Nancy Glick

The Obesity Bill of Rights: Priorities for government action

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Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

Americans need and now have an Obesity Bill of Rights for a reason: People with obesity do not receive the same concern, level of attention, and quality care as those with any other serious chronic disease.  

Put into real-life terms: Though the adult obesity rate now exceeds 42 percent – the highest level ever recorded – obesity is still viewed as a problem of lack of willpower; too many health professionals act in discriminatory ways based on people’s size; and those seeking obesity care often face exclusions in insurance plans, restrictive practices that delay or deny treatment, or are not factored into decisions regarding medicine use.   

The consequence is that only 10 percent of people with obesity get help from medical professionals and only 2 percent of those eligible for treatment with Food and Drug Administration (FDA)-approved anti-obesity medicines (AOMs) have been prescribed these drugs, meaning the disease remains undiagnosed and undertreated. Compounding the impact, untreated obesity worsens the outcomes of more than 230 other chronic diseases, which is why obesity is responsible for as many as 400,000 Americans dying from obesity annually and costs the nation $1.72 trillion a year  in direct and indirect health expenditures – more than what Social Security paid in retirement benefits in 2022. 

It does not have to be this way. 

And this is where the Obesity Bill of Rights enters the picture. Developed by the National Consumers League (NCL) and the National Council on Aging, in consultation with leading obesity specialists, the bill of rights establishes eight essential rights with the core requirements so adults will receive the same person-centered, quality care for obesity as those with other chronic conditions. As such, the bill of rights serves as a blueprint for necessary changes in medical practice and government policy, starting with actions that can happen now. 

One immediate action item is pressing Congress to pass the Treat and Reduce Obesity Act (TROA), an important legislation that will allow more seniors to be treated with FDA-approved anti-obesity medications under the Medicare program. This matter is a high priority because obesity rates have nearly doubled among older adults to include two in every five Americans ages 65 and older. 

Another priority is ensuring that health professionals have the prescribing information to effectively treat people with obesity when they are taking drugs for other conditions, such as depression, schizophrenia, infections, and cancer. The simple fact is that certain drugs work differently in people with obesity and the consequences can be underdosing, a delay in response time, or the drug remaining in the body too long, potentially causing side effects. For example, studies show the drug brexpiprazole (Rexulti®), which treats depression and schizophrenia, takes significantly longer to reach effective levels in people with obesity – and some patients never reach these levels. Fortunately, the same research provides an improved dosing regimen so all patients with obesity can achieve efficacy. 

A different challenge involves drugs like posaconazole (Noxafil®), an antifungal often prescribed by oncologists to prevent infections. Two separate clinical trials show that obesity significantly increases posaconazole’s “half-life” – a term reflecting the amount of time it takes to rid the drug from the body. Half-life is an issue with posaconazole because many oncology medications must be delayed until the drug is out of the body’s system. Thus, if the package insert does not flag this matter when patients have obesity, doctors prescribing posaconazole may not know about the increase in half-life and start using oncology medicines too soon.  

These problems are not rare, but drug labels to guide safe and effective prescribing are dismissing people with obesity. For this reason, the Obesity Bill of Rights includes language to make accurate prescribing a requirement for receiving person-centered obesity care. Moreover, because increasing research validates the consequences of “flying blind” when drugs behave differently in the bodies of people with obesity, the obesity community is raising alarm bells, supported by a position statement from the American College of Clinical Pharmacology (ACCP), which urges FDA to close gaps in the testing and approval process for new drugs intended for use by people with obesity.  

However, because more immediate action is needed, five leading obesity organizations – American Society for Metabolic and Bariatric Surgery, the Obesity Action Coalition, the Obesity Medicine Association, the STOP Obesity Alliance, and The Obesity Society – issued a joint statement calling on drug manufacturers to update their labeling immediately to provide correct usage instructions for people with obesity when there should be a difference in dosing.  

NCL stands with the obesity community in calling for this sensible action and urges FDA to be a catalyst in ensuring that health professionals have the prescribing information needed for their patients with obesity to take important therapeutics safely and achieve the maximum benefit. For more information, visit right2obesitycare.org.

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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.

