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
- 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
- The Best Lawyers in America©: “Ones to Watch” in Health Care Law (2024).
- 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
- District of Columbia
- U.S. District Court, District of Columbia
Professional & Community Involvement
- American Bar Association, Health Law Section
- American Health Lawyers Association
- 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.