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Date Printed: December 17, 2017: 04:31 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-86000-26

Original Effective Date: 10/15/05

Reviewed: 01/26/17

Revised: 02/15/17

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

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update    
           

DESCRIPTION:

An important part of treatment planning for patients with breast cancer involves determining which patients could benefit from adjuvant treatments. For example, for women with early-stage, invasive breast cancer (ie, cancer extending beyond the basement membrane of the mammary ducts into adjacent tissue), adjuvant cytotoxic chemotherapy consistently provides approximately an 30% relative risk reduction in 10-year breast cancer mortality regardless of prognosis. However, the absolute benefit of chemotherapy depends on the baseline risk of recurrence. Women with the best prognosis have small tumors, are estrogen receptor‒positive, and are lymph node–negative. These women have an approximately 15% baseline risk of recurrence; approximately 85% of these patients would be disease-free at 10 years with tamoxifen treatment alone and could avoid the toxicity of chemotherapy, if they could be accurately identified.No single classifier is considered a criterion standard, and several common criteria have qualitative or subjective components that add variability to risk estimates. As a result, more patients are treated with chemotherapy than can benefit. Better predictors of baseline risk could help women’s decision making, some who may prefer to avoid chemotherapy if assured that their risk is low.

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).

POSITION STATEMENT:

The use of the 21-gene reverse transcriptase-polymerase chain reaction (PT-PCR) assay (i.e., Oncotype DX™) to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy meets the definition of medical necessity in members with newly diagnosed (6 months or less) primary, invasive breast cancer meeting ALL of the following criteria:

Use of EndoPredict™, the Breast Cancer Indexsm, and Prosigna™ to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy meets the definition of medical necessity in members with primary, invasive breast cancer that meet the above criteria for for Oncotype DX.

Other than its use related to newly diagnosed (6 months or less) breast cancer as outlined above, all other uses of the 21-gene reverse transcriptase-polymerase chain reaction (PT-PCR) assay (i.e., Oncotype DX), EndoPredict, the Breast Cancer Index, and Prosigna, including determination of recurrence risk in invasive breast cancer members with positive lymph nodes, members with bilateral disease, or to consider length of treatment with tamoxifen are considered experimental or investigational. There is a lack of clinical data in peer-reviewed literature to permit conclusions on safety, efficacy and net health outcomes.

Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (i.e., Oncotype DX DCIS) to inform treatment planning following excisional surgery is considered experimental or investigational. The evidence is insufficient to permit conclusions on efficacy and net health outcomes.

All other gene expression assays (e.g., MammaPrint®, Mammostrat®, BreastOncPx, Insight® DX Breast Cancer Profile, NexCourse® Breast IHC4, PAM50 Breast Cancer Intrinsic Classifier, BreastPRS™, MapQuant Dx™, and BreastOncPx™.) are considered experimental or investigational, as there is insufficient clinical evidence to support the use of these tests to predict the baseline risk of breast cancer recurrence after surgery, radiation therapy or hormonal therapy. The evidence is insufficient to permit conclusions on efficacy and net health outcomes.

The following is considered experimental or investigational as the evidence is insufficient to permit conclusions on efficacy and net health outcomes:

BILLING/CODING INFORMATION:

CPT Coding:

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)

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)

S3854

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

REIMBURSEMENT INFORMATION:

Reimbursement is subject to post-service medical review. The following information is required documentation to support medical necessity: physician history and physical, pathology report, treating physician visit notes that include documentation that the intention to treat or not treat with adjuvant chemotherapy was contingent, at least in part, on the results of the test for the individual patient in question.

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Pathology Reports Sections

26439-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Pathology Study Reports

27898-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Gene Expression Profiling Panel for use in the Management of Breast Cancer Treatment (L33586)located at fcso.com.

The following billing and coding guidelines, located at palmettogba.com, were reviewed on the last guideline reviewed date:

• MolDX Breast Cancer Index℠ Genetic Assay (L35631)

• MolDX MammaPrint Billing and Coding Guidelines Update (M00029)

• MolDX Oncotype DX Breast Cancer Assay Coding and Billing Guidelines (M00003).

DEFINITIONS:

Adjuvant chemotherapy: chemotherapy given in addition to surgical therapy, in order to reduce the risk of local or systemic relapse.

ER-positive (estrogen receptor positive): Describes cells that have a protein to which the hormone estrogen will bind. Cancer cells that are ER-positive need estrogen to grow, and may stop growing when treated with hormones that block estrogen from binding.

Estrogen receptor: receptor for estrogens; it’s presence conveys a better prognosis for breast cancers.

Gene expression: the detectable effect of a gene.

HER2 (human epidermal growth factor receptor 2): A protein involved in normal cell growth. It is found in high levels on some breast cancer cells.

Micrometastasis: small numbers of cancer cells that have spread from the primary tumor to other parts of the body and are too few to be picked up in a screening or diagnostic test.

Node-negative: being or having cancer that has not spread to nearby lymph nodes.

PR-positive (progesterone receptor positive): Describes cells that have a protein to which the hormone progesterone will bind. Cancer cells that are PR-positive need progesterone to grow and will usually stop growing when treated with hormones that block progesterone from binding.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research (AHRQ) Evidence Reports and Summaries – Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes, Number 160, January 2008.
  2. American Cancer Society, Detailed Guide: Breast Cancer, Breast Cancer Treatment By Stage, revised 09/07.
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  98. Van de Vijver, M. J., He, Y. D., van ‘T Veer, L. J., Dai, H., Hart, A. A. M., Voskuil, D. W., Schreiber, G. J., Peterse, J. L., Roberts, C., Marton, M. J., Parrish, M., Atsma, D., Witteveen, A., Glas, A., Delahaye, L., van der Velde, T., Bartelink, H., Rodenhuis, S., Rutgers, E. T., Friend, S. H., Bernards, R. (2002). A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med, 347:1999-2009.
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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/26/17.

GUIDELINE UPDATE INFORMATION:

10/15/05

New Medical Coverage Guideline.

01/01/06

Annual HCPCS coding update: added code S3854.

09/15/06

Annual review: continue investigational status.

11/15/07

Annual review: position statements changed, description section updated, definitions section updated, guideline reformatted, references updated.

02/15/08

Revised position statement; updated description section, definition section and references.

01/01/09

Annual review: no change to position statements, description section and references updated.

11/15/09

Annual review: position statements updated; description section and references updated.

09/15/10

Annual review: position statements maintained and references updated.

11/15/10

Revision; formatting changes and Program Exceptions section updated.

08/15/11

Scheduled review; position statements maintained and references updated; formatting changes.

03/15/12

Revision; position statement updated; formatting changes.

10/15/12

Annual review; position statements maintained and references updated.

11/01/12

Remove CMN; formatting changes.

05/30/13

Revision; Program Exceptions section and references updated.

11/15/13

Annual review; position statements, program exception, and references updated; formatting changes.

07/01/14

Quarterly HCPCS update. Added code 0008M.

10/15/14

Annual review; position statement section, program exception section, and references updated; formatting changes.

01/01/15

Annual HCPCS/CPT update. Added code 81519.

11/15/15

Annual review; position statement, program exception, and references updated; formatting changes.

01/01/16

Annual HCPCS/CPT update; code S3854 deleted.

07/01/16

Quarterly HCPCS/CPT update. Added code S3854 (code reinstated).

02/15/17

Revision; description, position statements, and references updated; formatting changes.

Date Printed: December 17, 2017: 04:31 PM