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Date:Patient name:Patient DOB (MM/DD/YYYY):Insurance Company Name:Subscriber name:Policy #:Group #:ICD-10: CPT: Dear Medical Director:I am writing to request approval for full coverage for genetic testing for the above referenced patient. This patient has clinical signs/symptoms and/or laboratory abnormalities strongly suggestive of a primary (genetically determined) immune deficiency or immune dysregulatory disorder.Genetic testing is medically necessary for the following reasons:Other laboratory assays are not available to definitively determine the diagnosis without genetic testing.Identification of the underlying molecular diagnosis will have a direct impact on management and prognosis of this patient’s disorder. Identifying the genetic defect can predict the risk of infectious and non-infectious complications that will impact morbidity and the risk of premature mortality. Knowledge of the genetic defect can facilitate specific treatment for this patient, including targeted therapies and the appropriate choice of preventive strategies that can reduce the need for hospitalization. The genetic diagnosis may also identify patients for whom there is a potential cure via hematopoietic stem cell transplant or gene therapy.Identifying the genetic defect is fundamental for prognostic family counseling, and can provide recurrence risk information for the family.In this patient’s case: **CHOOSE ONE OF THE BELOW OPTIONS (DELETE 3 of the 4 OPTIONS BEFORE SUBMITTING)**TARGETED GENETIC TESTINGThe patient’s clinical phenotype and diagnostic evaluation is suggestive of a specific genetic condition, making targeted testing the best approach. (Choose either)Specifically, we are requesting coverage for sequencing and deletion/duplication analysis of ** (gene), CPT code **. The clinical features found in this patient that are suggestive of this disorder include **. ORSpecifically, we are requesting coverage for targeted mutation analysis for a familial variant in the ** gene, CPT code **. The mutation has been previously identified in the patient’s (**) and the patient has a **% risk to also be affected.GENE PANEL GENETIC TESTINGThe patient’s clinical phenotype and diagnostic evaluation is suggestive of several disorders with overlapping phenotypes, and therefore the best approach in this case is to employ a multi-gene panel. Specifically, the gene panel I am recommending includes ** genes associated with primary immunodeficiency/immune dysregulatory disorders. The CPT codes for this test are **. Testing through this method is the most cost-effective approach to obtaining a diagnosis.MICROARRAY TESTINGThe patient’s clinical phenotype and diagnostic evaluation suggests that a specific chromosomal deletion or duplication may be present. Therefore, I recommend a chromosomal microarray test. This testing is relevant for our patient considering features of **. The CPT code is **. WHOLE EXOME SEQUENCINGBased on the patient’s complex clinical phenotype and diagnostic evaluation, I suspect our patient has a condition that is not included in current gene panel tests, and/or may have more than one genetic mutation that is contributing to their phenotype. For this reason, I believe that whole exome sequencing represents the best and most cost-effective approach to defining a diagnosis. The CPT codes for this testing are **. Include if relevant:This patient has had genetic counseling and the risks, benefits and alternatives to testing have been explained. Appropriate follow-up genetic counseling will be provided.Three reference articles explaining the potential benefits of genetic testing for immune deficiencies are:1. Heimall J. Now is the time to use molecular gene testing for the diagnosis of primary immune deficiencies. J Allergy Clin Immunol Pract 2019;7:833-8.2. Stray-Pedersen A, Sorte HS, et al. Primary immunodeficiency diseases: genomic approaches delineate heterogeneous Mendelian disorders. J Allergy Clin Immunol. 2017;139:232-45.3. Heimall J, Hagin D, Abraham R. Use of genetic testing for primary immunodeficiency patients. J Clinical Immunology 2018;38:320-29.Thank you for taking the time to review this request. Please contact me should you have additional questions or concerns.Sincerely, ................
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