Download 12.04.28 Genetic Testing for Predisposition to Inherited Hypertrophic

MEDICAL POLICY – 12.04.28
Genetic Testing for Predisposition to Inherited
Hypertrophic Cardiomyopathy
BCBSA Ref. Policy: 2.02.28
Effective Date:
June 1, 2017
RELATED MEDICAL POLICIES:
Last Revised:
May 2, 2017
12.04.114 Genetic Testing for Dilated Cardiomyopathy
Replaces:
2.02.28
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
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Introduction
Hypertrophic cardiomyopathy is a condition where the muscle cells of the heart become big.
This can make the walls of the heart thicker than normal, and because the walls surrounding the
heart’s pumping chambers get thicker, the chambers become smaller than they should be.
Hypertrophic cardiomyopathy is usually inherited, and is caused by changes to one or more of
the person’s genes. The muscle problems eventually lead to enlargement of the heart and
possible problems with the heart’s rhythm and valves. This policy discusses when genetic testing
for this form of cardiomyopathy may be considered medically necessary.
Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a
service may be covered.
Policy Coverage Criteria
Testing
Medical Necessity
Genetic testing for
Genetic testing for predisposition to HCM may be considered
predisposition to HCM
medically necessary for individuals who are at risk for
developing HCM.

“At risk” is defined as having a first-degree relative who has a
confirmed diagnosis of HCM and the relative has a
documented pathogenic gene variant. (See below)
Genetic testing for HCM
Genetic testing for HCM gene variants may be considered
gene variants
medically necessary for the index patient with confirmed
clinical HCM, when used to assist unaffected first degree
family members.(See Benefit Application section)
Genetic testing for
Genetic testing for predisposition to HCM is considered not
predisposition to HCM
medically necessary for patients with a family history of HCM
in which a first-degree relative has tested negative for
pathologic variants.
Due to the complexity of genetic testing for hypertrophic cardiomyopathy (HCM) and the
potential for misinterpretation of results, the decision to test and the interpretation of test
results should be performed by, or in consultation with, an expert in the area of medical genetics
and/or HCM.
To inform and direct genetic testing for at-risk individuals, genetic testing should initially be
performed in at least one close relative with a confirmed diagnosis of HCM (index case), if
possible. See Practice Guidelines and Position Statements and Benefit Application section
for information regarding testing of the index case.
Because there are varying degrees of penetrance for different HCM variants, consideration for
testing of second- or third-degree relatives may be appropriate in certain circumstances. Some
judgment should be allowed for these decisions, for example, in the case of a small family
pedigree. Consultation with an expert in medical genetics and/or the genetics of HCM, in
conjunction with a detailed pedigree analysis, is appropriate when testing of second- or thirddegree relatives is considered.
Coding
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CPT
81405
Molecular pathology procedure, Level 6 (e.g., analysis of 6-10 exons by DNA sequence
analysis, mutation scanning or duplication/deletion variants of 11-25 exons, regionally
targeted cytogenomic array analysis). This code includes:

ACTC1 (actin, alpha, cardiac muscle 1) (e.g., familial HCM), full gene sequence

MYL2 (myosin, light chain 2, regulatory, cardiac, slow) (e.g., familial HCM), full gene
sequence

MYL3 (myosin, light chain 3, alkali, ventricular, skeletal, slow) (e.g., familial HCM),
full gene sequence

TNNC1 (troponin C type 1 [slow]) (e.g., hypertrophic cardiomyopathy or dilated
cardiomyopathy), full gene sequence
81406

TNNI3 (troponin I, type 3 [cardiac]) (e.g., familial HCM), full gene sequence

TPM1 (tropomyosin 1 [alpha]) (e.g., familial HCM), full gene sequence
Molecular pathology procedure, Level 7 (e.g., analysis of 11-25 exons by DNA
sequence analysis, mutation scanning or duplication/deletion variants of 26-50 exons,
cytogenomic array analysis for neoplasia). This code includes:

81407
TNNT2 (troponin T, type 2 [cardiac]) (e.g., familial HCM), full gene sequence
Molecular pathology procedure, Level 8 (e.g., analysis of 26-50 exons by DNA
sequence analysis, mutation scanning or duplication/deletion variants of >50 exons,
sequence analysis of multiple genes on one platform). This code includes:

MYBPC3 (myosin binding protein C, cardiac) (e.g., familial HCM), full gene sequence

MYH7 (myosin, heavy chain 7, cardiac muscle, beta) (e.g., familial HCM, Liang
distal myopathy), full gene sequence
81439
Inherited cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy,
arrhythmogenic right ventricular cardiomyopathy) genomic sequence analysis panel,
must include sequencing of at least 5 genes, including DSG2, MYBPC3, MYH7, PKP2,
and TTN (new code effective 1/1/17)
HCPCS
S3865
Comprehensive gene sequence analysis for hypertrophic cardiomyopathy
S3866
Genetic analysis for a specific gene mutation for hypertrophic cardiomyopathy (HCM)
in an individual with a known HCM mutation in the family
Note:
CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
Related Information
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Genetic Counseling
Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and
experts recommend formal genetic counseling in most cases when genetic testing for an
inherited condition is considered. The interpretation of the results of genetic tests and the
understanding of risk factors can be very difficult and complex. Therefore, genetic counseling
will assist individuals in understanding the possible benefits and harms of genetic testing,
including the possible impact of the information on the individual’s family. Genetic counseling
may alter the utilization of genetic testing substantially and may reduce inappropriate testing.
Genetic counseling should be performed by an individual with experience and expertise in
genetic medicine and genetic testing methods.
Benefit Application
Some Plans may have contract or benefit exclusions for genetic testing.
Local plan information:
Professional society recommendations indicate that, when possible, the family member who has
been diagnosed with HCM undergo genetic testing for hypertrophic cardiomyopathy (HCM).
This will allow unaffected, at-risk family members to undergo genetic testing for the specific
HCM variant found in the index case. This testing is intended to document whether a known
pathologic variant is present in the family and optimize the predictive value of predisposition
testing for at-risk relatives.
However, coverage for testing of the affected index case is dependent on contract benefit
language when there is no conclusive evidence of clinical benefit to the index case from testing.
Specific contract language must be reviewed and considered when determining coverage for
testing. In some cases, coverage for testing the index case may be available through the
contract that covers the unaffected, at-risk individual who will benefit from knowing the results
of the genetic test.
Evidence Review
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Description
Familial hypertrophic cardiomyopathy (HCM) is an inherited condition that is caused by a
disease-associated variant in one or more of the cardiac sarcomere genes. HCM is associated
with numerous cardiac abnormalities, the most serious of which is sudden cardiac death. Genetic
testing for HCM-associated variants is currently available through a number of commercial
laboratories.
Background
Familial Hypertrophic Cardiomyopathy (HCM)
Familial hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular
condition, with a phenotypic prevalence of approximately 1 in 500 adults (0.2%).1 It is the most
common cause of sudden cardiac death (SCD) in adults younger than 35 years of age and is
probably also the most common cause of death in young athletes.2 The overall death rate for
patients with HCM is estimated to be 1% per year in the adult population.3, 4
The genetic variant associated with HCM causes a defect in the cardiac sarcomere, which is the
basic contractile unit of cardiac myocytes and is composed of a number of different protein
structures.5 Nearly 1,400 individual variants in at least 18 different genes have been identified to
date.6-8 Approximately 90% of pathogenic variants are missense (ie, one amino acid is replaced
for another), and the strongest evidence for pathogenicity is available for 11 genes coding for
thick filament proteins (MYH7, MYL2, MYL3), thin filament proteins (TNNT2, TNNI3, TNNC1,
TPM1, ACTC), intermediate filament proteins (MYBPC3), and the Z-disc adjoining the sarcomere
(ACTN2, MYOZ2). Variants in myosin heavy chain (MYH7) and myosin -binding protein C
(MYBPC3) are the most common and account for roughly 80% of sarcomeric HCM. These
genetic defects are inherited in an autosomal dominant pattern with rare exceptions.5 Genetic
abnormalities can be identified in approximately 60% of patients with clinically documented
HCM. 7,9 Most of these patients have a familial pattern, although some exceptions are found
presumably due to de novo variants.9
