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LETTER OF MEDICAL NECESSITY FOR DILATED 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 DILATED CARDIOMYOPATHY (DCM) to be performed by Ambry Genetics Corporation. Dilated cardiomyopathy (DCM) is characterized by left ventricular enlargement and systolic dysfunction (reduced ejection fractions). Individuals with DCM can experience symptoms of fatigue; however, many individuals are asymptomatic for many years. Individuals with DCM develop arrhythmias, cardiac conduction disease, and progression to congestive heart failure (which may require a heart transplant).1,2A genetic etiology of DCM is established in one-third of cases and is associated with mutations in genes that encode sarcomeric proteins, Z-disc proteins, heat-shock chaperones, calcium or potassium channels, genes that cause metabolic disorders, and genes that cause different muscular dystrophies and syndromes. Identification of a mutation in one of these genes through genetic testing is able to confirm a diagnosis of DCM/predisposition to DCM. Genetic testing also informs prognosis, treatment options, and genetic counseling, which can vary depending on the specific gene implicated in the disease.1,2Significant aspects of my patient’s personal and/or family medical history that suggest a reasonable probability of inherited DCM are below:Based on my patient’s personal and/or family history above, he/she meets the Heart Failure Society of America/American College of Medical Genetics and Genomics’ (HFSA/ACMG) and the Heart Rhythm Society’s (HRS) published guidelines for genetic testing. 2,3 A positive result on this genetic testing would provide a definitive cause for this patient’s DCM and would impact medical management, screening, and prevention of potential complications of this disease. Examples of this include:Mutations in LMNA, EMD, and DES are associated with a high risk of conduction system disease and life-threatening arrhythmias; therefore, placement of prophylactic pace-makers or intra-cardiac defibrillators is considered.2,3 Individuals may have mutations in genes that cause different types of muscular dystrophy (such as LMNA, MYH7, DMD, and DES); in some cases, DCM can be the presenting feature, and follow-up with neuromuscular specialists would be required.1,3 Patients with mutations identified in a gene causing a syndrome (such as TAZ, DSP, and ALMS1) would require additional specialty visits for the evaluation of the extra-cardiac manifestations of this disorder.1Specifically 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 DCM (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 complications (including sudden cardiac death) and must be followed closely by a cardiologist.Due to the risks 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 DCM, 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 DCM 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: DCMNext/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:Hershberger RE, et al. Nat Rev Cardiol.?2013 Sep;10(9):531-47.Hershberger RE, et al. J Card Fail.?2018 May;24(5):281-302.Ackerman MJ, et al. Heart Rhythm.?2011 Aug;8(8):1308-39.Abustini E, et al. J Am Coll Cardiol.?2002?Mar 20;39(6):981-90. ................
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