Experts fear impact of US plan to end COVID-19 emergencies
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In the early months of 2020, amid a rapidly worsening pandemic, the U.S. government declared public health and national emergencies to help the country respond to COVID-19.
Congress provided billions of dollars in emergency funds for the response, which contributed to the development and purchasing of medical countermeasures such as vaccines, boosters and treatments, as well as tests and face masks that were made available for free to the public.
Additionally, Congress enacted several bills that included pandemic-specific requirements that these countermeasures be covered by both public and private insurers. Other regulations to protect patient access and promote equitable distribution were put in place.
In late January of this year, the White House announced plans to end both emergency declarations on May 11 — a move that will greatly impact many of the requirements currently in place and contribute to the “commercialization” or privatization of the pandemic response, experts said.
“Up until now, the federal government has basically paid for most of — if not all of — the response to the pandemic, including paying for vaccines, treatments and the medical countermeasures that we've all relied on,” Jennifer Kates, PhD, senior vice president and director of global health & HIV policy at the Kaiser Family Foundation, told Healio | Infectious Disease News.
“Privatizing or commercializing the pandemic is really the idea that those products are going to transition to the commercial market and they're no longer going to be purchased by the federal government and provided free to the public,” Kates said.
We spoke with Kates and other experts about the implications of ending the emergency declarations and what it could mean for public health in the U.S.
Ending the declarations
The announcement to lift the public health and national emergencies was made in a formal statement opposing two House bills that would have immediately ended both. The announcement was in line with the Biden administration’s assurance that there would be a 60-day “wind-down” before the end of the declarations.
"An abrupt end to the emergency declarations would create wide-ranging chaos and uncertainty throughout the health care system — for states, for hospitals and doctors' offices, and, most importantly, for tens of millions of Americans," the White House said in a statement.
The statement said that continuing the emergency declarations through May 11 would not impose any restrictions on individuals — such as mask or vaccine mandates — or on school or business operations. However, the statement noted that ending the declarations will have “significant impacts” on COVID-19-related operations.
This sparked concern among experts that the pandemic would shift from being a public fight to a commercialized response.
Melanie A. Thompson, MD, an Infectious Disease News Editorial Board Member, said the impact this will have is “not appreciated” by clinicians. In fact, she said, the pandemic has slowly been commercialized since congressional funding ran out.
“This has been little appreciated since we still have a stock of government-purchased vaccines, tests and Paxlovid,” Thompson said, adding that some treatments — such as bebtelovimab — were shifted to insurers, resulting in high costs and dramatically decreasing access. Thompson noted, though, that this point is moot as bebtelovimab is no longer used due to lack of efficacy against circulating variants.
“Clinicians need to understand what is coming and to advocate for policy solutions to mitigate the impact, especially on the most vulnerable populations,” Thompson said. “I am an advocate for clinician advocacy. Our voices are valued by policymakers, and we often don’t use the power we have to advocate for change.”
Privatizing the response
The COVID-19 response was bound to change, said Amesh A. Adalja, MD, FIDSA, FACEP, senior scholar at the Johns Hopkins Center for Health Security. Adalja agrees with the decision to end the emergencies, although he hopes some aspects remain.
“This situation was not going to be a perpetual taxpayer-funded endeavor, and it was always expected that the ordinary health care/pharma/insurance process would eventually absorb COVID-19,” Adalja said. “The key is making sure certain waivers such as the use of telemedicine, [medical] license portability and expansion of the practice scope of pharmacists become permanent.”
Lawrence O. Gostin, JD, faculty director of the O’Neill Institute for National & Global Health Law at Georgetown University, said that the privatization caused by these changes will affect the “full range of the COVID response,” including everything from the CDC collecting crucial surveillance data — for example, it will no longer have access to data from EDs, inpatient health care facilities, laboratories under the National Syndromic Surveillance Program, or states' COVID-19 vaccination data — access to health care, and funding.
According to Kates, one of the main and immediate things that will happen is the end of the policy that everyone is entitled to eight free COVID-19 home tests a month that can be reimbursed by insurance.
“That's going away,” she said.
Additionally, Medicaid programs have had the option to provide uninsured people in their state with free access to COVID-19 vaccines, treatments and tests, which 15 states did, Kates said.
“That’s also going away,” she said.
Thompson explained that people without insurance could see vaccine prices that are three to four times higher than the price paid by the government. (By law, vaccines that are recommended by the CDC — including COVID-19 vaccines — are free through insurance, Kates noted.)
Pfizer already announced that prices of its vaccine are expected to increase to $110 to $120 per dose despite being bought by the government for $19 to $30 per dose, Thompson noted. Moderna announced in February that its vaccine will remain free regardless of where it is administered or whether a person has insurance. At the time of publication, this made Moderna the only manufacturer of COVID-19 vaccines so far to announce that it is offering its shot for free to the uninsured.
Moderna’s announcement came after the company faced backlash for an announcement suggesting its vaccine would be priced between $82 to $100 per dose, despite being bought by the government at $15 to $26 per dose, Thompson said.
Thompson said a lack of free vaccines will worsen the “already poor” vaccination record in the U.S., and a lack of access to low-cost tests will make it harder for people to determine if they have COVID-19 — the first step to accessing appropriate treatment and protecting others. From there, the lack of access to appropriate treatment for those who are sick will create barriers for people whose comorbidities place them at higher risk for hospitalization and death, she said.
“This is especially of concern for treatments like Paxlovid, which must be started within 5 days of symptoms for the best response, and introduces the likelihood that insurers will institute time-consuming prior approval processes that will delay or prevent access, while also charging high copay or coinsurance costs,” Thompson said.
The good news, Kates said, is that the U.S. still has a federal supply of tests, treatments and vaccines that should last a while longer, meaning patients will not immediately face these barriers. But that is another thing that will run out, she said.
