LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: MammaPrint

A54194

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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
A54194
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: MammaPrint
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
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

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

MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.

The test can be performed using either a FDA-cleared in vitro microarray assay or a next generation sequencing (NGS)-based assay. Each assay has been assigned a unique Z-code identifier in the DEX Registry.

MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has demonstrated technically equivalent performance to the predicate microarray test.

To bill for MammaPrint® services, submit the following claim information:

  • 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. For dates of service on or after 1/1/2022, use CPT code 81523 for the test if performed by NGS.
    • 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

Only one test- NGS or microarray may be performed on a given date of service for a given patient.

Note: MolDX expects this test may be performed upon occasion twice per patient lifetime for bilateral disease. Should a patient experience an additional occurrence, coverage may be considered with supporting documentation through the appeal process.

 

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
81479 Unlisted molecular pathology
81521 Onc breast mrna 70 genes
81523 Onc brst mrna 70 cnt 31 gene
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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

(36 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male 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
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
Z17.0 Estrogen receptor positive status [ER+]
Z17.1 Estrogen receptor negative status [ER-]
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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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
11/22/2023 R16

Revision Effective: 11/22/2023

Revision Explanation: Updated LCD Reference Article section.

01/01/2022 R15

Revision Effective: 01/01/2022
Revision Explanation: Under Article Text deleted the first paragraph. The second paragraph was revised to read, “MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patient’s risk for distant metastasis” and a new third paragraph was added. The second bullet point was revised to add the verbiage, “For dates of service on or after 01/01/2022, use CPT code 81523 for the test if performed by NGS”. A new paragraph was added after verbiage regarding instructions on how to submit claims information. This revision is effective for dates of service on or after 1/1/2022.

Under CPT/HCPCS Codes Group 1: Codes added 81523. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on 1/1/2022.

10/08/2021 R14

Revision Effective: 10/08/2021
Revision Explanation: 

Under Article Text revised the first sentence to read, “MammaPrint®, a next-generation sequencing (NGS)-based diagnostic test that uses gene expression profiling to analyze the gene activity of the identified tumor, has been assigned a unique identifier” and revised the third sentence to read, “MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has demonstrated technically equivalent performance to the predicate microarray test”. Under CPT/HCPCS Codes Group 1: Codes added 81479. Mammaprint® was inserted throughout the article where applicable.

This revision is retroactive effective for dates of service on or after 10/8/2021.

10/31/2019 R13

Revision Effective: 09/23/2021
Revision Explanation: Annual review no changes made.

10/31/2019 R12

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

10/31/2019 R11

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: MammaPrint Billing and Coding Guidelines Update” to “Billing and Coding: MolDX: MammaPrint”. CPT® was inserted throughout the article where applicable.

10/03/2019 R10

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

05/01/2019 R9

Revision Effective date: 05/01/2019
Revision Explanation: Corrected formatting in text.

01/01/2018 R8

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

01/01/2018 R7

Revision Effective date: 01/01/2018
Revision Explanation: Replaced 81479 with new code during annual HCPCS update 81521.

 

10/01/2015 R6

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

04/27/2017 R5 Revision Effective date: 04/27/2017
Revision Explanation: Updated Part A and Part B billing instructions.
10/01/2015 R4 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
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: 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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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
11/14/2023 11/22/2023 - N/A Currently in Effect You are here
01/24/2022 01/01/2022 - 11/21/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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