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

Federal government contract domestic preference requirements are set for significant changes. McCarter & English Government Contracts and Global Trade co-leaders Franklin Turner and Alex Major and Senior Associate Cara Wulf provide guidance for federal contractors in a Feature Comment for Thomson Reuters’ The Government Contractor. In the comprehensive article, the authors review the current regulatory landscape and detail the changes portended by the Biden administration’s EO “Ensuring the Future Is Made in All of America by All of America’s Workers,” focusing on the significant implications the changes may ultimately have for government contractors.

Click to read full article.

On December 21, 2020, the Department of Defense (DoD) Office of the Undersecretary of Defense for Intelligence & Security published a Final Rule codifying the National Industrial Security Program Operating Manual (NISPOM)—currently published as part of DoD Manual 5220.22-M—in Title 34, Part 117 of the Code of Federal Regulations. The Final Rule became effective on February 24, 2021.

Continue Reading DOD Issues Final Rule Codifying The NISPOM

A new administration has moved into the White House, and, as anticipated, President Biden wasted no time in issuing, in the first few days of his presidency, a raft of Executive Orders (EOs) that appear calculated to set the tone of his administration. Notably, many of these executive actions walk back (or attempt to fully erase) some of the signature policies of the Trump Administration. Some of these presidential actions have immediate implications for government contractors, while others represent broad policy statements that, at least in the short term, will have little impact on contractors’ day-to-day operations – but they merit a close watch, particularly the Executive Order titled “Ensuring the Future Is Made in All of America by All of America’s Workers,” discussed in detail here. Contractors should take note of these early developments, as they are likely to evolve into concrete policies that will create new opportunities – or obstacles – for businesses in the federal marketplace in the months and years to come.

Continue Reading The Beginning of the Biden Administration – What Federal Contractors Need to Know

On January 25, 2021, President Biden issued a sweeping Executive Order titled “Ensuring the Future Is Made in All of America by All of America’s Workers” (Order), which is intended to be the first step toward fulfilling his campaign promise to commit to American businesses by strengthening domestic preference rules in government procurement. The Order states the administration’s policy that the US government should “use terms and conditions of Federal financial assistance awards and Federal procurements to maximize the use of goods, products, and materials produced in, and services offered in, the United States.” While this is not a novel policy objective—indeed, the Trump administration articulated similar goals—the Order introduces certain dramatic steps in furtherance of that objective that may ultimately have significant implications for contractors.

Continue Reading Big Changes to Buy American—Biden Issues Broad Executive Order on the Future of Domestic Purchasing in Federal Procurement

Each year, Congress presents us in Title VIII of the National Defense Authorization Act (NDAA) a potpourri of procurement reforms, changes, and additions. Some are effective immediately, while some are bound for rulemaking and regulation and surface years from enactment. Some require analyses, reports, and studies which have no immediate impact but provide a roadmap that can and should be used by government contractors in their business planning. Finally, some provisions of the NDAAs just wither away and have no impact whatsoever. Nineteen days before the Trump Administration ended, the US Senate followed the US House of Representatives in overriding the President’s veto of the William (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (H.R. 6395) (FY2021 NDAA), making it law on January 1, 2021.  Happy New Year! As for its Title VIII, the FY2021 NDAA is no different from its predecessors in its procurement potpourri. Here’s a tour of key provisions you oughta know.

Continue Reading Here to Remind You of the Key Provisions of the Fiscal Year 2021 National Defense Authorization Act – You Oughta Know!

The Department of Defense (DoD) has finalized regulations prohibiting the use of telecommunications equipment or services from Chinese entities or from entities that are owned or controlled by either the People’s Republic of China or the Russian Federation. The Final Rule, which went into effect on Friday, January 15, 2021, prohibits the DoD from buying or using banned telecommunications equipment and services that are a “substantial or essential component of any system” or that constitute a “critical technology.”

Continue Reading Changes to DoD Regulations Banning Chinese Telecommunications Equipment and Services Offer Potential Opportunities for Contractors

On the eve of the inauguration of President Biden, a lingering Trump-era policy finally made its way into the Federal Acquisition Regulation (FAR). On January 19, 2021, the FAR Council issued a final rule implementing changes first revealed in Executive Order 13881 (the E.O.), Maximizing Use of American-Made Goods, Products, and Materials (84 FR 34257, July 18, 2019). As we discussed in an earlier post on this topic, the E.O. mandated significant modifications to FAR clauses implementing the Buy American statute by (1) substantially increasing domestic content requirements and (2) increasing the price preferences for domestic products. On September 14, 2020, the FAR Council issued a proposed rule designed to implement the requirements of the E.O. (85 FR 56558, Sept. 14, 2020). Our post on that development noted that, while the proposed rule incorporated the overarching objectives of the E.O., it also significantly expanded on the E.O. by reintroducing the domestic content test for commercially available off-the-shelf (COTS) items made wholly or predominantly of iron or steel, or a combination of both (with the exception of fasteners).

Continue Reading FAR Council Issues Final Rule to Implement Trump Executive Order on Significant Buy American Changes