ModifiedCentenePolicy CP.PHAR.534

Insulin Delivery Systems (V-Go, Omnipod, InPen)

Defines prior authorization, medical necessity, coverage, and renewal criteria for V-Go, Omnipod DASH, Omnipod 5, and InPen insulin delivery systems for Centene lines of business.

Policy Summary

PayerCentene

PolicyInsulin Delivery Systems (V-Go, Omnipod, InPen)

Policy CodePolicy CP.PHAR.534

Change TypeCriteria and approval duration revisions

Effective Date06.01.21

Next Review Date

Key ActionPrior authorization is required for V-Go, Omnipod DASH, Omnipod 5, and InPen; ensure Omnipod 5 requests use product compatible with the plan-preferred CGM.

SourceLink

POLICY UPDATE CHANGES

Revised insulin administration method criterion to require duration only for multiple daily insulin injections and reduced duration requirements for monitoring and insulin administration method.

Added Omnipod 5 and Omnipod DASH NDCs and device-specific updates (compatibility with Dexcom G7 and FreeStyle Libre 2 Plus); added Appendix D describing a comprehensive diabetes management program (later removed as requirement).

For Omnipod 5 requests, member must use the product compatible with the health-plan preferred CGM.

4brands/devices covered

30/monthV-Go max qty

10/monthOmnipod pods max qty

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1/4 yrsdevice replacement limit

≤200Upod insulin capacity

Coverage Criteria

Revised coverage criteria highlights

Policy updates and device-specific coverage conditions:

ALL of the following

2Q 2023 annual review: revised minimum age requirement for V-Go from 21 years to 18 years per user guide; references reviewed and updated.
Date = 01.24.23; P&T Approval Date = 05.23.
Per SDC and line of business owner, modified from HIM-Medical Benefit to HIM.
Date = 06.13.23.
Added Omnipod GO and corresponding criteria; removed Omnipod as it will no longer be available in the US after 12/31/23 per the manufacturer (later removed after product not launched).
Date = 11.14.23 and 02.24.
2Q 2024 annual review: updated Omnipod 5 sections to reflect newly approved compatibility with Dexcom G7 (FDA Approved Indication(s), Dosing and Administration, and NDCs).
Date = 04.08.24; P&T Approval Date = 05.24.
For Omnipod DASH and Omnipod 5, moved device limit (1 per 4 years) from approval duration to criteria and revised approval duration to 30 days due to operational limitations for benefit programming; added NDC for Omnipod DASH PDM Kit per request.
Date = 07.09.24.
For Omnipod 5, updated FDA Approved Indication to reflect newly approved use of SmartAdjust technology in adults.
Date = 09.04.24.
Added Appendix D with description of a comprehensive diabetes management program, then per SDC removed requirement for participation in such program (changes implemented 11.27.24 and 01.07.25).
P&T Approval Date = 02.25.
2Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395 (effective 1/1/2026).
Date = 06.25.25.
Per manufacturer, removed Omnipod GO criteria as product never launched; for Omnipod 5, updated to reflect FreeStyle Libre 2 Plus compatibility (NDC updates).
Date = 08.27.25.
2Q 2026 annual review: revised insulin administration method criterion to require duration only for multiple daily insulin injections; for V-Go and Omnipod Pods, revised initial approval duration for Medicaid and HIM from 6 to 12 months; added exception to prescriber requirement for Oregon requests due to endocrinologist shortage; reduced duration requirement for blood glucose monitoring from 6 months to 2 months and for multiple daily injections from 6 to 3 months; clarified Omnipod 5 must be compatible with health-plan preferred CGM; added ICHRA line of business.
Date = 04.21.26; P&T Approval Date = 05.26.

