Download Molecular Pathology/Molecular Diagnostics/Genetic Testing

UnitedHealthcare® Medicare Advantage
Policy Guideline
MOLECULAR PATHOLOGY/MOLECULAR DIAGNOSTICS/
GENETIC TESTING
Guideline Number: MPG210.05
Table of Contents
Page
INSTRUCTIONS FOR USE .......................................... 1
POLICY SUMMARY .................................................... 1
APPLICABLE CODES ................................................. 6
REFERENCES .......................................................... 17
GUIDELINE HISTORY/REVISION INFORMATION .......... 30
Approval Date: April 12, 2017
Related Medicare Advantage Policy Guidelines

Clinical Diagnostic Laboratory Services

Corus® CAD (Coronary Artery Disease)
Related Medicare Advantage Coverage Summaries

Genetic Testing

Laboratory Tests and Services
INSTRUCTIONS FOR USE
This Policy Guideline is applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its
affiliates for health care services submitted on CMS 1500 forms and, when specified, to those billed on UB04 forms
(CMS 1450), or their electronic comparative. The information presented in this Policy Guideline is believed to be
accurate and current as of the date of publication.
This Policy Guideline provides assistance in administering health benefits. All reviewers must first identify member
eligibility, any federal or state regulatory requirements, Centers for Medicare and Medicaid Services (CMS) policy, the
member specific benefit plan coverage, and individual provider contracts prior to use of this Policy Guideline. When
deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific
benefit plan document may differ greatly from the standard benefit plan upon which this Policy Guideline is based. In
the event of a conflict, the member specific benefit plan document supersedes this Policy Guideline. Other Policies and
Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines
as necessary.
UnitedHealthcare follows Medicare coverage guidelines and regularly updates its Medicare Advantage Policy Guidelines
to comply with changes in CMS policy. UnitedHealthcare encourages physicians and other healthcare professionals to
keep current with any CMS policy changes and/or billing requirements by referring to the CMS or your local carrier
website regularly. Physicians and other healthcare professionals can sign up for regular distributions for policy or
regulatory changes directly from CMS and/or your local carrier. This Policy Guideline is provided for informational
purposes. It does not constitute medical advice.
POLICY SUMMARY
Overview
This policy overview addresses molecular and genetic tests that have proven efficacy in the diagnosis or treatment of
medical conditions.
Hereditary Breast and Ovarian Cancer
Anomalies in two genes, BRCA1 and BRCA2, are associated with an increased risk of breast and ovarian cancer.
Alterations in BRCA1 and BRCA2 explain many, but not all, of inherited forms of breast and ovarian cancer. With the
identification of BRCA1 and BRCA2, it is now possible to test for abnormalities in the genes to provide information on
the future risk of cancer and to make important treatment decisions in affected individuals. Approximately five- to
ten-percent of all breast cancers, and a similarly small percentage of ovarian cancers, are attributed to dominantly
inherited susceptibility. (See LCDs for Cancer section for specific coverage guidelines.)
Oncotype Assays for Breast Cancer
Oncotype DXTM is a gene panel test developed for node-negative, estrogen receptor (ER)-positive breast cancer. This
test is employed to identify breast cancer patients who are predicted to obtain the most therapeutic benefit from
adjuvant tamoxifen and may not require adjuvant chemotherapy.
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Oncotype DX DCIS assay is for breast cancer patients diagnosed with ductal carcinoma in situ (DCIS) who are
planning on having breast conserving surgery and considering adjuvant radiation therapy. (See LCDs for Cancer
section for specific coverage guidelines)
MammaPrint Test – Breast Cancer Prognosis
MammaPrint is an FDA cleared in vitro microarray diagnostic test that uses gene expression profiling to analyze the
gene activity of the tumor itself. MammaPrint enables a more accurate prognosis of breast cancer recurrence to assist
physicians in dealing with their patients with breast cancer. (See LCDs for Cancer section for specific coverage
guidelines.)
Breast Cancer Index (BCI) Genetic Assay
The BCI assay uses pathologic complete response to interrogate selected proliferation-related and endocrine
signaling-related genes, and may identify a subset of postmenopausal women who are at increased risk of late
relapses for estrogen receptor positive breast cancer and who may derive a greater benefit from extended hormone
therapy. (See LCDs for Cancer section for specific coverage guidelines.)
Hereditary Colorectal and Endometrial Cancer Syndromes
Lynch Syndrome (previously denoted as Hereditary Non-Polyposis Colorectal Cancer (HNPCC) syndrome), is an
autosomal dominant syndrome that accounts for about 3-5% of colorectal cancer cases. HNPCC syndrome mutations
occur in the following genes: hMLH1, hMSH2, hMSH6, PMS2 and EPCAM. Colorectal cancers associated with Lynch
syndrome occur at a younger age (average age of onset between 44-61 years of age) compared with the more
common colorectal cancers typically found during the seventh decade of life. Gynecologic cancers may precede
colorectal cancer in as many as 50% of female HNPCC gene mutation carriers.
Familial Adenomatous Polyposis (FAP) is an autosomal dominant syndrome caused by a germ-line mutation of the APC
gene. Characteristically, affected patients develop multiple adenomas diffusely throughout the colon beginning in their
teens. Colorectal cancer is inevitable in patients with FAP if colectomy is not performed.
MYH-associated polyposis (MAP) is an autosomal recessive syndrome linked to germ-line mutations of the MYH gene.
The full clinical picture of MYH-associated polyposis (MAP) is incompletely understood at this time. Current evidence
suggests it is associated with about 0.4-1.0% of colorectal cancers. (See LCDs for Cancer section for specific coverage
guidelines)
Therapy-Directing Testing
Coverage for KRAS testing is limited to use in patients with metastatic colorectal cancer for whom either cetuximab
(Erbitux) or panitumumab (Vectibix) therapy is contemplated as being appropriate.
Coverage for JAK2 testing is appropriate in patients with signs or symptoms suggesting an underlying chronic
myeloproliferative disorder, including increased red-cell mass, increased platelets, unexplained persistent peripheral
cytopenia to cytosis, unexplained peripheral or hepatic vein thrombosis (Budd-Chiari Syndrome) or bone marrow
examination showing features of a chronic myeloproliferative disorder. Documentation must also indicate that the
provider anticipates that the test result is likely to be of use in management of the condition.
The BCR/ABL fusion gene is the classic mutation seen in Chronic Myelogenous Leukemia (CML) and is also seen in
Acute Lymphocytic Leukemia (ALL) and certain other hematologic diseases. Major factors influencing consideration of
testing for this gene include some that are too non-specific to support coverage. (See LCDs for Cancer section for
specific coverage guidelines)
Multiple Myeloma Gene Expression Profile
MyPRS™ is a test for Multiple Myeloma Gene Expression Profile. Multiple myeloma is an incurable malignancy of
terminally differentiated antibody secreting plasma cells. The median overall survival is reported at 3-4 years. Disease
sequelae associated with this malignancy includes anemia, immunodeficiency, renal insufficiency/failure, lytic bone
lesions and hypercalcemia.
This test is used only after an initial diagnosis of multiple myeloma has been made and will be available to be used in
stratification of therapeutic interventions. The coverage is set to include only two clinical settings:

Once after initial diagnosis is made, or

If relapse has occurred and a change in the therapeutic modalities is contemplated
(See LCDs in Cancer section for coverage guidelines.)
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ® Test for Pancreatic Cyst/Mass
Combining pathologic study with molecular analyses of microdissected tissue, is claimed to enhance the ability to
provide more specific diagnostic information, to help guide treatment decisions. These testing combinations are
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generally known as topographic genotyping. Loss-of-heterozygosity based topographic genotyping and other
molecular analyses are combined in a patented technology known as PathfinderTG. (See LCD for Pathfinder,
Miscellaneous section for coverage guidelines.)
Circulating Tumor Cell (CTC) Assay
CTCs represent the point in the metastatic process of solid tumors when cells from a primary tumor invade, detach,
disseminate, colonize and proliferate in a distant site. Detection of elevated CTCs during therapy may be an accurate
indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer, noting that
FDA labeling includes each of these neoplasms. As a result of limited acceptable study data, CTCs are considered not
medically necessary, for all indications. (See LCDs for CTCs for specific coverage guidelines)
NRAS Genetic Testing of Tumor Tissue
This is genetic testing of tumor tissue for somatic mutations in the NRAS gene. RAS oncogene is a superfamily of
signal transduction proteins, which are proteins that communicate signals between the cells. DNA mutations in the
RAS family genes turn the signals on permanently such that the cells divide nonstop, leading to cancer. (See LCDs in
Cancer section for coverage guidelines.)
Bladder Tumor Markers
Cystoscopy in conjunction with bladder tumor markers is the standard practice to evaluate patients with symptoms
suggesting bladder cancer and to monitor treated patients for recurrence or progression. Urinary cytology has close to
a 90%-100% specificity, but only 10%-50% sensitivity for low grade urinary cancer (UC) detection. Due to this deficit,
clinicians have sought noninvasive tumor markers detectable in urine. Bladder Tumor Marker tests include: BTA
TRAK®, Nuclear matrix protein 22 (NMP-22), NMP-22 BladderChek®, The UroVysion®, BTA (bladder tumor antigen)
stat®, and The ImmunoCyt™. (See LCDs for Cancer section for coverage guidelines.)
NSCLC (non-small cell lung cancer), Comprehensive Genomic Profile Testing
This test is a comprehensive somatic genomic profiling on tumor tissue-only (hereafter called CGP) for patients with
metastatic non-small cell lung cancer (NSCLC) who are lifetime non-smokers (also known as never-smokers) or
former light smokers (≤ 15 pack year history) and who tested negative for epidermal growth factor receptor (EGFR)
mutations, EML4-ALK rearrangements, and ROS1 rearrangements when initial testing was done by an FDA-approved
companion diagnostic (CDx) or by a laboratory developed test (LDT) for these genomic alterations. (See LCDs for
Cancer section for coverage guidelines.)
Molecular Diagnostics: Infectious Disease Testing
Molecular diagnostic testing, which includes DNA- or RNA-based analysis, with or without amplification/quantification,
provides sensitive, specific and timely identification of diverse biological entities. These include bacterial organisms,
fungal organisms and tumors which are encountered for the majority of gynecological and other infectious disease
presentations. (See LCDs for Molecular Pathology section for coverage guidelines.)
