2022 was a busy year for the False Claims Act. While recoveries were down, new cases reached a record mark, and settlements addressed multiple important and developing enforcement areas, from cybersecurity to small business fraud, bid rigging, Trade Agreements Act compliance, pandemic fraud, and more. Of particular note, the U.S. Supreme Court held argument concerning
Payal Nanavati is a counsel in the firm's Washington, D.C. office, where she practices in the Health Care and Government Contracts groups. Payal’s government contracts practice focuses on defending companies under the False Claims Act, litigation before the Armed Services Board of Contract Appeals, and bid protests before the Government Accountability Office. Her health care practice includes working with providers and plans seeking to comply with laws and regulations applicable to digital health initiatives, fraud and abuse, and mental health parity.
Payal is a co-host of Crowell & Moring’s health care podcast, Payers, Providers, and Patients – Oh My!, which covers legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.
Payal’s recent pro bono representations include clients seeking asylum or legal immigration status under the Violence Against Women Act and successfully defending against eviction attempts by a client’s landlord. During law school, Payal served as a staff member for the Journal of Gender and Law.
Hundreds of Millions of Potential Liability Result from Federal Jury False Claims Act Verdict Against Ophthalmology Product Distributor
In a prime example of the significant interplay between the Anti-Kickback Statute (“AKS”) and the False Claims Act (“FCA”), a federal jury has returned a verdict of more than $43 million in damages against Cameron-Ehlen Group, Inc., which does business as “Precision Lens,” and its owner. The verdict in this long-running and closely watched fraud case out of the U.S. District Court for the District of Minnesota comes after a six-week trial, with the jury ultimately finding that the defendants paid kickbacks to ophthalmic surgeons to induce their use of defendants’ products in cataract surgeries reimbursed by Medicare, resulting in the submission of 64,575 false claims between 2006 and 2015. While the jury calculated damages at the massive sum of $43 million, that number may grow exponentially after the court applies the FCA’s treble-damages calculation (increasing the liability to $129 million) and statutory penalties of between $5,500 and $11,000 for each of the 64,575 claims (resulting in additional penalties of $355 million to $710 million). All told, the total FCA liability is expected to range between $485 million and $839 million.
Continue Reading Hundreds of Millions of Potential Liability Result from Federal Jury False Claims Act Verdict Against Ophthalmology Product Distributor
FCA Settlement Offers Reminder of the Importance of TAA and PRC Compliance
The Department of Justice has announced a $14 million False Claims Act (FCA) settlement with Coloplast, a medical product manufacturer, after Coloplast self-disclosed violations of the Trade Agreements Act (TAA) and Price Reduction Clause (PRC) while under contract with the Department of Veterans Affairs (VA). The TAA requires contractors to furnish end products that are U.S.-made or “substantially transformed” in designated countries. Coloplast disclosed that it misapplied the substantial-transformation standard, causing Coloplast to report incorrect countries of origin for products and to improperly retain certain products on contract after manufacturing moved to non-designated countries. Coloplast also disclosed that it overbilled the Government by failing to provide the VA with discounts pursuant to the terms of the PRC, which normally requires tracking discounts offered to designated commercial customers and offering corresponding downward price adjustments to VA customers. …
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The Top FCA Developments of 2021
2021 was another busy year in False Claims Act enforcement and litigation. Significant decisions were issued across the circuits, spanning government dismissal authority, materiality, scienter, Rule 9(b) pleading standards, the Eighth Amendment’s Excessive Fines Clause, and more. The year also saw proposed amendments introduced by Senator Chuck Grassley aimed at strengthening the statute and overruling …
The Top FCA Developments of 2019
The third year of False Claims Act (FCA) enforcement under the Trump administration was defined by a number of notable settlements, the implementation of several policy changes announced last year concerning how the Department of Justice (DOJ) will pursue (and in some instances, dismiss) cases under the FCA, and a Supreme Court decision addressing the…
DoD Increases DCMA Cybersecurity Responsibilities: DCMA to Implement and Assess Company-Wide Cyber Compliance
Adding to the Defense Contract Management Agency’s (DCMA) new cybersecurity responsibilities, the Department of Defense (DoD) Under Secretary of Defense for Acquisition and Sustainment (USDAS) recently issued a memorandum titled Strategically Implementing Cybersecurity Contract Clauses that increases DCMA’s role. The memorandum tasks DCMA with implementing a process to perform company-wide assessments of contractors’ compliance…
FY 2019 NDAA
On Monday, August 13, 2018, President Trump signed into law the H.R. 5515, the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (FY 2019 NDAA), the earliest an NDAA has been signed in over a decade. The FY 2019 NDAA includes several provisions relevant to contractors, including replacing the definition of “commercial item” with “commercial product” and “commercial services,” discouraging the use of lowest price technically acceptable contracting, and a clause designed to accelerate payments to small businesses.
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Incumbent Employees’ Self-Disclosure of Salaries is Not a Procurement Integrity Act Violation
In AlliantCorps, LLC, B-415744.2, the Government Accountability Office (GAO) denied a protest by AlliantCorps, LLC (Alliant) alleging violations of the Procurement Integrity Act (PIA) by the Department of the Navy (Navy) following Alliant’s prior protest of a task order award to DKW Communications, Inc. (DKW). Alliant asserted that DKW improperly received Alliant’s bid and proposal information when its proposed subcontractor’s labor rates were furnished to DKW “at the direction of the Navy.” GAO found that the facts asserted could not form the basis of a PIA violation because the employees voluntarily disclosed their salary information to DKW.
The Navy initially awarded the task order seeking software maintenance services to DKW. As part of its transition effort, DKW sent an email to Navy personnel providing a link to DKW’s employment application website. After the Navy provided Alliant with its debriefing, Navy personnel forwarded DKW’s email soliciting employment applications to personnel working on the incumbent contract for Alliant’s proposed subcontractor. Alliant subsequently protested the evaluation underlying the award challenging the Navy’s past performance evaluation and discussions, which prompted the Navy to take corrective action to clarify the solicitation and make a new source selection decision.…
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New Draft NIST Guidance on Systems Security Engineering
The National Institute of Standards and Technology (NIST) recently published a draft special publication titled Systems Security Engineering: Resiliency Considerations for the Engineering of Trustworthy Secure Systems (Volume 2), which provides guidance to professionals responsible for the activities and tasks related to the system life cycle processes in NIST’s flagship publication, NIST Special Publication 800-160…
GAO Implements Changes to Bid Protest Process with New Regulations
On April 2, 2018, the Government Accountability Office (GAO) published Final Rule 83 FR 13817, amending its bid protest regulations to implement the Electronic Protest Docketing System, make administrative and clerical changes, and “streamline the bid protest process.”
This Final Rule goes into effect on May 1, 2018. We detail below some key changes it implements to the protest process.…
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