Diagnosis: Diabetic Left Foot Ulcer.
Treatment: Pharmacy/Prescription Drugs (Regranex).

The health plan denied the requested prescription drug. The health plan's determination is upheld.

The case reviewed is regarding a patient with a non-healing diabetic ulcer of the left foot. The medical records reviewed state the treating provider has requested Regranex (Becaplermin) for the treatment of the diabetic ulcer. The question in the review is regarding the medical necessity for the use of Regranex.

The health plan's determination is upheld, in whole.

No, based on the indication for the use of Regranex (package insert) the requested service is not medically necessary at this time.

The indications for the adjunctive treatment of Regranex for diabetic neuropathic ulcers is an ulcer that extends into the subcutaneous tissue or beyond and have an adequate blood supply. The enclosed medical records reviewed have not established this information. It mentions the ulcer is through the epidermis. Therefore, the health plan's decision to deny the use of Regranex is supported currently.

The initial treatment for diabetic foot ulcers includes debridement, moisture balance dressings, and advanced wound care management (The Diabetic Foot Disorders, Ulcer Management, September/October 2006 Journal of Foot & Ankle Surgery).
Regranex is an advanced wound care modality. Regranex is a recombinant human platelet-derived growth factor. This agent has been shown to stimulate chemotaxis and mitogenesis of neutrophils, fibroblasts, monocytes and other components that form the cellular basis of wound healing. The package insert states, Regranex Gel, 0.01% contains Becaplermin, a human PDGF (platelet derived growth factor), "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". Regranex Gel is indicated as an adjunct to and not a substitute for good ulcer care practices.

In the medical records reviewed of the objective finding exam has no information recorded indicating the staging of the diabetic ulcer. The medical records have a check off type template. There is a handwritten note that states there is a left foot ulcer with dimensions 10 x 10 mm. However, there is no check off on the template of the depth of the wound: partial thickness, full thickness, subcutaneous, muscle tendon, or bone. There is no information provided regarding the characteristics of the wound. I was unable to determine where the ulcer is located on the left foot. In the same template note, the assessment (diagnosis) checked off was an ulceration through the epidermis. In the treatment section, the provider checked off the procedure performed. The area checked off states the ulcer was debrided through the epidermis.

An additional letter was provided by the treating doctor for the review. The letter mentions the diabetic ulcer has been present for 5 months. The treatments performed were discussed. There is no mention of the depth of the wound.