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LETTER OF MEDICAL NECESSITY FOR HYPERTROPHIC CARDIOMYOPATHY GENETIC TESTING Date: 01/01/2019 To:Utilization Review Department CignaRe:Smith, Jane DOB: 01/01/1960ICD-10 Codes: This letter is in regards to my patient and your subscriber, Jane Smith, to request full coverage of medically-indicated genetic testing for HYPERTROPHIC CARDIOMYOPATHY (HCM) to be performed by Ambry Genetics Corporation. Hypertrophic cardiomyopathy (HCM) occurs at a prevalence of 1 in 500 and is characterized by changes in the structure of the heart including thickening of the left ventricular wall. Individuals with HCM can experience symptoms of exercise fatigue and syncope; however, some individuals present with sudden cardiac death with no prior symptoms. Some individuals with HCM develop arrhythmias and congestive heart failure (which may require a heart transplant).1 The genetic etiology of HCM is established and is mostly associated with mutations in genes that encode sarcomeric proteins, genes that cause metabolic disorders, and genes that cause different syndromes. Identification of a mutation in one of these genes through genetic testing is able to confirm a diagnosis of HCM/predisposition to HCM. Genetic testing also informs prognosis, treatment options, and genetic counseling, which can vary depending on the specific gene implicated in the disease.2Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of inherited HCM are below:Based on my patient’s personal and/or family history above, he/she meets the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) and/or the Heart Failure Society of America/American College of Medical Genetics and Genomics (HFSA/ACMG) published guidelines for genetic testing. 1,2 A positive result on this genetic testing would provide a definitive cause for this patient’s HCM and would impact medical management, screening, and prevention of potential complications of this disease. Examples of this include:Patients with MYH7 mutations progress more often to end stage heart failure, requiring heart transplant, compared to other genes.6 The identification of a patient with a metabolic storage disorder (e.g. Fabry) is crucial for treatment options, including enzyme replacement therapy.3 While HCM due to a metabolic storage disorder is not a common etiology, the magnitude of an intervention such as enzyme replacement therapy is significant.Patients with mutations identified in a gene causing Noonan syndrome would require additional specialty visits for the evaluation of the extra-cardiac manifestations of this disorder.4 Mutations in TTR cause Hereditary Transthyretin Amyloidosis; patients with this disorder also require evaluation for extra-cardiac manifestations and may be eligible for gene-silencing therapies.5Specifically for this patient, the results of the genetic 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/ORGenetic testing will lead to changes in diagnostic procedures such that more potentially invasive alternative procedures could be avoided, reducing unnecessary tests and cost; AND/ORGenetic testing will lead to informed decisions for other family members with similar conditions, or that may be at risk for similar conditionsWhen a familial mutation has been identified through genetic testing of the index patient, genetic testing can identify family members who are not at increased risk to develop cardiomyopathy (non-mutation carriers). No other test can reliably differentiate unaffected family members, who do not require further intensive screening, from presymptomatic affected family members, who are at risk for sudden cardiac death and must be followed closely by a cardiologist.Due to the risk of sudden cardiac death associated with these mutations and the interventions available to reduce these risks, I am requesting coverage for this testing as medically necessary care and affirm that my patient has provided informed consent for genetic testing.I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective testing for HCM, along with a large database of tested patients to ensure highly validated, accurate, and informative test interpretation. I recommend that you support this request for coverage of diagnostic genetic testing for HCM in my patient. Genetic testing can take up to several weeks to complete and the laboratory will not bill until testing is concluded. Therefore, we are requesting that authorization be valid for 3 months. Thank you for your time and please don’t hesitate to contact me with any questions. 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 Test DetailsTest Name: HCMFirst reflext to HCMNext/HCMNext/CMNext/CardioNextCPT codes: 81439Laboratory: Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656References:Gersh BJ, et al with the ACCG/AHA Task Force on Practice Guidelines. J Thorac Cardiovasc Surg.?2011 Dec;142(6):1303-38.Hershberger RE, et al. J Card Fail.?2018 May;24(5):281-302.Nair V, et al. Cardiovasc Pathol.?2018 Dec 1;39:12-24.Romano AA, et al. Pediatrics.?2010 Oct;126(4):746-59. doi: 10.1542/peds.2009-3207.Walker S. Hosp Pharm.?2018 Jul;53(4):236-238.Sedaghat-Hamedani F, et al. Clin Res Cardiol.?2018 Jan;107(1):30-41. ................
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