Confirm plan terms and submit per policy

Coverage determinations must consider the terms of the member’s applicable benefit plan and services must be submitted in accordance with the Coverage Policy; claims lacking covered diagnosis/procedure codes or not submitted per policy criteria will be denied.

Justify ADM use and document risks

When using acellular dermal matrices (ADMs) for implant-based reconstruction, be prepared to justify the choice and document patient-specific indications because ADMs have differing safety profiles and some products have higher complication rates.

Authorize based on product-specific evidence

Prior authorization and review should reflect product-specific evidence and indications; established ADMs (e.g., AlloDerm, AlloMax, DermACELL, FlexHD) are described as accepted options while other products lack sufficient evidence.

Prior authorization for off‑label device use may be needed

FDA warning letters and communications note that some scaffolds/meshes are not cleared for breast reconstruction; prior authorization may be required when devices are used outside cleared indications to confirm appropriateness.

Coverage-linked coding — document and review

Certain CPT and HCPCS codes in the policy are medically necessary only when applicable clinical criteria are met; use of some codes (including codes for ADSC-enriched fat grafting and listed experimental products) requires prior review and supporting documentation.

• Codes such as 15771/15772/15777 and listed HCPCS mappings require documentation of policy criteria.
• Codes used to report ADSC-enriched fat grafting are considered experimental and likely not approved for payment.

Avance Nerve Graft — use CPT 64912/64913 and seek authorization

When reporting Avance Nerve Graft procedures, CPT codes 64912 and 64913 apply and require adherence to the policy’s clinical criteria and prior authorization as CPT-coded services.

Reference list — no new prior auth rules stated here

This section lists references and regulatory sources and does not by itself state additional prior authorization requirements.

Prior authorization may be required — check updated product lists

Prior authorization requirements may apply for reconstructive procedures and certain products; recent revision history changed covered/non-covered product lists, which can affect authorization determinations.

Sequence expander → removal → permanent implant; ADMs augment coverage

When tissue expanders are used, permanent implants are placed after adequate expansion and expander removal; ADMs are primarily used to provide additional coverage or reestablish anatomic landmarks when native tissue is insufficient.

Consider randomized comparative data when selecting ADM

Where randomized comparative data exist (for example Cortiva vs AlloDerm), consider those outcomes when selecting an ADM, acknowledging that no explicit step therapy requirements are provided in this policy.

Autologous fat grafting — adjunctive option; no step therapy mandated

Autologous fat grafting is described as an adjunct or alternative in reconstruction, with expected resorption and multiple sessions often required; the policy does not establish explicit step therapy rules for fat grafting.

• Expect clinical volume loss of approximately 40–60% within months and need for multiple sessions.

Lipectomy/skin excision: cosmetic alone; incidental with flap reconstruction

Suction-assisted lipectomy or excision of redundant skin performed alone is considered cosmetic and not medically necessary; when performed as part of a medically necessary flap breast reconstruction they are incidental and not separately reimbursable.

Use appropriate codes and support with documentation

When billing, use the most appropriate CPT/HCPCS codes effective on the date of service and submit documentation that supports medical necessity; reimbursement is provided only when documentation and coding align with the policy.

Report implant-capsule cancers to FDA and document findings

Report cases of squamous cell carcinoma, lymphomas, or other cancers in the implant capsule to the FDA and document specimen findings and pathology when examining implant-related specimens.

Document shared decision-making and adverse event reporting

Document shared decision-making that discusses potential benefits and risks of treatment options, and note that ADMs are not FDA-approved for implant-based breast reconstruction; report adverse events to FDA MedWatch as recommended.

Document device model/510(k) and indication

When using a device for soft tissue reinforcement, document the specific device model and 510(k) number or FDA indication and the clinical rationale linking its intended use to the patient’s reconstructive need.

WHCRA-required coverage — reconstruction, symmetry, prostheses

Benefits for reconstruction following mastectomy or lumpectomy must include reconstruction of the affected breast, surgery on the contralateral breast for symmetry, prostheses, and treatment of physical complications as required by the WHCRA federal mandate.

Maintain documentation proving policy criteria are met

Ensure documentation demonstrates that applicable policy criteria are met for items reported as medically necessary (for example, prosthesis codes L8000–L8039 and preparation of moulage code 19396).

Reference product-specific policy updates in documentation

Refer to product-specific policy language and recent revisions (e.g., GalaFLEX added as medically necessary; DuraSorb added to E/I/U list) and document product type and indication to support medical necessity.

Coding mismatch will risk denial

Claims for services lacking covered diagnosis and/or procedure codes under this Coverage Policy will be denied as not covered — ensure coding matches the policy’s covered code lists and supported indications.

ADM-associated higher complication signal — document justification

Use of ADMs in implant-based reconstruction has been associated with higher rates of seroma, infection, explantation, and reconstructive failure in some studies; failure to document patient risk and justification may affect approval or coverage.

FDA ADM safety concerns — document conversations and report events

FDA communications note that some ADMs have higher complication rates and that no ADMs are FDA‑approved specifically for implant-based breast reconstruction; failure to document shared decision-making and adverse events could raise regulatory concerns.

Risk when using devices outside cleared FDA indications

FDA warning letters identified that marketing/use of certain scaffolds (SERI, Strattice, SurgiMend) for breast reconstruction falls outside cleared indications; use outside FDA‑cleared indications may trigger compliance or coverage denial risks.

ADSC-enriched fat grafting codes are likely noncovered

Using codes to report autologous fat transplantation enriched with adipose-derived stem cells is considered experimental/investigational/unproven and is subject to noncoverage.

Billing for E/I/U products will trigger denial

Use of products listed as Experimental/Investigational/Unproven (for example, certain HCPCS/CPT mappings in the policy) will trigger noncoverage; verify product-code pairing before billing.

Do not bill removed/non‑covered products as covered

Do not bill products removed from coverage (e.g., hMatrix, Repriza) as covered items; billing these products as covered risks denial per the revised non‑covered product list.