TAG:
stark law
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…
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…
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…
Physicians Tempted by Lure of In-Office Labs, Payers Balk
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DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution
CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test…
Federal Healthcare Fraud Enforcement Turns to Emerging Areas
CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical l…
Seven Doctors Settle Lab Test Fraud Case
CEO SUMMARY: In January, a U.S. Attorney from East Texas announced that seven physicians and a hospital CEO had agreed to settle allegations of fraud involving the payment of bribes in exchange for lab test orders. This is a positive development for the clinical laboratory profession because it…
Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs
This is an excerpt of a 1,385-word article in the March 22, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Dark Report explains how changes to the Stark Law and Anti-Kickback Statute will benefit labs,…
Revised Stark and AKS Rules Are Good News for Labs
CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickb…
Understanding Key Parts of New AKS, Stark Law Rules
CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services a…
CURRENT ISSUE
Volume XXXIII, No. 9 – July, 2026
Newsmaker Interview with Revvity’s Yves Dubaquie > How Specialty Diagnostic Tests Connect with Lab Customers: In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows.
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