Obesity medicine specialists, health providers, insurers and employers urged to make obesity treatment a right of all Americans

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October 13, 2023

Media contact: National Consumers League – Nancy Glick, nancyg@nclnet.org, 202-823-8442 NCOA –Simona Combi, Simona.combi@ncoa.org, 571-527-3982

Washington, D.C. – With growing evidence that U.S. adults with obesity feel stigmatized and ignored by their health care providers, the National Consumers League (NCL) and National Council on Aging (NCOA) today urged health professionals, insurers and employers to join a national movement to define quality obesity care as a right for every American.

Taking the case directly to health professionals on the front lines in delivering obesity care, NCL and NCOA used The Obesity Society’s annual meeting in Dallas October 14-17 to announce plans to provide Americans with an Obesity Bill of Rights.  Today, over 100 million adults are living with obesity[1] (42 percent of the public), yet only 10 percent get help from medical professionals.[2] An Obesity Bill of Rights has the potential to transform obesity care by empowering Americans to demand the respect of their health providers and to be screened, diagnosed, and effectively treated for their obesity based on medical treatment guidelines.

“For too long, adults with obesity have encountered a healthcare system that works against them. They are stigmatized, discriminated against, not treated with respect by their health providers, and confront significant obstacles in receiving the care they deserve. ” said Sally Greenberg, Chief Executive Officer of the National Consumers League. “This must change; we need an overhaul of the health system, and we believe an Obesity Bill of Rights can drive this transformation.”

Because this change will only happen if there is agreement on a set of basic rights that ensure adults with obesity receive respectful, timely, and effective obesity care, NCL and NCOA unveiled www.Right2ObesityCare.org, a new online engagement platform, so the nation’s health providers, insurers and employers can play a role in developing the Obesity Bill of Rights.  Right2ObesityCare.org explains the purpose and research-driven process and encourages a wide range of health professionals – from obesity medicine specialists and physicians to dietitians, nutritionists, exercise physiologists, health educators, and mental health professionals – to contribute their ideas.

Town Halls Chart the Obstacles for Adults with Obesity and Their Providers

Along with hearing from health professionals, the Obesity Bill of Rights will be informed by the insights of both adults with obesity and their health providers who participated in four town hall meetings that NCL and NCOA hosted across the country. Held in senior centers and churches in

California, Delaware, Mississippi, and Oklahoma between June and August 2023, the town halls involved more than 250 older adults, community leaders, and local clinicians who laid bare a healthcare system that is inhospitable to delivering quality obesity care.                                                        

When asked to share their experiences, older adults attending the town halls spoke of feeling invisible when seeing a health provider, not being listened to, and being treated with disdain when they initiated conversations about their obesity. At the same time, physicians described feeling inadequate to provide obesity care due to the limited time for counseling, not enough training in obesity management, inadequate coverage and reimbursement for obesity care, and needing better tools to help patients recognize obesity risks. This confirms research that finds adults with excess weight often feel unwelcome in the doctor’s office or believe that seeking help for obesity signifies moral failure. [3]

“This is a chronic condition that no one wants to talk about,” said Ramsey Alwin, NCOA President and CEO. “For several decades, NCOA has worked to empower older adults to better manage their chronic conditions. To break down barriers related to obesity, we held town halls that allowed both older adults and their health providers to relay their lived experiences. What we learned is that encouraging more people to seek obesity care requires an investment in science-based, easy-to-understand, accessible information about obesity; a healthcare system that encourages informed decision-making and patient-centered care; and effective public policy that requires health plans to provide access to the treatments deemed appropriate by the health provider, including lifestyle interventions, FDA-approved weight loss medications, and bariatric surgery.”

Mobilizing for Change
With the townhalls as a guidepost, NCL and NCOA are now leading a rigorous process to finalize and release the Obesity Bill of Rights to the medical community and public before the end of 2023. The process includes hosting a meeting of top experts to review a preliminary draft with recommendations for refinement. NCL and NCOA will also seek feedback from specialists in minority health, aging, and rural health, as well as health professionals and other stakeholders who offer advice through the online engagement platform.

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About NCL

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. The organization’s 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.

About NCOA

The National Council on Aging (NCOA) is the national voice for every person’s right to age well. We believe that how we age should not be determined by gender, color, sexuality, income, or ZIP code. Working with thousands of national and local partners, we provide resources, tools, best practices, and advocacy to ensure every person can age with health and financial security. Founded in 1950, we are the oldest national organization focused on older adults. Learn more at www.ncoa.org.

