Certify & Establish

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How to Set Up a Certified SPRAVATO® 
Treatment Center

 

 

Step 1 Certification Step 2 Acquisition Step 3 Space

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.

REMS=Risk Evaluation and Mitigation Strategy.

LEARN MORE ABOUT THE SPRAVATO® REMS CERTIFICATION PROCESS ON THE REMS WEBSITE.

Step 2: 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. Note that each patient's unique insurance benefit design may dictate how you ultimately acquire SPRAVATO®.

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:

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Healthcare setting purchases multiple devices at once

For a list of Authorized Specialty Distributors, click here

facility

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

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

scheduling

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

insuranceaccepted

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

PROCESS:

number1

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

number2

Coordinate delivery and storage

number3

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

number4

Dispense product to patient for in-office administration

number5

Bill insurance for the drug and healthcare services

number6

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:

pharmacy

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

insuranceaccepted

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

medicalbenefitinvestigation

Payer may mandate the usage of a specialty pharmacy

rems

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

rems

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

PROCESS:

number1

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

number2

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

number3

Submit the prescription to the pharmacy

number4

Coordinate delivery with the pharmacy and schedule patient treatment session

number5

Dispense product to patient for in-office administration

number6

Bill insurance for healthcare services

number7

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 3: 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

Reference:

1. SPRAVATO® [Prescribing Information]. 
Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

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Next:

Preparing to Treat Patients