Medical Policy



Subject: Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures
Document #: SURG.00023 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

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

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 (that is, the breast has been removed because of breast cancer) or lumpectomy (that is, removal of the breast tumor and tissue surrounding it), but occasionally techniques of breast reconstruction are used to treat individuals who have an abnormal development of one or both breasts. 

Note: Please see the following related document(s) for additional information:

For information regarding surgical procedures of the breast for individuals with gender dysphoria, please see the following:

Note: The Women's Health and Cancer Rights Act of 1998 (WHCRA) is federal legislation that provides that any individual, with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA.  This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedemas. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well.  The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to men, as well as women.  WHCRA does not address lumpectomies.  Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy. 

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant physical functional impairment, AND the procedure can be reasonably expected to improve the physical functional impairment.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect.

Note: Not all benefit contracts include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Position Statement

Medically Necessary:

Removal of implants partially or completely filled with Silicone Gel is considered medically necessary when there is documented implant rupture (that is, using mammography, ultrasound, or MRI).

Removal of a Silicone Gel filled, Saline filled or "Alternative" implant is considered medically necessary for any of the following:

Reconstructive:

Breast surgery to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance, is considered reconstructive, following a mastectomy, lumpectomy, or other breast surgery to treat breast cancer. 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 and may be impacted by the overall treatment plan for the breast cancer itself.
Covered reconstructive procedures include any or all of the following (A through D):

  1. Reconstructive surgery and implant insertion;
  2. Procedures where muscle tissue is transposed from another site;
  3. Reconstruction of the contralateral breast to achieve symmetry with reduction mammaplasty, augmentation mammaplasty with implants, or mastopexy;
  4. Revision or removal of pre-existing breast implants placed for cosmetic purposes.

Breast surgery of both breasts is considered reconstructive following the mastectomy of both breasts.

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:

Removal of an implant (any type) with or without reimplantation is considered reconstructive when an implant, originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes as defined above, develops a visible distortion (Baker Class III contracture).  

Removal of a saline-filled or "Alternative" implant with or without reimplantation is considered reconstructive when originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes, as defined above, if it ruptures.

Surgery on the contralateral breast to produce a symmetrical appearance after removal of an implant and reimplantation is considered reconstructive when the implant was originally placed for reconstructive purposes in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer.

Not Medically Necessary:

Removal of a ruptured 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.

Removal of ANY type of breast implant is considered not medically necessary for any of the following:

Cosmetic and Not Medically Necessary:

Reimplantation of an implant inserted for cosmetic purposes only (that is, for reasons other than a history of mastectomy, lumpectomy, treatment of breast cancer, significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease) and removed as part of a medically necessary or reconstructive surgery (see above) is considered cosmetic and not medically necessary. 

Other breast procedures, (including augmentation mammaplasty/breast lift, implant repositioning, repair of inverted nipples, mastopexy) are considered cosmetic and not medically necessary except when performed as part of a covered breast reconstruction service.

Rationale

The Women's Health and Cancer Rights Act of 1998 (WHCRA) mandated that reconstructive breast surgery for women and men who have undergone mastectomy be covered by their benefits for those who have opted to have breast reconstruction.  In individuals who have undergone a medically necessary lumpectomy, surgery to create a more normal anatomy is considered reconstructive.    

Removal of silicone-filled implants has been shown to be necessary when 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 2011, the FDA published preliminary findings and analyses of anaplastic large cell lymphoma (ALCL) in women with breast implants.  As part of its analysis, the FDA conducted a thorough review of scientific literature published from January 1997 through May 2010.  From this review, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world.  In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature. Some cases have been identified through the FDA's contact with other regulatory authorities, scientific experts, and breast implant manufacturers, and it is not clear how many of these are duplicates of the ones found in the literature.  The number of identified cases is small compared to the estimated 5-10 million women who have received breast implants worldwide.  Based on these data:

The FDA believes that women with breast implants may have a very small but increased risk of ALCL.  Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled (FDA, 2011; Kim, 2011).

In the case of saline-filled implants, infection, implant exposure, or pain related to capsular contracture requires 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.

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.

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(s) 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 (that is, to return the individual 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) 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, that is, double lumen implants, consisting of an inner silicone-gel filled lumen surrounded by a saline-filled lumen.
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 sometime 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 (that is, TRAM flap), and allowed to heal. In the second phase, which begins 3 to 6 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 2 years.

