Diagnosis:
Endocrine/ Metabolic/ Nutritional
Treatment:
Durable Medical Equipment (DME) (including Wearable Defibrilllators)
Health Plan:
Fidelis Care New York
Decision:
Overturned overturned
Appeal Type:
Medical necessity
Gender:
Female
Age Range:
0-9
Decision Year:
2022
Appeal Agent:
IPRO
Case Number:
202203-147266
Summary

Diagnosis: Type 1 Diabetes Mellitus (T1DM). Treatment: A9276 x 180, A9277 x 1, and A9278 x 1, continuous glucose monitor (CGM). The insurer denied coverage for A9276 x 180, A9277 x 1, and A9278 x 1, continuous glucose monitor (CGM). The denial is overturned. This is a female patient diagnosed with Type 1 Diabetes Mellitus (T1DM). This request is for Dexcom generation 6 continuous glucose monitoring (G6 CGM) (transmitter; receiver and sensor). As reported, she is on Basal-bolus insulin regimen. She receives from 6 to 8 injections per day. She is checking her blood glucose (BG) minimum 6 to 8 times per day. Her parent will be able to monitor her remotely. Her glycated hemoglobin (A1C) was 9.6 % (percent). She is on Basaglar 6 units; Admelog insulin to carbohydrate ratio (ICR) of 1:25; insulin sensitivity factor (ISF) 1:50. She has been approved from Omnipod insulin pump. The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient, as the request is medically necessary as described below. Continuous glucose monitoring systems including real-time systems have Food & Drug Administration (FDA) approval (1, 2). They are not the subject of Phase I-III clinical trials. The peer reviewed literature supports the long-term use of CGMS (Continuous Glucose Monitor System) in adult (>=25 year old) patients. The American Diabetes Association (ADA) position statement on standards of medical care in diabetes, "Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1C 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 in adults with type 1 diabetes over a 6 month period (4). The latest ADA statement on the standards of medical care in diabetes- 2011 states the following regarding the use of CGM in children and adolescents(3): "Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device." The patient has type 1 diabetes and is on a basal bolus regimen with multiple daily injections of insulin. This includes an insulin sensitivity factor and an insulin to carbohydrate ratio which are modified for each meal based on the blood sugar and the carbohydrates eaten. The patient has an A1c that is not at goal. The patient is reported to be compliant with the insulin regimen. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary. The insurer's denial of coverage for medical equipment, disposable sensor (A9276 x 180), transmitter external (A9277 x 1), and external receiver system (A9278 x 1), continuous glucose monitor (CGM) is overturned. Medical Necessity is substantiated.

References

1) http://www.fda.gov/cdrh/PDF/p980022s015b.pdf In. 2) FDA 1999 CGMS approval. http://wwwfdagov/cdrh/pdf/P980022bpdf. 3) ADA 2011 Standards of medical care in diabetes--2011. Diabetes care 34 Suppl 1:S11-61. 4) Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D 2008 Continuous glucose monitoring and intensive treatment of type 1 diabetes. The New England journal of medicine 359:1464-1476. 5) Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. The New England journal of medicine 363:311-320. 6) ADA 2008 Standards of Medical Care in Diabetes-2008. Diabetes care 31:S12-S15. 7) 2009 Standards of medical care in diabetes--2009. Diabetes care 32 Suppl 1:S13-61 8) Chico A, Vidal-Rios P, Subira M, Novials A 2003 The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes care 26:1153-1157. 9) Bode B, Gross K, Rikalo N, Schwartz S, Wahl T, Page C, Gross T, Mastrototaro J 2004 Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system. Diabetes technology & therapeutics 6:105-113. 10) Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J 2004 Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clinic proceedings 79:1521-1526 11) Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L 2006 Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes care 29:44-50. 12) Maia FF, Araujo LR 2007 Efficacy of continuous glucose monitoring system (CGMS) to detect postprandial hyperglycemia and unrecognized hypoglycemia in type 1 diabetic patients. Diabetes research and clinical practice 75:30-34. 13) Larsen J, Ford T, Lyden E, Colling C, Mack-Shipman L, Lane J 2004 What is hypoglycemia in patients with well-controlled type 1 diabetes treated by subcutaneous insulin pump with use of the continuous glucose monitoring system? Endocr Pract 10:324-329.