Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Genetic Testing (Independence Administrators)

Policy #:06.02.35t

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.


This policy only applies to members for whom Independence Administrators serves as the claims administrator. For all other Independence members, refer to the policy entitled eviCore Lab Management Program.

The intent of this policy is to communicate the coverage positions for genetic testing.

For information on policies related to this topic, refer to the Cross References section in this policy.

Refer to Attachment A for a list of codes and services that may represent medically necessary genetic testing and may be covered for an individual when the testing has a direct effect on the management and clinical care of the individual being tested.

Refer to Attachment B for a list of codes and services that may represent medically necessary genetic testing and may be covered for an individual when the testing has a direct effect on the management and clinical care of the individual being tested and if test-specific criteria are met.

Refer to Attachment C for a list of codes and services that represent genetic testing for indications that the Company considers experimental/investigational. The peer-reviewed literature does not support at least one of the following for the testing:
  • The analytical validity and/or
  • The clinical validity and/or
  • Direct effect on the management and clinical care of the individual being tested based upon the test's results (i.e. clinical utility).

Any genetic testing not addressed in this policy may be considered medically necessary, and, therefore, covered when all of the following criteria are met:
  • The testing is used for individuals at risk by pedigree for a specific hereditary disease among other physiological and environmental factors, and when this testing is intended for screening, diagnosis, prognosis, predictive testing (pharmacogenomic), risk assessment, neonatal screening, and reproductive decision-making.
  • The analytical (technical) validity of the test has been confirmed (e.g., reliability and repeatability of the test are established through standard protocols).
  • Biological and clinical validity, (i.e. genotype to phenotype correlation), of the test have been established through the peer-reviewed literature.
  • Peer-reviewed support and data establish the objective effect(s) of the test results on direct management and care of the individual for all applicable indications and clinical situations to verify clinical utility of the test.

When a benefit exists, genetic testing is an eligible service for individuals who have a Company benefit and the genetic testing is used only for the covered individual’s clinical benefit. Testing of associated family members, without a Company benefit, is not eligible for reimbursement.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

The “stacking code” method (and associated modifiers usage) of reporting genetic testing should not be used, since these codes and modifiers have been retired as of 01/01/2013. Where available, the most specific CPT or HCPCS codes must be used for billing.

The specific genetic test(s) being performed should be reported when using CPT codes 81400-81408.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, genetic testing is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational OR not medically necessary are not eligible for coverage or reimbursement by the Company.


US FOOD AND DRUG ADMINISTRATION STATUS

Genetic testing is a laboratory procedure and is historically not regulated by the US Food and Drug Administration (FDA). Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing. However, recently, the FDA is reported to be involved in the evaluation of the service of genetic testing.

Description

Genetic testing identifies changes in chromosomes, genes, or proteins. The term "genetic testing" covers an array of techniques, including analysis of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), genes, or gene products (e.g., enzymes and other types of protein).
Genetic testing is performed for a variety of intended uses:
  • Diagnostic testing (to diagnose disease)
  • Predictive testing (generally performed to gather genetic data that can assist in clinical management, including therapeutic decisions for an individual)
  • Pre-symptomatic genetic testing (to predict future disease)
  • Carrier testing (to identify carriers of genetic mutations)
  • Prenatal testing (offered during pregnancy to identify fetuses that have certain diseases)
  • Pre-implantation genetic testing (done in conjunction with in vitro fertilization to determine whether embryos for implantation carry genes that could cause disease)
  • Newborn screening (to test newborns shortly after birth to determine whether they have certain diseases known to cause problems with health and development)
  • Pharmacogenetic testing (to determine the likelihood of an individual being responsive to a particular drug and/or to predict serious toxicity from a drug in order to optimize drug selection or drug dosage)
  • Research genetic testing (used to help with research and development of gene-based therapy).

The Centers for Disease Control and Prevention (CDC) Office of Public Health Genomics helped to establish and support the ACCE Model Project, which has become the standard for evaluating scientific data on new genetic tests. The ACCE Model System* for Collecting, Analyzing and Disseminating Information on Genetic Tests provides an evaluation framework that is applicable to a variety of genetic tests. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) used the ACCE framework and established this process as a way of evaluating an evidence-based method for assessing genetic tests and other types of genomic technology as it has transitioned from the research arena to the practice arena. The ACCE evaluation framework examines:
  • Analytical validity: Measures the specific genotypic test performance characteristics and whether the test accurately and reliably detects the gene marker(s) of interest. This refers to how well a test performs in the laboratory and how well the test measures the property or characteristic it is intended to measure. If the test does what its makers claim, it must produce the same results repeatedly and in different laboratories given the same set of procedures.
  • Clinical validity: Refers to the associations of the test result(s) with patient outcomes of interest, and may be expressed as clinical sensitivity, specificity, and predictive value for the outcome. Evidence is usually retrospective. This component refers to the accuracy with which a test predicts the presence or absence of a clinical condition or predisposition. Initially, the test has to be conducted on individuals who are known to have the condition (as well as those who do not) to determine its success rate.
  • Clinical utility: Clinical utility determines whether the use of genetic testing to modify medical management decisions improves patient outcomes. Best evidence is prospective, from randomized clinical trials of standard management procedures versus genetic test--directed management. Evidence may also be derived using banked samples from already completed clinical trials, or by constructing an indirect chain of evidence linking test results to clinical outcome. If a test has utility, it means that the result (positive or negative) provides information that can be used in the formulation of an effective treatment or preventive strategy.
  • Ethical, Legal, and Social Implications: Determines what, if any, ethical, legal, or social implications may arise from the use of this test and its results.

