean of the University of Washington’s School of Public Health and an HIV epidemiologist for more than a decade. “COVID is becoming just another disease that travels along the fault lines of the disparities in our society. (Hobbes, 2020)

A lot of HIV researchers are exasperated,” said Greg Millett, the vice president and director of public policy for amfAR, the Foundation for AIDS Research. “We’re old enough to have lived through the HIV response, and we’re watching the same mistakes taking place with COVID. (Hobbes, 2020)"

It’s no accident that the most trusted man in America – at least, trusted by intelligent Americans – is Dr. Anthony Fauci, one of the preeminent researchers and doctors of the HIV epidemic. He has long been honored as a beacon of integrity and leadership throughout the course of the HIV/AIDS epidemic.

Face consisting of the 50 states wearing mask
Photo Source: homelandprepnews.com

For those of us old enough to remember watching friends and loved ones die of HIV/AIDS, watching the same mistakes being repeated, only with greater incompetence and with a brazen refusal to do what’s necessary and right, is traumatic. One of the first casualties I knew personally was someone whose adult life was dedicated to serving people living with HIV:

Garry Bowie, with whom I collaborated for the Long Beach AIDS Foundation, in Long Beach, CA, passed away in the early months of the pandemic. He was a man in whom I found a trusted confidante, and his husband, Jeff Wacha, has been soldiering on as best he can.

After Garry’s passing, I wept for the first time since my partner and I separated. I can’t imagine what Jeff is experiencing, and worse, still, how infuriated he must be to watch idiots wandering around without masks, like their lives aren’t literally on the line.

So, yes – the HIV and COVID-19 epidemics share many similarities, and to anyone who says that I, as someone living with AIDS, shouldn’t say that, because it’s insensitive, I invite them to shut the hell up and pay better attention.

References:

  • Hobbes, M. (2020, August 11). Will America Let COVID-19 Become The Next HIV? Huffington Post. https://www.huffpost.com/entry/will-america-let-covid-19-become-next-hiv_n_5f31ad0ec5b6960c066af7d1?ncid=engmodushpmg00000004

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. 

Thursday, August 20, 2020

COVID-19 Essential Patient Resource: Pharmacists

By: Glen Pietrandoni, RPh, AAHIVP, VP Industry Relations, AVITA Pharmacy

Pharmacists have been on the front line of the COVID-19 response to ensure patients remain safe and continue to receive essential medicines on time. Pharmacists are the most easily accessible healthcare professionals in the community. No appointments are necessary, and pharmacists don’t charge to speak with them!

Man consults with pharmacist

Since the pandemic began, pharmacists have spent a lot of time educating people about COVID-19, and reinforcing messaging about how to reduce the spread, social distancing, hand washing, masks, etc. This is especially important where some may think they don't have to worry about the virus, or if it is not yet present in their community. Let’s face it, there’s a lot of mixed messages around the country. Pharmacists can help provide trusted information to help you and your family, absent of political views or stigma.

Forty years of helping people thrive within the context of HIV treatment and prevention gives pharmacists and patients an advantage today as we have learned how to care for each other during difficult times in the past. Most importantly, the need to continue a high rate of adherence to medication does not change because of this disruption in our daily routine due to the coronavirus. We are all champions for U=U. To stay undetectable during a pandemic of this new virus, we cannot let up on being adherent to the drugs for the old virus. YOU CAN DO THIS, and pharmacists can help.

I have often written and spoken about the importance of having a relationship with your pharmacist and pharmacy staff. That could be as simple as making a point of engaging in a simple conversation, for instance, asking their name, or asking if you can ask questions from time to time.  I’ve mentioned in the past that it’s more common to know the name of the person that cuts your hair or the barista at Starbucks, than to know the name of your pharmacist. If the pharmacy you are using pushes back or doesn’t make that easy for you, then you might want to consider looking for a pharmacy/pharmacist that understands HIV and YOU. You deserve that courtesy!

Let’s talk about how pharmacist can help you during the COVID-19 pandemic and beyond.

Pharmacists wearing COVID-19 masks

Pharmacies have remained open during the outbreak

You may need to check if the operating hours have changed, but pharmacists are considered essential workers and have been eager to accommodate unusual circumstances when possible. Try to plan ahead for refills if possible, as the pharmacies might be busier than usual.  Also, if your insurance or ADAP (AIDS Drug Assistance Program) plans require renewal or recertification, check into this before you are out of medication to avoid delays. Many pharmacists can help you if you have questions. With COVID-19  exceptions are being made to allow grace periods and extensions.

Consider requesting 90-day refills if the insurance coverage or ADAP allows.

Pharmacies often offer delivery options

Pharmacies continue helping people – particularly the most vulnerable – get prescriptions filled online or remotely, and have medications delivered to your home. Check with you pharmacy about options and potential cost of delivery.

By helping you stay healthy

Pharmacists can speak with you regarding your medication questions because they can see your prescriptions from all your providers in one place. Pharmacists can help you at times when you need prescription refills by contacting your doctors for you. During this time, providers are also very busy and difficult to reach. Pharmacists work closely with providers and could save you some time and stress.

Did you know you pharmacist can synchronize your medications to minimize the numbers of trips to the pharmacy or deliveries? Why not get all your medications at one time. That you also help you stay adherent and not run out of medication.  Makes sense! Another part of the pharmacists’ job is to check for drug interactions, monitor for potential adherence challenges and help you manage side effects or adverse reactions. 

Many pharmacies have apps to help people manage their health and medications. These have become more useful during COVID-19, allowing patients to manage medications through alerts for refills and even dosing reminders. We’re all a little more stressed than usual, so it might be worth trying these out.

By helping you save money 

Some people have prescription copays (money due to the pharmacy paid by the patient). It’s a good idea to ask you pharmacist (you know their name now, right?) if they are aware of ways to save money on out-of-pocket costs.

Now that you know your pharmacist’s name, it will be nice to speak to a friendly voice every month or so. In this time of COVID-19, isolation and depression can be a concern for so many people. As a pharmacist myself, I know that building relationships with my patients over time allowed me to check in with them monthly. In that interaction, our relationship provides some comfort and opens the door for questions and conversations. My favorite question to my patients were things like “how’s your dog?”, or “do you have a restaurant recommendation?” In doing this, I get a sense of how my patients were doing emotionally and is an indirect way to check on their well-being. Of course, with coronavirus, it is so important to stay connected, the questions are more directed toward staying safe and taking precautions. Because the relationship exists, this is an easy pivot based on mutual trust.

At this time, we can all use a helping hand and a friendly voice. Pharmacists can be that someone that fits this role during covid and long after.

Click here to download the "Talking to Patients About Access to Medication - A New Resource" published by the Community Access National Network (CANN) and the Partnership for Safe Medicines (PSM).

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.

Thursday, August 13, 2020

Community-Based, Nonprofits Address COVID-19's Impact on Marginalized Communities Living with HIV/AIDS

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

The ADAP Advocacy Association announced earlier this week that it had awarded micro grants to eight community-based, nonprofit organizations working to address the impact of the Coronavirus (COVID-19) on marginalized communities living with HIV/AIDS. The micro grants will assist these organizations raise awareness on the intersection between the global pandemic and HIV/AIDS in the United States.

We have devoted significant resources to providing relevant, timely information on COVID-19 and its impact on people living with HIV/AID since the global pandemic reached the United States. Our COVID-19 Community Grants initiative will continue to do so.

COVID-19

The grantees include:

