Local Coverage Article Billing and Coding

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

A58713

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Contractor Information

Article Information

General Information

Article ID
A58713
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
07/17/2022
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
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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 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 L38997.

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

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.

The following test have met the coverage criteria of the policy:

Trst (Manufacturer) and CPT code Methodology Specimen Source Intended Use Comments

Progensa PCA3 (Metamark – formerly Hologic Gen-Probe)

CPT 81313

mRNA expression assay Urine
(1st urine following a Digital Rectal Exam (DRE))
To avoid repeat biopsy after previous negative or non-malignant biopsy (as defined in the policy)  

ConfirmMDx (MDxHealth)

CPT 81551

Epigenetic (methylation) assay Formalin-fixed, paraffin embedded (FFPE) tissue To avoid repeat biopsy after previous negative or non-malignant biopsy (as defined in the policy)  

Coding Information

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
CodeDescription
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

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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
CodeDescription
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]

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

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.

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.

N/A

Other Coding Information

N/A

Revision History Information

N/A

Associated Documents

Related National Coverage Documents
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Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
05/26/2022 07/17/2022 - N/A Currently in Effect You are here

Keywords

  • Biomarkers for Prostate Cancer