Bad Medicine Prescribed by the Trump Administration, Putting Health Insurers before Patients

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

Earlier this week the Centers for Medicare & Medicaid Services ("CMS") issued the final Notice of Benefit and Payment Parameters for the 2021 benefit year, also referred to as the 2021 Payment Notice. CMS hailed the announcement as continuing "the Trump Administration's efforts to promote affordability, improve consumer choice, ensure program integrity, and increase market stability," yet it was met with strong criticism from the patient advocacy community. The ADAP Advocacy Association blasted the Trump Administration for putting the deep pockets of the health insurance industry before the needs of patients living with chronic health conditions, such as HIV/AIDS.

Photo Source: Patients Rising Now

Most troubling for patients is the decision allowing health insurance companies to disallow drug manufacturer co-pay assistance programs towards patient out-of-pocket cost sharing and deductibles.
Co-pay savings programs are offered by drugmakers, thereby reducing out-of-pocket costs for patients. Some programs, such as co-pay coupons are typically for "expensive, brand name drugs without a generic equivalent" (Chase, 2019).

According to a statement issued by Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, "In 2018, drug manufacturer copay assistance totaled $13 billion, according to data from IQVIA. The new rule is a complete reversal of the administration's policy announced last year that required copay assistance to count for brand name drugs that do not have a generic."

That sentiment was echoed by Bill Remak, chair of the International Association of Hepatitis Task Forces: "This is a major setback for patients living with viral hepatitis and related diseases and will effectively raise patient costs and reduce access to critical medications. On behalf of the millions of people living with viral hepatitis, we urge the Trump Administration to reverse this rule and not adopt policies that do not count copay assistance toward their deductible and annual out-of-pocket limit. With the COVID-19 pandemic, this move creates even more barriers preventing patients from getting the medications they need."

Twitter also was filled with condemnation from the patient advocacy community, including rebukes from the Community Access National Network (CANN) and The AIDS Institute.

The PAN Foundation warned disallowing co-pay accumulator programs will hurt vulnerable patients by shifting the cost burden over to them.

According to Patients Rising Now ("PRN"), "patient assistance programs are providing free medications, expanding patient support services and increasing access to care as a way to help millions of patients struggling to pay the bills during the COVID-19 pandemic." PRN characterized the decision by CMS as flawed and asked that they reconsider the final rule.

The All Copays Count Coalition - representing a broad spectrum of patient groups - sent a letter to HHS Secretary Azar prior to the final rule urging HHS to reconsider the co-pay provision. It obviously fell on deaf ears because the Trump Administration sided with the greedy health insurers rather than the patients who need the financial assistance.

A copy of the 2020 Final Payment Notice can be downloaded online: https://www.cms.gov/newsroom/press-releases/cms-announces-final-payment-notice-2021-coverage-year.

References:

• Chase, Lauren (2019, September 16). What Are Manufacturer Copay Cards? GoodRx. Retrieved online at https://www.goodrx.com/blog/what-are-manufacturer-copay-cards/. 
• Centers for Medicare & Medicaid Services (2020, May 7). CMS Announces Final Payment Notice for 2021 Coverage Year. Retrieved online at https://www.cms.gov/newsroom/press-releases/cms-announces-final-payment-notice-2021-coverage-year.
• Remak, Bill (2020, May 8). On May 7, 2020, the Centers for Medicare and Medicaid Services (CMS) released its final 2021 Notice of Benefit and Payment Parameters rule. LinkedIn. Retrieved online at https://www.linkedin.com/pulse/may-7-2020-centers-medicare-medicaid-services-cms-released-bill-remak/.
• Schmid, Carl (2020, May 7). Trump Administration Shocks Patients By Allowing Insurers to Increase Cost of Prescription Drugs. HIV+Hepatitis Policy Institute.

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

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

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

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

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

Photo Source: Sermo

How Many People Will Be Affected by the Changes?

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

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

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

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

How Does Co-Pay Assistance Help Those with HIV?

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

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

What is the Likely Fallout from These Proposed Changes?

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

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

Photo Source: Novartis

Help Us to Creat Change!

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

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

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

References:

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

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

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.

Hepatitis on the Hill

By: Emily Stets, Program and Policy Associate, National Viral Hepatitis Roundtable (NVHR)

Imagine a room filled with over a hundred people from around the country, all wearing name badges, mingling in small groups and with purple folders tucked under their arms. Purple shoulder bags emblazoned with Hepatitis on the Hill are scattered around the room, straps hanging off the backs of chairs, and many participants have donned little Hepatitis on the Hill pins on their lapels.

