know error® Coding and Billing Guidelines (CM00070)
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October 27, 2015 - Revised: 08.09.17

know error® Coding and Billing Guidelines (CM00070)

The know error® DNA Specimen Provenance Assay is a forensic assay to confirm that a surgical specimen belongs to the patient evaluated for treatment. Although MolDX agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling, tests performed to measure the quality of a process do not provide information to diagnose or treat a patient illness or injury as defined in the Medicare benefit category. Therefore, the know error® DNA Specimen Provenance Assay is a statutorily excluded test. Although an Advance Beneficiary Notice of Non-Coverage (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.

To receive a DNA Specimen Provenance Assay service denial, please submit the following claim information:

  • CPT code 84999 – unlisted chemistry procedure
  • An Advance Beneficiary Notice of Non-Coverage (ABN)External Website is not required for statutorily excluded services.
    • For a voluntary issued ABN, append with HCPCS modifier GX
    • To indicate a valid ABN is on file for a known statutorily excluded service, append with HCPCS modifier GY
  • Select the appropriate diagnosis for the patient
  • Enter the DEX Z-code identifier adjacent to the CPT code 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)

If you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:

  • Complete a Self-Audit
  • Identify incorrect submissions contain further claim submission errors
  • Consider Self-Disclosure Protocol (self-disclosure guidelines available on the website )

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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