ModifiedPremera BluecrossPolicy N/A

Insulin Therapy

Criteria for coverage of insulin products (vials and prefilled pens) across multiple formulary plan types, documentation and coding requirements, and benefit assignment (which insulins are pharmacy vs medical benefit). Affects providers prescribing or requesting coverage for insulin for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy

Policy CodePolicy N/A

Change TypeFormulary updates & benefit assignment changes

Effective DateJan 1, 2025

Next Review DateDec 1, 2025

Key ActionWhen submitting for non-preferred insulin coverage, document diagnosis, prior trials or intolerance to preferred agents, and A1C response to support a non-formulary exception.

SourceLink

POLICY UPDATE CHANGES

Lyumjev (insulin lispro-aabc) is managed through the pharmacy and medical benefit while all other drugs in this policy are managed through the pharmacy benefit.

Added separate coverage criteria and non-preferred listings for specific formulary plan sections and added new non-preferred insulins (e.g., insulin lispro protamine mix 75/25, Merilog, Afrezza).

Removed Levemir from the policy because it was withdrawn from the market.

3formulary sections

up to 3 yrstypical approval duration

J1813,J1814HCPCS codes listed

A1C ≥6.5%

diagnostic threshold

1pharm/med benefit moves

severalhistory entries 2025

Coverage Criteria for Insulin Products

Formulary-based insulin coverage

Covered when ALL of the following are met for the applicable formulary section

Formulary selection: Member's coverage follows the formulary section (Section 1: Incentive/Open/Select; Section 2: Essentials; Section 3: ISHIP Metallic).

See member's plan booklet or ID card

Preferred agents: Listed first-line insulin products in the member's formulary section are covered without pre-approval.

Examples include rapid-, short-, intermediate-, mix, and long-acting agents named per section (see policy sections).

Non-preferred coverage conditions: Non-preferred insulin products are considered medically necessary only 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.3 months trial and A1C not at goal

Long-acting non-preferred agents may require intolerance/contraindication to two preferred insulins in some sections.

Approval duration

Length of approval rules

Initial authorization: Non-formulary exception reviews for drugs listed in this policy may be approved up to 12 months; all other initial authorizations may be approved for up to 3 years.

Re-authorization: Non-formulary exceptions may be re-authorized up to 12 months if drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response; other reauthorizations may be approved up to 3 years with documentation of continued benefit.

Coverage criteria excerpts

Covered when ALL of the following are met (policy excerpts in this window):

Benefit application: Lyumjev (insulin lispro-aabc) is managed through the pharmacy and medical benefit; all other drugs addressed in this policy are managed through the pharmacy benefit.

(See policy Benefit Application).

Diagnostic documentation: Diagnosis of diabetes requires laboratory evidence: A1C >= 6.5% (NGSP-certified) OR 2-h OGTT >= 200 mg/dL after 75 g load OR random plasma glucose >= 200 mg/dL with symptoms; in the absence of unequivocal hyperglycemia, two abnormal test results are required.A1C >= 6.5%; 2-h OGTT >= 200 mg/dL; random >= 200 mg/dL; FPG thresholds for IFG 100-125 mg/dL

(See Criteria for Diagnosis of Diabetes).

Product characteristics: Insulin agents are categorized by rapid-, short-, intermediate-, long-acting and combination products with specified onset, peak, and duration parameters which inform clinical selection and coverage.

All uses of drugs for conditions not listed in this policy are considered investigational.

Levemir (insulin detemir) has been removed from this policy because it was withdrawn from the market.

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

Initial Therapy Requirements

Initial therapy

Initial coverage rules per formulary section

Diagnosis requirement: Insulin is considered medically necessary when the individual has a documented diagnosis of type 1 or type 2 diabetes.

Preferred vs non-preferred: Preferred (first-line) insulins listed for the member's formulary section are covered without pre-approval; non-preferred insulins require a contraindication/intolerance to preferred agents or a documented failure to reach A1C goal after a three-month trial.3 months

Examples of first-line agents vary by section (see Section 1/2/3 lists).

