Clinical Policy Title: Breast reconstruction following breast cancer surgery

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1 Clinical Policy Title: Breast reconstruction following breast cancer surgery Clinical Policy Number: Effective Date: April 1, 2017 Initial Review Date: November 16, 2016 Most Recent Review Date: November 16, 2017 Next Review Date: November 2018 Policy contains: Breast reconstruction Lumpectomy Mastectomy Related policies: CP# CP# CP# CP# CP# Bioimpedance devices for detecting lymphedema Prophylactic mastectomy Lymphedema garments Breast reduction surgery Cosmetic, plastic, and scar revision surgery ABOUT THIS POLICY: AmeriHealth Caritas Louisiana has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Louisiana s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Louisiana when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Louisiana s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Louisiana s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Louisiana will update its clinical policies as necessary. AmeriHealth Caritas Louisiana s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Louisiana considers the use of breast reconstruction following breast cancer surgery to be clinically proven and, therefore medically necessary. These surgeries include simple or radical mastectomy, or lumpectomy, following a diagnosis of cancer and prophylactic mastectomy for persons documented as high risk for cancer. Procedures included in this policy are breast implants, tissue flap procedures, and nipple/areolar reconstruction. Autologous fat grafts are also considered medically necessary if the physician and patient agree on this approach (Rainsbury, 2012; Alderman, 2014). Breast reconstruction must be performed by a credentialed plastic surgeon. This policy complies with the Women s Health and Cancer Rights Act of 1998, which requires plans that 1

2 provide coverage for mastectomy also cover reconstruction of the breast with mastectomy, to include surgery on the non-mastectomy breast to create a symmetrical appearance, breast prostheses, and treatment of any mastectomy complications (CMS, 2016). Limitations: All other uses of breast reconstruction following breast cancer surgery, including scar revision and surgery for cosmetic purposes, are considered investigational and experimental. Alternative covered services: Breast prosthesis. Background Breast cancer is the most commonly-diagnosed cancer in the U.S. A total of 249,260 new cases will be diagnosed in Americans in 2016, all but 2,600 of them women (Howlader, 2016), up from 175,900 new cases in 1991 (Ries, 1991). About 20 percent of breast cancer cases are classified as in situ, as opposed to invasive cancers. From , the proportion of U.S. women undergoing mastectomy who also had breast reconstruction rose from 46 to 63 percent. Part of this increase is the rising number of women who elect to have contralateral prophylactic mastectomy (Jagsi, 2014). Factors increasing the likelihood of women electing reconstruction include younger age, white race, metropolitan locale, and lower stage disease; rates also vary considerably by geographic areas (Agarwal, 2011). A breast can be surgically reconstructed after a mastectomy or lumpectomy (simultaneously or at a later date) by using artificial implants or autologous tissue from other body parts. Reconstruction may be completed in a single procedure, but multiple procedures may be needed. Reconstruction can be performed on the diseased breast, or on the other breast to address asymmetry. One means of surgical reconstruction of the breast uses implants of a silicone exterior that contain saline or silicone gel. In a single-procedure implant, breast tissue is removed and the implant is placed beneath the chest muscle; the implant is held in place by a graft made of skin. Some procedures must first implant tissue expanders during mastectomy. The tissue slowly expands the sac over several months to stretch the skin until the full size implant can be supported; a subsequent procedure removes the expander and inserts the transplant. While the durability of implants has improved over time, up to half of all implants must be replaced within 10 years, due to ruptures, infections, or pain experienced by the patient. The second type of surgical reconstruction is a tissue flap procedure. This procedure can either use 2

