CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Authorization criteria for drug/product use (general formulary authorization)

Defines general criteria for prior authorization/approval of drugs or products for Neighborhood Health Plan of Rhode Island Medicaid members, including initial approval, continuation criteria, and maximum coverage duration.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAuthorization criteria for drug/product use (general formulary authorization)

Policy CodePolicy N/A

Change Typeclarified

Effective DateJul 1, 2018

Next Review Date

Key ActionProviders must submit all relevant documentation and provide rationale for age-appropriate use and why formulary alternatives are not appropriate when applicable.

POLICY UPDATE CHANGES

Reviewed and revised on multiple dates with latest review 01/2025; no specific clinical policy statement changes indicated in document.

Up to 12 monthsMaximum Coverage Duration

MedicaidScope

Coverage Summary

Initial Authorization (Criteria for Approval)

An authorization may be granted when all the following criteria are met:

ALL of the following

Medically accepted indication: The requested drug/product is being used for an FDA-approved indication or a medically accepted indication as defined in one of the following compendia: AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed published medical literature indicating sufficient evidence supports use.
Dosing and quantity: The prescribed dose and quantity fall within the FDA-approved labeling or within compendium-supported dosing guidelines.
Documentation: All relevant documentation (e.g., lab values, treatment plan, medical chart notes) is provided.
Documentation must be submitted with the request.
Age rationale: Rationale provided for why the use of the requested drug is necessary for a patient of this age.
Formulary alternatives rationale: Rationale provided for why formulary alternatives (e.g., alternative dosage forms) are not appropriate, when applicable.

Medically accepted indication: an indication identified in standard reference compendia — American Hospital Formulary Service Drug Information (AHFS-DI), Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs — or in peer-reviewed published medical literature demonstrating sufficient evidence to support use.

Continuation Therapy Criteria

Continuation of Therapy

ALL of the following

Initial criteria: Patient meets all initial criteria.
Tolerability: Patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug.
Clinical response: Patient has disease stabilization or improvement in disease (as defined by established clinical practice guidelines).

Coverage Duration

Coverage duration up to 12 months as determined by FDA guidance and internal policies and procedures.

Provider Actions / Prior Authorization Requirements

Prior Authorization

Submit documentation with authorization request

Providers must submit all relevant documentation with the authorization request, including lab values, the treatment plan, medical chart notes, and a clear rationale for age-appropriate use and why formulary alternatives are not appropriate when applicable.

Relevant lab values
Treatment plan
Medical chart notes
Rationale for age-appropriate use
Rationale why formulary alternatives are not appropriate

Documentation Required

Dose and quantity must align with labeling or compendia

The prescribed dose and quantity must fall within FDA-approved labeling or within compendium-supported dosing guidelines. Requests specifying doses or quantities outside these parameters risk denial.

Denial Risk

Indication not supported by FDA or compendia

Requests for indications that are not FDA-approved or are not supported by the cited compendia or peer-reviewed published medical literature may be denied.

Background

This policy provides general authorization criteria for drugs/products requested for Medicaid members. Authorization may be granted when the drug is for an FDA-approved or medically accepted indication, prescribed dose and quantity align with FDA labeling or compendium-supported dosing, and all relevant documentation (e.g., lab values, treatment plan, medical chart notes) and rationale for age-appropriate use are submitted. When applicable, justification why formulary alternatives are not appropriate must be provided. Coverage duration is up to 12 months per internal policies and FDA guidance.

Definitions

Medically accepted indication: An indication as defined in AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed published medical literature indicating sufficient evidence exists to support use.

Providers must submit all relevant documentation (e.g., lab values, treatment plan, medical chart notes) and provide rationale for age-appropriate use and why formulary alternatives are not appropriate when applicable.

Prescribed dose and quantity must fall within FDA-approved labeling or compendium-supported dosing guidelines; nonconforming requests may be denied.