BlueCross BlueShield of Tennessee Medical Policy Manual

Platelet Rich Plasma as a Treatment for Wound Healing or Other Conditions

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.

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

Current results of trials using PRP are mixed and the studies are limited in both size and quality. The evidence is insufficient to determine the effects of this technology on health outcomes.

SOURCES 

American Academy of Orthopaedic Surgeons (AAOS). (May, 2013). American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis of the knee, 2nd ed. Retrieved November 9, 2016 from the National Guideline Clearinghouse (NGC:009911).

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Recombinant and autologous platelet-derived growth factors for wound healing and other non-orthopedic conditions (2.01.16). Retrieved September 25, 2017 from BlueWeb. (34 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Orthopedic applications of platelet-rich plasma (2.01.98). Retrieved September 25, 2017 from BlueWeb. (42 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for platelet-derived wound healing formula (270.3). Retrieved January 26, 2016 from http://www.cms.gov.

Di Matteo, B., Loibl, M., Andriolo, L., Filardo, G., Zellner, J., Koch, M., & Angele, P., (2016). Biologic agents for anterior cruciate ligament healing: a systematic review. World Journal of Orthopedics, 7 (9), 592-603. (Level 1 evidence)

Fitzpatrick, J., Bulsara, M., & Zheng, M. (2016). The effectiveness of platelet-rich plasma in the treatment of tendinopathy: a meta-analysis of randomized controlled clinical trials. American Journal of Sports Medicine, 2016 Jun 6 [epub ahead of print]. Abstract retrieved November 11, 2016 from PubMed database.

Gholami, M., Ravaghi, H., Salehi, M., Yekta, A., Doaee, S., & Jaafaripooyan. E. (2016). A systematic review and meta-analysis of the application of platelet rich plasma in sports medicine.  Electronic Physician, 8 (5), 2325-2332. (Level 1 evidence)

Kuang, M., Han, C., Ma, J., Li, F., Zhao, J., Fu, L., & Ma, X. (2016). The efficacy of intraoperative autologous platelet gel in total knee arthroplasty: a meta-analysis. International Journal of Surgery, 36 (pt A), 56-65. Abstract retrieved November 10, 2011 from PubMed database.

Lopez-Jornet, P., Sanchez Perez, A., Mendes, A., & Tobias, A. (2016). Medication-related osteonecrosis of the jaw: is autologous platelet concentrate application effective for prevention and treatment? A systematic review. Journal Craniomaxillofacial Surgery, 44 (8), 1067-1072. Abstract retrieved November 11, 2016 from PubMed database.

National Institute for Health and Clinical Excellence (NICE). (2013, January). Autologous blood injection for plantar fasciitis. Retrieved May 28, 2013 from http://www.nice.org.uk/ipg437.

National Institute for Health and Clinical Excellence (NICE). (2014, May). Platelet-rich plasma injections for osteoarthritis of the knee. Retrieved January 26, 2016 from http://www.nice.org.uk/guidance/ipg491.

National Institute for Health and Clinical Excellence (NICE). (2013, January). Autologous blood injection for tendinopathy. Retrieved November 11, 2016 from http://www.nice.org.uk/guidance/ipg438.

Senet, P., Vicaut, E., Beneton, N., Debure, C., Lok, C., & Chosiddow, O. (2011). Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: A randomized controlled trial. Archives of Dermatology, 147 (8), 926-930. (Level 2 Evidence - Industry sponsored)

Suthar, M. Gupta, S., Bukhari, S., and Ponemone, V. (2017). Treatment of chronic non-healing ulcers using autologous platelet rich plasma: a case series. Journal of Biomedical Science, 24 (16). (Level 4 evidence)

Tzeng, Y. S., Deng, S. C., Wang, C. H., Tsai, J. C., Chen, T. M., & Burnouf, T. (2013). Treatment of nonhealing diabetic lower extremity ulcers with skin graft and autologous platelet gel: A case series. BioMed Research International, 2013, 1-9. (Level 4 evidence)

U. S. Food and Drug Administration. (2007, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072330. Retrieved May 28, 2013 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. BK110040. Retrieved May 28, 2013 from http://www.fda.gov.

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search November 2016). Platelet-rich plasma for ligament and tendon injuries. Retrieved September 25, 2017 from www.hayesinc.com. (132 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  1/14/2012

MOST RECENT REVIEW DATE:  11/9/2017

ID_BT

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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