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ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0347XX

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

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Medical policy governing coverage criteria for continuous glucose monitoring (CGM) systems and external insulin delivery (insulin pumps) for UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Policy CodePolicy 2026T0347XX

Change TypeMaterial updates to insulin pump and CGM scope

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionSubmit prior authorization demonstrating InterQual medical necessity criteria are met for initial and continued long-term CGM; initial auths up to 6 months and reauth up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that 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).

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.

Updated Description of Services, Benefit Considerations, Clinical Evidence, FDA, and References sections to reflect the most current information.

6Initial auth (months)

12Reauth (months)

6 moProvider follow-up

≥18Implantable CGM age

1 yrEversense implant duration

OTC CGMsOut of scope

Coverage Criteria for CGM and Insulin Delivery

External insulin infusion pumps (medical necessity)

Insulin pumps (external): Covered when ALL of the following are met per InterQual CP

Insulin pump general: Device is an external continuous subcutaneous insulin infusion pump used according to FDA-labeled indications, contraindications, warnings, and precautions

Refer to InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology for specific medical necessity clinical coverage criteria for insulin pumps

Short-term CGM

Short-term CGM (3–14 days): Covered when used by a health care provider for diagnostic purposes

Short-term CGM: Device is used by a health care provider for diagnostic purposes for 3–14 days3-14 days

Proven and medically necessary for managing individuals with diabetes

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyContinuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Policy CodePolicy 2026T0347XX

Change TypeMaterial updates to insulin pump and CGM scope

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionSubmit prior authorization demonstrating InterQual medical necessity criteria are met for initial and continued long-term CGM; initial auths up to 6 months and reauth up to 12 months.

SourceLink

On This Page

Long-term nonimplantable CGM — intensive therapy

Long-term nonimplantable CGM (>14 days) for intensive insulin therapy: Covered when ALL of the following are met

Nonimplantable long-term CGM (intensive therapy): Device is used according to FDA-labeled indications, contraindications, warnings, and precautions; medical necessity clinical coverage criteria per InterQual CP are met; and the individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan>14 days

Initial and continued use require meeting InterQual criteria; see prior authorization guidance for initial (up to 6 months) and reauthorization (up to 12 months)

Long-term CGM — nonintensive therapy

Long-term CGM for nonintensive therapy (e.g., basal insulin and/or oral medications): Initial use covered when ALL of the following are met

Initial nonintensive CGM: 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 use is medically necessary when initial clinical criteria were met at initiation and the individual is assessed by a provider every 6 months for adherence to the prescribed CGM regimen and treatment plan

Implantable CGM (initial and continued)

Implantable CGM (e.g., Eversense): Initial use covered when ALL of the following are met

Implantable CGM initial: Device is used according to FDA-labeled indications, contraindications, warnings, and precautions; age ≥ 18 years; and one of the following: individual requires intensive insulin therapy (insulin treated at least three 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

Continued long-term implantable CGM is medically necessary when the individual continues to require intensive insulin therapy or met initial hypoglycemia criteria at initiation and is assessed every 6 months for adherence

Summary and evidence-based coverage context

Coverage stance and clinical summary

Coverage context: Most benefit plans include coverage for proven and medically necessary CGM and insulin delivery under the durable medical equipment benefit; coverage limitations and exclusions may apply and some plans exclude over-the-counter CGMs or route products to the pharmacy benefit.

Member-specific benefit documents determine exact benefits.

Insulin delivery devices evidence: Insulin pumps may be considered for diabetes due to other causes (e.g., cystic fibrosis-related diabetes, posttransplant diabetes) when insulin deficiency requires multiple daily injections; implantable pumps are only available in clinical trials and nonprogrammable transdermal devices (e.g., V-Go) lack sufficient high-quality evidence for routine coverage.

References: ADA 2026; McCall et al. 2023; observational and retrospective studies.

