UnitedHealthcare® Oxford
Clinical Policy
GENETIC TESTING
Policy Number: LABORATORY 018.4 T2
Effective Date: May 1, 2017
Table of Contents
Page
INSTRUCTIONS FOR USE .......................................... 1
CONDITIONS OF COVERAGE...................................... 1
BENEFIT CONSIDERATIONS ...................................... 1
COVERAGE RATIONALE ............................................. 2
APPLICABLE CODES ................................................. 4
REFERENCES ........................................................... 4
POLICY HISTORY/REVISION INFORMATION ................. 4
Related Policies

Chromosome Microarray Testing

Fecal DNA Testing

Fetal Aneuploidy Testing Using Cell-Free Fetal
Nucleic Acids in Maternal Blood

Gene Expression Tests

Genetic Testing for Hereditary Breast and/or
Ovarian Cancer Syndrome (HBOC)

Molecular Profiling to Guide Cancer Treatment
INSTRUCTIONS FOR USE
This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do
not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as
necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term
Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies.
When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member
specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan
Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the
event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first
identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan
coverage prior to use of this Clinical Policy. Other Policies may apply.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in
administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent
professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or
medical advice.
CONDITIONS OF COVERAGE
Applicable Lines of Business/ Products
This policy applies to Oxford Commercial plan
membership.
Benefit Type
General Benefits Package
Referral Required
(Does not apply to non-gatekeeper products)
Authorization Required
(Precertification always required for inpatient admission)
Precertification with Medical Director Review Required
No
Applicable Site(s) of Service
(If site of service is not listed, Medical Director review is
required)
Special Considerations
Laboratory
Yes
Yes1
1
Precertification with review by a Medical Director or
their designee is required.
BENEFIT CONSIDERATIONS
Before using this policy, please check the member specific benefit plan document and any federal or state mandates,
if applicable.
Genetic Testing
UnitedHealthcare Oxford Clinical Policy
©1996-2017, Oxford Health Plans, LLC
Page 1 of 4
Effective 05/01/2017
Essential Health Benefits for Individual and Small Group
For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured
non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten
categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small
group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to
provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be
removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is
made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit
plan document to determine benefit coverage.
COVERAGE RATIONALE
The following genetic tests are medically necessary when criteria are met:
Genetic Test
Arrhythmogenic Right Ventricular
Cardiomyopathy (ARVC Genes)
For Information Regarding Medical Necessity Review, Refer To...
MCG™ Care Guidelines, 21st edition, 2017, Arrhythmogenic Right
