Mask up! New Executive Order mandating mask-wearing a welcome development

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

On January 20, just hours following a historic inauguration, President Biden signed an Executive Order (EO) requiring mask-wearing on federal property and inside airports, planes, trains, ships, and intercity buses. Effective immediately, refusing to wear a mask in these locations will now be considered a federal offense. The President also called on governors and local health officials to encourage mask-wearing and social distancing. This comes as especially good news for airlines and their employees, as they now have a federal rule protecting them from passengers who refuse to wear masks inflight, in turn ensuring everyone’s safety.

The EO is the latest of many efforts to halt the spread of COVID-19 by influencing behavior around this necessary public health measure. The mandate to require mask-wearing is also poised to complement President Biden’s call to action for the American public to commit to 100 days of mask-wearing, during the early days of his presidency. Epidemiologists agree that concerted efforts towards pandemic-related precautions can significantly reduce COVID-19 cases in the country, providing much-needed relief for health care facilities currently operating beyond maximum capacity.

Over the course of the pandemic, mask-wearing has unfortunately morphed into a highly polarizing political issue. More than 405,000 Americans have perished in the last year, and irresponsible behavior, such as a stubbornness towards wearing masks, will only further exacerbate the crisis. There are many contributing factors behind this phenomenon, but a lot of it distills down to misinformation and propaganda.

The bottom line is that masks save lives and are powerful tools in preventing the spread of COVID-19. They should be worn to protect the wearer, as well as those they come into contact with. The EO mandating the use of masks is a great step in encouraging civic responsibility in containing the virus. As we forge ahead in our persistence against the coronavirus, consumers are encouraged to maintain adherence to federal health guidance pertaining to physical distancing, the usage of masks, and other public health measures.

Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.

COVID vaccine: Credit where credit is due

By Sally Greenberg, NCL Executive Director

It’s almost a miracle. We now have safe and effective vaccines to fight SARS CoV2, commonly known as COVID-19, the devastating illness that has swept across the globe and—as of January 16, 2021—has killed more than 390,938 Americans and infected 23.5 million in less than a year.

Nearly 40 percent of those who’ve died were beloved older Americans in long-term care facilities, where the disease spread like wildfire, and who were often unable to say goodbye to loved ones.

Sadly, many who contracted the illness and survived spent lengthy hospital stays clinging to life on respirators. Of those who recovered, millions report COVID’s debilitating long-term effects. The United States has four percent of the world’s population but nearly a fifth of its recorded coronavirus deaths—the most of any country. Think of this: we have lost in less than one year eight times the number of Americans who died in the whole Vietnam war, and nine times the number who die in car accidents each year.

But now there’s light at the end of the tunnel because, in record time, America’s pharmaceutical companies have successfully developed safe and highly effective vaccines. Since the SARS CoV 2’s grip over America in late March of 2020, all medical experts could talk about—beyond washing hands, wearing masks, and social distancing—was getting a vaccine to prevent this illness. But vaccines typically take many years to develop so, we were told, don’t hold your breath. And yet here we are.

Consumer groups and members of Congress have been known to criticize the pharmaceutical industry. I get it; too many drugs are expensive and out of reach for millions of Americans, and that must be addressed. But it’s also important to acknowledge value of the public private partnership and the vast resources these companies have put into the R&D and bringing to market life-saving vaccines.

The COVID-19 pandemic is a prime example. The leading vaccines developed for COVID-19 are here, thanks to the dedication of industry leaders and scientists. Pfizer CEO Albert Bourla shifted the company’s focus to singlemindedly developing a COVID vaccine, leveraging its substantial scientific and medical expertise, as well as 20 years of research on previous SARS-like illnesses. Pfizer committed hundreds of millions of dollars of its own resources to building a manufacturing network, and companies agreed to share their knowhow. These efforts were critical in achieving an effective and safe vaccine in record time. And in creating a distribution system that could maintain the very cold temperatures needed to preserve, especially the Pfizer vaccine, before it is administered.

