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SPRAVATO® (esketamine) nasal spray CIII place of service (POS) requirements

Intranasal esketamine (SPRAVATO®) is FDA approved for the treatment of treatment-resistant depression (TRD) in adults. Due to the risk of sedation, dissociation, respiratory depression, and potential for abuse or misuse, the medication is only available through a restricted program known as the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. 

The FDA requires that both health care settings (outpatient and inpatient) and pharmacies be certified in the REMS program, and that patients be enrolled before receiving treatment. Outpatient health care settings must complete formal REMS certification and comply with all program requirements, including monitoring documentation and reporting obligations. Certification requires designating an authorized representative, reviewing program materials, and submitting the official SPRAVATO® REMS Outpatient Healthcare Setting Enrollment Form. 

As mandated by the REMS:

  • SPRAVATO® may only be dispensed to REMS certified health care settings; it must never be dispensed directly to a patient for home use. Pharmacies must also be REMS certified and may dispense SPRAVATO® only to certified outpatient or inpatient health care settings. 
  • Outpatient health care setting enrollment is intended only for medical offices and clinics providing outpatient services.
  • Emergency departments and inpatient units within hospitals are certified through their inpatient pharmacy enrollment.
  • The medication is facility administered as an incident-to clinical service under the direct supervision of a health care provider within the certified setting.
  • Patients must be monitored for at least two hours after each dose, with vital sign and safety checks documented on the REMS patient monitoring form and submitted after every treatment session. 
  • Outpatient health care settings are required to enroll each patient before the first treatment and submit ongoing patient monitoring forms following all subsequent treatments. 

These measures ensure that SPRAVATO® is used safely and that the benefits outweigh the risks, in accordance with FDA requirements and REMS oversight.

Documentation requirements

  • All documentation must be maintained in the patient's medical record and made available to the contractor upon request.  
  • Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, date(s) of service). 
  • For outpatient settings, the documentation must include the Patient Monitoring Form with the legible name of the provider responsible for monitoring the patient.

 

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