Ventricular Cardiomyopathy - ARVC Genes ACG: A-0627 (AC)
Ashkenazi Jewish Genetic Panel
MCG™ Care Guidelines, 21st edition, 2017, Ashkenazi Jewish Genetic
Panel ACG: A-0592 (AC)
Catecholaminergic Polymorphic
Ventricular Tachycardia (RYR2 and
CASQ2 Genes)
MCG™ Care Guidelines, 21st edition, 2017, Catecholaminergic
Polymorphic Ventricular Tachycardia - RYR2 and CASQ2 Genes ACG: A0636 (AC)
Familial Dilated Cardiomyopathy,
Nonsyndromic - ANKRD1, BAG3, DMD,
DES, GATAD1, LDB3, LMNA, MYBPC3,
MYH6, MYH7, RBM20, SCN5A, TAZ,
TNNI3, TNNT2, and TTN Genes)
MCG™ Care Guidelines, 21st edition, 2017, Familial Dilated
Cardiomyopathy, Nonsyndromic - ANKRD1, BAG3, DMD, DES, GATAD1,
LDB3, LMNA, MYBPC3, MYH6, MYH7, RBM20, SCN5A, TAZ, TNNI3, TNNT2,
and TTN Genes ACG: A-0648 (AC)
Familial Hypertrophic Cardiomyopathy,
Nonsyndromic - Sarcomere Genes
MCG™ Care Guidelines, 21st edition, 2017, Familial Hypertrophic
Cardiomyopathy, Nonsyndromic - Sarcomere Genes ACG: A-0633 (AC)
Long QT Syndrome (Andersen -Tawil
Syndrome, Hereditary) - KCNJ2 Gene
MCG™ Care Guidelines, 21st edition, 2017, Long QT Syndrome
(Andersen-Tawil Syndrome, Hereditary) - KCNJ2 Gene ACG: A-0833 (AC)
Long QT Syndrome (Hereditary) - Gene
Panel
MCG™ Care Guidelines, 21st edition, 2017, Long QT Syndrome
(Hereditary) - Gene Panel ACG: A-0918 (AC)
Long QT Syndrome (Jervell and Lange Nielsen Syndrome, Type 1 and Type 2
Hereditary) - KCNE1 and KCNQ1 Genes
MCG™ Care Guidelines, 21st edition, 2017, Long QT Syndrome (Jervell
and Lange-Nielsen Syndrome, Type 1 and Type 2, Hereditary) - KCNE1
and KCNQ1 Genes ACG: A-0607 (AC)
Long QT Syndrome (Romano-Ward
Syndrome, Hereditary) - KCNE1,
KCNE2, KCNH2, KCNQ1, and SCN5A
Genes
MCG™ Care Guidelines, 21st edition, 2017, Long QT Syndrome (RomanoWard Syndrome, Hereditary) - KCNE1, KCNE2, KCNH2, KCNQ1, and
SCN5A Genes ACG: A-0831 (AC)
Long QT Syndrome (Timothy Syndrome,
Hereditary) - CACNA1C Gene
MCG™ Care Guidelines, 21st edition, 2017, Long QT Syndrome (Timothy
Syndrome, Hereditary) - CACNA1C Gene ACG: A-0834 (AC)
Lynch Syndrome (EPCAM, MLH1, MSH2,
MSH6, and PMS2 Genes)
MCG™ Care Guidelines, 21st edition, 2017, Lynch Syndrome - EPCAM,
MLH1, MSH2, MSH6, and PMS2 Genes ACG: A-0533 (AC)
The clinical utility of the following genetic tests have not been established and therefore these tests are
not medically necessary:
Genetic Test
5-Fluorouracil Pharmacogenetics (DPYD,
MTHFR, and TYMS Genes)
Refer To...
MCG™ Care Guidelines, 21st edition, 2017, 5-Fluorouracil
Pharmacogenetics - DPYD, MTHFR, and TYMS Genes ACG: A-0665 (AC)
Amyotrophic Lateral Sclerosis (C9ORF72
and SOD1 Genes)
MCG™ Care Guidelines, 21st edition, 2017, Amyotrophic Lateral Sclerosis
(ALS) - C9ORF72 and SOD1 Genes ACG: A-0591 (AC)
Azathioprine and 6-Mercaptopurine
Pharmacogenetics - TPMT Gene
MCG™ Care Guidelines, 21st edition, 2017, Azathioprine and 6Mercaptopurine Pharmacogenetics - TPMT Gene ACG: A-0628 (AC)
Clopidogrel Pharmacogenetics (CYP2C19
Gene)
MCG™ Care Guidelines, 21st edition, 2017, Clopidogrel Pharmacogenetics
- CYP2C19 Gene ACG: A-0631 (AC)
Coronary Artery Disease (9p21 Allele)
MCG™ Care Guidelines, 21st edition, 2017, Coronary Artery Disease 9p21 Allele ACG: A-0657 (AC)
Genetic Testing
UnitedHealthcare Oxford Clinical Policy
©1996-2017, Oxford Health Plans, LLC
Page 2 of 4
Effective 05/01/2017
Genetic Test
Refer To...
MCG™ Care Guidelines, 21st edition, 2017, Coronary Artery Disease KIF6 Gene ACG: A-0656 (AC)
Coronary Artery Disease (KIF6 Gene)
