Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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”
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
Billing & Coding: What to Know About New Category III CPT Codes for Digital Pathology
The new codes have garnered attention as a future mechanism for additional reimbursement and thus deserve further discussion.
Compliance Perspectives: How to Perform Excluded Provider Checks
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
Expert Q&A: Trends in Precision Medicine
Christian Olsen, a leader in R&D scientific software, discusses recent developments related to AI and solutions to current precision medicine challenges.
The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
Investigating the Cause of the 2022 Severe Acute Hepatitis Outbreak in Children
AAV2 virus detected with metagenomics, TE sequencing, and PCR in non-A–E hepatitis cases from two cohorts in Scotland/the UK and the US.
New Blood-Based PTSD Biomarkers Revealed
A simple blood test may help screen, identify, intervene, treat, monitor, and eventually, prevent PTSD.
Kentucky $1.74 Million Settlement Illustrates the Danger of Billing Medicare for Nonmedical Urine Drug Tests
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
Preparing for or Considering Sale: The Anatomy of a Deal and Maximizing Your Opportunity
This panel will help laboratory owners make decisions now to be better positioned in the future for a potential sale.
4 Things to Know About the End of the COVID-19 PHE
The end of the COVID-19 public health emergency on May 11 also brings certain flexibilities for labs and other providers to an end.
Prostate Cancer: National Guidelines Have Not Stopped Overuse of Low-Value PSA Screening in Older Males
New research suggests that the call to rein in low-value prostate cancer screening seems to be falling on deaf ears.
