ModifiedPremera BluecrossPolicy N/A

Insulin Therapy (vials and prefilled pens)

Defines medical necessity criteria, documentation, benefit application, and coding information for insulin products (vials and prefilled pens) used to treat type 1 and type 2 diabetes for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy (vials and prefilled pens)

Policy CodePolicy N/A

Change TypeHCPCS additionsformulary and product updates

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionSubmit office visit notes documenting diagnosis, history, physical exam, and medication history to support prior authorization or exception requests.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS codes J1813 and J1814 for Lyumjev.

Updated formatting removing the reference to Section 1: Open, Preferred, and Select Formulary Plans and removed Section 2: Essentials Formulary Plans and Section 3 Metallic references (formatting/section structure changes).

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

Added Kirsty (insulin aspart-xjhz) and Merilog (insulin aspart-szjj) as non-preferred rapid-acting insulins.

Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

20+insulin products listed or moved into this policy

J1813,J1814HCPCS codes listed for insulin billing

12 momax non-formulary exception duration

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.

A1C diagnostic threshold

Coverage Criteria for Insulin Products

Medical necessity criteria by insulin class

Insulin products (vials and prefilled pens) may be considered medically necessary when the following criteria are met for the specified product classes.

General requirement: Individual has a diagnosis of type 1 or type 2 diabetes.

Rapid-, short-, intermediate-, and mix insulins: Has a contraindication or intolerance to a preferred insulin OR this insulin product was ineffective in reducing A1C to goal after 3 months of therapy.3 months of therapy or intolerance/contraindication

First-line rapid-acting agents include Fiasp (aspart), insulin aspart, Novolog (aspart). First-line regular/short-acting and mix agents (e.g., Novolin R, Novolin N, Novolin Mix 70/30, Novolog Mix 70/30) do not require pre-approval.

Long-acting insulins (additional requirement): Has a contraindication or intolerance to 2 preferred insulins OR this insulin product was ineffective in reducing A1C to goal after 3 months of therapy.ineffective after 3 months or intolerance to 2 preferred agents

First-line long-acting insulins (Lantus, Toujeo, Tresiba) do not require pre-approval.

Formulary-based coverage rules

Policy contains multiple sections defining coverage by formulary type and designates certain insulins as non-preferred depending on section.

Formulary placement governs coverage: Coverage and any step therapy or prior authorization requirements depend on the member's specific formulary section (e.g., Incentive/Open/Select, Essentials, Metallic); some insulins are designated non-preferred in specified sections.

See policy history and plan-specific sections for details and for recent changes (e.g., addition of non-preferred agents and HCPCS code additions).

Uses of the drugs for conditions not listed in this policy are considered investigational. The policy states that, for medications included here, any use not specifically listed is investigational and subject to the product's FDA prescribing information.

Levemir (insulin detemir) was removed from this policy because it has been withdrawn from the market, as noted in the policy history.

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

This medical policy is intended as a guide to medical necessity determinations. Coverage is governed by the member's benefit contract; providers should consult the member benefit booklet or contact customer service for specific coverage limits. Services that do not meet the policy's medical necessity criteria or that exceed plan limits may be denied.

Coding and Diagnostic Criteria

HCPCS codes for LyumjevHCPCS

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

HCPCS additionsHCPCS

J1813	HCPCS code added for Lyumjev
J1814	HCPCS code added for Lyumjev

inv-09: A1C diagnostic threshold

A1C diagnostic threshold>= 6.5% (>= 48 mmol/mol) measured in an NGSP-certified laboratory standardized to the DCCT assay

Test method requirementPerformed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay

PopulationApplies to diagnosis of diabetes in nonpregnant individuals

inv-10: Non-formulary exception authorization duration

Maximum authorization duration for non-formulary exceptionsUp to 12 months

ApplicabilityNon-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months

Provider Requirements and Authorization Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred insulins and certain formulations. Requests for listed insulin products may require documentation showing failure, intolerance, or contraindication to preferred first-line insulins before approval.

Prior authorization applies to non-preferred rapid-acting, long-acting, and other listed insulin products.
Denial risk if diagnosis or required documentation is absent.

Billing Rule

Billing / HCPCS Codes for Lyumjev

HCPCS codes have been added for Lyumjev. Use these codes for billing and when submitting prior authorization requests for Lyumjev administered via DME (pump) or other routes as indicated.

