UnitedHealthcare CGM Insulin Delivery Coverage Update

Coverage Criteria for CGM and Insulin Delivery

Non-Implantable Long-term CGM

Long-term non-implantable CGM is covered when ALL of the following are met

Non-implantable CGM initial/continued use: Medical necessity clinical coverage criteria are met as defined by the InterQual CP (Durable Medical Equipment; Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology).

Refer to InterQual for specific medical necessity clinical criteria; initial authorization up to 6 months and reauthorization up to 12 months.

Device regulatory and use conditions: Device is used according to FDA labeled indications, contraindications, warnings, and precautions.

Use per FDA labeling is required for coverage.

Monitoring for continued use: Individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and diabetes treatment plan for continued long-term use.every 6 months

Provider assessment interval for continued long-term CGM use; documentation may be required.

Non-Intensive Diabetes Therapy

Initial and continued coverage for individuals on non-intensive therapy

Non-intensive therapy — initial coverage: Individual on a non-intensive treatment plan (e.g., basal insulin and/or oral medications) who has a history of a level 3 hypoglycemic event or recurrent (>1) level 2 hypoglycemic events that persist despite multiple (>1) attempts to adjust medication(s) and/or modify the diabetes treatment plan.

Long-term CGM is unproven and not medically necessary for non-intensive therapy for other indications.

Non-intensive therapy — continued coverage: Clinical criteria for initial use (above) were met at initiation AND the individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment plan.every 6 months

Continued use requires ongoing documentation of adherence and that initial criteria were satisfied.

Implantable CGM (e.g., Eversense)

Implantable CGM is covered when ALL of the following are met

Implantable CGM — device use: Device is used according to FDA labeled indications, contraindications, warnings, and precautions.

Use per FDA labeling is required for coverage.

Implantable CGM — age requirement: Individual is age ≥ 18 years.age ≥ 18

Minimum age listed for implantable CGM initial use.

Implantable CGM — insulin therapy requirement: Individual requires intensive insulin therapy (insulin-treated at least 3 times a day or insulin pump).

Intensive insulin therapy defined as insulin-treated at least 3 times per day or use of an insulin pump.

External Insulin Infusion Pumps

External continuous subcutaneous insulin infusion pumps are covered when used per FDA labeling and InterQual criteria

External insulin pump coverage: When used according to FDA labeled indications, contraindications, warnings, and precautions, external continuous subcutaneous insulin infusion pumps are proven and medically necessary in certain circumstances; medical necessity clinical coverage criteria are defined in the InterQual CP (Durable Medical Equipment; Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology).

Examples include individuals requiring intensive insulin therapy and those with diabetes due to other causes requiring intensive insulin therapy (e.g., fibrosis-related diabetes, post-transplantation diabetes, diabetes after pancreatic surgery). Omnipod 5 may be subject to member-specific benefit plan documents.

General coverage stance for CGM and insulin delivery

Covered when the device is proven and medically necessary per member plan and DME benefit

General coverage: CGM systems and insulin delivery devices are covered when they are proven and medically necessary and when the member's specific benefit plan provides coverage; refer to the Durable Medical Equipment benefit and member-specific plan documents for limitations and exclusions.

Prior authorization may be required per the member's plan; certain plans exclude coverage for over-the-counter CGMs.

Implantable insulin pumps

Not routinely available outside clinical trials

Availability: Implantable insulin pumps are only available in a clinical trial setting at this time.

Statement indicates lack of routine availability for implantable insulin pumps.

Nonprogrammable transdermal insulin delivery (e.g., V-Go)

Insufficient evidence for safety and efficacy

Evidence requirement: There is insufficient evidence demonstrating safety and efficacy of nonprogrammable wearable disposable insulin delivery devices (e.g., V-Go); larger, well-designed studies with long-term follow-up and comparative effectiveness data are needed.

Existing observational studies show potential glycemic improvements but are limited by lack of controls, small sample sizes, and high attrition.

