Would Your Spravato® Documentation PAAS an Audit?

Spravato® is a Schedule III controlled substance intranasal spray used in conjunction with an oral antidepressant for treatment-resistant depression in adults. It is part of the Risk Evaluation and Mitigation Strategy (REMS) Program and can only be dispensed and administered to patients in a REMS certified healthcare setting due to the risks of sedation, misuse, and abuse. PAAS National® alerted members in a February 2021 Newsline article How to Avoid Spravato® Audit Recoupments that we have seen attempted audit recoupments for Spravato® due to the pharmacy being unable to provide record of shipment received and dispensing information (including patient name, dose, number of devices, and date dispensed) per REMS guidelines. PBMs currently auditing Spravato® prescriptions include Elixir, MedImpact, Humana and Pharmacy Data Management, Inc. (PDMI.)

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  • Pharmacies that dispense Spravato® must:
    • Become certified: Have an authorized representative complete the certification process and monitor compliance with the REMS Program
    • Have policies and procedures in place to verify that a healthcare setting is also certified in the REMS Program prior to dispensing Spravato®
    • Be sure to train pharmacy staff that Spravato® can only be dispensed to a certified healthcare setting
    • Maintain records for proof of pharmacy employee training and that policies and procedures are in place and being followed
    • Maintain records of all shipments of Spravato® received and dispensing information including patient name, dose, number of devices dispensed and the date of the dispensing
    • Ensure proper documentation of dispensing to a certified healthcare setting occurs:
      • Need the name, address, and phone number of the doctor’s office
      • Need the printed name, title, signature, and date of the representative receiving the order
      • Need patient name, dose, number of devices dispensed and the date of the dispensing
    • Maintain records of all deliveries of Spravato®
  • Spravato® is intended for the patient to administer under the supervision of a healthcare professional
  • See our November 2019 Newsline article, Spravato® – Watch the Billing!,  for proper billing information, including package size and billing units
Jennifer Ottman, CPhT
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