The COVID-19 emergency has placed clinical laboratories at center stage, providing some lab owners with unprecedented opportunity — and scrutiny.
Most notably, the Eliminating Kickbacks in Recovery Act (EKRA) creates complex legal landmines for labs working with third-party specimen collection sites. Previously, infractions might have slipped under the radar. But with consumer and worker emotions riding high during the pandemic, the risks of lawsuits with hefty penalties (and big payouts for whistleblowers) have escalated.
Jackson LLP works with independent clinical laboratories as well as physician office laboratories (POLs) to navigate their federal and state legal requirements.
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.