POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY

Original Issue Date (Created): 6/21/2004 Most Recent Review Date (Revised): 3/24/2015 Effective Date: 12/31/2015 POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY I. POLICY Reconstructive breast surgery, including the use of prosthetic devices, may be considered medically necessary after a medically necessary mastectomy, accidental injury, or trauma. Medically necessary mastectomies, partial or total), are most typically done as treatment for cancer. Reconstruction may be performed by an implant based approach or through the use of autologous tissue. Explantation &/or capsulotomy of a silicone gel-filled breast implant may be considered medically necessary in all cases for any of the following indications; documented implant rupture; infection; extrusion; Baker Class IV contracture; or Surgical treatment of breast cancer. Explantation &/or capsulotomy of a saline-filled breast implant may be considered medically necessary for any of the following indications; infection; extrusion; Baker Class IV contracture; surgical treatment of breast cancer; or a ruptured implant if the original breast implantation was for reconstructive purposes. Page 1

Explantation &/or capsulotomy of a breast implant associated with a Baker Class III contracture may be considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes. The following indications for explantation of implants or capsulotomy are considered not medically necessary: Systemic symptoms, attributed to connective tissue diseases, autoimmune diseases, etc.; Patient anxiety; Baker Class I III contractures in patients with implants for cosmetic purposes; Rupture of a saline implant in patients with implants for cosmetic purposes; Pain not related to contractures or rupture. Reconstructive breast surgery after explantation of an implant is considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes. Application of the above policy regarding explantation of implants requires documentation of the original indication for implantation and the type of implant, either saline or silicone gel-filled, and the current symptoms, either local or systemic. (NOTE: See Attachment A to facilitate determination of the medical necessity of explantation). Mastopexy or reduction mammoplasty is considered reconstructive and medically necessary only when performed on the unaffected breast following previous mastectomy when the purpose is to provide symmetry with the breast on which the mastectomy has been performed. Patients who have originally undergone implantation of a cosmetic breast implant are not candidates for additional reconstructive surgery or replacement implantation following surgery. Products for Use in Breast Reconstructive Surgery Use of allogeneic acellular dermal matrix products* (i.e., AlloDerm, AlloMax, DermaMatrix, FlexHD, GraftJacket ) may be considered medically necessary for use in breast reconstructive surgery. Cross-references: MP-1.002 Augmentation Mammoplasty MP-1.004 Cosmetic and Reconstructive Surgery MP-1.036 Prophylactic Mastectomy and Prophylactic Bilateral Oophorectomy MP-1.013 Reduction Mammoplasty MP-1.017 Bio-Engineered Skin and Soft Tissue Substitutes Page 2

II. PRODUCT VARIATIONS TOP [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] Capital Cares 4 Kids [N] PPO [N] HMO [Y] Senior Blue HMO** Y] Senior Blue PPO** [N] Indemnity [N] SpecialCare [N] POS [Y] FEP PPO* *For products for use in breast reconstruction surgery, refer to FEP Medical Policy Manual MP- 7.01.113 Bio-Engineered Skin and Soft Tissue Substitutes. The FEP Medical Policy manual can be found at www.fepblue.org ** Refer to Novitas Solutions Local Coverage Determination (LCD) L35090 Cosmetic and Reconstructive Surgery. III. DESCRIPTION/BACKGROUND TOP Reconstructive breast surgery is defined as a surgical procedure that is designed to restore the normal appearance of the breast after surgery, accidental injury, or trauma. The most common indication for reconstructive breast surgery is a prior mastectomy. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone surgery, accidental injury, or trauma. Reduction mammoplasty is a common example of cosmetic breast surgery, but surgery to alter the appearance of a congenital abnormality of the breasts, such as tubular breasts, could also be considered cosmetic in nature. The most common type of reconstructive breast surgery is insertion of a silicone gel-filled or saline-filled breast implant, either inserted immediately at the time of mastectomy or sometime afterward in conjunction with the previous use of a tissue expander. Local complications of breast implants are frequent and may require removal of the implant. Contracture is the most common local complication of breast implants. Contractures have been graded according to the Baker classification as follows: 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 Page 3

