Non-Formulary Exception Criteria for Approval (Medicare Part D)
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Defines criteria for approval of non-formulary medication exceptions for Blue Cross Blue Shield of North Carolina Medicare Part D members; intended for providers requesting coverage of non-formulary drugs.
No material clinical or coverage changes in this revision.
Non-Formulary Exception Approval Criteria
Non-Formulary Exception Approval Criteria
Covered when ANY ONE of the following is met (approval length: 12 months):
Length of approval: 12 months
Length of approval: 12 months
Provider Requirements, Documentation, and Denial Triggers
Prior authorization: document trial of three formulary alternatives
Prior authorization requests must include evidence that the member has tried at least three alternative formulary medications that have a similar mechanism of action as the requested medication and that the member either did not respond to or did not tolerate those formulary alternatives; if three similar agents are not on formulary, documentation of trials of three medically acceptable formulary alternatives is required. As noted, when the requested drug is a multi‑source brand and a generic equivalent is on the formulary, the member must have tried and failed the generic equivalent as one of the three required alternatives.
- Trial of 3 formulary alternatives with similar mechanism of action when available
- If similar agents are not available, trial of 3 medically acceptable formulary alternatives
- If brand is multi‑source and generic equivalent is on formulary, failure of the generic counts as one required trial
Step therapy: three‑step trial required before exception approval
Step therapy is implicit in the exception criteria: approval requires documentation that the member has tried three formulary alternatives (as described above) before an exception will be approved unless the prescriber provides a medical justification explaining why formulary alternatives would not be effective or would cause adverse effects.
- Three‑drug trial is required prior to exception approval unless prescriber documents medical justification
- Prescriber rationale pathway may be used to request approval in lieu of trials
Required documentation: evidence of three alternative formulary trials
Include documentation showing the member tried at least three alternative formulary medications and evidence of non‑response or intolerance for each, or provide a prescriber explanation why formulary alternatives would not be effective or would cause adverse effects.
- Medication names and dates of trial for each of the three formulary alternatives
- Clinical notes documenting lack of response or adverse effects/intolerance for each trialed medication
- If applicable, prescriber rationale explaining why formulary options are not appropriate
Denial triggers: missing or insufficient trial documentation
A request may be denied if there is failure to document trials and failure or intolerance of three alternative formulary medications with a similar mechanism of action (or three medically acceptable alternatives when similar agents are not on formulary).
- Omitting documentation of the three required trials or evidence of non‑response/intolerance risks denial
- Failure to include the generic equivalent trial when the requested drug is a multi‑source brand and a generic is on formulary may result in denial
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