May 2021

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

In a time of uncertain federal budgets and an increasingly crowded marketplace, contractors of all sizes are on the lookout for ways to enhance their chances of winning federal business opportunities. Step one in this process is, of course, the identification of the government’s needs—which are typically codified in requests for proposals or quotations. Step two (i.e., the “pursuit” phase) involves the preparation of an offer designed to fulfill the government’s requirements. As most government contractors know all too well, this is an often laborious and expensive process that requires painstaking attention to detail. But what happens when there is, in fact, a real devil lurking in those details? What if the RFP or RFQ simply doesn’t make sense? What if the terms are in conflict with one another? What if the government includes requirements that run afoul of a law or regulation? Enter the pre-award protest exorcism.
Continue Reading Recent GAO Decision Demonstrates the Utility of Pre-Award Protests

In the months since President Biden took office, legislators have tried—and thus far failed—to pass legislation raising the federal minimum wage to $15 per hour. While the debate rages on, the Biden-Harris administration has taken executive action to ensure that some workers receive a higher wage for work under federal contracts. On April 27, 2021, President Biden issued the Executive Order on Increasing the Minimum Wage for Federal Contractors, which will have a (relatively) short-term impact on thousands of contractors and their employees. The Executive Order aims to “promote economy and efficiency in procurement by contracting with sources that adequately compensate their workers.” It would increase the minimum wage paid by federal contractors from $10.95 per hour to $15 per hour. The increased minimum wage will begin appearing in solicitations and contracts, and thereby subcontracts, in early 2022, and contractors should begin preparing now to meet the increased minimum wage requirements.
Continue Reading Raising the Wage: Biden-Harris Administration Dramatically Increases Minimum Wage for Federal Government Contractors