Draft Local Coverage Article Billing and Coding

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

DA58724

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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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General Information

Source Article ID
A58724
Draft Article ID
DA58724
Draft Article Title
Billing and Coding: MolDX: Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
Article Type
Billing and Coding
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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: Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer.

Medical record documentation must indicate the rationale for performance of such diagnostic biomarker tests.

To report a 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 criteria:

  • Only one test may be performed per date of service.
  • The patient must not have an established diagnosis of prostate cancer.
  • The patient has not been previously tested using the same or similar biomarker tests from the same samples OR for the same clinical indication.
  • Once it is determined that the test is medically reasonable and necessary in a beneficiary, the medical record must support the medical necessity for the test and there must be documented evidence of shared decision making between the patient and provider.

Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

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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

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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

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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.

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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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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Associated Documents

Related National Coverage Documents
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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
05/11/2021 N/A - N/A N/A You are here

Keywords

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