Diabetic Foot Ulcer denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for vacuum assisted wound therapy for treatment of the enrollee’s foot ulcers. Findings: 2/3 of the physician reviewers found that negative wound pressure treatment (NWPT) is appropriate for this patient’s diabetic foot infection. There have been multiple peer reviewed studies supporting the effectiveness of NWPT for treatment of diabetic foot ulcers. A study by colleagues concluded, “With emergent evacuation of abscess, early vascular intervention and appropriate debridement, NPWT can be a useful adjunct to the management of limb-threatening diabetic foot infections.” Another study by colleagues noted, “NPWT appears to be as safe as and more efficacious than advanced moist wound therapy for the treatment of diabetic foot ulcers.” As such, there has been consistent evidence of the superior benefits of this…

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the EpiFix placental allograft skin substitute for treatment of the enrollee’s chronic right heel wound. Findings: 2/3 of the physician reviewers found that EpiFix is an amniotic membrane biologic product that has strong evidence for healing diabetic foot ulcers versus standard care. EpiFix is also superior to other biologics. Standard wound care includes debridement, glycemic control, offloading and infection control. Although the patient underwent debridement, the patient remained on Santyl for two years with little variation. Recent notes do not mention appropriate offloading such as a total contact cast. In this case, dressings including iodine based products, collagen, foam, were not exhausted. There was no mention of local tissue oxygenation.

Where the denial was upheld

Physician 1: The patient is a 75-year-old male with a long history of a non-healing diabetic foot ulcer on the plantar left foot. His provider reports standard treatment modalities have been ineffective. The patient’s provider further states the patient has benefited from use of hyperbaric oxygen therapy. The Health Plan has denied coverage for hyperbaric oxygen therapy on the basis it is considered experimental for treatment of the patient’s condition. Review of the scientific evidence reveals there have been few trials involving hyperbaric oxygen therapy for diabetic ulcers. There is insufficient evidence hyperbaric oxygen therapy is superior to standard treatment modalities. In general there is limited quality data on the benefits of many of the therapies for diabetic ulcers. However, Regranex in sub-atmospheric oxygen dressing has been shown to be effective.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Grafix PL placental allografts performed on four dates of service, as well as prospective authorization and coverage for 6 units of Grafix Prime and Grafix PL Prime. Findings: Two of the three physician reviewers found that the services at issue and requested services were not and are not likely to be more beneficial for treatment of the patient’s medical condition than any other available standard therapy. While placental allografts do show promise for the treatment of diabetic foot ulcerations, most if not all of the studies on this type of allograft application are small. The studies advise that more research must be performed in order to demonstrate significant effectiveness of this type of allograft application beyond standard of care.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving diabetic foot ulcer, then check the rights and deadlines that apply to your plan.