CurrentAetnaPolicy 0035

Influenza Vaccine

This Aetna Clinical Policy Bulletin addresses medical necessity, coverage, coding, and clinical background for influenza vaccines for members, including injectable and intranasal formulations, per CDC/ACIP recommendations.

Policy Summary

PayerAetna

PolicyInfluenza Vaccine

Policy CodePolicy 0035

Change TypeNo material change

Effective DateOct 6, 1995

Next Review DateJan 11, 2024

Key ActionFollow current CDC/ACIP guidance when selecting and administering age-appropriate influenza vaccine (intranasal LAIV covered for ages 2–49 years).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ages 2–49intranasal medically necessary for

ages ≥6 monthsACIP routine annual vaccination

Z23ICD-10 encounter code

90672LAIV4 CPT example

03/06/2023last review

Coverage Criteria

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Medical Necessity / Covered Indications

Covered when meeting ACIP recommendations and age indications:

Main coverage: Standard or preservative-free trivalent or quadrivalent injectable influenza vaccines are medically necessary according to CDC/ACIP recommendations; intranasally administered influenza vaccine (LAIV) is medically necessary for members aged 2 through 49 years.

Follow ACIP for additional contraindications and age-specific guidance.

Priority groups when vaccine supply limited

When supply is limited, prioritize vaccination of persons at higher risk:

Priority groups: Includes children aged 6 through 59 months; all persons aged 50 years and older; persons (adults and children) with chronic pulmonary (including asthma), cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus); persons who are immunocompromised due to any cause; women who are or will be pregnant during the influenza season; children and adolescents (6 months through 18 years) receiving aspirin; residents of nursing homes and other long-term care facilities; American Indians/Alaska Natives; and persons who are extremely obese (BMI ≥40 for adults).

No hierarchy is implied by list order; vaccinate those without contraindications first.

Vaccine-type and population-specific coverage and use guidance

Vaccine use recommendations and population-specific considerations described in document excerpts

LAIV (Intranasal) use: LAIV4 (FluMist Quadrivalent) is indicated for persons aged 2 through 49 years; ACIP has at times not recommended LAIV4 in specific seasons because of concerns about low effectiveness (e.g., 2016–17 and 2017–18). LAIV is associated with increased upper respiratory symptoms (runny nose, nasal congestion, sore throat) compared with injected vaccines and has specific contraindications to consider.age 2-49 years; season-specific VE concerns

Follow current ACIP guidance for seasonal use and contraindications.

Inactivated vaccines (IIV): Quadrivalent and trivalent inactivated influenza vaccines are approved for broad age ranges (examples: Fluarix Quadrivalent approved for 6 months and older; Fluzone Quadrivalent approved for 6 months and older). High-dose and adjuvanted formulations (e.g., Fluzone High-Dose, Fluad) are intended for persons aged 65 years and older; ACIP does not express a preference among age-appropriate IIVs, high-dose, adjuvanted, or recombinant vaccines for persons 65+.age-specific approvals (e.g., ≥6 months; ≥65 years)

Use age-appropriate formulation per ACIP.

Certain historical intranasal live-attenuated influenza vaccine (LAIV) CPT codes are listed as not covered for the indications described in this Clinical Policy Bulletin. Examples called out in the policy include CPT 90660 and CPT 90664, which correspond to older LAIV formulations and are identified in the exclusions/code-not-covered section.

The policy identifies multiple contraindications for administration of intranasal live-attenuated influenza vaccine (LAIV). LAIV should not be given to: children younger than 2 years, adults older than 50 years, pregnant women and nursing mothers, and persons with medical conditions that increase risk for influenza complications (for example, chronic cardiac or pulmonary disease, diabetes, kidney failure, or other conditions that weaken the immune system). Additional contraindications include any patient with asthma, children 2–4 years with recent wheeze, persons with a history of Guillain–Barré syndrome after prior influenza vaccination, and individuals with severe allergies to egg proteins, chicken proteins, gentamicin, gelatin, arginine, or other nasal spray vaccine components.

For hematopoietic cell transplant (HCT) recipients the policy states that intranasal live influenza vaccine (LAIV) should not be given because an effective, inactivated alternative exists. Guidance from transplant and infectious disease societies cited in the policy supports use of inactivated vaccines rather than LAIV in this population.

