SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update

A54197

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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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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54197
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Progensa® PCA3 Assay Coverage Update
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
09/23/2021
Revision Ending Date
11/15/2023
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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

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

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Article Guidance

Article Text

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 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

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.

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
Code Description
81313 Pca3/klk3 antigen
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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(14 Codes)
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Group 1 Codes
Code Description
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]
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1 Codes

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ICD-10-PCS Codes

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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.

Code Description
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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.

Code Description
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Other Coding Information

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Group 1 Codes

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

Revision History Date Revision History Number Revision History Explanation
09/23/2021 R13

Revision Effective: 09/23/2021
Revision Explanation: Annual review no changes made.

10/31/2019 R12

Revision Effective: N/A
Revision Explanation: Annual review no changes made.

10/31/2019 R11

Revision Effective date: 10/31/2019
Revision Explanation:This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81313. CPT® was inserted throughout the article where applicable.

10/03/2019 R10

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

04/27/2017 R9

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2015 R8

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

04/27/2017 R7 Revision Effective date: 04/27/2017
Revision Explanation: Updated Part A and Part B billing instructions.
10/01/2015 R6 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2016 R5 Revision Effective: 10/01/2016
Revision Explanation: During annual ICD-10 update R31.2 and R97.2 were deleted and replaced with R31.21, R31.29, and R97.20. Removed table of diagnois codes from text since they are listed in the ICD-10 that shows medical necessity section.
10/01/2015 R4 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
01/01/2015 R2 Revision Effective: 01/01/2015
Revision Explanation: Added the correct CPT that should be used beginning 01/01/2015 81313 for this test.
10/01/2015 R1 Revision Effective: 10/01/2015
Revision Explanation: Corrected to show should use assigned ID instead of name of test and added Part A information.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
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
11/10/2023 11/16/2023 - N/A Currently in Effect View
09/16/2021 09/23/2021 - 11/15/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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