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Autologous fat grafting to the breast has been used as an adjunct to reconstructive breast surgery, for post mastectomy pain and in irradiated skin. Adipose-derived stem cells (ADSCs) have been proposed as a supplement to the fat graft in an attempt to improve graft survival.
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 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). Citing a lack of strong data and literature, 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.
In 2012, the ASPS published recommendations limited to fat transfer to the postmastectomy breast with no native breast tissue present.
“The existing evidence suggests autologous fat grafting as an effective option in breast reconstruction following mastectomy while demonstrating moderate to significant aesthetic improvement. In addition, the available evidence also cites autologous fat grafting as a useful modality for alleviating post mastectomy pain syndrome. Furthermore, the evidence suggests autologous fat grafting as a viable option for improving the quality of irradiated skin present in the setting of breast reconstruction.”
Adipose tissue physiology in fat grafting
Harvesting of adipose tissue by liposuction is technically easy, minimally invasive, and associated with little patient discomfort and morbidity, and small amounts (100-200 mL) can be obtained under local anesthesia. The most common technique, called the Coleman technique, also involves a purification step, which involves centrifugation to remove blood, fluid, and ruptured adipocytes.
Adipose tissue is a highly vascularized tissue, and adipocytes are in direct contact with adjacent capillary vessels. In free fat grafting, direct diffusion of nutrients from plasma in the surrounding bed and subsequent revascularization usually occurs within 48 hours and are essential for graft survival. If the local environment does not undergo revascularization, the grafted fat tissue eventually undergoes necrosis, 1 complication after fat grafting. Other complications include oil cyst formation, indurations in either the subcutis or the breast parenchyma, calcification, and severe breast deformity.
Indications for autologous fat grafting to the breast
Autologous fat grafting to the breast has been proposed for indications that include breast augmentation and following oncologic surgery. Proposed indications after oncologic surgery include as an adjunct to reconstruction post mastectomy or lumpectomy for contour deformities and improved shape and volume of the breast, for postmastectomy pain syndrome (neuropathic pain), and for irradiated skin to soften the skin and restore it to nonirradiated appearance and consistency.
Adipose-derived stem cells
Stem cell biology, and the related field of regenerative medicine, involves multipotent stem cells that exist within a variety of tissues, including bone marrow and adipose tissue. Studies have shown that 1 gram of adipose tissue yields approximately 5 x 10³ stem cells, which is up to 500 times greater than the number of mesenchymal stem cells in 1 gram of bone marrow. Stem cells, because of their pluripotentiality and unlimited capacity for self-renewal, offer promise for tissue engineering and advances in reconstructive procedures. Adipose tissue in particular represents an abundant and easily accessible source of ADSCs, which can differentiate along multiple mesodermal lineages. ADSCs may allow for improved graft survival and generation of new fat tissue after transfer from another site.
This identification of several potentially beneficial therapeutic properties of ADSC has led to proposed novel techniques of fat grafting in conjunction with ADSC therapy for breast fat grafting, including the differentiation of ADSC into adipocytes as a reservoir for adipose tissue turnover, the differentiation of ADSC into endothelial cells and the subsequent increase in blood supply to the grafted fat tissue, thereby decreasing the rate of graft resorption, the release of angiogenic growth factors by ADSC and the induction of angiogenesis, protection of the graft from ischemic reperfusion injury by ADSC and acceleration of wound healing at the recipient site.
Current methods for isolating ADSCs can involve a variety of processes which may include centrifugation and enzymatic techniques that rely on collagenase digestion followed by centrifugal separation to isolate the stem cells from primary adipocytes,. Isolated ADSCs can be expanded in monolayer on standard tissue culture plastic with a basal medium containing 10% fetal bovine serum, and newly developed culture conditions provide an environment within which the study of ADSCs can be done without the interference of animal serum. They also allow rapid expansion of autologous ADSCs in culture for use in human clinical trials. A standard expansion method has not yet been established.
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 to the breast, with or without adipose-derived stem cells, 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.
In 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 is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
09/16/2014: Policy reviewed; description updated regarding adipose tissue physiology in fat grafting, indications for autologous fat grafting to the breast, and adipose-derived stem cells. For clarity purposes, policy statement revised to state that the use of autologous fat grafting to the breast, with or without adipose-derived stem cells, is considered investigational.
08/21/2015: Code Reference section updated for ICD-10.
03/25/2016: Policy reviewed; no changes.
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.