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

On February 3, 2026, President Trump signed HR 7148, the Consolidated Appropriations Act, 2026 (“the Act”) ending the 4-day partial government shutdown. The Act, part of a broader fiscal year (FY) 2026 spending package, includes a

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

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

The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the

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

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

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

On November 12, 2025, President Trump signed H.R. 5371 the “Continuing Appropriations, Agriculture, Legislative Branch, Military Construction, and Veterans Affairs and Extensions Act, 2026” (the Act). The Act ended the federal government shutdown by providing necessary funding