Our government doesn’t have the resources to make that happen alone. Yes, something close to $10 billion in taxpayer dollars through Operation Warp Speed went to companies to assist with the rapid development of a vaccine, but Pfizer didn’t accept government funding for the initial development of the vaccine (though the company did receive $1.95 billion for manufacturing and nationwide distribution of 100 million doses).

And now we have Moderna, which also received more than $1 billion in funding, joining Pfizer in making available a two-dose vaccine that is safe and 95 percent effective, with Johnson & Johnson, Merck, and Novavax not far behind with vaccines that may only require one dose. The public-private partnership model works. And consumers won’t have to pay to receive these shots. Experts tell us we should have five vaccines available by March or April, which is important because it gives healthcare providers options for different populations.

The next challenge is getting it into the arms of enough of us so that we can reach herd immunity, which means at least 60-70 percent of the population needs to be vaccinated.

And while this process has been disappointingly slow, this is largely because states haven’t been given adequate resources from the federal government to support a massive vaccination program. That said, more than a million Americans and counting have now been vaccinated and, under the incoming Biden-Harris Administration and a Democratic Congress, vast additional resources will be going to support for states and localities. The good news for vaccines is that there is high demand for the shots. My own Washington, DC community has offered thousands of appointments for shots online in the morning and they are taken immediately.

We have many to thank for this vaccine’s rapid development, but we must acknowledge the success of this uniquely American public-private partnership. We applaud the heroic work of Pfizer, Moderna, and the other companies to speed R&D and clinical trials of thousands of patients, to ensure a vaccine that is safe and effective. And kudos also to the trusted scientists at FDA and CDC for reviewing the data, ensuring the safety and efficacy of the vaccines, and approving them.

A special thanks is due to two esteemed FDA directors: former director Dr. Scott Gottlieb and our current FDA head Dr. Stephen Hahn, who gave us the straight scoop this past year and promised and delivered on FDA’s integrity and reliance on science throughout the process. And of course, we owe a deep debt of gratitude to our national hero, Dr. Anthony Fauci, who provided honest, science-based advice to the American people throughout these tense and trying times, despite pressure from the Trump Administration to play down the pandemic. Americans clearly agree, as evidenced by “Thank You, Dr. Fauci” signs on lawns across America!

Ensuring completion of series for the COVID-19 vaccine

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

After 10 dark months and over 350,000 lives lost, there is finally light at the end of the tunnel in the fight against COVID-19. Developing a vaccine for COVID-19 in such a short timeframe was made possible by dedicated efforts on the part of scientists, public health experts, and private and public partnerships. It is truly a triumphant medical achievement.

Now health care providers face another summit to scale—ensuring compliance for the vaccine to encourage efficacy and herd immunity. The leading vaccines for COVID-19, Pfizer BioNTech, and Moderna, will require two doses to ensure efficacy. Evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose. Clearly, aside from the distribution and administration, ensuring completion of series for the vaccine will be a critical logistical challenge.

It is estimated that 75 to 85 percent of the population will need to be vaccinated in order to reach herd immunity. That’s a lot of people. And if we account for the odds of those who will receive the vaccine and do not complete their series, we’ve got a long road ahead before the pandemic is behind us.

While both the Pfizer BioNTech and Moderna vaccines were found to be 95 percent effective, require two doses, and use similar mRNA vaccine technology, they differ in timelines. The Pfizer BioNTech vaccine requires two doses that are spaced three weeks apart, and Moderna’s vaccine requires two doses that are spaced four weeks apart. Coordinating efforts to ensure that patients get the correct vaccine in a timely manner, will be a massive undertaking.

There are multiple barriers to address in order to enhance vaccine compliance to end the pandemic. The vaccine is expected to induce flu-like symptoms and may deter some patients from getting their second dose if they aren’t warned about what to expect. Common side effects of the vaccine include headache, fever, chills, soreness at the site of delivery, and fatigue, but patients will need transparency about all potential side effects.