3 tissue removed from the abdomen or the upper back, and transplanted to the breast. Autologous fat grafts, using the transverse rectus abdominis myocutaneous flap, are commonly used in breast reconstruction. The procedure uses fat, skin, and muscle from the abdomen to restore breast volume and contour in women after they undergo mastectomy or lumpectomy. Several surgeries may be necessary to complete the procedure. The procedure is well tolerated and is considered safe (NICE, 2012; Gutkowski, 2009). Another means of using abdominal fat and skin to reconstruct the breast is deep inferior epigastric perforation. It contains no muscle or fascia, as does the transverse rectus abdominis myocutaneous flap. The latissimus dorsi flap procedure is a relatively common method of breast reconstruction that uses muscle, fat, skin, and blood vessels from the upper back. Rather than removing this tissue from the body, the surgeon moves it to the front of the chest, into the breast area. Nipple and areolar reconstruction, whose purpose is to match the new nipple and areola to the original one, can be another procedure in breast restoration, if the patient elects. Tissue is taken from the new breast or from other skin, and transplanted. Some patients may only have a two-dimensional tattoo (breastcancer.org, 2016). If the patient is undergoing radiation therapy or chemotherapy, a postponement of any breast reconstruction is advised until after the therapy is completed. In November 2012, the United Kingdom s Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons issued a practice guideline on oncoplastic breast reconstruction. The guideline featured 25 quality indicators that include patient education, process of care, and measuring patient outcomes (Rainsbury, 2012). Soon after the UK guideline, the American Society of Plastic Surgeons approved an evidence-based guideline on breast reconstruction with expanders and implants (Alderman, 2014). The guideline provided evidence to support: 1. Patients undergoing mastectomy should be offered preoperative referral to a plastic surgeon 2. Irradiating the expander or implant is associated with elevated risk of postoperative complications 3. Use of pre-operative antibiotics is appropriate, as is halting antibiotic use 24 hours after surgery, except when a surgical drain is present 4. Post-operative expander/implant reconstruction does not adversely affect oncologic outcomes 5. Immediate and delayed reconstruction both have advantages and disadvantages, and physicians must carefully consider these for each patient 6. Risk factors for implant failure should be addressed: patients should be advised of the benefits of smoking cessation, physicians should be aware of obesity as a risk factor, and 3

4 should also practice glycemic control In addition, the guideline found that evidence is limited, varies, or is of substandard quality for association between postoperative complications and timing, association between acellular dermal matrix and surgical complications, and optimal timing of post mastectomy expander/implant breast reconstruction. Searches AmeriHealth Caritas Louisiana searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on October 5, Search term was: breast reconstruction. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Infections are common in breast reconstruction, often exceeding 20 percent (Phillips, 2013). The general consensus is that 24 hours of prophylactic antibiotics prior to breast reconstruction is warranted. However, there are conflicting data and opinions on the need for and duration of perioperative antibiotic administration and thus further studies on the topic are needed (Phillips, 2013; Phillips, 2016). A meta-analysis of 31 studies (n=139,894) found that women who had immediate breast reconstruction after mastectomy were 51 percent more likely to experience surgical site infection than those with no reconstruction after mastectomy. There were no significant differences in overall survival, disease-free survival, and local recurrence between the two groups (Zhang, 2017). Another meta-analysis of 10 articles found that rates of breast cancer recurrence in women with and without immediate breast reconstruction were similar (Gieni, 2012). A study of 5012 women compared outcomes for women who underwent autologous vs. implant-tissue- 4