[1] Hales CM,, et al. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. Centers for Disease Control and Prevention. NCHS Data Brief. No. 360. February 2020.

[2] Stokes A, et al. Prevalence and Determinants of Engagement with Obesity Care in the United States. Obesity. Vol. 26, Issue 5; May 2018, 814-818

[3] Gunther S, et al. Barriers and enablers to managing obesity in general practice: a practical approach for use in implementation activities. Qual Prim Care. 2012; 20: 93-103

The National Consumers League applauds the reintroduction of bipartisan legislation to give millions of Medicare beneficiaries access to safe and effective obesity treatments

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July 21, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – The National Consumers League (NCL) welcomes the reintroduction  of the Treat and Reduce Obesity Act (TROA) as a needed step to end outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.

Introduced by Senators Tom Carper (D-DE) and Bill Cassidy (R-LA) and Representatives Brad Wenstrup (R-OH), Raul Ruiz (D-CA), Mariannette Miller-Meeks (R-IA) and Gwen Moore (D-WI), TROA will end this regulatory logjam by expanding coverage under Medicare Part D to new FDA-approved anti-obesity medications, which are currently excluded under a policy dating back to 2003. TROA will also end Medicare Part B restrictions on intensive behavioral therapy (IBT) that limit the delivery of IBT to primary care providers and restrict the physical locations where this care can occur. Through TROA, clinical psychologists, registered dietitians and nutrition professionals will be able to provide IBT if an individual with obesity is referred by a physician.

At a time when the obesity rate among adult Americans exceeds 40 percent and is even higher among communities of color – virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity – passage of TROA could be a critical step in changing the trajectory of a disease that for too long has been overlooked and undertreated. The National Consumers League applauds TROA’s reintroduction in the 118th Congress and pledges our support to gain passage of this important legislation on an expedited basis.

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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 nclnet.org.

We must never forget the importance of vaccines

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Sally Greenberg

By Sally Greenberg, Chief Executive Officer

I have written before about being born into a family that experienced the agony of the polio epidemic. My uncle Roger Joseph’s battle with the disease—including his diagnosis in 1951 by my father, a practicing internist—devastated our entire family. My uncle, a golden boy, popular, handsome, brilliant, and kind, graduated from the University of Minnesota and Harvard Law School; he also won a silver star for his military service in WW2. Married with three daughters, he had a thriving law practice when he fell ill.

His case was severe and rendered him paralyzed. Confined to an Iron Lung for two years, the device was designed to stimulate breathing in patients whose lungs no longer functioned. With a great deal of therapy, my Uncle Roger, by then quadriplegic, moved to a motorized wheelchair that he ended up using for the rest of his life. He doted on his children, moved in with my grandmother, slept in a rocking bed to facilitate his breathing, and had an attendant on duty 24 hours a day. When we visited my grandmother, we visited our uncle too. He also came to our home for Sunday dinners, and I recall him taking breaths carefully before speaking, and when he did, he was wry and funny. He also had to learn to write again with his non-dominant hand. My mother, who had always idolized him, marveled at how his handwriting never changed.

My uncle lived 16 years with polio, thanks to a loving family, modern medicine, financial wherewithal, his wheelchair, and his attendant. Paralyzed from the neck down, he nonetheless spent these years productively, doting on his daughters, going to work every day, and attending baseball games, and even traveling abroad.

In 1954, U.S. physician Jonas Salk developed a vaccine to prevent the disease. The polio vaccine was first tested on 1.6 million children in Canada, Finland, and the United States before it was used more broadly. By 1957, annual cases had dropped from 58,000 to 5,600, and by 1961, only 161 cases remained. Had my uncle had access to the vaccine, he never would have gotten sick.

The powerful lessons about vaccines weren’t lost on anyone in my family. This explains why I feel obligated to confront head-on the dishonesty and lies of the anti-vaxxers. I have traveled to the CDC and the FDA numerous times to testify in support of childhood and adult vaccinations, and each time have been confronted by vaccine deniers.

Here’s the problem: Those of us with memories of family members with devastating diseases like polio are aging out. We are victims of our own success in wiping out childhood diseases. Younger generations have now been vaccinated for polio, measles, rubella, mumps, influenza, diphtheria, tetanus, and whooping cough so they do not know the trauma these illnesses caused to millions of families. Come to think of it, I’m in that category myself.

