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), the nation’s pioneering consumer advocacy organization, expresses concern about the Trump Administration’s Notice of Benefit and Payment Parameters Rule for 2021.
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.
By Nissa Shaffi, NCL Associate Director of Health Policy
The National Consumers League is troubled by the recent report by Public Citizen, “Insurers’ Offers of Free Care for Coronavirus Are Often Confusing and Limited.” In these traumatic and confusing times, it’s critical that consumers can rely on their healthcare insurers to follow the spirit of the law as well as the letter of the law. This includes being crystal clear about what is covered, under what conditions, and for how long.
Public Citizen’s research into 25 of the largest health insurers turned up a range of concerning practices. Most fee waivers will expire by early summer, well before the crisis will subside. Few appear to cover costs of out-of-network care, a hardship when the urgency of the illness and overwhelmed facilities may make it untenable to get in-network care. The 60 percent of people in private insurance plans who are covered by their employers’ self-insured plans may not even be covered if the employer does not opt-in. And of long concern to NCL, even free tests may come with associated services the patient may not be aware of, and that lead to surprise billing not prohibited by the law.
We urge insurers to act in good faith. Use the savings you are accruing from lower elective care costs to fully cover the costs associated with this pandemic. Remove arbitrary restrictions. Be clear and fully transparent about what you are offering. Hold the course for the duration. The consumer community is here to help make it happen.
By Sally Greenberg, NCL Executive Director
COVID has changed the way we live and has brought with it some drastic changes, like social distancing.
While we don’t want to live like this any longer than we have to, there are new habits that will not only help us get through this challenging time, but can stay with us as helpful tools in our everyday lives.
May 5, 2020
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) last week sent a letter to the CEOs of Cigna, Aetna, and UnitedHealth Group, urging them to enter into productive negotiations with air medical service providers to ensure coverage of emergency air medical transportation. The ask comes as the COVID-19 pandemic spreads across the country, making air medical services even more essential, particularly in rural America.
In its letter, NCL notes that it is increasingly concerned about emergency air medical access during this crisis, and that it believes this life-saving care should be covered by every insurance plan. NCL asks that insurers review the robustness of their coverage policies and immediately to enter into network negotiations with air medical providers so that this critical service is covered, and patients are never left with a bill they cannot pay.
Text of the letter, signed by NCL Executive Director Sally Green is below:
Dear Mr. Wichmann, Mr. Cordani, and Ms. Lynch:
The National Consumers League has long advocated for health care as a right and argued for fair treatment for all stakeholders across the health care spectrum – patients, physicians, hospitals, health plans, and health care providers. Our mission is particularly acute during the global COVID-19 pandemic, when medical professionals are on the frontlines fighting for our health and safety, stricken patients need life-saving care, and nearly everyone is focused on their health and that of their loved ones.
In this vein, we are increasingly concerned about access to emergency medical care, especially in rural America, as the virus indiscriminately makes its way across the country. When minutes count, Americans who fall victim to COVID-19 must be assured that they can get to the nearest, most appropriate medical facility as quickly as possible. As COVID-19 strains hospital capacity and critical medical equipment like ventilators become attenuated, emergency air medical transports between facilities are often the only way for patients to get the care they need.
According to the Centers for Disease Control and Prevention (CDC), 85 million Americans can only reach a Level 1 or Level 2 trauma center within one hour if they are flown by an air medical helicopter. The effects of this access problem are staggering, and even more pronounced as we wrestle with the COVID-19 crisis. For many Americans, air medical ambulances are a vital link to timely, life-saving care.
We believe that such life-saving care should be covered by insurance. Patients pay their monthly premiums – and copays and deductibles – so they are not bankrupted should the worst befall them or their loved ones. Unfortunately, there have been far too many stories of people who were transported by air ambulance because it was ordered by a first responder or doctor, only to be told later by their insurance company that they would have to shoulder the bulk of the cost. This should not be the case anytime, but especially now as our nation wrestles with a pandemic.
This explains why we at the National Consumers League are writing to you for your input and thoughts. We believe that emergency air medical transportation should be included in every health coverage plan. We think that insurance companies and air medical providers must work together to bring these services in-network, so patients are not left footing a bill they can never hope to pay. Adequate network agreements are imperative so that patients are not told – after the fact – that they were transported by an air ambulance that was not in-network. When an emergency happens, or worse yet, a pandemic strikes, patients are not choosing whether to take an air ambulance, let alone choosing a particular provider. Similarly, coverage denials based on “medical necessity” should be the exception, not the rule, in light of the fact that patients are not a part of the decision-making process.
