Government Contracts Law

Just when you didn’t think things could get any weirder, on Friday, January 21, 2022, the U.S. District Court for the Southern District of Georgia issued a ruling clarifying its prior EO 14042 injunction (currently on appeal to the 11th Circuit, and discussed previously here) by refusing to clarify the injunction. Yes, you read that right. Let us explain.

Continue Reading Executive Order 14042 – Update 15.0: U.S. District Court “Clarifies” Its Injunction Applies Only To The Vaccine Mandate

On January 13, 2022, the Supreme Court reinstated the nationwide injunction of the Occupational Safety and Health Administration’s (OSHA) COVID-19 Emergency Temporary Standard (ETS). (Technically, the Court overturned the Sixth Circuit’s decision dissolving the 5th Circuit’s injunction, discussed in the OSHA Emergency Temporary Standard Survival Guide.)  This means the OSHA ETS is no longer in force, and businesses, regardless of size, need not comply with the OSHA ETS vaccine/test mandate.

Continue Reading Supreme Court Enjoins OSHA Emergency Temporary Standard; Keeps CMS Rule Alive

It’s official: the Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program is no more.  The VA has announced that it will not revive MSPV 2.0 following several unusually painful protests at the U.S. Court of Federal Claims (see our prior blogs here and here). Instead the VA will move on to MSPV-“Z”.  Generally speaking, there seems to be little difference between “2.0” and “Z,” except that some division of geographies may change.  But importantly, the VA plans to make clear in the MSPV-Z solicitation—which currently is in the works—whether and when it will transfer the contracts’ requirements to the Defense Logistics Agency (“DLA”), an issue that has drawn significant criticism to date.  The VA says it is developing the business case for the transfer, and the business case analysis will determine both whether it will happen at all, and how the VA will execute the transfer.  In the meantime, the VA will extend the current bridge contracts under MSPV-Next Generation (“MSPV-NG”) for a full year, running December 2021 to December 2022, while the VA (and likely the DLA) get their ducks in a row.

Continue Reading MSPV 2.0 Is Dead – Long Live MSPV

On September 9, 2021, President Biden signed an Executive Order (EO) to implement COVID safety protocols for Federal service contractors. While the EO did not identify specific safety protocols, it did direct a Federal task force (the “Safer Federal Workforce Task Force,” created by Executive Order in January 2021) to issue COVID-19-related workplace safety guidance for prime contractors and subcontractors in the near future. Specifically, the Task Force is charged with issuing contractor guidance by September 24, 2021, including definitions of relevant terms, specific workplace safety protocols, and applicable exceptions.

Continue Reading COVID-19 Oversight and Enforcement: President Biden’s COVID Executive Order

The U.S. Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program (discussed previously here and here) has yet to make it off the ground, but in March 2021 the VA announced plans to eliminate the program by September 2023 and instead purchase from the Defense Logistics Agency’s (“DLA”) separate MSPV catalog. The VA and DLA MSPV programs are how the VA and DLA (separately) purchase most of their medical, surgical, and laboratory equipment for care centers across the country (and abroad, in the case of DLA). The VA and DLA have been exploring the possibility of consolidation since at least January 2019, but many vendors relied on the VA’s representations that it would not make any decisions on potential consolidation until at least 2025. So when the VA informed stakeholders of its new September 2023 target, Medline Industries, Inc. (“Medline”), one of the prime vendor awardees under the VA’s MSPV 2.0 Program, responded by filing a bid protest at the U.S. Court of Federal Claims. On May 28, 2021, the VA and DLA decided to take corrective action, asking the Court for six months to re-evaluate the issues raised by the protest. It seems that the government did not have all of its ducks in a row prior to announcing the targeted transition.
Continue Reading Ducks (Not) in a Row – VA Agrees to Take Corrective Action in Transitioning MSPV 2.0 Requirements to DLA

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President
Continue Reading “Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

With a new presidential administration promising vigorous antitrust enforcement, and a new Democratic majority in Congress seeking to make drastic changes to U.S. antitrust laws, the technology and healthcare industries have found themselves the main targets of increased antitrust scrutiny.  Though companies engaging in government contracting, particularly in the aerospace and defense industries, already have had to deal with a range of antitrust issues – for example, the Department of Justice, Antitrust Division (the “DOJ”) launched the Procurement Collusion Strike Force (“PCSF”) in 2019 (discussed in more detail here), which focused on “deterring, detecting, investigating and prosecuting antitrust crimes … in government procurement, grant and program funding” – they may find themselves subject to increased antitrust enforcement in 2021.  In fact, on February 23, 2021 PCSF Director Daniel Glad confirmed he is “focus[ed] on three things in 2021: expanding our platform with PCSF building out our data analytics program; and bringing investigations to the recommendation/disposition stage.”
Continue Reading How a New Era in Antitrust Enforcement May Impact Government Contractors

The Secretary of the U.S. Department of Health and Human Services recently added government contractors to the list of entities eligible for immunity from liability under the Secretary’s March 17, 2020, Public Readiness and Emergency Preparedness Act (“PREP Act”) declaration.  The PREP Act protects individuals and companies from liability for death or other tort-like harm in connection with the pandemic response, except for cases involving “willful misconduct.”  Under the recent amendment, government contractors acting with authorization from an executive department or agency—or who could be so authorized—are protected from liability when they prescribe, administer, deliver, distribute, or dispense Covered Countermeasures, as long as they meet the other requirements of the Act.  Covered Countermeasures could include the COVID-19 vaccine or personal protective equipment like respirators.  We wrote previously about the evolving list of masks and respirators qualifying as Covered Countermeasures here, here, and here.   
Continue Reading Authorized Government Contractors Now Covered Persons Under the PREP Act

According to a recent decision in United States ex rel. Scollick v. Narula, Case No. 14-cv-1339 (D.D.C. Nov. 6, 2020), the fraudulent inducement theory of False Claims Act (“FCA”) liability does not require plaintiffs to satisfy the “demanding” materiality standard set forth in Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016).  Though that may sound like good news for plaintiffs, it is not.  The fraudulent inducement theory holds that fraud in a contractor’s proposal can taint every claim for payment it submits under the resulting contract, making them all “false claims” under the FCA.  This bears hefty consequences if proven: the defendant could be liable for civil penalties on every single claim for payment submitted over the life of the contract, in addition to treble damages the government may have suffered as a result of the fraud.  Perhaps in recognition of these severe consequences, the U.S. District Court for District of Columbia held that a plaintiff must plead and prove an even higher standard than Escobar materiality to establish fraudulent inducement liability—actual causation.  Rather than alleging that misrepresentation by the defendant merely was material to the government’s decision to award the contract to defendant, the Scollick decision concludes that “a misrepresentation in the defendant’s bid must have caused the government to award the defendant the contract.”  If the FCA materiality standard is “demanding,” then the actual causation standard is formidable.
Continue Reading “Would You Rather…” – Escobar’s Demanding Materiality Standard or Actual Causation?

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

On July 15, 2020, the Department of Justice (“DOJ”) charged Andrew Marnell with bank fraud in connection with $8.5 million worth of Paycheck Protection Program (“PPP”) loans he obtained for fake business expenses, that were then spent on gambling and stock market bets, incurring millions of dollars in losses.  See United States v. Marnell, No. 2:20-mj-03313-DUTY (C.D. Cal. Jul. 15, 2020).
Continue Reading DOJ Cracks Down on COVID-Relief Fraud