CGM devices evidence: Implantable glucose sensors (Eversense) have evidence from multiple prospective multicenter studies (PROMISE, PRECISION, PRECISE II, PRECISE, ENHANCE) and HTA; accuracy and durability data exist but clinical utility evidence is limited.

ENHANCE reported overall MARD 8.8% and ~90% sensor survival at 365 days; HTA notes low to very poor-quality evidence overall.

Evidence and clinical findings

Evidence summary and clinical findings relevant to coverage decisions:

Evidence base for implantable CGM systems: Multiple prospective cohort studies, randomized trials, registry analyses, and HTA reports evaluated Eversense implantable CGM systems (90-, 180-, and 365-day devices) including PROMISE, PRECISION, PRECISE, PRECISE II, ENHANCE, and others.

Study designs and sample sizes vary; see cited trials for study-specific outcomes.

Performance metrics reported: Reported MARD values vary by study and device (examples: ENHANCE overall MARD 8.8%; other studies report MARDs around 11-15%); time-in-range and hypoglycemia metrics improved in some studies.

Accuracy may vary with exercise and rapid glucose changes.

Limitations of evidence: HTA and systematic reviews identify low-to-very-poor quality evidence, small sample sizes, heterogeneity of devices and regimens, and limited data on patient-oriented clinical outcomes, limiting certainty about clinical utility.

These limitations affect generalizability and strength of conclusions.

Safety and durability: Post-market registry and study data report low rates of serious adverse events; common nonserious events include site infection and removal difficulty; sensor survival varies by device and duration (e.g., 90% at 365 days in ENHANCE; 91% for 90-day and 75% for 180-day in registry).

No related serious adverse events reported in several studies.

CGM in type 2 diabetes on nonintensive therapy: Systematic reviews and meta-analyses of RCTs show modest but statistically significant improvements in HbA1c and time-in-range with rt-CGM and intermittently scanned CGM versus blood glucose monitoring in type 2 diabetes, but trials are short-term and patient-important outcomes remain limited.

Supports selective use in nonintensive therapy when hypoglycemia criteria are met; longer-term outcomes data needed.

Policy clarifications

Policy-level coverage clarifications from this document fragment

External CSII pump medical necessity: 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.

Applies when device use aligns with FDA labeling and InterQual clinical criteria.

CSII pumps for non–type 1/2/gestational diabetes: External CSII pumps are medically necessary for managing individuals with diabetes due to causes other than type 1, type 2, or gestational diabetes when intensive insulin therapy is required (insulin-treated at least three times a day).insulin-treated >= 3 times/day

Specifies intensity threshold for non-standard diabetes types

OTC CGM exclusion: CGM systems available over the counter without a prescription are out of scope for this policy and are obtained through local pharmacy rather than mail-order durable medical equipment providers.

Examples: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio

Nonprogrammable transdermal insulin delivery systems (for example, V‑Go) and noninvasive continuous glucose monitoring (CGM) devices are considered unproven and not medically necessary due to insufficient high‑quality evidence demonstrating safety and efficacy. The policy cites limited, low‑quality, or noncomparative studies for nonprogrammable transdermal devices and explicitly states noninvasive CGMs lack sufficient evidence to support routine coverage.

Some member benefit plans explicitly exclude coverage for over‑the‑counter (OTC) CGM products and may route OTC products through the retail pharmacy rather than mail‑order durable medical equipment suppliers. Examples of OTC CGM products referenced in the policy include Dexcom Stelo, Abbott Lingo, and Abbott Libre Rio; reviewers should confirm coverage and routing by referring to the member specific benefit plan document.

Implantable insulin pumps are not commercially available for routine clinical use and are currently only available in a clinical trial setting. The policy therefore treats implantable insulin pumps as investigational/unproven for routine coverage.

CGM systems that are available over the counter without a prescription are considered out of scope for this policy and are typically obtained via local retail pharmacy channels rather than mail‑order DME suppliers. Examples noted in the policy include Dexcom Stelo, Abbott Lingo, and Abbott Libre Rio.

