Our understanding of the healthcare industry’s regulatory landscape and trends gives Nelson Hardiman significant insight into the complex legal issues impacting medical laboratories. Independent clinical labs and those affiliated with hospitals and health systems are equally affected by ever-changing regulations and managed care contracting challenges. Nelson Hardiman has the knowledge and experience to ensure laboratories remain compliant and stay in business.

Whether you are concerned about the increasing frequency of audit activity, struggling to manage Medicare and Medicaid payment contracts, or challenged by the requirements and potential pitfalls of providing direct-to-consumer testing services, we have your back. Our team of experienced healthcare attorneys offer hands-on assistance tackling the most complex regulatory, business and strategic issues for healthcare and life sciences laboratories.

Our Work Includes:

  • Arbitration Obtained a favorable settlement for a laboratory group in arbitration brought against a managed care plan to recover payments for pathology services and testing.
  • Audits Provided strategic counsel on mitigating audit risk and effectively handled audit responses.
  • Business formation Prepared essential documents required for a company setting up multiple laboratory businesses. Documents included articles of incorporation, bylaws, operating agreements, management services agreements and IP licensing agreements.
  • FDA Investigation Defended FDA investigation of national clinical laboratory and persuaded FDA to refrain from action based on adoption of corrective action plan and compliance program.
  • Laboratory Acquisitions Counseled laboratory acquisitions, handling CHOWs and regulatory approvals.
  • Licensure and Certification Advised on licensure, certification and/or related matters with respect to laboratories.
  • Merger & Acquisition Represented a large dermatology practice, including a dermatopathology lab, in an approximately $15 million acquisition. The complex transaction required a complicated series of financial tranches structured to meet tax and regulatory requirements.
  • Regulatory Compliance Counseled on all regulatory aspects of healthcare for a laboratory client.