Reconstructive breast surgery refers to surgical procedures to rebuild the contour of the breast, along with the nipple and areola if desired. Typically, breast reconstruction is performed following a mastectomy (i.e., the breast has been removed because of breast cancer), but occasionally techniques of breast reconstruction are used to treat women who have an abnormal development of one or both breasts.  

This policy addresses the following three areas: reconstructive breast surgery, cosmetic surgeries designed to enhance the appearance of the breast and management of breast implants.  

Note: For information related to the medical necessity criteria for mammaplasty procedures, see Policy SURG.00086 Reduction Mammaplasty.

Policy Statement

A.  Reconstructive Breast Surgery

Breast surgery to restore the normal contour of the breast is considered reconstructive for the following conditions:

1. After the Treatment of Breast Cancer
   Breast surgery to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance, is considered reconstructive, and is a benefit mandate by federal regulation for both men and women following a mastectomy, lumpectomy, or other breast surgery to treat breast cancer.  This process may include reconstructive surgery and implant insertion or a procedure where the individual’s muscle tissue is transposed from another site to construct a more normal appearance. Following reconstruction of the affected breast, it may be necessary to reconstruct the contralateral breast to achieve symmetry. This could involve reduction mammaplasty, augmentation mammaplasty with implants, or mastopexy. The number of procedures and timing of these procedures varies, depending on the individualized treatment plan devised by the treating physician(s) and the individual.  This timing may be impacted by the overall treatment plan for the breast cancer itself.  The presence of pre-existing breast implants placed for cosmetic purposes will not affect the reconstructive determination nor will it impact the federal mandate for these procedures.
   
   
2. After Prophylactic Mastectomy
   In the case of a bilateral prophylactic mastectomy, breast surgery of both breasts is considered reconstructive following the mastectomy of both breasts.
   
   

   Note: For information related to the medical necessity criteria for prophylactic mastectomy, please see Policy SURG.00063 Prophylactic Mastectomy .
   
   

3. For the Indication of Breast Disfigurement
   Breast surgery to alter the contour of the breast is considered reconstructive when there are significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease.  A specific example of this is -- 
   Poland’s syndrome which may be diagnosed when all of the following are present: 
   • Congenital absence or hypoplasia of pectoralis major and minor muscles; and
   • Breast hypoplasia; and
   • Congenital partial absence of the upper costal cartilage.

Note: Specific requests for breast surgery for Poland’s syndrome, other cases of breast asymmetry, and others in this category require review within the framework of the specific benefit certificate contract language.

B. Management of Breast Implants  

Note: Before considering the medical necessity for the removal of breast implants, the following questions must be answered:

1. Was the original insertion of breast implant considered reconstructive or cosmetic in nature?
   Removal of a breast implant is considered reconstructive if the breast implant, originally inserted for reconstructive purposes, is associated with a significantly altered appearance, such that the goals of reconstruction (i.e., to return the patient to a whole) are not reached.
   
   
2. What signs or symptoms are present?
   The presence of signs and symptoms related to the breast implant (for example, painful capsular contracture or rupture) may be used to establish the medical necessity for implant removal. Certain signs or symptoms (see medical necessity criteria below) will establish the medical necessity of implant removal, regardless of whether the implant was originally implanted for reconstructive or cosmetic reasons .
   
   
3. What type of implant is being removed?
   The medical necessity criteria for explantation may depend on the type of implant. For example, the medical consequences of rupture of a silicone gel-filled implant differ from rupture of a saline-filled implant. The following implants are available:
   • Silicone gel-filled;
   • Saline-filled;
   • Combination implants, i.e., double lumen implants, consisting of an inner silicone-gel filled lumen surrounded by a saline-filled lumen.

Medically Necessary:

Removal of breast implants unrelated to a diagnosis of breast cancer is considered medically necessary when the following criteria are met:

For Silicone Gel-filled Implants Only:
Removal of a Silicone Gel-filled Implant is considered medically necessary for any ONE of the following:

• Documented implant rupture (i.e., using mammography, ultrasound, or MRI); or
• Infection; or
• Implant exposure/extrusion; or
• Pain related to capsular contracture (clinically confirmed as Baker Class IV); or
• Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In patients treated with breast conserving surgery [i.e., lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is optional.)

