TAG:
anti kickback statute
Labs Looking at Cash-Based Options Face Complexity
Given all the challenges of dealing with payers, many clinical laboratories find themselves tempted by the idea of offering cash-based business lines such as direct-to-consumer (DTC) testing. The patient pays up front and undergoes the test, and the lab banks the…
Recent OIG Opinion Explores Lab-Urgent Care Arrangement
For decades, the US Department of Health and Human Services’ Office of Inspector General (OIG) has analyzed clinical laboratory business arrangements by asking how much compliance risk they pose. With the release of Advisory Opinion 26-02 on …
Ruling Limits Lab Onus on Medical Necessity
CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision pr…
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
December 8, 2025, Intelligence: Late-Breaking Lab News
For the next 46 months, a Georgia fraudster will stay behind bars after pleading guilty to charges he violated the Anti-Kickback Statute by arranging for medically unnecessary genetic tests. A judge sentenced Patrick C. Moore, Jr. on Dec. 2. Moore was also ordered to pay $7.2 million in…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Federal Court Reverses Conviction in AKS Case
CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…
Labs: Why it Pays to Know Your Customers
WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERI…
Federal Lawsuit Favors Lab Accused of AKS Violations
CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…
CURRENT ISSUE
Volume XXXIII, No. 10 – August 2026
In the August 2026 briefing, The Dark Report explains the relevance behind CMS potentially changing how it pays for “software as a medical service”. Other topics include a look into how health system executives view clinical labs, possible CLIA updates, and a 30/60/90-day approach to reducing reliance on traveling medical lab techs.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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