The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]
FDA
Inside Washington: What’s Going on with Regulation of LDTs?
September 9, 2019
Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest … [Read more...]
PRECISION MEDICINE
Myriad Genetics Pays $9.1 Million to Settle Hereditary Cancer Test False Billing Claims
August 26, 2019
In March 2018, Myriad Genetics got a piece of mail no lab provider ever wants to see in its inbox: an OIG subpoena asking for billing records in connection with "an investigation into possible false … [Read more...]
CMS
Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform
August 26, 2019
Like the rest of the health care industry, labs need more not fewer new and modern Anti-Kickback Statute (AKS) safe harbors. So, the OIG's decision to cancel new safe harbors in incubation seems like … [Read more...]
PAMA
Business Trends: More Hospitals Looking to Outsource Their Lab Testing
August 26, 2019
'Looking for new business opportunities? A new survey shows a substantial jump in the number of hospitals looking to outsource lab services. creating potential opportunity for labs. Although no … [Read more...]
LEGISLATION
New Laws: Congress Tables Bill to Make Whole-Genome Sequencing Available to Medicaid Kids
August 26, 2019
In early August, Representatives Scott Peters (D-CA) and John Shimkus (R-IL) introduced in the US House of Representatives a bill to provide "certain undiagnosed children under the Medicaid program" … [Read more...]
INDUSTRY BUZZ
Google This: Labs Partner with Tech Giant
July 28, 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...]
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...]
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...]
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...]
