DraftColorado Rocky Mountain Health PlansPolicy CS0242OH.D

Insulin Delivery for Managing Diabetes (for Ohio Only)

This policy governs coverage and medical necessity criteria for external insulin delivery devices (programmable disposable pumps, standard external pumps, patch/nonprogrammable devices, and automated insulin delivery systems) for members in Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyInsulin Delivery for Managing Diabetes (for Ohio Only)

Policy CodePolicy CS0242OH.D

Change TypeRevised content and section updates

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests per Ohio Administrative Code and InterQual criteria for insulin delivery devices.

SourceLink

POLICY UPDATE CHANGES

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

State-specificPolicy applies to

OhioState regulatory refs

ADA 2025Clinical guidance cited

noneImplantable pumps FDA-approved

SeveralProcedure/supply codes

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Coverage and Medical Necessity Criteria

Coverage for Type 1/Type 2 and other diabetes types

Covered when clinical criteria per Ohio Administrative Code and referenced InterQual criteria are met.

General requirement: Medical necessity determinations for insulin pumps follow Ohio Administrative Code Rule 5160-10-29 (DMEPOS: insulin pumps) and, where indicated, InterQual CP criteria for insulin pumps and automated insulin delivery technology.

See Ohio Administrative Code Rule 5160-10-29 and InterQual CP: Durable Medical Equipment, Continuous Glucose Monitors, Insulin Pumps, and Automated Insulin Delivery Technology

Devices considered not medically necessary / unproven

The policy explicitly lists devices considered unproven or not medically necessary.

Not medically necessary devices: The following devices are considered unproven and not medically necessary due to insufficient evidence of safety and efficacy: implantable insulin pumps and nonprogrammable transdermal insulin delivery systems (e.g., V-Go).

Implantable insulin pumps are currently available only in clinical trial settings; nonprogrammable patch devices lack sufficient comparative effectiveness evidence.

Governance and reference-based determination

No explicit medical necessity criteria present in this excerpt; coverage must be determined per referenced guidelines and Ohio Administrative Code.

Governance: Coverage decisions must follow federal, state (Ohio Administrative Code) or contractual requirements; in the event of conflict, federal/state/OAC or contractual requirements govern.

UnitedHealthcare uses InterQual for primary medical/surgical criteria; where InterQual lacks applicable criteria, UnitedHealthcare medical policies or state-approved guidelines may be used. See OAC Rule 5160-10-29 and accompanying instructions.

The policy identifies certain insulin delivery technologies as unproven and therefore not medically necessary for diabetes management due to insufficient evidence of safety and efficacy. Specifically, the policy lists implantable insulin pumps and nonprogrammable transdermal insulin delivery systems (e.g., V-Go) as unproven and not medically necessary for treating individuals with diabetes.

The policy states that no implantable insulin pumps have received FDA approval and that implantable devices are currently available only in clinical trial settings. Coverage for implantable insulin pumps is therefore not supported by FDA approval at this time.

Nonprogrammable transdermal insulin delivery systems (wearable disposable devices such as V-Go) are considered not medically necessary because the clinical literature provides insufficient evidence of their safety and efficacy. The policy cites limitations in available studies (small sample sizes, retrospective designs, lack of control groups, and short follow-up) and indicates that larger, well-designed prospective trials with long-term comparative data are needed to establish clinical benefit.

Procedure, Product and Regulatory Codes

Applicable procedure/supply codesmixed

A4226	Supplies for maintenance of insulin infusion pump with dosage rate adjustment using therapeutic continuous glucose sensing, per week.
A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories.
E0784	External ambulatory infusion pump, insulin.
E0787	External ambulatory infusion pump, insulin, dosage rate adjustment using therapeutic continuous glucose sensing.
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.

FDA product codes referencedmixed

LZG	FDA product code referenced for external insulin pumps (PMN site)
QFG	FDA product code referenced for external insulin pumps (PMN site)
OZP	FDA product code referenced for automated insulin delivery systems / hybrid closed-loop (PMA site)

Insulin treatment intensity — criteria for pump consideration

ThresholdInsulin-treated at least 3 times per day (intensive insulin therapy)

Use casesConsideration for CSII in Type 1, Type 2, gestational, and diabetes due to other causes requiring intensive insulin therapy (e.g., cystic fibrosis-related diabetes, post-transplantation diabetes, diabetes after pancreatic surgery)

Source of criteriaCoverage determinations reference InterQual criteria for insulin pumps

Documentation noteClinical indication must demonstrate requirement for multiple daily insulin injections (>=3/day)

Prior Authorization, Documentation, and Provider Guidance

Denial Risk

Devices considered unproven / exclusions

The following devices are considered unproven and are NOT medically necessary due to insufficient evidence of safety and efficacy: implantable insulin pumps and nonprogrammable transdermal insulin delivery systems (e.g., V-Go). Requests for these devices are subject to denial risk under medical necessity review.

Implantable insulin pumps — not medically necessary
Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) — not medically necessary

Documentation Required

Conflicts with governing rules may affect coverage

Coverage decisions must follow federal, state (Ohio Administrative Code), and plan contractual requirements. If there is any conflict between this Medical Policy and federal, state (OAC), or contractual requirements, the federal, state (OAC), or contractual requirements govern. Providers must verify and follow the applicable Ohio Administrative Code rules (including Rule 5160-10-01 and Rule 5160-10-29) and plan-specific prior authorization processes when submitting requests.

Clinical Background

Diabetes mellitus encompasses type 1, type 2, gestational, and other specific forms of diabetes; inadequate glycemic control increases risk for both microvascular and macrovascular complications. Glycemic status is assessed using blood glucose monitoring, continuous glucose monitoring, and glycated hemoglobin (HbA1c). Patients who require intensive insulin therapy (multiple daily injections or insulin-treated ≥3 times/day) may be considered for external continuous subcutaneous insulin infusion (CSII) pump therapy when clinical criteria and applicable state rules are met.

Device Definitions

Programmable external insulin pump

DefinitionExternal device that connects via tubing or uses an on-skin reservoir (e.g., OmniPod) and can be programmed to deliver basal and bolus insulin doses.

Delivery modesProgrammable basal infusion and on-demand bolus dosing; may connect via tubing or use a patch-style reservoir

ExamplesInsulet Omnipod® series; standard tubed pumps (e.g., Tandem, Medtronic models listed elsewhere in policy)

Regulatory referenceRefer to FDA PMN/PMA product codes LZG or QFG for external pumps on FDA website

Nonprogrammable transdermal insulin delivery (patch) devices

DefinitionWearable disposable devices that deliver preset basal and on-demand bolus insulin transdermally and lack programmability (e.g., V-Go).

Policy Revision History

2025-11-01Policy revisionLatest

Updated Description of Services, Clinical Evidence, FDA, and References sections and archived previous policy version CS0242OH.C.