5 expander reconstruction immediately after mastectomy. The two groups experienced similar readmission rates. However, women in the autologous group experienced higher overall complications, i.e vs 5.86 percent), and higher rates of reoperation, i.e. 9.7 vs. 6.5 percent (Mlodinow, 2013). Several types of implants, such as saline/silicone, anatomically shaped/round, and fixed/variable volume, are available to patients. A limited number of studies to link these approaches with relative risk for adverse outcomes have been performed, and no conclusive evidence has been developed (Rocco, 2016). A review of 17 studies compared one-stage and two-stage prosthesis-based reconstruction. Women in the one-stage group had higher construction failure and overall complication rates (Lee, 2016). Another review found greater risk of flap necrosis and implant failure with direct-to-implant reconstruction (Basta, 2015). Another study determined that nipple-sparing mastectomy with immediate autologous breast reconstruction is safe when performed in a single stage, but stopped short of declaring that this should be the standard of care (Levine, 2013). Some studies have focused on the risks of nipple-sparing mastectomy, which affects subsequent reconstruction procedures. One systematic review of 48 studies found a 22 percent complication rate, a seven percent nipple necrosis rate, a locoregional recurrence rate of 1.8 percent, and a distant metastasis rate of 2.2 percent. The authors conclude that the procedure was safe due to the low rates of locoregional and distant metastasis rates. However, variations in complication and nipple necrosis rates by incision location and reconstruction method suggest further trials to determine the best methods needed (Endara, 2013). Studies of complications from autologous fat grafting found that necrosis was the most common complication (4.4 percent), biopsy was required in 2.7 percent of cases, and interval mammogram required in 11.5 percent. There were no observed differences in oncological event rates between mastectomy patients with and without autologous fat grafts (Agha, 2015). Breast cancer recurrences for mastectomy patients who did and did not undergo autologous fat grafts have been similar, even though not all studies were of good quality (Hayes, 2015). A systematic review of 23 articles (n=2419) of women with at least one autologous fat graft found almost all underwent mammography, ultrasound, or MRI to assess follow-up after reconstruction. Rates of complications included fat necrosis (5.31 percent), benign lesions (8.78), infections (0.96), and local cancer recurrence in (1.69), described by authors as low morbidity (De Decker, 2016). A review of 11 studies found a high morbidity odds ratio for women with mastectomy who had breast reconstruction and radiation compared to those who had no reconstruction. Delaying reconstruction until after radiation therapy had no effect on this finding (Barry, 2011). A review of seven studies (n=3692) demonstrated similar results in the odds of nipple-areolar complex necrosis (P = 0.647), or local recurrence (P = 0.627) between patients who received and did not receive radiation therapy, but a higher (P<.001) likelihood of skin flap necrosis in those treated with radiation (Zheng, 2017). A systematic review of seven trials (n=2921) determined post-mastectomy radiation therapy was 5

6 associated with significant increase in capsular contracture (p < ), revisional surgery (p = 0.002), reconstructive failure (p = ), lower patient satisfaction (p = ) and cosmetic outcome (p = 0.005) (Magill, 2017). A study of 45,465 women with breast cancer under age 65 who underwent mastectomy from found considerable variation of breast reconstruction rates after mastectomy among racial groups and payers. Compared to white women, lower rates of reconstruction were documented for African Americans (-43 percent), Hispanics (-30 percent), and Asians (-55 percent). Compared to women with private insurance, lower rates were found for those with public insurance (-65 percent) and those who are uninsured (-67 percent) (Shippee, 2014). A particularly large gap in rates of reconstruction after mastectomy between Latina women considered to have low versus high acculturation has been noted (13.5 and 41.2 percent, p<. 001), due to limited information about the procedure and less access to plastic surgeons (Alderman, 2009). Policy updates: A total of one guidelines/other and four peer-reviewed references were added to this policy, and no guidelines/other and three peer-reviewed references were removed in Summary of clinical evidence: Citation Lee (2016) Content, Methods, Recommendations Outcomes of one-stage vs. two-stage prosthesis-based breast reconstruction. Systematic review and meta-analysis of 17 studies. One-stage group at higher risk for reconstruction failure and overall complications. No difference in groups in results of nipple-sparing mastectomy, aesthetic results. One-stage group had lower costs, despite added expense to treat complications. Phillips (2016) Need for antibiotic prophylaxis after implantbased breast reconstruction. Review of 5 studies, 5 systematic reviews, on infectious complications from antibiotics. Conflicting data for optimal duration of antibiotic prophylaxis after breast reconstruction. 24 hours of pre-operative antibiotic prophylaxis is warranted. Zhang (2017) Comparison of outcomes for mastectomy with vs. without reconstruction. Meta analysis, 31 studies, n=139,894, with vs. without immediate breast reduction (IBR). Women with IBR 51% more likely to have surgical site infection. No differences for overall survival, disease-free survival, and local recurrence. 6

