CurrentUnitedHealthcarePolicy IEXD0031.07

Preventive Vaccines (Immunizations)

Defines coverage conditions for preventive vaccines (immunizations) under UnitedHealthcare, including when vaccines are considered covered for members and relation to member-specific benefit plans; affects providers administering vaccines and UnitedHealthcare plan members.

Policy Summary

PayerUnitedHealthcare

PolicyPreventive Vaccines (Immunizations)

Policy CodePolicy IEXD0031.07

Change TypeRevisions and clarifications

Effective DateDec 1, 2024

Next Review Date

Key ActionConfirm FDA approval, explicit ACIP routine recommendation, ACIP schedule listing, and absence of plan exclusions before considering a vaccine covered.

SourceLink

POLICY UPDATE CHANGES

Revised language to indicate a vaccine (immunization) is considered covered after all of the following conditions are satisfied: FDA approval, explicit ACIP routine recommendation (not permissive), listed on applicable ACIP immunization schedule, and not otherwise excluded by the plan.

Added clarification that in a public health emergency UnitedHealthcare may apply preventive benefits to a new vaccine with FDA approval even if ACIP recommendation has not been announced.

Added clarification that therapeutic vaccines are not subject to the coverage criteria in this policy.

Title changed from 'Vaccines' to 'Preventive Vaccines (Immunizations)'; updated Coverage Conditions language.

4coverage conditions required

1public health exception

1policy history entries

Coverage Conditions for Preventive Vaccines (Immunizations)

Coverage Conditions

A vaccine (immunization) is considered covered after ALL of the following conditions are satisfied:

Coverage Conditions: 1) The US Food and Drug Administration (FDA) has approved the vaccine (immunization).

Coverage Conditions: 2) The vaccine (immunization) is subject to explicit ACIP recommendations for routine use (e.g., 'should', 'shall', 'is') and not permissive ('may') recommendations, as published in the CDC MMWR.

Coverage Conditions: 3) The vaccine (immunization) is listed on the applicable ACIP immunization schedule.

Coverage Conditions: 4) The vaccine (immunization) is not otherwise excluded by the member specific benefit plan document.

Policy Summary

PayerUnitedHealthcare

PolicyPreventive Vaccines (Immunizations)

Policy CodePolicy IEXD0031.07

Change TypeRevisions and clarifications

Effective DateDec 1, 2024

Next Review Date

Key ActionConfirm FDA approval, explicit ACIP routine recommendation, ACIP schedule listing, and absence of plan exclusions before considering a vaccine covered.

SourceLink

On This Page

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Provider Requirements and Actions

Prior Authorization

Prior Authorization and Step Therapy

No universal prior authorization is required by this policy; however, coverage is conditional on regulatory and advisory criteria (see denial triggers).

No step therapy requirements specified in this policy.

Denial Risk

Triggers for Denial

Vaccines that do not meet the policy's coverage conditions are at risk for denial. Specifically, coverage may be denied when the vaccine is any of the following: not approved by the FDA; not subject to an explicit ACIP routine recommendation (i.e., only permissive "may" language is used); not listed on the applicable ACIP immunization schedule; or otherwise excluded by the member's specific benefit plan.

Triggers for denial include:
• Lack of FDA approval for the vaccine.
• Absence of an explicit ACIP routine recommendation (permissive "may" recommendations are insufficient).
• Vaccine not listed on the applicable ACIP immunization schedule.
• Vaccine expressly excluded by the member specific benefit plan or by applicable federal/state mandates.

Documentation Required

Document Member Plan and Mandates

Always check the member specific benefit plan document and any applicable federal or state mandates before determining coverage. In cases of conflict, the member specific benefit plan document governs.

Reference the member specific benefit plan document.
Confirm applicable federal or state mandates.

Definitions

Preventive vaccine (coverage definition)

FDA approvalThe U.S. Food and Drug Administration (FDA) must have approved the vaccine (immunization).

Explicit ACIP routine recommendationThe vaccine must be subject to explicit ACIP recommendations for routine use (e.g., 'should', 'shall', 'is') — permissive ('may') recommendations do not qualify.

Listed on ACIP immunization scheduleThe vaccine must be listed on the applicable ACIP immunization schedule as published by ACIP/CDC.

Not excluded by member benefit planThe vaccine must not be excluded by the member specific benefit plan document; the plan governs coverage if exclusions apply.

Therapeutic vaccine

Therapeutic vaccines excludedTherapeutic vaccines are not subject to the coverage criteria in this policy and therefore are excluded from preventive vaccine coverage rules.

Policy clarification dateClarified and recorded 12/01/2024 that therapeutic vaccines are excluded from this policy's coverage criteria.

Scope implicationCoverage criteria (FDA approval, explicit ACIP routine recommendation, listing on ACIP schedule) do not apply to therapeutic vaccines per this policy clarification.

Policy Revision History

2024-12-01material_revision

Title changed from 'Vaccines' to 'Preventive Vaccines (Immunizations)' and Coverage Conditions revised to require FDA approval, explicit ACIP routine recommendation, listing on the applicable ACIP immunization schedule, and absence of plan exclusions for a vaccine to be covered.

2024-12-01clarification

Clarified that during a public health emergency UnitedHealthcare may apply preventive benefits to a new vaccine with FDA approval even if an ACIP recommendation has not been announced.

2024-12-01clarificationLatest

Clarified that therapeutic vaccines are not subject to the coverage criteria in this policy.

OpenPayer

Preventive Vaccines (Immunizations)

Coverage Conditions for Preventive Vaccines (Immunizations)

Provider Requirements and Actions

Definitions

Background

Policy Revision History