Non-Formulary Exception Criteria for Approval
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Defines the clinical and documentation requirements for approval of non-formulary drug exceptions for Medicare Part D members, including required trials of formulary alternatives and acceptable prescriber rationale.
No material clinical or coverage changes in this revision.
Non‑Formulary Exception Coverage Criteria
Non-Formulary Exception Approval Criteria
Covered when ONE of the following is met
Length of approval: 12 months
Length of approval: 12 months
None explicitly stated in this document.
The policy does not list additional non-coverage conditions beyond failure to meet the stated exception criteria (for example, insufficient trials or lack of prescriber justification would result in non-approval).
Provider Requirements and Prior Authorization
Submit evidence that non‑formulary exception criteria are met
Prior authorization requires submission of evidence that the non‑formulary exception criteria are met: either documentation of three failed or intolerant trials of formulary alternatives (including trial/failure of the generic equivalent when the requested product is a multi‑source brand with a formulary generic) OR a prescriber explanation why formulary alternatives are unsuitable.
- If three formulary agents with a similar mechanism are not available, documentation of three medically acceptable formulary alternatives is required.
- Length of approval: 12 months.
Step therapy: try ≥3 formulary alternatives before exception
The policy requires a step trial of at least three formulary alternatives prior to approval of a non‑formulary exception unless the prescriber documents why those alternatives are not appropriate.
- Alternatives should have a similar mechanism of action when available; if not, three medically acceptable alternatives must be tried.
- Trial and lack of response or intolerance must be documented for each alternative.
Document trials and outcomes for ≥3 formulary alternatives
Provide clinical documentation that the member tried and either did not respond to or did not tolerate at least three alternative formulary medications with a similar mechanism of action, or documentation explaining why formulary alternatives would be ineffective or cause adverse effects. If the requested drug is a multi‑source brand with a formululary generic, include trial and failure of the generic as one of the three alternatives.
- Specify dates, doses, and reasons for discontinuation (nonresponse or intolerance) for each formulary alternative tried.
- If similar‑mechanism agents aren’t on formulary, document three medically acceptable alternatives tried.
Insufficient trials or missing documentation may lead to denial
Failure to document that the member has tried at least three alternative formulary medications with a similar mechanism of action (or three medically acceptable alternatives when similar agents are not available), or failure to document trial and lack of response or intolerance, may result in denial of the non‑formulary exception request.
- Include trial evidence (or prescriber justification) to avoid denial.
- For multi‑source brands, lack of documented trial of the generic equivalent as one of the three alternatives risks denial.
Step Therapy Requirements
| Step | Requirement | Documentation needed | Length of approval |
|---|---|---|---|
| 1 | Trial of at least three formulary alternatives with a similar mechanism of action prior to non‑formulary exception approval; if three similar agents are not available on formulary, trial of three medically acceptable formulary alternatives | Documentation that the member tried and did not respond to or did not tolerate each of the three formulary alternatives. If the requested medication is a multi‑source brand and a generic equivalent is on formulary, documentation must show trial and failure of the generic as one of the three alternatives. | 12 months |
| 2 | Or: prescriber provides a clinical explanation why formulary alternatives would be ineffective or would cause adverse effects | Written prescriber rationale explaining why formulary alternatives are not appropriate or would cause adverse effects | 12 months |
Definitions and Important Terms
Background
This policy governs exceptions to the plan formulary for Medicare Part D members when a prescriber requests coverage for a non-formulary medication. It establishes minimum trial and documentation expectations to demonstrate medical necessity or intolerance to formulary alternatives, including a specific requirement for multi-source brand drugs: if a generic equivalent is on the formulary, the generic must be tried and failed as one of the three required alternatives. The standard length of approval for an approved exception is 12 months.
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