Coding and Billing

Covered HCPCS (informational)HCPCS

A9274	External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories
E0784	External ambulatory infusion pump, insulin (PDM device)
A4211	Supplies for self-administered injection

NDCs for devices and podsNDC

62088000031	InPen Humalog, blue
62088000032	InPen Humalog, grey
62088000033	InPen Humalog, pink
62088000034	InPen Novolog/Fiasp, blue
62088000035	InPen Novolog/Fiasp, grey
62088000036	InPen Novolog/Fiasp, pink
08508200005	Omnipod DASH 5 Pack Pods
08508200000	Omnipod DASH PDM Kit
08508200032	Omnipod DASH Intro Kit
08508300021	Omnipod 5 DexG7G6 Pods (Gen 5)

1–10 of 13

1/2

Device replacement frequency

Device replacement frequencyDevice limit: 1 per 4 years

ContextDevice limit moved from approval duration into explicit coverage criteria for Omnipod DASH and Omnipod 5

Operational noteApproval duration revised operationally to 30 days while device replacement frequency remains 1 per 4 years

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for V-Go, Omnipod DASH, Omnipod 5, and InPen. Submit a prior authorization request with supporting clinical documentation demonstrating that the member meets all approval criteria before device provision.

Devices requiring prior authorization: V-Go, Omnipod DASH, Omnipod 5, InPen
For Omnipod 5, member must use the Omnipod 5 product compatible with the health-plan preferred CGM (examples for Medicaid and HIM: NDCs 08508300088 and 08508300042).
Prior authorization may also be required for associated CGMs and components.

Documentation Required

Documentation Required for Prior Authorization

Provider must submit sufficient documentation (office/chart notes, lab results, device records, prior therapy history) that supports the member has met all criteria, including step-therapy history and monitoring requirements. Requests lacking documentation may be delayed or denied.

Background

Insulin delivery systems provide subcutaneous insulin delivery to support basal and prandial glycemic control in people who require insulin. Device types covered in this policy include traditional pump systems, tubeless "pod" systems (such as Omnipod devices), smart insulin pens (InPen), and wearable disposable devices (V‑Go). These systems differ in components and operation: pods are tubeless, adhered to the skin and filled with insulin for multi‑day wear; patch‑based systems use a PDM or controller for programming and initial setup; smart pens include a digital component to support dose calculation and logging. Device‑specific requirements such as minimum age, CGM compatibility (e.g., Omnipod 5 compatibility with plan‑preferred CGM), monitoring frequency, and training or programming by the provider are applied in the coverage criteria.

Definitions

Pod (definition)

TermPod

DefinitionTubeless insulin pump (as used with Omnipod devices).

Typical useWorn on the body; filled with U-100 rapid-acting insulin for up to 3 days per Pod (see dosing guide).

CGM (term variant)

Term variantCGM

DefinitionContinuous glucose monitoring.

Abbreviation sourceListed in policy appendix abbreviation key (Appendix A).

Initial Therapy Criteria

Initial Therapy — Diabetes Device Criteria

Initial approval criteria for diabetes mellitus devices

Initial Device Approval - Operational Rules: 1. Provider must document that member meets the Initial Approval criteria (diagnosis, prescriber, age, prior insulin method, monitoring, device-specific requirements).

Initial Device Approval - Age and Prescriber: 2. Age limits and prescriber/consultation requirements apply per device (V-Go ≥18, InPen ≥7, Omnipod 5 ≥2); Oregon prescriber exception applies.

Initial Device Approval - Prior method and monitoring: 3. Member must have used either a continuous insulin delivery system or multiple daily injections (MDI) for required duration (MDI ≥3 months) with documented suboptimal control; member must have monitored BG ≥4 times/day for ≥2 months.

Continuation Therapy Criteria

Continuation Therapy — Device Criteria

Continued therapy — member must meet ALL of the following:

Continued Device Therapy - Eligibility: 1. Member is currently receiving the device via the Centene benefit or has previously met initial approval criteria; continuity of care regulations may apply in certain states/products.

Continued Device Therapy - Clinical response: 2. Member is responding positively to therapy as evidenced by clinical assessment and/or documented benefit.

Continued Device Therapy - Adherence: 3. Member remains adherent to provider follow-up and training requirements.

Continued Device Therapy - Omnipod 5 CGM compatibility: 4. For Omnipod 5 continuation, member must use the Omnipod 5 product compatible with the health-plan preferred CGM (NDCs cited for Medicaid and HIM).

