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ModifiedUnitedHealthcarePolicy CS024NM.F

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

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Defines UnitedHealthcare medical policy for continuous glucose monitoring (CGM) and insulin delivery devices and coverage criteria applicable to members in New Mexico.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS024NM.F

Change TypeMaterial updates to insulin pump coverage and documentation language

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionRequest prior authorization for long-term CGM or insulin delivery devices and provide legible medical records documenting history, exam, and relevant diagnostic tests to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

External continuous subcutaneous insulin infusion pumps (including Omnipod) are proven and medically necessary in certain circumstances when used according to FDA-labeled indications, contraindications, warnings, and precautions.

External continuous subcutaneous insulin infusion pumps are medically necessary for managing individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes that require intensive insulin therapy (insulin-treated at least three times a day).

Medical records documentation language clarified: coverage is determined by federal, state, or contractual requirements and documentation may be required to assess clinical criteria but does not guarantee coverage.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information and archived previous policy version CS024NM.E.

Up to 6 monthsInitial CGM auth

Up to 12 monthsReauthorization

Every 6 monthsProvider follow-up

≥18 yrsImplantable CGM age

≥3x/dayIntensive therapy

08/01/2026Policy effective

Coverage Criteria for CGM and Insulin Delivery

Insulin delivery - External pumps (medically necessary)

Insulin pumps (external) are covered when FDA-labeled indications and InterQual clinical criteria are met:

External insulin infusion pumps: Device is used according to FDA-labeled indications, contraindications, warnings, and precautions and medical necessity clinical coverage criteria per InterQual are met.

Includes individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes who require intensive insulin therapy (insulin-treated at least three times a day).

Insulin delivery - Unproven/not medically necessary

Devices considered unproven and not medically necessary:

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

Implantable insulin pumps are currently available only in clinical trial settings.

Non-implantable long-term CGM - Intensive therapy (covered with criteria)

Non-implantable long-term CGM (greater than 14 days):

Initial long-term CGM (intensive therapy): Device is used according to FDA labeling and InterQual clinical criteria are met for individuals requiring intensive insulin therapy (insulin-treated ≥3 times/day) or meeting other InterQual criteria.

Refer to InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology for full clinical criteria.

Continued long-term CGM (intensive therapy): Device used per FDA labeling; InterQual criteria met; individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan.assessment every 6 months

Initial authorization up to 6 months; reauthorization up to 12 months.

Non-Intensive therapy CGM - Covered for hypoglycemia indications

Long-term CGM for non-intensive therapy:

Initial long-term CGM (non-intensive therapy): Individual on non-intensive treatment (e.g., basal insulin and/or oral medications) with 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.

Continued long-term CGM (non-intensive therapy): Initial clinical criteria for non-intensive therapy were met at initiation of CGM; individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan.assessment every 6 months

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

Implantable CGM - Covered with criteria

Implantable CGM (e.g., Eversense):

Initial implantable CGM: Device is used according to FDA labeling; age ≥ 18 years; and one of the following: requires intensive insulin therapy (insulin-treated at least three times a day or insulin pump) OR 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.age ≥ 18

Refer to InterQual CP for further clinical details.

Continued implantable CGM: Individual continues to require intensive insulin therapy or met the initial hypoglycemia-based criteria at initiation; individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan.assessment every 6 months

Noninvasive CGM - Not medically necessary

Noninvasive CGM:

Noninvasive CGM: Use of noninvasive CGM devices is unproven and not medically necessary for managing individuals with diabetes due to insufficient evidence of efficacy.

Clinical coverage considerations and evidence summaries

Coverage considerations and clinical evidence summaries included in the policy inform medical necessity determinations for insulin pumps and CGMs in populations beyond type 1 and type 2 diabetes

Insulin pumps for other diabetes types: Professional societies state insulin pumps may be considered for specific diabetes types (e.g., cystic fibrosis–related diabetes, posttransplant diabetes, postpancreatic surgery) when insulin deficiency requires multiple daily injections; evidence is limited.