Grade IV: Breast is hard, painful, cold, tender, and distorted. Other types of reconstruction include nipple/areola reconstruction, nipple tattooing, and/or the use of autologous tissue, such as a transverse rectus abdominus myocutaneous flap (TRAM procedure) or a latissimus dorsi flap. In addition, mastopexy or reduction mammoplasty on the contralateral breast may be performed to achieve symmetry with the reconstructed breast. ACT 81 of 2002-No Time Limit on Reconstructive Surgery-is a Pennsylvania mandate which removes the 6-year time limit on mandatory insurance coverage for reconstructive surgery following mastectomy for breast cancer. Act 81 now supersedes Act 51 of 1997 (The Mastectomy Health Security Act). This act also directs that all healthcare policies: shall not require early discharge after a mastectomy. The act requires coverage for a home health care visit that the treating physician determines is necessary within forty-eight hours after discharge when the discharge occurs within forty-eight hours following admission for the mastectomy. The act requires coverage for prosthetic devices and requires coverage for physical complications from breast cancer, including lymphedema. The Women s Health and Cancer Rights Act of 1998 is a federal mandate requiring group health plans that cover mastectomies to also cover reconstructive breast surgery following a mastectomy. In addition, reconstructive surgery and services after mastectomy, partial or total, is a mandated benefit in many states (i.e., Act 81 of 2002). Products for Use in Breast Reconstructive Surgery Acellular Dermal Matrix Allograft acellular dermal matrix products derived from donated human skin tissue are supplied by U.S. AATB-compliant tissue banks using the standards of the American Association of Tissue Banks (AATB) and U.S. Food and Drug Administration's (FDA) guidelines. The processing removes the cellular components (i.e., epidermis and all viable dermal cells) that can lead to rejection and infection. Acellular dermal matrix products from human skin tissue are regarded as minimally processed and not significantly changed in structure from the natural material; the FDA classifies it as banked human tissue and therefore does not require FDA approval. AlloDerm (LifeCell Corporation) is an acellular dermal matrix (allograft) tissuereplacement product that is created from native human skin and processed so that the basement membrane and cellular matrix remain intact. Originally, AlloDerm required refrigeration and rehydration prior to use. It is currently available in a ready-to-use product that is stored at room temperature. An injectable micronized form of AlloDerm (Cymetra) is also available. Page 4

AlloMax Surgical Graft (Bard Davol) is an acellular non-cross-linked human dermis allograft. (AlloMax was previously marketed as NeoForm.) FlexHD (Ethicon) is an acellular hydrated dermis derived from donated human allograft skin. The Musculoskeletal Transplant Foundation acquires and processes the tissue. DermaMatrix (Synthes) is an acellular dermal matrix (allograft) derived from donated human skin tissue. DermaMatrix Acellular Dermis is processed by the Musculoskeletal Transplant Foundation (MTF ). GraftJacket Regenerative Tissue Matrix (KCI) is an acellular regenerative tissue matrix that has been processed from screened donated human skin supplied from U.S. tissue banks. The allograft is minimally processed to remove the epidermal and dermal cells, while preserving dermal structure IV. RATIONALE TOP Breast Reconstruction Surgery The evidence on breast reconstruction surgery consists primarily of case series, the majority of which are retrospective. A smaller number of prospective cohort studies have also been published. There is a lack of clinical trials, including a very limited number of randomized controlled trials. The main outcomes that are important in breast reconstruction research are the cosmetic result, measures of psychosocial functioning, and rates of procedure-related morbidity. Numerous case series have demonstrated improvements in psychosocial functioning for women undergoing breast reconstruction following mammography. For example, the Michigan Breast Reconstruction Outcomes Study (1), there were improvements in all subscales of the SF-36 health status questionnaire, and on the FACT-B scale, a breast-cancer specific health status instrument. These improvements were maintained for up to two years following surgery. There is uncertainty in several areas of breast reconstruction. For women with breast cancer who are to receive radiotherapy post-mastectomy, the optimal timing and the preferred approach to breast reconstruction is controversial. Another important clinical question is the comparative effectiveness of different surgical approaches to reconstruction. The evidence for these two questions is reviewed below: What is the optimal timing and approach to breast reconstruction in patients receiving radiotherapy post-mastectomy? The potential advantages of immediate reconstruction are an improved cosmetic result, and avoiding the need to operate later on irradiated tissue. On the other hand, complications of reconstruction are higher if immediate reconstruction is followed by radiotherapy. Radiotherapy post-reconstruction has been shown to be an independent predictor of contractures, fact necrosis, Page 5

