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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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: The Expanding Role of Z-Codes
Labs will have to submit Z-Codes with every molecular pathology testing code billed to UnitedHealthcare, starting Aug. 1.
August 2023 Labs in Court
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
Addressing the Challenges of Bile Acid Diarrhea Diagnosis
A new five-metabolite blood test designed by algorithm could simplify and speed up this challenging diagnosis.
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
Can Ophthalmic Biomarkers Offer Insights into Brain Pathologies?
Protein levels in the vitreous humor may have the potential to support the diagnosis and staging of neurodegenerative diseases.
Simplifying At-Home Tests with AI
A new assay uses AI-optimized enzymes to simplify and increase the accuracy of rapid pathogen detection.
Combating Cervical Cancer: Where Do We Stand?
Accessible screening tests and inclusive management strategies may limit the global cervical cancer incidence rate.
The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