Diagnosis
The clinical diagnosis of HCM depends on the presence of left ventricular hypertrophy (LVH, or
thickening of the walls of the ventricle). This may be measured by echocardiography or
magnetic resonance imaging, in the absence of other known causative factors such as valvular
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disease, long-standing hypertension, or other myocardial disease.7 In addition to primary cardiac
disorders, there are systemic diseases that can lead to LVH and thus “mimic” HCM. These
include infiltrative diseases such as amyloidosis, glycogen storage diseases (eg, Fabry disease,
Pompe disease), and neuromuscular disorders (eg, Noonan syndrome, Friedreich ataxia).10
These disorders need to be excluded before a diagnosis of familial HCM is made.
HCM is a very heterogeneous disorder. Manifestations range from subclinical, asymptomatic
disease to severe life-threatening disease. Wide phenotypic variability exists among individuals,
even when an identical variant is present, including among affected family members.2 This
variability in clinical expression may be related to environmental factors and modifier genes.11 A
large percentage of patients with HCM, perhaps the majority of all HCM patients, are
asymptomatic or have minimal symptoms.10,11 These patients do not require treatment and are
not generally at high risk for SCD. A subset of patients has severe disease that causes a major
impact on quality of life and life expectancy. Severe disease can lead to disabling symptoms, as
well as complications of HCM, including heart failure and malignant ventricular arrhythmias.
Symptoms and presentation may include SCD due to unpredictable ventricular
tachyarrhythmias, heart failure, or atrial fibrillation, or some combination.12 Management of
patients with HCM involves treating cardiac comorbidities, avoiding therapies that may worsen
obstructive symptoms, treating obstructive symptoms with β-blockers, calcium channel blockers,
and (if symptoms persist) invasive therapy with surgical myectomy or alcohol ablation,
optimizing treatment for heart failure, if present, and SCD risk stratification. ICD implantation
may be indicated if there is a family history of SCD.
Diagnostic screening of first-degree relatives and other family members is an important
component of HCM management. Guidelines have been established for screening in clinically
unaffected relatives of affected individuals. Screening with physical examination,
electrocardiography, and echocardiography is recommended every 12 to 18 months for
individuals age 12 to 18 years and every 3 to 5 years for adults.11 Additional screening is
recommended for any change in symptoms that might indicate the development of HCM.11
Genetic Testing
Genetic testing has been proposed as a component of screening at-risk individuals to determine
their predisposition to HCM. Patients at risk for HCM are defined as individuals who have a close
family member with established HCM. Results of genetic testing may influence management of
at-risk individuals, which may in turn lead to improved outcomes. Furthermore, results of
genetic testing may have implications for decision making in the areas of reproduction,
employment, and leisure activities.
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Commercial testing has been available since May 2003, and numerous companies currently offer
genetic testing for HCM.6,13-16 Testing is performed either as comprehensive testing or targeted
gene testing. Comprehensive testing, which is done for an individual without a known genetic
variant in the family, analyzes the genes that are most commonly associated with genetic
variants for HCM and evaluates whether any potentially pathogenic variants are present. Some
available panels include testing for multisystem storage diseases that may include cardiac
hypertrophy, such as Fabry disease (GLA), familial transthyretin amyloidosis (TTR), X-linked
Danon disease (LAMP2).
Other panels include testing for genes related to HCM but also those associated with other
cardiac disorders. For example, the Comprehensive Cardiomyopathy panel (ApolloGen, Irvine,
CA) is an next-generation sequencing (NGS) panel of 44 genes associated with HCM, dilated
cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy,
catecholaminergic polymorphic ventricular tachycardia, left ventricular noncompaction
syndrome, Danon syndrome, Fabry disease, Barth syndrome, and transthyretin amyloidosis.
For a patient with a known variant in the family, targeted testing is performed. Targeted variant
testing evaluates for the presence or absence of a single variant known to exist in a close
relative.
It can be difficult to determine the pathogenicity of genetic variants associated with HCM. Some
studies have reported that assignment of pathogenicity has a relatively high error rate and that
classification changes over time.17,18 With NGS and whole-exome sequencing techniques, the
sensitivity of identifying variants on the specified genes has increased substantially. At the same
