Clinical Policy: Continuous Glucose Monitors

Reference Number: SC.CP.MP.02
Date of Last Revision: 06/25

[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Continuous glucose monitors (CGMs) measure interstitial glucose, which correlates well with plasma glucose.

FDA Approved Indication(s)

CGMs are indicated for use in patients with diabetes mellitus to monitor blood glucose levels.

Policy/Criteria

  i. Any type of insulin dependency;  
  ii. Non-insulin treated diabetes who have recurrent moderate (level 2) or have had at least one severe (level 3) hypoglycemic event (*Appendix F*);

2. CGM must be prescribed by one of the following qualified healthcare providers (a, b, or c):
   a. primary care provider (physician, physician assistant or advanced practice registered nurse);
   b. obstetrician;
   c. endocrinologist.
3. If request is for a non-preferred CGM, member must try and fail ALL of the following preferred CGMs (a, b, c, d, and e):
   a. Dexcom G6;
   b. Dexcom G7;
   c. Freestyle Libre 2;
   d. Freestyle Libre 3;

CLINICAL POLICY

Continuous Glucose Monitors

e. Freestyle Libre 14 day;

4. If member was previously approved for any CGM device/receiver in the last 12 months, documentation in chart notes is required showing that a replacement or new device is necessary due to one of the following (i or ii):
   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;
   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*

1. Previously received the requested product via Centene benefit;

   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.

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

CLINICAL POLICY

Continuous Glucose Monitors

Not applicable

Appendix C: Contraindications/Boxed Warnings
None reported

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:
  ○ 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
    ○ 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
    ○ 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
    ○ 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:
  ○ Description of the disease process
  ○ Treatment options
  ○ Incorporation of nutritional management
  ○ Incorporation of physical activity into lifestyle
  ○ Safe medication usage
  ○ Monitoring of blood glucose and HbA1c along with other lab values to make self-management decisions
  ○ 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.

Appendix F: IHSG Definitions of Clinically Relevant Levels of Hypoglycemia

• Level 1 (mild) hypoglycemia: Blood glucose is less than 70 mg/dL (3.9 mmol/L) but is 54 mg/dL (3.0 mmol/L) or higher.
• Level 2 (moderate) hypoglycemia: Blood glucose is less than 54 mg/dL (3.0 mmol/L).
• Level 3 (severe) hypoglycemia: As defined by the ADA, severe cognitive impairment requiring external assistance for recovery.

Dosage and Administration

Usage regimen is individualized based on patient goals.

Product Availability

Monitor and test strip packaging vary by product and manufacturer.

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Important Reminder