Daniel C. Fundakowski s a Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices in the Washington, DC, office of Epstein Becker Green. His 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.
Mr. Fundakowski’s services include:
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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
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Representing health care clients in federal and state courts and before arbitration tribunals in cases involving claims of fraud and breach of contract
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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
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Conducting confidential internal investigations and audits concerning health care compliance and reimbursement matters, and assisting clients with self-disclosures
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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
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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
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Assisting clients with creating and implementing compliance programs as well as negotiating Corporate Integrity Agreements
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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, Medicare Part D compliance, and matters before state boards of pharmacy
