Bleakley Platt & Schmidt, LLP represents independent clinical laboratories and physician-owned clinical laboratories (POL) on the full range of legal issues they encounter. We have extensive experience assisting our laboratory clients in complying with complex state and federal laboratory regulations administered by the New York Wadsworth Center and other state regulatory bodies, and the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). Our firm also handles corporate transactions; establishing, buying, and selling laboratories; audits and investigations; and litigation matters for clinical laboratories.
Bleakley Platt routinely counsels clinical laboratories in matters relating to:
- CLIA certification and compliance and state licensure
- Medicare and Medicaid enrollment, conditions of participation and reimbursement issues, the prohibition on reassignment, and “lab-to-lab” billing requirements
- Compliance with CLIA and other laboratory regulations, insurance, and risk analysis and mitigation
- Technical component (TC) – professional component (PC) arrangements under the Stark Law and anti-markup rules
- Fraud and abuse, including compliance with the Stark Law, federal Anti-Kickback Statute (AKS), and False Claims Act (FCA)
- Development of compliance plans and compliance trainings, including under New York Medicaid compliance program regulations
- Sales and marketing practices and compliance under the AKS, Stark Law, FCA, Eliminating Kickbacks in Recovery Act of 2018 (EKRA) and analogous state laws
- Payor network participation
- Medicare, Medicaid and private payor audits and appeals
- HIPAA compliance, including data privacy and cyber security
- Corporate formation, governance, mergers, acquisitions, joint ventures, affiliations, changes of ownership applications, and other transactions
- Laboratory contracts, including employment agreements, professional service agreements, consulting agreements, and medical director agreements
- Employment related issues and the development and implementation of employee handbooks
Our health law practice provides comprehensive laboratory legal representation by working closely with attorneys across a range of the firm’s practice areas as needed to represent the clinical laboratory industry.