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

Medicare requires laboratory and molecular diagnostic tests be ordered by a treating physician per IOM 100-02 §80.6.1 and 42 CFR §410.32(b), but pathologists may order tests under specific IOM exemptions (§§80.6.3–80.6.5), especially for unsolicited specimens or when additional testing is urgently medically necessary. Test requisition forms are part of the medical record and may suffice to establish medical necessity if they contain qualifying clinical information; electronic signatures are acceptable and wet signatures are not required, though insufficient documentation commonly leads to improper payment.

"Services are covered when ordered by a treating physician as defined in IOM 100-02 Chapter 15 §80."

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