ModifiedCignaPolicy 0178

Breast reconstruction following mastectomy or lumpectomy

Defines medical necessity, covered procedures, and coding for breast reconstruction and related prostheses following mastectomy or lumpectomy for Cigna-administered health benefit plans; applies to both females and males and does not require a diagnosis of breast cancer.

Policy Summary

PayerCigna

PolicyBreast reconstruction following mastectomy or lumpectomy

Policy CodePolicy 0178

Change TypeAnnual review — revisions and removals

Effective DateApr 15, 2026

Next Review DateMar 15, 2027

Key ActionSubmit requests using the appropriate covered CPT/HCPCS codes and supporting documentation when seeking reimbursement or prior authorization.

SourceLink

POLICY UPDATE CHANGES

Revised policy statement for breast reconstruction following mastectomy or lumpectomy.

Revised policy statement for skin and soft tissue substitutes considered medically necessary.

Revised policy statement for skin and soft tissue substitutes considered experimental, investigational, or unproven.

Removed policy statement for the use of adipose-derived stem cells in autologous fat transplantation and xenograft cartilage grafting.

Added Essence Acellular Dermal Matrix to list of EIU products.

Added GalaFLEX products as medically necessary for breast reconstruction (prior review).

Removed policy statement for intraoperative assessment of tissue perfusion.

Annualpolicy review cadence

multipleestablished ADMs listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Essence ADMproducts now EIU

breast reconstructionpolicy statements revised

males & femalescoverage population

Coverage Criteria for Breast Reconstruction

Medically Necessary Indications

Breast reconstruction following mastectomy or lumpectomy is considered medically necessary for EITHER of the following:

Reconstruction on diseased/affected breast: Breast reconstruction procedures performed on the diseased/affected breast (i.e., breast on which the mastectomy/lumpectomy was performed), including areolar and nipple reconstruction (including correction of inverted nipple) and autologous fat transplant (lipoinjection, lipofilling, lipomodeling).

Supported by listing of covered procedures including implants, expanders, flap procedures, capsulotomy/capsulectomy, oncoplastic reconstruction, and reconstructive revisions.

Reconstruction on nondiseased/contralateral breast for symmetry: Breast reconstruction procedures performed on the nondiseased/unaffected/contralateral breast to produce a symmetrical appearance, including areolar and nipple reconstruction, augmentation mammoplasty, autologous fat transplant, implant removal/reimplantation for symmetry, breast reduction/mastopexy, capsulectomy/capsulotomy, liposuction of the breast, and reconstructive surgical revisions to produce symmetry.

Includes implant procedures and soft tissue substitutes when used for reconstruction.

Medically Necessary Materials/Adjuncts

The following are considered medically necessary when used in association with a medically necessary breast reconstruction procedure:

Approved skin and soft tissue substitutes: Specific products (AlloMax, Cortiva, DermACELL, FlexHD Acellular Hydrated Dermis, GalaFLEX™ collection) are considered medically necessary when used with medically necessary reconstruction procedures.

Refer to Appendix for product-to-code mapping and product variants (GalaFLEX, GalaFLEX 3D, GalaFLEX 3DR, GalaFLEX LITE).

Avance Nerve Graft is considered medically necessary when used in association with mastectomy or breast reconstruction procedures when nerves cannot be preserved.

Supported by referenced CPT codes for nerve allograft procedures.

Experimental/Investigational/Unproven

The following are considered experimental, investigational, or unproven and are not covered:

Listed products/procedures: Named products (ARTIA Reconstructive Tissue Matrix; BellaDerm Acellular Hydrated Dermis; Biodesign Nipple Reconstruction Cylinder; DuraSorb Monofilament Mesh; Essence Acellular Dermal Matrix; JUVÉDERM; OviTex PRS; Permacol; Phasix Mesh; Radiesse; Renuva; SimpliDerm; Strattice Reconstructive Tissue Matrix; SurgiMend PRS) and injections of listed non-covered fillers are considered experimental, investigational, or unproven when used in association with breast reconstruction procedures.

Specific CPT/HCPCS codes are identified in the policy appendix as experimental or noncovered for these products and injectable uses (see policy coding sections).

Cosmetic / Not Medically Necessary

Donor site asymmetry correction: Suction lipectomy, ultrasonically-assisted suction lipectomy (liposuction), or excision of redundant skin performed solely to correct surgically-induced donor-site asymmetry or tissue protruding at the end of a scar following flap breast reconstruction is considered cosmetic and not medically necessary.