The policy documents that LAIV4 (FluMist Quadrivalent) was not recommended for use in the United States during some recent seasons due to concerns about low effectiveness. Specifically, ACIP recommended against LAIV4 use in the 2016–17 and 2017–18 seasons because of poor effectiveness against certain circulating A(H1N1)pdm09-like viruses (the policy notes a 2015–16 LAIV VE estimate of 3% in children, indicating no measurable protective benefit that season).

A meta-analysis cited in the policy evaluated booster influenza vaccination in patients with chronic renal disease and renal transplant recipients and found no consistent improvement in sero-protection rates. The pooled rate differences for H1N1, H3N2 and B were small and not statistically significant; the authors concluded a booster dose did not effectively enhance immunogenicity. Therefore, a booster influenza dose is not recommended for patients on hemodialysis, peritoneal dialysis, or for renal transplant recipients.

Coding

Covered CPT codes (selection criteria apply)CPTCovered

90630	Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, for intradermal use
90653	Influenza vaccine, inactivated (IIV), subunit, adjuvanted, for intramuscular use
90654	Influenza virus vaccine, trivalent (IIV3), split virus, preservative-free, for intradermal use
90655	Influenza virus vaccine, trivalent (IIV3), split virus, preservative free, 0.25 mL dosage, for intramuscular use
90656	Influenza virus vaccine, trivalent (IIV3), split virus, preservative free, 0.5 mL dosage, for intramuscular use
90657	Influenza virus vaccine, trivalent (IIV3), split virus, 0.25 mL dosage, for intramuscular use
90658	Influenza virus vaccine, trivalent (IIV3), split virus, 0.5 mL dosage, for intramuscular use
90661	Influenza virus vaccine (ccIIV3), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use
90662	Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use
90672	Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use

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Covered HCPCS codes (selection criteria apply)HCPCSCovered

G0008	Administration of influenza virus vaccine
J3530	Nasal vaccine inhalation
Q2034	Influenza virus vaccine, split virus, for intramuscular use (agriflu)
Q2035	Influenza virus vaccine, split virus, when administered to individuals 3 years of age and older, for intramuscular use (Afluria)
Q2036	Influenza virus vaccine, split virus, when administered to individuals 3 years of age and older, for intramuscular use (Flulaval)
Q2037	Influenza virus vaccine, split virus, when administered to individuals 3 years of age and older, for intramuscular use (Fluvirin)
Q2038	Influenza virus vaccine, split virus, when administered to individuals 3 years of age and older, for intramuscular use (Fluzone) [also covered for Fluzone High-Dose for members age ≥65 when recommended]
Q2039	Influenza virus vaccine, split virus, not otherwise specified

CPT codes not covered for indications listed in the CPBCPTNot Covered

90660	Influenza virus vaccine, trivalent, live (LAIV3), for intranasal use
90664	Influenza virus vaccine, live (LAIV), pandemic formulation, for intranasal use

Related CPT/HCPCS and administration codesmixed

87275	Infectious agent antigen detection by immunoflourescent technique; influenza B virus
87276	Influenza A virus (immunofluorescent)
87400	Infectious agent antigen detection by enzyme immunoassay; influenza A or B
90460	Immunization administration through 18 years; with counseling; first or only component
90461	Each additional vaccine or toxoid component administered
90471	Immunization administration (injection); one vaccine
90472	Each additional vaccine (injection)
90473	Immunization administration by intranasal or oral route: one vaccine
90474	Each additional intranasal/oral vaccine
90666	Influenza virus vaccine (IIV), pandemic formulation, split virus, preservative free, IM

1–10 of 17

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ICD-10 codes (covered)ICD-10Covered

Z23	Encounter for immunization

Documentation Required

Provider action: Coverage and documentation guidance

Coverage of listed CPT and HCPCS vaccine and administration codes is contingent on meeting the policy's selection criteria and applicable clinical guidance (including ACIP recommendations). There are no step therapy requirements and no explicit prior authorization/denial trigger specified for these vaccine codes. Providers must document clinical rationale for vaccine selection consistent with ACIP guidance and patient-specific factors (age, pregnancy status, immunocompromise, chronic conditions, prior vaccine history, allergy history, LAIV contraindications and age limits, and HCT recipient considerations). Use ICD-10 code Z23 for vaccine encounter billing. LAIV (intranasal) has specific age and effectiveness contraindications per ACIP (e.g., not for certain ages, not recommended for some immunocompromised or pregnant patients); follow ACIP guidance when choosing LAIV. Required clinical documentation includes indication for vaccine, vaccine product and lot, route and site of administration, date, informed consent/counseling notes, and any relevant medical history affecting vaccine choice. No additional specific documentation beyond standard immunization record elements is mandated by the policy.

