Joseph Hudzik

Practice Areas

Joseph Hudzik leverages his extensive government and industry experience to guide healthcare, life sciences, and health technology companies through complex regulatory compliance and enforcement matters, providing strategic advice and counsel to facilitate business objectives while mitigating legal and regulatory risk.

Mr. Hudzik advises healthcare, life sciences, and health technology companies and their boards of directors on high-stakes regulatory compliance matters, including:

• Development of compliant operations and risk-mitigation strategies and practices

• Structure and formation of compliant financial arrangements and transactions

• Regulatory compliance program and quality management program development and implementation, including program effectiveness auditing and monitoring

• M&A and related regulatory diligence issues

• Fraud and abuse issues associated with disruptive health technology services and innovative healthcare delivery systems (including VBEs, ACOs and clinically integrated networks)

• Government subpoenas, audits, inspections, and evaluations

• Liability under federal and state healthcare laws and regulations, including the federal False Claims Act, the federal Anti-Kickback Statute, the Stark Law, federal program exclusion authorities, the civil monetary penalties law, and state law analogues

He also manages and conducts internal investigations and compliance audits, represents clients in enforcement actions and voluntary self-disclosures to government agencies, and negotiates and counsels on compliance with Corporate Integrity Agreement and Non-Prosecution Agreement obligations.

Mr. Hudzik’s extensive government experience includes having served as Senior Counsel in the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented HHS in healthcare fraud and abuse cases, negotiated and monitored compliance with Corporate Integrity Agreements, and provided compliance guidance to providers, suppliers, and industry organizations. Mr. Hudzik also served as Special Trial Attorney in the US Department of Justice Criminal Division, and Special Assistant United States Attorney for the Southern District of Florida. Following this tenure at OIG, Mr. Hudzik served as the Director of the Division of Technical Payment Policy at the Centers for Medicare & Medicaid Services (CMS), where he was responsible for Medicare policy and regulations for the Stark Law and various other statutory and regulatory payment rules, as well as overseeing the CMS Voluntary Self-Referral Disclosure Protocol.

Immediately prior to joining Latham, Mr. Hudzik served as chief legal officer to three hospitals in a large not-for-profit healthcare system, including a 900 bed major teaching and research hospital. There, he advised and counseled system and hospital executives on legal and regulatory compliance issues in support of business and strategic objectives.