'Conscience Rule' Dead...For Now

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

In early November 2019, a federal district judge voided the ‘Protecting Statutory Conscience in Healthcare’, declaring it was unconstitutional, in a defeat for the Trump Administration. The former rule had allowed healthcare workers to refuse to perform lifesaving medical procedures on patients based on their personal moral and religious beliefs.

The CEO of the National Women’s Law Center, Fatima Goss Graves, released a statement shortly after the ruling was announced, stating: “We are thrilled that the court saw the Trump-Pence refusal of care rule for what it is- unlawful, discriminatory, and an unconscionable attack on our health care.” (News@Jama)

The U.S. Department of Health & Human Services ("HHS") promulgated the regulation, which delved into hot topic issues including abortion and assisted suicide.

Photo Source: MedPage Today

"This rule ensures that healthcare entities and professionals won't be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life," said HHS Office of Civil Rights Director Robert Severino after the initial law was brought up. (NPR)

Had the law been ruled constitutional, it would have applied to both state and local governments and public and private healthcare. Those under Medicare of Medicaid would have been affected as well, impacting nearly 74 million people in the United States. (Statistica)

The final ruling would have allowed health care professionals to deny services constitutionally protected, such as abortion, treatment to the LGBTQ+ community, and others. The ruling would have allowed parents to object care on religious or moral grounds for their children- including suicide prevention, child abuse prevention, and vaccines.

For the many people, this is not the first time their access to healthcare has been threatened. Since the HIVAIDs epidemic first took place in the 80s, doctors and communities alike have alienated patients from treatment for fear of transmission. Since then, medical practices have improved care for HIV-infectio drastically, but the HHS law threatened to endanger more lives.

Currently a federal court case in Wisconsin is claiming violation of federal and state anti-discrimination laws. When an HIV positive woman sought treatment for a necessary gallbladder surgery, the surgeon denied the surgery because he was worried about HIV exposure to his medical team. Another hospital then removed her gallbladder in a “routine surgical procedure, which includes universal precautions taken to prevent the transmission of bloodborne pathogens such as HIV,” said the AMA Journal of Ethics. (AMA)

According to a study conducted by the National Women’s Law Center, approximately 8% of LGB individuals, nearly 27% of transgender and nonconforming individuals, and almost 20% of HIV-positive individuals report being denied needed healthcare outright. In another case, a 53-year old man was denied a kidney transplant by his insurance company because of his HIV-positive status, putting his life at risk. (NWLC)

“A patient with HIV who was admitted to a hospital reported that after he disclosed that he had sex with men, the hospital staff ignored him, refused to allow his family to visit, and did not honor his requests for his HIV medication.16 The doctor at the hospital told the patient’s personal doctor, “This is what he gets for going against God’s will” and “You must be gay, too, if you’re his doctor.”17 Despite explaining to the nurses the importance of taking his HIV medication, the patient missed five doses.18 Because some HIV medications are highly time-sensitive, a missed or delayed dose can make the medicine less effective or even completely ineffective,” said NWLC.

“Two judges in two days have recognized the Denial of Care Rule for what it is, an egregious and unconstitutional attack on women, LGBT people and other vulnerable populations. The Denial of Care Rule targets some of our most marginalized and vulnerable communities and deserves to be relegated to the dustbin of history,” said Jamie Gliksberg, a senior attorney at Lamda Legal, after the law was ruled unconstitutional.

References:

• Anderson JD, Bebe J. (December 2019). HIV Stigma and Discrimination Persist, Even in Health Care. AMA Journal of Ethics. Retrieved online at https://journalofethics.ama-assn.org/article/hiv-stigma-and-discrimination-persist-even-health-care/2009-12. 
• Gever, John (2018, November 6). Federal Judge Voids 'Conscience Rule' - Policy would have allowed providers to refuse care because of "moral objections". MedPage Today. Retrieved online at https://www.medpagetoday.com/publichealthpolicy/healthpolicy/83166?xid=NL_breakingnewsalert_2019-11-06&eun=g1295317d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=ConscienceAlert_110619&utm_term=NL_Daily_Breaking_News_Active. 
• Gostin, Lawrence O. (2019, May 15). JAMA Forum: The “Conscience” Rule: How Will It Affect Patients’ Access to Health Services? JAMA. Retrieved online at https://newsatjama.jama.com/2019/05/15/jama-forum-the-conscience-rule-how-will-it-affect-patients-access-to-health-services/.
• Kodjak, Alison (2019, May 2). New Trump Rule Protects Health Care Workers Who Refuse Care For Religious Reasons. NPR. Retrieved online at https://www.npr.org/sections/health-shots/2019/05/02/688260025/new-trump-rule-protects-health-care-workers-who-refuse-care-for-religious-reason.
• Mikulic, Matej (2018, October 26). Medicaid - Statistics & Facts. Statista. Retrieved online at https://www.statista.com/topics/1091/medicaid/. 
• National Women's Law Center (May 2014). Health Care Refusals Harm Patients: The Threat to LGBT People and Individuals Living with HIV/AIDS. Retrieved online at https://nwlc.org/wp-content/uploads/2015/08/lgbt_refusals_factsheet_05-09-14.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.

340B – Reply Hazy, Try Again

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

For the past three years, I have spent countless hours trying to make sense of the 340B Drug Pricing Program, how it is utilized by state and private entities, and how certain companies can take an ostensibly good program and turn it into what is essentially a slush fund for their organizations. As of January 15th, 2020, my understanding of the various working parts of this program, even after peer reviewing a white paper for the Community Access National Network (which can be found here) on the topic, remains unclear, at best.

For those unfamiliar with the 340B program, it was created in 1992 and requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations and covered entities at significantly reduced prices. It was designed to all covered entities to “…stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services” (Health Resources & Services Administration, 2020). “Eligible health care organizations/covered entities are defined in [the] statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers” (HRSA).

Some examples of “covered entities” include HIV/AIDS clinics and pharmacies such as those run by the AIDS Healthcare Foundation, AID Atlanta, Thrive Alabama, Trillium Health, Urban Health Solutions, Inc., and numerous others around the U.S. These Federal grantees must reinvest any revenues from the sale of drugs (340B or otherwise) and other patient revenues into the federal grant project, as well as report how they budget for and spend such “program income” (Community Access National Network, 2019). While these entities are required to report how they reinvest, hospitals are not required to do so.

Proponents of the program argue (rightly) that the 340B program has allowed for more patients to receive more medications, particularly as it pertains to HIV medications. Using 340B “income,” Ryan White clinics are able to provide eligible prescription medications to need patients at no or reduced cost, assist patients with their insurance premiums, and provide medical services as little or no cost to needy patients (Ryan White Clinics for 340B Access, 2016).

Critics argue that the 340B program is being abused by Pharmacy Benefit Managers (PBMs), Managed Care Organizations (MCOs), and hospitals and is no longer operating as it was intended. They argue that hospitals, which account for 80% of all 340B sales, essentially using the savings they receive to pad profits without being held accountable. Additionally, they argue that:

"The contract pharmacy model spurred some unique developments. Covered Entities and pharmacies have developed virtual inventory or replenishment systems through which the pharmacy dispenses its inventory to Covered Entity patients, then backfills or replenishes what could have been dispensed with a Covered Entity’s 340B drugs with 340B drugs purchased by the Covered Entity for the pharmacy. The replenishment model acts as a loan of non-340B drugs to be repaid with the Covered Entity’s drugs. The compensation model is also somewhat unique. Covered Entities own the 340B drugs dispensed to their patients (whether a physical 340B inventory or a retrospective virtual inventory is used). The contract pharmacies bill on behalf of the Covered Entities using the pharmacies’ payer contracts. Contract pharmacies collect the reimbursement owed to the Covered Entity on behalf of the Covered Entity, whether from the patient, his or her payer, or a combination of the two. The third-party administrator (TPA) then forwards that reimbursement to the Covered Entity, less its fee and the fee charged by the pharmacy for providing contract pharmacy services. Different contract pharmacy fee structures exist in the market, including flat per-dispense fees, percentage-of-reimbursement fees, pre-determined reimbursement and hybrids of the other methods. All contract pharmacy arrangements must comply with federal fraud-and-abuse laws." (CANN)