7 Citation Shippee (2014) Variations in reconstruction rates by payer group and racial/ethnic group. Endara (2013) Literature review on nipplesparing mastectomies. Mlodinow (2013) Comparison of outcomes between types of breast reconstruction. Barry (2011) Content, Methods, Recommendations Includes 45,465 women <65 with breast cancer/mastectomy in Reconstruction rates vs. white women were lower for African Americans (-43%), Hispanics (-30%), and Asians (-55%). Reconstruction rates vs. privately insured women were lower for those with public insurance (-65%) and uninsured (-67%). 48 studies (n=6615) nipple-sparing mastectomies. Complication rate= 22%, nipple necrosis rate = 7%, loco regional recurrence rate = 1.8%. Complication rate with autologous reconstruction = 23.7%, nipple necrosis rate = 17.3%. Study of 5012 patients who had implant/expander or autologous reconstruction. Groups had similar readmission rates (4.34% implant and 5.32% autologous). Autologous group had higher rate of complications (19.96% vs. 5.86%). Autologous group had higher rate of reoperation (9.7% vs. 6.5%). Common predictors of readmission include operative time, American Society of Anesthesiologist class 3 and 4, superficial surgical site infection. Breast reconstruction and radiotherapy. Meta-analysis of 11 studies (n=1105) of patients undergoing breast reconstruction with or without post-mastectomy radiotherapy. Radiation therapy more likely to suffer morbidity (OR = 4.2); thus autologous flap reconstruction is linked with less morbidity, compared to implant-based reconstruction. Delaying breast reconstruction until after radiation therapy had no effect on outcome. References Professional society guidelines/other: Alderman A, Gutowski K, Ahuja A, Gray D. Postmastectomy Expander Implant Breast Reconstruction Guideline Work Group. ASPS clinical practice guideline summary of breast reconstruction with expanders and implants. Plast Reconstr Surg. 2014;134(4):648e-655e. Breastcancer.org. Types of Breast Reconstruction. Ardmore PA: breastcancer.org, July 20, Accessed October 5,

8 Centers for Medicare & Medicaid Services (CMS), The Center for Consumer Information & Insurance Oversight. Women s Health and Cancer Rights Act (WHCRA). CMS, Protections/whcra_factsheet.html. Accessed October 5, 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): Hayes, Inc. Autologous Fat Grafting for Breast Reconstruction after Breast Cancer Surgery. Lansdale PA: Hayes, Inc., August 27, Last updated July 31, Accessed October 5, Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, Bethesda MD: National Cancer Institute. Updated September 12, Accessed October 5, National Institute for Health and Clinical Excellence (NICE). Breast reconstruction using lipomodelling after breast cancer treatment. Interventional Procedure Guidance 417. London, UK: NICE; January Accessed October 5, Rainsbury D, Willett A. Association of Breast Surgery (ABS) and British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS). Oncoplastic Breast Reconstruction: Guidelines for Best Practice. ABS and BAPRAS, November, Accessed October 5, Ries LAD, Hankey BF, Miller BA, Hartman AM, Edwards BK. Cancer Statistics Review, National Cancer Institute. NIH Pub. No , Peer-reviewed references: Agarwal S, Pappas L, Neumayer L, Agarwal J. An analysis of immediate post mastectomy breast reconstruction frequency using the surveillance, epidemiology, and end results database. Breast J. 2011;17(4): Agha RA, Fowler AJ, Herlin C, et al. Use of autologous fat grafting for breast reconstruction: A systematic review with meta-analysis of oncological outcomes. J Plast Reconstr Aesthet Surg. 2015;68(2): Alderman AK, Hawley ST, Janz NK, et al. Racial and ethnic disparities in the use of postmastectomy breast reconstruction: results from a population- based study. J Clin Oncol. 2009;27(32): Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011;127(1):

