ModifiedUnitedHealthcarePolicy CSO24IN.13

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (for Indiana Only)

This policy governs medical necessity, coverage, and coding for continuous glucose monitors (CGMs) and external insulin delivery systems for members in Indiana; it applies to device selection, authorization durations, and references InterQual criteria for clinical coverage.

Policy Summary

PayerUnitedHealthcare

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (for Indiana Only)

Policy CodePolicy CSO24IN.13

Change TypeModified — material change to CGM/implantable sensor guidancereferences state bulletin BT202520

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for non-preferred Indiana CGM products and applicable device codes per InterQual and state requirements.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale Continuous Glucose Monitoring (CGM) replaced coverage guidelines for implantable glucose sensors (Eversense) with instruction to refer to the Indiana Health Coverage Programs Bulletin BT202520 for medical necessity clinical coverage criteria.

Supporting Information and Clinical Evidence and References sections were updated to reflect the most current information.

Up to 6 moInitial auth

Up to 12 moReauth

Indiana onlyRegion

InterQual

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Up to 180 daysEversense duration

Clinical trial onlyImplantable pumps

Coverage Criteria for CGMs and Insulin Delivery Devices

Insulin pumps and CGM coverage tied to InterQual and FDA labeling

Covered when requirements of InterQual criteria and FDA labeling are met

General coverage prerequisites: Devices must be used according to FDA labeled indications, contraindications, warnings, and precautions; for clinical coverage criteria refer to InterQual CP: Durable Medical Equipment; Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology.

See InterQual for specific initial and continuation criteria.

External insulin pumps medically necessary examples: External continuous subcutaneous insulin infusion (CSII) pumps are medically necessary for individuals with diabetes due to other causes who require intensive insulin therapy (insulin-treated at least 3 times per day), for example cystic fibrosis–related diabetes, post‑transplantation diabetes, or diabetes following pancreatic surgery.insulin-treated >= 3 times/day

Refer to InterQual criteria for detailed qualifying and continuation criteria.

Devices considered not medically necessary

Not medically necessary

Unproven devices: Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) are considered unproven due to insufficient evidence of safety and efficacy and are not medically necessary.

Evidence gaps include lack of randomized controlled trials and long-term comparative data.

Implantable insulin pumps are considered unproven and not medically necessary; currently available only in clinical trial settings and not generally covered.

Coverage outside clinical trials is not supported by current evidence.

Coverage guidance (narrative)

Covered when aligned with guideline recommendations and device approvals:

Guideline-based offering: Automated insulin delivery systems and insulin pump therapy should be offered to youth and adults with type 1 diabetes and other insulin‑deficient diabetes who can use the device safely (by themselves or with a caregiver); pump therapy may also be offered to some individuals on multiple daily injections for type 2 diabetes.LOE A/E per guideline

Consistent with ADA 2024 guidance.

Device selection: Choice of device should be individualized based on patient circumstances, preferences, and needs, including caregiver support for pediatric patients.

Consider patient ability to use device safely and effectively.

Implantable pumps: Implantable insulin pumps are only available within clinical trials at this time and are not approved for general clinical use.

Refer to clinical trial availability and state requirements.

The policy explicitly lists certain devices as unproven and not medically necessary. Specifically, nonprogrammable transdermal insulin delivery systems (e.g., V-Go) and implantable insulin pumps are identified as not medically necessary due to insufficient evidence of efficacy and therefore are excluded from coverage.

Implantable insulin pumps are not generally covered outside of research settings; the policy states these devices are available only within clinical trials at this time. Similarly, the policy addresses nonprogrammable wearable disposable devices by noting that the current literature does not demonstrate sufficient safety and efficacy to support routine coverage and that larger, well‑designed comparative studies with long‑term follow‑up are needed.

The policy restates that both implantable insulin pumps and nonprogrammable transdermal insulin delivery systems are considered unproven and not medically necessary. Because available evidence is limited and methodologically weak, these device categories are not supported for general coverage.

For nonprogrammable wearable disposable insulin delivery devices such as V‑Go, the policy finds the evidence insufficient to establish safety and efficacy for routine management of diabetes. The existing studies (including prospective observational work and retrospective chart reviews) are limited by lack of randomized controls, small sample sizes, high attrition, and short follow‑up, so further well‑designed prospective comparative trials are required before coverage can be recommended.

CPT, HCPCS, and ICD-10 Codes

CPT Codes (implantable and ambulatory CGM)CPT

0446T	Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor; including system activation and patient training.
0447T	Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision.
0448T	Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor; including system activation.
95249	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; patient-provided equipment; sensor placement; hook-up, calibration of monitor, patient training, and printout of recording.
95250	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; physician or other qualified health care professional (office) provided equipment; sensor placement; hook-up, calibration of monitor, patient training, removal of sensor; and printout of recording.
95251	Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; analysis, interpretation and report.

