NCL testified before FDA Vaccines and Related Biological Products Advisory Committee

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – The National Consumers League (NCL) testified before the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (FDA). For over 120 years, NCL has advocated on behalf of consumers who depend on vaccines as lifesaving medical interventions. NCL extended its gratitude to the Vaccines and Related Biological Products Advisory Committee for all they do to protect public health and for the opportunity to speak before the Committee.

In its testimony, NCL highlighted the following priorities: the deployment of Emergency Use Authorizations; the safety and effectiveness of the vaccine; and the inclusion of diversity in clinical trials. These three concerns align directly with NCL’s efforts to enhance vaccine confidence and uptake, especially in the context of COVID-19.

Safety and Effectiveness:

NCL trusts that the FDA will release a vaccine only upon careful consideration of its safety and effectiveness. Post-market surveillance of the vaccine is imperative to determining the ongoing efficacy of the vaccine. Implementing the release of a vaccine on such a magnificent scale will involve precise coordination that traverses all levels of government and consumers will rely on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine.

Emergency Use Authorization (EUA):

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration. The FDA is entrusted with ensuring the safety, efficacy, and security of the treatments needed to treat and prevent the spread of the virus.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority, however, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs.

NCL appreciates that the FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment. Through our education and outreach of consumers, we support the FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine.

Diversity in Clinical Trials:

Finally, to mitigate the disproportionate disease burden experienced by people of color during the pandemic, NCL requests that clinical trials for the COVID-19 vaccine are inclusive and consist of diverse subjects. People of color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon will prove to be a challenge when encouraging vaccine uptake. Ensuring adequate representation in clinical trials would foster vaccine confidence across all demographics.

In closing, to stem the tide of deaths from these vaccine-preventable diseases, NCL submits these comments for review by the Committee to ensure that consumers are afforded with safe and effective vaccines to combat the pandemic.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Equitable allocation of a COVID-19 vaccine

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

As the world waits with bated breath for the release of a safe and effective COVID-19 vaccine, one concern that is paramount is the proper distribution of the vaccine. According to leaders of Operation Warp Speed (OWS)—a coordinated partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DoD)—detailed planning is ongoing to realize OWS’s lofty goal of delivering 300 million doses of a COVID-19 vaccine, with the initial doses available by January 2021.

Implementing a vaccine program of this magnitude is contingent upon precise coordination that traverses federal, state, local, tribal, and territorial governments. The prodigious task ahead is determining who would get the first initial doses of the vaccine upon release. The pandemic has further illustrated that communities most vulnerable to COVID-19 are often rife with systemic racism and socioeconomic factors conducive to higher infection rates. An initial limited supply of a vaccine will only intensify these inequities.

Multiple analyses conducted on the federal, state, and local levels confirm that people of color have experienced a disproportionate burden of COVID-19 cases and deaths. Hispanic or Latinx, and American Indian and Alaskan Native (AI/AN) communities have experienced three times the rate of infection, and Black communities two times the rate of infection, compared to White populations. The CDC warns that this imbalance in morbidity and mortality is begotten by deep-seated disparities that stem from generations of racism and unaddressed social determinants of health.

To mitigate these inequities, the National Academies of Science, Engineering, and Medicine (NASEM) have formed a committee to establish an overarching framework addressing key considerations for the equitable allocation of a COVID-19 vaccine, including at-risk communities, priority populations, geographic distribution, scalable measures, and vaccine hesitancy.

The framework proposes four phases of vaccine distribution and their corresponding priority populations, as follows:

[Source: NASEM]

The above proposal will inform CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendations in advance of a COVID-19 vaccine release; and it was developed through careful consideration of CDC’s Social Vulnerability Index (CDC SVI), and the apropos, COVID-19 Community Vulnerability Index (CCVI). To elucidate, these phases were designed with people of color in mind, as they experience heightened risk of exposure working in essential roles in society, and therefore succumb to higher rates of infection.

