While the federal enforcement community has made urine drug testing of opioid drug patients its number one target for lab-related False Claims Act (FCA) charges for the time being, nuclear stress … [Read more...]
FALSE CLAIMS
Enforcement Trends: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
April 11, 2018
COMPLIANCE
Physician Referrals: New Rules Offer Some Stark Law Relief but Not Nearly Enough
April 11, 2018
Like most budget bills, the new federal Bipartisan Budget Act of 2018 includes a number of changes to Medicare fraud and enforcement requirements. One set of changes affects the current physician … [Read more...]
FOCUS ON
New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
April 10, 2018
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
March 19, 2018
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
January 22, 2018
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
January 16, 2018
"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
December 12, 2017
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
December 12, 2017
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
November 6, 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
September 29, 2017
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...]