For Saline filled or Alternative Implants Only:
Removal of a Saline filled or “Alternative” Implant is considered medically necessary for any ONE of the following:

• Infection; or
• Implant exposure/extrusion; or
• Pain related to capsular contracture (clinically confirmed as Baker Class IV); or
• Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In patients treated with breast conserving surgery [i.e., lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is optional.)

Rupture of a saline-filled or “Alternative” implant is considered not medically necessary since the potential adverse medical consequences of implant rupture are related to silicone gel implants only.

For Combination Implants (i.e., consisting of both silicone and saline filled material):
Removal of a Combination Implant is considered medically necessary for any ONE of the following:

• Documented rupture of the silicone component using either mammography, ultrasound or MRI. (Rupture of the saline component alone does not meet medical necessity criteria.); or
• Infection; or
• Implant exposure/extrusion; or
• Pain related to capsular contracture (clinically confirmed as Baker Class IV); or
• Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In patients treated with breast conserving surgery [i.e., lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is optional.)

Reconstructive Applications of Breast Implant Replacement
For Patients with a History of Breast Cancer:

If an implant originally placed for reconstructive purposes as defined above, ruptures or develops a visible distortion (Baker Class III contracture) removal of the implant and reimplantation is considered reconstructive.

Not Medically Necessary:

The following indications for removal of ANY type of breast implant are considered not medically necessary:

• Systemic symptoms attributed to connective tissue disease, autoimmune diseases, etc;
• Patient anxiety;
• Pain not related to contractures or rupture;
• Saline implant rupture except as described above for reconstructive surgery.

C.  Cosmetic

Although removal of a breast implant originally inserted for cosmetic purposes only is considered medically necessary when criteria are met (detailed within this policy), reimplantation in this instance is considered cosmetic/not medically necessary. 

Other breast procedures, (including augmentation mammaplasty/breast lift, implant repositioning, repair of inverted nipples, mastopexy) are considered cosmetic/not medically necessary unless the above criteria are met.

Rationale

The Women’s Health and Cancer Rights Act of 1998 (WHCRA) mandated reconstructive breast surgery for women and men who have undergone mastectomy for breast cancer. This legislation states that any woman or man who undergoes breast surgery for a cancer-related indication has the right to reconstructive surgery to the affected and the contra-lateral breast, as well as treatment of all complications including lymphedema. (Lymphedema may occur as a complication of breast cancer surgery.)

Removal of silicone-filled implants has been shown to be necessary due to infection, implant exposure, or pain related to capsular contracture.  In addition, Grade IV contractures interfere with adequate mammography screening and thus, their presence has potential medical implications. Therefore, removal may be considered medically necessary. Grade III contractures do not interfere with mammography; therefore, Grade III contractures are not considered an absolute indication for removal.  However, since Grade III contractures do have an impact on the normal appearance of the breast, removal may be appropriate for implants originally placed for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved. Contracture is the most common local complication of breast implants. Contractures have been graded according to the Baker Classification which is outlined below:

Grade I:	Augmented breast feels as soft as a normal breast.
Grade II:	Breast is less soft and the implant can be palpated but is not visible.
Grade III:	Breast is firm, palpable, and the implant (or its distortion) is visible.
Grade IV:	Breast is hard, painful, cold, tender, and distorted.

The FDA labeling of silicone implants recommends removal of ruptured silicone implants.  Intact silicone implants are all associated with leakage of small amounts of silicone, and there has been concern that this leakage is associated with various autoimmune diseases.  The data from multiple studies is inadequate to support an association between silicone implants and autoimmune disease (Janowsky, 2000).

In the case of saline-filled implants, infection, implant exposure, or pain related to capsular contracture require implant removal. Ruptured saline-filled implants have not been shown to pose any health risks due to the physiologic nature of saline, and their removal does not meet medical necessity criteria, except where WHCRA addresses this issue.

