For more than 25 years, Laura Laemmle-Weidenfeld has successfully defended a broad spectrum of health care providers, digital health entities, distributors, and pharmaceutical and medical device manufacturers against health care fraud enforcement actions brought by the U.S. Department of Justice (DOJ), U.S. Attorney's Offices, private whistleblowers, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and state attorneys general. Earlier in her career, she led health care False Claims Act (FCA) investigations and litigation, including those brought under the FCA's qui tam (whistleblower) provisions, at the DOJ's Civil Division.
Laura also draws on her enforcement experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS), and FCA, and their state analogs. In addition, Laura helps clients conduct internal investigations, prepare and negotiate self-disclosures to regulators including HHS-OIG and the Centers for Medicare and Medicaid Services (CMS), and obtain advisory opinions from HHS-OIG. She also helps clients negotiate corporate integrity agreements (CIAs) with HHS-OIG and counsels clients on creating and maintaining effective compliance programs.
Laura frequently writes and speaks on health care enforcement issues, is an active member of the American Health Law Association (AHLA) (chair, Fraud and Abuse Practice Group, 2014-2017; member, Planning Committee for the 2023 Fraud and Compliance Forum), and is the author of Legal Issues in Health Care Fraud and Abuse, Fifth Edition, and its annual supplements, published by the AHLA.
Experience
The following represents experience acquired prior to joining Jones Day.
On behalf of multiple affiliated not-for-profit skilled nursing facilities, successfully resolved a False Claims Act quality-of-care investigation by negotiating a False Claims Act settlement with the Department of Justice on an ability-to-pay basis and negotiating a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General, in an investigation conducted by the U.S. Attorney's Office for the District of Maryland and the State of Maryland Office of the Attorney General.
Successfully represented a hospital in an investigation by the U.S. Department of Health and Human Services Office of Inspector General, which resulted in that office's declination of the matter.
Successfully represented a national home health care provider in a parallel civil False Claims Act and criminal investigation led by the U.S. Attorney's Office in Newark, New Jersey and negotiated a global resolution in which the company entered into a Deferred Prosecution Agreement and civil settlements with the United States and more than 30 states, as well as a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.
Filed successful motion in the Eastern District of Michigan to dismiss a complaint alleging False Claims Act violations by a dialysis provider in connection with the quality of care provided to Medicare and Medicaid patients.
Filed successful motion in the Middle District of Florida to dismiss a complaint alleging False Claims Act violations in connection with marketing practices allegedly undertaken by a for-profit provider of higher education.
Filed successful motion in federal district court in the District of Columbia to dismiss a complaint against small business subcontractor alleging False Claims Act violations relating to contract for provision of IT services to the United States Customs and Immigration Services.
On behalf of individual dermatologist, assisted in successfully negotiating a False Claims Act resolution in a matter involving alleged violations of the Anti-Kickback Statute.
Filed successful motions in the Western District of Wisconsin to dismiss a government complaint alleging False Claims Act violations by a pharmacy chain in connection with Medicaid billings for prescription drugs provided to consumers with primary private insurance coverage.
Represented an individual consultant who provided FDA-related assistance to a start-up medical device manufacturer, in an investigation by the U.S. Attorney's Office in Boston, Massachusetts, under the False Claims Act and the Federal Food, Drug, and Cosmetic Act, which the U.S. Attorney's Office ultimately declined to pursue.
On behalf of a well-known nationwide DME (durable medical equipment) provider, successfully resolved False Claims Act litigation relating to marketing practices by negotiating a civil settlement with the Department of Justice and a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.
Successfully defended a national home health care provider against a criminal investigation by a state attorney general's office, ultimately obtaining a formal declination of the matter, which related to Medicaid billing concerns.