Codes requiring coverage criteria: CPT and HCPCS vaccine and administration codes listed are covered only if selection criteria are met.
Coverage tied to ACIP recommendations: Vaccine use and selection should follow current ACIP recommendations; vaccine choice may vary based on age, pregnancy, immunocompromise, and HCT status.
LAIV contraindications: LAIV is contraindicated or not recommended for certain age groups, pregnant persons, and many immunocompromised persons; consult ACIP.
No explicit authorization/denial trigger: Policy does not specify an automatic authorization or denial trigger solely based on coding.
Use ICD-10 Z23: Use Z23 for encounter for immunization.

Provider Actions & Requirements

Billing Rule

Codes covered when selection criteria are satisfied

The CPT and HCPCS influenza vaccine and related administration codes listed in the policy are considered covered when the member meets the policy's selection criteria (age, ACIP recommendations, and other clinical considerations); verify and document that the chosen vaccine formulation is appropriate before submitting claims.

Covered vaccine CPT examples: 90630, 90661, 90672, 90686, 90694.
ICD-10 encounter code for immunization when selection criteria are met: Z23.

Prior Authorization

No prior authorization specified in excerpts; follow age-appropriate guidance

No specific prior authorization requirements for influenza vaccines are stated in the provided excerpts; providers should use age-appropriate formulations per ACIP guidance and follow any plan-specific prior authorization processes if separately required.

Policy notes age-appropriate options (e.g., high-dose/adjuvanted vaccines for persons 65+), but does not list PA steps in these excerpts.

Prior Authorization

No prior authorization requirements described here

The policy excerpts do not describe any prior authorization requirements for the influenza vaccines or administration codes; confirm any plan-level authorization rules outside this CPB before proceeding.

Prior Authorization

No prior authorization specified in this section

This portion of the policy does not specify prior authorization requirements for influenza vaccination; providers should rely on ACIP age/formulation guidance and local plan procedures.

Note

Consider LAIV age indication and historical effectiveness

LAIV (intranasal/FluMist) is indicated for persons aged 2 through 49 years but has had seasons when ACIP did not recommend its use due to reduced effectiveness; providers should consider age and historical effectiveness when selecting LAIV.

LAIV4 approved for ages 2–49 years (FDA approval noted).
ACIP recommended against LAIV4 use in 2016–17 and 2017–18 because of low effectiveness against certain H1N1 viruses.

Note

Follow current ACIP guidance; LAIV history affected recommendations

ACIP recommendations about LAIV were influenced by observed reduced effectiveness in certain seasons; when choosing vaccine type, follow current ACIP guidance and consider clinical history and prior seasonal VE data.

Data showed LAIV VE estimate of 3% in 2015–2016 among children versus 63% for IIV in that season.
ACIP reinstated LAIV4 for 2018–19 after review; providers must follow the current ACIP recommendation.

Prior Authorization

Avoid LAIV in HCT recipients — use inactivated vaccine

Do not administer intranasal live influenza vaccine to hematopoietic cell transplant (HCT) recipients; use an effective inactivated vaccine alternative instead.

Guidelines indicate LAIV should not be given to HCT recipients because an effective inactivated alternative exists.

Step Therapy

No step therapy described

No step therapy requirements for influenza vaccination are described in the provided excerpts.

Billing Rule

Use ICD-10 code Z23 for immunization encounters

When billing for an immunization encounter, use ICD-10 code Z23 (Encounter for immunization) when the member meets the policy's selection criteria.

Use Z23 to indicate the visit was for immunization when the vaccine and member meet policy criteria.

Documentation Required

Document age, allergy, pregnancy, immunocompromise, wheeze/GBS history

Document clinical details that support vaccine selection and appropriateness, including patient age, history of allergies (including severity of egg allergy), pregnancy status, immunocompromising conditions, recent wheeze/asthma history in young children, and any prior Guillain-Barré syndrome.

