CurrentCareSource GeorgiaPolicy PAD-0005-GA-MCD

Medical Necessity for Multi-Source Brands

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This policy governs prior authorization and coverage of multi-source brand medications for CareSource Georgia Medicaid members when therapeutically equivalent generic products are available. Providers must submit clinical documentation demonstrating that the policy criteria and any applicable drug-specific requirements are met.

Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Multi-Source Brands

Policy CodePolicy PAD-0005-GA-MCD

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with chart notes and documentation supporting medical necessity for each multi-source brand request.

SourceLink

POLICY UPDATE CHANGES

The generic-manufacturer failure criterion was revised to use inefficacy rather than adverse events as its basis.

Defined initial approval durations and subsequent reauthorization requirements were added.

Case-by-case EPSDT review was added for members younger than 21 years.

References to formulary requirements were revised, while same-class formulary alternative failure remains required.

2Generic manufacturers required for inefficacy pathway

Up to 6 monthsInitial approval duration

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CurrentCareSource GeorgiaPolicy PAD-0005-GA-MCD

Medical Necessity for Multi-Source Brands

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Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Multi-Source Brands

Policy CodePolicy PAD-0005-GA-MCD

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with chart notes and documentation supporting medical necessity for each multi-source brand request.

SourceLink

POLICY UPDATE CHANGES

The generic-manufacturer failure criterion was revised to use inefficacy rather than adverse events as its basis.

Defined initial approval durations and subsequent reauthorization requirements were added.

Case-by-case EPSDT review was added for members younger than 21 years.

References to formulary requirements were revised, while same-class formulary alternative failure remains required.

2Generic manufacturers required for inefficacy pathway

Up to 6 monthsInitial approval duration

Up to 12 monthsSubsequent renewal duration

4Serious adverse-event categories

<21 yearsAdditional EPSDT review

Coverage Criteria

Initial Therapy

Initial therapy for a multi-source brand medication is covered when at least one of the following pathways is met. Prior authorization requests must be submitted for each request with chart notes and documentation supporting medical necessity.

At least ONE of the following pathways

I. Trial and failure
- The member has tried and failed two generic manufacturers of the requested brand-name medication at an adequate dose for an adequate duration.
  Information must be provided regarding the treatment target or goal that was inadequately met.
- The member has tried and failed all formulary alternatives within the same drug class as the requested brand-name medication that have an FDA-approved indication to treat the member's condition.
II. Serious adverse event with generic version(s)
- The member had a serious adverse event with the generic version(s).
- The prescriber provided a copy and confirmation of a MedWatch form submission to the FDA documenting the adverse outcome experienced by the member.
  The MedWatch form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf.
- The adverse event was one of the following
  - Was life threatening
  - Required hospitalization
  - Caused disability or permanent damage
  - Required intervention to prevent permanent impairment or damage
III. Allergic reaction to inactive ingredient
- The member has a history of allergic reaction to an inactive ingredient in the generic product.
- The prescriber documented the inactive ingredient, the reaction including dates and clinical details, and the manufacturer of the generic product.

Initial approval duration for a multi-source brand product request: up to 6 months.

Continuation Therapy

Continuation therapy may be renewed for up to 12 months when all of the following are documented in chart notes submitted with the renewal request:

All of the following are required

Initial criteria were previously met
The member has had a positive clinical response to therapy with the requested brand-name product
The member has experienced no toxicities or serious adverse reactions with the brand-name product

Requests will not be approved for treatment of non-FDA-approved diagnoses or conditions not supported by compendia evidence. Please refer to the Medical Necessity Off-Label policy.

All other uses of brand-name medications are considered not medically necessary.

Use of a multi-source brand medication outside the approved initial-therapy or continuation-therapy pathways is not medically necessary.

Provider Submission Requirements

Prior Authorization

Prior Authorization Required

Submit a separate prior authorization request for each multi-source brand medication request. Include chart notes and supporting documentation establishing medical necessity.