This policy reiterates that OTC CGM products are out of scope and not supported through mail‑order durable medical equipment supply pathways; coverage determinations for OTC products are governed by the member specific benefit plan and retail pharmacy access.

Noninvasive continuous glucose monitoring devices are designated unproven and not medically necessary because the current clinical literature does not provide sufficient evidence of efficacy to support routine use for diabetes management.

Implantable CGM systems (for example, Senseonics Eversense models) have an evidence base of cohort studies, registries, and some comparative data, but the policy notes limited and low‑quality evidence in some areas. Because of concerns about inconsistent accuracy across glucose ranges and limited high‑quality comparative outcome data, use of implantable CGM systems is considered to have uncertain clinical utility for some indications and is treated cautiously in coverage decisions.

There is insufficient evidence to establish the safety and effectiveness of nonprogrammable, wearable, disposable transdermal insulin delivery devices for routine management of diabetes. The policy cites observational and retrospective studies with methodological limitations and calls for larger, prospective comparative studies with longer follow‑up.

Evidence for implantable CGMs shows variable accuracy metrics (reported mean absolute relative differences vary by study) and study heterogeneity. Health technology assessments and registries report moderate accuracy but highlight limitations such as small sample sizes, short follow‑up, and limited data on patient‑oriented outcomes, raising concerns about broader clinical utility until higher‑quality comparative data are available.

Some policy statements and benefit clarifications overlap: coverage of CGM and insulin delivery devices is generally available under durable medical equipment benefits when proven and medically necessary, but exclusions, benefit routing (pharmacy vs DME), and OTC product scope may vary by plan. Refer to member specific benefit documents for definitive coverage decisions.

Coding: CPT, HCPCS, ICD-10, and FDA Product Codes

CGM and implantable sensor CPTCPT

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.

HCPCS and supply/product 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, 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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ICD-10 diagnosis examplesICD-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.

Applicable HCPCS/S codes for devices and suppliesHCPCS

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.

1–10 of 17

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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 and device referencesmixed

product code LZG or QFG	External insulin pumps (FDA website reference).
product code OZP	Automated insulin delivery systems or hybrid closed-loop insulin pumps (FDA website reference).
product code SBA	Eversense 365 CGM system 510(k) clearance product code (FDA reference).
product codes MDS, QCD, QHJ	CGM device FDA PMA/510(k) references.

FDA product codes referencedmixed

MDS, QCD, QHJ, SBA

Product codes referenced for FDA PMA/510(k) lookup (MDS, QCD, QHJ) and Eversense 365 product code (SBA).

Hypoglycemia thresholds — Level 2 and Level 3 definitions

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

Hypoglycemia Level 3Severe event with altered mental and/or physical state requiring third‑party assistance for treatment; life‑threatening and requires emergent treatment.

Context/SourceDefinitions per ADA 2026 and cited guidance in policy.

Sensor longevity (Eversense 365) — ENHANCE study metrics

StudyENHANCE prospective, multicenter study (Eversense 365).

Sensor survival at 365 daysApproximately 90% of sensors survived 365 days in ENHANCE (110 participants).

Accuracy metric reportedOverall MARD 8.8% in ENHANCE; confirmed alert detection rates 96.6% (70 mg/dL) and 97.9% (180 mg/dL).

Implantable CGM duration — Eversense 365 indication

Indication durationIndicated for continually measuring glucose levels for up to 1 year (365 days) in individuals 18 years or older.

Regulatory basisEversense 365 CGM system (product code SBA) received FDA 510(k) clearance (K241335) with labeling supporting up to 1‑year use.

Intended useIndicated to replace finger‑stick blood glucose measurements for diabetes treatment decisions.

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Obtain prior authorization and note authorization durations

Initial and continued requests for long‑term CGM (nonimplantable and implantable) must meet InterQual medical necessity criteria; initial authorizations are for up to 6 months and reauthorizations may be approved for up to 12 months. Coverage criteria must be met whether the request is submitted via the UnitedHealthcare prior authorization process or by a contracted supplier.

