Download LETTER OF MEDICAL NECESSITY FOR INHERITED CARDIAC

LETTER OF MEDICAL NECESSITY FOR INHERITED CARDIAC ARRHYTHMIA GENETIC TESTING
(RhythmFirst)
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), and short QT
syndrome (SQTS) are potentially lethal disorders seen on electrocardiogram (EKG); however, the
EKG pattern for these inherited arrhythmias can be transitory, absent or uncertain. Inherited
arrhythmias may be asymptomatic; 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 to confirm a diagnosis or identify at-risk individuals. Based on symptoms and/or
EKG studies, my patient is suspected to have an arrhythmia. [His/Her] family history [is/is
not] remarkable for [LQTS/BrS/SQTS/sudden cardiac death], outlined below as applicable:
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This genetic test (RhythmFirst) analyzes the 3 most common genes associated with BrS, LQTS, and
SQTS, including KCNH2, KCNQ1, and SCN5A. These genes are implicated in over 80% of known
genetic causes of LQTS and BrS.1, 3 As such, this multi-gene test is the most efficient, 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 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 the sudden cardiac death risk for LQTS. Management
recommendations for these disorders typically include implantable cardioverter defibrillator (ICD)
or pacemaker placement, which is essential in the prevention of sudden cardiac death1, 2, 3.
RhythmFirst includes full gene sequencing and deletion/duplication analysis of the 3 most common
genes implicated in LQTS, BrS, and SQTS. 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
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.
2.
3.
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/.
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.
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/.