Lee Staley advises healthcare providers and life sciences organizations on complex regulatory, litigation, and transactional matters.

Mr. Staley counsels clients in matters related to Medicare reimbursement, the False Claims Act, Anti-Kickback Statute, and Physician Self-Referral (Stark) Law, as well as coding, coverage and payment for emerging medical technologies. He frequently advises clients on legal and policy matters involving the Centers for Medicare & Medicaid Services and other components of the Department of Health & Human Services. Mr. Staley also advises healthcare and life sciences clients in internal and government investigations, and he maintains a pro bono practice in which he assists clients in obtaining access to public benefits.

Mr. Staley represents a wide range of industry clients, including:

  • Medical device and pharmaceutical companies
  • Hospitals, physician groups, and provider organizations
  • Digital health companies
  • Diagnostic laboratories
  • Trade associations
  • Investment banks and private equity sponsors

Prior to joining Latham, Mr. Staley completed a joint JD/MPH at Boston University, where he was recognized as a G. Joseph Tauro Distinguished Scholar, and completed a legal externship for a large multispecialty physician organization and accountable care organization. He served as senior articles editor of the Boston University Law Review, in which he published on value-based reimbursement topics.

Mr. Staley is a member of the American Health Lawyers Association.

Mr. Staley’s experience includes the following:

Reimbursement

  • Counseling medical technology companies in obtaining HCPCS/CPT coding, third-party payor coverage, and payment recognition for new medical procedures and technologies
  • Advising clients on the applicability and implementation of new laws, regulations, and administrative policies related to reimbursement, digital health and telehealth, value-based care, and related topics
  • Engaging with the Centers for Medicare & Medicaid Services on matters related to Medicare payment policy

Regulatory & Compliance

  • Providing day-to-day counsel to healthcare providers and life sciences companies regarding compliance with federal and state laws and regulations
  • Interpreting and applying statutory and regulatory provisions, and engaging with regulatory authorities 
  • Designing and leading compliance reviews related to billing, coding, and medical documentation, including issues arising in connection with mergers, acquisitions, and public/private debt and securities offerings

Investigations

  • Counseling clients in responding to government investigations, subpoenas, and requests for information related to the False Claims Act, Anti-Kickback Statute, and Physician Self-Referral Law
  • Structuring and assisting with internal investigations and compliance audits

Bar Qualification

  • Massachusetts

Education

  • MPH, Boston University School of Public Health, 2019
  • JD, Boston University School of Law, 2018
    cum laude
  • BA in Economics & International Relations & Global Affairs, Eckerd College, 2014
    with High Honors