Are You Prepared for a Spravato® Audit?

Spravato® is a Schedule III controlled substance delivered via intranasal spray, used in conjunction with an oral antidepressant, to address treatment-resistant depression in adults. It is a part of the Risk Evaluation and Mitigation Strategies (REMS) Program, necessitating, dispensing and administration exclusively in a REMS-certified healthcare setting. The FDA mandates specific requirements to mitigate the risks of serious adverse effects stemming from sedation, dissociation, and the potential for abuse and misuse.

Prescribed for weekly or bi-weekly use, a single Spravato® claim can cost you thousands of dollars. PAAS National® has seen audits with full claim recoupments being requested as a result of missing dosage and frequency instructions, as well as incomplete dispensing records. To minimize the risk of a Spravato® claim being recouped during an audit, consider the following PAAS tips:

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

  • Review the REMS program requirements for Spravato®
  • Validate the prescription contains:
    • A specific quantity (NCPDP billing unit is 2 EACH or 3 each referring to the number of devices)
      • Each nasal spray device delivers two sprays containing a total of 28 mg of Spravato® (esketamine)
    • How much to administer
    • How often to administer
    • Patient address, prescriber address, phone number and DEA # need to be present on a controlled prescription
  • Neither the prescriber nor the pharmacy should use a default SIG – it MUST have a specific dose and frequency
  • The days’ supply should be based on the treatment regimen
  • Spravato® is intended for the patient to administer under the supervision of a healthcare professional
  • Ensure proper documentation of dispensing to a certified healthcare setting occurs. The delivery log MUST contain the following elements:
    • Patient name, dose, number of devices dispensed and the date of dispensing
    • Name, address and phone number of the prescriber’s office
    • Printed name, title, signature, and date of the representative receiving the order
  • See our November 2019 Newsline article, Spravato® – Watch the Billing! for proper billing information, including package size and billing units

Jennifer Ottman, CPhT