Document 5213

Rule Category:
Medical
Ref: No:
2013-MN-0008
`
Version Control:
Version No.1.1
Effective Date:
15 May 2013
Revision Date:
15 May 2014
Tumor Markers Indications
Adjudication Rule
Table of content
Abstract Scope
Page 1
Page
Adjudication Policy
Page 2
Adjudication examples
Page 4
Denial codes
Page 5
Appendices
Page 5
Approved by:
Daman
Abstract
Responsible:
Medical Strategy &
Development Department
For Members
Tumor markers are substances found in the blood, urine, stool, other bodily fluids, or
tissues of some patients with cancer.
Tumor markers may be used to help diagnose cancer, predict a patient’s response to
certain cancer therapies, check a patient’s response to treatment, or determine whether
cancer has returned.
More than 20 tumor markers are currently in use.
Related Adjudication
Rules:
None
System Rules:
None
Daman covers tumor markers if medically justified as per the best international medical
practice and as per the policy terms and conditions of each Health Insurance Plan
administered by Daman.
For Medical Professionals
Tumor markers are measurable biochemicals that are associated with a malignancy.
They are either produced by tumor cells (tumor-derived) or by the body in response to
tumor cells (tumor-associated). They include a variety of substances like cell surface
antigens, cytoplasmic proteins, enzymes, hormones, oncofetal antigens, receptors,
oncogenes and their products.
The various tumor markers differ in their usefulness for screening, diagnosis, prognosis,
assessing therapeutic response, and detecting recurrence.
As no tumor marker (except PSA) is proved to be ideal to be highly specific and
sensitive, so they cannot be constructed as primary for the diagnosis of cancer. The
main use of tumor marker in clinical medicine is as a supportive laboratory test for
diagnosis or in follow up of a patient being treated for malignancy.
Daman covers the tumor markers for cancer management if medically necessary, for all
plans administered by Daman as per the policy terms and conditions of each plan.
For screening purpose, Daman covers only PSA (Prostate specific antigen) tumor
marker for prostate cancer screening as per the policy terms and conditions.
Disclaimer
By accessing Daman Adjudication Rules,
you acknowledge that you have read
and understood the terms of use set out
in
the
disclaimer
below:
Daman Adjudication Rules are intended
to outline the procedures in adjudication
as applied by the National Health
Insurance Company – Daman PJSC
(hereinafter “Daman”). The Daman
Adjudication Rules are not intended to
be fully comprehensive and are not
intended to grant rights or impose
obligations on Daman. The Daman
Adjudication
Rules
are
not
recommendations for treatment and
should never be used as treatment
guidelines. Daman shall not be liable for
any direct, indirect, incidental or
consequential damages, costs, losses or
liabilities whatsoever arising out of the
use of, access to, or inability to use or
access the Daman Adjudication Rules or
reliance on any information provided on
this website.
Any information provided herein is
general and is not intended to replace
or supersede any laws or regulations
related to the Adjudication Rules as
enforced in the United Arab Emirates or
any other written document governing
the relationship between Daman and
its contracting parties.
National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550)
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Tumor Markers Indications
Scope
tumor
associated
antigen
(BTA)
This guideline aims to specify all coverage details of
tumor markers for all health insurance plans
administered by Daman as per policy terms and
conditions and as per best International medical
practice.
Adjudication Policy
Eligibility / Coverage Criteria
Tumor markers are covered as per best clinical
practice and as per the plan wise coverage criteria
for all health insurance plans administered by
Daman.
For screening purpose, Daman covers only PSA
(Prostate Specific Antigen) tumor marker for
prostate cancer screening for all those health
insurance plans, having this screening coverage
benefit.
Daman covers all the tumor markers given below
with cancer types mentioned for uses including but
not limited to the following
Tumor
Markers
AFP + bHCG
Levels raised in
Cancer Types
Non-seminoma
germ cell testicular
and ovarian tumors
Uses
ALK gene
rearrangem
ents
Non-small cell lung
cancer and
anaplastic large
cell lymphoma
For treatment and
prognosis
Alphafetoprotein
(AFP)
Hepatocellular
carcinoma,
nonseminomatous
germ cell tumors
To help diagnose and
follow response to
treatment
BCR-ABL
fusion gene
Chronic Myeloid
Leukemia
To confirm diagnosis
and monitor disease
status
Beta-2microglobul
in (B2M)
Multiple Myeloma
To determine
prognosis and follow
response to
treatment
Betahuman
chorionic
gonadotropi
n (BetahCG)
Trophoblastic
Ovarian and
Testicular Cancer
Bladder-
Bladder Cancer
BRAF
mutation
V600E
Cutaneous
Melanoma and
Colorectal Cancer
To predict response
to targeted therapies
CA (cancer
antigen)153/
CA27.29
Breast Cancer
To assess whether
treatment is working
or disease has
recurred
CA-125
Ovarian Cancer
To help in diagnosis,
assessment of
response to
treatment, and
evaluation of
recurrence
CA19-9
Pancreatic Cancer
(more specific) and
Biliary Tract
Cancers
To monitor response
to treatment and
early recurrence
Calcitonin
Medullary Thyroid
Cancer
To aid in diagnosis,
check whether
treatment is working,
and assess
recurrence
Colorectal Cancer
(Primary tumor)
and Breast Cancer
To check whether
colorectal cancer has
spread; to look for
breast cancer
recurrence and
assess response to
treatment
CD20
Non-Hodgkin
Lymphoma
To determine
whether treatment
with a targeted
therapy is
appropriate
Chromogra
nin A (CgA)
Neuroendocrine
Tumors (e.g.
