CurrentCareSourcePolicy PAD-0898-AR-PASSE

Medical Necessity for Multi‑source Brand Medications

Defines when CareSource will consider multi‑source brand medications medically necessary and the prior authorization, documentation, and trial requirements for members in the Arkansas PASSE program.

Policy Summary

PayerCareSource

PolicyMedical Necessity for Multi‑source Brand Medications

Policy CodePolicy PAD-0898-AR-PASSE

Change TypeRevised — administrative wording and clarification of approval durations

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes documenting trials of formulary alternatives or two generics, or MedWatch documentation for serious adverse events.

SourceLink

POLICY UPDATE CHANGES

Updated policy title to 'Medical Necessity for Multi-source Brands' and removed references to formulary.

6Initial approval (months)

12Renewal max (months)

180P&T review window (days)

Arkansas PASSEProgram

Coverage Criteria for Multi-Source Brand Medications

Policy Summary

PayerCareSource

PolicyMedical Necessity for Multi‑source Brand Medications

Policy CodePolicy PAD-0898-AR-PASSE

Change TypeRevised — administrative wording and clarification of approval durations

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes documenting trials of formulary alternatives or two generics, or MedWatch documentation for serious adverse events.

SourceLink

On This Page

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All other uses of brand name medications are considered not medically necessary. Requests for treatment of diagnoses that are not FDA‑approved, or for clinical indications not supported by recognized compendia, will not be approved under this policy. Refer to the Medical Necessity Off‑Label policy for guidance on off‑label requests.

Requests for treatment of non‑FDA approved diagnoses or conditions that lack support in accepted compendia are not medically necessary and will be denied. Documentation must demonstrate an FDA‑approved indication or compendia support to be considered for coverage.

Initial Therapy

Initial approval conditions

Initial approval: Member must meet the trial/failure or intolerance criteria described in the Initial Coverage Criteria: trials of all formulary alternatives within the same drug class with FDA‑approved indications and/or trials of two generics at adequate dose/duration with documentation of inadequate response; alternatively, documented serious adverse event to generic(s) with MedWatch confirmation or documented inactive‑ingredient allergy to the generic.6 months

If a medication‑specific policy exists, those requirements must also be met. Paid claims and medical record documentation (start date, duration, treatment targets/goals) must be supplied with the prior authorization request.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for multi-source brand medication requests. The prescriber must document failure of required alternatives or provide documentation of a qualifying adverse event or allergy to a generic inactive ingredient. Prior authorization requests must include chart notes and supporting medical record documentation confirming diagnosis, start date and duration of prior trials, and any MedWatch documentation when applicable.

Applies to all multi-source brand requests unless a medication-specific policy states otherwise
Initial approval duration: up to 6 months; subsequent approvals: up to 12 months with supporting chart notes
Prior authorization requests must be submitted with chart notes and medical records

Step Therapy

Step Therapy / Trials Required

Step therapy requirements enforce trials of formulary alternatives or generics before approval of a multi-source brand. The member must have tried and failed either all formulary alternatives within the same drug class with FDA‑approved indications for the condition OR two different generic manufacturers of the requested brand at adequate dose and duration. Claims history should be provided when available to verify trials.

Document treatment target or goal that was not met by prior therapies
If member was enrolled with CareSource when trial occurred, paid claims must be provided when available
Requests for members <21 years are reviewed for ESPDT in addition to step requirements

Documentation Required

Required Documentation

Prior authorization requests must include clinical documentation supporting medical necessity: chart notes confirming diagnosis, start date and duration of prior trials, clinical response to prior therapies, and documentation of any adverse events. Medical records may include test reports, provider chart notes, or hospital admission notes.

Provide start date and duration for each prior trial
If approval sought for adverse-event-based override, include MedWatch form submission or equivalent documentation
Include manufacturer information for the generic product when documenting an inactive-ingredient allergy

Denial Risk

Triggers for Denial

Requests will be denied if required generics or formulary alternatives have not been tried and failed, or if documentation is incomplete (e.g., missing chart notes, missing trial dates/durations, or absent MedWatch documentation when claiming a serious adverse event). Requests for non‑FDA‑approved indications without compendia support will be considered not medically necessary.

Denial risk when claims or medical records do not verify required trials
Denial risk when MedWatch or comparable documentation is not provided for claimed serious adverse events
Non‑FDA‑approved uses lacking compendia evidence are not approved

Step	Requirement	Failure Criteria	Coverage
1
Trial of formulary alternatives or lower‑cost agents per P&T guidance must be documented prior to approval of a multi‑source brand.
Failure of formulary alternatives and/or two generics at adequate dose/duration, or documented serious adverse event to generics (with MedWatch) or documented allergy to an inactive ingredient in the generic.
Covered with criteria

Definitions

inv-09: Multi-Source Brand

DefinitionBrand name medication sold or marketed by multiple manufacturers and has therapeutically equivalent generics available.

ContextCareSource will approve multi-source brand medications and consider their use medically necessary when specified criteria are met.

Related policy noteThis policy does not supersede drug-specific criteria developed and approved by the CareSource P&T Committee.

inv-10: Medical Necessity

DefinitionHealth care services, supplies, or drugs needed to diagnose, treat, or prevent illness, injury, conditions, diseases or associated symptoms in accordance with accepted standards in the practice of medicine.

Evaluation criteriaMedical necessity is evaluated based on the overall health and well-being of the member and impact on day-to-day health.

ApplicationPrior authorization requests for multi-source brands must include chart notes and documentation supporting medical necessity.

Background

CareSource pharmacy policy promotes appropriate therapy selection consistent with FDA labeling, clinical evidence, and formulary guidance while encouraging use of formulary or generic alternatives when clinically appropriate. For multi‑source brand medications, approval is considered only when specified criteria are met — for example, documented failure of required formulary alternatives or two generic manufacturers at adequate dose/duration, or documented serious adverse events to generics (with a MedWatch submission) or a documented allergy to an inactive ingredient in the generic. Initial approvals for multi‑source brand product requests are limited to up to 6 months, with possible subsequent renewals of up to 12 months when chart notes document prior criteria were met, a positive clinical response, and absence of toxicities or serious adverse reactions.

OpenPayer