Florence Kelley, who in 1899 launched the National Consumers League, wrote in the 1880s about the dark days of “diphtheria”; she lost three young siblings to the disease, which sent her mother into lifelong depression. But I have never known anyone with diphtheria, thanks to vaccines.

My 27-year-old son never had measles—nor any of his friends. But my siblings and I all did, along with rubella, chicken pox, and the mumps. Measles alone is far more serious than often understood. In 2021 alone it killed nearly 128,000 unvaccinated children under age 5 around the world.

All of which leads me to the reason I have written this blog. Each year, Uncle Roger’s daughters proudly award the Roger E. Joseph Prize, (created by my Uncle Burton Joseph, in honor of his brother and their dad) and for this year’s prize, my cousin Linda produced a video; it tells a compelling story of her experience with her father’s illness. Hebrew Union College, which graduates reform rabbis, hosts the awards. Honorees have included Rosa Parks, Henry Louis Gates, Morris Dees, Sara Bloomfield, and the Center for Reproductive Rights. A complete list is at the link below.

Indeed, the Roger E. Joseph Prize is a point of immense pride for our family, but it also gives us the opportunity to talk about diseases like polio and, now Covid, and the critical importance of the vaccines developed to prevent them.

How truly fortunate we are to have a medical establishment that has helped to prevent families from suffering, the way ours did, when a loved one falls ill from an infectious disease.

As the anti-vaccine movement grows each year—a = movement that traffics in conspiracy theories and junk medicine—note Robert Kennedy Jr.’s anti-vaccine crusade, which his own family has denounced in this article published by Politico.

Now more than ever we need to have conversations about the critical importance of vaccines.

http://www.rogerejosephprize.org/about-the-prize

It is time to give Medicare beneficiaries effective obesity care

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Sally Greenberg

By Sally Greenberg, Chief Executive Officer

“What we’ve got here is a failure to communicate.”

As one of the most recognized quotes of all time, this line from the 1967 movie, Cool Hand Luke, originally addressed the struggle of a person’s will over government control.

Now the line is applicable to another and equally intractable struggle: ending outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.

The struggle is not new. As documented in a 2010 report from the US Surgeon General, the prevalence of obesity began to increase sharply in the 1980s and by the 1990s, public health leaders were calling obesity a national emergency. Now, the obesity rate among adult Americans exceeds 40 percent but is even higher among communities of color: virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity. Moreover, because obesity is directly linked to over 230 medical conditions, the disease is responsible for an estimated 400,000 deaths a year, costing the nation over $1.72 trillion annually in direct and indirect health costs.

Confronting this growing crisis, in 2012, the United States Preventive Services Task Force (USPSTF) issued guidelines recommending screening all U.S. adults aged 18 and above for overweight and obesity and encouraging clinicians to treat or refer adults with obesity for treatment. Then, in 2013, the American Medical Association officially recognized obesity as “a disease state” on a par with other serious chronic diseases, like type 2 diabetes and hypertension, so healthcare professionals (HCPs) would be motivated to diagnose, counsel and treat obesity. These actions were the impetus for most private insurers, state health plans and state Medicaid programs to cover obesity care to some degree. Moreover, the Office of Personnel Management, which oversees health coverage for federal employees, now requires that insurers cover the full range of obesity treatment options, including intensive behavioral therapy (IBT), prescription weight loss drugs, and bariatric surgery. Additionally. Tri-Care, which covers military personnel and their families, and the Veterans Administration cover AOMs for adults who do not achieve weight loss goals through diet and exercise alone.

This leaves the Medicare program, which today represents the biggest obstacle impeding access to quality obesity care. Outdated Medicare Part B policy places undue restrictions on intensive behavioral therapy by allowing only primary care providers to deliver IBT and severely restricting the physical locations where this care can occur. Equally troubling, new FDA-approved anti-obesity medications (AOMs) are excluded from Medicare coverage based on a statutory prohibition tracing back to the start of the Part D program. This was in 2003 when fen-phen (the drug combination of fenfluramine and phentermine) controversy raised questions about the safety of weight loss drugs, leading the Centers for Medicare and Medicaid Services (CMS) to classify these medicines as “cosmetic” treatments not eligible for coverage, just like hair loss drugs and cold and flu treatments.

