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Effective Date: 02/03/2010 |
Title: Tumor Markers
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Revision Date: 01/01/2020
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Document: BI129:00
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CPT Code(s): 0002U, 0003U, 0005U, 0009U, 0021U, 0045U, 81313, 81479, 81518, 81519, 81522, 81539, 81551, 81599, 82378, 84152-84154, 84233, 84234, 86294, 86300, 86301, 86304, 86316, 86386
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Public Statement
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Effective Date:
a)
This policy will apply to all services performed on or after the above
revision date which will become the new effective date.
b)
For all services referred to in this policy that were performed before
the revision date, contact customer service for the rules that would apply.
1.
PSA is covered.
2.
Some tumor marker tests require pre-authorization.
3.
Tumor markers are substances that are produced by cancer or by other
cells of the body in response to cancer or certain benign conditions. These
substances can be found in the blood, tumor tissue, or other tissues or bodily
fluids of some patients with cancer.
4.
Some tumor markers are substances normally produced in low quantities by
cells in the body. Detection of a higher-than-normal serum levels may indicate
the presence of a certain type of cancer. Currently, the main use of such
markers is to assess a cancer`s response to treatment and to check for
recurrence.
5.
In some types of cancer, tumor marker levels may reflect the extent or
stage of the disease and can be useful in predicting how well the disease will
respond to treatment. This is especially the case for certain patterns of gene
expression and changes to DNA.
6.
CEA, CA125, CA15-3, NMP-22, and CA19-9 are covered for specific
diagnoses. All other tumor markers require preauthorization.
7.
CEA is not
covered as a screening test.
8.
Percent
free PSA is covered with elevated PSA but the 4K score and Prostate Health Index
(PHI)—both of which include free PSA—and the ConfirmMDx and PCA3 are not
covered. When NCCN guidelines or DNA Direct indicate that multiple testing
options exist for the same clinical scenario, we will only cover the test(s)
that meet medical necessity criteria (see BI024).
9.
In order to
avoid inaccurate, incomplete or untimely requests, all prior-authorization
requests for Blood genetic tests require the following:
a) The request is submitted by the ordering provider office, AND
b) Submitted clinical is from patient medical records such as provider clinic
progress notes. Information on lab request forms is not accepted, AND the
request is submitted before testing and not more than 3 business days after the
collection of blood specimen.
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Medical Statement
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1.
QualChoice considers any of the following serum
tumor markers for the stated indication medically necessary:
A.
For prostate cancer
screening, staging, monitoring response to therapy, and detecting disease
recurrence.
1)
Free PSA (to calculate
percent free PSA) is medically necessary per NCCN Guidelines (Version 2.2016) to
help decide whether or not to perform a prostate biopsy for patients with an
elevated PSA in the range of 3 – 10 or whether to perform a repeat prostate
biopsy in men who are felt to be at high risk of prostate cancer despite a
negative prostate biopsy.
2)
4K Score or the PHI
(Prostate Health Index) both include free PSA and offer no significant advantage
over percent free PSA testing (per NCCN guidelines)—therefore these tests are
not covered.
3)
PCA3 prostate cancer
antigen—offers no significant advantage over percent free PSA testing (per NCCN
guidelines)—therefore this test is not covered.
4)
ConfirmMDx—to decide on
repeat prostate biopsy in men with a negative prostate biopsy offers no
significant advantage over percent free PSA testing (per NCCN
guidelines)—therefore this test is not covered.
B.
Carcinoembryonic antigen
(CEA) is covered for members with a known history of
Colorectal and invasive breast cancers
for any of the following:
1)
To detect asymptomatic
recurrence after surgical and/or medical treatment (not as a screening test for
any cancer);
or
2)
As a preoperative
prognostic indicator when it will assist in staging and surgical treatment
planning;
or
3)
To monitor response to
treatment for metastatic cancer.
C.