Molecular Assays for Prostate Cancer
ConfirmMDx is associated with prostate cancer. ConfirmMDx is intended for use in patients with high-risk factors such
as elevated/rising prostate-specific antigen (PSA) or abnormal digital rectal examination (DRE), with a negative or
non-malignant abnormal histopathology finding (e.g., atypical cell or high grade prostate intraepithelial neoplasia
(HGPIN)) in the previous biopsy, and is being considered for repeat biopsy.
The PROGENSA® PCA3 Assay and ProMark Risk Score are automated molecular tests (assay) that help physicians
determine the need for prostate biopsies in men.
Prolaris™ is an RNA based assay measuring the expression of 31 cell cycle progression (CCP) genes and 15 genes that
act as internal controls and normalization standards in each patient sample. The assay results are reported as a
numerical score along with accompanying interpretive information.
The Decipher® prostate cancer assay, a 22-biomarker expression signature using oligonucleotide microarray
technology, interrogates 1.4 million RNAs extracted from the radical prostectomy specimen. The biomarkers that
comprise the Decipher classifier include cell cycle progression, androgen signaling, cell adhesion, tumor cell motility,
migration and immune evasion functions. (See LCDs for Cancer for coverage guidelines.)
AlloMap for Heart Transplant Recipients
AlloMap Molecular Expression Testing is a non-invasive gene expression test used to aid in the identification of heart
transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular
rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the
expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an
AlloMap test score. (See LCDs for Molecular Pathology section for coverage guidelines.)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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Molecular Pathology Procedures for Human Leukocyte Antigen (HLA) Typing
Human Leukocyte Antigen (HLA) typing is performed to assess compatibility of recipients and potential donors as a
part of solid organ and hematopoietic stem cell/ bone marrow pretransplant testing. HLA testing is also performed to
identify HLA alleles and allele groups (antigen equivalents) associated with specific diseases and individualized
responses to drug therapy (e.g., HLA-B*27 and ankylosing spondylitis; HLA-B57:01 and abacavir hypersensitivity;
HLA-B*15:02 and carbamazepine, phenytoin or fosphenytoin hypersensitivity), as well as other clinical uses. One or
more HLA genes may be tested in specific clinical situations (e.g., HLA A, B, C,-DRB1, and DQB1 for kidney
transplantation). Each HLA gene typically has multiple variant alleles or allele groups that can be identified by typing.
(See LCDs for Molecular Pathology for coverage guidelines.)
Cytogenetic Studies
Cytogenetics is the study of chromosomes by light or fluorescent microscopy. Cytogenetic testing is used to study an
individual's chromosome makeup. Specimens for cytogenetic analysis can be obtained for routine analysis from the
peripheral blood, in which case T lymphocytes are examined; from amniotic fluid for culture of amniocytes; from
trophoblastic cells from the chorionic villus; from bone marrow; from solid tumors, and from cultured fibroblasts,
usually obtained from a skin biopsy. (See LCDs for Cytogenetics, Miscellaneous section for coverage guidelines.)
GeneSight® Assay for Refractory Depression
GeneSight Psychotropic is a multiplex pharmacogenomic test involving the analysis of fifty alleles (SNPs) from six
different genes. The test results in the differentiation of psychoactive drugs that are likely to be effective and welltolerated by a particular patient versus those that are not. GeneSight testing may only be ordered by licensed
psychiatrists contemplating an alteration in neuropsychiatric medication for patients diagnosed with major depressive
disorder (MDD) after at least one prior neuropsychiatric medication failure. (See LCD for GeneSight in Miscellaneous
section for coverage guidelines.)
CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing for Drug Metabolism
Genetic alterations or “polymorphisms” are common in these drug metabolizing enzymes. These polymorphisms can
lead to differences in individual drug response secondary to variation in metabolism. Pharmacogenetic testing has
been proposed to predict individual response to a variety of drugs. In certain scenarios, an individual patient may
benefit from this genetic testing in determining dosage and likely response to specific medications. (See LCDs for Drug
Metabolism in Miscellaneous section for coverage guidelines.)
Assays for Rheumatoid Arthritis
The Avise PG Assay, developed to support dose optimization and therapeutic decision making for patients diagnosed
with rheumatoid arthritis (RA) on methotrexate ('MTX').
Vectra DA is multi-biomarker blood test to measure rheumatoid arthritis (RA) disease activity. Vectra DA measures 12
key proteins that represent multiple RA biological pathways. It is validated for use in adults diagnosed with RA. (See
Article section for coverage guidelines.)
Genetic Testing for Myeloproliferative Disease
Myeloproliferative disorders are a group of conditions that cause abnormal growth of blood cells in the bone marrow.
They include polycythemia vera (PV), essential thrombocytosis (ET), primary myelofibrosis (PMF), and chronic
myelogenous leukemia (CML). The World Health Organization (WHO) further classifies PV, ET, and PMF as Philadelphia
chromosome negative myeloproliferative neoplasms (MPNs). MPNs are characterized by an increase in the number of
blood cells. (See LCDs for Molecular Pathology for coverage guidelines.)
Molecular RBC (red blood cell) Phenotyping
Molecular RBC Phenotyping is pretransfusion molecular testing using the HEA BeadChip™ assay for the following
categories of patients:

Long term, frequent transfusions anticipated to prevent the development of alloantibodies (e.g. sickle cell anemia,
thalassemia or other reason);

Autoantibodies or other serologic reactivity that impedes the exclusion of clinically significant alloantibodies (e.g.
autoimmune hemolytic anemia, warm autoantibodies, patient recently transfused with a positive DAT, high-titer
low avidity antibodies, patients about to receive or on daratumumab therapy, other reactivity of no apparent
cause);

Suspected antibody against an antigen for which typing sera is not available; and

Laboratory discrepancies on serologic typing (e.g. rare Rh D antigen variants) (See LCDs for Molecular Pathology
for coverage guidelines)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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Guidelines
Based on the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (100-08), this policy
addresses the circumstances under which the item or service is reasonable and necessary under the Social Security
Act, §1862(a)(1)(A). For laboratory services, a service can be reasonable and necessary if the service is safe and
effective; and appropriate, including the duration and frequency that is considered appropriate for the item or service,
in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the
patient's condition; furnished in a setting appropriate to the patient's medical needs and condition; ordered and
furnished by qualified personnel; one that meets, but does not exceed, the patient's medical need; and is at least as
beneficial as an existing and available medically appropriate alternative.
Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent
medical review. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be
made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or
injury...". Furthermore, it has been longstanding CMS policy that "tests that are performed in the absence of signs,
symptoms, complaints, or personal history of disease or injury are not covered unless explicitly authorized by statute".
Screening services, such as pre-symptomatic genetic tests and services, are those used to detect an undiagnosed
disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare. Similarly,
Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the
risk assessment clearly and directly effects the management of the patient. However, Medicare does cover a broad
range of legislatively mandated preventive services to prevent disease, detect disease early when it is most treatable
and curable, and manage disease so that complications can be avoided. These services can be found on the CMS
website at http://www.cms.gov/PrevntionGenInfo/. Any preventive services and tests not listed on the CMS
Preventive Services webpage are considered non-covered screening (preventive) tests or services which are not a
benefit of the Medicare program.
Per 42 Code of Federal Regulations (CFR) section 410.32 (a) states the following requirements: All diagnostic x-rays
tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the
beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem
and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the
physician who is treating the beneficiary are not reasonable and necessary (see 411.15(k)(1)). Also, see Medicare
Benefit Policy Manual (100-02), Chapter 15, Section 80.6 for related physician order instructions.
Laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of
1988 (CLIA), as set forth at 42 CFR part 493. Section 1862(a)(1)(A) of the Act provides that Medicare payment may
not be made for services that are not reasonable and necessary. Clinical laboratory services must be ordered and
used promptly by the physician who is treating the beneficiary as described in 42 CFR 410.32(a), or by a qualified
nonphysician practitioner, as described in 42 CFR 410.32(a)(3).
Many applications of the molecular pathology procedures are not covered services given lack of benefit category
(preventive service) and/or failure to reach the reasonable and necessary threshold for coverage (based on quality of
clinical evidence and strength of recommendation). Furthermore, payment of claims in the past (based on stacking
codes) or in the future (based on the new code series) is not a statement of coverage since the service was not
audited for compliance with program requirements and documentation supporting the reasonable and necessary
testing for the beneficiary. Certain tests and procedures may be subject to prepayment medical review (records
requested) and paid claims must be supportable, if selected, for post payment audit by the MAC or other contractors.
Tests for diseases or conditions that manifest severe signs or symptoms in newborns and in early childhood or that
result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually
relevant to a Medicare beneficiary.
Documentation Guidelines
Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical
record must contain documentation that the testing is expected to influence treatment of the condition toward which
the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth
the diagnosis or condition that warrants the test(s).
Examples of documentation requirements of the ordering physician/nonphysician practitioner (NPP) include, but are
not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant
data (e.g., lab testing, imaging results).
Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab
accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.
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Documentation requirements for lab developed tests/protocols (when requested) include diagnostic test/assay,
lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence,
clinical validity evidence, and clinical utility.
Providers are required to code to specificity however, if an unlisted CPT code is used the documentation must clearly
identify the unique procedure performed. When multiple procedure codes are submitted on a claim (unique and/or
unlisted) the documentation supporting each code should be easily identifiable. If on review the contractor cannot link
a billed code to the documentation, these services will be denied based on Title XVIII of the Social Security Act,
§1833(e).
When the documentation does not meet the criteria for the service rendered or the documentation does not establish
the medical necessity for the services, such services will be denied as not reasonable and necessary under Section
1862(a)(1)(A) of the Social Security Act.
APPLICABLE CODES
The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in
this guideline does not imply that the service described by the code is a covered or non-covered 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 and Guidelines may apply.
