Download Letter of Medical Necessity Test Code 1307 <<Today`s Date

Letter of Medical Necessity Test Code 1307
<<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 #1307 include: 81479 (x23), 81406 (x3), 81408, 81321,
81323, 81405 (x2), 81317, 81319, 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, higher incidences of breast and/or ovarian cancer have been
observed in several syndromes. These conditions include, but are not limited to Li-Fraumeni syndrome,
Cowden syndrome, Peutz-Jeghers syndrome, Fanconi Anemia, Ataxia-telangiectasia-like disorder and
Nijmegen breakage syndrome caused by mutations in TP53, PTEN, STK11, PALB2, ATM, MRE11A and
NBN genes, respectively.
This overlap can result in falsely reassuring results when the incorrect target gene is selected. Therefore
the assessment of multiple genes associated with hereditary breast and ovarian cancers can be useful in
determining personal or familial risks . Recent data supports that “multigene panel testing for HBOC risk
2
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.”
3
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 this 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 salpingo-oopherectomy), increased surveillance (i.e.
mammography, clinical and self-breast exams, MRI, ultrasound, colonoscopy, endoscopy, prostate
screening) and consideration of chemo preventive pharmaceuticals.
4,5
6-10
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 Expanded
NextGen Sequencing (NGS) and Deletion/Duplication panel analyzes 20 genes known to be associated
with hereditary breast and ovarian cancer: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2,
MRE11A, MUTYH, NBN, PALB2, PMS2, PTEN, RAD50, RAD51C, RAD51D, SMARCA4, STK11, TP53,
XRCC2. 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.
6
<<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.
4.
5.
6.
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
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.
7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site:
Melanoma. Version 3.2015.
8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site:
Pancreatic Adenocarcinoma. Version 2.2015.
9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). NCCN Guidelines for Treatment of Cancer by Site: Kidney
Cancer. Version 3.2015.
10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colorectal Cancer Screening. Version 1.2015. NCCN.org
®