See citations: ADA 2026; McCall et al., 2023

Implantable insulin pumps are currently available only in a clinical trial setting.

Implantable pumps not standard of care

Nonprogrammable transdermal insulin delivery: Insufficient evidence demonstrates the safety and efficacy of nonprogrammable wearable disposable insulin delivery devices (e.g., V-Go); larger, well-designed prospective studies with long-term follow-up and comparative effectiveness data are needed.

Observational studies report HbA1c improvements but have limitations

Evidence and clinical utility

Evidence summary and clinical utility considerations from trials and assessments

Evidence summary: Multiple prospective cohort studies and several randomized trials evaluate implantable Eversense CGM systems; reported accuracy (MARD) and trial outcomes vary, with some trials showing reduced hypoglycemia time and modest HbA1c improvements. Overall evidence quality is variable and limited by small sample sizes, study design limitations, and limited comparative outcome data, leaving clinical utility for health outcomes uncertain.

Supported by PROMISE, PRECISION, PRECISE II, PRECISE, ENHANCE trials and HTA assessments.

Insulin delivery coverage criteria (summary)

Policy updates and coverage rationale highlights

External CSII pump coverage: External continuous subcutaneous insulin infusion pumps (including Omnipod) are proven and medically necessary in certain circumstances when used according to FDA-labeled indications, contraindications, warnings, and precautions.

Added language in 08/01/2026 revision

Intensive insulin therapy indication: External continuous subcutaneous insulin infusion pumps are medically necessary for managing individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes when the condition requires intensive insulin therapy (insulin-treated at least three times a day).insulin-treated >= 3 times/day

Added language in 08/01/2026 revision

The policy designates certain devices as unproven and not medically necessary when available evidence does not demonstrate safety or efficacy. Specifically, nonprogrammable transdermal insulin delivery systems (e.g., V‑Go), implantable insulin pumps, and noninvasive continuous glucose monitoring (CGM) devices are listed as not medically necessary for routine management of diabetes due to insufficient evidence of benefit.

Implantable insulin pumps are currently limited to research settings and are only available in a clinical trial context at this time. The policy also notes that nonprogrammable transdermal insulin devices lack high‑quality comparative evidence; larger, prospective studies with long‑term follow‑up are needed before these devices are considered medically necessary.

Continuous glucose monitoring systems that are sold over the counter (OTC) without a prescription are out of scope for this policy and are not supported through mail‑order durable medical equipment channels.

Examples of CGM products that are obtainable without a prescription and therefore out of scope include consumer OTC models such as Dexcom Stelo, Abbott Lingo, and Abbott Libre Rio.

Long‑term CGM for individuals who are not on intensive insulin regimens is covered only for specific hypoglycemia indications. The policy requires a history of a level 3 hypoglycemic event or recurrent (more than one) level 2 hypoglycemic events that persist despite multiple attempts to adjust therapy; otherwise, long‑term CGM for nonintensive therapy is considered unproven and not medically necessary.

The policy states there is insufficient evidence to support routine use of nonprogrammable wearable disposable insulin delivery devices. Observational and small retrospective studies report some HbA1c improvements, but limitations (lack of controls, small samples, attrition) mean safety and comparative effectiveness remain unestablished.

Reviewers noted a limited high‑quality comparative evidence base overall: many studies are single‑arm cohorts or small trials, and available randomized trials and health technology assessments report variable quality. Because of these limitations, consistent clinical benefit on health outcomes has not been conclusively established for several implantable or novel devices.

Billing, HCPCS, CPT, and Diagnosis Codes

CGM CPT and monitoring 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 ≥72 hours; patient-provided equipment, includes placement, calibration, training, and printout.
95250	Ambulatory continuous glucose monitoring ≥72 hours; office-provided equipment, placement, calibration, training, removal, and printout.
95251	Ambulatory continuous glucose monitoring analysis, interpretation and report.

