Every psychiatry practice offering SPRAVATO® faces the same challenge: creating a comprehensive consent form that satisfies FDA requirements, protects your practice legally, and ensures patients truly understand their treatment. Getting this wrong can result in regulatory violations, increased liability, and insurance claim denials.

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The FDA's REMS protocol for Spravato requires specific patient education and consent procedures before any treatment can begin. For a Schedule III controlled substance, proper documentation isn't just best practice—it's mandatory. Your consent form must cover everything from contraindications and side effects to safety monitoring requirements and patient responsibilities.

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Our team of clinical and legal experts has created a battle-tested consent form that covers all federal requirements while remaining patient-friendly. This template includes:

• Complete FDA/REMS compliance with all required safety information
• Legal protection through professionally drafted language covering risks, alternatives, and patient responsibilities
• Insurance optimization with proper documentation to support prior authorizations and reduce claim denials
• Patient-friendly format that improves understanding and treatment compliance

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To edit the form, click "File", "Make a Copy"
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Beyond Consent Forms: The Hidden Administrative Burden with Spravato (and how to fix it)

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While having a compliant consent form is crucial, it's just one piece of the Spravato administration puzzle. The real operational challenges often come from:
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•Spravato REMS Reporting Requirements: After each treatment, you must submit monitoring forms to the REMS database within 7 days. Most practices handle this manually—documenting the encounter, then separately logging into the REMS portal to submit required data.

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•Prior Authorization Complexity: Navigating payer-specific requirements for treatment-resistant depression can be overwhelming, with complex documentation requirements varying by insurance provider.

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•Insurance Verification: Spravato coverage varies dramatically between medical and pharmacy benefits, requiring specialized knowledge to verify benefits accurately.

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•Claims Management: Unlike traditional medication management, Spravato involves complex billing for both the drug (if buy-and-bill) and administration services, each with different coding requirements.

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These tasks consume valuable time and revenue when not handled properly. That's why leading practices favor all-in-one solutions that handle everythng from claims management to REMS.

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Osmind handles your entire Spravato workflow—from integrated REMS reporting to specialized billing experts who deliver 7-day prior auth turnaround on avg. across payers—so you can focus on patient care while maximizing your revenue.

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Learn how Osmind 360 can streamline your interventional practice operations →

Download the consent form above to get started, and then discover how Osmind 360 can transform your entire Spravato (and TMS) practice by scheduling a free consultati