Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Reconstructive Breast Surgery

Policy #:11.08.15v

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

When performed as a cosmetic service, breast surgery (e.g., augmentation, implant, mastopexy [the lifting, reshaping, and fixation of sagging breast tissue], reduction mammaplasty, and nipple/areola tattooing) to correct breast asymmetry is a benefit contract exclusion for all products of the Company and is not eligible for reimbursement consideration.

However, reconstructive breast surgery (e.g., augmentation, implant, mastopexy [the lifting, reshaping, and fixation of sagging breast tissue], reduction mammaplasty, and nipple/areola tattooing) to correct breast asymmetry is considered medically necessary and, therefore, covered for any of the following:
  • Following surgical correction of congenital chest wall deformities (i.e., Pectus Excavatum or Poland’s Syndrome) when the following criteria are met:
    • CT scans demonstrating the Haller Index of more than 3.2 for Pectus Excavatum or absence of rib formation for Poland Syndrome AND
    • Documented evidence of skeletal or muscle malformation causing cardiac or respiratory impairment.
  • Repair of breast asymmetry due to a medically necessary mastectomy or medically necessary lumpectomy
  • Repair of breast asymmetry due to trauma

Any revisions of previous reconstructive breast surgery performed for medically necessary indications are considered medically necessary.

Following mastectomy, there is no restrictive time limit for coverage of reconstructive breast surgery or coverage of prosthetic devices that may be inserted during reconstructive surgery. Additional or subsequent requests for revision and reconstruction (not related to a complication) require cosmetic review.

Upon cosmetic review, initial requests for reconstructive breast surgery following open excisional procedures are eligible for reimbursement.
  • Subsequent requests for treatment of complications are considered medically necessary.
  • Requests for reconstructive breast surgery following non-open (e.g., percutaneous) and/or non-excisional (e.g., ductal exploration) procedures on the breast are reviewed on the basis of being potentially cosmetic procedures.

AUTOLOGOUS FAT GRAFTING

Autologous fat grafting is considered medically necessary and, therefore, covered for the following, when medical necessity criteria for reconstructive breast surgery, as outlined in this policy, are met:
  • Breast reconstruction following mastectomy or lumpectomy on the diseased/affected breast
  • Breast reconstruction on the nondiseased/unaffected/contralateral breast, in order to achieve a symmetrical appearance.

Lipofilling is considered medically necessary and, therefore, covered when it is used for the management of secondary contour deformities, following reconstructive breast surgery, when medically necessary criteria, for reconstructive breast surgery, as outlined in this policy are met.

ADIPOSE-DERIVED STEM CELLS

Adipose-derived stem cells alone or in conjunction with autologous fat grafting for reconstructive breast surgery is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

ACELLULAR DERMAL MATRICES

When used in reconstructive breast surgery, the application of acellular dermal matrices (including each of the following: AlloDerm®, AlloMend®, Cortiva® (formerly AlloMax™ and Neoform™), DermACELL™, DermaMatrix™, FlexHD®, FlexHD® Pliable™,Graftjacket® RTM, Permacol™, Repriza®, Strattice™ Reconstructive Tissue Matrix, SurgiMend®, XCM Biologic® Tissue Matrix) is medically necessary and, therefore, covered for individuals who meet the medical necessity criteria for reconstructive breast surgery.

WOMEN'S HEALTH AND CANCER RIGHTS ACT (WHCRA)

The Women's Health and Cancer Rights Act was enacted as a federal mandate in October 1998. The federal mandate addresses reconstructive breast surgery following a mastectomy, and requires coverage for:
    (1) all stages of reconstruction of the breast on which the mastectomy has been performed;
    (2) surgery and reconstruction of the other breast to produce a symmetrical appearance; and
    (3) prostheses and physical complications of mastectomy, including lymphedemas.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the professional provider's office, hospital, nursing home, home health agency, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be made available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

All requests for reconstructive breast surgery require review by the Company and must include documentation. This documentation is to include, but is not limited to, color photographs, a letter of medical necessity from the provider, documentation from the individual's medical records regarding previous treatment, and other professional provider's reports.
Guidelines

HALLAR INDEX

The Haller Index can be calculated by dividing the measured transverse diameter (the horizontal distance of the inside of the ribcage) of the chest by the anteroposterior diameter (the shortest distance between the vertebrae and sternum) from a plain chest radiograph or a CT scan.