Description of Chest Wall Deformities

Congenital chest wall deformities include, but are not limited, to:  Poland syndrome, pectus excavatum (also referred to as sunken chest or funnel chest), and pectus carinatum (referred to as pigeon breast or chicken breast).  Poland syndrome is a rare, congenital disorder which is associated with a wide range of malformations of the ribs on one or both sides of the sternum.  This condition is characterized by absence or hypoplasia of the pectoralis major and minor muscles, absence of costal cartilages, hypoplasia of the breast and subcutaneous tissue, and a variety of hand and upper-extremity anomalies.  In general, the severity of congenital chest wall deformities is dependent upon the depth, symmetry and width of the deformity which is evaluated by chest radiographs.  In more severe cases where cardiac and/or pulmonary compression and cardiac displacement may be involved, the clinical evaluation may include chest computed tomography (CT) or magnetic resonance imaging (MRI), in addition to echocardiography and pulmonary function testing.  Surgical repair may be necessary in some severe cases where cardiopulmonary function is impaired.

Definitions

Alternative breast implants (also called combination implants): A type of breast implant that has two compartments that contain both silicone and saline. Some of these implants have silicone as the inner compartment and saline as the outer compartment. The saline compartment is filled at the time of surgery. Other implants in this category contain saline in the inner compartment and silicone in the outer compartment. 

Augmentation mammaplasty (also referred to as augmentation mammoplasty): 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. This excessive firmness of the breasts can occur soon after surgery or years later.

Contralateral: Pertaining to the opposite side which, in the case of breasts, 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 did 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 (also referred to as reduction mammoplasty): 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 document 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 Procedures following Breast Surgery
When services may be Reconstructive when criteria are met:

CPT  
11920-11922 Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less [when specified for nipple/areola reconstruction after breast surgery; includes codes 11920, 11921, 11922]
15877 Suction assisted lipectomy; trunk [when specified as a breast reconstruction procedure following breast surgery]
19316 Mastopexy
19318 Reduction mammaplasty
19324 Mammaplasty, augmentation; without prosthetic implant
19325 Mammaplasty, augmentation; with prosthetic implant
19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction
19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction
19350 Nipple/areola reconstruction [when specified as a breast reconstruction procedure following breast surgery]
19355 Correction of inverted nipples
19357 Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion
19361 Breast reconstruction with latissimus dorsi flap, with or without prosthetic implant
19364 Breast reconstruction with free flap
19366 Breast reconstruction with other technique
19367 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site
19368 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), single pedicle, including closure of donor site, with microvascular anastomosis (supercharging)
19369 Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), double pedicle, including closure of donor site
19380 Revision of reconstructed breast
19396 Preparation of moulage for custom breast implant
   
HCPCS  
C1789 Prosthesis, breast (implantable)
L8600 Implantable breast prosthesis, silicone or equal
S2066 Breast reconstruction with gluteal artery perforator (GAP) flap, including harvesting of the flap, microvascular transfer, closure of donor site and shaping the flap into a breast, unilateral
S2067 Breast reconstruction of a single breast with "stacked" deep inferior epigastric perforator (DIEP) flap(s) and/or gluteal artery perforator (GAP) flap(s), including harvesting of the flap(s), microvascular transfer, closure of donor site(s) and shaping the flap into a breast, unilateral
S2068 Breast reconstruction with deep inferior epigastric perforator (DIEP) flap or superficial inferior epigastric artery (SIEA) flap, including harvesting of the flap, microvascular transfer, closure of donor site and shaping the flap into a breast, unilateral
   
