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Health Advisory Council Newsletter | Summer 2021

Updates from our Members

America’s Health Insurance Plans (AHIP)

Biotechnology Innovation Organization (BIO)

CDC PROTECT | Centers for Disease Control and Prevention (CDC)

Consumers for Quality Care (CQC)

Deterra Drug Deactivation and Disposal System

FDA Office of Women’s Health

Healthcare Distribution Alliance (HDA)

Hepatitis B Foundation

The Pill Club

America’s Health Insurance Plans (AHIP)

Health insurance providers helped vaccinate more than *2 million seniors against COVID-19 in under 100 days as a result of the Vaccine Community Connectors (VCC) program. The VCC program is a public-private partnership including more than 50 health insurance providers which was initiated to encourage the vaccination of people over the age of 65 in socially vulnerable communities. In a recent USA Today op-ed, AHIP CEO Matt Eyles and Humana CEO Bruce Broussard discussed lessons learned from the VCC campaign and highlighted the need to focus on and overcome social barriers to health care to improve health equity.

AHIP continues to encourage consumers to enroll in health coverage through the current Marketplace Special Enrollment Period (SEP), which runs through August 15th. In a *recent blog post co-authored by Kelley Schultz, Executive Director of Commercial Policy for AHIP and Jeanette Contreras, Director of Health Policy for the National Consumers League, AHIP and NCL highlighted the expanded financial assistance that the American Rescue Plan Act of 2021 made available during the current SEP. Thanks to this legislation, 3.7 million Americans are now eligible for financial assistance to make premiums more affordable, including people who didn’t qualify for financial assistance before. This blog follows previous AHIP SEP resources for consumers including an *SEP Decision Tree, as well as a *blog post and *factsheet on navigating the SEP.

The Coalition Against Surprise Medical Bills, of which AHIP is a founding member, released a statement in response to the Biden Administrations’ Interim Final Rule, applauding the Administration’s desire to fully protect patients and its reinforcement of the patient protections in the No Surprises Act. The Coalition also urged the Administration to reinforce the importance of the qualified payment amount for final payment determinations, and limit potential abuse and misuse of arbitration by out-of-network providers and private equity firms.

To learn more about AHIP or health insurance providers’ actions to encourage Americans to get vaccinated against COVID-19, guide consumers during the SEP, and protect patients from surprise medical bills, and contact Nicole Eynard at neynard@ahip.org.

Biotechnology Innovation Organization (BIO)

Here’s an update from the team at BIO – a link to a recent op/ed BIO’s CEO, Dr. Michelle McMurry-Heath penned along with Linda Goler Blount, President and CEO of the Black Women’s Health Imperative. The publication explores strategies to encourage vaccine acceptance and uptake in Black communities by leveraging the unique position Black women hold in their communities to foster trust and vaccine confidence. To read the op-ed, click *here

CDC PROTECT | Centers for Disease Control and Prevention (CDC)

Please mark your calendars for the 14th annual meeting of the PROTECT Initiative (PRevention of Overdoses and Treatment Errors in Children Taskforce) which is currently scheduled for November 4-5, 2021. The PROTECT meeting provides a forum for reviewing new data, sharing updates on progress, and identifying priority action items for reducing medication exposures and other overdoses among young children. Additional details about the meeting will be shared in the coming months. For more information about the PROTECT Initiative please visit: *www.cdc.gov/medicationsafety/protect/protect_initiative.html or contact Jennifer Lind (vox2@cdc.gov).

Consumers for Quality Care (CQC)

Consumers for Quality Care (CQC) and 17 patient and consumer advocacy groups, including the National Consumers League, sent a letter to the U.S Department of Health and Human Services (HHS) Secretary Xavier Becerra and the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure calling for swift action to address policy and regulatory concerns to improve access to affordable, quality care for all Americans. The letter raises concerns around disturbing trends in insurer coverage denials of emergency room visits later deemed non-urgent, junk insurance plans that offer inadequate coverage, and harmful co-pay accumulator adjustment programs. The letter also calls for the continuance of telehealth visit coverage by insurers and pushes for HHS and CMS to improve Medicaid access by removing harmful provisions granted through the waiver process limiting quality, affordable coverage. Read the full letter here.

Deterra Drug Deactivation and Disposal System

More than 93,000 drug overdose deaths were reported in 2020 – a nearly 30% increase from 2019. These numbers have brought a renewed focus on America’s opioid crisis and the need for evidence-based prevention solutions. Healthcare providers play an essential role in reducing the number of opioids available for misuse through prescribing guidelines and by educating patients about the importance of proper disposal of unused medication.

Twin Cities Orthopedics, the Midwest’s largest orthopedic-physician group, has doubled the safe disposal behavior of patients by providing them with the Deterra® Drug Deactivation and Disposal System, a safe at-home medication disposal system that renders drugs inert and safe to discard in the household trash. In addition, the inclusion of a tangible, at-home disposal resource has resulted in higher reported patient satisfaction levels and lower reported pain levels. A case study detailing how Twin Cities Orthopedics is using Deterra to educate and protect patients is available on DeterraSystem.com.

Food and Drug Administration (FDA) – Office of Women’s Health

The FDA Office of Women’s Health held a webinar on May 20 to discuss COVID-19 vaccines and their use in women. The webcast recording can be viewed here.

In honor of Fibroid Awareness Month in July 2021, The FDA Office of Women’s Health (OWH) worked to bring broader awareness to this common yet often under discussed health condition.

