CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_General_Pa_Without_Specific_Drug_Criteria_20250507.Medical 2

General Prior Authorization form for medically administered medications

Governs prior authorization requirements for medically administered medications that lack drug-specific criteria under the medical benefit for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGeneral Prior Authorization form for medically administered medications

Policy CodePolicy Cmp_General_Pa_Without_Specific_Drug_Criteria_20250507.Medical 2

Change TypeAdministrative review — no material changes

Effective DateFeb 13, 2019

Next Review Date

Key ActionSubmit prior authorization requests with correct HCPCS code/units, indication, dosing, and all relevant documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial coverage duration

6 monthscontinuation coverage duration

Medicaid, Commercial, Medicare

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Coverage Criteria

Initial Therapy — Initial Coverage

Initial Coverage — Covered when ALL of the following are met

Initial Criteria: The medically administered medication is being used for an FDA approved indication or a medically accepted indication as defined in any one of the following standard reference compendia: AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or supported by peer-reviewed published medical literature; AND the medication is being dosed according to FDA guidelines; AND the medication is being requested with the correct HCPCS code and units; AND all relevant documentation (e.g., lab values, treatment plan, medical chart notes) is provided; AND patient must follow established clinical practice guidelines for treatment of their medical condition; AND if requesting a reference product when a biosimilar product is available, the patient must have failure, intolerance, or contraindication to the biosimilar product unless such therapies do not exist; OR the patient has experienced an inadequate treatment response or intolerance to all first-line agents, including the generic if available; OR Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

Logic includes AND requirements and OR exceptions as stated.

Continuation Therapy — Continuation of therapy

Continuation of therapy — Covered when ALL of the following are met

Continuation Criteria: Patient meets all initial criteria; AND patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug; AND patient has disease stabilization or improvement in disease as defined by established clinical practice guidelines.

Continuation coverage requires ongoing clinical benefit and tolerability.

Therapies administered at a dose or for a condition that is not recognized as a medically accepted indication are considered investigational. Medically accepted indications are those recognized in one of the standard reference compendia (AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs) or supported by peer‑reviewed published medical literature. Uses outside those recognized indications — including unlisted doses or unlisted conditions — do not meet coverage criteria.

Neighborhood does not provide coverage for drugs when used for investigational purposes. Investigational use is defined as therapy given at a dose or for a condition that is not recognized as a medically accepted indication per the listed compendia or peer‑reviewed literature. Such requests should not be approved under this policy.

Initial Therapy Specifics

Initial Therapy — Initial coverage criteria

Initial coverage criteria

Initial: See Initial Criteria node: indication per FDA or medically accepted compendia or peer‑reviewed literature; dosing per FDA guidelines; correct HCPCS code and units; required documentation provided; adherence to clinical practice guidelines; biosimilar preference rules (failure, intolerance, or contraindication to biosimilar required to request reference product unless biosimilars do not exist); OR prior inadequate response or intolerance to all first‑line agents including generics; OR Medicare members with prior receipt within 365 days are exempt from Step Therapy.

Summarizes the initial coverage requirements from the policy.

Continuation Therapy Specifics

Continuation Therapy — Continuation of therapy

Continuation of therapy

Continuation: Patient meets initial criteria; tolerates treatment without unacceptable toxicity; demonstrates disease stabilization or improvement per established clinical practice guidelines.

Continuation coverage requires documentation of ongoing benefit and tolerability.

Coding and Billing

Required codingHCPCS

HCPCS (provider must use correct code and units)

Requests must be submitted with the correct HCPCS code and units for the medically administered medication.

Prior use exemption window

Window length365 days (previous receipt within past 365 days)

Applies toMedicare members

EffectExempts member from Step Therapy requirements if medication was received within window

Referenced in criteriaIncluded as an OR exception within Initial Criteria Coverage

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required for medically administered medications without drug-specific criteria under the medical benefit; requests must demonstrate the medication is being used for an FDA‑approved indication or a medically accepted indication supported by an accepted compendium or peer‑reviewed literature, dosed per FDA guidelines, and billed with the correct HCPCS code and units.

Affected items: medically administered medications without drug‑specific criteria (Medical Benefit)
Documentation must include relevant lab values, treatment plan, and medical chart notes
HCPCS code and units must be correct on the request

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy exception for prior users — Medicare members who have received this medication within the past 365 days are exempt from step therapy requirements. For other members, prior failure, intolerance, or contraindication to biosimilars (when a biosimilar exists) or inadequate response/intolerance to first‑line agents (including generics when available) must be documented when applicable.

Definitions

Medically accepted indication

DefinitionAn indication recognized in any one of these standard compendia: AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or supported by peer-reviewed published medical literature.

Evidence standardSufficient evidence in peer‑reviewed literature may qualify an indication as medically accepted.

Use in coverage determinationsRequired for initial coverage: medication must be for an FDA‑approved or medically accepted indication per these sources.

Source documentsPolicy references the listed compendia and peer‑reviewed literature as authoritative sources for medically accepted indications.

Investigational use

DefinitionUse at a dose or for a condition not recognized as a medically accepted indication per AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs, or peer‑reviewed literature.

Background

This policy establishes a general prior authorization pathway for medically administered medications that lack drug‑specific criteria under the medical benefit. Prior authorization is required for these medications and requests must document an FDA‑approved or medically accepted indication, appropriate dosing, the correct HCPCS code and units, and all relevant supporting documentation (e.g., lab values, treatment plan, medical chart notes). The policy also defines continuation criteria focused on tolerability and clinical benefit and applies coverage durations of 6 months for initial therapy and 6 months for continuation therapy. Per regulatory guidance, this policy applies to Medicare only in the absence of an applicable NCD or LCD.

Step Therapy

Step	Requirement / Exception
1	Step therapy applies for medically administered medications without drug-specific criteria; EXCEPTION: Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy requirements.

Biosimilar Policy

Billing Rule

Reference product only after biosimilar failure/intolerance/contraindication

A reference (brand) product may be requested only if the patient has failure, intolerance, or contraindication to the biosimilar product unless biosimilar therapies do not exist.

Revision History

2019-02-13policy_effective

Policy effective date as listed in policy metadata.

2025-05-07last_reviewLatest

Policy last reviewed on this date per policy metadata; no material clinical changes noted.