On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary extension (2026 Extension) of its pandemic-era telehealth flexibilities, which
Health Law Diagnosis
Monitoring the Pulse of Health Care and Life Sciences
Health Law Diagnosis, published by Robinson & Cole LLP, focuses on legal issues in the healthcare sector, including regulatory compliance, healthcare fraud and enforcement, Medicare and Medicaid policies, telehealth, hospital price transparency, and diagnostic testing arrangements. The blog covers developments in healthcare law such as government regulations, advisory opinions from health authorities, litigation outcomes, and strategies for healthcare providers and laboratories to navigate legal challenges. It also addresses topics like immigration enforcement impacts on healthcare entities and the legal implications of healthcare pricing and billing practices.
Latest from Health Law Diagnosis - Page 4
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks
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…
Court Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot Program
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 the government’s implementation…
CMS Adds New Requirements to Hospital Price Transparency Reporting
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 transparency regulations. The…
Update on Processing of Telehealth Claims Impacted During the Government Shutdown
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…
OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07
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…
Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories
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…
Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case
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,…
From Risk to Readiness: Navigating the Payor Audit Landscape
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…
Telehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers
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…