Although it's still a profitable endeavor, enforcing federal health care fraud laws isn't providing the investment returns of yesteryears. That's the main takeaway of the new joint HHS and … [Read more...]
ENFORCEMENT
Enforcement Trends: Investment Return on Fraud Fighting Continues to Decline
July 22, 2019
REIMBURSEMENT
PAMAgeddon: Congress Tables Bill to Delay Next Round of Price Reporting for One Year
July 16, 2019
The PAMA data collection process has been a lightning rod for criticism from almost the moment CMS unveiled it. And now Congress may be getting ready to intervene. A newly proposed bill called … [Read more...]
FOCUS ON
State Law Round-up: New Privacy Breach Notification Laws Potentially Affecting Labs
July 16, 2019
As illustrated by the recent MIE settlement (click here for the story), security breaches involving patients' electronic protected health information (ePHI) exposes your lab to liability risks under … [Read more...]
ENFORCEMENT
Focus On: State AGs Break New Ground by Teaming Up to Enforce HIPAA
July 16, 2019
Lab managers and compliance officers take note: For the first time ever, state attorneys general (AGs) have banded together to go after a health care provider for HIPAA violations. Although the … [Read more...]
HEALTH CARE REFORM
Industry Buzz: Obamacare Appeal Set for Round 2
July 16, 2019
Seven months after a Texas U.S. District Court striking down Affordable Care Act, aka Obamacare, unconstitutional, the case is going back to court on appeal. The betting is that the Fifth Circuit, … [Read more...]
COURT CASES
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
July 16, 2019
Feds Salvage $2.5 Million from $90 Million Genetic Testing Scam Case: The feds accused Nevada Heart & Vascular Center (NHVC) of taking kickbacks from a pair of now defunct genetic testing … [Read more...]
FDA
New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
July 16, 2019
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]
FOCUS ON
Surviving PAMA: Keep an Eye on Industry Disruptors
July 16, 2019
A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]
GENETIC TESTING
OIG Issues Genetic Testing Fraud Alert
July 15, 2019
On June 3, the OIG issued a fraud alert warning of a genetic testing fraud scheme. According to the OIG, scammers are using telemarketing calls, booths at health fairs and public events and … [Read more...]
STARK LAW
Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready
July 8, 2019
After months of promises, posturing and public consultation, the Department of Health and Human Services is getting ready to unveil a proposed rule to liberate labs and other providers from the … [Read more...]
