Showing posts with label Fireside Chat. Show all posts
Showing posts with label Fireside Chat. Show all posts

Thursday, October 5, 2023

Fireside Chat Retreat in Philadelphia, PA Tackles Pressing Public Health Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy

ADAP Advocacy hosted its "Health Fireside Chat" retreat in Philadelphia, Pennsylvania among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened Thursday, September 21st through Saturday, September 23rd. The growing threat to public health from the spread of medical misinformation and disinformation, reforming the 340B Drug Pricing Program to better serve patients rather than providers, and the effective implementation of longer-acting HIV treatment and prevention programs were evaluated and discussed by the 20 diverse stakeholders.

The Fireside Chat's “ice breaker” activity included some fun and games at Dave & Buster's with their pool tables, video games, carnival challenges, and virtual reality. Attendees enjoyed some bonding and laughter before collectively rolling up their sleeves and taking a deep dive into the policy discussions.

FDR Fireside Chat
Photo Source: Getty Images

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

  • Public Health Alert: Medical Misinformation Can be Dangerous to Your Health — moderated by Rick Guasco, Acting Editor-in-Chief and Creative Director at Positively Aware
  • 340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions? — moderated by Tim Horn, Director, Medication Access at NASTAD
  • Long Acting Injectables: Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation — moderated by Jeffrey Crowley, Distinguished Scholar/Program Director, Infectious Disease Initiatives at the O'Neill Institute/Georgetown Law

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

  • Ninya Bostic, National Policy and Advocacy Director, IDV, Johnson & Johnson
  • Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
  • Theresa Daugherty, Patient Advocate
  • David Gana, Patient Advocate
  • Alexander Garbera, Co-Chair, New Haven Mayor’s Task Force on AIDS, City of New Haven, CT
  • Dusty Garner, Patient Advocate
  • Rick Guasco, Acting Editor-in-Chief and Creative Director at Positively Aware
  • Tim Horn, Director, Medication Access at NASTAD
  • Riley Johnson, Founder, RAD Remedy
  • Thomas Johnson, Executive Director, Alliance to Save America’s 340B Program
  • Jen Laws, President & CEO, Community Access National Network
  • Darnell Lewis, Program Coordinator, RAO Community Health
  • Brandon M. Macsata, CEO, ADAP Advocacy
  • J. Maurice McCants-Pearsall, Government Relations Director (Southeast), ViiV Healthcare
  • Aisha McKenzie, Patient Advocate
  • Warren O’Meara-Dates, Founder & CEO, The 6:52 Project Foundation
  • Brian Smith, Alliance Development and Strategic Advocacy
  • Matt Toresco, CEO & CPO, Archo Advocacy LLC & Elavay
  • Stacey L. Worthy, Director, Healthcare Policy & Strategy, Johnson & Johnson
  • Joey Wynn, Chairman, Florida HIV/AIDS Advocacy Network

The Covid-19 pandemic is still ongoing. Covid-19 cases and hospitalizations are both on the rise again, according to data by the Centers for Disease Control & Prevention (CDC) With that in mind, ADAP Advocacy implemented strong Covid-19 safety protocols for the Health Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned).

Health Fireside Chat

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

Medical Misinformation:

The first policy session, “Public Health Alert: Medical Misinformation Can be Dangerous to Your Health”, lead by the Positively Aware Magazine’s Rick Guasco, challenged guests to evaluate their own role in potentially sharing medical misinformation without even knowing it. Guasco highlighted that everyone can do something about misinformation, starting with being cognizant of how people can potentially spread it. A little information is a dangerous thing. Medical misinformation is information that is false, inaccurate, or misleading. A little misinformation can become the building block of lies and ignorance. As such, medical disinformation is misinformation with a purpose. According to the Kaiser Family Foundation's recent poll, most Americans encounter health misinformation, and most aren’t sure whether it’s true or false local TV.

Drawing on KFF's Misinformation Pilot Poll, KFF released three follow-up reports examining exposure to, and belief in, health misinformation among Black adults, Hispanic adults, and rural communities.

Guasco shared what he viewed as the best three ways to combat medical misinformation and disinformation. They included 1) promoting the truth by proactively talking about health literacy, 2) pre-bunking fake medical news by putting counter-arguments out in anticipation, and 3) de-bunking fake medical news, but it is more difficult because it is harder to change minds once the misinformation and disinformation is spread. Significant conversation centered around lingering medical mistrust in the Black community after the Tuskegee Airmen experiments. Rev. Alexander Garbera offered an excellent quote to summarize how to combat the dangers associated with medical misinformation and disinformation: "Combat fear with empathy."

Fake News
Photo Source: Florida International University

The following materials were shared with retreat attendees:

ADAP Advocacy would like to publicly acknowledge and thank Rick Guasco for facilitating this important discussion.