If all of this seems confusing, that’s because it is. Or, rather, the legislation has not kept up with how the U.S. healthcare “system” has developed since its inception. Further complicating the mix is the concern (which is really more of a reality) that some entities are abusing the 340B program and Medicaid program in order to receive duplicative discounts on the same drugs. This is, of course, is illegal, as covered entities are restricted from billing state Medicaid programs for reimbursement for 340B drugs if the drugs are subject to a manufacturer discount (CANN). Despite this clear prohibition, duplicate discounts continue to occur, because current policies and systems are woefully inefficient at preventing them, and the increased use of PBMs and MCOs under the Affordable Care Act has increased the likelihood that duplicate discounts will occur.

In an effort to bring some clarity to this complicated landscape of duplicate discounts, Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services form, conducted a 50-state survey on 340B program laws, regulations, and sub-regulatory guidance that govern how state programs reimburse for both 340B and non-340B drugs, and how those states ensure that the 340B drugs are not also subject to Medicaid rebates (Manatt, 2019). They found that:

• 12 states rely solely upon the federal Office of Pharmacy Affairs (OPA) Medicaid Exclusion File;
• 22 rely solely upon claims-level identifiers;
• 1 state prohibits all covered entities from using 340B drugs for Medicaid beneficiaries;
• 1 state permits 340B drugs for family planning clinics only;
• Other states rely on a combination of OPA and claims-level identifiers

Photo Source: Manatt Health

Unfortunately, the full report is behind a paywall, so I was unable to read the full findings to glean a fuller picture of their findings, and what they did publish for free in Manatt Health's infographic leaves people who aren’t already experts in the intricacies of 340B policies and politics with barely even a cursory understanding of what is being done to avoid duplicate discounts.

But, beyond the HIV arena, accusations of PBMs and MCOs successfully abusing the 340B program to increase profits continue to rise as other healthcare providers, particularly in areas hard hit by the opioid epidemic and endemic poverty, are sounding alarms that PBMs are reducing the rates they pay to pharmacies for the drugs they get at a discount (Candisky, 2020):

“What we’re seeing in Ohio and in other states across the country (is) that the PBMs are diverting those pharmacy savings from the 340B program intended to provide care to underserved patients and communities and using those dollars for themselves to increase their profit margins,” said Julie DiRossi King, chief operating officer for the Ohio Association of Community Health Centers.

Hopewell’s director of pharmacy, Logan Yoho, said “discriminatory contracting” by some PBMs makes it difficult to maintain services at its 25 clinics across Ohio’s Appalachian region. Not only has he seen the savings evaporate, but reimbursements from PBMs have dropped so low on some medicines that he’s losing money. (Candisky)

PBMs have come under intense scrutiny over the past five years, particularly in Ohio and Kentucky, where PBMs have overcharged the Ohio Bureau of Workers’ Compensation by millions of dollars (Rowland, 2019) and taken $123.5 million in hidden feeds from Kentucky health insurance plans that cover the state’s poor (Langreth, 2019).

The unfortunate reality is that the 340B program and the various methods through which it can be abused with relative ease (and even less oversight or repercussions) has made what is already a complicated mess even more contentious among healthcare providers, policy advocates, and healthcare access advocates. Furthermore, there is no “one” answer to solve the problems that have arisen that will leave any stakeholder completely happy. Moreover, there are likely going to be some “losers,” in terms of operating budgets, profits, and executive/management salaries of organizations that are illegally manipulating the 340B program and Medicaid to line their own pockets.

That, there, is really my personal axe to grind, not just about the 340B program, but about the American healthcare “system,” in general: providing healthcare to all Americans should never be about profit margins, higher salaries, or bonuses; it should be about keeping people healthy and saving lives to improve the quality of life for all American citizens, not just those profiting from their misery. This is a view shared by a majority of Americans, though there’s little consensus about how to eradicate the for-profit model. A good place to start, however, would be to reform the 340B program to make certain that all covered entities are governed by the same rules and that those who abuse the program are made to pay a steep price.

