BlueCross BlueShield of Tennessee Medical Policy Manual

Adipose-Derived Stem Cells in Autologous Fat Grafting to the Breast

DESCRIPTION

Autologous platelet concentrate suspended in plasma, also known as platelet-rich plasma (PRP), can be prepared from samples of centrifuged autologous blood. Exposure to a solution of thrombin and calcium chloride degranulates platelets, releasing the various growth factors and results in the polymerization of fibrin from fibrinogen, creating a platelet gel. The platelet gel can then be applied to wounds or may be used as an adjunct to surgery to promote hemostasis and accelerate healing.

In the operating room setting, PRP has been investigated as an adjunct to a variety of periodontal, reconstructive, and orthopedic procedures. For example, bone morphogenetic proteins are a type of transforming growth factors, and thus PRP has been used in conjunction with bone-replacement grafting (using either autologous grafts or bovine-derived xenograft) in periodontal and maxillofacial surgeries.

Alternatively, PRP may be injected directly into the tissue. PRP has also been proposed as a primary treatment of other conditions, such as epicondylitis, plantar fasciitis, and Dupuytren’s contracture. Some providers combine platelet-rich plasma with adipose cells, in addition, other agents may be added to the mix; the solution is then injected into various locations on the body. Some providers refer to this procedure as “fat graft stem cell treatment”; however, a legitimate stem cell transplant involves a much more complicated set of procedures.

There are a number of commercially available centrifugation devices that are approved by the U. S. Food and Drug Administration (FDA) and are used for the preparation of platelet rich plasma. However, these devices must be labeled as following: “The platelet rich plasma prepared by this device has not been evaluated for any clinical indications.”

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The evidence for the use of adipose-derived stem cells in individuals who have breast cancer and are undergoing autologous fat grafting to the breast includes small single-arm studies, some of which are prospective.  Limitations of the data are small numbers of participants, short-term follow-up and lack of understanding of the possible oncologic influence adipose-derived stem cells may have on the fat grafting procedure.  The evidence is insufficient to determine the effects of this technology on health outcomes.

SOURCES

American Society for Aesthetic Plastic Surgery/American Society of Plastic Surgeons. (2011). Joint ASPS & ASAPS Position Statement: Stem Cells and Fat Grafting. Retrieved January 11, 2017 from www.plasticsurgery.org.

BlueCross BlueShield Association. Evidence Positioning System. (1:2018). Adipose-derived stem cells in autologous fat grafting to the breast. (7.01.153). Retrieved October 22, 2018 from http://www.evidencepositioningsystem.com. (7 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for breast reconstruction following mastectomy (140.2). Retrieved January 21, 2016 from https://www.cms.gov.

Charvet, H., Orbay, H., Wong, M. & Sahar, D. (2015). The oncologic safety of breast fat grafting and contradictions between basic science and clinical studies: a systematic review of the recent literature. Annals of Plastic Surgery,75 (4), 471-479. Abstract retrieved January 11, 2017 from PubMed database.

Kamat, P., Schweizer, R., Kaenel, P., Salemi, S., Calcagni, M., Giovanoli, P.,et al. (2015). Human adipose-derived mesenchymal stromal cells may promote breast cancer progression and metastatic spread. Plastic and Reconstructive Surgery, 136 (1), 76-84. Abstract retrieved January 8, 2016 from PubMed database.

National Institute for Health and Care Excellence. (2012). Breast reconstruction using lipomodelling after breast cancer treatment. Retrieved January 11, 2017 from www.nice.org.uk/guidance/ipg417.

Simonacci, F., Bertozzi, N., Grieco, M., Grignaffini, E. & Raposio, E. (2016) Autologous fat transplantation for breast reconstruction: A literature review.Annals of Medicine and Surgery. 12 (2016), 94-100. (Level 2 evidence)

Toyserkani, N., Jørgensen, M., Tabatabaeifar, S., Jensen, C., Sheikh, S., & Sørensen, J. (2017). Concise review: a safety assessment of adipose-derived cell therapy in clinical trials: a systematic review of reported adverse events. Stem Cells Translational Medicine, 6 (9), 1786-1794. Abstract retrieved November 22, 2017 from PubMed database.

U. S. Food and Drug Administration. (2006). Center for Devices and Radiological Health. 510(k) Premarket Notification Database.  K060482. Retrieved September 5, 2014 from http://www.accessdata.fda.gov.

Waked, K., Colle, J., Doornaert, M., Cocquyt, V., & Blondeel, P. (2017). Systematic review: the oncologic safety of adipose fat transfer after breast cancer surgery. Breast, 31. 128-136. Abstract retrieved November 22, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  1/10/2015

MOST RECENT REVIEW DATE:  1/10/2019

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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