Spravato denied as experimental or investigational by Aetna?
An experimental denial requires the appeal to cite the FDA approval (if any), peer-reviewed phase III data, and the recognised specialty-society guideline that supports the treatment for your indication.
US health-plan appeal rights
Cite: Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules
Most US health plans are required by federal law to give you both an internal appeal (where the insurer reconsiders) and an external review (where an independent reviewer decides). The exact timelines and processes depend on what kind of plan you have — marketplace / employer group, self-funded, Medicare Advantage, or Medicaid MCO — but in every case there's a window after the denial during which you have the right to fight it.
What Aetna typically requires
TRD diagnosis: MDD with failure of >=2 adequate antidepressant trials at therapeutic dose >=6 wk in current episode (per FDA label). OR MDD with acute suicidal ideation/behavior (per Aug 2020 indication). Administered ONLY at REMS-certified site with >=2 hr post-dose monitoring (BP, sedation, dissociation). Reauth at induction completion (4 wk) with MADRS response; maintenance phase per SUSTAIN-1.
What works in the appeal
Spravato FDA-approved Mar 5, 2019 for TRD STANDALONE (with oral AD), Aug 3, 2020 for MDD with acute suicidal ideation. APA TRD 2022 + Voineskos JCP 2022 list ECT and esketamine as PARALLEL options — NOT step-therapy. TRANSFORM-2 Popova AJP 2019 — Spravato + AD vs AD-alone, primary endpoint met. SUSTAIN-1 Daly JAMA Psychiatry 2019 — relapse-prevention. ASPIRE-I/II — acute suicidal ideation. IV ketamine is OFF-LABEL; Spravato is FDA-approved with REMS — coverage required at REMS-certified site.
Next steps
- Find the date on the denial letter — your appeal window starts there.
- Read your plan's Summary of Benefits and Coverage (SBC) for the specific deadlines.
- Request the insurer's claim file in writing — they must provide it.
- Submit your appeal in writing with new clinical evidence and a physician statement.
Get the letter drafted
DenialHelp drafts your appeal in 5 minutes — $40 list price, $30 for your first letter (use code SEO25). We cite the federal regs and the specific clinical evidence your plan responds to. Your physician signs and sends.
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