Genetic Testing Oncology...Genetic Testing - Oncology 3 F. Because of the rapidly evolving field of genetic testing, this policy does not address every genetic test available. All

Genetic Testing – Oncology

Policy Number: Original Effective Date: MM.02.010 05/01/2010 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST 05/01/2012 Section: Medicine Place(s) of Service: Outpatient

I. Description

A genetic test is the analysis of human DNA, RNA, chromosomes, proteins, or certain metabolites in order to detect alterations related to a heritable disorder. This can be accomplished by directly examining the DNA or RNA that makes up a gene (direct testing), looking at markers co-inherited with a disease-causing gene (linkage testing), assaying certain metabolites (biochemical testing), or examining the chromosomes (cytogenetic testing).

For the purpose of this policy, first-degree relatives are defined as parents, full siblings, and offspring. Second-degree relatives are defined as grandparents, grandchildren, aunts, uncles, nephews, nieces, half-siblings and third-degree relatives are defined as great-grandparents, great-aunts, great-uncles, first cousins.

II. Criteria/Guidelines

A. Genetic testing is covered (subject to Limitations/Exclusions and Administrative Guidelines) when all of the following criteria are met:

1. There must be a reasonable expectation based on family history, pedigree analysis, risk factors, and/or symptomatology that a genetically inherited condition exists.

2. The genotypes to be detected by a genetic test must be shown by scientifically valid methods to be associated with the occurrence of the disease, and the analytical and clinical validity of the test must be established.

3. The clinical utility of the test must be established (e.g., test results will influence decisions concerning disease treatment or prevention).

B. Genetic testing is covered (subject to Limitations/Exclusions and Administrative Guidelines) when the following criteria are met:

Genetic Testing - Oncology 2

1. A positive or negative test will influence treatment decisions, course of treatment or medical management of the patient; or

2. Used to link genes with known cancer susceptibility. 3. Patient has a cancer or strong suspicion of cancer for the following conditions:

a. Acute myeloid leukemia b. Acute promyelocytic leukemia c. Chronic lymphocytic leukemia d. Ewing's sarcoma e. Medullary thyroid carcinoma f. Multiple Myeloma g. Myelodysplastic syndrome h. Myeloproliferative neoplasms i. Non-Hodgkin's lymphoma j. Non-small cell lung cancer k. Small lymphocytic lymphoma l. Breast cancer (see policies for Oncotype DX and Genetic Testing for Hereditary Breast

and/or Ovarian Cancer) m. Lynch Syndrome/Colorectal Cancer (see policy for Genetic Testing for Lynch

Syndrome/Colorectal Cancer and Polyposis Syndromes)

III. Limitations/Exclusions

A. Genetic testing is not covered for the following:

1. Family members of subscribers, who themselves are not subscribers 2. Members if the results of the genetic testing are for the benefit of family members who are

not covered by HMSA 3. In the absence of associated signs, symptoms or complaints 4. Home genetic testing is not a benefit. 5. Cytochrome P-450 with the exception of members being considered for treatment with

Plavix (see policy for Cytochrome p450 Genotyping). 6. Chemoresistance and chemosensitivity (e.g., ChemoFx) 7. UGT1A1 Molecular Assay (Invader) 8. Pathfinder (Genetic fingerprinting/DNA fingerprinting) and any other genetic expressing test

not supported by NCCN) 9. Detection of circulating tumor cells in the management of patients with cancer

B. Genetic counseling is not a covered benefit.

C. For a known deleterious mutation, HMSA will only cover a targeted single site analysis genetic test not a full analysis (i.e., testing for the mutation that has been identified in the family).

D. Most genetic tests are performed once per life time but neuro-oncologic therapies may warrant repeat testing and coverage based on current national clinical practices and guidelines.

E. Laboratories that conduct genetic testing must be CLIA certified.


F. Because of the rapidly evolving field of genetic testing, this policy does not address every genetic test available. All other conditions not mentioned in this policy will be reviewed based on medical necessity and the policy criteria.

IV. Administrative Guidelines

Precertification is not required. Documentation supporting the medical necessity should be legible, maintained in the patient's medical record and must be made available to HMSA upon request. HMSA reserves the right to perform retrospective review using the above criteria to validate if services rendered met payment determination criteria.

ICD-9 Codes Description

151.9 Malignant neoplasm of stomach, unspecified site

162.2, 162.3. 162.4, 162.5, 162.8, 162.9

Malignant neoplasm of the lung

170.9 Malignant neoplasm of bone and articular cartilage, unspecified (Ewing's sarcoma)

193 Malignant neoplasm of thyroid gland

202.00 - 202.08 Small lymphocytic lymphoma

202.80 - 202.88 Non-Hodgkin's lymphoma

203.00 - 203.02 Multiple Myeloma

204.1 - 204.2 Lymphoid leukemia

205.0, 205.1, 205.2

Myeloid leukemia

205.00 - 205.02 Acute promyelocytic leukemia

234.8 Carcinoma in situ of other specified sites (includes thyroid gland)

238.71- 238.79 Other lymphatic and hematopoietic tissues

V10.61 Lymphoid leukemia

V10.62 Myeloid leukemia

V10.71 Lymphosarcoma and reticulosarcoma

V10.72 Hodgkin's disease

V10.79 Other lymphatic and hematopoietic neoplasms

V10.87 Personal history of malignant neoplasm of thyroid


Applicable codes for services rendered prior to January 1, 2013:

CPT Codes Description

83890 Molecular diagnostics; molecular isolation or extraction

83891 isolation or extraction of highly purified nucleic acid

83892 enzymatic digestion

83893 dot/slot blot production

83894 separation by gel electrophoresis (e.g., agarose, polyacrylamide)

83896 nucleic acid probe, each

83897 nucleic acid transfer (e.g., Southern, Northern)

83898 amplification of patient nucleic acid (e.g., PCR, LCR), single primer pair, each primer pair

83900 Molecular diagnostics; amplification, target, multiplex, first two nucleic acid sequences

83901 amplification of patient nucleic acid, multiplex, each multiplex reaction

83902 Reverse transcription

83903 mutation scanning, by physical properties (e.g., single strand conformational polymorphisms (SSCP), heteroduplex, denaturing gradient gel electrophoresis (DGGE), RNA'ase A), single segment, each

83904 mutation identification by sequencing, single segment, each segment

83905 mutation identification by allele specific transcription, single segment, each segment

83906 mutation identification by allele specific translation, single segment, each segment

83907 Molecular diagnostics; lysis of cells prior to nucleic acid extraction (eg, stool specimens, paraffin embedded tissue), each specimen

83908 Molecular diagnostics; amplification, signal, each nucleic acid sequence

83909 Molecular diagnostics; separation and identification by high resolution technique (eg, capillary electrophoresis), each nucleic acid preparation

83912 interpretation and report

83913 RNA stabilization

83914 Mutation identification by enzymatic ligation or primer extension, single segment, each segment (eg, oligonucleotide ligation assay [OLA], single base chain extension [SBCE], or allele-specific primer extension [ASPE])


88230 Tissue culture for non-neoplastic disorders; lymphocyte

88233 skin or other solid tissue biopsy

88237 Tissue culture for neoplastic disorders; bone marrow, blood cells

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 baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (e.g., for ataxia telangiectasia, Fanconi anemia, fragile X)

88249 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 count 15-20 cells, 2 karyotypes, with banding

88263 count 45 cells for mosaicism, 2 karyotypes, with banding

88264 Analyze 20-25 cells

88271 Molecular cytogenetics, DNA probe, each (e.g., FISH)

88272 chromosomal in situ hybridization, analyze 3-5 cells (e.g., for derivatives and markers)

88273 chromosomal in situ hybridization, analyze 10-30 cells (e.g., for microdeletions)

88274 interphase in situ hybridization, analyze 25-99 cells


88280 Chromosome analysis; additional karyotypes, each study

88283 additional specialized banding technique (e.g., NOR, C-banding)

88285 additional cells counted, each study

88289 additional high resolution study

88291 Cytogenetics and molecular cytogenetics, interpretation and report

88384 Array-based evaluation of multiple molecular probes; 11 through 50 probes




HCPCS Description

S3840 DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2

S3841 Genetic testing for retinoblastoma

Applicable codes for services rendered after January 1, 2013:

CPT Description

81206 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative

81207 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative

81208 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative

81245 FLT3 (FMS-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis, internal tandem duplication (ITD) variants (ie, exons 14, 15)

81235 EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)

81245 FLT3 (FMS-RELATED TYROSINE KINASE 3) (eg, acute myeloid leukemia), gene analysis, internal tandem duplication (ITD) variants (ie, exons 14, 15)

81261 IGH (immunoglobulin heavy chain locus) (eg, leukemias and lymphomas, B-cell), gene rearrangement analysis to detect abnormal clonal population(s); amplified methodology (eg, polymerase chain reaction)

81262 ;direct probe methodology (eg, southern blot)

81263 ;variable region somatic mutation analysis

81264 IGK(immunoglobulin kappa light chain locus) (eg, leukemia and lymphoma, b-cell), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

81270 JAK2 (Janus Kinase 2) (eg, myeloproliferative disorder) gene analysis, P.VAL617PHE (V617F) variant

81310 NPM1 (Nucleophosmin) (eg, acute myeloid leukemia) gene analysis, exon 12 variants

81315 PML/RARALPHA, (T(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative


81316 ;single breakpoint (eg, intron 3, intron 6 or exon 6), qualitative or quantitative

81340 TRB (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s); using amplification methodology (eg, polymerase chain reaction)

81341 ;using direct probe methodology (eg, southern blot)

81342 TRG(T cell antigen receptor, gamma) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)

88230 Tissue culture for non-neoplastic disorders; lymphocyte

88233 skin or other solid tissue biopsy

88237 Tissue culture for neoplastic disorders; bone marrow, blood cells

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 baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (e.g., for ataxia telangiectasia, Fanconi anemia, fragile X)

88249 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 count 15-20 cells, 2 karyotypes, with banding

88263 count 45 cells for mosaicism, 2 karyotypes, with banding

88264 Analyze 20-25 cells

88271 Molecular cytogenetics, DNA probe, each (e.g., FISH)

88272 chromosomal in situ hybridization, analyze 3-5 cells (e.g., for derivatives and markers)

88273 chromosomal in situ hybridization, analyze 10-30 cells (e.g., for microdeletions)



88280 Chromosome analysis; additional karyotypes, each study

88283 additional specialized banding technique (e.g., NOR, C-banding)

88285 additional cells counted, each study


88289 additional high resolution study

88291 Cytogenetics and molecular cytogenetics, interpretation and report




HCPCS Description

S3840 DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2

S3841 Genetic testing for retinoblastoma

Codes effective after January 1, 2013 that do not meet payment determination criteria:

CPT Description

81350 UGT1A1 (UDP Glucuronosyltransferase 1 family, polypeptide A1) (eg, irinotecan metabolism), gene analysis, common variants (eg, *28, *36, *37)

86152 Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood);

86153 Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when required

Modifiers (These are listed for information purposes only)

Description

-0N TP53, commonly called p53

-1C FLI1, ERG, ETV1, or EWSR1 (Ewing’s sarcoma, desmoplastic round cell)

-2A RUNX1 or CBFA2T1, commonly called AML1 or ETO, genes associated with t(8;21) AML1-also ETO (acute myelogenous leukemia)

-2B BCR or ABL1, genes associated with t(9;22) (chronic myelogenous or acute leukemia) BCR-also ABL (chronic myeloid, acute lymphoid leukemia)

-2C PBX1 or TCF3, genes associated with t(1;19) (acute lymphoblastic leukemia) CGF1


-2D CBFB or MYH11, genes associated with inv 16 (acute myelogenous leukemia) CBF beta (leukemia)

-2E MLL (acute leukemia)

-2F PML or RARA, genes associated with t(15;17) (acute promyelocytic leukemia) PML/RAR alpha (promyelocytic leukemia)

-2G ETV6, commonly called TEL, gene associated with t(12;21) (acute leukemia) TEL (Leukemia)

-2H BCL20 (B cell lymphoma, follicle center cell origin) bcl-2 (Lymphoma)

-2I CCND1, commonly called BCL1, cyclin D1 (Mantle cell lymphoma, myeloma) bcl-1 (lymphoma)

-2J MYC (Burkitt’s lymphoma) c-myc (lymphoma)

-2K IgH (lymphoma/leukemia)

-2L IGK (lymphoma/leukemia)

-2M TRB, T cell receptor beta (lymphoma/leukemia)

-2N TRG, T cell receptor gamma (lymphoma/leukemia)

-2O SIL or TAL1 (T cell leukemia)

-2T BCL6 (B cell lymphoma)

-2Q API1 or MALT1 (MALT lymphoma)

-2R NPM or ALK, genes associated with t(2;5) (anaplastic large cell lymphoma)

-2S FLT3 (Acute myelogenous leukemia)

-4O Microsatellite loss (los of heterozygosity)

ICD-10 codes are provided for your information. These will not become effective until 10/1/2014:

ICD-10 Codes Description

C16.9 Malignant neoplasm of stomach, unspecified

C34.00 Malignant neoplasm of main bronchus, unspecified side

C34.01 Malignant neoplasm of right main bronchus

C34.02 Malignant neoplasm of left main bronchus

C34.10 Malignant neoplasm of upper lobe, bronchus or lung, unspecified side

C34.11 Malignant neoplasm of upper lobe, right bronchus or lung

C34.12 Malignant neoplasm of upper lobe, left bronchus or lung

C34.2 Malignant neoplasm of middle lobe, right bronchus or lung


C34.30 Malignant neoplasm of lower lobe, bronchus or lung, unspecified side

C34.31 Malignant neoplasm of lower lobe, right bronchus or lung

C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of bronchus and lung

C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90 Malignant neoplasm of bronchus or lung, unspecified, unspecified side

C34.91 Malignant neoplasm of right bronchus or lung, unspecified

C34.92 Malignant neoplasm of left bronchus or lung, unspecified

C41.9 Malignant neoplasm of bone and articular cartilage, unspecified

C73 Malignant neoplasm of thyroid gland

C82.90 Follicular lymphoma, unspecified, unspecified site

C82.99 Follicular lymphoma, unspecified, extranodal and solid organ sites

C82.91 Follicular lymphoma, unspecified, lymph nodes of head, face, and neck

C82.92 Follicular lymphoma, unspecified, intrathoracic lymph nodes

C82.93 Follicular lymphoma, unspecified, intra-abdominal lymph nodes

C82.94 Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb

C82.95 Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb

C82.96 Follicular lymphoma, unspecified, intrapelvic lymph nodes

C82.97 Follicular lymphoma, unspecified, spleen

C82.98 Follicular lymphoma, unspecified, lymph nodes of multiple sites

C85.80 Other specified types of non-Hodgkin lymphoma, unspecified site

C85.89 Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites

C85.81 Other specified types of non-Hodgkin’s lymphoma, lymph nodes of head, face, and neck

C85.82 Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes

C84.93 Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes

C85.83 Other specified types of non-Hodgkin lymphoma, intra abdominal lymph nodes


C85.84 Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb

C85.85 Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C85.86 Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes

C85.87 Other specified types of non-Hodgkin lymphoma, spleen

C85.88 Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites

C90.00 Multiple myeloma not having achieved remission

C90.01 Multiple myeloma in remission

C90.02 Multiple myeloma in relapse

C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.11 Chronic lymphocytic leukemia of B-cell type in remission

C91.12 Chronic lymphocytic leukemia of B-cell type in relapse

C91.Z0 Other lymphoid leukemia not having achieved remission

C91.Z1 Other lymphoid leukemia in remission

C91.Z2 Other lymphoid leukemia, in relapse

C92.00 Acute myeloblastic leukemia, not having achieved remission

C92.40 Acute promyelocytic leukemia, not having achieved remission

C92.50 Acute myeolomonocytic leukemia, not having achieved remission

C92.01 Acute myeloblastic leukemia, in remission

C92.41 Acute promyelocytic leukemia, in remission

C92.51 Acute myeolomonocytic leukemia, in remission

C92.02 Acute myeloblastic leukemia, in relapse

C92.42 Acute promyelocytic leukemia, in relapse

C92.52 Acute myeolomonocytic leukemia, in relapse

C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission

C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission

C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse

C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission


C92.21 Atypical chronic myeloid leukemia, BCR/ABL-negative, in remission

C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse

D09.3 Carcinoma in situ of thyroid and other endocrine glands

D09.8 Carcinoma in situ of other specified sites

D47.3 Essential (hemorrhagic) thrombocythemia

D46.0 Refractory anemia without ring sideroblasts, so stated

D46.1 Refractory anemia with ring sideroblasts

D46.20 Refractory anemia with excess of blasts, unspecified

D46.21 Refractory anemia with excess of blasts 1

D46.A Refractory cytopenia with multilineage dysplasia

D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts

D46.22 Refractory anemia with excess of blasts 2

D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

D46.9 Myelodysplastic syndrome, unspecified

D47.1 Chronic myeloproliferative disease

D47.Z1 Post-transplant lymphoproliferative disorder (PTLD)

C94.40 Acute panmyelosis with myelofibrosis not having achieved remission

C94.41 Acute panmyelosis with myelofibrosis, in remission

C94.42 Acute panmyelosis with myelofibrosis, in relapse

D47.1 Chronic myeloproliferative disease

D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified

D47.Z9 Other specified neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue

Z85.6 Personal history of leukemia

Z85.6 Personal history of leukemia

Z85.71 Personal history of Hodgkin lymphoma

Z85.79 Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Z85.831 Personal history of malignant neoplasm of soft tissue

Z85.850 Personal history of malignant neoplasm of thyroid

Z80.8 Family history of malignant neoplasm of other organs or systems


V. Scientific Background

Many genetic tests are imperfect predictors of either existing disease or disease susceptibility, particularly when used in the context of population screening, where individuals without family histories of disease, risk factors or symptoms are tested. For example, the probability exists that a disease may still occur, even when a negative test result is obtained. Conversely, a specific disease may not occur when there is a positive test result. While these concepts hold true for at-risk individuals as well, the probability of both these occurrences is greater in population screening, so test results are more difficult to interpret in a manner that will meaningfully affect health outcomes. With a few limited exceptions (e.g., PKU testing), general screening of populations for diseases that can be attributed to genetic mutations is not advocated in the published scientific literature. The genotypes to be detected by a genetic test must be shown by scientifically valid methods to be associated with the occurrence of the disease, and the analytical and clinical validity of the test must be established.

Analytical validity Analytical validity is an indicator of how well a test measures the property or characteristic it is intended to measure, and it is made up of three components Analytical sensitivity: the test is positive when the relevant gene mutation is present. Analytical specificity: the test is negative when the gene mutation is absent and reliability: the test obtains the same result each time. Clinical Validity Clinical validity in genetic testing is a measurement of the accuracy with which a test identifies or predicts a clinical condition and involves the following:

a. Clinical sensitivity: the probability that the test is positive if the individual being tested actually has the disease or a predisposition to the disease.

b. Clinical specificity: the probability that the test is negative if the individual does not have the disease or a predisposition to the disease.

c. Positive predictive value: the probability that an individual with positive test results will get the disease.

d. Negative predictive value: the probability that an individual with negative test results will not get the disease.

e. Heterogeneity: different mutations within the same gene may cause the same disease and can result in different degrees of disease severity; a failure to detect all disease-related mutations reduces a test's clinical sensitivity.

f. Penetrance: the probability that the disease will appear when a disease-related genotype is present. Penetrance is incomplete when other genetic or environmental factors must be present for a disease to develop.

There are both benefits and risks associated with genetic tests. Genetic tests that are not fully assessed for analytical and clinical validity prior to their use in clinical practice have the potential for causing harm to patients. For example, patients who are wrongly classified as at-risk may be subjected to increased and unnecessary surveillance or treatments, some of which


may be harmful, or even irreversible. Likewise, false negative test results may lead to delays in diagnosis and treatment.

The development of genetic tests that can diagnose or predict disease occurrence has far outpaced the development of interventions to treat, ameliorate or prevent those same diseases. Clinical utility refers to the ability of genetic test results, either positive or negative, to provide information that is of value in the clinical setting. Specifically for positive test results, this could involve instituting treatments or surveillance measures, making decisions concerning future conception, or avoiding harmful treatments. Negative test results can have clinical utility in that unnecessary treatments or surveillance can be avoided. In the absence of such interventions, the benefits of testing are limited, and in fact, can cause psychological harm.

VI. Important Reminder

The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.

Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA’s determination as to medical necessity in a given case, the physician may request that HMSA consider the application of this Medical Policy to the case at issue.

VII. References

1. ASCO Policy Statement Update: Genetic Testing for Cancer susceptibility. June 15, 2003. Journal of Clinical Oncology. 21(12): 2397-2406.

2. Blue Cross Blue Shield – Regence #20, Genetic and Molecular Diagnostic Testing. December 2011.

3. Update of Horizon scans of genetic tests currently available for clinical use in cancer. AHRQ Technology Assessment Program. Final Report April 15, 2011.

4. Secretary's Advisory Committee on Genetic Testing. A public consultation on oversight of genetic tests. December 1, 1999 - January 31, 2000. National Institutes of Health. Accessed on November 30, 2011. http://oba.od.nih.gov/oba/sacgt/reports/Public%20Consultation%20Summary.pdf.

http://oba.od.nih.gov/oba/sacgt/reports/Public%20Consultation%20Summary.pdf

Documents

Genetic Testing Oncology...Genetic Testing - Oncology 3 F. Because of the rapidly evolving field of genetic testing, this policy does not address every genetic test available. All