carcinoid tumors,
neuroblastoma and
small cell lung
cancer)
To help in diagnosis,
assessment of
treatment response,
and evaluation of
recurrence
Cytokeratin
fragments
21-1
Non-Small Cell
Lung Cancer
To help in monitoring
for recurrence and
differential diagnosis
of suspicious lung
masses
EGFR
(Epidermal
growth
factor
receptor)
mutation
analysis
Non-Small Cell
Lung Cancer
To help determine
treatment and
prognosis
Breast Cancer
To determine
whether treatment
with hormonal
therapy (such as
Carcinoemb
ryonic
antigen
(CEA)
To assess stage,
prognosis, and
response to
treatment of nonseminoma testicular
and ovarian germ
cell tumors and
undiagnosed pelvic
mass
To assess stage,
prognosis, and
response to
treatment
Estrogen
receptor
(ER)/proge
sterone
Follow up treatment
for bladder cancer
or, monitoring for
eradication of
bladder cancer or,
recurrences after
eradication
National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550)
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Tumor Markers Indications
receptor
(PR)
Fibrin/fibrin
ogen
HE4
HER2
(human
epidermal
growth
factor
receptor 2)
tamoxifen) is
appropriate
To monitor
progression and
response to
treatment
Bladder Cancer
Ovarian Cancer
To assess disease
progression and
monitor for
recurrence
Breast Cancer,
Gastric Cancer,
and
Esophagogastric
Junction
Adenocarcinoma
To determine
whether treatment
with trastuzumab is
appropriate in
inoperable, locally
advanced and
recurrent or
metastatic disease
when transtuzumab
therapy is considered
and there is no
history of prior
treatment for
metastatic disease.
Multiple Myeloma
and
Waldenströmmacro
globulinemia
To help diagnose
disease, assess
response to
treatment, and look
for recurrence
Gastrointestinal
Stromal Tumor
To help in diagnosing
and determining
treatment
KRAS
mutation
analysis
Colorectal Cancer
Metastatic
To determine
whether treatment
with a particular type
of targeted therapy
is appropriate
Lactate
dehydrogen
ase
Germ Cell Tumors
To assess stage,
prognosis, and
response to
treatment
MPO
(myelopero
xidase)
Acute Myeloid
Leukemia
Diagnosis of Acute
Myeloid Leukemia
Nuclear
matrix
protein 22
Bladder Cancer
To monitor response
to treatment.
Metastatic Germ
Cell Tumors
To diagnose germ
cell seminoma and
non-seminoma germ
cell tumors in
unknown primary
cancers
Immunoglo
bulins
KIT
PLAP
(placental
Alkaline
Phosphatas
e)
Prostatespecific
antigen
(PSA)
Prostate Cancer
Thyroid Cancer
To help in diagnosis,
assess response to
treatment, and look
for recurrence
Breast Cancer
To determine
aggressiveness of
cancer and guide
treatment for lymph
node negative breast
cancer patients who
are unlikely to
benefit from
adjuvant
chemotherapy.
UroVysion
Bladder Cancer
Follow up treatment
for bladder cancer
or, monitoring for
eradication of
bladder cancer or,
recurrences after
eradication
21-Gene
signature
(Oncotype
DX)
Breast Cancer
To evaluate risk of
recurrence
5-Protein
signature
(Ova1)
Ovarian Cancer
To pre-operatively
assess pelvic mass
for suspected ovarian
cancer
70-Gene
signature
(Mammapri
nt)
Breast Cancer
To evaluate risk of
recurrence
Thyroglobul
in
Urokinase
plasminoge
n activator
(uPA) and
plasminoge
n activator
inhibitor
(PAI-1)
Requirements for Coverage
ICD and CPT codes must be coded to the highest
level of specificity.