Step Therapy and Alternatives

Requirement	Details
Prior use of alternative insulin delivery method
Member must have utilized one of the following methods for at least the last 3 months (see exceptions for IL HIM per IL HB 5395): a) continuous insulin delivery system; or b) multiple daily insulin injections (≥3 daily injections of a basal and bolus regimen) with evidence of suboptimal blood sugar control (examples include repeated hypoglycemia [BG < 70 mg/dL], repeated DKA, wide excursions, hypoglycemia unawareness, HbA1c ≥ 7.0, or 'dawn phenomenon' with fasting BG > 200 mg/dL)
Blood glucose monitoring requirement
Member has monitored blood glucose ≥ 4 times/day for at least the last 2 months

Preferred device/therapy	Notes
Omnipod DASH Insulin Management System
Omnipod 5 Automated Insulin Delivery System
V-Go (wearable insulin delivery device; 20/30/40 options)
MiniMed System (examples: 530G, 630G, 670G) — tubed insulin pumps
t:slim X2 Insulin Pump — tubed insulin pump
Insulin agents (examples listed as therapeutic alternatives) — human insulins, insulin analogs, rapid-acting and intermediate agents; may vary by formulary

Jurisdiction / Line of business	Step therapy bypass
Illinois — HIM
Per Illinois HB 5395 (effective 1/1/2026), the step therapy requirements for insulin delivery systems do not apply for Illinois HIM requests (step therapy bypass added)

Quantity Limits and Device Caps

V-Go quantity limit

ProductV-Go

Standard quantity limit30 devices per month

Exceeding standard limitRequests >30/month require clinical rationale and supporting documentation

Omnipod DASH/Omnipod 5 pod quantity limit

ProductsOmnipod DASH / Omnipod 5 Pods

Pod quantity limit10 Pods per month

Exceeding limitRequests >10 Pods/month require clinical rationale and supporting documentation

Site of Care

Note

Devices intended for home use; training and device handling required

Devices such as V-Go, Omnipod pods, and InPen are designed for outpatient/home use and require provider training; V-Go is a single‑use disposable adhered to the skin and Omnipod pods are worn on the body.

V-Go: patient-fillable, single-use disposable, adhered to skin.
Omnipod pods: worn on the body and replaced every 1–3 days.
Devices require provider-led training and initial programming as described in user guides.

Policy Summary

PayerCentene

PolicyInsulin Delivery Systems (V-Go, Omnipod, InPen)

Policy CodePolicy CP.PHAR.534

Change TypeCriteria and approval duration revisions

Effective Date06.01.21

Next Review Date

Key ActionPrior authorization is required for V-Go, Omnipod DASH, Omnipod 5, and InPen; ensure Omnipod 5 requests use product compatible with the plan-preferred CGM.

SourceLink

On This Page

Required documentation examples: office chart notes, blood glucose logs, HbA1c results, history of insulin administration method (continuous insulin delivery or multiple daily injections), and rationale for digital components when applicable (e.g., InPen).
For Omnipod 5 requests, documentation must indicate the product NDC compatible with the plan-preferred CGM when applicable.

Denial Risk

Non‑FDA Indications Risk

Non‑FDA approved (off‑label) indications that are not addressed in this policy are not authorized unless the provider supplies sufficient evidence of efficacy and safety per the plan's off‑label use policies. Absent such documentation, coverage may be denied.

Off‑label coverage references: CP.CPA.09 (commercial), HIM.PA.154 (ICHRA/marketplace), CP.PMN.53 (Medicaid).
Include peer-reviewed evidence or evidence of coverage documentation when requesting coverage for non‑FDA indications.

Billing Rule

Provider Documentation and Coding Guidance

Providers should reference current professional coding guidance before claim submission. Codes and NDCs listed in this policy are informational and their presence does not guarantee coverage; incorrect coding can result in claim denials.

Example HCPCS/CPT/HCPCS referenced (informational): A9274, E0784, A4211.
Example NDCs (informational) include: Omnipod DASH and Omnipod 5 NDCs (e.g., 08508200005, 08508300021, 08508300088, 08508300042) and InPen NDCs (e.g., 62088000031-62088000036).
Providers must verify code applicability and payer billing rules for the member's line of business prior to submission.

Step Therapy

Step Therapy / Prior Method Requirement

Step therapy / prior method requirement: Member must have used either a continuous insulin delivery system or multiple daily injections for at least the required duration with supporting documentation, unless an applicable state-specific exception applies.

