TAG:
genetic testing registry
Top 10 Lab Stories for 2024 Reflect Important Trends
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…
UnitedHealth’s Lab Test Registry Implementation Delayed Again
ANOTHER DELAY WAS ANNOUNCED FOR IMPLEMENTATION of UnitedHealthcare’s Laboratory Test Registry Protocol, which requires clinical laboratories to register each of their tests with the health insurer. This latest delay likely is the result of operational issues on behalf of the managed care com…
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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