Implantable CGM (Eversense) — evidence summary

Mixed-quality evidence supports implantable CGM as an alternative to standard CGMs with uncertainty about accuracy across glucose ranges and limited data on health outcomes

Accuracy and validity: Comparative diagnostic accuracy and cohort studies report that implantable CGM (Eversense) provides relatively accurate glucose data, with reported MARDs varying across studies (example: ENHANCE reported MARD 8.8% for Eversense 365; other studies report MARDs in the ~11–15% range). Uncertainty remains about accuracy across the full glucose range (hypo/hyperglycemia) and during activities such as intense exercise.

Sources include ENHANCE, PROMISE, PRECISION/PRECISE trials, comparative studies, and HTA reviews.

Clinical outcomes: Evidence for clinical utility (HbA1c reduction, time in range, hypoglycemia reduction) is limited and mixed: some single-arm studies show modest HbA1c reductions (~0.4–0.5%), while randomized trials show inconsistent HbA1c benefits but possible reductions in time spent in severe hypoglycemia in selected populations.

Sources include PROMISE, Irace et al., Renard et al., and Hayes HTA summaries.

Safety and real-world performance: Post-market registry and observational data suggest an acceptable safety profile with infrequent serious adverse events and reasonable sensor survivorship (e.g., high percentage of intended sensor life achieved in PMCF registry); generalizability may be limited by study design and geographic differences in real-world experience.

Evidence summary and guideline context

Evidence summaries and guideline references relevant to coverage considerations

Evidence of accuracy and safety: Diagnostic accuracy cohort studies, trials, and registries report that implantable CGM (Eversense) provides relatively accurate glucose measurements (reported MARDs vary across studies) and an acceptable safety profile; limitations include small study sizes, heterogeneity, and limited generalizability.

References: PRECISION/PRECISE, ENHANCE, PMCF registry, ECRI and Hayes assessments.

Clinical outcomes and utility: Some prospective and observational studies report improvements in HbA1c and time-in-range with implantable CGM, but many studies lack comparators or are small and short-term; randomized evidence is limited and mixed regarding HbA1c benefit while hypoglycemia outcomes may show benefit in selected trials.

Sources: Irace et al., PROMISE, Renard et al., ENHANCE; Hayes HTA summarized limitations.

Limitations and generalizability: Evidence is limited by study design (single-arm cohorts, retrospective analyses), small samples, regional differences (most real-world data from Europe/South Africa), and inconsistent accuracy across glucose ranges and conditions (e.g., exercise), which may limit applicability to all U.S. populations.

Nonprogrammable transdermal insulin delivery systems (for example, V‑Go), implantable insulin pumps, and noninvasive CGM devices are considered unproven and not medically necessary due to insufficient evidence of safety or efficacy. External continuous subcutaneous insulin infusion pumps remain covered when used according to FDA labeled indications and when individual clinical necessity is established per referenced clinical criteria (see InterQual).

Implantable CGM systems (for example, Eversense) have distinct coverage rules from non‑implantable CGM devices; implantable sensors cleared for adult use include device‑specific requirements such as age and intensity of insulin therapy that must be met for coverage (see Implantable CGM criteria).

Some member benefit plans explicitly exclude coverage for over‑the‑counter (OTC) continuous glucose monitors. Providers and billing staff should verify the member’s specific benefit plan document before submitting claims or initiating a prior authorization request because OTC coverage varies by plan and by product.

OTC CGM models that are sold without a prescription are typically obtained from retail pharmacies and may not be supported through mail‑order DME supply channels; check the member plan for any exclusions or special instructions.

CGM systems that are available over the counter without a prescription (examples cited in the policy include certain Dexcom and Abbott OTC models) are out of scope for this Medical Policy. These products are typically acquired from local pharmacies and are not supported by mail‑order DME providers under the standard DME processes referenced in this policy.

Because OTC devices are out of scope for the policy, coverage determinations, billing procedures, and DME supplier responsibilities for OTC CGMs should follow the member‑specific benefit plan language and applicable pharmacy benefit rules rather than the Durable Medical Equipment processes described here.

The member‑specific benefit plan document governs coverage. When there is a difference between this Medical Policy and the member’s plan, the terms of the member‑specific plan prevail. Providers must check the applicable benefit document and any federal or state mandates prior to submitting requests or claims.

