COURT CASES

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by … [Read more...]

ENFORCEMENT

Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers

One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the target firm. Now one of those cases … [Read more...]

WHISTLEBLOWERS

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

No Dice for Whistleblower Claim Blaming Software Firm for Double-Billing Case: A physician coding supervisor for a North Carolina health system that used billing software from Epic filed a qui tam … [Read more...]

MEDICAL NECESSITY

Genetic Testing: Natera Settles Prenatal DNA Testing False Billing Claims for $11.4 Million

Before the opioid crackdown, false billing of genetic tests was the hottest thing in federal fraud enforcement against clinical labs. But while drug testing related to prescription opioids has stolen … [Read more...]

ANTI-KICKBACK

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Theranos & Its CEO Settle Stock Fraud Charges with SEC Case: Having settled with CMS, Walgreen's and the Arizona State Attorney General, Theranos has made peace with what may be the scariest of all … [Read more...]

FALSE CLAIMS

Enforcement Trends: Why Fending Off Whistleblowers Might Have Just Gotten Easier

Because government enforcers cannot be everywhere at once, the qui tam whistleblower lawsuit was invented. The result has been a proliferation of fraud cases against not just labs and health care … [Read more...]

FOCUS ON

DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases

A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the False Claims Act (FCA). … [Read more...]

ANTI-KICKBACK

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

ACLA Seeks Decisive Blow in PAMA Challenge Case Case: Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging the legality … [Read more...]

EHR

Enforcement Trends: Whistleblowers Get in on the EHR “Meaningful Use” Action

Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in government health fraud enforcement. (See GCA, July 10, 2017). And now private … [Read more...]

FALSE CLAIMS

Case of the Month: FMC Settlement Is Poster Child for False Billing of Lab Tests

In the grand scheme of things, $2 million is fairly small potatoes for false billing of lab tests—especially considering that it allegedly went on for 10 years. Even so, if you're running your lab's … [Read more...]


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