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Now the line is applicable to another and equally intractable struggle: ending outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease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.

NCL lends support to Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act, H.R. 2815

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September 24, 2021

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

Washington, DC—The National Consumers League (NCL) is pleased to support the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act (H.R. 2815), introduced by Representatives Adam Kizinger (R-IL) and Kurt Schrader (D-OR). NCL believes that expanding the use of biosimilars is a safe and effective option for making prescription drugs more affordable for all.

In the midst of a pandemic, consumers across the country are unable to receive necessary care for many reasons — the most prominent being high costs. Biologics are among the fastest-growing segments of the prescription product market, and costly to the patients who rely on them. What is unique about biologic treatments is that they are directly able to combat the underlying cause of a disease. NCL is committed to educating consumers about the value of biosimilars as alternatives to biologics.

Consumers are largely unaware that similar to generic prescription drugs, biosimilars are the generic equivalent to their biologic counterpart. As with generic prescription drugs, FDA-approved biosimilars have no clinically meaningful differences from their reference biologics. Biosimilars function in the same way as biologics and are subject to the same rigorous testing by the FDA to ensure their safety. The FDA has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more. Biosimilars can enter the market once the patent protections for brand-name biologics expire, and when multiple options exist on the market, competition drives prices down.

NCL believes that biosimilar treatment options are a great way to ensure that cost is not a factor that inhibits access to care. Currently, Medicare beneficiaries pay 20 percent coinsurance on Part B drugs, which includes both biologics and biosimilars. On average, biosimilars cut the price of biologics by about 30 percent, which provides beneficiaries with significantly lower prices than the biologic alternative. While biologics make up a small percentage of the total number of drugs on the market, and just 2 percent of prescriptions filled, they represent 40 percent of all drug spending.

Currently, Medicare reimburses participating physicians based on the average sales price (ASP) of a drug with an additional 6 percent of the reference price. However, because biosimilars are cheaper than biologics, physicians more often prescribe the higher-priced treatment. NCL supports increasing the reimbursement percentage for biosimilars as a way to incentivize physicians to prescribe biosimilars. The BIOSIM Act would maintain the 6 percent reimbursement for prescribing a biologic and increase the return for prescribing biosimilars to 8 percent for a five-year period.

The BIOSIM Act provides the needed incentives to boost utilization by providers to prescribe biosimilars and makes it cheaper for beneficiaries to receive the care they require. “If enacted, this policy would not only provide significant savings to consumers, it would also drive down Medicare spending overall,” said NCL Director of Health Policy Jeanette Contreras. “Congress should act on passing the BIOSIM Act in order to increase access to safe and effective biosimilars that provide consumers an affordable alternative to high-cost biologics.”

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.

AAPI Heritage Month: The ‘Model Minority Myth’ and its negative impact on health disparities

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The month of May marks Asian American Pacific Islander (AAPI) Heritage Month, a time where we celebrate, honor, and reflect upon the vast contributions members of the AAPI community have made to our collective society. The AAPI community comprises more than 23 million individuals with origins from 20+ countries, who speak more than 200 languages or dialects, and it is the fastest growing subset of the population.

The AAPI community is one that harbors complex cultural and historical narratives, and varied generational traumas, such as colonialism, war, and the trials of immigration. The AAPI community’s resilience against these factors, while commendable, has contributed to the myth of the “Model Minority,” and has led to a host of social and health inequities. The model minority myth is one rooted in “positive” stereotypes. It is the assumption that deems AAPI individuals as docile, over-achieving, high-earning, and well-educated—denoting AAPI individuals as exemplars to other communities of color. While at face value these qualities are considered desirable, they tend to relegate an astoundingly diverse community to a monolith, resulting in a detrimental impact on their overall wellbeing.

Due to these unrealistic cultural standards, AAPI consumers face a host of internal and external barriers when interacting with the healthcare system, and are often deterred from seeking necessary care. According to a 2019 Substance Abuse and Mental Health Services Administration (SAMHSA) study, AAPIs have the lowest help-seeking rate for mental health services than any racial or ethnic group. Cultural identity, faith, stigma, and fear contribute to lower utilization of mental health services. Other systemic barriers such as disparities in access to culturally competent care also influence underutilization.

AAPIs are also the only racial or ethnic group for whom cancer is the leading cause of death. Despite facing a confluence of cancer risks, due to unique exposures and environmental factors, AAPIs are screened significantly less for cancers compared to other Americans. Because the model minority myth implies that AAPIs are “better off,” screening, public health, and cultural needs are often masked.

This is best demonstrated by the case of Susan Shinagawa, a leading Asian American breast cancer activist and cancer survivor, whose multiple attempts to obtain screening for a suspected lump in her breast was denied, due to the belief that “Asian women don’t get breast cancer.”

