• Sun. May 29th, 2022

Health Administration

Come One, Come All To Health Administration

The Biden Administration’s New COVID-19 Preparedness Plan

Executive Summary

  • The Biden Administration last week released the next phase of its COVID-19 strategy, the National COVID-19 Preparedness Plan, which notably includes a new “test to treat” strategy to increase access to antiviral pills.
  • The plan centers around four key goals—protect against and treat COVID-19, prepare for new variants, prevent economic and educational shutdowns, and continue to vaccinate the world—many of which will require congressional action.
  • The administration does not include a clear estimate of how much its plan will cost; without congressional support for billions more in pandemic funding, the implementation and eventual outcomes of the administration’s preparedness initiatives are uncertain.

Introduction

The Biden Administration last week released a 96-page National COVID-19 Preparedness Plan outlining steps to continue the ongoing federal response to COVID-19 and prevent future outbreaks and shutdowns. In his State of the Union address, President Biden specified that the goal of the plan was not to learn to live with COVID-19, but rather to continue fighting COVID-19 while simultaneously returning to more normal routines and preparing for future disease outbreaks.

The plan centers around four main goals: protect against and treat COVID-19, prepare for new variants, prevent economic and educational shutdowns, and continue to vaccinate the world. As with the administration’s previous COVID-19 plan from January 2021, however, implementation of many of the included initiatives will require congressional action. While some of the plan’s initiatives encourage state and local governments to use remaining funds from the American Rescue Plan, the majority of the provisions require new funding. Though the plan does not include a concrete number for the funding required, the Biden Administration recently requested $22.5 billion for continued domestic and international COVID-19 relief, down from the $30 billion Secretary of Health and Human Services (HHS) Xavier Becerra had previously cited. While this request, which includes $18.25 billion for HHS and $4.25 billion for the Department of State and the United States Agency for International Development (USAID), accounts for initiation of many of the measures outlined below, the administration clearly states that continued support of such initiatives is likely to soon require additional funding. According to one of the president’s top advisors, this could be more than $100 billion next year and $15 billion per year after that to sustain preparedness efforts, though it is unclear what exactly is included in this estimate that makes it more than four times the current funding request.

Protect Against and Treat COVID-19

This first section of the Biden Administration’s plan focuses on increasing access to proven preventive and therapeutic measures to combat COVID-19, including vaccines and antivirals, and expanding existing testing strategies. In a somewhat different approach from the first year of Biden’s presidency in which he exclusively pushed vaccines as the silver bullet against COVID-19, this new strategy takes a more diversified and comprehensive approach by acknowledging the successes of monoclonal antibodies and antiviral treatments, in addition to protection from vaccines.

While nearly 70 percent of all Americans over the age of five are fully vaccinated, those under age five are not yet eligible for a COVID-19 vaccine. The administration is preparing for immediate distribution of such vaccines through a variety of health care centers and local sites in the event that they are approved by the Food and Drug Administration (FDA) and receive a recommendation from the Centers for Disease Control and Prevention (CDC). Additionally, the administration’s plan calls for accelerated research and development of a single vaccine to protect against all SARS-origin viruses, increased manufacturing capacity to produce one billion COVID-19 vaccine doses per year—more than triple the current U. S. population—and enhanced education efforts about vaccines and boosters, all of which will require that Congress approve significant additional resources.

In terms of testing, the new COVID-19 strategy offers more free rapid antigen tests through the COVIDtests.gov website, reiterates private insurance coverage of at-home tests, and promotes Medicare coverage of at-home tests “coming this spring,” without giving any further detail. While the COVIDtests.gov website that launched in early 2021 initially allowed four free at-home tests per residential address, each home is now allowed to order another set of four tests. Currently, private insurance coverage of at-home tests is set to expire with the end of the public health emergency, which was most recently extended until April 15, 2022. Yet as HHS has promised to provide a 60-day notice prior to lifting the emergency declaration—which would have been required by February 15, but was not issued—it appears the emergency declaration will likely be renewed again through the summer. Of note, the administration’s inclusion of private insurance coverage as part of its long-term COVID-19 testing strategy would require Congress to extend such coverage past the ongoing emergency declaration or make it permanent, either of which would have severe cost implications for insurers.

Most notable, the plan introduces a new “test to treat” initiative at pharmacies, community health centers, and long-term care facilities that will provide patients a one-stop option to receive both a free COVID-19 test and, if positive, a free course of antiviral treatment. Though the supply of antivirals has been somewhat limited since their FDA approval late last year, the administration touted that 1 million of the 20 million purchased courses of Pfizer’s Paxlovid pill will be available this month and 2.5 million more pills will be available next month to improve pharmacy supply and enable implementation of the “test to treat” initiative.