All patients who receive the COVID-19 vaccine will be given vaccine cards (see below). These cards will help track the type of vaccine administered, the dosage, date, and other information pertinent to providers and patients to ensure the completion of a series. Similar to contact tracing, massive follow up will be required via text messages, along with other interventions to remind patients of their upcoming second dose.

Source: CNN

The Food and Drug Administration (FDA) has issued a statement on the importance of properly adhering to FDA-issued vaccine guidelines. The vaccines have been issued with specified dosages and are scheduled at timed intervals. Individuals are instructed against reducing the number of doses (only taking one shot), extending the length of time between their booster vaccines, or changing guidance that is not rooted in evidence-based science, as it will directly impact the efficacy of the vaccine. Until new data is released by scientists and manufacturers of the COVID-19 vaccine regarding changes in dosage or schedules, FDA encourages continued adherence to its current issued guidance.

Vaccine hesitancy will surely further complicate matters. A study conducted by the Kaiser Family Foundation revealed that African Americans are increasingly skeptical of a COVID-19 vaccine. The findings allude to generational distrust of government and medical institutions by people of color, specifically, African Americans, where vaccine hesitancy has been influenced by lived experiences with discrimination and systemic racism. A successful vaccination plan will not only consider the herculean task of distribution and administration but should provide credible outreach within communities of color to foster confidence in the COVID-19 vaccine.

The National Consumers League continues to educate consumers on the importance of vaccine safety and compliance through our advocacy and engagement with the FDA. Our best line of defense against the pandemic is vaccine confidence and adherence. We encourage all who are able to get vaccinated for their own health and the health of their loved ones and community.

NCL testified before CDC committee on COVID-19 vaccine recommendations

For immediate release: December 22, 2020

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) testified before the Centers for Disease Control and Disease Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) this weekend on the equitable distribution of the Moderna vaccine and recommendations for consumer education on vaccine safety. In its testimony, NCL applauds the transparency and access afforded to the public throughout the COVID-19 vaccine approval process.

Equitable distribution:

NCL is encouraged that the Food and Drug Administration (FDA) has approved the Moderna vaccine and that the U.S. government will lead distribution efforts. Due to its ease of transport and storage, the Moderna vaccine stands to readily ship to rural and hard to reach communities. NCL calls on federal health officials at the helm of distribution to facilitate access to the Moderna vaccine to medically underserved areas.

Safety and efficacy:

NCL expressed its trust in the FDA and CDC’s robust inter-agency collaboration to continue ongoing, post-market surveillance of adverse events among recipients of the COVID-19 vaccine and to inform consumers of any additional safety recommendations. NCL urged the CDC to educate consumers about potential reactions and side effects, as this transparency will further encourage the compliance necessary to achieve herd immunity. The vaccine is expected to induce flu-like symptoms after the initial dose and this may deter some patients from getting their second dose if they aren’t warned about what to anticipate.

Vaccine adherence:

NCL encouraged the CDC to conduct culturally competent and inclusive public messaging about vaccine safety to ensure that communities of color and persons with limited English proficiency are informed and feel empowered in their decisions to vaccinate. Adding to the complexity of administering the vaccine, public health officials will need to ensure the completion of two doses in a series. This stands to create additional challenges because evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose.

Equitable allocation:

NCL applauds ACIP’s recommendations to prioritize vaccinations for health care workers and long-term care facility residents in Phase 1a. Now that there are two approved vaccines, NCL calls on ACIP to prioritize recommendations to vaccinate the approximately 87 million non-healthcare essential workers unable to work from home—such as bus drivers and grocery workers—who are at higher risk of exposure. Racial and ethnic minorities make up more than 40 percent of the essential workforce and are the backbone of many essential industries. The pandemic has illustrated that low-income minority communities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death.