Coronary Artery Disease Genetic Panel
MCG™ Care Guidelines, 21st edition, 2017, Coronary Artery Disease
Genetic Panel ACG: A-0658 (AC)
Genome-Wide Association Studies
MCG™ Care Guidelines, 21st edition, 2017, Genome-Wide Association
Studies ACG: A-0531 (AC)
Hyperhomocysteinemia (MTHFR Gene)
MCG™ Care Guidelines, 21st edition, 2017, Hyperhomocysteinemia MTHFR Gene ACG: A-0629 (AC)
Irinotecan Pharmacogenetics (UGT1A1
Gene)
MCG™ Care Guidelines, 21st edition, 2017, Irinotecan Pharmacogenetics
- UGT1A1 Gene ACG: A-0624 (AC)
Malignant Melanoma (Cutaneous) BAP1, CDK4, and CDKN2A Genes
MCG™ Care Guidelines, 21st edition, 2017, Malignant Melanoma
(Cutaneous) - BAP1, CDK4, and CDKN2A Genes ACG: A-0601 (AC)
Malignant Melanoma (Uveal) - BAP1,
CDK4, and CDKN2A Genes
MCG™ Care Guidelines, 21st edition, 2017, Malignant Melanoma (Uveal) BAP1, CDK4, and CDKN2A Genes ACG: A-0836 (AC)
MicroRNA Detection – Cancer
MCG™ Care Guidelines, 21st edition, 2017, MicroRNA Detection – Cancer
ACG: A-0705 (AC)
MicroRNA Detection - Heart Failure
MCG™ Care Guidelines, 21st edition, 2017, MicroRNA Detection - Heart
Failure ACG: A-0838 (AC)
MicroRNA Detection - Inflammatory
Bowel Disease
MCG™ Care Guidelines, 21st edition, 2017, MicroRNA Detection Inflammatory Bowel Disease ACG: A-0839 (AC)
MicroRNA Detection - Ischemic Heart
Disease
MCG™ Care Guidelines, 21st edition, 2017, MicroRNA Detection Ischemic Heart Disease ACG: A-0840 (AC)
MicroRNA Detection - Kidney Disease
MCG™ Care Guidelines, 21st edition, 2017, MicroRNA Detection - Kidney
Disease ACG: A-0841 (AC)
Parkinson Disease (ATP13A2, GBA,
LRRK2, MAPT, PARK2, PARK7, PINK1,
and SNCA Genes)
MCG™ Care Guidelines, 21st edition, 2017, Parkinson Disease - ATP13A2,
GBA, LRRK2, MAPT, PARK2, PARK7, PINK1, and SNCA Genes ACG: A0671 (AC)
Prostate Cancer - BRCA1 and BRCA2
Genes
MCG™ Care Guidelines, 21st edition, 2017, Prostate Cancer - BRCA1 and
BRCA2 Genes ACG: A-0612 (AC)
Prostate Cancer - PCA3 Gene
MCG™ Care Guidelines, 21st edition, 2017, Prostate Cancer - PCA3 Gene
ACG: A-0855 (AC)
Proteomics - Ovarian Cancer Biomarker
Panel (OVA1)
MCG™ Care Guidelines, 21st edition, 2017, Proteomics - Ovarian Cancer
Biomarker Panel (OVA1) ACG: A-0709 (AC)
Proteomics - Ovarian Cancer Biomarker
Panel (ROMA)
MCG™ Care Guidelines, 21st edition, 2017, Proteomics - Ovarian Cancer
Biomarker Panel (ROMA) ACG: A-0858 (AC)
Psychotropic Medication
Pharmacogenetics - BDNF, COMT, DRD,
HTR, MC4R, SLC6A4, SPTA1, and TPH1
Genes
MCG™ Care Guidelines, 21st edition, 2017, Psychotropic Medication
Pharmacogenetics - BDNF, COMT, DRD, HTR, MC4R, SLC6A4, SPTA1, and
TPH1 Genes ACG: A-0859 (AC)
Psychotropic Medication
Pharmacogenetics - CYP450
Polymorphisms and AmpliChip Panel
MCG™ Care Guidelines, 21st edition, 2017, Psychotropic Medication
Pharmacogenetics - CYP450 Polymorphisms and AmpliChip Panel ACG: A0692 (AC)
Psychotropic Medication
Pharmacogenetics - Gene Panels
MCG™ Care Guidelines, 21st edition, 2017, Psychotropic Medication
Pharmacogenetics - Gene Panels ACG: A-0861 (AC)
Psychotropic Medication
Pharmacogenetics - HLA Typing
MCG™ Care Guidelines, 21st edition, 2017, Psychotropic Medication
Pharmacogenetics - HLA Typing ACG: A-0862 (AC)
Septin 9 (SEPT9) DNA Methylation
Testing
MCG™ Care Guidelines, 21st edition, 2017, Septin 9 (SEPT9) DNA
Methylation Testing ACG: A-0706 (AC)
Tamoxifen Pharmacogenetics (CYP2D6
Gene)
MCG™ Care Guidelines, 21st edition, 2017,Tamoxifen Pharmacogenetics CYP2D6 Gene ACG: A-0647 (AC)
