After 15 months of quarantines, restrictions, and mandatory home schooling, summer 2021 is luring with escape and excitement across the country.  We all hope for beach days and reunions with loved ones as we (hopefully) paddle toward normalcy once again. However, before setting up the “out-of-office” auto-replies and heading for the sand and surf, Government contractors interested in the implications of the Biden Administration’s January 25, 2021 Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers (EO) will want to take note of a June 11, 2021 Memorandum from the Office of Management and Budget on Increasing Opportunities for Domestic Sourcing and Reducing the Need for Waivers from Made in America Laws (Memorandum). This Memorandum outlines the wave of changes the Made In America Office (MIAO) is poised to take over the summer of 2021 as it begins to implement the mandates of the EO.

Continue Reading Catching Waves: OMB Issues New Implementation Guidance for Biden Administration Buy American Executive Order

On May 12, 2021, the Biden administration unveiled a rather expansive executive order intent on “Improving the Nation’s Cybersecurity.” The lengthy and sweeping order is a comprehensive national cybersecurity overhaul. In addition to requiring significant improvements to the cybersecurity posture of the Federal Civilian Executive Branch (FCEB) agencies, the order also prescribes:

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Exercising its authority under Section 6(c) of the Occupational Safety and Health Act, the federal Occupational Safety and Health Administration (OSHA) issued its COVID-19 Healthcare Emergency Temporary Standard (ETS) on June 21, 2021. The ETS sets forth safety standards for employers (including federal contractors) with employees working in a healthcare setting—the workers OSHA has determined are at highest risk for workplace exposure to the virus that causes COVID-19. Healthcare employers are expected to comply with the primary ETS requirements as of July 6, 2021, while compliance with additional requirements concerning physical barriers, ventilation, and training is mandated as of July 21, 2021. OSHA is inviting comments on the ETS, including whether it should become a final rule. The deadline to submit comments regarding the ETS and whether it becomes a final rule is July 21, 2021, and the deadline to comment on the information collection determination is August 20, 2021.

Continue Reading The Compliance Deadline for OSHA’s COVID-19 Healthcare Emergency Temporary Standard Is Here. Are You Ready?

As you may recall, Section 818 of the National Defense Authorization Act for Fiscal Year 2018 (FY 2018 NDAA required the US Department of Defense (DoD) to draft regulations to establish comprehensive post-award debriefing rights for disappointed offerors involved in applicable DoD procurements. On March 22, 2018, the DoD responded by issuing a Class Deviation that implemented certain FY 2018 NDAA requirements—i.e., those requirements affording disappointed offerors the opportunity to submit additional written questions to the cognizant DoD agency within two business days of its agency debriefing conducted in accordance with FAR 15.506(d). In such circumstances, the cognizant DoD agency must provide written responses to the questions within five business days after receipt of the questions. Moreover, if a disappointed offeror chooses to submit timely post-debriefing questions, the debriefing does not conclude—and thus the disappointed offeror’s GAO protest “clock” does not begin to run—until the agency provides its written response. On May 20, 2021, the DoD published a Proposed Rule to amend the Defense Federal Acquisition Regulation Supplement to (1) codify the March 2018 Class Deviation and (2) implement the additional post-award debriefing requirements from the FY 2018 NDAA.

Continue Reading DoD Issues Proposed Rule on Enhanced Post-Award Debriefing Rights

As COVID-19 antibodies begin flooding the immune systems of most Americans, it is important to remember the important role that hygiene has played over the past fifteen months. For many, the risks and dangers of the pandemic were kept at bay by hand washing, masking, and sanitizing after every new touch. That same kind of attention to hygiene is something federal contractors should retain as they are permitted to reenter a world filled with supply chain enforcement risk.

Continue Reading Prevention v. Cure: Supply Chain Hygiene Is the Key to Defending Enforcement

“Now, the next part is very important…”

As scrutiny of domestic preference requirements increases in the wake of the Biden Administration’s Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers, the time is now for contractors to brush up on those requirements, examine supply chains to identify non-domestic content, and implement internal policies and procedures to ensure they are compliant with the domestic preference rules applicable to their contracts. On May 20, 2021, the US Attorney’s Office for the Eastern District of Pennsylvania announced a settlement under which a contractor agreed to pay $54,983 and implement “enhanced compliance measures” to resolve claims arising from its use of Chinese-made parts during a fire alarm installation and renovation project at Amtrak’s 30th Street Station in Philadelphia, PA. While the settlement amount is relatively minimal, the settlement is remarkable in that it telegraphs that funding agencies, along with the Department of Justice (DOJ), are willing to go to great lengths to be a nightmare for suppliers that do not adhere to the “Buy America” statutes and regulations.

