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October 5, 2015 - Revised 05.17.17

Progensa PCA3 Assay Coding and Billing Guidelines (CM00018, V3)

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, MolDX will consider a PCA3 test as investigational and thus, not a covered Medicare benefit. MolDX 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 Progensa PCA3 service, submit the following claim information:

  • Enter CPT code 81313 - PCA3/KLK3
  • For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
    • 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 diagnosis from the following list:
    • D29.1 – Benign neoplasm of prostate
    • D40.0 – Neoplasm of uncertain behavior of prostate
    • N40.0 – Enlarged prostate 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
    • R31.2 – Other microscopic hematuria(end date 09/30/2016)
    • 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
    • R97.2 – Elevated prostate specific antigen [PSA](end dated 09/30/2016)
    • R97.20-Elevated prostate specific antigen [PSA]

NOTE: Effective 10/15/2012, MolDX 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.

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