References:

• Candisky, C. (2020, January 13). Pharmacy middlemen benefit from drug discount program intended to help poor Ohioans. Columbus, OH: The Columbus Dispatch. Retrieved from: https://www.dispatch.com/news/20200113/pharmacy-middlemen-benefit-from-drug-discount-program-intended-to-help-poor-ohioans?utm_source=SFMC&utm_medium=email&utm_campaign=Columbus Dispatch politics 2020-01-14&utm_content=COLD_CD&utm_term=011420
• Community Access National Network. (2019, February). 340B Commission’s FINAL REPORT ON THE 340B DRUG DISCOUNT PROGRAM – The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. Washington, DC: Community Access National Network. Retrieved from: https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true
• Health Resources & Services Administration. (2020, January). 340B Drug Pricing Program. Rockville, MD: United States Department of Health and Human Services: Health Resources & Services Administration: 340B Drug Pricing Program. Retrieved from: https://www.hrsa.gov/opa/
• Langreth, R. (2019, February 21). Drug Middlemen Took $123.5 Million in Hidden Fees, State Claims. New York City, NY: Bloomberg: Prognosis. Retrieved from: https://www.bloomberg.com/news/articles/2019-02-21/drug-middlemen-took-123-5-million-in-hidden-fees-state-claims
• Manatt. (2019, October 15). Manatt Health Releases 50-State Survey on 340B in State Medicaid Programs. Washington, DC: Manatt, Phelps & Phillips, LLP: Manatt [dot] com: Insights: Press Releases: 2019. Retrieved from: https://www.manatt.com/Insights/Press-Releases/2019/Manatt-Health-Releases-50-State-Survey-on-340B-in
• Rowland, D. (2019, November 25). Pharmacy benefit manager OptumRx overcharged Ohio BWC by millions, Yost says. Columbus, OH: The Columbus Dispatch. Retrieved from: https://www.dispatch.com/news/20191125/pharmacy-benefit-manager-optumrx-overcharged-ohio-bwc-by-millions-yost-says
• Ryan White Clinics for 340B Access. (2016). What is 340B?. Retrieved from: https://www.rwc340b.org/

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

HIV/AIDS Fireside Chat Retreat in New Jersey / New York Tackles Pressing Issues

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

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Weehawken, New Jersey among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS. The Fireside Chat took place on Thursday, December 5th, and Friday, December 6th. U = U, Molecular HIV Surveillance, and Mental Health were evaluated by 20 diverse leaders in the fight against the HIV/AIDS epidemic.

Photo Source: Getty Images

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

• U = U: A Foundation for Ending the HIV Epidemic — moderated by Murray Penner, Executive Director, North America, Prevention Access Campaign
• Ryan White Program: Is Molecular HIV Surveillance a Public Health Tool or Weapon to Fuel Stigma  — moderated by Brandon M. Macsata, CEO, ADAP Advocacy Association (planned facilitator was sick)
• Mental Health: Implications of Co-Occurring Diagnosis of a Mental Condition and HIV/AIDS  — moderated by Brandon M. Macsata, CEO, ADAP Advocacy Association (planned facilitator was sick)

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

• Tez Anderson, Founder, Let's Kick ASS (AIDS Survivor Syndrome)
• Guy Anthony, Founder, Black, Gifted & Whole
• William E. Arnold, President & CEO, Community Access National Network (CANN)
• Robert Breining, spokesperson, Positively Fearless
• Patricia Charleston, Program Supervisor, Gaudenzia, Inc.
• Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
• Hilary Hansen, Executive Director, US Patient Advocacy & Strategic Alliances, Merck
• Catherine Hanssens, Founding Executive Director, The Center for HIV Law and Policy
• Ben Kelly, VP Operations, Maxor National Pharmacy Services
• Scott Kramer, President & Psychotherapist, Affirming Psychotherapy LCSW PC
• Jen Laws, policy consultant
• Vickie Lynn, Visiting Instructor, USF
• Brandon M. Macsata, CEO, ADAP Advocacy Association
• Julie Marston, Executive Director, Community Research Initiative of New England, Inc.
• Ann-Margaret Navarra, Faculty - Assistant Professor, NYU Rory Meyers College of Nursing
• Stephen Novis, Director, Government Relations, ViiV Healthcare
• Murray Penner, Executive Director, North America, Prevention Access Campaign
• Alan Richardson, Executive Vice President of Strategic Patient Solutions, Patient Advocate Foundation
• Lee Storrow, Executive Director, North Carolina AIDS Action Network (NCAAN)
• Marcus Wilson, National Policy & Advocacy Director, Johnson & Johnson

