Criteria
Policy Application
All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.
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 of30 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