Another key component of the vaccine plan is addressing vaccine hesitancy. People of Color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon, compounded by a general mistrust of medical establishments by minorities, will prove to be a challenge when encouraging vaccine uptake. Community engagement will be essential in building trust among the vaccine hesitant and messaging should be delivered by community leaders, or healthcare providers that resemble the population they treat. Culturally competent care has proven to have favorable effects on health outcomes and it is critical in encouraging vaccine confidence.

Once a vaccine becomes available, health officials across the country will need to deploy resources and personnel to ensure access to the vaccine among our most vulnerable. As affirmed by U.S. Army Lt. Gen. Paul Ostrowski (OWS), “We have to be able to go beyond the pharmacies, the hospitals and so forth to get after nursing homes; to get after meatpacking facilities; to get after those that are sheltered [at home]. We have to get this out to all four corners of this nation.” Getting to a vaccine is a challenge in itself, but once its released, it’s all hands-on deck.

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials
by Elena Rios, MD, MSPH, FACP
President & CEO, National Hispanic Medical Association

The COVID-19 pandemic has impacted the world and the United States with a double threat: decreasing health and function of many, especially older patients with underlying diseases (obesity, asthma, diabetes, hypertension, etc.) that decrease the body’s immune response to fight off the virus; and millions left jobless as businesses downsize or close. In the healthcare arena, scientists and physicians are learning about the disease and how to treat it: We now know to limit ventilators to avoid high air pressures that can hurt damaged lungs; to place infected patients on their stomachs to allow lungs to expand; to use dexamethasone to decrease inflammation; and to use new antiviral therapies like Remdesivir and monoclonal antibodies. While there is no vaccine to prevent COVID-19, vaccine developers, researchers, and manufacturers are expediting the development of one.

The National Institutes of Health (NIH) and several pharmaceutical companies are conducting research through clinical trials that have found potential vaccines to be safe. This summer they started to enroll people and closely follow them for any adverse effects. Historically, Hispanics, Blacks, and Native Americans have been underrepresented in clinical trial research for a variety of factors, chief among them, a distrust of research and the concept of fatalism (leaving life’s challenges in God’s hands). But it is crucially important to have diversity in clinical trials to have information on the vaccine impact for Hispanics, for example. I encourage all persons over the age of 18 to enroll in the important COVID-19 clinical trials — and recommend websites for two ongoing clinical trials: the CoronaVirusPreventionNetwork.org from the NIH and Moderna, and the CovidVaccineStudy1.com

from Pfizer Inc. Each site provides consumers with information on the locations and how to enroll.

The National Hispanic Medical Association (NHMA) was established in 1994 to represent trusted Hispanic physicians and to improve the health of Hispanics and underserved populations. Given that, by 2042, one out of four people living in our nation will be Latino, NHMA has joined as a partner to encourage the Latino community to join the NIH All of Us Research Program. In May 2018, the NIH opened national enrollment for the All of Us Research Program—a momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds—in collaboration with NHMA and other national partners. People ages 18 and older who reside in the United States, regardless of health status, are eligible to enroll. The overall aim is to enroll 1 million or more volunteers and to oversample communities that have historically been underrepresented in research to make the program the largest, most diverse resource of its kind. Our participation will provide information on how to better develop health care prevention and treatment programs for generations to come.

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. By partnering with 1 million diverse people who share information about themselves over a 10-year period, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

Participants can access their own health information, including genetics information, summary data about the entire participant community, and information about studies and findings, that come from All of Us. Participants are asked to share different types of health and lifestyle information, through online surveys and electronic health records (EHRs), which will continue to be collected over the course of the program. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight, to ensure that the program gathers information fromall types of people. This program is especially focused on those who have been underrepresented in research, but not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between. To learn more about the program and how to join, please visit https://www.JoinAllofUs.org.

About NHMA

NHMA is a nonprofit association representing the interests of 50,000 Hispanic physicians with the mission to improve the health of Hispanics in the U.S. For more information, please visit www.NHMAmd.org

Jeanette Contreras portrait

FDA Emergency Use Authorizations and public trust for COVID-19 treatments

By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. The FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.