HCPCS supplies and device 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, 1 month supply = 1 unit.
A4239	Supply allowance for nonadjunctive, nonimplanted CGM, 1 month supply = 1 unit.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
A9276	Sensor; invasive, disposable, for interstitial CGM, one unit = 1 day supply.
A9277	Transmitter; external, for use with nondurable medical equipment interstitial CGM.
A9278	Receiver (monitor); external, for use with nondurable medical equipment interstitial 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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Artificial pancreas and diagnosis codesmixed

S1034	Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm.
S1035	Sensor; invasive, 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.
E11.00	Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC).
E11.01	Type 2 diabetes mellitus with hyperosmolarity with coma.

Covered HCPCS/S Codes (CGM and insulin delivery)HCPCSCovered

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
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 = 1 day supply
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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Covered S Codes (Artificial pancreas systems)HCPCSCovered

S1034	Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices
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 CodesICD-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
E11.3211	Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

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FDA product codes (informational)mixed

LZG, QFG	External insulin pumps (FDA website reference)
OZP	Automated insulin delivery systems / hybrid closed-loop pumps (FDA website reference)
MDS, QCD, QHJ	CGMs (FDA website reference)

FDA product codesmixed

MDS, QCD, QHJ	FDA product codes referenced for CGM PMA/510(k) lookup
SBA	Eversense 365 CGM system product code referenced in FDA 510(k) clearance information

Age for implantable CGM — Age threshold for implantable CGM

Age thresholdAge ≥ 18 years

Population noteApplies to implantable CGM systems (e.g., Eversense) used per FDA labeling

Clinical requirement optionsRequires either intensive insulin therapy (≥3 injections/day or insulin pump) OR history of level 3 hypoglycemia OR recurrent (>1) level 2 hypoglycemic events despite >1 treatment adjustments

Hypoglycemia level 2 threshold — clinical threshold for level 2 hypoglycemia

Level 2 hypoglycemia definition

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior authorization required; initial and continued durations specified

Initial and continued requests for long-term CGM and insulin delivery devices are reviewed against the InterQual CP criteria; initial long-term CGM authorization will be for up to 6 months and reauthorization up to 12 months. For continued long-term use, the device must be used per FDA labeling, meet InterQual clinical criteria, and the individual must be assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan.

Initial CGM authorization: up to 6 months
Reauthorization: up to 12 months
Provider assessment for continued use: every 6 months
Clinical review uses InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology

Prior Authorization

Prior authorization implied for listed device and DME codes

Prior authorization is implied for the DME, CGM, and artificial pancreas HCPCS/S and CPT codes listed; providers should request authorization using the applicable HCPCS/S or CPT codes and supporting diagnosis codes to document medical necessity.

Background and Rationale

Continuous glucose monitoring systems provide continuous or near‑continuous interstitial glucose data via three components (sensor, transmitter, receiver) to guide diabetes management. CGMs may be short‑term (professional), real‑time, intermittently scanned (flash), disposable, or implantable; some systems integrate with insulin delivery to support automated or hybrid closed‑loop therapy.

Definitions and Device Types

Adjunctive Continuous Glucose Monitor

DefinitionA CGM that requires verification with a blood glucose monitor prior to making treatment decisions.

Guidance sourcesDefined per CMS and ADA references cited in policy

Clinical implicationNot intended to be used alone for insulin dosing without confirmatory SMBG

Nonadjunctive Continuous Glucose Monitor

DefinitionA CGM that can be used to make treatment decisions without confirmatory blood glucose checks.

Guidance sourcesDefined per CMS and ADA references cited in policy

Clinical implication

Policy Revision History

2026-08-01policy_revisionLatest

Added coverage rationale clarifying that external continuous subcutaneous insulin infusion (CSII) pumps (including Omnipod) are proven and medically necessary in certain circumstances when used per FDA labeling, and expanded indication to include individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes who require intensive insulin therapy (insulin-treated ≥3 times/day).