These procedures may be considered incidental when performed as part of a medically necessary flap reconstruction but are cosmetic when performed alone.

Covered reconstructive techniques and conditions

Covered when ALL of the following are met

General reconstruction context: Procedure is part of breast reconstruction following mastectomy or lumpectomy and intended to restore form, function, or appearance of the breast, nipple, or areola.

Applies to immediate or delayed reconstruction; coverage available to both females and males and not dependent on cancer diagnosis.

Technique-specific appropriateness: Selected technique is appropriate for the patient’s anatomy, prior treatments (e.g., radiation), and reconstructive goals; contraindications (active infection, untreated breast cancer, current breastfeeding, or excessively thin mastectomy flaps) are absent.

Includes consideration of suitability for tissue expanders and implants per clinical guidance.

Autologous fat grafting: Autologous fat transplant (lipoinjection/lipofilling/lipomodeling) is considered an acceptable adjunct to reconstruction when performed for oncologic reconstruction indications; staged treatments may be required to achieve desired volume.

ASPS guidance supports oncologic safety and need for serial treatments; documentation of planned serial procedures and outcomes is recommended.

Not supported / investigational

Not supported / investigational when ANY of the following are proposed

HA fillers for nipple/areola: Use of hyaluronic acid‑based dermal fillers (e.g., JUVÉDERM) for reconstruction of the nipple or areola is not supported due to insufficient high-quality evidence of safety and efficacy.

Manufacturer approvals are limited to facial aesthetic indications; literature review finds insufficient evidence for areolar/nipple use.

Calcium hydroxylapatite for nipple/areola: Use of calcium hydroxylapatite fillers (e.g., Radiesse) for nipple or areolar reconstruction is not supported due to insufficient high-quality evidence of safety and efficacy.

Radiesse PMA indications are for facial/hand/jawline uses; nipple/areola reconstruction is not an approved indication.

Biodesign NRC investigational: Use of the Biodesign Nipple Reconstruction Cylinder (NRC) is considered investigational/unsupported for areolar and nipple reconstruction because available clinical data are limited and of insufficient quality and duration.

The cited prospective study (82 reconstructions in 50 patients) had modest projection retention and methodological limitations (small, no control, short follow-up).

Accepted reconstruction methods

Covered when provided for reconstruction following mastectomy or lumpectomy and consistent with clinical indications

Reconstruction modalities: Implant-based reconstruction using FDA‑approved silicone gel or saline implants; autologous tissue (flap) reconstruction (multiple flap types listed); oncoplastic procedures (e.g., reduction, mastopexy) to restore breast shape after tumor excision; liposuction for secondary contour correction (typically 3–6 months postoperatively); and use of established skin and soft tissue substitutes (ADMs/HCT/Ps and GalaFLEX collection) supported by peer‑reviewed evidence.

Contraindications (active infection, untreated cancer, breastfeeding) and implant-specific complication risks should be considered in patient selection.

Management of BIA-ALCL and textured implants

Clinical recommendations and reasonable considerations

BIA-ALCL management and implant considerations: Recommend discontinuation of macrotextured implants; implement surveillance for patients with any implant surface; for confirmed BIA‑ALCL consider en bloc capsulectomy with explantation and appropriate oncologic management; prophylactic explantation of macrotextured implants may be reasonable and contralateral explantation may be considered when BIA‑ALCL is diagnosed.

Recommendations reflect professional society consensus (AAPS) and emphasize surgeon–patient shared decision‑making.

Coverage by evidence strength

Coverage stance is differentiated by the strength of published evidence for each product:

Established/Supported products: Products supported by published peer‑reviewed literature or randomized trials and considered established treatment options for breast reconstruction (examples: AlloMax, Cortiva, DermACELL, FlexHD, GalaFLEX collection).

These products are described as established based on cited evidence analyses and trials.

Products with insufficient evidence: Products for which evidence is insufficient or lacking to support safety and efficacy for breast reconstruction (examples: ARTIA RTM, BellaDerm, DuraSorb, Essence ADM, OviTex PRS, Permacol, Phasix, Renuva, SimpliDerm, Strattice, SurgiMend). Use of these may be considered experimental/investigational/unproven.

Policy explicitly lists these products as having limited or inconsistent published evidence.

Neurotization/Avance nerve graft: Neurotization using processed nerve allografts (e.g., Avance) has some supporting evidence for sensory recovery after mastectomy; Avance has regulatory approval/clearance for peripheral nerve deficits but evidence in postmastectomy reconstruction is limited to observational studies.