CPT Code
81161
Description
DMD (dystrophin) (e.g., Duchenne/Becker muscular dystrophy) deletion analysis,
and duplication analysis, if performed
81162
BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; full sequence analysis and full duplication/deletion analysis (Effective
01/01/2016)
81170
ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (e.g., acquired imatinib
tyrosine kinase inhibitor resistance), gene analysis, variants in the kinase domain
(Effective 01/01/2016)
81200
ASPA (aspartoacylase) (e.g., Canavan disease) gene analysis, common variants
(e.g., E285A, Y231X)
81201
APC (adenomatous polyposis coli) (e.g., familial adenomatosis polyposis [FAP],
attenuated FAP) gene analysis; full gene sequence
81202
APC (adenomatous polyposis coli) (e.g., familial adenomatosis polyposis [FAP],
attenuated FAP) gene analysis; known familial variants
81203
APC (adenomatous polyposis coli) (e.g., familial adenomatosis polyposis [FAP],
attenuated FAP) gene analysis; duplication/deletion variants
81205
BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) (e.g.,
Maple syrup urine disease) gene analysis, common variants (e.g., R183P, G278S,
E422X)
81206
BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous leukemia) translocation analysis;
major breakpoint, qualitative or quantitative
81207
BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous leukemia) translocation analysis;
minor breakpoint, qualitative or quantitative
81208
BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous leukemia) translocation analysis;
other breakpoint, qualitative or quantitative
81209
BLM (Bloom syndrome, RecQ helicase-like) (e.g., Bloom syndrome) gene analysis,
2281del6ins7 variant
81210
BRAF (B-Raf proto-oncogene, serine/threonine kinase) (e.g., colon cancer,
melanoma), gene analysis, V600 variant(s)
81211
BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; full sequence analysis and common duplication/deletion variants in
BRCA1 (i.e., exon 13 del 3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22
del 510bp, exon 8-9 del 7.1kb)
81212
BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; 185delAG, 5385insC, 6174delT variants
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81213
Description
BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer)
gene analysis; uncommon duplication/deletion variants
81214
BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis;
full sequence analysis and common duplication/deletion variants (i.e., exon 13 del
3.835kb, exon 13 dup 6kb, exon 14-20 del 26kb, exon 22 del 510bp, exon 8-9 del
7.1kb)
81215
BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis;
known familial variant
81216
BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis;
full sequence analysis
81217
BRCA2 (breast cancer 2) (e.g., hereditary breast and ovarian cancer) gene analysis;
known familial variant
81218
CEBPA (CCAAT/enhancer binding protein [C/EBP], alpha) (e.g., acute myeloid
leukemia), gene analysis, full gene sequence (Effective 01/01/2016)
81219
CALR (calreticulin) (e.g., myeloproliferative disorders), gene analysis, common
variants in exon 9 (Effective 01/01/2016)
81220
CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis)
gene analysis; common variants (e.g., ACMG/ACOG guidelines)
81221
CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis)
gene analysis; known familial variants
81222
CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis)
gene analysis; duplication/deletion variants
81223
CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis)
gene analysis; full gene sequence
81224
CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis)
gene analysis; intron 8 poly-T analysis (e.g., male infertility)
81225
CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (e.g., drug
metabolism), gene analysis, common variants (e.g., *2, *3, *4, *8, *17)
81226
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (e.g., drug
metabolism), gene analysis, common variants (e.g., *2, *3, *4, *5, *6, *9, *10,
*17, *19, *29, *35, *41, *1XN, *2XN, *4XN)
81227
CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (e.g., drug
metabolism), gene analysis, common variants (e.g., *2, *3, *5, *6)
81228
Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of
genomic regions for copy number variants (e.g., Bacterial Artificial Chromosome
[BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis)
81229
Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of
genomic regions for copy number and single nucleotide polymorphism (SNP) variants
for chromosomal abnormalities
81235
EGFR (epidermal growth factor receptor) (e.g., non-small cell lung cancer) gene
analysis, common variants (e.g., exon 19 LREA deletion, L858R, T790M, G719A,
G719S, L861Q)
81240
F2 (prothrombin, coagulation factor II) (e.g., hereditary hypercoagulability) gene
analysis, 20210G>A variant
81241
F5 (coagulation Factor V) (e.g., hereditary hypercoagulability) gene analysis, Leiden
variant
81242
FANCC (Fanconi anemia, complementation group C) (e.g., Fanconi anemia, type C)
gene analysis, common variant (e.g., IVS4+4A>T)
81243
FMR1 (Fragile X mental retardation 1) (e.g., fragile X mental retardation) gene
analysis; evaluation to detect abnormal (e.g., expanded) alleles
81244
FMR1 (Fragile X mental retardation 1) (e.g., fragile X mental retardation) gene
analysis; characterization of alleles (e.g., expanded size and methylation status)
81245
FLT3 (FMS-related tyrosine kinase 3) (e.g., acute myeloid leukemia), gene analysis,
internal tandem duplication (ITD) variants (i.e., exons 14, 15)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81250
Description
G6PC (glucose-6-phosphatase, catalytic subunit) (e.g., Glycogen storage disease,
Type 1a, von Gierke disease) gene analysis, common variants (e.g., R83C, Q347X)
81251
GBA (glucosidase, beta, acid) (e.g., Gaucher disease) gene analysis, common
variants (e.g., N370S, 84GG, L444P, IVS2+1G>A)
81252
GJB2 (gap junction protein, beta 2, 26kDa, connexin 26) (e.g., nonsyndromic hearing
loss) gene analysis; full gene sequence
81253
GJB2 (gap junction protein, beta 2, 26kDa; connexin 26) (e.g., nonsyndromic
hearing loss) gene analysis; known familial variants
81254
GJB6 (gap junction protein, beta 6, 30kDa, connexin 30) (e.g., nonsyndromic hearing
loss) gene analysis, common variants (e.g., 309kb [del(GJB6-D13S1830)] and 232kb
[del(GJB6-D13S1854)])
81255
HEXA (hexosaminidase A [alpha polypeptide]) (e.g., Tay-Sachs disease) gene
analysis, common variants (e.g., 1278insTATC, 1421+1G>C, G269S)
81256
HFE (hemochromatosis) (e.g., hereditary hemochromatosis) gene analysis, common
variants (e.g., C282Y, H63D)
81257
HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart
hydrops fetalis syndrome, HbH disease), gene analysis, for common deletions or
variant (e.g., Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2,
alpha20.5, and Constant Spring)
81260
IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase
complex-associated protein) (e.g., familial dysautonomia) gene analysis, common
variants (e.g., 2507+6T>C, R696P)
81261
IGH@ (Immunoglobulin heavy chain locus) (e.g., leukemias and lymphomas, B-cell),
gene rearrangement analysis to detect abnormal clonal population(s); amplified
methodology (e.g., polymerase chain reaction)
81262
IGH@ (Immunoglobulin heavy chain locus) (e.g., leukemias and lymphomas, B-cell),
gene rearrangement analysis to detect abnormal clonal population(s); direct probe
methodology (e.g., Southern blot)
81263
IGH@ (Immunoglobulin heavy chain locus) (e.g., leukemia and lymphoma, B-cell),
variable region somatic mutation analysis
81264
IGK@ (Immunoglobulin kappa light chain locus) (e.g., leukemia and lymphoma, Bcell), gene rearrangement analysis, evaluation to detect abnormal clonal
population(s)
81265
Comparative analysis using Short Tandem Repeat (STR) markers; patient and
comparative specimen (e.g., pre-transplant recipient and donor germline testing,
post-transplant non-hematopoietic recipient germline [e.g., buccal swab or other
germline tissue sample] and donor testing, twin zygosity testing, or maternal cell
contamination of fetal cells)
81266
Comparative analysis using Short Tandem Repeat (STR) markers; each additional
specimen (e.g., additional cord blood donor, additional fetal samples from different
cultures, or additional zygosity in multiple birth pregnancies) (List separately in
addition to code for primary procedure)
81267
Chimerism (engraftment) analysis, post transplantation specimen (e.g.,
hematopoietic stem cell), includes comparison to previously performed baseline
analyses; without cell selection
81268
Chimerism (engraftment) analysis, post transplantation specimen (e.g.,
hematopoietic stem cell), includes comparison to previously performed baseline
analyses; with cell selection (e.g., CD3, CD33), each cell type
81270
JAK2 (Janus kinase 2) (e.g., myeloproliferative disorder) gene analysis, p.Val617Phe
(V617F) variant
81272
KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (e.g.,
gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene
analysis, targeted sequence analysis (e.g., exons 8, 11, 13, 17, 18) (Effective
01/01/2016)
81273
KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (e.g.,
mastocytosis), gene analysis, D816 variant(s) (Effective 01/01/2016)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81275
Description
KRAS (Kirsten rat sarcoma viral oncogene homolog) (e.g., carcinoma) gene analysis;
variants in exon 2 (e.g., codons 12 and 13)
81276
KRAS (Kirsten rat sarcoma viral oncogene homolog) (e.g., carcinoma) gene analysis;
additional variant(s) (e.g., codon 61, codon 146) (Effective 01/01/2016)
81287
MGMT (O-6-methylguanine-DNA methyltransferase) (e.g., glioblastoma multiforme),
methylation analysis
81288
MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation
analysis
81290
MCOLN1 (mucolipin 1) (e.g., Mucolipidosis, type IV) gene analysis, common variants
(e.g., IVS3-2A>G, del6.4kb)
81291
MTHFR (5,10-methylenetetrahydrofolate reductase) (e.g., hereditary
hypercoagulability) gene analysis, common variants (e.g., 677T, 1298C)
81292
MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis
81293
MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants
81294
MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion
variants
81295
MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis
81296
MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants
81297
MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion
variants
81298
MSH6 (mutS homolog 6 [E. coli]) (e.g. hereditary non-polyposis colorectal cancer,
Lynch syndrome) gene analysis; full sequence analysis
81299
MSH6 (mutS homolog 6 [E. coli]) (e.g., hereditary non-polyposis colorectal cancer,
Lynch syndrome) gene analysis; known familial variants
81300
MSH6 (mutS homolog 6 [E. coli]) (e.g., hereditary non-polyposis colorectal cancer,
Lynch syndrome) gene analysis; duplication/deletion variants
81301
Microsatellite instability analysis (e.g., hereditary non-polyposis colorectal cancer,
Lynch syndrome) of markers for mismatch repair deficiency (e.g., BAT25, BAT26),