2026-08-01documentation_update

Clarified medical records documentation expectations for reviews: coverage determined by federal, state, or contractual requirements; records may be required to assess clinical criteria but do not guarantee coverage; records must fully support medical necessity, be legible, and be made available upon request.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS024NM.F

Change TypeMaterial updates to insulin pump coverage and documentation language

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

SourceLink

On This Page

Implantable CGM (Eversense): Eversense implantable CGM systems have trial evidence reporting accuracy metrics and sensor longevity, but the overall body of evidence is of low to moderate quality with uncertainties in accuracy across glucose ranges and limited comparative outcome data.

Hayes HTA 2022 (updated 2025) summarized evidence quality

Glucose < 54 mg/dL (3.0 mmol/L)

Clinical significanceAssociated with increased risk for cognitive dysfunction and mortality

Related levelLevel 3: severe event requiring third-party assistance (life-threatening)

Eversense sensor survival — 90% sensor survival at 365 days (ENHANCE)

Sensor survival at 365 days90% sensor survival at 365 days (ENHANCE study)

Study contextENHANCE was a prospective, multicenter, nonrandomized study of the Eversense 365 in 110 adults

CalibrationStudy used primarily one calibration per week

Eversense MARD — MARD 8.8% (ENHANCE)

Reported MARDMean absolute relative difference (MARD) 8.8% (ENHANCE)

Alert detection rates96.6% and 97.9% confirmed alert detection at 70 mg/dL and 180 mg/dL respectively

SafetyNo serious adverse events related to device or insertion/removal procedures reported in ENHANCE

Time in range (70-180 mg/dL) — 64.5% (Tweden et al. first cycle)

Time in range (70–180 mg/dL)64.5% (Tweden et al., first sensor cycle aggregate)

Equivalent minutes/dayApproximately 929 minutes per day in range during first cycle

Other glycemic ranges (first cycle)<54 mg/dL: 1.1% (16 min); <70 mg/dL: 4.6% (66 min); >180–250 mg/dL: 22.8% (328 min); >250 mg/dL: 8.1% (117 min)

Submit applicable HCPCS/S or CPT codes (examples: A4226, A4238, A4239, A9274–A9278, E0784, E0787, E2102–E2103, S1030–S1037, 0446T/0448T, 95249–95251) when requesting authorization
Include relevant ICD-10 diagnosis codes (e.g., E11.x, O24.x) to support claims

Note

Coverage channel and scope — implantable/prescription CGMs in scope; OTC CGMs out of scope

This policy applies to implantable and prescription CGM systems; continuous glucose monitoring systems available over the counter without a prescription are out of scope and are not supported by mail-order DME channels.

Implantable CGM systems (e.g., Eversense) and prescription nonimplantable CGMs are subject to this policy
OTC CGM products (examples: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope and generally obtained through a local pharmacy rather than mail-order DME

Prior Authorization

Prior authorization and required documentation may be requested for pumps and implantable CGMs

Policy updates clarify coverage criteria for external CSII pumps and implantable CGMs; prior authorization may be required per plan and documentation supporting medical necessity must be provided when requested.

External CSII pumps (including Omnipod) are medically necessary in certain circumstances when used according to FDA labeling and InterQual criteria
Documentation supporting medical necessity should be provided upon request and may affect authorization

Step Therapy

Nonprogrammable transdermal insulin devices (e.g., V-Go) — not medically necessary

Nonprogrammable transdermal insulin delivery systems (for example, V-Go) are considered unproven and not medically necessary and are not appropriate substitutes for covered programmable insulin pumps.

Nonprogrammable wearable disposable devices lack sufficient evidence of safety and efficacy
These devices are categorized as unproven and not medically necessary in this policy

Step Therapy

Step considerations — document prior therapies/rationale for nonprogrammable transdermal devices

Because evidence is limited for nonprogrammable transdermal insulin delivery devices, payers may require documentation of prior therapy trials or clinical rationale before considering coverage.

