Does a CLIA certificate tell me what insurance to buy?
No. CMS’s CLIA guidance concerns laboratory testing and certificates; it does not determine policy coverage. Use the facility’s testing role to describe operations, then ask the broker to identify the terms that apply to your services and products.
Tell the broker whether you report patient-specific results, provide interpretation, and sell an IVD. Those details distinguish a testing service from a product maker in the source guidance.1,2
Ask for the actual forms and exclusions for testing errors, product allegations, and lab equipment. Describe the lab’s certification status and the product’s classification separately in the application.3,7
Read the Diagnostics Insurance Buying Guide
Sources and Further Reading for Diagnostics
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