We ask that your companies immediately take a comprehensive look at your coverage policies for air medical services and the robustness of your provider networks. We urge you and the air ambulance community to enter into network negotiations, take patients out of the middle, find a middle ground on reimbursement that fairly compensates both sides, and ensure rural communities have access to air ambulance transports. Refusing to fairly negotiate is simply not an option in light of the current crisis. Entering into productive negotiations immediately will ensure that patients across the country have access to the medical care they need and that they are simultaneously protected from balance bills.
Thank you for your attention to our concerns.
Sincerely,
Sally Greenberg
Executive Director
National Consumers League
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneering 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.
By Nailah John, Linda Golodner Food Safety and Nutrition Fellow
In these uncertain times of COVID-19, many workers are being exposed to the disease at poultry plants across the United States. Eater notes that many of these workers are Black, Latino, or immigrants earning low wages and working in overcrowded conditions to package the items that end up on the plates of many families across the States.
Let us dive in a little deeper. The Los Angeles Times has highlighted the spike in coronavirus and meat plants across the United States, with hundreds of reported cases in the last week. This is, of course, a concern to the food supply chain and worker safety. The Associated Press has reported that massive meat processing plants have temporarily closed due to workers contracting COVID-19. This raises concerns about shortages of beef, pork, and poultry. At the same time, workers are being exposed and are succumbing to COVID-19.
The New York Times also reported that workers are standing elbow-to-elbow to do the low-wage work of cutting and packing meat. Many have been on the front line of these packing plants while being sick because they cannot afford to stay home and sacrifice paychecks. Some have staged walkouts to protest being insufficiently protected. United Food and Commercial Workers (UFCW), which has a seat on the National Consumers League’s Board of Directors, has engaged in talks with Cargill, which has agreed to give employees a $2/hour emergency pay increase in addition to a pay raise. The union and Cargill are working on ways to better practice social distancing within the packing plants. Increased sanitization and screening at the plants, and virtual health visits will be expanded for those seeking care health care.
Each day brings new information about COVID-19. When going to the store to purchase meat, let us remember that someone stood in a plant slaughtering and packing it. They are on the frontline risking their lives so that we can eat. UFCW is calling on ALL food employers to step up by developing ways to protect workers and by compensating them commensurate with the risks they are taking to deliver quality products to the grocery stores, restaurants, and family tables of America.
April 23, 2020
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), the nation’s oldest consumer and worker advocacy organization, is demanding that the federal government put its support behind massive COVID-19 test production and, as quickly as is feasible, put in place a testing protocol for every citizen so that America can get back to work.
“There are calls across the country to reopen businesses; we understand and share that frustration,” said NCL Executive Director Sally Greenberg. “However, as we are currently not allowing tests for people who are asymptomatic—and because 25 percent of people who carry the virus don’t show symptoms—doing so would be reckless. It’s a Catch-22. Until everyone is tested, we can’t send symptom-free people back into the world. So the government’s first order of business must include giving America’s labs and drug companies the goal and the means to produce rapid-response testing for every American within the next month.”
NCL has laid out the following recommendations:
Meet the need for testing in clinics and doctors’ offices
The Food and Drug Administration (FDA) must oversee the process of improving techniques and reliable, accurate test production. Many labs are working on this, addressing the immediate need for care providers to have enough, high-quality tests.
“The Senate has voted to include $25 billion for the clinical labs that make the tests in the next COVID legislative package” said Greenberg. “That is welcome news because states cannot do this alone; they end up competing against each other for tests and other supplies.”
As Maryland Governor Larry Hogan (R-MD) said this week, “Every governor in America has been pushing and fighting and clawing to get more tests, not only from the federal government, but from every private lab in America and from across the world. It’s nowhere where it needs to be.” Virginia Governor Ralph Northam (D-VA) noted that the President’s claims that the country has enough tests for the virus are “delusional.”
Clearly, quality is paramount. The serious stumbles at such premier institutions as the Centers for Disease Control and Prevention (CDC) cannot continue. “The federal government must continue to support and expand the production of quality tests, and at capacity to meet the current needs of care providers,” said Greenberg.
