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Kristen M. Schwendinger

Senior Counsel

202.466-8960
kschwendinger@ftlf.com

Kristen M. Schwendinger is a senior counsel in the firm’s Federal Grants, Health Law, and Litigation & Government Investigations practice groups.  Ms. Schwendinger focuses her practice on compliance matters, including Federal laws affecting university health and research operations and broad corporate compliance with the Stark Law, Anti-Kickback Statue, HIPAA, and data privacy.

Ms. Schwendinger brings her regulatory compliance expertise to bear when counseling clients and pursuing litigation on their behalf.  She advises clients on government investigations, healthcare compliance, and the financial, administrative, and scientific management of grants and cooperative agreements.

Prior to joining the firm, Ms. Schwendinger served for nearly eight years as an attorney and senior counsel in the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG).  Ms. Schwendinger brings extensive experience in HHS-OIG investigations and administrative proceedings, as well as False Claims Act matters.  She represented HHS on a government-wide grant fraud task force, and, among other accomplishments, worked on many of the significant False Claims Act matters brought against universities over the past decade,  including Duke, Columbia, University of Florida, Harvard affiliated Brigham and Women’s Hospital, Iowa State, and the University of North Texas.

Ms. Schwendinger also led numerous health care fraud cases, investigating instances of potential fraud to the Medicare and Medicaid programs, including Anti-kickback and Stark Law violations.  Ms. Schwendinger collectively resolved nearly two hundred matters in government service and advised several Fortune 500 companies and small business life science enterprise in private practice.

Representative Matters

  • Advised federal agents on approaches to grant fraud investigation.
  • In cases involving HHS programs, managed pleadings and motions in certain civil and administrative matters.
  • Advised on research for DOJ and HHS OIG, including assessment of False Claims Act, Civil Monetary Penalty, and Self-Disclosure matters.
  • Worked with forensic data experts to prove the fabrication and falsification of data in research fraud cases on behalf of HHS.
  • Defended the Inspector General’s exclusion determinations before Administrative Law Judges while leading affirmative investigations of companies and individuals alleged to have committed fraud.
  • Provided expert witness and consulting witness services to clients regarding internal investigations and whistleblower complaints.
  • Provided universities and start-ups with advice about Federal grant and contract fraud allegations.
  • Provided counsel to clients regarding GDPR, IRB, and clinical trial compliance – including Federal and Corporate funded research.

Honors/Awards

  • Selected to the Washington, DC, Super Lawyers “Rising Stars” list (2020)
  • Exceptional Achievement Award for Investigation and Exclusion of a DME Executive (2017)
  • Exceptional Achievement Award for Compliance Monitoring of a Nationwide Provider (2016)
  • Exceptional Achievement Award for Leadership and Guidance for a Grants Summit (2016)
  • Exceptional Achievement Award for Investigation of Individuals Accepting Kickbacks (2016)
  • Exceptional Achievement Award for Work on Corporate Integrity Agreement (2015)
  • Exceptional Achievement Award for Cases Against Individual Physicians (2014)
  • Exceptional Achievement Award for Work on a DME CMPL and Exclusion Settlement (2014)
  • Exceptional Achievement Award for Work on the Update of the OIG Self-Disclosure Protocol (2014)
  • Award for Advancing Excellence and Innovation –Grants and Procurement Fraud (2014)
  • Exceptional Achievement Award for Enhancing Oversight of Grants and Procurement (2013)
  • Exceptional Achievement Award for Grant Fraud False Claims Act Settlement (2013)

Published Works

  • Kristen M. Schwendinger & Derek M. Adams, Opinion: Disclosures Scientists Must Make of Foreign Ties, The Scientist Magazine (February 2020)

Certifications

  • Certified Grants Management Specialist (NGMS)
  • Certified Title IX Investigation and Coordination (ATIXA)
  • Certified Corporate Compliance and Ethics Professional (SCCE)
  • Certified Fraud Examiner (ACFE)

Introduction

Kristen M. Schwendinger is a senior counsel in the firm’s Federal Grants, Health Law, and Litigation & Government Investigations practice groups.  Ms. Schwendinger focuses her practice on compliance matters, including Federal laws affecting university health and research operations and broad corporate compliance with the Stark Law, Anti-Kickback Statue, HIPAA, and data privacy.