Cancer antigen 125 (CA
125) levels for any of the following:
1)
As a screening test for
ovarian cancer when there is a history of hereditary cancer syndrome (a pattern
of clusters of ovarian cancer within two or more generations);
or
2)
Diagnosis of ovarian cancer
in women with new symptoms (bloating, pelvic or abdominal pain, difficulty
eating or feeling full quickly, or urinary frequency and urgency) that have
persisted for three or more weeks, where the clinician has performed a pelvic
and rectal examination and suspects ovarian cancer;
or
3)
As a preoperative
diagnostic aid in women with ovarian masses that are suspected to be malignant,
such that arrangements can be made for intraoperative availability of a
gynecological oncologist if the CA 125 is increased;
or
4)
In members with known
ovarian cancer, as an aid in the monitoring of disease, response to treatment,
detection of recurrent disease, or assessing value of performing second-look
surgery;
or
5)
In members with
adenocarcinoma of unknown primary, to rule out ovarian cancer.
6)
In members with
endometrial cancer who have extra-uterine disease.
D.
Serial measurements of CA
15-3 (also known as CA 27-29 or Truquant RIA) in following the course of
treatment in women diagnosed with breast cancer, especially advanced metastatic
breast cancer (an increasing CA 15-3 level may suggest treatment failure).
E.
CA 19-9 to monitor the
clinical response to therapy or detect early recurrence of disease in members
with known gastric cancer, pancreatic cancer, cholangiocarcinoma or
adenocarcinoma of the ampulla of Vater.
F.
Serial measurements of
human chorionic gonadotropin (HCG) to diagnose germ cell tumors in members with
adenocarcinoma, or carcinoma not otherwise specified, involving mediastinal
nodes, or to monitor treatment in members with known trophoblastic tumors
(invasive Hydatidiform moles and choriocarcinomas) and germinal cell tumors
(teratocarcinoma and embryonal cell carcinoma) of the ovaries or testes, or to
monitor for relapse after remission is achieved.
G.
Serial measurements of
alpha fetoprotein (AFP) to diagnose germ cell tumors in members with
adenocarcinoma, or carcinoma not otherwise specified, involving mediastinal
nodes; or the diagnosis and monitoring of hepatocellular carcinoma (e.g., before
considering liver transplantation).
H.
Serial measurements of AFP
and HCG together to diagnose and monitor testicular cancer.
I.
Measurement of estrogen and
progesterone receptors on primary breast cancers, and on metastatic lesions if
the results would influence treatment planning.
J.
Human epidermal growth
factor receptor 2 (HER2) evaluation in breast cancer –
K.
The following markers are
covered only when the result of the test(s) will directly determine the
treatment course:
1)
K-ras (KRAS) mutation
analysis to predict non-response to Cetuximab (Erbitux) and Panitumumab
(Vectibix) in the treatment of metastatic colorectal cancer.
2)
Urokinase plasminogen
activator (uPA) and plasminogen activator inhibitor 1 (PAI-1) for the
determination of prognosis in patients with newly diagnosed, node negative
breast cancer.
3)
Steroid hormone receptor
status in both pre-menopausal and post-menopausal members to identify
individuals most likely to benefit from endocrine forms of adjuvant therapy and
therapy for recurrent or metastatic breast cancer.
4)
CD117 (c-kit), for
determining eligibility for treatment with imatinib mesylate (Gleevec).
5)
CD 20, for determining
eligibility for anti-CD20 treatment (rituximab)
6)
CD 25, for determining
eligibility for denileukin diftitox (Ontak) treatment.
7)
CD 33, for determining
eligibility for anti-CD33 (gemtuzumab, Mylotarg) treatment.
8)
CD 52, for determining
eligibility for anti-CD52 (Alemtuzumab, Campath) treatment.
L.
CD 31 immunostaining, for
diagnosis of angiosarcoma.
M.
Cyclin D1, for diagnosis and predicting disease
recurrence of mantle cell lymphoma.
N.
ZAP-70, for assessing
prognosis and need for aggressive therapy in persons with chronic lymphocytic
leukemia.
O.
