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. 

Mr. Hudzik’s representative experience includes:

  • Advising healthcare, life sciences , and health technology companies on compliance with healthcare laws and regulations, including the AKS and the Stark Law
  • Leading internal investigations and representing healthcare, life sciences, and health technology companies on matters involving the FCA, AKS, and Stark Law, as well as issues relating to billing, coding, and reimbursement 
  • Negotiating Corporate Integrity Agreement obligations with OIG and advising healthcare and life sciences clients on CIA implementation and reporting obligations
  • Developing healthcare regulatory compliance programs and policies for, and providing related advice and training to, healthcare, life sciences, and health technology companies and boards of directors
  • Advising disruptive health technology and service providers, including major and niche electronic health records system developers, on regulatory compliance program development and compliant operations 
  • Conducting comprehensive compliance program effectiveness reviews, including for a large not-for-profit integrated health system
  • Advising a national healthcare provider on compliance with requirements of a Non-Prosecution Agreement with DOJ, and representing the provider before DOJ and the DOJ-appointed Independent Compliance Monitor
  • Preparing submissions to the OIG and CMS voluntary self-disclosure protocols and representing clients in the resolution of such disclosures 
  • Defending various healthcare providers, including hospitals, health systems, and clinical labs, as well as medical device manufacturers, against allegations of FCA liability arising from improper coding and kickback schemes 
  • Representing individual clients in the negotiation and resolution of program exclusion actions before the OIG, including negotiating the release of OIG’s permissive exclusion authority on behalf of a hospital chain
  • Representing health industry service clients in seeking OIG advisory opinions on unique and cutting-edge network and supply chain business models

Thought Leadership

Mr. Hudzik writes and speaks frequently on healthcare, life sciences, and heath technology topics, including regulatory risks and compliance strategies, compliance with fraud and abuse laws and regulations, and voluntary self disclosures to the government.
Some of his recent thought leadership includes:

  • “The Stark Law: A Fundamentals Discussion,” American Health Lawyers Association, Fraud & Compliance Forum (Sept. 2019)
  • “Conducting and Managing Internal Investigations,” American Bar Association Webinar (May 2019) 
  • “Report & Return: Overpayments & Self-Disclosures,” American Health Lawyers Association, Institute on Medicare & Medicaid Payment Issues (Mar. 2019)
  • “60 Day Repayment-Deeper Dive,” American Health Lawyers Association, Institute on Medicare & Medicaid Payment Issues (Mar. 2019)

Bar Qualification

  • District of Columbia
  • Illinois


  • JD, Saint Louis University School of Law
  • BS in Finance, University of Illinois, Urbana-Champaign