Currentblue cross blue shield - louisianaPolicy 00395

Non-long acting insulins (non-preferred products and concentrated insulins)

This policy governs coverage eligibility for non-long acting insulin products (excluding Novolog, Novolin, and Fiasp families) for members of Blue Cross and Blue Shield of Louisiana and HMO Louisiana, Inc., and addresses use of concentrated insulin formulations with external insulin pumps.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyNon-long acting insulins (non-preferred products and concentrated insulins)

Policy CodePolicy 00395

Change TypeAdded coverage restriction for concentrated insulin use in external pumpsadded Merilog

Effective DateJan 1, 2014

Next Review DateMay 1, 2027

Key ActionObtain prior authorization and document that preferred Novolin/Novolog/Fiasp were ineffective or caused adverse reaction; prescriber must attest concentrated insulin will not be used in an external pump when pump use is not FDA‑approved.

SourceLink

POLICY UPDATE CHANGES

Added new criterion requiring that concentrated insulin products will not be used in an external insulin pump.

Added Merilog as a non-preferred product to the policy.

U-100Standard insulin concentration compatible with external pumps

U-200/U-300/U-500Concentrated insulin formulations referenced

MerilogNew rapid-acting biosimilar added

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial coverage eligibility

Covered when ALL of the following are met:

Patient selection criterion: (1) There is clinical evidence or patient history that suggests the use of the Novolin, Novolog, or Fiasp family of products will be ineffective or cause an adverse reaction to the patient; AND (2) For Lyumjev Kwikpen U-200 and Humalog Kwikpen U-200 requests: Prescriber attests that the requested concentrated insulin will not be used in an external insulin pump when pump administration is not included in the FDA-approved labeling of the requested concentrated insulin product, or when use of concentrated insulin is not in accordance with the pump's FDA-cleared instructions for use.

Humulin U-500 is not subject to this policy.

Use of concentrated insulin in an external insulin pump is considered investigational and not covered when pump administration is not included in the concentrated insulin product's FDA-approved labeling or when use is not in accordance with the pump's FDA-cleared instructions for use. The policy requires that requests for concentrated insulins (for example, Lyumjev Kwikpen U-200 and Humalog Kwikpen U-200) include a prescriber attestation that the product will not be used in an external insulin pump unless such use is explicitly supported by the insulin's FDA labeling or the pump manufacturer's FDA-cleared instructions.

The policy states that the use of non-long acting insulin products other than the Novolin, Novolog, or Fiasp families is considered not medically necessary when the patient selection criterion is not met. Coverage for non-preferred, non-long acting insulins requires documentation that the preferred families would be ineffective or cause an adverse reaction; absent that documentation, requests will be denied as not medically necessary.

Coding and Definitions

Insulin concentration compatibility — external insulin delivery devices

Compatibility statementExternal insulin delivery devices (CSII) are compatible only with rapid-acting U-100 insulin formulations.

Risk of concentrated insulin in pumpsConcentrated formulations (U-200, U-300, U-500) may cause dosing errors or unpredictable insulin delivery when used in devices calibrated for U-100.

Manufacturer safeguards absentManufacturers have not provided dosing safeguards or validated algorithms for non-U-100 insulin within product labeling.

Regulatory/labeling implicationPer FDA-approved labeling and FDA-cleared manufacturer instructions, concentrated insulin products must not be administered using an insulin pump.

Concentrated insulins — definition

Definition

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required when substituting a non-preferred or concentrated insulin product for the Novolin®, Novolog®, or Fiasp® families. Documentation must demonstrate that benefits are available and medical necessity criteria are met, including clinical evidence or patient history indicating that Novolin/Novolog/Fiasp products would be ineffective or cause an adverse reaction.

Applies to non-long acting insulin products other than the Novolin, Novolog, or Fiasp families (examples: Humulin, Humalog, Insulin Lispro [Authorized Generic], Insulin Aspart [Authorized Generic], Apidra, Afrezza, Lyumjev, Admelog, Merilog).
Humulin U-500 is excluded from this policy.

