CYBERSECURITY

HIPAA Briefing: Can Patients Sue Labs for Privacy Breaches?

Violating HIPAA restrictions subjects your lab to fines and other penalties dished out by the HHS Office of Civil Rights (OCR) and other regulators. But can the individual victims whose personal … [Read more...]

CONSUMER FRAUD

The End May Be Near for Theranos & Elizabeth Holmes

Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of $70 billion in annual sales. Today, the company and … [Read more...]

SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

By Oleg Bess, M.D.  bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]

NEWS AT A GLANCE

Case of the Month: $11.4 Million Natera Settlement Shows Genetic Billing & Coding Remains a False Claims Hot Button

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...]

MARKETING

Theranos & Its CEO Settle Stock Fraud Charges with SEC

CMS; The Arizona Attorney General; Walgreen's; Its own shareholders. And now Theranos has a new legal adversary: the US Securities Exchange Commission which has charged Theranos and its founder … [Read more...]

INDUSTRY NEWS

CAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA Lawsuit

The College of American Pathologists (CAP) filed an amicus curiae brief in support of a motion by the American Clinical Laboratory Association (ACLA) for summary judgement to set aside how the … [Read more...]

FALSE CLAIMS

Case of the Month: Judge Who Said Labs Must Independently Verify Medical Necessity Takes It Back

"That CAN'T Be Right: Court Says Labs Must Independently Verify Medical Necessity of M.D. Ordered Tests" That was the headline we used in reporting a highly disturbing federal court … [Read more...]

NEWS AT A GLANCE

Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests

While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests (NSTs) ordered by … [Read more...]

LEGISLATION

PAMA-Geddon: Lab Industry Takes CMS to Court

The nearly three-year struggle between HHS and the lab industry over PAMA has entered a new phase. On December 11, the American Clinical Laboratory Association (ACLA) filed a lawsuit asking the U.S. … [Read more...]

CYBERSECURITY

New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches

While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is a relatively recent phenomenon. Breach Liability of Labs Because … [Read more...]


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