SAMPLE LETTER OF MEDICAL NECESSITY
FOR
CHROMOSOME MICROARRAY ANALYSIS (180K Oligo Array or SNP Array)
Date: Date of service/claim
To: Utilization Review Department
Insurance Company Name, Address, City, State, ZIP
Re: Patient Name, DOB, ID #
ICD-9 Codes: (list codes)
Dear Medical Director:
I am writing this letter on behalf of my patient and your subscriber, listed above, to request coverage of medically-indicated chromosomal microarray analysis (CMA) in support of the diagnosis and/or treatment of intellectual disability (ID). This genetic test will be performed by Ambry Genetics Corporation.
According to the American Psychiatric Association, the diagnosis of ID is based on three main criteria: deficits in intellectual functions significantly lower than average, reduced adaptive skills, and onset of symptoms before the age of 18. Individuals with ID may also have congenital anomalies and developmental delay. The majority of cases of intellectual disability and/or developmental delay are due to an underlying genetic cause. Chromosome abnormalities, like those found by CMA, are the single most common cause of intellectual disability/developmental delay a 15-20% yield among affected patients.1,2,3 For this reason, CMA has been recommended as a first-line molecular diagnostic test for these clinical indications.4,5
For this patient, I have determined that this genetic test is medically necessary based on [his/her] clinical symptoms, history, and/or family history. Significant aspects of my patient’s personal and/or family medical history that raise reasonable suspicion of an underlying genetic diagnosis are as follows:
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Due to the heterogeneous nature of my patient’s symptoms, there is a reasonable probability of detecting a causative chromosomal abnormality using this test. Per American Academy of Pediatrics and American College of Medical Genetics and Genomics guidelines, CMA analysis is recommended as a first-tier test for my patient.3,4
CMA via array-based comparative genomic hybridization (aCGH) allows for high resolution genome-wide detection of unbalanced structural and numerical chromosomal abnormalities. This analysis can be done using two different platforms, the 180K Oligo Array and the SNP Array. Both detect copy number variations (deletions and duplications) within chromosomes that routine karyotyping may miss. [CMA may also detect microdeletions/microduplications in a specific gene(s) in patients negative for point mutations or small intragenic aberrations. The SNP Array can also detect copy number neutral variations, such as regions of homozygosity (ROH) and uniparental disomy (UPD), which can cause certain genetic disorders.]
Specifically for this patient, the results of the CMA test are necessary to consider in the following areas [check all that apply]:
Genetic testing will lead to changes in my medical management strategies; AND/OR
Genetic testing will lead to changes in diagnostic procedures such that more potentially invasive alternative procedures could be avoided, reducing unnecessary tests and cost; AND/OR
Genetic testing will lead to informed decisions for other family members with similar conditions, or that may be at risk for similar conditions
Due to the medical risks associated with chromosomal alterations and available interventions, this genetic testing is medically indicated. As such, I am ordering this test and affirm that my patient/patient’s family member has provided informed consent for genetic testing.
A positive test result would confirm a genetic diagnosis and/or risk in my patient, and would ensure my patient is being managed appropriately. I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective CMA analysis, along with a large database of tested patients to ensure highly validated, accurate, and informative test interpretation.
Please review this information and provide support for this request for coverage of diagnostic genetic testing for my patient. Coordinating and completing complex testing of this nature can sometimes take up to several months; we are requesting that the authorization be valid for at least 4 months.
Thank you for your time and further consideration. If you have any questions, please do not hesitate to contact me at the numbers below.
Sincerely,
Ordering Clinician Name (Signature Provided on Test Requisition Form)
(MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*)
*Authorized clinician requirements vary by state
[Clinician Address]
[Clinician Phone Number]
Test Details
CPT codes: 81228x1 (for 180k Oligo array); 81229x1, 81405x2 (for SNP Array)
Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656
References
1. Flint J, et al. The detection of subtelomeric chromosomal rearrangements in idiopathic mental retardation. Nat Genet. 1995 Feb;9(2):132–40.
2. Bartnik M, et al. The usefulness of array comparative genomic hybridization in clinical diagnostics of intellectual disability in children. Dev Period Med. 2014 Jul-Sep;18(3):307-17.
3. Ellison JW, et al. Clinical utility of chromosomal microarray analysis. Pediatrics. 2012 Nov;130(5):e1085-95.
4. Moeschler JB,et al. Comprehensive evaluation of the child with intellectual disability or global developmental delays.Pediatrics.2014 Sep;134(3):903-918.
5. Miller DT, et al. Consensus statement: chromosomal microarray is a first-tier clinical diagnostic test for individuals with developmental disabilities or congenital anomalies. Am J Hum Genet. 2010 May 14;86(5):749-64.