BREAST RECONSTRUCTIVE SURGERY

BREAST RECONSTRUCTIVE SURGERY Policy Number: 2013M0043A Effective Date: January 1, 2014 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION 2 Bioengineered Skin Substitutes, COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 2013M0011A BACKGROUND 4 REGULATORY STATUS 6 CLINICAL EVIDENCE 8 APPLICABLE CODES 9 REFERENCES 13 POLICY HISTORY/REVISION INFORMATION 16 INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page. 1 of 16

POLICY DESCRIPTION: This policy describes reconstructive breast surgery and the surgical procedures that are used to rebuild the contour of the breast, along with the nipple and areola if desired. Typically, breast reconstruction is performed following a mastectomy (e.g., the breast has been removed because of breast cancer) or lumpectomy (e.g., 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. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: RECONSTRUCTIVE AND MEDICALLY NECESSARY: A. Breast surgery to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance, is considered RECONSTRUCTIVE AND MEDICALLY NECESSARY, following a medically necessary mastectomy, lumpectomy, or other medically necessary breast surgery that results in a significant deformity (e.g., mastectomy or lumpectomy for treatment of or prophylaxis for breast cancer and mastectomy or lumpectomy performed for chronic, severe fibrocystic breast disease). The number and timing of these procedures varies, depending on the individualized treatment plan devised by the treating physician(s) and the individual, and may be impacted by the overall treatment plan for the breast cancer itself. MEDICALLY NECESSARY procedures may include: Capsulectomy Capsulotomy Implantation of Food and Drug Administration (FDA)-approved internal breast prosthesis Mastopexy Insertion of breast prostheses Use of tissue expanders Extensive flap reconstructive procedures where muscle tissue is transposed from another site 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 The use of acellular dermal matrices (biosynthetic skin substitutes): Alloderm, Alloderm-RTU, FlexHD, DermaMatrix, AlloMax (formerly NeoForm), and Strattice. Note: For more information on skin substitutes (acellular dermal matrices) refer to medical policy Bioengineered Skin Substitutes, 2013M0011A. Nipple and areolar reconstruction and tattooing of the nipple Reduction (or some cases augmentation) mammoplasty and related reconstructive procedures on the unaffected side for symmetry are also considered MEDICALLY NECESSARY. B. Removal and reimplantation of breast prostheses Removal of a ruptured breast implant is MEDICALLY NECESSARY regardless of the indication for the initial implant placement. Reimplantation of a removed breast implant is considered RECONSTRUCTIVE and MEDICALLY Page. 2 of 16

NECESSARY if the original implantation was done for mastectomy, lumpectomy or other reconstructive purposes as defined above on section A. Surgery to produce a symmetrical appearance on the unaffected breast, after removal and reimplantation of a medically necessary implant, is also considered RECONSTRUCTIVE and MEDICALLY NECESSARY if the original implantation was done for mastectomy, lumpectomy or other reconstructive purposes as defined above on section A. C. Breast surgery to alter the contour of the breast is considered reconstructive when there are significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease. A specific example of this is Poland's syndrome which may be diagnosed when all of the following are present: Congenital absence or hypoplasia of pectoralis major and minor muscles; and Breast hypoplasia; and Congenital partial absence of the upper costal cartilage. COSMETIC AND NOT MEDICALLY NECESSARY: 1. Removal or replacement of ANY type of breast implant that is not ruptured, has no visible distortion, or is unassociated with local breast complications is considered COSMETIC AND NOT MEDICALLY NECESSARY when reconstructive criteria listed above have not been met and the sole purpose is improving appearance. 2. Other breast procedures, (including augmentation mammoplasty, breast lift, implant repositioning, repair of inverted nipples, mastopexy) are considered COSMETIC AND NOT MEDICALLY NECESSARY except when performed as part of a medically necessary, reconstructive health service. Examples: scar revision after breast biopsy, removal of a cyst, or revision of prior reconstructed breast due to normal aging. Note: The Women's Health and Cancer Rights Act of 1998 (WHCRA) mandated that reconstructive breast surgery for women and men who have undergone mastectomy, surgery and reconstruction of the other breast to produce a symmetrical appearance, AND prostheses and treatment for physical complications at all stages of a mastectomy, including lymphademas, 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. There is not a time frame in which the enrollee is required to have the reconstruction done. Refer below to the REGULATORY STATUS/MANDATED BENEFITS UNDER FEDERAL LAW section. Clinical Considerations: Risk Factor: Smoking is associated with an increased risk of complications and an increased risk of reconstructive failure in patients undergoing post-mastectomy expander/implant breast reconstruction. Patients should be informed of the increased risks and advised on smoking cessation as means to decrease surgical complications. A body mass index (BMI) of 25 or greater is associated with an increased risk of post-operative complications and reconstructive failure among patients undergoing post-mastectomy expander/implant breast reconstruction. These risks are even higher among patients with a BMI greater than 30. Obese Page. 3 of 16

