ModifiedmhnPolicy CP.CPA.355

Continuous Glucose Monitors

Defines medical necessity criteria, coverage stance, and coding implications for continuous glucose monitors (CGMs) for members with diabetes mellitus under the payer's commercial lines.

Policy Summary

Payermhn

PolicyContinuous Glucose Monitors

Policy CodePolicy CP.CPA.355

Change TypeMaterial revisions and coding additions

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all medical necessity criteria when requesting CGM coverage.

SourceLink

POLICY UPDATE CHANGES

Removed requirement for participation in a comprehensive diabetes management program.

Added Coding Implications section listing HCPCS A4238, A4239, A9276-A9278, E2102, E2103 and descriptions.

Added coverage pathways for gestational diabetes and history of problematic hypoglycemia, and removed option for management with oral agents for type 2 diabetes.

12 monthsapproval duration

1/12 moreplacement limit

A9276-A9278HCPCS referenced

≥5 yrsreplacement threshold

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Coverage Criteria for Continuous Glucose Monitors

Initial Therapy

Covered when ALL of the following are met:

A. Diabetes Mellitus (must meet all): 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, b, c, or d): a. Intensive insulin therapy evidenced by (i) insulin injections ≥ 3 times per day OR (ii) continuous insulin infusion pump; b. Type 2 diabetes managed with basal injections; c. Gestational diabetes; d. History of problematic hypoglycemia with either (i) recurrent level 2 hypoglycemic events (glucose < 54 mg/dL) that persist despite two or more attempts to adjust medication/plan OR (ii) level 3 hypoglycemic event requiring third-party assistance; 4. Member must use the health-plan preferred product if available unless younger than FDA-approved age for the product; 5. Request does not exceed health-plan quantity limit.

Replacement of functional features for upgrade is not considered medically necessary.

Continuation Therapy

Covered for continuation when ALL of the following are met:

II. Continued Therapy - Diabetes Mellitus (must meet all): 1. Previously received the requested product via Centene benefit or previously met the initial approval criteria; 2. Documentation supports all of the following (a, b, and c): a. If request is for a new receiver, replacement is necessary due to (i) loss/theft/damage not covered by warranty OR (ii) device age incompatible with necessary software/components and not under warranty OR (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. Member must use the health-plan preferred product if available unless younger than FDA-approved age for the product; 4. Request does not exceed health-plan quantity limit.

Replacement of functional features for upgrade is not considered medically necessary; if replacement is due to change in clinical status, review using initial criteria.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the Health Plan's off‑label use policy (CP.CPA.09 for commercial).

Coverage determinations for continuous glucose monitors are guides to medical necessity and are subject to the terms, conditions, exclusions, and limitations of the applicable coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). Coverage and administration of benefits must also comply with applicable state and federal requirements and Health Plan‑level administrative policies and procedures.

Requests to replace functional features of an existing continuous glucose monitor solely for the purpose of upgrading to newer functionality are not medically necessary and are not routinely authorized. If a replacement is due to a change in clinical status that makes features of a different device type medically necessary, the request should be evaluated against the initial approval criteria. For continuation requests, replacement receivers may be approved only when one of the specified reasons applies (loss/theft/damage not covered by warranty, device age rendering it incompatible with necessary software/components and not covered by warranty, or when the device's reasonable and useful lifetime of ≥ 5 years has passed).

Coding Implications and Device Lifecycle

Coding ImplicationsHCPCS

A4238	Supply allowance for adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service.
A4239	Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service.
A9276	Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial continuous glucose monitoring system, one unit = 1 day supply.
A9277	Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring system.
A9278	Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring system.
E2102	Adjunctive, non-implanted continuous glucose monitor or receiver.

Coding Implications continuedHCPCS

E2103

Non-adjunctive, non-implanted continuous glucose monitor or receiver.

inv-08: Device lifetime threshold — replacement guidance

Device reasonable/useful lifetime threshold>= 5 years (reasonable and useful lifetime for receiver replacement consideration)

Replacement criteria contextIf request is for a new receiver, replacement may be authorized when loss/theft/damage not covered by warranty, device age makes it incompatible with required software/components not covered by warranty, or the reasonable/useful lifetime ≥ 5 years.