BGW represents a revolutionary attempt to improve the collective narrative of Black Queer folx. Their mission is to empower, educate and mobilize Black Queer folx by acknowledging, celebrating and affirming their whole selves. BGW believes that Black Queer folx are multifaceted and deserve innovative and meticulously researched approaches when being engaged. They believe that Sexual Health + Higher Education + Access to Resources can drastically improve the trajectory of their lives. BGW — conduct intake of — young Black Queer folx while in High School, College, or Graduate School, assess their needs, aspirations and sexual health awareness and provide them with financial and emotional support. Donate to Black, Gifted & Whole Foundation.
CEG is a 501(c)3 not-for-profit organization working to eliminate disparities in health outcomes and improve public health in disadvantaged populations and under-served communities.  CEG accomplish this by conducting research, training community health workers, educating and testing people who are hard to reach or at risk, sharing our expertise through national networks and local capacity building efforts, and advocating for practical and effective health policies that lead to social change. CEG has offices in both Washington, DC, and Shepherdstown, WV, and has recently partnered with TruEvolution, Inc. (Riverside, CA) to found the Rural Health Service Providers Network which advocates on behalf of organizations providing essential services to clients living in rural America. Donate to Community Education Group.
Founded in the City of Hartford, CT, in 1986, LCS provides culturally responsive care and prevention services to people living with HIV/AIDS and their communities. Beginning it's operations in the height of the HIV/AIDS epidemic,  LCS is the only Latino led organization with it's experience providing direct services to marginalized PLWH and other underrepresented populations of color throughout Hartford, Middlesex and Tolland Counties. Latino Community Services recognizes the challenges posed by COVID-19 and the impact that the virus has had worldwide. Throughout these challenging times, they remain committed to their clients and the public as they continue to adapt and evolve throughout the outbreak and recovery phases. Donate to Latino Community Services.  
Let's Kick ASS — AIDS Survivor Syndrome has been empowering HIV Long-Term Survivors to thrive since 2013. They are an all-volunteer, grassroots movement, united in compassion, committed to action, and insisting on visibility. Let's Kick ASS started by and for people living longest with HIV/AIDS to address an unmet need — addressing the present-day psychosocial ramifications of living in the aftermath of the early AIDS pandemic. They are the originator and lead sponsor of the June 5th "HIV Long-Term Survivors Awareness Day" #HLTSAD. Donate to Let's Kick ASS — AIDS Survivor Syndrome.
RAD Remedy is a national grassroots organization dedicated to connecting trans, gender non-conforming, intersex, and queer (TGIQ) folks to accurate, safe, respectful, and comprehensive care. The Referral Aggregator Database (RAD) is a comprehensive and nationally-collaborative database that combines the referral lists of trusted community organizations and the detailed reviews of TGIQ clients. In addition to the organization's database activities, RAD Remedy provides community-informed policy and practice guidance and consulting to organizations, agencies, and individual providers looking to help TGIQ communities thrive. Donate to RAD Remedy.
RAHMA addresses HIV, AIDS, Female Genital Mutilation/Cutting (FGM/C), Sexual Health and Gender-Based Violence (GBV) in faith communities through education, advocacy, and empowerment. Their programs include a retreat for HIV+ Muslims and their allies, sexual health & HIV trainings and development og a virtual FGM/C toolkit for survivors and health care providers, created in collaboration with the George Washington University, Milken School of Public Health hosted at https://fgmtoolkit.gwu.edu. RAHMA is also the founder of National Faith HIV & AIDS Awareness Day, which unites Muslim, Christian, Jewish, Buddhist, Sikh, Hindu and Baha'i faiths to take a stand against stigma in their congregations and raise awareness on HIV and AIDS. Donate to Reaching All HIV+ Muslims in America.
SAYA is an empowerment focused intimate partner violence prevention and intervention non-profit organization in Miami, FL. SAYA's programming includes direct assistance like escape planning and protective order assistance, as well as policy advocacy campaigns, referral for support services, and linkage to care and victim services navigation. SAYA currently relies on a word-of-mouth model in order to ensure the safety of our clients. Through the COVID pandemic, SAYA has also partnered with Panera Bread end night donations to provide to IPV survivors facing homelessness or the risk of homeless. Donate to Simply Amazing You Are.

SBPAN is a non-profit 501(c)(3) organization that was created in 2018 to improve health, social, and economic conditions facing Black communities living in the U.S. South. SBPAN's mission is to improve health outcomes and reduce social, and economic disparities impacting Black communities living in the U.S. South through training, education, advocacy and mobilization. SBPAN is committed to building and strengthening programs and partnerships focused on improving the health and quality of life for diverse populations of Black southern communities in the U.S., specifically those living at the intersection of marginalized Black communities including, but not limited to those who are same gender loving (SGL), lesbian, gay, bisexual, transgender (LGBT), youth, women, and persons over the age of 55. Donate to Southern Black Policy and Advocacy Network.

The ADAP Advocacy Association will work with these grantees to disseminate relevant information to community stakeholders over the few months. 

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.

Thursday, August 6, 2020

HIV & Diabetes

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Diabetes is a disease all too familiar in the United States. Those who are of older age, have family history of the disease, and are overweight are at high risk of developing either Type 1 or Type 2 diabetes at some point in their lifetime. One risk factor that is not spoken on is the risk HIV positive persons being more likely to have Type 2 diabetes. 