But obesity medicine has improved substantially since 2003. Due to the latest science on obesity as a serious chronic disease, there have been major advances in drug development, including new anti-obesity medications that achieve meaningful weight loss. Yet, while science has moved forward, CMS policy is stuck in the past.

To change this situation, advocates have gone to both Congress and CMS for help. In Congress, public health and aging organizations have been working to pass bipartisan legislation called the Treat and Reduce Obesity Act (TROA) that would end the exclusion under Medicare Part D prohibiting coverage for AOMs and change Medicare Part B rules to permit all qualified health practitioners to provide Intensive Behavioral Therapy (IBT) to Medicare beneficiaries. With CMS, advocates have written to and met with key staffers on several occasions, urging the agency to use its inherent authority to allow flexibility to include drugs under Part D that might otherwise be excluded. One key argument is that CMS has already done this on multiple occasions, ending exclusions for treatments for AIDS wasting and other medical conditions when it is urgent to do so.   And yet, ten years have passed since AMA classified obesity as a chronic disease with no action from either Congress or CMS. In Congress, TROA did not receive a floor vote in the House of Representatives in 2022 despite having 154 co-sponsors and widespread support from medical societies, public health organizations and the aging community. Similarly, CMS has kept the exclusion on coverage for anti-obesity medications, even though the Biden Administration has asked for ways to address systemic racial inequity and obesity is a throughline to better health outcomes.

To start a dialogue that could lead to meaningful action, the National Consumers League and the National Council on Aging decided to change the dynamic. In September 2022, our organizations sent an urgent letter to CMS Administrator Chiquita Brooks-LaSure requesting a meeting so we could speak to her directly on behalf of  about 18 million traditional Medicare beneficiaries whose diagnosis of obesity puts them at risk of other serious conditions. Our letter was well received and on January 17, this meeting took place.

Recognizing that there has been a “failure to communicate” the urgency of the moment, our purpose was to put a human face on seniors with obesity and to convey that bureaucracy and intransigence cannot be the reason that 18 million older adults are denied effective obesity care. As such, we asked Administrator Brooks-LaSure to end the impasse in Part D coverage of FDA-approved AOMs by making access to obesity treatment an agency priority. This action could be the catalyst empowering CMS staff to think differently about obesity and be more open to interpreting the statutory exclusion provision in a way that would permit coverage for anti-obesity medications.

It is too soon to know what the outcome of the meeting will be. We opened a door and pledged to maintain a frank and constructive dialogue with Administrator Brooks-LaSure and staff she designates on the needs of Medicare beneficiaries living with obesity. Our hope is to elevate obesity as a priority for CMS policy and to work with CMS and other stakeholders to remove the access barriers that keep too many Americans from seeking obesity care.

Promising new therapies are giving hope to Alzheimer’s patients and families, so why limit access?

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Sally Greenberg

By Sally Greenberg, Executive Director

For years, Alzheimer’s patients, families, and caregivers have battled a condition with no treatment options. This year alone, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s.

The good news is, we’ve recently seen remarkable progress in the fight against Alzheimer’s disease as innovative treatments demonstrated the ability to halt disease progression in a major clinical trial and proved to curb cognitive decline. These therapies targeting the buildup of amyloid beta plaque in the brain (one of the telltale signs of Alzheimer’s) have shown promise for so many patients and families facing this fatal diagnosis.

The first such therapy was approved by the U.S. Food and Drug Administration (FDA) in June of last year. This should give us all hope for a brighter future, but this progress may be moot if regulatory barriers hinder patient access.

Rather than ensure broad coverage through the Medicare program – as is the case for nearly every other type of drug that receives FDA approval – the Centers for Medicare and Medicaid (CMS) decided this spring to restrict access to these new Alzheimer’s treatments only to patients participating in approved clinical trials. This puts severe limitations on coverage for an entire class of innovative Alzheimer’s disease treatments, with CMS in direct conflict with the FDA, whose medical experts approved the drug as safe and effective.

In fact, this puts the FDA’s entire accelerated approval pathway in the crossfire, sounding an alarm to millions of patients hoping for medical breakthroughs.

No one is arguing the therapy is a miracle cure, but that’s not how new therapies tend to work. History has shown that when it comes to serious conditions with high unmet medical needs, even small improvements are critical.

