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DESCRIPTIONAcellular tissue matrix is a specially prepared tissue replacement product that is created from native human skin that has been processed so that the basement membrane and cellular matrix remain intact. However, the processing removes cellular components that can lead to both rejection and infection.
Reports of use of this tissue matrix (allograft) in breast reconstructive surgery are being published. Most reports describe use of the allograft to create a “hammock” or “sling” to provide improved inferior and lateral support for breast implants. This has been used in immediate and delayed reconstruction as well as in revision of prior reconstructive surgery. There also is some interest in using the allograft in nipple reconstruction post-mastectomy.
The potential advantages of using this device are to reduce the total time for reconstructive surgery post-mastectomy, minimize the likelihood of implant migration, and improve esthetic outcomes. For example, use of the allograft may allow for implantation of a silicone implant during immediate reconstruction in some patients.
AlloDerm® is an acellular dermal matrix (allograft) derived from donated human skin tissue supplied by US AATB-compliant tissue banks utilizing the standards of the American Association of Tissue Banks (AATB) and U.S. Food and Drug Administration's (FDA) guidelines. Since AlloDerm® is regarded as minimally processed and not significantly changed in structure from the natural material, the FDA has classified it as banked human tissue.
Note: This policy only addresses use of the allograft material for use in breast reconstructive surgery.
POLICYUse of allograft material (AlloDerm®) may be considered medically necessary for use in breast reconstructive surgery -
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY1/11/2008: Policy added
3/27/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions
05/15/2009: Policy updated to include medically necessary indications. Code reference setion updated. HCPC code Q4100, ICD-9 codes 174.0-174.9, 233.0, V10.3, V45.71 added to policy
12/01/2011: Policy reviewed. Policy statement unchanged. Removed deleted HCPCS code J7344 from the Code Reference section.
05/09/2012: Policy reviewed; no changes.
04/18/2013: Policy reviewed; no changes to policy statement. Added CPT codes 15271 - 15274 and HCPCS code Q4116 to the Code Reference section. Removed deleted CPT codes 15330, 15331, 15335, and 15336 from the Code Reference section.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.113
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necesary if the procedure is performed according to the "Policy" section of this document.