AUTOLOGOUS FAT GRAFTING

Medical necessity consideration for autologous fat grafting for repair of breast asymmetry due to trauma or for the surgical correction of a congenital breast anomaly with documented skeletal or muscle malformation requires additional supporting material (e.g., individual's medical records, colored photographs) for review by the Company.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, reconstructive breast surgery is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as either experimental/investigational or cosmetic are not eligible for coverage or reimbursement by the Company.

MANDATES

This policy is consistent with applicable state and federal mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage.

Description

Reconstructive breast surgeries are designed to restore the normal appearance of the breast. These surgical procedures can include augmentation with the insertion of an implant, mastopexy (the lifting, reshaping, and fixation of sagging breast tissue), reduction mammaplasty, and nipple/areola tattooing. The most common type of reconstructive surgery involves inserting an implant, usually for the purpose of increasing the size of a breast. In addition, following mastectomy or lumpectomy (removal of part of the breast) for a malignancy, reconstructive breast surgeries are performed to achieve symmetry of the ipsilateral breast. In some cases, they are performed on the contralateral normal breast to achieve bilateral symmetry.

TYPES OF RECONSTRUCTIVE BREAST SURGERY

AUTOLOGOUS TISSUE FLAP
Breast reconstruction may also use autologous tissue flap surgery, which involves the use of an individual's own tissue and is dependent on the adequacy of the adjacent blood supply at the transplant site. There are numerous flap surgeries, such as a free flap, a latissimus dorsi flap, or, more commonly, a transverse rectus abdominis myocutaneous (TRAM) flap. Other types of flap procedures for breast reconstruction may include, but are not limited to, the following:
  • Deep inferior epigastric artery and vein (DIEP)
  • Superficial inferior epigastric perforator (SIEP)
  • Inferior or super gluteal free flap
  • Inferior or superior gluteal artery perforator (IGAP or SGAP)
  • Thoracodorsal artery perforator (TDAP)

STAGED SURGERIES
Immediate breast reconstruction is performed at the same time as a mastectomy and may mean fewer reconstructive surgeries. This surgery is also known as one-stage immediate breast reconstruction. However, this immediate reconstruction is not an option for individuals who need radiation to the chest area after a mastectomy.

Two-stage reconstruction, or two-stage delayed reconstruction, is usually done after a tissue expander has been placed under the skin and chest muscle to increase volume in the breast area. A second surgery takes place when the chest skin has been sufficiently stretched to remove the expander and insert a permanent implant. Two-staged delayed reconstruction procedures allow options, such as a delay for radiation treatments.

EXPLANTATION OF BREAST IMPLANT
Reconstructive surgery may also be needed following explantation of a breast implant previously implanted for medical reasons. Mastopexy after explantation may be performed to raise, reshape, and restore the appearance of the breast.

REDUCTION MAMMAPLASTY
Reduction mammaplasty is a reconstructive surgical procedure to reduce the size and weight of a breast. This procedure involves removing a portion of the breast, including the skin and underlying glandular tissue. The breast is reshaped, and the areola and nipple are repositioned. This surgery may be performed to restore symmetrical breast appearance. Reduction mammaplasty leaves surface scarring and may result in decreased sensation in the nipple and breast.

RECONSTRUCTIVE BREAST SURGERY FOR CHEST WALL DEFORMITIES DUE TO CONGENITAL DEFECT OR CHEST INJURY
Congenital deformities such as Poland's syndrome, trauma, and chest injuries may be causative factors for reconstructive breast surgery. Poland's syndrome is a rare congenital defect that involves the underdevelopment or absence of chest musculature on one side of the rib cage, and may be evidenced by the absence or underdevelopment of the affected side's breast. Because the purpose of reconstructive breast surgery is to restore the normal appearance of the breast, some procedures may need to be performed on the contralateral normal breast in order to achieve symmetry.