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

Undetectable = Untransmittable:

Murray Penner provided a basic overview on the science behind "undetectable equals untransmittable" ("U=U"), which is clear and indisputable. Treatment as prevention dates back to the 1990s, including preventing mother-to-child transmission. According to Penner, there have been four large international studies that have demonstrated U=U is sound public health policy.

According to Penner: "Four major scientific studies have proven that HIV-positive individuals who have an undetectable viral load and stay on their medications do not transmit the virus to sexual partners. The findings were initially announced in 2008 with the Swiss Statement, and they were confirmed again in 2016. For many people diagnosed with the virus, the news is nothing short of life-changing. Diagnosis doesn’t mean no more satisfying relationships. And that lifts people out of depression. They feel like they can be intimate and free in their sexual relations, and that’s at the heart of it.”

It was noted that U=U has been endorsed by the World Health Organization ("WHO"), as well as the U.S. Centers for Disease Control & Prevention ("CDC"). The foundation of U=U includes treatment, labs, and connection to care (or "TLC"), and it provides the public health argument for the U=U campaign.

The discussion also focused on the role of providers in educating patients and the general community, as well as how best to communicate the U=U message. There was also some conversation about how the messaging needs to adapt to address diverse communities. The group agreed more needed to be done to use U=U to change the outdated HIV Criminalization laws.

The following materials were shared with retreat attendees:

• Providers Should Discuss U=U with all Patients Living with HIV
• HIVMA Pocket Guide for Providers 
• CDC Letter Approving U=U 
• U=U Basic Fact Sheet – October 2019
• Basic Fact sheet from FHI 360 
• Video: Chloe Orkin is past-chair of the British HIV Association and Gareth Thomas is a rugby player in the U.K. (from Wales) 
• Resources from Prevention Access Campaign (U=U)

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

Molecular HIV Surveillance:

Molecular HIV surveillance involves data collection and sharing between healthcare practitioners and public health departments to track individual treatment resistance, as well as trends in HIV infections. It also leverages cluster detection to identify new infections.

The discussion included an overview on healthcare & privacy rights, which fuel many of the concerns expressed by patients, advocacy groups, and some leading civil rights organizations. Background context included HIV-related stigma, dating back to early 1980s to current times; it also touched on HIV-related criminalization.

Weighing the pros and cons of this took was at the center of the debate on the issue. Whereas it is favored by Health Departments and some public health advocates, there remains considerable push-back from the community. There is no informed consent by patients for data collected using individuals’ blood samples. State and local health departments report de-identified data to the CDC, but there are obvious patient privacy concerns.

HIV Criminalization occupied a lot of the group's time during the discussion. Draconian HIV-specific criminalization laws still exist in 34 states; another 24 states have used general criminal statutes against people living with HIV for “HIV exposure” or non-disclosure of HIV status (CHLP, 2019). These laws relegate people living with HIV to second-class citizenship for numerous reasons. According to the Center for HIV Law and Policy, state HIV criminalization laws “criminalize non-disclosure of HIV status or exposure of a third party to HIV; make exceptions to confidentiality and privacy rights of people living with HIV; provide for sentence enhancements for people living with HIV convicted of underlying crimes such as prostitution and solicitation; and require sex offender registration for people living with HIV” (CHLP, 2019).

The following materials were shared with retreat attendees:

• Molecular HIV surveillance: public health tool or weapon?

Jeffrey R. Lewis, President & CEO of the Legacy Health Endowment, was suppose to facilitate this discussion on Molecular HIV Surveillance but he was unable to attend due to illness. The ADAP Advocacy Association thanks him, nonetheless.