340B Drug Discount Program:

As a backdrop to the discussion over the 340B Drug Discount Program, an opinion piece dropped calling out the hypocrisy behind the forces fighting reform. NASTAD's Tim Horn kicked-off the discussion with an overview of the program, including an analysis on how 340B intersects with the Ryan White HIV/AIDS Program, including State AIDS Drug Assistance Programs (ADAP). In that, some challenges were addressed – such as explosive program growth, lack of transparency, and calls for more oversight. There was particular focus on ADAPs and their specific programmatic use of the 340B dollars exclusively for patient care, and that in many ways it represents the "gold standard" among Covered Entities participating in the program. The discussion also centered around some of the pros and cons associated with ongoing reform proposals; they included contract pharmacy restrictions, discriminatory reimbursement laws, and possible federal legislation (e.g., ASAP 340B). The conversation touched the rising medical debt crisis in the United State (of which, most medical debt is actually hospital-associated debt), declining charity care among hospitals, as well as the adverse impact on patients via provider consolidation. Ongoing scrutiny over the lack of transparency in the program continues to grow, evidenced by the Request for Information (RFI) issued by a group of bipartisan senators, including Senator John Thune (R-SD), Senator Debbie Stabenow (D-MI), Senator Shelley Moore Capito (R-WV), Senator Tammy Baldwin (D-WI), Senator Jerry Moran (R-KS), and Senator Benjamin Cardin (D-MD). Read the joint statement by ADAP Advocacy and CANN, here.

Photo Source: Positively Aware

The following materials were shared with retreat attendees:

ADAP Advocacy would like to publicly acknowledge and thank Tim Horn for facilitating this important discussion.

Editor's Note: The ADAP Advocacy Association has offered opinions on 340B over the last several years, including Industry’s Changes to 340B Drug Discount Program (April 2022), 340B – Reply Hazy, Try Again (January 2020), The Federal 340B Program: A Call to Order (March 2019), and 340B Program: Don't Throw the Baby Out with the Bathwater (March 2017)

Long-Acting Injectables:

The O'Neill Institute for National and Global Health Law recently published a brief, Effective Implementation of Longer-Acting HIV Treatment and PrEP Requires Delivery System Innovation. The O'Neill Institute summarized long-acting injectables:

"Scientific advancements resulting from our long-term national commitment to HIV research have begun producing new products both for HIV treatment and prevention that do not require daily dosing. The first standalone longer-acting (LA) FDA-approved products are delivered by intramuscular injection every 1-2 months, but future products may require far less frequent injections or could come in other forms such as small implants under the skin or oral medications. These products represent exciting advances because they give users more options to stay engaged in the HIV treatment or prevention continuum. While many patients and providers speak of how transformative these products can be, access to these products is limited and a myriad of barriers prevent individuals from accessing them. Deliberate policy actions are needed to ensure that these innovations do not bypass the individuals and communities that stand to benefit the most from them."

Read the brief and its related materials. 

Jeffrey S. Crowley led this important discussion. While early in the implementation of these products, several barriers have arisen that must be overcome.  Among these are:

  1. Adapting our current clinics and health care programs to allow for greater scale;
  2. Overcoming insurance and financing barriers to access;
  3. Addressing regulatory and financing barriers to new delivery models, such as greater use of pharmacies, mobile clinics, or self-administration; and,
  4. Ensuring that innovations in HIV services delivery reduces rather than increases equity.

Some perspective was also shared on the work done by the O'Neill Institute in this area. Dusty Garner offered his perspective on some of the challenges he has encountered accessing his LAI treatment. Additionally, several members of the ADAP Advocacy's ADAP Injectables Advisory Committee, including Jen Laws, Riley Johnson, and Warren O-Dates, offered their perspectives on LAIs and the challenges being faced by patients.

Long-Acting Injectables
Photo Source: European AIDS Treatment Group

The following materials were shared with retreat attendees: 

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

Additional Fireside Chats are planned for 2023 in New Orleans, Louisiana.

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.
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Thursday, May 11, 2023

Fireside Chat Retreat in Nashville, TN Tackles Pressing Public Health Issues

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Jen Laws, Board Co-Chair, ADAP Advocacy Association

The ADAP Advocacy Association hosted its "Health Fireside Chat" retreat in Nashville, Tennessee among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Health Fireside Chat convened Thursday, April 27th through Saturday, April 29th. The state of Tennessee cutting funding for HIV prevention, detection and treatment programs, a growing chorus calling for reforms to the 340B Drug Pricing Program, and the intersection between U=U (undetectable equals untransmittable) and reforming HIV criminalization laws were evaluated and discussed by the 24 diverse stakeholders.

The series was rebranded to encompass a broader focus on public health, changing from the HIV/AIDS Fireside Chat to the Health Fireside Chat. Unlike previous Fireside Chats, Nashville’s event added an “ice breaker” activity, themed in light of the hosting city – a line dancing lesson, as well as an informal town hall meeting convened in partnership with Positively Aware. The additional half day of activities — including the ice breaker, townhall meeting, and meet and greet — allowed attendees to settle into conversation expediently after having a solid hour of good laughs, encouragement, and bonding.

