Aetna considers reconstructive breast surgery medically necessary after a medically necessary mastectomy or a medically necessary lumpectomy that results in a significant deformity (i.e., mastectomy or lumpectomy for treatment of or prophylaxis for breast cancer and mastectomy or lumpectomy performed for chronic, severe fibrocystic breast disease, also known as cystic mastitis, unresponsive to medical therapy).  Medically necessary procedures include capsulectomy, capsulotomy, implantation of Food and Drug Administration (FDA)-approved internal breast prosthesis, mastopexy, insertion of breast prostheses, the use of tissue expanders, or reconstruction with a latissimus dorsi (LD) myocutaneous flap, Ruben’s flap, superficial inferior epigastric perforator (SIEP) flap, superior or inferior gluteal free flap, transverse upper gracilis (TUG) flap, transverse rectus abdominis myocutaneous (TRAM) flap, deep inferior epigastric perforator (DIEP) flap, or similar procedures, including skin sparing techniques. 

Harvesting and grafting of autologous fat as a replacement for implants for breast reconstruction, or to fill defects after breast conservation surgery or other reconstructive techniques, is considered medically necessary.

The use of the following acellular dermal matrices are considered medically necessary for breast reconstruction: Alloderm (LifeCell Corp., Branchburg, NJ), Alloderm-RTU (LifeCell Corp., Branchburg, NJ), FlexHD (Musculoskeletal Transplant Foundation/Ethicon, Inc., Somerville, NJ), DermaMatrix (Musculoskeletal Transplant Foundation/Synthes CMF, West Chester, PA), AlloMax (formerly NeoForm) (Davol, Inc., Warwick, RI), and Strattice (LifeCell Corp., Branchburg, NJ).

Aetna considers associated nipple and areolar reconstruction and tattooing of the nipple area medically necessary.  Reduction (or some cases augmentation) mammoplasty and related reconstructive procedures on the unaffected side for symmetry are also considered medically necessary.

Aetna considers breast reconstructive surgery to correct breast asymmetry cosmetic except for: (i) surgical correction of chest wall deformity causing functional deficit in Poland syndrome when criteria are met in CPB 0272 - Pectus Excavatum and Poland’s Syndrome: Surgical Correction; or (ii) repair of breast asymmetry due to a medically necessary mastectomy or a medically necessary lumpectomy that results in a significant deformity.  Medically necessary procedures on the non-diseased/unaffected/contralateral breast to produce a symmetrical appearance may include areolar and nipple reconstruction, areolar and nipple tattooing, augmentation mammoplasty, augmentation with implantation of FDA-approved internal breast prosthesis when the unaffected breast is smaller than the smallest available internal prosthesis, breast implant removal and subsequent re-implantation when performed to produce a symmetrical appearance, breast reduction by mammoplasty or mastopexy, capsulectomy, capsulotomy, and reconstructive surgery revisions to produce a symmetrical appearance; or (iii) prompt* repair of breast asymmetry due to trauma.  (*Note: See CPB 0031 - Cosmetic Surgery for criteria related to surgical repair of cosmetic disfigurement due to trauma).

Aetna considers Biodesign Nipple Reconstruction Cylinder experimental and investigational becasue its effectiveness has not been established.

See also CPB 0017 - Breast Reduction Surgery and Gynecomastia Surgery, and CPB 0244 - Wound Care.

Breast reconstruction using autologous tissue is most commonly performed using the transverse rectus abdominis myocutaneous (TRAM) flap.  This flap has been in use for 20 years and has provided excellent aesthetic results.  However, a drawback of the TRAM flap is related to donor site morbidity of the abdomen.  The pedicle TRAM flap frequently requires use of the entire rectus abdominis muscle, while the free TRAM flap requires use of as little as a postage-stamp size portion of the muscle.  Abdominal complications resulting from a sacrifice of all or a portion of the rectus abdominis muscle include a reduction in abdominal strength (10 to 50 %), abdominal bulge (5 to 20 %), and hernia (less than 5 %).