Approval limits related to replacementApproval duration: 12 months; 1 replacement receiver per 12 months (other components may be replaced as needed).

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of continuous glucose monitoring (CGM) devices. Submit clinical documentation demonstrating that the member meets all medical necessity criteria before services are rendered.

Include office chart notes, relevant lab results, and diabetes treatment history.
Requests may be denied if required documentation is not provided.

Documentation Required

Providers must submit supporting documentation (such as office notes, lab results, and pump/insulin regimens) showing the member meets all applicable approval criteria.

Documentation should demonstrate diagnosis, insulin regimen, history of hypoglycemia events, and need for frequent treatment adjustments.
Approval duration and quantity limits (e.g., 12 months, 1 receiver per 12 months) will be enforced based on submitted evidence.

Background

Continuous glucose monitors (CGMs) measure interstitial glucose, which correlates with plasma glucose, and are FDA‑indicated for use in patients with diabetes mellitus to monitor blood glucose levels. CGM data can guide treatment adjustments and self‑management. This clinical policy provides medical necessity guidance to assist coverage decisions and does not replace clinical judgment or constitute a guarantee of payment.

Definitions

inv-18: Definition — CGM (continuous glucose monitor)

Definition of CGMContinuous glucose monitor (CGM): device that measures interstitial glucose which correlates with plasma glucose to monitor blood glucose levels in patients with diabetes mellitus.

FDA-approved indication summaryCGMs are indicated for use in patients with diabetes mellitus to monitor blood glucose levels.

Clinical use noteCGM data can guide treatment adjustments and self-management; CGMs that are also insulin delivery systems may require additional approval criteria per related policy.

Policy contextThis clinical policy provides medical necessity guidance and does not guarantee payment; 'Health Plan' refers to plans operated or administered, in whole or in part, by Centene Management Company, LLC or affiliates.

inv-19: Definition — Health Plan

Health Plan definition

Policy Summary

Payermhn

PolicyContinuous Glucose Monitors

Policy CodePolicy CP.CPA.355

Change TypeMaterial revisions and coding additions

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all medical necessity criteria when requesting CGM coverage.

SourceLink

On This Page

Note

Use Health-Plan Preferred Product

Providers must use the health-plan preferred CGM product when available. An exception applies if the member is younger than the FDA‑approved age for the preferred product.

If a non-preferred product is requested, include justification and supporting clinical rationale.
Age-based exceptions must reference FDA-approved ages for the preferred device.

Denial Risk

Upgrades / Functional Feature Replacements Not Covered

Requests for replacement of functional features of an existing monitor for the purpose of an upgrade are not considered medically necessary and may be denied.

Replacement is allowed for worn-out or non-functioning components when clinically indicated (e.g., defective transmitter or sensor), but not for feature upgrades alone.

Denial Risk

Denial Risk from Plan Terms

Coverage determinations are subject to the Health Plan's terms, conditions, exclusions, and limitations. Even when medical criteria are met, claims may be denied if plan-level rules or exclusions apply.

Adjudication may be affected by member benefits, contract language, and applicable state/federal regulations.
Providers should verify member benefits and obtain prior authorization when indicated to reduce denial risk.

Billing Rule

Documentation and Claims

When submitting claims, follow this clinical policy and Health Plan administrative billing requirements. Ensure claims reflect the approved device, quantity limits, and any required modifiers.

Adhere to quantity limits (e.g., 1 receiver per 12 months); replace other components (transmitters, sensors) as clinically indicated per policy.
Include prior authorization reference numbers and attach supporting clinical documentation when required.

Prior Authorization

Prior Authorization May Be Required

Coverage decisions and benefit administration may require prior authorization and are governed by Health Plan guidelines and policies.

Follow the Health Plan's prior authorization process and timelines.
Contact the Health Plan for questions about specific member coverage or administrative exceptions.

'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

Policy effect on coverage determinationsCoverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents and applicable state/federal requirements and Health Plan-level administrative policies.

Non-contractual natureThis clinical policy is a guide to medical necessity and does not constitute a contract or guarantee regarding payment or results.