Clinical Policy: Insulin Delivery Systems (V-Go, Omnipod, InPen)
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Prior authorization and medical necessity criteria for wearable and smart insulin delivery systems (V-Go, Omnipod variants, InPen) for Ambetter Georgia members across commercial, HIM, and Medicaid lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Approval — Omnipod GO
Covered when ALL of the following are met for Omnipod GO
Policy I.A items 1-8 and quantity limit guidance
Initial Approval — V-Go, Omnipod DASH, Omnipod 5, InPen
Covered when ALL of the following are met for V-Go, Omnipod DASH, Omnipod 5, or InPen
Policy I.B items 1-3
Device-specific age limits (Policy I.B items 4-6)
Policy I.B item 7 with sub-criteria
Policy I.B items 8-10
Policy I.B items 11 and 16
Initial therapy nodes
Initial coverage criteria differ for Omnipod GO versus other devices; see device-specific nodes below
Consolidated initial therapy requirements per Policy I.A and I.B
Omnipod 5 initial therapy notes
Device-specific initial use details for Omnipod 5
Omnipod 5 dosing and operation: Appendix C dosing/regimen
InPen initial therapy notes
Device-specific initial use details for InPen
Appendix C: Dosage and Administration details
Continued Therapy
Continuation of therapy covered when ALL of the following are met
Policy II.A items 1-3
Policy II.A item 4
Continued Therapy (Diabetes Mellitus)
Covered when ALL of the following are met for continued therapy:
Policy II.A
Continuation
Continued therapy / continuation requirements for members already receiving covered devices
Policy II.A continuation criteria
Continuation Therapy
Continuation requirements for members already receiving covered devices:
Policy II.A
Other Diagnoses/Indications
For other diagnoses/indications, coverage requires meeting one of the following:
Policy I.C and II.B routing to formulary/non-formulary/off-label policies
If the requested use is not listed under the policy’s Diagnoses/Indications or the request does not meet the exceptions for recent label changes, the request should be routed per the policy’s referral rules. Specifically, when a drug/device has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage or non‑formulary policy for the member’s line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/PDL items or CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary items). If the requested use is not listed and no recent label change applies, refer the request to the applicable off‑label use policy for the line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).
Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the provider supplies sufficient documentation of safety and efficacy consistent with the applicable off‑label use policy or evidence‑of‑coverage documents. Refer to CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid) when evaluating requests for off‑label uses.
No explicit exclusion conditions are present in this excerpt. Appendix headings indicate there are contraindications and boxed warnings in the full appendices, but specific exclusion statements are not provided in the section of the policy reviewed here.
Per the policy revision history, the original Omnipod product was removed from the policy because the manufacturer indicated it will no longer be available in the U.S. after 12/31/23. New Omnipod variants (e.g., Omnipod GO) and their corresponding criteria were added during that update.
Within the provided excerpt there are no statements designating any devices or indications as not medically necessary. Contraindications and boxed warnings are referenced by appendix headings, but the policy segment reviewed does not include explicit 'not medically necessary' language.
Initial Therapy Criteria
Initial therapy nodes
Planner duplicate of initial therapy nodes
Initial Approval — Omnipod GO
Covered when ALL of the following are met for Omnipod GO
Policy I.A (items 1-7, pod quantity statement)
Initial Approval — V-Go, Omnipod DASH, Omnipod 5, InPen
Covered when ALL of the following are met for V-Go, Omnipod DASH, Omnipod 5, or InPen
Policy I.B items 1-3
Device-specific age limits
Policy I.B item 7 with sub-criteria
Monitoring and training requirements
Policy I.B items 11-16
Omnipod 5 initial therapy notes
Device-specific initial use details where present
Appendix C: Omnipod 5 dosing and CGM requirements
InPen initial therapy notes
InPen setup and administration
Appendix C: InPen dosing, handling, and replacement
Continuation / Continued Therapy
Continued Therapy
Continuation of therapy covered when ALL of the following are met
Policy II.A.1 (continuity of care)
Policy II.A.2-3
Policy II.A.4 and quantity‑limit rationale requirements
Continued Therapy (Diabetes Mellitus)
Covered when ALL of the following are met for continued therapy:
Policy II.A (Diabetes Mellitus continuation)
Continuation
Continuation requirements for members already receiving covered devices:
Policy II.A continuation requirements and documentation for higher quantities
Continuation Therapy
Continuation of therapy covered when ALL of the following are met
Policy II.A continuation therapy
Continued therapy: required documentation and quantity limits
For continuation requests for diabetes mellitus, submit documentation showing the member currently receives the device via the Centene benefit or previously met initial approval (or is in a continuity-of-care situation), is responding positively to therapy, is adherent to follow-up/training, and that the requested quantity meets device-specific limits (V‑Go ≤ 30 devices/month; Omnipod DASH/Omnipod 5/Omnipod GO ≤ 10 Pods/month; InPen ≤ 1 system/year). Requests exceeding the stated quantities must include a clinical rationale with supporting documentation.
