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202208-152372

2022

Fidelis Care New York

Medicaid

Endocrine/ Metabolic/ Nutritional

Diabetic Equipment/ Supplies/ Self-Management Education

Medical necessity

Overturned

Case Summary

Diagnosis: Diabetes
Treatment: Durable medical equipment (continuous glucose monitoring device - K0553x6 and K0554x1)
The insurer denied: Durable medical equipment (continuous glucose monitoring device - K0553x6 and K0554x1)
The denial is overturned.

This is an adult female with type II diabetes. Request for Freestyle Libre II is under review. The prior request was denied because approval on criteria requires the patient is on an insulin treatment plan that requires frequent adjustment of insulin dosing or use of an insulin pump. The provider is appealing this determination because the patient is injecting U-500 insulin three times per day with doses adjusted based on glucose levels and is testing glucose four times per day. The patient's glycated hemoglobin (A1C) was 11.2% (percent).

The proposed Freestyle Libre II is medically necessary.

This request is for Freestyle Libre II for the management of type II diabetes. This patient is on multiple daily insulin injections and is adjusting her U-500 insulin dose based on pre-meal glucose levels.

Continuous glucose monitoring has been shown to lower glycated hemoglobin (A1C) in patients with uncontrolled type II diabetes on multiple daily insulin injections (adjusted difference in mean change of glycated hemoglobin [A1C] with use of continuous glucose monitoring, 0.3% [95% CI, 0.5% to 0.0%]; P = 0.022) [1].

In a second study of 101 patients with type II diabetes on two or more injections per day, use of the continuous glucose monitoring system significantly improved glycated hemoglobin (A1C) levels. The changes in glycated hemoglobin (HbA1c) were 0.82% versus 0.33% in the intervention group using the continuous glucose monitoring system and control group, respectively (P = 0.005), and 68.6% of the patients in the intervention group using the continuous glucose monitoring system had their glycated hemoglobin (HbA1c) reduced by 0.5% compared with 30.2% in the control group (P < [less than] 0.001), and 39.2% had their glycated hemoglobin (HbA1c) reduced by 1.0% versus 18.6% in the control group without an increased frequency of hypoglycemia [2].

Without Freestyle Libre II, this patient will be at increased risk for ongoing hyperglycemia, which can cause retinopathy, neuropathy, and nephropathy. Therefore, yes, the proposed Freestyle Libre II is medically necessary.

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