CANN Hosts 3rd Annual Community Roundtable on Correctional Hepatitis

By: Marcus J. Hopkins, Policy Consultant

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

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

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

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

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

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

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

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

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

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

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

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

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

Contact CANN to learn more.

References:

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

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

HIV/AIDS Fireside Chat Retreat in California Tackles Pressing Issues

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

The ADAP Advocacy Association hosted an HIV/AIDS "Fireside Chat" retreat in Monterey, California among key stakeholder groups to discuss pertinent issues facing people living with HIV/AIDS. The Fireside Chat took place on Thursday, March 28th, and Friday, March 29th. The 340B Drug Discount Program, Medicare's Six Protected Classes ("6PC"), and the Ryan White HIV/AIDS Program ("RWHAP") were dissected 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:

• 340B Program Reform: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions, moderated by Jeffrey R. Lewis
• Medicare’s Part D Six Protected Classes: Proposed Changes Could Harm the Most Vulnerable Patients, moderated by Tim Vaske
• Ryan White Program: Ensuring the Sustainability of Community-Based Programs, moderated by Robert Skinner

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:

• Evelyn Alvarez, Chronic Disease Prevention Coordinator, Monterey County Health Department (**unable to attend**)
• Tez Anderson, Executive Director & Founder, Let’s Kick ASS (AIDS Survivor Syndrome)
• Guy Anthony, President & CEO, Black, Gifted & Whole Foundation
• Jovan Antunovic, Senior V.P. and Chief Commercial Officer, Theratechnologies
• William E. Arnold, President & CEO of the Community Access National Network (CANN)
• Noel Chavez-Guizar, Medical Case Manager, Servicios de La Raza
• Hilary Hansen, Executive Director, Advocacy & Strategic Alliances (US), Merck
• Andrew Herbert, Policy Team, Gilead Sciences
• Hema Kapoor, MD, Medical Director, Infectious Diseases/Immunology, Quest Diagnostics
• Jeffrey R. Lewis, President & CEO, Legacy Health Endowment
• Shayna Linov, Fiscal Health Manager, HealthHIV
• Brandon M. Macsata, CEO, ADAP Advocacy Association
• Kassy Perry, President & CEO, Perry Communications Group
• Robert Skinner, President & CEO, Valley AIDS Information Network
• Brian Smith, Government Affairs, Biotechnology Innovation Organization 
• Kristen Tjaden, Community Government Relations Director, ViiV Healthcare
• Tim Vaske, Senior Director for Advocacy and Strategic Alliances, PhRMA
• Jennifer Vaughan, Founder, Facebook Women’s HIV+ Support Group
• LaWanda Wilkerson, patient advocate
• Marcus A. Wilson, National Policy & Advocacy Director, Johnson & Johnson

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

340B Program:

The discussion on the 340B Drug Pricing Program (hereafter "340B program") was facilitated by Jeffrey R. Lewis, who co-chaired the Community Access National Network's 340B Commission. Unlike all other federal health programs, the costs of the 340B program are born by the pharmaceutical industry. The 340B program requires pharmaceutical manufacturers that participate in Medicaid and Medicare (Part B) programs to provide discounts on covered outpatient medicines to nonprofit healthcare providers (Covered Entities) licensed to provide care under the 340B program. When the 340B program was created, many uninsured patients used hospital emergency rooms for primary care; nonprofit hospitals were often paying for the needed medications to keep the patient from showing up again; and, the cost impact on the hospitals was rising. Congress wanted to ensure that nonprofit healthcare providers could stretch limited dollars. So, the 340B program was designed to aid that effort.[1]

Much has changed in the healthcare landscape since the inception of the 340B program. As such the issues discussed included clarifying the purpose and intent of the 340B program. It asked tough questions, such as should Covered Entities be accountable for how they use 340B program savings, and has the program grown too rapidly or is it too large? It reviewed the growth of Contract Pharmacies, as well as duplicative discounts, and payer discrimination. What authority is needed to better manage the 340B program, and what about updating the patient definition (who are 340B patients) were also questions on the table.

The following materials were shared with retreat attendees:

• CANN 340B Commission’s final report 
• CANN 340B Commission’s background materials

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

6PC:

Tim Vaske, Senior Director for Advocacy and Strategic Alliances with the Pharmaceutical Research and Manufacturers of America ("PhRMA") opened the discussion with an analogy to Article V of the NATO treaty, whereby an attack on one member is considered an attack on all. The same can be said for 6PC!

