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

Pathologists may order molecular diagnostic tests when they meet the treating-physician exemptions in IOM 100-02 Chapter 15 (especially §80.6.5), including when diagnosing from submitted specimens without a specific test order or when additional testing is urgently medically necessary. Test requisition forms can suffice to establish medical necessity if they contain complete qualifying clinical information, electronic signatures are acceptable, and all orders must otherwise comply with 42 C.F.R. §410.32(b); insufficient documentation may lead to denial.

"A pathologist may order molecular diagnostic tests when the order falls under the treating-physician exemptions in IOM 100-02 Chapter 15 §§80."

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