Persons who recovered from COVID-19:

Lastly, over 18 million individuals in the U.S. have been infected with the coronavirus. It is expected that individuals who recover will acquire some natural immunity to COVID-19. Individuals who recover from the coronavirus want to know if they are protected from reinfection and for how long. We call on the CDC to expedite developing vaccine recommendations for persons who’ve recovered from COVID-19.

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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.

NCL testified before FDA committee meeting on Pfizer-BioNTech COVID-19 vaccine

For immediate release: December 11, 2020

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) testified before the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) this week regarding the Pfizer-BioNTech COVID-19 Vaccine.

“As the nation’s oldest consumer advocacy organization, NCL has been encouraged by the honesty, transparency, and access afforded to the public during this critical time.” NCL commended the Food and Drug Administration, Centers for Disease Control and Prevention, and other public health entities for their commitment to fostering public trust throughout the COVID-19 vaccine development and approval process and thanked the committee for the opportunity to speak.

In its testimony, NCL noted that there has never been a more critical time for consumers to have confidence in the FDA.

Emergency Use Authorization (EUA):

The FDA has undergone scrutiny from the scientific community for prematurely issuing EUAs for COVID-19 therapeutics. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority and appreciates that the FDA recognizes that an EUA is not intended to replace long-term randomized clinical trials data associated with full FDA approval. We are encouraged by data reporting a consistent vaccine efficacy rate of 95 percent across age, gender, race, and ethnicity demographics and look forward to seeing more guidance around the vaccine, as the trial continues to collect safety and efficacy data.

Safety and Effectiveness:

NCL noted the public’s growing trust in the FDA’s rigorous vaccine approval process and called on the agency to perform ongoing post-market surveillance. Such surveillance performed in the United Kingdom found that the vaccine may be unsafe for individuals with severe allergies. Consumers will rely on ongoing guidance from public health agencies regarding any potential adverse events from the vaccine and expect that the FDA will be aware of these concerns.

Innovative Vaccine Delivery Systems:

Additionally, ensuring innovative vaccine delivery methods, such as including oral or nasal options, could address geographical access issues, diverse health needs, and increase uptake overall.

Diversity in Clinical Trials:

We applaud Pfizer’s efforts to ensure diversity in their COVID-19 vaccine clinical trials. NCL requests that the FDA continue to prioritize vaccine clinical trial data that reflects diversity, as people of color will need to have confidence in the vaccine’s efficacy. This will affect the overall uptake of the vaccine.

The development of a COVID-19 vaccine in such a short time frame is a huge scientific feat, made possible through robust collaboration between private and public entities. NCL will continue to support the FDA and CDC in efforts to release a COVID-19 vaccine safely and expeditiously.

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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.

NCL statement on vaccine for COVID-19

For immediate release: November 12, 2020

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) welcomes the very hopeful news that a coronavirus vaccine with a reported efficacy rate of 90 percent may be approved and rolled out in the next few months. NCL has historically advocated for vaccines because they have overwhelming effectiveness and safety profiles, preventing billions of often debilitating and deadly diseases across the globe—from small pox to measles to polio. The clinical evidence on the coronavirus vaccine—developed by Pfizer Inc. and partner BioNTech SE—though incomplete at the moment, is very promising.

“We applaud the unprecedented cooperation by public and private entities, along with concerted coordination among scientists, doctors, and researchers that has gone into developing a vaccine to combat this terrible pandemic, which has killed over 237,000 Americans, struck 10 million people, and only shows signs of worsening over the winter months,” said NCL Executive Director Sally Greenberg. “As this vaccine moves closer to being cleared for widespread use and the safety data verified, we are grateful to the companies and government officials who urgently prioritized the development of an effective and safe vaccine to combat the scourge of COVID-19. We are also encouraged that other companies are in the later stages of reviewing their own COVID-19 vaccines, which use different technologies to fight the virus but hopefully will be effective and safe as well.”