- Evidence of current benefit coverage or prior approval status
- Clinical notes documenting positive response to therapy
- Records of attendance/adherence to provider follow-up and training
- Quantity requested with calculation against device limits; clinical rationale and supporting documentation if exceeding limits
Authorization risks: documentation, non‑FDA uses, and coding
Prior authorization is required for covered insulin delivery systems; incomplete requests lacking supporting clinical documentation (office chart notes, lab results, or other information showing the member meets all approval criteria) may be denied. Non‑FDA uses not addressed in this policy are not authorized unless supported by the applicable off‑label use/non‑formulary policy. Also ensure claims reference the HCPCS/NDC coding listed in the policy to avoid coding‑related claim issues.
- Provide office/chart notes, lab results, or other clinical information that demonstrate the member meets the policy approval criteria
- Route non‑listed or recently changed label uses per the referenced off‑label/no‑coverage policies
- Verify and include appropriate HCPCS/NDC codes on claims to prevent coding-related denials
Quantity Limits and Usage
Coding & Identifiers
| No codes listed |
| 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 |
| 08508200032 | Omnipod DASH Intro Kit |
| 08508300021 | Omnipod 5 G6 Refill 5 Pack Pods |
| 08508300001 | Omnipod 5 G6 Intro Kit |
Coding-related denial risk — include referenced HCPCS/NDC codes
Claims or requests may be affected or denied if submitted coding does not reference the HCPCS (A9274, E0784, A4211) or device NDCs listed in the policy; providers should verify and include the appropriate codes on requests/claims.
Provider Actions & Prior Authorization
Prior authorization required for listed insulin delivery systems
Prior authorization is required for all requests for V-Go, Omnipod DASH, Omnipod 5, Omnipod GO, and InPen; the provider must submit documentation showing the member meets all applicable policy criteria.
- Submit clinical documentation (office chart notes, lab results, etc.) demonstrating all approval criteria are met
Prior authorization guidance — include HCPCS/NDC codes on PA requests
Follow the plan's prior authorization process and reference the policy's coding guidance; insulin delivery systems and supplies in this policy reference HCPCS (A9274, E0784, A4211) and multiple device NDCs — include relevant codes on the PA request.
Approval duration and quantity limits — per line of business and device
Approval durations and device quantity limits vary by line of business: Medicaid/HIM approvals are typically 12 months for devices/pods (V-Go, Omnipod DASH/Omnipod 5/Omnipod GO pods, InPen), while Commercial approvals are typically 6 months (or to member renewal date) with device replacement intervals as noted. Quantity ceilings: V‑Go ≤ 30 devices/month; Omnipod Pods ≤ 10/month; InPen ≤ 1 system/year.
- Medicaid/HIM: typically 12 months for pods/devices (device replacement intervals specified per device)
- Commercial: typically 6 months or to member renewal date
- Quantity limits: V-Go ≤30/month; Omnipod pods ≤10/month; InPen ≤1/year
Document the exact device model/kit configuration on requests
When requesting coverage, document the specific device model or kit configuration (for example: Omnipod 5 Intro Kit, Omnipod 5 Refill 5 Pack Pods, V‑Go 20/30/40, Omnipod GO pack sizes, InPen model/color) to match policy product availability listings.
- List product kit names and pack sizes (e.g., Omnipod 5 Intro Kit, Omnipod 5 Refill 5 Pack Pods, V-Go 20/30/40, Omnipod GO pack options)
- Include device NDC when available
Prior insulin method — document 6 months of prior method
For non-Omnipod GO device requests, the member must have used either a continuous insulin delivery system or multiple daily injections for at least the last 6 months prior to approval; documentation must show prior method and duration.
