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A.7.01.153
Following a mastectomy, patients often experience pain and irradiated skin; as an adjunct to reconstructive breast surgery, surgeons will sometimes graft autologous fat to the breast. Adipose-derived stem cells (ADSCs) have been proposed as a supplement to the fat graft in an attempt to improve graft survival; however, whether ADSCs play a role in tumorigenesis is still relatively unknown.
Fat Grafting to the Breast
Autologous fat grafting to the breast has been proposed for indications that include breast augmentation following oncologic surgery. Grafting would be performed as an adjunct to reconstruction after mastectomy or lumpectomy, and it would be of benefit in the following areas: for contouring purposes, improving breast shape and volume; and for alleviating post-mastectomy pain syndrome (neuropathic pain) and irradiated skin (thereby reducing complication and failure rates of implant reconstruction). Variability in long-term results and oncologic concerns have limited application of autologous fat grafting in the breast.
This policy does not address the use of autologous fat tissue in aesthetic breast augmentation (ie, cosmesis).
Adipose-Derived Stem Cells
Stem cell biology and the related field of regenerative medicine involve multipotent stem cells that exist within a variety of tissues, including bone marrow and adipose tissue. A single gram of adipose tissue yields approximately 5,000 stem cells; this is 100 to 500 times the number of mesenchymal stem cells found in an equivalent amount 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. In particular, adipose tissue represents an abundant and easily accessible source of adipose-derived stem cells (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.
The potentially therapeutic properties of ADSC have led to novel techniques of fat grafting in conjunction with ADSC therapy for breast fat grafting. Differentiation of ADSC into adipocytes may provide a reservoir for adipose tissue turnover. Differentiation of ADSC into endothelial cells, with the release of angiogenic growth factors by ADSC, may decrease the rate of graft resorption by increasing blood supply to the grafted fat tissue. Further, ADSC may serve to accelerate wound healing and protect the graft from ischemia reperfusion injury. Current methods for isolating ADSCs can involve various processes, which may include centrifugation and enzymatic techniques that rely on collagenase digestion—which, in turn, is followed by centrifugal separation to isolate the stem cells from primary adipocytes. Isolated ADSCs can be expanded in monolayer on standard tissue culture plastic surfaces with a basal medium containing 10% fetal bovine serum. Newly developed culture conditions provide an environment in which the study of ADSCs can be done without the interference of animal serum and may also allow rapid expansion of autologous ADSCs in culture for use in human clinical trials. A standard expansion method has not yet been established.
To address the problems of unpredictability and low rates of fat graft survival, Yoshimura and colleagues developed a technique known as cell-assisted lipotransfer, which produces autogenous fat rich in ADSCs. In cell-assisted lipotransfer, half of the lipoaspirate is centrifuged to obtain a fraction of concentrated ADSCs; meanwhile, 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 is designed to transfer a patient’s adipose tissue from one part of the body to another in the same surgical procedure.
In September 2006, Celution Cell Concentration System (Cytori Therapeutics; San Diego, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process as a cell saver device. The system is cleared for the collection, concentration, washing, and re-infusion of a patient’s cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urologic surgeries and procedures. In 2007, Cytori Therapeutics received the FDA 510(k) clearance to market the Autologous Fat Transfer system, which transfers a patient’s own adipose tissue from one part of the patient’s body to another. FDA product code: CAC.
The use of adipose-derived stem cells in autologous fat grafting to the breast is considered investigational.
Federal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
07/21/2011: 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.
06/01/2016: Policy number A.7.01.153 added.
10/19/2017: Policy title changed from "Autologous Fat Grafting to the Breast and Adipose-derived Stem Cells" to "Adipose-Derived Stem Cells in Autologous Fat Grafting to the Breast." Policy description extensively revised. Added information regarding autologous fat grafting to the breast and adipose-derived stem cells. Policy statement revised to state that the use of adipose-derived stem cells in autologous fat grafting to the breast is considered investigational. It previously stated: The use of autologous fat grafting to the breast, with or without adipose-derived stem cells, is considered investigational. Sources section updated.
02/08/2018: Policy reviewed; no changes.
03/08/2019: Policy description updated regarding devices. Policy statement unchanged.
02/18/2020: Policy description updated. Policy statement unchanged.
12/22/2020: Code Reference section updated regarding deleted CPT code.
03/03/2021: Policy description updated regarding devices. Policy statement unchanged.
02/14/2022: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT code 19366.
03/23/2023: Policy reviewed; no changes.
02/22/2024: Policy description updated regarding devices. Policy statement unchanged.
03/19/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 7.01.153
Code Number | Description | ||
CPT-4 | |||
19499 | Unlisted procedure, breast | ||
HCPCS | |||
ICD-9 Procedure | ICD-10 Procedure | ||
85.55 | Fat graft to breast | 0HRT37Z, 0HRU37Z, 0HRV37Z | Replacement of breast (right, left, or bilateral) with autologous tissue substitute, percutaneous approach **Include applicable code from Extraction of Subcutaneous Tissue and Fascia** |
ICD-9 Diagnosis | ICD-10 Diagnosis |
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