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"Regranex® Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, Regranex® Gel increases the complete healing of diabetic ulcers. The efficacy of Regranex® Gel for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers has not been evaluated."

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."

Autologous PDGFs have also been investigated as wound healing products. For example, platelets are a rich source of PDGFs, 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 various growth factors. There is a number of commercially available centrifugation devices used for the preparation of PRP. Examples include AutoloGel™ (Cytomedix) and SafeBlood® (SafeBlood Technologies) which are two (2) related but distinct autologous blood-derived preparations that can be prepared at the bedside for immediate application. Both Autologel^TM and SafeBlood® have been specifically marketed for wound healing.

Other devices may be used in the operating room setting, such as Medtronic Electromedic, Elmd-500 Autotransfusion system, the Plasma Saver device, or the Smart PreP device. The Magellan® Autologous Platelet Separator System (Medtronic) includes a disposable kit designed for use with the Magellan® Autologous Platelet Separator portable tabletop centrifuge.  BioMet Biologics received marketing clearance through the FDA's 510(k) process for a gravitational platelet separation system (GPSII), which uses a disposable separation tube for centrifugation and a dual cannula tip to mix the platelets and thrombin at the surgical site.  Filtration or plasmapheresis may also be used to produce platelet-rich concentrations.  The use of different devices and procedures can lead to variable concentration of active platelets and associated proteins increasing variability between studies of clinical efficacy.  

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. In addition, PRP has also been proposed as a primary treatment of miscellaneous conditions, such as epicondylitis, plantar fasciitis, and Dupuytren's contracture.

Platelet-rich plasma must be distinguished from fibrin glues or sealants, which have been used for many years as a surgical adjunct to promote local hemostasis at incision sites. Fibrin glue is created from platelet-poor plasma and consists primarily of fibrinogen. Commercial fibrin glues are created from pooled homologous human donors. Examples of commercially available fibrin sealants include Tissel (Baxter) and Hemaseal. Autologus fibrin sealants can be created from platelet-poor plasma. This policy does not address the use of fibrin sealants.

Note: This policy only addresses the use of blood-derived growth factors, including platelet-rich plasma as a primary treatment of wounds or other conditions, including but not limited to treatment of lateral epicondylitis (i.e. tennis elbow), plantar fasciitis, or Dupuytren's contracture. This policy does NOT address the use of blood-derived growth factors as an adjunct to surgery, including but not limited to their use in periodontal, plastic/reconstructive, or orthopedic procedures.

• When used according to the FDA-labeled indication; i.e., neuropathic diabetic ulcers extending into the subcutaneous tissue.

Appropriate candidates for becalpermin gel for treatment of neuropathic diabetic ulcers should meet ALL of  the following criteria:

1. 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.
2. Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues
3. Participation in a wound management program, which includes sharp debridement, pressure relief (i.e., non-weight-bearing), and infection control

Appropriate candidates for becalpermin gel for the treatment of pressure ulcers should meet ALL of the following criteria:

1. Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues
2. Ulcer in an anatomic location that can be offloaded for the duration of treatment
3. Albumin concentration >2.5 dl
4. Total lymphocyte count > 1,000
5. Normal values of vitamins A and C

Patients are typically treated once daily for up to 20 weeks or until complete healing. Application of the gel may be performed by the patient in the home.

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.

Autologous blood-derived preparations (i.e. platelet-rich plasma) are considered investigational in the treatment of chronic non-healing wounds including but not limited to, Autologel^TM, and SafeBlood®.

Autologous blood-derived preparations (i.e. platelet-rich plasma) are considered investigational as a primary procedure for other miscellaneous conditions including, but not limited to, adjunctive use in surgical procedures, epicondylitis (i.e. tennis elbow), plantar fasciitis or Dupuytren's contracture.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

5/2000: Comprehensive revision with medically necessary indications approved by MPAC; policy renamed

2/11/2002: Investigational definition added

5/2/2002: Type of Service and Place of Service deleted

11/2002: Reviewed by MPAC; indications expanded to include venous stasis and pressure ulcers, FEP exception added, Sources updated, Code Reference updated, 707.1 5th digit added, ICD-9 diagnosis 459.81, 707.0 added covered codes, HCPCS S0157 added covered codes, non-covered table added, HCPCS S9055 added non-covered codes

9/2/2003: Code Reference section updated, ICD-9 diagnosis code range 250.60-250.63, 250.80-250.83 listed separately

10/20/2004: Code Reference section updated, ICD-9 diagnosis code 707.0 deleted effective 9/30/2004, ICD-9 diagnosis code 707.0 5th digit effective 10/1/2004

5/18/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC)

6/26/2006: Code reference section updated, ICD-9 diagnosis codes 440.23, 440.24, 454.0, 454.2, 459.81 deleted from medical policy.

1/25/2007: Policy description reviewed and updated. Name of policy changed from Platelet-Derived Growth Factors for Wound Healing to Recombinant and Autologous Platelet-Derived Growth Factors as a Primary Treatment of Wound Healing and Other Miscellaneous Conditions

5/9/2007: Policy reviewed, no changes

7/10/2008: Policy reviewed, statement concerning black box warning added to description

9/17/2008: Annual ICD-9 updates effective 10-1-2008 applied

3/19/2010: Description section was updated to include language about the Magellan® Autologous Platelet Separator System and BioMet Biologics platelet separation system (GPSII); Policy Statement section was revised for clarity; Code Reference section was revised to remove ICD-9 diagnosis codes 249.60 - 249.61, 250.60 - 250.63 and descriptions were revised for ICD-9 diagnosis codes 707.23 and 707.24.

06/21/2011: Policy reviewed; no changes.

05/09/2012: Policy reviewed; no changes.

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;10:33-38.

TEC Assessments, 1999 and 1992

A search of literature was completed through the MEDLINE database for the period of January 1992 through June 1999. The search strategy focused on references containing the following words:

• Platelet-Derived Growth Factors
• Platelet-Derived Wound Healing Formula
• Platelet Releasate
• Procuren

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policy # 2.01.16 (added 11/2002)

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.

Non-Covered Codes

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