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National Survey Shows a Vast Majority of Americans Want Comprehensive Reform of the 340B Drug Pricing Program

Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829  

National Poll Demonstrates Strong Support for Policies That Ensure Qualifying Patients Benefit Directly From 340B Drug Discounts, Hold 340B Hospitals & Covered Entities Accountable

Washington, DC – Today, the National Consumers League (NCL) released results from a new Morning Consult national poll of more than 10,000 American adults, revealing overwhelming concern about the burden of medical debt and strong public demand for comprehensive reforms of the 340B Drug Pricing Program. Nearly four in five surveyed adults (78%) support establishing requirements to ensure that qualifying patients directly benefit from 340B drug discounts through reduced out-of-pocket prescription drug costs. More than three in four surveyed adults (77%) believe hospitals should be required to pass 340B savings directly onto patients.

The national poll also found that:

  • 54% of surveyed adults currently have or previously had medical debt, with those in rural areas and the South disproportionately affected. Among adults who have experienced medical debt, more than half (54%) reported skipping additional needed medical care due to cost.
  • Three in four surveyed adults (76%) expressed concern that hospitals benefiting from 340B drug discounts often pursue aggressive debt collection practices against patients.
  • A majority of polled adults strongly supported proposed reforms of the 340B program, including policies to ensure qualifying patients benefit directly from 340B through reduced out-of-pocket costs, allow audits on how hospitals and pharmacies are using the 340B program, and add a requirement that 340B hospitals share a portion of the savings they generate with qualifying 340B patients.

“The 340B program is supposed to help vulnerable patients access and afford life-saving medicines and care, but the evidence shows some hospitals, the pharmacies they contract with, and middlemen are abusing 340B for profit at the expense of low-income and uninsured patients,” said National Consumers League (NCL) CEO Sally Greenberg, JD. “Americans have said loud and clear: They want a 340B program that puts patients first, not profits. Congress must act now to institute comprehensive reforms that restore integrity and accountability to 340B before more patients are left behind.”

The 340B Drug Pricing Program allows hospitals and other covered healthcare entities to access medications at discounted prices from manufacturers with the intent that they pass savings onto patients. However, over time, some hospitals, the pharmacies they contract with, and pharmacy benefit managers (PBMs) have manipulated the program into a major profit-generating enterprise. In many cases, 340B hospitals charge patients full price for discounted drugs, keep the difference as profit, provide minimal levels of charity care, and pursue aggressive debt collection practices against the very patients the program was meant to protect.

This April, Senator Bill Cassidy, M.D. (R-LA), the Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report detailing finds from a multi-year investigation of how covered entities abuse the 340B program. In the report, Sen. Cassidy outlined reforms meant to bring greater transparency to the 340B program, including requiring annual reporting on how 340B revenue is used to ensure direct savings for patients and providing clear guidelines to ensure that drug discounts actually benefit 340B-eligible patients.

By the Numbers: 340B Program Abuses Harm American Patients

  • Massive Price Markups. Medicine price markups are 6.6 times higher at 340B hospitals than at independent clinics, and research shows participation in 340B does not improve health outcomes for uninsured and low-income patients.
  • Declining Charity Care. 340B has grown exponentially to become the second largest federal prescription drug program after Medicare Part D. However, only $1 is invested in charity care for every $10 in profit collected by profitable 340B hospitals.
  • Lack of Transparency. Discounted purchases under 340B totaled a massive $66.3 billion in 2023. However, hospitals are not required to disclose their 340B profits or even whether their revenue is used to lower patient costs.

To learn more about the 340B Drug Pricing Program and the need for federal reforms of the program, visit: https://nclnet.org/340b-program/.

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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.  

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Exposing the 340B Scam: Congress Must Stop Hospitals and Middlemen From Profiting off Low-Income Patients

Op-Ed by NCL CEO Sally Greenberg

As the expression goes, the road to hell is paved with good intentions. As this new administration seeks to root out fraud and abuse in government programs, there’s actually one that could use scrutiny and a major overhaul. Created with the best intentions, the 340B Drug Pricing Program was designed to help low-income and uninsured patients access their medications through drug manufacturer discounts to hospitals. Instead, sadly, 340B has veered wildly off course to the detriment of patients. Today, the program has morphed into a financial bonanza for “non-profit” hospitals and the nation’s biggest chain retail pharmacies while patients in desperate need don’t get the benefits of 340B drug discounts.

