Description

Breast reconstruction surgery rebuilds a breast's shape following a mastectomy or trauma and may be performed immediately, be delayed or be completed in stages. The surgeon forms a breast mound by using autologous tissue taken from other areas of an individual’s body (abdomen, back, buttocks, thighs), placing an artificial implant, or using a tissue expander if necessary, depending on the final desired breast size.

Breast implants are silicone sacs filled with saline (salt water) or silicone gel. The development of scar tissue around a breast implant may necessitate a capsulotomy (surgical opening and release of scar tissue) or capsulectomy (surgical removal of the entire capsule containing the breast implant surrounded by abnormally thick, hardened tissue).

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Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The type of reconstruction recommended (autologous tissue or implants) depends on an individual’s age, body composition, general health status, method of planned cancer treatment or other reason for reconstruction.

Breast reconstruction may require multiple surgeries, such as:

• Nipple and areola reconstruction and tattoo pigmentation
• Revision surgery involving the breast and/or donor site
• Surgery on the opposite breast to correct asymmetry

Autologous fat graft, autologous fat transplant (lipoinjection or lipomodeling) via excision lipectomy, suction lipectomy or liposuction involves the removal of adipose tissue (fat) from another area of the body (abdomen, buttocks, thighs, etc.) which is then transferred to the breast(s) during initial reconstructive surgery.

Chest wall reconstruction with flat closure is a reconstructive surgery option for an individual who is not a candidate for or has chosen not to undergo breast reconstruction with autologous tissue or an implant. The procedure may be done at the time of mastectomy or may be delayed and involves the removal and tightening of extra tissue to create a flat chest wall contour.

Oncoplastic surgery refers to integrating tumor removal and immediate breast reconstruction into the initial surgical procedure. Generally, the surgical oncologist removes the tumor, and the plastic surgeon immediately begins reconstruction.

Examples of breast reconstruction techniques (also called flaps) that use autologous tissue include, but may not be limited to:

• Deep circumflex iliac artery (DCIA)/Ruben’s free flap
• Deep inferior epigastric perforator (DIEP)
• Gluteal artery perforator (GAP)
• Latissimus dorsi (LD)
• Profunda artery perforator (PAP)
• Superficial inferior epigastric artery (SIEA)
• Thoracodorsal artery perforator (TAP or TDAP)
• Transverse gracilis (TUG)
• Transverse rectus abdominus muscle (TRAM)

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Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The flap description and name are related to the muscles or blood-supplying vessels used and involve surgically removing tissue, typically fat, skin and muscle, from one area of the body and reattaching it to the chest.

Pedicled flaps are positioned with the corresponding vascular origin intact while free flaps require microsurgery to connect the tiny blood vessels needed to supply the transplanted tissue.

Other technologies used or being studied for use in conjunction with breast reconstruction procedures include, but may not be limited to:

• Intraoperative tissue perfusion assessment methods have been developed to assist surgeons in determining the viability of tissue-transfer circulation during micro, plastic and reconstructive surgery. The suggested benefits involve reducing tissue necrosis (death) and decreasing the need for a second corrective procedure.
• Known as fluorescent angiography or spy angiography, involves intravenous injection of ICG dye during surgery. The ICG dye binds to proteins in the blood and emits light when stimulated by a low energy laser or near infrared light. The emitted light facilitates visualization of blood flow through the operative tissue, thus determining perfusion and viability.
• Examples of US Food & Drug Administration (FDA)-approved imaging devices or systems used to capture fluorescent images for this purpose include, but may not be limited to, Fluobeam LM, Infrared 800 with Flow 800 option, Leica FL 800, PDE-Neo, PDE-Neo II, SPY fluorescent imaging systems (SPY Elite, SPY-PHI) and EleVision IR Platform (including the VS3-Iridium System).
• Multispectral imaging involves taking several photographs under many different wavelengths of light in order to ascertain tissue oxygenation measurements for selected tissue regions. The camera determines the approximate values of oxygen saturation (StO2), relative oxyhemoglobin (HbO2) and deoxyhemoglobin levels (Hgb) in superficial tissues and displays a two-dimensional color-coded image of tissue oxygenation. The SnapshotNIR is an example of an FDA-approved multispectral imaging device.
• Near-infrared spectroscopy (NIRS) technology is being explored to assess circulation or perfusion in tissue samples. While near-infrared light is scattered in human tissue, some structures, such as hemoglobin, absorb it. NIRS technology uses reflected light to determine the ratio of oxyhemoglobin (HgbO2) and deoxyhemoglobin (Hgb) to permit real-time measurement of tissue oxygen saturation (StO2) within the selected tissue. The T.Ox and its newer modification the Intra.Ox are examples of FDA-approved devices that measure tissue oximetry.