FDR Fireside Chat
Photo Source: Getty Images

The townhall meeting, which was facilitated by Rick Guasco, Acting Editor-in-Chief of Positively Aware, started with recognition that Nashville was explicitly chosen as a hosting city due to the state of Tennessee’s rejection of federal HIV prevention dollars. While a later discussion was specific to that issue, the town hall dug into underlying (and broader) concerns around systemic discrimination as a driver of today’s HIV epidemic. Digging into how racism, as an example, manifests can be a touchy subject in any group, even among those who generally align. Such a charged set of topics, especially among HIV’s thought-leadership, can and does lead to transformational moments, particularly because creating a space of “internal” advocacy provides a chance for us to experience, and navigate, conflict amongst ourselves. That conflict and navigation also provides us a chance to grow together and to break down silos of interest, work, and thought. And this townhall did exactly that.

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

  • Tension in Tennessee: Is an HIV Access to Care & Treatment Crisis Looming? — moderated by Jeffrey S. Crowley, Distinguished Scholar/Program Director, Infectious Disease Initiatives at the O'Neill Institute/Georgetown Law
  • 340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions? — moderated by Kassy Perry, President & CEO, Perry Communications Group
  • U=U: Is 'Undetectable Equals Untransmittable' Changing the Landscape for HIV Criminalization Laws? — moderated by Murray Penner, Executive Director, U=U plus, and S. Mandisa Moore-O'Neal, Executive Director, The Center for HIV Law & Policy

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

  • Guy Anthony, President & Founder, Black, Gifted & Whole Foundation
  • Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
  • Brady Etzkorn-Morris, Executive Assistant for Global Operations, Prevention Access Campaign
  • Earl Fowlkes, President & CEO, Center for Black Equity
  • Rick Guasco, Acting Editor-in-Chief, Positively Aware 
  • Hilary Hansen, Global Public Affairs Head, Oncology, Sanofi
  • Kathie Hiers, President & CEO, AIDS Alabama
  • Marcus Hopkins, Founder & Executive Director, Appalachian Learning Initiative
  • Mark Hubbard, Patient Advocate
  • Vanessa Lathan, HIV Health Policy Director, Black Ladies in Public Health
  • Jen Laws, President & CEO, Community Access National Network
  • David Wyley Long, Change The Pattern Associate, Southern AIDS Coalition 
  • Brandon M. Macsata, CEO, ADAP Advocacy Association
  • Judith Montenegro, Program Director, Latino Commission on AIDS
  • Mandisa Moore-O’Neal, Executive Director, Center for HIV Law & Policy
  • Warren O’Meara-Dates, Founder & CEO, The 6:52 Project Foundation
  • Murray Penner, Executive Director, U=U plus
  • Kassy Perry, President & CEO, Perry Communications Group
  • Amanda Pratter, Associate Director, Policy Advocacy and Alliances, Gilead Sciences
  • Gwen Rathbun, Associate Director, Alliance Development, Merck
  • Alan Richardson, EVP of Strategic Patient Solutions, Patient Advocate Foundation
  • Donna Sabatino, Director State Policy & Advocacy, The AIDS Institute
  • Andrew Scott, Director of Strategic Alliances and Issue Advocacy, Bristol Myers Squibb
  • Robert Suttle, Patient Advocate

The Covid-19 pandemic is still ongoing. Covid-19 has killed at least 1,129,573 people and infected over 104 million in the United States since January 2020, according to data by the Centers for Disease Control & Prevention (CDC).

With that in mind, the ADAP Advocacy Association implemented strong Covid-19 safety protocols for the Health Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned). 

Health Fireside Chat

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

Tension in Tennessee:

The first policy session, “Tension in Tennessee: Is an HIV Access to Care & Treatment Crisis Looming?”, lead by the O’Neill Institute’s Jeffrey S. Crowley, invited local advocates to discuss their internal view of Tennessee’s “troubles” with some national advocacy representation. While much of the discussion focused on the details of local communication and national assumptions, some discussion on how the state may implement its newly allocated funding (will the state’s budget continue to fund prevention efforts next year?), much of the conversation that followed was explicitly about how local advocates can communicate and collaborate with national advocacy efforts. What became clear from that conversation is much of the national and state level advocacy we tend to reflect fondly of when speaking on decades past is relatively fragile and not well-coordinated. Planning bodies have diminished to largely being provider groups and some don’t even meet – despite a statutory requirement to do exist. An attendee with capacity building expertise pointed out the need for investment in this space. Many planning bodies have been weakened by atrophy, others have faced a demographic shift (and as a result a change in the barriers and assistance needed in order to appropriately activate affected community). The discussion as a whole highlighted the extreme silos working against a cohesive and collaborative advocacy network necessary to support ending the HIV epidemic.

Tennessee Governor Bill Lee
Photo Source: Rolling Stone

 The following materials were shared with retreat attendees:

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

340B Drug Discount Program:

340B remains an important issue for HIV advocates. As such, “340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions?“ was the focus of the second policy session. Some of the advocates in attendance knew little about the program, so the discussion provided an excellent educational opportunity on how the discount drug program works. Laser focused on issues of health equity, Kassy Perry of Perry Communications Group lead the group to dig in – and quickly. Advocates less familiar with 340B were readily able to identify the need for reform when assessing reductions in charity care and increases in medical debt. The group readily recognized 340B as a powerful tool toward addressing health disparities, especially economic consequences for patients, and where those consequences can and do negatively impact entire areas of patients’ lives. Attendees from industry partners listened intently as advocates described their concerns and the need for the program to better reflect the intent in which it was established. Equally important, what is being proposed in New York has alarmed both patients and providers alike.