Non-Coverage
Daman does not cover tumor markers for the
Visitor’s Plan.
Daman does not cover any of the diagnosis and
services considered to be experimental or unproven
for doing tumor markers.
Daman does not cover any of the tumor markers
which are considered to be experimental or
unproven.
Payment and Coding Rules
Please apply HAAD payment rules and regulations
and relevant coding manuals for ICD, CPT, etc.
To help in diagnosis,
assess response to
treatment, and look
for recurrence.
Screening for
prostate cancer (as
per the policy terms
and conditions)
National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550)
Doc Ctrl No.:
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Version No.: 1
Revision No.:
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Date of Issue:
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Tumor Markers Indications
Adjudication Examples
3. American Society of Clinical Oncology. (Feb 2,
2010).
Understanding
Tumor
Markers.
Available:
http://www.cancer.net/patient/All+About+Canc
er/Cancer.Net+Feature+Articles/Treatments%2
C+Tests%2C+and+Procedures/Understanding+
Tumor+Markers. Last accessed August 2, 2012.
Example 1
Question: A 35 years old female holding Basic
card with the H/O malignant neoplasm of ovary and
had taken her chemotherapy treatment. Doctor
wants to check the response to therapy and is
claiming for a test for CA 125. Will this case be
paid?
4. Greg L. Perkins, M.D., Evan D. SLATER, M.D.,
Georganne K. Sanders, M.D. (September
2003). Serum Tumor Markers. AMERICAN
FAMILY PHYSICIAN. 68 (6), p 1-7.
5. Catharine Sturgeon. (2002). Practice Guidelines
for Tumor Marker Use in the Clinic. Clinical
Chemistry by the American Association. 48 (8),
p 1-9.
Answer: Yes, the claim will be paid
Example 2
6. N. Lynn Henry, Daniel F. Hayes. (2006). Uses
and Abuses of Tumor Markers in the Diagnosis,
Monitoring, and Treatment of Primary and
Metastatic Breast Cancer. The Oncologist by
Department of Internal Medicine, Breast
Oncology Program, University of Michigan
Comprehensive Cancer Center, Ann Arbor,
Michigan, USA. 11 (1), p 1-13.
Question: A 40 year old female holding Thiqa card
with family H/O breast malignancy. Doctor is
claiming for CA 15-3 to screen for breast cancer for
her. Will this claim be paid?
Answer: No, the claim will be rejected with NCOV003 as no tumor marker is proved to be used for
screening except PSA.
7. M.J. Duffy and P. McGing on behalf of the
Scientific Committee of the Association of
Clinical Biochemists in Ireland (ACBI). (2005).
Guidelines for the Use of Tumour Markers. The
Scientific Committee of the Association of
Clinical Biochemists in Ireland (ACBI). 3 (1), p
1-15.
Denial codes
Code
Code description
MNEC-003
Service is not clinically indicated based
on good clinical practice.
MNEC-004
Service is not clinically indicated based
on good clinical practice, without
additional supporting diagnosis/activities.
NCOV-003
Service(s) is (are) not covered.
MNEC-003
Service is not clinically indicated based
on good clinical practice.
MNEC-003
Service is not clinically indicated based
on good clinical practice.
8. American Society of Hematology. (1993). The
ABL-BCR fusion gene is expressed in chronic
myeloid leukemia. Blood. 81 (1), p 158-165.
9. Harbeck N, Kates RE, Gauger K, Willems A,
Kiechle M, Magdolen V, Schmitt M.. (2004).
Urokinase-type plasminogen activator (uPA)
and its inhibitor PAI-I: novel tumor-derived
factors with a high prognostic and predictive
impact in breast cancer. PUB Med, US National
Library of Medicine, National Institute of Health.
91 (3), p 1.
10.National Institute for Health and Clinical
Excellence. (July 2010). Diagnosis and
management of metastatic malignant disease of
unknown primary origin. NICE Clinical Guideline
104. 1 (1), p 1-34
Appendices
Revision History
Reference
1. National Cancer Institute. (July 7, 2011).
Tumor
Markers.
Available:
http://www.cancer.gov/cancertopics/factsheet/
detection/tumor-markers. Last accessed August
2, 2012.
Date
01-07-13
Change
V 1.1: New template
2. The National Academy of Clinical Biochemistry.
(2009). Use of Tumor Markers in Clinical
Practice: Quality Requirements. Laboratory
Medicine Practice Guidelines. 1 (1), page 1-37.
National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550)
Doc Ctrl No.:
TEMP/MSD-008
Version No.: 1
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Date of Issue:
08.05.2013
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