OTHER RELATED RECONSTRUCTIVE BREAST SURGERIES

AUTOLOGOUS FAT GRAFTING
For reconstructive breast surgery following mastectomy or lumpectomy for a malignancy, there is evidence in available published peer-reviewed literature that autologous fat grafting is safe and effective for the management of secondary contour deformities of the reconstructed breast (Coleman et al. 2007, Missana et al. 2007, Spear et al. 2005). Autologous fat grafting has become accepted and standard in the medical community for secondary breast reconstruction (Losken, 2011). Residual contour defects such as fat necrosis from flap transfer or radiation, or capsular contraction after radiation, which can be treated with autologous fat grafts to improve contour, volume, and overall breast symmetry. In addition, there is no significant increase in breast cancer or false positive breast cancer mammogram readings after autologous fat grafting. Long-term follow-up of individuals who underwent autologous fat grafting as part of reconstructive breast surgery for a malignancy have not shown any increase in breast cancer recurrence.

ADIPOSE-DERIVED STEM CELLS
Stem cells, because of their pluripotentiality and unlimited capacity for self renewal, propose to offer advances in reconstructive procedures in conjunction with autologous fat grafting. Adipose tissue is an accessible source of adipose-derived stem cells. The use of adipose-derived stem cells in conjunction with autologous fat grafting to the breast offers a possible role that the stem cells could play in graft survival through adipogenesis and angiogenesis. Yoshimura et al. (2008) observed outcomes of 40 individuals who underwent cell-assisted fat injection in which autologous adipose-derived stem cells were used in combination with fat injection for soft tissue augmentation in breast surgery. Although the preliminary results demonstrated that cell-assisted fat injection with autologous adipose-derived stem cells was superior to conventional lipoinjection, the authors concluded that additional study is necessary to further evaluate the efficacy of this technique. Moreover, Sterodimas et al. (2010) noted that a complete understanding of the mechanisms of interaction of autologous fat grafting in conjunction with adipose-derived stem cells is lacking. In 2011, the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) released a joint statement based on their systematic review of the peer-reviewed literature, concluding that, while there is potential for the future for stem cells in aesthetic surgical procedures, the scientific evidence and other data are very limited in terms of assessing the safety and efficacy of stem cell therapies in aesthetic medicine.

NIPPLE AND AREOLA RECONSTRUCTION
Breast reconstruction may also involve the creation of a nipple and areola. Nipple and/or areola tattooing may be performed for repigmentation purposes. Hypopigmented areas of the dermis of the reconstructed nipple and areola are tattooed with nonreactive, hypoallergenic natural iron oxide-colored pigments.

ACELLULAR DERMAL MATRICES AND SURGICAL MESH PRODUCTS
Reconstructive breast surgeries use a variety of materials and surgical methods. Several acellular dermal matrices and/or surgical mesh products are used to promote regenerative skin healing. Acellular dermal matrices are soft tissue grafts created by a process that results in decellularization but leaves the extracellular matrix intact. Acellular dermal matrices and surgical mesh products act as a scaffold for normal tissue remodeling and support regeneration into functional tissue where tissue has been damaged or lost. Human-derived products, such as AlloDerm®, are classified as banked human tissue and do not require FDA approval. Regulation is by the American Association of Tissue Banks and the FDA guidelines for banked human tissue.
References


Agha RA, Pidgeon TE, Borrelli MR, et al. Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit. Plast Reconstr Surg. 2018;141(5):633e-638e.

Alam M, Gladstone H, Kramer EM, et al; American Society for Dermatologic Surgery. ASDS guidelines of care: injectable fillers. Dermatol Surg. 2008;34 Suppl 1:S115-48.

Alderman A, Atisha D, Streu R, et al. Patterns and correlates of post-mastectomy breast reconstruction by US plastic surgeons: results from a national survey. Plast Reconstr Surg. 2011;127(5):1796-1803.

American Cancer Society (ACS). Breast Reconstruction Surgery. [ACS Website]. Available at: https://www.cancer.org/cancer/breast-cancer/reconstruction-surgery.html. Accessed April 11, 2019.

American Society of Plastic Surgeons (ASPS). 2015 Post-Mastectomy Fat Graft/Fat Transfer ASPS Guiding Principles. [ASPS Web site]. June, 2015. Available at: https://www.plasticsurgery.org/Documents/Health-Policy/Principles/principle-2015-post-mastectomy-fat-grafting.pdf. Accessed April 11, 2019.