WHCRA-required coverage and cosmetic exclusions

Covered when related to medically necessary breast reconstruction following mastectomy or lumpectomy and when documentation supports clinical need

WHCRA-required coverage: All stages of reconstruction of the breast on which the mastectomy was performed, surgery and reconstruction of the other breast to produce a symmetrical appearance, prostheses, and treatment of physical complications of the mastectomy are covered per WHCRA when reconstruction is medically necessary and documentation supports clinical need.

WHCRA does not require coverage for breast asymmetry unrelated to mastectomy/lumpectomy, trauma-related deformity, or poor cosmetic results after cosmetic surgery.

Updated coverage criteria highlights

Policy statements updated during annual review (4/15/2026).

Breast reconstruction: Revised policy statement for breast reconstruction following mastectomy or lumpectomy.

Refer to the full policy for detailed criteria and product lists; effective 4/15/2026.

Skin and soft tissue substitutes - medically necessary: Revised policy statement listing products considered medically necessary (e.g., GalaFLEX products retained as medically necessary).

See Appendix for updated product-to-code mappings.

Skin and soft tissue substitutes - experimental/investigational/unproven: Revised policy statement and addition of Essence Acellular Dermal Matrix to the experimental/investigational/unproven list.

Products listed as EIU are not covered per the revised policy.

Suction-assisted lipectomy (liposuction) and excision of redundant skin are recontouring procedures intended to improve donor-site appearance. When performed alone to correct surgically-induced donor-site asymmetry or excess tissue resulting from flap breast reconstruction (for example, dog-ear or standing-cone deformities), these procedures are considered cosmetic and not medically necessary. If performed concurrently and incidental to a medically necessary flap breast reconstruction, suction-assisted lipectomy of the trunk may be considered incidental to the primary reconstructive procedure and not billed as a separate reconstructive service.

Hyaluronic acid fillers (e.g., JUVÉDERM) and calcium hydroxylapatite fillers (e.g., Radiesse) are marketed and approved for facial and related aesthetic indications, not for nipple or areolar reconstruction. The policy notes that the current peer‑reviewed literature provides insufficient high-quality evidence to support the safety, efficacy, or clinical utility of these fillers for breast, areolar, or nipple reconstruction; use for these indications may therefore be excluded or denied.

Contraindications that should preclude reconstruction procedures or the use of implantable devices and certain tissue products include active infection, untreated breast cancer, and current breastfeeding. Additionally, some human cell and tissue products (HCT/Ps) and animal‑derived skin or soft tissue substitutes require specific FDA clearance or have regulatory constraints; when regulatory requirements or safety concerns exist (for example very thin mastectomy flaps), these should be considered in patient selection and documentation.

The policy identifies a set of named products for which the published peer‑reviewed evidence is insufficient to support safety and effectiveness in breast reconstruction. Examples listed as experimental, investigational, or unproven include ARTIA RTM, BellaDerm, Biodesign Nipple Reconstruction Cylinder (NRC) evidence limitations, DuraSorb, Essence Acellular Dermal Matrix, OviTex PRS, Permacol, Phasix Mesh, Renuva, SimpliDerm, Strattice, and SurgiMend. Use of these products for breast reconstruction may be considered not medically necessary and subject to denial absent stronger supporting evidence.

When suction‑assisted lipectomy or excision of redundant skin is performed as an isolated procedure solely to address donor‑site contour or asymmetry after flap reconstruction, it is considered a cosmetic-only procedure and is not covered. Conversely, these techniques are considered incidental and may be part of covered reconstruction when performed contemporaneously with a medically necessary flap breast reconstruction.

The Appendix contains product-to-code mappings, HCPCS/Q‑code assignments, and reference listings intended to support coding and billing. This appendix material provides coding examples and crosswalks but does not itself establish additional coverage criteria or change the policy’s medical necessity determinations.

During the Annual Review dated 4/15/2026, several policy statements were removed, including the statement for intraoperative assessment of tissue perfusion and for the use of adipose‑derived stem cells in autologous fat transplantation; other administrative statements (for example regarding external prostheses) were also removed as noted in the revision details.

Correction of surgically‑induced donor‑site asymmetry or excess tissue that results from flap breast reconstruction (for example dog‑ear deformities) is considered cosmetic and not medically necessary when performed solely for donor‑site contouring. However, contouring limited to addressing deformity that is incidental to a medically necessary flap reconstruction may be considered part of the reconstructive episode and documented as such.