patients should be informed of their increased surgical risks with expander/implant reconstruction and advised on practical weight loss solutions. The optimal timing of radiation is within eight weeks of the mastectomy. Radiation is associated with an increased risk of complications and reconstructive failure among patients undergoing post-mastectomy expander/implant breast reconstruction. Patients should be counseled in regards to these increased risks. Potential Harms: Complications associated with expander/implant breast reconstruction most commonly include the following: infection, hematoma, seroma, wound dehiscence, skin flap necrosis, expander/implant loss, malposition, expander/implant deflation, capsular contracture, hypertrophic or keloid scaring, venous thromboembolism disease, implant rupture or loss of shell integrity. Rupture or leakage of a silicone implant may lead to a variety of other related complications, such as: enlarged lymph nodes, scar formation, inflammation, granulomatous foreign body reaction, presence of foamy histiocytes, silicone mastopathy, nodule formation, migration of silicone gel to adjacent or other tissue. 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. BACKGROUND: More than 96,000 breast cancer patients in the United States undergo breast reconstruction each year after mastectomy or lumpectomy. The goal of reconstruction is to correct physical breast deformities, create a breast mound that looks and feels natural, and improve the patient s quality of life (QOL) without interfering with the diagnosis or prognosis of a recurrence. A variety of techniques for breast reconstruction are available to accommodate the wide range of deformities resulting from mastectomy. Choice of the appropriate surgical technique must be made by the surgeon and will depend on the individual circumstances and needs of the patient. The breast can be reconstructed by tissue expansion and insertion of a breast silicone- or saline-filled implant, by the creation of a mound of tissue using the patient s skin and fat (autologous flap reconstruction), or by a combination of artificial implants with allogeneic or autologous tissues. The success of these reconstructive approaches depends upon several factors, including compliance of the subpectoral muscles, the adequacy of the subpectoral pocket, and the health of the mastectomy flap. When muscle and skin are insufficient or missing, it may be necessary to use an adjacent skin flap from the chest, abdomen, or back. o Reconstruction with a latissimus dorsi (LD) myocutaneous flap o Ruben s flap o Superficial inferior epigastric perforator (SIEP) flap o Superior or inferior gluteal free flap o Transverse upper gracilis (TUG) flap Page. 4 of 16

o Transverse rectus abdominis myocutaneous (TRAM) flap o Deep inferior epigastric perforator (DIEP) flap o Other similar procedures, including skin sparing techniques Although flap reconstructions are generally considered to give a more long-lasting and natural result than implants-based reconstructions, this type of reconstructive surgery is complex, requires longer operating room time, involves donor site morbidity and scarring, and generally requires a longer recovery time than implant surgery. The transverse rectus abdominis musculocutaneous (TRAM) flap is frequently used. It has the advantage of providing relatively large amounts of tissue for reconstruction, usually avoiding implant use, and leaving an acceptable donor site defect. Microsurgical techniques may be useful to augment TRAM-flap circulation when necessary to ensure flap viability. The latisimus dorsi flap is another regional flap that is used frequently. This flap, while it provides additional tissue, often requires an implant as well to provide adequate contour. 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. In some cases, the skin does not cover the entire implant, or the muscles over the implant are too thin to provide adequate support, even after tissue expansion with a temporary implant. Alternative bioengineered skin substitutes matrices, derived from collagen-rich tissues of human, porcine, or bovine sources, have been evaluated for their usefulness in providing additional coverage and support during breast reconstruction procedures. The acellular matrices may also be cross-linked, which inhibits collagen degradation by blocking collagenase-binding sites, thereby allowing the mesh to maintain its structure for a longer period with slower incorporation into the adjacent tissue. Diverse acellular dermal matrices are available. These products vary in terms of the source of tissue, processing, storage, surgical preparation, and available sizes. Acellular dermal matrix products used for repair and reconstruction include: AlloDerm, AlloMax, Dermacell, DermaMatrix, FlexHD, Strattice, and SurgiMend. Autologous fat grafting (AFG) is used as an adjunct to standard breast reconstruction following mastectomy or breast-conserving surgery (lumpectomy or partial mastectomy). The first step in AFG is the identification of donor sites, such as the lower abdomen, back, or thighs. The second step involves harvesting of fat from the identified donor site for the final step, the processing of the harvested fat, and injection into the surgical site. Patients subsequently undergo repeat treatments (typically 2 to 4 sessions) (NICE, 2012). Breast reconstruction can be challenging, particularly in cases of scarring and radiation skin injuries or muscle atrophy. Postoperative breast defects or deformities, such as volume asymmetry, lack of projection, visible rippling, or implant extrusion can significantly impact a patient s emotional and physical well-being, and will often result in surgical revision. Stages of Breast Reconstruction: 1. One-stage immediate breast reconstruction may be done at the same time as the mastectomy. After the general surgeon removes the breast tissue, a plastic surgeon places a breast implant where the breast tissue was removed to form the breast mound. Page. 5 of 16

