Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Germline testing for use of PARP inhibitors

A55295

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Article Information

General Information

Article ID
A55295
Article Title
Billing and Coding: MolDX: Germline testing for use of PARP inhibitors
Article Type
Billing and Coding
Original Effective Date
10/15/2017
Revision Effective Date
07/28/2022
Revision Ending Date
N/A
Retirement Date
N/A
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CPT codes, descriptions and other data only are copyright 2022 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.

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CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA) §1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

Article Guidance

Article Text

The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Results of tests that assess for deleterious variants in homologous recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in patients who are being considered for treatment with PARP inhibitors in accordance with published guidelines and approved therapeutic product labeling. These genes are often tested as part of routine management of these cancer patients as part of services that interrogate a panel of genes as described in LCD L38974. In rare circumstances limited testing for only a select group of genes may be tested to ensure compliance with FDA indicated drug usage, wherein additional genes outlined in guidelines such as the NCCN are not necessary because the patient does not meet testing criteria for larger panels.

According to criteria defined by L38974, billing for these services can occur in the following situation:

  • The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use AND
  • The patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing AND
  • The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing.

To report a service, please submit the following claim information:

  • Select appropriate CPT® code
  • One (1) unit of service
  • 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
  • Select at least one ICD-10-CM diagnosis code.

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

CPT® codes that are also referenced in other articles.

Group 1 Codes
CodeDescription
81162 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND FULL DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(64 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.3 Malignant neoplasm of pancreatic duct
C25.4 Malignant neoplasm of endocrine pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C48.0 Malignant neoplasm of retroperitoneum
C48.1 Malignant neoplasm of specified parts of peritoneum
C48.2 Malignant neoplasm of peritoneum, unspecified
C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left 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
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left 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
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.01 Malignant neoplasm of right fallopian tube
C57.02 Malignant neoplasm of left fallopian tube
C61 Malignant neoplasm of prostate
C79.61 Secondary malignant neoplasm of right ovary
C79.62 Secondary malignant neoplasm of left ovary
C79.63 Secondary malignant neoplasm of bilateral ovaries
C79.9 Secondary malignant neoplasm of unspecified site
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.3 Personal history of malignant neoplasm of breast
Z85.43 Personal history of malignant neoplasm of ovary
Z85.44 Personal history of malignant neoplasm of other female genital organs
Z85.46 Personal history of malignant neoplasm of prostate

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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.

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.

N/A


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Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
07/28/2022 R8

Under Article Title revised to Germline testing for use of PARP inhibitors.

Under Article Text deleted second paragraph and revised the verbiage in the third paragraph. Added new verbiage following the third paragraph. Deleted Table 1, fourth, fifth, and sixth paragraphs. Revised seventh paragraph first sentence to read, “To report service, please submit the following claim information”. Revised the seventh paragraph first bullet to read, “Select appropriate CPT® code”. Deleted the eighth and ninth paragraphs.

Under CPT/HCPCS Codes Group 1: Codes added 81479.

01/06/2022 R7

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C25.9, C48.2, C50.911, C50.912, C50.921, C50.922, C56.9, and C79.9. The deletion of these codes with Revision 15 was done in error and is retroactive effective for dates of service on or after 4/29/2021.

10/01/2021 R6

Effective 04.29.021: Under CMS National Coverage Policy added regulation Title XVIII of the Social Security Act (SSA) §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C25.9, C48.2, C50.911, C50.912, C50.921, C50.922, C56.9, and C79.9.

Typographical errors were corrected throughout the article.

Effective 10.01.2021: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3 and C79.63. This revision is due to the Annual ICD-10 Update.

07/17/2020 R5

Under Article Title replaced the trademark symbol with a registered symbol. Under Article Text removed the verbiage “Lynparza™ (olaparib), as a treatment for women with advanced ovarian cancer or women or men with metastatic breast cancer, and the companion diagnostic BRACAnalysis CDx™, the laboratory test to detect mutated BRCA genes” and revised the first paragraph to state “The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer”. Added the verbiage “BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR” to the second paragraph. Added the verbiage “Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling” to the third paragraph. Added Table 1: Companion diagnostic indications. Added the verbiage “This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108” to the fourth paragraph. Added the verbiage “This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for this test” to the fifth paragraph. Removed the verbiage “Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, blocks enzymes involved in repairing damaged DNA and is intended for women with heavily pretreated ovarian cancer or HER2-negative metastatic breast cancer associated with defective BRCA genes. BRACAnalysis CDx™ detects the presence of BRCA1 and BRCA2 gene mutations. According to the FDA, results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza® (olaparib)” and revised the sixth paragraph to state “BRACAnalysis CDx® is only covered for individuals diagnosed with ovarian cancer, breast cancer, pancreatic cancer, or prostate cancer and who have not been previously tested for BRCA mutations”. Removed the word “Lynparza” and added the word “PARPi” to the second sentence in the eighth paragraph. Removed the verbiage “or other hereditary cancer syndromes” and added the verbiage “pancreatic, or prostate cancer” to the first bullet in the ninth paragraph. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added ICD-10 codes C25.0, C25.1, C25.2, C25.3, C25.4, C25.7, C25.8, C25.9, C61, Z85.07, and Z85.46. BRACAnalysis CDx® was inserted throughout the article where applicable. CPT® was inserted throughout the article where applicable. Typographical errors were corrected throughout the article.

11/01/2019 R4

relating LCD to Article

11/01/2019 R3

This article was converted to a billing and coding type article. There is no change in coverage.

02/21/2019 R2

Revised the first paragraph to include men in the treatment for metastatic breast cancer and included non-coverage indications.

Effective 1/1/2019, 81479 is replaced with CPT code 81162.

 

 

07/05/2018 R1

Revised opening paragraphs and added the following ICD-10 codes:

C48.0, C48.1, C48.2, C48.8, C50.011, C50.012, C50.021, C50.022, C50.111, C50.112, C50.121, C50.122, C50.211, C50.212, C50.221, C50.222, C50.311, C50.312, C50.321, C50.322, C50.411, C50.412, C50.421, C50.422, C50.511, C50.512, C50.521, C50.522, C50.611, C50.612, C50.621, C50.622, C50.811, C50.812, C50.821, C50.822, C50.911, C50.912, C50.921, C50.922, C57.01, C57.02, Z85.3, Z85.43, Z85.44.

Removed ICD-10 C79.60

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
07/22/2022 07/28/2022 - N/A Currently in Effect You are here
01/24/2022 01/06/2022 - 07/27/2022 Superseded View
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