Oncotype Dx (CPT
81519:also known as 21 gene mRNA RT-PCR test, in contrast to the non-covered CPT
81518: 11 gene mRNA RT-PCR test and the non-covered CPT 0045U or 81522: 12 gene
mRNA RT-PCR) to assess necessity of adjuvant chemotherapy in women with recently
diagnosed invasive breast tumors (once per lifetime), where all of the following
criteria are met:
1)
Breast cancer is
nonmetastatic (or 3 or fewer ipsilateral nodes involved per NCCN guidelines);
and
2)
Breast tumor is estrogen
receptor positive;
and
3)
Breast tumor is HER2
receptor negative or breast tumor is HER2 receptor positive and less than 1 cm
in diameter. (Rationale: adjuvant chemotherapy with Trastuzumab (Herceptin) is
considered to be medically necessary regardless of an Oncotype Dx score for HER2
receptor positive lesions 1 cm or more in diameter);
and
4)
Adjuvant chemotherapy is
not precluded due to any other factor (e.g., advanced age and/or significant
co-morbidities);
and
5)
Member and physician
(prior to testing) have discussed the potential results of the test and agree to
use the results to guide therapy (i.e., member will forgo adjuvant chemotherapy
if Oncotype Dx score is low).
Repeat Oncotype Dx testing or testing of multiple tumor sites in the same
person has no proven value. Oncotype Dx is considered experimental and
investigational for these and all other indications including its use in male
breast cancer.
P.
Myeloperoxidase (MPO)
immunostaining, for diagnosis of acute myeloid leukemia.
Q.
Placental alkaline
phosphatase (PLAP), to diagnose germ cell seminoma and non-seminoma germ cell
tumors in unknown primary cancers.
2.
QualChoice considers the bladder tumor antigen
(BTA) Stat test, the nuclear matrix protein (NMP22) test, the fibrin/fibrinogen
degradation products (Aura-Tek FDP) test, or the UroVysion fluorescent in situ
hybridization (FISH) test medically necessary in any of the following
conditions:
A.
Follow-up of treatment for
bladder cancer;
or
B.
Monitoring for eradication
of bladder cancer;
or
C.
Recurrences after
eradication.
QualChoice considers the BTA Stat test, the NMP22 test, the Aura-Tek FDP test,
or the UroVysion fluorescent in situ hybridization (FISH) test experimental and
investigational for screening of bladder cancer and all other indications.
3.
QualChoice considers the use of the ImmunoCyte
immunohistochemistry test medically necessary as an adjunct to cystoscopy or
cytology in the monitoring of persons with bladder cancer.
QualChoice considers the ImmunoCyte
immunohistochemistry test experimental and investigational in the diagnosis of
bladder cancer or for screening for bladder cancer in asymptomatic persons.
Codes Used In This BI:
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0002U
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PolypDx -
urine ascorbate, carnitine & succinic acid
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0003U
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Overa GNRG –
serum assay of 5 proteins (incl CA 125 II)
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0005U
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ExosomeDX
prostate risk score
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0009U
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DEP Array TM
HER2 for breast tumor tissue by FISH
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0021U
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Prostate
(oncology) detection of 8 autoantibodies
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0045U
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Breast mRNA
RT-PCR gene expression 12 genes
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81313
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PCA3 Prostate
Cancer Antigen
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81479
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Unlisted
Molecular Pathology Procedure
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81518
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ONCOLOGY
BREAST MRNA GENE EXPRESSION 11 GENES
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81519
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OncotypeDx
for breast cancer, mRNA RT-PCR of 21 genes
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81539
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4K Score
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81551
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ConfirmMDx
for Prostate Cancer
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81599
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Unlisted
multianalyte assay
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82378
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Carcinoembryonic antigen
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84152
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Assay of psa
complexed
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84153
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Assay of psa
total
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84154
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Assay of psa
free
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84233
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Assay of
estrogen
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84234
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Assay of
progesterone
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86294
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Immunoassay
for tumor antigen (e.g., bladder tumor)
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86300
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Immunoassay
tumor ca 15-3
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86301
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Immunoassay
tumor ca 19-9
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86304
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Immunoassay
tumor ca 125
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86316
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Immunoassay
for tumor antigen, other antigen
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86386
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Nuclear
matrix protein 22
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81522 – Onc(breast), mRNA, gene expression profiling by RT-PCR of 12 genes (8
content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue,
algorithm reported as recurrence risk score
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Limits
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1.
QualChoice considers each of the following experimental and
investigational. The peer reviewed medical literature does not support these
tests as having sufficient sensitivity or specificity necessary to define their
clinical role:
A.
CEA used for all other indications including any of the following:
I.
