Letter of Medical Necessity Test Code 1305
<<Today’s Date>>
<<Insurance Company Name>>
<<Address 1>>
<<Address 2>>
<<City, State ZIP>>
Regarding: <<Patient full name>>
DOB: <<MM/DD/YYYY>>
Subscriber ID: <<Member ID#>>
Group ID: <<Group ID#>>
Re: Request for prior authorization and coverage for Hereditary Breast and Ovarian Cancer Syndrome
genetic testing. Billing is through <<billing institution>> 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
<<ICD code(s)>>.
Hereditary Breast and Ovarian Cancer Syndrome
As many as 10% of cancer diagnoses are thought to be associated with a hereditary predisposition .
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.
1
Although the majority of individuals with Hereditary Breast and Ovarian Cancer Syndrome (HBOC) have
pathogenic variants in BRCA1 or BRCA2 , 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.
2
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 risks . Recent data supports that “multigene panel testing for
HBOC risk assessment yielded findings likely to change clinical management for substantially more
3
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. Risk reduction strategies outlined in NCCN
management guidelines include surgical interventions (i.e. prophylactic mastectomy and salpingooopherectomy), increased surveillance (i.e. mammography, clinical and self-breast exams, MRI,
ultrasound, colonoscopy, endoscopy, prostate screening) and consideration of chemo preventive
pharmaceuticals.
5,6
7-11
Personal History
<<Personal Medical History: Include details of patient’s relevant medical history>>
Family History
<<Family History: Include list of relevant family history information if applicable Appropriate risk assessment
models or limited history should be noted >>
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) 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.
7.
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 <<Mr/Mrs/Ms/Miss patient’s last name’s>> benefit. Please
contact me at <<Phone #>> with the result of this prior authorization and/or if you need additional
information.
Sincerely,
<<Name, credentials>>
<<Title>>
<<Institution>>
References:
1.
2.
3.
4.
5.
6.
7.
Mauer et al. Genetics in Medicine. 2013
Petrucelli et al. GeneReviews. 2011
Foulkes. New England Journal of Medicine. 2008; 359: 2143-2153
Desmond et al. JAMA Oncol. 2015;1(7):943-951
Domcheck et al. JAMA. 2010;304 (9): 697-975
Finch et al. J Clin Oncol. 2014;32(15):1547-1553
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ). Genetic/Familial High-Risk Assessment: Breast and
Ovarian. Version 2.2015, 06/25/2015.
8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site:
Melanoma. Version 3.2015.
9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site:
Pancreatic Adenocarcinoma. Version 2.2015.
10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site: Kidney
Cancer. Version 3.2015.
11. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colorectal Cancer Screening. Version 1.2015. NCCN.org
®