Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 2 Diabetes Mellitus.
Treatment: OneTouch Verio VI STRP. 

The insurer denied coverage for OneTouch Verio VI STRP. The denial is overturned. 

This patient is a male with a history of Type 2 Diabetes Mellitus and Acute Lymphoblastic Leukemia (ALL).  He has had a recent bone marrow transplant and is immunocompromised. The request is for the use of OneTouch Verio VI STRP because the patient does not have a computer. The patient can use an application on this phone to log his blood sugars and e-mail those results to his provider. The remaining alternative meters do not have that capacity. The patient has tried FreeStyle Lite glucose meter. Because the patient is immunocompromised, he cannot come for frequent clinic visits. 

"Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch() VerioVue met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting..." (Katz, et al., 2015). 

"This real-world study demonstrates that SMBG implemented via this new blood glucose meter not only leads to an improvement in metabolic control, but also is associated with a significant improvement in diabetes management." (Schnell, et al., 2017). 

"OneTouch Verio test strips are accurate and precise over a wide range of patient, environmental, and pharmacologic conditions. In addition, lay-users were able to successfully use the OneTouch VerioIQ PatternAlert Technology without HCP training." (Bailey, T., Chang, A., Rosenblit, P. D., Jones, L., Teft, G., Setford, S., & Mahoney, J., 2012).

"The OneTouch Verio displayed sufficient analytical quality and satisfactory user-friendliness. It is suitable for point-of-care testing of blood glucose concentration when handled by patients and healthcare professionals." (Littmann, K., Petersen, E. R., Pussinen, C., Danielson, K., Djurisic, S., Eilertsen, H., Garabet, L., Greibe, E., Lauritzen, T., Olsen, D. A., Othman, S., Palimaru, I., & Westerlund, J., 2013).                                                         

The health care plan did not act reasonably and with sound medical judgment and the patient's best interest. 

One Touch Verio VI STRP should be considered medically necessary. The patient has had a recent bone marrow transplant and is immunocompromised he should not be going into the clinic for appointments or downloads. The requested One Touch Verio VI STRP will allow him to use an application on his phone and transmit his blood sugars to his provider who can adjust his medications. 

Based on the above, the medical necessity for OneTouch Verio VI STRP is substantiated.  The insurer's denial is overturned.