ModifiedUnitedHealthcarePolicy CS024NJ.AC

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

Medical necessity and coverage criteria for continuous glucose monitors (CGMs) and external insulin delivery systems for members in New Jersey, including device types, duration, and documentation requirements.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS024NJ.AC

Change TypeTerminology, coding, and evidence updates

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionObtain UnitedHealthcare prior authorization and document initial authorization duration (up to 6 months) and reauthorization duration (up to 12 months).

SourceLink

POLICY UPDATE CHANGES

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

Removed CPT code 0447T from Applicable Codes.

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

≤6 moInitial auth duration

≤12 moReauthorization

Every 6 moProvider assessment

≥18Min age implantable CGM

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for CGMs and Insulin Delivery

Long-term CGM for Intensive Insulin Therapy (Initial and Continued)

Covered when ALL of the following are met for intensive insulin therapy

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

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

InterQual contains the specific clinical eligibility details

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

Long-term CGM for Non-Intensive Diabetes Therapy (Initial and Continued)

Covered when ALL of the following are met for individuals on non-intensive treatment

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

Hypoglycemia history: 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 plan

Assessment for continued use: For continued use, the clinical criteria for initial use were met at initiation and the individual is assessed every six months for adherence to the prescribed CGM regimen and treatment planevery 6 months

Implantable CGM (Initial and Continued)

Covered when ALL of the following are met for implantable CGM

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

Age >= 18>=18

Clinical need: Individual requires intensive insulin therapy (insulin-treated at least 3 times a day or insulin pump) OR 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 plan

Assessment for continued use: For continuation, individual continues to require intensive insulin therapy or met initial hypoglycemia criteria at initiation, and is assessed every six months for adherence

Availability and evidence considerations

Policy statements and evidence summaries relevant to coverage decisions in this section include:

Device availability and evidence requirements: Implantable insulin pumps are limited to clinical trial settings; nonprogrammable wearable disposable insulin delivery devices have insufficient evidence to establish safety and efficacy; implantable CGM (Eversense) has supportive evidence but with uncertainties in accuracy across glucose ranges and limited high-quality comparative data.

synthesis of availability and evidence statements

Insulin pumps for specific diabetes etiologies

Professional society guidance summarized:

Use of insulin pumps for other diabetes types: In selected non–type 1 diabetes causes (e.g., cystic fibrosis–related diabetes, post-transplantation diabetes, post-pancreatic surgery) pumps may be considered for patients with insulin deficiency requiring multiple daily injections.

Society statements cited

The policy considers several device types that are not supported as standard therapy because current evidence is insufficient. Noninvasive continuous glucose monitoring (CGM) devices—those that measure glucose without a transcutaneous sensor or implant—are considered unproven and not medically necessary for managing individuals with diabetes due to insufficient evidence of efficacy. Requests for these devices may be denied on that basis. Additionally, certain external insulin delivery systems are not supported as standard care: implantable insulin pumps and nonprogrammable transdermal insulin delivery systems (e.g., V-Go) are identified as unproven and not medically necessary in the absence of adequate safety and effectiveness data.

Implantable insulin pumps are not commercially available for routine clinical use and are limited to research settings: implantable insulin pumps are only available in a clinical trial setting and therefore are not covered as standard therapy. Nonprogrammable transdermal insulin delivery devices (for example, V-Go) currently lack sufficient high-quality evidence demonstrating safety and efficacy; the literature consists primarily of observational and retrospective studies with important limitations. For these reasons, both implantable insulin pumps and nonprogrammable wearable disposable insulin delivery devices are considered investigational or unproven and may be denied.

Some CGM systems are sold over the counter without a prescription and are out of scope for this medical policy. Examples noted in FDA and policy references include Dexcom Stelo, Abbott Lingo, and Abbott Libre Rio. These OTC CGM products are typically obtained through retail pharmacies and are not supported by mail-order DME suppliers under this policy.

Long-term CGM used in individuals on a non-intensive treatment plan (for example, basal insulin and/or oral agents) is covered only for specific hypoglycemia-related indications described in the policy. Outside those described indications—namely a history of a level 3 hypoglycemic event or recurrent level 2 hypoglycemic events that persist despite multiple attempts to adjust therapy—long-term CGM for non-intensive treatment plans is considered unproven and not medically necessary.

There is insufficient evidence to establish the safety and efficacy of nonprogrammable wearable disposable insulin delivery devices. Available studies include observational series and retrospective reviews with limitations (lack of randomized controls, small sample sizes, high attrition), and larger, well-designed comparative studies with long-term follow-up are needed before these devices can be considered standard therapy.

