Specialty

False Claims Act

Defending companies and individuals in False Claims Act matters—from investigations to litigation—with proven, trial-ready strategies

Foley Hoag's White-Collar Crime and Government Investigations practice has extensive experience representing companies and individuals in False Claims Act (FCA) matters across diverse industries. We defend clients against allegations of fraud involving federal and state government programs, including qui tam whistleblower actions, and conduct internal investigations to assess potential FCA exposure. Our team guides clients through every phase of FCA matters—from initial inquiry through investigation, litigation, and resolution—with strategies tailored to each client's unique circumstances and business objectives. Our experienced trial attorneys understand how FCA cases are tried—and won—and bring this perspective to our aggressive defense strategies.

The False Claims Act imposes substantial civil and criminal liability for knowingly submitting false claims for payment to the federal government or causing others to do so. With treble (triple) damages, significant per-claim penalties, and the threat of government intervention in whistleblower suits, FCA investigations carry serious financial and reputational consequences. Our lawyers understand the nuances of FCA law, including the statute's scienter requirements, materiality standards, and public disclosure bar, and we leverage this knowledge to mount effective defenses and negotiate favorable outcomes.

Our team includes former high-level federal and state prosecutors who bring firsthand knowledge of government enforcement priorities and decision-making processes. We regularly represent clients before the Department of Justice, U.S. Attorneys' Offices, state Attorneys General, and agency Inspectors General. We have successfully persuaded the government not to intervene in qui tam actions, obtained dismissals of FCA claims, and negotiated favorable settlements that minimize financial exposure and protect our clients' reputations and ongoing business relationships with government agencies. When litigation is necessary, our team brings substantial trial experience before juries, courts and arbitrators. 

Areas of Focus

  • Healthcare & Life Sciences: Medicare, Medicaid, and TRICARE fraud; the anti-kickback statute (AKS) and its safe harbor provisions, eliminating kickback in recovery act (EKRA) and Stark law violations; pharmaceutical pricing and marketing practices; fair market value (FMV); discounts and rebates; personal services contracts; independent contractor compensation; the Federal Food Drug and Cosmetic Act (FFDCA); off-label marketing and prometon; diagnostic testing; hospital and physician billing; durable medical equipment (DME); genetic testing; and skin substitutes.
  • Government Contracting & Procurement: Compliance certifications, product quality and testing; contract compliance; procurement fraud; sales to federal and state agencies
  • Energy: Alternative energy programs; renewable energy supplier compliance
  • Education & Research: Research grant fraud; federal funding compliance; compliance certifications
  • Qui Tam Whistleblower Defense: Defending private actions; obtaining dismissals; advocating for government non-intervention; civil investigative demand (CID) and grand jury subpoena response

Experience

Government Contracting & Procurement

  • Represented a government contractor in a parallel criminal and civil False Claims Act investigation involving alleged misrepresentations concerning product quality and testing.
  • Represented a government contractor against claimed violations of the federal False Claims Act asserted in a qui tam action by a purported whistleblower, persuading the federal government not to intervene in the case and eventually obtaining dismissal of all counts.
  • Represented global manufacturer in the defense industry in a False Claims Act investigation arising out of sales to various federal and state government agencies.
  • Represented a government subcontractor in the aerospace industry in a False Claims Act investigation concerning manufacturing and testing practices.
  • Represented senior managers of a construction company in federal and state False Claims Act investigations.
  • Represented global consulting firm in a state False Claims Act investigation.
  • Represented a government contractor in False Claims Act investigation concerning alleged theft or other misuse of classified and/or proprietary government information.

