Clinical, Assisted Reproductive Technology and Biotechnology Laboratories

The field of laboratory medicine and science is growing exponentially. The critical role clinical laboratories play in the diagnosis and treatment of human diseases and conditions has been highlighted by the need for rapid and accurate COVID 19 testing and reporting of results. The increasing success of assisted reproduction and the role played in the process by ART laboratories, and the rapidly developing science of biotechnology, and especially CRISPR, have placed heavy legal demands on all laboratories. Federal and state regulation, and even international standards, are becoming more and more complex. Governmental and private commercial insurance payment disputes are now commonplace, with sometimes millions to hundreds of millions of dollars at issue, complicated by unclear and often archaic billing rules and the increasing use by payors of statistical sampling and extrapolation techniques to quantify overpayments. Critical laboratory testing is increasingly being denominated as experimental or investigational. Fraud and abuse laws, such as the federal Antikickback law, the Stark law, and now EKRA, have focused heavily on the clinical laboratory industry.

Our health law practice has represented clinical laboratories for nearly 40 years. We represent laboratories, their owners and Laboratory Directors, laboratory trade associations, andrologists and embryologists, and now ART and biotechnology labs all over the country. Whether it involves defending the lab against criminal or civil false claims litigation or investigations, overpayment audits and recoupment administrative hearings or civil litigation, regulatory noncompliance, corporate restructuring, the purchase or sale of lab companies or their assets, general compliance and advice, or commencing litigation on the lab’s behalf against state or federal governmental agencies, vendors or other business entities, our attorneys have the decades of experience and success to help you achieve your goals or satisfy your legal needs.

Our record of success includes successfully representing hospitals and laboratories in high-stakes litigation, including our representation of hospitals and independent clinical laboratories in two lawsuits against the New York State Department of Health challenging the amounts that DOH was charging labs for their regulation. These two lawsuits resulted in approximately $22 million being refunded to the affected laboratories and prospective changes in the methodology used by the State of New York in calculating regulatory fees.

Trust your legal needs to the law firm that has represented laboratories for 40 years.

Locations We Serve

Statewide with focus larger metro areas

Related Practice Areas

Commercial & Corporate Transactions  Commercial Financing  Administrative & Regulatory  Healthcare Fraud | Abuse | White Collar Crime  Healthcare Transactions Litigation and Appeals Medicaid, Medicare, and Third Party Payor Compliance
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