The policy reiterates that hyaluronic acid–based fillers (including JUVÉDERM) and calcium hydroxylapatite fillers (including Radiesse) lack sufficient peer‑reviewed evidence to support their use for nipple or areolar reconstruction. Because these products are approved for facial and other specific indications rather than nipple/areolar reconstruction, their use for these breast indications is described as unsupported and may be denied.

The document notes that product and device lists are examples and not exhaustive; absence of a device from the lists does not imply endorsement or coverage. Likewise, not all devices have explicit 'not medically necessary' statements in the policy text; the appendix mappings and narrative examples are provided to guide coding and prior authorization but are not an all‑inclusive catalog.

Skin and soft tissue substitutes (including ADMs, scaffolds, and HCT/Ps) require adequate peer‑reviewed clinical evidence to support use in breast reconstruction. The policy states that use of substitutes lacking sufficient published evidence may be considered not medically necessary or investigational; providers should supply supporting clinical literature when requesting coverage for less‑established products.

Certain acellular dermal matrices and related products are specifically identified in the policy as having insufficient evidence for breast reconstruction. Examples called out include Renuva, SimpliDerm, Strattice, SurgiMend and others; these products are listed among those considered experimental, investigational, or unproven for breast reconstruction and may be denied when used for that purpose.

Products listed in the policy as experimental, investigational, or unproven—such as Essence Acellular Dermal Matrix—are considered not medically necessary for breast reconstruction due to insufficient peer‑reviewed evidence. The appendix identifies code mappings for these products but their classification as E/I/U makes them subject to noncoverage.

Coding and Product Code Mappings

Covered CPT CodesCPTCovered

15771	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50 cc or less injectate.
15772	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; each additional 50 cc injectate, or part thereof (List separately in addition to code for primary procedure).
15777	Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (eg, breast, trunk) (List separately in addition to code for primary procedure).
15877	Suction assisted lipectomy; trunk.
19316	Mastopexy.
19318	Breast reduction.
19325	Breast augmentation with implant.
19328	Removal of intact breast implant.
19330	Removal of ruptured breast implant, including implant contents (eg, saline, silicone gel).
19340	Insertion of breast implant on same day of mastectomy (ie, immediate).

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Covered HCPCS/Codes for skin/tissue substitutes and related productsHCPCSCovered

Q4122	Dermacell, per square centimeter.
Q4128	Flex hd or allopatch hd, or matrix hd per square centimeter.
C1781	Mesh (implantable).
Q4100	Skin substitute, not otherwise specified.
C9399	Unclassified drugs or biologicals.

Experimental/Investigational/Unproven codesmixedExperimental

C9358	Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm.
C9360	Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm.
C9364	Porcine implant, Permacol, per sq cm.
Q2026	Injection, Radiesse, 0.1 ml.
Q4130	Strattice TM, per sq cm.
C1763	Connective tissue, nonhuman (includes synthetic).
C1762	Connective tissue, human (includes fascia lata).
J3590	Unclassified biologics.
11950	Subcutaneous injection of filling material (eg, collagen); 1 cc or less.
11951	Subcutaneous injection of filling material (eg, collagen); 1.1 to 5.0 cc.

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Device and FDA identifiers discussedmixed

P050047	JUVÉDERM PMA identifier
P110033	JUVÉDERM PMA identifier
LMH	FDA product code for certain dermal fillers
P050037	Radiesse PMA identifier
P050052	Radiesse PMA identifier
K110402	Biodesign Nipple Reconstruction Cylinder 510(k) identifier
LCJ	FDA product code for tissue expanders

FDA product identifiers (examples)mixed

P020056	Natrelle Silicone-Filled Breast Implants (FDA identifier)
P030053	MemoryGel Silicone Gel-Filled Breast Implants (FDA identifier)
P040046	Natrelle Highly Cohesive Silicone-Filled Breast Implants (FDA identifier)
P060028	Mentor MemoryShape Breast Implants (FDA identifier)
P070004	Sientra Silicone Gel Breast Implants (FDA identifier)
P230005	Motiva SmoothSilk Round Ergonomix / SmoothSilk Round Silicone Gel-Filled Breast Implants (FDA identifier)
P120011	Puregraft Serene Breast Implant (FDA identifier)
P990074	Natrelle Saline Breast Implants (FDA identifier)
P990075	Mentor Corporation Saline-Filled And Spectrum Mammary Prostheses (FDA identifier)

