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Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
Roche and Abbott received the most approvals for new lab tests last year.
While labs were absent from recent enforcement actions, last week saw kickback schemes involving DME companies and a medical device company.
Some labs took advantage of COVID coverage rules to bill Medicare for medically unnecessary RPPs, allergy, and genetic tests.
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
The new practice guideline also recommends NIPS to screen for fetal sex chromosome aneuploidy.
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.
The recent Declaration of North America makes updating the current North American Plan for Animal and Pandemic Influenza a priority.
Dispute resolution mechanism is being overwhelmed by unexpected case volume and complexity.
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.