Refer to the member specific benefit plan for limitations, exclusions, and prior authorization requirements; this policy is intended to assist interpretation of standard plans but does not override plan language.

For individuals on a non‑intensive treatment plan (for example, basal insulin and/or oral medications), long‑term CGM is covered only when there is a documented history of either a level 3 hypoglycemic event or recurrent (>1) level 2 hypoglycemic events that persist despite multiple (>1) attempts to adjust medications and/or modify the diabetes treatment plan. Continued coverage requires that the same clinical criteria were met at initiation and that the individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan.

Long‑term CGM for individuals on non‑intensive therapy is otherwise considered unproven and not medically necessary for indications beyond the specified hypoglycemia history.

Long‑term CGM use is supported for patients with clear indications related to hypoglycemia risk and where device use aligns with FDA labeling and clinical coverage criteria; however, outside those indications, evidence for benefit is limited. Specifically, noninvasive CGM devices are identified as unproven and not medically necessary because current literature does not establish sufficient efficacy for diabetes management.

Nonprogrammable wearable disposable insulin delivery devices (such as V‑Go) are similarly noted to have insufficient evidence of safety and efficacy; the policy cites the need for larger, well‑designed comparative studies with longer follow‑up before these devices can be considered medically necessary.

An ECRI assessment and multiple cohort studies have evaluated implantable CGM (Eversense) and reported relatively accurate glucose data and an acceptable safety profile in registry settings, although most real‑world data derive from Europe and South Africa and may not be fully generalizable to all U.S. settings. Evidence from randomized and observational studies is mixed with respect to clinical outcomes such as HbA1c reduction and hypoglycemia reduction.

The policy notes that updates to evidence appraisals (including a 2025 update of prior assessments) have influenced guideline and technology‑assessment conclusions; despite improving evidence, uncertainties remain about accuracy across glucose ranges and the strength of clinical‑outcome benefits.

Applicable Codes and Diagnostic Listings

Applicable CPT / HCPCS Procedure CodesCPT

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 via subcutaneous sensor for >=72 hours; patient-provided equipment; sensor placement, hook-up, calibration, patient training, and printout of recording.
95250	Ambulatory continuous glucose monitoring via subcutaneous sensor for >=72 hours; office-provided equipment; sensor placement, hook-up, calibration, patient training, removal of sensor, and printout of recording.
95251	Ambulatory continuous glucose monitoring - analysis, interpretation and report.

Applicable HCPCS / DME / Supply CodesHCPCS

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; monthly supply = 1 unit.
A4239	Supply allowance for nonadjunctive, nonimplanted continuous glucose monitor (CGM); includes all supplies and accessories; monthly supply = 1 unit.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
A9276	Sensor; invasive (subcutaneous), disposable, for use with nondurable medical equipment interstitial CGM system; one unit = supply day.
A9277	Transmitter; external, for use with nondurable medical equipment interstitial CGM system.
A9278	Receiver (monitor); external, for use with nondurable medical equipment interstitial CGM system.
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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CGM Device Product Codes Mentionedmixed

SBA	Eversense 365 CGM system (product code SBA) - FDA cleared for up to one year continuous glucose measurement in individuals >=18 years.
MDS/QCD/QHJ	CGM Models reference product codes for payer website (examples listed).

Applicable ICD-10 Codes (examples) - Type 2 Diabetes and ComplicationsICD-10

E11.00	Type 2 diabetes mellitus with hyperosmolarity without coma.
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.

Applicable ICD-10-CM / Other Diagnosis Codes (partial list)ICD-10

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.
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye.
E11.3212	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye.
E11.3213	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral.
E11.3219	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye.
E11.3291	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye.

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Additional ICD-10-CM Codes (required by completeness review)ICD-10

E11.3551	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye.
E11.3552	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye.
E11.3553	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral.
E11.3559	Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye.
E11.3591	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye.
E11.3592	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye.
E11.3593	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral.
E11.3599	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye.
E11.36	Type 2 diabetes mellitus with diabetic cataract.
E11.37X1	Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment; right eye.