Documentation Required

Apply Medication-Specific Requirements

Medication-specific requirements apply in addition to the multi-source brand criteria. Confirm that the requested drug meets any applicable Medication Specific Policy requirements before submitting the request.

The multi-source brand policy does not supersede drug-specific criteria or applicable benefit exclusions.

Policy Background

CareSource uses pharmacy policies to support selection of therapies consistent with product labeling, clinical guidelines, clinical studies, and formulary use. Coverage decisions are based on medical necessity and are interpreted with the member’s specific benefit plan, applicable medication-specific policies, and benefit exclusions.

Key Definitions

Allergic Reaction

DefinitionAn allergic reaction occurs when the immune system overreacts to a harmless substance.

Medication symptomsSymptoms may include skin rashes or hives, itching, respiratory problems, swelling, or anaphylaxis.

Adverse reactionsAll medications can cause side effects, but only about 5% to 10% of adverse drug reactions are allergic.

Clinical Judgment

DefinitionClinical judgment consists of decisions made within the scope of a pharmacist's expertise.

Information reviewedThe pharmacist reviews subjective and objective medical data for the member.

Initial Approval

Initial Approval Criteria

Initial coverage is available when one qualifying pathway is met:

Initial approval pathway

Generic and same-class alternative failure
- Two generic manufacturers: The member has tried and failed two generic manufacturers of the requested brand name medication at an adequate dose for an adequate duration.2 generic manufacturers; adequate dose and duration
  Document the treatment target or goal that was inadequately met.
- Same-class formulary alternatives: The member has tried and failed all formulary alternatives within the same drug class as the requested brand name medication that have an FDA-approved indication to treat the member's condition.All applicable same-class formulary alternatives

Subsequent Approval

Subsequent Approval Criteria

Subsequent approval requires all of the following:

Continuation approval

Initial criteria previously met: The initial multi-source brand criteria were previously met.
Positive clinical response: The member has a positive clinical response to therapy with the requested brand name product.
No brand toxicities or serious adverse reactions: The member has experienced no toxicities or serious adverse reactions with the requested brand name product.

Required Alternative Trials

Step	Required trials	Dose and duration	Failure requirement
1	Two generic manufacturers of the requested brand name medication and all formulary alternatives within the same drug class that have an FDA-approved indication for the member’s condition.	Adequate dose for an adequate duration.	The treatment target or goal was inadequately met with each generic manufacturer.

Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Multi-Source Brands

Policy CodePolicy PAD-0005-GA-MCD

Change TypeMaterial revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit a prior authorization request with chart notes and documentation supporting medical necessity for each multi-source brand request.

SourceLink

On This Page

Step Therapy

Document Generic and Same-Class Alternative Trials

Document the applicable trial history. The member must have tried and failed two generic manufacturers of the requested brand at an adequate dose and duration, as well as all FDA-approved same-class formulary alternatives, unless an exception pathway applies.

For each generic manufacturer, identify the treatment target or goal that was inadequately met.
List each applicable same-class formulary alternative and document failure or intolerance.
If the applicable criteria are not met, the request does not qualify under this policy.

Unsupported block type: documentation

Documentation Required

Include Complete Trial History

Provide the start date and duration for every medication trial. If the member was enrolled with CareSource when a trial occurred, paid claims must be available for that trial.

Include trial dates and duration for generic manufacturers and same-class formulary alternatives.
Address paid-claims availability when applicable.

Documentation Required

Explain Generic Inefficacy

For generic inefficacy, explain the treatment target or clinical goal that was inadequately met with each generic manufacturer.

Tie each failed generic trial to the member's condition, treatment goal, and outcome.

Documentation Required

Document Serious Adverse Events

For a serious adverse event with a generic product, submit a copy of the FDA MedWatch form and confirmation that it was submitted. The documented event must meet an applicable serious-outcome standard.

Qualifying outcomes include a life-threatening event, hospitalization, disability or permanent damage, or intervention required to prevent permanent impairment or damage.

