Independent Review Entity (IRE) decision: what it means and what to do

A decision from C2C Innovative Solutions, the outside reviewer that reviews a plan's unfavorable redetermination.

An Independent Review Entity (IRE) decision comes from C2C Innovative Solutions, the outside reviewer under contract with CMS — not the plan — that reviews a redetermination you asked it to look at (or that the plan itself forwarded after missing its own deadline).

If the IRE's decision doesn't fully reverse the denial, its notice has to explain your right to an Administrative Law Judge hearing and how to request one.rule42 CFR 423.602

The IRE reviews the case independently — it isn't rubber-stamping the plan's own redetermination, and its reviewers weren't involved in the earlier decisions.

Moving to an ALJ hearing is the first level after this that isn't automatic — you have to actively request it, within 65 days of this notice, and the case has to meet a minimum dollar amount still in dispute.

Part D's own rule sets a fixed deadline for the ALJ to decide once you do request a hearing — 90 days standard, 10 days if expedited — a real difference worth knowing about if the case gets to that point.

If an expedited request carried through from an earlier level, that status carries forward to the IRE's own review too — you don't have to ask again separately, though it's worth confirming the notice itself reflects that.

You can submit additional evidence directly to C2C at this stage, not just through the plan — if your prescriber has more to add since the redetermination, sending it straight to the reviewer can be faster than routing it back through the plan first.

Read the outcome. The notice states whether the independent reviewer (C2C Innovative Solutions) reversed the plan's denial, in whole or in part, or upheld it.

If upheld, you may request an ALJ hearing. 65 days from the date on the plan's redetermination notice (60 days plus the same 5-day mailing presumption as Level 1).

Check the dollar threshold. The dollar amount still in dispute must meet a yearly minimum set by the Secretary — $200 for 2026, the same combined threshold Medicare publishes annually for Parts A, B, C, and D appeals together (42 CFR § 423.2006).