Continuous Glucose Monitors Form

Continuous glucose monitors (CGMs) measure interstitial glucose, which correlates well with plasma glucose. ___ If request is for a CGM that is also an insulin delivery system, additional approval criteria apply. Refer to CP.PHAR.534 Insulin Delivery Systems (V-Go, Omnipod, InPen). FDA Approved Indication(s) CGMs are indicated for use in patients with diabetes mellitus to monitor blood glucose levels.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that CGMs are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Diabetes Mellitus (must meet all):
Replacement of functional features of an existing monitor for an upgrade is not considered medically necessary

1. Diagnosis of diabetes mellitus;

2. Frequent adjustments to the member’s treatment regimen are necessary based on glucose testing results;

   3. Member meets one of the following (a or b): a. Member requires intensive insulin therapy as evidenced by one of the following (i or ii): i. Requires insulin injections ≥ 3 times per day; ii. Uses a continuous insulin infusion pump; b. Member is ≥ 18 years of age and has a diagnosis of type 2 diabetes that is currently managed with basal injections and/or oral agents;
   4. Member has completed or is actively participating in a comprehensive diabetes management program (see Appendix E);
   5. If age ≥ 4 years, member must use FreeStyle® Libre; Page 1 of 7

   CLINICAL POLICY Continuous Glucose Monitors

   6. Request does not exceed health-plan quantity limit. Approval duration: 12 months (1 receiver per 12 months only; other components [such as transmitters and sensors] may be replaced as needed – see Appendix D for examples) B. Other diagnoses/indications: Not applicable II. Continued Therapy A. Diabetes Mellitus (must meet all):
      Replacement of functional features of an existing monitor for an upgrade is not considered medically necessary. If the replacement request is due to change in clinical status and features of a different device type are medically necessary, the request should be reviewed using the initial approval criteria
3. Previously received the requested product via Centene benefit;
4. Documentation supports all of the following (a, b, and c): a. If the request is for a new receiver: A replacement device is necessary due to one of the following (i, ii, or iii): i. Loss, theft, or damage that is not covered by manufacturer warranty; ii. Age of device makes it incompatible with available medically necessary software, components, or accessories required for function or integration and is not covered by manufacturer warranty; iii. The reasonable and useful lifetime of ≥ 5 years has passed; b. Member is using the product properly and continues to benefit from it; c. Ongoing physician or clinical specialist monitoring;
   3. If age ≥ 4 years, member must use FreeStyle Libre;

5. Request does not exceed health-plan quantity limit. Approval duration: 12 months (1 replacement receiver per 12 months only; other components [such as transmitters and sensors] may be replaced as needed – see Appendix D for examples) B. Other diagnoses/indications: Not applicable III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CGM: continuous glucose monitoring FDA: Food and Drug Administration SMBG: self-monitoring of blood glucose Appendix B: Therapeutic Alternatives
   Not applicable
   Appendix C: Contraindications/Boxed Warnings None reported
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   CLINICAL POLICY Continuous Glucose Monitors Appendix D: General Information • Blood glucose monitoring (either with self-monitoring [SMBG] or CGM) is a tool used to evaluate whether glycemic targets are being achieved. It enables evaluation of response to both pharmacologic therapy and lifestyle modifications and can therefore help guide treatment decisions and/or self-management.
   • The American Diabetes Association, American Association of Clinical Endocrinologists, and American College of Endocrinology do not prefer any one blood glucose monitor brand over another. • The choice of device should be made on the individual’s circumstance, preferences, and needs.
   • Examples of CGMs and their components include, but are not limited to, the following: o Dexcom G6® CGM System:  Receiver (Dexcom receiver): replacement frequency not specified A personal smart device (e.g., smart phone, smart watch) may also be used, either instead of or in addition to the Dexcom receiver  Transmitter (G6 transmitter): replaced every 3 months  Sensor (applicator with built-in sensor): replaced every 10 days o Dexcom G7® CGM System:  Receiver (Dexcom G7 receiver): 3 years for typical use A personal smart device (e.g., smart phone, smart watch) may also be used, either instead of or in addition to the Dexcom G7 receiver  Sensor (with built in transmitter): replace every 10 days o FreeStyle Libre 14 Day Flash Glucose Monitoring System:  Receiver (FreeStyle reader): replaced every 3 years  Sensor (sensor pack and sensor applicator): replaced every 14 days
   o FreeStyle Libre 3 Glucose Monitoring System:  Receiver (Reader): replace every 3 years A personal smart device (e.g., smart phone, smart watch) may also be used instead of the receiver  Sensor: replaced every 14 days Appendix E: Comprehensive Diabetes Management Programs • A comprehensive diabetes management program is based on an assessment of an individual's specific needs. Education is designed to promote self-management or assist caregivers when appropriate while offering support to improve health outcomes (American Diabetes Association, Diabetes Care 2023, 46: Supplement_1:S68-S96; U.S. Department of Veteran Affairs, Management of Type 2 Diabetes Mellitus in Primary Care. 2017. update Mar 2021; National Institute for Health and Clinical Excellence (NICE), Diabetes (type 1 and type 2) in children and young people: diagnosis and management. Clinical guideline 18. 2015. update 2020; Powers et al., Diabetes Care 2020, 43: 1636-49; National Institute for Health and Care Excellence (NICE), Type 2 diabetes in adults: management. Clinical guideline 28. 2015). Content areas include: o of the disease process o Treatment options o Incorporation of nutritional management o Incorporation of physical activity into lifestyle o Safe medication usage Page 3 of 7

   CLINICAL POLICY Continuous Glucose Monitors o Monitoring of blood glucose and HbA1c along with other lab values to make self- management decisions o Weight management • Additional content areas include education in preventing, detecting, and treating acute and chronic conditions, as well as strategies to address psychosocial issues and to promote health and behavior changes. Continuous education, with reinforcement and periodic assessment of treatment goals, is necessary. V. Dosage and Administration
   Usage regimen is individualized based on patient goals. VI. Product Availability
   Monitor and test strip packaging vary by product and manufacturer. VII.