A New Administration Takes a Totally Different Approach to COVID-19 Testing

Fair or unfair, the general perception has been that the White House has been less than fully supportive of COVID-19 testing efforts during the pandemic. On Jan. 21, his first full day in office, President Biden released his plan to deal with the COVID-19 crisis. While vaccination takes center stage, the National Strategy for the COVID-19 Response and Pandemic Preparedness (National Strategy) emphasizes the importance of scaling and expanding testing by doing something the previous administration refused, namely, creating a centralized federal agency to “oversee implementation of a clear, unified approach to testing.”

The 7 Objectives

The National Strategy is organized around seven objectives:

• Restoring the trust of the American people;
• Mounting a safe, effective, and comprehensive vaccination campaign;
• Mitigating spread of the virus through the establishment of clear public health standards and expansion of masking, testing, data collection and analysis, treatments and the health care workforce;
• More extensive use of federal government control over industry under the Defense Production Act (DPA) to promote vaccination and testing;
• Safely reopening schools, businesses and travel;
• Protect those most at risk, including across racial, ethnic and rural/urban lines; and
• Restoring U.S. global leadership globally and advancing preparedness for future threats.

While the goals are pretty much what you’d expect, the key policy change is the establishment of a central COVID-19 Response Office responsible for coordinating pandemic response across all federal departments and agencies. To monitor outcomes, the National Strategy also calls for creation of publicly accessible performance dashboards to establish a data-driven, evidence-based approach to evaluate progress in the fight against COVID-19. Both of these initiatives are things that leading lab, hospital and other provider industry associations asked the previous White House and its COVID-19 Task Force leader, Vice President Pence, to pursue.

Increased Testing Figures Prominently in the Plan

Another bit of welcome news to the lab industry is the commitment to scale and expand COVID-19 testing. “To control the COVID-19 pandemic and safely reopen schools and businesses, America must have wide-spread testing,” the National Strategy declares. “A national testing strategy is a cornerstone to reducing the spread of COVID-19 and controlling outbreaks, and clear federal guidance and a unified national approach to implementation are essential.” A key part of the National Strategy is direct involvement by the federal government to expand supplies of rapid tests, double test supplies and increase testing capacity.

The Pandemic Testing Board Executive Order

The administration has already taken steps to execute the National Strategy. Among the new President’s first Executive Orders is one that establishes the COVID-19 Pandemic Testing Board to oversee implementation of a clear, unified approach to testing. The Executive Order 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 and among asymptomatic individuals. Further, technical assistance will support more widespread adoption of testing to improve timely diagnosis and public confidence in the safety of settings like schools.

The DPA Executive Order

Another dramatic difference in approach is the new administration’s willingness to use the DPA to promote the production of vaccines, tests, PPE, reagents and other critical testing materials that have been in short supply. With that in mind, the President issued a separate Executive Order directing federal agencies to exercise the DPA and other applicable legal powers to get industry to accelerate the manufacturing, delivery and distribution of 12 categories of critical supplies, including taking action to increase the availability of supplies including:

• N95 masks, isolation gowns, nitrile gloves and other PPE;
• PCR sample collection swabs;
• Test reagents;
• Pipette tips;
• Lab 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 COVID-19 vaccine.

$50 Billion More for COVID-19 Testing

The administration’s new relief package is also putting the money where the National Strategy’s mouth is. Thus, the proposed $1.9 trillion American Rescue Plan includes $50 billion to expand COVID-19 testing and $30 billion more 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.

Lab Industry Response

The initial response from the lab industry has been largely positive. In a statement, American Clinical Lab Association (ACLA) president Julie Khani, “commend[ed] President Biden for taking a national, science-driven approach to combatting COVID-19. . . . and [giving] public health officials additional tools they need to combat this devastating virus.”

Mark Birenbaum, executive director of the National Independent Laboratory Association (NILA), also praised the National Strategy, including the proposed funds for testing and protective supplies. He added, however, that NILA member labs would also like to see more efforts to provide transparency around how those supplies are distributed.

Takeaway

The point of this analysis is not to contend that the Biden approach to COVID-19 response is superior to that of the Trump administration. For those who believe in limited federal government, the National Strategy is bound to be most disconcerting and even horrifying. But elections have consequences and the fact is that the new President is going at things in a diametrically opposite way from his predecessor with a willingness to leverage every bit of federal government power and authority to tackle the crisis. It’s the same approach that Lincoln and Franklin D. Roosevelt followed to confront the national emergencies they faced. Whether it’s the right strategy and will prove effective for COVID-19 remains to be seen.