Born too soon; the difference a day makes
Dr. Joia Adele Crear-Perry of the National Birth Equity Collaborative…
Dr. Joia Adele Crear-Perry of the National Birth Equity Collaborative…
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 If the ACA is repealed, 25 million Americans may lose their coverage overnight, without the promise of its replacement.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.
By NCL Health Policy intern Alexa Beeson
This July, the House Energy and Commerce’s Health Subcommittee passed the No Surprises Act (H.R. 3630) to protect patients from surprise billing. The Senate Health, Education, Labor and Pensions Committee also passed its companion to address surprise billing, the Lower Health Care Costs Act (S.1895). These bills were being considered after a press conference at which President Trump called for reform in surprise billing.
Stakeholder witnesses at the House hearing this June on H.R. 3630 included patient, provider, and insurance payer groups. Reimbursement models were discussed at length, but the unifying theme was that patients should be held harmless in surprise billing situations.
Surprise billing happens mostly in a small subsect of out-of-network providers; the patient has no idea about who’s in or out of network. Some professionals are out-of-network technicians subcontracted by an in-network facility, such as a last-minute anesthesiologist switch for a surgery, or any other non-disclosed provider. To get reimbursed for their services, providers send a bill to the patient for whatever wasn’t covered by the insurance company.
Surprise billing also occurred among patients who should receive reduced prices for care. Johns Hopkins Hospital filed suit on more than 2,400 patients in the last decade, collecting the equivalent of 0.03 percent of its operating revenue. Some of these patients were never told about their right to charity care, and many who qualify never received a discounted rate. These bill collections are inconsequential for Johns Hopkins but could bankrupt a patient.
Legislation to address balance or surprise bills will protect patients, ensuring they will only have to pay in-network rates for out-of-network emergency care. This will help patients avoid bills that can set them back, sometimes, hundreds of thousands of dollars. Although surprise bills only come from a small portion of providers, 1 in 7 insured adults will receive a surprise medical bill from an in-network hospital. The Kaiser Family Foundation found that 70 percent of such patients were not aware that the provider was out-of-network when they received the care.
Panelist Sonji Wilkes, a patient advocate, presented testimony about her struggle with a surprise bill sent after the birth of her son, who was diagnosed with hemophilia. That child was treated by a charitable out-of-network hematologist who did not charge them for her services. However, the NICU that observed the boy was subcontracted to a third-party provider. This meant that the NICU was out-of-network. The Wilkes were sent a $50,000 bill by the hospital that still haunts them 15 years later.
Thomas Nickels, the executive vice president of the American Hospitals Association, claimed that fixed reimbursement rates, such as a median benchmark or percentage of the Medicaid reimbursement value, would disincentivize insurers from maintaining adequate provider networks. Nickels supported the Alternative Dispute Resolutions method, which involves baseball-style arbitration where providers and payers settle on reimbursement value on a case-by-case basis.
Jeanette Thornton, a senior vice president at America’s Health Insurance Plans, argued that the New York model of baseball-style arbitration would create immense clerical burden, resulting in lost time and greater administrative costs. She argued the arbitration reimbursement model would raise costs for patients in the end. Instead, she advocated for the government-dictated fixed reimbursement rates.
Both versions of the bill call for a benchmark to resolve payments between insurance plans and out-of-network providers. This benchmark says health plans would reimburse providers with the median in-network rate already contracted within specific geographic areas. The House bill contains binding arbitration as a fallback in case either the provider or payer decide the payment was an unfair price.
The National Consumers League supports Congress’ tackling of this issue of surprise or balance billing. NCL has taken no position on how these bills are settled between the payer and provider, as long as patients are protected from outrageously expensive bills they can never hope to pay and were never anticipating. In addition, medical debt is the greatest contributor to consumers declaring bankruptcy, and balance billing is a contributor to that troubling consumer issue. The bottom line is that a bill for medical services should never cause bankruptcy, and a patient should never have to choose between medical treatment and food or housing. We are hopeful this issue will be resolved during this Congressional session.
Alexa is a student at Washington University in St. Louis where she studies Classics and Anthropology and concentrates in global health and the environment. She expects to graduate in May of 2020
August 2, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC—As the nation’s pioneer consumer organization, the National Consumers League (NCL) strongly supports consumer access to safe, effective, and affordable prescription drugs. The recent announcement by the White House to open a pathway for importation of drugs from outside of the United States seems unworkable and poses safety and purity challenges.
