CurrentcaresourcegeorgiaPolicy N/A

Medical Necessity for Preferred and Non-Preferred Medications

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This policy governs CareSource Georgia Medicaid coverage and prior authorization review for preferred/formulary and non-preferred/non-formulary prescription medications. It establishes medical necessity, step therapy, quantity or dose limit, documentation, initial authorization, renewal, and exception requirements for providers.

Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Preferred and Non-Preferred Medications

Policy CodePolicy N/A

Change TypeRevised

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit a separate prior authorization request for each preferred or non-formulary medication with chart notes and member-specific clinical documentation supporting medical necessity.

SourceLink

POLICY UPDATE CHANGES

The policy was revised to add criteria addressing requests for preferred medications subject to prior authorization, step therapy, and quantity or dose limits and to update the policy name to Medical Necessity for Preferred and Non-Preferred Medications.

The renewal approval duration was changed from up to 6 months to up to 12 months and complex or rare disease states were added to the specialist-prescribing consideration.

The policy added case-by-case Early and Periodic Screening, Diagnosis, and Treatment review for members younger than 21 years.

6 monthsMaximum initial authorization duration

12 monthsMaximum renewal authorization duration

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CurrentcaresourcegeorgiaPolicy N/A

Medical Necessity for Preferred and Non-Preferred Medications

Customize your policy alerts

Sign up for all caresourcegeorgia policy alerts

Know when caresourcegeorgia releases new policies or updates existing guidance.

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Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Preferred and Non-Preferred Medications

Policy CodePolicy N/A

Change TypeRevised

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit a separate prior authorization request for each preferred or non-formulary medication with chart notes and member-specific clinical documentation supporting medical necessity.

SourceLink

POLICY UPDATE CHANGES

The renewal approval duration was changed from up to 6 months to up to 12 months and complex or rare disease states were added to the specialist-prescribing consideration.

The policy added case-by-case Early and Periodic Screening, Diagnosis, and Treatment review for members younger than 21 years.

6 monthsMaximum initial authorization duration

12 monthsMaximum renewal authorization duration

90 daysRequired product trial duration when applicable

12 monthsClaim history evaluation period

Under 21Additional EPSDT review

Coverage Criteria

Preferred Drug Prior Authorization

Coverage requires prior authorization for preferred drugs subject to prior authorization requirements.

ALL of the following

CareSource has received and approved a request for medical necessity for the preferred drug.
The request is reviewed against drug-specific criteria developed and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee.
The prior authorization request is submitted for the individual preferred drug with chart notes and/or member-specific documentation supporting medical necessity.
Requests may be submitted by fax, phone, mail, or electronically.

Step Therapy Exceptions

A prior authorization request for a preferred drug subject to step therapy may be approved when ANY one of the following exceptions applies:

ANY of the following

The member previously used the prerequisite drug(s), or a drug in the same therapeutic class or with the same mechanism of action, but discontinued therapy because of lack of efficacy, diminished effect, or an adverse event.
If the member has no previous paid claims for the prerequisite or related drug(s), documentation of previous trials is required.
The member is currently using and stable on the requested drug and is expected to experience adverse outcomes from switching therapy, such as worsening of a comorbid condition or decreased ability to achieve or maintain reasonable functional ability in daily activities, based on submitted documentation and medical history.
The member has an allergy or intolerance to one or more prerequisite drug(s), based on submitted documentation and medical history.
One or more prerequisite drug(s) is expected to cause an adverse effect, based on submitted documentation and medical history.
One or more prerequisite drug(s) is expected to be ineffective or less effective for the member, based on submitted documentation and medical history.

Quantity or Dose Limit Exceptions

A prior authorization request for a preferred drug subject to quantity or dose limits may be approved when EITHER of the following pathways is met:

EITHER of the following

ALL of the following
- The requested quantity or dose does not exceed the maximum recommended dose approved by the FDA and is medically necessary based on submitted documentation and medical history.
- The requested quantity or dose does not exceed the limits covered by the plan or applicable state and federal laws.
ALL of the following
- The provider submits clinical documentation supporting use of an off-label quantity or dose in accordance with the CareSource Medical Necessity—Off Label Policy.

Non-Preferred Medication — Initial Criteria

CareSource will approve a non-preferred drug when ALL of the following initial criteria are met:

ALL of the following

Package-insert requirements
- The requested medication is prescribed for an FDA-approved indication and age.
- The requested medication is prescribed at an FDA-approved dosage.
- The member does not have a contraindication to the requested medication.
Chart notes and relevant screening results are provided to confirm the diagnosis.
The requested medication is prescribed by or in consultation with an appropriate specialist, when applicable.

