Clinical Review of Formulary and Non-Formulary Medications
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Defines CareSource Georgia's criteria and administrative process for prior authorization, step therapy, quantity/dose limits, and exceptions for formulary and non-formulary prescription drugs; applies to providers submitting drug coverage requests for members under CareSource Marketplace plans.
No material clinical or coverage changes in this revision.
Coverage and Exception Criteria
Non-Formulary Drug Exception
Use of non-formulary drugs will be approved when ALL of the following are met:
Non-Formulary Exception - Core Requirements
- C. Supporting documentation (one required): 1) Documentation of clinically adequate trial and therapeutic failure of at least 3 potential covered alternatives on the Marketplace Formulary OR if fewer than 3 alternatives exist then trials of all available alternatives; 2) If member enrolled with CareSource at time of trial, documentation must be supported by paid claims; 3) Documentation of contraindication to ALL alternative drugs on the Marketplace Formulary based on diagnosis/medical conditions/other therapies; 4) If no clinically adequate trial, submit clinical reasons why alternatives are expected to be ineffective or less effective; Additional: for combination products provide clinical reason why active ingredients cannot be taken separately unless separate ingredients are not on formulary; for long-acting formulations provide clinical reason why immediate-release cannot be used unless immediate-release is not on formulary; for multi-source branded drugs, documentation of trial and failure of at least two generic manufacturers with therapeutic failure details.
Detailed evidentiary requirements
Quantity/Dose Limit Exception
Exceptions to Quantity or Dose Limits will be approved when EITHER of the following are met:
Two alternative paths for exception approval
Step Therapy Exception
Exceptions to Step Therapy will be approved when any ONE of the following is met:
Any one criterion suffices for approval
Prior Authorization
Prior authorization required for designated formulary drugs and reviewed against drug-specific criteria approved by P&T Committee.
Operational submission methods listed
Renewal / Continuation
Renewal approval requires BOTH of the following:
Authorization period is through end of member's plan year unless otherwise indicated.
This policy does not supersede drug-specific criteria developed and approved by the P&T Committee or any drug/therapeutic category benefit exclusions. Requests for drugs that are provider‑administered or billed through the medical benefit must follow the Marketplace Medical Benefit Medications policy rather than this pharmacy policy. Additionally, formulary drugs that are subject to prior authorization, step therapy, or other utilization management controls will be denied at point of purchase unless CareSource has received and approved the required request or exception.
Provider Requirements and Operational Notes
Prior authorization required for designated formulary drugs
Prior authorization is required for any formulary drug designated as subject to Prior Authorization; providers must submit the request with chart notes and/or member-specific documentation and may send requests via fax, phone, mail, or electronically. Requests will be reviewed against drug-specific criteria developed and approved by the P&T Committee; when approved, member cost share will reflect the formulary tier shown in the Marketplace Drug Formulary and Member EOC.
- Submit chart notes and member-specific documentation with each request
- Submission methods: fax, phone, mail, or electronic
Step therapy requirements and approved exception reasons
Formulary drugs subject to step therapy will be denied at point of purchase unless the member has a prior paid claim for the required prerequisite drug(s) or CareSource has approved a Prescription Drug Exception; approved exceptions include prior use with documented lack of efficacy or adverse event, clinical stability on the requested drug with risk from switching, allergy/intolerance, expected adverse effects or ineffectiveness, or significant adherence barriers, based on submitted documentation and medical history.
- Member paid claim history for prerequisite drug(s) or an approved exception is required to avoid denial at point of purchase
- Exceptions accepted when any one listed reason (A–F) is met with supporting documentation
Required supporting documentation for PA and non‑formulary exceptions
Prior authorization and non‑formulary exception requests must include chart notes and member‑specific documentation that support the clinical judgment for the request; non‑formulary requests must document trials of alternatives or contraindications to formulary alternatives as specified in the Non‑Formulary criteria.
- Include chart notes and member‑specific documentation with each Prior Authorization or Non‑Formulary Exception request
- For non‑formulary requests, provide documentation of clinically adequate trials (e.g., at least 3 formulary alternatives or all available alternatives if fewer than 3), paid claims if the member was enrolled during the trial, or contraindications/clinical rationale why alternatives are expected to be ineffective
Point‑of‑purchase denial risk if utilization management requirements are not met
Formulary drugs subject to Prior Authorization, Step Therapy, or Quantity/Dose Limits will be denied at the point of purchase unless CareSource has received and approved the required request or exception; failure to submit required documentation or paid‑claim history creates a denial risk at point of sale.
- Denial at point of purchase will occur without received and approved PA, exception, or paid claim history for prerequisite drugs
- Ensure required documentation/supporting evidence is submitted to avoid claim denial
Conditions of Coverage Codes
| NDC | National Drug Code (referenced as a condition of coverage item) |
| HCPCS | HCPCS codes (referenced as a condition of coverage item) |
Renewal and Continuation Requirements
Renewal Criteria
Renewal/continuation requirements
Step Therapy Requirements
| Requirement | Details | Coverage Status |
|---|---|---|
| Prerequisite paid claim | ||
| Member must have a prior paid claim history for the prerequisite drug(s) required by the step therapy criteria before a formulary drug subject to step therapy will be covered at point of purchase. | ||
| Covered with criteria | ||
| Approved exception | ||
| If member lacks prior paid claims, an approved Prescription Drug Exception request will allow bypass of step therapy when documentation supports one of the exception reasons (previous use with documented lack of efficacy/adverse event, clinical stability on requested drug, allergy/intolerance, expected adverse effects, expected ineffectiveness, or significant adherence barriers). | ||
| Covered with criteria |
Definitions and Clinical Terms
Background and Governance
CareSource maintains a Marketplace Formulary that is reviewed and governed by the Pharmacy & Therapeutics (P&T) Committee. Utilization management tools — including prior authorization, step therapy, and quantity/dose limits — may be applied to formulary drugs to align coverage with clinical best practices and cost‑effective care. Prior authorization requests must be submitted with chart notes or member‑specific documentation and will be reviewed against drug‑specific criteria approved by the P&T Committee. Submission methods include fax, phone, mail, or electronic channels.
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