Download LETTER OF MEDICAL NECESSITY FOR INHERITED CARDIAC

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-9 Codes: (list codes)
This letter is in regards to my patient and your subscriber, First, Last Name to request full coverage
of medically-indicated genetic testing for inherited cardiac arrhythmia 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.
Inherited arrhythmias like long QT syndrome (LQTS), Brugada syndrome (BrS), short QT syndrome
(SQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), and arrhythmogenic 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 these inherited 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/or EKG studies,
my patient is suspected to have one of these disorders. [His/Her] family history [is/is not]
remarkable for [LQTS/BrS/SQTS/CPVT/ARVD/sudden cardiac death], outlined below as
applicable:



This genetic test (RhythmNext) analyzes 34 genes associated with inherited 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, PKP2, RYR2, SCN1B,
SCN3B, SCN4B, SCN5A, SNTA1, TGFB3, TMEM43, TRDN, and TRPM4. This multi-gene test is the most
efficient and cost-effective way to analyze highly relevant genes implicated in each of these
conditions, 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 of these genes will help clarify my patient’s diagnosis and/or risk to develop
(and potentially die of) sudden cardiac arrest highly 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 medications can
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
RhythmNext includes full gene sequencing and deletion/duplication analysis of 34 genes implicated
in LQTS, BrS, SQTS, ARVD, CPVT, and other inherited arrhythmias. 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 CAPaccredited and
CLIA-certified laboratory located at 15 Argonaut, Aliso Viejo, CA 92656
References:
1.
Alders M, Mannens MMAM. Romano-Ward Syndrome. 2003 Feb 20 [Updated 2012 May 31].
In: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews® [Internet]. Seattle
(WA): University of Washington, Seattle; 1993-2014. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK1129/.
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: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews® [Internet].
Seattle (WA): University of Washington, Seattle; 1993-2014. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK1517/.
4.
McNally E, MacLeod H, Dellefave-Castillo L. Arrhythmogenic Right Ventricular
Dysplasia/Cardiomyopathy. 2005 Apr 18 [Updated 2014 Jan 9]. In: Pagon RA, Adam MP,
Ardinger HH, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of
Washington, Seattle; 1993-2014. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK1131/.
5.
Napolitano C, Priori SG, Bloise R. Catecholaminergic Polymorphic Ventricular Tachycardia.
2004 Oct 14 [Updated 2014 Mar 6]. In: Pagon RA, Adam MP, Ardinger HH, et al., editors.
GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2014.
Available from: http://www.ncbi.nlm.nih.gov/books/NBK1289/.