REPRESENTATION OF LABORATORIES AND TESTING FACILITIES

;Attorneys at MDRXLaw – Sauchik & Giyaur, P.C. offers comprehensive guidance to laboratories and testing facilities across the entirety of their business operations. We are frequently called upon to provide comprehensive legal and regulatory advice, addressing a broad spectrum of industry challenges. Our expertise extends to ensuring compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and associated regulations, as well as navigating state licensure and accreditation requirements. Whether our clients are involved in litigation, government investigations, or transactional matters, we represent their interests with dedication. Additionally, we offer valuable insights and recommendations on reimbursement issues.

We also represent laboratories in government investigations and False Claims Act litigation. Our track record includes successful resolutions of claims pertaining to sales and marketing practices, billing and medical necessity, testing/test kit quality, and COVID-related reimbursement issues.

Examples of our representation of laboratories and testing facilities include:

• Providing guidance on the application of the Stark Law, Anti-Kickback Statute, and EKRA to prevalent industry practices such as in-office phlebotomists, supply provisions to physician practices, leases involving referring physicians, and non-monetary compensation;
• Counseling on Medicare reimbursement issues and billing requirements;
• Structuring joint venture arrangements with other laboratory providers;
• Ensuring compliance with privacy and security of laboratory test results, including investigations by the Office for Civil Rights, and patient access to lab test results;
• Licensure, accreditation, and CLIA requirements