Documentation may include prior trial of programmable pumps or explanation why such trials are not appropriate
Limited evidence and study design weaknesses are cited as reasons for requiring additional documentation

Note

FDA clearance is informational and not sole basis for coverage

FDA clearance or approval is informational only; FDA approval alone is not a basis for coverage decisions and UnitedHealthcare evaluates evidence and benefit considerations when determining coverage.

Policy explicitly states FDA approval alone is not a basis for coverage
Coverage determinations use clinical evidence and benefit considerations in addition to regulatory status

Note

Use of external utilization management tools (e.g., InterQual)

UnitedHealthcare may use third-party tools such as the InterQual criteria to assist in administering benefits; utilization management tools can influence step therapy and authorization decisions.

InterQual CP may be used to assess clinical criteria for DME, CGMs, pumps, and automated insulin delivery
Use of external tools can affect prior authorization and utilization management

Documentation Required

Document clinical history, exam, and test results to support medical necessity

The patient's medical record must document relevant medical history, physical examination, and pertinent diagnostic test results that fully support the medical necessity for the requested services; records should be legible, maintained in the chart, and made available upon request.

Include relevant history, exam findings, and diagnostic test results that justify the device
Maintain legible documentation in the patient's medical record and provide it on request

Billing Rule

Required coding on claims — include listed HCPCS/S/CPT and ICD-10 codes

Submit applicable HCPCS, S, and CPT codes and relevant ICD-10 diagnosis codes on claims to support coverage and payment; examples of device and supply codes are listed in the policy.

Examples include A4226, A4238, A4239, A9274–A9278, E0784, E0787, E2102–E2103, S1030–S1037, 0446T/0448T, 95249–95251
Include appropriate ICD-10 codes (e.g., E11.x, O24.x) to document the diagnosis

Note

OTC CGM products are out of scope and have distinct documentation/benefit handling

Continuous glucose monitors available over the counter without a prescription are out of scope for this policy; OTC CGM products obtained through retail pharmacies are not supported by mail-order durable medical equipment providers and have distinct benefit considerations.

Examples of OTC CGMs: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio
OTC devices should not be billed as mailed DME; benefit coverage differs from prescription devices

Denial Risk

Denial risk if medical records do not support medical necessity or are unavailable

When medical records do not fully support medical necessity or are not made available upon request, coverage may be denied in accordance with federal, state, or contractual benefit plan requirements.

Coverage determinations are governed by federal, state, or contractual plan requirements; conflicts are resolved in favor of those requirements
Failure to provide supporting medical records may result in denial

Denial Risk

Denial risk — long-term CGM for nonintensive therapy without specified hypoglycemia history

Requests for long-term CGM for individuals on nonintensive therapy without the required history of a level 3 hypoglycemic event or recurrent level 2 hypoglycemic events that persisted despite multiple treatment adjustments are considered unproven and not medically necessary and may be denied.

Initial non-intensive therapy CGM requires history of level 3 hypoglycemia OR recurrent (>1) level 2 hypoglycemia despite >1 attempts to adjust medications/treatment
Long-term CGM for other nonintensive therapy indications is unproven and not medically necessary

Billing Rule

Repair and replacement coverage — follow the DME/Repairs & Replacements policy

Refer to the Durable Medical Equipment, Orthotics, Medical Supplies, and Repairs/Replacements medical policy for details on repair and replacement coverage; failure to follow that policy could affect coverage of repairs or replacements.

Repair and replacement provisions are governed by the referenced DME/Repairs policy
Providers should consult that policy when requesting replacements or repairs to ensure coverage

Denial Risk

OTC CGMs out of scope — do not bill OTC products as mailed DME

CGM systems that are available over the counter without a prescription are out of scope for this policy and are not supported by mail-order durable medical equipment providers; billing OTC CGMs as mailed DME may lead to denial.

OTC CGMs are typically obtained through local pharmacies and are excluded from mail-order DME channels
Coverage and billing for OTC devices differ from prescription CGM systems

Note

Benefit rule precedence — federal/state/contractual requirements govern

Coverage is subject to federal, state, or contractual benefit plan requirements; in the event of a conflict those requirements govern — providers must check applicable benefit plan terms before relying on this policy.