Renewal Criteria

Renewal coverage requires ALL of the following:

ALL of the following

Chart notes show that the member has had a positive response to therapy.
The requested use and dosage remain consistent with FDA-approved prescribing information in the drug package insert.
Renewal approval is limited to the length of the request and may not exceed 12 months.

CareSource will approve non-formulary medications and consider their use medically necessary only when the applicable criteria in this policy are met. This policy does not supersede drug-specific criteria developed and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee or drug or therapeutic category benefit exclusions.

Prior authorization requests must be submitted for each non-formulary medication and should include chart notes and documentation supporting medical necessity. Non-preferred requests should include chart notes and/or documentation.

Any request for a branded medication when a generic is available must follow the CareSource Medical Necessity for DAW policy.

All other uses of non-formulary medications are considered experimental or investigational and follow the CareSource Medical Necessity—Off Label Policy.

When the requested medication is a combination product, convenience alone does not meet medical necessity. The member must have tried a 90-day trial of the active ingredients separately taken at the same time, and chart notes must support a clinical reason why the separate agents cannot be used.

Provider Actions and Authorization Requirements

Prior Authorization

Preferred Drug Prior Authorization

Submit a prior authorization request for each preferred drug subject to prior authorization before dispensing. Requests are reviewed against the drug-specific criteria developed and approved by the CareSource P&T Committee.

Step Therapy

Step Therapy Exception Authorization

A step therapy exception may be authorized when the member meets a documented exception circumstance, including prior failure, diminished effect, adverse event, allergy or intolerance, expected ineffectiveness, adherence barriers, or clinical stability on the requested drug.

Submit documentation and medical history supporting the applicable exception.
An exception may also be approved when switching a stable member is expected to cause adverse outcomes.

Policy Background

CareSource administers pharmacy coverage through a Preferred Drug List established and reviewed by its Pharmacy and Therapeutics Committee, with applicable state regulatory requirements also governing the program. Drug selection and review are intended to support product labeling, clinical guidance, medical necessity, formulary use, and cost-effective care.

Definitions

Preferred Drug List (PDL)

DefinitionA list of prescription drugs covered by CareSource.

Drug typesThe list includes selected generic and brand-name drugs.

Coverage roleA drug's inclusion on the list identifies it as a preferred drug for CareSource coverage purposes.

Medical Necessity

DefinitionHealth care services, supplies, or drugs needed to diagnose, treat, or prevent illness, injury, conditions, diseases, or associated symptoms.

StandardMedical necessity is evaluated in accordance with accepted standards in the practice of medicine.

Member-focused review

Initial Therapy Criteria

Non-Preferred Medication Initial Therapy

Initial coverage of a non-preferred medication requires ALL of the following.

Non-preferred medication initial therapy

FDA labeling: The request meets the FDA-approved indication and age, uses the FDA-approved dosage, and the member has no contraindication.
Diagnosis and specialist: Chart notes and relevant screening results support the diagnosis, and the medication is prescribed by or in consultation with an appropriate specialist when applicable.
Alternative treatment pathway
- Same-class alternatives failed or not tolerated: The member has had an adequate trial and failure or intolerance of all formulary alternatives in the same drug class that can be used for the same diagnosis.

Continuation and Renewal Criteria

Renewal of Non-Preferred Medication

Renewal approval requires ALL of the following.

Continuation therapy: The member has had a positive response to therapy, and the requested use and dosage remain consistent with FDA-approved prescribing information in the drug package insert.

Renewal approval is limited to the requested duration and may not exceed 12 months.

Step Therapy Requirements

Step	Prerequisite requirement	Exception handling
1	Use the prerequisite drug or drugs required by the applicable step therapy criteria. The member must have a previous paid claim for the prerequisite drug(s). If there is no paid claim, provide documentation of the prior trial.	A prior authorization exception may be approved when the prerequisite drug or a related drug was ineffective, lost effect, caused an adverse event, is contraindicated or intolerable, is expected to cause an adverse effect or be ineffective, would create a significant adherence barrier, or when the member is stable on the requested drug and switching is expected to cause an adverse outcome.

Policy Summary

PayerCareSource Georgia

PolicyMedical Necessity for Preferred and Non-Preferred Medications

Policy CodePolicy N/A

Change TypeRevised

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit a separate prior authorization request for each preferred or non-formulary medication with chart notes and member-specific clinical documentation supporting medical necessity.