Perforator flaps have gained increasing attention with the realization that the muscle component of the TRAM flap does not add to the quality of the reconstruction and serves only as a carrier for the blood supply to the flap.  Thus, the concept of separating the flap (skin, fat, artery, and vein) from the muscle was realized as a means of minimizing the morbidity related to the abdominal wall and maintaining the aesthetic quality of the reconstruction.  The deep inferior epigastric perforator (DIEP) flap was introduced in the early 1990's and is identical to the free TRAM flap except that it contains no muscle or fascia.  Use of this flap has been popular in the Europe for a number of years and is now gaining popularity in the United States.  The DIEP flap has been performed at Johns Hopkins for several years.  Candidates for this operation are similar to those for the free TRAM in that there must be adequate abdominal fat to create a new breast.  However, caution must be exercised in performing this technique in women who require large volume reconstruction to prevent the occurrence of fat necrosis or hardening of the new breast.  The operation can be performed immediately following mastectomy or on a delayed basis.  Performance of this operation is slightly more difficult than the free TRAM flap because it requires meticulous dissection of the perforating vessels from the muscle.

Deep inferior epigastric perforator flaps tend to have less robust blood flow than is typical with a standard TRAM reconstruction, so careful patient selection is important.  In patients who are non-smokers, who require no more than 70 % of the TRAM flap skin paddle to make a breast of adequate size, and who have at least 1 perforating vessel greater than 1-mm in diameter with a detectable pulse, the incidence of flap complications reportedly is similar to that seen in standard free TRAM flap reconstruction.

Superior gluteal artery perforator (SGAP) flaps may be performed on women who are not candidates for a TRAM flap or who have had a failed TRAM flap.  Thin women who may not have much tissue in the lower abdominal area often have an adequate amount of tissue in the gluteal region.  The inferior gluteal artery perforator (SGAP) flap shares the same indications as the superior gluteal flap, namely the inability to use the TRAM flap and an abundance of soft tissue in the gluteal region.

Poland syndrome is an extremely rare developmental disorder that is present at birth (congenital).  It is characterized by absence (agenesis) or under-development (hypoplasia) of certain muscles of the chest (e.g., pectoralis major, pectoralis minor, and/or other nearby muscles), and abnormally short, webbed fingers (symbrachydactyly).  Additional findings may include underdevelopment or absence of 1 nipple (including the darkened area around the nipple [areola]) and/or patchy hair growth under the arm (axilla).  In females, 1 breast may also be under-developed (hypoplastic) or absent (amastia).  In some cases, affected individuals may also exhibit under-developed upper ribs and/or an abnormally short arm with under-developed forearm bones (i.e., ulna and radius) on the affected side.  In most cases, physical abnormalities are confined to one side of the body (unilateral).  In approximately 75 % of the cases, the right side of the body is affected.  The range and severity of symptoms may vary from case to case.  The exact cause of Poland syndrome is not known.

Autologous fat grafting (or lipomodeling) uses the patient's own fat cells to replace volume after breast reconstruction, or to fill defects in the breast following breast-conserving surgery (NICE, 2012). It can be used on its own or as an adjunct to other reconstruction techniques. The procedure aims to restore breast volume and contour without the morbidity of other reconstruction techniques.  With the patient under general or local anesthesia, fat is harvested by aspiration with a syringe and cannula, commonly from the abdomen, outer thigh or flank. The fat is usually washed and centrifuged before being injected into the breast. Patients subsequently undergo repeat treatments (typically 2 to 4 sessions) (NICE, 2012). Autologous fat grafting may be delayed for a variable period of time after mastectomy. Most of the evidence for the use of autologous fat grafting in breast reconstruction is as a technique to repair contour defects and deformities. There is less information about the use of autologous fat grafting for complete breast reconstruction.

Guidance from the National Institute for Health and Clinical Excellence (NICE, 2012) states that current evidence on the efficacy of breast reconstruction using lipomodelling after breast cancer treatment is adequate and the evidence raises no major safety concerns. The guidance noted that there is a theoretical concern about any possible influence of the procedure on recurrence of breast cancer in the long term, although there is no evidence of this in published reports. The guidance notes that a degree of fat resorption is common in the first 6 months and there have been concerns that it may make future mammographic images more difficult to interpret.  

A technology assessment on autologous fat injection for breast reconstruction prepared for the Australian and New Zealand Horizon Scanning Network (Humphreys, 2008) found that the technique has the potential to improve some contour defects; however, the results appear to be highly variable, with 2 case series finding that following autologous fat injection between 21 % and 86.5 % of patients showed substantial improvement at post-operative assessment.  Patient satisfaction with the procedure was not reported.  The assessment stated that longer-term follow-up is needed to determine how much of the injected fat survives and how much is eventually re-absorbed by the body.  There are also important safety issues with the procedure, especially in association with the lipo-necrotic lumps that can form in the breast from the injected fat.  Both case series reported this to occur in approximately 7 % of cases, and there is concern that such lumps will impede future cancer detection.