Baxter RA. Intracapsular allogenic dermal grafts for breast implant-related problems. Plast Reconstr Surg. 2003;112(6):1692-1696; discussion 97-98.

Benefit Contracts.

Bindingnavele V, Gaon M, Ota KS, et al. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. J Plast Reconstr Aesthet Surg. 2007;60(11):1214-1218.

Blue Cross and Blue Shield Technology Evaluation Center. Graftskin for the treatment of skin ulcers. TEC Assessments 2001; Volume 16, Tab 12.

Breuing KH, Colwell AS. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction. Ann Plast Surg. 2007;59(3):250-255.

Butterfield JL. 440 Consecutive immediate, implant-based, single-surgeon breast reconstructions in 281 patients: a comparison of early outcomes and costs between SurgiMend fetal bovine and AlloDerm human cadaveric acellular dermal matrices. Plast Reconstr Surg. 2013;131(5):940-51.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).140.2: Breast reconstruction following mastectomy. [CMS Web site]. 08/1989. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=64&ncdver=1&bc=AAAAQAAAAAAA&. Accessed April 11, 2019.

Chan CW, McCulley SJ, Macmillan RD. Autologous fat transfer--a review of the literature with a focus on breast cancer surgery. J Plast Reconstr Aesthet Surg. 2008;61(12):1438-48.

Chang EI, Liu J. Prospective unbiased experience with three acellular dermal matrices in breast reconstruction. J Surg Oncol. 2017;116(3):365-370.

Claro F Jr, Figueiredo JC, Zampar AG, Pinto-Nero AM. Applicability and safety of autologous fat for reconstruction of the breast. Br J Surg. 2012;99(6):768-780.

Coleman SR, Saboeiro AP. Fat grafting to the breast revisited; safety and efficacy. Plast Reconstr Surg. 2007;119(3):775-785.

Colwell AS, Breuing KH. Improving shape and symmetry in mastopexy with autologous or cadaveric dermal slings. Ann Plast Surg. 2008;61(2):138-142.

Davila AA, Seth AK, Wang E, et al. Human acellular dermis versus submuscular tissue expander breast reconstruction: a multivariate analysis of short-term complications. Archives of plastic surgery. 2013;40(1):19-27.

de Blacam C, Momoh AO, Colakoglu S, et al. Evaluation of clinical outcomes and aesthetic results after autologous fat grafting for contour deformities of the reconstructed breast. Plast Reconstr Surg. 2011;128(5):411e-418e.

Delaware State Code. Division of Research of Legislative Council of the General Assembly. Title 18, Insurance code. Chapter 33: Health insurance contracts. § 3347: Required coverage for reconstructive surgery following mastectomies. [Delaware Code Web site]. 10/31/08. Available at: http://delcode.delaware.gov/title18/c033/index.shtml#P584_74708. Accessed April 11, 2019.

Delaware State Code. Division of Research of Legislative Council of the General Assembly. Title 18, Insurance code. Chapter 35: Group and blanket health insurance. § 3563: Required coverage for reconstructive surgery following mastectomy. [Delaware Code Web site]. 10/31/08. Available at: http://delcode.delaware.gov/title18/c035/sc03/index.shtml. Accessed April 11, 2019.

Dikmans RE, Negenborn VL, Bouman MB, et al. Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial. The Lancet Oncology. 2017;18(2):251-258.

D’Souza N, Darmanin G, Fedorowicz Z. Immediate versus delayed reconstruction following surgery for breast cancer (Protocol). The Cochrane Collaboration. The Cochrane Library 2010, Issue 9.

Eaves FF III, Haeck PC, Rohrich RJ. ASAPS/ASPS position statement on stem cells and fat grafting. Plast Reconstr Surg. 2012;129(1):285-287.

ECRI Institute. Plymouth Meeting (PA): ECRI Institute; 2009 Feb 20. Deep Inferior Epigastric Perforator (DIEP) Flap and Transverse Rectus Abdominus Musculocutaneous (TRAM) Flap for Breast Reconstruction.

Endress R, Choi MS, Lee GK. Use of fetal bovine acellular dermal xenograft with tissue expansion for staged breast reconstruction. Ann Plast Surg. 2012;68(4):338-41.