ICD-10 Procedure  
0H0T07Z-0H0V0ZZ Alteration of breast [right, left or bilateral, with or without tissue or synthetic substitute, by approach; includes codes 0H0T07Z, 0H0T0JZ, 0H0T0KZ, 0H0T0ZZ, 0H0U07Z, 0H0U0JZ, 0H0U0KZ, 0H0U0ZZ, 0H0V07Z, 0H0V0JZ, 0H0V0KZ, 0H0V0ZZ]
0HHT0NZ-0HHV0NZ Insertion of tissue expander into breast, open approach [right, left or bilateral; includes codes 0HHT0NZ, 0HHU0NZ, 0HHV0NZ]
0HPT0NZ-0HPU8NZ Removal of tissue expander from breast [right or left, by approach; includes codes 0HPT0NZ, 0HPT3NZ, 0HPT7NZ, 0HPT8NZ, 0HPU0NZ, 0HPU3NZ, 0HPU7NZ, 0HPU8NZ]
0HRT075-0HRV075 Replacement of breast using latissimus dorsi myocutaneous flap, open approach [right, left or bilateral; includes codes 0HRT075, 0HRU075, 0HRV075]
0HRT076-0HRV076 Replacement of breast using transverse rectus abdominis myocutaneous flap, open approach [right, left or bilateral; includes codes 0HRT076, 0HRU076, 0HRV076]
0HRT077-0HRV077 Replacement of breast using deep inferior epigastric artery perforator flap, open approach [right, left or bilateral; includes codes 0HRT077, 0HRU077, 0HRV077]
0HRT078-0HRV078 Replacement of breast using superficial inferior epigastric artery flap, open approach [right, left or bilateral; includes codes 0HRT078, 0HRU078, 0HRV078]
0HRT079-0HRV079 Replacement of breast using gluteal artery perforator flap, open approach [right, left or bilateral; includes codes 0HRT079, 0HRU079, 0HRV079]
0HRT07Z-0HRV07Z Replacement of breast with autologous tissue substitute, open approach [right, left or bilateral; includes codes 0HRT07Z, 0HRU07Z, 0HRV07Z]
0HRT0JZ-0HRV0JZ Replacement of breast with synthetic substitute, open approach [right, left or bilateral; includes codes 0HRT0JZ, 0HRU0JZ, 0HRV0JZ]
0HRT0KZ-0HRV0KZ Replacement of breast with nonautologous tissue substitute, open approach [right, left or bilateral; includes codes 0HRT0KZ, 0HRU0KZ, 0HRV0KZ]
0HRW07Z-0HRXXKZ Replacement of nipple [right or left, by type of substitute and approach; includes codes 0HRW07Z, 0HRW0JZ, 0HRW0KZ, 0HRW37Z, 0HRW3JZ, 0HRW3KZ, 0HRWX7Z, 0HRWXJZ, 0HRWXKZ, 0HRX07Z, 0HRX0JZ, 0HRX0KZ, 0HRX37Z, 0HRX3JZ, 0HRX3KZ, 0HRXX7Z, 0HRXXJZ, 0HRXXKZ]
0HST0ZZ-0HSV0ZZ Reposition breast, open approach [right, left or bilateral; includes codes 0HST0ZZ, 0HSU0ZZ, 0HSV0ZZ]
0HUT07Z-0HUV0KZ Supplement breast, open approach [right, left or bilateral with tissue or synthetic substitute; includes codes 0HUT07Z, 0HUT0JZ, 0HUT0KZ, 0HUU07Z, 0HUU0JZ, 0HUU0KZ, 0HUV07Z, 0HUV0JZ, 0HUV0KZ]
0J060ZZ-0J063ZZ Alteration of chest subcutaneous tissue and fascia [by approach, includes codes 0J060ZZ, 0J063ZZ]
0JD60ZZ-0JD63ZZ Extraction of chest subcutaneous tissue and fascia [by approach; includes codes 0JD60ZZ, 0JD63ZZ]
0KXK0Z6-0KXL0Z6 Transfer abdomen muscle, transverse rectus abdominis myocutaneous flap, open approach [right or left; includes codes 0KXK0Z6, 0KXL0Z6]
   
ICD-10 Diagnosis  
C50.011-C50.929 Malignant neoplasm of breast
C79.81 Secondary malignant neoplasm of breast
D05.00-D05.92 Carcinoma in situ of breast
N65.0-N65.1 Deformity and disproportion of reconstructed breast
T81.4XXA-T81.4XXS Infection following a procedure
T85.41XA-T85.49XS Mechanical complication of breast prosthesis and implant
T85.79XA-T85.79XS Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
Z42.1 Encounter for breast reconstruction following mastectomy
Z85.3 Personal history of malignant neoplasm of breast
Z90.10-Z90.13 Acquired absence of breast and nipple

Reconstructive Breast Procedures for Other Indications:
When services may also be Reconstructive when criteria are met:
For the procedure codes listed above; for the following diagnoses:

ICD-10 Diagnosis  
N64.82 Hypoplasia of breast
Q67.6-Q67.7 Pectus excavatum, pectus carinatum
Q79.8 Other congenital malformations of musculoskeletal system (Poland syndrome)
Q83.0 Congenital absence of breast with absent nipple
Q83.2 Absent nipple
S21.001A-S21.009S Unspecified open wound of breast
S21.011A-S21.019S Laceration without foreign body of breast
S21.021A-S21.029S Laceration with foreign body of breast
S28.211A-S28.229S Traumatic amputation of breast

When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.