2. Two-stage immediate or two-stage delayed reconstruction is done if the skin and chest wall tissues are inadequate for immediate reconstruction. An implanted tissue expander, like a balloon, is placed beneath the skin and chest muscle. Through a tiny valve beneath the skin, the surgeon injects a saltwater solution at regular intervals to fill the expander over time. After the skin over the breast area has stretched enough, the expander is usually removed in a second operation, and a permanent implant is put in its place. Some expanders are left in place as the final implant. Reconstruction of the Nipple/Areolar Complex Secondary surgery to provide optimal results involves restoration of a simulated nipple and surrounding areolar complex on the reconstructed breast mound. Available techniques include skin grafts, flaps, tattooing, and occasionally, transplantation of tissues from the opposite breast. Surgery on the Opposite Breast Because of the limitations of the current available techniques, reconstruction of a new breast mound often results in a shape and contour that is significantly different from the remaining, opposite (contralateral) breast. Because the breasts are paired organs, reconstructive surgery on the contralateral breast is therefore often necessary to achieve the best possible match of size and configuration. These surgical procedures may include reduction mammoplasty (reduction of the size of the breast), mastopexy (correction of the drooping breast) or implant mammoplasty (augmentation). Miscellaneous Procedures Frequently, additional surgical procedures may be required to achieve an optimal final reconstructive result. These may include excision of redundant tissue, repositioning of an implant, release of internal scar tissue, creation of an inframammary fold, scar revision, and other tissue rearrangement. Poland syndrome: This 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 underdeveloped (hypoplastic) or absent (amastia). In some cases, affected individuals may also exhibit under-developed upper ribs and/or an abnormally short arm with underdeveloped 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. REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): Breast reconstruction surgery is a procedure and, therefore, is not subject to FDA regulation. However, devices used during the harvesting and processing of adipose tissue, as well as surgical devices utilized during breast reconstruction surgery are regulated by the FDA premarket approval process. The FDA has approved five breast implants for marketing in the United States: Page. 6 of 16

o In May 2000, Mentor and Allergan (formerly named Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age. o In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age. o In March 2012, Sientra received approval for their silicone gel-filled breast implants. They are approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age. The Food and Drug Administration (FDA) panel advises that women with implants see their physicians regularly and, if an implant is found to have ruptured, discuss the need to have it removed. In 2011, the FDA published preliminary findings and analyses of anaplastic large cell lymphoma (ALCL) in women with breast implants. As part of its analysis, the FDA conducted a thorough review of scientific literature published from January 1997 through May 2010. From this review, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants. Based on this data, "The FDA believes that women with breast implants may have a very small but increased risk of ALCL. Human acellular dermal matrix (ADM) products are regulated by the FDA as human tissue for transplantation. Human tissue products may be classified as devices under the jurisdiction of the FDA Center for Devices and Radiological Health (CDRH), or as biologics under the jurisdiction of the Center for Biologics Evaluation and Research (CBER). 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): CMS has an NCD for postmastectomy breast reconstruction (140.2). http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=64&ncdver=1&coverageselection=national&keyword=breast+reconstruction+foll owing+mastectomy&keywordlookup=title&keywordsearchtype=and&ncd_id=140.2&ncd_version=1 &basket=ncd%253a140.2%253a1%253abreast+reconstruction+following+mastectomy&bc=gaaaaba AAAAA&. The NCD for postmastectomy breast reconstruction provides the following coverage statement: Reconstruction of the affected and the contralateral unaffected breast following a medically necessary mastectomy is considered a relatively safe and effective noncosmetic procedure. Accordingly, program payment may be made for breast reconstruction surgery following removal of a breast for any medical reason. Program payment may not be made for breast reconstruction for cosmetic reasons. 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): MN DHS in its provider manual states that reconstructive surgery (such as after a mastectomy, after surgery for in injury, illness or other disease; for birth defects) is a covered health service. MN DHS does not cover cosmetic surgery. 4. MANDATED BENEFITS UNDER FEDERAL LAW: Page. 7 of 16

