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Clinical Policy Title: Breast reconstruction following breast cancer surgery

Clinical Policy Number: CCP.1284

Effective Date: April 1, 2017

Initial Review Date: November 16, 2016

Most Recent Review Date: November 6, 2018

Next Review Date: November 2019

Related policies:

CCP.1308 Bioimpedance devices for detecting lymphedema

CCP.1254 Prophylactic mastectomy

CCP.1326 Lymphedema garments

CCP.1048 Breast reduction surgery

CCP.1184 Cosmetic, Plastic, and Scar Revision Surgery

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’

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 peer-reviewed 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 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’ 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’ clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas’ clinical policies are not guarantees of payment.

Coverage policy

AmeriHealth Caritas considers the use of breast reconstruction following breast cancer surgery to

correct asymmetry and other deformities 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

(Alderman, 2104; Rainsbury, 2012).

Breast reconstruction must be performed by a credentialed plastic surgeon.

Policy contains:

Breast reconstruction

Lumpectomy

Mastectomy

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This policy complies with the Women’s Health and Cancer Rights Act of 1998, which requires plans that

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 (Centers for Medicare & Medicaid Services, 2017).

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 271,220 new cases will be

diagnosed in Americans in 2018, all but 2,550 of them women (Noone, 2018), 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 1998-2007, 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 study of 1.2 million U.S. women with early-stage breast cancer diagnosed between 1998 and 2011

showed 35.5 percent underwent mastectomy, with a rising rate of 34 percent in the most recent eight

years. Increases were greatest in women with clinically node-negative disease (38 percent) and in situ

disease (105 percent). In women undergoing mastectomy, rates of breast reconstruction increased from

11.6 to 36.4 percent from 1998 to 2011 (P < .001). Rates of bilateral mastectomy for unilateral disease

increased from 1.9 to 11.2 percent (P  < .001). (Kummerow, 2015).

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

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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

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

(National Institute for Health and Clinical Excellence, 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.

Searches

AmeriHealth Caritas 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.

We conducted searches on August 31, 2018. Search term was: “breast reconstruction.”

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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

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 was issued, 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

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.

Infections are common in breast reconstruction, often exceeding 20 percent (Phillips, 2013). In a review

of five studies and five systematic reviews, one prospective randomized trial indicated a single

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preoperative dose was better than placebo, and another revealed no difference between 24 hours

versus until drain removal. Two of three studies showed significant reduction in infectious complications

with prolonged antibiotic use. One systematic review identified a greater infection rate with prolonged

antibiotic use, while the other showed no difference between <24 hours and > 24 hours, but showed a

reduction in infections compared to no treatment (Phillips, 2016). 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, 2016; Phillips, 2013).

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-

expander reconstruction immediately after mastectomy. The two groups experienced similar

readmission rates. However, women in the autologous group experienced higher overall complications,

i.e. 19.96 versus 5.86 percent), and higher rates of reoperation, i.e. 9.7 versus 6.5 percent (Mlodinow,

2013). However, a systematic review/meta-analysis of 14 studies (n>3000) indicated autologous

abdominal tissue had lower relative risks (0.14) associated with reconstructive failure than did tissue

expander/implant (0.14) and surgical-site infection (0.37) (Tsoi, 2014).

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

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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

magnetic resource imaging 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 =.647), or local

recurrence (P =.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 associated with

significant increase in capsular contracture ( P <.00001), revisional surgery ( P =.002), reconstructive

failure ( P =.0007), lower patient satisfaction ( P =.0003) and cosmetic outcome ( P =.005) (Magill,

2017).

Breast reconstruction may also have psychological impacts on women with breast cancer. A meta-

analysis of five studies (n=1285) compared breast cancer patients receiving mastectomy with or without

breast reconstruction. The reconstruction group had lower incidence rates of anxiety (P = 0.0006), and

depression (P = 0.02) (Chen, 2018).

A 1998 to 2012 study of 496,488 U.S. women with unilateral breast cancer documented an increase in

the percent who had a contralateral prophylactic mastectomy, from 3.9 to 12.7 percent from 2002 to

2012 (P <.001). No significant improvement in breast conserving or overall survival was observed in

these women when compared with breast-conserving therapy (Hazard Ratios both 1.08) (Wong, 2017).

Some women who elect to have prophylactic mastectomy also have breast reconstruction after surgery.

A systematic review of seven studies reviewed breast pain, numbness, sexuality, and quality of life for

these women. Most were satisfied with the overall results of the procedure, but were not satisfied with

the softness of the reconstructed breasts, and had problems with breast hardness, numbness and sex.

