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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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
Lab Industry Earnings Take a Beating in the Fourth Quarter
Drying COVID-19 testing demand drove revenues down, but not as much as expected.
Federal Court Tosses Consumer Fraud Lawsuit Against Labcorp
Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.
Weekly Enforcement Update: Inflated Claims Are a Key Theme
Though last week’s cases didn’t involve labs or lab testing, most were FCA-related issues including inflated claims.
Labs Partner with Pharma for New Companion Diagnostics Tests
Specially crafted lab tests speed up adoption of novel drug treatments.
Lab Companies See Mixed Bag of Financial Results in Q4 2022
Q4 2022 financial results released by three key lab companies over the past week mainly included losses, but there were positives as well.
No Routine Lipid Screening for Asymptomatic Children, Says USPSTF
Influential panel cites lack of evidence of tests’ harms and benefits.
Weekly Enforcement Report: 23 People Charged in 2 Big Fraud Schemes
Last week saw the usual False Claims Act and kickback-related charges, with the biggest action involving urine drug testing.
End of Public Health Emergency Won’t End COVID-19 EUAs
FDA will still be able to issue EUAs for COVID-19 tests after May 11.
A Better Test for Early Detection of Multiple Cancers?
A new method of early, multi-cancer detection could prove more effective for non-invasive screening than other emerging options.
Lab Industry Hit by New Wave of Layoffs
Cost cutting and restructuring has become the order of the day for many lab companies.
