SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: PIK3CA Gene Tests

A54295

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54295
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: PIK3CA Gene Tests
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/05/2023
Revision Ending Date
11/14/2023
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

N/A

Article Guidance

Article Text

Effective for dates of service on and after May 24, 2019.

The U.S. Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets, to be used in combination with the (FDA)-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.

To submit a claim for PIK3CA targeted gene sequencing service, please submit the following claim information:

  • Enter the appropriate CPT® code
  • Select the appropriate diagnosis for the patient
  • Enter 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 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

 

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
014x Hospital - Laboratory Services Provided to Non-patients
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
81309 PIK3CA (PHOSPHATIDYLINOSITOL-4, 5-BIPHOSPHATE 3-KINASE, CATALYTIC SUBUNIT ALPHA) (EG, COLORECTAL AND BREAST CANCER) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (EG, EXONS 7, 9, 20)
0155U ONCOLOGY (BREAST CANCER), DNA, PIK3CA (PHOSPHATIDYLINOSITOL-4,5BISPHOSPHATE 3-KINASE, CATALYTIC SUBUNIT ALPHA) (EG, BREAST CANCER) GENE ANALYSIS (IE, P.C420R, P.E542K, P.E545A, P.E545D [G.1635G>T ONLY], P.E545G, P.E545K, P.Q546E, P.Q546R, P.H1047L, P.H1047R, P.H1047Y), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED BREAST TUMOR TISSUE, REPORTED AS PIK3CA GENE MUTATION STATUS
N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(55 Codes)
Group 1 Paragraph

The code Z17.0 should be on the claim in addition to one of the following:

Group 1 Codes
Code Description
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.019 Malignant neoplasm of nipple and areola, unspecified female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.029 Malignant neoplasm of nipple and areola, unspecified male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.119 Malignant neoplasm of central portion of unspecified female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.129 Malignant neoplasm of central portion of unspecified male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.619 Malignant neoplasm of axillary tail of unspecified female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.629 Malignant neoplasm of axillary tail of unspecified male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.829 Malignant neoplasm of overlapping sites of unspecified male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C50.929 Malignant neoplasm of unspecified site of unspecified male breast
Z17.0 Estrogen receptor positive status [ER+]
N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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.

Code Description
014x Hospital - Laboratory Services Provided to Non-patients
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.

Code Description
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/05/2023 R19

Revision Effective date: 01/05/2023
Revision Explanation: Annual review, no changes 

01/01/2022 R18

Revision Effective date: 01/01/2022
Revision Explanation: Under CPT/HCPCS Codes Group 1: Codes the description was revised for 0155U. This revision is due to the 2022 Annual CPT®/HCPCS Code Update and is effective on 1/1/2022.

04/25/2020 R17

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

04/25/2020 R16

Revision Effective: 5-24-2019
Revision Explanation: Under ICD-10 Codes that Support Medical Necessity - Group 1: Paragraph and Group 1: Codes changed ICD-10 code from Z17.1 to Z17.0. This revision has a retro-effective date of 5/24/19.

01/23/2020 R15

Revision Effective: 1-23-2020
Revision Explanation:Under Article Text replaced the verbiage in the first bulleted sentence that reads “CPT® code 81404 – PIK3CA” with the verbiage “Enter the appropriate CPT® code”.

01/01/2020 R14

Revision Effective: 1-1-2020
Revision Explanation:Under Article Text replaced the verbiage in the first bulleted sentence that reads “CPT® code 81404 – PIK3CA” with the verbiage “Enter the appropriate CPT® code”.

01/01/2020 R13

Revision Effective: 1-1-2020
Revision Explanation: Under CPT/HCPCS Codes Group 1: Codes added HCPCS code 0155U and CPT® code 81309. The CPT® code 81404 was deleted. This revision is due to the Annual CPT®/HCPCS Code Update and becomes effective on 1/1/20. Also, under CPT/HCPCS Codes Group 1: Codes the description was changed for CPT® code 81404. This revision is due to 4th quarter CPT®/HCPCS Code update 

10/24/2019 R12

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

10/24/2019 R11

Revision Effective date: 10/24/2019

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 Article Title changed the title to “Billing and Coding: MolDX: PIK3CA Gene Tests”. Acronyms were inserted where appropriate throughout the LCD. 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.

05/24/2019 R9

Revision Effective date: 05/24/2019
Revision Explanation: Added coverage criteria for PIK3CA test as this is now covered effective 05/24/2019.

07/20/2017 R8

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

10/01/2015 R7

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

07/20/2017 R6

Revision Effective date: 07/20/2017
Revision Explanation: Added DEX Z-Code identifier information instead of Z-identifier.

10/01/2015 R5 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
07/14/2016 R4 Revision Effective: 07/14/2016
Revision Explanation: Corrected the CPT code that should be used for submitting claims for this test from 81479 to 81404.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
N/A

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 11/15/2023 - N/A Currently in Effect View
12/29/2022 01/05/2023 - 11/14/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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