Strategic Counsel for a Rapidly Evolving Regulatory Landscape 

At Robinson+Cole, we provide comprehensive legal support to clinical and pathology laboratories traversing the complex and ever-evolving regulatory environment. Our cross-disciplinary team advises on transactional structuring, regulatory compliance, and litigation defense — helping our clients remain compliant, competitive, and protected. Our team services laboratories to address their business needs in a compliant manner to navigate operational and legal challenges. 

We regularly publish in laboratory journals, speak at industry events, and lead webinars — ensuring our team stays at the forefront of regulatory and legal trends.  

Our Services for Clinical Laboratories 

Our firm provides strategic counsel to clinical and pathology laboratories. With our industry insight and regulatory fluency, we help clients structure deals that align with both their business goals and compliance obligations. Such services include, but are not limited to: 

Transactional 

• Structuring joint ventures, acquisitions, and affiliations; 

• Drafting and negotiating laboratory service agreements and marketing agreements; and

• Conducting regulatory and compliance due diligence. 

Regulatory Compliance 

• Advising on reimbursement issues, lab-to-lab billing requirements, and overall billing compliance; 

• Reviewing and drafting sales and marketing practices and advising on compliance;

• Counseling on the Anti-Kickback Statute, the Stark Law, the Eliminating Kickbacks in Recovery Act, and other fraud and abuse laws; 

• Developing compliance plans and training; 

• Providing guidance on CLIA certification and state licensure; 

• Advising on HIPAA (Health Insurance Portability and Accountability Act) and data privacy compliance; 

• Assisting with internal compliance audits and policy development; and  

• Providing representation before CMS and in state agency matters. 

Litigation and Enforcement Defense 

• Defending against government investigations and enforcement actions; 

• Responding to audits, subpoenas, and qui tam complaints; 

• Negotiating corporate integrity agreements and other settlements with the U.S. Department of Health and Human Services Office of Inspector General; and

• Managing appeals of adverse regulatory determinations. 

Why Clients Choose Us 

• Long-standing industry knowledge: Our attorneys understand the operational realities of clinical and pathology  labs. 

• Proactive risk management: We help clients anticipate and mitigate compliance risks before they escalate. 

• Integrated legal solutions: From deal structuring to defense strategy, we offer end-to-end support.