ModifiedPremera BluecrossPolicy 5.01.648

Insulin Therapy

Defines medical and pharmacy benefit coverage criteria for insulin products (vials, pens, and select pump-administered insulin) across multiple Premera formulary plan types and specifies diagnostic criteria for diabetes relevant to coverage.

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy

Policy CodePolicy 5.01.648

Change TypeMaterial updates to codes, formulary sections, and product listings

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionRequest a non‑formulary exception or prior authorization when prescribing non-preferred or investigational insulin products per the member's formulary section.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS codes J1813 and J1814 for Lyumjev.

Added Afrezza (insulin human) as a non-preferred rapid-acting insulin across all sections.

Added Kirsty (insulin aspart-xjhz) as a non-preferred rapid-acting insulin across all sections.

Removed Levemir from the policy as it has been withdrawn from the market.

Added separate coverage criteria and formulary distinctions for Metallic (individual/small group/student ISHIP) and clarified sections for other formulary plan groups.

3formulary sections

~30+listed insulin products

Lyumjev managed bothdrug benefit routing

>=6.5%A1C diagnostic threshold

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J1813,J1814HCPCS codes added

Coverage criteria and policy scope

Formulary-specific coverage logic

Covered when conditions below are met, varying by formulary section and insulin product class.

Section 1 - Open, Preferred, and Select (and plans with no pharmacy benefit): Preferred first-line insulins listed do not require pre-approval. Non-preferred insulins are considered medically necessary when the individual has a diagnosis of type 1 or type 2 diabetes and has a contraindication or intolerance to the preferred insulin OR the non-preferred insulin was ineffective in reducing A1C to goal after three months of therapy.A1C goal failure after 3 months

Long-acting non-preferred insulins may require contraindication/intolerance to TWO preferred insulins for medical necessity in some cases.

Section 2 - Essentials and HCLV: Preferred first-line insulins listed do not require pre-approval. Non-preferred insulins are considered medically necessary when the individual has a diagnosis of type 1 or type 2 diabetes and has a contraindication or intolerance to the preferred insulin OR the non-preferred insulin was ineffective in reducing A1C to goal after three months of therapy.A1C goal failure after 3 months

Long-acting non-preferred insulins require contraindication/intolerance to TWO preferred insulins.

Section 3 - Individual/Small Group/Student ISHIP METALLIC: Preferred first-line insulins listed do not require pre-approval. Non-preferred insulins are considered medically necessary when the individual has a diagnosis of type 1 or type 2 diabetes and has a contraindication or intolerance to the preferred insulin OR the non-preferred insulin was ineffective in reducing A1C to goal after three months of therapy.A1C goal failure after 3 months

Applies to listed pen and vial products in Section 3.

Investigational / Not medically necessary

Investigational uses: All other uses of the drugs for conditions not listed in this policy are considered investigational.

May lead to denial for those indications.

Not medically necessary uses: All other uses of the drugs for approved conditions listed in this policy are considered not medically necessary.

Formulary Sections and Applicability

Coverage and formulary distinctions are defined by policy Sections mapped to specific Rx plans; medications are designated preferred or non-preferred and some drugs moved from a prior policy.

Formulary section applicability: Section 1 includes Incentive, Open, and Select formulary plans (Rx plan A1, A2, B3, B4, C4, F1, and G3) and plans with no pharmacy benefit coverage. Section 2 includes Essentials formulary plans (Rx plan E1, E3, and E4). Section 3 includes Metallic formulary plans (Rx plan M1, M2, and M4).

Coverage, preferred/non-preferred status, and any prior authorization requirements depend on the member's plan section.

Non-preferred Insulins and Exception Policy

Non-preferred designations and exceptions

Non-preferred insulin designations: Afrezza (insulin human) and Kirsty (insulin aspart-xjhz) were added as non-preferred rapid-acting insulins across all sections; multiple other products were listed as non-preferred for Metallic plans specifically.

Non-formulary exception reviews for listed drugs may be approved up to 12 months.

All uses of the drugs for conditions not listed in this policy are considered investigational and may be denied. This policy’s formulary-specific sections list the covered indications and circumstances under which listed insulin products are considered medically necessary; any use outside those listed conditions does not meet medical necessity criteria.

This policy does not apply to Medicare Advantage plans. Coverage, preferred/non-preferred status, and any prior authorization requirements described here are for the specified Premera formulary plan groups and do not govern Medicare Advantage benefit determinations.

All other uses of the drugs for otherwise approved conditions listed in this policy are considered not medically necessary. Non-formulary exception reviews may be approved up to 12 months, and other reviews for listed drugs may be approved for up to 3 years, subject to documentation that the individual continues to show a positive clinical response.

No additional coverage statements are provided for this placeholder section.

