Katherine A. Lauer

Katherine Lauer retired from the partnership in April 2023. She has regularly guided 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.

Katherine, past Global Co-Chair of the firm’s Healthcare & Life Sciences Practice for more than a decade, has advised 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 has leveraged trusted relationships with top US regulators, including the DOJ, US Department of Health & Human Services, and the Centers for Medicare & Medicaid Services. Katherine represented 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, she has brought 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 wrote and spoke on emerging trends within the healthcare and life sciences space. Katherine 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, Katherine is a past Co-Chair of the American Bar Association Litigation Section’s Health Law Litigation Committee. At the time of her retirement, she was 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. She has served on the Scripps Health Board of Trustees and chaired its Audit and Compliance Committee.

Thought Leadership

External Publications:

• “Putting the ‘Fair’ in Fair Market Value: Can Fair Market Value Payments Constitute Remuneration?” American Bar Association (2022)
• “Criminal, Civil, and Administrative Enforcement in Kickback Cases” American Bar Association (2020)
• “Individual Prosecutions” American Health Lawyers Association Connections (2019)
• “Anti-kickback Statue Developments” American Bar Association (2019)
• “Individual Prosecutions” American Health Law Association Connections (2018)
• “Anti-kickback Statue Developments” American Bar Association (2018)
• “Still Useful? Senate Finance Evaluates Possible Stark Law Changes, Including Repeal” BNA Health Care Fraud Report (2016)
• “Lessons From Omnicare Settlement In ‘Swapping’ Case” Law360 (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” American Health Law Association Connections (2014)
• “How a Former Employee's Privilege Against Self-Incrimination can Incriminate Your Company - And what You can do About It” American Health Law Association Fraud & Abuse Newsletter (2013)
• “Speculative Statistics: Objections to the Use of Extrapolation and Sampling in False Claims Act Cases” American Bar Association (2012)
• “Violations of Conditions of Payment and Participation as Predicates for False Claims” American Bar Association Health Law Litigation Newsletter (2011)
• “Discharging False Claims Liability in Bankruptcy, Section 1121(d)(6)(A) of the Bankruptcy Code: An Incentive to Settle FCA Cases?” The Health Lawyer (2010)
• “Getting Personal: Enforcement Focus on Responsible Senior Corporate Officials for Corporate Bad Acts” American Bar Association (2010)
• “Was that a Yes or a No: Depositions in the YouTube Era” Practical Litigator (2010)
• “Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009” The Lawyer’s Brief (2009)
• “Using Voluntary Disclosure to Resolve Anti-kickback Statute Liability” American Bar Association (2009)
• “Arrangements Between Medical Device Manufacturers, Physician Consultants in the Crosshairs” San Diego Daily Transcript (2008)
• “Welcome to the Field of Healthcare Fraud Defense: Where Nothing is Static and “Victory” is Hard to Define” American Bar Association (2008)
• “The Real Good News From GEICO: Reasonable Negotiations Negate Scienter Under the False Claims Act” Andrews Litigation Reporter (2007)
• “Negotiating CIA’s: It’s the Little Things that Matter” American Bar Association (2007)
• “Defending Pharmaceutical Fraud Investigations: Assessing Strategic Options” American Bar Association Health Law Litigation Committee Newsletter (2007)
• “Stark Naked: The Open Letter Disrobes the Fundamental Flaw in the Tainted Claims Theory of Damages In FCA Cases Based on Stark Law Violations” American Bar Association (2006)
• “Ten Things You Wanted to Know About Internal Investigations But Were Afraid to Ask” American Health Lawyers News (2006)
• “Question: To What Extent Did the 2004 Acquittals in the TAP Case Affect the Government’s Zeal for Investigating and Prosecuting Health Care Fraud and Abuse Matters in 2005? Answer: Not At All” American Bar Association (2006)
• “Establishing Intent to Violate the Anti-kickback Statute: Rethinking the “One Purpose” Test” American Bar Association (2006)
• “Federalizing Quality of Care: New Frontiers In Enforcement” American Bar Association (2005)
• “Using the Ambiguity Defense to Negate Falsity and Scienter in Healthcare Fraud Prosecutions” American Bar Association (2004)
• “Square Pegs and Round Holes: Violations of Healthcare Statutes and Regulations As False Claims” American Bar Association (2004)
• “Show Me The Money: Proving Damages In False Claims Act Litigation Based On Illegal Referral Arrangements” American Health Lawyers Association (2003)
• “Anti-kickback Act Violations as False Claims: Not Yet Time For Unconditional Surrender” American Bar Association (2003)
• “Physician Financial Relationships: Auditing and Monitoring Anti-Kickback Statute and Stark Compliance,” Health Care Compliance Association (2002)
• “Through the Glass Starkly: Murky Statutes and Unfair Enforcement” American Bar Association (2002)
• “Pharmaceutical Industry Business Practices Attracting Government Attention” PhRMA (2001)
• “It’s Not That Easy: Why Extrapolation is Inappropriate In the False Claims Act Context” American Institute of Certified Public Accountants (2001)
• “Tilting at Windfalls: Rejecting the Tainted Claims Theory of Damages in False Claims Act Cases” American Bar Association (2001)
• “Is There Any 'There' There? Damages and Penalties in False Claims Act Litigation Based on Anti-Kickback and Stark Violations” American Bar Association (2000)
• Contributing editor of the BNA Health Care Program Compliance Guide (2000)

