LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: EndoPredict® Breast Cancer Gene Expression Test

A57607

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A57607
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: EndoPredict® Breast Cancer Gene Expression Test
Article Type
Billing and Coding
Original Effective Date
11/01/2019
Revision Effective Date
11/04/2021
Revision Ending Date
N/A
Retirement Date
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AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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 which lacks the necessary information to process the claim.

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

CMS Internet-Only Manuals, Publication 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, 60.1.2 Independent Laboratory Specimen Drawing, 60.2. Travel Allowance.

CMS Internet Online Manual Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 §Section 10 Reporting ICD Diagnosis and Procedure Codes.

Article Guidance

Article Text

The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDx: EndoPredict Breast Cancer Gene Expression Test.

To report an EndoPredict® service, please submit the following claim information:

  • Select CPT® code 81522
  • 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

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
999x Not Applicable
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

(1 Code)
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Group 1 Codes
Code Description
81522 ONCOLOGY (BREAST), MRNA, GENE EXPRESSION PROFILING BY RT-PCR OF 12 GENES (8 CONTENT AND 4 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS RECURRENCE RISK SCORE
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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(16 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
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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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
999x Not Applicable
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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.

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Code Description
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Other Coding Information

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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
11/04/2021 R4

Updated to indicate this article is an LCD Reference Article.

11/04/2021 R3

Under ICD-10-CM Codes that Support Medical Necessity Group 1: Codes deleted C50.911 and C50.912 

Under article text added select CPT® code 81522 

Under Article Text: Added The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDx: EndoPredict Breast Cancer Gene Expression Test.  

07/11/2021 R2

The related LCD MolDX: EndoPredict Breast Cancer Gene Expression Test is being presented for notice.

Under CMS National Coverage Policy added CMS Internet-Only Manuals, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories.

01/01/2020 R1

01/01/2020: This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related MolDX: ProMark Risk Score LCD and placed in this article.

Under Article Text removed CPT® 81599 and added CPT® 81522. Under CPT/HCPCS Codes Group 1: Codes deleted CPT® code 81599.

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81522. This revision is due to the 2020 Annual CPT®/HCPCS Code Update and becomes effective on January 1, 2020.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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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Public Versions
Updated On Effective Dates Status
11/22/2023 11/04/2021 - N/A Currently in Effect You are here
11/23/2021 11/04/2021 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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