Initial authorization duration: up to 6 months
Reauthorization duration: up to 12 months
Requests must meet InterQual CP clinical coverage criteria

Billing Rule

Route authorizations and link to specific device codes

Use the policy’s listed HCPCS/CPT and S codes when requesting prior authorization and when submitting claims; coverage of devices, supplies, and pumps may be subject to plan‑specific prior authorization and benefit limitations.

Use applicable device/supply codes (e.g., A4226, A4238, A4239, A9274, A9276–A9278, E0784, E0787, E2102–E2103, S1030–S1037) when requesting authorization
Confirm plan‑level prior authorization and benefit limits before ordering

Prior Authorization

Identify device‑specific prior authorization needs (implantable CGM)

For implantable CGM systems (for example, Senseonics Eversense models including Eversense 365), prior authorization pathways and documentation may be required because these devices have device‑specific indications and FDA clearance information; note the Eversense 365 is FDA‑cleared for up to 1 year in adults 18+.

Document device model and FDA status (e.g., Eversense 365: indicated up to 1 year, adults ≥18)
Prior authorization may be required for placement and related DME supply routing

Prior Authorization

Prior authorization check for external insulin pumps (CSII)

External continuous subcutaneous insulin infusion (CSII) pumps (including Omnipod) are considered medically necessary in certain circumstances when used per FDA‑labeled indications; prior authorization should ensure use aligns with FDA labeling and that the individual meets intensive insulin therapy criteria when applicable.

Confirm FDA‑labeled indication, contraindications, warnings and precautions are met
For non‑type 1/2/gestational diabetes, document that the individual requires intensive insulin therapy (insulin treated ≥3 times/day)

Step Therapy

Follow insulin delivery device pathway and exclude unproven devices

When FDA‑labeled and supported by InterQual criteria, external programmable insulin pumps are medically necessary in certain circumstances; nonprogrammable transdermal devices (e.g., V‑Go) and implantable insulin pumps are considered unproven/not medically necessary and should not be requested as standard DME.

Follow InterQual CP for medical necessity of external insulin pumps
Do not request coverage for nonprogrammable transdermal or implantable insulin pumps outside trial settings (considered unproven)

Step Therapy

Verify benefit routing and potential step therapy

Confirm benefit routing and verify whether the product is covered under the durable medical equipment benefit or the pharmacy benefit; some plans may route certain products through pharmacy or apply product‑specific restrictions or step therapy per the member’s plan.

Check member specific benefit plan document for whether the CGM or supplies are pharmacy‑benefit or DME
Be aware that step therapy or product‑specific restrictions may apply

Step Therapy

Consider step progression for nonintensive therapy

For nonintensive therapy (type 2 on basal/oral therapy), consider step progression because evidence shows only modest short‑term benefits; policies may require trial of standard blood glucose monitoring or less advanced CGM before approving long‑term or implantable systems.

Consider trial of less advanced monitoring prior to long‑term/implantable CGM for nonintensive therapy
Document prior attempts to adjust medications and treatment plan if seeking CGM for recurrent level 2 hypoglycemia

Note

Apply member plan and Medicare guidance when deciding coverage

Apply this medical policy in conjunction with the member‑specific benefit plan document and any applicable Medicare NCD/LCD guidance; in case of conflict, the member‑specific benefit plan governs and reviewers should reference applicable federal/state mandates.

Check member specific benefit plan document before approving coverage
When applicable, review Medicare NCD/LCD guidance for Medicare Advantage members

Documentation Required

Provide medical record evidence with requests

Include relevant medical records when submitting prior authorization — reviewers may require documentation to assess whether clinical criteria are met; medical records do not guarantee coverage but are used to verify eligibility under the criteria.

Provide clinical notes documenting hypoglycemia history, treatment adjustments, and insulin regimen
Attach prior CGM trial results or supplier documentation if available

Billing Rule

Code devices/supplies and link to diagnoses on claims

When submitting claims, use the policy’s listed HCPCS/CPT/S codes and support them with appropriate ICD‑10 diagnosis codes; ensure diagnosis linkage is documented in the medical record.