There was considerable conversation over the news about a new coalition, designed to support true safety-net providers and the communities they serve. The Alliance to Save America’s 340B Program (ASAP 340B) is a partnership of community health centers, patient, provider, and consumer advocates, and leaders from the biopharmaceutical industry. The ADAP Advocacy Association and the Community Access National Network have joined the alliance, and numerous groups in attendance expressed interest in also joining the fight to make 340B reflect the needs of patients, and not hospitals and mega providers. 

340B Drug Pricing Program
Photo Source: CANN YouTube Channel

The following materials were shared with retreat attendees:

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

Editor's Note: The ADAP Advocacy Association has offered opinions on 340B over the last several years, including Industry’s Changes to 340B Drug Discount Program (April 2022), 340B – Reply Hazy, Try Again (January 2020), The Federal 340B Program: A Call to Order (March 2019), and 340B Program: Don't Throw the Baby Out with the Bathwater (March 2017)

U = U:

The final policy session, “U=U: Is 'Undetectable Equals Untransmittable' Changing the Landscape for HIV Criminalization Laws?“, focused on the intersection of issues between U=U and reforming HIV Criminalization Laws with the conversation hosted by Mandisa Moore-O’Neal, executive director of the Center for HIV Law and Policy, and Murray Penner, executive director of U=U Plus. Mandisa shared with the group the exceptional nature of HIV criminalization laws, but also how general criminal codes are out of date, furthering the HIV epidemic, and nearly exclusively used against Black and Brown people living with HIV. Mandisa also discussed how these laws can and are leveraged to further domestic violence (and coercive control). Murray then discussed how laws which allow for “affirmative defenses” only help those people living with HIV which can readily access and maintain care. All of which emphasized that the design of these laws assume that because someone is living with HIV, they are necessarily presumed “guilty”. Advocates discussed how to break silos, including the potential to partner in prosecutor and public defender education efforts. Advocates focused on health or with strong relationships with their local health departments, for example, might wish to participate in education efforts alongside legal advocacy organizations or a state Bar.

HIV Criminalization in the United States
Photo Source: CHLP

The following materials were shared with retreat attendees: 

The ADAP Advocacy Association would like to publicly acknowledge and thank Murray Penner and Mandisa Moore-O'Neal for facilitating this important discussion.

Additional Fireside Chats are planned for 2023 in Philadelphia, Pennsylvania, and New Orleans, Louisiana.

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.
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Thursday, October 13, 2022

Fireside Chat Retreat in Chicago, IL Tackles Pressing Public Health Issues

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

The ADAP Advocacy Association hosted its "Fireside Chat" retreat in Chicago, Illinois among key stakeholder groups to discuss pertinent public health issues facing patients in the United States. The Fireside Chat took place on Thursday, September 29th, and Friday, September 30th. Counterfeit Drugs, 340B Drug Pricing Program, and Covid-19 were evaluated and discussed by the 22 diverse stakeholders.

FDR Fireside Chat
Photo Source: Getty Images

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

  • Counterfeit Medicines: What Can We Do to Protect the US Drug Supply Chain from Nefarious Activities — moderated by Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines (PSM)
  • 340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions — moderated by Brandon M. Macsata, CEO, ADAP Advocacy Association
  • Covid-19: What is its Impact on HIV, Viral Hepatitis, Sexually Transmitted Infections (STIs), and Substance Use Disorder — moderated by Jen Laws, President & CEO, Community Access National Network (CANN) & Board Member, ADAP Advocacy Association

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, Executive Director, Let’s Kick ASS – AIDS Survivor Syndrome
  • Jeff Berry, Executive Director, The Reunion Project
  • Tori Cooper, Director of Community Engagement, Human Rights Campaign
  • Jeffrey S. Crowley, Distinguished Scholar & Program Director at the Infectious Disease Initiatives, O'Neill Institute for National and Global Health Law, Georgetown Law
  • Erin Darling, Associate Vice-President and Counsel, Federal Policy, Merck
  • Heather Eagleton, Director, Government Relations (Midwest), ViiV Healthcare
  • Karen King, fierce Patient Advocate
  • Lisa Johnson-Lett, Peer Support Specialist, AIDS Alabama
  • Jen Laws, President & CEO, Community Access National Network
  • Darnell Lewis, Patient Advocate
  • Brandon M. Macsata, CEO, ADAP Advocacy Association
  • Mike Maginn, HIV Prevention Director, Illinois Public Health Association
  • Aisha McKenzie, Consultant – Event Producer and Administrative Project Management
  • Judith Montenegro, Program Director, Latino Commission on AIDS
  • Murray Penner, Executive Director, North America, Prevention Access Campaign
  • Glen Pietrandoni, Chief Advocacy Officer, Avita Pharmacy
  • Kalvin Pugh, Sr. Manager, Community Engagement at International Association of Providers of AIDS Care
  • Shabbir Imber Safdar, Executive Director, Partnership for Safe Medicines (PSM)
  • Larry Scott-Walker, Executive Director, THRIVE Support Services
  • Sara Stevens, Head, U.S. Issue Advocacy, Novartis
  • Scott Suckow, Senior Consultant, Perry Communications Group
  • Varela, Milani, Patient Advocate, Getting to Zero-Illinois Community Advisory Board

The Covid-19 pandemic is still ongoing. Covid-19 has killed at least 1,051,277 people and infected about 95.4 million in the United States since January 2020, according to data by Johns Hopkins University (CNN, 2022).