Billing and diagnostic codes

HCPCS codes for LyumjevHCPCS

J1813	Insulin (Lyumjev) for administration through DME (i.e., insulin pump) per 50 units.
J1814	Insulin (Lyumjev) per 5 units.

Added HCPCS CodesHCPCS

J1813	HCPCS code added for Lyumjev (per policy history)
J1814	HCPCS code added for Lyumjev (per policy history)

Diabetes diagnostic criteria — A1C, FPG, OGTT, random glucose thresholds

A1CGreater than or equal to 6.5% (>=48 mmol/mol); test performed in a laboratory using an NGSP‑certified method standardized to the DCCT assay

Fasting plasma glucose (FPG)Greater than or equal to 126 mg/dL (>=7.0 mmol/L); fasting defined as no caloric intake for at least 8 hours

2‑hour plasma glucose (OGTT)Greater than or equal to 200 mg/dL (>=11.1 mmol/L) during a 75 g OGTT performed per WHO guidance

Random plasma glucose (with classic symptoms)Greater than or equal to 200 mg/dL (>=11.1 mmol/L) at any time of day in an individual with classic hyperglycemia symptoms or hyperglycemic crisis

Fasting plasma glucose (FPG) threshold

FPG diagnostic threshold

Prior authorization, documentation, and prescribing guidance

Prior Authorization

Prior Authorization and Exceptions

Prior authorization is required for non-preferred and non-formulary insulin products; preferred insulins listed for the member's formulary section do not require pre-approval. Non-formulary exception reviews may be approved for up to 12 months. For continuation/re‑authorization, chart notes must document continued positive clinical response and coverage criteria must be met; routine reauthorizations (when criteria met) may be approved for up to 3 years.

Premera formulary sections determine which insulin products are preferred (first‑line) vs non‑preferred (require prior authorization or failure of preferred products).
Non‑formulary exception duration: may be approved up to 12 months.
Re‑authorization: chart notes must demonstrate continued positive clinical response; when criteria met, approvals may be issued for up to 3 years.
Prescribing must follow the product's FDA dosing and administration information; consult the member’s benefit booklet or ID card for plan‑specific coverage (Section 1, Section 2, Section 3 distinctions).
HCPCS codes J1813 and J1814 apply to Lyumjev for DME administration/pump billing (see coding).

Clinical background

Diabetes is a disorder of glucose metabolism resulting from defects in insulin production (type 1) or insulin action (type 2). Insulin replacement is required for individuals with type 1 diabetes and may be necessary for individuals with type 2 diabetes when glycemic control is inadequate with other therapies. This policy defines when specific insulin formulations (vials, prefilled pens, and select pump-administered products) are considered medically necessary across Premera formulary sections and links coverage to documented diagnosis and treatment response per the product’s FDA prescribing information.

Definitions and staging

Type 1 diabetes — pancreas no longer makes insulin; requires external insulin

DefinitionPancreas no longer makes insulin due to beta‑cell destruction; requires external insulin

Typical onsetUsually diagnosed in children and young adults

Clinical implicationInsulin replacement is required for treatment

Type 2 diabetes — insulin resistance with persisting production; may require insulin therapy

DefinitionPersisting insulin production with insulin resistance; bodies do not respond well to insulin

Age of onsetCan be diagnosed at any age

Treatment implication

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy

Policy CodePolicy 5.01.648

Change TypeMaterial updates to codes, formulary sections, and product listings

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionRequest a non‑formulary exception or prior authorization when prescribing non-preferred or investigational insulin products per the member's formulary section.

SourceLink

On This Page

Greater than or equal to 126 mg/dL (>=7.0 mmol/L)

Fasting definitionNo caloric intake for at least 8 hours

Confirmatory testingIn absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results obtained at the same time or at two different time points

2-hour plasma glucose (OGTT) threshold

2‑hour OGTT diagnostic thresholdGreater than or equal to 200 mg/dL (>=11.1 mmol/L) during a 75 g oral glucose tolerance test

OGTT procedureTest performed as described by WHO using a glucose load equivalent to 75 g anhydrous glucose dissolved in water

Alternative OGTT criteria (stage 2 context)30-, 60-, or 90‑min plasma glucose >=200 mg/dL used in some trials for adults (confirmatory testing may be required)

Random plasma glucose (with symptoms) threshold

Random plasma glucose threshold (with symptoms)Greater than or equal to 200 mg/dL (>=11.1 mmol/L) in an individual with classic symptoms of hyperglycemia or hyperglycemic crisis

TimingRandom = any time of day without regard to time since previous meal

Confirmatory requirementIf hyperglycemia is not unequivocal, confirm with additional abnormal test results

Stage 2 FPG range (Type 1 diabetes staging)

Stage 2 FPG rangeFasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L)

Associated 2‑h PG range2‑hour plasma glucose 140–199 mg/dL (7.8–11.0 mmol/L)

