The ColLABorative Brief

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After uncertainty over the last few months, the last few weeks saw potential changes to the Protecting Access to Medicare Act of 2014 (PAMA) under section 6226 of the Consolidated Appropriations Act of 2026. On January 20, 2026, the House Appropriations Committee released the Consolidated Appropriations Act 2026, which included several healthcare extenders, among them…

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

Introduction

On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a new report analyzing Medicare Part B (Part B) spending on laboratory tests in 2024. The Protecting Access…

Plaintiffs’ firms are adapting the California Invasion of Privacy Act (CIPA), a 1960s-era wiretapping statute, to modern web technologies such as pixels, chatbots, and session replay tools. For laboratories, the practical problem is not only the legal uncertainty, but also that small website implementation details, including when tags fire, what free-text inputs are captured, and…

The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities, and laboratories. EKRA mostly mirrors the Anti-Kickback Statute (AKS) but extends its reach to commercial health insurance as well as federal programs like…

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

The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims Act (FCA) violations, Anti-Kickback…

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…