Background

Diabetes is a disorder of glucose metabolism characterized by either insulin deficiency (type 1) or insulin resistance with relative insulin deficiency (type 2). Insulin therapy is required for type 1 diabetes and is often used in type 2 diabetes to achieve glycemic control. This policy defines when specific insulin products (vials and prefilled pens) are considered medically necessary based on diagnosis, intolerance or contraindication to preferred agents, and documented lack of effectiveness after 3 months of therapy.

Definitions

inv-20: Type 1 diabetes definition

DefinitionAutoimmune destruction of pancreatic beta cells resulting in absence of endogenous insulin; external insulin required

Typical onsetUsually diagnosed in children and young adults

Therapeutic implicationRequires external insulin therapy to use glucose

inv-21: Type 2 diabetes definition

DefinitionCharacterized by insulin resistance with relative insulin deficiency

Age of onsetCan be diagnosed at any age

Modifying factors

Policy Summary

PayerPremera Bluecross

PolicyInsulin Therapy (vials and prefilled pens)

Policy CodePolicy N/A

Change TypeHCPCS additionsformulary and product updates

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionSubmit office visit notes documenting diagnosis, history, physical exam, and medication history to support prior authorization or exception requests.

SourceLink

On This Page

Decision contextApproval duration is clarified in policy history/changes and applies per plan-specific exception review

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

Note

Preferred First-Line Insulins

The policy specifies preferred first-line insulins that do not require pre-approval and should be tried before non-preferred agents are authorized.

Preferred first-line rapid-acting insulins: Fiasp (aspart), insulin aspart, Novolog (aspart).
Preferred first-line long-acting insulins: Lantus (glargine), Toujeo (glargine), Tresiba (degludec).
Note: These first-line insulins do not require prior authorization for coverage when clinically appropriate.

Step Therapy

Formulary Placement and Step Requirements

Formulary placement and step requirements apply: many listed products are non-preferred and require failure or intolerance to preferred agents (step therapy) before coverage is approved.

Non-preferred insulins require documentation of contraindication/intolerance to preferred insulins OR lack of efficacy (A1C not at goal) after ≥ 3 months on a preferred product.
Some long-acting agents require prior trial of two preferred long-acting insulins (e.g., Basaglar, degludec, insulin glargine brands require prior trial of Lantus, Toujeo, and Tresiba).
Novolog Mix 70/30 and insulin aspart protamine + insulin aspart mix 70/30 are noted as first-line mixes and do not require pre-approval.

Documentation Required

Documentation Submission Requirements

When submitting requests, include office visit notes with diagnosis, relevant history, physical evaluation, and medication history to demonstrate medical necessity.

Provide documentation of diagnosis (type 1 or type 2 diabetes), prior medication trials, dates/duration of therapy, and reason for discontinuation or intolerance.
Include A1C results showing inadequate control after trial of preferred agents when claiming inefficacy.

Note

Member Benefit Verification Guidance

Verify member benefits and formulary status before submitting a prior authorization to confirm coverage, benefit limits, and any plan-specific step edits or exceptions.

Check the member’s benefit booklet or contact member services to determine plan-specific coverage and any exclusions.
Non-formulary exception reviews are available per plan; benefits differ by contract — verification reduces risk of denials.

Denial Risk

Denial Risk When Documentation Absent

Requests for listed insulin products may be denied if the diagnosis, prior treatment history, or supporting documentation is not provided.

Ensure the medical record documents trials of preferred insulins, dates, and clinical response. Missing documentation may result in denial.
If the patient has a documented contraindication or intolerance, include clinical details explaining the adverse reaction or contraindication.

Prior Authorization

Non-Formulary Exception Review Process

If the insulin product is non-formulary for the member’s plan, an exception review may be pursued; include full clinical rationale and supporting records.

Follow the plan’s non-formulary exception process and submit comprehensive clinical justification.
Confirm whether the member’s plan (including Metallic formulary plans) has distinct coverage rules before submitting an exception request.

Can be affected by diet, exercise, and other health conditions

inv-22: Product prescribing information references

ScopeOfficial FDA-approved prescribing information is referenced for listed insulins and governs dosage and administration

Example prescribing information citedNovolog, Fiasp, Humalog, Apidra, Admelog, Lyumjev, Afrezza, Kirsty, Merilog (see References)

Policy statementMedications listed in this policy are subject to the product's FDA dosage and administration prescribing information