Overview
Attorney Daniel Fundakowski’s practice focuses on representing leading pharmaceutical and device manufacturers, retail pharmacy chains, compounding pharmacies, academic medical centers, skilled nursing facilities, and other institutional providers in health care regulatory and litigation matters.
Daniel’s services include:
- Defending health care clients in civil and criminal litigation matters, including qui tam whistleblower cases, that are predicated on allegations of upcoding, medical necessity, off-label promotion, research cost mischarging, and improper reporting of usual and customary prices, among other regulatory allegations
- Representing health care clients in federal and state courts and before arbitration tribunals in cases involving claims of fraud and breach of contract
- Assisting providers in matters before state boards of pharmacy, including licensure and complex regulatory disputes
- Representing hospitals and health systems in disputes related to reimbursement matters, including proceedings before the Provider Reimbursement Review Board and the Office of Medicare Hearings and Appeals
- Conducting confidential internal investigations and audits concerning health care compliance and reimbursement matters, and assisting clients with self-disclosures
- Advising health care clients on how to prepare for and respond to inquiries and audits conducted by the federal government, state attorneys general, and government contractors
- Counseling clients on day-to-day regulatory issues relating to the health care fraud and abuse laws, including the False Claims Act (FCA), the Anti-Kickback Statute, the Physician Self-Referral (Stark) Law, and the Civil Monetary Penalties Law
- Assisting clients with creating and implementing compliance programs as well as negotiating Corporate Integrity Agreements
- Advising retail pharmacies on a diverse array of compliance and regulatory issues, including patient reward and drug discount programs, usual and customary price reporting, manufacturer and third-party payor relations, and Medicare Part D compliance
Focus Areas
Services
- Antitrust
- Commercial and Contract Litigation
- Drug and Medical Device Litigation
- Federal and State False Claims Act (Including Qui Tam)
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Health Care Litigation
- Litigation & Business Disputes
- Managed Care
- Stark and Self-Referral Laws
Experience
Recognition
- The Best Lawyers in America©: “Ones to Watch” in Health Care Law (2024, 2025).
Credentials
Education
- Saint Louis University School of Law (J.D., 2012)
- Editorial Board, Saint Louis University Law Journal
- Health Law Certificate – Center for Health Law Studies
- Saint Louis University (M.H.A., 2012)
- School of Public Health
- Butler University (B.A., 2008)
- Philosophy, Business Administration, Classical Studies
Bar Admissions
- District of Columbia
- Missouri
Court Admissions
- U.S. District Court, District of Columbia
Professional & Community Involvement
- American Bar Association, Health Law Section
- American Health Lawyers Association
Media
Events
Insights
Insights
- BlogsSupreme Court Denies Two Certiorari Petitions on Federal Anti-Kickback Statute’s Willfulness Standard7 minute read
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - Media CoverageLaw360’s Hottest Firms and Stories Features Epstein Becker Green Insight on False Claims Act Enforcement Trends ...1 minute read
- PublicationsMid-2024 FCA Enforcement and Litigation Trends to Watch3 minute read
- BlogsDOJ’s FY 2023 Statistics: Highest Number of Settlements, Judgments, and Civil Investigative Demands in History and a ...7 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - PublicationsFCA Enforcement and Litigation Trends to Watch3 minute read
- BlogsDOJ’s FY 2022 False Claims Act Recoveries: A Mixed Bag5 minute read
- BlogsDOJ Announces Enforcement Action Involving “Largest and Most Wide-Ranging” COVID-19 Fraud Detected to Date4 minute read
- Media CoverageLaw360’s Hottest Firms and Stories Features Epstein Becker Green Insight on 2021 Health Care Fraud Stats and Trends to ...2 minute read
- PublicationsFCA Trends to Watch for Health, Life Sciences Cos.3 minute read
- BlogsDOJ Releases FY 2021 False Claims Act Recoveries: A Record-Shattering Year for Health Care and Life Sciences Enforcement ...4 minute read
- BlogsU.S. Department of Justice Announces Interagency Task Force to Combat COVID-19 Relief Fraud6 minute read
- BlogsDefendant Aventis Pharma Awarded Over $17.2 Million in Attorneys’ Fees in False Claims Act Case4 minute read
- BlogsU.S. Department of Justice Announces First Charges Brought Under the Accelerated and Advance Payment Program5 minute read
- Media CoverageDaniel Fundakowski Quoted in “Investigation, Interpretation and Enforcement: FCA in the COVID-19 Era”3 minute read
- BlogsU.S. Department of Justice Reports on Heightened Enforcement Activities Against COVID-19 Related Fraud6 minute read
- PublicationsCourt Declines Resolving Circuit Split on What Constitutes a “False” Claim, but Will Consider Legality of Trump ...
