3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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 flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.
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.