Clinical Laboratories

Independent Clinical Laboratories and Physician Owned Laboratories (POLs)

Overview
Legal Experience
Independent Clinical Laboratory and POL Focus Areas
Outside Resources
Speeches
Articles

Overview

Wachler & Associates’ independent clinical laboratory and physician-owned laboratory (POL) clients face a complex regulatory landscape. We have considerable experience representing our independent clinical laboratories and POL client on a variety of legal issues, and are dedicated to equipping them with the strategies and tools they need to thrive in this challenging environment.

Wachler & Associates counsels independent clinical laboratories and POLs in matters relating to:

• Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification and compliance
• FDA regulatory compliance
• Marketing and labeling
• State licensure
• Network participation and departicipation
• Medicare enrollment and reimbursement policies
• RAC, ZPIC, MAC, Medicare, Medicaid or private payor audits and appeals
• Personalized medicine
• HIPAA and other regulatory compliance
• Fraud and Abuse counseling including compliance with the Stark law and federal Anti-Kickback Statute
• Clinical research contracts and institutional review board (IRB) compliance
• Contractual and transactional arrangements
• Operations, corporate governance, structural issues and compliance policies
• Other regulatory and health care law matters

Legal Experience

Regulatory Compliance Counseling – Wachler & Associates attorneys have counseled independent clinical laboratories regarding Medicare Conditions of Participation and Conditions for Coverage, CLIA certification and compliance, and state licensure matters. We also have experience assisting laboratory clients in compliance matters related to institutional review board (IRB) compliance, HIPAA, FDA, Medicare reimbursement, and Fraud and Abuse issues including the Stark law and federal Anti-Kick-back Statute.

Audit Defense – Our firm has expertise representing laboratory clients in RAC, ZPIC, MAC, Medicare, Medicaid, and private payor audits. We also assist our clients when appealing claim denials through all levels of the appeals process. We have an expert understanding of the procedural, substantive, and strategic issues involved in Medicare audit defense appeals from the initial redetermination stage up to and including appeals in federal district court. We work with our clients to understand the substantive issues unique to each clinical laboratory or POL audit and to develop an effective and practical audit defense strategy, including drafting position papers and written submissions specifically tailored to each audit. We also have expertise in advising clients who have been placed on pre-payment review or payment suspension.

Coverage Issues – Wachler & Associates has counseled our clients on issues related to coverage of laboratory tests by Federal health care programs, and litigated these issues in federal court in an effort to obtain coverage.

Independent Clinical Laboratories and POL Focus Areas

• RAC, ZPIC, MAC, Medicare, Medicaid and private payor audits
• Fraud and Abuse counseling including compliance with the Stark law and federal Anti-Kickback Statute
• CLIA Certification and Compliance
• FDA regulatory compliance
• Personalized Medicine
• Coverage Issues
• Reimbursement issues and the Protecting Access to Medicare Act (PAMA)

Outside Resources

For the Center for Medicare and Medicaid Services’ Clinical Labs Center page, please see here.

For the Center for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA) page, please see here.

For the CLIA Compliance Manual, please click here.

Articles

Our attorneys have written many articles relevant to clinical laboratories. For a complete list of Wachler & Associates articles, please click here.

Speeches

The attorneys of Wachler & Associates often speak on issues relevant to clinical laboratories. For a complete list of Wachler & Associates speaking engagements, please click here.

Contact Us

Call us at (248) 544-0888 or send us an e-mail to schedule a meeting to discuss your concerns with legal issues related to independent clinical and physician owned laboratories or to address your other healthcare law-related needs.