Jackson LLP works with independent clinical laboratories and physician-owned laboratories to navigate the legal and regulatory requirements imposed upon them. Our attorneys’ services address federal and state compliance for clinical labs and POLs.
Examples of these services include:
- Compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
- CLIA certification
- Compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- State laboratory licensure process
- Medicare enrollment
- Compliance with Medicare laboratory reimbursement policies
- Corporate compliance planning
- Compliance with Food and Drug Administration (FDA) regulations
- Institutional Review Board (IRB) compliance
- Compliance with the Stark Law, the Anti-Kickback Statute, and the False Claims Act
- Federal and state fraud, waste, and abuse avoidance planning
Comprehensive contracting, transactional assistance, and marketing support for laboratories.
Our attorneys are frequently called upon for their healthcare experience to draft, review, and negotiate contracts. For laboratories, this might entail handling real estate transactions, employment matters, HIPAA business associate agreements, and more. Jackson LLP can also guide you through an advertising review to ensure that your marketing and labeling practices comply with applicable laws and regulations.
Contact us today to discuss how Jackson LLP can support your clinical laboratory or POL.