FDA

LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

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?

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

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

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

'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

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

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

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

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

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...]


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