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

This policy clarifies that pathologists may order molecular diagnostic tests only when specific exemptions to the 'treating physician' requirement apply (IOM 100-02 Chapter 15 §§80.6.3–80.6.5) and only if they meet the exemption criteria (reasonable and necessary, documented rationale, and results communicated). Test requisition forms with complete qualifying clinical information may suffice as documentation, electronic signatures are acceptable, but insufficient requisitions or lack of other evidence of intent can make orders non-covered; additional documentation should be obtained when needed.

"Pathologists may order molecular diagnostic services when the order falls under exemptions to the 'treating physician' requirement per IOM 100-02 Chapter 15 §§80."

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