Universal testing
As stated above, though, in order to get people back out to restart the economy, we cannot only test those who show serious symptoms and go to care providers to get tested. We must develop tests that can be self-administered, and in adequate numbers so that each person can test for COVID before leaving the home on any given day.
“Millions of workers have to take drug tests every day to keep their jobs; those tests are rapid-response. Consumers can buy rapid response tests for strep throat and pregnancy,” said Greenberg. “Those are approved FDA products that are tested for accuracy and safety. We must get to a rapid response COVID-19 home test as soon as possible.”
In order to determine who has COVID-19 and should be quarantined, every American must be able to test for the virus on a regular basis. Those who test positive, with or without symptoms, go into quarantine for 14 days, as do the people in that individual’s household. Those who test negative are cleared to go out in the world to get the trains running again. This would call for hundreds of millions of tests to enable on-going testing, as it is the only path forward at this time.
And the technology is not “pie-in-the-sky.” The FDA has already approved one home-test kit, though it requires lab analysis. And BARDA/HHS has funded another company to develop “a rapid antigen and antibody diagnostic to identify current or past SARS-CoV-2 infections in 60 seconds.” We are on the road.
Antibody testing
While it’s not clear how long antibodies create immunity, there is a belief that they at least do so for the short-term. So the next step would be to provide serology testing for people who test negative for COVID-19, using only tests approved by the FDA to ensure quality and accuracy. To date, the FDA has approved only four tests of the many available, but this is an important start.
Those who are determined to have a sufficient level of antibodies should be cleared to go back to work, while still wearing masks and gloves until science has confirmed decisively that antibodies create immunity. If the individuals don’t have antibodies, they would be advised to stay home, but could be cleared to go back to work so long as they test every day before heading out.
Contact tracing
Everyone who tests positive reaches out to everyone they’ve had contact with and those people test for COVID-19. Anyone then testing positive goes into quarantine, and the process repeats.
Use technology to self-surveil
Finally, we need a system for uploading test results each day to our phones – like the bar codes we use to board an airplane – or to carry evidence that we have taken the test, have antibodies to COVID-19, and can work or otherwise go out. Enforcement would be a new challenge, given our commitment to civil liberties, but one that we can certainly work out.
Longer term: Vaccinate
In a year or more, when a vaccine arrives, 95 percent of Americans will need to be vaccinated to achieve herd immunity and widespread protection.
“Our nation has the know-how and manufacturing infrastructure to produce the millions of tests needed to determine whether someone has the virus,” said Greenberg. “But due to lack of leadership at the top, our testing capacity is still, several months after the outbreak, extremely limited. To date only 3.3 million people have been tested, according to the COVID Tracking Project. That’s about 1 percent of the population. That is simply not enough.”
NCL is demanding that the Federal government respond to the current national Coronavirus emergency as President Roosevelt responded to World War II, and challenge Americans to “harness the efficient machinery of America’s manufacturers” to fight the pandemic.
“We need that call to action now, to challenge America’s labs and drug companies with the goal of producing testing for every American within the next month. Federal health care agencies including CDC, National Institutes of Health (NIH), and FDA should be their partners, and this should be a shared cost,” said Greenberg. “In the midst of the worst unemployment numbers ever seen in American history, and with millions of businesses having their existence threatened, we need federal leadership, expertise, and financial support to make this happen, and we need it now.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneering 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.
Dr. Joia Adele Crear-Perry of the National Birth Equity Collaborative…
By Sally Greenberg, NCL Executive Director
During this Covid pandemic, Americans have been incredibly patient and observant of guidelines for social distancing and staying home. But it can’t last forever. Where the heck is the universal testing for Covid-19? We’ve been talking about it for more than two months and yet you can’t get access to Covid-19 testing unless you’re showing symptoms of the virus. If, as experts believe, 25-50 percent of us might be carrying the virus without symptoms, what does that say?
It says we could be spreading the virus without knowing it! And yet we can’t get tested? We need greater accessibility to testing to know where we stand. If everyone could be tested each day to know if we do or don’t have the disease, or be tested for antibodies to Covid-19 to learn that we can fight the disease, we’d be better equipped to know what we’re dealing with and make smart decisions. Such universal testing can get the country back to work, especially at a time when the economy is in even worst shape since the Great Depression with the retail, restaurant, airline, entertainment, film and hotel industries ground to a halt and millions of workers across the economy out of jobs.
