Retired Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Progensa® PCA3 Assay

A54492

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Contractor Information

Article Information

General Information

Article ID
A54492
Article Title
Billing and Coding: MolDX: Progensa® PCA3 Assay
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/01/2019
Revision Ending Date
08/08/2022
Retirement Date
08/08/2022
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

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Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

Progensa® PCA3 Assay, an FDA approved test by Gen-Probe Incorporated, is an mRNA expression assay used alone or in combination with other molecular tests for prostate cancer determination to identify patients with increased risk of prostate cancer. PCA3 may help to improve the specificity of prostate cancer detection providing additional information about the risk of prostate cancer over the use of the PSA test alone. Based on the ratio of PCA3 mRNA/PSA mRNA x1000, the PCA3 assay is performed on the first urine collected following an attentive digital rectal examination.

PCA3 testing is covered ONLY when all biopsies in previous encounter(s) are negative and when the patient or physician wants to avoid repeat biopsy (watchful waiting).

When the physician plans to biopsy the prostate, the CMS MolDX contractor will consider a PCA3 test as investigational and thus, not a covered Medicare benefit. The CMS MolDX contractor considers all other indications for PCA3 not reasonable and necessary.

Medical record documentation must indicate the rationale to perform a PCA3 assay. Providers who report a PCA3 service AND perform a biopsy may be referred for additional action.

To report a PCA3 service, submit the following claim information:

  • 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 2300 or 2400 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: Effective 10/15/2012, Noridian will deny all laboratory developed tests (LDT) for PCA3 as statutorily excluded services that do not support the required clinical utility for the established Medicare benefit category. Only the unmodified FDA approved test will be reimbursed.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
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)

CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(14 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
D29.1 Benign neoplasm of prostate
D40.0 Neoplasm of uncertain behavior of prostate
N40.0 Benign prostatic hyperplasia without lower urinary tract symptoms
N40.2 Nodular prostate without lower urinary tract symptoms
N40.3 Nodular prostate with lower urinary tract symptoms
N41.0 Acute prostatitis
N42.9 Disorder of prostate, unspecified
R31.1 Benign essential microscopic hematuria
R31.21 Asymptomatic microscopic hematuria
R31.29 Other microscopic hematuria
R35.1 Nocturia
R39.12 Poor urinary stream
R39.14 Feeling of incomplete bladder emptying
R97.20 Elevated prostate specific antigen [PSA]

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

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ICD-10-PCS 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

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
08/08/2022 R4

The information in this article has been incorporated within the Billing and Coding: MolDX Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer A58724. 

11/01/2019 R3

As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.

10/01/2016 R2 The following revisions were made due to annual ICD-10 updates effective 10/1/16: R31.21, R31.29 and R97.20 were added and R31.2 and R97.2 were deleted. The Part A article (A54490) is retired and Part A contract numbers are added to the Part B article. Z-Code Identifier references were replaced with unique identifier.
10/01/2015 R1 Article is revised to replace CPT 81479 with 81313 effective for dates of service on/after 10/1/15. The following verbiage was added to the Note: Only the unmodified FDA approved test will be reimbursed.

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - MolDX: Molecular Diagnostic Tests (MDT)
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
08/08/2022 11/01/2019 - 08/08/2022 Retired You are here
10/16/2019 11/01/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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