As a screening test for any cancer; or
II.
As a sole determinant to treat a colorectal or invasive breast cancer
member with adjuvant therapy or systemic therapy for presumed metastatic
disease; or
III.
For routine use of CEA alone for monitoring response to treatment of
colorectal and invasive breast cancer when there are other simple tests
available to indicate a response; or
IV.
For diagnosis, prognosis, or monitoring of treatment in members with lung
cancer; or
B.
CA 19-9 for all other indications including pancreatic pseudo
cyst; colorectal, liver, breast, esophageal, or uterine cancer; or screening
persons with primary sclerosing cholangitis without signs or symptoms of
cholangiocarcinoma.
C.
AFP for the diagnosis of trophoblastic tumors and other oncologic
indications.
D.
CA 125 for all other indications including use as a screening test for
colorectal cancer or ovarian cancer (other than as indicated above) or for
differential diagnosis of members with symptoms of colonic disease.
E.
Estrogen and progesterone receptors when used alone to assign a member
with breast cancer to prognostic groupings since they are relatively weak
predictors of long-term relapse and breast cancer related mortality rates.
F.
Assaying for loss of heterozygosity (LOH) on the long arm of chromosome
18 (18q) or deleted in colon cancer (DCC) protein (18q-LOH/DCC) for colorectal
cancer.
G.
Ova Check test
H.
Ova Sure
I.
Cell Search assay
J.
Mamma print
K.
Path work Tissue of Origin test
L.
Ras oncogenes (except KRAS)
M.
Rotterdam Signature 76-gene Panel
N.
Breast Cancer Gene Expression Ratio (HOXB13:IL17BR)
O.
Gene Search™ Breast Lymph Node (BLN) assay
P.
Thymidylate synthase
Q.
Topographic genotyping (Pathfinder TG)
R.
Biomarker Translation (BT) test for breast cancer and other indications
S.
HE4 for ovarian cancer and other indications
T.
Vascular Endothelial Growth Factor (VEGF)
U.
Des-gamma-carboxy prothrombin (DCP) (also known as "prothrombin produced
by vitamin K absence or antagonism II" [PIVKA II]) for diagnosing and monitoring
hepatocellular carcinoma and other indications.
V.
Oncotype DX Colon Cancer Assay
W.
Any of the following circulating tumor markers also are considered
experimental and investigational for screening asymptomatic subjects for cancer,
diagnosis, staging, routine surveillance of cancer and monitoring the response
to treatment:
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a2-PAG |
CA-SCC |
MAM-6 |
TAG12 |
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AMACR |
Cathepsin-D,
Cathepsin-L |
MGMT |
TAG72 |
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Bcl-2 |
Cyclin E
(fragments or whole length) |
Motility-related protein (MRP) |
TAG72.3 |
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BCM |
DU-PAN-2 |
Multidrug
resistance glycoprotein (Mdr1 |
TAG72.5 |
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CA195 |
Early
prostate cancer antigen (EPCA) |
NSE |
TATI |
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CA242 |
Guanylyl
cyclase C (GCC) |
p53
(TP53) |
Thrombospondin-1 (THBS-1) |
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CA50 |
Hepsin |
PCA3
(DD3) / UpM3 |
Thymosin
B15 |
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CA549 |
Human
kallikrein 2 (HK2) |
PNA/ELLA |
TNF-a |
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CA72-4 |
LASA |
Prostate
stem cell antigen (PSCA) |
Topoisomerase II Alpha (TOP2A) |
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CAM17-1 |
LPA |
SCC |
TPA |
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CAM26 |
M 26 |
SLEX |
Thymosin
B15 |
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CAM29 |
M 29 |
SPAN-1 |
Nuclear
Matrix Protein 66 (NMP66) |
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CYFRA21-1 |
MCA |
ST-439 |
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CAR-3 |
MSA |
SLX |
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Background
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Background Information Upon Request
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Reference
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Application to Products
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This
policy applies to all health plans and products administered by QualChoice, both
those insured by QualChoice and those that are self-funded by the sponsoring
employer, unless there is indication in this policy otherwise or a stated
exclusion in your medical plan booklet. Consult the individual plan sponsor
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or COC, as applicable, will prevail. State and federal mandates will be
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