Continue Reading I Will Find You: DOJ Uses Its Particular Set of Skills to Enforce Domestic Preference Rules

The cards are on the table, and the Hawaiian state legislature has dealt its state contractors a risky hand. A new bill, SB 1329, is set to eliminate the monetary cap on the bond required to challenge a procurement officer’s final decision on a bid protest. If the bill is signed into law, protestors could benefit from a quicker protest response time that would mandate a decision within 75 days (absent an extension). The rub is that if the protestor wishes to appeal that quicker decision, it would be required to stake a bond of 1 percent of the total contract value of the project. If that appeal then proves fruitless, the Hawaiian “house” wins and collects that 1 percent stake. Beyond serving as a wager Hawaiian contractors need to consider, ultimately the higher stakes will likely serve as a barrier to entry for many small businesses feeling wronged by state procurement decisions.

Continue Reading A Gamble for Hawaiian Contractors: Hawaii Raises the Stakes for Contractors Betting on State Bid Protest Appeals

On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and nonprofit institutions, in most circumstances, to take title to inventions made under federally funded projects (subject inventions) and to freely commercialize items, and methods used to produce items, embodying subject inventions.

Continue Reading NIST on Track to Clarify Bayh-Dole to Ensure High Prices Cannot Be Used as Grounds for Exercising March-in Rights – Or Is It?

Akin to the exasperations of the newly minted “homeschool teachers” the pandemic has created, the Biden administration’s recent Executive Order on Improving the Nation’s Cybersecurity (Order) is a mix of sound logic and utter frustration. The lengthy and sweeping Order is resoundingly one of the most comprehensive national cybersecurity overhauls to date and ushers the Department of Homeland Security’s Cybersecurity & Infrastructure Security Agency (CISA) into a forward-leaning position of leadership that has been missing since its inception. In addition to requiring significant improvements to the cybersecurity posture of the Federal Civilian Executive Branch (FCEB) agencies, the Order also prescribes (i) the implementation of cyber incident sharing requirements between the Government and private industry; (ii) the necessary demands of security on software development; and (iii) the inclusion of software bills of materials, operational technology (e.g., industrial machining), and the internet of things in the fabric of cybersecurity regulations. Set against the backdrop of an ambitious timeline that calls for drastic changes before the end of this fiscal year—i.e., September 30, 2021—the Order requires that the Federal government scale administrative mountains at breakneck speed while simultaneously working with the industry and developing new regulations with which contractors will have to comply in short order. Accordingly, while a brief summary of the Order is provided below, the size and magnitude of the Order call for a larger analysis. Accordingly, we have prepared a user-friendly Analysis of the Order that includes considerations for manufacturers and government contractors. Additionally, to better explain the compliance timeline associated with the Order, a listing of the EO Key Dates is provided for convenience.

Continue Reading Enough’s Enough: A New Executive Order Signals Sweeping Changes to Federal Cybersecurity Requirements

In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement and defrauded the government by offering unreasonably low prices to nursing homes for Medicare Part A patients’ prescription drugs in exchange for the opportunity to provide the same drugs at much higher costs to the nursing homes’ Medicaid and Medicare Part D patients for reimbursement. In a recent Order, the federal district court in New Jersey revived previously dismissed claims and permitted the relator to file a new, and fourth, amended complaint that asserts a new theory of liability to buttress the core kickback scheme allegations. The new complaint asserts that prescription drug event (PDE) data and enrollee encounter data are “claims for payment” under the False Claims Act (FCA)—and that even accurate PDE data can be a “false claim” under the FCA in cases where a pharmacy is alleged to pay kickbacks to its customers.

Continue Reading How the Truth Is False: Accurate Prescription Drug Event Data Can Trigger False Claims Act Liability