Overview

Ms. Schwendinger brings her regulatory compliance expertise to bear when counseling clients and pursuing litigation on their behalf.  She advises clients on government investigations, healthcare compliance, and the financial, administrative, and scientific management of grants and cooperative agreements.

Prior to joining the firm, Ms. Schwendinger served for nearly eight years as an attorney and senior counsel in the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG).  Ms. Schwendinger brings extensive experience in HHS-OIG investigations and administrative proceedings, as well as False Claims Act matters.  She represented HHS on a government-wide grant fraud task force, and, among other accomplishments, worked on many of the significant False Claims Act matters brought against universities over the past decade,  including Duke, Columbia, University of Florida, Harvard affiliated Brigham and Women’s Hospital, Iowa State, and the University of North Texas.

Ms. Schwendinger also led numerous health care fraud cases, investigating instances of potential fraud to the Medicare and Medicaid programs, including Anti-kickback and Stark Law violations.  Ms. Schwendinger collectively resolved nearly two hundred matters in government service and advised several Fortune 500 companies and small business life science enterprise in private practice.

Representative Matters

  • Advised federal agents on approaches to grant fraud investigation.
  • In cases involving HHS programs, managed pleadings and motions in certain civil and administrative matters.
  • Advised on research for DOJ and HHS OIG, including assessment of False Claims Act, Civil Monetary Penalty, and Self-Disclosure matters.
  • Worked with forensic data experts to prove the fabrication and falsification of data in research fraud cases on behalf of HHS.
  • Defended the Inspector General’s exclusion determinations before Administrative Law Judges while leading affirmative investigations of companies and individuals alleged to have committed fraud.
  • Provided expert witness and consulting witness services to clients regarding internal investigations and whistleblower complaints.
  • Provided universities and start-ups with advice about Federal grant and contract fraud allegations.
  • Provided counsel to clients regarding GDPR, IRB, and clinical trial compliance – including Federal and Corporate funded research.

Honors/Awards

  • Selected to the Washington, DC, Super Lawyers “Rising Stars” list (2020)
  • Exceptional Achievement Award for Investigation and Exclusion of a DME Executive (2017)
  • Exceptional Achievement Award for Compliance Monitoring of a Nationwide Provider (2016)
  • Exceptional Achievement Award for Leadership and Guidance for a Grants Summit (2016)
  • Exceptional Achievement Award for Investigation of Individuals Accepting Kickbacks (2016)
  • Exceptional Achievement Award for Work on Corporate Integrity Agreement (2015)
  • Exceptional Achievement Award for Cases Against Individual Physicians (2014)
  • Exceptional Achievement Award for Work on a DME CMPL and Exclusion Settlement (2014)
  • Exceptional Achievement Award for Work on the Update of the OIG Self-Disclosure Protocol (2014)
  • Award for Advancing Excellence and Innovation –Grants and Procurement Fraud (2014)
  • Exceptional Achievement Award for Enhancing Oversight of Grants and Procurement (2013)
  • Exceptional Achievement Award for Grant Fraud False Claims Act Settlement (2013)

Published Works

  • Kristen M. Schwendinger & Derek M. Adams, Opinion: Disclosures Scientists Must Make of Foreign Ties, The Scientist Magazine (February 2020)

Certifications

  • Certified Grants Management Specialist (NGMS)
  • Certified Title IX Investigation and Coordination (ATIXA)
  • Certified Corporate Compliance and Ethics Professional (SCCE)
  • Certified Fraud Examiner (ACFE)

Practices

  • Federal Grants
  • Health Law
  • Litigation & Government Investigations

Education

  • J.D., Washington University (2010)
  • M.P.A., Indiana University (2007)
  • B.A., Washington University, cum laude (2002)

Bar/Court Admissions

  • District of Columbia
  • Missouri

Publications / Blog Posts

  • CLIENT ALERT: Overview of Federal Enforcement Activity & Compliance Tips for Healthcare Organizations Receiving Funding from Pandemic Relief Programs
    March 03, 2021
  • FTLF Attorneys to Present on Research Grant Fraud
    January 13, 2021
  • The Harvard Crimson Quotes FTLF Attorney in an Article about the Charles Lieber Case
    November 18, 2020
  • August 2020 Uniform Guidance Changes: Key Takeaways from the Five-Year Update
    August 17, 2020
All Articles by this Attorney

Professional Memberships

  • National Institute of Trial Advocacy, Advocate Designation

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