Clinical Laboratories are subject to complex regulatory schemes that include requirements of the Clinical Laboratory Improvement Amendments (CLIA), State Law, Center for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Center for Disease Control (CDC).
In addition, clinical laboratories, whether free standing or integrated into a physician practice or hospital that elects to offer lab services to its patients, tend to be subject to heightened fraud and abuse oversight by federal and state civil and criminal enforcement agencies, with particular concerns regarding Federal Stark and Anti-kickback, False Claims Acts, and State Medicaid laws. Garfunkel Wild is very active in providing the following services to clinical laboratories:
- Applying for and obtaining CLIA certificates and State licenses and permits
- Responding to statements of deficiency from State oversight agencies
- Applying for approvals for Laboratory Developed Tests
- Responding to Federal and State Department of Health and Office of Medicaid Inspector General audits
- Negotiating equipment and supply contracts
- Preparing employment and service agreements for laboratory directors and supervisors
- Providing guidance on relationships with physicians, hospitals, nursing homes, FQHCs and reference laboratories, as well as billing procedures
- Defending enforcement actions by the Office of Inspector General and Federal and State attorney generals
- Providing guidance to specialty laboratories (e.g., IVF laboratories, physician office laboratories, mobile laboratories)
- Providing guidance on staff qualifications unique to the laboratory industry
- Reviewing agreements for Laboratory Information Systems (LIS) and interfaces with prescribers
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Stacey L. Gulick
Partner