CurrentCareSourcePolicy N/A

Continuous Glucose Monitors

Policy governing medical necessity, coverage, prior authorization, and replacement/repair rules for continuous glucose monitors (CGMs) for Arkansas PASSE members; affects providers requesting CGM coverage for patients with diabetes or glycogen storage disease.

Policy Summary

PayerCareSource

PolicyContinuous Glucose Monitors

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date06/01/2023

Next Review DateN/A

Key ActionObtain prior authorization with a board-certified endocrinologist's letter of medical necessity and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

06/01/2023policy effective date

1 yrcontinuation review interval

>=50%required minimum CGM use rate

>=7%A1C threshold

Coverage Criteria for Continuous Glucose Monitors

Initial long-term CGM coverage

Covered when ALL of the following are met:

Initial criteria: 1) Patient has a confirmed diagnosis of type 1 diabetes mellitus or any other type of diabetes meeting one of: uses insulin >= 3 times/day; evidence of Level 2 (blood glucose < 54 mg/dL) or Level 3 hypoglycemia; diagnosis of glycogen storage disease type 1a; HgbA1C >= 7% despite appropriate adjustments to therapy based on previous short-term CGM and self-monitoring; or patient uses an insulin pump. 2) Patient is unresponsive to standard medical therapy. 3) Patient is pregnant with poorly controlled type 1 diabetes (defined as unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected post-prandial hyperglycemia, or recurrent diabetic ketoacidosis). 4) A letter of medical necessity from a board-certified endocrinologist and supporting documentation (diagnosis documentation, chart notes, test reports, and hospital admission notes when applicable) is provided with the prior authorization. 5) Documentation that the patient has completed a comprehensive diabetes education program within the last 12 months. 6) Regular follow-up with a healthcare provider is planned at minimum every 6 months to assess ongoing benefit.all listed conditions required

Criteria assembled from policy text

Continuation (after 1 year)

Continuation of CGM after 1 year is medically necessary when BOTH criteria are met:

Policy Summary

PayerCareSource

PolicyContinuous Glucose Monitors

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date06/01/2023

Next Review DateN/A

Key ActionObtain prior authorization with a board-certified endocrinologist's letter of medical necessity and supporting clinical documentation.

SourceLink

On This Page

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Continuation criteria: 1) Objective documented evidence of improvement in control of diabetes specific to the patient’s baseline status; 2) Documented evidence of compliance to CGM defined as at least 50% device use rate based on device log data.all listed conditions required

Continuation requires both improvement and documented device use

Coverage excludes certain device types and clinical situations. CareSource will not approve non–FDA-approved devices for use as continuous glucose monitors. Pregnant women with gestational diabetes are not eligible under this policy; however, pregnant members with poorly controlled type 1 diabetes may qualify when policy criteria are met. Artificial pancreas device systems (APDS) are not approved. In addition, replacement of an existing CGM solely to obtain additional features that are not medically necessary will not be covered.

Replacement or upgrade requests that are intended to provide additional, non‑medically necessary features will be denied. Specifically, CareSource will not cover replacement of an existing CGM device when the replacement is for added features that do not meet medical necessity criteria. Providers should document clinically necessary reasons for replacement (for example, device malfunction) and include supporting evidence with the prior authorization request.

Coding and Measurement Thresholds

inv-05: Device compliance use rate

Device compliance use rate>= 50% device use rate based on device log data

Measurement sourceDetermined from device log data (objective documented evidence)

Applicable periodRequired for continuation of CGM after 1 year

inv-06: A1C threshold

A1C threshold>= 7% (HgbA1C >= 7%)

Context for useConsidered as one qualifying criterion for initial long-term CGM when >= 7% despite therapy adjustments

BasisThreshold noted in initial coverage criteria after prior short-term CGM and SMBG adjustments

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Continuous Glucose Monitor (CGM) coverage. The prior authorization submission must include a letter of medical necessity from a board-certified endocrinologist and supporting clinical documentation to validate medical necessity.

Letter of medical necessity from a board-certified endocrinologist
Documentation of diagnosis (e.g., diabetes type, glycogen storage disease type 1a)
Chart notes from provider's office
Device test result reports and device log data (use/compliance evidence)
Hospital admission notes, if applicable
Documentation of completion of a comprehensive diabetes education program within the last 12 months

Note

Short- vs Long-term CGM Considerations

Short-term (up to 7 days) and long-term CGM are considered medically necessary when clinical criteria are met. Short-term CGM may be used for diagnostic/evaluation purposes to optimize therapy. Long-term CGM is considered medically necessary when the member meets ALL clinical criteria for ongoing use. Continuation after 1 year requires documented compliance (≥50% device use rate from device log data) and objective evidence of improvement in diabetes control compared to baseline. Regular follow-up with a healthcare provider at least every 6 months is required to assess ongoing benefit.

Short-term CGM: up to 7 days for evaluation/optimization of therapy
Long-term CGM: meets clinical criteria for chronic use
Continuation criteria: ≥50% use rate (device log), and objective improvement in control
Follow-up: at minimum every 6 months

Denial Risk

Not Approved Device Types / Non‑Covered Replacements

Certain device types and replacements are not approved. CareSource will not approve non–FDA-approved devices or artificial pancreas device systems (APDS). Replacement of an existing CGM solely for additional non–medically necessary features (e.g., cosmetic or convenience features) is not covered.

Non–FDA-approved devices: not approved
Artificial pancreas device systems (APDS): not approved
Replacement for added non-medical features: not covered

Background and Rationale

Diabetes prevalence is increasing across populations, including children, and both type 1 and type 2 diabetes contribute to substantial morbidity. Continuous glucose monitors (CGMs) provide ongoing interstitial glucose measurements and are most beneficial when used consistently to inform treatment decisions, reduce hypoglycemia risk, and guide therapy adjustments. Glycated hemoglobin (A1C) targets should be individualized based on patient circumstances and treatment goals.

Definitions

inv-12: Continuous Glucose Monitor (CGM)

DefinitionContinuous Glucose Monitor (CGM): an instrument or device, including repair and replacement parts, designed to aid an individual with diabetes by measuring glucose levels at set intervals via a small electrode placed under the skin and held in place by an adhesive

Included componentsRepair and replacement parts are included in the definition of CGM

Intended usersDesigned and offered for the purpose of aiding an individual with diabetes; generally not useful for individuals without diabetes

inv-13: Hypoglycemia Level 2

DefinitionHypoglycemia Level 2: Blood glucose level < 54 mg/dL

Clinical relevanceClassified as an abnormally low plasma glucose concentration that exposes the individual to harm

Use in criteriaEvidence of Level 2 hypoglycemia is a qualifying condition for long-term CGM coverage

inv-14: Hypoglycemia Level 3

DefinitionHypoglycemia Level 3: Severe hypoglycemic event with severe cognitive impairment requiring external assistance (administration of carbohydrate, glucagon, or other resuscitative actions)

Clinical implicationDenotes an event where the individual cannot self-treat and requires external help

Use in criteriaEvidence of Level 3 hypoglycemia is a qualifying condition for long-term CGM coverage

inv-15: Glycogen Storage Disease Type 1a

DefinitionGlycogen Storage Disease Type 1a: Hereditary disorder caused by buildup of glycogen causing impairment of liver, kidneys, and small intestine; associated with short stature

Relevance to CGMListed as a diagnosis that qualifies a patient for long-term CGM coverage

Clinical featuresImpairment of liver, kidneys, and small intestine due to glycogen accumulation