The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
In a major regulatory reversal, the U.S. Food and Drug Administration (FDA) has officially rescinded its 2024 final rule that sought to regulate Laboratory Developed Tests (LDTs) as medical devices. The decision, announced on...more
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that. Multiple lawsuits were...more
On August 11, 2025, New Jersey Lieutenant Governor Tahesha Way, acting for Governor Phil Murphy, signed into law two bills, A3973/S3952 and A3974/S3955 (collectively, the 2025 amendment), that modify New Jersey’s existing...more
In 2018, the Eliminating Kickbacks in Recovery Act (EKRA) made it an offense for someone to knowingly and willfully pay or offer any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or...more
On Sept. 22, the U.S. District Court for the Middle District of Tennessee issued an opinion in United States, et al., ex rel. Nolan, et al. v. HCA Healthcare, Inc., 2025 WL 2713747 (M.D. Tenn. Sept. 22, 2025) that signals a...more
The Eliminating Kickbacks in Recovery Act (EKRA), passed in 2018 as part of the SUPPORT Act, was originally designed to combat fraud and abuse in substance use disorder treatment and recovery services. But in the years since,...more
The Ninth Circuit recently decided United States v. Schena, 142 F.4th 1217 (9th Cir. 2025), which considered the Eliminating Kickbacks in Recovery Act (“EKRA”). EKRA, enacted in 2018 to address “body brokering” and other...more
On July, 11, 2025, the Ninth Circuit Court of Appeals affirmed laboratory operator Mark Schena’s conviction under Eliminating Kickbacks in Recovery Act (EKRA). This is the first time a higher court has addressed the lab...more
In a qui tam action filed under the False Claims Act, the relator, Barbara Senters, appealed the district court’s dismissal of her fourth amended complaint (FAC), which alleged that Quest Diagnostics submitted false claims...more
On July 31, 2025, the United States Department of Justice (DOJ) announced a $9.8 million settlement with Illumina, Inc. (Illumina) to resolve alleged False Claims Act (FCA) violations related to cybersecurity vulnerabilities...more
Agendia made two posts on LinkedIn that linked to articles in which Dr. Nathalie Johnson touts Agendia’s genomic test to evaluate early-stage breast cancer over Genomic Health’s competing test. Genomic Health filed an NAD...more
As Holland & Knight previously reported, since its enactment in 2018, the Eliminating Kickbacks Recovery Act (EKRA) has been a source of anxiety and confusion for the clinical laboratory and behavioral health industries in...more
On July 11, 2025, the Ninth Circuit issued a decision clarifying the scope of Eliminating Kickbacks in Recovery Act (EKRA). In affirming a Northern California-based medical testing laboratory’s convictions under EKRA, the...more
In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more
The cannabis industry has undergone a rapid transformation over the past decade, spurred by evolving federal and state legislation. Yet, beneath the promise of legalization and medical innovation lies a growing public safety...more
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
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...more
Adult possession and use of cannabis has been legal in Maryland since Maryland’s Cannabis Reform Act (“CRA”) took effect in July 2023. The CRA established the Maryland Cannabis Administration (“MCA”) and tasked it with...more
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more
The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services....more
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more