NCL leads advocates in urging FDA to protect patient access to critical therapy for preterm birth

By Sally Greenberg, NCL Executive Director

The National Consumers League and 14 leading health organizations and individual providers have collaborated in sending a letter to the Food and Drug Administration (FDA) as the agency considers whether to withdraw the only FDA-approved therapy that reduces the risk of preterm birth in women with a history of preterm birth.

Why did we and our fellow advocates decide to send this letter in the midst of the COVID-19 pandemic? Several important reasons.

First, preventing preterm birth is always a vital cause—during or without a pandemic. The leading cause of infant death in the United States, premature birth has devastating effects on families and is very costly to our health care system. For babies who do survive, short and long-term complications can accompany preterm birth. For mothers, a history of spontaneous preterm birth is a leading risk factor for recurrent preterm birth, yet providers have only one therapeutic option – hydroxyprogesterone caproate or “17P,” in one branded and five generic forms – to prevent recurrent preterm birth for these at-risk mothers.

Taking away these options—especially in the midst of a pandemic—would be concerning for pregnant women who are at high-risk for preterm birth, including those that reduce their risk of being admitted to the hospital for early delivery.

Secondly, as recent events surrounding both COVID-19 and continued fundamental rights injustices have reminded us, a profound and systemic inequity exists in the United States where institutional racism contributes to health disparities—including preterm birth and infant mortality. COVID-19 has disproportionally impacted African American women, the same population that is most likely to experience preterm birth. The preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women, according to the March of Dimes.

Thirdly, 17P is the only FDA-approved therapy that reduces the risk of preterm birth and has been used for nearly a decade. We are concerned that removing access to the only FDA-approved therapy may deepen maternal and infant health inequities that exist within the U.S.

It is also troubling that if providers cannot access FDA-approved forms of 17P, this may expose pregnant women to compounded medications, which have no labeling to provide guidance on administration, contraindications, or potential side effects.

Removing 17P products in the absence of suitable alternatives would leave patients and providers significantly disadvantaged in the fight against prematurity. While we recognize the FDA is encountering tremendous challenges in addressing the COVID-19 pandemic, it is important to underscore the public health need for continued access to approved treatment options, and we trust that the agency will consider the patient impact as they evaluate this issue.

To add your voice to the letter to FDA, urging the agency to preserve patient access to the only FDA-approved therapy to reduce the risk of preterm birth, you can sign on here.

Vaccine hesitancy and the unique challenge of COVID-19

headshot of NCL Health Policy intern Talia

By NCL Health Policy intern Talia Zitner

Around the globe, researchers and scientists are racing to find a vaccine for the COVID-19 virus. Developing a safe, effective, and affordable vaccine is already a challenging feat, but vaccine hesitancy presents another unique challenge to scientists, government researchers, and community leaders.

“Vaccine hesitancy” refers to the reluctance or refusal to be vaccinated or have one’s children vaccinated against a disease, even if a vaccine is proven to be safe and effective. Vaccine hesitancy poses dangers to both the individual and their community, since exposure to a contagious disease puts the person at risk, and they are far more likely to spread the disease to others if they won’t get vaccinated. Ironically, these communities may be the most vulnerable to COVID-19, and a serious effort must be made to create a sense of comfort around the COVID-19 vaccine once it’s available to the public.

Not to be confused with the vaccine-hesitant, “anti-vaxxers” represent a movement of people who dispute the safety of vaccinations and challenge laws that mandate vaccinations. This is a more insidious movement funded by dubious sources (reportedly, one New York couple has donated millions of dollars to the movement) that deceptively politicize public health measures under the guise of protecting personal liberties.

Public health agencies are trying to get vaccination levels to 95 percent to guarantee herd immunity. Some concerns that are top of mind for consumers include knowing the timeframe for a vaccine, who will have access to it, what it will cost consumers, if anything, and how states will determine methods of enforcing vaccination. The possibility of a COVID-19 vaccine also begs the question of whether vaccination will be mandatory for public schools and government workers.