This type of event may not seem uncommon in HIV advocacy, where inspiring events like AIDSWatch constitute the nation’s largest constituent-based national HIV/AIDS advocacy event. However, such events have only just begun to take off for the viral hepatitis community, where the urgent need for national stakeholders to address the viral hepatitis pandemics has heightened in the past few years.

Hepatitis B and C are distinct blood-borne viruses transmitted through blood-to-blood contact. Left untreated, the viruses attack an individual’s liver, and represent the leading cause of liver cancer in the United States.[1] The CDC’s March 2016 Report to the Nation on the Status of Cancer indicated that while the rate of most cancers in the U.S. have declined, liver cancer has increased 2.3% between 2003 and 2012. The report notes hepatitis C as a major contributing factor to liver cancer, and cited that 25% of people with hepatitis B develop serious liver problems, including liver cancer.

For many reasons, there is an urgent need for the viral hepatitis movement to unite and bring advocates together on a national stage. Alarmingly, recent data from the CDC has shown that deaths associated with hepatitis C surpassed deaths associated with all fifty-nine other notifiable infectious diseases combined.[2]

Rising Mortality Associated with HCV in the U.S.

The opioid and heroin epidemics are fueling the spread of new hepatitis B and C infections among people who inject drugs (PWID) across the country. Though many officials focused on HIV outbreak in Scott County, Indiana, a CDC report shows that 85% of PWID who contracted HIV were also coinfected with hepatitis C. Due to similar routes of transmission, studies show that about 25% of all people with HIV also have chronic hepatitis C, and 10% of people with HIV are living with hepatitis B.

Hepatitis B disproportionately affects the Asian American/Pacific Islander (AAPI) community.  While AAPIs make up less than 5% of the total U.S. population, they account for more than 50% of Americans living with chronic hepatitis B. We also continue to see perinatal transmission of hepatitis B despite having a safe and effective vaccine to prevent the disease. Community organizations struggle to address these vast disparities within the populations they serve with finite resources.

To address the necessity of uniting advocates, three national coalitions took action. This March, Hep B United (HBU), the Hepatitis Appropriations Partnership (HAP), and the National Viral Hepatitis Roundtable (NVHR) coordinated an event similar to AIDSWatch called Hepatitis on the Hill (HOTH). Over a two-day period, over one hundred constituents from twenty-seven states descended on Capitol Hill to educate their legislators on the impact of hepatitis B and C in their communities.

Throughout the event, advocates from across the nation engaged in conversation about the importance of screening, education, and treatment access, as well as the barriers they face in addressing these issues in their communities.

A key part of HOTH included networking, connecting advocates with resources, and framing constituents’ experience with viral hepatitis for legislators. In practicing their stories through role-play, participants prepared to ask their legislators to:

1. Support increased funding for the Division of Viral Hepatitis at CDC in the FY 2017 LHHS Appropriations Bill.
2. Urge legislators to maintain the modified syringe language included in the FY 2016 Appropriations Bill, which allows syringe service programs to use federal funds to support existing organizational efforts, though not to specifically purchase syringes.

Another highlight of the event was the participation of Dr. John Ward, the Director for the Division of Viral Hepatitis (DVH) at the CDC, and Dr. Rich Wolitski, the Acting Director from the Office of HIV/AIDS and Infectious Disease Policy (OHAIDP). Participants had the opportunity to engage in conversation with these officials, and a special forum allowed advocates the opportunity to provide Dr. Wolitski with input on the planned update of the HHS Viral Hepatitis Action Plan.

These parallel events in the viral hepatitis and HIV communities highlight the overlap between these movements that serve populations living with certain infectious diseases, particularly with HIV and hepatitis B and C. The rates of HIV, HBV, and HCV coinfection remind us that these movements are not separate from one another, but interconnected. At this stage of these pandemics, there is enormous potential for collaboration and resource-sharing to combat HIV and viral hepatitis.

We encourage you to join the fight and explore how HIV and viral hepatitis coinfection impacts the population you serve. There are many ways to connect with others working in hepatitis! Here are a few:

Want to become more involved in hepatitis and appropriations?

Visit the Hepatitis Appropriations Partnership’s (HAP) website to learn more!

Want to connect with other organizations working in viral hepatitis?

Join NVHR and follow us on Facebook and Twitter!

Want to be involved with hepatitis B?

Visit www.hepbunited.org for more information, and follow HBU on Facebook and Twitter!

[1] Perz, J. F., Armstrong, G. L., Farrington, L. A., Hutin, Y. J., & Bell, B. P. (2006). The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. Journal of hepatology, 45(4), 529-538.
[2] Ly, K. N., Hughes, E. M., Jiles, R. B., & Holmberg, S. D. (2016). Rising Mortality Associated with Hepatitis C Virus in the United States, 2003-2013.Clinical Infectious Diseases, ciw111.

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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.