Statistics released by the U.S Department of Health and Human Services ("HHS") recommend those living with HIV should have blood glucose levels checked before starting treatment with HIV medications, as some may need to avoid certain medications if they have higher blood glucose levels.

Diabetes
Photo Source: extremetech.com

While people living with HIV/AIDS are at a higher risk of developing Type 2 diabetes, it can be prevented and managed properly. HHS recommends maintaining a healthy weight, eating healthy and adding physical activity to one’s daily routine. However, for HIV-positive patients who already have diabetes, finding proper medications for HIV that work alongside diabetes medication can be difficult. 

“As antiretroviral therapy is now recommended for all patients regardless of CD4 T lymphocyte (CD4) cell count, and because therapy must be continued indefinitely, the focus of patient management has evolved from identifying and managing early antiretroviral-related toxicities to individualizing therapy to avoid long-term adverse effects, including diabetes and other metabolic complications, atherosclerotic cardiovascular disease, kidney dysfunction, bone loss, and weight gain,” HSS said on its website. 

Predisposed conditions also put individuals at risk of adverse effects of ARV medications for HIV: these include underlying liver disease, viral hepatitis, psychiatric disorders and genetic factors. Finding an effective regimen for HIV that works alongside other medications is a tricky business, according to the HHS.

“Switching a patient from an effective ARV agent or regimen to a new agent or regimen must be done carefully and only when the potential benefits of the change outweigh the potential risks of altering treatment. The fundamental principle of regimen switching is to maintain viral suppression,” HHS said. (HHS, 2019)

In 2018, a cross sectional study looking at people living with HIV/AIDS in London was held to determine prevalence and risk factors for type two diabetes. Alastair Duncan and his colleagues discovered that the prevalence of Type 2 diabetes was alarmingly high. One in three patients had pre-diabetes or Type 2 diabetes. (Duncan, A., Goff, L., & Peters, B.)

“The duration of HIV infection, ARV treatment and particularly the use of metabolically toxic ARVs, weight gain following initiation of ARVs, and the presence of lipodystrophy are all significantly associated with an increased risk of dysglycaemia,” Duncan said.

This high prevalence of Type 2 diabetes in HIV-positive patients requires improved screening targeted to older patients, according to Duncan’s study. Antiretrovirals cause weight gain, which can in turn greatly increase the chance of developing Type 2 diabetes. (NIH, 2019).

People living with HIV/AIDS who are concerned about the chance of developing diabetes should speak to their primary care provider about solutions and new medications to look at. 

References:
  • Duncan, A., Goff, L., & Peters, B. (2018, March 12). Type 2 diabetes prevalence and its risk factors in HIV: A cross-sectional study. Retrieved July 29, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5847234/
  • Adverse Effects of ARV Limitations to Treatment Safety and Efficacy Adult and Adolescent ARV. (2019, December 18). Retrieved July 29, 2020, from https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/31/adverse-effects-of-arv
  • HIV and Diabetes Understanding HIV/AIDS. (2019, October 18). Retrieved July 29, 2020, from https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/22/59/hiv-and-diabetes
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.

Thursday, July 30, 2020

NASTAD Releases 2020 Monitoring Project Annual Report

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor

In early June 2020, the National Alliance of State and Territorial AIDS Directors (NASTAD) released its “2020 National RWHAP Part B and ADAP Monitoring Project Annual Report”, and within, unveiled some interesting statistics.


In Calendar Year (CY) 2018, the Ryan White HIV/AIDS Program (RWHAP) provided service to 283,480 clients. This represents 26% of the estimated 1.1 million people estimated to be living with HIV in the U.S. (NASTAD, 2020). This represented a 16% increase from the 245,245 clients served in CY2017.  By comparison, in 2018, Medicaid was the largest source of coverage for adults living with HIV in the U.S., covering 40% of People Living with HIV (PLWH) (Dawson & Kates, 2020).

A more interesting revelation is how those clients are access healthcare via the RWHAP’s AIDS Drug Assistance Program (ADAP). Of the 242,727 clients who received services via ADAP in CY2018, 54% of them did so using insurance (either public, or private insurance for which the ADAP program paid premium(s), deductibles, and/or cost-sharing/co-payments), whereas 46% benefited from the full-pay prescription program, only (NASTAD, 2020).