Lymphatic microvascular surgery is proposed in conjunction with reconstructive surgery to prevent the development of lymphedema that may occur following a mastectomy with axillary lymph node dissection. Lymphatic microsurgical preventive healing approach (LYMPHA) procedures include, but may not be limited to, lymphaticovenous anastomosis (LVA), lymphaticovenous bypass (LVB) or lymph node transfer.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Refer to Coverage Limitations section For information regarding topics related to breast reconstruction, please refer to:

• Diagnosis and treatment of lymphedema - Lymphedema — Diagnosis and Treatment
• Mastectomy to reduce breast cancer risk - Prophylactic Mastectomy
• Skin and tissue substitutes used during breast reconstruction - Skin and Tissue Substitutes
• Breast reduction (cancer/symmetry related and noncancer-related) - Reduction Mammaplasty
• Breast surgery related to gender - Gender Affirmation Surgery

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Commercial Plan members: requests for autologous fat graft, autologous fat transplant (lipoinjection or lipomodeling) via excision lipectomy, suction lipectomy or liposuction as stand-alone procedures (not in conjunction with other breast reconstruction techniques) require review by a medical director.

Coverage Determination

Any state mandates for breast reconstruction take precedence over this medical coverage policy.

Humana members may be eligible under the Plan for breast reconstruction following, or in conjunction with:

• A medically necessary mastectomy or lumpectomy (regardless of the date of the mastectomy or lumpectomy); OR
• A medically necessary prophylactic mastectomy; OR
• Trauma (within 12 months post-injury); AND for surgical procedures including, but may not be limited to:
• Chest wall reconstruction with flat closure; OR
• Free or pedicled flap (DIEP, GAP [IGAP, SGAP], LD, PAP, Ruben’s, SIEA, TAP, TDAP, TUG, TRAM, or others); OR
• Insertion of breast implants; OR
• Insertion of tissue expanders; OR
• Mastopexy (including prior to a nipple-sparing mastectomy); OR
• Nipple reconstruction and repigmentation (tattoo); OR
• Reduction mammaplasty only if necessary to preserve nipple viability prior to a nipple-sparing mastectomy (medical director review required for commercial Plan members)

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Correction of Breast Asymmetry

Breast reconstruction surgery to correct breast asymmetry is considered cosmetic except for:

• A medically necessary lumpectomy that results in a deformity; OR
• A medically necessary mastectomy; OR
• Complications with or removal of breast implant(s) following a medically necessary mastectomy; OR
• Trauma (within 12 months post-injury)

Further modification related to achieving symmetry is subject to the Plan’s medical necessity language and does not include procedures to fill the flap donor site.

Capsulectomy, Capsulotomy, Breast Implant Removal

Humana members may be eligible under the Plan for capsulectomy, capsulotomy or breast implant removal when the following criteria are met:

• Breast implants were placed in conjunction with a medically necessary (noncosmetic) surgery;AND any of the following
• Capsular contracture (Baker grade III or IV); OR
• Extrusion; OR
• Rupture of saline filled, silicone gel or alternative breast implant (confirmed by imaging such as magnetic resonance imaging [MRI] or ultrasound); OR
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• Implant infection refractory to medical management (e.g., antibiotics) unless contraindicated;AND either:
• Infection confirmed by microbiological analysis of peri-implant fluid aspirate; OR
• Presence of symptoms such as fever, redness, elevated white blood cell (WBC) count

Breast Implant Associated Anaplastic Large Cell Lymphoma

Note: The following criteria applies ONLY to implant removal related to breast implant associated anaplastic large cell lymphoma BIA-ALCL, as total capsulectomy (complete surgical resection) is the only recommended treatment.3,22,23,42

Humana members may be eligible under the Plan for total capsulectomy with breast implant removal for the following indications:

• Pathologic confirmation of breast implant associated anaplastic large cell lymphoma BIA-ALCL by cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and anaplastic lymphoma kinase (ALK) markers42; OR
• Removal of Allergan BIOCELL textured breast implants and tissue expanders (due to increased risk of breast implant-associated anaplastic large cell lymphoma [BIA-ALCL])

Breast Implant Associated Squamous Cell Carcinoma

Humana members may be eligible under the Plan for total capsulectomy with breast implant removal for a confirmed diagnosis of breast implant associated squamous cell carcinoma.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for reinsertion of breast implants following a medically necessary removal.