FDA 510(k) product clearances citedmixed

K140533	GalaFLEX Scaffold 510(k) clearance
K161092	GalaFLEX 510(k) clearance
K162922	GalaFLEX 510(k) clearance
K233999	GalaFLEX 510(k) clearance
K162752	ARTIA Tissue Matrix 510(k) clearance
K181094	DuraSorb Monofilament Mesh 510(k) clearance
K141053	OviTex PRS 510(k) clearance
K214070	OviTex PRS 510(k) clearance
K241126	OviTex PRS 510(k) clearance
K243595	OviTex PRS 510(k) clearance

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Biologics licensemixed

BLA 125816

Avance (acellular nerve allograft) Biologics License Application approval

Appendix CPT/HCPCS mappingsmixed

15777	Considered Medically Necessary (used for many ADM products) - CPT
C1781	HCPCS mapping shown for multiple products
Q4100	HCPCS mapping shown for multiple products
Q4122	DermACELL HCPCS
Q4128	FlexHD HCPCS
Q4130	Strattice HCPCS
C9358	SurgiMend HCPCS mapping
C9360	SurgiMend HCPCS mapping
C1763	HCPCS code referenced in appendix mappings
C1762	Essence ADM HCPCS mapping

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Covered product CPT/HCPCS mappingsmixedCovered

15777	Implantation of biologic implant; listed for many products (ADM/scaffold) per appendix
C1781	HCPCS mappings used for multiple scaffolds/ADMs (product-specific)
C9399	Unclassified biologics HCPCS code used in appendix mappings
Q4100	Product-specific HCPCS/Q-code used in appendix mappings

Additional product CPT/HCPCS mappingsmixedCovered

15777	Mapped to many ADM products (see product list)
C1763	HCPCS code mapped to several products (e.g., BellaDerm) per appendix
C1762	HCPCS mapping for specific product (Essence)
Q4122	HCPCS/Q-code mapped to DermACELL
Q4128	HCPCS/Q-code mapped to FlexHD Acellular Hydrated Dermis
Q4130	HCPCS/Q-code mapped to Strattice Reconstructive Tissue Matrix
C9358	HCPCS mapped to SurgiMend PRS
C9360	HCPCS mapped to SurgiMend PRS
C9364	HCPCS mapped to Permacol
Q2026	HCPCS mapped to Radiesse

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Procedure CPT mappings for specific injectables and nipple proceduresCPT

11950-11954	Injection codes referenced for JUVÉDERM usage
19530	Repair of nipple/areolar complex; mapped to Biodesign Nipple Reconstruction Cylinder and Radiesse in appendix
19350	Nipple/areola reconstruction mapping noted for Biodesign

FDA 510(k) product codesmixed

FTL	Product code cited in FDA 510(k) database
FTM	Product code cited in FDA 510(k) database
LCJ	Product code cited in FDA 510(k) database
OOD	Product code cited in FDA 510(k) database
OWT	Product code cited in FDA 510(k) database
OXH	Product code cited in FDA 510(k) database

FDA PMA product codesmixed

FTR	Product code cited in FDA PMA database
FWM	Product code cited in FDA PMA database
LMH	Product code cited in FDA PMA database

Autologous fat graft injectate threshold

Primary injectate allowanceCPT 15771: grafting of autologous fat by liposuction technique — 50 cc or less injectate.

Additional volume reportingCPT 15772: grafting of autologous fat — each additional 50 cc injectate (list separately in addition to primary procedure).

Billing note15772 is reported in addition to the primary 15771 when injectate exceeds 50 cc (or part thereof).

Timing for liposuction after reconstruction

Provider Requirements, Prior Authorization, and Documentation

Documentation Required

Clinical review and coding documentation

Each coverage request is reviewed on its own merits. Reimbursement is provided only if the service is submitted according to applicable policy criteria and billed with the most appropriate covered diagnosis and/or procedure code(s) as of the service date. Claims for services not accompanied by covered code(s) under this policy will be denied as not covered.

Use the most appropriate codes as of the date of service.
Claims without covered codes will be denied.

Prior Authorization

Prior Authorization Required for Device Implantation

Prior authorization is required for procedures that involve implantation of FDA‑approved internal breast prostheses (breast implants) or tissue expanders. Requests for authorization should indicate the device type and model when available and include the clinical rationale for implantation.

Background and Rationale

Breast reconstruction following mastectomy or lumpectomy is performed to restore the shape, appearance, symmetry, and size of the affected and/or contralateral breast. Primary reconstruction approaches include implant‑based and autologous (flap) techniques, and may include adjunctive procedures such as nipple/areolar reconstruction, tattooing, fat grafting, liposuction, and symmetry procedures to achieve the desired reconstructive result.