time, the number of variants of uncertain significance is also increased with NGS. In addition, the
percentage of individuals who have more than 1 variant that is thought to be pathogenic is
increasing. A 2013 study reported that 9.5% (19/200) patients from China with HCM had
multiple pathogenic variants and that the number of variants correlated with severity of
disease.19
Summary of Evidence
For individuals who are asymptomatic with risk for hypertrophic cardiomyopathy (HCM) because
of a positive family history who receive testing for a specific HCM-related variant identified in
affected family member(s), the evidence includes studies reporting on the analytic and clinical
validity of testing. Relevant outcomes are overall survival, test accuracy and validity, changes in
reproductive decision making, symptoms, and morbid events. For individuals at risk for HCM
(first-degree relatives), genetic testing is most useful when there is a known disease-associated
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variant in the family. In this situation, genetic testing will establish the presence or absence of
the same variant in a close relative with a high degree of certainty. Absence of this variant will
establish that the individual has not inherited the familial predisposition to HCM and thus has a
similar risk of developing HCM as the general population. Such patients will no longer need
ongoing surveillance for the presence of clinical signs of HCM. Although no direct evidence
comparing outcomes for at-risk individuals managed with and without genetic testing was
identified, there is a strong chain of evidence that management changes can improve outcomes
with genetic testing when there is a known familial variant. The evidence is sufficient to
determine that the technology results in a meaningful improvement in the net health outcome.
For individuals who are asymptomatic with risk for HCM because of a positive family history who
receive nonspecific testing for a HCM-related variant, the evidence includes studies reporting on
the analytic and clinical validity of testing. Relevant outcomes are overall survival, test accuracy
and validity, changes in reproductive decision making, symptoms, and morbid events. Given the
wide genetic variation in HCM and the likelihood that not all causative variants have been
identified, there is imperfect clinical sensitivity. Therefore, a negative test is not sufficient to rule
out a disease-associated variant in patients without a known family variant. For at-risk
individuals without a known variant in the family, there is no clear relation between testing and
improved outcomes. The evidence is insufficient to determine the effects of the technology on
health outcomes.
Ongoing and Unpublished Clinical Trials
Some trials that might influence this review are listed below.
Table 1. Summary of Key Trials
NCT No.
NCT01915615
Trial Name
HCMR - Novel Markers of Prognosis in Hypertrophic
Planned
Completion
Enrollment
Date
2750
Nov 2018
540
May 2020
Cardiomyopathy
NCT00156429
Genetic Predictors of Outcome in HCM Patients
NCT: national clinical trial.
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Clinical Input Received From Physician Specialty Societies and Academic
Medical Centers
While the various physician specialty societies and academic medical centers may provide
appropriate reviewers who collaborate with and make recommendations during this process,
input received does not represent an endorsement or position statement by the physician
specialty societies or academic medical centers, unless otherwise noted.
Clinical input was solicited in January 2011 regarding general agreement with the policy. This
was followed up by a second round of focused clinical vetting in October 2011 to address
specific questions raised after the first round of vetting. The initial vetting indicated uniform
agreement with the medically necessary indication for individuals with a first-degree relative
who has a known pathologic mutation. This vetting also asked whether testing should be
restricted to first-degree relatives. For this question, there was a mixed response, with two
reviewers indicating that they agree with testing only first-degree relatives, two reviewers
indicating that testing should be offered to non -first-degree relatives, and one reviewer who
was unsure.
The second round of clinical vetting focused on the changes in management that could result
from genetic testing. Reviewers were uniform in responding that a positive test will result in
heightened surveillance. All but one reviewer indicated that a negative test will eliminate the
need for future surveillance in all cases. There was general agreement that the surveillance
schedule used in clinical practice was that proposed by Maron et al.11
Practice Guidelines and Position Statements
European Society of Cardiology (ESC)
In 2014, the European Society of Cardiology issued guidelines on the diagnosis and
management of hypertrophic cardiomyopathy (HCM), which included the following
recommendations related to genetic testing 36
Class I Recommendations

