Latest Review Date: January 2024

Category: Surgery   

Note: Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:

• Federal Women's Health and Cancer Rights Act (WHCRA)

The use of autologous fat grafting to the breast using adipose-derived stem cells is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 plays a role in tumorigenesis it still relatively unknown.

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 postmastectomy 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 which may reduce complications and failure rates and oncologic concerns have limited application in the breast.

NOTE: This policy does not address the use of autologous fat tissue in aesthetic breast augmentation (i.e., cosmesis).

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 one 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 one 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 adipose derived stem cells (ADSC), 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 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 ischemic 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 a 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 et al 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; 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 (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.

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through November 28, 2023.

Summary of Evidence

For individuals who have breast cancer who receive autologous fat grafting to the breast with adipose-derived stem cells (ADSC) enrichment of the graft, the evidence includes small single-arm studies, some of which are prospective. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, resource utilization, and treatment-related morbidity. The observational studies were heterogeneous in the patient selection, methods in harvesting stem cells, number of procedures, and outcomes measured. Studies have mainly reported patient and investigator satisfaction and functional and cosmetic results. One small, prospective study found that the use of ADSC enrichment with autologous fat grafting over autologous fat grafting alone improved the retention rate of the fat graft postoperatively at 6 and 12 months. Larger clinical trials are needed to confirm this benefit. Limitations of the data include sample sizes, short-term follow-up, and uncertainty about the possible oncologic influence ADSC may have on the fat grafting procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society for Aesthetic Plastic Surgery and American Society of Plastic Surgeons

The American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons released a joint position statement on the use of stem cells in aesthetic surgery in 2011. Based on a systematic review of the peer-reviewed literature, the societies concluded that while there is potential for the future use of stem cells in aesthetic surgical procedures, the scientific evidence and other data are very limited in terms of assessing the safety or efficacy of stem cell therapies in aesthetic medicine.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Fat grafting, autologous fat grafting, adipose-derived stem cells, Celution™ System, Cytori Therapeutics, breast reconstruction with fat grafting,  breast reconstruction with adipose-derived stem cells, ADSC, autologous fat transplantation to the breast, autologous cell-enriched fat grafting, lipoaspirate transplant, cell-assisted lipotransfer, CAL, Celution 800 System®, Revolve Envi 600

APPROVED BY GOVERNING BODIES:

Cytori Therapeutics, Inc was awarded 510(k) marketing clearance in September 2006 from the U.S. Food and Drug Administration’s (FDA) 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.

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. 

In 2017, the Revolve Envi 600 Advanced Adipose System (LifeCell Corporation, Branchburg, NJ) was cleared for marketing by the FDA through the 510(k) process. The system harvests, filters, and transfers autologous adipose tissue for fat grafting. Uses include reconstructive surgery.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

The following CPT codes should not be used:

CPT Codes:

REFERENCES:

1. Agha RA, Pidgeon TE, Borrelli MR, et al. Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit. Plast Reconstr Surg. May 2018;141(5):633e-638e.
2. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
3. Jeon HJ, Choi DH, Lee JH, et al. A Prospective Study of the Efficacy of Cell-Assisted Lipotransfer with Stromal Vascular Fraction toCorrect Contour Deformities of the Autologous Reconstructed Breast. Aesthetic Plast Surg. Jun 2021; 45(3): 853-863.
4. Kamakura T, Ito K. Autologous cell-enriched fat grafting for breast augmentation. Aesthetic Plast Surg. Dec 2011; 35(6):1022-1030.
5. Mizuno H, Hyakusoku H. Fat grafting to the breast and adipose-derived stem cells: recent scientific consensus and controversy. Aesthtic Surg J 2010; 30(3):381-387.
6. Perez-Cano R, Vranckx JJ, Lasso JM et al. Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial. Eur J Surg Oncol 2012; 38(5):382-389.
7. Rigotti G, Marchi A, Galie M et al. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: A healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg 2007; 119(5):1409-1422; discussion 1423-1404.
8. Sterodimas A, de Faria J, Nicaretta B eta al. Tissue engineering with adipose-derived stem cells (ADSCs): Current and future applications. J Plast Reconstr Aesthet Surg 2010; 63(11):1886-1892.
9. Wilson A, Butler PE, Seifalian AM. Adipose-derived stem cells for clinical applications:  a review. Cell Prolif 2011; 44(1):86-98.
10. Yoshimura K, Sato K, Aoi N et al. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesth Plast Surg 2008; 32(1):48-55; discussion 56-47.

POLICY HISTORY:

Medical Policy Panel, June 2011

Medical Policy Group, June 2011(2): new policy

Medical Policy Administration Committee, June 2011

Available for comment June 23 – August 8, 2011

Medical Policy Group, July 2011: Added Code 20926

Medical Policy Group, March 2013 (1): Update to Codes with addition of code range 11950-11954 as potentially usable codes

Medical Policy Group, July 2013 (2): Update to Codes not to be used—19380 Revision of reconstructed breast

Medical Policy Panel, April 2014

Medical Policy Group, April 2014 (1): Rewording for clarification to policy statement, no change in intent of coverage; update to Description, Key Points and References

Medical Policy Panel, October 2015

Medical Policy Group, November 2015 (2): 2015 Updates to Description; no change in policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): 2017 Updates to Title, Key Points and References. Autologous fat grafting (excluding use of adipose-derived stem cells) removed from policy for archival. Procedure will now be subject to MP# 106- Reconstructive versus Cosmetic Surgery and Member’s benefits.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7): 2018 No new literature to add. No change in Policy Statement.

Medical Policy Panel, January 2018

Medical Policy Group, March 2019 (7): Update to Key Points, Approved by Governing Bodies and References. Added Key Words: Revolve Envi 600. No change in Policy Statement.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Added CPT codes 15769, 15771, 15772 to the Current coding section. Created Previous Coding section to include 20926. No change in Policy Statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (7): Minor update to Key Points. No new literature to add. No change in Policy Statement.

Medical Policy Group, October 2020 Annual Coding Update. Revised description of CPT 19380 to state “Revision of reconstructed breast (eg, significant removal of tissue, re-advancement and/or re-inset of flaps in autologous reconstruction or significant capsular revision combined with soft tissue excision in implant-based reconstruction). CPT 19366 deleted and moved to Previous Coding Section.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (7): Minor update to Key Points. No new literature to add. Removed previous Policy Statement prior to November 2017. No change in Policy Statement.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (7): Update to Key Points and References. Removed “not medically necessary” verbiage from Policy Statement. No change in intent.  

Medical Policy Group, November 2022 (7): Update to Policy Statement- added statement that coverage may be subject to legislative mandates: Federal Women's Health and Cancer Rights Act (WHCRA).

Medical Policy Group, December 2022 (7): Added Key Words- “Women's Health and Cancer Rights Act, WHCRA”

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (7): Minor update to Key Points. Removed Previous Coding section.  No change to Policy Statement.

Medical Policy Group, January 2023 (7): Removed codes 11950, 11951,11952, 11954, 19499 from Current Coding section. No change in policy intent.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (7): Update to Key Points, Benefit Application, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.