sierra health and life CGM Insulin Delivery Coverage Update

Medical Necessity Criteria for CGM and Insulin Delivery

Insulin Pumps (External)

External continuous subcutaneous insulin infusion pumps are medically necessary when used per FDA labeling and when InterQual clinical coverage criteria are met; implantable pumps and nonprogrammable transdermal systems are not medically necessary.

ALL of the following

Device is used according to FDA labeled indications, contraindications, warnings, and precautions
Examples of diabetes due to other causes where external pumps are medically necessary
- Cystic fibrosis-related diabetes requiring intensive insulin therapy (insulin-treated at least 3 times a day)
- Post-transplantation diabetes requiring intensive insulin therapy (insulin-treated at least 3 times a day)
- Diabetes following pancreatic surgery requiring intensive insulin therapy (insulin-treated at least 3 times a day)

Devices considered unproven / not medically necessary (Insulin Delivery)

The following are considered unproven and not medically necessary due to insufficient evidence:

ANY of the following

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

Short-Term CGM (3-14 days)

Short-term CGM used by a healthcare provider for diagnostic purposes:

ANY of the following

Proven and medically necessary for managing individuals with diabetes when used by a healthcare provider for diagnostic purposes

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

Coverage criteria must be met regardless of prior authorization pathway. Authorization durations are specified.

ALL of the following

Coverage criteria noted must be met whether request comes through UHC prior authorization (type 2 or gestational diabetes) or a contracted supplier (type 1 diabetes)
Initial CGM authorization will be for up to six months
Reauthorization will be for up to 12 months

Long-Term CGM — Intensive Insulin Therapy (Initial & Continued)

Initial long-term CGM is medically necessary when InterQual criteria are met; continued use requires periodic assessment.

ALL of the following

Device is used according to FDA labeled indications, contraindications, warnings, and precautions
Medical necessity clinical coverage criteria are met; refer to InterQual CP for Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology
Individual is assessed by a provider every six months for adherence to the prescribed CGM regimen and treatment plan
required for continued long-term use

Long-Term CGM — Non-Intensive Diabetes Therapy (Initial & Continued)

Criteria for individuals on non-intensive regimens (basal insulin and/or oral meds) with hypoglycemia history:

ALL of the following

Initial criteria — one of the following
- History of a level 3 hypoglycemic event
- 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
Individual is on a non-intensive treatment plan (e.g., basal insulin and/or oral medications)

Continued long-term CGM

Clinical criteria for initial use were met at initiation of CGM

Implantable Continuous Glucose Monitoring (e.g., Eversense) — Initial & Continued

Initial and continued criteria for implantable CGM systems.

Initial long-term implantable CGM

Device is used according to FDA labeled indications, contraindications, warnings, and precautions
Age ≥ 18
One of the following
- Individual requires intensive insulin therapy (insulin-treated at least 3 times a day or insulin pump)
- 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

Noninvasive CGM Devices

Policy stance on noninvasive CGM devices:

ANY of the following

Use of a noninvasive CGM device is unproven and not medically necessary due to insufficient evidence of efficacy

Relevant Procedure, Supply, Device, and Diagnosis Codes

CPT/HCPCS Procedure Codes (listed)mixed

0446T	Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training
0448T	Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation
95249	Ambulatory CGM, patient-provided equipment, sensor placement, calibration, training, printout (≥72 hours)
95250	Ambulatory CGM, physician/office-provided equipment, sensor placement, calibration, training, removal, printout (≥72 hours)
95251	Ambulatory CGM analysis, interpretation and report

HCPCS Supply 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
A9276	Sensor; invasive (subcutaneous), disposable, for use with nondurable medical equipment 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 CGM or receiver

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

E11.00	Type 2 diabetes mellitus with hyperosmolarity without coma
E11.01	Type 2 diabetes mellitus with hyperosmolarity with coma
E11.10	Type 2 diabetes mellitus with ketoacidosis without coma
E11.11	Type 2 diabetes mellitus with ketoacidosis with coma
E11.21	Type 2 diabetes mellitus with diabetic nephropathy
E11.22	Type 2 diabetes mellitus with diabetic chronic kidney disease
E11.649	Type 2 diabetes mellitus with hypoglycemia without coma
E11.641	Type 2 diabetes mellitus with hypoglycemia with coma
E11.9	Type 2 diabetes mellitus without complications
O24.414	Gestational diabetes mellitus in pregnancy, insulin controlled

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Listed CGM models / insulin delivery devices (informational)mixed

Abbott FreeStyle Libre 2	Intermittently scanned CGM
Abbott FreeStyle Libre 3	Real-time/continuous CGM
Abbott FreeStyle Libre 3 Plus	CGM model
Abbott FreeStyle Libre 14-Day	Flash CGM with 14-day wear
Dexcom G6	Real-time CGM
Dexcom G7	Real-time CGM
Ascensia Eversense E3	Implantable CGM (Eversense series)
Eversense 365 (K241335)	Implantable CGM cleared for up to 1 year continuous use (510k K241335)
Medtronic Guardian Connect	Real-time CGM
Dexcom Stelo	OTC CGM (out of scope for this policy)

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Regulatory / informational codesmixed

SBA	Eversense 365 product code (FDA clearance referenced)
K241335	510(k) clearance ID for Eversense 365
MDS, QCD, QHJ	FDA product codes referenced for CGM PMA listings
LZG, QFG	FDA product codes referenced for external insulin pumps
OZP	FDA product code referenced for automated insulin delivery systems

Prior Authorization, Documentation, and Administrative Actions

Prior Authorization

Prior authorization pathway

Requests for long-term CGM must meet the coverage criteria whether submitted through UnitedHealthcare prior authorization (type 2 or gestational diabetes) or via a contracted supplier (type 1 diabetes). Initial authorizations are for up to six months and reauthorizations are for up to 12 months.