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. CLINICAL EVIDENCE: 1. EVIDENCE FROM AVAILABLE PUBLISHED STUDIES: Summary Autologous Fat Grafting (AFG): The evidence on the efficacy and safety of AFG for breast reconstruction following mastectomy or breast-conserving surgery for treatment of breast cancer consists of two prospective case series, two prospective nonrandomized controlled studies, four retrospective case series, and three retrospective nonrandomized controlled studies. The sample sizes ranged from 49 patients to 880 patients and follow-up times ranged from 3 months to 10 years. No randomized controlled trials evaluating this therapy were identified. The available studies consistently reported positive surgical and cosmetic outcomes with minimal complications. Cosmetic improvement (restoration of breast contour) and high rates of satisfaction were observed in 70% to 100% of patients who underwent AFG procedures for breast reconstruction in both the uncontrolled and comparative studies. The comparative studies reported significant cosmetic improvements in AFG patients compared with controls who did not have AFG. Improved clinical outcomes, such as adequate survival of the fat grafts, and stability of or improvement in breast tissues damaged by radiation therapy were reported in more than 60% of patients treated with AFG. However, several studies report only on subjective aesthetic outcomes with few studies reporting on objective clinical outcomes. No studies evaluated the impact of the procedure on quality of life (QOL). While outcomes were positive, the follow-up periods, which with a couple of exceptions, generally ranged from a few months to approximately 2 years, may be inadequate to fully elucidate treatment efficacy and fat graft durability. The rate of complications following AFG ranged from 2.8% to 20%; the most common of which included fat necrosis/oily cysts, ecchymosis, striae, and infection. One study reported that the patients stayed 1 night in the hospital before discharge. While these early results are promising, the overall quality of the evidence is low since all of the studies were of poor to fair quality due to study design and other limitations including small patient populations, lack of controls, lack of standardized measures to assess outcomes (including inconsistent Page. 8 of 16

reporting of radiological outcomes), and varying follow-up times, as well as differences in surgical protocols and techniques, types of prosthetics used, and whether or not patients received radiation therapy. There is a need for randomized controlled trials with well-defined outcomes and sufficient follow-up to establish the safety, efficacy, and long-term stability of AFG in patients who have had breast cancer surgery. The cost of AFG for breast reconstruction (excluding prescription costs) is approximately $12,000. Acellular dermal matrices: 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: 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 regarding the clinical value of this product in breast reconstructive surgery. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. HCPCS Codes C1789 L8020 - L8039 L8600 L8600 Q4116 Q4130 S2066 S2067 S2068 Description Prosthesis, breast (implantable) Breast prostheses Implantable breast prosthesis, silicone or equal Implantable breast prosthesis, silicone or equal Alloderm, per square centimeter Strattice TM, per sq cm 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 Page. 9 of 16

ICD-9 Codes Description 174.0 Malignant neoplasm of nipple and areola of female breast 174.1 Malignant neoplasm of central portion of female breast 174.2 Malignant neoplasm of upper-inner quadrant of female breast 174.3 Malignant neoplasm of lower-inner quadrant of female breast 174.4 Malignant neoplasm of upper-outer quadrant of female breast 174.5 Malignant neoplasm of lower-outer quadrant of female breast 174.6 Malignant neoplasm of axillary tail of female breast 174.8 Malignant neoplasm of other specified sites of female breast 174.9 Malignant neoplasm of breast (female), unspecified site 175.0 Malignant neoplasm of nipple and areola of male breast 198.81 Secondary malignant neoplasm of breast 233.0 Carcinoma in situ of breast V10.3 Personal history of malignant neoplasm of breast V45.71 Acquired absence of breast and nipple V51.0 Encounter for breast reconstruction following mastectomy 756.3 Other anomalies of ribs and sternum [related to Poland's syndrome] 756.81 Absence of muscle and tendon [related to Poland's syndrome] 757.6 Specified anomalies ICD-10 Codes Description C50.011 Malignant neoplasm of nipple and areola, right female breast C50.012 Malignant neoplasm of nipple and areola, left female breast C50.019 Malignant neoplasm of nipple and areola, unspecified female breast C50.021 Malignant neoplasm of nipple and areola, right male breast C50.022 Malignant neoplasm of nipple and areola, left male breast C50.029 Malignant neoplasm of nipple and areola, unspecified male breast C50.111 Malignant neoplasm of central portion of right female breast C50.112 Malignant neoplasm of central portion of left female breast C50.119 Malignant neoplasm of central portion of unspecified female breast C50.121 Malignant neoplasm of central portion of right male breast C50.122 Malignant neoplasm of central portion of left male breast C50.129 Malignant neoplasm of central portion of unspecified male breast C50.211 Malignant neoplasm of upper-inner quadrant of right female breast C50.212 Malignant neoplasm of upper-inner quadrant of left female breast C50.219 Malignant neoplasm of upper-inner quadrant of unspecified 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 C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast C50.311 Malignant neoplasm of lower-inner quadrant of right female breast C50.312 Malignant neoplasm of lower-inner quadrant of left female breast C50.319 Malignant neoplasm of lower-inner quadrant of unspecified 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 C50.329 Malignant neoplasm of lower-inner quadrant of unspecified 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 C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast Page. 10 of 16