Accelerated approval first surfaced during the AIDS crisis, when HIV was a death sentence and there were no treatments. AIDS advocates demanded something – anything — despite minimal benefits “because we have nothing now and no hope.” The first AIDS treatments in the 1980s were grueling regimens with serious side effects, but they had to start somewhere. Today, as medicines have evolved, HIV-positive patients require one pill a day and can live with the disease.

The same is true for Duchenne’s Muscular Dystrophy, a terminal disease that lands young boys in wheelchairs often before they reach 10 years old. Approval of the first drug to treat Duchenne’s met significant controversy in 2016 because it was minimally effective. Yet, the FDA approved it because these patients had no hope. Today there are five treatment options for the disease that slows down the progression and buys time.

And in 2001, a game-changing therapy for chronic myeloid leukemia received approval; the treatment helped to spur innovation in what became targeted therapies for cancers.

The science and medical ecosystem will continue to naturally progress, moving us from zero treatment options to medicines that mitigate symptoms, to treatments that halt disease progression, and eventually, cures. This is true in the Alzheimer’s space, but by limiting access to an entire class of Alzheimer’s treatments, CMS is putting future scientific breakthroughs at risk and creating a ripple effect throughout the entire healthcare system. This new promising drug class will only be available to those with the financial wherewithal to pay thousands of dollars out of their own pockets.

With this precedent, any drug that emerges from the rigorous development pipeline could be deemed too expensive or too early in the discovery phase. CMS acting as the final arbiter on what new treatments will be made available and overriding the scientific judgment of FDA experts should concern all of us.

As we look ahead toward a new Congress, our lawmakers can and should put pressure on CMS to keep pace with the science and give hope to Alzheimer’s patients and families.

NCL offers support for Increasing Access to Biosimilars Act (S. 1427)

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December 16, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Increasing Access to Biosimilars Act (S. 1427), as introduced by Senators Michael Bennet (D-CO) and John Cornyn (R-TX). This Act directs the U.S. Department of Health and Human Services (HHS) to launch a pilot program that increases Medicare payments for providers who use biosimilars. Representative Tony Cárdenas (D-CA) introduced a similar bill (H.R. 2869) in the House of Representatives.

Since 2014, the growth in pharmaceutical spending has been primarily driven by increased spending on biologic drugs. Biosimilars demonstrate no clinically meaningful differences in terms of safety, purity, and potency against their FDA-approved biologic counterpart, and are generally 15 percent to 35 percent lower in price. Therefore, biosimilars pose great potential to reduce health care costs.

The Increasing Access to Biosimilars Act would create a new pilot program administered by the Center for Medicare & Medicaid Innovation (CMMI) that aims to encourage physicians to prescribe less expensive biosimilars through shared savings. Shared savings is a payment strategy that offers providers a percentage of any net savings generated in order to reduce health care spending overall.

The following statement can be attributed to NCL’s Health Policy Director Jeanette Contreras:

“This legislation would not only broaden access to cost-saving biosimilars and reduce unnecessary spending on costly biologics, but it could also foster greater competition. In addition, it signals to future participants the viability of the biosimilars market, which is a win for consumers.

NCL believes that well-aligned payment incentives can steer providers toward cost-saving behavior with the overall objective of reducing Medicare expenditures. We strongly urge Congress to pass the Increasing Access to Biosimilars Act as the FDA continues to approve new biosimilars to market at increasing rates.”

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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.

Jeanette Contreras portrait

Listen up: FDA’s proposed OTC hearing aid rule

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By NCL Director of Health Policy Jeanette Contreras

Whether it be listening to your grandchildren share a story or having dinner with a friend, many consumers rely on devices to help them hear and understand speech every day. Hearing loss is something that we need to be mindful of at all ages, and as consumers, we look to our nation’s regulators to make sure these devices are safe to use.

Some people with hearing loss are able to work closely with hearing care professionals to finely adjust their hearing aids at sound levels that enable them to hear speech at comfortable levels without causing any harm. But, as more Americans struggle with their hearing, accessible hearing aids becomes increasingly important. Proposed regulations by the Food and Drug Administration will allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss, a step forward in making them more affordable and accessible.

