The Need for Laboratory Legal Services: Supporting Innovation, Compliance, and Growth
Laboratories are under intense scrutiny by payors, as well as state and federal governmental regulators. Arrangements that involve payor-exclusive and/or preferred provider relationships, and payor efforts to steer members to “preferred” labs, must be carefully weighed in order to protect their client base and ensure viability. To secure, maintain and grow market share, Laboratories must not only evolve to adopt innovative structures and pursue compliant alignments with physicians and hospitals, but also remember to pay attention to a myriad of legal pitfalls.
Strategic Counsel for Laboratories and Life Sciences Companies
At Frier Levitt, we provide comprehensive legal services to laboratories, diagnostic companies, and life sciences organizations, helping them navigate the evolving regulatory, transactional, and litigation landscape. With a deep understanding of the healthcare and life sciences industries, our attorneys offer strategic guidance to ensure compliance, mitigate risk, and drive business success.
Regulatory & Compliance Expertise
In an industry governed by complex federal and state regulations, laboratories and life sciences companies must stay ahead of evolving compliance requirements. Frier Levitt attorneys have significant experience representing independent, physician-office and hospital-affiliated clinical laboratories and are able to assist with all aspects of laboratory business models, including:
- Formation, Structuring, Licensing, Financing, and Billing
- Guidance navigating federal and state laws including: Health Insurance Portability and Accountability Act (HIPAA), Stark Law, Anti-Kickback Statute (AKS), Eliminating Kickbacks in Recovery Act (EKRA), False Claims Act (FCA), Clinical Laboratory Improvement Amendments (CLIA), and Civil Monetary Penalties (CMP) Law
- Food and Drug Administration (FDA) compliance
- Centers for Medicare & Medicaid Services compliance
- Reimbursement and payer Audits
- Group Purchasing Organization (GPO) relationships
- Marketer relationships
- Physician/Hospital alignment
- Draw Stations/Patient Service centers
Data Privacy & Security Compliance
Laboratories handle vast amounts of sensitive patient data, making compliance with data privacy laws essential. Our team provides guidance on:
- HIPAA and HITECH Act and data privacy compliance
- Data breach response and notification requirements
- Cybersecurity risk assessments and best practices
- State and federal patient privacy regulations
- Representation in investigations related to data breaches and unauthorized disclosures
Transactional & Corporate Support
Frier Levitt advises laboratories and life sciences businesses in structuring transactions that align with industry regulations while supporting operational growth. Our services include:
- Mergers, acquisitions, and joint ventures
- Contract negotiations with payers, providers, and suppliers
- Licensing and intellectual property protections
- Employment agreements and physician relationships
- Real Estate matters
Litigation & Enforcement Defense
With government scrutiny increasing, our attorneys provide aggressive defense strategies for laboratories facing regulatory investigations, payer disputes, or private litigation. We represent clients in:
- Government relations, investigations, and enforcement actions
- Criminal matters
- Anti-trust matters
- Commercial and reimbursement litigation
- Payor audits and appeals
- Fraud and abuse allegations
- Qui tam actions and whistleblower defense
- Evaluation of False Claims Act (FCA) claims
- Defense against federal and state audits
Why Frier Levitt?
Frier Levitt stands at the intersection of healthcare, life sciences, pharmacy and the law, uniquely positioned to offer practical, industry-focused legal solutions. With a team of experienced attorneys, many with backgrounds in healthcare and life sciences, we provide innovative strategies tailored to the challenges laboratories and life sciences companies face today. We carefully monitor industry trends and governmental initiatives, including prosecutorial focuses, to apprise their laboratory clients of ways in which they can remain competitive, exploit business opportunities, and avoid/reduce the likelihood of scrutiny and prosecutions.
How Frier Levitt Can Help
Whether you’re a clinical laboratory, diagnostic company, or life sciences innovator, we are here to support your legal and business needs. Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you navigate your legal challenges.