With that in mind, the ADAP Advocacy Association implemented strong Covid-19 safety protocols for the Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned). 

September 29th marked the one year anniversary of Bill Arnold's passing, so Brandon M. Macsata took a few moments to reflect on his life and his dedication to improving access to care and treatment for all patients, regardless of their ability to pay. 

Bill Arnold standing at Cape Agulhas, South Africa
Bill Arnold standing at Cape Agulhas, South Africa

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

Counterfeit Medicines:

Shabbir Imber Safdar provided a basic overview on the drug supply chain and the ongoing threat poised by counterfeit medicines seeping into it, which is what he often says keeps him up at night. Safdar offered a primer on the Track-and-Trace system, which determines a drug’s current and past locations, and an explanation on how it protects the drug supply chain. To that end, attendees were shared two bottles of medicines; one reflected how a legitimate prescription bottle would look, compared to a counterfeit bottle. The Track-and-Trace systems leverages both technology and regulation to maintain a safe drug supply chain in the United States.

As part of the discussion, Safdar shared some major drug safety incidents in the United States over the last twenty years. They included fake blood thinners recently found in Mexico, counterfeit and diverted HIV medications distributed to pharmacies, counterfeit COVID-19 tests, masks, and unapproved treatments, diverted and unsafe PrEP medications fraudulently obtained and sold to pharmacies and dispensed to patients, counterfeit oncology medicines, and counterfeit IUDs.

There was a deep dive into the recent news on how Gilead Sciences discovered $250 million of counterfeit Biktarvy and Descovy. On August 5, 2021, Gilead Sciences released a press release stating that it had become aware of counterfeit and tampered versions of Biktarvy and Descovy in the supply chain in the United States. The press release resulted from a sealed lawsuit Gilead filed against the sources of the counterfeit in July of 2021. The U.S. District Court of the Eastern District of New York unsealed the documents on January 18, 2022, revealing the details. Stakeholders discussed the reasons why patients are forced to look for alternative sources for their medications.

Additionally, significant discussion centered around the false belief that drug importation would solve ongoing issues over the amount of money Americans pay for their prescription drugs. All cost-estimates yield basically zero savings to federal publicly-financed programs, as well as little help for patients. In reality, consumers in the United States are the largest importers of counterfeit drugs via fake online pharmacies, as well as traveling over the border into Mexico (where the drug supply chain is extremely prone to nefarious activity. With respect to ordering medications online from overseas, some of that could be changing once the United States Postal Service finally implements its small package electronic notification system, which was part of the "STOP Act of 2017" (The Strengthen Opioid Misuse Prevention).

Track-and-Trace on package
Photo Source: pharmaspective.com

 The following materials were shared with retreat attendees:

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

340B Drug Discount Program:

There are probably fewer issues that generate such passion than the need to reform the 340B Drug Discount Program. Macsata (me) offered his perspective on clarifying the purpose and intent of the 340B program, including why reforming the program is in the best interest of the patient community. The program was a well-intended attempt to increase access to prescription drugs for low-income, uninsured patients, and in many ways it has succeeded in doing so. There is no doubt that the program has plugged the funding gaps for many Covered Entities – including Ryan White grantees, and Federally Qualified Health Centers – and that, by in large, federal grantees are not abusing the program to the extent done by hospitals. 

Insufficient funding increases approved by Congress coupled with the lack of buy-in from state legislatures for additional dollars has led many federal grantees to overly rely on their 340B revenue. No matter the program's success, it is no excuse to turn a blind eye to the waste, fraud and abuse that actually serves to hamper even greater patient access, nor is it fruitful to grant a pass to federal and state legislators for failing to appropriate adequate funding for public safety-net programs.

In 2021, annual 340B-related purchases by Covered Entities totaled $43.9 billion, up from only $12.2 billion only six short years ago. Whereas hospitals accounted for most of the growth,[1] federal grantees also benefited from the lucrative revenue stream. In theory, that is good news because it would mean more patients are gaining access to prescription drugs. But in practice, providers are not required by law to apply the discounted savings to patients and there are numerous reports where "charity care" offered to patients has declined over the same six year period. Ryan White grantees, however, aren't absent from program abuse, with several attendees identifying excessive executive compensation as an example. One participant rightly and repeatedly reminded the group, “there are no requirements as to how those dollars are spent.”

