Joseph Hudzik leverages years of government and industry experience to guide healthcare and life sciences organizations through complex compliance and enforcement matters, providing strategic advice and counsel to facilitate business objectives while mitigating regulatory risk.
Mr. Hudzik advises healthcare and life sciences companies, executives, boards of directors, and in-house counsel on healthcare regulatory compliance and enforcement matters. He 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. He also advises clients on regulatory compliance program and quality management program development and effectiveness, M&A regulatory diligence issues, fraud and abuse issues associated with innovative healthcare delivery systems (including VBEs, ACOs and clinically integrated networks), and the structure and formation of compliant financial arrangements and transactions.
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 involving the federal False Claims Act (FCA), the federal Anti kickback Statute (AKS), the Stark Law, federal program exclusion authorities, and the Civil Monetary Penalties Law. During his tenure with OIG, Mr. Hudzik also served as a Special Trial Attorney in the US Department of Justice (DOJ) prosecuting healthcare fraud crimes with the Medicare Fraud Strike Force, and as a Special Assistant United States Attorney for the Southern District of Florida. In addition, 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 (SRDP).
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 a wide range of legal and regulatory compliance issues in support of business and strategic objectives. In addition, Mr. Hudzik previously served as an Adjunct Professor at Georgetown University School of Nursing and Health Studies.
Mr. Hudzik is a recognized and respected advisor on regulatory compliance and enforcement matters affecting healthcare and life sciences companies.
Mr. Hudzik’s representative experience includes:
Mr. Hudzik writes and speaks frequently on a variety of healthcare and life sciences topics, including regulatory risks and compliance strategies, compliance with the Stark Law and the AKS, and voluntary self disclosures to the government.
Recent thought leadership includes: