Monday, March 11, 2019

CPT 0008M, 81460, 81465, 81504, 81520 , S3854 - Patients with Breast Cancer

Code Description CPT

0008M Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk  score (Prosigna) (code terminated 1/1/18)

81460 Whole mitochondrial genome (eg, 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 (eg, Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy


Code Description  detection, if performed 

81504 Oncology (tissue of origin), micro-array gene expression profiling of >2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores 

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 (Oncotype DX)

81520 Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score (new code effective 1/1/18)

81521 Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffinembedded tissue, algorithm reported as index related to risk of distant metastasis (new code effective 1/1/18)

HCPCS

S3854 Gene expression profiling panel for use in the management of breast cancer treatment 




Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer


Introduction
Breast cancer is a complex disease. Scientists are learning more about breast cancer every year. In the past decade research has shown that measuring certain genes or markers in breast cancer tissue may provide information about prognosis that can be used to make decisions about therapy. Therapies for breast cancer may include surgery, radiation and chemotherapy. The size of the cancer, whether lymph nodes are involved, and what markers or genes are present in the cancer are all factors that are used to select the best treatments for a person with breast cancer. A number of tests are now offered which are specifically for early-stage, hormone-receptorpositive breast cancer. These tests provide an estimate of how likely the cancer is to recur after treatment. Using these tests, some women may decide not to have chemotherapy as a treatment when there is a low risk of recurrence. This policy describes when genetic testing to help make decisions about adjuvant treatment after breast cancer surgery may be considered medically necessary and paid for by the health plan. It also describes which tests the plan covers. Some tests need more published studies to show that they accurately describe the risk of recurrence, and those tests are considered investigational by the plan, and would not be paid for.


Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 
Policy Coverage Criteria 

Test  Medical Necessity  21-Gene reverse transcriptase polymerase chain reaction (RT-PCR) assay:

* Oncotype DX® * EndoPredict® * Breast Cancer Index® * Prosigna®

These tests may be considered medically necessary to determine recurrence risk in women with primary, invasive breast cancer meeting ALL of the following characteristics: * Unilateral tumor * Hormone receptor*positive (that is, estrogen receptor [ER]+
(positive) , or progesterone receptor [PR]+ (positive)) * Human epidermal growth factor receptor 2 (HER2)*(negative)  * Tumor size 0.6 to 1 cm with moderate/poor differentiation or  unfavorable features OR tumor size larger than 1 cm * Node-negative (lymph nodes with micrometastases which are  <2 adjuvant="" are="" aromatase="" be="" br="" chemotherapy="" considered="" decide="" eg="" endocrine="" in="" individual="" inhibitors="" mm="" nbsp="" negative="" node="" of="" on="" size="" tamoxifen="" test="" the="" therapy="" to="" treated="" use="" used="" will="" with="">treat the patient’s breast cancer (when chemotherapy is a therapeutic option)
* The test is ordered within 6 months after diagnosis * Only one of the tests is covered per individual tumor
o In unusual circumstances such as test failure or testing two separate breast cancers, individual consideration is applied

The use of these tests for other indications not outlined above are considered investigational, including but not limited to the following:  * Determination of  recurrence risk in invasive breast cancer  patients with positive lymph nodes


Test  Medical Necessity

* Predicting recurrence risk in patients with noninvasive ductal carcinoma in situ(ie, Oncotype DX® DCIS)
* Patients with bilateral breast cancer * The use of gene expression assays in men with breast cancer * To consider length of treatment with tamoxifen

Test Investigational  MammaPrint® BluePrint®

Use of 70 gene signature (MammaPrint®) for any indication is considered investigational.  The use of BluePrint® in conjunction with MammaPrint® or alone is considered investigational.

TargetPrint® Use of gene expression assays for quantitative assessment of ER, PR, and HER2 overexpression (eg, TargetPrint®) is considered investigational.
Other gene expression assays

Coding 

The use of other gene expression assays (Mammostrat® Breast Cancer Test, BreastOncPx™, NexCourse® Breast IHC4, BreastPRS™) for any indication is considered investigational.


Related Information 

Note About Testing

This policy addresses gene expression profiling in women. No peer reviewed published medical literature on the use of gene expression profiling in men with breast cancer has been identified.

Suggested Testing Management

The 21-gene RT-PCR assay Oncotype DX should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (ie, the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician- patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted for testing. It is not necessary to conduct testing on each tumor; treatment is based on the most aggressive lesion  Unfavorable features that may prompt testing in tumors from 0.6 to 1 cm in size include the following: angiolymphatic invasion, high histologic grade, or high nuclear  grade.

The 21-gene reverse transcriptase polymerase chain reaction (RT-PCR) assay Oncotype DX® should not be ordered as a substitute for standard estrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2 (HER2) testing. 

The current American Society of Clinical Oncology/College of American Pathologists joint guidelines on HER2 testing in breast cancer (Wolff et al, 2013) has defined positive, negative, and equivocal HER2 test results.

Evidence Review 

Description

Laboratory tests have been developed that detect the expression, via messenger RNA, of many different genes in breast tumor tissue and combine the results into a prediction of distant recurrence risk for women with early-stage breast cancer. Test results may help providers and patients decide whether to include adjuvant chemotherapy in postsurgical management of breast cancer or to alter treatment in patients with ductal carcinoma in situ (DCIS) , or to recommend extended endocrine therapy in patients who are recurrence-free at 5 years. This report summarizes the evidence of 5 tests, which are organized by indication: Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint, and Prosigna


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