New Clinical Trials Billing Policy and Procedure

In January, you received an email from Drs. Glickman and Rackow, reiterating the provisions of the NYUMC Clinical Trial Billing Policy adopted in August 2004, which specifically requires that all clinical trials conducted at the Medical Center by SOM faculty include a Billing Plan. To support that requirement, we have made several revisions to the clinical trials process; including a new procedure for the submission, approval and communication of services associated with clinical trials services.

The two most notable changes are:  the requirement to complete a billing plan for all trials regardless of funding source; and the use of tickets to alert providers that services are part of a clinical trial. The purpose of both of these documents is to increase compliance by improving communication.

The procedure as well as the associated forms which are required to implement the process can be found in a folder on the OCT web site http://www.med.nyu.edu/oct labeled “New Clinical Trials Policy and Procedure Documents.”  Additionally, we have created several resource documents to assist you in navigating the process and completing the forms which can also be found in the “New Clinical Trials Policy and Procedure Documents” folder.

These forms and resource documents are:

Clinical Trials Policy for Compliance of Medical Billing
Billing Plan Form
Inpatient Clinical Trials Billing Ticket
Outpatient Clinical Trials Billing Ticket
Guidance for Clinical Research Billing
Clinical Trials Procedure
Quick Reference Document for Implementing Clinical Trials
Quick Instructions for Completing the Billing Plan Form
Billing Plan Frequently Asked Questions (FAQ)
Clinical Trials Billing Ticket How-To Instruction Document

Training and Education:

1. Three training sessions have been scheduled over the next several weeks during which we will take you through the process, review all of the forms in detail, and answer questions.   
   
   §           March 30 th, 2-4pm                       Skirball Seminar Rm. 3 rd Floor (for Research Coordinators)
   
   §           April 6 th, 9:30-11:30am               Skirball Seminar Rm. 4 th Floor (for PI’s/Coordinators/Dept. Admins.)
   
   §           April 13 th, 2:00-4:00pm               Skirball Seminar Rm. 3 rd Floor (general session, open to all)
   
   As seating is limited, please RSVP to Sandra Fiorelli at 263-6808 of your intention to attend. 
   
2. In addition to being available by phone, the Office of Clinical Trials has reserved Wednesdays from 1-3 pm for walk-in support to assist coordinators and PI’s in completing the forms and understanding the process.
   
3. We are also available to meet with your department faculty and staff. Please call the Office of Clinical Trials at 212-263-4210 to schedule. 

We consider this to be the initial version of a procedure that not only supports the policy, but also increases the communication to providers of service and the associated billing of those services. While we have included input from many clinical investigators, we anticipate a review and revision in the months to come to increase the efficiency of the process, and we will be including additional input from investigators, research coordinators and administration.

Thank you for your support.