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 miscellaneous 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
Platelet rich plasma as a treatment for wound healing or other conditions is considered investigational.
See also: Prolotherapy
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of controlled trials evaluating the clinical utility of platelet rich plasma to improve patient management decisions or to predict or improve health outcomes
SOURCES
American Academy of Orthopaedic Surgeons. (2007). Clinical use of platelet-rich plasma in orthopaedics. Retrieved May 29, 2011 from http://www6.aaos.org/news/PDFopen/PDFopen.cfm?page_url=http://www.aaos.org/news/bulletin/sep07/research2.asp.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Recombinant and autologous platelet-derived growth factors as a treatment of wound healing and other conditions (2.01.16). Retrieved August 29, 2011 from BlueWeb. (31 articles and/or guidelines reviewed)
Children’s Oncology Group. (2008, October). Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Retrieved August 26, 2011 from http://www.guideline.gov/content.aspx?id=15470&search=breast+reconstruction.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Blood-derived products for chronic nonhealing wounds (NCD 270.3, p. 2-216 – 2-217). Ingenix.
De Vos, R. J., Weir, A., van Schie, H. T. M., Bierma-Zeinstra, S. M. A., Verhaar., J. A. N., Weinans, H., et al. (2010). Platelet-rich plasma injection for chronic achilles tendinopathy. Journal of American Medical Association, 303 (2), 144-149. (Level 2 evidence)
Mishra, A., Woodall, Jr., J., & Vierira, A. (2009). Treatment of tendon and muscle using platelet-rich plasma. Clinics in Sports Medicine, 28, 113-125. (Level 5 evidence)
Sampson, S., Gerhardt, M., Mandelbaum, B. (2008). Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Current Reviews in Musculoskeletal Medicine, 1 (3-4), 165-174. (Level 5 evidence)
U. S. Food and Drug Administration. (2009, December). Center for Devices and Radiological Health. Substantially equivalent 510(k) device information. BK090008 Letter. Retrieved May 27, 2011 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/UCM216862.pdf.
U. S. Food and Drug Administration. (2010, February). Center for Devices and Radiological Health. Magellan® Autologous Platelet Separator System BK040068 Warning Letter. Retrieved May 27, 2011 from http://www.fda.gov/ICECI/EnformcementActions/WarningLertters/ucm203679.htm.
U. S. Food and Drug Administration. (2010, March). Center for Devices and Radiological Health. Substantially equivalent 510(k) device information. BK100027 Letter. Retrieved May 27, 2011 from http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm216861.htm.
Winifred S. Hayes, Inc. Medical Technology Directory. (2007, November). Autologous platelet concentrate and gel for wound healing. Retrieved August 29, 2011 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2011, February). Platelet-rich plasma for ligament and tendon injuries. Retrieved August 29, 2011 from www.Hayesinc.com/subscribers. (51 articles and/or guidelines reviewed)
Work Loss Data Institute. (2011). Ankle & foot (acute & chronic). Retrieved August 29, 2011 from http://www.guideline.gov/content.aspx?id=33177.
Work Loss Data Institute. (2011). Elbow (acute & chronic). Retrieved August 29, 2011 from http://www.guideline.gov/content.aspx?id=33179.
Work Loss Data Institute. (2011). Knee & leg (acute & chronic). Retrieved August 29, 2011 from http://www.guideline.gov/content.aspx?id=33183.
Work Loss Data Institute. (2011). Shoulder (acute & chronic). Retrieved August 29, 2011 from http://www.guideline.gov/content.aspx?id=25704.
ORIGINAL EFFECTIVE DATE: 1/14/2012
MOST RECENT REVIEW DATE: 1/14/2012
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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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