Perhaps one of the most important projects right now surrounding vaccine hesitancy is the Vaccine Confidence Project (VCP), which is dedicated to “conducting a global study to track public sentiment and emotions around current and potential measures to contain and treat COVID-19.” Using a mix of population surveys and social media tracking, VCP “will investigate perception and sentiment of COVID-19 social distancing measures and potential medical tools globally.” This project will be essential moving forward, as it will continue to inform understanding on how the global population perceives the eventual vaccine.

As of now, VCP reports that only 25 percent of African Americans—a population that has been disproportionately hit by the virus—plan to get the COVID-19 vaccine. Why is this the case? Due to lack of access to hospitals, pharmacies, doctors and clinics in Black communities, failure to expand Medicaid, and other root causes; the COVID-19 pandemic has laid bare the disparities in our health care system.

To ensure herd immunity—which is somewhere north of 90 percent immunity—much work needs to be done, especially with the Black community, to increase confidence when a COVID-19 vaccine is released. At this time, Black leaders such as former U.S. Surgeon General, Dr. Regina Benjamin, and current U.S. Surgeon General Dr. Jerome Adams, are among those leading the charge to encourage public health efforts such as advocating for face-mask usage and collaborating with the National Newspaper Publishers Association (NNPA) Coronavirus Task Force and Resource Center, which provides expertise on the virus and its impact on the Black community.

Another community that will be crucial to prioritize surrounding vaccine hesitancy is the older Americans. The New York Times reported that of the “241 interventional COVID-19 studies undertaken in the United States and listed on clinicaltrials.gov…37 of these trials—testing drugs, vaccines and devices—set specific age limits and would not enroll participants older than 75, 80 or 85 years old. A few even excluded those over 65.” Why would older Americans trust a vaccine not tested for their age groups? Clinical trials will need to include people across all ages, otherwise, this will only increase vaccine hesitation. The vaccine must be safe and effective, and ample outreach must be conducted to ensure vaccine confidence across all demographics.

There are many questions left to be addressed. As we continue to navigate preventive measures for COVID-19, independent researchers and organizations will become increasingly more important to guiding decision making before and after a vaccine is developed.

Vaccine hesitancy is a global problem that will only be compounded by the COVID-19 pandemic. Fostering vaccine confidence will be imperative when the second wave of the virus sweeps the globe, as it inevitably will.

Talia is a Washington, D.C. native, and a rising sophomore at Wesleyan University, where she majors in English. Beyond health, Talia’s interests are in journalism, law, and social justice.

An old threat to public health is resurfacing amidst COVID-19 worries

By Sally Greenberg, NCL Executive Director

While all of us have learned to adapt to the ‘new’ ways to stay healthy we can’t let our need to avoid contact with others get in the way of the important steps we have always taken to keep disease at bay; staying up to date on vaccinations.

Since the COVID-19 pandemic hit, most of us have dutifully complied with stay-at-home orders to avoid contracting the virus. While that is critically important, there are other diseases that we must guard against. While the world awaits a COVID-19 vaccine, we need to keep ourselves and our families safe by protecting overall health. This includes taking steps to diminish the risk of other dangerous outbreaks that would weaken our immune systems and put additional strain on the healthcare system.

Before the coronavirus, low vaccination rates were already a concern for many populations. But in the last several weeks, we have been alarmed to learn that the numbers of people receiving vaccinations—from the very young to the very old—have plummeted. That is extremely worrisome for public health officials.

In fact, prominent organizations like the World Health Organization (WHO) and the National Foundation for Infectious Diseases (NFID) have stressed the importance of maintaining vaccination against illnesses like the flu and pneumonia, which affect lung health during the pandemic. This is even more important for those with underlying conditions and those over the age of 65 who are more vulnerable to these diseases.

Early in the pandemic, we thought children might be spared from much of the outbreak. That turns out not to be true. Children need their vaccinations more than ever! Time has proven that there is still much we don’t know about the Coronavirus and how it affects the vulnerable—so staying up-to-date on pediatric vaccines is equally important.

Hesitation to visit the doctor’s office is completely understandable, but I can speak from personal experience that our health care providers are making doctor visits very safe.

