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DESCRIPTIONRecent advances and innovations in surgical techniques and radiology and the discovery that multipotent adult stem cells are present in human adipose tissue have contributed to renewed interest in performing autologous fat grafting to the breast for aesthetic and reconstructive purposes.
Autologous Fat Grafting to the Breast
Technical advances in fat grafting such as the development of devices like liposuction cannulae and more sophisticated methods to detect breast cancer, which can provide a relatively precise distinction between microcalcifications associated with fat grafting and those associated with cancer, led physicians to develop improved fat grafting techniques. However, in 2007, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) announced that fat grafting for breast augmentation was still not recommended based on a lack of available clinical data on the safety and efficacy of the procedure and the possibility that the procedure might interfere with cancer detection.
In 2009, the ASPS issued a new position on fat transfer, grafting, and injection to the body, which was based on a review of the literature of patients who had undergone fat grafting (238 of whom underwent fat grafting to the breast). The ASPS task force concluded that fat grafting could be considered for breast augmentation and to correct defects associated with medical conditions and previous breast operations, although it cautioned that the results are largely dependent on technique and surgeon expertise and that because the lifetime of fat grafts is unknown, additional treatments may be necessary. Although no scientific evidence was found that specifically addressed patient selection, physicians were advised to exercise caution when considering patients at high risk for developing breast cancer (e.g. BRCA-1, BRCA-2, and/or a personal or family history of breast cancer) when determining whether a patient is an appropriate candidate for autologous fat grafting to the breast.
Yoshimura and colleagues, in an effort to address the problems of unpredictability and low rates of fat graft survival, developed a technique known as cell-assisted lipotransfer (CAL), which produces autogenous fat rich in ADSCs. In CAL, half of the lipoaspirate is centrifuged to obtain a fraction of concentrated ADSCs while the other half is washed, enzymatically digested, filtered and spun down to an ADSC-rich pellet. The latter is then mixed with the former, converting a relatively ADSC-poor aspirated fat to ADSC-rich fat.
A point-of care system is available for concentrating ADSC from mature fat. The Celution™ system (Cytori Therapeutics, Inc.) is designed to transfer a patient’s own adipose tissue from one part of the body to another in the same surgical procedure.
Cytori Therapeutics, Inc. was awarded 510(k) marketing clearance in September 2006 from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) for the Celution™ Cell Concentration System as a cell saver device. The system is cleared for the collection, concentration, washing and re-infusion of a patient’s own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urological surgeries and procedures.
POLICYThe use of autologous fat grafting and adipose-derived stem cells for augmentation or reconstruction of the breast is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESIn this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease, or congenital defect.
Investigative 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 HISTORY07/21/2011: Approved by Medical Policy Advisory Committee.
04/29/2013: Added ICD-9 procedure code 85.55 to the Code Reference section.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.129
This may not be a comprehensive list of procedure codes applicable to this policy.