Medical Necessity Justification
Patient/Member InformationPatient Name: DOB:Subscriber Name:DOBSubscriber Number:Provider/Contact InformationOrdering Provider:Contact Person:Phone:Fax:Genetic Test InformationName of test: Targeted Comparative Genomic Hybridization (CGH)Test Code:CPT code(s):ICD10 code(s): Z82.79 (family history of a chromosome abnormality)List price:Do you have a preferred clinical laboratory for genetic testing? X NO (or not applicable) __ YES, (provide preferred lab name): Please state the reason why testing should/must be performed at this laboratory: Clinical Reasoning for Genetic Test (Attach the clinic note)-What laboratory and/or clinical testing have been performed to date (genetic and other testing)? Mr. @LNAME@’s child, ***, has ***developmental delays, unusual facial features and hearing loss. ***Name of Insurance*** already authorized the child’s testing by array CGH to establish a genetic cause of these features. Those test results indicate a small portion of the *** chromosome is missing***repeated. -Why is genetic testing necessary at this time? Formal recommendations have existed since 2006 to pursue CGH for children presenting with developmental delays, autism and congenital anomalies.1 CGH is applied as first tier diagnostic test to address specific questions about the cause of developmental and physical features.2,3,4 Wisconsin medical assistance/Badgercare does not require prior authorization for array CGH.Parental results will provide more information regarding the clinical significance of this imbalance.-How will the results of the genetic test, whether negative or positive, impact the future management of the member being tested? (explain all that apply):Testing parents will distinguish between 2 genetic scenarios. Either negative or positive, the test is diagnostic as the result will clarify @FNAME@’s uncertain result.A parent hasConsequence of the previously unreported variantThe same variantEvidence for a benign population variationNo variantStrong evidence for a cause of the child’s concernsInform on prognosis: Confirmation of a clinically significant chromosomal imbalance may identify future medical risks.Change treatment plan or surveillance: The chance of a change in medical management is as high as 54%.4 Recommendations may include malignancy screening, management of a metabolic condition, surveillance of organ systems or specific educational intervention.Provide information for family members: Identifying whether a parent has, or does not have, the same chromosomal variant directly affects the recurrence risk for other family members.-What is the probability that this test will be positive? If this is not known, then please indicate which clinical features increase the probability that this test will provide a diagnosis. Two independent groups4,5 recently reported that at least 30% of children tested by CGH due to autism and/or dysmorphic features and as much as 40% of patients referred for isolated neurodevelopmental disorders, had results interpreted as causal.-If this is a request is for a gene panel, describe why a single gene test is not as useful. NA-Please list specific guidelines and/or references in support of your request:1. Moeschler JB, Shevell M; American Academy of Pediatrics Committee on Genetics. Clinical genetic evaluation of the child with mental retardation or developmental delays. Pediatrics. 2006 Jun;117(6):2304-16.2. 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):749-64.3. Manning M, Hudgins L; Professional Practice and Guidelines Committee. Array-based technology and recommendations for utilization in medical genetics practice for detection of chromosomal abnormalities. Genet Med. 2010 Nov;12(11):742-5.4. Henderson LB et al. The impact of chromosomal microarray on clinical management: a retrospective analysis. Genet Med. 2014 Sep;16(9):657-64.5. Roberts JL, Hovanes K, Dasouki M, Manzardo AM, Butler MG. Chromosomal microarray analysis of consecutive individuals with autism spectrum disorders or learning disability presenting for genetic services. Gene. 2014 Feb 1;535(1):70-8. ................
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