includes comparison of neoplastic and normal tissue, if performed
81302
MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis; full
sequence analysis
81303
MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis; known
familial variant
81304
MECP2 (methyl CpG binding protein 2) (e.g., Rett syndrome) gene analysis;
duplication/deletion variants
81310
NPM1 (nucleophosmin) (e.g., acute myeloid leukemia) gene analysis, exon 12
variants
81311
NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) (e.g., colorectal
carcinoma), gene analysis, variants in exon 2 (e.g., codons 12 and 13) and exon 3
(e.g., codon 61) (Effective 01/01/2016)
81313
PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related
peptidase 3 [prostate specific antigen]) ratio (e.g., prostate cancer)
81314
PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (e.g.,
gastrointestinal stromal tumor [GIST]), gene analysis, targeted sequence analysis
(e.g., exons 12, 18) (Effective 01/01/2016)
81315
PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha)
(e.g., promyelocytic leukemia) translocation analysis; common breakpoints (e.g.,
intron 3 and intron 6), qualitative or quantitative
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81316
Description
PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha)
(e.g., promyelocytic leukemia) translocation analysis; single breakpoint (e.g., intron
3, intron 6 or exon 6), qualitative or quantitative
81317
PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis
81318
PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants
81319
PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion
variants
81321
PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma
tumor syndrome) gene analysis; full sequence analysis
81322
PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma
tumor syndrome) gene analysis; known familial variant
81323
PTEN (phosphatase and tensin homolog) (e.g., Cowden syndrome, PTEN hamartoma
tumor syndrome) gene analysis; duplication/deletion variant
81324
PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie-Tooth, hereditary
neuropathy with liability to pressure palsies) gene analysis; duplication/deletion
analysis
81325
PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie-Tooth, hereditary
neuropathy with liability to pressure palsies) gene analysis; full sequence analysis
81326
PMP22 (peripheral myelin protein 22) (e.g., Charcot-Marie-Tooth, hereditary
neuropathy with liability to pressure palsies) gene analysis; known familial variant
81327
SEPT9 (Septin9) (eg, colorectal cancer) methylation analysis (Effective
01/01/2017)
81330
SMPD1(sphingomyelin phosphodiesterase 1, acid lysosomal) (e.g., Niemann-Pick
disease, Type A) gene analysis, common variants (e.g., R496L, L302P, fsP330)
81331
SNRPN/UBE3A (small nuclear ribonucleoprotein polypeptide N and ubiquitin protein
ligase E3A) (e.g., Prader-Willi syndrome and/or Angelman syndrome), methylation
analysis
81332
SERPINA1 (serpin peptidase inhibitor, clade A, alpha-1 antiproteinase, antitrypsin,
member 1) (e.g., alpha-1-antitrypsin deficiency), gene analysis, common variants
(e.g., *S and *Z)
81340
TRB@ (T cell antigen receptor, beta) (e.g., leukemia and lymphoma), gene
rearrangement analysis to detect abnormal clonal population(s); using amplification
methodology (e.g., polymerase chain reaction)
81341
TRB@ (T cell antigen receptor, beta) (e.g., leukemia and lymphoma), gene
rearrangement analysis to detect abnormal clonal population(s); using direct probe
methodology (e.g., Southern blot)
81342
TRG@ (T cell antigen receptor, gamma) (e.g., leukemia and lymphoma), gene
rearrangement analysis, evaluation to detect abnormal clonal population(s)
81350
UGT1A1 (UDP glucuronosyltransferase 1 family, polypeptide A1) (e.g., irinotecan
metabolism), gene analysis, common variants (e.g., *28, *36, *37)
81355
VKORC1 (vitamin K epoxide reductase complex, subunit 1) (e.g., warfarin
metabolism), gene analysis, common variants (e.g., -1639G>A, c.173+1000C>T)
81370
HLA Class I and II typing, low resolution (e.g., antigen equivalents); HLA-A, -B, -C, DRB1/3/4/5, and -DQB1
81371
HLA Class I and II typing, low resolution (e.g., antigen equivalents); HLA-A, -B, and DRB1/3/4/5 (e.g., verification typing)
81372
HLA Class I typing, low resolution (e.g., antigen equivalents); complete (i.e., HLA-A,
-B, and -C)
81373
HLA Class I typing, low resolution (e.g., antigen equivalents); one locus (e.g., HLA-A,
-B, or -C), each
81374
HLA Class I typing, low resolution (e.g., antigen equivalents); one antigen equivalent
(e.g., B*27), each
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81375
Description
HLA Class II typing, low resolution (e.g., antigen equivalents); HLA-DRB1/3/4/5 and
-DQB1
81376
HLA Class II typing, low resolution (e.g., antigen equivalents); one locus (e.g., HLADRB1/3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each
81377
HLA Class II typing, low resolution (e.g., antigen equivalents); one antigen
equivalent, each
81378
HLA Class I typing, high resolution (i.e., alleles or allele groups); complete (i.e., HLAA, -B, and -C)
81379
HLA Class I typing, high resolution (i.e., alleles or allele groups); complete (i.e., HLAA, -B, and -C)
81380
HLA Class I typing, high resolution (i.e., alleles or allele groups); one locus (e.g.,
HLA-A, -B, or -C), each
81381
HLA Class I typing, high resolution (i.e., alleles or allele groups); one allele or allele
group (e.g., B*57:01P), each
81382
HLA Class II typing, high resolution (i.e., alleles or allele groups); one locus (e.g.,
HLA-DRB1, -DRB3, -DRB4, -DRB5, -DQB1, -DQA1, -DPB1, or -DPA1), each
81383
HLA Class II typing, high resolution (i.e., alleles or allele groups); one allele or allele
group (e.g., HLA-DQB1*06:02P), each
81400
Molecular pathology procedure, Level 1 analysis (short description)
81401
Molecular pathology procedure, Level 2 analysis (short description)
81402
Molecular pathology procedure, Level 3 analysis (short description)
81403
Molecular pathology procedure, Level 4 analysis (short description)
81404
Molecular pathology procedure, Level 5 analysis (short description)
81405
Molecular pathology procedure, Level 6 analysis (short description)
81406
Molecular pathology procedure, Level 7 analysis (short description)
81407
Molecular pathology procedure, Level 8 analysis (short description)
81408
Molecular pathology procedure, Level 9 analysis (short description)
81410
Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler
Danlos syndrome type IV, arterial tortuosity syndrome); genomic sequence analysis
panel, must include sequencing of at least 9 genes, including FBN1, TGFBR1,
TGFBR2, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, and MYLK
81411
Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler
Danlos syndrome type IV, arterial tortuosity syndrome); duplication/deletion analysis
panel, must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1
81412
Ashkenazi Jewish associated disorders (e.g., Bloom syndrome, Canavan disease,
cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease,
Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at
least 9 genes, including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1,
and SMPD1 (Effective 01/01/2016)
81413
Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT
syndrome, catecholaminergic polymorphic ventricular tachycardia); genomic
sequence analysis panel, must include sequencing of at least 10 genes, including
ANK2, CASQ2, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, RYR2, and SCN5A
(Effective 01/01/2017)
81414
Cardiac ion channelopathies (eg, Brugada syndrome, long QT syndrome, short QT
syndrome, catecholaminergic polymorphic ventricular tachycardia);
duplication/deletion gene analysis panel, must include analysis of at least 2 genes,
including KCNH2 and KCNQ1 (Effective 01/01/2017)
81415
Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence
analysis
81416
Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence
analysis, each comparator exome (e.g., parents, siblings) (List separately in addition
to code for primary procedure)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81417
Description
Exome (e.g., unexplained constitutional or heritable disorder or syndrome); reevaluation of previously obtained exome sequence (e.g., updated knowledge or
unrelated condition/syndrome)
81420
Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence
analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis
of chromosomes 13, 18, and 21
81422
Fetal chromosomal microdeletion(s) genomic sequence analysis (eg, DiGeorge
syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood
(Effective 01/01/2017)
81425
Genome (e.g., unexplained constitutional or heritable disorder or syndrome);
sequence analysis
81426
Genome (e.g., unexplained constitutional or heritable disorder or syndrome);
sequence analysis, each comparator genome (e.g., parents, siblings) (List separately
in addition to code for primary procedure)
81427
Genome (e.g., unexplained constitutional or heritable disorder or syndrome); reevaluation of previously obtained genome sequence (e.g., updated knowledge or
unrelated condition/syndrome)
81430
Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome);
genomic sequence analysis panel, must include sequencing of at least 60 genes,
including CDH23, CLRN1, GJB2, GPR98, MTRNR1, MYO7A, MYO15A, PCDH15, OTOF,
SLC26A4, TMC1, TMPRSS3, USH1C, USH1G, USH2A, and WFS1
81431
Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome);
duplication/deletion analysis panel, must include copy number analyses for STRC and
DFNB1 deletions in GJB2 and GJB6 genes
81432
Hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary
ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel,
must include sequencing of at least 14 genes, including ATM, BRCA1, BRCA2, BRIP1,
CDH1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53
(Effective 01/01/2016)
81433
Hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary
ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel,
must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11
81434
Hereditary retinal disorders (e.g., retinitis pigmentosa, Leber congenital amaurosis,
cone-rod dystrophy), genomic sequence analysis panel, must include sequencing of
at least 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31,
PRPH2, RDH12, RHO, RP1, RP2, RPE65, RPGR, and USH2A (Effective 01/01/2016)
81435
Hereditary colon cancer disorders (e.g., Lynch syndrome, PTEN hamartoma
syndrome, Cowden syndrome, familial adenomatosis polyposis); genomic sequence
analysis panel, must include sequencing of at least 10 genes, including APC, BMPR1A,
CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, and STK11
81436
Hereditary colon cancer disorders (e.g., Lynch syndrome, PTEN hamartoma
syndrome, Cowden syndrome, familial adenomatosis polyposis); duplication/deletion
analysis panel, must include analysis of at least 5 genes, including MLH1, MSH2,
EPCAM, SMAD4, and STK11
81439
Inherited cardiomyopathy (eg, 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 (Effective 01/01/2017)