Coverage Criteria (not present in excerpt)

No explicit criteria in provided chunks: This excerpt contains references, policy revision history, and instructions for use but does not include the specific medical necessity criteria or coverage decision rules.

Full criteria likely present in other parts of the policy not included in this extract.

Applicable Codes and Coding Details

Applicable CPT / 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 a minimum of 72 hours; patient-provided equipment, sensor placement, hook-up, calibration, patient training, and printout of recording.
95250	Ambulatory CGM via subcutaneous sensor for a minimum of 72 hours; physician/office provided equipment, sensor placement, hook-up, calibration, patient training, removal of sensor, and printout.
95251	Ambulatory CGM analysis, interpretation and report.

Applicable HCPCS / Supplier 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 CGM, includes all supplies and accessories, 1 month supply = 1 unit.
A4239	Supply allowance for nonadjunctive, nonimplanted CGM, includes all supplies and accessories, 1 month supply = 1 unit.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
A9276	Sensor; invasive (e.g., subcutaneous), disposable, for use with CGM system, one unit = 1 day supply.
A9277	Transmitter; external, for use with CGM.
A9278	Receiver (monitor); external, for use with CGM.
E0784	External ambulatory infusion pump, insulin.
E0787	External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing.
E2102	Adjunctive, nonimplanted CGM or receiver.

1–10 of 14

1/2

Artificial pancreas system HCPCSHCPCS

S1035	Sensor; invasive (e.g., subcutaneous), disposable, for use with artificial pancreas device system.
S1036	Transmitter; external, for use with artificial pancreas device system.
S1037	Receiver (monitor); external, for use with artificial pancreas device system.

Applicable ICD-10 Diagnosis Codes (sample list continues)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.

Applicable ICD-10 Diagnosis CodesICD-10

E11.3513	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral.
E11.3519	Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye.
E11.3521	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye.
E11.3522	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye.
E11.3523	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral.
E11.3529	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye.
E11.3531	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye.
E11.3532	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye.
E11.3533	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral.
E11.3539	Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye.

1–10 of 68

1/7

FDA product codes referencedmixed

SBA	Product code for Eversense 365 (FDA 510k ID K241335) referenced
MDS, QCD, QHJ	Product codes referenced for CGM information on FDA site
LZG, QFG	Product codes referenced for external insulin pumps information
OZP	Product code referenced for automated insulin delivery/hybrid closed-loop insulin pumps

Applicable Codes (removed)CPT

0447T

CPT code removed from Applicable Codes

Age — implantable CGM

Minimum ageAge ≥ 18 for implantable CGM (initial coverage)

Continued use assessmentIndividual assessed every six months for adherence to prescribed CGM regimen

Device labeling requirementDevice must be used according to FDA labeled indications, contraindications, warnings, and precautions

Time in range (Eversense Tweden study)

Time in range (TIR)≥ 70–180 mg/dL = 64.5% (929 minutes)

Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for long-term continuous glucose monitors (CGM) (greater than 14 days). Requests for long-term CGM (including type 2, gestational, and type 1 where applicable) must be submitted through UnitedHealthcare prior authorization processes or contracted supplier channels as specified by the member's plan.

Initial authorization: up to 6 months
Reauthorization: up to 12 months
Prior authorization applies whether request comes through UnitedHealthcare PA process (type 2 or gestational diabetes) or a contracted supplier (type 1 diabetes)

Documentation Required

Diagnosis Codes Affect PA Decisions

Include applicable diagnosis codes when submitting prior authorization requests; these codes are used to support medical necessity and PA decisions. Use ICD-10 and other relevant codes that reflect the individual's diabetes type, complications, and hypoglycemia history.

Background and Scope

Continuous glucose monitoring (CGM) systems and external insulin delivery technologies are distinct classes of devices with different applications. CGMs continuously measure interstitial glucose using a sensor, transmitter, and receiver and are available as short-term professional devices, real-time CGM (rtCGM), intermittently scanned (isCGM/"flash") systems, disposable sensors, or implantable sensors. External insulin infusion/delivery systems include traditional programmable pumps with tubing and cannula or patch-style reservoirs that provide basal and bolus dosing; implantable pumps deliver insulin internally and are controlled remotely. Coverage decisions in this policy reflect those functional and regulatory distinctions when determining medical necessity and appropriate documentation requirements.

