SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer

A58700

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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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To see the currently-in-effect version of this document, go to the section.

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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58700
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
Article Type
Billing and Coding
Original Effective Date
07/03/2022
Revision Effective Date
11/02/2023
Revision Ending Date
03/20/2024
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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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

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 Manual, Pub. 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: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer L38985.

To report a Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer 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
    • 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

NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.

Additional information:

  • Only one molecular biomarker test may be performed per date of service.
  • Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

The following tests may be billed in the post-biopsy setting (after a negative or non-malignant biopsy, as defined in the policy) for individuals contemplating a repeat biopsy:

  • Progensa PCA3 assay (CPT 81313), performed on post-digital rectal exam (DRE) urine specimens
  • ConfirmMDx assay (CPT 81551), performed on formalin-fixed, paraffin embedded (FFPE) tissue specimens.

 

Group 1 Codes
Code Description
81313 PCA3/KLK3 (PROSTATE CANCER ANTIGEN 3 [NON-PROTEIN CODING]/KALLIKREIN-RELATED PEPTIDASE 3 [PROSTATE SPECIFIC ANTIGEN]) RATIO (EG, PROSTATE CANCER)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
81551 ONCOLOGY (PROSTATE), PROMOTER METHYLATION PROFILING BY REAL-TIME PCR OF 3 GENES (GSTP1, APC, RASSF1), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A LIKELIHOOD OF PROSTATE CANCER DETECTION ON REPEAT BIOPSY

Group 2

(1 Code)
Group 2 Paragraph

The following test may be billed in the pre-biopsy setting as defined in the policy:

SelectMDx assay (PLA 0339U), performed on post-digital rectal exam (DRE) urine specimens.

Group 2 Codes
Code Description
0339U ONCOLOGY (PROSTATE), MRNA EXPRESSION PROFILING OF HOXC6 AND DLX1, REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR), FIRST-VOID URINE FOLLOWING DIGITAL RECTAL EXAMINATION, ALGORITHM REPORTED AS PROBABILITY OF HIGH-GRADE CANCER
N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Group 2

Group 2 Paragraph

N/A

Group 2 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(5 Codes)
Group 1 Paragraph

The following codes are covered

Group 1 Codes
Code Description
D29.1 Benign neoplasm of prostate
D40.0 Neoplasm of uncertain behavior of prostate
N40.2 Nodular prostate without lower urinary tract symptoms
N40.3 Nodular prostate with lower urinary tract symptoms
R97.20 Elevated prostate specific antigen [PSA]

Group 2

(5 Codes)
Group 2 Paragraph

The following codes are covered

Group 2 Codes
Code Description
D29.1 Benign neoplasm of prostate
D40.0 Neoplasm of uncertain behavior of prostate
N40.2 Nodular prostate without lower urinary tract symptoms
N40.3 Nodular prostate with lower urinary tract symptoms
R97.20 Elevated prostate specific antigen [PSA]
N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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.

Code Description
N/A

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
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/02/2023 R1

Under Article Text revised the 3rd and 6th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”. Added “NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line”. Under subheading Additional information deleted third sentence and Table 1. This revision is effective 11/2/2023.

Under CPT/HPCS Codes Group 2: Paragraph added “The following test may be billed in the pre-biopsy setting as defined in the policy: SelectMDx assay (PLA 0339U), performed on post-digital rectal exam (DRE) urine specimens”. Under CPT/HCPCS Codes Group 2: Codes added 0339U. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph added “The following codes are covered”. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added D29.1, D40.0, N40.2, N40.3, and R97.20. The revision is due to new covered assay that has successfully completed a TA and is effective 2/17/2023.

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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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Other URLs
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Public Versions
Updated On Effective Dates Status
03/12/2024 03/21/2024 - N/A Currently in Effect View
10/26/2023 11/02/2023 - 03/20/2024 Superseded You are here
05/13/2022 07/03/2022 - 11/01/2023 Superseded View

Keywords

  • Biomarkers for Prostate Cancer