Verify federal, state, or contractual plan requirements prior to requesting services
This policy is informational and does not replace plan-specific coverage mandates

Permits insulin dosing decisions based on CGM readings alone when indicated

Intermittently Scanned (Flash) CGM

DefinitionDevices with a combined sensor/transmitter and a separate reader that require scanning to visualize and store glucose values; available with or without alarms.

ComponentsSensor/transmitter plus reader; measures continuously but data are accessed by scanning

Use caseDesigned for long-term personal use but requires user scanning for real-time visualization

Professional CGM

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

Typical useUsed for short-term diagnostic assessment rather than continuous home monitoring

OwnershipDevices are owned by the clinic, not the patient

Real-Time CGM

DefinitionSystems with a sensor, transmitter, and receiver/smartphone that display glucose readings in real time and provide alerts.

ComponentsSensor (subcutaneous), transmitter, and receiver/smartphone display

FunctionMeasures and displays glucose continuously with audible/visual out‑of‑range alerts; some systems require user calibration

Hypoglycemia level 2

DefinitionGlucose < 54 mg/dL (3.0 mmol/L).

Clinical significanceAssociated with increased risk for cognitive dysfunction and mortality

Role in coverageUsed to define recurrent events that may qualify individuals for CGM coverage

Hypoglycemia level 3

DefinitionA severe event characterized by an altered mental and/or physical state requiring third‑party assistance for treatment.

Clinical significanceLife‑threatening and requires emergent treatment

Role in coverageA history of level 3 hypoglycemia can qualify individuals on non‑intensive therapy for long‑term CGM coverage

CGM components and types

ComponentsSensor, transmitter, and receiver (or smartphone) are the three CGM components.

Device typesIncludes short‑term professional CGM, real‑time CGM, intermittently scanned (flash) CGM, disposable and implantable sensors, and systems integrated with insulin pumps.

Sensor optionsAvailable sensors may be disposable or implantable (e.g., Eversense uses implantable fluorescence sensor)

Insulin delivery systems

External pumpsStandard external insulin pumps deliver basal and bolus insulin via tubing and subcutaneous infusion.

Patch devicesPatch devices (e.g., V‑Go) deliver preset basal and on‑demand boluses transdermally and lack programmability.

Implantable pumpsImplantable insulin pumps exist but are currently available only in clinical trial settings.

Eversense 365

Device identitySenseonics Eversense 365 implantable CGM system

Indication/durationIndicated for continual glucose measurement for up to 1 year in individuals 18 years or older (FDA 510(k) clearance)

Replacement of SMBGCleared for use to replace finger‑stick blood glucose measurements for diabetes treatment decisions

MARD

DefinitionMean absolute relative difference — a measure of CGM accuracy compared with reference glucose values.

Use in trialsReported as a primary accuracy metric (e.g., MARD values in Tweden et al. and ENHANCE) to compare sensor performance against SMBG/reference methods.

InterpretationLower MARD indicates closer agreement with reference glucose values

Eversense 365 (implantable CGM details)

Device identitySenseonics Eversense 365 implantable CGM system (implantable sensor with smart transmitter and mobile app)

FDA clearance510(k) clearance for up to 1 year continuous use in adults (18+); can replace finger‑stick testing for treatment decisions

Study supportENHANCE and other trials provided accuracy and sensor survival data informing device labeling and policy consideration

Over-the-counter CGMs

DefinitionCGM systems obtainable without a prescription (examples: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) that are out of scope for this policy.

Acquisition channelObtained through local pharmacies and not supported by mail‑order DME providers per policy

Coverage implicationOTC CGMs are excluded from this policy's coverage and prior authorization processes

2026-08-01supporting_information_update

Updated Description of Services, Clinical Evidence, FDA, and References sections and archived previous policy version CS024NM.E.