Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type II Diabetes

Treatment: Durable Medical Equipment (K0553 x 12) (glucose monitor), Pre-service

The insurer denied the Durable Medical Equipment (K0553 x 12) (glucose monitor), Pre-service.

The denial is upheld.

The patient is a male diagnosed with T2DM (type 2 diabetes mellitus). This request is for Dexcom Durable Medical Equipment (K0553 x 12) (glucose monitor).

As reported, the patient is on Ozempic (0.5 mg [milligrams] every week), Freestyle Libre sensor and reader, Lantus up to 60 units, Humalog up to 80 units, Jardiance 25 mg 1 tablet a day, Steglatro 15 mg 1 tablet every day. He has diabetic polyneuropathy. Per his Dexcom status page, he is reported to be testing four times a day. The note shows that the patient's average blood glucose is 198 with very high glucoses 15% of the time, high glucoses 40% of the time, in range 45% of the time, and no low blood sugars. His glucoses range between 87 and 371.

The patient's A1c (glycated hemoglobin) was 9.8% (percent). Approximately 3 months later it was 8.6%.

The patient's C (connecting)-peptide was 5.

No, the Durable Medical Equipment (K0553 x 12) (glucose monitor) is not medically necessary.

Continuous glucose monitoring systems, including real-time systems, have FDA (United States Food and Drug Administration) approval [1]. They are not the subject of Phase I-III clinical trials. The peer-reviewed literature supports the long-term use of CGMS (continuous glucose monitoring system) in adult (25 years old) patients. The ADA (American Diabetes Association) position statement on standards of medical care in diabetes [2] states, "Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1C [glycated hemoglobin] in selected adults (age 25 years) with type 1 diabetes." The ADA considers this to have a level of evidence of "A," which is "Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered."

This is based on a recent large-scale trial published in the New England Journal of medicine that showed that CGMS is effective in reducing HbA1c (glycated hemoglobin) in adults with type 1 diabetes over a six-month period [3].

The latest ADA statement on the standards of medical care in diabetes states the following regarding the use of CGM in children and adolescents [2]: "Although the evidence for A1C [glycated hemoglobin] lowering is less strong in children, teens, and younger adults, CGM [continuous glucose monitoring] may be helpful in these groups. Success correlates with adherence to ongoing use of the device."

This is based on a recent trial published in the New England Journal of Medicine [4], showing benefit of CGMS in children and adolescents with type 1 diabetes who are not well-controlled.

In addition, the peer-reviewed literature supports the use of long-term CGMS in patients with type 1 diabetes with hypoglycemia unawareness and episodes of hypoglycemia [5]. The ADA position statement on standards of medical care in diabetes [6] states, "CGM [continuous glucose monitoring] may be a supplemental tool to SMBG [Self-Monitoring of Blood Glucose] in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes." There is evidence that real-time CGMS with an alarm function detects hypoglycemia [7], leads to an improvement in glycemic excursion, leads to a reduction in duration of hypoglycemia, and prevents hypoglycemic reactions in adult patients with type 1 diabetes [8-11]. Although not all episodes were detected [12], the majority were detected. This represents a 60% reduction in patients with complete hypoglycemia unawareness.

The patient in this case does not have documentation of type 1 rather than type 2 diabetes in the form of a low c-peptide with positive autoantibodies. Long term CGMS use in type 2 diabetes has not been shown to improve outcomes.

There are studies showing that the flash glucose monitoring system Freestyle Libre [13-16] is FDA-approved for persons age 18 and older with diabetes. It has been shown to be effective in patients with type II diabetes who are on an intensive insulin therapy. It was associated with sustained reduction in hypoglycemia and safely and effectively replaced blood glucose monitoring [17, 18].

The patient's physician cites these studies. The studies apply to the Freestyle Libre, which the patient is on. They do not apply to the Dexcom, which is the requested product. The request, therefore, is not consistent with generally accepted standards of medical practice. The request, therefore, is not medically necessary.