Anti Cd 20 Ocrevus denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for anti cd20 ocrevus are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Aetna Denies Ocrevus as Not FDA-Approved

A "not FDA-approved" denial for Ocrevus (ocrelizumab) almost always reflects one of three situations: (1) the diagnosis code submitted does not match an FDA-approved indication for this drug, (2) there is a coding or administrative error on the claim or prior-authorization request, or (3) Aetna's system has not been updated to reflect a more recent FDA approval. Ocrevus received FDA approval for relapsing forms of MS and for primary progressive MS; any denial asserting the drug lacks approval for these indications is factually incorrect and should be appealed immediately.

This type of denial is among the most straightforward to reverse, because it rests on an objectively verifiable fact — the FDA approval record — rather than a clinical judgment.

## Federal Appeal Rights

• Internal appeal: File under ERISA §503 (employer plan) or ACA internal-review rules. The deadline is on your denial letter; do not let it lapse.
• External review: Under ACA §2719, this denial category is externally reviewable. An IRO will simply verify the FDA approval record and the submitted diagnosis code — a fact-based review highly favorable to the enrollee.
• Peer-to-peer review: Before filing a formal appeal, ask the prescribing neurologist to request a peer-to-peer call with Aetna's medical director. Many not-FDA-approved denials are resolved at this stage once a physician reviews the FDA label directly with the reviewer.
• Expedited review: Available if delay poses serious health risk.

## What to Gather

1. FDA label for ocrelizumab — download the current prescribing information from DailyMed (dailymed.nlm.nih.gov). Print the "Indications and Usage" section and highlight the approved indication that matches the submitted diagnosis. 2. Diagnosis confirmation — neurologist notes and MRI reports confirming MS subtype (relapsing or primary progressive) consistent with the FDA-approved indication. 3. Claim or PA submission records — obtain a copy of what was submitted to Aetna to identify any coding mismatch that may have triggered the denial. 4. Prescriber letter — brief, factual statement from the neurologist: the patient's confirmed diagnosis, the FDA-approved indication, and a direct rebuttal of the not-approved characterization.

## Criteria-Mapping Structure

| Denial Basis | Rebuttal Documentation | |---|---| | Drug asserted not FDA-approved | FDA label "Indications and Usage" section from DailyMed | | Submitted diagnosis not matching indication | Correct ICD-10 code confirmed by neurologist; MRI + notes | | Administrative/coding error suspected | Original PA/claim submission vs. denial; request correction |

Lead your appeal letter with the FDA approval fact and attach the label as Exhibit A. Keep the letter concise — the argument is factual, not clinical, and brevity signals confidence.