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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Change and Constancy: The 2025 CLFS Update
The 2025 CLFS update—what has changed, what has stayed the same, and what that means for diagnostic test reimbursement in 2025
An Automated Assist in Revenue Cycle Management
How automation, artificial intelligence, and other emerging technologies are elevating the efficiency and output of labs’ revenue cycles
FTC’s Ban of Noncompete Agreements Halted
With the rule recently struck down by a Texas court, how should employers, including labs, handle such agreements going forward?
Six Sigma Can Help Monitor New CLIA Proficiency Testing Changes
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
2024 Laboratory Reimbursement Trends and What to Expect in 2025
Revenue cycle management experts weigh in on the biggest developments of 2024 and how labs can best prepare for 2025 and beyond
Labs in Court: A Full Circle
Cases filed or resolved by the U.S. Department of Justice in the fourth quarter reveal the same compliance issues from early in 2024
Staffing: 2024’s Biggest Lab Operations Challenge
ADLM president Anthony Killeen looks at labs’ staffing struggles in 2024 and what can be done to alleviate them in the coming year
FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Labs in Court: A Focus on Individual Accountability
Recent False Claims Act settlements underscore the government’s emphasis on individual accountability in healthcare fraud matters