Required prior method: continuous insulin delivery system OR multiple daily insulin injections for at least the last 3 months (documentation required of administration frequency and evidence of suboptimal control when applicable).
Illinois HIM: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (step therapy bypass).
Oregon: prescriber endocrinologist requirement may be waived due to shortage per policy notes.

CGM (alternate casing)

Term variantCGM (lowercase)

Definitioncontinuous glucose monitoring

UsageUsed interchangeably with CGM in policy language and criteria.

CSII (definition)

AcronymCSII

Definitioncontinuous subcutaneous insulin infusion

ContextUsed to describe insulin pump therapy in device classifications and criteria.

InPen (definition & references)

DeviceInPen System

Regulatory referenceFDA 510(k) summary referenced (K160629).

Manufacturer resourcesInPen System Instructions for Use referenced for device operation and handling.

Initial Device Approval - Omnipod 5 CGM compatibility:

4. Omnipod 5 requests require use of the Omnipod 5 product compatible with the health-plan preferred CGM (specific NDCs for Medicaid and HIM noted in policy).

Initial Device Approval - Quantity limits and device frequency: 5. Quantity limits for initial approval: V-Go ≤30 devices/month; Omnipod DASH/Omnipod 5 ≤10 Pods/month and ≤1 device per 4 years; InPen ≤1 system/year.

Initial Device Approval - Documentation: 6. Provider must submit supporting documentation (office notes, lab results) demonstrating criteria are met.

Initial Device Therapy Requirements

Device-specific initiation and programming requirements

Omnipod DASH initial use: Provider recommends initial program settings and meets with the patient and an Omnipod System Trainer to program the PDM device and first Pod; PDM primes and activates the Pod per user guide.

V-Go initiation and filling: V-Go is a single-use disposable device filled with U-100 fast-acting insulin (Humalog/Novolog tested); follow user guide for filling (EZ Fill), storage, and 24-hour wear instructions.

Pod filling and capacity: Pods must be filled with at least 85 units of rapid-acting U-100 insulin; Pod capacity accommodates 85 to 200 units depending on need; Pod replacement typically every 1 to 3 days.

InPen dosing and programming: InPen dosing ranges from 0.5 to 30 units per injection (doses >30 units must be split); a healthcare professional must provide patient-specific insulin-to-carb ratios and insulin sensitivity parameters to program the calculator-based dosing in the InPen app prior to use.

Initial Device Approval — Operational Rules

Operational and duration rules for initial device approvals

Omnipod DASH/Omnipod 5 operational duration: Initial approval duration for Omnipod DASH and Omnipod 5 Pods is operationally set to 30 days; device replacement frequency limit of 1 per 4 years is enforced in criteria.30 days; 1 per 4 years

Medicaid/HIM duration exception: For Medicaid and HIM lines of business, initial approval duration for V-Go and Omnipod Pods was revised from 6 months to 12 months (see approval duration table).

Device limit moved to criteria: The device limit (1 per 4 years) was moved from approval duration to explicit criteria to reflect benefit programming constraints.

Continued Device Therapy - Quantity limits: 5. Continuation quantity limits: V-Go ≤30 devices/month; Omnipod DASH/Omnipod 5 ≤10 Pods/month and ≤1 device per 4 years; InPen ≤1 system/year.

Continued Device Therapy - Approval duration: 6. Approval durations for continuation vary by line of business (see policy approval duration section for Medicaid/HIM/Commercial differences).

Omnipod DASH/Omnipod 5 device limit

DeviceOmnipod DASH / Omnipod 5 PDM/device

Device limit1 device per 4 years

Policy noteDevice limit was moved from approval duration into explicit criteria; approval duration operationally set to 30 days

InPen quantity limit

ProductInPen system

Quantity/limit1 system per year

Operational noteRequests should not exceed 1 system/year per coverage criteria

Pod fill capacity

Pod fill capacity range85 to 200 units per Pod (minimum 85 units per Pod fill; maximum 200 units per Pod/day)

Maximum dose per PodMaximum 200 units per day (1 Pod)

Insulin types testedRapid-acting U-100 insulin analogs tested and referenced for Pod use (e.g., insulin glulisine, insulin lispro, insulin aspart)