ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]

ENFORCEMENT

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...]

ENFORCEMENT

Theranos Announces Settlement Agreements with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

ENFORCEMENT

Theranos Settles with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

ENFORCEMENT

CMS, OIG Reps Address PAMA, Fraud Enforcement 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...]

COMPLIANCE

OIG and DOJ Provide Tips for Determining Effectiveness of Compliance Programs

Labs have two new compliance tools—from the Department of Justice (DOJ) and the Office of Inspector General (OIG)—focused on evaluating the effectiveness of compliance programs. The DOJ's resource … [Read more...]

ENFORCEMENT

Emphasis on Individual Responsibility Likely to Continue Even After Yates Departure

Pursuing False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs is just one of the things the U.S. Department of Justice does to crack down on corporate wrongdoing. On Sept. 9, 2015, … [Read more...]

ENFORCEMENT

Health Care Fraud and Abuse Program Faces Declining ROI

The federal government's return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and Abuse … [Read more...]

HIPAA

Breach Notification Violation Ends in $475,000 Settlement

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. Three years ago, a new … [Read more...]

FALSE CLAIMS

DOJ Surveys False Claims Victories for 2016

As we closed out the calendar year, the U.S. Department of Justice (DOJ) reflected on its successes for the fiscal year 2016 (FY 2016) which ended Sept. 30, 2016. Principal Deputy Assistant Attorney … [Read more...]


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