The sheer scope, size, and growth of the 340B program is staggering. In 2023 alone, 340B program hospitals, chain pharmacies, and other participating entities facilitated a jaw-dropping $66.3 billion in drug purchases, making it the second-largest federal prescription drug program after Medicare Part D. Hospitals account for nearly 90% of these drug purchases, with little transparency about how much profit they derive from the program—or, more importantly, whether these funds are passed along to patients. We do know, however, that only $1 is invested in charity care for every $10 in profit collected by profitable 340B hospitals. This raises serious questions about how hospitals are benefiting financially while vulnerable patients see little relief.

The perverse incentives and lack of transparency in the 340B program – with no requirement that discounts be passed along to patients – has meant an explosion of tens of thousands of hospitals and contract pharmacies with their hands in the till, financed by the discounts that drug companies are required to provide. Many of those hospitals and contract pharmacies operate far from the vulnerable populations 340B was designed to support. One striking example of this is the expansion of the Rural Referral Center (RRC) hospital designation within 340B. Despite the name, 82% of 340B-affiliated RRCs are in urban areas, serving primarily urban patients. Meanwhile, truly rural communities, which face persistent provider shortages and healthcare access challenges, see little to no benefit.

To compound these challenges, millions of Americans struggle with medical debt, often pursued aggressively by hospitals that benefit from 340B. If 340B were working as intended, we would expect to see measurable relief for these patients. Instead, research consistently shows that 340B hospitals charge markups 6.6 times higher than independent clinics.

In states that have put a magnifying glass on 340B, the results are devastating. In Minnesota, the Department of Health found that 340B covered entities, healthcare organizations that are eligible to participate in 340B including hospitals, health centers, and other safety net providers, earned a collective net revenue of at least $630 million in 2023 from the programs. In North Carolina, the State Treasurer found that hospitals used 340B to overcharge cancer patients, state employees, and taxpayers for oncology medicines. When treating state employees with outpatient oncology infusion drugs, 340B hospitals imposed an average price markup of 5.4 times their acquisition costs.

Even more troubling is how pharmacy benefit managers (PBMs), contract pharmacies, and third-party administrators have carved out a lucrative role in the 340B supply chain. Rather than directing cost savings to low-income patients, these middlemen are profiting off the safety net. PBMs negotiate drug prices, often prioritizing their own profits through fees and markups. Contract pharmacies, which are supposed to increase access to medications, retain significant portions of the discounts as profit. Third-party administrators manage program complexities, but their fees can consume much of the savings. An  investigation by The New York Times found that a private business that oversees the program has played a key role in morphing 340B into a profit center and aiding hospitals in efforts to generate more revenue.

340B reform demands comprehensive efforts with clear, enforceable policies to restore the program’s focus of easing the burden for vulnerable patients of prescription drug costs. Hospitals must disclose what their 340B discounts are and demonstrate how those funds are being reinvested in patient care. Implementing a clearinghouse and claims-level data system would provide much-needed visibility into whether hospitals are using 340B savings as intended rather than padding their bottom lines.

If Washington is serious about cutting waste and protecting American consumers, let’s start with the well-intentioned but off-kilter 340B program. It must not continue to be a financial windfall for hospitals, pharmacies, and middlemen while leaving patients behind. Congress must act now to restore 340B to its original mission—ensuring it helps the low-income and vulnerable patients it was designed to serve. 

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PBPA Commends HHS Funding to Support Maternal and Infant Health

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

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

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

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

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

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

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

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

By Sally Greenberg, NCL Executive Director

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

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

Existing efforts to improve inclusion

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

Recognizing the potential for RWE in maternal health

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

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

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

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

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

WASHINGTON, DC, August 26, 2021 –

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

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

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

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

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

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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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