There is no medical evidence that supports the removal of breast implants for systemic symptoms, anxiety, or pain not related to contractures or rupture. The placement or removal of an implant in a healthy woman is not considered to have any medically necessary justification and is considered cosmetic.

Background/Overview

Description of Technology

Reconstructive breast surgery is a surgical procedure that is designed to restore the normal appearance of a breast after a medically necessary mastectomy or other medical condition, injury or congenital abnormality. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone a medically necessary surgery, an accidental injury, or trauma.

Breast reconstruction following a mastectomy can be done immediately after or some time following a procedure to remove a breast. In an immediate procedure, after removal of the breast tissue, the surgeon will place a breast implant in the location where the breast was removed. This is referred to as a one-stage procedure and has no impact on the outcome of any chemotherapy treatments. A delayed reconstruction procedure may be necessary if radiation therapy following the surgery is needed, since implants may interfere with such treatment. In some circumstances, it is necessary to do a two-stage procedure, which involves the placement of a tissue expander to stretch the skin where an implant will be inserted. Placement of the expander will be followed several months later by placement of an implant. This type of procedure may be done either immediately or some time after the breast removal surgery. Regardless of which procedure is done, the reconstruction will not interfere with the doctor’s ability to detect any disease recurrence.

Another technique used in breast reconstruction involves a two-phase procedure. In the first phase, the breast mound is created, using either an implant with or without a tissue expander, or an autologous tissue reconstruction procedure with a transverse rectus abdominus musculocutaneous flap (i.e., TRAM flap), and allowed to heal. In the second phase, which begins three to six months after the first stage is completed, the breast shape is refined and the nipple-areola is created. Tattooing of the nipple and/or areola is the final stage of reconstruction and in some cases may be delayed up to two years.

Definitions

Augmentation mammaplasty: a surgical procedure in which the purpose is to enlarge the breast or breasts

Contracture: a condition where scar tissue forms internally around the breast implant, tightens and makes the breast round, firm, and possibly painful; excessive firmness of the breasts can occur soon after surgery or years later

Contralateral: pertaining to the opposite side; in the case of breasts, it refers to the breast not being medically treated.

Extrusion: a condition where the lack of adequate tissue coverage, infection, or other conditions where skin may be weakened, results in exposure of the implant through the skin

Mastectomy: the surgical removal of a breast

Mastopexy: a surgical procedure designed to elevate sagging breasts to a normal position, often with some improvement in shape

Poland’s Syndrome: a condition where an individual is born missing some of their chest muscles and cartilage and does not develop a breast on one side of the chest during puberty

Prophylactic mastectomy: a surgical procedure to remove a breast or both breasts with the purpose of reducing the risk of breast cancer in women determined to be at intermediate or high risk for developing breast cancer

Reconstructive breast surgery: surgical procedures performed to correct or repair abnormal structures of the breast that are designed to restore the normal appearance of one or both breasts

Reduction mammaplasty: a surgical procedure to decrease breast size

Rupture: a condition where a liquid or gel-filled breast implant bursts, allowing leakage of its contents into the surrounding tissue

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Reconstructive Breast Surgery

When services are Reconstructive:

CPT

ICD-9 Diagnosis

When services may be Cosmetic/Not Medically Necessary:

For the procedure code listed above, for all other diagnoses not listed above; or when the code describes a procedure indicated in the Policy section as cosmetic/not medically necessary.

When services are Reconstructive:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

When services may be Reconstructive when criteria are met:

For all procedure codes listed above; for the diagnoses below:

ICD-9 Diagnosis

When services are Cosmetic/Not Medically Necessary:

For the procedures listed above, when criteria not met, for all other diagnosis not listed; or when the code describes a procedure indicated in the Policy section as cosmetic/not medically necessary.

Management of Breast Implants 

When services are Medically Necessary:

CPT

ICD-9 Diagnosis

When services may be Medically Necessary when criteria are met:

CPT

ICD-9 Procedure

ICD-9 Diagnosis

When services are Not Medically Necessary:

For the procedure codes listed above for all other diagnoses not listed above; or when the code describes a procedure indicated in the Policy section as not medically necessary.

