LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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Articles and Reports
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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.
The Promise of Mobile Photoacoustic Imaging
The flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.
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.