Photo Source: The National Council

In Medicare Part D, the six protected classes policy protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness.  Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions.[2]

Some background information was reviewed, including a description of the proposed rule and some of the rationale used by the U.S. Department of Health & Human Services ("HHS"), overview of prior authorization, and step therapy. The discussion challenged whether the price controls within the proposed rule which would potentially restrict access for patients, and asked about the impact the proposed rule could have for people stable on their medications, including people taking medications for HIV and/or mental illness. Finally, there was speculation about the potential timeline, if finalized.

Significant attention was dedicated to the ongoing 6PC advocacy efforts, especially since there is broad opposition to the proposed rule. Additional discussion focused on how the 6 PC proposed rule is counter to other Administration action around HIV prevention and treatment, as well as identified engagement opportunities.

The following materials were shared with retreat attendees:

• Partnership for Part D Access – Fact Sheet: CMS Proposal Erodes Patient Protections for Medicare’s Six Protected Classes
• Partnership for Part D Access – Comment Letter
• RealClearHealth, “Providers Should Call The Shots In Mental Health Care, Not Insurers” – Patrick Kennedy (3/6) 
• Miami Herald, “Trump Wants To End HIV Transmission By 2030. That Means, He Should Withdraw Proposal That Undercuts Treatment” – Smith & Acosta (2/19) (Equality Florida)

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

Ryan White Program:

The Ryan White HIV/AIDS Program and Ryan White-funded supports and services have been the cornerstone of the public health system assisting underserved populations living with HIV-infection. Yet, Ryan-White-funded AIDS Service Organizations ("ASOs") and Community-Based Organizations ("CBOs") have increasingly found themselves challenged to remain financially solvent in today's rapidly changing healthcare environment. The unevenness of the Affordable Care Act's ("ACA") Medicaid expansion has made the challenge even more cumbersome.

The discussion centered on how ASO’s and CBO’s have the potential to play a significant role in changing from a disease model to a wellness model, with respect to the HIV care continuum. With that in mind, it asked what kinds of system changes are needed to incorporate more client concerns and improve service delivery? What pushback would result?

It is essential that Ryan White-funded ASOs and CBOs find new ways to thrive in a changing environment. Some of the conversation focused on what would these changes look like, as well as where they are already underway. Finally, some attention was directed to Administration’s recently unveiled plan to eliminate HIV/AIDS, while at the same time calling for an end to the ACA.

The following materials were shared with retreat attendees:

• Enhancing the Sustainability of Ryan White-Funded AIDS Service Organizations and Community-Based Organizations
• Health Systems Integration: Provider Sustainability
• HRSA: Goals and the Future of the Program 

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

Additional 2019 Fireside Chats are planned in Detroit, Michigan, and Richmond, Virginia, and New York, New York.

__________
[1] Lewis, Jeffrey R. & William E. Arnold. (2019, March 28). The Federal 340B Program: A Call to Order. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/03/the-federal-340b-program-call-to-order.html.
[2] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.

Reflections from an HIV Advocate's Journey: David Pable

By: David Pable, Community Co-Chair, South Carolina HIV Planning Council

In June of 2002, I was ready for my life to end. I was married and had wonderful children, but I was unable to live the lie I had created by trying to live a straight life. I thought the only thing to do would be ending my pretend life.

During that next 6 months I met someone, and he encouraged me find a counselor and that helped me tremendously for a while. But, in January of 2003, he took his own life. I was devastated, obviously. He had helped talk me off of the ledge. I would have loved to have been able to do the same for him.

I found out the day after he passed away that he had HIV and by June a year later, I too, found out that I had HIV. Once again, I fell into depression and saw no hope for the future. There had been bouts with substance abuse that I kept secret and I had lived in state of denial for many years.

They say that time heals all wounds, and little by little and with a lot of help from the Ryan White Program in Charleston, SC, my excellent psychiatrist along with my therapist, I was able to piece things back together enough to want to live. It took about seven years for me to realize that one of the most tragic moments of my life had been the seed for change within me.

The clinic where I received care was forming a community advisory board and I was asked to chair it. I was so happy to be able to be part of this at the time and it also inspired me to be more present at other group events they held at the clinic. By attending such events, I met my partner, Rick. I remember thinking: he is not leaving here without my phone number! We have been together almost 7 years now.

I have volunteered at our local AIDS Walk and Art for Charity by donating some of my paintings. I found myself making more and more friends who were also advocates and together we joined the SC HIV Taskforce, and SC HIV Planning Council, of which I am the current Community Co-Chair.

In 2013, I went to the United Stated Conference on AIDS (USCA), held in New Orleans. I was blown away with how many advocates attended this event and really began to see how we can all inspire each other. So many people at this conference who at the time were strangers to me, have had an impact on my life in positive, productive and compassionate ways. I alone cannot do much in this world, but myself along with this patient and persistent group of advocates, we can change the world a little bit each day.

