SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: ResponseDX Tissue of Origin®

A54198

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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
A54198
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: ResponseDX Tissue of Origin®
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/16/2023
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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text

Tissue of Origin®, a microarray-based gene expression assay designed to determine the similarity of unknown or unresolved tumors to cancers from 1 of 15 known tumors of origin, has been assigned a unique identifier. To bill for Tissue of Origin services, please provide the following claim information:

  • CPT® code 81504 – Oncology (tissue of origin)
  • Enter “1” in the Days/Unit field
  • Select the appropriate ICD-10-CM diagnosis.
  • Enter 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 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

Note: MolDX expects this test to ONLY be ordered by the treating physician.

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(115 Codes)
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Group 1 Codes
Code Description
C18.1 Malignant neoplasm of appendix
C18.9 Malignant neoplasm of colon, unspecified
C22.0 Liver cell carcinoma
C22.2 Hepatoblastoma
C22.3 Angiosarcoma of liver
C22.4 Other sarcomas of liver
C22.7 Other specified carcinomas of liver
C22.8 Malignant neoplasm of liver, primary, unspecified as to type
C22.9 Malignant neoplasm of liver, not specified as primary or secondary
C25.2 Malignant neoplasm of tail of pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C33 Malignant neoplasm of trachea
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C45.9 Mesothelioma, unspecified
C47.0 Malignant neoplasm of peripheral nerves of head, face and neck
C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified
C48.0 Malignant neoplasm of retroperitoneum
C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck
C49.9 Malignant neoplasm of connective and soft tissue, unspecified
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C61 Malignant neoplasm of prostate
C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.2 Malignant neoplasm of left kidney, except renal pelvis
C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis
C67.5 Malignant neoplasm of bladder neck
C67.9 Malignant neoplasm of bladder, unspecified
C76.0 Malignant neoplasm of head, face and neck
C77.0 Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck
C77.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes
C77.2 Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes
C77.3 Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes
C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes
C77.5 Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes
C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions
C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified
C78.00 Secondary malignant neoplasm of unspecified lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung
C78.5 Secondary malignant neoplasm of large intestine and rectum
C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.00 Secondary malignant neoplasm of unspecified kidney and renal pelvis
C79.01 Secondary malignant neoplasm of right kidney and renal pelvis
C79.02 Secondary malignant neoplasm of left kidney and renal pelvis
C79.2 Secondary malignant neoplasm of skin
C79.31 Secondary malignant neoplasm of brain
C79.51 Secondary malignant neoplasm of bone
C79.52 Secondary malignant neoplasm of bone marrow
C79.60 Secondary malignant neoplasm of unspecified ovary
C79.61 Secondary malignant neoplasm of right ovary
C79.62 Secondary malignant neoplasm of left ovary
C79.63 Secondary malignant neoplasm of bilateral ovaries
C79.89 Secondary malignant neoplasm of other specified sites
C79.9 Secondary malignant neoplasm of unspecified site
C80.0 Disseminated malignant neoplasm, unspecified
C80.1 Malignant (primary) neoplasm, unspecified
C82.57 Diffuse follicle center lymphoma, spleen
C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen
C84.97 Mature T/NK-cell lymphomas, unspecified, spleen
C85.17 Unspecified B-cell lymphoma, spleen
C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen
C85.87 Other specified types of non-Hodgkin lymphoma, spleen
C85.97 Non-Hodgkin lymphoma, unspecified, spleen
C86.1 Hepatosplenic T-cell lymphoma
D01.5 Carcinoma in situ of liver, gallbladder and bile ducts
D01.7 Carcinoma in situ of other specified digestive organs
D01.9 Carcinoma in situ of digestive organ, unspecified
D02.20 Carcinoma in situ of unspecified bronchus and lung
D02.21 Carcinoma in situ of right bronchus and lung
D02.22 Carcinoma in situ of left bronchus and lung
D03.51 Melanoma in situ of anal skin
D03.52 Melanoma in situ of breast (skin) (soft tissue)
D03.59 Melanoma in situ of other part of trunk
D49.0 Neoplasm of unspecified behavior of digestive system
D49.1 Neoplasm of unspecified behavior of respiratory system
D49.2 Neoplasm of unspecified behavior of bone, soft tissue, and skin
D49.3 Neoplasm of unspecified behavior of breast
D49.4 Neoplasm of unspecified behavior of bladder
D49.511 Neoplasm of unspecified behavior of right kidney
D49.512 Neoplasm of unspecified behavior of left kidney
D49.6 Neoplasm of unspecified behavior of brain
D49.7 Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system
D49.89 Neoplasm of unspecified behavior of other specified sites
D49.9 Neoplasm of unspecified behavior of unspecified site
J91.0 Malignant pleural effusion
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

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Group 1 Codes

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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
11/16/2023 R16

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

10/01/2021 R15

Revision Effective date: 10/01/2021
Revision Explanation: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3 and C79.63. This revision is due to the Annual ICD-10 update and will become effective on 10/1/21.

10/03/2019 R14

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

10/03/2019 R13

Revision Effective date: 10/31/2019
Revision Explanation: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Under Article Title changed title from “MolDx: ResponseDX Tissue of Origin® Coding and Billing Guidelines” to “Billing and Coding: MolDx: ResponseDX Tissue of Origin®”. Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81504. CPT® was inserted throughout the article where applicable.

10/03/2019 R12

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

08/24/2017 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

08/24/2017 R9

Revision Effective date: 08/24/2017
Revision Explanation: Added ICD-10 D49.7 t group 1 codes that support medical necessity.

07/20/2017 R8

Revision Effective date: 07/20/2017
Revision Explanation: Added DEX Z-Code identifier information instead of Z-identifier.

10/01/2015 R7 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2016 R6 Revision Effective: 10/01/2016
Revision Explanation: During annual ICD-10 update D49.5 was deleted and replaced with D49.511 and D49.512. Removed table of diagnois codes from text since they are listed in the ICD-10 that shows medical necessity section.
10/01/2015 R5 Revision Effective: 10/01/2015
Revision explanation: Changed MolDX ID field to SV101-7 and Z-code to ZCode™ Identifier.
10/01/2015 R4 Revision Effective: 10/01/2015
Revision Explanation: Added the information for Part B concerning the new MolDX identifier field and corrected code 81479 to 81504.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop 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 2
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
05/30/2024 11/16/2023 - 05/30/2024 Retired View
11/07/2023 11/16/2023 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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