Use listed device/supply codes (e.g., A4238, A4239, A9276–A9278, E0784, E0787, 0446T, 0448T, 95249–95251)
Include an appropriate ICD‑10 diagnosis code linked to diabetes care in the claim

Documentation Required

Document device model and FDA status when requested

Document device model and FDA clearance/approval status when requested; FDA product codes and device references are provided for informational use and may be requested by reviewers.

Be prepared to document FDA status (e.g., Eversense 365 received 510(k) clearance; product code SBA)
Use FDA references only as informational support — coverage depends on benefit rules and criteria

Note

Reference member specific benefit document for final coverage determination

Reviewers will refer to the member specific benefit plan document and applicable mandates when making coverage decisions; ensure the benefit document is consulted because plan terms may differ from this medical policy.

Member specific benefit plan document governs in event of conflict
Confirm any applicable state or federal mandate that affects coverage

Denial Risk

Denial risk: missing qualifying hypoglycemia or noninvasive/OTC devices

Requests for long‑term CGM in nonintensive therapy patients without documented qualifying hypoglycemia (history of a level 3 event or recurrent level 2 events despite treatment adjustments) or requests for noninvasive/OTC devices may be denied as not medically necessary.

Denial trigger: no documented level 3 event or recurrent level 2 events with failed treatment adjustments for nonintensive therapy
Denial trigger: requests for noninvasive CGM devices (considered unproven)

Denial Risk

Plan exclusions and benefit limitations may trigger denial

Coverage limitations and exclusions may apply at the plan level; certain plans explicitly exclude over‑the‑counter CGMs and some products may only be provided under the pharmacy benefit — verify member plan exclusions to avoid denial.

Confirm whether OTC CGMs are excluded for the member’s plan
Verify whether the device/supplies must be provided via pharmacy rather than DME

Denial Risk

Do not request coverage for OTC CGMs under this policy

Devices that are available over the counter without a prescription (for example, Dexcom Stelo, Abbott Lingo, Abbott Libre Rio) are out of scope for this policy and generally obtained through retail pharmacy; do not request coverage under this DME‑focused policy for OTC CGMs.

OTC CGMs are out of scope for this policy and not supported by mail‑order DME suppliers
Examples of OTC products: Dexcom Stelo, Abbott Lingo, Abbott Libre Rio

Denial Risk

OTC CGM products are out of scope and may be denied

Requests for CGM systems that are available without a prescription may be denied under this policy because OTC products are out of scope and are obtained through retail pharmacy rather than mail‑order durable medical equipment providers.

If product is OTC, direct member/provider to local pharmacy channels rather than DME prior authorization
Document if OTC product was provided and consider benefit routing implications

Background and Scope

Continuous glucose monitoring (CGM) systems consist of a sensor, transmitter, and receiver or compatible smart device and provide ongoing interstitial glucose measurements. CGMs may be deployed as short‑term, professional (3–14 day) diagnostic systems or as long‑term personal systems (real‑time or intermittently scanned) with disposable or implantable sensors. CGM modality (adjunctive vs nonadjunctive, real‑time vs intermittently scanned) and intended use determine clinical indications and coverage requirements.

Definitions and Device Types

Adjunctive Continuous Glucose Monitor — definition

DefinitionAdjunctive Continuous Glucose Monitor: a CGM that requires the user to verify CGM glucose levels or trends with a blood glucose monitor prior to making treatment decisions.

Typical useMay provide continuous interstitial glucose data but results must be confirmed by finger‑stick testing before treatment changes.

ReferencesCMS and ADA definitions cited in policy document.

Nonadjunctive Continuous Glucose Monitor — definition

DefinitionNonadjunctive Continuous Glucose Monitor: a CGM that can be used to make treatment decisions without confirming results on a separate blood glucose monitor.

Clinical implicationAllows direct treatment actions (insulin dosing) based on CGM readings per device labeling.