and poor cosmetic outcomes. (2) Delayed reconstruction avoids the problem of radiation complications in the reconstructed breast. The disadvantages of this approach are the psychologic distress associated with waiting for reconstruction following mastectomy, and the difficulty of operating on previously irradiated tissue. (3, 4) A Cochrane systematic review of immediate versus delayed breast reconstruction following mastectomy was published in 2011. (3) This review was confined to randomized controlled trials (RCTs) of immediate versus delayed surgery. Only one RCT from 1983 was identified, the results of which are probably not relevant to current clinical practice. As a result no conclusions could be drawn on immediate versus delayed reconstruction. Winters et al. (5) published a systematic review that focused on the health-related quality of life outcomes following breast reconstruction surgery. These authors included articles that compared the outcomes of different types of reconstruction, or that compared immediate versus delayed reconstruction. They identified two RCTs, 11 prospective longitudinal studies, and 21 retrospective studies. The majority of the studies used general QOL instruments, such as the SF- 36, rather than breast-specific QOL measures. The authors reported that the overall quality of the evidence was low. Most of the studies did not follow recommended methods for health-related quality of life research, and there was a high degree of variability in the reported outcomes. Combined analysis was not performed due to variations in study methodology and outcomes. Conclusions from this systematic review were that limitations of methodology precluded any meaningful conclusions on whether immediate or delayed reconstruction is the preferred approach. The Michigan Breast Reconstruction Outcomes Study (1) was a prospective longitudinal study from 12 centers, which followed patients who had undergone breast reconstruction following mastectomy for up to two years. The main outcomes that were evaluated were psychosocial measures, including the SF-36 and the Functional Assessment of Cancer Therapy Breast (FACT-B). A total of 287 women completed baseline surveys, and 173 completed the two-year follow-up for a response rate of 60.3%. The authors classified patients into the categories of immediate (n=116) versus delayed (n=57) reconstruction, and by the type of reconstructive surgery performed: pedicle TRAM (n=91), free TRAM (n=40) or expander/implant (n=42). There was an improvement in QOL for all groups following reconstruction. At two years, the magnitude of improvement was greater for the immediate reconstruction group. Statistically significant improvements compared to baseline were noted for the SF-36 subscales of vitality, general mental health, role emotional, and social functioning; and for the FACT-B social wellbeing scale. In the delayed reconstruction group, there was a significant improvement in the FACT-B social well being scale, but not for the subscales of the SF-36. This study suggests that QOL outcomes may be better in immediate reconstruction versus delayed reconstruction. However, these conclusions are limited by the methodologic weaknesses of the study, which include a lack of formal comparisons between groups, a large number of Page 6

dropouts at two years, and potential baseline differences in clinical characteristics of the groups that are compared. What is the comparative efficacy of different surgical techniques for breast reconstruction? There is a single RCT published comparing different techniques of breast reconstruction. (6) In this study, 87 women were randomized to one of three breast reconstruction techniques, and 75 women actually underwent one of the three procedures: Lateral thoracodorsal flap (n=16); Latissimus dorsi flap (n=30); or Transverse rectus abdominis muscle flap (TRAM) (n=29). At six months and one-year following surgery, patients were asked about their satisfaction with the cosmetic result and the impact of the surgery on important areas of their lives. In addition, patients completed the SF-36 health status survey. At six months there were 56 responses (75%) to the survey and at one-year there were 61 responses (81%). The majority of women reported a positive impact on major life areas and a positive change in overall health status. There were not significant differences among groups on any measure, except that the Latissimus dorsi group scored significantly lower on having problems with social situations compared to the other two groups. The results of this study support the conclusion that the benefit of breast reconstruction, in terms of cosmesis and quality of life, is roughly equivalent across different surgical techniques. In the Barry et al. (4) systematic review, the authors evaluated whether implant-based approach or an autologous tissue approach led to better outcomes in patients receiving radiotherapy. Of all patients receiving radiotherapy (n=380), 216 underwent implant-based reconstruction and 164 underwent autologous reconstruction. There was no significant difference in overall morbidity between those receiving implant-based reconstruction and those receiving autologous reconstruction (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.47-1.62). However, for the subset of women who underwent both radiotherapy and immediate breast reconstruction, overall morbidity was less common in women undergoing autologous reconstruction (OR 0.20, 95% CI 0.11-0.39). The Michigan Breast Reconstruction Outcomes Study (1) compared outcomes among patients. For most of the comparisons between types of surgeries, there were not significant differences noted. Patients who received delayed reconstruction with TRAM surgery had greater gains in body image compared with patients receiving implant-based reconstruction. Management of breast implants. Complications of breast implants are common and may require explantation. (7) Determining the medical necessity of explantation requires documentation of the type of implant and its original indication, i.e., whether reconstructive or cosmetic. The basic underlying principle is that cosmetic implants require explantation only for absolute medical indications that pose significant health consequences, while the criteria for explantation of reconstructive implants are broader. Since the purpose of reconstructive implants is the Page 7