Additional Publications
September 2013
How Not to Go Down in Flames with Your Client in Fraud Matters: Compliance with the Ethical Rules is Not Enough!, coauthor, American Health Lawyers Association/Health Care Compliance Association Fraud and Compliance Institute Course book
2013
Navigating the Complexities of Health Care Law Enforcement and Compliance, Inside the Minds: Health Care Law Enforcement and Compliance, 2013 ed., Aspoatore Books
Spring 2013
The Intersection of the Stark Law and Medicaid Claims: Catching Providers in a Legal Quagmire, coauthor, AHLA Connections
March 2013
Coronia: The Anticipated Effect on Off-Label Cases, American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues coursebook
February 20, 2013
Negotiating a Criminal Settlement in a Health Care Case, coauthor, BNA Health Care Fraud Report
December 2012
Manufacturer Liability Under the False Claims Act Based on Violations of Other Statutes: No Relief in Sight, Practising Law Institute, Health Care and Life Sciences Law 2012 conference coursebook
June 2012
The Intersection Between the Civil False Claims Act and the 60-Day Overpayment Rule, coauthor, American Health Lawyers 2012 Annual Meeting coursebook
May 2012
Supreme Court Continues Status Quo on FCA ‘Implied Certification’ Theory, American Health Lawyers Association Fraud and Abuse Newsletter, Vol. I, Issue 2
November 2009
In-House Counsel Beware: The False Claims Act May Impact Your Business, coauthor, ACC Docket
Speaking Engagements
- September 28, 2023
Speaker, "Joint Ventures Guidance Going on 30 Years - Where Do We Go From Here?" American Health Law Association, Fraud and Compliance Forum 2023 - September 14, 2023
Speaker, "Effective Life Sciences Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries - March 22, 2023
Speaker, "Fraud and Abuse Hot Topics," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2023 - December 8, 2022
Speaker, "Enforcement Trends in Health Care Law - Lessons Learned in 2022," Practising Law Institute, Hot Topics in Health Care Law 2022 - November 7-9, 2022
Panelist, "Anatomy of a False Claims Act Case," Health Care Compliance Association, Healthcare Enforcement Compliance Conference - September 28, 2022
Speaker, "Effective Compliance Programs and Investigations: A Hypothetical," Practising Law Institute, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries - September 28-30, 2022
Speaker, "Current State of Telehealth Enforcement," American Health Law Association, Fraud and Compliance Forum - September 13, 2022
Speaker, "Ethical Issues in Qui Tam Investigations," American Bar Association, 2022 Virtual Civil False Claims Act and Qui Tam Enforcement Institute - June 27-29, 2022
Speaker, "Telemedicine Post-COVID: Where Are We and What's Next?" American Health Law Association, Annual Meeting 2022 - June 22-24, 2022
Panelist, "False Claims Act Developments," American Bar Association, Health Care Fraud 2022 - March 23-25, 2022
Speaker, "Hot Topics in Fraud and Abuse," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2022 - December 9, 2021
Speaker, "Enforcement Trends in Health Care Law - Lessons Learned in 2021," Practising Law Institute, Hot Topics in Health Care Law 2021 - December 7-9, 2021
Panelist, "Dispelling Myths in Telehealth," American Telemedicine Association, EDGE2021 - October 5, 2021
Speaker, "Effective Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2021: Navigating Legal Challenges in Drug and Device Industries - September 21-22, 2021
Speaker, "EKRA: Enforcement Trends and Future Projections," American Health Law Association, Fraud and Compliance Forum Program 2021 - March 24-26, 2021
Speaker, "Hot Topics in Fraud and Abuse," American Health Law Association, Institute on Medicare and Medicaid Payment Issues 2021 - October 13, 2020
Speaker, "Effective Compliance Programs and Investigations," Practising Law Institute, Life Sciences 2020: Navigating Legal Challenges in Drug and Device Industries - September 30-October 2, 2020
Speaker, "Managing Fraud and Abuse Challenges in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum - December 11, 2019
Speaker, "Enforcement Trends in Health care Law - Lessons Learned in 2019," Practising Law Institute Hot Topics in Health Care Law 2019 - October 10, 2019
Speaker, "Effective Compliance Programs and Investigations: a Hypothetical," Practising Law Institute, Life Sciences: Navigating Legal Challenges in Drug and Device Industries 2019 - September 25-27, 2019
Speaker, "Fraud and Abuse in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum 2019 - March 20-22, 2019
Panelist, "Hot Topics in Fraud and Abuse," American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues 2019 - 12/12/2018
Hot Topics in Health Care Law 2018, Enforcement Trends in Health Care Law -- Overview and Lessons Learned in 2018 - September 26-28, 2018
Speaker, "Fraud and Abuse Issues in Telehealth," American Health Lawyers Association, Fraud and Compliance Forum 2018 - May 22-23, 2018
Panelist, "Settling False Claims Act Cases and Considerations for Potential Follow-on Litigation," American Conference Institute, Life Sciences & Healthcare Qui Tam and False Claims Summit - March 21-23, 2018
Institute on Medicare and Medicard Payment Issues, AHLA - December 14, 2017
PLI's Health Care Law Institute 2017 - October 4-6, 2017
Fraud and Compliance Forum, AHLA - June 26-28, 2017
Modern Ethics Rules for Attorneys Managing Internal and Government Investigations and Litigation, panelist, AHLA Annual Meeting - April 4, 2017
Fraud and Abuse Advanced Enforcement, Part I: Advanced Tactics and Strategies for Handling FCA Actions (Advanced) - March 29-31, 2017