Continuation and Re-authorization Criteria

Continuation therapy

Re-authorization rules

Continued use: Re-authorization requires meeting drug-specific coverage criteria and submission of chart notes demonstrating continued positive clinical response to therapy.

Reauthorizations may be approved up to 3 years (12 months for non-formulary exceptions).

Continuation/exception duration

Non-formulary exception authorization duration

Non-formulary exception duration: Non-formulary exception review authorizations for drugs listed in this policy may be approved for up to 12 months.

(Applies to all drugs in this policy).

Step Therapy and Preferred Agent Trials

Step	Requirement	Failure/Duration	Coverage Label
1
Trial of preferred insulin(s) unless contraindicated or intolerant; preferred (first-line) insulins listed per member's formulary section are covered without pre-approval
Ineffective in reducing A1C to goal after three months of therapy (3 months) — non-preferred products considered medically necessary only after trial and intolerance/contraindication to preferred agents
Coverage depends on formulary placement; non-preferred agents require documentation of intolerance/contraindication or 3-month failure to achieve A1C goal

Formulary Section	Preferred (first-line) examples	Non-preferred / step requirements	Coverage Label
Section 1: Incentive/Open/Select (Rx plans A1, A2, B3, B4, C4, F1, G3)
Rapid-acting (e.g., Fiasp, Novolog), mixes (e.g., Novolog Mix 70/30), long-acting (e.g., Lantus, Toujeo, Tresiba) — medications listed do not require pre-approval
Non-preferred agents added by history (e.g., insulin lispro protamine mix 75/25, Merilog, Afrezza) require intolerance/contraindication to preferred agents or failure after 3 months; some long-acting non-preferred agents may require intolerance to TWO preferred insulins
Formulary placement determines step/tier requirements; see member's plan for applicable section

Coding and Diagnostic Thresholds

HCPCS codes listedHCPCS

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

A1C Diagnostic Threshold

A1C diagnostic threshold>= 6.5% (NGSP-certified method)

DCCT standardizationTest should be performed using an NGSP‑certified method standardized to the DCCT assay

Confirmatory testingIn the absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results

Diabetes Diagnostic Thresholds

A1C>= 6.5% (>= 48 mmol/mol); NGSP-certified method

2‑hour OGTT (75 g)>= 200 mg/dL (>= 11.1 mmol/L) during OGTT per WHO procedure

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Benefit Assignment

Prior authorization requirements vary by product and member plan. Many insulins listed in Section 1 and Section 2 (including preferred rapid‑ and long‑acting agents) do not require prior authorization when used according to the formulary placement described in this policy. Some agents (including non‑preferred or specialty insulins and products billed through the medical benefit such as Lyumjev when administered in a clinical setting) may be managed under either the pharmacy or medical benefit and could require prior authorization. Always verify the member's specific plan (Rx Plan A1/A2/B3/B4/C4/F1/G3, E1/E3/E4, or M1/M2/M4) and benefit design before dispensing or administering.

Many formulary first‑ and second‑line insulins listed in Sections 1–3 do not require preapproval when used per formulary placement.
Lyumjev and other insulins administered in clinic may be billed to medical benefit and require medical‑benefit prior authorization.
Confirm benefit (pharmacy vs medical) and prior authorization rules for the member’s specific plan before claim submission.

Benefit Assignment and Site of Care Guidance

Billing Rule

Bill Lyumjev to medical benefit for pump/DME using HCPCS J1813/J1814

Lyumjev may be billed through the medical benefit for use with insulin pumps/DME using HCPCS codes J1813 (per 50 units) or J1814 (per 5 units); other insulins in this policy are managed through the pharmacy benefit and should be dispensed via retail or specialty pharmacy.

When billing medical benefit for pump administration of Lyumjev, use HCPCS J1813 or J1814 as appropriate.
All other insulins in this policy are managed through the pharmacy benefit unless otherwise specified.