When I visited the doctor on a non-coronavirus issue, they staggered patient appointments so patients never had to share a waiting room; everyone wore a mask; we observed 6-foot social distancing; there was an abundance of soap and water and hand sanitizer. The staff at the office was exceptional. They were organized, completely protected with all of the proper PPE, and very focused on making sure that I—the patient—felt safe and secure.

The best advice? Call ahead to ask your health care provider about the precautions they have in place and the best timing for a visit to update your vaccines. Adults, get your shingles, pneumococcal pneumonia, and flu shots. You don’t want those illnesses! And every child needs the array of measles, mumps, tetanus, diphtheria, whooping cough, and other vaccines recommended by the Centers for Disease Control (CDC) for children.

As we continue to live in this new world, we have a responsibility to ourselves, to our families, and our communities to stay as healthy as possible. Modern medicine’s gift to humankind is an array of extremely safe and effective childhood and adult vaccines to prevent diseases that once, collectively, have killed billions globally. As the COVID-19 pandemic has shown, we are lucky to have these vaccines. They keep us safe and healthy. We all have to do our part and get vaccinated from preventable diseases.

COVID-19 shows us the extraordinary importance of vaccines

By Sally Greenberg, NCL Executive Director

What a bittersweet moment for advocates like NCL fighting off the lies and falsehoods spread by the anti-vaccine movement, as we start to see some anti-vaxxers changing their tune while still others continue to hold firm to their dangerously misinformed views. The reality is that a vaccine to fight COVID-19 would have prevented the global devastation caused by this disease and prevented the loss of nearly 60,000 lives and 27 million jobs nationwide.

Over the past decade, NCL has become a champion of vaccines and their extraordinary power to protect humans around the globe safely and effectively from many deadly diseases. Illnesses such as polio, tetanus, measles, smallpox, flu, mumps, measles, tuberculosis, human papillomavirus (HPV), that have maimed and killed billions of people, have ebbed or been eradicated, thanks to vaccines.

As a commitment to our advocacy, NCL has twice testified before the Advisory Committee on Immunization Practices (ACIP) in support of the meningitis B and pneumonia vaccine (PCV-13). In our testimonies, NCL called for universal vaccination for children and adults, reaffirming vaccines as one of the greatest gifts modern medicine has provided to the human race.

Our comments also challenged the outrageous falsehoods spread by the small but vocal anti-vaccine movement. Their claims of vaccines causing autism have been debunked over and over, yet their power to scare parents lives on.

I grew up with an uncle who contracted polio a year before the vaccine was introduced. His illness was utterly devastating. Having a quadriplegic member of the family meant that from a very young age I developed an appreciation for vaccines and was comforted in knowing that I didn’t have to worry as my grandparents did about losing my son to a terrible disease.

Now Americans wait anxiously for labs and drug companies to develop a safe and effective COVID-19 vaccine. This could take many months due to our remarkably high standards of safety and efficacy. I certainly hope this calamitous COVID-19 outbreak will be the death knell of the anti-vaccine movement. Sadly, I fear it will not.

COVID-19, what could it cost you?

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

As the nation continues to navigate the COVID-19 pandemic, another top-of-mind concern is the cost associated with both testing and treatment for the illness. Between the boldness of certain state officials relaxing restrictions and the rapid ascension of cases, exposure to COVID-19 will inevitably rise.

The reassuring news is that the majority of Americans diagnosed will be able to recover from home. But what if you’re among the 15 percent that will need hospitalization? This subset of the population will require the most acute care, including admission into an intensive care unit and use of a ventilator. Between testing and treatment, there are a lot of factors for the consumer and patient to consider—outright costs of care, as well as cost-sharing (co-pays, deductibles, out-of-network costs, and more)—we did some of the research below.