Clinical contextStage 2 characterized by autoimmunity plus dysglycemia and is presymptomatic

A1C for Stage 2 dysglycemia

A1C range for Stage 2 dysglycemiaA1C 5.7–6.4% (39–47 mmol/mol) or a greater than or equal to 10% increase in A1C

AssociationStage 2 requires islet autoantibodies (usually multiple) plus dysglycemia (IFG and/or IGT)

Use in trialsAlternative OGTT time‑point criteria (30/60/90 min) have been used in adults with confirmatory testing

Note

Formulary / Prior Authorization Mapping

Formulary mapping: coverage and prior authorization requirements differ by formulary section (Section 1: Open/Preferred/Select and plans with no pharmacy benefit; Section 2: Essentials; Section 3: Metallic individual/small group/student ISHIP). Preferred‑tier insulins listed under a member’s specific section do not require pre‑approval. Non‑preferred insulins are subject to prior authorization and, when applicable, require documented intolerance, contraindication, or clinical failure of preferred agents (typically after ~3 months at therapeutic dose unless otherwise clinically indicated).

Section 1 (Open/Preferred/Select and plans with no pharmacy benefit): specified rapid‑acting, mix, and long‑acting insulins are first‑line and do not require pre‑approval; listed non‑preferred agents require failure/intolerance of preferred agents.
Section 3 (Metallic individual/small group/student ISHIP): has separate coverage criteria; preferred agents for Section 3 are noted and non‑preferred agents require prior authorization.
Refer to member’s Rx Plan (e.g., A1, A2, B3, B4, C4, F1, E1/E3/E4, M1/M2/M4) to determine which products are preferred for that member.

Step Therapy

Preferred‑First / Failure‑Based Coverage

Preferred‑first and failure‑based coverage: members should be trialed on preferred insulins listed for their formulary section before non‑preferred products will be approved, unless there is documented intolerance or contraindication. For long‑acting insulins in certain sections, two preferred agents may need to be tried before coverage of specified non‑preferred long‑acting products is considered.

Preferred‑first: preferred insulins in the member’s formulary section are treated as first‑line and do not require prior approval.
Failure‑based: non‑preferred agents require documentation of contraindication/intolerance to the preferred agent OR inadequate glycemic control after ~3 months of therapy at an appropriate dose.
Examples: some long‑acting non‑preferred insulins require trial and failure of TWO preferred long‑acting insulins before approval is considered.

Step Therapy

Formulary Tiers and Step Edits

Formulary tiers and step edits may be applied consistent with the member’s Rx plan: Section 1 (Incentive/Open/Select), Section 2 (Essentials), Section 3 (Metallic). Step therapy and tier placement determine prior authorization and coverage pathways; always verify plan‑specific tiering through the member benefit.

Section distinctions (1/2/3) affect which products are preferred vs non‑preferred.
Step edits: when applied, require trial of lower‑tier/preferred insulin before higher‑tier or non‑preferred products are approved.
Verify formulary tier for the member’s specific Rx plan (ID card or plan booklet).

Documentation Required

Re‑authorization Documentation Requirements

Re‑authorization documentation must include chart notes demonstrating that the individual continues to have a positive clinical response to therapy (e.g., improved/maintained A1C, fewer hypoglycemic events, or other clinically relevant benefit).

Reauthorization approvals may be issued for up to 3 years when criteria are met and documentation demonstrates continued benefit.
Non‑formulary exception reauthorizations may be approved up to 12 months provided ongoing clinical benefit is documented.

Denial Risk

Investigational Uses and Prescribing Guidance

Uses of insulin products not listed in this policy or not supported by the policy’s coverage criteria are considered investigational/unproven and may be denied. Prescribers should follow FDA‑approved indications and dosing; for off‑label requests include supporting clinical rationale and evidence.

Investigational uses not described in this policy are subject to denial.
When seeking coverage for off‑label use, submit clinical justification and relevant literature.
Follow FDA dosing/administration guidance for all covered insulin products.

May require insulin therapy when glycemic control is inadequate with other measures

FPG definition and fasting instructions

FPG termFasting plasma glucose (FPG)

Fasting instructionFasting defined as no caloric intake for at least 8 hours

UsageUsed as one of the diagnostic criteria for diabetes when >=126 mg/dL

Type 1 diabetes stages — Stage 1/2/3 descriptions

Stage 1Autoimmunity, normoglycemia, presymptomatic; diagnostic criteria include multiple islet autoantibodies and no IGT or IFG

Stage 2Autoimmunity with dysglycemia (IFG and/or IGT); FPG 100–125 mg/dL, 2‑h PG 140–199 mg/dL, A1C 5.7–6.4% or >=10% increase

Stage 3Autoimmunity with overt hyperglycemia and symptomatic diabetes; meets standard diagnostic criteria for diabetes