This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Recombinant platelet-derived growth factor (i.e., becaplermin [Regranex]) may be considered medically necessary when used as an adjunct to standard wound management when EITHER of the following criteria has been met:

• Neuropathic diabetic ulcers extending into the subcutaneous tissue or beyond and have an adequate blood supply; or
• Pressure ulcers extending into the subcutaneous tissue.

Becaplermin gel for treatment of neuropathic ulcers may be considered medically necessary when ALL of the following criteria are met:

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

Becaplermin gel for the treatment of pressure ulcers may be considered medically necessary when ALL of the following criteria are met:

• Full-thickness ulcer (i.e., Stage III or IV), extending through dermis into subcutaneous tissues; and
• Ulcer in an anatomic location that can be off-loaded for the duration of treatment; and
• Albumin concentration greater than 2.5 dL; and
• Total lymphocyte count greater than 1,000; and
• Normal values of vitamins A and C.

All other applications of recombinant platelet-derived growth factor (i.e., becaplermin [Regranex]) are considered experimental/investigational, and therefore, non-covered including, but not limited to, ischemic ulcers, ulcers related to venous stasis, and ulcers not extending through the dermis into the subcutaneous tissue. The safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.

Use of autologous blood-derived preparations (i.e., injection of PRP) is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness cannot be established by review of the published peer-reviewed literature. This includes, but is not limited to use in the following situations:

• Treatment of acute or chronic wounds including non-healing ulcers
• Adjunctive use in surgical procedures
• Primary use (injection) for other conditions such as epicondylitis (i.e., tennis elbow), plantar fasciitis, or Dupuytren's contracture.

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Recombinant and autologous platelet-derived growth factors for wound healing and other non‒orthopedic conditions is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid con is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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• Link to References