While these regulations are positive for access, the FDA’s proposed thresholds for volume or output for over-the-counter hearing devices are more in line with those for earbuds people use to listen to music for short periods than they are for hearing aids that are worn for several hours a day. These draft rules would allow a maximum sound output level of between 115 and 120 dBA, which is the equivalent to the volume of a chain saw. According to the CDC, exposure of sounds at 120 dB could become dangerous in as little as nine seconds. As you can imagine, being exposed to this level of sound for long periods of time is unsafe and could increase hearing loss and significantly damage the ear.

Hence, there is widespread concern among hearing care professionals that allowing an unnecessarily high level of amplification can lead to further hearing loss. Leading hearing care associations recommend a maximum output limit of 110 dBA for OTC hearing aids and establishing a gain limit of 25 dB.

As the leading consumer healthcare organization, we applaud the FDA’s efforts to increase access to hearing aids for those who need them. We do hope that the FDA will adjust its proposal, so it is in line with the recommendations of hearing care professionals before finalizing the regulations. Consumers shouldn’t be concerned that they may find their situation worsened by devices that are intended to help.

To learn more about gain and output and how to protect yourself from hearing loss, check out our new infographic.

NCL offers support for Star Rating for Biosimilars Act, H.R. 2855

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October 13, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (724) 799-5392

Washington, DC—The National Consumers League (NCL) is pleased to support the Star Rating for Biosimilars Act, as introduced by Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH). NCL believes that implementing a rating system for biosimilars would incentivize insurers to provide lower cost drug alternatives and alleviate the financial burdens on patients.

The Centers for Medicare and Medicaid Services (CMS) currently has a star ratings system for insurance plans under Medicare Advantage and Part D. The quality measures capture items such as clinical quality, beneficiary satisfaction, patient outcomes, and regulatory compliance. This rating system helps the CMS evaluate which plans to keep and discontinue. To date, we do not have a comparable rating system where biosimilars are concerned. “Biosimilars are on average 30 percent cheaper than their biologic counterparts, yet many existing barriers in our current healthcare plans prevent patients from accessing these cost-saving medicines,” said NCL Director of Health Policy Jeanette Contreras.

The Star Ratings for Biosimilars Act would require the CMS to put in place a five-star performance rating system for biosimilar products under Medicare Advantage Plans. For each plan, the ratings will be based on quality measures meant to evaluate the level of access that each insurance plan provides to biosimilars, such as whether a biosimilar is on the formulary, and the percentage of enrollees prescribed a biosimilar when its biologic counterpart is available. Aside from Advantage Plans, the bill would also require the CMS to incorporate these measures into a similar rating system for plans under the Medicare Part D prescription drug benefit.

The NCL believes in transparency as a core function of informed decision-making. Knowing whether cost saving biosimilars would be available to enrollees under various Medicare (including the Medicare Advantage plans) and Part D plans would bring in more transparency to help consumers be more informed when selecting a plan. “Allowing consumers to see which plans are offering access to lower cost biosimilars would also incentivize Medicare plans to increase patient access to biosimilars,” said Contreras. We encourage Congress to pass the Star Rating for Biosimilars Act in order to broaden access to and encourage increased provision of cost-saving biosimilars.

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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.

National Consumers League applauds decision to ban vaccine misinformation from YouTube

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September 29, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, today applauded YouTube and its parent company Alphabet for their decision to ban anti-vaccine misinformation from the platform. NCL has been a leading voice in promoting vaccine confidence and pushing online platforms to do more to counter misinformation and disinformation about COVID-19 and vaccines, which has contributed to far too many preventable deaths.

The accounts being removed are known anti-vaccine organizations. Robert F. Kennedy’s Children’s Health Defense Fund, one of the most high-profile anti-vaccine organizations in America, was responsible for more than half of the paid advertisements on Facebook in years past. Joseph Mercola, founder of Mercola.com Health Resources, authored an article falsely stating that COVID-19 vaccines released via emergency authorization may cause massive side effects. Tenpenny Integrative Medical Center, spearheaded by physician, Sherri Tenpenny, promotes alternative health in lieu of vaccines and authored the book, “Say No to Vaccines: A Resource Guide for All Ages.”

The following statement is attributable to NCL Director of Health Policy: Jeanette Contreras:

“Vaccine hesitancy driven by rampant misinformation online is costing lives every day and prolonging a pandemic that has devastated consumers financially as well as physically. YouTube’s decision to ban anti-vaccine misinformation, while overdue, is nonetheless an important step forward in the fight against the COVID-19 pandemic.”

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.