OWH welcomed Dr. Erica Marsh, Associate Professor and Chief of the Division of Reproductive Endocrinology, and Infertility in the Department of OBGYN at the University of Michigan as the featured scientific seminar series speaker. Dr. Marsh presented a very informative seminar to FDA highlighting not only the severe physical outcomes, but also the serious emotional and psychosocial consequences that can impact women suffering from uterine fibroids. Staff from OWH also shared their personal journeys with uterine fibroids in the July blog post.

Throughout the month of August, our office will be focused on giving women the tools and information to help them #KHOWHmore about the benefits of breastfeeding, how to safely handle breast milk, and more in honor of National Breastfeeding Month. Attached, please find social media sample messages you can share with associated graphics you can download here. You can also find a dedicated blog post on our website at www.fda.gov/OWHblog.

FDA OWH also hosted a Twitter FAQ on Wednesday, August 11 at 1pm ET, where we provided answers to commonly asked questions through the @FDAWomen Twitter account. Join the conversation by using #KHOWHmore and #NationalBreastfeedingMonth.

Healthcare Distribution Alliance (HDA)

In June, the Healthcare Distribution Alliance (HDA) sponsored the Milken Institute’s 2021 Future of Health Summit. As part of the event, HDA President and CEO Chip Davis participated in a panel discussion entitled, “Medical Supply Chains During the Pandemic: Lessons Learned & Best Practices”.

The discussion, moderated by STAT’s Nicholas Florko, focused on COVID-19’s impact on the pharmaceutical supply chain and what must be done to prepare for future emergencies. Additional panelists included *Dr. Nicolette Louissaint, Executive Director at Healthcare Ready; Bill Peacock, Chief of Operations at Cleveland Clinic; and Matthew Wilson, Senior Partner at McKinsey. Watch a recording of the full panel discussion here.

This year’s Future of Health Summit featured insightful policy discussions on a variety of issues that are shaping healthcare in our country. You can explore and access other sessions here.

For additional information about HDA and the value the distribution industry brings to its supply chain partners, providers, communities and ultimately patients, visit: HealthDelivered.org.

Hepatitis B Foundation

On August 11, the Hepatitis B Foundation hosted a webinar to discuss the cost-effectiveness of a one-time universal screening for chronic hepatitis B infection among adults in the United States. Despite CDC and U.S. Preventive Services Task Force recommendations to screen adults at high risk for infection that have been in place for over a decade, a significant majority of people (~65-75%) remain undiagnosed. Dr. Mehlika Toy from the Asian Liver Center at Stanford University School of Medicine will provide a background on current screening practice, barriers and challenges and discuss results of a study to assess the economic and public health impact of a one-time universal screening of the general adult population for chronic hepatitis B infection in the U.S. 

July 28 was World Hepatitis Day! To recognize the nearly 300 million people around the world who are living with chronic hepatitis B, the Hepatitis B Foundation led a virtual week of advocacy from July 21 to July 28. Advocates were encouraged to complete a list of actions to raise awareness about hepatitis B, highlight its impact around the world, and help drive progress towards elimination. The calls to action included sharing hepatitis B information and resources on social media, reaching out to legislators and government officials to provide them with hepatitis B educational materials, promoting hepatitis B advocacy priorities, and more. You can join our B the Change Advocacy Action Center to continue receive the latest hepatitis B policy/advocacy updates and action alerts!

On a federal level, the Congressional Hepatitis Caucus co-chairs, Representatives Grace Meng (NY-6) and Hank Johnson (GA-4), introduced a resolution recognizing World Hepatitis Day.  The resolution is intended to: 1) highlight the global nature of chronic viral hepatitis epidemics; 2) recognize that hepatitis can be prevented and eliminated in part through a comprehensive public education and awareness campaign 3) inform patients about new treatments that are available for hepatitis; and 4) help increase the length and quality of life for people diagnosed with chronic hepatitis B and hepatitis C infections. Additionally, the resolution calls for a robust governmental and public health response, and urges CDC to partner with State and local health departments to increase the rate of hepatitis B adult vaccination and hepatitis C treatment. You can view the resolution *here.

The Pill Club


The Pill Club promoted the Special Enrollment Period during the Young Adult Week of Action with an educational blog series and accompanying social media posts as well as influencer activations and paid ads (see screenshot attached). We also engaged our member base directly through a direct email to a subset of members (also attached). We wanted to spread the word about the SEP because getting covered has never been more affordable. The ACA transformed contraceptive access and affordability through the contraceptive mandate, yet far too many people that can benefit from birth control either aren’t covered or pay out of pocket. As a company working to make birth control more convenient, affordable, and accessible, helping educate our members was a no-brainer.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

Health Advisory Council Newsletter | Summer 2021

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Member Updates

June Meeting Summary

Member Spotlight: BIO

  • Our Impact

    The work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.

    Read about NCL’s impact

  • Preventing yet another victim

    Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.

    Read about NCL’s impact

  • Building a stronger generation

    A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.

    Read about NCL’s impact

  • Script Your Future saved my life

    Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.

    Read about NCL’s impact

  • For a safer workplace

    Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.

    Read about NCL’s impact

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PBPA Commends HHS Funding to Support Maternal and Infant Health

The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.

“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”

The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.

“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued.  “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”

The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.

“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg.  “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”

Diverse research for a diverse America: The value of equitable, real-world research

August 12, 2021/in Blog, Health, Prevention Blog Post

By Sally Greenberg, NCL Executive Director

While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.

The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.

Existing efforts to improve inclusion

Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.

Recognizing the potential for RWE in maternal health

The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.

Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.

Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.

The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.

PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

WASHINGTON, DC, August 26, 2021 –

Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.

We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”

Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”

While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.

###

ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org

LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.

Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

###

ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

MEDIA CONTACT:

Carol McKay, carolm@nclnet.org

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