CurrentUnitedHealthcarePolicy CS024SS.AG

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

UnitedHealthcare medical policy CS024SS.AG defines medical necessity coverage criteria for short-term and long-term continuous glucose monitoring (CGM), implantable CGM, noninvasive CGM, and external insulin infusion pumps (including indications, continued use criteria, exclusions such as implantable insulin pumps and nonprogrammable transdermal systems). It references InterQual CP criteria for detailed clinical coverage and applies except in multiple listed states with state-specific policies.

Policy Summary

PayerUnitedHealthcare

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Policy CodePolicy CS024SS.AG

Change TypeRevised (coverage wording) + Removed CPT

Effective DateNov 1, 2025

Next Review Date

Key ActionEnsure coverage criteria are met whether the request comes through UnitedHealthcare prior authorization or a contracted supplier and follow initial authorization (up to 6 months) and reauthorization (up to 12 months) rules.

POLICY UPDATE CHANGES

Coverage Rationale: Replaced references to 'non-intensive insulin treatment plan' with 'non-intensive treatment plan'.

Applicable Codes: Removed CPT code 0447T.

Supporting Information: Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

Archived previous policy version CS024SS.AF.

3Authorization Durations (initial/reauthorization/assessment interval)

2CGM Modalities (implantable vs noninvasive status)

2Insulin Delivery Status (external pumps covered; implantable pumps not covered)

Notable device clearance

91%Full intended life achieved for 90-day sensors (PMCF)

75%Full intended life achieved for 180-day sensors (PMCF)

Coverage Summary

UnitedHealthcare Medical Policy CS024SS.AG (effective November 1, 2025) defines coverage for continuous glucose monitoring (CGM) and insulin delivery for diabetes. The policy takes a mixed coverage stance: short-term (professional) CGM for diagnostic use is covered; long-term CGM (rtCGM/isCGM and implantable sensors) is covered when FDA labeling is followed and InterQual clinical criteria are met; noninvasive CGM devices are considered unproven and not medically necessary. The policy references InterQual CP criteria and FDA labeling/product-code resources to determine medical necessity and device-specific indications. Modalities explicitly addressed include short-term (professional) CGM (3–14 days), long-term real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), and implantable CGM (e.g., Eversense). For insulin delivery, external continuous subcutaneous insulin infusion pumps (including patch/Omnipod-style systems) are covered when used per FDA labeling and InterQual criteria; implantable insulin pumps are unproven and not medically necessary (only in clinical trials).

Key Thresholds / Parameters

Age for implantable CGM>= 18

Intensive insulin therapy definitioninsulin-treated at least 3 times a day or insulin pump

Hypoglycemia Level 2Glucose < 54 mg/dL (3.0 mmol/L)

Hypoglycemia Level 3Severe event requiring third-party assistance

Initial CGM authorization durationup to 6 months

Reauthorization durationup to 12 months

Medical-Necessity Criteria

Short-Term CGM (3-14 Days)

Short-term CGM use by a healthcare provider for diagnostic purposes is covered when used by a healthcare provider for diagnostic purposes:

ALL of the following

Short-term CGM use by a healthcare provider for diagnostic purposes

Long-Term CGM (Greater Than 14 Days) - General

Duration and general rules for authorization:

Initial CGM authorization will be for up to six monthsup to 6 months

Reauthorization will be for up to 12 monthsup to 12 months

Coding (CPT / HCPCS / ICD-10 / Product Codes)

CPT/HCPCS/Other Procedures and Supplies (reference list)mixed

0446T	Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training.
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.
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, 1 month supply = 1 unit of service.
A4239	Supply allowance for nonadjunctive, nonimplanted continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service.

ICD-10 Diagnosis Codes (examples listed)ICD-10

E11.3531	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene, right leg.
E11.3532	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene, left leg.
E11.3533	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene, bilateral legs.
E11.3539	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene, unspecified extremity.
E11.3541	Type 2 diabetes mellitus with diabetic peripheral angiopathy with ulceration, right leg.
E11.3542	Type 2 diabetes mellitus with diabetic peripheral angiopathy with ulceration, left leg.
E11.3543	Type 2 diabetes mellitus with diabetic peripheral angiopathy with ulceration, bilateral legs.
E11.3549	Type 2 diabetes mellitus with diabetic peripheral angiopathy with ulceration, unspecified extremity.
E11.3551	Type 2 diabetes mellitus with diabetic peripheral angiopathy with skin ulcer, right leg.
E11.3552	Type 2 diabetes mellitus with diabetic peripheral angiopathy with skin ulcer, left leg.