- BlogsSCOTUS Today: Court Declines Resolving Circuit Split on What Constitutes a “False” Claim, but Will Consider Legality of ...3 minute read
- BlogsCourt Declines Resolving Circuit Split on What Constitutes a “False” Claim, but Will Consider Legality of Trump ...3 minute read
- BlogsExploring Intentional Bias in the Marketing of Consumer Products3 minute read
- PublicationsKey False Claims Act Developments Affecting the Health Care Industry: What We Learned in 2020 & Predictions for What We Can ...5 minute read
- PublicationsKey FCA Developments from 2020 and What to Expect Next2 minute read
- Firm AnnouncementsDaniel Fundakowski, Gary Herschman, Jack Wenik Receive Burton Award for Legal Writing2 minute read
- PublicationsOIG Issues New Guidance on Its Evaluation Process and Non-Binding Criteria for Section 1128(b)(7) Exclusions9 minute read
- Media CoverageEpstein Becker Green Mentioned in "Nautic Partners Makes an Investment in ExactCare Pharmacy"1 minute read
- BlogsAntitrust Enforcement Agencies Issue Joint Statement Encouraging Repeal of Virginia's CON Program5 minute read
- PublicationsAnother Setback for State Regulatory Boards: Federal Court Denies Texas Medical Board's Motion to Dismiss Teladoc's ...2 minute read
- BlogsU.S. District Court Holds that FCA’s Retaliation Provision Requires “But-for” Causation3 minute read
- BlogsAnother Setback for State Regulatory Boards: Federal Court Denies Texas Medical Board's Motion to Dismiss Teladoc's ...5 minute read
- Publications2015 False Claims Act Year in Review: 5 Major Developments Affecting the Health Care Industry2 minute read
- PublicationsFTC Issues State Action Guidance for State Regulatory Boards8 minute read
- PublicationsFresenius Beats FCA Lawsuit: Court Holds That Owner of Renal Dialysis Facilities Never "Knowingly" Submitted False Claims ...2 minute read
- PublicationsDOJ Focuses on Individual Accountability: New Guidance for Corporate Investigations Places Pressure on Companies and ...8 minute read
- PublicationsThe Clock's Running Fast: The First Decision Interpreting "Identification" Under the FCA's "60-Day-Rule" for Government ...2 minute read
- PublicationsEntering a New Era: Criminalizing Health Care Non-Compliance2 minute read
- PublicationsFTC Issues First Statement of Enforcement Under Section 5 in 101 Years9 minute read
- PublicationsThe Clock's Running Fast: SDNY Is First to Interpret “Identification” Under the FCA's “60-Day Rule” for Government ...10 minute read
- PublicationsDepartment of Justice Sues Four Michigan Hospitals for Allocating Marketing Territories8 minute read
- PublicationsFederal Trade Commission Obtains a Near Record-Breaking Disgorgement in a Monopolization Case10 minute read
- PublicationsFederal Trade Commission and Department of Justice Hold Joint Workshop on Payment Models and Competition Within the ...12 minute read
- PublicationsNo State Action Antitrust Immunity for North Carolina Dental Board: Implications for the Health Care Sector12 minute read
- PublicationsSixth Circuit Holds That Government Audit Insufficient to Trigger FCA's Public Disclosure Bar2 minute read
- PublicationsProMedica Health System, Inc. v. Federal Trade Commission: Setting the Stage for Certiorari1 minute read
- PublicationsIllegal Premerger Coordination Leads to DOJ "Gun Jumping" Enforcement Action and $5 Million Settlement—Key Lessons ...13 minute read
- Media CoverageAlert by Breen, Matyas, and Fundakowski Featured in "Legal Report Looks at Key False Claims Act Cases of 2014"2 minute read
- Media CoverageAlert by Breen, Matyas, and Fundakowski Featured in "5 of the Biggest False Claims Act Developments in 2014"2 minute read
- PublicationsThe False Claims Act and the Health Care Industry: 2014 Year in Review15 minute read
- PublicationsKey FCA Developments for Health Care in 20142 minute read
- PublicationsSupreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims12 minute read
Recent Representations
- Defending a medical device manufacturer against FCA allegations of fraudulent billing practices and pursuing breach of contract counterclaims against relators
- Representing an operator of skilled nursing facilities in litigation against a Medicare Advantage organization involving allegations of fraud and breach of contract
- Counseling a supplier of wound care products in connection with appealing audits conducted by Unified Program Integrity Contractors (UPICs), including representation through the administrative law judge hearing phase
- Defending an operator of skilled nursing facilities in investigations by Congress, the Office of Inspector General of the U.S. Department of Health and Human Services, and state attorneys general
Academic and Professional Background
In a joint degree program, Daniel received his J.D., with a Health Law Certificate, from Saint Louis University School of Law and his M.H.A. from Saint Louis University School of Public Health. During that time, he served on the Editorial Board of the Saint Louis University Law Journal.
While attending law school, Daniel clerked in the U.S. Attorney's Office in the Eastern District of Missouri, where he worked on health care fraud and abuse investigations. He also interned at Cleveland, Ohio’s largest multispecialty academic medical center, and at a nonprofit provider of continuing care communities for seniors.
Additionally, during law school, Daniel spent a semester in Washington, DC, clerking full time for the Health Care Division of the Federal Trade Commission, Bureau of Competition. In this capacity, he assisted with antitrust and competition law investigations and related proceedings within the health care sector.
After graduating from law school, Daniel joined Epstein Becker Green in its Health Care and Life Sciences practice. He later served as an attorney in the Life Sciences Health Industry Group of a global law firm. In the fall of 2020, Daniel returned to Epstein Becker Green.
Daniel regularly writes and speaks on health care enforcement trends and developments. He is a recipient of the 2016 Burton Award for Distinguished Legal Writing for his work on the criminalization of health care noncompliance.
A native of Saint Louis, Missouri, Daniel enjoys distance running, fishing, and following major league baseball.