- If multiple daily injections, document at least 3 daily injections of basal and bolus regimen and evidence of suboptimal control as defined in the policy
- If prior continuous insulin delivery, reference Appendix B examples and document duration
Therapeutic alternatives — document trials or rationale for bypassing alternatives
Therapeutic alternatives (other insulin pumps, insulin formulations, and non‑insulin antidiabetic agents) are listed in the appendices and may be considered; providers should document rationale if an alternative was tried or is not appropriate.
- Document prior trials of alternative insulin delivery methods or antidiabetic agents when relevant
- Provide clinical rationale if alternatives are contraindicated or have failed
No step therapy rules included in this excerpt
No step therapy rules are specified in this excerpt; do not apply additional step requirements beyond those explicitly stated in the policy.
Step therapy — no specific rules provided here
Policy history and template notes reference step therapy-related changes but do not define specific step therapy rules in this section; rely on the policy's explicit requirements for approval decisions.
Required documentation — submit clinical notes, labs, BG data, and education records
Provider must submit office chart notes, lab results, and other clinical information to show the member meets all approval criteria; incomplete requests lacking this documentation may be denied.
- Include chart notes, glucose monitoring data, HbA1c results, and documentation of education/training completion
- For InPen, include justification for digital component when required
Denial risk if clinical documentation is missing or incomplete
Requests missing clinical documentation that demonstrates the member meets all approval criteria (e.g., chart notes, lab results, evidence of prior therapy, training completion) may be denied; ensure documentation of positive response, adherence, and quantity rationale when applicable.
- Absence of proof of prior method use or duration (6 months) risks denial
- Failure to document response to therapy or training adherence risks denial
Label change or off-label requests — follow referenced formulary/off‑label policies
If the product had a label change within the last 6 months or the requested use is not listed in the policy, route the request per the referenced formulary/non‑formulary or off‑label use policies for the applicable line of business.
- For formulary drugs with recent label changes, follow no coverage/non‑formulary policy references (CP.CPA.190, HIM.PA.33, CP.PMN.255)
- For non‑formulary or off‑label uses, follow the indicated off‑label or non‑formulary policies
Include device availability and pack/kit names in requests
Include product availability details (e.g., Omnipod 5 Intro Kit, Omnipod 5 Refill 5 Pack Pods, InPen model/color, V‑Go 20/30/40, Omnipod GO pack options) in the PA request so the plan can match the request to listed items.
- List exact pack size or kit and, when available, NDC for the requested product
Documentation and coding guidance — verify HCPCS/NDCs and professional coding rules
Follow the policy's coding guidance: reference the HCPCS and NDC listings and consult up‑to‑date professional coding sources prior to claim submission; coverage remains subject to benefit terms, exclusions, and limitations.
Definitions
Background
Insulin delivery systems are wearable or handheld devices that provide subcutaneous basal and/or bolus insulin to manage diabetes mellitus. Examples covered by this policy include disposable patch pumps (Pods) that provide preset basal delivery with on‑demand boluses, wearable disposable devices that deliver continuous basal infusion with bolus capability, and smart insulin pen systems that log doses and pair with mobile apps. Device features vary: some systems (e.g., Omnipod 5) integrate with a compatible continuous glucose monitor to enable automated insulin adjustments, while others (e.g., V‑Go, Omnipod GO) provide preset basal options and bolus dosing appropriate to their FDA‑approved populations.
Site of Care
No site‑of‑care restrictions specified
No site‑of‑care restrictions are specified in this portion of the policy; devices are intended for outpatient/home use unless other benefit terms apply.
Home use — outpatient/home setting with initial provider training required
Devices are intended for outpatient/home use; initial provider training/programming as appropriate per the device user guide should be documented in the request when relevant to safe use.
- Document completion of physician‑directed comprehensive diabetes management program or device training
- For Omnipod 5/InPen, include device setup or app/CGM connection details if applicable
Home use — devices designed for ambulatory/home use (waterproof/tubeless details)
Devices are designed for ambulatory/home use; Omnipod is tubeless and waterproof allowing placement similar to injection sites — include user‑guide–recommended placement and wear‑time information when relevant to the request.
- Omnipod Pod wear time: up to 3 days; Pod capacity 85–200 units
- Note tubeless, waterproof design when documenting suitability for home use
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