Legal Update
Apr 3, 2020
Federal Government Adopts New Process for States and Tribes to Request Ventilators from the Limited Federal Supply
On April 1, 2020, a FEMA advisory issued that announced a new, more formalized process for distributing the limited available supply of ventilators to states and tribes. The federal government’s supply of available ventilators, as of April 1, 2020, totaled 10,469.
On April 1, 2020, the U.S. Department of Homeland Security (“DHS”) distributed an advisory from the Federal Emergency Management Agency (“FEMA”) announcing a new process to manage federal ventilator resources and implement their distribution to states and tribes in response to the immediate COVID-19 crisis. Notably, DHS acknowledges the dearth of ventilators available from the federal government. As of April 1, 2020, there are 10,469 ventilators available – 9,404 in the Strategic National Stockpile (“SNS”) and 1,065 available from the Department of Defense. The CARES Act, signed into law on March 27, 2020, contains several provisions that are designed to prevent future disruptions to the SNS akin to this grave ventilator shortage, and to enhance supply chain viability on the other side of this coronavirus pandemic.
The DHS Advisory announces the adoption of a more formalized process for states and tribes to request ventilators from the remaining federal supply. States and tribes must work through their FEMA / HHS regional leadership to make requests, and the requests must include detailed responses to five questions regarding current ventilator capacity, hospital bed occupancy, ability to increase bed and ventilator capacity, the decompression ability of hospitals in the state/tribe, and the volume of anesthesia machines and whether they have been converted to ventilator capability. The regional leadership is to verify the responses and forward them to FEMA’s National Response Coordination Center for processing.
The Advisory also encourages state and tribal officials to share the FDA’s Emergency Use Authorization (“EUA”) for ventilators. The EUA provides guidance on the machinery that can be modified for use as ventilators, and provides guidance to health care personnel regarding the use of other types of ventilators that can be used on COVID-19 patients in respiratory distress. A link to the EUA is here.
Although the new process is designed for states and tribes to submit requests, healthcare providers and facilities facing supply shortages – and the businesses and organizations assisting them in the procurement of supplies – are encouraged to review the guidance in the EUA. Moreover, such groups are encouraged to seek out guidance from state or tribal authorities who do receive supplies from the federal government to understand the changing landscape of how those supplies will be distributed to providers and facilities.