Definitions

Adjunctive CGM — definition

DefinitionAdjunctive CGM: a CGM that requires the user to verify glucose levels or trends with a blood glucose monitor before making treatment decisions

Reference sourcesCMS; American Diabetes Association (ADA), 2024

Clinical implicationAdjunctive systems cannot be used alone to make treatment decisions without confirmatory BGM

Hypoglycemia (Level 2 and Level 3) — definitions

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

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

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS024NJ.AC

Change TypeTerminology, coding, and evidence updates

Effective DateNovember 1, 2025

Next Review DateN/A

Key ActionObtain UnitedHealthcare prior authorization and document initial authorization duration (up to 6 months) and reauthorization duration (up to 12 months).

SourceLink

On This Page

Source cohortAnalysis included 945 users who had at least four sensor cycles

Measurement methodTIR calculated from CGM sensor glucose over 24-hour period using Eversense Data Management System

Hypoglycemia percent (Eversense Tweden study)

Percent time <54 mg/dL (Level 2 hypoglycemia)1.1% (≈16 minutes per day)

Percent time <70 mg/dL4.6% (≈66 minutes per day)

ContextValues derived from calibration-matched CGM vs SMBG pairs across first sensor cycle

Sensor survival (Eversense 365)

365‑day sensor survival90% of sensors survived 365 days in the ENHANCE/ENROLL study (Eversense 365)

Confirmed alert detection rates96.6% at 70 mg/dL and 97.9% at 180 mg/dL reported in ENHANCE

Study population110 participants received the Eversense 365 CGM System in ENHANCE

Sensor wear durations reported

Reported sensor wear durations90‑day sensors (full-life achieved 91% in PMCF registry)

Reported sensor wear durations180‑day sensors (full-life achieved 75% in PMCF registry)

Reported sensor wear durations365‑day sensor (Eversense 365 cleared for up to one year; ENHANCE study evaluated 365‑day wear)

Placeholder item(No value provided in inventory)

NotesInventory placeholder retained; no specific threshold or value in source document

ActionNone — reserved for future updates if data provided

Examples of applicable ICD-10 codes are listed in the policy (e.g., E11.* series and O24.* series) — include the most specific code(s) that describe the member's condition and any hypoglycemia events

Documentation Required

Device Model and FDA Clearance Documentation

Documentation should identify the specific CGM device model and include FDA clearance/510(k)/PMA details when available. Payers may request device model, product code, or FDA clearance documentation to confirm the device indication aligns with coverage criteria.

Provide device model name (e.g., Dexcom G6/G7, Abbott FreeStyle Libre models, Eversense E3/365)
If device is implantable (e.g., Eversense), include FDA labeling and age indication
Over-the-counter (OTC) CGM systems (e.g., Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope for this medical policy and are not covered via DME suppliers

Denial Risk

Plan-Specific Requirements May Trigger Denial

Verify plan-specific benefit terms and third-party utilization management tools before ordering devices. Coverage may be limited or denied based on the member’s federal/state/contractual benefit plan, or if PA requirements are not met.

Check the member’s governing benefit plan (federal, state, or contractual terms) — these govern if there is a conflict with this policy
Confirm whether the plan requires submission via a specific PA portal or contracted supplier
Coverage decisions may be denied if PA is not obtained or if plan-specific exclusions or limitations apply

Documentation Required

Six-Month Adherence Assessment

For continued (maintenance) long-term CGM use, the provider must assess the individual at least every six months for adherence to the prescribed CGM regimen and the diabetes treatment plan. Document these assessments in the medical record to support reauthorization.

Document adherence assessment and any changes to therapy at least every 6 months
Include evidence of ongoing need (e.g., continued intensive insulin therapy, recurrent/level 2–3 hypoglycemia history, or other InterQual criteria met)

Documentation Required

Authorization Duration Documentation

Authorization duration must be documented on the PA submission: initial authorizations may be approved for up to 6 months and reauthorizations for up to 12 months per policy.

Initial CGM authorization: up to 6 months
Reauthorization: up to 12 months
Specify requested authorization length and supporting rationale in the PA request

Note

Check Applicable Benefit Plan Terms

When applying this policy, always check and follow the federal, state, or contractual benefit plan terms that govern the member’s coverage. In case of conflict, the federal/state/contractual requirements take precedence over this policy.

Before ordering or approving CGM, verify governing benefit plan language
Document any plan-specific limitations or exceptions on the PA request

Documentation Required

InterQual Criteria Required

Clinical coverage decisions for initial use of insulin pumps and long-term CGMs are guided by FDA labeled indications and the InterQual CP criteria. Use InterQual criteria when documenting medical necessity for initial and continuation requests.

