|
Medical Policy: 02.01.32
Original Effective Date: August 2007
Reviewed: August 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Growth factors are proteins binding to receptors on the cell surface where they activate cellular proliferation and/or differentiation. Many are quite versatile and capable of stimulating cellular division in different cell types; while others are specific to a particular cell type. Growth factors can be obtained either by using recombinant DNA technology or through centrifuged autologous blood. Autologous platelet-derived growth factors have been hypothesized to contribute to healing of chronic wounds as well as the healing of various injured tendons and ligaments. There are a number of commercially available centrifugation devices used for the preparation of platelet-rich plasma.
Autologous platelet-derived growth factors (PDGF) have been investigated as wound healing products. For example, platelets are a rich source of platelet-derived growth factors, transforming growth factors (which function as a mitogen for fibroblasts, smooth muscle cells, and osteoblasts), and vascular endothelial growth factors. 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 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. Activated platelets then degranulate, releasing the various growth factors.
A recombinant PDGF product, becaplermin gel (Regranex®, McNeil Pharmaceutical) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have adequate blood supply. Regranex Gel has been shown to increase the complete healing of diabetic ulcers when used as an adjunct to good ulcer care practices including initial sharp debridement, pressure relief and infection control. In 2008, the manufacturer added this black box warning to the labeling for Regranex, “An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex Gel in a post-marketing retrospective cohort study. Regranex Gel should only be used when the benefits can be expected to outweigh the risks. Regranex Gel should be used with caution in patients with known malignancy.”
A number of commercially available centrifugation devices are used for the preparation of platelet-rich plasma. For example, AutoGel™ (Cytomedix) and SafeBlood® (SafeBlood Technologies) are two related but distinct autologous blood-derived preparations that can be prepared at the bedside for immediate application. Both AutoGel and SafeBlood have been specifically marketed for wound healing. Other devices may be used in the operating room setting. Filtration or plasmapheresis can also be used to produce platelet-rich plasma.
Plantar fasciitis occurs when the plantar fascia ligament along the bottom of the foot develops tears resulting in pain and inflammation. Common causes include physical activity or exercise overload, arthritis, and diabetes. Plantar fasciitis may also be influenced by the mechanics of the foot such as high arches, flat feet, abnormal gait, and pronation. The discomfort of plantar fasciitis is characterized by stabbing, burning, or aching in the heel of the foot where the fascia attaches to the calcaneus.
Lateral epicondylitis, commonly known as tennis elbow, is an overuse injury involving the extensor/supinator muscles that originate on the lateral epicondylar region of the distal humerus. Presenting symptoms include lateral elbow and forearm pain exacerbated by use. It has been suggested that the concentrated growth factors contained in autologous platelet-derived plasma initiates a healing response within the tendon leading to increased functionality and reduced pain.
Dupuytren’s contracture is a condition in which the pretendinous bands of the palmar fascia thickens and tightens. As the bands tighten the fingers may be pulled down toward the palm of the hand. Standard treatment involves surgical release of the contracted bands.
 Top
Prior Approval:
Not applicable
Top
Policy:
Autologous platelet-derived growth factor injections and autologous platelet gels are considered investigational for all indications including, but not limited to, as a treatment of chronic non-healing wounds, plantar fasciitis, epicondylitis, chronic Achilles tendinopathy, and Dupuytren’s contracture because there is insufficient evidence of improvement in net health outcomes in the peer-reviewed, medical literature.
Recombinant platelet-derived growth factor (i.e., becaplermin) may be considered medically necessary when used as an adjunct to standard wound management for the following indications:
- Neuropathic diabetic ulcers meeting ALL of the following criteria:
- Adequate tissue oxygenation, as measured by a transcutaneous partial pressure of oxygen of 30 mm Hg or greater on the foot dorsum or at the margin of the ulcer
- Full-thickness ulcer (Stage III or IV) extending through dermis into subcutaneous tissue
- Participation in a wound management program which includes sharp debridement, pressure relief (i.e., non-weight bearing), and infection control
- Pressure ulcers meeting ALL of the following criteria:
- Full-thickness ulcer (Stage III or IV) extending through dermis into subcutaneous tissue
- Ulcer is in an anatomic location that can be off-loaded for the duration of the treatment
- Albumin concentration > 2.5 dL
- Total lymphocyte count > 1,000
- Normal values of vitamins A and C
Other applications of becaplermin are considered investigational, including, but not limited to, ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue because there is insufficient evidence of improvement in net health outcomes.
Top
Procedure Codes and Billing Guidelines:
-
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
-
S9055 Procuren or other growth factor preparation to promote wound healing
-
0232T Injecton(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed
-
P9020 Platelet rich plasma, each unit
-
S0157 Becaplermin gel 0.01%, 0.5 gm
Top
Selected References:
-
Kiter E, Celikbas, E, Akkaya S et al. Comparison of injection modalities in the treatment of plantar heel pain: a randomized controlled trial. J Am Podiatr Med Assoc. 200696(4):293-6.
-
Logan LR, Klamar K, Leon J et al. Autologous blood injection and botulinum toxin for resistant plantar fasciitis accompanied by spasticity. Am J Phys Med Rehabil. 2006;85(8):699-703.
-
Barrett SJ, Erredge SE. Growth factors for chronic plantar fasciitis. Podiatry Today. 2004;17(11):36-42.
-
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):1502-8.
-
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):482-8.
-
Mishra A, Pavelko T. Treatment of Chronic Elbow Tendinosis with Buffered Platelet-Rich Plasma. Am J Sports Med 2006; 34(11):1774-8.
- Martinez-Zapata MJ, Marti-Carvajal A, Sola I et al. Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Transfusion 2009; 49(1):44-56.
- Mishra A, Woodall J Jr, Vieira A. Treatment of tendon and muscle using platelet-rich plasma. Clin Sports Med 2009; 28(1):113-25.
- Kon E, Buda R, Filardo G et al. Platelet-rich plasma: intra-articular knee injections produced favorable results on degenerative cartilage lesions. Knee Surg Sports Traumatol Arthrosc. 2009 Oct 17. [Epub ahead of print]
- de Vos RJ, Weir A, van Schie HTM et al. Platelet-rich plasma injection for chronic Achilles tendinopathy. A Randomized Controlled Trial. JAMA. 2010; 303(2):144-49.
- Almdahl SM, Veel T, Halvorsen P et al. Randomized prospective trial of saphenous vein harvest site infection after wound closure with and without topical application of autologous platelet-rich plasma. Eur J Cardiothorac Surg. 2011 Jan;39(1):44-8. Epub 2010 Jul 15.
- Castillo TN, Pouliot MA, Kim HJ et al. Comparison of growth factor and platelet concentration from commercial platelet-rich plasma separation systems. Am J Sports Med. 2011 Feb;39(2):266-71. Epub 2010 Nov 4.
- Peerbooms JC, Sluimer J, Bruijn DJ et al. Positive effect of an autologous platelet concentrate in laterla epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62.
- Kazakos K, Lyras DN, Verettas D et al. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. Epub 2008 Aug 13.
- Castricini R, Longo UG, De Benedetto M et al. Platelet-rich plasma augmentation for athroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. Epub 2010 Dec 15.
- Margolis DJ, Bartus C, Hoffstad O et al. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers. Wound repair Regen 2005; 13(6):531-6.
- Niezgoda JA, Van Gils CC, Frykberg RG et al. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care 2005; 18(5 pt 1):258-66.
Top
Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