The FDA will be reviewing the safety data in the next few weeks on the Pfizer vaccine and will then determine to whom the first doses will be directed. Pfizer has said the vaccine could become available before the end of the year and that the company can produce 50 million doses globally—equivalent to reaching 25 million people because two doses are required for maximum protection from the virus. The most vulnerable populations are likely to receive the first batch of vaccines.

NCL cautioned consumers that during this period, people should maintain all the safety practices for preventing spread of the virus—wearing masks and practicing social distancing and keeping social gatherings to a minimum.

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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.

Jeanette Contreras portrait

Low-income essential workers lack adequate COVID-19 testing

By NCL Director of Health Policy Jeanette Contreras

As the United States enters the third wave of COVID-19, low-income and minority communities hit hardest by the virus continue to disproportionately lack access to testing. The pandemic is shining a spotlight on the underlying health disparities that have long persisted within these medically underserved communities. Racial and ethnic minorities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death from COVID-19. This is due largely to the prevalence of chronic conditions such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease (COPD).

In addition, racial and ethnic minorities make up a significant portion of the low-wage essential workers on farms, in grocery stores and warehouses, and in truck shipping. The essential workforce is composed of  64 percent women and 41.2 percent people of color. This translates to a higher risk of exposure to the virus among minorities because their employment involves interacting with the general public or co-workers in an unsafe environment. According to an August 2020 report from the U.S. Department of Health and Human Services (HHS), Hispanic/Latino persons were the largest demographic living in counties identified as coronavirus hotspots (3.5 million persons), followed by Black/African American persons (2 million).

HHS released a comprehensive strategy to address the lack of access to COVID-19 testing in vulnerable communities, which included expanded testing at federally qualified health centers (FQHCs) and partnerships with retail pharmacies. However, the very social determinants of health that these communities face, such as lack of transportation, child care, and paid sick leave, create significant barriers to getting to a community health clinic or a drive-through testing site. Despite higher demand in minority communities, there are fewer testing sites available to them when compared to access in predominantly white, more affluent areas. Researchers of the COVID Tracking Project found that zip codes with white populations of 75 percent had significantly more testing sites per capita than zip codes that were 75 percent minority.

Though adequate testing is only one of the prongs in confronting the pandemic, followed by contact tracing and isolation, it provides critical data needed to provide resources in the communities hardest hit by this pandemic. The World Health Organization (WHO) recommends conducting around 10–30 tests per confirmed case as a general benchmark–less than 5 percent positivity rate suggests the pandemic is under control. The U.S. currently has a positivity rate of 6 percent, and many states are not testing at a rate needed to contain the spread. Further adding to the disproportionate burden, there is no federal guidance for routine testing of essential workers. To provide adequate testing in low-income and minority communities, we need to address the underlying social determinants of health that place them at greater risk.

What you should know about the Healthcare.gov Open Enrollment

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

From November 1, 2020 to December 15, 2020, consumers will be able to enroll in health coverage through the health insurance marketplace, Healthcare.gov. Choosing the right health plan involves thoughtful decision-making, with careful consideration of your needs and your budget. COVID-19 testing and treatment, telehealth, and mental health services have been vital pandemic necessities, and consumers are advised to pay attention to any changes in their current health plans to account for any adjustments in health needs.

It is estimated that annually consumers typically spend 17 minutes when selecting plan options during open enrollment, most simply sticking with their plans from the previous year. If you need assistance navigating the health insurance marketplace, you can consult a healthcare navigator to help in comparing the coverage options that make sense for you. Healthcare navigators provide free, unbiased advice and offer services in a number of languages. To find a navigator in your area, please click here.

Even with the election and looming challenge to the ACA coming before the Supreme Court, California v. Texas, consumers should know that the federal health insurance marketplace, also known as Obamacare, is still available. The Supreme Court will hear oral arguments on November 10, but the ultimate decision can come as late as June 2021. We’ve written more about the implications of California v. Texas here. Despite multiple attempts by opponents to repeal the ACA, over 20 million people have gained coverage through the marketplace in the past decade.

