Local Coverage Article Billing and Coding

Billing and Coding: MolDX: PIK3CA Gene Tests

A55602

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Article Information

General Information

Article ID
A55602
Article Title
Billing and Coding: MolDX: PIK3CA Gene Tests
Article Type
Billing and Coding
Original Effective Date
08/28/2017
Revision Effective Date
01/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

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Article Guidance

Article Text

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 a 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
    • Item 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

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)
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Group 1 Codes
CodeDescription
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

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
CodeDescription
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+]

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

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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.

CodeDescription
014x Hospital - Laboratory Services Provided to Non-patients

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

Group 1

Group 1 Paragraph

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Group 1 Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2022 R6

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at PalmettoGBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history but is updated with the revisions made in an accurate timeline. However, these revisions do not change coverage or guidance.

01/01/2022 R5

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at PalmettoGBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history but is updated with the revisions made in an accurate timeline. However, these revisions do not change coverage or guidance.

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.

04.01.2020: 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.

10/31/2019: 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: 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.

 

01/01/2020 R4

In Article Text, (HER2)-negative was revised to (HER2)-positive. Under ICD-10 Codes that Support Medical Necessity, Z17.1 was deleted and Z17.0 was added effective 05/24/2019.

01/01/2020 R3

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.

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

05/24/2019 R2

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. Indications and Limitations were revised. Diagnosis criteria was added. Bill Type 014x was added.

08/28/2017 R1

The following sentences were deleted from the first paragraph: 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.

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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Public Versions
Updated On Effective Dates Status
02/23/2022 01/01/2022 - N/A Currently in Effect You are here
02/07/2022 01/01/2022 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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