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CGM Device Product Codes Mentioned (reference)mixed

SBA	Eversense 365 CGM system product code (SBA) - FDA clearance 09/16/2024 noted.
MDS	CGM models reference product code for payer website.
QCD	CGM models reference product code for payer website.
QHJ	CGM models reference product code for payer website.

Applicable Codes (removed)CPT

0447T

Removed from Applicable Codes per Policy History (09/01/2025).

Hypoglycemia criteria for CGM use

Hypoglycemia criteria for CGM useHistory of level 3 hypoglycemia or recurrent level 2 events despite treatment adjustments

CGM performance highlights

Sensor survivorshipEversense 365 reported ~90% survival at 365 days

MARDEversense 365 MARD 8.8% (ENHANCE study)

Time in range examples reported

Time in range examplesExamples reported: ~62-64% time in range (70-180 mg/dL) in studies; other ranges detailed in trials.

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

DME Coverage and Prior Authorization

Most member benefit plans include coverage for medically necessary continuous glucose monitoring (CGM) and insulin delivery devices under the Durable Medical Equipment (DME) benefit; however, coverage limitations and exclusions may apply. Verify the member-specific benefit plan to confirm DME coverage, repair/replace rules, and whether over-the-counter (OTC) CGMs are excluded. OTC CGMs available without a prescription are out of scope for this policy, are obtained through retail pharmacies, and are not supported by mail-order DME suppliers.

Most plans: CGM and insulin delivery covered under DME — verify member plan
Refer to Medical Policy: Durable Medical Equipment Orthotics; Medical Supplies and Repairs/Replacements for repair/replace rules
Certain plans exclude OTC CGMs — verify member-specific benefit

Prior Authorization

Eversense 365 (product code SBA) — Prior Authorization Note

The Eversense 365 (product code SBA) received FDA 510(k) clearance on 2024-09-16 and is indicated for continuous glucose monitoring for up to one year in adults (18+). Prior authorization is required where UnitedHealthcare authorization processes apply; document indication that the device is intended to replace fingerstick blood glucose measurements for diabetes treatment decisions when applicable. Requests for Eversense 365 should include device-specific clinical rationale and any supporting records.

Background and Scope

Continuous glucose monitoring systems include several device types: short‑term professional (clinic‑placed) sensors, real‑time CGM (rtCGM) systems, intermittently scanned (flash) CGM (isCGM), non‑adjunctive and adjunctive systems, disposable sensors, and implantable sensors with transmitters. These categories determine coverage pathways and billing codes referenced in the policy.

Implantable CGM (for example, Eversense 365) is cleared for adult use for up to one year and is intended to replace fingerstick blood glucose measurements for diabetes treatment decisions; implantable devices have specific inclusion criteria (age ≥ 18, requirement for intensive insulin therapy, and qualifying hypoglycemia history) that differ from non‑implantable long‑term CGM.

This Medical Policy provides guidance to interpret standard UnitedHealthcare benefit plans but requires that the member‑specific benefit plan document and applicable federal or state mandates be consulted for final coverage determinations; UnitedHealthcare may also use external tools (such as InterQual) to assist in administering benefits.

Key Definitions

Adjunctive CGM definition

DefinitionAdjunctive CGM: A CGM that requires the user to verify their glucose levels or trends displayed on the CGM with a blood glucose monitor prior to making treatment decisions.

Use caseTypically used as supplemental information; not relied upon alone for treatment dosing decisions.

Reference sourcesDefinition based on CMS and ADA wording as cited in the policy definitions section.

Non-Adjunctive CGM definition

DefinitionNon-Adjunctive CGM: A CGM that can be used to make treatment decisions without the need for a standalone blood glucose monitor to confirm testing results.

Use caseAllows dosing and insulin adjustments based solely on CGM readings per device labeling.

OpenPayer

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Coverage Criteria for CGM and Insulin Delivery

Applicable Codes and Diagnostic Listings

Prior Authorization, Documentation, and Provider Responsibilities

Background and Scope

Key Definitions