Latham & Watkins Client Alerts:

• “11th Circuit: Difference in Opinion Not Enough for FCA Liability” Latham & Watkins Client Alert (2019)
• “OIG Provides Regulatory Considerations for Gainsharing Agreements in Advisory Opinion 17-09” Latham & Watkins Client Alert (2018)
• “Tax Act Changes Deductibility of False Claims Act Payments” Latham & Watkins Client Alert (2018)
• “Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases” Latham & Watkins Client Alert (2017)
• “SCOTUS Upholds Implied Certification for Some Cases But Imposes ‘Rigorous Materiality Requirement’ for FCA Liability” Latham & Watkins Client Alert (2016)
• “SCOTUS Oral Argument Suggests FCA Implied Certification Theory Is Here to Stay - But Perhaps with Limits” Latham & Watkins Client Alert (2016)
• “SCOTUS: Dismissal Not Mandatory for False Claims Act Seal Violation ” Latham & Watkins Client Alert (2016)
• “What to Do When You Are Served With a Search Warrant” Latham & Watkins Client Alert (2015)
• “Fourth Circuit May Address Use of Statistical Sampling in False Claims Act Actions” Latham & Watkins Client Alert (2015)
• “Omnicare Settles Two Qui Tam Cases Alleging “Swapping” Kickbacks to Nursing Homes” Latham & Watkins Client Alert (2014)
• “Latest Developments in Healthcare Fraud: Companies Facing Increased Scrutiny” Latham & Watkins Q&A (2014)
• “OIG Solicits Comments Regarding New Healthcare Rules” Latham & Watkins Client Alert (2014)
• “CMS Proposes Major Changes to Overpayment Reporting Requirements, Extending Liability to Ten Years” Latham & Watkins Client Alert (2012)
• “CMS Issues Proposed Regulations Interpreting the Physician Payment Sunshine Act” Latham & Watkins Client Alert (2011)
• “Violations of Payment/Participation Conditions as Predicates for False Claims” Latham & Watkins Article (2011)
• “The Implications of FRE 502 on Healthcare E-Discovery and Privilege Review” Latham & Watkins Article (2010)
• “Was That a Yes or a No?: Depositions in the YouTube Era” Latham & Watkins Client Alert (2010)
• “Was That a Yes or a No?: Depositions in the YouTube Era” Latham & Watkins Article (2010)
• “Discharging False Claims Liability in Bankruptcy, Section 1141(D)(6)(A) of the Bankruptcy Code: An Incentive To Settle FCA Cases?” Latham & Watkins Article (2010)
• “CMS Proposes Major Changes to Overpayment Reporting Requirements, Extending Liability to Ten Years” Latham & Watkins Client Alert (2012)
• “CMS Issues Proposed Regulations Interpreting the Physician Payment Sunshine Act” Latham & Watkins Client Alert (2011)
• “Violations of Payment/Participation Conditions as Predicates for False Claims” Latham & Watkins Client Alert (2011)
•  “The Implications of FRE 502 on Healthcare E-Discovery and Privilege Review” Latham & Watkins Article (2010)
• “Newly Amended False Claims Act Expands Liability for Inadvertent Stark Law Violations” Latham & Watkins Client Alert (2009)
• “Significant False Claims Act Amendments Enacted as Part of the Fraud Enforcement and Recovery Act of 2009” Latham & Watkins Client Alert (2009)
• “New Disclosure, Ethics and Internal Controls Requirements for US Government Contractors” Latham & Watkins Client Alert (2008)
• “Arrangements Between Medical Device Manufacturers, Physician Consultants in the Crosshairs” Latham & Watkins Client Alert (2008)
• “How to Defend Against Accusations That Payments to Consultants Are Improper Remuneration” Latham & Watkins Client Alert (2008)
• “Defending Government Pharmaceutical Fraud Investigations: Assessing Strategic Options” Latham & Watkins Client Alert (2007)

Speaking Engagements/National Conference Planning Committees:

• Planning Committee and Moderator, “Criminal, Civil, and Administrative Enforcement in Kickback Cases” American Bar Association National Institute on Health Care Fraud (2022)
• Planning Committee and Moderator, “Criminal, Civil, and Administrative Enforcement in Kickback Cases” American Bar Association National Institute on Health Care Fraud (2020)
• Planning Committee, American Health Law Association Fraud and Compliance Forum (2020)
• Speaker, “Anatomy of a False Claims Act” Health Care Compliance Association Healthcare Enforcement Compliance Conference (2020)
• Speaker, “Stark and Anti-Kickback Compliance and Foreign Corruption Practices Act Compliance” Health Care Compliance Association Board & Audit Committee Compliance Conference (2020)
• Speaker, “The Impact of the Pandemic on the Career Path of Latham’s Female Attorneys” Latham & Watkins Event (2020)
• Planning Committee and Moderator, “Criminal, Civil And Administrative Enforcement” American Bar Association National Institute on Health Care Fraud (2019)
• Planning Committee, American Health Law Association Fraud and Compliance Forum (2019)
• Speaker, “Anatomy of a False Claims Act Case” Health Care Compliance Association Healthcare Enforcement Conference (2018)
• Planning Committee and Moderator, “Criminal, Civil And Administrative Enforcement” American Bar Association National Institute on Health Care Fraud (2018)
• Planning Committee and Plenary Session Moderator, “Who Broke My Crystal Ball: Advising In The Time of Uncertainty” American Health Law Association Fraud and Compliance Conference (2017)
• Planning Committee and Moderator, “Criminal, Civil and Administrative Enforcement in Kickback Cases” American Bar Association National Institute on Health Care Fraud (2017)
• Speaker, “Recent Developments in Health Care Enforcement” Deloitte Webcast (2017)
• Speaker, “Government Enforcement Trends that Dictate Compliance Protocols: Understanding How the False Claims Act and Anti- Kickback Laws Have Shaped Life Sciences Compliance Programs” American Conference Institute Life Sciences Compliance Boot Camp (2017)
• Conference Chair and Speaker, “Characterization of Claims Under the False Claims Act” CLE International Qui Tam Conference (2016)
• Speaker, “Escobar Distilled and Debated: the State of False Certification Liability under the False Claims Act Following the Supreme Court’s Recent Decision” American Health Law Association Webcast (2016)
• Planning Committee and Moderator, “Government Enforcement Panel” American Bar Association National Institute on Health Care Fraud (2014)
• Speaker, “Fraud and Abuse” Annual Meeting and Spring Seminar, California Society for Healthcare Lawyers (2014)
• Speaker, “The Anticipated Increase in False Claims Act Investigations in the Healthcare and Pharmaceutical Industries” American Conference International False Claims and Qui Tam Enforcement (2014)
• Planning Committee and Moderator, “Government Enforcement Panel” American Bar Association National Institute on Health Care Fraud (2013)
• Conference Chair and Speaker, “False Claims Act: All Points of View” CLE International, Qui Tam (2013)
• Guest Lecturer, Cornell Law School Whistleblower Class, Cornell Law Forum (2013)
• Planning Committee and Moderator, “Government Enforcement Panel” American Bar Association National Institute on Health Care Fraud (2012)
• Speaker, “Enforcement Update” Health Care Compliance Association Western Regional Conference (2012)
• Speaker, “False Claims Act Damages” American Bar Association National Institute on False Claims and Qui Tam Litigation (2012)
• Planning Committee and Moderator, “Government Enforcement Panel” and “Defense Counsel Workshop” American Bar Association National Institute on Health Care Fraud (2011)
• Speaker, “Physician Sunshine Act” The International Publication Planning Association Annual Meeting (2011)
• Speaker, “Repayment Obligations” American Bar Association Health Law Section Webinar – Overpayments (2011)
• Speaker, “False Claims Act Amendments and Overpayments” American Health Law Association / Healthcare Compliance Association Fraud and Compliance Conference (2011)
• Planning Committee and Moderator, “Government Enforcement Panel” American Bar Association National Institute on Health Care Fraud (2010)
• Speaker, “Compliance, Investigations and Defense in Healthcare Fraud” Silicon Valley Association of General Counsel Annual All Hands Meeting (2010)
• Speaker, “Repayments and Disclosures” American Health Law Association / Health Care Compliance Association Fraud and Compliance Institute (2010)
• Speaker, “Health Care Reform” Federal Bar Association Annual Meeting and Convention (2010)
• Speaker, “Federal and State Aggregate Spend Rules” ACI Life Sciences Compliance Bootcamp (2010)
• Speaker, “False Claims Act Damages” American Bar Association National Institute on Civil False Claims Act (2010)
