Josiah S. Irvin

Josiah Irvin is an attorney with Smith Anderson’s Regulatory practice, with a focus on advising clients on health care regulatory, enforcement and transactional matters.

He provides contracting, transactional and regulatory compliance advice to a wide range of health care providers and health care industry investors, including physician practices and management organizations, adult care homes, other long-term care facilities, hospitals, pharmacies, hospice care, behavioral health providers and value-based care organizations.

He also regularly advises life science companies, pharmaceutical and medical device manufacturers, contract research organizations, digital health companies (both early stage and publicly traded) on health care regulatory compliance, transactional and contracting matters. Josiah’s experience advising clients on regulatory compliance includes areas such as reimbursement under federal health care programs, health care fraud and abuse laws like the Anti-Kickback Statute, the Stark Law and the False Claims Act; North Carolina professional and facility licensure and health care regulatory laws; corporate practice of medicine; advocacy with North Carolina licensing regulatory bodies; state practice and licensure requirements; research compliance; insurer regulation; and compliance program requirements. He also has experience advising clients on data privacy and security matters under HIPAA and other federal and state privacy and security laws.

Prior to joining Smith Anderson, Josiah was an associate with an international law firm in Washington, D.C. and New York City, where he practiced in the firm’s health care group. He enjoys running, spending time with family and friends, rooting for the Tar Heels and gardening.

Education

• Boston University School of Law, J.D., with Health Care concentration, magna cum laude, 2016
  • Articles Editor, Boston University Law Review     
• University of North Carolina at Chapel Hill, B.A., 2011
  • Phi Beta Kappa National Honors Society
  • Economics National Honors Society

Bar & Court Admissions

• Represented a private equity fund in its acquisition of a leading contract research organization and contract development and manufacturing organization specializing in cell and gene therapy.
• Advised a growing health and home services organization in its acquisition of an organization providing home care services.
• Advised health care providers and insurers -value-based contracting, corporate governance, charitable organization requirements, formation of joint ventures, and value.
• Advised pharmaceutical manufacturers and other life science companies on Anti-Kickback Statute compliance.
• Counseled digital health companies and health care providers on HIPAA, information blocking and CCPA compliance.
• Counseled health care providers on responding to potential data security and privacy breaches.
• Advised private equity firms on investments in a variety of health care targets, including management services organizations, physician group practices, pharmacies, digital health companies, behavioral health providers and kidney care providers.
• Advised Fortune 500 insurance company on acquisition of a non-profit Medicaid health plan.
• Defended digital health company in connection with civil and criminal investigations by U.S. Department of Justice into alleged Medicare and Medicaid fraud and violations of the Anti-Kickback Statute.
• Defended Fortune 100 health care company in connection with investigations by a U.S. Attorney’s Office and state Attorneys General into alleged Medicare and Medicaid fraud.
• Managed all aspects of internal investigation of a health care system.
• Conducted an internal targeted compliance audit of a medical device manufacturer.