restoration of normal breast appearance, in a small subset of patients explantation may be warranted in cases of unsatisfactory aesthetic outcome. Complications can be subdivided into local or systemic complications. Local complications include implant contracture, rupture, extrusion, or infection. Extrusion or infection are considered absolute medical indications for explantation in all cases, whether the implant was originally cosmetic or not. Documented rupture of a silicone gel-filled implant is considered an absolute indication for explantation in all cases. However, explantation of a ruptured saline implant is considered medically necessary only in the setting of prior reconstruction. Since normal saline is physiologic, rupture poses no health threat, and thus explantation would not be considered medically necessary in patients with cosmetic implants. However, a ruptured saline implant compromises the aesthetic outcome and thus explantation may be considered appropriate in cases of reconstructive implants. Rupture of the breast implant may be difficult to document, but physical exam, mammography, ultrasonography, or magnetic resonance imaging has been used. There is no consensus on which method affords the best sensitivity and specificity. (8-10) Although it has been suggested that older implants are associated with a higher incidence of rupture, there is no consensus that screening implants for rupture is warranted. Specifically, in the hearings on breast implants by the U.S. Food and Drug Administration (FDA), held in 1992, the FDA did not recommend screening for asymptomatic ruptures. Instead, workup for a potential rupture is typically initiated at the onset of local symptoms, such as sudden change in the size or consistency of an implant, or the development of local pain. Local complications of breast implants are frequent and may require removal of the implant. Contracture is the most common local complication of breast implants. Contractures are somewhat subjective findings, and can be graded according to the Baker classification as follows: (11) 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 Grade IV contractures interfere with adequate mammography screening and are the cause of local symptoms, and thus their presence constitutes a health risk. (12) Therefore, explantation may be considered medically necessary in all cases, regardless of whether the implant was originally inserted for cosmetic or reconstructive purposes. Grade III contractures, which describe firm, palpable implants, do not interfere with mammography; therefore, explantation of these implants is not considered an absolute indication for explantation. However, since Grade III contractures have an impact on the normal appearance of the breast, explantation may be appropriate in implants inserted for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved. Page 8

Potential systemic complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, has been controversial in the past. In particular, it had been hypothesized that leakage of silicone, due either to an implant rupture or to bleeding of silicone through an intact capsule, may incite an autoimmune response with the development of systemic symptoms. However, to date, large epidemiologic studies have not demonstrated that women with breast implants are overrepresented among all those with connective tissue disease. (13-16) In addition, there are inadequate empiric studies to demonstrate that removal of breast implants is associated with resolution of systemic symptoms. As a result of this evidence, there is not considered to be a relationship between silicone breast implants and systemic disease, particularly connective tissue disease. Patients with cosmetic implants may develop breast cancer. While lumpectomy can be accomplished without removal of the implant, in general, explantation as an adjunct to surgical treatment for breast cancer would be considered medically necessary. However, explantation is not necessary in patients who are undergoing chemotherapy or radiation therapy for breast cancer. Once an implant has been removed, patients who have originally undergone reconstructive implantation are candidates for additional reconstructive breast surgery, either insertion of another breast implant, or for autologous reconstruction of the breast, as described here. Patients who have originally undergone implantation of a cosmetic breast implant are not candidates for additional reconstructive breast surgery after explantation. Clinical Input Received from Academic Medical Centers and Specialty Societies None. Summary Breast reconstruction is intended for patients undergoing mastectomy for breast cancer, or who have an injury or trauma to the breasts. For the general population of women undergoing mastectomy, the evidence supports the conclusion that breast reconstruction improves psychosocial outcomes, such as anxiety, social functioning, and perception of body image. Thus, breast reconstruction may be considered medically necessary when reconstruction is needed as a result of breast cancer, injury, or trauma. Important clinical questions remain concerning the optimal timing of breast reconstruction in women undergoing radiotherapy, and concerning which of the surgical approaches leads to better outcomes. For women undergoing radiotherapy following mastectomy, the evidence is not sufficient to determine whether immediate or delayed surgery is preferred. The evidence is also not sufficient to determine the comparative efficacy of different procedures. There is some evidence that an autologous tissue approach leads to better cosmetic outcomes in patients receiving radiotherapy, but this is not from high-quality evidence and is not a consistent finding across studies. Page 9