C50.421 Malignant neoplasm of upper-outer quadrant of right male breast C50.422 Malignant neoplasm of upper-outer quadrant of left male breast C50.429 Malignant neoplasm of upper-outer quadrant of unspecified 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 C50.519 Malignant neoplasm of lower-outer quadrant of unspecified 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 C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast C50.611 Malignant neoplasm of axillary tail of right female breast C50.612 Malignant neoplasm of axillary tail of left female breast C50.619 Malignant neoplasm of axillary tail of unspecified female breast C50.621 Malignant neoplasm of axillary tail of right male breast C50.622 Malignant neoplasm of axillary tail of left male breast C50.629 Malignant neoplasm of axillary tail of unspecified male breast C50.811 Malignant neoplasm of overlapping sites of right female breast C50.812 Malignant neoplasm of overlapping sites of left female breast C50.819 Malignant neoplasm of overlapping sites of unspecified female breast C50.821 Malignant neoplasm of overlapping sites of right male breast C50.822 Malignant neoplasm of overlapping sites of left male breast C50.829 Malignant neoplasm of overlapping sites of unspecified male breast C50.911 Malignant neoplasm of unspecified site of right female breast C50.912 Malignant neoplasm of unspecified site of left female breast C50.919 Malignant neoplasm of unspecified site of unspecified female breast C50.921 Malignant neoplasm of unspecified site of right male breast C50.922 Malignant neoplasm of unspecified site of left male breast C50.929 Malignant neoplasm of unspecified site of unspecified male breast C79.81 Secondary malignant neoplasm of breast D05.00 Lobular carcinoma in situ of unspecified breast D05.01 Lobular carcinoma in situ of right breast D05.02 Lobular carcinoma in situ of left breast D05.10 Intraductal carcinoma in situ of unspecified breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.80 Other specified type of carcinoma in situ of unspecified 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 D05.90 Unspecified type of carcinoma in situ of unspecified breast D05.91 Unspecified type of carcinoma in situ of right breast D05.92 Unspecified type of carcinoma in situ of left breast Z42.1 Encounter for breast reconstruction following mastectomy Z85.3 Personal history of malignant neoplasm of breast Z90.10 Acquired absence of unspecified breast and nipple Z90.11 Acquired absence of right breast and nipple Z90.12 Acquired absence of left breast and nipple Z90.13 Acquired absence of bilateral breasts and nipples CPT Codes Description Page. 11 of 16

19301 Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy); 19302 Mastectomy, partial (eg, lumpectomy, tylectomy, quadrantectomy, segmentectomy); with axillary lymphadenectomy 19303 Mastectomy, simple, complete 19304 Mastectomy, subcutaneous 19305 Mastectomy, radical, including pectoral muscles, axillary lymph nodes 19306 Mastectomy, radical, including pectoral muscles, axillary and internal mammary lymph nodes (urban type operation) 19307 Mastectomy, modified radical, including axillary lymph nodes, with or without pectoralis minor muscle, but excluding pectoralis major muscle 11920 Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less 11921 Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.1 to 20.0 sq cm 11922 Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; each additional 20.0 sq cm, or part thereof (list separately in addition to code for primary procedure) 11970 Replacement of tissue expander with permanent prosthesis 11971 Removal of tissue expander(s) without insertion of prosthesis 15271 Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15272 Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure) 15777 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children 19316 Mastopex 19324 Mammaplasty, augmentation; without prosthetic implant 19325 Mammaplasty, augmentation; with prosthetic implant 19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction 19350 Nipple/areola reconstruction 19357 Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion 19361 Breast reconstruction with latissimus dorsi flap, without prosthetic implant 19364 Breast reconstruction with free flap 19366 Breast reconstruction with other technique 19367 Breast reconstruction with transverse rectus abdominis myocutaneous flap (tram), single pedicle, including closure of donor site; 19368 Breast reconstruction with transverse rectus abdominis myocutaneous flap (tram), single pedicle, including closure of donor site; with microvascular anastomosis (supercharging) 19369 Breast reconstruction with transverse rectus abdominis myocutaneous flap (tram), double pedicle, including closure of donor site 19380 Revision of reconstructed breast 19396 Preparation of moulage for custom breast implant 19499 Unlisted procedure, breast 19318 Reduction mammaplasty CPT is a registered trademark of the American Medical Association. Page. 12 of 16

