On March 18, 2020, in response to bipartisan calls from Congress and governors across the US, President Trump issued an executive order finding that health and medical resources needed to respond to the spread of COVID-19 meet the criteria under the Defense Production Act (DPA) to be given priority for purposes of supporting the national defense. The order identifies personal protective equipment (PPE) and ventilators as specific types of health and medical resources that will now be given priority. Examples of PPE the order is likely to cover include masks, goggles, gowns and gloves. Other health and medical resources, such as diagnostic test supplies, may soon be added to the list as the executive order delegates authority to the Secretary of Health and Human Services (HHS) to identify additional specific health and medical resources that meet applicable criteria under the DPA.

Because ongoing US production of essential health and medical resources is already addressing shortfalls related to the domestic impact of the COVID-19 pandemic, some experts, including at the Center for Strategic and International Studies, believe that the President’s invocation of the DPA may be used principally to provide financial incentives for increased and expanded production efforts. Moreover, soon after issuing the order, President Trump shared via social media that he, “only signed the [the order] … should we need to invoke it in a worst case scenario in the future.” In response, expressing the collective sense of urgency of state governments throughout the US, in a March 19, 2020, memorandum to the President and Vice President Mike Pence, the National Governors Association included in its list of top state priorities in response to the COVID-19 outbreak, “guidance on implementation of [the] Defense Production Act to include what health and medical resources Secretary of Health and Human Services Azar is prioritizing under his new authority.”

This advisory provides an overview of the DPA and what this executive order could mean for government contractors and their supply chains.

As discussed in our prior advisory, the DPA provides the President and delegated federal agencies the authority to essentially force private companies to prioritize orders rated for national defense. Rated orders may cover not only the manufacture and delivery of goods, but may also apply to services. What this means, in practice, is that companies must put the federal government’s orders at the front of the line to ensure timely delivery under a rated order. Companies receiving a rated order must also place rated orders with their suppliers (with limited exceptions) to meet delivery requirements, which means that entire supply chains may soon be subject to rated order requirements.

Many DoD contractors and subcontractors are already very familiar with the Defense Priorities and Allocation System (DPAS), as implemented by regulations issued by the Department of Commerce. 15 C.F.R. 700 et seq. Companies may be less familiar with the Health Resources Priorities and Allocations System, as implemented by the Department of Health and Human Services. 45 C.F.R. 101 et seq. The President’s recent executive order very likely will mean that private companies that have either never done business with the federal government or have done so on more routine “commercial item” basis may suddenly be faced with rated orders. Rated orders must be accepted or rejected in writing within specified periods of time. Moreover, the bases for rejection are specific and narrow. Ultimately, willful refusal to comply with a rated order can subject private companies and individuals to a variety risks, including potential criminal charges.

Companies with products and services that may fall within the scope of health and medical resources should immediately familiarize themselves with the DPA, its implementing regulations, and any nationwide priorities and regulations that may be established by the HHS Secretary. Given the pace of the pandemic and the changes and disruptions to the supply chain that are already being observed, another key consideration is how the DPA and the national security needs that it seeks to address in operation collide with state and local police power. Specifically, contractors and/or their suppliers are very likely located in places where workers have been encouraged or directed to work from home, among other social distancing practices that have been recommended or mandated. Similarly, business operations have likely been impacted by travel restrictions, significantly limited airline schedules, and regulations in foreign jurisdictions limiting the export of materials required to produce the health and medical resources necessary to combat COVID-19 that are in short supply in the US. In the most extreme cases, some local or state jurisdictions have issued orders for their residents to “shelter in place.”

California issued such an order, effective Thursday, March 19. In the face of these challenges, accepting and performing a rated order (or any other order) may well prove impossible. State and local officials and the federal government are working to provide clarity that the DPA allows continued performance by contractors and their employees not withstanding local orders limiting or closing businesses. While this is developing by the hour, the Department of Homeland Security issued guidance confirming that contractors performing defense or health related contracts are part of the nation’s “critical infrastructure.”

From a supply chain perspective, companies receiving rated orders must recognize that orders they place to support performance of a rated order must also be issued as a rated order, unless exceptions apply. Issuing a rated order properly requires:

• Specifying the appropriate rating on the order, including special language in the order so that the supplier is notified of its obligations;
• Obtaining timely written acceptance or rejection;
• Identifying a specific delivery date for items being ordered; and
• Obtaining timely acceptance or rejection of any changes made to the order, which amounts to a new rated order.

Any company combining rated items and un-rated items in the same order must separately designate those times. Further, a company does not need to issue an order as rated if it is under certain dollar thresholds, unless the company cannot ensure timely delivery without using the rating.

The issuance of rated orders for certain medical technologies may also have a wider impact in the overall supply chain that affects other contractors. This may include electronic components that are common to a variety of products, including medical devices. In addition, we have seen examples, such as in the UK, where the general manufacturing industry is being drafted to transition to medical device manufacturing. The UK Government, for example, asked both Rolls-Royce and Ford to transition to manufacturing ventilators. Similar realignment of the industrial base both in the US and abroad could have far reaching consequences for the overall supply chain for a variety of goods and services.

If entities receiving rated orders encounter problems, there are procedures to follow to secure what is known as special priorities assistance. There are also avenues to appeal the rating applied to orders and the rating itself.

Ultimately, the discussion above highlights the complexity and risk associated with the DPA and DPAS that private companies with no prior background in the area will soon be facing. The best way to deal with these extraordinary circumstances effectively is to be proactive and to secure assistance from knowledgeable counsel, where and when appropriate.

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