On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020.  HL Pulse summary is available here.  Specifically, the Executive Order identified the following materials:

  • N-95 Filtering Facepiece Respirators;
  • Other Face Filtering Facepiece Respirators (N99, N00, R95, R99, R100, P95, P99, and P100);
  • Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
  • PPE surgical masks; and
  • PPE gloves or surgical gloves.

The Interim Final Rule (IFR) provides that as of April 7, 2020, “there were over 333,000 cases of COVID-19 in the United States, resulting in over 9,500 deaths due to the disease, with new cases being reported daily.”  The IFR provides that before any shipments of these covered materials my leave the United States, the shipment will be detained by Customs and Border Patrol  and FEMA will determine whether the items should be retained for domestic use, whether to permit the export of part or all of the shipment, or whether to issue a rated order for the items.  A determination will be made by FEMA “within a reasonable time of being notified of an intended shipment and will make all decisions consistent with promoting the national defense.”  In determining whether it is necessary to promote the national defense to purchase covered materials or allocate them for domestic use, FEMA will examine these factors:

  1. the need to ensure that scarce or threatened items are appropriately allocated for domestic use;
  2. minimization of disruption to the supply chain, both domestically and abroad;
  3. the circumstances surrounding the distribution of the materials and potential hoarding or price gouging concerns;
  4. the quantity and quality of the materials;
  5. humanitarian considerations; and
  6. international relations and diplomatic considerations.

The IFR exempts “covered materials from shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the United States in the preceding 12 months.”

Additionally, on April 8, The Joint Commission announced that the suspension of regular surveys will continue through the end of May as a result of the continued spread of COVID-19.  The Joint Commission also released Frequently Asked Questions relating to the Joint  Commission Position Statement on the use of facemasks brought from home.  The FAQs to the Position Statement advise that if a hospital cannot provide N95 masks for staff performing aerosolizing procedures or who work in close proximity to where aerosolizing procedures are done, staff should be allowed to bring in their own masks.

Norton Rose Fulbright attorneys will continue to follow on a daily basis COVID-19-related developments pertinent to health care providers and publish regular updates in the Health Law Pulse.