Breast implants can be used as part of breast reconstruction, or for cosmetic reasons. Local complications of breast implants are common, and may lead to explantation. The medical necessity of implant explantation is dependent on the type of implant, the indication for removal, and the original indication for implantation (see Policy Guidelines). Clinical Practice Guidelines and Consensus Statements The 2014 National Comprehensive Cancer Network (NCCN) guidelines (17) did not produce formal guidelines concerning breast reconstruction, however, they included a section in their breast cancer that was titled Principles of Breast Reconstruction Following Surgery. The following summarizes the statements in this section: The breast can be reconstructed using breast implants, autologous tissue or a combination of the two. Breast reconstruction can be performed immediately following mastectomy or after a delay following mastectomy. Skin-sparing mastectomy is probably equivalent to standard mastectomy in terms of local and regional recurrence. Skin sparing mastectomy should be performed by an experienced breast surgery team. When post-mastectomy radiation is required: o Delayed reconstruction is generally preferred for autologous reconstruction o Immediate reconstruction is generally preferred for implant reconstruction Selection of type of reconstruction is dependent on cancer treatment, body habitus, smoking history, comorbidities, and patient preferences. An evaluation of the likely cosmetic outcome of lumpectomy should be performed prior to surgery. Women who are not satisfied with the cosmetic outcome following completion of breast cancer treatment should be offered a plastic surgery consultation. V. DEFINITIONS TOP AUTOLOGOUS refers to originating within an individual; i.e., self-donation. CAPSULOTOMY-refers to division of a capsule as around a breast implant; creation of an opening through a capsule; e.g., of a scar that might form around a foreign body. CONTRACTURE refers to fibrosis of connective tissue in skin, fascia, muscle or a joint capsule that prevents normal mobility of the related tissue or joint. COSMETIC SURGERY is an elective procedure performed primarily to restore a person s appearance by surgically altering a physical characteristic that does not prohibit normal function, but is considered unpleasant or unsightly. EXPLANTATION refers to the removal of an implant. Page 10

MAMMOPLASTY refers to plastic reconstructive surgery of the breast. MASTECTOMY per Act 81 is defined as: the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician. (This is NOT restricted to cancer indications.) MASTOPEXY is the correction of a pendulous breast or surgical fixation and plastic surgery. PROSTHETIC DEVICES refers to the initial and subsequent artificial devices to replace the removed breast or portions thereof, ordered by the patient s physician. RECONSTRUCTIVE SURGERY-a procedure performed to improve or correct a functional impairment, restore a bodily function or correct a deformity resulting from birth defect or accidental injury. The fact that a member might suffer psychological consequences from a deformity does not, in the absence of bodily functional impairment, qualify surgery as being reconstructive surgery. VI. BENEFIT VARIATIONS TOP The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VII. DISCLAIMER TOP Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. Page 11