Testing

  • Affordable Care Act (ACA)-compliant Plans: Under the Families First Coronavirus Response Act, all comprehensive health plans (individual, employer-sponsored, or ACA marketplace plans), must cover testing for COVID-19 at 100 percent.
  • Medicare & Medicaid: Testing is covered at 100 percent for Medicare and Medicaid.
  • Uninsured: Testing will be covered at 100 percent by Medicaid, as mandated by the CARES Act.
  • Non-ACA-Compliant Plans: Testing coverage may vary for consumers with non-ACA-compliant plans (i.e., short-term plans), as these plans are not subject to the protections found in the ACA.

Apart from non-ACA plans, there’s testing done in an emergency room, urgent care, or physician’s office, and all that should be covered. In addition, the health plan cannot impose prior authorization or cost-sharing restrictions (i.e., copays, deductibles, coinsurance) on the patient. Of course, access to testing is currently limited to those with symptoms or those working in health care facilities or other consumer-facing businesses. There are still strict criteria established by the Centers for Disease Control and Prevention (CDC).[1]

Treatment

Newly passed emergency bills do not address coverage of treatment. The Kaiser Family Foundation estimates that out-of-pocket costs for COVID-19 treatment for someone insured on an employer-based health plan could run upwards of $10,000, provided that there are no complications. For patients that require more acute care, costs could reach $20,000.

ACA-Compliant Plans: Health plans are not required to fully cover the cost of positive tests. A majority of the treatments for COVID-19 under ACA-compliant plans will qualify as essential health benefits, and as such will be covered. However, every state defines its own criteria for essential health benefits, and it is possible that some treatments will not be covered, based on where you live. Furthermore, coverage may vary depending on the type of group health plan you have (large vs. small).

Cost-sharing will also likely be imposed. Marketplace plans are required to cap maximum out-of-pocket costs for services covered in-network. In 2020, the maximum out-of-pocket cap is $8,150, meaning that if your care is deemed medically necessary, your out-of-pocket costs should not exceed that amount. Some plans have offered to cover patient-cost sharing for out-of-network care for COVID-19 in the absence of in-network availability. As an emergency course of action, several health plans have waived out-of-pocket costs like copays and coinsurance associated with treatment for COVID-19. To see where your health plan stands, click here.

Medicare and Medicaid: Medicare Part A (hospital stays) and Part B (doctor’s visits) will continue to charge copays and deductibles. The deductible for a 60-day hospital stay under Part A is $1,408. For Part B, the annual deductible is approximately $200. Cost-sharing related to Medicare Advantage and Medicaid plans will depend on your individual plan.

Uninsured: The Trump Administration has announced that part of the $100 billion of the $2 trillion appropriated for COVID-19-related relief in the CARES Act will be dedicated to reimbursing providers who treat uninsured patients. Provisions within the law include treatment for primary diagnosis of COVID-19 in a variety of settings, both emergency and non-emergency transportation, and post-acute care. Services that will be excluded from coverage include hospice and outpatient prescription drugs.

While further guidance is pending, Health and Human Services Secretary Alex Azar has clarified the following: “as a condition of receiving funds under this program, providers will be forbidden from balance billing the uninsured for the cost of their care.” This caveat reinforces that providers would get reimbursed at Medicare rates for delivery of uncompensated care and cannot balance bill the difference between Medicare reimbursement and the hospital’s charges.

In addition to the above, the law prohibits hospitals from charging patients beyond what they would pay in-network or what Medicare pays. The mandate against surprise billing serves to protect patients covered by government programs, employer-based plans, and self-purchased insurance.

Also, the growing loss of employer-based health coverage has prompted several states to extend their special enrollment periods to accommodate newly unemployed/uninsured patients during the pandemic. To see if you qualify for a special enrollment period, click here.

Non-ACA-Compliant Plans: Off-marketplace plans are not regulated by the ACA, and this could affect coverage for COVID-19-related treatment, where there is a possibility that treatment may not be covered outright. Examples of non-ACA plans include short-term health, fixed indemnity, and critical illness plans. These plans do not qualify for minimum essential coverage and are insufficient on their own, in our view.

