Katherine Lauer regularly guides some of the nation’s largest healthcare systems and life sciences companies through complex government enforcement matters, qui tam/whistleblower actions, and comprehensive proactive and reactive compliance advice to maximize business objectives while mitigating regulatory risk.

Ms. Lauer, past Global Co-Chair of the firm’s Healthcare & Life Sciences Practice for more than a decade, advises corporate and hospital C-suite executives, boards of directors, and in-house counsel on ways to structure their most significant transactions and strategic initiatives relating to:

  • Proactive compliance with multiple, complex regulatory schemes
  • Civil and criminal government enforcement defense, including False Claims Act litigation
  • Corporate integrity agreements and US Department of Justice (DOJ) monitorships
  • M&A regulatory support, particularly in the context of due diligence
  • Internal investigations, voluntary disclosures, and compliance program development and audits
  • Joint ventures
  • Pharmaceutical and medical device marketing

She leverages trusted relationships with top US regulators, including the DOJ, US Department of Health & Human Services, and the Centers for Medicare & Medicaid Services. Ms. Lauer represents clients in matters involving the federal Anti-kickback Statute, Stark Laws, and False Claims Act, as well as issues relating to billing, coding, and reimbursement. As a co-owner of Bryn Mawr Vineyards in Oregon’s Willamette Valley, Ms. Lauer brings her substantial operations and business development experience to each client engagement.

A recognized voice at national conferences and within leading legal, business, and industry publications, she regularly writes and speaks on emerging trends within the healthcare and life sciences space. Ms. Lauer has served on the planning committees for the American Health Lawyers Association (AHLA) for its Fraud and Compliance Forum and the ABA Annual National Institute on Healthcare Fraud. In addition, the DOJ tapped her to train government lawyers on how to successfully resolve healthcare fraud investigations.

Deeply entrenched in the healthcare and life sciences law community, Ms. Lauer is a past Co-Chair of the American Bar Association Litigation Section’s Health Law Litigation Committee. She is a member of AHLA, the American Bar Association Health Law Section, the Federal Bar Association’s Healthcare and Government Contracts Section, and the California Society for Healthcare Attorneys. Since 2012, she has served on the Scripps Health Board of Trustees and chairs its Audit and Compliance Committee.

Thought Leadership

  • “Putting the 'Fair' in Fair Market Value: Can Fair Market Values Constitute Remuneration?” National Institute on Health Care Fraud: Criminal, Civil and Administrative Enforcement in Kickback Cases (June 2022)
  • “11th Circuit: Difference in Opinion Not Enough for FCA Liability” Latham & Watkins Client Alert (September 2019)
  • “New DOJ Guidance on 'Cooperation Credit'” AHLA Weekly (May 2019)
  • “OIG Provides Regulatory Considerations for Gainsharing Agreements in Advisory Opinion 17-09” Latham & Watkins Client Alert (July 2018)
  • “Tax Act Changes Deductibility of False Claims Act Payments” Latham & Watkins Client Alert (January 2018)
  • “Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases” Latham & Watkins Client Alert (February 2017)
  • “SCOTUS: Dismissal Not Mandatory for False Claims Act Seal Violation ” Latham & Watkins Client Alert (December 2016)
  • “Still Useful? Senate Finance Evaluates Possible Stark Law Changes, Including Repeal” Latham & Watkins Article (July 2016)
  • “Fourth Circuit May Address Use of Statistical Sampling in False Claims Act Actions” Latham & Watkins Client Alert (July 2015)
  • “SCOTUS Upholds Implied Certification for Some Cases But Imposes “Rigorous Materiality Requirement” for FCA Liability ” Latham & Watkins Client Alert (June 2016)
  • “SCOTUS Oral Argument Suggests FCA Implied Certification Theory Is Here to Stay – But Perhaps with Limits ” Latham & Watkins Client Alert (April 2016)
  • “OIG Solicits Comments Regarding New Healthcare Rules” Latham & Watkins Client Alert (October 2014)
  • “Lessons From Omnicare Settlement In 'Swapping' Cases” Latham & Watkins Article (July 2014)
  • “Latest Developments in Healthcare Fraud: Companies Facing Increased Scrutiny” Latham & Watkins Q&A (July 2014)
  • “Omnicare Settles Two Qui Tam Cases Alleging “Swapping” Kickbacks to Nursing Homes” Latham & Watkins Client Alert (July 2014)
  • “Violations of Payment/Participation Conditions as Predicates for False Claims” Latham & Watkins Article (April 2011)
  • “How a Former Employee’s Privilege Against Self-Incrimination can Incriminate Your Company — And what You can do About It” Latham & Watkins Article (December 2013)
  • “Swapping for Good: How the Rise in False Claims Act Cases Involving “Swapping Schemes” Undermines Health Care Providers’ Ability to Seek Discounts as the Legislature and Regulators Intended” Latham & Watkins Article (March 2014)
  • “What To Do When You Are Served With a Search Warrant” Latham & Watkins Client Alert (December 2015)
  • “CMS Proposes Major Changes to Overpayment Reporting Requirements, Extending Liability to Ten Years” Latham & Watkins Client Alert (March 2012)
  • “CMS Issues Proposed Regulations Interpreting the Physician Payment Sunshine Act” Latham & Watkins Client Alert (December 2011)
  • “Discharging False Claims Liability in Bankruptcy, Section 1141(D)(6)(A) of the Bankruptcy Code: An Incentive To Settle FCA Cases?” Latham & Watkins Article (October 2010)
  • “Was That a Yes or a No?: Depositions in the YouTube Era” Latham & Watkins Article (November 2010)
  • “Was That a Yes or a No?: Depositions in the YouTube Era” Latham & Watkins Client Alert (June 2010)
  • “The Implications of FRE 502 on Healthcare E-Discovery and Privilege Review” Latham & Watkins Article (April 2010)
  • “Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009” Latham & Watkins Article (July 2009)
  • “Newly Amended False Claims Act Expands Liability for Inadvertent Stark Law Violations” Latham & Watkins Client Alert (June 2009)
  • “Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009” Latham & Watkins Client Alert (June 2009)
  • “New Disclosure, Ethics and Internal Controls Requirements for US Government Contractors” Latham & Watkins Client Alert (November 2008)
  • “Arrangements Between Medical Device Manufacturers, Physician Consultants in the Crosshairs” Latham & Watkins Article (July 2008)
  • “How to Defend Against Accusations That Payments to Consultants Are Improper Remuneration: Part 1” Latham & Watkins Article (April 2008)
  • “The Real Good News From GEICO: Reasonable Interpretations Negate Scienter Under the False Claims Act” Latham & Watkins Article (November 2007)
  • “White Collar and Government Investigations Newsletter, Issue 1” Latham & Watkins Newsletter (August 2007)
  • “Defending Government Pharmaceutical Fraud Investigations: Assessing Strategic Options” Latham & Watkins Article (May 2007)
  • “Tilting at Windfalls: Rejecting the Tainted Claims Theory of Damages in False Claims Act Cases” Latham & Watkins Article (May 2001)
  • “It's Not That Easy: Why Extrapolation is Inappropriate in the False Claims Act Context” Latham & Watkins Article (October 2001)

Ms. Lauer’s recent experience includes representing:

  • HCA in:
    • National civil and criminal kickback and Stark Law investigations involving numerous qui tam actions and multiple US Attorney’s offices, including negotiating a criminal plea and multiple civil settlements
    • Its US$1.125 billion acquisition of HealthMidwest
  • Tenet Healthcare in:
    • Multiple civil and criminal kickback and Stark Law investigations in which she convinced prosecutors not to pursue criminal prosecution relating to alleged illegal kickbacks and to decline intervention into several related qui tam actions, including Clinica de la Mama investigation and the Alvarado Hospital criminal kickback trial
    • Implementing a DOJ corporate monitorship
  • Sutter Health in multiple government investigations, including a US$90 million Medicare Managed Care DOJ settlement and a US$45 million Stark DOJ settlement
  • NuVasive Spine in a civil False Claims Act settlement of off-label marketing and Anti-Kickback Statute allegations 
  • Advocate Health Care in the acquisition of Condell Medical Center and the attendant voluntary disclosure resulting in a US$36 million settlement with the Department of Justice
  • Catholic Healthcare West in a systemwide cost-report fraud investigation 
  • University Hospitals Health System of Cleveland in civil and criminal kickback and Stark Law investigations
  • Defendants in multiple non-intervened False Claims Act actions pending across the United States
  • Defendants in multiple False Claims Act investigations in which she persuaded the government not to intervene and the matter was dismissed by relator
  • Numerous clients in negotiating corporate integrity agreements, advising on implementation, and reporting to the Office of Inspector General
  • Individual defendants in multiple investigations into criminal kickbacks and off-label promotions
  • Multiple clients in congressional investigation into hospital billing practices of uninsured patients
  • Aetna Government Health Plans in multiple bid protest proceedings before the General Accounting Office and in federal court relating to the CHAMPUS/TRICARE US$3.5 billion managed care contract award

Bar Qualification

  • California

Education

  • JD, University of Michigan Law School, 1988
  • BA, University of Michigan, 1985