Documentation Required

Document Inactive-Ingredient Allergy

For an allergy to an inactive ingredient in the generic product, document the inactive ingredient, the reaction dates and clinical details, and the generic product manufacturer and product information.

The documentation must link the allergic reaction to an inactive ingredient in the generic product.

Documentation Required

Support Renewal Requests

For renewal, submit chart notes showing that the initial criteria were previously met, the member has a positive clinical response to the requested brand, and continued therapy remains needed.

Document that no toxicities or serious adverse reactions have occurred with the brand product.
Initial approval may be granted for up to 6 months; subsequent approvals may be renewed for up to 12 months.

Documentation Required

Submit EPSDT Documentation for Members Under 21

For members younger than 21 years, submit documentation for case-by-case Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) review in addition to the standard policy criteria.

The request remains subject to documentation of the applicable standard criteria.

Denial Risk

Non-FDA-Approved or Unsupported Use

Requests for treatment of a non-FDA-approved diagnosis or a condition not supported by compendia evidence will not be approved.

Do not submit unsupported off-label uses under this policy.
Refer to the Medical Necessity Off-Label policy when applicable.

Denial Risk

Criteria Not Met or Use Outside Policy

Uses outside the listed medical-necessity pathways are considered not medically necessary. Requests that do not meet the applicable criteria, lack a qualifying exception, or are for other uses are not approvable under this policy.

Applicable pathways include documented failure of required generic and same-class alternatives, a qualifying serious adverse event, or a documented inactive-ingredient allergy.
Clearly identify the pathway and submit evidence that every applicable criterion is met.

Denial Risk

Incomplete Documentation Risks Denial

Approval may be prevented when clinical documentation is incomplete or does not confirm the applicable criteria. Include records supporting the diagnosis, medical necessity, trial history, outcomes, and any exception pathway relied upon.

Submit the required documentation with each prior authorization request rather than relying on undocumented history.
Confirm that the records support the requested brand, indication, and duration.

Outside the pharmacist's expertise

If a request is outside the pharmacist's scope of expertise, the benefit determination is made in collaboration with a medical director.

Multi-Source Brand

DefinitionA multi-source brand is a brand-name medication sold or marketed by multiple manufacturers.

Manufacturer availabilityThe medication is available from more than one manufacturer.

Generic availabilityTherapeutically equivalent generic products are available.

Drug

DefinitionA drug is a medication or substance that induces a physiologic effect on a member's body.

Included productsThe term includes medication, agent, drug therapy, treatment, product, and biosimilar drugs.

Physiologic effectThe defining characteristic is an induced physiologic effect on the member's body.

Formulary Drug List

DefinitionA Formulary Drug List is a list of prescription drugs covered by CareSource.

Generic drugsThe list includes selected generic prescription drugs.

Brand-name drugsThe list includes selected brand-name prescription drugs.

Medical Necessity

DefinitionMedical necessity means health care services, supplies, or drugs needed to diagnose, treat, or prevent illness, injury, conditions, diseases, or associated symptoms.

Practice standardsThe services, supplies, or drugs must be provided in accordance with accepted standards in the practice of medicine.

Member healthMedical necessity is evaluated based on the member's overall health and well-being and whether the member's day-to-day health would be impacted.

Non-Formulary Drug

DefinitionA non-formulary drug is a drug that is not on the Formulary Drug List.

Formulary referenceThe Formulary Drug List is the list of prescription drugs selected for coverage by CareSource.

Coverage statusA drug is non-formulary when it is absent from CareSource's selected generic and brand-name prescription drug list.

Serious adverse event with generic product

Qualifying serious adverse event: The event was life threatening, required hospitalization, caused disability or permanent damage, or required intervention to prevent permanent impairment or damage.At least 1 of 4 severity categories

Allergic reaction to generic inactive ingredient: The member has a history of allergic reaction to an inactive ingredient in the generic product, and the prescriber documented the inactive ingredient, the reaction including dates and clinical details, and the manufacturer of the generic product.