Download Clinical Genetics- BH6N-601A

Insurance Company Name
Address
City, State
Date of claim
Re: Ambry Genetics Corporation, Letter of Medical Necessity (LMN) for DCM 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 37 genes, when mutated, are known to
be associated with cause for dilated cardiomyopathy (DCM) 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. These genes include: ABCC9, ACTC1,
ACTN2, ANKRD1, BAG3, CRYAB, CSRP3, DES, DMD, EMD, EYA4, ILK, LAMP2, LDB3/ZASP,
LMNA, MYBPC3, MYH6, MYH7, MYPN, NEBL, NEXN, PDLIM3, PLN, RBM20, SCN5A, SGCD,
TAZ, TCAP, TMPO, TNNC1, TNNI3, TNNT2, TPM1, TTN, TTR, TXNRD, and VCL.
DCM refers to heart muscle disease where the left ventricle dilates, or enlarges, leading
to reduced systolic (pumping) function. Up to 50% of idiopathic DCM is believed to be familial
and has been associated with mutations in any one of over 30 genes. Mutations in more than 30
autosomal genes and several X-linked genes have been associated with DCM, although not all
of these genes are available for clinical testing. Clinical testing through Ambry is estimated to
detect a disease associated mutation or variant in up to 38% of patients who are appropriately
tested.
Based on my evaluation and review of the available literature, genetic testing for DCM is
medically necessary for this patient, who was diagnosed at age ______ with dilated
cardiomyopathy to confirm his/her diagnosis and establish if there is a genetic cause/a known
family history of DCM to identify if he/she inherited a high risk for this condition. A molecular
diagnosis can help guide management for this patient. Furthermore, a positive genetic test
result can provide the following benefits to this patient:
 Confirm a clinical diagnosis and thus impact management decisions, surveillance,
therapy options and genetic counseling
 Help estimate familial risk as first-degree relatives of an affected individual with an
autosomal dominant FDC mutation, each have a 50% chance of being affected
 Allow specific gene analysis for family members when a familial mutation has been
identified

Identify family members who are not at increased risk to develop cardiomyopathy (nonmutation carriers)
No other test can reliably differentiate unaffected family members, who do not require further
extensive screening, from presyptomatic family members, who are at risk for heart failure,
arrhythmias, or sudden cardiac death and must be followed closely by a cardiologist.
Genetic testing will be performed through Ambry Genetics Corporation, a CLIA-certified
laboratory given their long-standing 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, highly
sensitive and cost-effective genetic testing for DCM.
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
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