Author Carolyn Myss says: “Once we are awakened to something - a truth or injustice - we are held accountable and must take action according to that truth."

Once I returned from USCA, I really got involved with advocacy through the SC HIV Task Force by advocating at our State House for Medicaid expansion, as well as being involved with planning community forums around the state to educate the public on what Medicaid expansion would mean to the people of South Carolina. To date we have not expanded Medicaid, but I believe we should keep our eye on the brass ring…

I went to AIDSWatch in the early part of 2014 for the first time, and once again I was surrounded by a group of people from over 30 states who were there to talk to and advocate for people living with HIV.  I believe we had 12 people from South Carolina. I have been there multiple times since then and plan on going again in the future.

I have a few friends that I have been blessed with and we together have gone to events like HIV is Not A Crime, ADAP Advocacy Association Annual AIDS Drug Assistance Program Conference, and Positive Living Conferences. Each time, I learn from my peers about how I can become a better advocate.

I am very thankful to and have learned so much from the conferences over the last few years. There are so many things I have been able to bring back to our planning council and also to those in the community after attending these events.

Ghandi said “Be the change you wish to see in the world.” I think about this often and I thank God for giving me an opportunity to change and grow in positive ways, and I know he has done so through all the amazing advocates i have met over the years.



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.

Bipartisan lawmakers urge Administration to rethink proposed changes to six protected classes policy

By: Tom Wilbur, Director of Public Affairs, PhRMA

Reprinted with Permission from the Pharmaceutical Research and Manufacturers of America

At the end of 2018, the Centers for Medicare & Medicaid Services (CMS) introduced a dangerous proposed rule that would weaken the Medicare Part D six protected classes policy. The six protected classes policy covers patients whose conditions – like HIV, cancer, and epilepsy among others - are treated with medicines covered under six specific drug classes. The proposed rule would weaken the six protected classes policy by allowing increased use of step therapy or utilization management, including for patients already stable on a medicine. This practice is meant to reduce drug costs by requiring patients to begin treatment with a therapy preferred by the insurer before they can access the one their doctor thinks will work best for them.

Since the proposed rule was released, patient groups and advocates — particularly those representing patients with the diseases and conditions treated by medicines in these classes— have come out strongly against the proposed rule changes. Now, Members of Congress from both sides of the aisle are expressing their concerns as well because of the potential negative impacts on patients’ health.

Last week, a bipartisan group of 73 Members of Congress, led by Congresswoman Barbara Lee and Congressman Will Hurd, sent a letter to Health and Human Services Secretary Alex Azar asking the Secretary to withdraw a proposal that would modify the Part D program protections afforded to the six classes of drugs. The Members write, “We are concerned that prior authorization and step therapy requirements could have devastating public health outcomes for those receiving treatment of HIV and the additional five protected classes. Considering the public health implications of the proposed changes to Part D protected classes related to prior authorization and step therapies – we respectfully request that you withdraw the relevant provisions of the rule.”

The bipartisan Congressional Mental Health Caucus, led by Congresswoman Grace Napolitano and Congressman John Katko, also pushed back against the rule in a letter – signed by 39 Members of Congress – to Secretary Azar. The letter states, in part, that the proposed changes are “particularly worrisome” for Medicare beneficiaries living with mental illness.

In the Senate, Senators Marco Rubio and Krysten Sinema led a bipartisan letter alongside more than a dozen Senators outlining reasons the proposed rule should be reconsidered. In the letter, they note how the rule would not just adversely affect HIV patients but also cancer patients needing “highly personalized therapies;” schizophrenia and depression patients who “often struggle to find a medicine that works for them and could risk relapse if forced to switch to alternatives;” epilepsy patients who “often find that only one treatment works for them and any disruptions in treatment could increase the likelihood of seizures;” and organ transplant patients who have “complex medical needs and should not be required to jump through hoops in order to prevent transplant rejection.”

Bipartisan lawmakers, on both sides of aisle and on both sides of the Capitol, clearly oppose this proposed rule because for over 10 years, one of the cornerstones of the Medicare Part D program has been to ensure the sickest and most vulnerable patients have access to the clinically critical medicines they rely on. Letting plans restrict access for some of the sickest and most vulnerable Part D beneficiaries would reduce adherence to those medicines, jeopardize their health, increasing their need for medical care and result in poorer health outcomes and potentially higher costs for seniors and Medicare.

Visit PrescriptionForMedicare.org to learn more.

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.