07/28/2022
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R20
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Due to annual review
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07/28/2022
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R19
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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 nineth paragraphs. Under CPT/HCPCS Codes Group 1: Codes added 81479.
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06/23/2022
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R18
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Under Article Text the third paragraph was revised to read, “Results of the test are used as an aid in patients who are being considered for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.”
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01/06/2022
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R17
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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.
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10/01/2021
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R16
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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 and will become effective on 10/1/2021.
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04/29/2021
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R15
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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.
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07/17/2020
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R14
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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.
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10/24/2019
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R13
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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 title from “MolDX: Myriad’s BRACAnalysis CDx™ Coding and Billing Guidelines” to “Billing and Coding: MolDX: Myriad’s BRACAnalysis CDx™”. Under CPT/HCPCS Codes Group 1: Paragraph added verbiage “CPT codes that are also referenced in other articles". CPT® was inserted throughout the article where applicable.
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04/04/2019
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R12
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Removed C50.919 and C50.929 from Covered ICD-10 Codes. These codes were erroneously left in the article from revision #9. This revision is effective 7/5/18.
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02/21/2019
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R11
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Added "men" to the first paragraph to include them in treatment for metastatic breast cancer. Also included non-coverage indications.
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01/01/2019
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R10
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Deleted 81479 and added 81162 to the article. Added all CPT code: 81162 to CPT/HCPCS Codes Group 1. This change is due to the CPT/HCPCS 2019 Annual Update and is effective 1/1/19.
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07/05/2018
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R9
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Replaced "Box" with "item" in the article text and removed the following ICD-10 codes: C50.019, C50.029, C50.119, C50.129, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.919, C50.929, C57.00, C79.60.
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05/31/2018
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R8
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Revised opening paragraphs and added the following ICD-10 codes: C48.0, C48.1, C48.2, C48.8, C50.011, C50.012, C50.019, C50.021, C50.022, C50.029, C50.111, C50.112, C50.119, C50.121, C50.122, C50.129, C50.211, C50.212, C50.219, C50.221, C50.222, C50.229, C50.311, C50.312, C50.319, C50.321 ,C50.322, C50.329, C50.411, C50.412, C50.419, C50.421, C50.422, C50.429, C50.511, C50.512, C50.519, C50.521, C50.522, C50.529, C50.611, C50.612, C50.619, C50.621, C50.622, C50.629, C50.811, C50.812, C50.819, C50.821, C50.822 C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C57.00, C57.01, C57.02, Z85.3, Z85.43, Z85.44
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02/26/2018
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R7
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The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
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01/29/2018
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R6
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The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
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07/06/2017
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R5
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Updated the Part A and Part B Billing Instructions.
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11/27/2015
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R4
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Change all references of MolDX ID to Z-Code™ Identifier Change all references of MolDX ID (MID) field back to SV101-7
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11/19/2015
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R3
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Replaced SV101-7 with MolDX Identifier (MID) field
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10/01/2015
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R2
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Added clarification verbiage.
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10/01/2015
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R1
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Removed ICD-9 and ICD-10 codes from article text.
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