Fansa H, Schirmer S, Warnecke IC, et al. The transverse myocutaneous gracilis muscle flap: a fast and reliable method for breast reconstruction. Plast Reconstr Surg. 2008;122(5):1326-33.

Frojahn Kolle SF, Oliveri RS, Glovinski PV, et al. Importance of mesenchymal stem cells in autologous fat grafting: a systematic review of existing studies. J Plast Surg Hand Surg. 2012;46(2):59-68.

Garramone CE, Lam B. Use of AlloDerm in primary nipple reconstruction to improve long-term nipple projection. Plast Reconstr Surg. 2007;119(6):1663-1668.

Gaster RS, Berger AJ, Monica SD, et al. Histologic Analysis of Fetal Bovine Derived Acellular Dermal Matrix in Tissue Expander Breast Reconstruction. Ann Plast Surg. 2013 Mar 11. [Epub ahead of print]

Glasberg SB, D'Amico RA. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery. Plast Reconstr Surg. 2006;118(1):8-15.

Glasberg SB, Light D. AlloDerm and Strattice in breast reconstruction: a comparison and techniques for optimizing outcomes. Plast Reconstr Surg. 2012;129(6):1223-1233.

Gutowski KA. Current applications and safety of autologous fat grafts: A report of the ASPS Fat Graft Task Force. Plast Reconstr Surg. 2009;124:272-280.

Hinchcliff KM, Orbay H, Busse BK, et al. Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2017;70(5):568-576.

Hyakusoku H, Ogawa R, Ono S, Ishii N, Hirakawa K. Complications after autologous fat injection to the breast. Plast Reconstr Surg. 2009;123(1):360-70; discussion 371-2.

Illouz YG, Sterodimas A. Autologous fat transplantation to the breast: a personal technique with 25 years of experience. Aesth Plast Surg. 2009;33(5):706-715.

Internal Department Federal & State Mandates Chart. Breast reconstruction, mastectomy and minimum stays (Pennsylvania): 40 PS §764(d) and Act 81 of 2002 (S.B. 1417).

Kamakura T, Ito K. Autologous cell-enriched fat grafting for breast augmentation. Aesthetic Plast Surg. 2011;35(6):1022-1030.

Kanchwala SK, Glatt BS, Conant EF, Bucky LP. Autologous fat grafting to the reconstructed breast: the management of acquired contour deformities. Plast Reconstr Surg. 2009;124(2):409-418.

Kim JY. Breast reconstruction with acellular dermis. [Medscape Web site]. 01/04/2019. Available at: http://emedicine.medscape.com/article/1851090-overview#showall. Accessed April 11, 2019.

Lee KT, Mun GH. Updated evidence of acellular dermal matrix use for implant-based breast reconstruction: a meta-analysis. Ann Surg Oncol. 2016;23(2):600-610.

Lieber J, Kirschner HJ, Fuchs J. Chest wall repair in Poland syndrome: complex single-stage surgery including Vertical Expandable Prosthetic Titanium Rib stabilization--a case report. J Pediatr Surg. 2012; 47(3):e1-5.

Liu AS, Kao HK, Reish RG, et al. Postoperative complications in prosthesis-based breast reconstruction using acellular dermal matrix. Plast Reconstr Surg. 2011; 127(5):1755-1762.

Liu DZ, Mathes DW, Neligan PC, et al. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014;72(5):503-507.

Loo YL, Kamalathevan P, Ooi PS, et al. Comparing the Outcome of Different Biologically Derived Acellular Dermal Matrices in Implant-based Immediate Breast Reconstruction: A Meta-analysis of the Literatures. Plast Reconstr Surg Glob Open. 2018;6(3):e1701.

Losken A, Pinell X, Sikoro K, et al. Autologous fat grafting in secondary breast reconstruction. Ann Plast Surg. 2011;66(5):518-522.

McCarthy CM, Lee CN, Halvorson EG, et al. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012;130(5 Suppl 2):57S-66S.

Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial Stage II: ADM breast reconstruction outcomes from definitive reconstruction to 3 months postoperative. Plastic and reconstructive surgery Global open. 2017;5(1):e1209.