Definitions

Breast reconstruction — definition

DefinitionBreast reconstruction: surgical procedures and prostheses following mastectomy or lumpectomy to restore breast shape and symmetry (applies to affected and contralateral breasts; coverage available to both females and males).

ScopeIncludes implant-based and autologous tissue (flap) reconstruction; may be immediate or delayed and does not require a diagnosis of breast cancer.

ComponentsMay include areolar/nipple reconstruction, autologous fat transplant, tissue expanders, implants, and reconstructive revisions.

Areolar and nipple reconstruction (final stage) — definition

Definition (final stage)Areolar and nipple reconstruction: the final stage of breast reconstruction intended to restore the shape, color, and overall appearance of the nipple and areola.

Techniques

Policy Changes and Review History

2026-04-15Annual Review - RevisedLatest

Revised policy statement for breast reconstruction following mastectomy or lumpectomy and updated related coverage statements for skin and soft tissue substitutes, including additions to experimental/investigational/unproven listings.

Policy Summary

PayerCigna

PolicyBreast reconstruction following mastectomy or lumpectomy

Policy CodePolicy 0178

Change TypeAnnual review — revisions and removals

Effective DateApr 15, 2026

Next Review DateMar 15, 2027

Key ActionSubmit requests using the appropriate covered CPT/HCPCS codes and supporting documentation when seeking reimbursement or prior authorization.

SourceLink

On This Page

Avance is listed as considered medically necessary when nerves cannot be preserved but evidence for broader neurotization outcomes remains evolving.

Typical timingLiposuction of the breast is typically performed 3–6 months after the initial reconstructive surgery or after completion of adjuvant therapy.

PurposePerformed for secondary contour correction once tissues have stabilized and swelling has subsided.

Combination useMay be used alone or with fat grafting, direct tissue excision, or implant augmentation for optimal aesthetic outcomes.

Minimum follow-up in included studies

Minimum follow-up required in included studies>= 6 months (studies included in systematic review required at least 6 months follow-up).

Study scopeSystematic review of biosynthetic mesh included 24 studies meeting the ≥6 months follow-up criterion.

Outcomes assessedFollow-up duration used to assess hematoma, seroma, infection, skin necrosis, and implant loss rates.

PA is implied/required for implantation of tissue expanders and FDA‑approved internal breast prostheses.

Include device type/model and clinical justification in the PA request.

Prior Authorization

Prior authorization: use appendix code mappings

When requesting prior authorization for use of an ADM, scaffold, or other skin/soft tissue substitute, providers must reference the appendix product-to-code mappings and include the specific product name mapped to the HCPCS/CPT code used for the request and subsequent claims.

Use appendix product-to-code mappings when requesting PA.
Link the product name to the HCPCS/CPT code in documentation and claims to avoid denial.

Billing Rule

Use appendix mappings for documentation

Appendix product-to-code mappings must be used in clinical documentation and on claims. Failure to map the specific product to the billed code may result in claim denial or payment delay.

Appendix lists product-to-CPT/HCPCS mappings (e.g., AlloMax, Cortiva, DermACELL, GalaFLEX entries).
Ensure the product listed in the patient's record matches the code submitted on the claim.

Denial Risk

Risks associated with tissue expanders

Tissue expanders carry known risks that should be discussed with patients and documented in the medical record. Adverse events may include infection, rupture, pain (including during saline expansion), skin/tissue injury or thinning, port complications, and need for reoperation or removal.

Document discussion of infection, rupture, pain during filling, skin thinning, and potential need for additional surgeries.
Be aware that complications may necessitate reoperation or explantation.

Documentation Required

Required documentation of informed discussion

Document that an informed discussion occurred with the patient and include evidence of counseling regarding benefits, risks, alternatives, and device‑specific information. For implants and expanders, document review of manufacturer's patient labeling, surveillance recommendations (e.g., MRI/ultrasound for silicone implants), and discussion of potential long‑term monitoring and reoperation needs.

Document that the manufacturer's patient labeling and surveillance recommendations were reviewed with the patient.
Record the informed consent discussion covering benefits, risks, alternatives, and potential need for future surgeries.

Documentation Required

Supporting evidence required

When requested by the reviewer, provide clinical literature, evidence summaries, or rationale supporting the selection of a specific skin/soft tissue substitute or product. For products with limited published evidence, include surgeon rationale and clinical history to justify medical necessity.