• Conference Chair and Speaker, “Effective Practice and Procedure” CLE International False Claims Act and Qui Tam Litigation (2010)
• Speaker, “The Life-Cycle of Hospital/Physician Business Arrangements and Legal Compliance Requirements” American Health Law Association / Health Care Compliance Association Fraud and Compliance Institute (2009)
• Speaker, “Medicare/Medicaid Repayments and Disclosures” American Health Law Association / Health Care Compliance Association Fraud and Compliance Institute (2009)
• Speaker, “Developing A Compliance Program: Appropriate Interactions Between Sales Professionals and Healthcare Practitioners” Medical Device Manufacturers Association Medical Technology Executive Forum (2009)
• Speaker, “Medicare/Medicaid Repayments and Disclosures: New Laws, New Obligations, New Risks and How to Respond to Them” American Bar Association Health Care Section Teleconference (2009)
• Speaker, “Criminal and Civil Enforcement of the Anti-kickback Statute” American Bar Association National Institute on Health Care Fraud (2009)
• Speaker, “Successful Strategies for Negotiating A Health Care Fraud Case: The View from the Defense” National Advocacy Center DOJ Training Program for Assistant United States Attorneys (2009)
• Speaker, “The Fair Market Value Defense in Health Care Fraud Investigations” Health Care Compliance Association Annual Meeting (2008)
• Speaker, “Fair Market Value for Legitimate Services: Defending Against Accusations the Payments to Consultants are Improper Remuneration” ACI National Forum on Fraud & Abuse in the Sales and Marketing of Drugs (2008)
• Speaker, Health Care Panel American Bar Association National Institute on White Collar Crime (2008)
• Speaker, “Negotiating False Claims Act Settlements and Living Under A CIA” American Bar Association National Institute on Health Care Fraud (2007)
• Speaker, “The Fair Market Value Defense in Health Care Fraud Investigations” Health Care Compliance Association Annual Meeting (2007)
• Speaker, “Overview of the Anti-kickback Statute and the Stark Law” Health Care Compliance Association Annual Meeting (2007)
• Speaker, “What Corporate Counsel Needs to Know About Internal Investigations, But Is Afraid To Ask” American Bar Association Section of Litigation Annual Conference (2007)
• Speaker, “Assessing Your Options Once A Government Investigation is Initiated – It’s not Necessarily Time to Throw in the Towel” ACI Government Investigation Preparedness for Pharma Conference (2007)
• Speaker, “Enforcement Activities” American Health Law Association / Health Care Compliance Association Fraud and Compliance Institute (2006)
• Speaker, “Lessons Learned from U.S. v. Weinbaum” American Health Law Association / Health Care Compliance Association Fraud and Compliance Institute (2006)
• Speaker, Health Care Panel American Bar Association National Institute on White Collar Crime (2006)
• Speaker, “Ten Things You Always Wanted to Know About Internal Investigations But Were Afraid to Ask” American Health Law Association Teleconference (2006)
• Speaker, “The Defense Perspective on How the Government Tries Kickback Cases” American Health Law Association / Health Care Compliance Association Fraud and Compliance Forum (2005)
• Speaker, Health Care Panel American Bar Association National Institute on White Collar Crime (2004)
• Speaker, “Living with Stark and the Anti-Kickback Statute after Thompson” American Health Law Association / Health Care Compliance Association Fraud and Compliance Forum (2003)
• Speaker, “The Implications of Enforcement Litigation” Health Industry Group Purchasing Association National Pharmacy Forum (2003)
• Speaker, “Handling the Complex Fraud Litigation Matter” Association of Independent Certified Public Accountants Fraud Conference (2001)
• Speaker, “Strategic Defenses to Pharmaceutical Investigations” Health Care Compliance Association Pharmaceutical Industry Regulatory & Compliance Summit (2001)

Accolades, Directory Rankings, and Other Press Coverage

• How 3 Big Law first-year associates are adapting to their new virtual programs and what their firms are planning for the next class (Business Insider 2021)
• Trailblazers – Health Care and Life Science (The National Law Journal 2020)
• California Litigation Star (Benchmark Litigation 2020 – 2022)
• Local Litigation Star (Benchmark Litigation 2020 – 2022)
• Top Health Care Lawyers 2019 (Daily Journal 2019)
• Band 1 Ranking for Healthcare – California (Chambers USA 2018 – present)
• Health Group of the Year: Latham (Law360 2016)
• LMG Life Sciences Star (LMG Life Sciences 2012, 2015, and 2016)
• Top Women Lawyers 2011 (Daily Journal 2011)
• BTI Client Service All Star Team (2011)
• “Outstanding Healthcare Litigator” (Nightingale's Healthcare News 2006 and 2004)