Guidelines for Prior Authorization of Pharmacologic Therapies
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Defines Blue Cross of Idaho requirements and criteria for prior authorization, formulary exceptions, and evaluation of on- and off-label pharmacologic therapies for members covered under BCI benefit plans.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Coverage criteria
Coverage and prior authorization determinations are made when criteria from the member contract and recognized clinical evidence sources are satisfied.
Sources used include FDA, MPS, InterQual, PBM criteria, NCCN, AHFS, Facts & Comparisons, and peer-reviewed literature.
Applies only to contracts permitting non‑formulary coverage (e.g., Qualified Health Plans).
Effectiveness determination prioritizes scientific evidence, then professional standards, then expert opinion; more cost‑effective alternatives may require trial and failure unless contraindicated.
HOPA guidance and other recognized oncology resources may inform dosing optimization and application.
This policy does not require coverage for drugs when the U.S. Food and Drug Administration has determined the use to be contraindicated. In addition, therapies that meet the policy's definition of investigational are excluded from coverage. Providers requesting coverage for off‑label uses should be aware that such requests must meet the policy's evidentiary standards (see investigational and off‑label criteria) to be considered non‑investigational and eligible for benefit determination.
A medication or technology is considered investigational and not covered when it fails to meet Blue Cross of Idaho's required criteria. Specifically, the product must have final approval from the appropriate regulatory body (interim approval is insufficient) for the same condition under review; there must be sufficient peer‑reviewed scientific evidence permitting conclusions about effects on health outcomes; the benefits must outweigh harms and be at least as good as established alternatives; and demonstrated improvements must be reproducible in usual clinical practice. For off‑label drug uses not found in recognized references, at least two peer‑reviewed studies supporting efficacy and safety must be submitted and will be evaluated on their strength of evidence before the use can be considered non‑investigational.
Prior Authorization & Provider Requirements
Submit prior authorization for PA‑listed medications
All medications listed on the Blue Cross of Idaho prior authorization list must undergo the prior authorization process before coverage will be approved.
Provide trial/failure of formulary therapeutic equivalents
When a formulary exception is sought (where the contract allows), provide evidence that the member has tried and failed formulary therapeutic equivalents or that those equivalents are expected to cause harm; utilization management rules for drugs in the same therapeutic class will also be applied as applicable.
- Requested medication must be for an FDA‑approved indication.
- Medication and dose must be medically necessary and appropriate.
- Document that all available therapeutic equivalents on formulary were ineffective or are expected to cause harm.
- Meet any applicable utilization management requirements for the therapeutic class.
Submit required clinical documentation
Provide appropriate clinical documentation demonstrating member eligibility under the benefit plan and clinical justification for the request; for formulary exception requests include documentation that therapeutic equivalents were tried and found ineffective or contraindicated.
- Evidence of member eligibility per the member contract.
- Clinical information supporting medical necessity or investigational status per contract criteria.
- For formulary exceptions: documentation that therapeutic equivalents were ineffective or expected to cause harm.
Denial risks: non‑coverage, lack of medical necessity, or missing documentation
Requests may be denied if the medication is not covered under the member's benefit plan, medical necessity is not demonstrated, or required clinical documentation is not provided.
- Medication not on the member's benefit plan (non‑covered).
- Insufficient demonstration of medical necessity or investigational exclusion per contract.
- Missing or incomplete clinical documentation to support the request.
Step Therapy / Therapeutic Trial Requirements
| Requirement | Details / Documentation | Coverage Label |
|---|---|---|
| FDA‑approved indication | ||
| Requested medication must be used for an FDA‑approved indication. | ||
| Formulary exception requires trial and failure of formulary therapeutic equivalents when contract allows; documentation that equivalents were ineffective or expected to cause harm must be provided. | ||
| The prescribing provider must document that all available therapeutic equivalents on the formulary (or other medically appropriate medications if no equivalents exist) either: (a) were ineffective for the condition OR (b) are reasonably expected to cause a harmful or adverse clinical reaction or response. | ||
| Utilization management | ||
| The requested drug must meet any applicable utilization management requirements if it is in the same therapeutic class as formulary drugs that require such authorization. | ||
| Submission | ||
| Formulary exception requests (when contractually allowed) may be submitted using the Formulary Exception Request form. |
Background and Evidence Sources
Blue Cross of Idaho evaluates medications for medical necessity using evidence-based sources, including FDA approvals and guidance, recognized clinical compendia such as NCCN, and established utilization criteria (InterQual, PBM criteria), as well as peer‑reviewed literature. Off‑label uses may be considered when they meet BCI medical necessity standards and are supported by recognized references (NCCN, AHFS, Facts & Comparisons) or by a minimum of two peer‑reviewed studies when not present in those resources. Oncologic drugs are assessed using NCCN recommendations, with NCCN category 1 or 2A guidance considered medically necessary when appropriately applied.
Key Definitions
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