REFERENCES: 1. Aetna. Breast Reconstructive Surgery. Clinical Policy Bulletin No. 0185. Last Review 6/7/2013. Available at: http://www.aetna.com/cpb/medical/data/100_199/0185.html. Accessed November 10, 2013. 2. American Society of Plastic and Reconstructive Surgeons (ASPS). ASPS Recommended Insurance Coverage Criteria for Third-Party Payers: Breast Reconstruction Following Diagnosis and Treatment for Breast Cancer. Arlington Heights, IL. September 2004. Available at: http://www.plasticsurgery.org/documents/medical- professionals/health-policy/key-issues/breast-reconstruction-following-diagnosis-and-treatment-for-breast- Cancer.pdf. Accessed November 10, 2013. 3. American Society of Plastic Surgeons. Policy Statement: Breast Augmentation in Teenagers. Arlington Heights, IL. December 2004. Available at: http://www.plasticsurgery.org/documents/medical-professionals/healthpolicy/key-issues/policy-statement-on-breast-augmentation-in-teenagers.pdf. Accessed November 10, 2013. 4. American Society of Plastic Surgeons. Practice Parameter: Treatment Principles of Silicone Breast Implants. Arlington Heights, IL. March 2005. Available at: http://www.plasticsurgery.org/documents/medicalprofessionals/health-policy/key-issues/treatmentprinciplesofsiliconebreastimplants.pdf. Accessed November 10, 2013. 5. Araco A, Caruso R, Araco F, Overton J, Gravante G. Capsular contractures: a systematic review. Plast Reconstr Surg. December 2009;124(6):1808-1819. 6. Bhatty MA, Berry RB. Nipple-areola reconstruction by tattooing and nipple sharing. Br J Plast Surg. 1997;50(5):331-334. 7. Blondeel N, Vanderstraeten GG, Monstrey SJ, et al. The donor site morbidity of free DIEP flaps and free TRAM flaps for breast reconstruction. Br J Plast Surg. 1997;50(5):322-330. 8. Blondeel PN, Boeckx WD. Refinements in free flap breast reconstruction: The free bilateral deep inferior epigastric perforator flap anastomosed to the internal mammary artery. Br J Plast Surg. 1994;47(7):495-501. 9. Blondeel PN, Demuynck M, Mete D, et al. Sensory nerve repair in perforator flaps for autologous breast reconstruction: Sensational or senseless? Br J Plast Surg. 1999;52(1):37-44. 10. Bostwick J. Breast reconstruction after mastectomy and breast implants. Current status in the USA. Ann Chir Plast Esthet. 1997;42(2):100-106. 11. Brandberg Y, Malm M, Rutqvist LE, et al. A prospective randomized study (named SVEA) of three methods of delayed breast reconstruction. Study, design, patients' preoperative problems and expectations. Scand J Plast Reconstr Surg Hand Surg. 1999;33(2):209-216. 12. Brinton LA. The relationship of silicone breast implants and cancer at other sites. Plast Reconstr Surg. 2007;120(7 Suppl 1):94S-102S. 13. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Breast Reconstruction Following Mastectomy (140.2). http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=64&ncdver=1&docid=140.2&bc=gaaaabaaaaaa&. Accessed November 10, 2013. 14. Chang DS, McGrath MH. Management of benign tumors of the adolescent breast. Plast Reconstr Surg. 2007;120(1):13e-19e. 15. Chavoin JP, Grolleau JL, Lanfrey E, Lavigne B. Breast reconstruction after mastectomy for cancer. Rev Prat. 1998;48(1):67-70. 16. Cheng A, Saint-Cyr M. Comparison of different ADM materials in breast surgery. Clin Plast Surg. 2012;39(2):167-175. 17. Claro F Jr, Figueiredo JC, Zampar AG, et al. Applicability and safety of autologous fat for reconstruction of the breast. Br J Surg. 2012;99(6):768-80. 18. Cook Biotech Incorporated. Biodesign Nipple Reconstruction Cylinder [website]. West Lafayette, IN: Cook Biotech Incoporated; 2009. Available at: http://www.cookmedical.com/sur/content/mmedia/fp0054-01c.pdf. Accessed November 10, 2013. 19. Delay E, Gounot N, Bouillot A, Zlatoff P, et al. Autologous latissimus breast reconstruction: A 3-year clinical Page. 13 of 16