Genetic counseling is recommended for all patients with HCM when their disease cannot be
explained solely by a non-genetic cause, whether or not clinical or genetic testing will be
used to screen family members. (Level of Evidence: B)
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
Genetic testing is recommended in patients fulfilling diagnostic criteria for HCM, when it
enables cascade genetic screening of their relatives. (Level of Evidence: B)

It is recommended that genetic testing be performed in certified diagnostic laboratories with
expertise in the interpretation of cardiomyopathy-related variants. (Level of Evidence: C).

In the presence of symptoms and signs of disease suggestive of specific causes of HCM,
genetic testing is recommended to confirm the diagnosis. (Level of Evidence: B)

Cascade genetic screening, after pre-test counseling, is recommended in first-degree adult
relatives of patients with a definite disease-causing mutation. (Level of Evidence: B)

Clinical evaluation, employing ECG and echocardiography and long-term follow-up, is
recommended in first-degree relatives who have the same definite disease-causing mutation
as the proband (index patient). (Level of Evidence: C)
Class IIa Recommendations

Genetic counselling should be performed by professionals trained for this specific task
working within a multidisciplinary specialist team. (Level of Evidence: C)

Genetic testing in patients with a borderline diagnosis of HCM should be performed only
after detailed assessment by specialist teams. (Level of Evidence: C)

Post-mortem genetic analysis of stored tissue or DNA should be considered in deceased
patients with pathologically confirmed HCM, to enable cascade genetic screening of their
relatives. (Level of Evidence: C)

First-degree relatives who do not have the same definite disease-causing mutation as the
proband (index patient) should be discharged from further follow-up but advised to seek reassessment if they develop symptoms or when new clinically relevant data emerge in the
family. (Level of Evidence: B)

When no definite genetic mutation is identified in the proband (index patient) or genetic
testing is not performed, clinical evaluation with ECG and echocardiography should be
considered in first-degree adult relatives and repeated every 2–5 years (or 6–12 monthly if
non-diagnostic abnormalities are present). (Level of Evidence: C)

The children of patients with a definite disease-causing mutation should be considered for
predictive genetic testing—following pre-test family counseling—when they are aged 10 or
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more years and this should be carried out in accordance with international guidelines for
genetic testing in children. (Level of Evidence: C)

In first-degree child relatives aged 10 or more years, in whom the genetic status is unknown,
clinical assessment with ECG and echocardiography should be considered every 1–2 years
between 10 and 20 years of age, and then every 2–5 years thereafter. (Level of Evidence: C)
Class IIb Recommendations

If requested by the parent(s) or legal representative(s), clinical assessment with ECG and
echocardiography may precede or be substituted for genetic evaluation after counselling by
experienced physicians and when it is agreed to be in the best interests of the child. (Level of
Evidence: C)

When there is a malignant family history in childhood or early-onset disease or when
children have cardiac symptoms or are involved in particularly demanding physical activity,
clinical or genetic testing of first-degree child relatives before the age of 10 years may be
considered. (Level of Evidence: C)

