Diabetic Supplies denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Omnipod 5 G6 Pods (Gen 5). Researchers explain, “Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of the disease remains significant.” The U.S. Food and Drug Administration (FDA) approves the Omnipod 5 automated insulin delivery (AID) system for managing type 1 and type 2 diabetes mellitus. This system consists of a wearable, tubeless, disposable insulin pump, or Pod, coupled with the Dexcom G6 continuous glucose monitoring (CGM) system (Dexcom).

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for five additional Omnipod Generation 5 G6 Pods per month (for a total of 15 Pods per month). The records indicate that this patient presents with a diagnosis of diabetes mellitus type 1. The provider noted that since starting treatment with the Omnipod, the patient has required changes of the insulin pod every two days, rather than every three days because the insulin is ineffective by the third day. The patient’s diabetes is under reasonable control with changing the pods every two days with hemoglobin A1C under 7%. Review of the patient’s continuous glucose monitor reports show a pattern of hyperglycemia every third day. The medical literature includes reports that patients should change insulin pods after two or three days as indicated.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee was diagnosed with type 2 diabetes mellitus. Laboratory results indicated that the patient’s blood glucose level was 134 and the hemoglobin A1c level was 6.8%. It was noted the patient had been following a diabetic diet and had been taking metformin and glipizide. No polyuria, polydipsia, or significant weight changes were noted. The patient has requested coverage for a non-formulary exception for One Touch Verio Flex strips for glucose testing. The Health Plan denied the request and reported the requested equipment is not medically necessary for the evaluation of this patient. At issue in this case is whether non-formulary One Touch Verio Flex strips for glucose testing are medically necessary for the evaluation of the enrollee’s medical condition.

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for FreeStyle Libre blood glucose 14-day reader device and FreeStyle Libre sensors. According to the medical literature, FreeStyle Libre flash glucose monitor obtained approval to function as an alternative for self-monitoring, such as finger-stick glucose monitoring. The factory-calibrated disk-like sensor is worn on the upper arm for 14 days and promotes the ease of taking multiple glucose readings per day. An enrollee may do so by passing a reader device over the sensor and obtain real-time glucose levels and trends.

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 Supplies, then check the rights and deadlines that apply to your plan.