While the administration states that “test to treat” sites will be available in March, some have raised concerns about the roll-out given ongoing staffing shortages, and the American Pharmacists Association noted that only pharmacies with onsite medical clinics are eligible to participate. Additionally, while Pfizer’s touts a nearly 90 percent reduction in hospitalizations with its Paxlovid pill, others have pointed out that careful consideration must be taken before prescribing Paxlovid as it interacts negatively with common medications, such as blood thinners and some antidepressants, and should not be taken by patients with certain liver and kidney conditions. Further, Paxlovid’s emergency use authorization fact sheet indicates that the relevant clinical trial excluded patients who had received a COVID-19 vaccine or who had a prior COVID-19 infection. The administration’s plan acknowledges the need for such critical education efforts and commits to broadening awareness and understanding of antiviral treatments among providers. Therefore, the March timeline may be overambitious. Ultimately, the “test to treat” initiative is an innovative and vital aspect of the administration’s new COVID-19 response, and time will tell if the plan can successfully overcome supply challenges and concerns about coordination with pharmacists.

Additional plans to protect against and treat COVID-19 include several measures to improve health equity and support at-risk populations. For those with disabilities, the plan will build on the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics program and expand HHS’s Disability Information and Access Line to provide assistance in the use of at-home tests or finding alternative testing options for those unable to use an at-home test. Consistent with the announcement from the White House last month about making masks and tests more available for disabled and at-risk populations, the plan also indicates new priorities for mask and treatment distribution to centers that treat large populations of immunocompromised and disabled individuals. To support those with behavioral and mental health issues, especially affected youth and health care workers, the administration will seek funding from Congress to launch new workforce training programs and integrate behavioral and mental health care into pediatric primary care settings. Additionally, as part of the administration’s plan to combat COVID-19 misinformation, Surgeon General Vivek Murthy issued a Request for Information asking social media companies, search engines, and messaging systems to submit data by May 2 on the availability and viewership of COVID-19 misinformation on their platforms along with evaluations of their company misinformation policies. This broad and unusual data request from the federal government prompted opposition from some libertarian and right-of-center groups.

Other notable provisions include efforts to detect, prevent, and treat long COVID, building on the $1.5 billion Researching COVID to Enhance Recovery (RECOVER) Initiative in the NIH. While long COVID is broadly understood as physical and mental health symptoms that persist for weeks to months following COVID-19 infection—such as lingering shortness of breath, chest tightness, or problems with concentration and memory—scientists are still learning about its causes and clinical presentations; it is likely the definition will continue to evolve as further research is conducted. Furthermore, President Biden will, depending on funds from Congress, launch Centers of Excellence across the country to provide care for patients with long COVID and direct federal agencies such as HHS, Veterans Affairs, and the Department of Defense (DoD) to develop a National Research Action Plan on Long COVID to advance research efforts and data sharing.

Prepare for New Variants

Americans have experienced five waves of COVID-19 since March 2020, including waves of the most-known variants such as Delta and Omicron. Given the virus’ ability to mutate again, the administration’s plan offers several measures to bolster national preparedness against future variants. In addition to maintaining existing collection and sequencing efforts to track circulating variants, the administration emphasizes continued enhancement of the CDC’s National Wastewater Surveillance System to track community transmission of COVID-19 without the need for individual test results.

Another priority of the administration’s pandemic preparedness plan is to replenish and maintain a fully stocked Strategic National Stockpile with the addition of new COVID-19-related supplies, such as at-home tests, masks, personal protective equipment, and ventilators. In addition to the logistical challenges, this expansion will require significant funds from Congress for purchasing equipment and supplies to sustain the entire U.S. population in the face of another wave of the virus.

In addition to COVID-19-specific measures, the administration’s plan also highlights the need for flexible pandemic preparedness policies that will protect against all future pandemics. Such measures include strengthening existing collaborations between federal agencies and private academic labs and supporting surge response systems led by the Federal Emergency Management Agency and HHS to ensure rapid deployments of medical and emergency personnel, and expanded hospital capacity and vaccination and testing capacities, during surges. The plan also calls for new processes to expedite the development and deployment of variant-specific vaccines and treatments, which the administration claims will allow updated vaccines to be ready in 100 days after detection of a new variant, dependent on appropriate funding from Congress. It is worth pointing out, however, that cases of the Omicron variant peaked in the United States only 67 days after it was first identified in South Africa on November 8, 2021, and an Omicron-specific vaccine has yet to emerge.

