Clinical Laboratory

While clinical laboratories continue to develop novel approaches and increasingly tailored and accurate diagnostic and molecular tests, the legal and business environments in which they operate are also evolving. Managed care, value-based, and other evolving payment arrangements present opportunities and potential risks. At the same time, government scrutiny and the costs and disruptions that can follow are ever-present concerns. HLB works with independent clinical laboratories, physician’s office laboratories (POL), and hospital-operated labs on every day-to-day and long-range issue that intersects with the law.   

Our experience serving clinical laboratories extends back decades, including representing the American Clinical Laboratory Association and the California Clinical Laboratory Association in many high-profile matters. HLB attorneys have played instrumental roles in some of the industry’s most impactful cases, including establishing favorable state and federal court precedent on Medicare payment and coverage issues, alleged fraud and abuse, and other matters. We are recognized throughout the health care industry for our reimbursement practice and compliance capabilities, while a deep bench of litigators, transactional attorneys, and government relations and health care policy professionals complete the full suite of services we provide to clinical laboratories. 

Our clinical laboratory representation includes: 

Regulatory Compliance Counseling

• Medicare Conditions of Participation and Conditions for Coverage, including coverage of molecular and diagnostic testing and other lab-developed tests
• CLIA certification and compliance
• State licensure and compliance matters
• Institutional review board (IRB) compliance
• HIPAA, FDA, and Medicare reimbursement
• Fraud and abuse issues, including Stark Law and the federal anti-kickback statute
• Anti-markup issues
• Coronavirus Aid, Relief, and Economic Security (CARES) Act compliance

Medicare Audits, Investigations, Suspensions, and Claims Appeals, and Public and Private Payor Reimbursement Disputes

• Payor audits, including RAC, ZPIC, MAC, Medicare, Medicaid, and private payor
• Other reimbursement matters involving the Clinical Lab Fee Schedule, Medicare Physician Fee Schedule, and Medicare Outpatient Prospective Payment System
• Medicare audit defense appeals
• Appeals of claim denials
• Medicare suspension investigations and rebuttals
• Medicare overpayment defense appeals
• Medicare post-payment review
• COVID-19 reimbursement issues, including cash price rules for COVID-19 tests and the payment of claims through the HRSA COVID-19 Uninsured Fund
• Managed care payment disputes 
• Private payor reimbursement matters

Litigation

• Defense of False Claims Act, Stark Law, anti-kickback, fraud and abuse, and qui tam relator matters
• Criminal matters
• Antitrust matters
• Commercial litigation
• Payor litigation
• Medical necessity
• Marketing and labeling claims
• Managed care payment litigation

Operational, Transactional, and Policy Advocacy Matters

• Formation, structuring, licensing, financing, and billing
• Operations and corporate governance
• Provider agreements
• Ancillary agreements
• Mergers, acquisitions, joint ventures, affiliations, and other arrangements
• Clinical research contracts
• Managed care contracts
• Change of ownership