Addition interesting info are as follows:

RYHAP Part B:
  • Among RWHAP Part B clients served during calendar year 2018, 49% had incomes less than 100% of the federal poverty level (FPL) whereas 12% of the general population were living at or below the FPL. By comparison, 53% of RWHAP Part B clients were reported as having incomes below 100% FPL in calendar year 2017.
  • RWHAP Part B clients were also more likely to be people of color (57% vs. 23%), with the majority 82% of clients of color reported as Black/African American.
  • By ethnicity, 21% of RWHAP Part B clients were reported as Hispanic/Latinx (vs. 18% in the general population).
  • The majority of clients served identified as male (72%) whereas 26% were identified as female. Comparatively, 49% and 51% of the U.S. population in 2018 were reported as male and female, respectively. This difference is reflective of the disproportionate prevalence of HIV among men nationally; 76% of all adult PLWH in 2017 were male.
  • One percent of RWHAP Part B clients were reported as transgender in CY2018, 86% of whom identified as trans women, 3% as trans men, and 10% as transgender - other.
ADAP:
  • Forty percent of ADAP clients served in CY2018 had incomes below 100% FPL, 13% less than those served by RWHAP Part B (53%).
  • In 2017, 40% of all RWHAP clients were enrolled in Medicaid.
  • 44% of ADAP clients were reported as people of color – slightly less than the 57% of RWHAP Part B clients.
  • A greater proportion of ADAP clients (89%) were Black/African American, compared to 82% of RWHAP Part B clients.
  • 27% were of Hispanic/Latinx ethnicity (vs. 21% among RWHAP Part B clients).
  • By gender, ADAP clients were more likely to be male than those PLWH served by RWHAP Part B; 77% of ADAP clients were reported as male, 21% as female, and 1% as transgender.
  • Among transgender ADAP clients, 84% were reported as trans women, 3% as trans men, and 13% as transgender – other.
It is clear, from NASTAD's reporting, that the Ryan White HIV/AIDS Program continues to serve a vital role in ensuring that PLWH in the U.S. continue to have access to the essential healthcare and medication coverage and services necessary to reach viral suppression and the elimination of HIV in the United States. The report can be downloaded online at https://www.nastad.org/PartBADAPreport.

References:
  • Dawson, L. & Kates, J. (2020, July 09). Insurance Coverage and Viral Suppression Among People with HIV in the United States, 2015-2018. 4. Washington, DC: Kaiser Family Foundation: Charts & Slides. https://www.kff.org/slideshow/insurance-coverage-and-viral-suppression-among-people-with-hiv-in-the-united-states-2015-2018/
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.

Thursday, July 23, 2020

Is Long-Lasting, Injectable Medication the Future of HIV Therapy?

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Long-lasting medication to treat patients living with HIV/AIDS has been a goal of the medical field since the early days of the epidemic. Currently, most HIV therapies include daily medication involving multiple pills, which has proven to be expensive for the average patient, as well as potentially challenging for medication adherence. That could be changing, because an investigational, long-acting, injectable, 2-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV is showing promise.

At the 2020 Conference on Retroviruses and Opportunistic Infections, ViiV Healthcare announced results from its 96-week global phase III FLAIR study. The results demonstrated the injectable therapy "continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC)." Also, compared to their previous, oral treatment, patients who participated in the study expressed a high level of treatment satisfaction at week 48, as well as week 96 (ViiV Healthcare).

Cabotegravir
Photo Source: Christian Today

"Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV," said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.

"Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future," said Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London (ViiV Healthcare).

The use of cabotegravir has implications broader than HIV therapy, too. Injectable cabotegravir is also being evaluated for pre-exposure prophylaxis (PrEP). Whereas the aforementioned news of cabotegravir’s (in combination with and rilpivirine) initial effectiveness in treating patients is new to celebrate, questions still remain as it relates to its use in HIV prevention - one being its effectiveness in women living with HIV.

As it relates to PrEP, Molly Walker wrote in MedPage Today on May 19 that she worries this drug will be approved for only one HIV positive population.

"While results for the long-acting HIV prevention medication cabotegravir are promising in men who have sex with men (MSM), there is still no data on this drug in women, begging the question of whether this will be another HIV prevention option that ends up being approved for only one population," said Walker (MedPage Today).

Mitchell Warren is executive director of AVAC: Global Advocacy for HIV Prevention. He described the experience with another drug, F/TAF as 'completely dropping the ball early on in the process'. According to Walker, the experience with cabotegravir is not similar to F/TAF.