Authors state the need to inform patients about potential post-op complications (Aygin, 2018).Certain

factors can increase risk of adverse outcomes from breast reconstruction. In a meta-analysis of 29

studies (n=71,368, 20,061 of whom with a body mass index >30 kg/m2), obese women had a higher rate

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of surgical complications (2.29 times that of non-obese, P <.00001), medical complications (2.89,

Cp < .00001), reoperation risk (1.91, P < .00001) (Panayi, 2018). A systematic review of 53 studies

calculated that smoking significantly (Odds Ratio = 1.91) increases risk of complications after breast

reconstruction (Theocharidis, 2018).

A study of 45,465 women with breast cancer under age 65 who underwent mastectomy from 2002-2006

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 guideline/other and four peer-reviewed references were added to, and two

guidelines/other and two peer-reviewed references were removed from this policy in August 2018.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Zhang (2017)

Comparison of outcomes

for mastectomy with vs.

without reconstruction.

Key points:

Meta-analysis, 31 studies, n=139,894, with versus without immediate breast reduction.

Women with immediate breast reduction 51percent (%) more likely to have surgical site

infection.

No differences for overall survival, disease-free survival, and local recurrence.

Lee (2016)

Outcomes of one-stage vs.

two-stage prosthesis-

based breast

reconstruction.

Key points:

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 implant-

based breast

reconstruction.

Key points:

Review of five studies, five 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.

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Citation Content, Methods, Recommendations

Shippee (2014)

Variations in reconstruction

rates by payer group and

racial/ethnic group.

Key points:

Includes 45,465 women <65 with breast cancer/mastectomy in 2002-2006.

Reconstruction rates versus white women were lower for African Americans (-43%),

Hispanics (-30%), and Asians (-55%).

Reconstruction rates versus privately insured women were lower for those with public

insurance (-65%) and uninsured (-67%).

Endara (2013)

Literature review on nipple-

sparing mastectomies.

Key points:

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%.

Mlodinow (2013)

Comparison of outcomes

between types of breast

reconstruction.

Key points:

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% versus 5.86%).

Autologous group had higher rate of reoperation (9.7% versus 6.5%).

Common predictors of readmission include operative time, American Society of

Anesthesiologist class 3 and 4, superficial surgical site infection.

Barry (2011)

Breast reconstruction and

radiotherapy.

Key points:

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 (Odds Ratio = 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. Doi:

10.1097/PRS.0000000000000541.

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Breastcancer.org. Types of Breast Reconstruction. Ardmore PA: breastcancer.org, July 20, 2016.

http://www.breastcancer.org/treatment/surgery/reconstruction/types. Accessed August 31, 2018.

Centers for Medicare & Medicaid Services, The Center for Consumer Information & Insurance Oversight.

Women’s Health and Cancer Rights Act (WHCRA). Baltimore MD: Centers for Medicare & Medicaid

Services, 2018. https://www.cms.gov/CCIIO/Programs-and-Initiatives/Other-Insurance-

Protections/whcra_factsheet.html. Accessed August 31, 2018.

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. Doi:

10.1097/PRS.0b013e3181a09506.

National Institute for Health and Clinical Excellence. Breast reconstruction using lipomodelling after

breast cancer treatment. Interventional Procedure Guidance 417. London, UK: National Institute for

Health and Clinical Excellence, January 2012. https://www.nice.org.uk/guidance/ipg417. Accessed

August 31, 2018.

Noone AM, Howlader N, Krapcho M, et al.(eds). SEER Cancer Statistics Review, 1975-2015, Bethesda

MD: National Cancer Institute, April 2018. https://seer.cancer.gov/csr/1975_2015/. Accessed August

31, 2018.

Rainsbury D, Willett A. Association of Breast Surgery and British Association of Plastic Reconstructive

and Aesthetic Surgeons. Oncoplastic Breast Reconstruction: Guidelines for Best Practice. Association of

Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons, November,

2012. http://www.bapras.org.uk/docs/default-source/commissioning-and-policy/final-oncoplastic-

guidelines---healthcare-professionals.pdf?sfvrsn=0. Accessed August 31, 2018.

Ries LAD, Hankey BF, Miller BA, Hartman AM, Edwards BK. Cancer Statistics Review, 1973-88. National

Cancer Institute. NIH Pub. No. 91-2789, 1991.

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):352--358. Doi: 10.1111/j.1524-4741.2011.01105.x.