81440
Nuclear encoded mitochondrial genes (e.g., neurologic or myopathic phenotypes),
genomic sequence panel, must include analysis of at least 100 genes, including
BCS1L, C10orf2, COQ2, COX10, DGUOK, MPV17, OPA1, PDSS2, POLG, POLG2,
RRM2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81445
Description
Targeted genomic sequence analysis panel, solid organ or hematolymphoid
neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes
(e.g., ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2,
JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA,
PTEN, RET), interrogation for sequence variants and copy number variants or
rearrangements, if performed
81450
Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder,
DNA and RNA analysis when performed, 5-50 genes (e.g., BRAF, CEBPA, DNMT3A,
EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1),
interrogation for sequence variants, and copy number variants or rearrangements, or
isoform expression or mRNA expression levels, if performed
81455
Targeted genomic sequence analysis panel, solid organ or hematolymphoid
neoplasm, DNA and RNA analysis when performed, 51 or greater genes (e.g., ALK,
BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT,
KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN,
RET), interrogation for sequence variants and copy number variants or
rearrangements, if performed
81460
Whole mitochondrial genome (e.g., Leigh syndrome, mitochondrial
encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic
epilepsy with ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis
pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence,
must include sequence analysis of entire mitochondrial genome with heteroplasmy
detection
81465
Whole mitochondrial genome large deletion analysis panel (e.g., Kearns-Sayre
syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy
detection, if performed
81470
X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID);
genomic sequence analysis panel, must include sequencing of at least 60 genes,
including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM,
MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2
81471
X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID);
duplication/deletion gene analysis, must include analysis of at least 60 genes,
including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM,
MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2
81479
Unlisted molecular pathology procedure
81490
Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays,
utilizing serum, prognostic algorithm reported as a disease activity score (Effective
01/01/2016)
81500
Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing
serum, with menopausal status, algorithm reported as a risk score
81503
Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1,
beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm
reported as a risk score
81519
Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21
genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as
recurrence score
81525
Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes
(7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue,
algorithm reported as a recurrence score (Effective 01/01/2016)
81535
Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by
DAPI stain and morphology, predictive algorithm reported as a drug response score;
first single drug or drug combination (Effective 01/01/2016)
81536
Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by
DAPI stain and morphology, predictive algorithm reported as a drug response score;
each additional single drug or drug combination (List separately in addition to code
for primary procedure) (Effective 01/01/2016)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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CPT Code
81538
Description
Oncology (lung), mass spectrometric 8-protein signature, including amyloid A,
utilizing serum, prognostic and predictive algorithm reported as good versus poor
overall survival (Effective 01/01/2016)
81539
Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total
PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum,
prognostic algorithm reported as a probability score (Effective 01/01/2017)
81540
Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time
RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main
cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as a probability of a predicted main cancer type and subtype (Effective
01/01/2016)
81545
Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle
aspirate, algorithm reported as a categorical result (e.g., benign or suspicious)
(Effective 01/01/2016)
81595
Cardiology (heart transplant), mRNA, gene expression profiling by real-time
quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subfraction
of peripheral blood, algorithm reported as a rejection risk score (Effective
01/01/2016)
81599
Unlisted multianalyte assay with algorithmic analysis
84999
Unlisted chemistry procedure
85999
Unlisted hematology and coagulation procedure
86152
Cell enumeration using immunologic selection and identification in fluid specimen
(e.g., circulating tumor cells in blood)
86153
Cell enumeration using immunologic selection and identification in fluid specimen
(e.g., circulating tumor cells in blood); physician interpretation and report, when
required
86294
Immunoassay for tumor antigen, qualitative or semiquantitative (e.g., bladder tumor
antigen)
86316
Immunoassay for tumor antigen, other antigen, quantitative (e.g., CA 50, 72-4,
549), each
86386
Nuclear Matrix Protein 22 (NMP22), qualitative
86849
Unlisted immunology procedure
87260
Adenovirus ag if (short description)
87280
Respiratory syncytial ag if (short description)
87471
Bartonella DNA amp probe (short description)
87476
Lyme dis DNA amp probe (short description)
87480
Infectious agent detection by nucleic acid (DNA or RNA); Candida species, direct
probe
87481
Infectious agent detection by nucleic acid (DNA or RNA); Candida species, amplified
probe
87483
Infectious agent detection by nucleic acid (DNA or RNA); central nervous system
pathogen (eg, Neisseria meningitidis, Streptococcus pneumoniae, Listeria,
Haemophilus influenzae, E. coli, Streptococcus agalactiae, enterovirus, human
parechovirus, herpes simplex virus type 1 and 2, human herpesvirus 6,
cytomegalovirus, varicella zoster virus, Cryptococcus), includes multiplex reverse
transcription, when performed, and multiplex amplified probe technique, multiple
types or subtypes, 12-25 targets (Effective 01/01/2017)
87486
Chylmd pneum DNA amp probe (short description)
87490
Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis,
direct probe
87491
Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis,
amplified probe
87496
Cytomeg DNA amp probe (short description)
87497
Cytomeg DNA quant (short description)
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 14 of 30
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Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
CPT Code
87498
Description
Enterovirus probe&revrs trns (short description)
87500
Vancomycin DNA amp probe (short description)
87501
Influenza DNA amp prob 1+ (short description)
87502
Influenza DNA amp probe (short description)
87503
Influenza DNA amp prob addl (short description)
87510
Infectious agent detection by nucleic acid (DNA or RNA); Gardnerella vaginalis, direct
probe
87516
Hepatitis b DNA amp probe (short description)
87517
Hepatitis b DNA quant (short description)
87521
Hepatitis c probe & rvrs trnsc (short description)
87522
Hepatitis c revrs trnscrpj (short description)
87526
Hepatitis g DNA amp probe (short description)
87529
HSV DNA amp probe (short description)
87532
HHV-6 DNA amp probe (short description)
87534
HIV-1 DNA dir probe (short description)
87535
HIV-1 probe&reverse trnscrpj (short description)
87536
HIV-1 quant&revrse trnscrpj (short description)
87537
HIV-2 DNA dir probe (short description)
87538
HIV-2 probe&revrse trnscripj (short description)
87539
HIV-2 quant&revrse trnscripj (short description)
87541
Legion pneumo DNA amp prob (short description)
87551
Mycobacteria DNA amp probe (short description)
87556
M.tuberculo DNA amp probe (short description)
87561
M.avium-intra DNA amp prob (short description)
87581
M.pneumon DNA amp probe (short description)
87590
Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae,
direct probe
87591
Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae,
amplified probe
87624
HPV high-risk types (short description)
87640
Staph a DNA amp probe (short description)
87641
Mr-staph DNA amp probe (short description)
87650
Strep a DNA dir probe (short description)
87653
Strep b DNA amp probe (short description)
87660
Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis,
direct probe
87661
Trichomonas vaginalis amplif (short description)
87797
Detect agent nos DNA dir (short description)
87798
Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified;
amplified probe
87901
Genotype DNA HIV reverse t (short description)
87902
Genotype DNA/rna hep c (short description)
87903
Phenotype DNA HIV w/culture (short description)
87904
Phenotype DNA HIV w/clt add (short description)
87906
Genotype DNA/rna HIV (short description)
87999
Unlisted microbiology procedure
88120
Cytopathology, in situ hybridization (e.g., FISH), urinary tract specimen with
morphometric analysis, 3-5 molecular probes, each specimen; manual
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 15 of 30
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Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
CPT Code
88121
Description
Cytopathology, in situ hybridization (e.g., FISH), urinary tract specimen with
morphometric analysis, 3-5 molecular probes, each specimen; using computerassisted technology
88199
Unlisted cytopathology procedure
88230
Tissue culture for non-neoplastic disorders; lymphocyte
88233
Tissue culture for non-neoplastic disorders; skin or other solid tissue biopsy
88235
Tissue culture for non-neoplastic disorders; amniotic fluid or chorionic villus cells
88237
Tissue culture for neoplastic disorders; bone marrow, blood cells
88239
Tissue culture for neoplastic disorders; solid tumor
88240
Cryopreservation, freezing and storage of cells, each cell line
88241
Thawing and expansion of frozen cells, each aliquot
88245
Chromosome analysis for breakage syndromes; baseline Sister Chromatid Exchange
(SCE), 20-25 cells
88248
Chromosome analysis for breakage syndromes; baseline breakage, score 50-100
cells, count 20 cells, 2 karyotypes (e.g., for ataxia telangiectasia, Fanconi anemia,
fragile X)
88249
Chromosome analysis for breakage syndromes; score 100 cells, clastogen stress
(e.g., diepoxybutane, mitomycin C, ionizing radiation, UV radiation)
88261
Chromosome analysis; count 5 cells, 1 karyotype, with banding
88262
Chromosome analysis; count 15-20 cells, 2 karyotypes, with banding
88263
Chromosome analysis; count 45 cells for mosaicism, 2 karyotypes, with banding
88264