Breast Implant Removal or Revision 
When services may be Medically Necessary or Reconstructive when criteria are met: 

CPT  
19328 Removal of intact mammary implant
19330 Removal of mammary implant material
   
ICD-10 Procedure  
0H2TXYZ-0H2UXYZ Change other device in breast, external approach [right or left; includes codes 0H2TXYZ, 0H2UXYZ]
0HPT0JZ-0HPU0JZ Removal of synthetic substitute from breast, open approach [right or left; includes codes 0HPT0JZ, 0HPU0JZ]
0HPT0KZ-0HPU0KZ Removal of nonautologous tissue substitute from breast, open approach [right or left; includes codes 0HPT0KZ, 0HPU0KZ]
0HWT0JZ-0HWU0JZ Revision of synthetic substitute in breast, open approach [right or left; includes codes 0HWT0JZ, 0HWU0JZ]
0HWT0KZ-0HWU0KZ Revision of nonautologous tissue substitute in right breast, open approach [right or left; includes codes 0HWT0KZ, 0HWU0KZ]
   
ICD-10 Diagnosis  
C50.011-C50.019 Malignant neoplasm of nipple and areola, female
C50.111-C50.119 Malignant neoplasm of central portion of breast, female
C50.211-C50.219 Malignant neoplasm of upper-inner quadrant of breast, female
C50.311-C50.319 Malignant neoplasm of lower-inner quadrant of breast, female
C50.411-C50.419 Malignant neoplasm of upper-outer quadrant of breast, female
C50.511-C50.519 Malignant neoplasm of lower-outer quadrant of breast, female
C50.611-C50.619 Malignant neoplasm of axillary tail of breast, female
C50.811-C50.819 Malignant neoplasm of overlapping sites of breast, female
C50.911-C50.919 Malignant neoplasm of breast of unspecified site, female
C79.81 Secondary malignant neoplasm of breast
D05.00-D05.92 Carcinoma in situ of breast
T81.4XXA-T81.4XXS Infection following a procedure
T85.41XA-T85.49XS Mechanical complication of breast prosthesis and implant
T85.79XA-T85.79XS Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
Z42.1 Encounter for breast reconstruction following mastectomy
Z45.811-Z45.819 Encounter for adjustment or removal of breast implant
Z85.3 Personal history of malignant neoplasm of breast

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

References

Peer Reviewed Publications:

  1. Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001; 28(5):996-1003.
  2. Contant CM, Menke-Pluijmers MB, 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(6):627-632.
  3. Davila AA1, Mioton LM, Chow G, et al. Immediate two-stage tissue expander breast reconstruction compared with one-stage permanent implant breast reconstruction: a multi-institutional comparison of short-term complications. J Plast Surg Hand Surg. 2013; 47(5):344-349.
  4. Gabriel SE, Woods JE, O'Fallon WM, et al. Complications leading to surgery after breast implantation. N Engl J Med. 1997; 336(10):677-682.
  5. 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):616-621.
  6. 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):343-351.
  7. 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):583-589.
  8. 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(11):781-790.
  9. Kim B, Roth C, Chung KC, et al. Anaplastic large cell lymphoma and breast implants: a systematic review. Plast Reconstr Surg. 2011; 127(6):2141-2150.
  10. Lipworth L, Tarone RE, McLaughlin JK. Breast implants and fibromyalgia: a review of the epidemiologic evidence. Ann Plast Surg. 2004; 52(3):284-287.
  11. Mathes SJ. Breast implantation: the quest for safety and quality, N Engl J Med. 1997; 336(10):718-719.
  12. McLaughlin JK, Lipworth L, Murphy DK, Walker PS. The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Ann Plast Surg. 2007; 59(5):569-580.
  13. McIntosh SA, Horgan K. Breast cancer following augmentation mammoplasty - a review of its impact on prognosis and management. J Plast Reconstr Aesthet Surg. 2007; 60(10):1127-1135.
  14. Roostaeian J, Sanchez I, Vardanian A, et al. Comparison of immediate implant placement versus the staged tissue expander technique in breast reconstruction. Plast Reconstr Surg. 2012; 129(6):909e-918e.
  15. Song JW, Kim HM, Bellfi LT, Chung KC. The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis. Plast Reconstr Surg. 2011; 127(3):1029-1044.
  16. Stevens WG1, Harrington J, Alizadeh K, et al.  Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel.  Plast Reconstr Surg. 2012; 130(5):973-981.
  17. Tanna N, Broer PN, Weichman KE, et al. Microsurgical breast reconstruction for nipple-sparing mastectomy. Plast Reconstr Surg. 2013; 131(2):139e-147e.
  18. Weiss PR. Breast reconstruction after mastectomy. Am J Managed Care. 1997; 3(6):932-937.
  19. Zion SM, Slezak JM, Sellers TA, et al. Re-operations after prophylactic mastectomy with or without implant reconstruction. Cancer. 2003; 98(10):2152-2160.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Society of Plastic and Reconstructive Surgeons Citizens' Petition to the Food and Drug Administration submitted by the American Society of Plastic and Reconstructive Surgeons which requests that silicone gel-filled implants remain available because the device is necessary for the public health. Nov. 29, 1991. Arlington Heights, Ill.
  2. American Society of Plastic Surgeons (ASPS). Evidence-Based Clinical Practice Guideline: Breast Reconstruction with Expanders and Implants. 2013. Available at: http://www.plasticsurgery.org/Documents/Health-Policy/Guidelines/guideline-2013-breast-recon-expanders-implants.pdf. Accessed on July 10, 2017.
  3. Baker JL. Augmentation mammaplasty. In Owsley JG, Peterson RA, eds: Symposium on Aesthetic Surgery of the Breast. St. Louis: Mosby, 1978.
  4. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Breast reconstruction following mastectomy. NCD #140.2. Effective January 1, 1997; revised October 3, 2003. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=64&ncdver=1&bc=AgAAQAAAAAAA&. Accessed on July 11, 2017.
  5. Chung KC. Discussion: Managing late periprosthetic fluid collections (seroma) in patients with breast implants: a consensus panel recommendation and review of the literature. Plast Reconstr Surg. 2011; 128(1):13-16.
  6. Department of Health and Human Services (HHS). Proposed Rule on Nondiscrimination in Health Programs and Activities. §1557 of Affordable Care Act (ACA); Proposed 45 C.F.R. §92.206; 80 Fed. Reg. 54176-54177. RIN 0945-AA02. The Kaiser Commission on Medicaid and the Uninsured. Issue Brief. October 2015. Final Rule. Published May 18, 2016. Effective July 18, 2016. Available at: https://www.federalregister.gov/articles/2016/05/18/2016-11458/nondiscrimination-in-health-programs-and-activities . Accessed on July 11, 2017.
  7. Jagsi R1, Jiang J, Momoh AO, Alderman A, et al. Trends and variation in use of breast reconstruction in patients with breast cancer undergoing mastectomy in the United States. J Clin Oncol. 2014; 32(9):919-926.
  8. NCCN Clinical Practice Guidelines in Oncology. © 2017. National Comprehensive Cancer Network Clinical Practice guidelines in Oncology. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on July 11, 2017.
    • Breast Cancer (V2.2017). Revised April 6, 2017.
  9. The Women's Health and Cancer Rights Act (WHCRA), §713; October 21, 1998. Available at: http://www.cms.gov/Regulations-and-Guidance/Health-Insurance-Reform/HealthInsReformforConsume/downloads/WHCRA_Statute.pdf.  Accessed on July 11, 2017.
  10. U.S. Food and Drug Administration (FDA). Regulatory history of breast implants in the U.S. Last updated September 25, 2013. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm. Accessed on July 11, 2017. 
  11. U.S. Food and Drug Administration (FDA). Study of silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Published in May 2001. Page last updated May 2009. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064382.htm. Accessed on July 11, 2017.
  12. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Update on the Safety of Silicone Gel-Filled Breast Implants. June 2011. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf. Accessed on July 11, 2017.
  13. U.S. Food and Drug Administration (FDA). Guidance for industry and FDA staff: saline, silicone gel, and alternative breast implants. November 17, 2006. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071228.htm. Accessed on July 11, 2017.
  14. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Executive Summary: Silicone Gel-Filled Breast Implants General Issues Panel. August 30-31, 2011. Available at: https://www.pharmamedtechbi.com/~/media/Images/Publications/Archive/Health%20News%20Daily/2011/8/30/110830g1/082911_fda_breast_implant_summary.pdf . Accessed on July 11, 2017.
  15. U.S. Food and Drug Administration (FDA). Labeling for approved breast implants. Updated March 21, 2017. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063743.htm. Accessed on July 11, 2017.
  16. U.S. Food and Drug Administration (FDA). Information on breast implants and anaplastic large B-cell lymphoma. Updated March 23, 2017. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed on July 11, 2017.
Websites for Additional Information
  1. American Cancer Society (web site). Information regarding the Women's Health and Cancer Rights Act. Available at: http://www.dol.gov/ebsa/publications/whcra.html. Accessed on July 11, 2017.
  2. American Cancer Society: Breast reconstruction after mastectomy. Updated 2013. Available at: http://www.cancer.org/Cancer/BreastCancer/MoreInformation/BreastReconstructionAfterMastectomy/index. Accessed on July 11, 2017.
  3. American Cancer Society: Information and Resources for Cancer. Available at: http://www.cancer.org/Search/index?QueryText=breast+cancer&x=50&y=23. Accessed on July 11, 2017.
  4. American Society for Aesthetic Plastic Surgery (ASAPS). Breast augmentation. Available at: http://www.surgery.org/consumers/procedures/breast/breast-implants. Accessed on July 11, 2017.
  5. American Society of Plastic Surgeons: Breast reconstruction. Available at: http://www.plasticsurgery.org/Patients_and_Consumers/Procedures/Reconstructive_Procedures/Breast_Reconstruction.html. Accessed on July 11, 2017.
  6. National Cancer Institute: Breast cancer. Available at: http://www.cancer.gov/cancertopics/types/breast. Accessed on July 11, 2017.
Index

