MolDX: Clarification of Order Requirements for Laboratory and Molecular Diagnostic services

Medicare covers laboratory and molecular diagnostic services when ordered by a treating physician per IOM 100-02 §80.6.1 and 42 CFR §410.32(b), but pathologists may place orders under specified IOM exemptions (§§80.6.3–80.6.5), including when diagnosing a submitted sample without a prior specific test order. Test requisition forms may serve as sufficient documentation if they include qualifying clinical information; electronic signatures are acceptable if they attest to the physician's order, but insufficient documentation or lack of evidence of intent may lead to denial or improper payment.

"Laboratory and molecular diagnostic services are covered when ordered by a treating physician as defined in IOM 100-02 Chapter 15 §80."

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