Laboratories

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A clinical lab in Anderson, South Carolina, and its founder and CEO have agreed to pay a minimum of $6.8 million to settle a federal qui tam case based on allegations for paying illegal kickbacks to physicians in exchange for referrals of laboratory tests. Under the settlement agreement, this figure may increase to approximately…

This post is co-authored with Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.

On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free, FDA-approved companion diagnostic test…

This was was authored by Edward J. Heath, co-chair of Robinson+Cole’s Enforcement, Investigations + Litigation in Health Care team.

Since January, there have been almost daily media reports about federal government agents conducting operations intended to sweep up individuals who are in the U.S. illegally. The primary agency responsible for these activities is Immigration and…

This post is co-authored by Julianna M. Charpentier, a member of Robinson+Cole’s Enforcement, Investigations + Litigation in Health Care team.

Earlier this year, a Florida jury fully acquitted two owners of an independent clinical laboratory located in San Antonio, Texas accused of conspiring to commit health care fraud and wire fraud. Defendants Diego Sanchez…

As payer audits become more frequent and complex, laboratories and healthcare providers must be equipped to respond effectively. Labs are especially vulnerable due to high-cost services and billing complexity. Triggers include but are not limited to sudden spikes in service volume, changes in test panels or clientele, use of uncommon codes or modifiers, and high…

This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice in Massachusetts.

On June 25, 2025, Connecticut Governor Ned Lamont signed into law Public Act No. 25-96, “An Act Concerning the Department of Public Health’s Recommendations Regarding Various Revisions to the Public Health Statutes” (the Act). The Act…

This post was authored by Roma Patel, Associate in Robinson+Cole’s Data Privacy + Cybersecurity Team.

We often cover consumer class action complaints against companies regarding the privacy and security of personal information. However, litigation can also arise from alleged breach of contract between two companies. This week, we will analyze a medical diagnostic testing…

*This post was authored by Nicole Benevento, law intern at Robinson+Cole. Nicole is not admitted to practice law.

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and post-marketing requirements of mass-produced…

As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the “60-Day Rule”) that (1) align the standard for when an overpayment is identified with the applicable standard under the…

*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.

On September 30, 2024, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida issued an order in United States ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, holding that the…