Medical Policy Bulletin

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Title:

Autologous Platelet-Derived Growth Factors as a Treatment for Wound Healing and Other Miscellaneous Conditions

Policy #:

07.07.09

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The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the experimental/investigational coverage decision for autologous platelet-derived growth factors. For information on policies related to this topic, refer to the Cross References section in this policy.

Description

Impaired wound healing may be caused by venous stasis, peripheral neuropathy, ischemia, or a poor healing response related to local trauma. These clinical conditions are often present in individuals with diabetes. Current treatment of chronic, non-healing wounds includes debridement, management of infection, limitation of weight-bearing activities, and revascularization of the affected area. The science of wound healing is advancing rapidly due to new therapeutic approaches such as the use of growth factors. Several growth factors contribute to wound healing, including platelet-derived growth factor, epidermal growth factor, fibroblast growth factor, transforming growth factor, and insulin-like growth factor. Topically applied autologous platelet-derived growth factor and autologous platelet-rich plasma have been evaluated as primary clinical agents to help promote wound healing. The use of platelet-rich plasma has also been proposed for conditions such as epicondylitis (tennis elbow) and plantar fasciitis (an inflammatory condition that causes intense heel pain). Autologous platelet-derived growth factors originate from the individual's own blood; thus, they are not regulated by the US Food and Drug Administration (FDA). Procuren®, a type of platelet-derived growth factor has not been marketed since 2002. AutoloGel™ (Cytomedix Inc.) and SafeBlood® (SafeBlood Technologies) are two types of similar, yet distinct, autologous platelet-derived products that are currently marketed for wound healing. Both products centrifuge patient blood samples to create platelet-rich plasma, which is then activated by various reagents. The resultant gel-like substance (AutoloGel™) or semi-solid graft (SafeBlood®) can then be immediately applied to the wound or used as an adjunct with surgery to promote hemostasis and accelerate healing. Unlike Procuren®, which required processing at a specialty laboratory, AutoloGel™ and SafeBlood® can be prepared on-site using proprietary portable centrifuges. Both platelet-rich plasma products may therefore be used in wound care clinics, home settings, skilled nursing facilities, and acute care facilities. At the present time, there is insufficient published medical literature to support the clinical safety and/or efficacy of autologous platelet-derived products to promote healing of chronic, non-healing wounds or for use with other miscellaneous conditions. The current published medical literature regarding platelet-rich plasma products notes that the differences in platelet concentrations and viability depend on the preparation, but no controlled clinical trials of platelet-rich plasma products have been reported.

Policy

Autologous platelet-derived growth factors in the treatment of chronic, non-healing wounds or when used for other miscellaneous conditions are considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these services cannot be established by review of the available published peer-reviewed literature.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the use of autologous platelet-derived growth factors in the treatment of chronic, non-healing wounds and when used for other miscellaneous conditions are not eligible for payment under the medical benefits of the Company’s products because the services are considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

MEDICARE This policy is consistent with Medicare's coverage determination. US FOOD AND DRUG ADMINISTRATION (FDA) STATUS Autologous platelet-derived growth factors originate from the individual's own blood; thus, they are not regulated by the US Food and Drug Administration (FDA).

References

Centers for Medicare & Medicaid Services (CMS). Decision memo for autologous blood-derived products for chronic non-healing wounds (CAG-00190N). [CMS Web site]. 12/15/03. Available at: http://www.cms.gov/mcd/viewdecisionmemo.asp?id=95. Accessed October 12, 2009. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). 270.3: Blood-derived products for non-healing wounds. [CMS Web site]. Original: 12/28/92. (Revised: 3/19/2008). Available at:http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=270.3&ncd_version=4&basket=ncd%3A270%2E3%3A4%3ABlood%2DDerived+Products+for+Chronic+Non%2DHealing+Wounds. Accessed October 12, 2009. Crovetti G, Martinelli G, Issi M, et al. Platelet gel for healing cutaneous chronic wounds. Transfus Apher Sci. 2004;30:(2)145-151. Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: Implications for wound healing. Plast Reconstr Surg.2004;114(6):1502-1508. Floryan KM, Berghoff WJ. Intraoperative use of autologous platelet-rich and platelet-poor plasma for orthopedic surgery patients. AORN J. 2004;80(4):667-678. Freedman BM, Oplinger EH, Freedman IS. Topical becaplermin improves outcomes in work-related fingertip injuries. J Trauma. 2005;59(4):956-958. Glover JL, Weingarten MS, Buchbinder DS, et al. A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care. 1997;10(1):33-38. Kevy SV, Jacobson MS. Comparison of methods for point of care preparation of autologous platelet gel. J Extra Corpor Technol. 2004;36(1):28-35. Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers. Wound Repair Regen. 2005;13(6):531-536. Margolis DJ, Kantor J, Santanna J, Strom BL, Berlin JA. Effectiveness of platelet releasate for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2001;24(3):483-488. McAleer JP, Kaplan E, Persich G. Efficacy of concentrated autologous platelet-derived growth factors in chronic lower-extremity wounds. J Am Podiatr Med Assoc. 2006;96(6):482-488. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care.2005;18(5 pt 1):258-266. SafeBlood® Technologies. Overview of the autologous platelet grafting. The need and the market approach. [SafeBlood® Technologies Web site]. Available at: http://safebloodtech.com/press/3-%20SafeBlood%20Market%20Overview.pdf. Accessed October 12, 2009. Senet P, Bon FX, Benbunan M, et al. Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers. J Vasc Surg. 2003;38(6):1342-1348. Stacey MC, Mata SD, Trengove NJ, Mather CA. Randomized double-blind placebo controlled trial of topical autologous platelet lysate in venous ulcer healing. Eur J Vasc Endovasc Surg. 2000;20(3):296-301.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	N/A
ICD Procedure	N/A
ICD Diagnosis	Use of autologous growth factors is considered experimental/investigational for all diagnoses.
HCPCS Level II	S9055: Procuren® or other growth factor preparation to promote wound healing
Revenue Codes	N/A

Cross References

Version Effective Date: 01/20/2006