Six years ago, the U.S. government enacted a safe system to “track and trace” drugs sold to U.S. consumers through the Drug Supply Chain Security Act. The law required, that by 2023, all drugs sold to U.S. consumers must have both a product identifier and a unique package code to allow Food and Drug Administration (FDA) and any buyer in the supply chain to obtain a comprehensive history of where the drug was manufactured and packaged. This secure supply chain system best ensures consumers are receiving medications that are not counterfeit or substandard.
“The recent announcement by the White House ignores the Drug Supply Chain Security Act and undermines the security of the U.S. pharmaceutical supply chain,” said Sally Greenberg, NCL executive director. “This new pathway for importation could easily lead to counterfeit or substandard drugs finding their way to consumer’s medicine cabinets, thus putting patient health and safety at risk.”
In addition to the safety risks posed by this new policy announcement, there are no guarantees that it will save consumers money. The proposal opens the door for states, pharmacies, and distributors to obtain the medications outside of U.S. borders, but it does not require that any cost savings from obtaining those “lower-priced” medications be passed on to consumers. So, even if safety concerns could be addressed, it is not clear that there will be any direct cost savings benefit to consumers.
The threat to public health is real. Counterfeit medications may contain the wrong active ingredient, the wrong amount of the active ingredient, no active ingredient, harmful ingredients, or even poisons such as mercury, road tar, or antifreeze. Counterfeit medications made with deadly ingredients have been found in more than 40 states across America, posing a significant public health threat.
“Allowing importation will only serve to exacerbate the challenge of preventing counterfeit drugs from reaching American patients,” said Greenberg.
NCL continues to advocate for more responsible strategies to ensure the affordability and accessibility of safe and effective prescription drugs.
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About the National Consumers League
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.
On Tuesday, July 9, the U.S. Court of Appeals for the 5th Circuit will hear oral arguments that will determine whether or not the Affordable Care Act (ACA) may be overturned. Throughout the course of its life, the ACA has been under the specter of possible repeal. While there have been piecemeal attempts to strike down the legislation over time, none have been as concerning as the most recent Texas v. United States case, which argues that since the individual mandate is no longer enforced, ACA would be unconstitutional.
The individual mandate requires that most people maintain a minimum level of health insurance or be subject a financial penalty. In 2017 however, the Tax Cuts and Jobs Act (TCJA), set the individual mandate to $0 as of 2019. As a result of this ruling, the Texas v. United States case was filed by 20 Republican state attorneys general and governors. The plaintiffs argue that the ruling rendered the individual mandate futile, as it no longer produces revenue for the federal government, and since Congress declared the individual mandate to be “essential” when enacting the ACA, this would now make the entire law invalid.
In an ideal situation, the court would maintain the ACA as it exists today, absent the individual mandate. If the ACA is repealed along with the protections that come with it, close to 20 million people would lose their health coverage. Those affected will include mostly low-income adults and children with chronic or pre-existing conditions, dependent adult children ages 26 and younger, Medicare and Medicaid enrollees, employer and employee groups, and more.
Repealing the ACA would jeopardize Medicaid expansion, further burdening uncompensated care and provider reimbursement. In addition, repealing the ACA would increase health care costs among the uninsured by $50.2 billion, result in more than 9 million people losing federal subsidies to purchase health insurance via the marketplace, and would endanger consumers’ ability to obtain essential health benefits.
California’s Attorney General, Xavier Beccerra, is leading a coalition of 21 Democratic attorneys general who have intervened to defend the ACA. Advocates interested in joining these efforts can contact izzy@xavierbecerra.com – please do so and sign the petition by July 14. In addition, organizations can participate in the TXvUS Tweetstorm to express their concerns regarding this case, using the hashtags #TXvUS and #WhatsAtStake, on July 9th at 2 pm EST/ 11 am PST.
NCL is a zealous supporter of the ACA and notes that it is still the law of the land. We are following the developments of this case closely and will continue to fight for access to affordable healthcare for all Americans. For more information on developments of this case, please 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
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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.”
/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.
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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.
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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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