NEWS AT A GLANCE

Another Decision in the HDL Case Highlights Kickback Risks of Patient Responsibility Waivers Involving Private Payers

The Health Diagnostics Laboratory, Inc. (HDL) and Singulex saga continues. The latest chapter involves not the labs themselves but BlueWave Healthcare Consultants, their marketing firm. And it raises … [Read more...]

CODING

False Billing of Nuclear Stress Tests at Center of $50 Million Cardio Fraud Scheme

The feds arrested a cardiologist, neurologist and four others for their role in an elaborate fraud scheme. The government contends that over a 12- year period, the defendants' New York City medical … [Read more...]

FDA

23andMe Gains FDA Approval for DTC Test

23andMe and the U.S. Food and Drug Administration (FDA) announced this month that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]

ENFORCEMENT

CMS, OIG Reps Address Attendees at ACLA Annual Meeting

At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector … [Read more...]

IMMIGRATION

Brief Your CEO: 8 Changes in Trump Travel Ban

Although it applies to all industries, the Trump travel ban will have a disproportionate impact on labs and other health care providers. We recently outlined the major effects and the steps you can … [Read more...]

INDUSTRY BUZZ

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

Suing Theranos has become something of a cottage industry. And now a whole new front in the legal war appears ready to open: state consumer fraud lawsuits. The Arizona Attorney General's Office (AGO) … [Read more...]

NEWS

DOJ Touts 2016 as Bumper Year for False Claim Act Recoveries

The False Claims Act (FCA) remains the federal government's most potent fraud enforcement tool. After sagging a tad in recent years, FCA recoveries bounced back in fiscal year 2016. As usual, the … [Read more...]

NEWS

Enforcement Firsts: Presence Health Fined $475,000 for Taking Too Long to Report HIPAA Breach

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. A new HIPAA rule took … [Read more...]

HIPAA

First HIPAA Breach Notification Settlement Totals $475,000

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Four years ago, a new … [Read more...]

ENFORCEMENT

Enforcement Trends: 5 Insights from the OIG Semi-Annual Report

You can always count on OIG semiannual reports to Congress for two things: self-congratulation and insight into the enforcement priorities for the next six months. The most recent edition, published … [Read more...]


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