On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944), which required the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. We previously wrote about this Executive Order in August (available here), expecting that once the list was issued, government agencies would begin implementing the “Buy American” priorities for these products and materials. The FDA has identified around 227 drugs and 96 devices, along with their respective critical inputs or active ingredients, that the FDA believes “are medically necessary to have available at all times” for the public health. Agencies across the federal government should now begin making non-competitive awards “to the maximum extent permitted by law,” for drugs and medical supplies on this list that are produced in the United States. We have yet to see how agencies will implement these requirements in regulations or class deviations, but publication of this list is an important first step in implementing the rest of the “Buy American” priorities in the Executive Order.
Continue Reading “Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020.
Continue Reading PREP Act Update: All NIOSH-Approved Respirators Now Are Covered Countermeasures Eligible for Immunity

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.
Continue Reading The CARES Act – Who’s Minding the Store?

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.
Continue Reading Presidential Executive Orders Delegate Additional Authorities To Respond To COVID-19 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.
Continue Reading Gifting Goods & Services to the U.S. Government in the Wake of the Coronavirus Outbreak

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

The Department of Veterans Affairs (“VA”), Veterans Health Administration (“VHA”) has begun the move toward its new Medical/Surgical Prime Vendor (“MSPV”) 2.0 program by issuing the formal RFP seeking prime vendors for distribution and supply management services on June 3, 2019. The MSPV 2.0 program will replace the current MSPV-Next Generation program, and is designed to deliver medical, surgical, dental, and laboratory supplies to VA medical centers using a just-in-time model. Under MSPV 2.0, several prime vendors will manage distribution of some 49,000 different supplies, which they acquire from manufacturers and other suppliers, to all VA medical centers around the United States and U.S. territories. MSPV 2.0 involves three interrelated sets of agreements: (1) prime vendor IDIQs with the VA, (2) VA BPAs with suppliers, and (3) prime vendor agreements with the suppliers.
Continue Reading VA Begins Seeking MSPV 2.0 Partners