When services are Cosmetic/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Contant CME, Menke-Pluijmers MBE, Seynaeve C, et al. Clinical experience of prophylactic mastectomy followed by immediate breast reconstruction in women with hereditary risk of breast cancer (HB(O)C) or a proven BRCA1 and BRCA2 germ-line mutation. Eur J Surg Oncology. 2002; 28:627-632.
2. Gabriel SE, Woods JE, O'Fallon WM, et al. Complications leading to surgery after breast implantation. NEJM. 1997; 336:677-682. 
3. Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast implants and connective tissue diseases in female health professionals.  A retrospective cohort study.  JAMA. 1996; 275(8):616-21.
4. Henriksen TF, Fryzek JP, Holmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors.  Ann Plast Surg. 2005; 54(4):343-51.
5. Holmich LR, Fryzek JP, Kjoller K, et al. The diagnosis of silicone breast implant rupture: clinical findings compared with findings at magnetic resonance imaging.  Ann Plast Surg. 2005; 54(6):583-9.
6. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Eng J Med. 2000; 342:781-90. 
7. Mathes SJ. Breast implantation: The quest for safety and quality, NEJM. 1997; 336(10):718-719.
8. Weiss, Paul R. Breast reconstruction after mastectomy. Am J Managed Care. 1997; 932.
9. Zion SM, Slezak JM, Sellers TA, et al. Re-operations after prophylactic mastectomy with or without implant reconstruction. Cancer. 2003; 98:2152-2160.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Baker JL. Augmentation mammaplasty. In Owsley JG, Peterson RA, eds: Symposium on Aesthetic Surgery of the Breast. St. Louis: Mosby, 1978.
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Breast Reconstruction Following Mastectomy. NCD #140.2. Effective January 1, 1997. Available at:    http://www.cms.hhs.gov. Accessed on: July 18, 2006. 
3. National Cancer Institute.  Women with silicone breast implants have no increased risk of death from most causes.  April 2001. Available at:  http://www.cancer.gov/newscenter/silicone-mortality.  Accessed on: July 19, 2006.
4. Schwartz SI, Shires GT, Spencer FC, ed. Principles of Surgery 5th ed. McGraw-Hill Book Company. New York, NY. 1989. Pp. 664.
5. The Women’s Health and Cancer Rights Act (WHCRA), §713; October 21, 1998. 
6. U.S. Food and Drug Administration (FDA).  Breast implants home page.  Available at:    http://www.fda.gov/cdrh/breastimplants/index.html.  Accessed on:  July 19, 2006.
7. U.S. Food and Drug Administration (FDA).  Study of silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.  May 2001.  Available at:  http://www.fda.gov/cdrh/breastimplants/extracapstudy.html.  Accessed on:  July 19, 2006.

Web Sites for Additional Information

1. American Cancer Society (web site).  Information regarding the Women’s Health and Cancer Rights Act.  Available at:  www.cancer.org/docroot/MIT/content/MIT_3_2X.asp.  Accessed on:  July 18, 2006.
2. American Cancer Society: Breast reconstruction after mastectomy.  Available at:  http://www.cancer.org.  Accessed on:  July 19, 2006.
3. American Society of Plastic Surgeons: Breast reconstruction following breast removal.  Available at:  http://www.plasticsurgery.org.  Accessed on:  July 19, 2006.
4. National Cancer Institute: What you need to know about breast cancer:  Available at:  http://www.cancer.gov/cancer_information/doc_wyntk.aspx? viewid=41a364e8-6f7e-4c6c-981a-fce1c07f9c5d. Accessed on:  July 18, 2006.
5. National Library of Medicine. Medical Encyclopedia. Mastectomy.  Available at:    http://www.nlm.nih.gov/. Accessed on:  July 18, 2006.

Index

Augmentation Mammaplasty
Breast Implants
Breast Lift
Breast Procedures
Mastopexy
Reconstructive Breast Surgery

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association