Covered when ALL of the following required documentation elements are submitted and justify the requested coverage determination (prior authorization, formulary exception, quantity limit exception, tiering exception, or reimbursement).
Required elements for review: All of the following must be submitted: completed request form; prescriber statement when required; diagnosis with ICD-10 code(s); medication details (name, strength, route, frequency, quantity per 30 days); drug history including trials, dates, outcomes and whether failure or intolerance; documentation of contraindications or reasons alternatives are not suitable; rationale for exception (e.g., stable on current therapy, medical need for different dosage form, prior adverse effects).
Supported by form sections: Type of Request; Prescriber Information; Diagnosis and Medical Information; Drug History; Rationale for Request
Types of requests that require prescriber statement: A prescriber MUST provide a statement when the request is any of the following: formulary exception (including drugs not on formulary, removal from formulary, exceptions to step therapy, quantity limit exceptions, or exceptions to prior authorization rules).
See Type of Request checkboxes identifying request types that require prescriber completion of Supporting Information for an Exception Request or Prior Authorization.
Clinical details required in prescriber submission: Prescriber must document: diagnoses being treated with corresponding ICD-10 code(s); medication name, strength, route, frequency, date started, expected length of therapy, and quantity per 30 days; height/weight and drug allergies where relevant.
Captured in Diagnosis and Medical Information section of the supporting information form.
Drug history and prior trials: Provide complete drug history for the condition: drugs tried (including unit dose/total daily dose if quantity limit issue), dates of trials, results, and whether failure or intolerance. Explain current regimen and why alternative medications would not be as effective or would cause adverse effects.
See DRUG HISTORY section; required when requesting step therapy or formulary/tiering exceptions.
Step therapy / prior authorization exceptions: To request an exception to step therapy or to bypass prior authorization requirements, prescriber must include a statement documenting prior trials and failures, contraindications, or intolerance that justify bypassing step requirements, and explain why alternatives are not suitable.
Supported by RATIONALE FOR REQUEST items describing required details for alternatives tried, contraindications, and clinical rationale.
Rationale elements for formulary tier or quantity exceptions: When requesting tiering or quantity limit exceptions, include: formulary/preferred drugs tried and results; if adverse outcome occurred, list drugs and adverse outcomes; if therapeutic failure, list maximum dose and length of therapy for drugs trialed; or specific clinical reasons why preferred drugs are contraindicated or not suitable.
See RATIONALE FOR REQUEST checkboxes for formulary tier exception and quantity/alternative explanations.
Expedited review request: If expedited review is requested, the prescriber must certify that applying the 72-hour standard review timeframe may seriously jeopardize the enrollee's life, health, or ability to regain maximum function. Expedited requests are documented by checking the expedited review box and signing the form.24 hours
REQUEST FOR EXPEDITED REVIEW checkbox and certification required; expedited timeframe is 24 hours when criteria met.
Safety and contraindication disclosure: Disclose any FDA-noted contraindications to the requested drug and explain; document concerns for drug interactions or other safety issues that affect medical necessity.
DRUG SAFETY section asks about FDA-noted contraindications and interaction concerns.
Operational/documentation notes: Include representative authorization (e.g., CMS-1696) if the requester is not the enrollee. Submit any supporting documents referenced on the form (clinical notes, lab results, hospitalization records) to substantiate trials, failures, contraindications, or adverse outcomes. Failure to provide required prescriber supporting information may result in denial or incomplete processing.
Supported by Required supporting documentation and Missing supporting prescriber documentation guidance.