In fact, a recent study concluded: "Seventy-two percent of private, nonprofit hospitals had a fair share deficit, meaning they spend less on charity care and community investment than they received in tax breaks."[2] The abuses by hospitals has resulted in a growing number of pharmaceutical manufacturers to place restrictions on their 340B discounts, which isn't necessarily a good thing especially if those restrictions are inadvertently hurting federal grantees. The ADAP Advocacy Association and the Community Access National Network (CANN), back in October 2020, issued a Dear Colleague letter to our industry partners in the pharmaceutical manufacturing space surrounding HIV therapies. The letter sought a carve-out for Ryan White grantees. 

During the discussion, stakeholders kept coming back to a question one attendee asked, "Where does the patient in all of this mess?" Clearly the hospitals benefit from the program, as do federal grantees, as well as contract pharmacies and pharmacy benefit managers (PBMs). In each case, dollars can be tied directly to the program's participants measured by the revenue being reported...except for the patients. It begged the question: Is the program benefitting providers, or patients? That question became more evident because three recent studies found that consumers in the United States are burdened by $195 billion in medical debt. Yes, billion!

Generally, there was agreement that the 340B Drug Discount Program is long-overdue for an update. Diving into the specifics over what needs to be reform saw a bit more variation of opinion. 

340B Drug Pricing Program
Photo Source: CANN YouTube Channel

The following materials were shared with retreat attendees:

Editor's Note: The ADAP Advocacy Association has offered opinions on 340B over the last several years, including Industry’s Changes to 340B Drug Discount Program (April 2022), 340B – Reply Hazy, Try Again (January 2020), The Federal 340B Program: A Call to Order (March 2019), and 340B Program: Don't Throw the Baby Out with the Bathwater (March 2017)

Covid-19's Impact on Public Health:

Covid-19’s impact on public health programs remains constant, evidenced by a slew of recent news reports documenting area after area falling behind with respect to efforts on prevention, testing, and treatment. Jen Laws took the liberty of deviating the discussion away from policy issues in favor of assessing patient advocacy and provider services as a response. With concentration on sustainability and succession planning, participants reflected how the crisis phase of the pandemic highlighted not just the weaknesses in public health programs, but also re-emphasized the need for HIV advocacy to consider appropriate succession planning and mentorship, as much as our service organization partners need to find room in their budgets to hire enough staff to not burn out their existing staff. 

Reminding the audience, Laws reflected, “Because eventually Bill Arnold dies.” The statement hit home for the room’s audience, referring to the empty seat draped in the fishing vest with the AIDS red ribbon on the lapel once worn by our Lion of HIV/AIDS advocacy. The group agreed that agencies need to plan better, and they have to be willing to make these investments now, not later. 

The discussion also focused on how the Covid-19 challenges have been further complicated by the emergence of yet another public health crisis: Monkeypox. The public health infrastructure is literally at a breaking point, which isn't helped by ongoing public attacks by certain politicians seeking nothing more than soundbites. 

Sign that reads: Get Tested for COVID Today"
Photo Source: MedPage Today

The following materials were shared with retreat attendees: 

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

Additional Fireside Chats are planned for 2023.

[1] Pitts, Peter J. and Robert Popovian (Fall 2022). 340B and the Warped Rhetoric of Healthcare Compassion. Food and Drug Law Institute. Retrieved online at https://www.fdli.org/2022/09/340b-and-the-warped-rhetoric-of-healthcare-compassion/

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.
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Thursday, June 23, 2022

HIV/AIDS Fireside Chat Retreat in Wilmington, NC Tackles Pressing Issues

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

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Wilmington, North Carolina among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS. It was the first Fireside Chat in over two and a half years, after they were suspended in response to the ongoing Covid-19 pandemic. The Fireside Chat took place on Thursday, June 16th, and Friday, June 17th. Utilization Management, Ending the HIV/AIDS Epidemic (in the South), and Covid-19's Impact on Public Health were evaluated and discussed by 22 diverse leaders in the fight against the HIV/AIDS epidemic.

FDR Fireside Chat
Photo Source: Getty Images

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

  • Utilization Management: What is its Impact on Patient Access to Care and Treatment — moderated by Murray Penner, U.S. Executive Director, Prevention Access Campaign (PAC)
  • Ending the Epidemic (EHE): What is its Impact in the South — moderated by Lee Storrow, National Policy Director, Community Education Group (CEG) & Board Chair, Southern AIDS Coalition (SAC)
  • Covid-19: What is its Impact on HIV, Viral Hepatitis, Sexually Transmitted Infections (STIs), and Substance Use Disorder — moderated by Jen Laws, President & CEO, Community Access National Network (CANN) & Board Member, ADAP Advocacy Association

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:

  • Guy Anthony, Founder, Black, Gifted & Whole
  • De' Shea Coney, HepConnect Coordinator, North Carolina AIDS Action Network
  • Tori Cooper, Director of Community Engagement, Human Rights Campaign
  • Dawn Patillo Exum, Director of Public Policy, Merck
  • Jasmine Ford, HIV Clinical Coordinator, Virginia Department of Health
  • Dusty Garner, Board Member, Community Access National Network
  • Aquarius D. Gilmer, Associate Director, Corporate Policy & Alliances, Gilead Sciences
  • Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative
  • Tim Horn, Director, Health Care Access, National Alliance of State & Territorial AIDS Directors (NASTAD)
  • Venton Jones, Chief Executive Officer, Southern Black Policy & Advocacy Network
  • Jen Laws, President & CEO, Community Access National Network
  • Brandon M. Macsata, CEO, ADAP Advocacy Association
  • Judith Montenegro, Program Director, Latino Commission on AIDS
  • Murray Penner, Executive Director, North America, Prevention Access Campaign
  • Kalvin Pugh, Sr. Manager, Community Engagement at International Association of Providers of AIDS Care
  • Alan Richardson, Executive Vice President of Strategic Patient Solutions, Patient Advocate Foundation
  • Carl Schmid, Executive Director at HIV + Hepatitis Policy Institute
  • Robert Skinner, Advocate — Florida
  • Cindy Snyder, Director, Government Relations, ViiV Healthcare
  • Lee Storrow, National Policy Director, Community Education Group
  • LaWanda Wilkersaon, Advocate — North Carolina
  • Joey Wynn, Chairman, Florida HIV/AIDS Advocacy Network (FHAAN)

The Covid-19 pandemic is still ongoing, and accordingly to The New York Times (as of June 14th), “The average number of new cases in the United States fell to 98,867 yesterday, a 2 percent decrease from the day before. Since January 2020, at least 1 in 4 people who live in the United States have been infected, and at least 1 in 330 people have died” (NYT, 2022).

With that in mind, the ADAP Advocacy Association implemented strong Covid-19 safety protocols for the Fireside Chat, which included proof of vaccination/booster, robust self-administered testing (prior to travel, upon arrival, and after returning home), complimentary rapid self-test kits and hand sanitizer for each of the attendees, as well as guidelines for masks on commercial travel to the event, and optional masks during the sessions (which some attendees exercised without feeling shunned). 

At the meeting's outset, a signature fishing vest with its AIDS red ribbon owned by the late Bill Arnold, longtime President & CEO of the Community Access National Network (CANN), was gently placed on one of the chairs in the room. It was meant to symbolize that Bill would always have a seat at the table in an honorary way to pay tribute to the decades of advocacy work done on behalf of people living with HIV/AIDS dating back to the 1980s. There wasn't a dry eye in the room!

Bill Arnold's signature fishing vest with AIDS red ribbon
Bill Arnold, August 13, 1938 - September 29, 2021

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

Utilization Management (UM):

Murray Penner provided a basic overview on the managed care practice, often referred to as utilization management (or utilization review), used by payers of health services, such as commercial insurance plans, public health programs (i.e., Medicaid, Medicare, Ryan White), Veterans Affairs, and other programs. Today, patients need to be savvy, because the United States has one of the most expensive and fragmented healthcare delivery systems in the world. UM can indeed serve a purpose, but the reality is that purpose if often clouded by the pitfalls.

According to Penner: "UM is a process that payers and healthcare plans utilize to evaluate the medical necessity, appropriateness, and efficiency of the use of health care services (medicines, procedures, etc.). There are valid reasons for UM (particularly medical necessity), but UM is also often used to help contain costs and to deny coverage of high cost meds and procedures in favor of lower cost alternatives. With HIV medications, in particular, it often restricts access to medications that providers and patients have determined as necessary for appropriate care and treatment. UM practices in theory are appropriate for safety and continuity of care, but far too often they have become discriminatory and present challenges to accessing medications and remaining adherent to them."

Penner's discussion on UM started with a broad overview of the practice, including examples, clinical efficacy, and provider feedback. It also included the impacts of UM on patient access, Ending the Epidemic efforts, and viral suppression, as well as the statutory and regulatory protections and limitations. 

Prior authorization is probably the most commonly-known technique exercised by payers, but many others exist. An important part of the conversation centered around a recent survey on prior authorization released by the American Medical Association (AMA), 2021 AMA prior authorization (PA) physician survey.  

The survey found, sadly, that one in four patients often abandon their recommended course of treatment, and a staggering "82% report that PA can at least sometimes lead to treatment abandonment." The survey focused on patient impact, but it also featured relevant information on physician impact and employer impact. The survey results can be found online at https://www.ama-assn.org/system/files/prior-authorization-survey.pdf.

Abandoned treatment associated with PA - Q: How often do issues related to the PA process lead to patients abandoning their recommended course of treatment?
Photo Source: American Medical Association

Patients needing to complete eligibly "recertification" under the State AIDS Drug Assistance Program (ADAP) was also a hot topic of conversation. Most States require the bureaucratic red tape be rolled-out every six months, which is widely accepted as unnecessary. Fortunately, some flexibility was recently authorized by the Health Resources & Services Administration (HRSA) on the ADAP recertification process. The Virginia Department of Health, for example, is extending their program recertification to every 24 months!!!

Other UM-related issues discussed included drug formularies, convoluted Rx refill cycles, safety protections afforded to patients (i.e., drug contraindications), and the "prescriber prevails" provisions under New York Medicaid.

