Lab Industry Hit by New Wave of Layoffs
Cost cutting and restructuring has become the order of the day for many lab companies.
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Researchers Report First “Routine Clinical Use” of AI for Breast Biopsies
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
Lab Compliance Will Change When Public Health Emergency Ends
Your current COVID-19 testing arrangements may no longer be compliant on May 11.
Weekly Enforcement Report: Telemedicine Scheme Trend Continues
Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
The 2022 Year in FDA 510(k) Approvals
Roche and Abbott received the most approvals for new lab tests last year.
Weekly Enforcement Report: Medical Equipment & Kickbacks
While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.
CMS to Crack Down on False Billing of COVID-19 Add-on Tests
Some labs took advantage of COVID coverage rules to bill Medicare for medically unnecessary RPPs, allergy, and genetic tests.
New Cancer Diagnostic Tests Stand Out
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
ACMG Recommends NIPS for Common Fetal Trisomies
The new practice guideline also recommends NIPS to screen for fetal sex chromosome aneuploidy.
Weekly Enforcement Report: Lab Owner Gets Prison Time for UDT Fraud
In last week’s key cases, those involved in UDT fraud schemes face the music, and a doctor is convicted of stealing COVID relief money.
North American Leaders Commit to Better Pandemic Preparedness
The recent Declaration of North America makes updating the current North American Plan for Animal and Pandemic Influenza a priority.
No Surprises Act Payment Disputes Are Getting Out of Hand, CMS Says
Dispute resolution mechanism is being overwhelmed by unexpected case volume and complexity.
Weekly Enforcement Report: A Biotech Outlier
While most recent cases were the usual FCA and kickback-related issues, one involved the mischarging of federal grants by two biotech companies and their co-founder.