HCPCS Codes (supplies, pumps, implantable and system components)HCPCS

A4226	Supplies for maintenance of insulin infusion pump with dosage rate adjustment using therapeutic continuous glucose sensing, per week.
A4238	Supply allowance for adjunctive, nonimplanted continuous glucose monitor (CGM) , includes all supplies and accessories, month supply unit of service.
A4239	Supply allowance for nonadjunctive, nonimplanted continuous glucose monitor (CGM); includes all supplies and accessories, month supply = unit of service.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
A9276	Sensor; invasive (e.g., subcutaneous), disposable, for use with nondurable medical equipment interstitial continuous glucose monitoring system (CGM), one unit = supply day.
A9277	Transmitter; external, for use with nondurable medical equipment interstitial continuous glucose monitoring system (CGM).
A9278	Receiver (monitor); external, for use with nondurable medical equipment interstitial continuous glucose monitoring system (CGM).
E0784	External ambulatory infusion pump, insulin.
E0787	External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing.
E2102	Adjunctive, nonimplanted continuous glucose monitor (CGM) or receiver.

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ICD-10 Codes (examples listed in policy)ICD-10

E11.00	Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC).
E11.01	Type 2 diabetes mellitus with hyperosmolarity with coma.
E11.10	Type 2 diabetes mellitus with ketoacidosis without coma.
E11.11	Type 2 diabetes mellitus with ketoacidosis with coma.
E11.21	Type 2 diabetes mellitus with diabetic nephropathy.
E11.22	Type 2 diabetes mellitus with diabetic chronic kidney disease.
E11.29	Type 2 diabetes mellitus with other diabetic kidney complication.
E11.311	Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema.
E11.319	Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema.
E11.9	Type 2 diabetes mellitus without complications.

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Applicable diagnosis examplesICD-10

Gestational diabetes mellitus in the puerperium, unspecified control

Diagnosis text listed under Applicable Codes_

Hypoglycemia level thresholds

Hypoglycemia level 2 thresholdGlucose < 54 mg/dL

Hypoglycemia level 3 definitionSevere event requiring third‑party assistance; life‑threatening and requires emergent treatment

Clinical relevance of Level 2Associated with increased risk for cognitive dysfunction and mortality

V‑Go study baseline HbA1c

V‑Go study baseline HbA1c>= 7% (patients enrolled had HbA1c ≥7%)

Study design noteProspective, observational, open‑label, multicenter; no control group and high attrition

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for many continuous glucose monitors (CGMs), insulin pumps, and related supply codes. For Indiana members: preferred Indiana CGM products do not require authorization; non-preferred Indiana CGM products must meet the coverage criteria below whether the request is submitted through UnitedHealthcare prior authorization or via a contracted supplier. Initial CGM authorizations are up to six months; reauthorizations up to 12 months. Follow federal, state, and contractual requirements when deciding coverage — in the event of conflict, those requirements govern.

Initial CGM authorization: up to 6 months
Reauthorization: up to 12 months
Preferred Indiana CGMs: no authorization required
Non-preferred Indiana CGMs: authorization required and must meet criteria

Documentation Required

Follow Policy and State Bulletin

Background and Scope

Diabetes includes several distinct classifications—most commonly type 1 and type 2 diabetes, as well as gestational diabetes and diabetes due to other specific causes (for example, cystic fibrosis–related diabetes or post‑transplantation diabetes). Poorly controlled diabetes increases the risk of macrovascular and microvascular complications; CGMs and insulin delivery systems are tools intended to help maintain glycemic control and reduce complication risk. This policy addresses coverage and medical necessity for continuous glucose monitors and external insulin delivery systems in the Indiana member population.

Definitions

Adjunctive CGM

TermAdjunctive CGM

DefinitionA CGM that requires verification of glucose readings or trends with a blood glucose monitor prior to making treatment decisions (CMS; ADA, 2024)

Use implicationRequires confirmatory fingerstick testing before treatment decisions

Non‑Adjunctive CGM

TermNon‑Adjunctive CGM

DefinitionA CGM that can be used to make treatment decisions without confirmatory testing from a standalone blood glucose monitor (CMS; ADA, 2024)

Use implication

Policy Summary

PayerUnitedHealthcare

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (for Indiana Only)

Policy CodePolicy CSO24IN.13

Change TypeModified — material change to CGM/implantable sensor guidancereferences state bulletin BT202520

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for non-preferred Indiana CGM products and applicable device codes per InterQual and state requirements.

SourceLink

On This Page

Nonprogrammable transdermal devices: Nonprogrammable wearable disposable insulin delivery devices lack sufficient evidence to establish safety and efficacy for general coverage; further well‑designed comparative studies with long‑term follow‑up are needed.

Examples include V‑Go; existing studies are limited by design and attrition.

