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

Medicare permits pathologists to order molecular diagnostic tests only under specified exemptions to the 'treating physician' requirement (IOM 100-02 §§80.6.3–80.6.5), most commonly when evaluating a submitted specimen without a prior specific test order or when additional testing is medically necessary and delays would harm the beneficiary. Test requisition forms that include complete qualifying clinical information can substitute for an ordering provider's documentation; electronic signatures are acceptable, but pathologists must meet all applicable §80.6.5 criteria and fully document medical necessity and communication of results to avoid improper payment or denial.

"Pathologists may order molecular diagnostic services when they fall under exemptions to the 'treating physician' requirement as defined in IOM 100-02 Chapter 15 §§80."

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