Telomere Analysis
MCG™ Care Guidelines, 21st edition, 2017, Telomere Analysis ACG: A0672 (AC)
Topographic Genotyping (PathFinderTG)
MCG™ Care Guidelines, 21st edition, 2017, Topographic Genotyping –
PathFinderTG ACG: A-0632 (AC)
Genetic Testing
UnitedHealthcare Oxford Clinical Policy
©1996-2017, Oxford Health Plans, LLC
Page 3 of 4
Effective 05/01/2017
Genetic Test
Warfarin Pharmacogenetics (CYP2C9,
CYP4F2 and VKORC1 Genes)
Refer To...
MCG™ Care Guidelines, 21st edition, 2017, Warfarin Pharmacogenetics CYP2C9, CYP4F2, and VKORC1 Genes ACG: A-0587 (AC)
Whole Genome/Exome Sequencing Autism Spectrum Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Autism Spectrum Disorders ACG: A-0870 (AC)
Whole Genome/Exome Sequencing –
Cancer
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing – Cancer ACG: A-0710 (AC)
Whole Genome/Exome Sequencing Cardiovascular Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Cardiovascular Disorders ACG: A-0865 (AC)
Whole Genome/Exome Sequencing Congenital Anomalies
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Congenital Anomalies ACG: A-0872 (AC)
Whole Genome/Exome Sequencing Developmental Delay
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Developmental Delay ACG: A-0926 (AC)
Whole Genome/Exome Sequencing Immunodeficiency Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Immunodeficiency Disorders ACG: A-0866 (AC)
Whole Genome/Exome Sequencing Intellectual Disability
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Intellectual Disability ACG: A-0867 (AC)
Whole Genome/Exome Sequencing Metabolic Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Metabolic Disorders ACG: A-0868 (AC)
Whole Genome/Exome Sequencing Mitochondrial Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Mitochondrial Disorders ACG: A-0869 (AC)
Whole Genome/Exome Sequencing Neurologic Disorders
MCG™ Care Guidelines, 21st edition, 2017, Whole Genome/Exome
Sequencing - Neurologic Disorders ACG: A-0871 (AC)
APPLICABLE CODES
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all
inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan
document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply
any right to reimbursement or guarantee claim payment. Other Policies may apply.
CPT Code
81479
Description
Unlisted molecular pathology procedure
81599
Unlisted multianalyte assay with algorithmic analysis
88299
Unlisted cytogenetic study
89240
Unlisted miscellaneous pathology test
CPT® is a registered trademark of the American Medical Association
REFERENCES
The foregoing Oxford policy has been adapted from an existing UnitedHealthcare national policy that was researched,
developed and approved by UnitedHealthcare Medical Technology Assessment Committee. [2017T0575C]
POLICY HISTORY/REVISION INFORMATION
Date

05/01/2017

Genetic Testing
UnitedHealthcare Oxford Clinical Policy
Action/Description
Revised coverage rationale for clinical utility of genetic tests that are not
medically necessary:
o Updated reference to applicable MCG™ Care Guideline for Coronary Artery
Disease (9p21 Allele); replaced “MCG™ Care Guidelines, 21st edition,
2017, Clopidogrel Pharmacogenetics – CYP2C19 Gene ACG: A-0631 (AC)”
with “MCG™ Care Guidelines, 21st edition, 2017, Coronary Artery Disease –
9p21 Allele ACG: A-0657 (AC)”
Archived previous policy version LABORATORY 018.3 T2
©1996-2017, Oxford Health Plans, LLC
Page 4 of 4
Effective 05/01/2017