Prior Authorization

Confirm Lyumjev benefit assignment (pharmacy vs medical) when submitting requests

Lyumjev is managed through both the pharmacy and medical benefits; confirm whether the member's coverage requires pharmacy dispensing or medical‑benefit billing when prescribing Lyumjev and include that determination in the authorization request.

Definitions and Disease Stages

Type 1 Diabetes

DefinitionAutoimmune destruction of pancreatic beta cells resulting in little or no endogenous insulin production

Treatment implicationRequires exogenous insulin for glucose utilization

Typical onsetUsually diagnosed in children and young adults

Type 2 Diabetes

DefinitionCharacterized by residual insulin production with target‑tissue insulin resistance

ContributorsInfluenced by lifestyle factors and comorbid conditions; can be diagnosed at any age

Treatment implication

Background

Diabetes is a metabolic disease resulting from abnormalities in insulin production, insulin action (resistance), or both. Type 1 diabetes results from autoimmune beta cell destruction leading to little or no endogenous insulin production and requires exogenous insulin for survival. Type 2 diabetes is characterized by insulin resistance with variable residual insulin secretion and may require insulin therapy when other treatments fail to achieve glycemic control.

Clinical staging of type 1 diabetes includes preclinical autoimmunity with normoglycemia (Stage 1), progression to dysglycemia (Stage 2) often identified by impaired fasting glucose, impaired glucose tolerance, or rising A1C, and symptomatic overt hyperglycemia meeting diagnostic criteria (Stage 3). These pathophysiologic stages guide clinical monitoring and the timing of insulin initiation.

Policy Revision History

2025-09-01interim_reviewLatest

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

2025-05-01interim_review

Updated policy section formatting to define Section 1 (Incentive/Open/Select), Section 2 (Essentials), and Section 3 (Metallic) for clearer formulary mapping.

2025-04-01interim_review

Removed Levemir from the policy because it was withdrawn from the market and added Merilog (insulin aspart-szjj) as a non-preferred insulin to applicable sections.

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy

Policy CodePolicy N/A

Change TypeFormulary updates & benefit assignment changes

Effective DateJan 1, 2025

Next Review DateDec 1, 2025

Key ActionWhen submitting for non-preferred insulin coverage, document diagnosis, prior trials or intolerance to preferred agents, and A1C response to support a non-formulary exception.

SourceLink

On This Page

(See Insulin Agents table).

Interchangeability guidance: Different brand-name insulin products can have similar pharmacokinetic profiles; switching between brands should be done in consultation with a physician and requires medical supervision with close glucose monitoring.

(See Insulin Interchangeability).

Formulary and non-preferred designations: Policy history documents placement of specific insulins into preferred and non-preferred lists across multiple formulary sections and additions/removals of agents; non-formulary exceptions may be approved up to 12 months.

(See History entries).

Fasting plasma glucose (FPG) / IFG range

FPG 100–125 mg/dL indicates impaired fasting glucose (IFG)

2‑hour plasma glucose for IGT2‑h PG 140–199 mg/dL indicates impaired glucose tolerance (IGT)

Random plasma glucose>= 200 mg/dL (>= 11.1 mmol/L) in an individual with classic symptoms of hyperglycemia

Note

Formulary Placement and Non‑Formulary Exception Duration

Formulary placement determines preferred vs non‑preferred status. Non‑formulary (non‑preferred) exception authorizations when granted are limited in duration — authorization approvals for non‑formulary exceptions for drugs listed in this policy may be approved for up to 12 months. Review the member’s specific formulary section (Section 1, Section 2, or Section 3) to determine whether a product is preferred or non‑preferred.

Non‑preferred (non‑formulary) insulins may require exception review prior to coverage.
Exception authorizations for drugs in this policy may be approved for up to 12 months.
Check the formulary section applicable to the member’s plan to confirm placement and any plan‑specific limits.