Hyakusoku et al (2009) reported several cases of complications following fat grafting to the breast.  These investigators retrospectively reviewed 12 patients who had received autologous fat grafts to the breast and required breast surgery and/or reconstruction to repair the damage presenting between 2001 and 2007.  All 12 patients (mean age of 39.3 years) had received fat injections to the breast for augmentation mammaplasty for cosmetic purposes.  They presented with palpable indurations, 3 with pain, 1 with infection, 1 with abnormal breast discharge, and 1 with lymphadenopathy.  Four cases had abnormalities on breast cancer screening.  All patients underwent mammography, computed tomography, and magnetic resonance imaging to evaluate the injected fats.  The authors concluded that autologous fat grafting to the breast is not a simple procedure and should be performed by well-trained and skilled surgeons.  Patients should be informed that it is associated with a risk of calcification, multiple cyst formation, and indurations, and that breast cancer screens will always detect abnormalities.  Patients should also be followed-up over the long-term and imaging analyses (e.g., mammography, echography, computed tomography, and magnetic resonance imaging) should be performed.

The American Society of Plastic Surgeons (ASPS) fat grafting task force (Gutowski, 2009) concluded that autologous fat grafting is a promising and clinically relevant research topic.  The current fat grafting literature is limited primarily to case studies, leaving a tremendous need for high-quality clinical studies.

Mizuno and Hyakusoku (2010) stated that recent technical advances in fat grafting and the development of surgical devices such as liposuction cannulae have made fat grafting a relatively safe and effective procedure.  However, guidelines issued by the ASPS in 2009 announced that fat grafting to the breast is not a strongly recommended procedure, as there are limited scientific data on the safety and efficacy of this particular type of fat transfer.  Recent progress by several groups has revealed that multi-potent adult stem cells are present in human adipose tissue.  This cell population, termed adipose-derived stem cells (ADSC), represents a promising approach to future cell-based therapies, such as tissue engineering and regeneration.  In fact, several reports have shown that ADSC play a pivotal role in graft survival through both adipogenesis and angiogenesis.  Although tissue augmentation by fat grafting does have several advantages in that it is a non-invasive procedure and results in minimal scarring, it is essential that such a procedure be supported by evidence-based medicine and that further research is conducted to ensure that fat grafting is a safe and effective procedure.

Acellular dermal matrices are considered a standard-of-care as an adjunct to breast reconstruction. The clinical literature on acellular dermal matrix product in breast reconstruction primarily consists of single institution case series focusing on surgical technique. Much of the early literature focused on AlloDerm brand of acellular dermal matrix, since this product was first to market, but more recent literature has considered other acellular dermal matrix products. Recent literature has provided comparisons of AlloDerm to certain other acellular dermal matrix products, with the authors concluding that there is no significant difference among products (see, e.g., Ibrahim, et al., 2013; Cheng, et al., 2012). While different acellular dermal matrix products are processed differently, these appear to result in minor differences in performance in breast reconstruction.

The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.  It is supplied sterile and is intended for 1-time use.  There is a lack of evidence regading the clincial value of this product in breast reconstructive surgery.

Llewellyn-Bennett et al (2012) noted that latissimus dorsi (LD) flap procedures comprise 50 % of breast reconstructions in the United Kingdom.  They are frequently complicated by seroma formation.  In a randomized study, these researchers investigated the effect of fibrin sealant (Tisseel(®)) on total seroma volumes from the breast, axilla and back (donor site) after LD breast reconstruction.  Secondary outcomes were specific back seroma volumes together with incidence and severity of wound complications.  Consecutive women undergoing implant-assisted or extended autologous LD flap reconstruction were randomized to either standard care or application of fibrin sealant to the donor-site chest wall.  All participants were blinded for the study duration but assessors were only partially blinded.  Non-parametric methods were used for analysis.  A total of 107 women were included (sealant = 54, control = 53).  Overall, back seroma volumes were high, with no significant differences between control and sealant groups over 3 months.  Fibrin sealant failed to reduce in-situ back drainage volumes in the 10 days after surgery, and did not affect the rate or volume of seromas following drain removal.  The authors concluded that the findings of this randomized study, which was powered for size effect, failed to show any benefit from fibrin sealant in minimizing back seromas after LD procedures.