In definite mutation carriers who have no evidence of disease expression, sports activity may
be allowed after taking into account the underlying mutation and the type of sport activity,
and the results of regular and repeated cardiac examinations. (Level of Evidence: C)
American College of Cardiology (ACC) Foundation and the American
Heart Association (AHA)
The American College of Cardiology Foundation and the American Heart Association issued
joint guidelines on the diagnosis and treatment of HCM in 2011.12
Class I Recommendations

Evaluation of familial inheritance and genetic counseling is recommended as part of the
assessment of patients with HCM. (Level of Evidence: B)

Patients who undergo genetic testing should also undergo counseling by someone
knowledgeable in the genetics of cardiovascular disease so that results and their clinical
significance can be appropriately reviewed with the patient. (Level of Evidence: B)
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
Screening (clinical, with or without genetic testing) is recommended in first-degree relatives
of patients with HCM. (Level of Evidence: B)

Genetic testing for HCM and other genetic causes of unexplained cardiac hypertrophy is
recommended in patients with an atypical clinical presentation of HCM or when another
genetic condition is suspected to be the cause. (Level of Evidence: B)
Class IIa Recommendations

Genetic testing is reasonable in the index patient to facilitate the identification of firstdegree family members at risk for developing HCM (Level of Evidence: B).
Class IIb Recommendations

The usefulness of genetic testing in the assessment of risk of SCD in HCM is uncertain (Level
of Evidence: B).
Class III indications: No Benefit

Genetic testing is not indicated in relatives when the index patient does not have a definitive
pathogenic mutation (Level of Evidence: B).

Ongoing clinical screening is not indicated in genotype-negative relatives in families with
HCM (Level of Evidence: B).
Heart Rhythm Society (HRS) and European Heart Rhythm Association
(EHRA)
The HRS and the EHRA published recommendations for genetic testing for cardiac
channelopathies and cardiomyopathies in 2011.37For hypertrophic cardiomyopathy, the
following recommendations were made:

Comprehensive or targeted HCM genetic testing is recommended for any patient in whom a
cardiologist has established a clinical diagnosis of HCM based on examination of the
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patient’s clinical history, family history, and electrocardiographic/echocardiographic
phenotype