Healthcare & Life Sciences

  • Represented a large public company in responding to federal healthcare False Claims Act investigation conducted jointly by US Attorney's Offices in several districts across the country concerning potential federal health care program reimbursement fraud arising out of alleged sales, marketing and pricing practices.
  • Represented genetic testing company and negotiated settlement of whistleblower complaint in investigation initiated by HHS OIG administrative subpoena concerning potential False Claims Act violations.
  • Represented specialty health care provider in False Claims Act litigation.
  • Obtained dismissal of a federal and state False Claims Act lawsuit brought by a qui tam purported whistleblower against large medical product manufacturer.
  • Represented genetic testing and precision medicinecompany in defending non-intervened (Government declined to join the lawsuit) False Claims Act litigation
  • Represented national specialty pharmacy chain in defense of parallel criminal/civil investigations, including False Claims Act litigation and global resolution of both investigations.
  • Represented a pharmaceutical company in an anti-kickback statute/False Claims Act investigation related to speaker programs.
  • Represented genetic testing company in responding to HHS-OIG subpoena in connection with investigation regarding false claims for payment under the Medicare and Medicaid programs; sales and marketing practices at issue included coding & reimbursement, cost vs. reimbursement marketing, marketing co-pay, discount and maximum out-of-pocket price caps.
  • Represented healthcare company in responding to Medicaid fraud unit civil investigative demand subpoena concerning potential anti-kickback and Stark law violations.
  • Represented a physicians' association in responding to grand jury subpoena in connection with False Claims Act and anti-kickback investigation; practices at issue included pricing, marketing discounts, rebates, pharmacy management and product substitution, grants and sponsorships.
  • Successfully resolved State Attorney General investigation of home health agency related to allegations of overbilling.
  • Represented leading university-affiliated teaching hospital and physicians' organization in qui tam action alleging improper billing of Medicare and Medicaid.
  • Advised academic medical center in defense of federal False Claims Act investigation into alleged research grant fraud.*
  • Engaged by a Fortune 50 Life Sciences company to represent it in connection with an anti-kickback and off-label promotion investigation by the Department of Justice and the U.S. Attorney’s Office for the District of Tennessee; investigation concluded with a declination by the government and a voluntary dismissal of the qui tam complaint by the relator.
  • Represented compound pharmacy manufacturer in False Claims Act litigation and parallel FDA enforcement.
  • Represented regenerative medicine companyin False Claims Act litigation resulting in successful motion to dismiss
  • Represented a provider of dental, optometry, podiatry and audiology services to long-term care residents, in a state False Claims Act investigation and related false claims act lawsuit regarding submission of dental services claims.

Energy

  • Represented a major awardee under the Greenhouse Gas Reduction Fund in a federal investigation launched under the Federal Claims Act regarding allegations of misuse of federal funding and abuse of the EPA grant process.
  • Represented an alternative energy supplier against False Claims Act allegations brought by the Massachusetts Attorney General. Successfully negotiated a favorable consent decree.

Education & Research

  • Conducted investigation for a public university concerning compliance with research misconduct investigation policies and procedures and the unauthorized disclosure of confidential documents and the applicability of the federal False Claims Act.
  • Advised research institution concerning compliance issues related to compliance certifications, federal funding and the applicability of the federal False Claims Act.
  • Represented higher education institution in False Claims Act investigation concerning certain financial aid practices.

Individual Representation

  • Represented Chief Operating Officer of a provider of behavioral health care services in government investigation involving alleged False Claims Act violations.
  • Represented the CEO of a health care diagnostics company in a False Claims Act investigation by the Department of Justice and the U.S. Attorney's Office in New Jersey; resolved with no charges brought against our client.
  • Represented company leadership and employees in Department of Justice criminal investigation into alleged federal health care fraud violations, including responding to subpoenas and preparing clients for interviews.
  • Represented physician in connection with False Claims Act investigation involving Durable Medical Equipment (DME) and alleged violations of the federal anti-kickback statute (AKS).*
  • Represented CEO of telemedicine company in False Claims Act litigation related to compound pharmacy prescriptions, TRICARE, and DME supply.
  • Represented CEO of DME supplier and genetic testing lab owner in parallel criminal and civil FCA investigations.
  • Represented physician in False Claims Act investigation involving pharmaceutical consultant agreements and speaker programs and alleged violations of the AKS and FCA.*

 

* Denotes matter handled by Foley Hoag LLP attorney prior to joining the firm