Laboratory Services

Nelson Mullins’ attorneys provide a wide range of legal services for the laboratory community. Our experienced attorneys in this focused practice area offer compliance, regulatory, and reimbursement counsel and assistance with matters related to criminal, civil, and administrative enforcement, as well as investigation and audit matters. 

Our team counsels diverse laboratory clients who share the common goals of successfully navigating compliance and regulatory requirements while meeting their business objectives and minimizing enforcement risks. With our depth of experience in the laboratory sector, we provide strategic planning for high stakes matters.
 

The scope of our focused laboratory practice includes many key services:

Enforcement, Investigations & Audits

Nelson Mullins attorneys assist clinical laboratories in responding to criminal, civil, and administrative enforcement actions by the Department of Justice (DOJ), the Office of Inspector General of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS). We have also supported laboratories with Clinical Laboratory Improvement Amendments (CLIA) inspection readiness and responding to inspection deficiencies. 

Our team has experience advising clients on responding to and participating in all forms of Medicare audits, including Targeted Probe & Educate (TPE) and Recovery Audit Contractor (RAC) audits, Unified Program Integrity (UPIC) investigations, and Supplemental Medical Review (SMRC) audits. We also represent laboratory clients in responding to government Grand Jury subpoenas, Civil Investigative Demands, and defending qui tam actions brought by whistleblowers pursuant to the False Claims Act (FCA).

Regulatory and Corporate Counsel

Our team of attorneys assists laboratories with compliance and regulatory requirements, including certification, licensure, proficiency testing, quality system, and personnel regulations. We also provide regulatory due diligence in conjunction with lab transactions, collaborations, and government securities filings and advise clients on regulatory concerns related to federal and state marketing and billing. Our compliance and regulatory experience allow our attorneys to provide counsel related to CLIA requirements, Substance Abuse and Mental Health Services Administration (SAMHSA) and U.S. Nuclear Regulatory Commission (NRC) regulations, third-party accreditation programs, state frameworks, and compliance with the federal Anti-Kickback Statute (AKS), the Physician Anti Self-Referral Law (STARK), the Eliminating Kickbacks in Recovery Act (EKRA), and their applicable state analogues.

Compliance & Reimbursement

Our experienced healthcare attorneys have acted as compliance professionals for numerous lab clients, including officially pursuant to the requirements of Corporate Integrity Agreements (CIAs) with the Office of Inspector General of HHS and regularly counsel laboratories on federal and state compliance and reimbursement issues. We assist with the obligations and implementation of compliance programs to help our clients manage risk and by providing counsel on commercial payor requirements as well as payment disputes with Medicare, Medicaid and other federal programs. 

New Developments in the Industry

Our team stays up to date on new developments and hot topics that affect the healthcare industry and are specific to laboratories. We continue to evaluate opportunities and have experience in the areas of:

• Laboratory Developed Tests (LDTs)
• Precision Health/Medicine, including FDA’s regulation of companion diagnostics (CDx)
• CLIA rulemakings regarding new proficiency testing and personnel requirements 
• Genetic lab testing and reimbursement
• Telehealth
• COVID-19 reimbursement and compliance 
• Mpox (Monkeypox) test development

Our clients

Our diverse laboratory clients share the common goals of successfully navigating compliance and regulatory requirements while meeting their business objectives and minimizing enforcement risks. We serve a variety of clients including clinical labs (e.g., independent, reference, and esoteric), forensic labs, hospitals, nursing homes, academic medical centers, physicians’ office labs, genetic testing labs, toxicology labs, research and development (R&D) labs, SAMHSA- and NRC-regulated labs, labs registered to work with select agents and toxins, and international labs subject to U.S. jurisdiction.

The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

• Representated clinical laboratories in criminal, civil, and administrative enforcement actions, including defense of FCA cases and government contractor audits and overpayment matters and directing internal investigations of allegations of fraud and misconduct.
• Supported clinical labs in preparing numerous Emergency Use Authorization (EUA) submissions during the COVID-19 public health emergency.
• Represented multiple clients in in-person and virtual meetings with the federal CLIA office at CMS.
• Assisted clients in drafting the Plan of Correction in response to Form CMS-2567 issued after CLIA inspections.
• Drafted state legislation that was signed into law in multiple jurisdictions regarding the regulation of clinical labs.
• Aided client in preparing public testimony before the Texas Forensic Science Commission concerning proposed rulemaking.
• Guided client in the transformation of an R&D lab to a CLIA-certified, high-complexity lab.
• Represented clinical labs in the Medicare Administrative Appeals process through the Administrative Law Judge level.
• Negotiated commercial payor settlements for labs resulting in significant reductions to original overpayment amount.
• Advised clinical lab with marketing of services to physician group practices and direct-to-consumer programs.
• Represented clinical labs in various Medicaid overpayment audits.
• Represented genetic testing labs in investigations by the DOJ, Federal Bureau of Investigation, and state agencies of PGx, CGx, and cardiogenetic testing.
• Served as outside compliance counsel for genetic testing lab from formation to operations.