Provide peer‑reviewed clinical literature or evidence summaries when requested.
For products with limited evidence (listed in policy as insufficient), include detailed justification and expected benefit.

Note

WHCRA coverage components

WHCRA requires coverage for all stages of reconstruction following mastectomy, surgery and reconstruction of the contralateral breast for symmetry, prostheses, and treatment of physical complications (including lymphedema). Ensure PA requests and documentation reflect all applicable WHCRA components.

Coverage must include all stages of reconstruction for the operated breast.
Include documentation for contralateral symmetry procedures, prostheses, and management of physical complications as part of the overall reconstruction plan.

Note

Evidence‑informed selection (informational)

Evidence‑informed selection: where higher‑quality evidence exists for established ADMs and scaffolds (for example, AlloMax, Cortiva, DermACELL, FlexHD, GalaFLEX), prefer these options when clinically appropriate. The literature compares complication rates and outcomes across products; clinicians should consider available evidence, device characteristics, and patient‑specific factors.

No explicit step therapy is required; however, evidence summaries suggest differing complication profiles among ADMs and biosynthetic meshes.
When multiple appropriate products exist, document why the chosen product is preferred for this patient based on evidence and clinical factors.

Billing Rule

Device coding for prior authorization and billing

Select and document the most appropriate CPT/HCPCS codes that correspond to the specific product and procedure. Incorrect coding or failure to link the product to the procedure code(s) may result in denial. Submit product name and its appendix mapping in the PA and on the claim.

Incorrect or mismatched coding may trigger denials.
Always link product name to the billed code and include mapping reference from the appendix in PA and claims.

Documentation Required

Staged procedures and contralateral symmetry — documentation expectations

Autologous fat grafting is commonly staged; document the indication, prior treatments, number of planned staged procedures, and expected benefit. Contralateral symmetry procedures should have rationale documented; cosmetic procedures performed alone are not covered.

Document indication, technique, prior treatments, and expected benefit for staged fat grafting.
Document rationale for contralateral symmetry procedures; standalone cosmetic lipectomy/excision is not covered.

May use autogenous flaps, local bilobed or trilobed flaps, skin grafts, nipple sharing methods, and tattooing for pigmentation.

TimingMay be performed immediately during reconstruction or delayed until the breast has achieved a more definitive shape; decision is patient-driven.

Areolar and nipple reconstruction — alternate wording

Alternate wordingAreolar and nipple reconstruction: reconstruction to restore shape, color, and appearance of the nipple and areola using flaps, grafts, sharing techniques, and tattooing.

Clinical roleRepresents the final stage of breast reconstruction and may correct inverted nipples.

Patient decisionTiming and pursuit of nipple-areolar reconstruction should be based on patient preference.

Autologous fat transplant (fat grafting) — definition

DefinitionAutologous fat transplant (fat grafting): harvesting, processing (eg, washing/decanting), and reinjecting the patient’s own fat to restore volume, contour, and symmetry in breast reconstruction.

Staged treatmentOften requires multiple (serial) treatments due to expected volume loss and resorption; may be performed on affected and/or contralateral breast or with implants/flaps.

Donor sitesCommon donor sites include flanks, abdomen, thighs, buttocks, and lower back.

Biodesign Nipple Reconstruction Cylinder (NRC) — description

Product descriptionBiodesign Nipple Reconstruction Cylinder (NRC): a tightly rolled cylinder of extracellular matrix collagen derived from porcine small intestinal submucosa (SIS) intended to reinforce soft tissue and act as a stent to achieve nipple projection during reconstructive surgery.

MechanismSIS is a scaffold of fibrillar collagens, glycosaminoglycans, and adhesive glycoproteins that support cellular migration and organized extracellular matrix formation.

Intended useImplanted to reinforce weak soft tissue and serve as biomaterial stent over which skin flaps can be created to form nipple projection.

Internal breast prosthesis (breast implant) — definition

DefinitionInternal breast prosthesis (breast implant): a medical device composed of an outer silicone shell filled with silicone gel or saline used for reconstructive or cosmetic breast surgery.

IndicationsUsed for restoration of breast appearance after mastectomy, correction of congenital or traumatic defects, management of asymmetries, and revision surgeries.

Contraindications & risksContraindications include active infection, untreated breast cancer, and current breastfeeding; complications can include seroma, infection, capsular contracture, implant rupture, and rare malignancies (eg, BIA-ALCL).