experience with 100 patients. Plast Reconstr Surg. 1998;102(5):1461-1478. 20. Delay E, Jorquera F, Pasi P, Gratadour AC. Autologous latissimus breast reconstruction in association with the abdominal advancement flap: A new refinement in breast reconstruction. Ann Plast Surg. 1999;42(1):67-75. 21. Edlich RF, Winters KL, Faulkner BC, et al. Advances in breast reconstruction after mastectomy. J Long Term Eff Med Implants. 2005;15(2):197-207. 22. Evans GR, Kroll SS. Choice of technique for reconstruction. Clin Plast Surg. 1998;25(2):311-316. 23. Feller AM. Reconstruction of the female breast with free transverse lower abdominal flap as perforator flap. Langenbecks Arch Chir Suppl Kongressbd. 1998;115:971-972. 24. Fentiman IS, Hamed H. Breast reconstruction. Int J Clin Pract. 2006;60(4):471-474. 25. Fischbacher C. Cosmetic breast augmentation. STEER: Succint and Timely Evaluated Evidence Reviews. Bazian, Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; 2003:3(1):1-12. 26. Fischbacher C. Immediate versus delayed breast reconstruction. STEER: Succint and Timely Evaluated Evidence Reviews. Bazian, Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; 2002; 2(17):1-18. 27. Gutowski KA; ASPS Fat Graft Task Force. Current applications and safety of autologous fat grafts: A report of the ASPS fat graft task force. Plast Reconstr Surg. 2009;124(1):272-280. Available at: http://www.plasticsurgery.org/documents/medical_profesionals/health_policy/guiding_principles/fat- Grafting-Task-Force-Report.pdf. Accessed November 10, 2013. 28. Guzzetti T, Thione A. Successful breast reconstruction with a perforator to deep inferior epigastric perforator flap. Ann Plast Surg. 2001;46(6):641-643. 29. Hamdi M, Weiler-Mithoff EM, Webster MH. Deep inferior epigastric perforator flap in breast reconstruction: Experience with the first 50 flaps. Plast Reconstr Surg. 1999;103(1):86-95. 30. Hayes, Winifred S. Directory Report. AlloDerm Regenerative Tissue Matrix (LifeCell Corp.) for Postmastectomy Breast Reconstruction. Annual Review May 16, 2011. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 31. Hayes, Winifred S. Directory Report. Autologous Fat Grafting for Postmastectomy Breast Reconstruction. Annual review April 30, 2013. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 32. Hayes, Winifred S. Directory Report. FlexHD Acellular Dermis (Musculoskeletal Transplant Foundation) for Breast Reconstruction. August 3, 2012. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 33. Hayes, Winifred S. Directory Report. Human Acellular Dermal Matrix Grafts for Breast Reconstruction. August 20, 2013. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 34. Hayes, Winifred S. Directory Report. Prophylactic Mastectomy. Annual Review December 29, 2006. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 35. Hayes, Winifred S. Directory Report. Strattice Reconstructive Tissue Matrix (LifeCell Corporation) for Breast Reconstruction. March 20, 2013. Available at: http://www.hayesinc.com. Accessed November 10, 2013. 36. Hidalgo DA, Borgen PJ, Petrek JA, et al. Immediate reconstruction after complete skin-sparing mastectomy with autologous tissue. J Am Coll Surg. 1998;187(1):17-21. 37. Hyakusoku H, Ogawa R, Ono S, et al. Complications after autologous fat injection to the breast. Plast Reconstr Surg. 2009;123(1):360-370; discussion 371-372. 38. Ibrahim AM, Ayeni OA, Hughes KB, et al. Acellular dermal matrices in breast surgery: A comprehensive review. Ann Plast Surg. 2013 Feb 12. 39. Javaid M, Song F, Leinster S, et al. Radiation effects on the cosmetic outcomes of immediate and delayed autologous breast reconstruction: An argument about timing. J Plast Reconstr Aesthet Surg. 2006;59(1):16-26. 40. Keller A. The deep inferior epigastric perforator free flap for breast reconstruction. Ann Plast Surg. 2001;46(5):474-480. 41. Kotwall CA. Breast cancer treatment and chemoprevention. Can Fam Physician. 1999;45:1917-1924. 42. Kroll SS. Bilateral breast 16. reconstruction. Clin Plast Surg. 1998;25(2):251-259. Serletti JM, Moran SL. The combined use of the TRAM and expanders/implants in breast reconstruction. Ann Plast Surg. 1998;40(5):510- Page. 14 of 16

