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Testing is Temporarily Suspended as of 6/26/2013 Insurance Company Name Address City, State Date of claim Re: Ambry Genetics Corporation, Letter of Medical Necessity for Cardiovascular Disease Predisposition Testing Patient First, Last Name DOB ID Number Dear Medical Director, This letter is in regards to my patient and your subscriber, First, Last Name, to request full coverage for inherited cardiovascular disease genetic testing to be performed by Ambry Genetics Corporation (TIN 33-0892453 / NPI 1861568784), a CAP approved and CLIA certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656. The Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) recommend genetic testing be offered to individuals with suspected channelopathies or cardiomyopathies in situations where test results can be interpreted, and when they can influence medical management of the patient (Ackerman etal. Europace. 2011;13:1077–1109). Inherited susceptibility to cardiovascular disease is suspected in individuals with a personal or family history of any of the following: Sudden cardiac arrest or sustained arrhythmia of unknown etiology Cardiovascular disease with known genetic cause, for example: o Long QT Syndrome/ Long QTc interval (LQTS) o Brugada Syndrome (BrS) o Catecholeminergic Polymorphic Ventricular Tachycardia (CPVT) o Dilated Cardiomyopathy (DCM) o Hypertrophic Cardiomyopathy (HCM) o Restrictive Cardiomyopathy (RCM) o Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) o Congenital Heart Disease (CHD) A close relative who died from sudden cardiac death or sudden unexplained death Combination of several cardiovascular conditions As such, this patient’s personal and/or family history(ies) are suggestive of genetic cardiovascular disease. Molecular testing is instrumental in establishing or confirming a genetic syndrome diagnosis and in guiding appropriate medical management. A positive genetic testing result could provide the following benefits to this patient: Help to establish a definitive diagnosis Modification of cardiovascular surveillance options and age of initial screening for relevant cardiovascular risk factors (e.g. implications during pregnancy) Appropriate medical management and other treatment guidance (e.g. placement of an internal cardiac defibrillator and/or pacemaker, avoidance of arrhythmia inducing medications and preventive or risk-reducing pharmacologic treatment) Avoidance of a preventable sudden death due to cardiac arrhythmia Delaying or avoiding the need for heart transplantation Genetic testing will be performed through Ambry Genetics Corporation, given its longstanding experience with next-generation sequencing, consistent variant analysis, detailed results reporting and continuous support from highly trained medical directors and genetic counselors. By ordering testing, I, the authorized clinician/medical professional acknowledge that the patient has been supplied with information regarding genetic testing and the patient has given informed consent for genetic testing to be performed. I confirm that the ordered testing is medically necessary for the diagnosis or detection of a predisposition to and/or current disease, illness, impairment, syndrome or disorder, and that these results will be used in the medical management and treatment decisions for this patient. I recommend that you support this request for coverage of diagnostic genetic testing for cardiovascular disease predisposition for my patient. Genetic testing can take up to four months to complete and the laboratory will not bill until testing is concluded. Therefore, we are requesting that the authorization be valid for 6 months. SUMMARY OF DIAGNOSIS - ICD-9 CODES (input all that apply) – (use v codes for secondary dx) 359.10 Hereditary progressive muscular 428.0 Congestive heart failure dystrophy 425.11 Hypertrophic obstructive cardiomyopathy 759.89 Noonan syndrome 441.03 Thoracic aortic dissection 780.2 Syncope and collapse 441.9 Aortic aneurysm of uns site 794.31 Abnormal EKG 425.18 Hypertrophic non-obstructive cardiomyopathy 425.4 759.82 Marfan syndrome 428.1 Left heart failure 745.4 Cardiomyopathy, other primary 746.3 w/o rupture V12.53 Hx. sudden cardiac arrest Ventricular septal defect V18.9 Genetic disease carrier Aortic stenosis, congenital V82.71 Scr for genetic disease carrier status 425.8 Syndromic cardiomyopathy 746.89 Brugada syndrome 426.82 Long QTc/Long QT syndrome 746.9 Congenital heart disease (NOS) Others _______________________________ _______________________________ Thank you for your time and please don’t hesitate to contact me with any questions. Sincerely, Ordering Clinician Signature ________________________________ Date ______________ (MD/DO, Clinical Nurse Specialist, Nurse-Midwives, Nurse Practitioner, Physician Assistant, Genetic Counselor*) *Authorized clinician requirements vary by state