The Centers for Medicare & Medicaid Services (CMS) recently announced that marketplace premiums have dropped by 2 percent nationally. Additionally, as a result of the pandemic, the marketplace has seen greater insurer participation – in turn, offering consumers with more robust options for coverage. Plans offered via Healthcare.gov are required to cover a set of essential health benefits mandated by the ACA, ensuring that you have access to comprehensive care – a provision that is of chief importance during this time. The ACA has afforded consumers with a host of health protections and prohibits insurance plans from discriminating against enrollees based on health status, including pre-existing conditions. To learn more about the marketplace, click here.

The National Consumers League encourages consumers to seek coverage via ACA compliant plans offered on the marketplace. If you miss the deadline to apply for coverage within the open enrollment period, you may be able to qualify for a Special Enrollment Period (SEP). Applying during a SEP is contingent upon meeting certain criteria, such as life events like having a child or losing health coverage. If you qualify for Medicaid or the Children’s Health Insurance Program (CHIP), you can apply at any time. Most importantly, in order to have coverage that is effective by January 1, 2021, you must sign up by December 15, 2020.

CMS Proposed Rule Ignores Data & Bipartisan Support for the Value of Copay Assistance Programs

By NCL Director of Health Policy Jeanette Contreras

Americans love getting a discount. As consumers, we like to shop to save without compromising the quality of the products we buy. But in healthcare, the stakes are higher at the checkout counter. Patients not only want a discount, they depend on it to afford necessary, sometimes lifesaving, medication to treat their health condition.

Despite what we know about the value and impact of copay assistance programs, a new policy from the Centers for Medicare & Medicaid Services (CMS) could put a barrier between these critical programs and the patients who need them most.

Manufacturer copay assistance programs include discounts, coupon cards, and vouchers which many of our friends, family members, and neighbors use to afford their prescriptions. Studies have shown that without these financial support systems, many patients couldn’t afford their medicines.

The CMS proposal, which has yet to be finalized, would require manufacturers to guarantee that this assistance goes directly to patients—and if manufacturers do not, they would be required to include the value of the copay assistance in Medicaid Best Price and Average Manufacturer Price (AMP) calculations. That would be fine but there’s a  problem.

CMS has a separate policy that was already finalized earlier this year: the Notice of Benefit and Payment Parameters (NBPP) Rule for 2021. In part, the NBPP allows health insurance companies and pharmacy benefit managers (PBMs) to use policies that stop copay assistance from counting towards a patient’s out-of-pocket burden—sometimes called copay accumulator adjustment programs.

NCL criticized HHS for permitting health plans to use these so-called copay accumulator adjustment programs.

“Removing this cost-sharing assistance will force those patients to pay thousands of dollars more in unexpected costs at the pharmacy. These new costs could push some to forego those medications, leading to worsened health outcomes. This could compromise medication adherence and will lead to increased health care costs over time.” – NCL Executive Director Sally Greenberg

Separate studies conducted by the Centers for Disease Control and Prevention (CDC) and IQVIA show that out-of-pocket costs can contribute substantially to reduced adherence or to patients not taking their medication altogether. This is counterproductive because if patients do not take their meds as directed, it means higher costs in other parts of the healthcare system stemming from increased hospitalizations, ER visits, and long-term health issues.

If the data doesn’t convince CMS, voters should. Weeks before the presidential election, we can clearly see widespread support for the value of copay assistance regardless of political affiliation. According to a new National Hemophilia Foundation national survey, more than 80 percent of registered voters believe the government should require copay assistance to be applied to patients’ out-of-pocket costs. Even lawmakers agree that CMS should stop this policy before it launches. A bipartisan group of 36 members of the U.S. House of Representatives sent a letter to CMS urging the agency to not finalize the “contentious line extension section or the Medicaid best price change as currently defined in the notice of proposed rulemaking.”

Clearly, copay assistance is critical to Americans. We hope CMS reevaluates the potentially harmful consequences of this new rule on patients and pulls back this counterproductive proposal.