Download Clinical Genetics- BH6N-601A

Insurance Company Name
Address
City, State
Date of claim
Re: Ambry Genetics Corporation, Letter of Medical Necessity (LMN) for HCM Panel
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 DNA sequence analysis for a panel of 31 genes when mutated are known to be
associated with hypertrophic cardiomyopathy (HCM)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. Referenced genes include: ACTC1, ACTN2,
ANKRD1, CALR3, CAV3, CSRP3, DES, FXN, GLA, JPH2, LAMP2, MYBPC3, MYH6, MYH7,
MYL2, MYL3, MYOM1, MYOZ2, NEXN, PLN, PRKAG2, PTPN11, RAF1, TCAP, TNNC1, TNNI3,
TNNT2, TPM1, TTN, TTR and VCL.
Hypertrophic cardiomyopathy occurs with a prevalence of 1 in 500 and is suspected in
individuals whose personal or family histories include any of the following:
 Structural changes of the heart including thickening of the left ventricular wall
 Severe fatique (present in 20%)
 Arrhythmias
 Exercise fatique and syncope
 Congestive heart failure, embolic stroke and sudden cardiac death (present in 10%)
As such, First, Last Name personal and/or family history(ies) are suggestive of hypertrophic
cardiomyopathy susceptibility. Based on my evaluation and review of the available literature,
Ambry Genetics’ 31 gene panel testing for hypertrophic cardiomyopathy is crucial in order to
establish/confirm a genetic diagnosis and in guiding appropriate and immediate medical
management. A positive genetic test result can provide the following benefits to this patient:
 Appropriate management and other treatment guidance
 Predict disease prognosis and risk for secondary findings
 Help identify the cause for HCM
 Allow specific gene analysis for family members when a familial mutation has been
identified
 Help identify family members who are not at an increased risk to develop
cardiomyopathy
Genetic testing will be performed through Ambry Genetics Corporation given their longstanding experience with next-generation sequencing, consistent variant analysis, detailed
results reporting and continuous support from highly trained medical directors and genetic
counselors.
Ambry Genetics offers the most comprehensive genetic testing for HCM by sequencing the
entire coding region of all clinically available genes responsible for HCM. At least 40 – 80% of
all cases of hypertrophic cardiomyopathy are estimated to be due to the 31 genes included in
the HCM Panel. The majority of the remaining 20 -60% of inherited HCM is thought to be due
to a mutation in yet unidentified genes and clinical testing is not available.
I recommend that you support this request for coverage of diagnostic genetic testing for
HCM for my patient. Genetic testing can take up to four months to complete and the laboratory
will not bill until testing is complete. 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
428.1 Left heart failure
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
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