For egg-allergic persons, note reaction type (urticaria only versus more severe) and, if using a vaccine other than ccIIV4 or RIV4 for severe egg reactions, document administration in a setting equipped to manage severe allergic reactions.
Document contraindications to LAIV (e.g., age <2 or >50 years, pregnancy, immunocompromised status, asthma/wheezing, prior GBS).

Note

Documentation Required

No additional documentation requirements stated here

The provided excerpt does not list additional specific documentation requirements beyond standard clinical documentation; ensure records support vaccine choice and administration.

Note

Providers responsible for medical advice and treatment

Participating providers are independent contractors and are solely responsible for medical advice and treatment of members; ensure clinical decisions and documentation reflect this responsibility.

Aetna's CPB is informational and does not substitute for the treating provider's clinical judgment.

Denial Risk

LAIV covered only for ages 2–49 years per ACIP/medical necessity

Coverage for intranasal live attenuated influenza vaccine is limited to members aged 2 through 49 years and is tied to ACIP recommendations and medical necessity; billing for LAIV outside that age range or contrary to ACIP guidance may be denied.

Confirm member age (2–49 years) and ACIP appropriateness before administering and billing for LAIV.

Denial Risk

Do not give LAIV to persons with contraindications — risk of denial

Do not administer LAIV to persons with listed contraindications (including children <2 years, adults >50 years, pregnant or nursing women, the immunocompromised, patients with asthma or recent wheeze, history of GBS after prior influenza vaccination, or severe allergy to vaccine components); administration in these situations is inappropriate and likely to be denied.

Contraindications explicitly include: age under 2 or over 50, pregnancy, immunocompromise, chronic heart or lung disease (including asthma), recent wheezing in children 2–4 years, prior GBS, and severe allergies to egg, chicken proteins, gentamicin, gelatin, arginine, or other LAIV components.

Prior Authorization

No explicit authorization or billing triggers in excerpts

No explicit authorization or billing triggers are presented in the cited document segments; verify plan-specific billing and authorization rules if applicable.

Denial Risk

No specific authorization or denial triggers stated

The provided policy segments do not specify particular authorization or denial triggers; ensure vaccination follows ACIP recommendations and document medical necessity to reduce risk of claim denial.

Note

CPB is informational and not a contract — verify coverage

This Clinical Policy Bulletin is a partial, general description of plan benefits and does not constitute a contract; providers should apply clinical judgment and confirm coverage details with the payer.

Definitions

LAIV (Live Attenuated Influenza Vaccine)

DefinitionA live, cold-adapted intranasal influenza vaccine formulation (e.g., FluMist) administered as a nasal spray, historically indicated for certain age groups (originally 5–49 years, later expanded to 2–49 years)

FormulationCold-adapted live attenuated virus delivered intranasally as an aerosol into both nostrils

Safety noteIncreased risk of hospitalization and wheezing observed in children younger than 2 years in trials; contraindications and precautions apply

LAIV4 / FluMist Quadrivalent

Product exampleLAIV4 (FluMist Quadrivalent) — live attenuated intranasal vaccine containing two A subtypes and two B strains

Age indicationIndicated for persons aged 2 through 49 years

Effectiveness historyACIP did not recommend LAIV4 for certain seasons (2016–17 and 2017–18) due to low effectiveness against some H1N1 pdm09-like viruses

IIV / RIV / cell-based vaccines

Class descriptionInactivated influenza vaccines (IIV) include standard quadrivalent and trivalent formulations, high-dose, adjuvanted, and cell-based (ccIIV) products; recombinant vaccines (RIV) are egg-free options produced from recombinant HA proteins

Age/examplesFluarix and Fluzone Quadrivalent approved for use in persons 6 months and older; Flucelvax (cell-based) approved for persons 4 years and older; Flublok (recombinant) approved for adults 18+ (quadrivalent available)

Clinical noteHigh-dose and adjuvanted formulations target persons ≥65 years as acceptable options per ACIP

H1N1 (swine flu)

DiscoveryH1N1 (2009 'swine flu') was first detected in people in the U.S. in April 2009

VirologyA quadruple reassortant virus with gene segments from swine, avian, and human influenza strains

Clinical impactCaused higher hospitalization and death rates in people younger than 65 during 2009 compared with seasonal influenza

OpenPayer

Influenza Vaccine

Coverage Criteria

Coding

Provider Actions & Requirements

Background

Definitions