ENFORCEMENT

Investment Returns on the Federal Enforcement Dollar Continue to Drop

The business of enforcing federal health care fraud laws isn't as robust as it used to be. While revenues have remained pretty steady, return on investment (ROI) has been trending downward, providing … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

ENFORCEMENT

New Laws: 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...]

FALSE CLAIMS

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...]

LAB SAFETY

Safety lapses continue with select agents

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio The approach of the holiday season signals the end of another year. Was this just another year in a long line of them for you in lab safety, … [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...]

DOJ

Medical Necessity Requirement Bites Anatomic Pathologists

By Robert Mazer  bio The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains. Medicare permits a pathologist to order special stains when … [Read more...]

REIMBURSEMENT

CMS Enforcement Discretion Eases Pressure on Labs

After we went to press last month, the Centers for Medicare and Medicaid Services (CMS) announced just in the nick of time that it wouldn't impose civil monetary penalties against labs which failed to … [Read more...]

ENFORCEMENT

Liability Traps to Avoid:
Commission-Based Lab Marketing Arrangements

Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on the volume or value … [Read more...]

ENFORCEMENT

Enforcement E¢onomi¢$: ROI on US Fraud & Abuse Program Continues to Decline

While still profitable, the business of enforcing health care fraud laws has been providing the federal government a steadily declining return on investment (ROI) in recent years. This long-term trend … [Read more...]


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