514. 43. Kroll SS. Fat necrosis in free transverse rectus abdominis myocutaneous and deep inferior epigastric perforator flaps. Plast Reconstr Surg. 2000;106(3):576-583. 44. Llewellyn-Bennett R, Greenwood R, Benson JR, et al. Randomized clinical trial on the effect of fibrin sealant on latissimus dorsi donor-site seroma formation after breast reconstruction. Br J Surg. 2012;99(10):1381-1388. 45. Losken A, Hamdi M. Partial breast reconstruction: Current perspectives. Plast Reconstr Surg. 2009;124(3):722-736. 46. 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. 47. Mizuno H, Hyakusoku H. Fat grafting to the breast and adipose-derived stem cells: Recent scientific consensus and controversy. Aesthet Surg J. 2010;30 (3):381-387. 48. Nahabedian MY, Dooley W, Singh N, et al. Contour abnormalities of the abdomen after breast reconstruction with abdominal flaps: The role of muscle preservation. Plast Reconstr Surg. 2002;109(1):91-101. 49. National Institute for Health and Clinical Excellence (NICE). Breast reconstruction using lipomodelling after breast cancer treatment. Interventional Procedure Guidance 417. London, UK: NICE; January 2012. 50. National Institute for Health and Clinical Excellence (NICE). Laparoscopic mobilisation of the greater omentum for breast reconstruction. Interventional Procedure Guidance 253. London, UK: NICE; 2008. 51. National Organization for Rare Disorders, Inc. (NORD). Poland syndrome. In: NORD Rare Disease Database. New Fairfield, CT: NORD; 1996. Availableat:http://www.stepstn.com/cgiwin/nord.exe?proc=Redirect&type=rdb_sum&id=440.htm. Accessed November 10, 2013. 52. Papp C, McCraw JB. Autogenous latissimus breast reconstruction. Clin Plast Surg. 1998;25(2):261-266. 53. Papp C, Wechselberger G, Schoeller T. Autologous breast reconstruction after breast-conserving cancer surgery. Plast Reconstr Surg. 1998;102 (6):1932-1936; discussion 1937-1938. 54. Phillips BT, Bishawi M, Dagum AB, et al. A systematic review of antibiotic use and infection in breast reconstruction: What is the evidence? Plast Reconstr Surg. 2013;131(1):1-13. 55. Polednak AP. Postmastectomy breast reconstruction in Connecticut: Trends and predictors. Plast Reconstr Surg. 1999;104(3):669-673. 56. Rainsbury RM. Breast-sparing reconstruction with latissimus dorsi miniflaps. Eur J Surg Oncol. 2002;28(8):891-895. 57. Salmon RJ. Evolution of the surgery of cancer of the breast. Bull Cancer. 1998;85(6):539-543. 58. Sauven P; Association of Breast Surgery Family History Guidelines Panel. Guidelines for the management of women at increased familial risk of breast cancer. Eur J Cancer. 2004;40(5):653-665. 59. Spear SL, Pennanen M, Barter J, Burke JB. Prophylactic mastectomy, oophorectomy, hysterectomy, and immediate transverse rectus abdominis muscle flap breast reconstruction in a BRCA- 2-positive patient. Plast Reconstr Surg. 1999;103(2):548-553; discussion 554-555. 60. Strozzo MD. An overview of surgical management of stage I and stage II breast cancer for the primary care provider. Lippincotts Prim Care Pract. 1998;2(2):160-169. 61. Walker PS, Walls B, Murphy DK. Natrelle saline-filled breast implants: a prospective 10-year study. Aesthetic Surg J. January/February 2009;29(1):19-25. 62. Yap LH, Whiten SC, Forster A, et al. The anatomical and neurophysiological basis of the sensate free TRAM and DIEP flaps. Br J Plast Surg. 2002;55 (1):35-45. 63. Yeh KA, Lyle G, Wei JP, Sherry R. Immediate breast reconstruction in breast cancer: Morbidity and outcome. Am Surg. 1998;64(12):1195-1199. Page. 15 of 16

POLICY HISTORY: DATE ACTION/DESCRIPTION 11/13/2013 New Policy 2013M0043A. Reviewed by Interim Medical Policy Committee. 11/21/2013 Reviewed and approved by the Quality Improvement Advisory and Credentialing Council (QIACC). 11/25/2013 Published to ucare.org Page. 16 of 16