Health & Life Sciences

Clinical Laboratories

The Quarles & Brady Health Law Group provides a wide range of legal advice to clinical laboratories. We advise labs and related stakeholders on numerous complex and evolving regulatory issues, including licensing and compliance with state and federal requirements such as the Clinical Laboratory Improvement Amendments (CLIA). The Quarles & Brady team helps labs and other entities in negotiating and drafting provider and service agreements and regularly advises on cutting-edge issues involving fraud, waste, and abuse matters relating to billing, payor arrangements, and related commercial transactions.

The Quarles & Brady team also has specific experience in advising clinical laboratories faced with fast-moving regulatory and compliance issues during the COVID-19 pandemic. Clients rely on Quarles & Brady attorneys to advise them on structuring lab relationships with testing vendors and to assess the unique issues on such arrangements from a variety of angles.

The firm advises labs and stakeholders on the False Claims Act (FCA), the Anti-Kickback Statute, the Eliminating Kickbacks in Recovery Act (EKRA), and the Stark law and how each may affect the unique role clinical labs play in the healthcare realm. Our attorneys work closely with clients on the day-to-day operational issues that arise, including employment law, contractual matters, intellectual property protection, and litigation and enforcement risk management.

Related Experience

  • Drafting and negotiating agreements related to lab services and specimen collection.
  • Assisting with licensure questions, contracting needs, operational management, data privacy and security issues, billing, payment, and reimbursement questions.
  • Advising on fraud and abuse issues and risks, including FCA, Anti-Kickback, EKRA, Stark, and other state and federal laws.
  • Handling federal and state investigations from the United States Department of Justice (DOJ), state Attorneys General offices, and United States Department of Health and Human Services, Office of Inspector General (HHS-OIG) targeting laboratories.
  • Advising on health privacy issues, including the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and other applicable laws involving data breaches.
  • Employment law and whistleblower protection analysis.
  • Intellectual property protection and pre-litigation dispute resolution.
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