Download Testing is Temporarily Suspended as of 6/26/2013

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