Criteria
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 of 30 mm Hg or greater measured by either:
- A transcutaneous partial pressure on the foot dorsum or at the margin of the ulcer; or
- Toe photoplethysmography (PPG) with infrared reflectance technique; 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.
Procedure Codes