Additionally, ending the emergencies will eventually impact decisions made by the FDA, experts said. The agency has indicated what it will do next, including issuing a Federal Register notice explaining how ending the COVID-19 public health emergency will impact its COVID-19-related guidance and which of those guidelines it will temporarily extend or let expire. The FDA clarified that ending the public health emergency will not impact its ability to authorize devices — including tests — or treatments and vaccines for emergency use. The agency said existing emergency use authorizations (EUAs) will remain in effect — unless terminated by the HHS secretary — and that it may continue to issue more.
“Before an EUA declaration is terminated, the secretary will issue a Federal Register notice providing advanced notice to the public that the EUA declaration is being terminated,” the FDA said in an update. “This starts the transition, which must be of a reasonable period to allow for proper dispositioning.”
Transition ‘into a new normal’
Kates suggested that the public may misinterpret the end of the emergencies to mean that COVID-19 itself is “over.” She emphasized that that is not the case.
“It doesn't operate that way,” she said. “It's more complex than that, and it's more about how we transition from the emergency state into a new normal.”
“Undoubtedly, the poor will bear the brunt of commercialization,” Gostin said. “This includes the poor within rich countries like the U.S., where the Biden administration is planning to move products to the commercial market.”
More specifically, Thompson said the changes will hurt uninsured people who are disproportionately Hispanic/Latino, American Indian/Alaska Native or Black. In 2021, 27.5 million nonelderly people were uninsured, according to the Kaiser Family Foundation. Additionally, people with low incomes will be impacted, and they are disproportionately people of color, Thompson added.
The emergency declarations “allowed the government to purchase and mobilize vaccines, tests and treatments for cost-free access by all U.S. residents” but “there have been substantial and persistent disparities in uptake by race, ethnicity, geographic region, political ideology and socioeconomic status,” she said, suggesting that privatizing COVID-19 prevention and treatment could worsen those disparities.
For example, studies have demonstrated that demographics, socioeconomic factors and experiencing economic hardship during the pandemic “explained a statistically significant portion of vaccination coverage disparities,” CDC researchers reported in a study last spring in the American Journal of Preventive Medicine. Their study, for example, showed that the largest disparity was observed among people who identified as Hispanic or Latino, whose vaccination coverage was 8 percentage points lower than their non-Hispanic white counterparts (95% CI, 7.1-8.9). Additionally, the study demonstrated that socioeconomic factors, including health insurance status, income, education and employment, explained 4.8 percentage points of this disparity (95% CI, 4.3-5.2) and economic hardship explained an additional 1.4 percentage points (95% CI, 1.2-1.6).
The CDC listed other factors that create and compound challenges to vaccine access and acceptance, including working conditions, racism and other forms of discrimination, gaps in health care access, transportation and neighborhood conditions, and lack of trust.
Thompson added that these disparities have persisted throughout the pandemic, including when booster vaccines became available.
Uptake of boosters has been “remarkably low,” Thompson said, signaling that this would not be the best time to make them more expensive and less available.
“When vaccines, tests and treatments are no longer provided cost free by the federal government, uninsured and low-income persons will experience much higher barriers to access due to cost alone, but they may also experience barriers as access points are likely to decrease,” she said. “If pharma decides to implement patient assistance programs for low-income individuals, remember that these impose burdens on health care systems and patients alike, and are not a substitute for low-barrier, no-cost vaccines, tests and treatments.”
Will profit come first?
Public health crises require a robust public health response, but the public health infrastructure in the U.S. is not only underfunded, it is “fractured into wildly varying responses by state,” Thompson said.
Lack of access to quality affordable health care impacts all Americans, not just those who do not have it, Thompson continued.
“This becomes graphically apparent in times of health crises, such as the COVID-19 pandemic,” she said.
Gostin thinks pharmaceutical companies will “follow the money” — especially as more variants emerge and vaccine manufacturers race to make boosters that are effective against them.
“What would make them the most profit?” he asked. “If chasing variants will be lucrative, they will do that. If it is not lucrative, they will stop.”
Adalja said that as long as there is a market demand for new and improved medical countermeasures — “with a promise of sufficient return on investment” — pharmaceutical companies will continue to develop new and improved products to help the response.
“Just because something is not a public health emergency does not mean that advancement ceases,” he said.
References:
- CDC. COVID-19 Vaccine equity for racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html. Posted March 29, 2022. Accessed Feb. 15, 2023.
- FDA. FAQs: What happens to EUAs when a public health emergency ends? https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends. Published Jan. 31, 2023. Accessed Feb. 15, 2023.
- Moderna’s commitment to patient access in the United States. https://investors.modernatx.com/Statements--Perspectives/Statements--Perspectives-Details/2023/Modernas-Commitment-to-Patient-Access-in-the-United-States/default.aspx. Posted Feb. 15, 2023. Accessed Feb. 15, 2023.
- Tolbert J, Drake P. Key facts about the uninsured population. KFF. Dec. 19, 2022. https://www.kff.org/uninsured/issue-brief/key-facts-about-the-uninsured-population/. Published Dec. 19, 2022.
- Williams AM, et al. Am J Prev Med. 2022;doi:10.1016/j.amepre.2021.10.008
For more information:
Amesh A. Adalja, MD, FIDSA, FACEP, can be reached at aadalja1@jhu.edu.
Lawrence O. Gostin, JD, can be reached at gostin@georgetown.edu.
Jennifer Kates, PhD, can be reached at jkates@kff.org.
Melanie A. Thompson, MD, can be reached at drmt@mindspring.com.
Click the links to read experts’ answers to two questions regarding Paxlovid: “Should the FDA approve Paxlovid before the emergencies end?” and, “Why is it important to maintain access to Paxlovid?”
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