And take note: this kind of testing is possible because testing does not need to require a site visit. A study funded by UnitedHealth Group shows people can self-administer a diagnostic test with a much smaller swab, a process that should save potentially thousands of clinicians from being exposed to the virus while at the same time making the testing simpler. The study, which used data from 500 OptumCare patients, comes amid a parade of diagnostic test approvals for Coronavirus following weeks of criticism of the Trump administration and federal agencies for the lack of testing.
On March 24, the “White House Coronavirus Task Force reported in a briefing that “self-swabbing” options were going to be available that week, so the study supports what the federal government is pursuing.” That’s almost a month ago – so where are they?
What’s worse is that the United States is considered well behind other countries when it comes to the availability of testing generally. Why can’t we figure out this solution?
NCL friend and brilliant inventor of the SawStop, a safe table saw, Steve Gass, came up with a novel approach to employ universal testing that would get most of us back to work. His proposal is below. I’ll end with it, because it says it all:
A cure for the coronavirus pandemic already exists. Contrary to our expectation that cures manifest exclusively as biological agents – medicine for the sick or vaccines for the healthy – the cure for this outbreak is technological. From the Oval Office to Kansas kitchens we’re already talking about it, even while failing to recognize its true potential. Those elusive Covid-19 tests, if utilized daily, by every American, have the power to save our lives and our economy within the month.
To date, the U.S. has only employed testing reactively — to diagnosis a disease after symptoms indicate probable infection — which wins us no real advantage when epidemiological evidence indicates up to 40 percent of transmissions occur covertly, days before symptoms appear, and CDC director Dr. Robert Redfield estimates that 25 percent of carriers (and spreaders) may never manifest symptoms at all. We can continue to hide out at home indefinitely, banking on a vaccine in 12-18 months, but public health expert Dr. David Katz calls that a recipe for “ineffectively fighting the contagion even as we are causing economic collapse.”
Instead, we must deploy tests offensively. They must become our mass-produced instruments of war.
Here’s the plan of attack: one month from today, each of us is tested daily for Covid-19, obtaining immediate results. If positive, you isolate at home and instantaneously eliminate the virus’s prime advantage: its ability to stealthily propagate from “people out there shedding the virus who don’t know that they’re infected,” according to infectious diseases expert Dr. Jeffery Shaman. Meanwhile, the healthy among us freely move back out into our communities, flashing our daily health certificates like boarding passes to gain admittance to workplaces, schools, and stores, certain we won’t harm or be harmed by the people with whom we interact. We’ll have immediately shifted, as economists Dr. Paul Romer and Dr. Alan M. Garber insist we must, to a “targeted approach that limits the spread of the virus but still lets most people go back to work.” The very first day we implement universal daily testing and selective isolation commerce resumes, the viral transmission rate plummets, and the virus exponentially decays. The crisis ends.
The challenge in this crisis of scarcity, when too few can access masks let alone diagnostic devices, is to build enough testing units, now, so that all 330 million Americans can be tested daily. This will require at least 1 million community-based machines adapted for parallel processing of multiple tests simultaneously. If we begin tomorrow and labor 24 hours per day it will take just under 12 days to produce and deploy a million machines at a production rate of one unit every second. That’s not just daunting. It’s mind-boggling.
But it’s not impossible.
In May of 1940 the Greatest Generation listened incredulously as President Roosevelt challenged them to “harness the efficient machinery of America’s manufacturers” to produce 50,000 combat aircraft in 12 months to confront the “approaching storm” of a global war – a goal exceeding the total of all planes built in the U.S. since the Wright brothers’ initial 1903 flight. No one believed an 18-ton plane with 450,000 parts and 360,000 rivets in 550 different sizes could be mass produced, let alone efficiently. But our repurposed auto factories did just that, with Ford Motor Co. churning out one bomber per hour at peak production to secure our safety and win the war.
Our nation still has the know-how, the manufacturing infrastructure, and the industrial resources to save ourselves again by building and deploying a million Covid-19 testing units by the end of the month if we make it our highest national priority starting today. We have men and women yearning to go back to work and we must employ them to optimize established supply chains, man assembly lines, and reinvigorate distribution channels. No single state’s factories can meet the one-unit-per-second output required, but pooled national resources can. The cost and effort will be substantial, certainly, but pale in comparison to the misery wreaked if we let a quarter million Americans die instead.