Missana MC, et al. Autologous fat transfer in reconstructive breast surgery: indications, technique and results. Eur J Surg Oncol. 2007;33(6):685-690.

Mizuno H, Hyakusoku H. Fat grafting to the breast and adipose-derived stem cells: recent scientific consensus and controversy. Aesthtic Surg J. 2010;30(3):381-389.

National Institute for Health and Clinical Excellence (NICE). Interventional procedure overview IPG 417 Interventional procedure overview of breast reconstruction using lipomodelling after breast cancer treatment. Issued January 2012. Available at: https://www.nice.org.uk/guidance/ipg417. Accessed April 11, 2019.

National Library of Medicine. Breast Reconstruction. Updated March 6, 2018. Available at: http://www.nlm.nih.gov/medlineplus/breastreconstruction.html. Accessed April 11, 2019.

New Jersey Statute. Insurance Laws. Title 17, Title 17B, Title 26, Title 34. Reconstructive breast surgery. New Jersey Mandate: Breast reconstruction. [New Jersey Legislature Web site]. Available at: http://www.njleg.state.nj.us/. Accessed April 11, 2019.

Novaes AB, Jr., de Barros RR. Acellular dermal matrix allograft. The results of controlled randomized clinical studies. J Int Acad Periodontol. 2008;10(4):123-129.

Parikh RP, Doren EL, Mooney B, et al. Differentiating fat necrosis from recurrent malignancy in fat-grafted breasts: an imaging classification system to guide management. Plast Reconstr Surg. 2012;130(4):761-72.

Perez-Cano R, Vranckx JJ, Lasso JM, et al. Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial. Eur J Surg Oncol. 2012;38(5):382-389.

Petit JY, Botteri E, Lohsiriwat V, et al. Locoregional recurrence risk after lipofilling in breast cancer patients. Ann Oncol. 2011 May 24.

Petit JY, Lohsiriwat V, Clough KB, et al. The oncologic outcome and immediate surgical complications of lipofilling in breast cancer patients: a multicenter study-milan-paris-lyon experience of 646 lipofilling procedures. Plast Reconstr Surg. 2011;128(2):341-6.

Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017;139(3):521-528.

Potter S, Brigic A, Whiting P, et al. Reporting clinical outcomes of breast reconstruction: a systematic review. Surgical Research Unit, School of Social and Community Medicine, University of Bristol, Bristol, UK. Natl Cancer Inst. 2011;103(1):31-46.

Preminger BA, McCarthy CM, Hu QY, et al. The influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched-cohort study. Ann Plast Surg. 2008;60(5):510-513.

Rawlani V, Buck DW, Johnson SA, et al. Tissue expander breast reconstruction using prehydrated human acellular dermis. Ann Plast Surg. 2011;66(6):593-7.

Rigotti G, Marchi A, Galiè M, et al. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: A healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007;119(5):1409-1422.

Rosing JH, Wong G, Wong MS, et al. Autologous fat grafting for primary breast augmentation: a systematic review. Aesthetic Plast Surg. 2011;35(5):882-90.

Rubin E. Breast imaging considerations in fat grafting to the breast. Plast Reconstr Surg. 2011;128(5):5703-571e.

Rubin JP, Coon D, Zuley M, et al. Mammographic changes after fat transfer to the breast compared with changes after breast reduction: a blinded study. Plast Reconstr Surg. 2012;129(5):1029-1038.

Saint-Cyr M, Rojas K, Colohan S, Brown S. The role of fat grafting in reconstructive and cosmetic breast surgery: a review of the literature. J Reconstr Microsurg. 2012;28(2):99-110.

Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006;57(1):1-5.

Sbitany H, Sandeen SN, Amalfi AN, et al. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009;124(6):1735-1740.

Seth AK, Hirsch EM, Kim JY, Fine NA. Long-term outcomes following fat grafting in prosthetic breast reconstruction: a comparative analysis. Plast Reconstr Surg. 2012;130(5):984-90.

Spear SL, et al. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005;116(5):1300-1305.

Sterodimas A, de Faria J, Nicaretta B, et al. Tissue engineering with adipose-derived stem cells (ADSCs): Current and future applications. J Plast Reconstr Aesthet Surg. 2010;63(11):1886-1892.