SourceLink

On This Page

One or more prerequisite drug(s) is expected to create a significant barrier to the member’s adherence or compliance with the plan of care, based on submitted documentation and medical history.

The requested quantity or dose is medically necessary based on submitted documentation and medical history.

A claim for a preferred drug subject to quantity or dose limits will be denied at the point of service when it exceeds the applicable limits unless CareSource has received and approved a prior authorization request.

ONE of the following formulary-alternative pathways

The member has had an adequate trial and failure or intolerance of ALL formulary alternatives in the same drug class that can be used for the same diagnosis.
Provide trial start and end dates, or paid claims history when the member was a CareSource member.
If there is no alternative in the same drug class, the member has had an adequate trial and failure or intolerance of TWO available formulary alternatives that can be used for the requested indication according to clinical guidelines or standard of care.
Provide trial start and end dates, or paid claims history when the member was a CareSource member.
The member has a contraindication to ALL other formulary medications based on the member’s diagnosis, medical conditions, or other medication therapies.
There are no other formulary medications available to treat the member’s condition, such as for an orphan drug.

If applicable

ALL of the following
- The requested medication is a combination product.
- The member has tried a 90-day trial of the active ingredients separately taken at the same time.
- Chart notes support a clinical reason why the separate agents cannot be used.
  A request solely for convenience does not meet medical necessity.
ALL of the following
- The requested medication is a long-acting product.
- The member has tried a 90-day trial of a short-acting product, or has a clinical reason why the short-acting product cannot be used.

Initial approval is limited to the length of the request and may not exceed 6 months.

Prior Authorization

Quantity and Dose Limit Authorization

Submit a prior authorization request for a claim exceeding an applicable quantity or dose limit. Approval requires that the requested amount is medically necessary and meets the applicable FDA, plan, and legal limits, or is supported as an off-label quantity or dose under the CareSource Medical Necessity - Off Label Policy.

For an FDA-labeled request, document that the dose does not exceed the FDA maximum and remains within plan or applicable State and Federal limits.
For an off-label request, provide clinical documentation supporting medical necessity.

Unsupported block type: prior_auth

Documentation Required

Renewal Authorization

For renewal, submit chart notes showing a positive response to therapy and confirming that the requested use and dosage remain consistent with FDA-approved prescribing information in the drug package insert. Renewal approval is limited to the requested duration and no more than 12 months.

Step Therapy

Prerequisite Drug Exception

A prerequisite drug exception requires documentation that the member previously used the prerequisite drug, a same-class or same-mechanism drug, or cannot appropriately use the prerequisite therapy. If no prior paid claim exists, document the previous trial and its outcome.

A paid claim for the prerequisite drug or an approved exception authorization satisfies the prerequisite requirement.
Document prior failure, diminished effect, adverse event, allergy, intolerance, expected ineffectiveness, or a significant adherence barrier when applicable.

Documentation Required

Medical Necessity Documentation

Submit a separate prior authorization request for each medication with chart notes and member-specific clinical documentation supporting medical necessity. Documentation should address the applicable indication, treatment history, exception rationale, and requested dose or quantity.

Include chart notes and/or other member-specific supporting documentation.
For non-formulary medications, do not rely on this policy when drug-specific P&T criteria or benefit exclusions apply.

Note

Submission Methods

Preferred-drug prior authorization requests may be submitted by fax, telephone, mail, or electronically.

Documentation Required

Diagnosis and Specialist Documentation

For non-preferred medication requests, provide chart notes and relevant screening results confirming the diagnosis, and identify the appropriate specialist when the medication is prescribed by or in consultation with one.

Confirm the diagnosis with chart notes and any relevant screening results.
Provide specialist information when required by the drug criteria or clinically appropriate for a complex or rare condition.

Documentation Required

Alternative Trial History

Document adequate trials of formulary alternatives, including trial start and end dates. When the member was a CareSource member during the trial, paid pharmacy claims may be used to establish the trial history.

Document failure or intolerance of all applicable same-class alternatives.
If no same-class alternative exists, document adequate failure or intolerance of two available formulary alternatives when applicable.

Documentation Required

Exception Rationale

Support an exception with medication history and member-specific clinical documentation. The rationale may include prior failure or intolerance, allergies, adverse events, expected ineffectiveness, adherence or compliance barriers, or the member's stability on the requested therapy.

Explain why the prerequisite or formulary alternative is unsuitable for this member.
For a stable member, document the expected adverse outcomes of switching therapy.