1–10 of 53

1/6

Removed CPT codes (per revision history)CPT

0446T	Previously listed; see revision history for details.
0448T	Previously listed; see revision history for details.

External resources / FDA product code referencesmixed

Eversense (example)	Implantable CGM system product reference (FDA-labeled indications apply).
Omnipod 5 (example)	Hybrid closed-loop insulin delivery system product reference; federal/state/contractual requirements may apply.

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization required per policy

Coverage criteria must be met whether the request comes through the UnitedHealthcare prior authorization process or a contracted supplier. Initial authorization periods are up to 6 months and reauthorization periods are up to 12 months. Clinical medical necessity criteria are detailed in the InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology.

Initial authorization: up to 6 months
Reauthorization: up to 12 months
Refer to InterQual clinical criteria

Documentation Required

Six-month adherence assessment for continued CGM

For continued long-term CGM (including implantable sensors), the individual must be assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment plan; this assessment is required for continued coverage.

Background, Evidence, and Definitions

This policy background summarizes device categories and clinical rationale: CGM device types include professional/short-term CGM (clinic-placed, worn for ~7–14 days), real-time CGM (rtCGM), intermittently scanned/flash CGM (isCGM), and implantable sensors (e.g., Eversense implantable system). Insulin pump types described include standard external pumps with tubing, patch/OmniPod-style reservoir-on-skin devices, and implantable pumps (currently available only in clinical trial settings). The clinical rationale cites evidence that improved glycemic control (assessed by CGM metrics and HbA1c) can slow the onset or progression of diabetes complications, and that CGM use may improve time in range and reduce hypoglycemia in selected populations. The policy directs reviewers to InterQual clinical criteria for detailed medical necessity determinations and to FDA labeling and product-code resources for device-specific indications and clearance information.

Study / Source	Key Finding
ENHANCE (Bailey et al. 2025)
Eversense 365: MARD 8.8%; 90% sensors survived 365 days; no serious device-related adverse events.
PROMISE (Garg et al. 2022)
Eversense evaluated up to 180 days accuracy/safety in 181 patients.
Hayes assessment (2022, updated 2025)
Concluded low-quality evidence suggests moderate accuracy for Eversense; clinical utility evidence limited.
HbA1c change (180 days)
Observed mean HbA1c decrease −0.43% ±0.69% (p < 0.0001) at 180 days in one prospective study.
Systematic review (Jancev et al., 2024)
CGM vs BGM: average decrease in HbA1c by 3.43 mmol/mol and increased time in range by 6.36%.
ECRI (updated 2025)
Updated recommendation favorable for CGM replacing BGM in noninsulin therapies based on systematic review evidence.

Term	Definition
Adjunctive CGM
Requires the user to verify CGM readings with a blood glucose monitor prior to making treatment decisions.
Non-Adjunctive CGM
Can be used to make treatment decisions without need for standalone blood glucose monitor confirmation.
Intermittently Scanned (Flash) CGM (isCGM)
Devices measure continuously but require scanning for visualization and are available with or without alarms.
Professional CGM
Clinic-placed devices worn for discrete period (generally 7-14 days) used for assessment; not owned by user.
Real-Time CGM (rtCGM)
Devices with sensor, transmitter, and receiver/smartphone that display glucose in real time and provide alerts.
Hypoglycemia Level 2
Glucose < 54 mg/dL (3.0 mmol/L).
Hypoglycemia Level 3
Severe event with altered mental/physical status requiring third-party assistance.
CGM
Continuous glucose monitoring systems, including real-time (rtCGM), intermittently scanned (isCGM/flash), transcutaneous and implantable sensors.
BGM
Blood glucose monitoring (fingerstick capillary glucose measurement).

Medicare Local Coverage Determinations

Name	Number	Type
Glucose monitors
L33822
LCD

Revision History

2025-11-01revisedLatest

Coverage Rationale: Replaced references to 'non-intensive insulin treatment plan' with 'non-intensive treatment plan'.

2025-11-01removedLatest

Applicable Codes: CPT code 0447T removed from the policy's applicable codes list.

