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

On December 29, 2025—just three days before the 340B Rebate Model Pilot Program (the Rebate Program) was set to begin—the U.S. District Court for the District of Maine issued an order granting a preliminary injunction to block…

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

On November 21, 2025, the Centers for Medicare & Medicaid Services (CMS) published the CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule (the Rule), which includes several significant changes to hospital price…

The recent government shutdown caused multiple Medicare statutory payment provisions to lapse on October 1, 2025, due to the absence of Congressional action. With the passage of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37), (discussed here), Congress has retroactively restored many of these…

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…