Documentation Required

Prescriber Attestation for Concentrated Insulin

Prescribers must attest that requested concentrated insulin (e.g., Lyumjev Kwikpen U-200, Humalog Kwikpen U-200) will not be used in an external insulin pump when pump administration is not included in the concentrated insulin's FDA-approved labeling or is not consistent with the pump's FDA-cleared instructions for use.

Background

Insulin is available in multiple formulations and concentrations that affect dosing and delivery. U-100 is the standard concentration compatible with the widest range of delivery devices, including syringes, pens, and external insulin pumps. Concentrated formulations such as U-200, U-300, and U-500 contain more units per milliliter and, per FDA-approved labeling, must not be administered using an insulin pump. External insulin pumps (traditional tubed pumps and patch/tubeless systems) are calibrated for rapid-acting U-100 insulin; using concentrated insulins in these devices is off-label and may lead to dosing errors because manufacturers have not validated algorithms or provided dosing safeguards for non-U-100 formulations.

Revision History

2026-05-13Material policy changeLatest

Added new criterion requiring that concentrated insulin products will not be used in an external insulin pump (operationalizes investigational determination and coverage denial).

2026-02-11Background update

Updated background section and references.

2025-11-12Product list update

Policy Summary

Payerblue cross blue shield - louisiana

PolicyNon-long acting insulins (non-preferred products and concentrated insulins)

Policy CodePolicy 00395

Change TypeAdded coverage restriction for concentrated insulin use in external pumpsadded Merilog

Effective DateJan 1, 2014

Next Review DateMay 1, 2027

SourceLink

On This Page

Insulins formulated with greater than 100 units per milliliter (examples: U-200, U-300, U-500).

CharacteristicContain a higher number of units per mL compared with standard U-100, affecting dosing and delivery considerations.

Administration restrictionPer FDA-approved labeling, concentrated insulin formulations must not be administered using an insulin pump.

External insulin pumps (CSII) — definition and examples

DefinitionExternal insulin pumps are devices that provide continuous subcutaneous insulin infusion (CSII), including traditional tubed pumps and patch/tubeless pumps.

Examples — traditional (tubed)Tandem Diabetes Care systems (e.g., t:slim X2, Tandem Mobi) and Medtronic MiniMed systems.

Examples — patch/tubelessOmnipod systems (Omnipod 5, Omnipod DASH) and disposable patch pumps (e.g., CeQur Simplicity, V-Go).

Device calibrationCurrently available external insulin delivery devices are calibrated for rapid-acting U-100 insulin formulations.

External insulin pumps include tubed and tubeless systems (examples: Omnipod DASH®, Omnipod® 5, twiist™, Tandem t:slim X2™, Tandem Mobi™, Medtronic MiniMed™ 780G/770G/630G, iLet®).
Concentrated insulins are formulations >100 units/mL.

Note

Preference for Novolin/Novolog/Fiasp Families

The policy prefers the Novolin®, Novolog®, or Fiasp® families as first-line non-long acting insulin products. Non-preferred products will be considered eligible for coverage only when the patient selection criterion is met (clinical evidence or history showing Novolin/Novolog/Fiasp would be ineffective or cause harm). Requests that do not meet the criterion are considered not medically necessary.

Preference applies to non-long acting (prandial/bolus) insulins; long‑acting insulins (e.g., Lantus®, Levemir®) are not covered by this preference statement.
Coverage decisions require both evidence of contraindication/ineffectiveness and prior authorization.

Added new product Merilog to the policy as a non-preferred product.

2024-08-14Routine review

Medical Policy Implementation Committee approval; coverage eligibility unchanged.

2020-12-09Product update

Added the Authorized Generic Insulin Aspart and the new product Lyumjev to the list of non-preferred products.

2019-06-19Policy creation/approval

Medical Policy Implementation Committee approval; added the Insulin Lispro branded generic to the policy.