The pandemic has illuminated disparities experienced by AAPIs, such as being overrepresented among frontline healthcare workers, increasing risk of exposure to COVID-19. As a result, case fatality among AAPI healthcare workers is three times greater than their white counterparts. AAPIs also tend to live in multigenerational households, more than other minorities, where 29 percent of AAPI households consist of two or more generational families, further increasing risk of household transmission. Approximately 30 percent of AAPIs have limited English proficiency, augmenting overall barriers to care and government relief resources. This disparity has been especially cumbersome for AAPI consumers seeking telehealth, an integral part of our lives throughout the pandemic, where 50 percent of AAPIs with limited English proficiency were less likely to utilize telehealth than individuals with English proficiency.

One way to dispel the model minority myth and encourage greater health equity for AAPI consumers, is to disaggregate racial and ethnicity data in research studies. Disaggregation of data simply means breaking data into smaller, more precise segments. For example, recent United States census data reveal that AAPIs were less likely overall to live in poverty. However, when that data is disaggregated, it shows that Hmong, Bhutanese, and Burmese Americans experience higher incidence of poverty, in contrast to the greater AAPI community. Disaggregating data not only paints a more accurate picture regarding the different social and demographic characteristics that impact varied health statuses within the community, it influences proper allocation of community resources.

Disaggregation of data can only also happen when there is a prioritization of AAPI participants in research. The most illuminating example of this is highlighted by a 2019 study, which revealed that in the past 26 years, only 0.17 percent of the National Institute of Health’s (NIH) budget was allocated to research focused on the AAPI community. These gaps in funding have led to a paucity in data necessary for public health officials and policy makers to meaningfully address AAPI-specific health disparities. A lack of representation in research impacts how AAPI consumers seek, access, and utilize healthcare. It also impacts the greater community public health goals, impacting health equity for everyone.

Greater investments in culturally competent care, AAPI-focused research, and preventive services, such as screening and early intervention, can help improve overall health outcomes for AAPI consumers. The National Consumers League commends the Biden-Harris Administration’s efforts, such as the COVID-19 Hate Crimes Act and the establishment of a subcommittee on Structural Drivers of Health Inequity and Xenophobia, which aim to ensure the federal government’s response to COVID-19 mitigates anti-Asian xenophobia and bias. These measures are critical in addressing structural inequities experienced by the AAPI community, enhancing community health outcomes as a whole.

The decline in COVID-19 testing nationwide could derail pandemic response wins

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

NCL supports permanently lifting restrictions on access to mifepristone

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April 26, 2021

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

Washington, DC—The National Consumers League (NCL) applauds the U.S. Food and Drug Administration (FDA) for moving to increase access to the abortion pill, mifepristone. As of April 12, the FDA will temporarily allow mifepristone to be dispensed by mail for the duration of the COVID-19 public health emergency. Patients are now able to obtain a safe and effective abortion pill through a telemedicine consult, without risking exposure to COVID-19 with an in-person visit.

Though mifepristone has been used in the United States for more than 20 years to safely and effectively end early pregnancies and treat early miscarriage, the FDA has placed particular restrictions on mifepristone when it’s used for pregnancy termination. Unlike other medications, patients can only obtain the abortion pill directly from a certified medical provider who has a prescriber agreement with the drug manufacturer.

In the early months of the pandemic, the American College of Obstetricians and Gynecologists (ACOG) and other provider groups filed a lawsuit that challenged these restrictions and subsequently won the suit to temporarily lift the restrictions to abortion care during the pandemic.

“This was a win for women’s health, but more importantly for women who live in rural and medically underserved communities who rely on telemedicine for their health care,” said NCL Executive Director Sally Greenberg.

The win, however, was short-lived. In January 2021, the Supreme Court ruled in favor of an appeal by the Trump Administration that put an end to the temporary lift, effectively restricting patient access to medication abortion care.

On April 11, Acting FDA Commissioner Janet Woodcock, sent a letter to ACOG and the Society for Maternal-Fetal Medicine (SMFM), stating that the FDA reviewed recent evidence and found that using telemedicine to provide abortion pills would not increase risks and would help patients avoid potential exposure to COVID-19.

“While we welcome this temporary change, we urge the FDA to continue to review the evidence and scientific data and permanently lift unnecessary restrictions beyond the public health emergency. If it’s safe enough to prescribe through telemedicine during COVID, then it is clearly safe enough to use beyond COVID,” said Greenberg. “We hope the FDA will consider the vast health and socioeconomic benefits that increased access to medically safe abortion via telemedicine would pose for women who rely on this essential reproductive service.”

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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.