Documentation Required

Combination Product Documentation

For a combination product, document that the member completed a simultaneous 90-day trial of the active ingredients taken separately and provide a clinical reason, supported by chart notes, why the separate agents cannot be used.

A request based only on convenience does not meet medical necessity.

Documentation Required

Long-Acting Product Documentation

For a long-acting product, document a 90-day trial of a short-acting product and/or provide a clinical reason why the short-acting product cannot be used.

Documentation Required

Off-Label Quantity or Dose Documentation

For an off-label quantity or dose, submit clinical documentation supporting medical necessity under the CareSource Medical Necessity - Off Label Policy.

Denial Risk

Preferred Drug Prior Authorization Required

A preferred drug subject to prior authorization will be denied at the point of purchase unless CareSource has received and approved the medical-necessity request before dispensing.

Denial Risk

Step Therapy Prerequisite Not Met

A preferred drug subject to step therapy will be denied at the point of purchase unless the member has a paid claim for the required prerequisite drug or CareSource has approved a step therapy exception authorization.

Denial Risk

Quantity or Dose Limit Exceeded

A claim exceeding a quantity or dose limit will be denied at the point of service unless the required exception authorization has been approved.

Denial Risk

Non-Preferred Drug Criteria Not Met

A non-preferred medication must meet the applicable coverage criteria, including the FDA-approved indication and age, FDA-approved dosage, absence of contraindications, diagnosis confirmation, specialist involvement when applicable, and required formulary alternative history.

Document failure or intolerance of required alternatives, contraindication to all other formulary options, or that no formulary medication is available for the condition.
Combination and long-acting products must also meet their applicable trial and clinical-justification requirements.

Denial Risk

Use Outside Policy Criteria

Uses of non-formulary medications that fall outside the policy criteria are considered experimental or investigational and are reviewed under the CareSource Medical Necessity - Off Label Policy.

Billing Rule

Brand Requested When Generic Is Available

When a branded medication is requested and a generic is available, follow the CareSource Medical Necessity for DAW policy.

The evaluation considers the member's overall health and well-being and whether day-to-day health would be impacted.

Non-Preferred Drug

DefinitionA drug not on the Preferred Drug List.

PDL statusThe medication is excluded from the list of selected generic and brand-name drugs covered by CareSource.

Related reviewRequests for a non-preferred drug may be evaluated through medical necessity review and clinical review when an exception is requested.

Prior Authorization

DefinitionA requirement for medical necessity review for a preferred drug that may not be clinically appropriate for all members or may pose risk if used inappropriately.

Provider responsibilityThe provider must submit additional clinical information to CareSource for review and approval.

TimingReview and approval are required before the drug is available to the member.

Quantity or Dose Limit

DefinitionA limit that restricts the amount of medication dispensed.

How appliedThe restriction may apply per prescription order, refill, or time period.

Amount coveredThe restriction may limit the total quantity or total dose.

Specialty Drug

DefinitionA drug that treats complex diseases or requires special handling or distribution.

CostSpecialty drugs are usually high cost.

AuthorizationMany specialty drugs require prior authorization.

DispensingSpecialty drugs may be dispensed at limited locations.

Step Therapy

DefinitionA requirement that a member use a medication or series of medications before the requested medication.

Prerequisite treatmentThe member may need to use one or more prerequisite medications first.

Requested treatmentThe requested medication is considered after the required medication or medication series.

Adequate Trial

DefinitionA stable dose maintained for up to 90 days, or for the duration specified in treatment guidelines or the package insert as sufficient to observe treatment benefit.

Standard durationThe usual stable-dose period is up to 90 days when no other sufficient duration is specified.

Clinical reviewA pharmacist reviewer may use clinical judgment to determine a sufficient treatment duration, adequate number of trials, or appropriate dosing.

Adequate trial; provide trial start and end dates or qualifying paid claims

Two alternatives when no same-class alternative exists: If there is no alternative in the same drug class, the member has had an adequate trial and failure or intolerance of two available formulary alternatives, if available, that can treat the indication according to clinical guidelines or standard of care.Two alternatives, if available; provide trial start and end dates or qualifying paid claims

Contraindication to formulary medications: The member has a contraindication to all other formulary medications based on the diagnosis, medical conditions, or other medication therapies.

No formulary treatment available: No other medication is available on the formulary to treat the member's condition, such as in an orphan-drug situation.

Combination or long-acting product requirement: When applicable, the member has completed the required 90-day trial of the active ingredients taken separately at the same time or of a short-acting product, unless a documented clinical reason prevents that trial.90 days

Convenience alone is insufficient for combination products.