Testing Strategy

The Biden Administration Initiates New Plan for National COVID-19 Testing

As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a new president takes office in the midst of a pandemic, that impact becomes not only magnified but also more immediate. This is particularly true when the new president’s views are diametrically opposed to those of his/her predecessor. The most dramatic illustration of these principles occurred on Jan. 20, 2021, the Biden administration’s first day in office, with the rollout of a bold new plan for COVID-19 testing called the National Strategy for COVID-19 Response and Pandemic Preparedness (National Strategy).

The Diagnostic Challenge

Back on Jan. 20, 2020, COVID-19 coronavirus was only just beginning to transform from an Asian to global threat. Because the virus was novel, there was no proven laboratory test to diagnose it. In late February, the U.S. declared a public health emergency and the U.S. Centers for Disease Control and Prevention (CDC) secured the first ever Food and Drug Administration (FDA) emergency use authorization (EUA) for a test to detect the coronavirus. However, as we would learn later, the CDC assay was seriously flawed. And the efforts to distribute it to state laboratories and public health agencies was beset with roadblocks and administrative error.

The Trump administration policy was to assign top priority to developing new COVID-19 diagnostics and industry rose heroically to the challenge. By the end of March, more than a dozen COVID-19 tests had received EUA, including assays from Roche, Thermo Fisher Scientific, Hologic, Quidel, Abbott (two tests), Quest, DiaSorin, Cepheid, BioMérieux and Quidel. In addition to these RT PCR products, FDA loosened the rules to allow SARS-CoV-2 antibodies and antigen tests to reach the market on an expedited basis. And so they did, including many assays of dubious reliability.

But while the system succeeded in generating an adequate volume of test products, logistics, supplies and distribution proved to be the Achilles’ heal. Laboratory scientific and trade associations urged the White House to take immediate and direct action to resolve the challenges; but the idea of exercising central control over the economy was anathema for an administration dedicated to cutting business regulation.

The National Strategy

In almost every aspect, the Biden National Strategy for COVID-19 testing is the diametrical opposite of the approach taken by its predecessor. Perhaps the most notable change is with regard to tone and sense of urgency. Here are the key changes with regard to substantive policy.

  1. More Money for COVID-19 Testing

The first big difference between Trump and Biden is with regard to money for COVID-19 testing. The new administration’s proposed $1.9 trillion American Rescue Plan includes $50 billion to expand COVID-19 testing by providing funding to purchase rapid tests, expand lab capacity and support regular testing efforts of schools and local governments.

  1. Ensure Free COVID-19 Testing

The National Strategy calls for continuing the free testing policy of the previous administration but in a more direct and hands-on fashion. A new Executive Order establishes the COVID-19 Pandemic Testing Board to oversee implementation of a clear, unified approach to testing and directs agencies to facilitate testing free of charge for those who lack health insurance and to clarify insurers’ obligation to cover testing. The federal government will also provide testing protocols to inform the use of testing in congregate settings, schools, and other critical areas as well as among asymptomatic individuals. Technical assistance will support more widespread adoption of testing to improve timely diagnosis and public confidence in the safety of settings like schools.

  1. Stepped Up Production of COVID-19 Tests

On Feb. 17, the White House COVID-19 Response Team announced that the administration will provide $1.6 billion to expand and improve COVID-19 testing and genomic sequencing. The CDC will invest almost $200 million to finance a threefold expansion of sequencing for the virus and its variants from 7,000 to about 25,000 samples per week. That is not as much money as some experts believe is necessary to achieve maximum COVID-19 sequencing capacity, but it is a nice start.

The sequencing initiative comes about two weeks after the Response Team announced that the administration is finalizing contracts with six undisclosed companies to increase domestic testing capability for at-home SARS-CoV-2 tests, which would lead to 61 million point-of-care or at-home tests by the end of the summer.

  1. Stepped Up Production of Testing Supplies

Another cornerstone of the National Strategy is to promote production of vaccines, tests, PPE, reagents and other critical testing materials that have been in short supply. As with free testing, the most dramatic change is not in the policy but its execution, specifically the administration’s willingness to invoke federal government control over industry under a law called the Defense Production Act (DPA). A new Executive Order directs federal agencies to exercise their DPA legal powers to get industry to accelerate the manufacturing, delivery and distribution of 12 categories of critical supplies, including:

  • N95 masks, isolation gowns, nitrile gloves and other PPE;
  • PCR sample collection swabs;
  • Test reagents;
  • Pipette tips;
  • Laboratory analysis machines for PCR tests;
  • High-absorbency foam swabs and nitrocellulose material for rapid antigen tests;
  • Rapid test kits;
  • Low dead-space needles and syringes; and
  • Necessary equipment and material to accelerate the manufacture, delivery and administration of the COVID-19 vaccine.

Meanwhile, the new Pandemic Testing Board is establishing regional coordinating centers to identify laboratory testing capacity and match it to specific areas of need. The coordinating centers will partner with laboratories, including academic and commercial laboratories, to collect specimens, perform tests and report results.

  1. Fix the COVID-19 Testing Supply Chain

In addition to hitting the gas on immediate production, the National Strategy includes measures to fix the structural and systemic supplies and logistical bottlenecks that have bedeviled COVID-19 testing efforts during all phases of the public health emergency. The $1.9 trillion rescue plan provides $30 billion to the Disaster Relief Fund to help ramp up production of supplies including items like vials, reagents, and protective gear that are essential to collecting and running clinical samples. In addition, key federal agencies have been ordered to collaborate and work alongside industry to support projects to expand and improve production and distribution of PPE and testing supplies.

Takeaway

The point of this overview is not that the Biden plan is superior to the Trump COVID-19 testing strategy but that it is vastly different. An administration philosophically opposed to government regulation has been succeeded by a regime prepared to use any and every source of legal authority at its disposal to tackle the crisis. It is the same approach that Lincoln and Franklin D. Roosevelt followed to confront the national emergencies they faced upon taking office. Time will tell whether it succeeds for COVID-19.

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