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:

  • Advising healthcare and life sciences companies on compliance with healthcare laws and regulations, including the AKS and the Stark Law
  • Leading internal investigations and representing healthcare and life sciences 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 and life sciences companies and boards of directors
  • Conducting a comprehensive compliance program effectiveness review 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 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:

  • “The Stark Law: A Fundamentals Discussion,” American Health Lawyers Association, Fraud & Compliance Forum (September 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 (March 2019)
  • “60 Day Repayment-Deeper Dive,” American Health Lawyers Association, Institute on Medicare & Medicaid Payment Issues (March 2019)
  • “Due Diligence & Letter of Intent – The Forgotten Components of a Deal,” American Health Lawyers Association, Health Care Transactions (May 2018)
  • “Report, Return, (Try not to) Repeat: Overpayments & Self Disclosures,” American Health Lawyers Association, Institute on Medicare & Medicaid Payment Issues (March 2018)
  • “Conducting an Internal AKS & Stark Investigation and Managing Resolution Risks,” Health Care Compliance Association, Health Care Enforcement Compliance Institute (October 2017)
  • “A View from the Trenches: Legal & Practical Considerations in Internal Compliance Reviews and Self Disclosures,” American Health Lawyers Association, Institute on Medicare & Medicaid Payment Issues (March 2017)
  • “Investigating Noncompliance Under New Stark Law Regs,” Law360 (October 2016)
  • “Stark Law & the SRDP,” Health Care Compliance Association, Healthcare Enforcement Compliance Institute (October 2016)
  • “Risky Business? How an effective compliance program can save your organization,” Health Care Compliance Association Webinar (August 2016)
  • “Still Useful? Senate Finance Evaluates Possible Stark Law Changes, Including repeal” Bloomberg BNA’s Health Care Fraud Report (July 20, 2016)
  • “Understanding & Managing the Self Disclosure Protocol,” American Health Lawyers Association, Annual Meeting (June 2016)
  • “CMS Finalizes Long awaited Rule Implements ACA’s Overpayment Reporting Requirements,” Latham & Watkins Client Alert (February 2016)

Bar Qualification

  • District of Columbia
  • Illinois

Education

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