Katherine A. Lauer

Katherine Lauer is a partner in the San Diego office of Latham & Watkins and former Global Co-Chair of the firm’s Healthcare & Life Sciences Practice. Ms. Lauer focuses her practice on healthcare litigation, with emphasis on healthcare fraud defense. She has defended some of the country's largest and most high-profile civil and criminal government healthcare fraud investigations and qui tam cases, representing such clients as HCA, Tenet Healthcare, Sutter Health, Adventist Health West, and NuVasive.

Ms. Lauer has extensive experience in the federal Anti-kickback Statute, the Stark Laws, and the federal False Claims Act, as well as cost reporting and other reimbursement issues. She advises a wide array of healthcare industry clients on issues related to pharmaceutical and medical device marketing, the structure and formation of joint ventures, and other corporate transactions, including mergers and acquisitions. She also has particular experience in the design and implementation of compliance programs, and has structured and conducted many internal investigations, voluntary disclosures, and compliance audits.

She is the past Co-Chair of the Health Law Litigation Committee of the American Bar Association Section of Litigation. She is a member of the American Health Lawyers Association, the Healthcare and Government Contracts section of the Federal Bar Association, and the California Society for Healthcare Attorneys. She is a member of the Planning Committees for the AHLA Fraud and Compliance Forum and the ABA Annual National Institute on Healthcare Fraud, and has been selected by the Department of Justice to provide training to government attorneys on how to successfully resolve healthcare fraud investigations. Ms. Lauer is also a member of the Scripps Health Board of Trustees and currently chairs the Audit and Compliance Committee.

Accolades

• Recognized by Chambers USA and The Legal 500 US for her work in healthcare
• Named a Healthcare Trailblazer
  The National Law Journal 2020
• Named a Litigation Star
  Benchmark Litigation 2020-2022
• Named a Top Healthcare Lawyer
  The Daily Journal, California’s legal newspaper of record
• Selected as a Life Science Star
  LMG Life Sciences, a list of highest profile, most sought-after and best lawyers working in life sciences
• Named to the BTI Client Service All Star Team for her work in healthcare litigation
• Repeatedly recognized by Nightingale's Healthcare News as one of the country's top healthcare attorneys – both as an Outstanding Fraud and Compliance Lawyer and as an Outstanding Healthcare Litigator

Ms. Lauer's experience includes representation of:

• HCA in national civil and criminal kickback and Stark Law investigations involving numerous qui tam actions and multiple United States Attorney’s offices; negotiated criminal plea and civil settlement 
• HCA in the US$1.125 billion acquisition of HealthMidwest
• Tenet Healthcare Corporation in multiple civil and criminal kickback and Stark Law investigations where she successfully convinced prosecutors not to pursue criminal prosecution in connection with alleged illegal kickbacks and to decline intervention into several related qui tam actions
• Tenet Healthcare Corporation in US v. Weinbaum, the Alvarado Hospital criminal kickback trial
• 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 system-wide 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 throughout the United States
• Defendants in multiple False Claims Act investigations where she successfully persuaded the government not to intervene; matter was dismissed by relator
• Numerous clients in the negotiation of Corporate Integrity Agreement and advising on implementation and reporting to the Office of Inspector General
• Individual defendants in multiple criminal kickback and investigation and off-label promotion investigations
• 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 CHAMPUS/TRICARE US$3.5 billion managed care contract award

• 11th Circuit: Difference in Opinion Not Enough for FCA Liability  -  September 13, 2019
• OIG Provides Regulatory Considerations for Gainsharing Agreements in Advisory Opinion 17-09 -  July 16, 2018
• Tax Act Changes Deductibility of False Claims Act Payments -  January 22, 2018
• Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases -  February 23, 2017
• Still Useful? Senate Finance Evaluates Possible Stark Law Changes, Including Repeal -  July 20, 2016
• SCOTUS Upholds Implied Certification for Some Cases But Imposes “Rigorous Materiality Requirement” for FCA Liability  -  June 21, 2016
• SCOTUS Oral Argument Suggests FCA Implied Certification Theory Is Here to Stay – But Perhaps with Limits  -  April 21, 2016
• What To Do When You Are Served With a Search Warrant -  December 16, 2015
• Fourth Circuit May Address Use of Statistical Sampling in False Claims Act Actions -  July 21, 2015
• OIG Solicits Comments Regarding New Healthcare Rules -  October 06, 2014
• Latest Developments in Healthcare Fraud: Companies Facing Increased Scrutiny -  July 22, 2014
• Lessons From Omnicare Settlement In 'Swapping' Cases -  July 21, 2014
• Omnicare Settles Two Qui Tam Cases Alleging “Swapping” Kickbacks to Nursing Homes -  July 10, 2014
• 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 -  March 01, 2014
• How a Former Employee’s Privilege Against Self-Incrimination can Incriminate Your Company — And what You can do About It -  December 01, 2013
• CMS Proposes Major Changes to Overpayment Reporting Requirements, Extending Liability to Ten Years -  March 7, 2012
• CMS Issues Proposed Regulations Interpreting the Physician Payment Sunshine Act -  December 19, 2011
• Violations of Payment/Participation Conditions as Predicates for False Claims -  April 01, 2011
• Was That a Yes or a No?: Depositions in the YouTube Era -  November 1, 2010
• Discharging False Claims Liability in Bankruptcy, Section 1141(D)(6)(A) of the Bankruptcy Code: An Incentive To Settle FCA Cases? -  October 2010
• Was That a Yes or a No?: Depositions in the YouTube Era -  June 2, 2010
• The Implications of FRE 502 on Healthcare E-Discovery and Privilege Review -  April 1, 2010
• Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009 -  July 29, 2009
• Newly Amended False Claims Act Expands Liability for Inadvertent Stark Law Violations -  June 22, 2009
• Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009 -  June 8, 2009
• New Disclosure, Ethics and Internal Controls Requirements for US Government Contractors -  November 17, 2008
• Arrangements Between Medical Device Manufacturers, Physician Consultants in the Crosshairs -  July 16, 2008
• How to Defend Against Accusations That Payments to Consultants Are Improper Remuneration: Part 1 -  April 24, 2008
• The Real Good News From GEICO: Reasonable Interpretations Negate Scienter Under the False Claims Act -  November 2007
• White Collar and Government Investigations Newsletter, Issue 1 -  Summer 2007
• Defending Government Pharmaceutical Fraud Investigations: Assessing Strategic Options -  May 2007