Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type 2 diabetes mellitus. 
Treatment: K0553: supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service and K0554: Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system. 

The insurer denied coverage for K0553 and K0554.  The denial is upheld. 

This is a female patient with a medical history of gestational diabetes. She has type 2 diabetes mellitus with hyperglycemia. She had been on Lantus insulin injection and stopped due to feeling lightheaded. She had also been on metformin with complaints of gastrointestinal side effects. The plan was to add a glucagon-like peptide-1 (GLP-1) agonist, Rybelsus to her medication regimen if covered and will continue metformin. The patient's provider noted that the patient will benefit from Continuous Glucose Monitoring (CGM) system and a prescription has been ordered. 

The American Diabetes Association (ADA) position statement on standards of medical care in diabetes published in January 2020 states, "When used properly, intermittently scanned continuous glucose monitors in conjunction with insulin therapy are useful tools to lower A1C levels and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia unawareness, and/or have episodes of hypoglycemia...continuous glucose monitoring (CGM) should be considered in all children and adolescents with type 1 diabetes, whether using injections or continuous subcutaneous insulin infusion, as an additional tool to help improve glucose control. Benefits of CGM correlate with adherence to ongoing use of the device." 

As per Weinstock et al. (2019), "Objective: To determine whether self-monitoring of blood glucose (SMBG) is associated with lower HbA1c [hemoglobin A1c] in youth with type 2 diabetes taking oral medications only or after starting insulin for persistently elevated HbA1c...Conclusions: Low SMBG adherence was common and associated with higher HbA1c.  Optimal SMBG frequency in youth using or not using insulin, and whether less frequent SMBG is a marker for overall worse self-care, require further study." 

Per the National Institute of Diabetes and Digestive and Kidney Diseases, (2017), "Most people who use [continuous glucose monitors (CGMs)] have type 1 diabetes. Research is underway to learn how CGMs might help people with type 2 diabetes."  

Based on the medical facts from the available records, claim documentation, and any additional information obtained from the claimant's treating provider(s) from the perspective of Endocrinology, Diabetes, & Metabolism/Internal Medicine, continuous glucose monitor (CGM) is not considered medically necessary for the patient. Self-monitoring of blood glucose with or without additional training in incorporating the results into self-care was associated with lower quality of life in patients with non-insulin treated type 2 diabetes. In light of this, and no clinically significant differences in other outcomes, self-monitoring of blood glucose is not the standard of care. SMBG or usage of CGM is generally unnecessary in patients who are treated with diet alone or who take oral or injectable agents that do not cause hypoglycemia. The patient is on metformin and Rybelsus (semaglutide) which are oral agents that carry a low risk of hypoglycemia.  

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 
                                                      
The carrier's denial of coverage for K0553: supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service and K0554: Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system should be upheld. The medical necessity is not substantiated.