2025-11-01revised

Policy Summary

PayerUnitedHealthcare

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Policy CodePolicy CS024SS.AG

Change TypeRevised (coverage wording) + Removed CPT

Effective DateNov 1, 2025

Next Review Date

On This Page

Coverage criteria noted below must be met whether the request comes through the UnitedHealthcare prior authorization process or a contracted supplier

Long-Term CGM - Intensive Insulin Therapy (Initial and Continued Use)

Long-term CGM is medically necessary when used per FDA labeling and when InterQual clinical criteria are met:

Device is used according to FDA labeled indications, contraindications, warnings, and precautionsper FDA labeling

Medical necessity clinical coverage criteria are met; refer to the InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technologyrefer to InterQual

Continued use: Individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment planevery 6 months

Long-Term CGM - Non-Intensive Diabetes Therapy (Initial)

Initial long-term CGM for non-intensive treatment plans is medically necessary when:

Individual is on a non-intensive treatment plan (e.g., basal insulin and/or oral medications)non-intensive treatment plan

At least one of the two hypoglycemia criteria must be present

Individual has a history of a level 3 hypoglycemic event OR recurrent (more than one) level 2 hypoglycemic events that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment planlevel 3 or recurrent level 2 despite adjustments

Long-Term CGM - Non-Intensive Diabetes Therapy (Continued)

Continued long-term CGM for non-intensive plans is medically necessary when ALL are met:

Clinical criteria for initial use were met at initiation of CGMinitial criteria met

Individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment planevery 6 months

Implantable Continuous Glucose Monitoring - Initial

Initial long-term implantable CGM (e.g., Eversense) is medically necessary when ALL are met:

Device is used according to FDA labeled indications, contraindications, warnings, and precautionsper FDA labeling

Age >= 18>= 18

One of the following

Individual requires intensive insulin therapy (insulin-treated at least 3 times a day or insulin pump)intensive insulin therapy definition
Individual has a history of a level 3 hypoglycemic event or recurrent (more than one) level 2 hypoglycemic events that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment planhypoglycemia criteria

Implantable Continuous Glucose Monitoring - Continued

Continued long-term implantable CGM is medically necessary when ALL are met:

ALL of the following

Either
- Individual continues to require intensive insulin therapy (insulin-treated at least 3 times a day or insulin pump)intensive insulin therapy definition
- Clinical criteria for initial use were met at initiation of CGM for Hypoglycemiainitial hypoglycemia criteria met

Individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment planevery 6 months

Noninvasive CGM Devices

Coverage stance:

The use of a noninvasive CGM device is unproven and not medically necessary for managing individuals with diabetes due to insufficient evidence of efficacynot medically necessary

Insulin Delivery - External Insulin Infusion Pumps

External continuous subcutaneous insulin infusion pumps are medically necessary when used per FDA labeling and in certain circumstances:

Used according to FDA labeled indications, contraindications, warnings, and precautionsper FDA labeling

Refer to InterQual CP for medical necessity clinical coverage criteriarefer to InterQual

Medically necessary for managing individuals with diabetes due to other causes who require intensive insulin therapy (insulin-treated at least 3 times a day); examples include cystic fibrosis-related diabetes, post-transplantation diabetes, diabetes following pancreatic surgeryintensive insulin therapy definition

Examples include cystic fibrosis-related diabetes, post-transplantation diabetes, diabetes following pancreatic surgery

Insulin Delivery - Not Medically Necessary / Unproven

Devices considered not medically necessary:

Implantable insulin pumps - unproven and not medically necessary (only available in clinical trial setting)not medically necessary

Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) - unproven and not medically necessary due to insufficient evidencenot medically necessary

Documentation Required

Medical records for reviews

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage. When requested, provide medical records per the Medical Records Documentation Used for Reviews protocol.

Billing Rule

Supply unit definitions

HCPCS supply codes specify unit definitions and should be used when billing supplies.

A4238 / A4239 — 1 month supply = 1 unit
A9276 — one unit = 1 day supply

Documentation Required

Reference federal/state/contractual benefit terms

Benefit coverage for health services is determined by federal, state, or contractual requirements, which may differ from this policy and govern in the event of a conflict. Reference applicable federal, state, or contractual benefit terms when making coverage decisions.

Billing Rule

Over-the-counter CGMs out of scope for DME mail-order

CGM systems available over the counter without a prescription are out of scope for this policy and are obtained through local pharmacies rather than supported by mail-order DME providers.

Dexcom Stelo
Abbott Lingo
Abbott Libre Rio

Documentation Required

Use FDA resources for device details

Use FDA PMN/PMA/510(k) resources to obtain device-specific regulatory information. Product codes referenced in this policy include LZG, QFG, OZP for pumps and MDS, QCD, QHJ, SBA for CGMs and implantable sensors.

Product codes: LZG, QFG, OZP, MDS, QCD, QHJ, SBA
Use FDA PMN/PMA/510(k) websites listed in policy for device details

Supporting Information sections (Clinical Evidence, FDA, and References) updated to reflect the most current information.

2025-11-01archivedLatest

Previous policy version CS024SS.AF archived.

2025-11-01noteLatest

Policy effective date: November 1, 2025 (Policy number CS024SS.AG).