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

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.

Document History

Status

Date

Action

Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.  Coding and References sections were updated.
Reviewed 08/04/2016 MPTAC review. References were updated. Removed ICD-9 codes from Coding section.
Reviewed 08/06/2015 MPTAC review. References were updated.
Reviewed 08/14/2014 MPTAC review. The Background, Coding and References sections were updated.
Reviewed 08/08/2013 MPTAC review. References were updated.
Revised 08/09/2012 MPTAC review. Position statements section was reformatted for clarification. Position statement for other procedures (including augmentation mammaplasty/breast lift, implant repositioning, repair of inverted nipples, mastopexy) was revised to state that these procedures are considered cosmetic and not medically necessary except when performed as part of a covered breast reconstruction service.  The Rationale, Coding and References were updated.
  07/01/2012 Updated Coding section to recategorize CPT 19355.
Reviewed 08/18/2011 MPTAC review. The Definitions and References were updated.
Reviewed 08/19/2010 MPTAC review. References were updated.
  04/21/2010 Updated Coding section to add CPT 11921, 11922.
Revised 08/27/2009 MPTAC review. The language of the criteria under each category has been reformatted for clarification with no substantial revisions.  References were updated.
Revised 08/28/2008 MPTAC review. The Reconstructive and medically necessary language for implant removal and replacement was clarified. Cosmetic language was also clarified. References were updated.  Updated coding section with 10/01/2008 ICD-9 changes.
  02/21/2008 The phrase "cosmetic/not medically necessary" was clarified to read "cosmetic and not medically necessary." This change was approved at the November 29, 2007 MPTAC. meeting. A NOTE was added after the Reconstructive Definition to clarify that not all benefit contracts include a reconstructive services benefit.
Revised 08/23/2007 MPTAC review. Information was added to the Description and to the statements under Reconstructive Surgery and Management of Breast Implants sections regarding the definitions of "Reconstructive," "Medically Necessary" and "Cosmetic" for clarification. References were also updated.
  07/01/2007 Updated Coding section with 07/01/2007 HCPCS changes.
Reviewed 09/14/2006 MPTAC review. References were updated.
  11/17/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised 09/22/2005 MPTAC review. Revision based on Pre- merger Anthem and Pre-merger WellPoint Harmonization. 
     
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

04/27/2004 SURG.00023 Breast Procedures; including Prophylactic Mastectomy; Reconstructive Surgery, including implants; Reduction Mammaplasty; Mastectomy for Gynecomastia
WellPoint Health Networks, Inc. 06/24/2004 3.01.09 Reconstructive Breast Surgery
  12/02/2004 Clinical Guidelines Removal of Breast Implants
  12/02/2004 Clinical Guidelines Reimplantation of Breast Implants