VIII. CODING INFORMATION TOP Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Covered when medically necessary: CPT Codes 11920 11921 11922 19316 19318 19324 19325 19328 19330 19340 19342 19350 19355 19357 19361 19364 19366 19367 19368 19369 19370 19371 19380 19396 19499 Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. HCPCS Code C1789 L8600 S2066 S2067 S2068 Description Prosthesis, breast (implantable) Implantable breast prosthesis, silicone or equal 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 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 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-9-CM Diagnosis Description Code* 174.0 Malignant neoplasm of female breast; nipple and areola 174.1 Malignant neoplasm of female breast; central portion 174.2 Malignant neoplasm of female breast; upper-inner quadrant 174.3 Malignant neoplasm of female breast; lower-inner quadrant 174.4 Malignant neoplasm of female breast; upper-outer quadrant 174.5 Malignant neoplasm of female breast; lower-outer quadrant 174.6 Malignant neoplasm of female breast; axillary tail 174.8 Malignant neoplasm of female breast; other specified sites 175.0 Malignant neoplasm of male breast; nipple and areola Page 12

ICD-9-CM Diagnosis Description Code* 175.9 Malignant neoplasm of male breast; other specified sites 198.81 Secondary malignant neoplasm of other specified sites; breast 233.0 Carcinoma in situ of breast 238.3 Neoplasm of uncertain behavior of breast 611.0 Inflammatory disease of breast 611.3 Fat necrosis of breast 611.71 Mastodynia 611.83 Capsular contracture of breast implant 612.0 Deformity of reconstructed breast 612.1 Disproportion of reconstructed breast 996.54 Mechanical complication due to breast prosthesis 996.69 Infection and inflammatory reaction due to other internal prosthetic device, implant, and graft 996.79 Other complications due to other internal prosthetic device, implant, and graft V10.3 Personal history of malignant neoplasm of breast V16.3 Family history of malignant neoplasm of breast V43.82 Organ or tissue replaced by other means; breast V45.71 Acquired absence of breast and nipple *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. The following ICD-10 diagnosis codes will be effective October 1, 2015: ICD-10-CM Diagnosis Description Code* C20.212 Malignant neoplasm of upper-inner quadrant of left female breast C50.011 Malignant neoplasm of nipple and areola, right female breast C50.012 Malignant neoplasm of nipple and areola, left female breast C50.021 Malignant neoplasm of nipple and areola, right male breast C50.022 Malignant neoplasm of nipple and areola, left male breast C50.111 Malignant neoplasm of central portion of right female breast C50.112 Malignant neoplasm of central portion of left female breast C50.121 Malignant neoplasm of central portion of right male breast C50.122 Malignant neoplasm of central portion of left male breast C50.211 Malignant neoplasm of upper-inner quadrant of right female breast C50.221 Malignant neoplasm of upper-inner quadrant of right male breast C50.222 Malignant neoplasm of upper-inner quadrant of left male breast Page 13

ICD-10-CM Diagnosis Description Code* C50.311 Malignant neoplasm of lower-inner quadrant of right female breast C50.312 Malignant neoplasm of lower-inner quadrant of left female breast C50.321 Malignant neoplasm of lower-inner quadrant of right male breast C50.322 Malignant neoplasm of lower-inner quadrant of left male breast C50.411 Malignant neoplasm of upper-outer quadrant of right female breast C50.412 Malignant neoplasm of upper-outer quadrant of left female breast C50.421 Malignant neoplasm of upper-outer quadrant of right male breast C50.422 Malignant neoplasm of upper-outer quadrant of left male breast C50.511 Malignant neoplasm of lower-outer quadrant of right female breast C50.512 Malignant neoplasm of lower-outer quadrant of left female breast C50.521 Malignant neoplasm of lower-outer quadrant of right male breast C50.522 Malignant neoplasm of lower-outer quadrant of left male breast C50.611 Malignant neoplasm of axillary tail of right female breast C50.612 Malignant neoplasm of axillary tail of left female breast C50.621 Malignant neoplasm of axillary tail of right male breast C50.622 Malignant neoplasm of axillary tail of left male breast C50.811 Malignant neoplasm of overlapping sites of right female breast C50.812 Malignant neoplasm of overlapping sites of left female breast C50.821 Malignant neoplasm of overlapping sites of right male breast C50.822 Malignant neoplasm of overlapping sites of left male breast C79.81 Secondary malignant neoplasm of breast D05.01 Lobular carcinoma in situ of right breast D05.02 Lobular carcinoma in situ of left breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.81 Other specified type of carcinoma in situ of right breast D05.82 Other specified type of carcinoma in situ of left breast D48.61 Neoplasm of uncertain behavior of right breast D48.62 Neoplasm of uncertain behavior of left breast N61 Inflammatory disorders of breast N64.1 Fat necrosis of breast N64.4 Mastodynia N64.89 Other specified disorders of breast N65.0 Deformity of reconstructed breast N65.1 Disproportion of reconstructed breast T85.41XA T85.41XD Breakdown (mechanical) of breast prosthesis and implant, initial encounter Breakdown (mechanical) of breast prosthesis and implant, subsequent encounter Page 14

