Article Detail - JE Part B
Billing and Coding: MolDX: Myriad’s BRACAnalysis CDx - R5
This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (HI and Territories), and 01312 (NV).
Effective Date: July 17, 2020
Summary of Article Changes:
- 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.
- Typographical errors were corrected throughout the article.
- 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 (history of/malignant neoplasm of pancreas/prostate).
Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.
Last Updated Thu, 09 Jul 2020 17:56:04 +0000