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 for Amtrak Projects

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?

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