Thousands of women are getting cabotegravir injections and the same data safety monitoring board oversees both studies," he noted, adding HPTN 083 data has not been fully analyzed and yet to be peer reviewed. "It's still a long way from submission to the FDA and other regulators," said Warren.

Unlike F/TAF trials, the test trials for cabotegravir is almost 'fully enrolled' among women, which is promising. Warren also noted that if cabotegravir is effective in HIV positive women or at-risk women, it could be good news to those who still carry the social stigma of taking multiple pills a day.

"While PrEP has been "normalized" in the gay community, he added, the idea of carrying "a large pill bottle" still imparts a great deal of stigma for at-risk women," Warren said.

Warren emphasized that having more options with HIV medications is helpful to those around the world, citing that many women are comfortable getting injections every 3 months for contraception.

Cabotegravir is still in the testing stages, but the initial results of effectiveness in trail patients has been positive. The hope is that this new drug will be effective for both men and women, while also lessening the social stigma of taking large dosages of pills to treat and prevent HIV.

References:
  • ViiV Healthcare (2020, March 9). ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting injectable treatment regimen in adults living with HIV-1. Retrieved from https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-presents-positive-long-term-data-from-phase-iii-/#:~:text=Cabotegravir%20is%20being%20developed%20by,prior%20to%20long%2Dacting%20injection
  • Walker, Molly (2020, May 19). HIV Injectable Tx May Work in Men -- But What About Women? MedPage Today. Retrieved from https://www.medpagetoday.com/hivaids/hivaids/86580.
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.

Thursday, July 16, 2020

CMS Co-Pay Accumulator Rule Aims to Increase Consumer Costs

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor

Co-Pay Accumulators are management tools used by health insurance companies, Pharmacy Benefit Managers (PBMs) and other health plans that excludes co-pay assistance coupon and program payments from counting toward patients’ deductibles (Schweitz, 2019). The Centers for Medicare & Medicaid Services (“CMS”) recently promulgated new rules potentially excluding drug manufacturer co-pay assistance programs towards patient out-of-pocket cost sharing and deductibles.

Co-Pay Accumulators

I wrote about this issue, last September, for the ADAP Advocacy Association (read blog, here), and have been asked to take another look at this issue after CMS decided, after some deep soulless searching and poor timing, to put this program fully into place in the middle of a pandemic outbreak.

Here is the rule in question:
1. See, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020, Final Rule, 84 Fed. Reg. 17454 (April 25, 2019) (the “Final Rule”).2. 45 C.F.R. § 156.130(h) reads in its entirety as follows:“(h) Use of drug manufacturer coupons. For plan years beginning on or after January 1, 2020:(1) Notwithstanding any other provision of this section, and to the extent consistent with state law, amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to enrollees to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing (as defined in paragraph (a) of this section).”3. In general, “accumulator programs” are a relatively recent component of pharmacy benefit designs offered by many health insurers and PBMs for commercially insured enrollees. Accumulator programs track utilization of drug manufacturer-sponsored copay or other assistance to ensure that the drug manufacturer contribution no longer counts toward an enrollee deductible. Accumulator programs tend to reduce the health insurers’ or plan sponsors’ overall contribution to the total spend on high-cost branded prescription medications as opposed to shifting more cost toward them when accumulator programs are not in effect. There are many variations of these programs depending on plan design and other factors.4. See, Final Rule at 17544 - 17545.5. See, The Center for Consumer Information & Insurance Oversight, Affordable Care Act Implementation FAQs - Set 12, Q1 and Q2 (February 2, 2013), and Affordable Care Act Implementation FAQs - Set 18.
Looking for a bit more insight, I turned to JD Supra, a great source of press releases and legal analysis for those looking at government rules and regulations. Here was their finding in May 2020:

The Final Rule states that consistent with specific state law, coupons, and copay cards offered directly by drug manufacturers may be, but are not required to be, counted towards a patient’s annual cost-sharing limit under the plan. This is a notable change from CMS’ prior proposal that would prohibit copay accumulator programs for branded drugs without therapeutic alternatives. (Fox, Atkins, & Trunk, 2020)

Essentially, what a co-pay accumulator attempts to do is increase the amount of money consumers pay in order to decrease the amount of money insurers have to pay, once their annual deductible and/or Out-of-Pocket Maximum (OPM) is met. When consumers are allowed to count co-pay assistance cards against their deductible/OPM, they reach those limits sooner, meaning that insurers are then on the hook for every pharmaceutical fill after that date.