9 Basta MN, Gerety PA, Serletti JM, Kovach SJ, Fischer JP. A systematic review and head-to-head metaanalysis of outcomes following direct-to-implant versus conventional two-stage implant reconstruction. Plast Reconstr Surg. 2015;136(6): De Decker M, De Schriver L, Thiessen F, Tondu T, Van Goethem M, Tjalma WA. Breast cancer and fat grafting: efficacy, safety and complications-a systematic review. Eur J Obstet Gynecol Reprod Biol. 2016;207: De La Cruz L, Blankenship SA, Chatterjee A, et al. Outcomes after oncoplastic breast-conserving surgery in breast cancer patients: a systematic literature review. Ann Surg Oncol. 2016;23(10): Endara M, Chen D, Verma K, Nahabedian MY, Spear SL. Breast reconstruction following nipple-sparing mastectomy: a systematic review of the literature with pooled analysis. Plast Reconstr Surg. 2013;132(5): Gieni M, Avram R, Dickson L, et al. Local breast cancer recurrence after mastectomy and immediate breast reconstruction for invasive cancer: a meta-analysis. Breast. 2012;21(3): Jagsi R, Jiang J, Momoh AO, et al. Trends and variation in use of breast reconstruction in patients with breast cancer undergoing mastectomy in the United States. J Clin Oncol. 2014;32(9): Kummerow KL, Du L, Penson DF, Shyr Y, Hooks MA. Nationwide trends in mastectomy for early-stage breast cancer. JAMA Surg. 2015;150(1):9 16. Lee KT, Mun GH. Comparison of one-stage vs two-stage prosthesis-based breast reconstruction: a systematic review and meta-analysis. Am J Surg. 2016;212(2): Levine SM, Snider C, Gerald G, et al. Buried flap reconstruction after nipple-sparing mastectomy: advancing toward single-stage breast reconstruction. Plast Reconstr Surg. 2013;132(4):489e 497e. Magill LJ, Robertson FP, Jell G, Mosahebi A, Keshtgar M. Determining the outcomes of post-mastectomy radiation therapy delivered to the definitive implant in patients undergoing one- and two-stage implantbased breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2017;70(10): Mlodinow AS, Ver Halen JP, Lim S, Nguyen KT, Gaido JA, Kim JY. Predictors of readmission after breast reconstruction: a multi-institutional analysis of 5012 patients. Ann Plast Surg. 2013;71(4): Phillips BT, Bishawi M, Dagum AB, Khan SU, Bui DT. A systematic review of antibiotic use and infection in breast reconstruction: what is the evidence? Plast Reconstr Surg. 2013;131(1):

10 Phillips BT, Halvorson EG. Antibiotic prophylaxis following implant-based breast reconstruction: what is the evidence? Plast Reconstr Surg. 2016;138(4): Rocco N, Rispoli C, Moja L, et al. Different types of implants for reconstructive breast surgery after mastectomy. Cochrane Database Syst Rev. 2016;(5):CD Shippee TP, Kozhimannil KB, Rowan K, Virnig BA. Health insurance coverage and racial disparities in breast reconstruction after mastectomy. Womens Health Issues. 2014;24(3):e Tsoi B, Ziolkowski NI, Thoma A, et al. Safety of tissue expander/implant versus autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients: A systematic review and metaanalysis. Plast Reconstr Surg. 2014;133(2): Wong SM, Freedman RA, Sagara Y, Aydogan F, Barry WT, Golshan M. Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. Ann Surg. 2017;265(3): Zhang P, Li CZ, Wu CT, et al. Comparison of immediate breast reconstruction after mastectomy and mastectomy alone for breast cancer: a meta-analysis. Eur J Surg Oncol. 2017;43(2): Zheng Y, Zhong M, Ni C, Yuan H, Zhang J. Radiotherapy and nipple-areolar complex necrosis after nipple-sparing mastectomy: a systematic review and meta-analysis. Radiol Med. 2017;122(3): CMS National Coverage Determinations (NCDs): Breast Reconstruction Following Mastectomy. CMS Medicare Coverage Database Web site. eyword=breast+reconstruction&keywordlookup=title&keywordsearchtype=and&bc=gaaaacaaaaa AAA%3d%3d&. Medicare payment may be made for breast reconstruction following mastectomy for any medical, non-cosmetic reason. Effective January 1, Accessed October 5, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. 10

11 CPT Code Description Comments Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion Breast reconstruction with latissimus dorsi flap, without prosthetic implant Breast reconstruction with free flap Breast reconstruction with other technique Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), singe pedicle, including closure of donor site Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), singe pedicle, including closure of donor site; with microvascular anastomosis Breast reconstruction with transverse rectus abdominis myocutaneous flap (TRAM), double pedicles, including closure of donor site ICD-10 Code Description Comments C C Malignant neoplasm, breast Z42.1 Encounter for breast reconstruction following mastectomy HCPCS Level II Code N/A Description Comments 11