The SPRAVATO REMS Checklist Your EHR Should Make Automatic (2026)

Step 1: Confirm the healthcare setting is REMS-certified

Outpatient healthcare settings must be certified in the SPRAVATO REMS to prescribe and administer the product. The REMS is explicit that SPRAVATO is intended for use only in a certified healthcare setting and is administered under the direct observation of a healthcare provider. Your EHR should track certification status and prevent staff from scheduling treatments if the site is not certified.

Step 2: Enroll every patient before treatment begins

The REMS requires outpatient healthcare settings to enroll patients prior to patient treatment. That means a patient cannot receive their first SPRAVATO session until enrollment is complete. Your EHR should enforce a hard stop on scheduling and documentation if enrollment status is missing.

Step 3: Submit a Patient Monitoring Form after every session

The Patient Monitoring Form is not optional. The REMS requires that it be completed after every treatment session and submitted within seven days. In practical terms, your EHR should treat the form as part of the session note, not a separate administrative task that can be forgotten.

Step 4: Document the two-hour monitoring requirement

The Patient Monitoring Form explicitly states that the patient must be monitored for at least two hours. It also captures total treatment duration from first device administration through completion of monitoring. EHR workflows should capture start and end timestamps so staff do not have to backfill these times later.

Step 5: Capture required vitals and adverse event checks

The monitoring form includes fields for blood pressure readings prior to administration, 40 minutes post-administration, and prior to treatment completion. It also collects data on sedation and dissociation timing, resolution, and any medications used to manage those symptoms. An EHR template should mirror these fields so the clinical team can complete the form as part of routine documentation.

Step 6: Build the compliance workflow into the session template

Compliance gaps are rarely intentional. They happen because staff are moving fast and the documentation system does not require the right fields. A purpose-built SPRAVATO template should enforce required data fields, prevent session closure when fields are missing, and queue staff to submit the monitoring form within the required timeframe.

Ease is often a strong choice here because it can embed the REMS fields directly into the session workflow and prevent closure until required monitoring documentation is complete.

What to test in your EHR demo

• Show a SPRAVATO visit note with required REMS monitoring fields already embedded.
• Demonstrate automatic prevention of session closure when mandatory fields are missing.
• Prove that monitoring form submission status is visible at the program dashboard level.
• Audit a sample chart to confirm REMS-required steps are tracked across multiple sessions.

Bottom line

The SPRAVATO REMS is a workflow problem as much as a clinical one. When your EHR treats the monitoring form as a first-class part of the visit, compliance becomes routine instead of reactive. That is the difference between a program that scales and one that constantly scrambles.

Editorial Standards

Last reviewed: April 13, 2026

Methodology

• Extracted the REMS requirements directly from the official outpatient healthcare setting guidance and patient monitoring form.
• Translated each requirement into a concrete EHR workflow requirement that can be validated during demos.
• Focused on repeatable compliance steps rather than one-off administrative checklists.

Primary Sources

• SPRAVATO REMS Outpatient Healthcare Settings
• SPRAVATO REMS Patient Monitoring Form
• Ease Health Homepage
• Ease EHR Product Page