Initial CGM authorization: up to six months
Reauthorization: up to 12 months

Documentation Required

Six-month assessments for continued CGM use

For continued long‑term CGM coverage, the provider must assess the individual every six months for adherence to the prescribed CGM regimen and treatment plan.

Required follow‑up interval: every six months
Applies to intensive, non‑intensive, and implantable CGM continued-use criteria

Clinical Rationale and Device Descriptions

Diabetes mellitus includes several distinct forms. Type 1 diabetes is due to autoimmune beta‑cell destruction that usually results in absolute insulin deficiency (including latent autoimmune diabetes in adults). Type 2 diabetes is characterized by progressive loss of beta‑cell insulin secretion on the background of insulin resistance. Other recognized categories include gestational diabetes mellitus and specific types due to other causes (for example, cystic fibrosis‑related diabetes, diabetes following pancreatic surgery, monogenic syndromes, or drug‑induced diabetes). Poorly controlled diabetes increases risk of macrovascular and microvascular complications; evidence shows that improved glycemic control can slow the onset or progression of major complications and is therefore central to management (assessments include BGM, CGM, and HbA1c).

Continuous glucose monitoring (CGM) and insulin delivery technologies provide tools to track and manage glycemia more closely. A Continuous Glucose Monitor (CGM) measures interstitial glucose continuously or intermittently and has three components: a sensor, a transmitter, and a receiver or compatible smart device. CGM systems include short‑term/professional devices (clinic‑placed and worn for a discrete period, typically 7–14 days, for diagnostic use) and long‑term systems for personal use. Professional (short‑term) CGM is used by a healthcare provider to collect retrospective or blinded data for diagnostic assessment; these devices are clinic‑based and not owned by the user.

Long‑term personal CGM comes in two common formats: Real‑Time CGM (rtCGM), which displays glucose readings continuously with trend information and audible or mobile alerts and may require calibration, and Intermittently Scanned (flash) CGM (isCGM), which continuously measures glucose but requires the user to scan a reader to visualize stored values (some isCGM devices offer alarms). Sensors may be disposable transcutaneous units or implantable sensors (e.g., fluorescence‑based systems with a subcutaneously inserted sensor plus smart transmitter and mobile app).

Insulin delivery options include standard external continuous subcutaneous insulin infusion pumps (tubed pumps) that use tubing and an infusion set, and patch pumps that combine an on‑skin reservoir with wireless control. These external pumps can provide programmable basal and bolus delivery and may be integrated with CGM in hybrid closed‑loop systems. By contrast, nonprogrammable transdermal disposable devices (e.g., V‑Go) deliver preset basal and on‑demand bolus insulin and lack programmability; implantable insulin pumps are not currently approved for routine clinical use.

Clinical Thresholds and Select Policy Metrics

Key thresholds and performance metrics

Level 2 hypoglycemiaGlucose < 54 mg/dL

Level 3 hypoglycemiaSevere event with altered mental and/or physical status requiring third‑party assistance

Eversense 90‑day sensor intended life achieved91% full intended sensor life achieved

Eversense 180‑day sensor intended life achieved75% full intended sensor life achieved

Time in range (first 205 commercial Eversense users)62.3% (≥ 70–180 mg/dL)

6 monthsInitial authorization duration

Policy Definitions and Acronyms

Definitions

Adjunctive CGMRequires user verification with a blood glucose monitor prior to making treatment decisions.

Non-Adjunctive CGMCan be used to make treatment decisions without a standalone blood glucose monitor.

Professional CGMPlaced/managed by healthcare professionals for a discrete period (generally 7–14 days); clinic-based and not owned by the user.

Intermittently Scanned (Flash) CGM (isCGM)Sensor/transmitter with separate reader that requires scanning to visualize and store glucose values; may have alarms.

Real-Time CGM (rtCGM)Sensor, transmitter, and receiver/smartphone display glucose readings in real time with alerts; may require calibration.

Hypoglycemia Level 2Glucose < 54 mg/dL.

Policy Update Changes

2026-01-01clarifiedLatest

Listed under Policy History with effective date 2026-01-01 (template update); created shared policy version to support application to Oxford plan membership and archived previous policy versions.

OpenPayer

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Medical Necessity Criteria for CGM and Insulin Delivery

Relevant Procedure, Supply, Device, and Diagnosis Codes

Prior Authorization, Documentation, and Administrative Actions

Clinical Rationale and Device Descriptions

Clinical Thresholds and Select Policy Metrics

Policy Definitions and Acronyms

Policy Update Changes

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Medical Necessity Criteria for CGM and Insulin Delivery

Relevant Procedure, Supply, Device, and Diagnosis Codes

Prior Authorization, Documentation, and Administrative Actions

Clinical Rationale and Device Descriptions

Clinical Thresholds and Select Policy Metrics

Policy Definitions and Acronyms

Cross-References

Policy Update Changes