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Labs Should Prepare for Arrival of ‘Perfect Storm’

Three significant dynamics are poised to reshape how labs comply with FDA and CLIA, and get claims paid

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming reforms and updates to the 1992 CLIA rules. …

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