ICD-10-CM Diagnosis Code* T85.41XS T85.42XA T85.42XA T85.42XD T85.43XA T85.43XA T85.43XD T85.44XA T85.44XA T85.44XA T85.44XD T85.44XD T85.44XS T85.49XA T85.49XA T85.49XD T85.79XA T85.79XD T85.79XS T85.82XA T85.82XD T85.82XS Description Breakdown (mechanical) of breast prosthesis and implant, sequela Displacement of breast prosthesis and implant, initial encounter Displacement of breast prosthesis and implant, sequela Displacement of breast prosthesis and implant, subsequent encounter Leakage of breast prosthesis and implant, initial encounter Leakage of breast prosthesis and implant, sequela Leakage of breast prosthesis and implant, subsequent encounter Capsular contracture of breast implant, initial encounter Capsular contracture of breast implant, initial encounter Capsular contracture of breast implant, sequela Capsular contracture of breast implant, subsequent encounter Capsular contracture of breast implant, subsequent encounter Capsular contracture of breast implant, sequela Other mechanical complication of breast prosthesis and implant, initial encounter Other mechanical complication of breast prosthesis and implant, sequela Other mechanical complication of breast prosthesis and implant, subsequent encounter Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, initial encounter Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, subsequent encounter Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, sequela Fibrosis due to internal prosthetic devices, implants and grafts, not elsewhere classified, initial encounter Fibrosis due to internal prosthetic devices, implants and grafts, not elsewhere classified, subsequent encounter Fibrosis due to internal prosthetic devices, implants and grafts, not elsewhere classified, sequela T85.84XA Pain due to internal prosthetic devices, implants and grafts, not elsewhere classified, initial encounter T85.84XD Pain due to internal prosthetic devices, implants and grafts, not elsewhere classified, subsequent encounter T85.84XS Pain due to internal prosthetic devices, implants and grafts, not elsewhere classified, sequela T85.89XA Other specified complication of internal prosthetic devices, implants and grafts, not elsewhere classified, initial encounter T85.89XD Other specified complication of internal prosthetic devices, implants and grafts, not elsewhere classified, subsequent encounter T85.89XS Other specified complication of internal prosthetic devices, implants and grafts, not elsewhere classified, sequela Z80.3 Family history of malignant neoplasm of breast Z85.3 Personal history of malignant neoplasm of breast Z90.11 Acquired absence of right breast and nipple Z90.12 Acquired absence of left breast and nipple Page 15

ICD-10-CM Diagnosis Description Code* Z90.13 Acquired absence of bilateral breasts and nipples Z98.82 Breast implant status *If applicable, please see Medicare LCD or NCD for additional covered diagnoses. IX. REFERENCES TOP 1. Atisha D, Alderman AK, Lowery JC et al. Prospective analysis of long-term psychosocial outcomes in breast reconstruction: two-year postoperative results from the Michigan Breast Reconstruction Outcomes Study. Ann Surg 2008; 247(6):1019-28. 2. Serletti JM, Fosnot J, Nelson JA et al. Breast reconstruction after breast cancer. Plast Reconstr Surg 2011; 127(6):124e-35e. 3. D'Souza N, Darmanin G, Fedorowicz Z. Immediate versus delayed reconstruction following surgery for breast cancer. Cochrane Database Syst Rev 2011; (7):CD008674. 4. Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat 2011; 127(1):15-22. 5. Winters ZE, Benson JR, Pusic AL. A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient- reported outcome measures and health-related quality of life. Ann Surg 2010; 252(6):929-42. 6. Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg 2000; 105(1):66-74; discussion 75-6. 7. Gabriel SE, Woods JE, O'Fallon WM et al. Complications leading to surgery after breast implantation. The New England journal of medicine 1997; 336(10):677-82. 8. Chung KC, Wilkins EG, Beil RJ, Jr. et al. Diagnosis of silicone gel breast implant rupture by ultrasonography. Plast Reconstr Surg 1996; 97(1):104-9. 9. Netscher DT, Weizer G, Malone RS et al. Diagnostic value of clinical examination and various imaging techniques for breast implant rupture as determined in 81 patients having implant removal. South Med J 1996; 89(4):397-404. 10. Samuels JB, Rohrich RJ, Weatherall PT et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg 1995; 96(4):865-77. 11. Baker JL. Augmentation mammoplasty. In: Owsley JQ, Jr., Peterson RA, eds. Symposium on aesthetic surgery of the breast. St. Louis: CV Mosby; 1978. Page 16