Understanding insurance benefits can be daunting under ideal circumstances, let alone during a global health crisis. Consumers need enhanced accessibility and coverage now more than ever and NCL commends health plans for acting promptly to waive various cost-sharing measures. NCL urges Congress to continue to fortify and provide clear guidance for consumer protections, to ensure that they are not left stranded without vital care. Consumers, please know that there are COVID-19-related resources available to you—for more information, click here.

[1] To find a drive-thru testing site near you, click here.

New study says Chipotle management presses workers to work sick and skip food safety practices, creating health risks for consumers

February 6, 2020

The Unsavory side of ‘Food with Integrity.’ ” report details management practices that lead to worker abuses and call into question protocols Chipotle put in place after recent food safety crises

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

New York — After dozens of outbreaks of foodborne illness incidents over the past four years, Chipotle gave lip service to reforms in their work practices, but the fast-casual restaurant has continued to engage in management practices that lead to abuses of workers that may create food safety risks for consumers, a new study says.

Scores of employees interviewed for the study reported management pressure to work fast without following proper food safety procedures, such as:

  • One worker being pressured to work while sick, even after the worker vomited partway into his shift;
  • Undercooked chicken being served to a customer because the grill cookout in place had not been properly trained;
  • Workers pressured to work so fast that during lunch and dinner rushes, they often flipped over  chopping boards used to cut raw meat, and reused the boards without washing them;
  • One worker who cooked food had to clean feces off the floor or ceiling of a bathroom multiple times without hazmat suit or adequate protection equipment;
  • Pressure to work without stopping, with no time left to wash their hands for hours on end.

In the report, “The Unsavory Side of ‘Food with Integrity,'” workers told researchers that their managers often knew when supposedly independent audits were coming because other managers or field leaders who have undergone inspection often tip them off. Workers reported that managers relax rules outside of inspection periods and tightened up adherence to food safety protocols when inspections are imminent.

“The findings of this report call into question the effectiveness of measures that Chipotle put in place to solve their food safety crises of a few years ago,” said Sally Greenberg, executive director of the National Consumers League, which co-authored the report. “If Chipotle executive management and the Food Safety Advisory Council are responsible for making sure that this program is implemented effectively to keep the public safe, they have been asleep at the wheel.”

The National Consumers League, America’s pioneering consumer advocacy organization which has been representing consumers and workers on marketplace and workplace issues since their founding in 1899, undertook the study after SEIU Local 32BJ brought the organization information from field organizers about what were learning about practices that could affect consumer food safety from Chipotle workers they were supporting in their organizing efforts.

Organizers and researchers spoke to hundreds of workers, then undertook formal interviews with 47 workers at 25 stores in New York City. These interviews and statements form the basis of the report, which also included analysis of a variety of corporate filings, press reports, and other publicly available documents.

“We chose to blow the whistle on these practices and abuses because our Chipotle managers did not listen to us,” Jeremy Espinal, a Chipotle worker, said. “It’s a pressure-packed workplace where supervisors intimidate you and retaliate against you.”

“I am speaking out because I want to make Chipotle a better place to work and a better place for customers to eat,” Jahaira Garcia, another Chipotle worker, said. “This job is how I support myself, how I help my father out with expenses at home and how I am able to partly pay for my school fees.”

32BJ President Kyle Bragg thanked the National Consumers League for working with the union and thanked the workers for their courage.

“I believe that these workers are Chipotle’s best assets,” Bragg said. “They can put the integrity back into ‘food with integrity.’ Give them a voice on the job and they will help Chipotle achieve the lofty ideals of its marketing.”

Report findings include:

  • Managerial pay incentives that promote cutting food safety corners:  managers can earn up to an additional 25% of base pay by meeting performance goals that include reducing labor costs, creating a highly pressurized work environment. This bonus program may incentivize managers to meet productivity goals by cutting corners on food safety or by violating worker protection laws.
  • Ineffective store audits: Worker interviews revealed that general managers frequently know when supposedly independent audits are coming because other managers or field leaders who have been inspected often tip them off. Workers reported that managers have relaxed rules following outside of inspection periods and tightened up adherence to food safety protocols when an audit is imminent.
  • Pressure to work sick: New York-based workers reported that managers have pressured crew members to work while sick or retaliated against workers for taking paid sick leave.
  • Minimal training: Despite the substantial skills needed to safely prepare Chipotle’s fresh food menu, many new hires receive minimal training and “learn as they go” from co-workers who may not have received much training themselves.

