There is more than $2 trillion on the line and the multi-trillion-dollar question is: Who’s minding the store? On March 27, 2020, in response to the financial set-back created by the novel COVID-19 pandemic, President Trump signed into law the more than $2 trillion Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) – by far the largest economic relief package in U.S. history.[1] The CARES Act’s purpose is to keep the U.S. economy afloat and provide relief to struggling Americans, large corporate sectors, and small businesses while the nation battles this pandemic. With $500 billion allocated for big corporations, $377 billion for small businesses, and another $153.5 billion for healthcare, these relief moneys (like with most government funds) are sure to come with strings attached in the form of complex regulations and substantial oversight, with enforcement not far behind.
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Healthcare
Presidential Executive Orders Delegate Additional Authorities To Respond To COVID-19 Outbreak
Last week the White House issued two additional Executive Orders (“EOs”) related to EO 13909, the subject of our March 20, 2020 blog post: Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources.
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Gifting Goods & Services to the U.S. Government in the Wake of the Coronavirus Outbreak
COVID-19 (a.k.a. the Coronavirus) is upon us and it looks like it is here to stay, at least for the foreseeable future. In January, the Department of Health and Human Services declared the Coronavirus outbreak to constitute a Public Health Emergency, and on March 13, 2020, President Trump declared it a National Emergency. The President noted that the spread of the virus “threatens to strain our Nation’s healthcare systems.” As medical needs surge coupled with increases in state and city shutdowns to combat and contain the virus, a drain on government resources is almost certain. As such, in the wake of the Coronavirus outbreak, many companies are looking for ways to help, and some are willing to do so at no cost through free goods and services to the United States Government in hopes of alleviating such strain. Many companies, however, fear that such gifts might be prohibited under federal gift rules and the Antideficiency Act (an Act originating in the 1880s that, in some cases, prevents the Government from accepting voluntary services). This article explores how companies can provide free goods and services to the Government within the strictures of applicable statutes and regulations.
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Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths
On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this legislation offers manufacturers and distributors of industrial-grade face masks, referred to as “personal respiratory protective devices,” immunity from liability arising from use of the masks in connection with COVID-19. This immunity is retroactive to January 27, 2020, will last through October 1, 2024, and stems from the Federal Government’s effort to respond to the shortage of available masks. The law follows the Food & Drug Administration’s Emergency Use Authorization for emergency use of industrial-grade face masks in health care settings on March 2, 2020.
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COVID-19 Federal Contractor’s Survival Guide 2.0
Last week, we (Ryan and Jonathan) published the COVID-19 Federal Contractor’s Survival Guide in the Coalition For Government Procurement’s Friday Flash. The Guide was very well received – perhaps because it didn’t once instruct anyone to wash his/her hands – and several readers asked us to expand it to cover additional topics and new developments. Because the COVID-19 contracting landscape is changing so fast, we agreed an update made sense. To make the update as comprehensive as possible, we have retained the information from the original Survival Guide, and supplemented it with a wealth of new information, including answers to the questions asked during last week’s Coalition Survival Guide webinar, which is available for free download from the Coalition here.
Thus, without further ado, we offer you the COVID-19 Federal Contractor’s Survival Guide 2.0.
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Key Provisions in the Senate Stimulus Bill
On March 25, 2020 the Senate passed a $2 trillion stimulus bill “[p]roviding emergency assistance and healthcare response for individuals, families and businesses affected by the 2020 coronavirus pandemic.” The House and the President are both expected to approve the Bill in short order. The Bill contains many provisions important to all companies, including government contractors. Sheppard Mullin’s Government Contracts, Investigations and International Trade Practice Group prepared a summary of the Bill, available here. In addition, for your reference, we are providing a section-by-section analysis from Capitol Hill, as well as the text of the bill itself. Do not hesitate to contact us with any questions about the legislation or its implementation.
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Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources
On March 18, 2020, the President issued an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “EO”). The EO was issued pursuant to the Defense Production Act of 1950 (50 U.S.C. §4501 et seq.) (“DPA”), which allows the President to invoke special Federal Contracting powers to address shortages in medical resources needed to respond to the COVID-19 pandemic. The EO specifically mentions personal protective equipment and ventilators as necessary to curb the spread of COVID-19, but also delegates authority to the Secretary of Health and Human Services (“HHS”) to identify additional necessary health and medical resources such as drugs, medical devices, health supplies, and health services and equipment.
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What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance
On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020).
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Federal Circuit Changes the Game for Selling Single-API Drugs to the Government
Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door…
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Why the Health Care Industry Should Be Concerned About Section 889 of the 2019 National Defense Authorization Act
On August 13, 2018, President Trump signed into law the National Defense Authorization Act (NDAA) of 2019. While the annual NDAAs are tracked, analyzed, and picked apart with great care…
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