• Abstract and Figures
• Public Full-text

Letter of Medical Necessity Test Code 1305

<> <> <

> <

> <>

Regarding: <> DOB: <> Subscriber ID: <> Group ID: <>

Re: Request for prior authorization and coverage for Hereditary Breast and Ovarian Cancer Syndrome genetic testing. Billing is through <> with testing performed at PreventionGenetics, LLC. CPT codes for PreventionGenetics test code #1305 include: 81406(x2), 81479 (x5), 81321, 81323, 81405 (x2), 81404, 81211, and 81213. The ICD 10 code(s) associated with the patient’s diagnosis include <>.

Hereditary Breast and Ovarian Cancer Syndrome As many as 10% of cancer diagnoses are thought to be associated with a hereditary predisposition1. Hereditary cancers are caused by germline mutations in multiple different genes which significantly increase an individual’s risk to develop cancer. Individuals with mutations in inherited predisposition genes tend to develop cancer at earlier ages, often with bilateral and / or multifocal tumors, which can also occur in less frequently affected genders (i.e. male breast cancer). Families with hereditary cancer syndromes generally have several family members affected with cancer across multiple generations. Although individual mutated genes can be associated with an increased risk for specific cancers (i.e. BRCA1 and BRCA2 with breast and ovarian cancers) there are often multiple additional cancers seen with lower frequency (i.e. prostate, male breast, melanoma, pancreatic, gallbladder, bile duct and gastric cancer in BRCA1 and BRCA2 families). Considering that multiple cancers, including ovarian, pancreatic, melanoma, kidney, breast, uterine, colorectal, sarcoma, brain, leukemia, gastric, thyroid and prostate cancer have been linked with several different cancer predisposition genes, there is significant complexity in choosing a single gene to target for analysis.

Although the majority of individuals with Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have pathogenic variants in BRCA1 or BRCA22, significant incidences of breast and/or ovarian cancer have been observed in several syndromes including Li-Fraumeni syndrome, Cowden syndrome, Peutz-Jeghers syndrome, and Fanconi Anemia caused by pathogenic variants in TP53, PTEN, STK11, PALB2, and RAD51C. This overlap can result in falsely reassuring results when the incorrect target gene is selected. Therefore the assessment of multiple genes associated with a high risk for hereditary breast and ovarian cancers can be useful in determining personal or familial risks3. Recent data supports that “multigene panel testing for HBOC risk assessment yielded findings likely to change clinical management for substantially more patients than does BRCA1/2 testing alone. Multigene testing in this setting is likely to alter near-term cancer risk assessment and management recommendations for mutation-affected individuals across a broad spectrum of cancer predisposition genes.” 4

Diagnosis of an individual with HBOC or an associated syndrome has significant effects on medical management. Gene specific medical management guidelines demonstrate the clinical utility of hereditary cancer predisposition testing. Many of the cancer syndromes covered in the Hereditary Breast and Ovarian Cancer High Risk testing panel have published clinical management guidelines. Implementation of published clinical management guidelines for HBOC can help to reduce the risk of morbidity and mortality in patients affected with HBOC and related syndromes.5,6 Risk reduction strategies outlined in NCCN management guidelines include surgical interventions (i.e. prophylactic mastectomy and salpingo-oopherectomy), increased surveillance (i.e. mammography, clinical and self-breast exams, MRI, ultrasound, colonoscopy, endoscopy, prostate screening) and consideration of chemo preventive pharmaceuticals.7-11

Personal History <> Family History <>

Based on published NCCN guidelines, the personal and family history of this patient warrants analysis of genes known to be associated with hereditary breast and ovarian cancer (HBOC)7. The HBOC High Risk NextGeneration Sequencing (NGS) panel analyzes 8 genes which are associated with a high risk of hereditary breast and ovarian cancer including, BRCA1, BRCA2, CDH1, PALB2, PTEN, RAD51C, STK11, and TP53. Many hereditary cancer syndromes involving breast and ovarian cancers have overlapping clinical features. Therefore, analysis of a panel of genes known to be associated with hereditary breast and ovarian cancers is the most cost-effective and comprehensive testing option.

The laboratory providing the genetic testing is PreventionGenetics, LLC, (Tax ID: 83 0343803) who is a sponsor of Pediatric Lab Utilization Guidance Services (PLUGS®). PreventionGenetics is committed to providing comprehensive, high quality, and affordable genetic testing that adds value to patient care. Through utilization management strategies at PreventionGenetics, over 1.3 million healthcare dollars are saved annually.

I am hopeful that we can work together for <> benefit. Please contact me at <> with the result of this prior authorization and/or if you need additional information.

Sincerely, <> <