Furthermore, the administration will invest in the national volunteer emergency medical response corps and expand the public health workforce through the CDC’s variety of workforce programs in epidemiology and laboratory training. Additionally, the newly established logistics hub for COVID-19, the HHS Coordination Operations and Response Element (H-CORE), will be a permanent place to build on the existing partnership between the HHS and DoD to deploy COVID-19 vaccines and therapeutics and prepare for future disease outbreaks.

Prevent Economic and Educational Shutdowns

The COVID-19 plan includes several provisions to promote economic recovery and prevent future shutdowns. Such proposals center around providing schools and businesses with the necessary tools to open and operate safely, such as a new Clean Air in Buildings Checklist from the Environmental Protection Agency, updated workplace guidelines from the Occupational Safety and Health Administration, and additional investments in the educational workforce, including teaching and support staff. To support necessary ventilation and testing updates, the administration encourages state and local governments and school districts to use the $130 billion included in the American Rescue Plan. Additionally, to “lead by example,” the administration announced the reopening of most federal agencies and encouraged increased levels of service at public-facing federal offices, such as local Social Security offices. As parents return to in-person work, President Biden says his administration will work with Congress to invest in early childcare centers and Head Start programs.

Of note, the president’s plan also calls on Congress to reinstate small- and mid-sized businesses’ refundable tax credits for offering their employees paid sick and family leave related to COVID-19. Similar tax credits were included in several previous COVID-19 relief bills—the most recent coverage from the American Rescue Plan Act expired in September 2021—though preliminary estimates suggest employee claims for the credits have been lower than initially projected.  If approved by Congress, the administration’s new plan specifically states that businesses would be able to claim up to $17,110 for 14 weeks of paid leave for each affected employee to take time off related to COVID-19—either for personal sickness or to take care of a family member.

Vaccinate the World

The final section of the administration’s COVID-19 strategy focuses on global efforts to distribute vaccines and emergency supplies, expand global manufacturing efforts, and increase global health security. Moving forward, the administration will continue delivering 1.2 billion doses of the COVID-19 vaccine across the globe; although, according to the plan, the United States has delivered only 475 million, or roughly 4 percent, of the committed doses to date. In order to ensure that delivered vaccines are getting in the arms of those who need them, the administration will also bolster cold chain logistics and storage capacities in low- and middle-income countries through partnerships with the CDC, the USAID, and the President’s Emergency Plan for AIDS Relief. As with many other provisions, the plan notes that expanding such global “shots-in-arms” efforts will require additional funding from Congress. Additional funding will also be requested to make emergency supplies, such as oxygen, COVID-19 tests, and personal protective equipment, widely available to other countries to respond to future COVID-19 surges.

In terms of global COVID-19 vaccine manufacturing efforts, the administration’s plan calls for additional investments in the “Quad partnership” between the United States, India, Japan, and Australia, as well as continued financing to strengthen manufacturing efforts in South Africa. According to the plan, the goal of such efforts is to diversify international production of COVID-19 vaccines while creating jobs and boosting local economies. In these global vaccination efforts, the administration would be wise to consider a longer-term plan that accounts for necessary shifts to address new variants—such as a variant-specific vaccines that may offer better protection than vaccines originally formulated to protect against the Alpha variant.

Finally, the administration reiterated its commitment to establish a new Global Health Security Financial Intermediary Fund at the World Bank to advance health security and preparedness for future pandemics, which Vice President Kamala Harris announced in September of last year. According to Harris’s announcement, the administration contributed $250 million in seed funding and is requesting an additional $850 million from Congress to contribute to the fund, with a goal of reaching $10 billion total from participating countries.

Conclusion

While some of the initiatives included in the Biden Administration National COVID-19 Preparedness Plan are reasonable and necessary steps toward bolstering the nation’s pandemic preparedness capabilities and protecting against future outbreaks, many require additional funding from Congress, and some are initiatives in name only. Given ongoing concerns over inflation and following a call from Republican senators for an analysis on the use and allocation of past federal COVID-19 funds, additional COVID-19 funding is unlikely to garner broad bipartisan support in the near future. Though the administration asked Congress to include the $22.5 billion in supplemental COVID-19 funding in the government funding bill that has a March 11 deadline, some Democratic senators have been wary about doing so over fears it would derail the already-fragile negotiations, which would push the administration’s new COVID-19 provisions into a separate bill. As the administration clearly states in its plan, “without these investments, many of the activities described cannot be initiated or sustained.” Ultimately, given wavering levels of congressional support for billions more in pandemic funding, the implementation and eventual outcomes of the administration’s preparedness initiatives are uncertain.


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