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
New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
2023 Lab Industry Layoffs: Where Do Things Stand?
An overview of the layoffs announced by major lab diagnostic companies in the first half of 2023 and the key trends.
Expert Discusses Key Developments in Breath Biopsy
Owlstone Medical CEO discusses recent trends, the advantages of breath testing, and the challenges that must be met for wider clinical use.
SCOTUS Ruling May Save Labs from Baseless Qui Tam Lawsuits
The recent 8-1 decision expands the DOJ’s power to request such cases be thrown out.
Insights into Attracting Top Talent to Your Lab
Lab staffing expert shares three key strategies for recruiting and retaining talent during difficult economic times.
Could SALSA Pass This Year?
Lab industry insiders say they’re confident the Saving Access to Laboratory Services Act (SALSA) will pass in 2023.
Weekly Enforcement Report: Big Settlements but Lab Cases Scarce
While the last few weeks haven’t seen many lab-related enforcement actions, several healthcare companies had to pay big.
Supporting Medical Labs During Tough Economic Times
G2 Intelligence’s June 13-14 virtual event offers expert advice to help labs navigate today’s economic challenges.
How Super-Clean Orders Could Disrupt Health Care
Two recent panel discussions focused on why super-clean orders are important in health care and the challenges that currently prevent them.
Weekly Enforcement Report: Drug Testing Fraud Dominates
Last week’s three key cases included two involving drug testing that was either medically unnecessary, or not provided at all.
