Step 1: REMS Certification in Healthcare Settings

Complete the SPRAVATO® REMS 
Certification

While becoming REMS certified is a multistep process, information you need to complete the certification process can be found on the official SPRAVATO® REMS website.

Step 2: Education

Educate Relevant Staff

The SPRAVATO® Clinical Education Training Video is available to support healthcare providers within your REMS-certified SPRAVATO® treatment center in learning about safety, handling, dosing, administration, monitoring, and storage requirements for SPRAVATO®.¹ Educating your staff includes, but is not limited to, having your staff watch the video below.

Note that protocols for handling Schedule III products must always be followed in accordance with federal, state, and local regulations. Healthcare providers must also be properly licensed to handle Schedule III products and hold an active Drug Enforcement Administration (DEA) registration at the site of care.

Use this video and information to begin educating your staff.

Step 3: Acquisition

Determine How to Acquire SPRAVATO®

SPRAVATO® has a controlled distribution network that ensures that it is distributed only to certified healthcare settings and certified pharmacies. Your facility or pharmacy must be SPRAVATO® REMS certified prior to acquiring SPRAVATO®. SPRAVATO® will not be delivered directly to patients.¹

HEALTHCARE SETTINGS: A REMS-certified healthcare setting has 2 options for acquiring SPRAVATO®. Select either BUY-AND-BILL or PHARMACY to learn more about each option.

• BUY-AND-BILL
• PHARMACY

A REMS-certified healthcare setting purchases SPRAVATO® from an Authorized Specialty Distributor. The practice appropriately stores and dispenses SPRAVATO® to the patient at the time of administration, and then seeks reimbursement from insurance.

KEY CHARACTERISTICS:

Healthcare setting purchases multiple devices at once

• For a list of Authorized Specialty Distributors, click here

Healthcare setting stores and handles drug supply in accordance with state and federal regulations

REMS-certified SPRAVATO® treatment center is responsible for obtaining prior authorization before patient administration

Drug supply is not pre-assigned to specific patients, allowing for dosing and scheduling flexibility

REMS-certified SPRAVATO® treatment center is responsible for submitting reimbursement claims for both drug and healthcare services

PROCESS:

Order multiple devices at once (for help, click here)

Coordinate delivery and storage

Identify patient’s coverage and secure prior authorization as needed (for help, click here)

Dispense product to patient for in-office administration

Bill insurance for the drug and healthcare services

Bill patient for cost-share of the drug and healthcare services after insurance payment (for help, click here)

A REMS-certified healthcare setting acquires SPRAVATO® from a REMS-certified pharmacy that handles and stores pharmaceuticals and dispenses them directly to the REMS-certified healthcare setting for administration by a specified patient.

KEY CHARACTERISTICS:

Healthcare setting receives patient-specific product from a pharmacy, which must be REMS certified:

• For a list of REMS-certified national specialty pharmacies, click here. For additional REMS-certified pharmacies call 855-382-6022

Pharmacies can typically handle pharmacy benefit coverage and, in some instances, may be able to handle medical benefit (check with insurance and pharmacy)

Mandated or preferred pharmacies may apply for certain insurance

REMS-certified SPRAVATO® treatment center is responsible for obtaining prior authorization before patient administration

REMS-certified SPRAVATO® treatment center is responsible for submitting reimbursement claim for healthcare services

PROCESS:

Complete a benefits investigation to determine patient’s coverage. If prior authorization is required, then obtain as needed (for help, click here)

Identify a REMS-certified pharmacy (confirm if the insurance mandates or prefers a specific pharmacy). For a list of Authorized Specialty Pharmacies, click here

Submit the prescription to the pharmacy

Coordinate delivery with the pharmacy and schedule patient treatment session

Dispense product to patient for in-office administration

Bill insurance for healthcare services

Bill patient for cost-share of healthcare services after insurance payment (for help, click here)

Once you have chosen your source for SPRAVATO®, you will need to coordinate with them and become familiar with their dispensing protocol.

For more information on coverage for monitoring and observation, click here.

Step 4: Space

Identify Space 
for Administration and Monitoring

Your REMS-certified SPRAVATO® treatment center will need a space with seating where patients can self-administer SPRAVATO® under the supervision of a trained healthcare provider.¹

The patient must then be monitored for a minimum of 2 hours after administering SPRAVATO®, followed by an assessment to determine whether the patient is clinically stable and ready to have a friend, loved one, taxi, or rideshare service drive them home from the facility.¹