CurrentAnthemPolicy CC-0136

Drug Dosage, Frequency, and Route of Administration

Clinical criteria governing review and approval of dosage, frequency, and route of administration for drugs, biologics, and biosimilars under the medical benefit; applies to providers requesting coverage for injectable, biologic, or specialty drugs (not pharmacy-benefit oral agents).

Policy Summary

PayerAnthem

PolicyDrug Dosage, Frequency, and Route of Administration

Policy CodePolicy CC-0136

Change TypeNo material changes

Effective Date07/23/2025

Next Review DateN/A

Key ActionProvide supporting citations such as FDA prescribing information or recognized drug compendia (AHFS, DRUGDEX, NCCN); if unavailable, submit peer‑reviewed study methodology demonstrating the proposed dosage, frequency, and route.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CC-0136Document identifier

06/09/2025Most recent review

Medical benefit onlyScope limitation

FDA/AHFS/DRUGDEX/NCCNAccepted sources

Coverage Criteria - Dosage, Frequency, and Route

Approval criteria

Covered when ANY one of the following sources supports the requested dosage, frequency, and route of administration:

Accepted sources: Requested dosage, frequency, and route are supported by U.S. Food and Drug Administration (FDA) prescribing information

FDA prescribing information is an acceptable basis for approval

Accepted sources: Supported by American Hospital Formulary Service (AHFS) Drug Information

AHFS is an accepted compendium

Accepted sources: Supported by DRUGDEX (Truven Health Analytics)

DRUGDEX is an accepted compendium

Policy Summary

PayerAnthem

PolicyDrug Dosage, Frequency, and Route of Administration

Policy CodePolicy CC-0136

Change TypeNo material changes

Effective Date07/23/2025

Next Review DateN/A

SourceLink

On This Page

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Contingent on Supporting Sources

Prior authorization may be approved when the requested regimen is supported by FDA prescribing information or recognized compendia (AHFS, DRUGDEX, or NCCN).

Affected sources: FDA prescribing information; AHFS; DRUGDEX; NCCN.

Documentation Required

Required Supporting Documentation

Provide supporting documentation with the prior authorization request. Acceptable documentation includes FDA prescribing information or citations from recognized drug compendia (AHFS, DRUGDEX, NCCN). If compendia or FDA labeling do not support the requested dosage, frequency, or route, include peer‑reviewed literature (major medical journals such as JAMA, NEJM, Lancet) demonstrating the regimen is safe and effective for the treatment indication.

If FDA/compendia support is available: include exact section or page from prescribing information or compendium.
If relying on peer‑reviewed literature: include full citation and methodology demonstrating dosage, frequency, and route are safe and effective.

Denial Risk

Unsupported Dosing May Be Denied

Requests for dosing, frequency, or route of administration that are not supported by FDA prescribing information, AHFS, DRUGDEX, NCCN, or peer‑reviewed scientific evidence may be denied.

Denial risk applies when no supporting compendia, FDA labeling, or peer‑reviewed study methodology is provided.

Background

This guideline addresses review of dosing parameters — including dosage, frequency, and route of administration — for drugs, biologics, and biosimilars that are paid under the medical benefit. It focuses on injectable, biologic, and specialty agents and excludes medications managed under the pharmacy benefit. Check applicable state mandates, any specific drug clinical criteria that take precedence, and member benefits or formulary limitations when making coverage decisions.

Definitions

Drugs (medical benefit)

DefinitionDrugs included in this document are injectables, biologics, and specialty pharmacy drugs that fall under the medical benefit.

Exclusions — pharmacy benefitMedications managed under the pharmacy benefit (including oral agents) are not covered by these criteria.

Scope note — precedenceAny specific clinical criteria document for an individual drug takes precedence over this guideline.

Coverage limitationsThis document does not require coverage when the FDA has determined use to be contraindicated, when the benefit plan excludes the drug, or when formulary limitations exclude the drug.

State mandatesState laws that supersede this document (e.g., governing dosage, frequency, or route) must be followed when applicable.