But the rule change at CMS is trickier than that, according to another JD Supra author:
"In conclusion, the Final Rule prohibits individual market, small group, large group and self-insured group health plans from using accumulator adjustment programs only when there is no generic for a branded pharmaceutical.  However, under federal law, all such health plans may continue pharmacy benefit designs which do not count manufacturer coupons toward an enrollee’s maximum out-of-pocket cost sharing (a) when there exists a generic equivalent for a branded drug, and (b) under any circumstances, for more expensive biologics. 
Still, as a final cautionary note, please keep in mind that the Final Rule, by its own terms, does not pre-empt state laws. Some states are considering or have passed legislation that may prohibit the use of accumulator programs regardless of the availability of generic substitutes. However, such state laws, if passed, may be limited to health insurers and may not be able to reach self-funded group health plans which are governed by ERISA. Thus, those subject to the Final Rule must remain cognizant of similar laws in the states in which they offer health benefit plans. (Hanna, 2019)."
The problem with this issue is that the CMS rule is aimed directly at insurers providing plans for the Medicare program. For those unfamiliar with that whole mess, Medicare insurance programs are offered to eligible beneficiaries not by state, but by zip code, meaning that there are well over 1,000 plans and options being offered across America. As a result of this, trends in the general health insurance market tend to follow the standards set by Medicare insurers, because they essentially glut the market (and, frankly, it’s just easier).

National Association of Insurance Commissioners

And this is the crux of this piece: can State Insurance Commissioners (and thus, state laws) use their influence and sway to essentially force insurance companies to count co-pay assistance cards toward deductibles/OPMs? The answer is a big, “…maybe?”

In most cases, federal law supersedes state law. In this case, that law is the Affordable Care Act (ACA, aka Obamacare). In order for states to engage in the health insurance marketplace (where consumers can buy individual plans), they have to live under ACA rules. As part of that, this new CMS rule would apply to the ACA, as well. That, however, is also unclear.

However, some states, such as Arizona, Illinois, Virginia, and West Virginia, have passed laws that prohibit insurers from using Co-Pay Accumulators in part, or in total. While Arizona and Virginia’s laws have a bit of wiggle room in their language, allowing for insurers to argue that they can use them in certain instances, both Illinois and West Virginia bar their utilization, outright, by not distinguishing between prescription drugs that do or do not have generic equivalents (Aimed Alliance, n.d.).

So, there’s not a lot of real light, here, to guide our way.

Advocates could attempt to get states to push through laws banning the practice (which, I think they should do, regardless of any advocacy), but let’s be honest – most state legislatures are out of session, for the remainder of 2020, and they’re almost all in the middle of an election year. There’s not going to be much movement on this issue until after November 4th.

The real question is whether or not federal rules supersede State Insurance Commission rules. If so, who the hell knows what’s going to happen, next?

References:
  • Aimed Alliance. (n.d.) COPAY ACCUMULATORS – ENACTED LAWS. Washington, DC: Aimed Alliance. Retrieved from: https://aimedalliance.org/copay-accumulators-enacted-laws/
  • Fox, A., Atkins, E., Trunk, S. (2020, May 29). HHS Clarifies Position on Copay Accumulators? Or Does It?. Sausalito, CA: JD Supra, LLC: Legal News. Retrieved from: https://www.jdsupra.com/legalnews/hhs-clarifies-position-on-copay-19750/
  • Hanna, D. (2019, June 18). HHS Issues Final Regulation Of Drug Co-Pay Accumulator Programs:. Sausalito, CA: JD Supra, LLC: Legal News. Retrieved from: https://www.jdsupra.com/legalnews/hhs-issues-final-regulation-of-drug-co-93372/
  • Schweitz, M.C. (2019, January). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: SLACK Incorporated: Healio: Healio Rheumatology: Practice Management. Retrieved from: https://www.healio.com/rheumatology/practice-management/news/print/healio-rheumatology/%7B04769e45-fca4-4ce6-90be-8f441d6afc7d%7D/the-cost-shift-conundrum-of-copay-accumulator-programs
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.