Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer

A58187

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Contractor Information

Article Information

General Information

Article ID
A58187
Article Title
Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer
Article Type
Billing and Coding
Original Effective Date
07/25/2021
Revision Effective Date
07/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

Article Guidance

Article Text

The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer L38649

To report a service, please submit the following claim information:

  • Select the appropriate CPT® code
  • Enter 1 unit of service (UOS)
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form
  • Select the appropriate ICD-10-CM code

Coding Information

CPT/HCPCS Codes

Group 1

(6 Codes)
Group 1 Paragraph

If a test for FGFR2 and/or FGFR3 is performed as part of a panel, it must be billed as part of the panel.

Many of these codes refer to more than 1 possible gene. As such, these codes may be mentioned in unrelated coverage articles as well.

Group 1 Codes
CodeDescription
81401 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 2 (EG, 2-10 SNPS, 1 METHYLATED VARIANT, OR 1 SOMATIC VARIANT [TYPICALLY USING NONSEQUENCING TARGET VARIANT ANALYSIS], OR DETECTION OF A DYNAMIC MUTATION DISORDER/TRIPLET REPEAT)
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDENT REACTIONS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 2-5 EXONS)
81404 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 5 (EG, ANALYSIS OF 2-5 EXONS BY DNA SEQUENCE ANALYSIS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 6-10 EXONS, OR CHARACTERIZATION OF A DYNAMIC MUTATION DISORDER/TRIPLET REPEAT BY SOUTHERN BLOT ANALYSIS) UGT1A1 (UDP GLUCURONOSYLTRANSFERASE 1 FAMILY, POLYPEPTIDE A1) (EG, HEREDITARY UNCONJUGATED HYPERBILIRUBINEMIA [CRIGLER-NAJJAR SYNDROME]) FULL GENE SEQUENCE
81445 TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN NEOPLASM, DNA ANALYSIS, AND RNA ANALYSIS WHEN PERFORMED, 5-50 GENES (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), INTERROGATION FOR SEQUENCE VARIANTS AND COPY NUMBER VARIANTS OR REARRANGEMENTS, IF PERFORMED
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
0016M ONCOLOGY (BLADDER), MRNA, MICROARRAY GENE EXPRESSION PROFILING OF 219 GENES, UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS MOLECULAR SUBTYPE (LUMINAL, LUMINAL INFILTRATED, BASAL, BASAL CLAUDIN-LOW, NEUROENDOCRINE-LIKE)

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(9 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
C67.0 Malignant neoplasm of trigone of bladder
C67.1 Malignant neoplasm of dome of bladder
C67.2 Malignant neoplasm of lateral wall of bladder
C67.3 Malignant neoplasm of anterior wall of bladder
C67.4 Malignant neoplasm of posterior wall of bladder
C67.5 Malignant neoplasm of bladder neck
C67.6 Malignant neoplasm of ureteric orifice
C67.7 Malignant neoplasm of urachus
C67.8 Malignant neoplasm of overlapping sites of bladder

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

CodeDescription
999x Not Applicable

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
07/01/2022 R3

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0016M. This revision is due to the Q3 2022 CPT/HCPCS Code Update and is effective on July 1, 2022.

01/01/2022 R2

Under CPT/HCPCS Code Group 1: Codes the description was revised for 0016M. The revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on January 1, 2022. 

09/30/2021 R1

Under Article Text deleted #1 Verbiage regarding coverage for Decipher Bladder criteria and #2 verbiage related to coverage for tests FGFR2 and FGFR2. This revision included the removal of the fourth bullet to remove cystectomy. Formatting, punctuation and typographical errors were corrected throughout the article.

Associated Documents

Related National Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
07/27/2022 07/01/2022 - N/A Currently in Effect You are here
01/14/2022 01/01/2022 - 06/30/2022 Superseded View
10/20/2021 09/30/2021 - 12/31/2021 Superseded View
06/03/2021 07/25/2021 - 09/29/2021 Superseded View

Keywords

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