Clinical laboratories face some of the most demanding regulatory requirements in healthcare. From federal laws like EKRA, Stark, and HIPAA to state licensure and reimbursement rules, labs must balance compliance with the practical realities of running a business. Jackson LLP works with independent labs and physician office laboratories (POLs) to navigate these obligations and stay focused on delivering accurate, reliable results.
Our services for clinical laboratories and POLs include:
- Clinical Laboratory Improvement Amendments of 1988 (CLIA) compliance
- CLIA certification
- Specimen collection site agreements
- The Coronavirus Aid, Relief, and Economic Security (CARES) Act compliance
- EKRA, Stark Law, Anti-Kickback Statute, and the False Claims Act compliance
- HIPAA compliance
- State laboratory licensure process
- Medicare enrollment
- Medicare laboratory reimbursement policies
- Corporate formation and compliance planning
- Food and Drug Administration (FDA) regulations
- Institutional Review Board (IRB) compliance
- Website terms and conditions, privacy policies, and end-user license agreements (EULAs)
- Advertising review
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. Such contracts include real estate transactions, employment matters, relationships with testing sites, HIPAA business associate agreements, and more.
To Jackson LLP Healthcare Lawyers can support your clinical laboratory or POL, schedule a consultation with one of our attorneys.