*From: Haddow JE, Palomaki GE. ACCE: A Model Process for Evaluating Data on Emerging Genetic Tests. In: Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease. Khoury M, Little J, Burke W (eds.), Oxford University Press, pp. 217-233, 2003.

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Hayes, Inc. Hayes Genetic Test Evaluation (Report). Comparative Genomic Hybridization (CGH) Microarray Testing for Chromosomal Imbalances. Lansdale, PA: Hayes, Inc.; April, 2010.

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Hayes, Inc. Hayes Genetic Test Evaluation (Report).Counsyl Universal Genetic Test. Lansdale, PA: Hayes, Inc.; September, 2012.

Hayes, Inc. Hayes Genetic Test Evaluation (Synopsis). Cystic Fibrosis Transmembrane Regulator (CFTR) Testing for Cystic Fibrosis (CF). Lansdale, PA: Hayes, Inc.; August, 2011.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2C19 Genotyping to Predict Response to Clopidogrel. Lansdale, PA: Hayes, Inc.; November, 2010.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2D6 Genotyping for Dose Management of Tamoxifen. Lansdale, PA: Hayes, Inc.; September, 2008.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). CYP2C9 and VKORC1 Variant Testing for Management of Warfarin Dose Initiation. Lansdale, PA: Hayes, Inc.; June, 2008.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Epidermal Growth Factor Receptor (EGFR) Sequence Variant Analysis for Predicting Response to Non-Small Cell Lung Cancer (NSCLC) Drug Therapy. Lansdale, PA: Hayes, Inc.; February, 2012.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Factor V Leiden (FVL) for Risk Assessment for Venous Thromboembolism (VTE) or Obstetric Complications. Lansdale, PA: Hayes, Inc.; October, 2008.

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Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.;GJB2 (Connexin 26) and GJB6 (Connexin 30) Sequence Variant Analysis for Nonsyndromic Hearing Loss. June 2010.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). Genetic Carrier Testing for Cystic Fibrosis. Lansdale, PA: Hayes, Inc.; June, 2004.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; Genetic Testing for Lynch Syndrome (Hereditary Non-Polyposis Colorectal Cancer [HNPCC]). August 2009.

Hayes, Inc. Hayes Genetic Test Evaluation (Report). HFE-Associated Hereditary Hemochromatosis (HFE-HHC). Lansdale, PA: Hayes, Inc.; June, 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; HLA-B*5701 Screening for Abacavir (Ziagen®) Hypersensitivity in HIV Patients. November 2011.

Hayes, Inc. Hayes Genetic Test Evaluation (Synopsis). Immunoglobulin Heavy Variable Group (IgHV) Gene Testing in Chronic Lymphocytic Leukemia (CLL). Lansdale, PA: Hayes, Inc.; September, 2010.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; JAK2 Mutations for Chronic Myeloproliferative Disorders. February 2008.

Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; KRAS Sequence Variant Analysis for Non-Small Cell Lung Cancer (NSCLC). October 2008.

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Hayes, Inc. Hayes Genetic Testing Evaluation (Report). Lansdale, PA: Hayes, Inc.; Prader-Willi Syndrome (PWS). October 2008.

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Rodriguez-Revenga L, Mila M, Rosenberg C, et al. Structural variation in the human genome: the impact of copy number variants on clinical diagnosis. Genet Med. 2007;9(9):600-6.

Rohlfs EM, Zhou Z, Heim RA, et al. Cystic fibrosis carrier testing in an ethnically diverse US population. Clin Chem. 2011;57(6):841-848.