Step Therapy

Formulary Step/Failure Requirement

Coverage is subject to formulary step/failure requirements and the plan's tiering. For many plans, coverage of certain non‑preferred insulins requires prior trial and inadequate response or intolerance to preferred agents (typically documented failure to achieve A1C goals after an adequate trial of preferred insulin(s)).

Step/failure requirement generally: inadequate response (e.g., failure to reduce A1C to goal after ~3 months) or contraindication/intolerance to preferred insulin(s).
Some long‑acting non‑preferred insulins may require trial of TWO preferred insulins before approval per the formulary section language.

Note

Step/Tier Coverage Implied by Formulary Sections

Formulary sections imply step/tier coverage distinctions: Section 1 and Section 2 list preferred first‑ and second‑line agents that do not require prior authorization when used per placement; other listed agents are designated as non‑preferred across one or more sections and are subject to exception review or step requirements.

Section 1 (Incentive/Open/Select and plans with no pharmacy benefit): preferred rapid‑ and long‑acting insulins listed as not requiring preapproval.
Section 2 (Essentials plans): has its own preferred agents; non‑preferred agents in this section follow step/failure rules.
Section 3 (Metallic/Individual/Small Group/Student ISHIP): includes separate coverage rules and designated non‑preferred listings.

Documentation Required

Required Documentation

Medical record documentation must support that medical necessity criteria are met. Submit complete records with the prior authorization request to facilitate timely review.

Include office visit notes with diagnosis, relevant history, physical exam, and medication history.
Document prior trials of preferred insulins, dates of therapy, and response (including A1C and other glycemic measures).
If the request is for a non‑formulary exception, include documentation of contraindication, intolerance, or therapeutic failure of preferred agents.

Documentation Required

Diagnostic Documentation Required

Diagnostic documentation supporting a diagnosis of diabetes is required. Use standard laboratory criteria when submitting records.

A1C ≥ 6.5% (NGSP certified method) qualifies for diabetes diagnosis.
Fasting plasma glucose ≥ 126 mg/dL or 2‑hour OGTT plasma glucose ≥ 200 mg/dL also meet diagnostic criteria.
Random plasma glucose ≥ 200 mg/dL with classic hyperglycemia symptoms is acceptable.
When hyperglycemia is not unequivocal, two abnormal test results (either two different tests or the same test repeated) are required.

Denial Risk

Benefit Limitations May Trigger Denial

Benefit limitations and member‑specific plan terms may result in denial even when clinical criteria are met. Confirm member eligibility, benefit coverage, dispensing limits, quantity limits, and formulary exclusions prior to submitting a request.

Coverage is subject to the limits and conditions of the member’s benefit plan — consult the member benefit booklet or customer service for plan‑specific limits.
This policy does not apply to Medicare Advantage; Medicare members should follow applicable Medicare rules.
Products or uses not listed in this policy are considered investigational and may be denied.

State whether the Lyumjev request is for pharmacy fulfillment or medical administration (e.g., pump/DME) in the prior authorization.
Verify benefit assignment with the member's plan to ensure correct routing and reduce claim denials.

May require insulin when other therapies do not achieve glycemic control

Stages of Type 1 Diabetes

Stage 1Autoimmunity present, normoglycemia, presymptomatic; diagnostic criterion: multiple islet autoantibodies without IFG/IGT

Stage 2Autoimmunity with dysglycemia (presymptomatic); diagnostic criteria include islet autoantibodies plus dysglycemia: FPG 100–125 mg/dL, 2‑h PG 140–199 mg/dL, A1C 5.7–6.4% or >=10% rise in A1C

Stage 3Autoimmunity with overt symptomatic hyperglycemia meeting standard diabetes diagnostic criteria

2025-02-01annual_review

Annual review approved; added insulin lispro protamine (insulin lispro mix 75/25) as a non-preferred insulin to Sections 1 and 2 and clarified non-formulary exception authorizations may be approved up to 12 months.

2025-01-01new_policy

New policy published (approved December 10, 2024) establishing formulary-based coverage and moving multiple insulin products into this policy, and defining Lyumjev benefit assignment between pharmacy and medical benefits.