Note: The criteria for breast reconstruction are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for breast reconstruction, capsulectomy, capsulotomy or breast implant removal procedures other than those listed above, or for any indications other than those listed above.

All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for nipple reconstruction for inverted nipples or breast reconstruction for naturally occurring breast asymmetry as these are considered cosmetic. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for lymphatic microvascular surgery in conjunction with breast reconstruction to prevent lymphedema. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Autologous fat graft, autologous fat transplant (lipoinjection or lipomodeling) via excision lipectomy, suction lipectomy or liposuction when performed in conjunction with other breast reconstruction techniques is considered integral to the primary procedure and not separately reimbursable.

Intraoperative assessment of tissue perfusion by any technology including, but not limited to, fluorescence angiography, fluorescent angiography, multispectral imaging, near-infrared spectroscopy, oximetry or visible light spectroscopy is considered integral to the primary procedure and not separately reimbursable.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Background

Additional information about breast cancer, breast conditions, breast reconstruction and breast surgeries may be found from the following websites:

• American Cancer Society
• National Cancer Institute
• National Library of Medicine

Additional information about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) or breast implant-associated squamous cell carcinoma (BIA- SCC) may be found from the following websites:

• American Cancer Society
• American Society of Plastic Surgeons
• US Food & Drug Administration

Medical Alternatives

Alternatives to breast reconstruction include, but may not be limited to, the following:

• Breast prosthesis (please refer to Prosthetics Medical Coverage Policy)

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

CPT® Code(s)

Description

Description

Comments

Comments

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Mastopexy Breast reduction Breast augmentation with implant Removal of intact breast implant Removal of ruptured breast implant, including implant contents (eg, saline, silicone gel)19330Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Breast Reconstruction Effective Date: 05/25/2023
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review. Breast reconstruction after mastectomy: a systematic review and meta-analysis. https://www.ahrq.gov. Published July 2021. Updated October 2021. Accessed April 26, 2023.
• American Society of Plastic Surgeons (ASPS). ASPS statement on breast implant associated squamous cell carcinoma (BIA-SCC). https://www.plasticsurgery.org. Published September 8, 2022. Accessed May 3, 2023.
• American Society of Plastic Surgeons (ASPS). BIA-ALCL summary and quick facts. https://www.plasticsurgery.org. Published March 21, 2018. Updated February 24, 2020. Accessed April 27, 2023.
• American Society of Plastic Surgeons (ASPS). Evidence-Based Clinical Practice Guideline. Autologous breast reconstruction with DIEP or pedicled TRAM abdominal flaps. https://www.plasticsurgery.org. Published November 2017. Accessed April 27, 2023.
• American Society of Plastic Surgeons (ASPS). Evidence-Based Clinical Practice Guideline (ARCHIVED). Breast reconstruction with expanders and implants. https://www.plasticsurgery.org. Published March 2013. Accessed April 27, 2023.
• Breast Reconstruction Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0443-029 Page: 15 of 20
• Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
• American Society of Plastic Surgeons (ASPS). Guiding Principles. Post-mastectomy fat graft/fat transfer. https://www.plasticsurgery.org. Published December 2012. Updated June 2015. Accessed April 27, 2023.
• American Society of Plastic Surgeons (ASPS). Statement on breast implant specimens and pathology. https://www.plasticsurgery.org. Accessed April 27, 2023.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Breast reconstruction following mastectomy (140.2). https://www.cms.gov. Published January 1, 1997. Accessed May 1, 2023.
• ClinicalKey. Schaverien M, Raine C. Breast reconstruction. In: Dixon J and Barber M. Breast Surgery: A Companion to Specialist Surgical Practice. 6th ed. Elsevier; 2019:174-191. https://www.clinicalkey.com. Accessed May 1, 2023.
• ECRI Institute. Clinical Evidence Assessment. Lymphatic microsurgical preventive healing approach (LYMPHA) for preventing lymphedema. https://www.ecri.org. Published June 16, 2020. Accessed April 20, 2023.
• ECRI Institute. Clinical Evidence Assessment. Spy Elite system (Stryker) for assessing tissue perfusion during plastic and reconstructive surgery. https://www.ecri.org. Published April 11, 2011. Updated April 25, 2022. Accessed April 20, 2023.
• ECRI Institute. Hotline Response (ARCHIVED). Cosmetic areola micropigmentation after postmastectomy breast reconstruction. https://www.ecri.org. Published May 5, 2017. Accessed April 20, 2023.
• ECRI Institute. Product Brief (ARCHIVED). PDE-Neo (Mitaka USA/Hamamatsu Photonics) versus Spy Elite system (Novadaq Technologies) for visualizing intraoperative blood flow during breast reconstructive surgery. https://www.ecri.org.