The following materials (partial list) were shared with retreat attendees:

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

Ending the HIV Epidemic (in the South):

The Ending the HIV Epidemic (EHE) in the United States initiative has been front and center among HIV advocacy circles since it was announced during a previous president's State of the Union. According to the U.S. Centers for Disease Control & Prevention (CDC), "The EHE initiative is scaling up four science-based strategies that can end the epidemic: Diagnose, Treat, Prevent, and Respond. For maximum impact, CDC is continuing to invest in communities most affected by HIV — to help local HIV programs recover, rebuild, and begin to expand EHE strategies in the wake of COVID-19."

Lee Storrow summarized it more clearly as, "Refocusing limited resources to target the hot spots." Despite the EHE initiative being characterized by some advocates as off to a middling start, it does still represent the first new influx of significant federal dollars in quite some time. Of particular importance to this discussion was EHE's footprint in the South (and Appalachia), which is disproportionately impacted by HIV/AIDS.

Of course, one of the biggest - and still ongoing - topics of intense conversation center around why some apparent hot spots are included under the EHE initiative, while others were excluded. For example, West Virginia. Neither West Virginia nor any of its 55 counties were included as Phase 1 jurisdictions of the EHE initiative. Considering the state has two enduring, intertwined epidemics, West Virginia's exclusion highlighted some of the initiative's shortcomings.

According to Storrow: "The participants of the fireside chat had a wealth of big ideas about how we could make a big impact when it comes to HIV rates in the South and Appalachia. Ending the Epidemic isn’t just a reference to the plan and funding source, it’s a mindset to catalyze new energy and bring new resources to bare to combat HIV. When I was working in HIV advocacy in North Carolina, we took advantage of the moment in time the announcement of the federal EHE created to get new state funding from the NC General Assembly. We’ve got to leave it all on the line and leave no stone unturned to make sure the HIV advocacy community has the resources and tools to get this work done."

Storrow's discussion on EHE (in the South) included a history of the initiative, as well as where we are today fighting the epidemic in the South and in Appalachia. Discussions centered around targets (and whether they'll be met), disruptions caused by Covid-19, state-level EHE plans, and future federal EHE expansion to include other jurisdictions.

THE SOUTHERN EPIDEMIC: Are the South's cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs, to function effectively in this region?
Photo Source: ADAP Advocacy Association

Storrow also used the session to raise awareness about the Opioid Settlement Plans that are currently unfolding nationwide. It led to a lively conversation about how those settlement dollars could be leveraged to boost public health programs that specifically impact HIV, viral hepatitis, sexually-transmitted infections, and substance use disorder programs.

Other EHE-related issues discussed included social determinants of health, and ongoing challenges to achieve better health equity.

The following materials were shared with retreat attendees:
The ADAP Advocacy Association would like to publicly acknowledge and thank Lee for facilitating this important discussion.

Editor's Note: In May 2014, the ADAP Advocacy Association published an issue brief, "THE SOUTHERN EPIDEMIC: Are the South's cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs, to function effectively in this region?" Ironically, many of the topics raised during the EHE (in the South) session were raised nearly ten years ago in our issue brief. The issue brief can be downloaded here.

Covid-19's Impact on Public Health:

In early 2021, Jen Laws penned a blog evaluating the mess being caused by the Covid-19 pandemic. At that time, Laws argued, "Covid-19 has also clearly highlighted the impact of social determinants of health and health disparities of which HIV and HCV [Hepatitis C] advocates have long been aware." He was right, and unfortunately not much as changed 18 months later.

According to Laws: "Public health has taken on new, both exciting and unfortunate, shapes as a result of our collective responses to Covid-19. The expanded use of telemedicine has helped modernize our access to care while also leaving those in more rural areas and impoverished communities of the country at distinct disadvantage due to lack of infrastructure, threatening to widen already existing health disparities. Defining a still shifting landscape as Covid-19 related flexibilities and legal changes, presents numerous challenges to public health as an industry and public health professionals will be digesting these changes and challenges for years, if not decades, to come. This is as true, if not more true, for pre-Covid-19 public health programs focused on infectious disease, including STIs, HIV, and viral hepatitis, as these infrastructures and personnel continue to face uncertain futures in politically hostile environments."

Laws' discussion on Covid-19 impact included background context on the state of public health programs pre-Covid-19, as well as related changes to public health and public health programs. It included discussion on the current and future state of the public health programs important to the HIV community. Some of the key questions asked included: What changes do we want to keep? What changes do we need to do away with? How do we evaluate the paradigm shift in publics' mood toward public health (i.e., anti-science, anti-vaccination)?

CDC HIV surveillance report
Photo Source: CDC

The stated goal of the session was "to define the impacts of COVID-19 on public health infrastructure and programs." It celebrated flexibility and innovation offered by various temporary governmental regulation and the “forced modernization” of health care in many situations – namely, telehealth. Of dire concern, however, are these flexibilities are threatened to end as the public health emergency winds down, including the continuous coverage requirement for Medicaid programs under the public health emergency declaration. Some attendees also stressed that there are downsides to relying on telehealth, especially for rural communities lacking the necessary infrastructure to make health care accessible.

CDC's own HIV surveillance data proves earlier Covid-19 concerns, which was regularly noted.

The following materials (partial list) were shared with retreat attendees: 

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

Additional Fireside Chats are planned in September 2022 (Chicago, Illinois).

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.
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