CurrentCareSourcePolicy PAD-0898-AR-PASSE

Dispense As Written (DAW) / Non-Formulary Brand Medication Policy

Defines criteria for approving brand-name medications when a generic exists (DAW) for CareSource members in Arkansas Medicaid PASSE; applies to providers submitting prior authorizations for non-formulary/DAW medications.

Policy Summary

PayerCareSource

PolicyDispense As Written (DAW) / Non-Formulary Brand Medication Policy

Policy CodePolicy PAD-0898-AR-PASSE

Change TypeNo material change

Effective Date01/01/2022

Next Review Date

Key ActionSubmit prior authorization with chart notes and documentation of medical necessity including trial history and MedWatch forms for serious adverse events.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

01/01/2022Effective date

PAD-0898-AR-PASSEPolicy identifier

Arkansas PASSEProgram / scope

YesIncludes medical necessity

Dispense As Written (DAW) / Non-Formulary Approval Criteria

DAW / Non-Formulary Approval Criteria

Covered when ALL of the following are met:

ALL of the following

A or B
- All formulary alternatives within the drug class of the requested brand-name medication that have FDA-approved indication to treat the member's condition have been tried and failed.
- B: Two generic manufacturers of the requested brand-name medication have been tried and failed; information must be provided on the adverse event experienced by the member for each generic manufacturer.

If a serious adverse event occurred with the generic(s), the prescriber must provide a copy and confirmation of a MedWatch form submission to the FDA documenting the adverse outcome, and the MedWatch documentation must indicate one or more of the following: was life‑threatening; required hospitalization; caused disability or permanent damage; or required intervention to prevent permanent impairment/damage.

Policy Summary

PayerCareSource

PolicyDispense As Written (DAW) / Non-Formulary Brand Medication Policy

Policy CodePolicy PAD-0898-AR-PASSE

Change TypeNo material change

Effective Date01/01/2022

Next Review Date

Key ActionSubmit prior authorization with chart notes and documentation of medical necessity including trial history and MedWatch forms for serious adverse events.

SourceLink

On This Page

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Billing and Coding Notes

No billing or procedure codes specifiedmixed

No codes listed

Generic trial and failure requirements

Trial & failure requirementMember must have trialed and failed either: (A) all formulary alternatives in the drug class with FDA‑approved indications for the condition, OR (B) two generic manufacturers of the requested brand with documented adverse events for each generic.

Serious adverse event documentationIf a serious adverse event occurred with the generic(s), the prescriber must provide a copy and confirmation of a MedWatch submission to the FDA documenting that the event was life‑threatening, caused disability/permanent damage, required hospitalization, or required intervention to prevent permanent impairment/damage.

Allergic reaction to inactive ingredientApproval may be granted if there is a documented allergic reaction to an inactive ingredient in the generic product; prescriber must document the inactive ingredient, reaction details and dates, and the manufacturer of the generic trialed.

Prior Authorization & Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for certain medications and services as indicated by the member's benefit plan and any applicable Medication Specific Policy. Providers must submit a prior authorization request when coverage criteria are not met by a standard formulary agent or when a non-formulary/brand product is being requested. Approval of a prior authorization is not a guarantee of payment; benefits are determined at claim adjudication and subject to member-specific plan limitations and the Evidence of Coverage.

Submit completed prior authorization request with supporting documentation before providing service when required
Include dates and duration of any prior medication trials and paid claims history if the member was enrolled with CareSource during the trial
If claiming generic intolerance/adverse reaction, provide manufacturer-specific information and a copy/confirmation of FDA MedWatch form submission when applicable
Documented diagnoses must be supported by portions of the medical record (e.g., test reports, chart notes, hospital admission notes)
For medications with a Medication Specific Policy, meet both the DAW (Dispense as Written) policy requirements and the Medication Specific Policy criteria

Note

Formulary Governance — P&T Committee

CareSource maintains a formulary that is established, reviewed and approved by the CareSource Pharmacy & Therapeutics (P&T) Committee and applicable state regulatory bodies. The P&T Committee routinely reviews the formulary; formulary status and preferred agents may change. Changes to the formulary or P&T decisions may affect coverage or require different prior authorization criteria.

Formulary placement, preferred agents, and prior authorization criteria are governed by the P&T Committee
Formulary removal or changes (including when brand products become generic or when cost-effectiveness shifts) do not guarantee payment for a specific claim
Providers should verify member-specific coverage and prior authorization requirements in the member's benefit plan/Evidence of Coverage
Clinical rationale and supporting medical records must be provided to support medical necessity for exceptions to formulary or to request non-formulary agents

Key Definitions

DAW / Non‑Formulary Drug

Definition (DAW)DAW means 'dispense as written' — use of the brand product instead of the generic.

Approval conditionCareSource will approve DAW (non‑formulary/brand) medications when specified criteria demonstrating medical necessity are met and prior authorization documentation is submitted.

Prior authorization requirementPrior authorization requests should be submitted for each non‑formulary medication with chart notes and documentation supporting medical necessity.

Medical Necessity

DefinitionMedical Necessity: health 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 basisMedical necessity is evaluated based on the overall health and well‑being of the member and when the member's health would be impacted.

Relation to coverageServices or drugs must meet medical necessity standards and submitted documentation must support the determination for authorization decisions.