Download Letter of Medical Necessity Test Code 1355 <<Today`s Date

Letter of Medical Necessity Test Code 1355
<<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 Cancer genetic testing. Billing is through
<<billing institution (preferred) / insurance>> with testing performed at PreventionGenetics, LLC. CPT
codes for PreventionGenetics test code #1355 include 81479 (x15), 81406 (x4), 81408 (x2), 81295, 81298,
81321, 81405 (x4), 81404 (x2), 81201, 81292, 81317, 81214, 81216. The ICD 10 code(s) associated with
the patient’s diagnosis include <<ICD code(s)>>.
Hereditary Cancer Syndromes
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. This overlap can result in falsely reassuring results when the incorrect target
gene is selected. Therefore the assessment of multiple genes associated with hereditary 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
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.”
1
2
3
Diagnosis of an individual with a hereditary cancer 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 this testing panel have published
clinical management guidelines which can help to reduce the risk of morbidity and mortality in patients
affected with a hereditary cancer syndrome. Risk reduction strategies outlined in NCCN management
guidelines include surgical interventions (ie prophylactic mastectomy and salpingo-oopherectomy);
increased surveillance (mammography, clinical and self-breast exams, MRI and ultrasound, colonoscopy,
endoscopy, prostate screening) and consideration of chemo preventive pharmaceuticals.
4,5,6,7,8
Personal History
<<Personal Medical History: Include details of patient’s relevant medical history, including cancer age of
onset, tumor markers, data from risk assessment models>>
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 cancer . The requested Cancer NextGen Sequencing Panel
analyzes 35 genes with known correlation to hereditary cancer: APC, ATM, BAP1, BLM, BMPR1A, BRCA1,
BRCA2, BRIP1, BUB1B, CDH1, CDK4, CDKN2A, CHEK2, DICER1, EPCAM, KIT, MEN1, MET, MLH1,
MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, PPM1D, PTEN, RAD51C, RAD51D, SMAD4, STK11,
TP53, VHL, and WT1. Many hereditary cancer syndromes have overlapping clinical features. Therefore,
analysis of a wide range of genes associated with multiple conditions is the most cost-effective and
comprehensive testing option.
4
<<Mr/Ms/Mrs/Miss patient’s last name’s>> <<personal/family history>> is consistent with a hereditary
cancer syndrome. The significant increase in cancer risk and availability of specific gene driven
management guidelines which improve clinical outcome demonstrate the medical necessity of testing for
this patient.
The testing laboratory, PreventionGenetics, LLC, (Tax ID: 83 0343803) 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 have been saved annually.
I am hopeful that we can work together for <<Mr/Mrs/Ms/Miss patient’s last name>> benefit, and the benefit
of his / her family. Please contact me at <<Phone # / email>> with the prior authorization or should you
require additional information.
Sincerely,
<<Name, credentials>><<Title>>
<<Institution>>
References:
1.
2.
3.
Mauer et al. Genetics in Medicine. 2013
Foulkes. New England Journal of Medicine. 2008; 359: 2143-2153
Desmond et al. JAMA Oncol. 2015;1(7):943-951
4.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ). Genetic/Familial High-Risk Assessment: Breast and
Ovarian. Version 2.2015, 06/25/2015.
®
5.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by
Site: Melanoma. Version 3.2015.
6.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by
Site: Pancreatic Adenocarcinoma. Version 2.2015.
7.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by
Site: Kidney Cancer. Version 3.2015.
8.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colorectal Cancer Screening. Version 1.2015.
NCCN.org