Commercial

Medical Policy

Title:

Reconstructive Breast Surgery and Post-Mastectomy Prostheses

Policy #:

11.08.15ae

Policy

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, aesthetic flat closure, 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, aesthetic flat closure, 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. External prosthetic devices may be covered post-mastectomy in accordance with state and federal mandates.

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 medically necessary reconstructive breast surgery.

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®, Coll-e-Derm™, Cortiva® [formerly AlloMax™ and Neoform™], DermACELL™, DermaMatrix™, FlexHD®, FlexHD® Pliable™,Graftjacket® RTM, hMatrix® PR ADM, Permacol™, Repriza®, SimpliDerm™, 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.

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.

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.

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

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

11920, 11921, 11922, 11970, 11971, 15271, 15272, 15769, 15771, 15772, 15777, 19316, 19318, 19325, 19328, 19330, 19340, 19342, 19350, 19355, 19357, 19361, 19364, 19367, 19368, 19369, 19370, 19371, 19380, 19396

THE FOLLOWING CODES ARE USED TO REPRESENT AESTHETIC FLAT CLOSURE IN RECONSTRUCTIVE BREAST SURGERY:

14301, 14302

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

ICD - 10 Procedure Code Number(s)

N/A

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)

A4280 Adhesive skin support attachment for use with external breast prosthesis, each

C1789 Prosthesis, breast (implantable)

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

L8000 Breast prosthesis, mastectomy bra, without integrated breast prosthesis form, any size, any type

L8001 Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, unilateral, any size, any type

L8002 Breast prosthesis, mastectomy bra, with integrated breast prosthesis form, bilateral, any size, any type

L8015 External breast prosthesis garment, with mastectomy form, post mastectomy

L8020 Breast prosthesis, mastectomy form

L8030 Breast prosthesis, silicone or equal, without integral adhesive, any type

L8031 Breast prosthesis, silicone or equal, with integral adhesive, any type

L8032 Nipple prosthesis, prefabricated, reusable, any type, each

L8033 Nipple prosthesis, custom fabricated, reusable, any material, any type, each

L8035 Custom breast prosthesis, post mastectomy, molded to patient model, any type

L8039 Breast prosthesis, not otherwise specified

L8600 Implantable breast prosthesis, silicone or equal

Q4107 Graftjacket, per sq cm

Q4116 Alloderm, per square centimeter (add-on, list separately in addition to primary procedure)

Q4122 Dermacell, dermacell awm or dermacell awm porous, per sq cm

Q4128 Flex hd, or allopatch hd, per square centimeter

Q4130 Strattice tm, per square centimeter (add-on, list separately in addition to primary procedure)

Q4134 HMatrix, per sq cm

Q4142 Xcm biologic tissue matrix, per sq cm

Q4143 Repriza, per sq cm

Q4193 Coll-e-Derm, 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

S8460 Camisole, postmastectomy

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

Q4433 361 hct/p skin substitute product, not otherwise specified (list in addition to primary procedure)

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 11.08.15ae:

10/01/2026

Revisions From 11.08.15ad:

01/01/2026

Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.

This policy version has been identified for the CPT/HCPCS code update, effective 01/01/2026.

The following HCPCS codes have been revised in this policy:
Q4130:
FROM: Strattice, per sq cm
TO: Strattice tm, per square centimeter (add-on, list separately in addition to primary procedure)

Q4116:
FROM: AlloDerm, per sq cm
TO: Alloderm, per square centimeter (add-on, list separately in addition to primary procedure)

The following NOC code has been terminated (no longer valid code) and is being replaced by the following NOC code:
TERMINATED: Q4100: Skin substitute, not otherwise specified
REPLACED: Q4433: 361 hct/p skin substitute product, not otherwise specified (list in addition to primary procedure)

The following HCPCS codes have been terminated (no longer valid codes) and removed from this policy:
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)

Revisions From 11.08.15ac:

05/28/2025	This policy has been reissued in accordance with the Company's annual review process.
04/01/2025	This policy has been identified for the HCPCS code update, effective 04/01/2025. The following HCPCS code has been termed and removed from this policy: L8010 Breast prosthesis, mastectomy sleeve

Revisions From 11.08.15ab:

10/21/2024

The version of this policy will be issued on 12/16/2024 with a retroactively effective date of 10/21/2024.

The following criteria have been added to this policy as medically necessary:

Aesthetic flat closure

Additional accellular dermal matrices: Coll-e-Derm™, hMatrix® PR ADM, SimpliDerm™

The following CPT codes have been added to this policy as medically necessary to represent aesthetic flat closure:
14301, 14302

The following HCPCS codes have been added to this policy as medically necessary:
Q4134 hMatrix, per sq cm
Q4193 Coll-e-Derm, per sq cm

The following HCPCS code will represent SimpliDerm:
Q4100 Skin substitute, not otherwise specified

Revisions From 11.08.15aa:

11/01/2023

This policy has been reissued in accordance with the Company's annual review process.

10/01/2022

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

This policy has been identified for the HCPCS code update, effective 10/01/2022.

The following HCPCS code has been revised in this policy: Q4128.

FROM:

FlexHD, AllopatchHD, or Matrix HD, per sq cm

TO:

Flex hd, or allopatch hd, per square centimeter

Revisions From 11.08.15z:

03/01/2021

This version of the policy will become effective 03/01/2021.

This policy has had a title change from Reconstructive Breast Surgery to Reconstructive Breast Surgery and Prostheses Post-Mastectomy

Policy language for lipofiling was amended for clarity, intent remains the same.

Policy language for external prothetic devices was added as a covered service per state regulations.

External prosthetic devices are covered post-mastectomy according to state and federal regulation.

The following codes have been added to the policy: A4280, L8000, L8001, L8002,

L8010, L8015, L8020, L8030, L8031, L8032, L8033, L8035, L8039, S8460 (Medically Necessary)

Revisions From 11.08.15x:

04/08/2020

This policy has been reissued in accordance with the Company's annual review process.

01/01/2020

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

This policy has been identified for the CPT code update, effective 01/01/2020.

The following CPT codes have been added to this policy: 15769 (Medically Necessary), 15771 (Medically Necessary), 15772 (Medically Necessary)

The following CPT code has been removed from this policy: 20926

Revisions From 11.08.15w:

10/01/2019

This policy has been identified for the HCPCS code update, effective 10/01/2019.

The following narrative change (as indicated in bold) was made to HCPCS code Q4122:

Dermacell, dermacell awm or dermacell awm porous, per square centimeter

Revisions From 11.08.15v:

06/03/2019

Policy 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:

11/21/2018

This policy has been reissued in accordance with the Company's annual review process.

12/01/2017

This 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:

10/1/2026

Version Issued Date:

10/1/2026

Version Reissued Date:

Commercial

Medical Policy

Notification

Policy

Guidelines

Description

References

Coding

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)

ICD - 10 Diagnosis Code Number(s)

HCPCS Level II Code Number(s)

Revenue Code Number(s)

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History