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Russi EW. Alpha-1 antitrypsin: now available, but do we need it? Swiss Med Wkly.2008;138(13-14):191-196.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

See Attachments A, B, and C


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

See Attachments A, B and C


Revenue Code Number(s)

N/A


Misc Code

N/A:

N/A


Coding and Billing Requirements


Cross References

Attachment A: Genetic Testing (Independence Administrators)
Description: Services that are Considered Medically Necessary

Attachment B: Genetic Testing (Independence Administrators)
Description: Services that are Considered Medically Necessary with Criteria

Attachment C: Genetic Testing (Independence Administrators)
Description: Services that are Considered Experimental/Investigational



 Policy: 06.02.06p:Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations (Independence Administrators)

 Policy: 06.02.09g:Human Immunodeficiency Virus (HIV) Genotyping and Phenotyping (Independence Administrators)

 Policy: 06.02.10q:Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) (Independence Administrators)

 Policy: 06.02.18k:Pharmacogenetics and Metabolite Monitoring for Using Azathioprine (AZA)/6-Mercaptopurine (6-MP) Therapy (Independence Administrators)

 Policy: 06.02.24j:Preimplantation Genetic Testing (Independence Administrators)

 Policy: 06.02.27l:Assays of Genetic Expression in Tumor Tissue for Breast Cancer Prognosis (Independence Administrators)

 Policy: 06.02.29d:AlloMap™ Molecular Expression Testing for Heart Transplant Rejection (Independence Administrators)

 Policy: 06.02.30e:Pharmacogenetic Testing to Determine Drug Sensitivity (Independence Administrators)

 Policy: 06.02.31f:Genetic Testing for Congenital Long QT Syndrome (Independence Administrators)

 Policy: 06.02.32d:Multigene Expression Assays for Predicting Recurrence in Colon Cancer (Independence Administrators)

 Policy: 06.02.04d:Fetal Fibronectin Enzyme (fFN) Immunoassay

 Policy: 06.02.14h:In Vitro Chemosensitivity and Chemoresistance Assays

 Policy: 06.02.17e:Serodiagnosis of Inflammatory Bowel Disease (IBD) and the Prometheus® IBD sgi Diagnostic™ Test

 Policy: 07.03.07r:Evaluation and Management of Autism Spectrum Disorders (ASD)

 Policy: 12.01.01as:Experimental/Investigational Services


Policy History

Revisions from 06.02.35t:
01/01/2019Effective 01/01/2019, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

81163
81164
81165
81166
81167
81171
81172
81173
81174
81177
81178
81179
81180
81181
81182
81183
81184
81185
81186
81187
81188
81189
81190
81204
81233
81234
81236
81237
81239
81271
81274
81284
81285
81286
81289
81305
81306
81312
81320
81329
81333
81336
81337
81343
81344
81345
81443
81518
0081U

Effective 01/01/2019, narratives for the following CPT codes have been revised in Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

81162, 81212, 81215, 81216, 81217, 81244, 81287

Effective 01/01/2019, the following CPT code narrative has been revised in Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental/investigational:

81327

Effective 01/01/2019, the following CPT codes have been deleted from Attachment B for this policy due to coding updates:

81211, 81213, 81214

Revisions from 06.02.35s:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
10/01/2018Effective 10/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:
    0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

Effective 10/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:
    0067U, 0068U, 0069U, 0078U, 0079U

Effective 10/01/2018, the following CPT code has been deleted from this policy due to coding updates:
    0028U

Revisions from 06.02.35r:
07/01/2018Effective 07/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0046U, 0049U

Effective 07/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:

0045U, 0047U, 0048U, 0050U, 0053U, 0055U, 0056U, 0057U, 0060U

Revisions from 06.02.35q:
04/01/2018Effective 04/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0040U

Effective 04/01/2018, the following CPT codes have been added to Attachment C for this policy due to coding updates. The services represented by these procedure codes are considered experimental investigational:

0036U, 0037U, 0012M, 0013M

The following CPT codes have been deleted from Attachment C for this policy because of their termination by AMA:

0004U, 0015U

06.02.35p
1/1/2018Effective 01/01/2018, the following CPT codes have been added to Attachment B for this policy due to coding updates. The services represented by these procedure codes are considered medically necessary only when criteria are met:

0500T, 81105, 81106, 81107, 81108, 81109, 81110, 81111, 81112, 81120, 81121, 81175, 81176, 81232, 81238, 81247, 81248, 81249, 81258, 81259, 81269, 81334, 81335, 81361, 81362, 81363, 81364, 81520, 81521, 81551, 87634, 87662, 0027U

Effective 01/01/2018, the following CPT codes have been added to Attachment C for this policy due ti coding updates. The services represented by these procedure codes are considered experimental investigational:

81230, 81231, 81283, 81328, 81346, 81448, 81541, 0026U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0011M

Effective 01/01/2018, the narratives for the following procedure codes have been revised due to coding updates:

81257, 81432, 81439

06.02.35o
11/22/2017This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/04/2019
Version Reissued Date: N/A

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