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October 19, 2015 - Updated 08.14.17

PreDx® Coding and Billing Guidelines (CM00040)

The MolDX Team has determined that PreDx® Diabetes Risk Score (DRS) developed by Tethys Bioscience, Inc., has insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the PreDx® Diabetes Risk Score (DRS) is a statutorily excluded service.

To receive a PreDx service denial, please submit the following claim information:

  • CPT code 81506 – Endocrinology, biochemical assays of seven analytes
  • An Advance Beneficiary Notice of Non-Coverage (ABN)External website is not required for statutorily excluded services
  • Select the appropriate diagnosis for the patient
  • Enter the assigned DEX Z-Code Identifier in the comment/narrative field for the following claim field/types:
    • Part A: Loop 2300 NTE 01/ SV202-7 (electronic claim); Form Locator 80 (paper claim)
    • Part B: Loop 2400 or SV101-7 (electronic claim); Item 19 (paper claim)

Reference: Sec. 1862 (1)(A) Statutory Exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,…"

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