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):143-161.

Doi: 10.1016/j.bjps.2014.10.038.

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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):5325-5330. Doi:

10.1200/JCO.2009.22.2455.

Aygin D, Cengiz H. Life quality of patients who underwent breast reconstruction after prophylactic

mastectomy: systematic review. Breast Cancer. 2018 May 2. doi: 10.1007/s12282-018-0862-8.

Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat.

2011;127(1):15-22. Doi: 10.1007/s10549-011-1401-x.

Basta MN, Gerety PA, Serletti JM, Kovach SJ, Fischer JP. A systematic review and head-to-head meta-

analysis of outcomes following direct-to-implant versus conventional two-stage implant

reconstruction.Plast Reconstr Surg. 2015;136(6):1135-1144. Doi: 10.1097/PRS.0000000000001749.

Chen W, Lv X, Xu X, Gao X, Wang B. Meta-analysis for psychological impact of breast reconstruction in

patients with breast cancer. Breast Cancer. 2018;25(4):464-469. Doi: 10.1007/s12282-018-0846-8.

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;207:100-108. Doi: 10.1016/j.ejogrb.2016.10.032.

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):1043-1054. Doi: 10.1097/PRS.0b013e3182a48b8a.

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):230-236. Doi:

10.1016/j.breast.2011.12.013.

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):919-926. Doi:

10.1200/JCO.2013.52.2284.

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. Doi: 10.1001/jamasurg.2014.2895.

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):336-344. Doi:

10.1016/j.amjsurg.2015.07.015.

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 implant-

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based breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg.

2017;70(10):1329-1335. Doi: 10.1016/j.bjps.2017.05.057.

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):335-341. Doi:

10.1097/SAP.0b013e3182a0df25.

Panayi AC, Agha RA, Sieber BA, Orgill DP. Impact of obesity on outcomes in breast reconstruction: A

systematic review and meta-analysis. Reconstr Microsurg. 2018;34(5):363-375. Doi: 10.1055/s-0038-

1627449.

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):1-13. Doi:

10.1097/PRS.0b013e3182729c39.

Phillips BT, Halvorson EG. Antibiotic prophylaxis following implant-based breast reconstruction: what is

the evidence? Plast Reconstr Surg. 2016;138(4):751-757. Doi: 10.1097/PRS.0000000000002530.

Rocco N, Rispoli C, Moja L, et al. Different types of implants for reconstructive breast surgery after

mastectomy. Cochrane Database Syst Rev. 2016;(5):CD010895. Doi: 10.1002/14651858.CD010895.pub2.

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):e261-269. Doi:

10.1016/j.whi.2014.03.001.

Theocharidis V, Katsaros I, Sgouromallis E, et al. Current evidence on the role of smoking in plastic

surgery elective procedures: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg.

2018;71(5):624-636. Doi: 10.1016/j.bjps.2018.01.011.

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 meta-

analysis. Plast Reconstr Surg. 2014;133(2):234-249. Doi: 10.1097/01.prs.0000436847.94408.11.

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):581-589. Doi: 10.1097/SLA.0000000000001698.

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):285-293. Doi:

10.1016/j.ejso.2016.07.006.

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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):171-178.

Doi: 10.1007/s11547-016-0702-x.

Centers for Medicare & Medicaid Services National Coverage Determinations:

140.2 Breast Reconstruction Following Mastectomy.Medicare payment may be made for breast

reconstruction following mastectomy for any medical, non-cosmetic reason. Effective January 1, 1997.

Accessed August 31, 2018.

Local Coverage Determinations:

L33428 Cosmetic and reconstructive surgery. Effective date May 15, 2018. Accessed August 31, 2018.

L34698 Cosmetic and reconstructive surgery. Effective date January 1, 2018. Accessed August 31, 2018.

L35090 Cosmetic and reconstructive surgery. Effective date April 14, 2017. Accessed August 31, 2018.

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.

CPT Code Description Comments

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), singe pedicle, including closure of donor site

19368 Breast reconstruction with transverse rectus abdominis myocutaneous flap

(TRAM), singe pedicle, including closure of donor site; with microvascular

anastomosis

19369 Breast reconstruction with transverse rectus abdominis myocutaneous flap

(TRAM), double pedicles, including closure of donor site

ICD-10

Code

Description Comments

C50.011-

C50.929

Malignant neoplasm, breast

Z42.1 Encounter for breast reconstruction following mastectomy

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HCPCS

Level II

Code

Description Comments

N/A