CGM devices and approvals: Recognized CGM models are listed for reference; the Eversense implantable CGM has FDA approval for up to 180 days in adults but FDA approval alone does not automatically determine coverage—refer to InterQual and the Indiana Health Coverage Programs Bulletin BT202520 for implantable sensor coverage criteria.Eversense indicated up to 180 days in adults

Follow state and contractual requirements for implantable sensors; see policy instructions for authorization durations (initial up to 6 months; reauthorization up to 12 months).

12‑month retention112 of 188 patients (60%) remained in study at 12 months

UnitedHealthcare follows InterQual clinical criteria for medical necessity determinations for CGMs, insulin pumps, and automated insulin delivery technology. For implantable glucose sensors (for example, Eversense), providers must refer to the Indiana Health Coverage Programs Bulletin BT202520 for the state-specific medical necessity clinical coverage criteria.

Refer to InterQual: Durable Medical Equipment; Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology
For implantable glucose sensors: Indiana Bulletin BT202520

Denial Risk

Unproven Devices May Be Denied

The following device types are considered unproven and may be denied as not medically necessary due to insufficient evidence of safety and effectiveness: nonprogrammable transdermal insulin delivery systems (e.g., V-Go) and implantable insulin pumps. Providers should be aware these devices carry a higher denial risk.

Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) — denial risk
Implantable insulin pumps — denial risk

Billing Rule

Repairs/Replacements and Plan Requirement Checks

For repair and replacement coverage and requirements, refer to the Medical Policy titled Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements for Indiana Only. Confirm plan-specific repair/replacement rules and benefit limits prior to submission.

See Durable Medical Equipment / Repairs & Replacements (Indiana only) for details
Verify member’s plan requirements and limits before requesting repairs/replacements

Note

Therapy Selection Considerations

Consider insulin pump therapy for individuals with diabetes due to other causes who require intensive insulin management (insulin-treated at least 3 times daily) — examples include cystic fibrosis–related diabetes, post-transplantation diabetes, or diabetes following pancreatic surgery. Device selection should account for clinical needs, evidence of benefit, and product authorization status (preferred vs non-preferred).

Consider pumps when multiple daily injections are required
Evaluate appropriateness for specific diabetes etiologies (e.g., cystic fibrosis–related, post-transplant, post-pancreatectomy)
Select devices that meet coverage criteria and authorization requirements

Documentation Required

Authorization and Documentation for CGM Products

For non-preferred Indiana CGM products or other devices not on the preferred list, authorization must be obtained through UnitedHealthcare or a contracted supplier per Indiana requirements. If InterQual criteria do not determine medical necessity, refer to InterQual Medicare: Post Acute & Durable Medical Equipment Glucose Monitors or applicable state guidance.

Non-preferred Indiana CGMs: obtain authorization through UnitedHealthcare or contracted supplier
If InterQual cannot determine medical necessity, use InterQual Medicare: Post Acute & Durable Medical Equipment Glucose Monitors

Can be relied upon for insulin dosing and therapy adjustments without additional SMBG confirmation

Intermittently Scanned (Flash) CGM (isCGM)

TermIntermittently Scanned (Flash) CGM (isCGM)

DefinitionDevices with two components (combined sensor/transmitter and separate reader) that measure glucose continuously but require scanning to visualize and store glucose values; available with or without alarms

Use implicationData are not continuously displayed unless the user scans the sensor/reader

Professional CGM

TermProfessional CGM

DefinitionClinic‑owned CGM devices placed and worn for a discrete period (generally 7–14 days) to assess glycemic patterns; data may be blinded or visible

Use implicationUsed for short‑term assessment in clinical settings rather than ongoing home monitoring

Real‑Time CGM (rtCGM)

TermReal‑Time CGM (rtCGM)

DefinitionDevices with a sensor, transmitter, and receiver/smartphone that display glucose readings in real time and provide audible/visual alerts; some systems require user calibration

Use implicationProvides continuous real‑time alerts for out‑of‑range glucose values to support immediate action

Hypoglycemia Level 2 and 3 definitions

Level 2Glucose < 54 mg/dL (3.0 mmol/L); associated with increased risk for cognitive dysfunction and mortality

Level 3Severe event characterized by altered mental and/or physical state requiring third‑party assistance; life‑threatening and requires emergent treatment

Gestational diabetes mellitus (GDM)

TermGestational diabetes mellitus (GDM)

DefinitionDiabetes diagnosed in the second or third trimester of pregnancy that was not clearly overt prior to gestation and usually resolves after childbirth; fetal and maternal health can be compromised if poorly controlled

Clinical noteGDM resembles type 2 diabetes and is often insulin‑managed during pregnancy

Insulin pump (definition and delivery types)

TermInsulin pump

DefinitionExternal devices that deliver basal and bolus insulin via tubing that connects to an infusion set or via patch‑style reservoirs; newer devices may deliver transdermal insulin or be nonprogrammable; implantable pumps exist but currently are available only in clinical trials

Delivery typesProgrammable CSII pumps (tubing), patch‑style wearable pumps (reservoir on skin), and nonprogrammable transdermal disposable devices (e.g., V‑Go) described separately