• ECRI Institute. Product Brief (ARCHIVED). T.Ox tissue oximeter (ViOptix, Inc.) for assessing tissue viability in breast reconstruction. https://www.ecri.org. Published February 4, 2015. Accessed April 20, 2023.
• ECRI Institute. Product Brief (ARCHIVED). T-Stat VLS tissue oximeter (Spectros Corp.) for monitoring postsurgical tissue viability. https://www.ecri.org. Published May 21, 2018. Accessed April 20, 2023.
• Gutowski K. Current applications and safety of autologous fat grafts: a report of the ASPS Fat Graft Task Force. Plast Reconstr Surg. 2009;124:272-280. https://www.prsjournal.com. Accessed April 18, 2016.
• Hayes, Inc. Evidence Analysis Research Brief. Fluorescence angiography for mastectomy breast flap perfusion. https://evidence.hayesinc.com. Published August 2, 2022. Updated May 3, 2023. Accessed May 5, 2023.
• Hayes, Inc. Health Technology Assessment. Autologous fat grafting for breast reconstruction after breast cancer surgery. https://evidence.hayesinc.com. Published October 21, 2020. Updated November 14, 2022. Accessed April 21, 2023.
• Hayes, Inc. Health Technology Assessment. Microsurgery for primary prevention of breast cancer associated lymphedema. https://evidence.hayesinc.com. Published October 15, 2019. Updated November 14, 2022. Accessed April 21, 2023.
• Hayes, Inc. Health Technology Brief (ARCHIVED). Superficial inferior epigastric artery (SIEA) flap procedure for postmastectomy breast reconstruction. https://evidence.hayesinc.com. Published November 20, 2014. Updated October 12, 2016. Accessed April 21, 2023.
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Breast cancer. https://www.nccn.org. Published March 23, 2023. Accessed May 2, 2023.
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. T-cell lymphomas. https://www.nccn.org. Published January 5, 2023. Accessed May 2, 2023.
• UpToDate, Inc. Breast implant-associated anaplastic large cell lymphoma. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Breast implant infections. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Complications of reconstructive and aesthetic breast surgery. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Implant-based breast reconstruction and augmentation. https://www.uptodate.com. Updated March 15, 2023. Accessed April 21, 2023.
• UpToDate, Inc. Oncoplastic breast surgery. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Options for autologous flap-based breast reconstruction. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Overview of breast reconstruction.https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.
• UpToDate, Inc. Overview of flaps for soft tissue reconstruction. https://www.uptodate.com. Updated March 2023. Accessed April 21, 2023.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0443-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

510(k) Summaries

• 510(k) summary: Fluobeam 800. Published May 7, 2014. Accessed April 14, 2016.
• 510(k) summary: Infrared 800 with flow 800 option. Published March 3, 2010. Accessed April 14, 2016.
• 510(k) summary: Kent Camera. Published May 5, 2017. Accessed May 5, 2020.
• 510(k) summary: Leica FL 800. Published May 9, 2008. Accessed April 14, 2016.
• 510(k) summary: ODISsey Tissue Oximeter (T.Ox). Published July 1, 2014. Accessed May 1, 2018.
• 510(k) summary: PDE Neo. Published March 27, 2014. Accessed April 14, 2016.
• 510(k) summary: SPY fluorescent imaging system. Published September 7, 2007. Accessed April 14, 2016.
• 510(k) summary: SPY PHI open field handheld fluorescence imaging system. Published January 11, 2017. Accessed April 19, 2019.
• 510(k) summary: T-Stat microvascular tissue oximeter. Published July 28, 2008. Accessed May 3, 2022.
• 510(k) summary: VS3-IR-MM. Published June 17, 2015. Accessed April 14, 2016.
• Risks and complications of breast implants. Updated March 8, 2023. Accessed April 27, 2023.
• Safety Communication (ARCHIVED). The FDA requests Allergan voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Published July 24, 2019. Updated June 1, 2020. Accessed April 27, 2023.
• Safety Communication. Update: reports of squamous cell carcinoma (SCC) in the capsule around breast implants. Updated March 22, 2023. Accessed April 27, 2023.

Breast Reconstruction Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
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Appendix A – Baker Grading Scale

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Appendix B – Autologous Tissue Procedures