Laboratory/Pathology

Molecular Pathology: Claims Review and Supporting Information to Submit on the Claim

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Molecular Pathology: Claims Review and Supporting Information to Submit on the Claim

National Government Services reminds all providers that many applications of the molecular pathology procedures are not covered services by Medicare given a lack of a Medicare benefit category in the Social Security Act (e.g., preventive service or screening for a genetic abnormality in the absence of a suspicion of disease) and/or failure to meet the reasonable and necessary threshold for coverage (e.g., based on quality of clinical evidence and strength of recommendation or when the results would not reasonably be used in the management of a beneficiary). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service may not have been audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary.

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Prepayment and/or Post Payment Review

Certain molecular pathology procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit by NGS or other Medicare contractors. Molecular pathology tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or result in early death (e.g., Canavan disease) may be subject to denial since these tests are not usually relevant to a Medicare beneficiary.

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Tier 2 Codes

All Tier 2 codes in the CPT code range of 81400–81479 must be described in the Remarks section of the claim and must include:

  • Clear identification of the unique molecular pathology procedure performed: this must clearly identify the gene being tested.
  • When multiple procedure codes are submitted on a claim (unique and/or unlisted), the documentation supporting each code should be easily identifiable.
  • Please note that NGS does not recognize or use MolDX codes.

Upon review, if the contractor cannot link a billed code to the documentation, these services will be rejected or denied.

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Unlisted Molecular Pathology Procedure

Providers are required to code to the highest specificity. If the gene tested is not listed under one of the Tier 2 codes or is not represented by a Tier 1 code in CPT, use of the NOC CPT code 81479 (unlisted molecular pathology procedure) is required. When CPT 81479 (unlisted molecular pathology procedure) is used the documentation in the Remarks section of the claim must include:

  • Clear identification of the unique molecular pathology test(s) performed.
  • When multiple test codes are submitted on a claim (unique and/or unlisted), the documentation supporting each code should be easily identifiable.
  • Also note: For these tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation
  • Upon review, if the contractor cannot link a billed code to the documentation, these services will be rejected or denied.

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Additional Documentation Reminder

The patient’s full medical record should not be necessary to support the tests billed. Therefore, when responding to a request for additional information please limit your documentation to relevant information that supports the tests billed. Such medical records should clearly document the molecular diagnostic test and reason for its performance.

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FISS DDE Remarks Information

FISS DDE information: The FISS Remarks Field (MAP1714) on claim page 04 is a 78-position alphanumeric field with ten lines available. Providers may utilize the <F6/PF6> key to scroll forward for two additional pages of remarks space, if needed. Thus, there are ten lines per each of three pages available. Therefore, 78 spaces x 10 lines per page is 780 x 3 = 2340 spaces.

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Reviewed 9/3/2024