FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
The 14-Day Rule & Billing Medicare for Tests on Stored Specimens
While this reimbursement rule has been in effect since 2018, it can still be quite confusing; this article provides a guide to the basics.
Court Refuses to Dismiss EKRA Charges against Former Arrayit CEO
In this month’s Labs in Court roundup, Arrayit’s former president loses his bid to have EKRA charges dismissed, and more.
Take 14 Steps to Protect Lab Staff from Workplace Violence
While rules differ by state, the basic measures required to protect employees from workplace violence are pretty much the same everywhere.
Provide Lab Staff Training on Workplace Violence and Active Shooter Events
Part of the duty to protect workers is to ensure those at risk receive proper training on what to do if an active shooter incident occurs.
Theranos In Court: Balwani Lawyers Lose Bid to Exclude Damning Evidence
Legal team’s bid to dismiss part of CMS inspector’s testimony as hearsay is denied by the Northern District of California federal court.
Alleged Violation of Medicare’s 14-Day Rule Costs Company $2.8 Million
Caris Life Sciences agrees to pay $2.8 million to settle claims that it purposely delayed submitting lab tests to get around Medicare’s 14-day rule.
CMS Reschedules PAMA Reporting & Adds New PLA Codes
Here are the two key CLFS changes, set to take effect on July 1, 2022, that your billing staff needs to know about.
What the Federal COVID-19 Fraud Crackdown Means for Labs
If your lab received federal relief funds from the US government during the COVID-19 pandemic, you could be at risk of FCA lawsuits.
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