Mental Health:

Mental health and its intersection with HIV/AIDS included important statistics about both health issues in the United States. Research has found considerable overlap between many mental health disorders and HIV infection. Individuals who are receiving care for a mental health condition are four times as likely to be living with HIV compared to the general population, according to a multisite study of the prevalence of HIV with rapid testing in mental health settings.

Increasingly, it is an emerging issue among an aging population living with HIV/AIDS as it has become a chronic disease. As of 2015, over half of the 1.6 million individuals with HIV/AIDS are  50 years, or older. The discussion presented an excellent opportunity to discuss AIDS Survivor Syndrome, which is the term coined by Tea Anderson to describe the “spectrum of sustained trauma survivorship resulting from living through the AIDS pandemic.”

An important tool to address the unmet needs is targeted case management under Medicaid, although not widely utilized for individuals living with HIV/AIDS. Assertive community treatment is an intensive and highly integrated approach for community mental health service delivery. Four states have taken this approach to address the needs of the HIV community.

Once again, HIV Criminalization was discussed because it is linked to numerous mental health conditions among individuals living with HIV/AIDS. According to the CDC's Medical Monitoring Project, four in five HIV-positive patients report feeling internalized HIV-related stigma; two in three say that it is difficult to tell others about their HIV infection; one in three report feeling guilty or ashamed of their HIV status; and one in four say that being HIV-positive makes them feel dirty or worthless (CDC, 2018).

The following materials were shared with retreat attendees:

• Implications of Co-Occurring Diagnosis of a Mental Condition and HIV/AIDS
• MENTAL HEALTH INFOGRAPHIC #1: Implications of Co-Occurring Diagnosis of a Mental Condition and HIV/AIDS (August 2019)
• AIDS Survivor Syndrome & Understanding the Linkages between Mental Health and HIV/AIDS
• MENTAL HEALTH INFOGRAPHIC #2: Implications of Co-Occurring Diagnosis of Depression and HIV/AIDS
• Implications of Health Stigma, Mental Health and HIV/AIDS
• MENTAL HEALTH INFOGRAPHIC #3: Implications of Health Stigma, Mental Health & HIV/AIDS

John Williamson, candidate for Masters in Social Work at Fordham University, was suppose to facilitate this discussion on Mental Health but he was unable to attend due to illness. The ADAP Advocacy Association thanks him, nonetheless.

Additional Fireside Chats are planned in 2020.

References:

• Centers for Disease Control and Prevention. (2018). Medical Monitoring Project. Retrieved from: https://www.cdc.gov/hiv/statistics/systems/mmp/resources.html#Fact%20Sheets,%20
• Center for HIV Law and Policy (March 2019). HIV Criminalization in the United States: A Sourcebook on State and Federal HIV Criminal Law and Practice (Third Edition). Retrieved online at http://www.hivlawandpolicy.org/sourcebook. 

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.

Patients Ask FDA

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

Last year while attending the Biotechnology Innovation Organization's ("BIO") Patient & Health Advocacy Summit in Washington, DC, an important, but little known patient resource was shared during one of the panel discussions. It involves the U.S. Food & Drug Administration ("FDA") and the ability of patients to and their caregivers ask questions to FDA or to request a meeting.

The Patients Ask FDA is an online portal located at https://www.fda.gov/patients/learn-about-fda-patient-engagement/patients-ask-fda.

This innovative, patient-center resource makes available information about ongoing initiatives on how to engage with the FDA, testimonials from FDA patient representatives, as well as how to apply to the FDA Patient Representative Program. It also includes current FDA Patient Listening Sessions, which are in partnership with the National Organization for Rare Disorders ("NORD").

The ADAP Advocacy Association places a premium on patient engagement and we encourages to use this important tool afforded to them by the FDA.

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

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

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

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

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

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

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

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



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

Now a chronic disease, HIV is turning gray

By: Jeffrey R. Lewis

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

Photo Source: NAMES Project

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Photo Source: HIV.gov

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

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

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

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

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

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

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

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

References:

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

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

FDA Approves New Injectable Naloxone

By: Marcus J. Hopkins, Policy Consultant

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

Photo Source: NPR

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

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

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

References:

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

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