Mutation-specific testing is recommended for family members and appropriate relatives
following the identification of the HCM-causative mutation in an index case.
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage
decisions are left to the discretion of local Medicare carriers.
Regulatory Status
Clinical laboratories may develop and validate tests in-house and market them as a laboratory
service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the
Clinical Laboratory Improvement Act (CLIA). Sequencing tests for hypertrophic cardiomyopathy
(HCM) are available under the auspices of CLIA. Laboratories that offer LDTs must be licensed by
CLIA for high-complexity testing.
To date, the U.S. Food and Drug Administration (FDA) has chosen not to require any regulatory
review of this test.
There are no assay kits approved by FDA for genetic testing for HCM.
References
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30. Michels M, Soliman OI, Phefferkorn J, et al. Disease penetrance and risk stratification for sudden cardiac death in asymptomatic
hypertrophic cardiomyopathy mutation carriers. Eur Heart J. Nov 2009;30(21):2593-2598. PMID 19666645
31. Axelsson A, Iversen K, Vejlstrup N, et al. Efficacy and safety of the angiotensin II receptor blocker losartan for hypertrophic
cardiomyopathy: the INHERIT randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. Feb
2015;3(2):123-131. PMID 25533774
32. Ho CY, Lakdawala NK, Cirino AL, et al. Diltiazem treatment for pre-clinical hypertrophic cardiomyopathy sarcomere mutation
carriers: a pilot randomized trial to modify disease expression. JACC Heart Fail. Feb 2015;3(2):180-188. PMID 25543971
33. Oliveira TG, Mitne-Neto M, Cerdeira LT, et al. A variant detection pipeline for inherited cardiomyopathy-associated genes using
next-generation sequencing. J Mol Diagn. Jul 2015;17(4):420-430. PMID 25937619
34. Chiou KR, Chu CT, Charng MJ. Detection of mutations in symptomatic patients with hypertrophic cardiomyopathy in Taiwan. J
Cardiol. Mar 2015;65(3):250-256. PMID 25086479
35. Adalsteinsdottir B, Teekakirikul P, Maron BJ, et al. Nationwide Study on Hypertrophic Cardiomyopathy in Iceland: Evidence of a
MYBPC3 Founder Mutation. Circulation. Sep 30 2014;130(14):1158-1167. PMID 25078086
36. Authors/Task Force m, Elliott PM, Anastasakis A, et al. 2014 ESC Guidelines on diagnosis and management of hypertrophic
cardiomyopathy: The Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society
of Cardiology (ESC). Eur Heart J. Oct 14 2014;35(39):2733-2779. PMID 25173338
37. Ackerman MJ, Priori SG, Willems S, et al. HRS/EHRA expert consensus statement on the state of genetic testing for the
channelopathies and cardiomyopathies this document was developed as a partnership between the Heart Rhythm Society
(HRS) and the European Heart Rhythm Association (EHRA). Heart Rhythm. Aug 2011;8(8):1308-1339. PMID 21787999
History
Date
Comments
03/13/12
New Policy – Add to Pathology/Laboratory section. Policy created with literature
search/TEC Assessment through October 2011; may be considered medically necessary
for individuals who are at risk for development of HCM, defined as having a firstdegree relative with established HCM, when there is a known pathogenic gene
mutation present in an affected relative; considered not medically necessary for
patients with a family history of HCM in which a first-degree relative has tested
negative for pathologic variants; considered medically necessary as a plan variance for
the index patient with confirmed clinical symptoms and considered investigational for
all other indications.
09/17/12
Update Coding Section – ICD-10 codes are now effective 10/01/2014. Policy
renumbered and moved to Genetic Testing section; the number was 2.02.28 and is
Page | 15 of 17
∞
Date
Comments
now 12.04.28.
02/11/13
Replace policy. Policy updated with literature search through October 2012. References
6, 26, and 27. No change to policy statement. CPT codes 83890 – 83913 deleted as of
12/31/12; CPT codes 81405 - 81407 and 81599, effective 1/1/13, are added to the
policy.
05/14/13
Update Related Policies. Add 12.04.91.
02/24/14
Replace policy. Policy update with literature search through October 31, 2013.
References 15-17 and 30-33 added. The policy statements are unchanged. Deleted
CPT codes 83890 – 83912 and 81599 (no specific to this testing) removed from the
policy; ICD-9 Diagnosis codes are not used to adjudicate the policy and have been
removed.
03/21/14
Update Related Policies. Add 12.04.114.
07/23/14
Update Related Policies. Remove 12.04.91.
02/25/15
Annual Review. Policy updated with literature review through October 29, 2014.
Added list of commercially available testing companies to Policy Guidelines from the
Description section found in Table 1. Added TNNC1 (troponin C type 1 [slow]) full
gene sequence to CPT 81405 description in Policy Guidelines. Benefit Application
section rewritten to match the plan variance. Policy Statement for testing of the index
patient as medically necessary. References 11, 28-29, 32-33, 36-37, 41, and 43 added,
broken hyperlinks repaired; others renumbered/removed. Policy statements
unchanged.
02/09/16
Annual Review. Genetic Counseling information added to Guidelines section. Policy
updated with literature review; references added. Policy statements unchanged.
01/01/17
Coding update; added new CPT code 81439 effective 1/1/17. Reformatted coding
table, removed duplicate coding table near end of policy. Other minor formatting
corrections were made.
06/01/17
Annual Review, approved May 2, 2017. Policy moved into new format. Policy updated
with literature review through January 25, 2017; Rationale revised; reference 9 added;
some references removed. Removed CPT code 81479. Policy statements unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The
Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and
local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review
and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply.
CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2017 Premera
All Rights Reserved.
Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to
Page | 16 of 17
∞
the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Page | 17 of 17
∞
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Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357
Email [email protected]
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https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue SW, Room 509F, HHH Building
Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD)
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ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
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‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).