FOCUS ON

New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse

Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite their obvious and immediate … [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...]

COMPLIANCE

Case of Month: Judge Takes Back Ruling that Labs Must Independently Verify Medical Necessity

Thanks for clearing that up. As if the lab industry doesn't already have enough legal agita to deal with, last June a federal D.C. District Court upheld a whistleblower's right to sue Boston Heart … [Read more...]

FOCUS ON

CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look

"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]

LEGISLATION

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...]

PRECISION MEDICINE

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

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]

EMPLOYMENT LAW

Employment Law Update for HR Managers October 2017

By Mike O'Brien  bio Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws. In this update: Federal agencies take … [Read more...]

COMPLIANCE

Enforcement Trends: Private Sector Playing a Bigger Role in Lab Fraud Crackdown

Laboratories have been on the receiving end of health care fraud allegations for decades. But while the risk of prosecution and litigation haven't changed, the dynamics have. Although federal … [Read more...]

FOCUS ON

Kickbacks: Does OIG Green Light of Free Product Replacements Open Door for Lab Freebies?

The OIG's aversion to offering freebies of any kind to referral sources is longstanding and well known. So the Aug. 25, 2017 Advisory Opinion clearing the way for a provider to replace spoiled … [Read more...]

ENFORCEMENT

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

Lab Charged in Kickback Scheme Fights to Keep Its CLIA License Case: Next Health is in a legal fight for its life. Earlier this year, the feds indicted two officials of the Dallas lab company for … [Read more...]


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