Coverage Guideline

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:

• SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting
• CG-SURG-71 Reduction Mammaplasty

Note: This document does not address gender affirming surgery or procedures. Criteria for gender affirming surgery or procedures are found in applicable guidelines used by the plan.

For autologous fat grafting and other soft tissue augmentation procedures of the breast see:

• MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures

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 functional impairment, AND the procedure can be reasonably expected to improve the 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.

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:

1. Infection of the implant or surrounding tissue; or
2. Implant exposure/extrusion; or
3. Pain related to Baker Class IV capsular contracture; or
4. Confirmed cases of breast implant-associated anaplastic large cell lymphoma; or
5. Elective removal in individuals with an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) due to use of Allergan BIOCELL textured breast implants and tissue expanders; or
6. Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In individuals treated with breast conserving surgery [that is, lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is at the discretion of the treating physician and the treated individual).

Reconstructive:

Breast surgery is considered reconstructive to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance following a mastectomy, lumpectomy, or other breast surgery for breast cancer.

Surgical procedures, such as reduction mammaplasty, may be considered reconstructive when done in advance of mastectomy or lumpectomy for breast cancer in order to produce improved cosmesis and prevent postoperative complications.

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 syndrome which may be diagnosed when all of the following are present:

1. Congenital absence or hypoplasia of pectoralis major and minor muscles; and
2. Breast hypoplasia; and
3. Congenital partial absence of the upper costal cartilage.

Removal of an implant (any type) with or without reimplantation is considered reconstructive when:

1. An implant, originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes as defined above; and
2. There has been development of a visible distortion (Baker Class III contracture).  

Removal of a ruptured 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.

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:

1. Systemic symptoms attributed to connective tissue disease, autoimmune diseases, etc.; or
2. Personal anxiety; or
3. Pain not related to contractures or rupture; or
4. The medically necessary or reconstructive criteria listed above have not been met.

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.

The Women’s Health and Cancer Rights Act of 1998 (WHCRA) mandated that reconstructive breast surgery for individuals 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 breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in individuals 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 BIA-ALCL in women with breast implants throughout the world. 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 individuals 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 BIA-ALCL. Because the risk of BIA-ALCL appears very small, the 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).

As of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients. Of these, 272 of the 414 reports included information on the surface of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces. Also noted, 413 of the 414 reports included information on the type of implant fill. Of these, 234 reported implants filled with silicone gel and 179 reported implants filled with saline. This further clarifies that saline implants are also reported to be associated with BIA-ALCL (FDA, 2017).

The FDA continues to collect and evaluate information about BIA-ALCL associated with breast implants. In collaboration with the American Society of Plastic Surgeons and the Plastic Surgery Foundation (ASPS/PSF), the FDA has developed a registry of BIA-ALCL cases, known as the PROFILE Registry (Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma [ALCL] etiology and Epidemiology), to prospectively track and collect scientific data on ALCL in individuals with breast implants. The primary goal of this ongoing collaboration is to better understand the role of breast implants in the etiology of primary ALCL in individuals with breast implants. The research will also focus on identifying potential risk factors and criteria detection for the identification of at-risk individuals and the management of BIA-ALCL. Based on global data sharing, at the present time, the ASPS claims to be aware of 573 cases of BIA-ALCL worldwide with 33 disease-related deaths over 30 countries. From the current total of 573 confirmed cases of BIA-ALCL, 481 are reported to have had Allergan breast implants at the time of diagnosis. Information from the PROFILE registry about breast implants and treatment for BIA-ALCL will be available for practitioners and individuals with implants or considering breast implants. Registry data on confirmed cases of primary ALCL in individuals with breast implants will also be available for analytical epidemiological studies. The current status of the PROFILE registry is listed as collecting cases; additional information is available at: https://www.thepsf.org/research/registries/profile.

In 2016, the World Health Organization (WHO) provisionally designated BIA-ALCL as a unique form of T-cell lymphoma that can develop in some breast implant recipients. The following is noted:

The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces (WHO, 2016).

In October of 2019, researchers from Memorial Sloan Kettering Cancer Center presented preliminary evidence from a prospective cohort study of individuals who received reconstructive textured implants from a single surgeon between April 1993 and December 2017. The study followed 3546 women from a prospective database who received 6023 implants; 8 of these recipients developed BIA-ALCL after a median of 11.2 years of exposure. This equates to a risk of 0.294 cases per 1000 person-years (1 case per 443 women). Although the full study has not been published to date, this finding indicates that the risk of BIA-ALCL following implantation of a textured implant may be significantly higher than previously estimated (Ghione, 2019).

On July 24, 2019, the FDA announced the voluntary recall of specific models of textured breast implants manufactured by Allergan (Irvine, CA) from the U.S. market, due to the risk of BIA-ALCL. Following the FDA request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL^® textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. However, the FDA has recommended against removal of breast implants in individuals who have no symptoms due to the low risk of developing BIA-ALCL (FDA, 2019). On September 29, 2020, the FDA issued its final Guidance for Industry and FDA Staff for saline, silicone gel, and alternative breast implants, which is intended to guide implant manufacturers about labeling requirements and other necessary information for any future pre-market applications for breast implants. It includes detailed instructions about post-approval core studies to be conducted for 10 years to include data about complications and implant extractions to be reported to the FDA.

It has been noted in recent studies reporting on incidence of BIA-ALCL associated with breast implants that risk estimates of ALCL vary widely, prompting different responses from regulatory authorities around the world. Given the strong association between textured implants and ALCL, the rising incidence may be associated with both the increasing use of textured implants in the U.S. and increased recognition of the disease but may also reflect an increase in the incidence of all breast lymphomas. These updated risk estimates should increase the accuracy of epidemiological studies and support continued surveillance of breast ALCL by government and regulatory agencies (Kinslow, 2022).

On October 27, 2021, the FDA issued new labeling requirements for all legally marketed breast implants due to ongoing concerns about the possible risk of systemic illness or BIA-ALCL in individuals with silicone gel-filled breast implants. Also, the sale and distribution of breast implants will be restricted only to health care providers and facilities “That provide information to patients using the Patient Decision Checklist.” The manufacturers are required to post the following updated device labeling to their websites:

• Boxed warning;
• Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device;
• Updated silicone gel-filled breast implant rupture screening recommendations;
• Device description with a list of specific materials in the device;
• Patient device card.

In addition to BIA-ALCL, saline-filled implants have also been associated with infection, implant exposure, or pain related to capsular contracture, all requiring 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 in the case of confirmed BIA-ALCL.

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 person 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

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 for breast cancer 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/trauma, congenital defect, infection or other non-malignant disease.

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 as the second-stage procedure. 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. In some cases of breast cancer, reconstructive surgery (that is, reduction mammaplasty) is performed before the mastectomy or lumpectomy, in order to produce improved cosmesis and also to prevent postoperative complications following the mastectomy or lumpectomy. Regardless of the timing and which procedure(s) are 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.

Another surgical option that has gained some favorable feedback from individuals who have had a mastectomy is called aesthetic flat chest closure. This involves contouring of the chest wall after mastectomy without traditional breast reconstruction. The surgeon removes extra skin, pockets of fat or excess tissue, and tightens and smooths out the remaining tissue to create a flat chest wall contour. This procedure is considered reconstructive following a mastectomy for breast cancer and can be done immediately following the mastectomy or delayed until a few months later. In most cases individuals opt for removal of the contralateral breast and flat closure of that side also, in order to create a symmetrical appearance. A team of plastic surgeons from New York University noted that, to date, "There is no plastic surgery literature on specific techniques to achieve an aesthetic flat closure after mastectomy" (Morrison, 2022).

The National Cancer Institute (NCI) defines aesthetic flat closure as the following:

A type of surgery that is done to rebuild the shape of the chest wall after one or both breasts are removed. An aesthetic flat closure may also be done after removal of a breast implant that was used to restore breast shape. During an aesthetic flat closure, extra skin, fat, and other tissue in the breast area is removed. The remaining tissue is then tightened and smoothed out so that the chest wall appears flat (NCI, 2011).

Baker and colleagues described results of a satisfaction survey of 931 women who had a history of uni- or bilateral mastectomy for treatment of breast cancer or elevated breast cancer risk without current breast mound reconstruction. Satisfaction with outcomes and surgeon support for the individual’s experience were characterized using 5-level scaled scores. Mastectomy alone was the first choice for 73.7% of the respondents. The top two reasons for choosing flat closure were a desire for a faster recovery and avoidance of foreign body placement. Overall, the mean scaled satisfaction score was 3.72 ± 1.17 out of 5. In the multivariable analysis, low levels of surgeon support for the choice of flat closure were the strongest predictor of having a satisfaction score lower than 3 (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.59–5.72; p<0.001). The authors noted that dissatisfaction was more likely among respondents reporting a body mass index (BMI) of 30 kg/m2 or higher (OR, 2.74; 95% CI, 1.76–4.27; p<0.001) and those undergoing a unilateral procedure (OR, 1.99; 95% CI, 1.29–3.09; p=0.002). Greater satisfaction was associated with a perception of having received adequate information about surgical options (OR, 0.48; 95% CI, 0.32–0.69; p<0.0001) and having a surgeon with a specialized breast surgery practice (OR, 0.56; 95% CI, 0.38–0.81; p=0.002). The authors concluded that the majority of individuals who had undergone a mastectomy alone were satisfied with their surgical outcome. They noted that surgeons may optimize the individual’s experience by recognizing and supporting the choice of flat closure.

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.

Concepts of Medical Necessity, Reconstructive and Cosmetic

The coverage eligibility of medical and surgical therapies to treat breast conditions is often based on a determination of whether repair of the abnormality is considered medically necessary, reconstructive, or cosmetic in nature. In many instances, the concept of reconstructive overlaps with the concept of medical necessity. For example, breast surgery to address pain related to Baker Class IV capsular contracture will be considered medically necessary and thus eligible for coverage, regardless of the contract language pertaining to reconstructive services, unless some other exclusion applies. Generally, reconstructive is often taken to mean that the service “returns the person to whole” as a result of a congenital anomaly, disease, or other condition, including post trauma or post therapy. Cosmetic generally describes changing a physical appearance that would be considered within normal human anatomic variation. Categories of conditions without associated functional impairment that may be included as reconstructive definitions, include or may be due to the following: surgery, accidental trauma or injury, diseases, congenital anomalies (including Poland syndrome), severe anatomic variants, and chemotherapy or radiation therapy.

Choice of Breast Reconstruction Procedure

Breast reconstruction can play a pivotal part in recovery from breast cancer surgery. Reconstruction has been shown to improve quality of life in several domains including psychological, emotional, sexual, and social well-being. The choice and timing of breast reconstruction depends on a variety of factors that may be unique to each individual. Such factors include personal preference, degree of resection, prior surgeries or radiation treatments, body habitus including the amount of tissue available from donor sites, ongoing cancer treatment plans, and coexisting medical conditions. Common reconstructive techniques may include, but are not limited to, implant insertion, revision or removal of pre-existing implants (including implants placed for cosmetic purposes), reduction mammaplasty, surgery to the contralateral breast to achieve symmetry (which may include reduction mammaplasty, augmentation mammaplasty, mastopexy, or other procedures), tissue transfer, or chest wall reconstruction with flat chest closure.

Timing of Procedures

The number and timing of reconstructive breast procedures varies, depending on the individualized treatment plan developed by the treating physician(s) and the individual. These plans may be impacted by the overall treatment plan for the breast cancer itself.

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.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): This is a rare form of T-cell lymphoma (that is, Non-Hodgkin lymphoma) which is associated with breast implants. ALCL is characterized by abnormal growth of T-lymphocytes (T-cells) and strong expression of a protein, cytokine receptor CD30. ALCL can involve many parts of the body, including the lymph nodes and skin. There are currently two major variants of ALCL recognized in the literature, one of which expresses the protein anaplastic lymphoma kinase (ALK-positive) and a second which does not (ALK-negative). Reports in the scientific community have suggested a possible association between ALK-negative ALCL and silicone- and saline-filled breast implants. Optimum treatment is complete removal of the breast implants.

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, that 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 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.

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 before or after Breast Surgery
When services may be Reconstructive when criteria are met:

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:

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:

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.

Peer Reviewed Publications:

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24. Mathes SJ. Breast implantation: the quest for safety and quality, N Engl J Med. 1997; 336(10):718-719.
25. 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.
26. 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.
27. Mess SA. Lipoaugmentation following implant removal preferred by plastic surgeons and the general public. Plast Reconstr Surg Glob Open. 2018; 6(8):e1882.
28. Morrison K, Karp NS. Not just a linear closure: aesthetic flat closure after mastectomy. Plas Recon Surg - Global Open: May 2022; 10(5):e4327.
29. Nelson JA, McCarthy C, Dabic S, et al. BIA-ALCL and textured breast implants: a systematic review of evidence supporting surgical risk management strategies. Plast Reconstr Surg. 2021; 147(5S):7S-13S.
30. Panayi AC, Agha RA, Sieber BA, Orgill DP. Impact of obesity on outcomes in breast reconstruction: a systematic review and meta-analysis. J Reconstr Microsurg. 2018; 34(5):363-375.
31. 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.
32. 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.
33. Stanec Z1, Zic R, Budi S, et al. Skin and nipple-areola complex sparing mastectomy in breast cancer patients: 15-year experience. Ann Plast Surg. 2014; 73(5):485-491.
34. Steffens D, Kappos EA, Lunger A, et al. The double S technique to achieve aesthetic flat closure after conventional mastectomy. World J Surg Oncol. 2022; 20(1):42.
35. Stevens WG, Calobrace MB, Alizadeh K, et al. Ten-year core study data for Sientra's Food and Drug Administration-approved round and shaped breast implants with cohesive silicone gel. Plast Reconstr Surg. 2018; 141(4S):7S-19S.
36. 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.
37. Tanna N, Broer PN, Weichman KE, et al. Microsurgical breast reconstruction for nipple-sparing mastectomy. Plast Reconstr Surg. 2013; 131(2):139e-147e.
38. Weiss PR. Breast reconstruction after mastectomy. Am J Managed Care. 1997; 3(6):932-937.
39. Winocour S1, Saksena A, Oh C, et al. A systematic review of comparison of autologous, allogeneic, and synthetic augmentation grafts in nipple reconstruction. Plast Reconstr Surg. 2016; 137(1):14e-23e.
40. 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 Surgeons (ASPS). ASPS recommended insurance coverage for third party payers. Breast Implant Associated Anaplastic Large Cell Lymphoma. Approved Oct 2017; Reapproved June 2020. Available at: https://www.plasticsurgery.org/documents/Health-Policy/Reimbursement/Insurance-2017-BIA-ALCL.pdf. Accessed on October 30, 2023.
2. Baker JL. Augmentation mammaplasty. In Owsley JG, Peterson RA, eds: Symposium on Aesthetic Surgery of the Breast. St. Louis: Mosby, 1978.
3. 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 October 30, 2023.
4. 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.
5.  Coroneos CJ1, Selber JC, Offodile AC 2nd, et al. U.S. FDA breast implant postapproval studies: long-term outcomes in 99,993 patients. Ann Surg. 2019; 269(1):30-36.
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 October 30, 2023.
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. Lee BT, Agarwal JP, Ascherman JA, et al. Evidence-Based Clinical Practice Guideline: Autologous Breast Reconstruction with DIEP or Pedicled TRAM Abdominal Flaps. Plast Reconstr Surg. 2017; 140(5):651e-664e.
9. NCCN Clinical Practice Guidelines in Oncology^™. © 2023. National Comprehensive Cancer Network Clinical Practice guidelines in Oncology. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on September 21, 2023.
   • Breast Cancer (V3.2023). Revised March 23, 2023.
   • T-Cell Lymphoma (V1.2023). Revised January 5, 2023.
10. 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 October 30, 2023.
11. U.S. Food and Drug Administration (FDA). Breast implants: Additional Resources. Current: March 8, 2023. Available at: https://www.fda.gov/medical-devices/breast-implants/breast-implants-additional-resources. Accessed on October 30, 2023. 
12. 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 January 18, 2018. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064382.htm. Accessed on October 30, 2023.
13. 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. Current as of July 16, 2018. Available at: https://www.fda.gov/medical-devices/breast-implants/update-safety-silicone-gel-filled-breast-implants-2011-executive-summary. Accessed on  October 30, 2023.
14. U.S. Food and Drug Administration (FDA). Guidance for industry and FDA staff: saline, silicone gel, and alternative breast implants. September 29, 2020. Available at: https://www.fda.gov/media/71081/download. Accessed on October 30, 2023.
15. U.S. Food and Drug Administration (FDA). Labeling for approved breast implants. Current: August 4, 2022. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063743.htm. Accessed on October 30, 2023.
16. U.S. Food and Drug Administration (FDA). Information on breast implants and anaplastic large B-cell lymphoma. Current: October 23, 2019. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed on October 30, 2023.

1. American Society for Aesthetic Plastic Surgery (ASAPS). Breast augmentation. Available at: http://www.surgery.org/consumers/procedures/breast/breast-implants. Accessed on October 30, 2023.
2. American Society of Plastic Surgeons (ASPS): Breast reconstruction. Available at: http://www.plasticsurgery.org/Patients_and_Consumers/Procedures/Reconstructive_Procedures/Breast_Reconstruction.html. Accessed on October 30, 2023.
3. American Society of Plastic Surgeons (ASPS). BIA-ALCL Resources and frequently asked questions. ASPS 2022. Available at: https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary/frequently-asked-questions. Accessed on October 30, 2023.
4. National Cancer Institute: Breast cancer. Available at: http://www.cancer.gov/cancertopics/types/breast. Accessed on September 21, 2023.
5. National Cancer Institute (NCI). Dictionary of Cancer Terms – Aesthetic flat closure.. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/aesthetic-flat-closure. Accessed on October 30, 20232.
6. The Plastic Surgery Foundation. PROFILE registry. Available at: https://www.thepsf.org/research/registries/profile. Accessed on October 30, 2023.

Aesthetic flat chest closure
Augmentation Mammaplasty
BIOCELLTextured Implants
Breast Implants
Breast Lift
Breast Procedures
Mammoplasty
Mastopexy
Natrelle Saline-Filled breast implants
Natrelle Silicone-Filled breast implants
Natrelle Inspira Silicone-Filled breast implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
Reconstructive Breast Surgery
Reduction Mammaplasty

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.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Coverage Guidelines 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. Coverage Guidelines, 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 Coverage Guidelines periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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