LETTER OF MEDICAL NECESSITY FOR INHERITED CARDIAC ARRHYTHMIA GENETIC TESTING (RhythmNext)
Date: Date of service/claim
To:Utilization Review Department
Insurance Company Name, Address, City, State
Re:Patient Name, DOB, ID #
ICD-10 Codes: (list codes)
This letter is in regards to my patient and your subscriber, First, Last Nameto request full coverage of medically-indicated genetic testing for inherited cardiac arrhythmia to be performed by Ambry Genetics Corporation.
Inherited arrhythmias like long QT syndrome (LQTS), Brugada syndrome (BrS), short QT syndrome (SQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), andarrhythmogenic right ventricular dysplasia (ARVD)are potentially lethal disorders that can be diagnosed with routine cardiac studies including echocardiogram and electrocardiogram (EKG);however, the EKG pattern for theseinherited arrhythmias can be transitory, absent or uncertain. Inherited arrhythmias may be asymptomatic and sudden cardiac death can occur without warning. A family history of sudden cardiac death and/or an inherited arrhythmia increases the likelihood of finding an underlying genetic cause. Despite this, a negative family history for sudden cardiac death and/or inherited arrhythmia does not rule out a genetic etiology. Thus, genetic testing may be the most effective way of confirming a diagnosis or identifying at-risk individuals (particularly in those with sudden unexpected death or sudden infant death syndrome).Based on symptoms and/orEKG studies, my patient is suspected to have one of these disorders. [His/Her] family history is remarkable for [LQTS/BrS/SQTS/CPVT/ARVD/sudden cardiac death], outlined below as applicable:
This genetic test (RhythmNext) uses gene sequencing and deletion/duplication analyses for 36genes associated withinherited arrhythmias, including:AKAP9, ANK2, CACNA1C, CACNA2D1, CACNB2, CALM1, CASQ2, CAV3, DSC2, DSG2, DSP, GPD1L, HCN4, JUP, KCND3, KCNE1, KCNE2, KCNE3, KCNH2, KCNJ2, KCNJ8, KCNQ1, LMNA, NKX2.5, PKP2, RYR2, SCN1B, SCN3B, SCN4B, SCN5A, SNTA1, TBX5, TGFB3, TMEM43, TRDN, and TRPM4.This multi-gene test is the most efficient and cost-effective way to analyze highly relevant genes, and has significant potential to identify a causative gene mutation in my patient. As my patient is suspected to have an inherited arrhythmia, there is a reasonable probability of detecting a mutation in my patient. Per the HRS/EHRA Consensus Statement recommendations (particularly for LQTS), germline genetic testing is warranted.2
Genetic testing will help clarify my patient’s diagnosis and/or risk to develop (and potentially die of) sudden cardiac arresthighly correlated with these arrhythmias. This genetic testing will directly impact medical management, screening, and prevention of potential complications of this disease. If a mutation is identified, we can then adjust medical care to reduce my patient’s risk of sudden cardiac arrest. For LQTS, genetic testing can identify specific arrhythmia triggers that patients should avoid;additionally, certain medicationscan prolong the QT interval and increase sudden cardiac death risk.Management recommendations for these disorders typically include specific medication use, implantable cardioverter defibrillator (ICD) and/or pacemaker placement, essential to prevent sudden cardiac death.1-5
Due to the medical risks associated with these mutations and the available interventions, this genetic testing is medically warranted. As such, I am ordering this testing as medically necessary and affirm that my patient has provided informed consent for genetic testing.
A positive test result would confirm a genetic diagnosis and/or risk in my patient, and would ensure my patient is being managed appropriately. I am specifying Ambry Genetics Corporation because this laboratory has highly-sensitive and cost-effective testing for inherited arrhythmias, 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 inherited arrhythmias in my patient. Depending on the exact test ordered, genetic testing can take up to several 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.
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 Details
CPT codes: 81280, 81282, 81404, 81406x8, 81408
Laboratory: Ambry Genetics Corporation (TIN 33-0892453/NPI 1861568784), a CAP-accredited and CLIA-certified laboratory located at 7 Argonaut, Aliso Viejo, CA 92656
References:
1.Alders M, Mannens MMAM. Romano-Ward Syndrome. 2003 Feb 20 [Updated 2012 May 31]. In: Pagon RA,et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.
2. Ackerman MJ, et al. HRS/EHRA Expert Consensus Statement on the State of Genetic Testing for the Channelopathies and Cardiomyopathies. Heart Rhythm. 2011 Aug;8(8):1308-39.
3. Brugada R, Campuzano O, Brugada P, et al. Brugada Syndrome. 2005 Mar 31 [Updated 2014 Apr 10]. In: PagonRA,et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.
4. McNally E, MacLeod H, Dellefave-Castillo L. Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy. 2005 Apr 18 [Updated 2014 Jan 9]. In: PagonRA,et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.
5. Napolitano C, Priori SG, Bloise R. Catecholaminergic Polymorphic Ventricular Tachycardia. 2004 Oct 14 [Updated 2014 Mar 6]. In: PagonRA,et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.