Letter of Medical Necessity
Solid Tumor Mutation Panel by Next-Generation Sequencing
A physician may want to include a letter of medical necessity with a preauthorization request, claim
submission, to facilitate the insurance review process for the benefit of the patient. Most major
insurance companies consider mutation testing medically necessary to establish a molecular
diagnosis of a disease when specific conditions are met;
1. The patient displays clinical features of the disease;
2. The result of the test will directly impact the treatment being delivered to the patient
We encourage health care providers to cover as many of the following points as possible that are
applicable to the patient:

Explanation that the mutation test has been ordered by a physician;

Explanation of the medical necessity for the test requested;

Treatment plan, including specific statements about the anticipated impact of the mutation
test on the patient’s medical management;

Patient's diagnosis and prognosis;
We remind you to read carefully through the entire letter of medical necessity to make sure it
makes sense for your patient.
<On Office Letterhead>
<Date>
<Insurance Company Name>
<Medical Director>, MD
<Address 1>
<Address 2>
<City>, <ST> <ZIP>
Re: <Patient Full Name>
Member ID: <Enter Member ID>
DOB: <MM/DD/YYYY>
Group ID: <Enter Group ID>
Dear Medical Director:
I am writing this letter on behalf of my patient, <Patient Name>, to request coverage for the Solid
Tumor Mutation Panel by Next-Generation Sequencing testing. Massively parallel sequencing,
better known as next generation sequencing (NGS), will make it possible to obtain results from
multiple DNA regions in a single assay allowing for mutation analysis of multiple genes.
Specific somatic mutations have been discovered in multiple solid tumor related genes. This test
will be useful for patients at initial diagnosis or for a patient with refractory disease. Targeted
next-generation sequencing is utilized in this test for the detecting hotspot mutations within 48
cancer-related genes. This mutational profile will be useful in predicting the patient’s response to
targeted therapies as well as diagnostic and prognostic utility. Mutations detectable by this assay
are listed below;
Genes – ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2,
ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1,
IDH2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA,
PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL
With the increasing availability of drugs that are directed to specific molecular targets or signaling
pathways (targeted therapy), and the need to determine the presence or absence of specific
molecular alterations before making therapeutic decisions, panel sequencing is critical to the
workup of this advanced cancer by detection of these actionable alterations.
I am requesting this test for <Patient Name>. This letter documents the medical necessity of this
test to assist in the treatment, prognosis and diagnosis of <his/her> solid tumor cancer. Below is
additional information about the patient’s medical history and potential impact of the test resulted
for the patient’s medical management.
Patient History and Diagnosis:
<Patient Name> is a <Age> -year-old <Gender > with a diagnosis of solid tumor associated cancer
based on the following symptoms and clinical findings:
1. <Symptom/Diagnosis #1 with ICD-9 code>
2. <Symptom/Diagnosis #2 with ICD-9 code>
Family History: (if applicable)
<Patient Name> also has a family history, including:
<Family History>
Clinical Impression:
The patient’s symptoms and clinical history, in addition to other diagnostic testing indicates a solid
tumor cancer. The Solid Tumor Mutation Panel by Next-Generation Sequencing test will play an
important role in establishing specific somatic tumor mutations which will guide appropriate
medical management of the patient. An accurate multi-mutation analysis can assist the patient by:



Decrease overall costs by eliminating the need to order multiple single gene mutation tests,
decreased time to implementation of patient therapy by multiple mutation analysis
performed by one assay,
useful for patient stratification, diagnosis, prognosis, and prediction for therapeutic
response,
I recommend that you support this request for coverage of the Solid Tumor Mutation Panel by
Next-Generation Sequencing testing for <Patient Name> through ARUP Laboratories test code
2007991, Federal Tax ID#87-0403206 / NPI#:1376548271 with the following CPT codes 81210,
81235, 81275, 81310, 81402, 81403 x4 (ABL1, HRAS, IDH1, IDH2) , 81404 x7 (FGFR2, FGFR3, KIT,
KRAS, NRAS, PDGFRA, RET) , 81405 (TP53), 81479, and G0452. Please note that this test is
performed for clinical management in a laboratory that is CLIA approved for high complexity
testing. Please feel free to contact me at <Physician Phone> if you require additional information.
Sincerely,
<Signature>
<Print Name>
References
1. Raffan E, Semple RK: Next generation sequencing–implications for clinical practice. Br
Med Bull 2011, 99:53-71.
2. Harris TJ, Mccormick F. The molecular pathology of cancer. Nat Rev Clin Oncol.
2010;7:251–65
3. Bronte G, Rizzo S, La Paglia L, et al. Driver mutations and differential sensitivity to
targeted therapies: a new approach to the treatment of lung adenocarcinoma. Cancer
Treat Rev. 2010;36(suppl 3):S21–S29
4. Swanton C, Caldas C, From genomic landscapes to personalized cancer management:
is there a roadmap? Ann N Y Acad Sci. 2010;1210:34–44.
5. Macconaill LE, Garraway LA. Clinical implications of the cancer genome. J Clin Oncol.
2010;28:5219–5228
6. Swanton C, Caldas C. Molecular classification of solid tumours: towards pathwaydriven therapeutics. Br J Cancer. 2009;100(10):1517–1522
7. Ellis MJ, et al. Analysis of luminal-type breast cancer by massively parallel sequencing.
Presented Saturday, April 2, 2011 at the 102nd Annual Meeting of the American
Association for Cancer Research in Orlando, Florida, USA
8. Leary RJ, et al. Development of personalized tumor biomarkers using massively
parallel sequencing. Sci Transl Med. 2010;2(20):20ra14
9. Ross J, Cronin M. Whole Cancer Genome Sequencing by Next-Generation Methods,
(2011) American Journal of Clinical Pathology, 136, 527-539.
10. Helwick C. Genomic Sequencing Assay Potentially a Game Changer. Value –Based
Cancer Care Issue: June 2013 Vol 4, No 5
http://www.valuebasedcancer.com/article/genomic-sequencing-assay-potentiallygame-changer