Chromosome analysis; analyze 20-25 cells
88267
Chromosome analysis, amniotic fluid or chorionic villus, count 15 cells, 1 karyotype,
with banding
88269
Chromosome analysis, in situ for amniotic fluid cells, count cells from 6-12 colonies,
1 karyotype, with banding
88271
Molecular cytogenetics; DNA probe, each (e.g., FISH)
88272
Molecular cytogenetics; chromosomal in situ hybridization, analyze 3-5 cells (e.g., for
derivatives and markers)
88273
Molecular cytogenetics; chromosomal in situ hybridization, analyze 10-30 cells (e.g.,
for microdeletions)
88274
Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells
88275
Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells
88280
Chromosome analysis; additional karyotypes, each study
88283
Chromosome analysis; additional specialized banding technique (e.g., NOR, Cbanding)
88285
Chromosome analysis; additional cells counted, each study
88289
Chromosome analysis; additional high resolution study
88291
Cytogenetics and molecular cytogenetics, interpretation and report
88299
Unlisted cytogenetic study
88341
Immunohistochemistry or immunocytochemistry, per specimen; each additional
single antibody stain procedure (List separately in addition to code for primary
procedure)
88342
Immunohistochemistry or immunocytochemistry, per specimen; initial single
antibody stain procedure
88363
Examination and selection of retrieved archival (i.e., previously diagnosed) tissue(s)
for molecular analysis (e.g., KRAS mutational analysis)
88365
In situ hybridization (e.g., FISH), each probe
88367
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each
probe; using computer-assisted technology
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 16 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
CPT Code
88368
Description
Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each
probe; manual
88399
Unlisted surgical pathology procedure
89240
Unlisted miscellaneous pathology test
89398
Unlisted reproductive medicine laboratory procedure
CPT® is a registered trademark of the American Medical Association
HCPCS Code
G0452
Description
Molecular pathology procedure; physician interpretation and report
S0265
Genetic counseling, under physician supervision, each 15 minutes
S3800
Genetic testing for amyotrophic lateral sclerosis (ALS)
S3841
Genetic testing for retinoblastoma
S3842
Genetic testing for Von Hippel-Lindau disease
S3845
Genetic testing for alpha-thalassemia
S3846
Genetic testing for hemoglobin E beta-thalassemia
S3849
Genetic testing for Niemann-Pick disease
S3850
Genetic testing for sickle cell anemia
S3852
DNA analysis for APOE epsilon 4 allele for susceptibility to Alzheimer's disease
S3853
Genetic testing for myotonic muscular dystrophy
S3861
Genetic testing, sodium channel, voltage-gated, type V, alpha subunit (SCN5A) and
variants for suspected Brugada Syndrome
S3870
Comparative genomic hybrization (CGH) microarray testing for developmental delay,
autism spectrum disorder intellectual disability
Modifier
TC
Description
Technical component
ICD-10 Diagnosis Codes
Molecular Pathology
ICD-10 Dx Coding.xls
REFERENCES
CMS National Coverage Determinations (NCDs)
NCD 190.3 Cytogenetic Studies
Reference NCD: NCD 190.7 Human Tumor Stem Cell Drug Sensitivity Assays
CMS Local Coverage Determinations (LCDs)
LCD
Medicare Part A
Medicare Part B
Cytogenetics, Immunohistochemistry, Drug Metabolism Testing, GeneSight for Depression, HLA Testing,
Pathfinder for Pancreas
L34864 (Loss-of-Heterozygosity Based
Topographic Genotyping with
PathfinderTG®) Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L35072 (MolDx: CYP2C19, CYP2D6,
CYP2C9, and VKORC1 Genetic Testing)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35443 (MoPath: GeneSight® Assay for
Refractory Depression) CGS
KY, OH
KY, OH
L35332 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) CGS
KY, OH
KY, OH
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 17 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
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Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Medicare Part A
Medicare Part B
Cytogenetics, Immunohistochemistry, Drug Metabolism Testing, GeneSight for Depression, HLA Testing,
Pathfinder for Pancreas
L35660 (Pathology and Laboratory:
CYP2C19, CYP2D6, CYP2C9, and
VKORC1 Genetic Testing) Cahaba
AL, GA, TN
AL, GA, TN
L35633 (MolDX: GeneSight® Assay for
Refractory Depression) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35698 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) First
Coast
FL, PR, VI
FL, PR, VI
L35922 (Special Histochemical Stains
and Immunohistochemical Stains)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35986 (Special Histochemical Stains
and Immunohistochemical Stains) CGS
KY, OH
KY, OH
L36033 (MolDX: HLA-B*15:02 Genetic
Testing) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36048 (MolDX: HLA-B*15:02 Genetic
Testing) CGS
KY, OH
KY, OH
L36145 (MolDX: HLA-B*15:02 Genetic
Testing) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36149 (MolDX: HLA-B*15:02 Genetic
Testing) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36234 (Special Histochemical Stains
and Immunohistochemical Stains) First
Coast
FL, PR, VI
FL, PR, VI
L36310 (MolDX: CYP2C19, CYP2D6,
CYP2C9, and VKORC1 Genetic Testing)
Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36312 (MolDX: CYP2C19, CYP2D6,
CYP2C9, and VKORC1 Genetic Testing)
Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36398 (Genetic Testing for CYP2C19,
CYP2D6, CYP2C9, and VKORC1) WPS
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L36464 (MolDX: HLA-DQB1*06:02
Testing for Narcolepsy) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36485 (MolDX: HLA-DQB1*06:02
Testing for Narcolepsy) CGS
KY, OH
KY, OH
L36544 (MolDX: HLA-DQB1*06:02
Testing for Narcolepsy) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36551 (MolDX: HLA-DQB1*06:02
Testing for Narcolepsy) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36634 (In Vitro Chemosensitivity &
Chemoresistance Assays) Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L36322 (MolDX: GeneSight® Assay for
Refractory Depression) Noridian
Retired 11/16/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36324 (MolDX: GeneSight® Assay for
Refractory Depression) Noridian
Retired 11/16/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 18 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Medicare Part A
Medicare Part B
Cytogenetics, Immunohistochemistry, Drug Metabolism Testing, GeneSight for Depression, HLA Testing,
Pathfinder for Pancreas
L36346 (Special Histochemical Stains
and Immunohistochemical Stains)
Noridian Retired 11/16/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36352 (Special Histochemical Stains
and Immunohistochemical Stains)
Noridian Retired 11/16/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36309 (MolDX: CYP2C19, CYP2D6,
CYP2C9, and VKORC1 Genetic Testing)
Noridian Retired 07/08/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36311 (MolDX: CYP2C19, CYP2D6,
CYP2C9, and VKORC1 Genetic Testing)
Noridian Retired 07/08/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L34067 (Cytogenetic Studies) Noridian
Retired 10/01/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L24295 (Cytogenetic Studies) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L30487 (Cytogenetic Studies) WPS
Retired 09/30/2015
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L31144 (Loss-of-Heterozygosity Based
Topographic Genotyping with
PathfinderTG) Novitas
Retired 09/30/2015
DC, DE, MD, NJ, PA
DC, DE, MD, NJ, PA
L31873 (Immunohistochemistry) CGS
Retired 09/30/2015
KY, OH
KY, OH
L34499 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35327 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) CGS
Retired 09/30/2015
KY, OH
KY, OH
L35366 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) First
Coast Retired 09/30/2015
FL, PR, VI
FL, PR, VI
L35430 (MolDX: GeneSight® Assay for
Refractory Depression) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35437 (MoPath: GeneSight® Assay for
Refractory Depression) CGS
Retired 09/30/2015
KY, OH
KY, OH
L35472 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L35478 (CYP2C19, CYP2D6, CYP2C9,
and VKORC1 Genetic Testing) Noridian
Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L35504 (MolDX: GeneSight® Assay for
Refractory Depression) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L35520 (MolDX: GeneSight® Assay for
Refractory Depression) Noridian
Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 19 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Medicare Part A
Medicare Part B
Cytogenetics, Immunohistochemistry, Drug Metabolism Testing, GeneSight for Depression, HLA Testing,
Pathfinder for Pancreas
L34655 (Cytogenetic Studies) WPS
Retired 09/01/2015
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L33420 (Bladder Tumor Markers)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L33586 (Gene Expression Profiling
Panel for use in the Management of
Breast Cancer Treatment) First Coast
FL, PR, VI
FL, PR, VI
L33965 (Urinary Tumor Markers for
Bladder Cancer) First Coast
FL, PR, VI
FL, PR, VI
L34912 (Genetic Testing for Lynch
Syndrome) First Coast
FL, PR, VI
FL, PR, VI
L35024 (MolDX: Genetic Testing for
Lynch Syndrome) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35062 (Biomarkers Overview) Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L35073 (MolDX: NRAS Genetic Testing)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35349 (MolDX: Genetic Testing for
Lynch Syndrome) CGS
KY, OH
KY, OH
L35396 (Biomarkers for Oncology)
Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L35442 (NRAS Genetic Testing) CGS
KY, OH
KY, OH
L35553 (Pathology and Laboratory:
Genetic Testing for Lynch Syndrome)
Cahaba
AL, GA, TN
AL, GA, TN
L35631 (MolDX: Breast Cancer Index℠
Genetic Assay) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35632 (MolDX: ConfirmMDx Epigenetic
Molecular Assay) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35869 (MolDX-CDD: Prolaris™
Prostate Cancer Genomic Assay)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35974 (MolDX: MGMT Promoter
Methylation Analysis) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36006 (MolDX-CDD: ConfirmMDx
Epigenetic Molecular Assay) CGS
KY, OH
KY, OH
L36082 (MolDX: BRCA1 and BRCA2
Genetic Testing) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36113 (MolDX: MGMT Promoter
Methylation Analysis) CGS
KY, OH
KY, OH
L36125 (MolDX: Breast Cancer Assay:
Prosigna) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36143 (MolDX-CDD: NSCLC,
Comprehensive Genomic Profile
Testing) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36153 (MolDX-CDD: Genomic Health™
Oncotype DX® Prostate Cancer Assay)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
Cancer Genetic Testing
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 20 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
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Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Cancer Genetic Testing
Medicare Part A
Medicare Part B
