Working across every dimension in the laboratory space, Polsinelli attorneys advise laboratories on a diversity of legal and policy issues. Our counsel is anchored in a deep understanding of the health care industry and each sector of the laboratory environment, and enhanced by capabilities in the area of regulatory advocacy.

Often combining the experience of our health law and public policy teams, our diversified practice advises clients in every aspect of the life cycle of a laboratory, including Clinical Laboratory Improvement Amendments (CLIA) regulations and state certification, Medicare and commercial payer coverage and reimbursement, pricing, data reporting, coding, and issues related to molecular diagnostics and other clinical laboratory tests. We also have an extensive experience with program integrity issues and have advised and defended laboratories on resolution of federal health care program and commercial payer audits, investigations, appeals, enrollment and licensure issues.

Many of our laboratory clients are on the cutting edge of genetic and genomic testing, and we provide counsel on the coverage and reimbursement of laboratory developed tests (LDTs). Attorneys in the practice also advise on regulatory issues such as payment under the Clinical Lab Fee Schedule and compliance with reporting obligations under the Protecting Access to Medicare Act of 2014 (PAMA).

The primary dimensions of our service to laboratory clients include:
  • Regulatory counsel, compliance and litigation defense: includes application and analysis of a myriad of federal laws as applied in the laboratory space, from specific applications of the Federal Anti-Kickback Statute, the federal Physician Self-Referral Law (commonly known as the Stark Law), the Federal Civil False Claims Act, CLIA, and state certification and licensure issues. Our experienced team assists with audits and investigations, including audits by Medicare contractors. Many of our attorneys joined the firm from regulatory and enforcement agencies – including OIG, OCR and DOJ—and bring a unique understanding of the perspective and goals of law enforcement agencies. Our team also includes seasoned litigators with direct experience in a wide range of commercial payor disputes including contracting, recoupment and payment matters.
  • Policy and advocacy: work in this area includes advocacy before the Centers for Medicare & Medicaid Services (CMS) and Medicare contractors on coding, coverage, and payment rules and guidelines related to diagnostic laboratory services, including advanced diagnostic services such as new methods of testing and molecular diagnostic services. In addition, as new testing issues implicate guidance from the Federal Drug Administration (FDA), our robust FDA practice counsels on issues related to laboratory testing equipment, testing methodologies, advertising and promotion.
  • Transactional practice: with a significant number of transactional attorneys specializing in the health care industry, we counsel laboratories, hospitals, and health systems on a number of transactional issues. This includes private equity investment, mergers and acquisitions of laboratories, joint ventures with hospitals and other parties, management structure arrangements, and other contractual arrangements with physicians and hospitals. We also provide a wide range of tailored due diligence solutions for transactional work tapping into our team of experienced corporate and regulatory attorneys.