NEWS

FDA Watch: Agency Okays Marketing of Zika Test for First Time

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

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

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

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

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

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

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

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

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

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...]


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