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Date Printed: October 20, 2017: 08:41 AM

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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.

02-12000-15

Original Effective Date: 01/01/01

Reviewed: 08/24/17

Revised: 09/15/17

Subject: Prophylactic Mastectomy

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 Updates    
           

DESCRIPTION:

Prophylactic mastectomy is defined as the removal of the breast in the absence of malignant disease to reduce the risk of breast cancer occurrence. The literature on prophylactic mastectomy primarily consists of observational studies and retrospective reviews; however, evidence demonstrates that prophylactic mastectomy reduces breast cancer incidence and increases survival in high-risk patients.

POSITION STATEMENT:

Prophylactic mastectomy meets the definition of medical necessity for members at high risk of breast cancer.

Prophylactic mastectomy meets the definition of medical necessity for members with extensive mammographic abnormalities (i.e., calcifications) that adequate biopsy or excision is impossible.

High risk of breast cancer may be defined as one or more of the following:

It is recommended that candidates for prophylactic mastectomy consider undergoing counseling regarding cancer risks from a health professional skilled in assessing cancer risk other than the operating surgeon. Cancer risk should be assessed by performing a complete family history, with the use of the Gail or Claus model to estimate the risk of cancer. Also, discussion of the various treatment options with the candidate, including increased surveillance or chemoprevention with tamoxifen or raloxifene.

Prophylactic mastectomy is considered experimental or investigational for all other indications, including but not limited to contralateral prophylactic mastectomy in women with breast cancer who do not meet high-risk criteria for breast cancer.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS codes to report prophylactic mastectomy.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

BRCA1 and BRCA2: breast cancer 1 susceptibility gene.

Mutation: in genetics, a permanent transmissible change in the genetic material.

RELATED GUIDELINES:

OTHER:

Federal Law-SEC 713 Required Coverage for Reconstructive Surgery following Mastectomies

A group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan, that provides medical and surgical benefits with respect to a mastectomy shall provide, in a case of a participant or beneficiary who is receiving benefits in connection with a mastectomy and who elects breast reconstruction in connection with such mastectomy, coverage for:

1) All stages of reconstruction of the breast on which the mastectomy has been performed;

2) Surgery and reconstruction of the other breast to produce a symmetrical appearance; and

3) Prostheses and physical complications all stages of mastectomy, including lymphedemas; in a manner determined in consultation with the attending physician and the patient.

Florida Statute-Chapter 627-627.6417 Coverage for surgical procedures and devices incident to mastectomy.

Any health insurance policy that provides coverage for mastectomies must also provide coverage for prosthetic devices and breast reconstructive surgery incident to the mastectomy. Breast reconstructive surgery must be in a manner chosen by the treating physician, consistent with prevailing medical standards, and in consultation with the patient.

The term "mastectomy" means the removal of all or part of the breast for medically necessary reasons as determined by a licensed physician, and the term "breast reconstructive surgery" means surgery to reestablish symmetry between the two breasts.

Other names used to report prophylactic mastectomy:

Preventive Mastectomy
Risk reduction Mastectomy

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual 7.01.09 Prophylactic Mastectomy, 07/17.
  2. Boughey JC. Contralateral Prophylactic Mastectomy (CPM) Consensus Statement from the American Society of Breast Surgeons: Data on CPM Outcomes and Risks. Annals of Surgical Oncology 2016; 23(10): 3100-3105.
  3. Fayanju OM, Stoll CR, Fowler S, et al. Contralateral prophylactic mastectomy after unilateral breast cancer: a systematic review and meta-analysis. Annals of Surgery 2014; 260(6):1000-1010.
  4. Federal Law SEC. 713 Required coverage for reconstructive surgery following mastectomies, 2008.
  5. Florida Legislature, SB 530 & 848, Breast Cancer Treatment, October 01, 1997.
  6. Florida Statute-Chapter 627-627.6417 Coverage for surgical procedures and devices incident to mastectomy, 2016.
  7. Giuliano AE, Boolbol S, Degnim A et al. Society of Surgical Oncology: Position Statement on Prophylactic Mastectomy. Approved by the Society of Surgical Oncology Executive Council, March 2007. Annals of Surgical Oncology, 2007.
  8. Hartmann LC, Schaid DJ, Woods JE et al. Efficacy of Bilateral Prophylactic Mastectomy in Women with a Family History of Breast Cancer. New England Journal of Medicine 1999; 340 (2): 77-84.
  9. Jatoi I, Parsons HM. Contralateral prophylactic mastectomy and its association with reduced mortality: evidence for selection bias. Breast Cancer Research and Treatment 2014; 148(2):389-396.
  10. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Breast Cancer Version 2. 2017-April 6, 2017.
  11. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Breast Cancer Risk Reduction Version 1.2017-December 16, 2016.
  12. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology Genetic/Familial High-Risk Assessment: Breast and Ovarian Version 2.2017-December 7, 2016.
  13. Newman LA, Kuerer HM, Hunt KK et al. Educational Review: Role of the Surgeon in Hereditary Breast Cancer. Annals of Surgical Oncology 2001; 8:368-378.
  14. Newman LA, Kuerer HM, Hunt KK et al. Prophylactic Mastectomy2000; 191(3): 322-329.
  15. Nichols HB, Berrington de Gonzalez A, Lacey JV, Jr., et al. Declining incidence of contralateral breast cancer in the United States from 1975 to 2006. Journal of Clinical Oncology 2011; 29 (12):1564-1569.
  16. Oppong BA, King TA. Recommendations for women with lobular carcinoma in situ (LCIS). Oncology (Williston Park). Oct 2011;25 (11):1051-1056, 1058.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/24/17.

GUIDELINE UPDATE INFORMATION:

01/01/01

Medical Coverage Guideline Developed.

05/15/03

Annual review. Added coverage statement for counseling and reconstructive surgery/prosthetic device. Added diagnosis V10.3. Deleted code 19180 and 19181. Added statement for the Florida State Mandate for “Breast Cancer Treatment”.

01/15/05

Annual review; next review changed to NLR; no change in coverage.

09/15/07

Reformatted guideline. Updated description section. Revise 6th bullet under Position Statement, definition of high risk of breast cancer; change two (change to one) second-degree with breast cancer and one or more with ovarian cancer. Deleted reconstructive surgery/prosthetic device (implant) coverage statement. Updated references. Added Prosthetics, 09-L0000-05 to related guidelines section.

01/01/08

Updated guideline (Florida Statute 627.641). Updated references and related Internet links.

10/15/09

Updated description section. Added additional high-risk indications (presence of a p53 or PTEN mutation and received radiation therapy to the chest. Deleted first bullet under moderately increased risk of breast cancer; patients who do not meet the definition of high risk. Updated references.

02/15/13

Added Federal law for reconstructive surgery following mastectomies. Updated references.

05/11/14

Revision: Program Exceptions section updated.

03/15/17

Revision; updated description, revised position statement: added statement for high risk breas cancer and mammographic abnormalities and revised statement for lobular carcinoma in situ. Revised reimbursement information, definitions and updated references.

09/15/17

Revision; add clarification statement for high risk. Updated references.

Date Printed: October 20, 2017: 08:41 AM