ReferenceCenters for Medicare and Medicaid Services; ADA (policy definitions).

Intermittently Scanned (Flash) CGM — definition

DefinitionIntermittently Scanned (Flash) CGM: devices with a combined sensor/transmitter and a separate reader that measure glucose continuously but require scanning for visualization and storage of glucose values.

FeaturesAvailable with and without alarms; user must scan reader to view stored data.

Use caseOften used for long‑term personal monitoring where active scanning is acceptable.

Real-Time CGM — definition

DefinitionReal‑Time CGM: system composed of a sensor (inserted subcutaneously), transmitter, and receiver/smartphone that displays glucose readings in real time and provides alerts when glucose is out of range.

FunctionalityProvides continuous displayed glucose values with audible/visual alarms; some systems require user calibration.

Intended usersDesigned for ongoing personal diabetes management and immediate treatment decisions.

Hypoglycemia Level 2 — definition

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

DefinitionHypoglycemia Level 3: Severe event with altered mental and/or physical state requiring third‑party assistance; life‑threatening and requires emergent treatment.

Clinical relevanceLevel 2 and Level 3 events are used in coverage criteria to determine eligibility for long‑term CGM in nonintensive therapy.

Hypoglycemia Level 3 — definition

DefinitionHypoglycemia Level 3: A severe hypoglycemic event characterized by altered mental and/or physical state requiring third‑party assistance for treatment; life‑threatening and requires emergent treatment.

Coverage useHistory of a Level 3 event is an initial‑use criterion for long‑term CGM in nonintensive therapy per policy.

SourceADA 2026 and policy definitions cited in document.

Continuous glucose monitor (CGM) — definition

DefinitionContinuous glucose monitor (CGM): device with a sensor, transmitter, and receiver that continuously monitors interstitial glucose; available as short‑term/professional or long‑term personal use, with disposable or implantable sensors.

ComponentsSensor (disposable or implantable), transmitter, and receiver/smartphone app.

Use typesShort‑term diagnostic/professional (3–14 days) and long‑term personal use (real‑time or intermittently scanned).

Insulin delivery devices — definition

DefinitionInsulin delivery devices: includes external programmable insulin pumps (tubed), patch/on‑skin reservoirs (e.g., Omnipod), nonprogrammable transdermal devices (e.g., V‑Go), and implantable pumps; used to deliver basal and bolus insulin.

Device typesExternal tubed pumps, patch pumps, nonprogrammable transdermal systems, and implantable pumps (implantable pumps currently investigational/clinical trial).

Clinical functionProgrammed to deliver continuous basal insulin and on‑demand bolus doses to manage glycemia.

Eversense 365 — definition and indication

DeviceEversense 365: a Senseonics implantable continuous glucose monitoring system cleared by the FDA for up to 1 year (365 days) of use in adults 18 years or older.

Intended useIndicated to replace finger‑stick blood glucose measurements for diabetes treatment decisions; can be used alone or with digitally connected medical devices.

Sensor typeImplantable, fluorescence‑based sensor communicating with a smart transmitter and mobile application.

Noninvasive CGM — definition and regulatory status

DefinitionNoninvasive CGM: CGM devices that measure glucose without transcutaneous or implanted sensors.

Regulatory statusAs of this document, there are no FDA‑approved noninvasive CGMs on the U.S. market.

Policy stanceNoninvasive CGMs are considered unproven and not medically necessary under this policy.

Eversense 365 (510(k)-cleared implantable CGM) — device labeling summary

Device labeling summaryEversense 365 is a 510(k)‑cleared implantable CGM system indicated for continual glucose measurement for up to 1 year in individuals 18 years or older and to replace finger‑stick measurements for diabetes treatment decisions.

Regulatory detailProduct code: SBA; clearance date: September 16, 2024; additional FDA PMN information available (K241335).

Clinical study supportENHANCE study (110 participants) supported labeling with overall MARD 8.8% and ~90% sensor survival at 365 days.