INDUSTRY BUZZ

Arizona Fraud Suit Opens New Front in the Legal War against Theranos

The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos: state consumer fraud lawsuits. The AGO indicated in its request that it … [Read more...]

LEGISLATION

New Laws: Civil Monetary Penalties Get More Expensive—and Easier to Dish Out

One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse. That includes the new Regulation on civil … [Read more...]

ENFORCEMENT

False Claims Act Cases Continue to Be a Cash Cow for the Feds

Easy liability; High penalties; Private individuals willing to do the heavy lifting by bringing qui tam whistleblower lawsuits. It is not hard to understand why few federal government ventures … [Read more...]

ENFORCEMENT

CMS Bars Theranos’ California Lab from Medicare Program

Elizabeth Holmes dropped out of college to start up Theranos. Now Theranos and Holmes have been dropped from the Medicare program. Theranos has confirmed that the Centers for Medicare & Medicaid … [Read more...]

ENFORCEMENT

Dallas Dermatopathology Lab Accused of Fraudulent Billing of Tricare

By Ron Shinkman, Editor, Laboratory Industry Report A prominent dermatopathology laboratory in Dallas has been implicated in a CBS News investigation regarding potential fraudulent billing of the … [Read more...]

ENFORCEMENT

Theranos Now Under Criminal Investigation

The plot continues to thicken for Theranos. As the California-based startup tries to strain toward greater transparency, it is now apparently the subject of a criminal investigation. Both the Wall … [Read more...]

FDA

FDA Recalls Focus Diagnostics Test Kit

The U.S. Food and Drug Administration has issued a rare recall of a laboratory test kit, claiming a fault in its manufacturing process could endanger patients. The test in question is manufactured … [Read more...]

ENFORCEMENT

CMS Scrutiny Continues for Theranos

By Ron Shinkman, Editor, Laboratory Industry Report The Theranos saga has just entered its most critical state, as the Centers for Medicare & Medicaid Services (CMS) recommended the company's … [Read more...]

DTC

FDA Issues Informational Queries to Two Startup Labs

Although the laboratory sector is at loggerheads with the U.S. Food and Drug Administration (FDA) over the regulation of LDTs, that has not prevented the agency from warning two nascent players from … [Read more...]

Pathway Genomics Settles False Claims Case

Pathway Genomics ended 2015 by settling a whistleblower suit with the federal government for $4.03 million. The San Diego-based Pathway and the U.S. Attorney's Office announced the settlement on Dec. … [Read more...]


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