Make no mistake: World War III is upon us. We must once again wake the sleeping giant, mustering America’s industrial might to save ourselves and the whole world with us by rallying resources to test each of us, over and over again, as if our livelihoods and lives depend on it.
Because they do.
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Stephen Gass, PhD, J.D., is a physicist, a patent attorney, and the retired President and founder of SawStop, LLC, the nation’s foremost supplier of premium table saws and the world leader in table saw safety. He is the principal inventor on over 100 patents covering electrical and mechanical innovations in power tools.
By Nissa Shaffi, NCL Associate Director of Health Policy
Ten years ago, the United States Congress adopted the Affordable Care Act (ACA), after many decades of unsuccessful attempts at achieving universal health care by advocates. For the first time, the ACA provided coverage options for every American across the economic spectrum, expanding Medicaid in many states and offering the self-employed access to insurance on the open exchange. For NCL, the ACA is the safety net program the founders of the League sought to see put in place from the organization’s inception at the turn of the 20th Century.
Today with the rapid spread of the COVID-19 virus across America, patients’ access to health care is more critical than ever. Yet despite the clear need we all have for health care coverage, over the past decade, the ACA has been under attack by conservatives in Congress and survived multiple attempts at repeal. The latest came from the Texas v. United States case – and now it threatens to render the entire ACA unconstitutional, following the repeal of the ACA’s individual mandate provision. Why conservatives wish to deprive people of health care escapes us at the NCL. In fact, the ACA has transformed the way Americans interact with the healthcare system.
Throughout its short life, the ACA has cemented into law numerous consumer health protections and has expanded access to health coverage for over 20 million people. 37 states have expanded Medicaid, the health care program for low-income Americans. Prioritizing preventive care, the ACA mandated that health insurance providers cover preventive services for all adults, women, and children – free of cost to the patient. The ACA also made it unlawful for insurers to deny or reduce benefits based on preexisting conditions. These include diagnostic included screenings, vaccines, birth control, and access to certain medications. For the first time, those 26 under could retain their health coverage through their parents’ insurance plans.
Research has shown that ACA Medicaid Expansion has improved access to care, financial security, health outcomes, economic mobility, and have reduced uncompensated care. Despite the progress made by the ACA, there are still 29 million uninsured people in the United States. If the ACA is repealed, 25 million Americans may lose their coverage overnight, without the promise of its replacement. Perhaps the COVID-19 outbreak will change the calculus and bring home how devasting it would be to repeal the ACA. Insurers would no longer be obligated to provide protections offered by the law, allowing plans to deny coverage indiscriminately, leaving millions of families along with low-income and high-risk individuals without care.
The true impact of the ACA will be even more apparent as the national continues to grapple with the COVID-19 pandemic in the coming months. COVID-19 has upended the economy and affected virtually every industry and has caused unemployment to soar. On March 21, unemployment claims reached a record 3.3 million – the highest level of jobless claims in history (the Great Depression saw levels of 24 percent unemployment at its peak but there was no unemployment insurance safety net during the 1930s and thus no jobless claims, just breadlines). Economist Heidi Shierholz of the Economic Policy Institute estimates that by summer, approximately “14 million workers will lose their jobs due to the coronavirus shock.”
A report by FAIR Health estimates that potential treatment for COVID-19, resulting in an average six-day hospital stay, could total to a whopping $73,300 for the uninsured: a devastating prospect in the middle of a global financial collapse. With the increased loss of employer-based health insurance, the ACA proves to be more crucial than ever as individuals and families may turn to the health insurance marketplace to secure coverage. NCL is backing legislation – and the health plans support this too – to move workers losing jobs and health insurance to the COBRA program with heavy subsidies so they can ride out the pandemic – COVID-19 has exposed so many severe deficiencies in the healthcare system. To learn more about statewide efforts to mitigate the impact of COVID-19, click here.
While the fate of the ACA remains uncertain, it is still the law of the land. If you are concerned about loss of coverage during this time, several state-run health plans have enacted Special Enrollment Periods (SEPs) in response to the COVID-19 outbreak, click here to learn more. NCL believes that healthcare is a right and that protections offered by the ACA make this country a far stronger, more robust nation. We will continue to work diligently to protect universal access affordable and reliable health coverage. To learn more about what’s at stake and how you can help prevent the potential repeal of the ACA, click here.
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
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
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
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
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
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.