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
XiFin’s Payor Rate Transparency Monitor Helps Clinical Labs Compare In-Network Rates
The free online tool can set a foundation for renewed reimbursement strategies and contract negotiations with insurance carriers
Recent Decision in FCA Case Has Key Implications for Labs
The decision deepens a split among circuit courts regarding how to determine liability for false claims
MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
Labcorp, Quest, and ARUP Develop Bird Flu Tests with CDC Help
The assays were developed with the CDC as part of recent trend of public-private partnerships to improve pandemic preparedness
Implementing Accessible On-Demand Testing: A Lab Director’s Experience
On-demand testing doesn’t require registration, billing, or scheduling, keeping costs low while collecting “real” dollars upfront
Dx Deals: Could Health Coaching Be a New Opportunity for Labs?
Quest Diagnostics will find out as it launches a new health coaching business that relies on lab testing, via its Pack Health subsidiary
Reimbursement Top Challenge for Labs in 2025
ACLA president Susan Van Meter discusses some of the key issues labs faced in 2024, along with work to address these developments through 2025
Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Reimbursing Genetic Counselors in the Clinical Lab
Sara Pirzadeh-Miller offers advice on overcoming the reimbursement barriers genetic counselors face in the clinical lab and beyond
POC Testing: More FDA Approved Tests Than Ever, But Will Labs Be Reimbursed?
Revenue cycle management leaders provide their thoughts on how lab leaders may want to proceed when it comes to POC tests
