Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]
STARK LAW
Compliance Head’s Up: New Kickback Safe Harbors Rule Is Almost Ready
June 17, 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...]
FALSE CLAIMS
Case of the Month: Physicians Come Under Fire for Taking Blood Processing Fee Kickbacks from HDL
June 17, 2019
Like the tango, it takes two to break the anti-kickback laws: one to offer and pay the kickback and the other to accept it. When a major scheme involving payment of kickbacks for lab testing referrals … [Read more...]
GENETIC TESTING
OIG Issues Genetic Testing Fraud Alert
June 17, 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...]
INDUSTRY BUZZ
Google This: Labs Partner with Tech Giant
May 21, 2019
In recent months, several diagnostic companies have announced alliances with Google, and all involve Google Cloud Platform. Here is how four companies are using Google's … [Read more...]
NEWS
DNA Testing at the Border
May 21, 2019
The Department of Homeland Security (DHS) is piloting a DNA testing program at the U.S.-Mexico border. The program aims to establish "DNA-based family relationship (kinship) verification to improve … [Read more...]
NEWS
The President’s Proposed 2019 Federal Budget: The 6 Things Labs Must Know
May 6, 2019
While President Trump's proposed $4.75 trillion budget may be the largest in U.S. history, it calls for important cuts affecting health care in general and labs in particular. Here are the six things … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
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...]
NEWS
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
March 25, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
ANTI-KICKBACK
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
March 15, 2019
On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to lower the prices and out-of-pocket costs of prescription drugs by having manufacturers give discounts … [Read more...]