Autologous (flap) reconstruction — definition

DefinitionAutologous (flap) reconstruction: use of the patient’s own tissue (skin, fat, sometimes muscle) from donor sites (eg, abdomen, back, thigh, buttocks) to reconstruct the breast; may be pedicled or free with microsurgical revascularization.

OutcomesFlap-based reconstruction produces a breast with texture and appearance closely resembling natural tissue and may improve aesthetically over time.

ExamplesExamples include DIEP, TRAM, LD, SGAP, PAP, DCIA, IGAP, LTP, and others listed in the policy.

Acellular dermal matrix (ADM) / HCT/P — definition

DefinitionAcellular dermal matrix (ADM) / HCT/P: tissue-derived or synthetic substitute used to support soft tissue coverage and reconstruction; ADM consists of collagen, elastic fibers, and extracellular matrix components and may be harvested from human or animal sources.

Regulatory noteHCT/Ps that meet criteria (eg, minimally manipulated, homologous use) may be marketed without FDA clearance; other HCT/Ps and animal-derived ADMs are regulated by the FDA as devices and require clearance/approval and registration.

FunctionIntended to enhance skin coverage and potentially reduce capsular contracture risk after implant or expander placement; synthetic meshes and scaffolds may provide structural support and guide tissue ingrowth.

HCT/P — regulatory note

Regulatory summaryHCT/P regulatory note: HCT/Ps meeting 21 CFR 1271 and Section 361 PSA requirements (minimally manipulated, homologous use) are not required to be FDA approved or cleared; products not meeting these criteria are regulated as drugs/devices/biologics and require FDA clearance or approval. All HCT/Ps require FDA registration prior to marketing.

Animal-derived productsSkin and soft tissue substitutes harvested from animals are regulated as medical devices and require FDA clearance or approval to be marketed.

Synthetic meshesSynthetic meshes and scaffolds are regulated as medical devices and require FDA clearance/approval.

P4HB scaffold / GalaFLEX / Phasix — definition

Definition / examplesP4HB scaffold (eg, GalaFLEX, Phasix): a bioabsorbable poly-4-hydroxybutyrate monofilament polymer used in scaffolds/meshes for soft tissue reinforcement; examples include GalaFLEX and Phasix which have FDA 510(k) clearances but variable evidence in breast reconstruction.

Regulatory statusThese products are Class II medical devices cleared via the FDA 510(k) pathway (multiple K-numbers cited in the policy).

Evidence notePublished literature supporting some P4HB products for breast reconstruction is limited, often retrospective with small populations and short follow-up.

ADM / reconstructive tissue matrix — description

DefinitionADM / reconstructive tissue matrix: biologic or xenograft-derived soft tissue scaffolds (human-, porcine-, or bovine-derived) intended to reinforce soft tissue, repair or replace damaged integumental tissue, and support reconstructive procedures.

ComponentsConsist of extracellular matrix elements (collagen, fibronectin, laminin, hyaluronic acid) to support tissue ingrowth and healing.

Intended benefitMay enhance soft tissue coverage and provide reinforcement after implant or expander placement; specific products have varying evidence bases.

FDA 510(k) product codes — definition

DefinitionFDA 510(k) product codes: regulatory identifiers used in the FDA 510(k) premarket notification database referenced for devices cited in the policy (eg, FTL, FTM, LCJ, OOD, OWT, OXH).

UseReferenced to locate device clearances and supporting regulatory information in FDA databases cited in the references section.

ReferencePolicy cites the FDA 510(k) database (Reference 104) for listed product codes and clearances.

Human cell and tissue establishment registration — definition

DefinitionHuman cell and tissue establishment registration: public FDA registry used to identify establishments marketing HCT/Ps; cited as a resource for cellular and tissue products (HCT/P) used in reconstruction.

AccessFDA Human Cell and Tissue Establishment Registration — Public Query (Reference cited in policy).

ImplicationEstablishment registration is required for HCT/P marketing and is referenced to support regulatory status statements in the policy.

FDA references — PMA/510(k) and labeling resources

DefinitionFDA references: PMA/510(k) and labeling resources cited in the policy to support regulatory status and product information for implants, tissue products, and devices.

Key resourcesIncludes FDA 510(k) database, PMA database, guidance documents on HCT/Ps and animal-derived materials, and device safety/labeling pages referenced in the policy (References 104–113+).

PurposeUsed to verify regulatory clearances/approvals, product codes, and safety labeling pertinent to breast reconstruction devices and materials.