Information and supporting rationale required for coverage determination or exception requests.
Requester must indicate the type of coverage determination requested (e.g., formulary exception, prior authorization, tiering exception, quantity limit exception, reimbursement).
If requesting a formulary or tiering exception, the prescriber MUST provide a supporting statement; prior authorization requests may require supporting information.
See 'Supporting Information for an Exception Request or Prior Authorization' section.
List all diagnoses being treated with the requested drug and provide corresponding ICD-10 code(s).
Include the diagnosis causing any listed symptom, if applicable.
Provide full drug history for the condition(s) requiring the requested drug, including drugs tried, dates of trials, results, and whether prior agents failed or caused intolerance; include current regimen and quantities per 30 days.
ALL of the following
ONE of
Alternate drug(s) contraindicated or previously tried with adverse outcome — specify drugs tried, results, adverse outcomes, or reasons for contraindication.
Patient stable on current drug(s) with high risk of significant adverse clinical outcome if medication changed — provide specific explanation of anticipated adverse outcome and supporting clinical history.
Medical need for a different dosage form and/or higher dosage — specify dosage forms/doses tried, outcomes, and medical reason why alternatives are not acceptable.
Request for formulary tier exception — document preferred/formulary drugs tried, results, adverse outcomes, or therapeutic failure including maximum dose and duration tried.
Other explanation — describe specific clinical justification.
Report drug safety concerns: indicate any FDA‑noted contraindications or potential drug interactions; if present, explain the issue, discuss benefits versus risks, and provide a monitoring plan to ensure safety.
If the requested drug is an opioid, provide opioid‑specific information: daily cumulative Morphine Equivalent Dose (MED in mg/day), other prescribers of opioids for the enrollee, and clinical justification for the requested MED.
If an 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; attach the prescriber's supporting statement. Expedited review is not available for retroactive reimbursement requests.
If someone other than the enrollee or prescriber is submitting the request, attach documentation of authority (e.g., CMS‑1696) to represent the enrollee.
The requester/prescriber signature and date are required on the form to complete submission.