12. American Society of Plastic and Reconstructive Surgeons. American Society of Plastic and Reconstructive Surgeons Citizens' Petition to the Food and Drug Administration which requests that silicone gel-filled implants remain available because the device is necessary for the public health. Arlington Heights, IL November 29 1991. 13. Gabriel SE, O'Fallon WM, Kurland LT et al. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994; 330(24):1697-702. 14. Hennekens CH, Lee IM, Cook NR et al. Self-reported breast implants and connectivetissue diseases in female health professionals. A retrospective cohort study. JAMA 1996; 275(8):616-21. 15. Sanchez-Guerrero J, Colditz GA, Karlson EW et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med 1995; 332(25):1666-70. 16. Silverman BG, Brown SL, Bright RA et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med 1996; 124(8):744-56. 17. National Comprehensive Cancer Network. Invasive Breast Cancer: Principles of breast reconstruction following surgery. Version 3.2014. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed January 28, 2015. Other Sources: Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) 140.2 Breast Reconstruction Following Mastectomy. Effective 01/01/97. CMS [Website]: http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=64&ncdver=1&docid=140.2&bc=gaaaabaaaaaa& Accessed March 13, 2014. Novitas Solutions. Local Coverage Determination (LCD) L35090 Cosmetic and Reconstructive Surgery. Effective 12/31/1/5. [Website]: https://www.novitas-solutions.com/policy/mac-ab/l31481-r1.html Accessed November 13, 2015. Taber s Cyclopedic Medical Dictionary, 20 th edition. Page 17

Attachment A The following chart should facilitate determination of the medical necessity of explantation or capsulotomy. Yes indicates that the explantation or capsulotomy would be considered medically necessary given the symptoms, type of implant, and original indication for implantation. Page 18

*Rupture of implants requires documentation with an imaging study, such as mammography, magnetic resonance imaging, or ultrasonography. Lack of imaging confirmation of rupture in association with persistent local symptoms requires case by case consideration. ** Pain as an isolated symptom is an inadequate indication for explantation. The pain should be related to the Baker classification or a diagnosis of rupture. X. POLICY HISTORY TOP MP 1.103 CAC 2/24/04 CAC 11/30/04 CAC 11/29/05 CAC 11/28/06 CAC 2/27/07 CAC 1/29/08 CAC 3/31/09 CAC 3/30/10 Consensus Review CAC 4/26/11 Consensus 10/12/11 FEP variation updated with FEP policy MP 7.01.113 Allograft Use in Breast Reconstruction Surgery. CAC 8/28/12 Consensus review. References updated. Added statement regarding methods by which reconstruction can be performed. Code reviewed 8/16/12 klr CAC 7/30/13 Consensus. No change to policy statements. References updated. No coding changes. CAC 3/25/14 Consensus. Deleted the medically necessary statement regarding use of allograft material in breast reconstructive surgery and added the following statement, " Use of allogeneic acellular dermal matrix products* (i.e., AlloDerm, AlloMax, DermaMatrix, FlexHD, GraftJacket ) may be considered medically necessary for use in breast reconstructive surgery. No change to other policy statements. For FEP variation - changed title of policy to match title on FEP policy. CAC 3/24/15 Consensus review. No changes to policy statements. Rationale added. References updated. Coding reviewed. 12/31/15 Administrative Change. Added variation to reference LCD L35090 Cosmetic and Reconstructive Surgery. Top Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company, Capital Advantage Assurance Company and Keystone Health Plan Central. Independent licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 19