Townsend Jr, CM, Beauchamp RD, Evers BM, Mattox KL. Sabiston Textbook of Surgery: Expert Consult Premium Edition: Enhanced Online Features. Elsevier Health Sciences; 2012.

Wilson A, Butler PE, Seifalian AM. Adipose-derived stem cells for clinical applications: a review. Cell Prolif. 2011;44(1):86-98.

Winters Z, Benson J, Pusic A. A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient-reported outcome measures and health-related quality of life. Clinical Sciences at South Bristol, Breast Reconstruction Quality of Life Group, University Hospitals Bristol NHS Foundation Trust. Ann Surg. 2010;252(6):929-42.

Yoshimura K, Sato K, Aoi N, et al. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesth Plast Surg. 2008;32(1):48-55.

Zenn MR. Free TRAM Breast Reconstruction. [eMedicine Web site]. Updated 12/01/2015. Available at: http://www.emedicine.com/plastic/topic136.htm. Accessed February 21, 2017.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

11920, 11921, 11922, 11970, 11971, 15271, 15272, 15777, 19316, 19318, 19324, 19325, 19328, 19330, 19340, 19342, 19350, 19355, 19357, 19361, 19364, 19366, 19367, 19368, 19369, 19370, 19371, 19380, 19396

THE FOLLOWING CODE IS USED TO REPRESENT AUTOLOGOUS FAT GRAFTING (WHICH REPRESENTS THE HARVESTING AND PLACEMENT OF THE AUTOLOGOUS FAT GRAFT) IN RECONSTRUCTIVE BREAST SURGERY:

20926

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT ADIPOSE DERIVED STEM CELL ALONE OR IN CONJUNCTION WITH AUTOLOGOUS FAT GRAFTING IN RECONSTRUCTIVE BREAST SURGERY:

19499


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy


HCPCS Level II Code Number(s)



C1789 Prosthesis, breast (implantable)

C5271 Application of low cost 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

C5272 Application of low cost 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)

C9358 Dermal substitute, native, non-denatured collagen, fetal bovine origin (Surgimend collagen matrix), per 0.5 square centimeters

C9360 Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm

C9364 Porcine implant, Permacol, per square centimeter

L8600 Implantable breast prosthesis, silicone or equal

Q4107 Graftjacket, per sq cm

Q4116 Alloderm, per sq cm

Q4122 DermACELL, per sq cm

Q4128 FlexHD, AllopatchHD, or Matrix HD, per sq cm

Q4130 Strattice TM, per sq cm

Q4142 Xcm biologic tissue matrix, per sq cm

Q4143 Repriza, per sq cm

S2066 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

S2067 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

S2068 Breast reconstruction with deep inferior epigastric perforator (DIEP) flap, or superficial inferior epigastric artery (SIEA) flap, including harvesting of the flap, microvascular transfer, closure of donor site and shaping the flap into a breast, unilateral

THE FOLLOWING CODE IS USED TO REPRESENT ALLOMEND, DERMAMATRIX, PERMACOL, SURGIMEND AND CORTIVA:

Q4100 Skin substitute, not otherwise specified



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.08.15v:
06/03/2019Policy Language addressing Acellular Dermal Matrices was revised to add Cortiva® and FlexHD® Pliable™.

Coding:

Allomax and Neoform were removed, and Cortiva was added to the header stating that HCPCS code Q4100 should be used to represent these products.

Revisions from 11.08.15u:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
12/01/2017This version of the policy will become effective 12/01/2017.

Autologous fat grafting is now considered medically necessary for all of the following, when medical necessity criteria for reconstructive breast surgery, as outlined in this policy, are met:
  • Breast reconstruction following mastectomy or lumpectomy on the diseased/affected breast
  • Breast reconstruction on the nondiseased/unaffected/contralateral breast, in order to achieve a symmetrical appearance.

Policy Language addressing Acellular Dermal Matrices was revised to add AlloMend® and DermACELL™, and to remove the following statement:
    The application and placement of acellular dermal matrices is considered for separate reimbursement.

HCPCS codes C9360 and Q4122 were added to the coding table.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 06/03/2019
Version Issued Date: 06/03/2019
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.