L36161 (MolDX: BRCA1 and BRCA2
Genetic Testing) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36163 (MolDX: BRCA1 and BRCA2
Genetic Testing) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36174 (MolDX-CDD: NSCLC,
Comprehensive Genomic Profile
Testing) CGS
KY, OH
KY, OH
L36188 (MolDX: MGMT Promoter
Methylation Analysis) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36192 (MolDX: MGMT Promoter
Methylation Analysis) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36194 (MolDX-CDD: NSCLC,
Comprehensive Genomic Profile
Testing) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36198 (MolDX-CDD: NSCLC,
Comprehensive Genomic Profile
Testing) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36206 (MolDX-CDD: Genomic Health™
Oncotype DX® Prostate Cancer Assay)
CGS
KY, OH
KY, OH
L36327 (MolDX-CDD: ConfirmMDx
Epigenetic Molecular Assay) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36329 (MolDX-CDD: ConfirmMDx
Epigenetic Molecular Assay) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36335 (MolDX: NRAS Genetic Testing)
Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36339 (MolDX: NRAS Genetic Testing)
Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36341 (MolDX: Decipher® Prostate
Cancer Classifier Assay) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36344 (MolDX: Decipher® Prostate
Cancer Classifier Assay) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36364 (MolDX-CDD: Genomic Health™
Oncotype DX® Prostate Cancer Assay)
Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36368 (MolDX-CDD: Genomic Health™
Oncotype DX® Prostate Cancer Assay)
Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36370 (MolDX: Genetic Testing for
Lynch Syndrome) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36374 (MolDX: Genetic Testing for
Lynch Syndrome) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36376 (Genomic Sequence Analysis
Panels in the Treatment of Non-Small
Cell Lung Cancer) NGS
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
L36380 (MolDX: Breast Cancer Assay:
Prosigna) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36386 (MolDX: Breast Cancer Assay:
Prosigna) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36425 (MolDX: Breast Cancer Assay:
Prosigna) CGS
KY, OH
KY, OH
L36446 (Partial Genome Profiling in Non
Small Cell Lung Cancer (NSCLC))
Cahaba
AL, GA, TN
AL, GA, TN
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 21 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Cancer Genetic Testing
Medicare Part A
Medicare Part B
L36456 (MolDX: BRCA1 and BRCA2
Genetic Testing) CGS
KY, OH
KY, OH
L36458 (MolDX: Breast Cancer Index℠
Genetic Assay) CGS
KY, OH
KY, OH
L36483 (MolDX: Chromosome 1p/19q
Deletion Analysis) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36487 (MolDX: Chromosome 1p/19q
Deletion Analysis) CGS
KY, OH
KY, OH
L36499 (BRCA1 and BRCA2 Genetic
Testing) First Coast
FL, PR, VI
FL, PR, VI
L36542 (MolDX: Chromosome 1p/19q
Deletion Analysis) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36557 (MolDX: Chromosome 1p/19q
Deletion Analysis) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36582 (Pathology and Laboratory: Kras Testing prior to Treatment of
Colorectal Cancer (CRC)) Cahaba
AL, GA, TN
AL, GA, TN
L36665 (MolDX- CDD: ProMark Risk
Score) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36715 (BRCA1 and BRCA2 Genetic
Testing) Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L36741 (Pathology and Laboratory:
BRCA1 and BRCA2 Genetic Testing)
Cahaba
AL, GA, TN
AL, GA, TN
L36763 (MolDX: 4Kscore Assay)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36827 (MolDX: APC and MUTYH Gene
Testing) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36854 (MolDX-CDD: Percepta©
Bronchial Genomic Classifier) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36912 (MolDX - CDD: Oncotype DX®
Breast Cancer for DCIS (Genomic
Health ™)) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36941 (MolDX - CDD: Oncotype DX®
Breast Cancer for DCIS (Genomic
Health ™)) Noridian
Effective 03/27/2017
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36947 (MolDX - CDD: Oncotype DX®
Breast Cancer for DCIS (Genomic
Health ™)) Noridian
Effective 03/27/2017
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36951 (MolDX - CDD: Oncotype DX®
Breast Cancer for DCIS (Genomic
Health ™)) CGS
KY, OH
KY, OH
L36979 (MolDX: 4Kscore Assay) CGS
KY, OH
KY, OH
L36313 (MolDX: Breast Cancer Index℠
Genetic Assay) Noridian
Retired 11/16/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36316 (MolDX: Breast Cancer Index℠
Genetic Assay) Noridian
Retired 11/16/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 22 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Cancer Genetic Testing
Medicare Part A
Medicare Part B
L36340 (MolDX-CDD: Prolaris™
Prostate Cancer Genomic Assay)
Noridian Retired 11/16/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36349 (MolDX: Prolaris™ Prostate
Cancer Genomic Assay) Noridian
Retired 11/16/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36326 (MolDX-CDD: ConfirmMDx
Epigenetic Molecular Assay) Noridian
Retired 10/01/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36328 (MolDX-CDD: ConfirmMDx
Epigenetic Molecular Assay) Noridian
Retired 10/01/2016
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L34193 (Bladder Tumor Markers)
Noridian Retired 02/29/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36115 (MolDX: BRCA1 and BRCA2
Genetic Testing) CGS
Retired 02/14/2016
KY, OH
KY, OH
L35868 (MolDX: Decipher® Prostate
Cancer Classifier Assay) Palmetto
Retired 01/06/2016
NC, SC, VA, WV
NC, SC, VA, WV
L36009 (MolDX: Decipher® Prostate
Cancer Classifier Assay) CGS
Retired 01/06/2016
KY, OH
KY, OH
L34101 (Genetic Testing) Noridian
Retired 10/01/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L24308 (Genetic Testing) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L28849 (Gene Expression Profiling
Panel for use in the Management of
Breast Cancer Treatment) First Coast
Retired 09/30/2015
FL
FL
L28882 (Gene Expression Profiling
Panel for use in the Management of
Breast Cancer Treatment) First Coast
Retired 09/30/2015
PR, VI
PR, VI
L29303 (Urinary Tumor Markers for
Bladder Cancer) First Coast
Retired 09/30/2015
FL
FL
L29405 (Urinary Tumor Markers for
Bladder Cancer) First Coast
Retired 09/30/2015
PR, VI
PR, VI
L32118 (Bladder Tumor Markers)
Palmetto Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L33511 (Bladder Tumor Markers)
Noridian Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L33638 (Biomarkers Overview) Novitas
Retired 09/30/2015
AR, CO, LA, MS, NM, OK, TX
AR, CO, LA, MS, NM, OK, TX
L33779 (MolDX: Genetic Testing for
Lynch Syndrome) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L34483 (Genetic Testing for Lynch
Syndrome) First Coast
Retired 09/30/2015
FL, PR, VI
FL, PR, VI
L34627 (NRAS Genetic Testing)
Palmetto Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 23 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Cancer Genetic Testing
Medicare Part A
Medicare Part B
L34781 (Pathology and Laboratory:
Genetic Testing for Lynch Syndrome)
Cahaba Retired 09/30/2015
AL, GA, TN
AL, GA, TN
L34796 (Biomarkers for Oncology)
Novitas Retired 09/30/2015
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L35294 (MolDX: Breast Cancer Index℠
Genetic Assay) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35347 (Genetic Testing for Lynch
Syndrome) CGS
Retired 09/30/2015
KY, OH
KY, OH
L35368 (MolDX: ConfirmMDx Epigenetic
Molecular Assay) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35440 (NRAS Genetic Testing) CGS
Retired 09/30/2015
KY, OH
KY, OH
L35500 (MolDX: Breast Cancer Genetic
Assay) Noridian Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L35510 (MolDX: Breast Cancer Genetic
Assay) Noridian Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L35629 (MolDX: Prolaris™ Prostate
Cancer Genomic Assay) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35650 (MolDX: Decipher® Prostate
Cancer Classifier Assay) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35796 (MolDX: ConfirmMDx Epigenetic
Molecular Assay) Noridian
Retired 09/30/2015
AS, CA GU, HI, MP, NV
AS, CA GU, HI, MP, NV
L35848 (MolDX: ConfirmMDx Epigenetic
Molecular Assay) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L33640 (Biomarkers Overview) Novitas
Retired 08/12/2015
DC, DE, MD, NJ, PA
DC, DE, MD, NJ, PA
L36155 (MolDX: Genetic Testing for
Hypercoagulability / Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR)) Noridian
AS, CA GU, HI, MP, NV
AS, CA GU, HI, MP, NV
L36159 (MolDX: Genetic Testing for
Hypercoagulability / Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR)) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L33433 (Infectious Disease Molecular
Diagnostic Testing) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L34518 (Molecular Pathology
Procedures for Human Leukocyte
Antigen (HLA) Typing) First Coast
FL, PR, VI
FL, PR, VI
L34519 (Molecular Pathology
Procedures) First Coast
FL, PR, VI
FL, PR, VI
L34943 (Pathology and Laboratory:
Molecular Pathology Procedures for
Human Leukocyte Antigen (HLA)
Typing) Cahaba
AL, GA, TN
AL, GA, TN
Molecular Pathology
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 24 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Molecular Pathology
Medicare Part A
Medicare Part B
L35000 (Molecular Pathology
Procedures) NGS
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
L35015 (Molecular Diagnostics:
Genitourinary Infectious Disease
Testing) Novitas
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, PA, TX
L35025 (MolDX: Molecular Diagnostic
Tests (MDT)) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35160 (MolDX: Molecular Diagnostic
Tests (MDT)) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L35878 (Infectious Disease Molecular
Diagnostic Testing) CGS
KY, OH
KY, OH
L35984 (MolDX: Genetic Testing for
Hypercoagulability / Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR)) CGS
KY, OH
KY, OH
L36011 ((MolDX: Molecular RBC
Phenotyping) CGS
KY, OH
KY, OH
L36021 (Molecular Diagnostic Tests
(MDT)) CGS
KY, OH
KY, OH
L36074 (MolDX: Molecular RBC
Phenotyping) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36089 (MolDX: Genetic Testing for
Hypercoagulability / Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR)) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36044 (MolDX: Genetic Testing for
BCR-ABL Negative Myeloproliferative
Disease) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L36117 (MolDX: Genetic Testing for
BCR-ABL Negative Myeloproliferative
Disease) CGS
KY, OH
KY, OH
L36167 (Molecular RBC Phenotyping)
Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36171 (Molecular RBC Phenotyping)
Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36180 (MolDX: Genetic Testing for
BCR-ABL Negative Myeloproliferative
Disease) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36186 (MolDX: Genetic Testing for
BCR-ABL Negative Myeloproliferative
Disease) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36256 (MolDx: Molecular Diagnostic