Reference InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology for clinical criteria
Ensure device use and member clinical status meet InterQual and FDA-labeled indications

Note

Consideration Before Advanced Devices

Before initiating advanced devices (e.g., insulin pumps for diabetes due to other causes), consider professional society guidance and limited evidence for non-type 1 diabetes etiologies. Document clinical justification when using pumps in these populations.

Examples of diabetes due to other causes: cystic fibrosis-related diabetes, post-transplantation diabetes, diabetes following pancreatic surgery
Include rationale and any supporting society guidance or clinical evidence in the PA when treating these populations

Step Therapy

Evidence May Influence Step Therapy

Evolving evidence may change prior step-therapy or utilization management requirements. Providers should be prepared to supply updated clinical evidence or rationale if step-therapy requirements are challenged or waived.

New evidence (e.g., guideline updates or RCTs) can influence whether step-therapy is required or can be bypassed
Document clinical reasons for exception requests and reference recent evidence where applicable

SourcesADA, 2024; McCall et al., 2023; Blonde et al., 2022

Intermittently Scanned (Flash) CGM (isCGM)

DefinitionIntermittently Scanned (Flash) CGM (isCGM): devices with a combined sensor/transmitter and a separate reader that measure glucose continuously but require scanning to view and store values

Alarm capabilityisCGM devices are available with and without alarms

Use caseDesigned for long‑term personal use; data require scanning to be visualized

Real‑Time CGM (rtCGM)

DefinitionReal‑Time CGM (rtCGM): systems with a sensor, transmitter, and receiver/smartphone that display glucose readings continuously in real time and provide audible alerts when glucose is out of range

Calibration noteSome rtCGM systems require user calibration

ComponentsSensor (subcutaneous), transmitter that attaches to the sensor, and handheld receiver and/or smartphone

Professional CGM

DefinitionProfessional CGM: clinic‑owned devices placed for a discrete period (generally 7–14 days) used to assess glycemic patterns; data may be blinded or visible to the wearer

OwnershipDevices are clinic‑based and not owned by the user

PurposeShort‑term diagnostic assessment rather than ongoing patient‑managed monitoring

Insulin pump — definition

DefinitionInsulin pump: device that delivers insulin via external tubing and cannula or via patch‑style reservoirs; programmable pumps provide basal and bolus dosing

Patch‑style devicesExamples include Omnipod (reservoir on skin) and V‑Go (nonprogrammable transdermal delivery)

Implantable pumpsImplantable insulin pumps deliver insulin internally and are controlled remotely

Continuous glucose monitor (CGM)

DefinitionContinuous glucose monitor (CGM): system with a sensor, transmitter, and receiver that continuously monitors interstitial glucose

Device typesAvailable as short‑term professional devices, real‑time CGM (rtCGM), intermittently scanned CGM (isCGM), disposable sensors, or implantable sensors

Components noteImplantable sensors include a smart transmitter and mobile application; sensors communicate wirelessly to mobile devices

MARD — definition

DefinitionMARD (mean absolute relative difference): a measure of CGM accuracy versus reference SMBG or plasma glucose

ContextReported MARD values for Eversense ranged ~8.8% (ENHANCE) to ~11.5–11.9% across real‑world sensor cycles

UseCommon metric used to compare CGM accuracy across studies and devices

Time in range (TIR)

DefinitionTime in range (TIR): percentage of time sensor glucose is between 70–180 mg/dL

Typical range reportedEversense studies reported TIR ≈62–64.5% in real‑world and clinical samples

Clinical relevanceTIR is used as a key outcome in CGM studies to assess glycemic control

Noninvasive CGM

DefinitionNoninvasive CGM: devices that measure glucose without transcutaneous sensors or implants

Regulatory noteNo FDA‑approved noninvasive CGM devices are available at this time

Coverage implicationUse of noninvasive CGM devices is considered unproven and not medically necessary in this policy

continuous glucose monitoring (CGM)

Term entrycontinuous glucose monitoring (CGM)

NoteEntry present as glossary/term placeholder in source material

UsageSee full Definitions section for related CGM terms

Wearable insulin delivery device — definition

DefinitionWearable insulin delivery device: an external device delivering basal and bolus insulin (e.g., V‑Go) typically worn on the body

ExampleV‑Go: a disposable, nonprogrammable transdermal insulin delivery device delivering preset basal and on‑demand bolus doses

Coverage stanceNonprogrammable wearable disposable insulin delivery devices have insufficient evidence to establish safety and efficacy