TAG:
lab risk & compliance
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
Trump Signs Executive Order on Price Transparency
ON FEBRUARY 25, PRESIDENT DONALD TRUMP SIGNED AN EXECUTIVE ORDER targeted at driving price transparency requirements for hospitals and insurers. The order aims to strictly enforce a previous rule, signed during his first term, intended to provide patients with cl…
Some Health Plans Drop Deductibles as Response to New Consumerism
It may surprise many pathologists and clinical laboratory administrators to learn that one major health insurer’s best-selling plan has only copays and no deductible, no coinsurance, and no cost-shifting! That plan is Surest, a group plan offered by UnitedHealthcare in recent ye…
Proposed Clinical Laboratory Price Transparency Bill
IN DECEMBER, THE CLINICAL LABORATORY PRICE TRANSPARENCY ACT OF 2023 was referred to the U.S. House Ways and Means Subcommittee on Health for final approval. The bill requires labs to disclose information regarding pricing before administering services. The goal is to ensure patients better understand…
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…
Multi-year Prison Sentence for Genetic Test Fraud
CEO SUMMARY: In recent years, federal prosecutors are filing ever greater numbers of civil actions and criminal indictments against individuals accused of healthcare fraud and abuse. This includes prosecutions of doctors alleged to have received illegal kickbacks from lab companies in exc…
Owens & Minor Sues Anthem BCBS of Virginia
CEO SUMMARY: For years, clinical laboratories and pathology groups have expressed frustration with the lack of transparency by health plans in how they handle claims, set prices, and establish coverage guidelines. Now, because of recent federal laws and rules concerning health data transp…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Internet Tracking Lawsuits Target Quest and Labcorp
CEO SUMMARY: Here is the clinical lab industry’s first intelligence briefing on how class action attorneys are filing lawsuits against healthcare providers—including clinical laboratories. The allegations are that providers are using internet tracking tools, such as those offered by M…
Federal Cases against Labs Result in Convictions
CEO SUMMARY: Over the past 24 months, federal prosecutors have announced a steady parade of criminal convictions, guilty pleas, and settlement agreements involving fraud and clinical laboratory testing. Not only are these cases numerous, but some resolve legal actions initiated by the fed…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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