Hot Topics in Health Care Fraud and Abuse, panelist, AHLA Medicare and Medicaid Payment Institute - March 26, 2017
Anatomy of a False Claims Act Case, panelist, Health Care Compliance Association's 21st Annual Compliance Institute - December 13, 2016
PLI's Health Care Law Institute 2016: Emerging Challenges and Trends in Reimbursement, Enforcement, Compliance and other Hot Topics - November 2, 2016
PLI's Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries - October 25, 2016
Negotiating and Surviving a Corporate Integrity Agreement, panelist, Health Care Compliance Association's Healthcare Enforcement Compliance Institute - October 6-7, 2016
The Lifecycle of a CIA: How to Get Started, Survive and Thrive, panelist, AHLA Fraud and Compliance Forum - May 4, 2016
Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry - April 17, 2016
20th Annual Compliance Institute, Health Care Compliance Association - April 13-14, 2016
Institute on Medicare and Medicaid Payment Issues, AHLA - January 21, 2016
The Year in Review - What Recent Cases Reveal about Future False Claims Act Litigation, panelist, American Conference Institute's 3rd Annual Executive Forum on False Claims & Qui Tam Enforcement - November 11, 2015
Compliance Programs and Investigations, panelist, Health Care Law Institute 2015: Emerging Challenges and Trends in Reimbursement, Enforcement and Other Hot Topics - October 28, 2015
Effective Compliance Programs and Investigations: A Hypothetical, panelist, PLI's Life Sciences 2015: Navigating Legal Challenges in the Drug and Device Industries - October 25, 2015
Anatomy of False Claims Act Case: Investigation, Negotiation, Resolution, panelist, Health Care Compliance Association's 2015 Healthcare Enforcement Compliance Institute - September 28-29, 2015
Managed Care: Fraud and Abuse's New Frontier. panelist, American Health Lawyer's Association Fraud and Compliance Forum - May 15, 2015
Anatomy of an Internal Investigation and its Aftermath, panelist, Health Care Compliance Association Regional Conference - May 13-15, 2015
Litigating False Claims Act Cases, moderator, American Bar Association's 25th Annual National Institute on Health Care Fraud - March 25-27, 2015
Recent Developments in Fraud and Abuse Enforcement, moderator, American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues - January 21-22, 2015
Inside the Most Significant Legal Issues Arising from False Claims Act Litigation, panelist, American Conference Institute's 2nd Advanced Forum on False Claims Act and Qui Tam Enforcement - January 16, 2015
Legal Perspectives Essential to Reimbursement, American Telemedicine Association - October 24, 2014
Effective Compliance Programs and Investigations: A Hypothetical, Practising Law Institute's Health Care and Life Sciences Law 2014 - October 6-7, 2014
Tips on Negotiating and Then Living Under a CIA, panelist, American Health Lawyers Association Fraud and Compliance Forum
Speaking Engagements Prior to Jones Day
March 26-27, 2014
Recent Developments in Fraud and Abuse Enforcement, panelist, American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues
Baltimore, MD
January 28, 2014
FCA and Qui Tam Settlement Strategy Session: The Finer Points for Determining When to Engage in Settlement Discussions, and How to Negotiate with Federal and State Authorities, panelist, ACI Executive Forum on False Claims and Qui Tam Enforcement
New York, New York
October 4, 2013
Enforcement Trends, panelist, Practising Law Institute’s Health Care and Life Sciences Law 2013
New York, NY
September 30-October 1, 2013
Legal Ethics: How Not to Go Down in Flames with Your Client, panelist, American Health Lawyers Association/Health Care Compliance Association’s Fraud and Compliance Forum
Baltimore, MD
July 1-3, 2013
Fraud and Abuse: Hot Topics, panelist, American Health Lawyers Association’s Annual Meeting
San Diego, CA
April 21-24, 2013
Navigating the OIG’s Self-Disclosure Protocol, panelist, Health Care Compliance Association’s 17th Annual Compliance Institute
National Harbor, MD
April 18-19, 2013
Litigating Under the False Claims Act, panelist, CLE International’s False Claims Act and Qui Tam Conference
San Francisco, CA
March 20-22, 2013
Evolving Fraud and Abuse Issues, panelist, American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues
Baltimore, MD
June 26-27, 2012
Fraud and Abuse Year in Review: Hot Topics, panelist, American Health Lawyers Association’s Annual Meeting
Chicago, IL
June 6-8, 2012
Investigation of a False Claims Act Case, panelist, American Bar Association’s Ninth National Institute on the Civil False Claims Act and Qui Tam Enforcement
Washington, DC
September 27, 2011
Settling False Claims Act Cases in the Healthcare Fraud and Enforcement World: Tips and Traps for Providers and Payors, panelist, American Health Lawyers Association’s Fraud and Compliance Forum
Baltimore, MD
- Georgetown University (J.D. 1996); Northwestern University (B.A. and B.M. 1991)
- District of Columbia, Virginia, and U.S. District Courts for the District of Columbia, Northern District of Illinois, Eastern District of Michigan, Western District of Wisconsin, and Eastern and Western Districts of Virginia
- Trial Attorney, Frauds Section, Civil Division, U.S. Department of Justice (2000-2005)
Chambers USA (2020-2023)
Two special commendations awarded by the Department of Justice Civil Division for her role in a precedent-setting matter against a major pharmaceutical company (2004) and for her role in a landmark case against a national hospital chain (2003)