LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Oncotype DX® Colon Cancer Assay Update

A54196

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54196
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Oncotype DX® Colon Cancer Assay Update
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/22/2023
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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

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Article Guidance

Article Text

The Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence risk for patients with Stage II colon cancer, has been assigned a unique identifier. To bill an Oncotype DX Colon service, please provide the following claim information:

  • CPT code 81525-Oncology (colon), mRNA gene expression of 21 genes
  • Enter “1” in the Days/Unit field
  • For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
      • 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
      • Box 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:

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(13 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.1 Malignant neoplasm of anal canal
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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ICD-10-PCS Codes

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Group 1 Codes

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Additional ICD-10 Information

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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.

Code Description

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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.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/22/2023 R15

Revision Effective: 11/22/2023
Revision Explanation: Updated LCD Reference Article section.

09/23/2021 R14

Revision Effective: 09/23/2021
Revision Explanation: Annual review, updated name of article removed guidelines and added assay update.

10/03/2019 R13

Revision Effective: N/A
Revision Explanation: Annual review no changes made.

10/03/2019 R12

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

04/27/2017 R11

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2015 R10

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

04/27/2017 R9 Revision Effective date: 04/27/2017
Revision Explanation: Updated Part A and Part B billing instructions.
10/01/2015 R8 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
01/01/2016 R7 Revision Effective: N/A
Revision Explanation: Removed old code 81479 since 81525 was established for this test in 2016.
10/01/2015 R6 Revision Effective: 10/01/2015
Revision explanation: Changed MolDX ID field to SV101-7 and Z-code to ZCode™ Identifier.
10/01/2015 R5 Revision Effective: 10/01/2015
Revision Explanation: Added the information for Part B concerning the new MolDX identifier field and new 2016 code 81525.
10/01/2015 R4 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: 10/01/2015
Revision Explanation: Corrected to show should use assigned ID instead of name of test and added Part A information.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
11/15/2023 11/22/2023 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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