LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: PIK3CA Gene Tests

A53558

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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
N/A
Article ID
A53558
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
01/01/2022
Revision Ending Date
N/A
Retirement Date
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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

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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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+]
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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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ICD-10-PCS Codes

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.

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

Group 1

Group 1 Paragraph

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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
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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
01/01/2022 R15

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.

04/01/2020 R14

 

Under CPT/HCPCS Codes Group 1: Codes the description was changed for HCPCS code 0155U. This revision is due to the 2nd Quarter CPT®/HCPCS Code Update and is effective on 4/1/20.

03/26/2020 R13

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.

01/01/2020 R12

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 R11

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.

10/31/2019 R10

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 and becomes effective on 10/1/2019.

10/24/2019 R9

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.

05/24/2019 R8

Pik3CA was previously not covered. The FDA approved a new drug for breast cancer that requires PIK3CA testing. This change is effective 5/24/19.

07/19/2018 R7

Removed the sentence: "Therefore, the MolDX Team has determined PIK3CA gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the PIK3CA gene."

02/26/2018 R6 The Jurisdiction "J" Part A and Part B Contracts for Alabama (10111/10112), Georgia (10211/10212) and Tennessee (10311/10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these 6 contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 6 Part A and B contract numbers) have been completed in this revision.
07/20/2017 R5

Updated the DEX Z-Code identifier information. Added the Part A contractor numbers.

07/14/2016 R4 Completed annual validation. In the 1st bullet, added the word "targeted" between the words PIK3CA and gene. Corrected CPT code 81403 81404.
11/19/2015 R3 Changed MolDX ID (MID) back to SV101-7
11/19/2015 R2 Replaced SV101-7 with MID, Removed Palmetto GBA reference and replaced with MolDX.
10/01/2015 R1 Completed Annual Validation. Updated CPT code from 81479 to 81403.
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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
L35025 - 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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Public Versions
Updated On Effective Dates Status
01/18/2022 01/01/2022 - N/A Currently in Effect You are here
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