Tests) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L36400 (Genetic Testing for
Hypercoagulability/Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR) WPS
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L36444 (Pathology and Laboratory:
Molecular RBC Phenotype) Cahaba
AL, GA, TN
AL, GA, TN
L36807 (MolDX: Molecular Diagnostic
Tests (MDT)) WPS
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 25 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Molecular Pathology
Medicare Part A
Medicare Part B
L34762 (Molecular Diagnostic Testing)
WPS Retired 02/15/2017
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L31747 (Infectious Disease Molecular
Diagnostic Testing) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L32567 (Molecular Diagnostics:
Genitourinary Infectious Disease
Testing) Novitas Retired 09/30/2015
DC, DE, MD, NJ, PA
DC, DE, MD, NJ, PA
L33219 (Molecular Diagnostic Testing)
WPS Retired 09/30/2015
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L33541 (Molecular Diagnostic Tests
(MDT)) Noridian Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L33599 (Molecular Diagnostic Tests
(MDT)) Palmetto Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L33644 (Molecular Diagnostics:
Genitourinary Infectious Disease
Testing) Novitas Retired 09/30/2015
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, TX
AR, CO, DC, DE, LA, MD, MS, NJ, NM,
OK, TX
L33703 (Molecular Pathology
Procedures) First Coast
Retired 09/30/2015
FL, PR, VI
FL, PR, VI
L33732 (Molecular Pathology
Procedures for Human Leukocyte
Antigen (HLA) Typing) First Coast
Retired 09/30/2015
FL, PR, VI
FL, PR, VI
L34506 (Molecular Pathology
Procedures) NGS
Retired 09/30/2015
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
L34511 (Pathology and Laboratory:
Molecular Pathology Procedures for
Human Leukocyte Antigen (HLA)
Typing) Cahaba
Retired 09/30/2015
AL, GA, TN
AL, GA, TN
L35394 (Molecular Diagnostic Tests
(MDT)) CGS Retired 09/30/2015
KY, OH
KY, OH
L35768 (Infectious Disease Molecular
Diagnostic Testing), CGS
Retired 09/30/2015
KY, OH
KY, OH
L35827 (MolDX: Molecular RBC
Phenotyping) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35896 (MolDX: NSCLC,
Comprehensive Genomic Profile
Testing) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35912 (MolDX: Genetic Testing for
Hypercoagulability / Thrombophilia
(Factor V Leiden, Factor II Prothrombin,
and MTHFR) ) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 26 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
LCD
Molecular Pathology
Medicare Part A
Medicare Part B
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L33279 (Circulating Tumor Cell Testing)
First Coast
FL, PR, VI
FL, PR, VI
L33951 (Circulating Tumor Cell Marker
Assays) CGS
KY, OH
KY, OH
L34066 (Circulating Tumor Cell (CTC)
Assay) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L34273 (Pathology and Laboratory:
Circulating Tumor Cells (CTC) Assays)
Cahaba
AL, GA, TN
AL, GA, TN
L35071 (Circulating Tumor Cell (CTC)
Assay) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
L35710 (Circulating Tumor Cell (CTC)
Assay) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L34531 (Circulating Tumor Cell Marker
Assays) WPS Retired 04/01/2016
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L33587 (Circulating Tumor Cell (CTC)
Assay) NGS Retired 02/29/2016
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
L32096 (Circulating Tumor Cell Testing)
First Coast Retired 09/30/2015
FL, PR, VI
FL, PR, VI
L32218 (Circulating Tumor Cell Marker
Assays) WPS Retired 09/30/2015
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
IA, IN, KS, MI, MO, NE
L32293 (Pathology and Laboratory:
Circulating Tumor Cells (CTC) Assays)
Cahaba Retired 09/30/2015
AL, GA, TN
AL, GA, TN
L32301 (Circulating Tumor Cell Marker
Assays) CGS Retired 09/30/2015
KY, OH
KY, OH
L32528 (Circulating Tumor Cell Marker
Assays) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
L32965 (Circulating Tumor Cell (CTC)
Assay) NGS Retired 09/30/2015
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
L34631 (Circulating Tumor Cell Marker
Assays) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
L35217 (Circulating Tumor Cell Marker
Assays) Noridian
Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
L36255 (MolDX: Molecular Diagnostic
Tests (MDT)) Noridian
Retired 09/30/2015
Circulating Tumor Cell Assays
CMS Articles
Article
A52955 (Decision DX-GMB Billing
Instruction) Noridian
Medicare Part A
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
Medicare Part B
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
A53095 (Bladder Tumor Marker FISH
Billing and Coding Guidelines Update)
Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 27 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.
Article
A53100 (MolDX: Avise PG Assay
Billing/Coding Update) Palmetto
Medicare Part A
NC, SC, VA, WV
Medicare Part B
NC, SC, VA, WV
A53103 (MolDX: HERmark® Assay by
Monogram Update) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
A53110 (MolDX: Vectra™ DA Coding
and Billing Guidelines) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
A53112 (MolDX: OncoCee™ Billing
and Coding Guidelines) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
A53799 (Approved Gene Testing)
CGS
KY, OH
KY, OH
A54191 (MolDX: FDA-Approved BRAF
Tests) CGS
KY, OH
KY, OH
A54240 (Bladder Tumor Marker FISH
Billing and Coding Guidelines Update)
CGS
KY, OH
KY, OH
A54338 (MolDX: Myriad’s
BRACAnalysis CDx™ Coding and
Billing Guidelines) Palmetto
NC, SC, VA, WV
NC, SC, VA, WV
A54355 (MolDX: Afirma™ Assay by
Veracyte Billing and Coding
Guidelines) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54357 (MolDX: Afirma™ Assay by
Veracyte Billing and Coding
Guidelines) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
A54363 (MolDX: AlloMap Billing and
Coding Guidelines) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54444 (MolDX: MammaPrint Billing
and Coding Guidelines) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54446 (MolDX: MammaPrint Billing
and Coding Guidelines) Noridian
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
A54483 (MolDX: Oncotype DX®
Colon Cancer Coding and Billing
Guidelines) Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54509 (MolDX: Vysis® Kit by Abbott
Coding and Billing Guidelines)
Noridian
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54385 (MolDX: bioTheranostics
Cancer TYPE ID® Billing and Coding
Guidelines) Noridian
Retired 10/01/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54428 (MolDX: Corus® CAD Test
Billing and Coding Guidelines)
Noridian Retired 10/01/2016
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A50751 (Immunohistochemistry Supplemental Instructions Article),
CGS Retired 09/30/2015
KY, OH
KY, OH
A51601 (Bladder Tumor Marker FISH
Billing and Coding Guidelines Update)
Palmetto Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
A51985 (Sources of Information and
Basis for Decision Noncovered
Services LCD) First Coast
Retired 09/30/2015
FL, PR, VI
FL, PR, VI
A52331 (Molecular pathology
procedures new LCD) First Coast
Retired 09/30/2015
FL, PR, VI
FL, PR, VI
Molecular Pathology/Molecular Diagnostics/Genetic Testing
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Article
A52983 (Molecular pathology
procedures for human leukocyte
antigen (HLA) typing revision to the
LCD) First Coast
Retired 09/30/2015
Medicare Part A
Medicare Part B
FL, PR, VI
FL, PR, VI
A53256 (OncoCee™ Coding and
Billing Guidelines) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
A53684 (Bladder Tumor Marker FISH
Billing and Coding Guidelines Update)
CGS Retired 09/30/2015
KY, OH
KY, OH
A53718 (Approved Gene Testing)
CGS Retired 09/30/2015
KY, OH
KY, OH
A54010 (MolDX Excluded Tests)
Noridian Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54012 (MolDX Excluded Tests)
Noridian Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
A54140 (Response to Comments:
Infectious Disease Molecular
Diagnostic Testing L35768) CGS
Retired 09/30/2015
KY, OH
KY, OH
A54216 (Response to Comments:
MolDx: Breast Cancer Genetic Assay,
L33500) Noridian
Retired 09/30/2015
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
AK, AZ, ID, MT, ND, OR, SD, UT, WA,
WY
A54224 (Response to Comments:
MolDX: ConfirmMDx Epigenetic
Molecular Assay, L35796) Noridian
Retired 09/30/2015
AS, CA, GU, HI, MP, NV
AS, CA, GU, HI, MP, NV
A54231 (MolDX: Response to
Comments for MolDX: Genetic
Testing for Hypercoagulability /
Thrombophilia (Factor V Leiden,
Factor II Prothrombin, and MTHFR))
Palmetto Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
A54318 (MoldX: Response to
Comments for MolDX: NSCLC,
Comprehensive Genomic Profile
Testing) Palmetto
Retired 09/30/2015
NC, SC, VA, WV
NC, SC, VA, WV
A52339 (Response to Comments for
Genetic Testing for Lynch Syndrome)
Palmetto Retired 06/17/2015
NC, SC, VA, WV
A52896 (Response to Comments for
Circulating Tumor Cell Marker
Assays) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
A52905 (Response to Comments for
NRAS Genetic Testing) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
A52908 (Response to Comments for
CYP2C19, CYP2D6, CYP2C9 and
VKORC1 Genetic Testing) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 29 of 30
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Approved 04/12/2017
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Article
A53169 (LCD - Comment/Response Pathology and Laboratory: Genetic
Testing for Lynch Syndrome
(L34781)) Cahaba
Retired 01/15/2015
Medicare Part A
AL, GA, TN
Medicare Part B
AL, GA, TN
A53761 (Response to Comments
MolDX: Breast Cancer Index℠
Genetic Assay) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
A53765 (Response to Comments for
MolDX: ConfirmMDx Epigenetic
Molecular) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
A53758 (Response to Comments
MolDX: GeneSight® Assay for
Refractory Depression) Palmetto
Retired 06/17/2015
NC, SC, VA, WV
A53977 (Response to Comments for
Prolaris™ Prostate Cancer Genomic
Assay) Palmetto
Retired 08/01/2015
NC, SC, VA, WV
A54056 MolDX: Approved Gene
Testing (M00041, V9) Palmetto
Retired 07/01/2015
NC, SC, VA, WV
CMS Benefit Policy Manual
Chapter 15; § 80.1–80.1.3 Clinical Laboratory Services
CMS Claims Processing Manual
Chapter 12; § 60 Payment for Pathology Services
Chapter 16, § 10.2 General Explanation of Payment; § 20 Calculation of Payment Rates - Clinical Laboratory Test Fee
Schedules; § 40 Billing for Clinical Laboratory Tests
UnitedHealthcare Commercial Policies
Chemosensitivity and Chemoresistance Assays in Cancer
Gene Expression Tests
Genetic Testing
Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC)
Others
CMS Clinical Laboratory Fee Schedule, CMS Website
MolDx Approved Tests, Palmetto Website
MolDx Excluded Tests, Palmetto Website
GUIDELINE HISTORY/REVISION INFORMATION
Date
04/12/2017

Action/Description
Announcement at MAPG Committee with approval
Molecular Pathology/Molecular Diagnostics/Genetic Testing
Page 30 of 30
UnitedHealthcare Medicare Advantage Policy Guideline
Approved 04/12/2017
Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.