“As chairman of the New York City Council Public Health Committee, this is deeply troubling to me,” said New York Councilmember Mark Levine. “Risk of contagion should not be aggravated by an aggressive incentive structure that encourages managers to abuse workers and cut food safety corners. The public needs to know more and Chipotle needs to change their policies. That is why I am calling for a public hearing in the Council. I encourage Chipotle workers and consumers to come forward to discuss these issues. I also invite the company to be there to engage in this conversation.”

Nick Freudenberg, distinguished professor of Public Health at the CUNY Graduate School of Public Health & Health Policy and Director of the CUNY Urban Food Policy Institute, discussed Chipotle’s history of food borne disease outbreaks.

In 2015 and 2016, Chipotle was rocked by a series of food safety crises that sickened hundreds of customers across the country and included exposure to virulent pathogens like E. coli, salmonella, and norovirus, resulting in vomiting, pain, and in some cases hospitalizations. Despite claiming major food safety reforms instituted in 2016 to recapture consumer confidence, the company continued to have food-borne illness problems in 2017 and 2018, including an Ohio outbreak in which 647 people were sickened.

Despite Chipotle implementing an “enhanced food safety program” in 2016, the City’s Department of Health found 260 critical violations at 74 out of 84 restaurants from 2017 to 2019. Critical violations are those most likely to pose “a substantial risk to the public’s health” and lead to food-borne illness. The critical violation examples found by health inspectors include food left at dangerous temperatures that allow for the growth of pathogens, practices that allow for the contamination of ready-to-eat foods, evidence of various pests, and stores supervised by managers without a certificate in food protection. Just two weeks ago, the City cited a Chipotle restaurant where they found a crewmember working while “ill with a disease transmissible by food or [an] exposed infected cut or burn on [their] hand”.

Worker advocates and community groups were surprised by the findings and expressed support for Chipotle workers:

“Chipotle has not only acted duplicitously—championing a mission of integrity and freshness in public while speeding up production and cutting corners behind the counter—the company has created added risks for workers and consumers in the pursuit of profits,” said Ana Maria Archila of the Center for Popular Democracy. “Outlined in this report are issues that range from cautionary to alarming. Will Chipotle wait for another outbreak before they take corrective action—or will they take action ‘with integrity’ now to reduce potential harm?”

“This report is vital to understanding that the exploitation of workers in the food industry does not just impact workers and their families, it impacts everyone, including consumers,” Suzanne Adely of the Food Chain Workers Alliance said. “Chipotle and all food service workers deserve fair working conditions. Denying them basic, humane rights like sick days, proper healthy and safe working spaces, cannot be justified. Exploiting food workers for profit does not only harm workers and their families, it harms everyone, including consumers.”

“Chipotle is another example of worker safety and consumer safety being undermined together,” said Charlene Obernauer of the New York Committee for Occupational Safety and Health (NYCOSH). “Chipotle has a legal responsibility to provide a safe and healthy workplace and they need to take the appropriate steps to make this possible.”

“This report details how Chipotle’s low-road labor standards and incentives for managers to cut corners are endangering the dining public,” said Paul Sonn, State Policy Program Director for the National Employment Law Project. “Chipotle needs to recognize that investing in its workforce with stable, quality jobs is essential for delivering a safe and healthy dining experience for its customers.”

“We are deeply concerned with the workplace issues, especially that of forced arbitration described by Chipotle workers in this study,” Deborah Axt of Make the Road said. “We stand with Chipotle workers, the majority of whom are workers of color and many of whom are from communities like the ones our members are from, in calling for company-wide reforms and a commitment to invest in a stable workforce.”

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About 32BJ SEIU

With 175,000 members in 11 states, including 85,000 in New York, 32BJ SEIU is the largest property service workers union in the country.

About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.