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.
Continue Reading Gifting Goods & Services to the U.S. Government in the Wake of the Coronavirus Outbreak

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.
Continue Reading Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

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.
Continue Reading COVID-19 Federal Contractor’s Survival Guide 2.0

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.
Continue Reading Key Provisions in the Senate Stimulus Bill

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.
Continue Reading Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources

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).
Continue Reading What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

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
Continue Reading Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

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
Continue Reading Why the Health Care Industry Should Be Concerned About Section 889 of the 2019 National Defense Authorization Act

There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics under the management of the Department of Defense (DOD), Defense Health Agency (DHA). But some may be unexpected, reaching all the way to Department of Veterans Affairs (VA) procurement, though the extent to which the VA will ultimately be affected is unclear. In the past few weeks, at least three major announcements were made regarding military healthcare: (1) DHA and the Defense Logistics Agency (DLA) signed a memorandum of agreement (MOA) regarding their respective rolls in DOD healthcare, (2) DLA gave the VA access to its medical/surgical prime vendor formulary indefinitely, and (3) the VA cancelled its long-anticipated prime vendor solicitation under the Medical/Surgical Prime Vendor (MSPV) 2.0 program. Is this all a coincidence? Probably not.
Continue Reading What’s the VA Got to Do With It? Military Medical Procurement Changes Reach the VA