Welcome to the NYU Office of Clinical Trials
Revised Clinical Trials Research Billing
EFFECTIVE November 15th, 2006
The current clinical research billing compliance processes have been revised for all involved stakeholders, including principal investigators, coordinators, and research teams.
PI's SHOULD NO LONGER SUBMIT BILLING PLANS WITH IRB APPLICATIONS OR TO THE OFFICE OF CLINICAL TRIALS
Effective immediately, a revised IRB application form
(available at the IRB website) will capture information from the previous billing plan. The OCT will review all projects submitted directly to the office or to the IRB using the new application form for analysis of billing plan necessity.
For projects with potentially billable items (including projects that are sponsored by industry, grant-funded, PI-initiated, or utilizing the GCRC), a billing plan will be generated by the Office of Clinical Trials staff upon receipt of a full protocol and IRB application. Additional informaiton may be required.
Research Encounter Tickets are still required to be submitted by PI's and research teams on the research subject's service date to clinicaltrials@nyumc.org.
Monthly Enrollment/Milestone forms are still required and due on the 5th of each month for the prior month's enrollment and milestone visits for each enrolling project.
Billing Plans
Billing Plans are no longer required to be submitted by the Principal Investigator. Every protocol will utilize the new IRB application form. The OCT will review the application and associated materials. If a billing plan is required, it will be generated by the Office of Clinical Trials for the PI.To generate a required billing plan and perform a Medicare Coverage Analysis on applicable projects,the OCT must have a copy of the protocol and IRB application form. Additional documentation might be required and will be requested as needed:
- Any Templates or drafts(ICF, Contract)
- Investigator's Brochure (if available)
- NOGA or budget award
- Draft Budget (if available)
If a research project meets the published billing plan exemption criteria as noted on the IRB application form, an email notice will be provided to the PI, IRB, and all impacted affiliates indicating no billing plan is required.
MEDICARE COVERAGE ANALYSIS
OCT is responsible for creating a Medicare Coverage Analysis for any procedure that will be billed to the patient’s insurance, within a clinical trial. The purpose of this analysis is to show that third party payers will cover the tests/procedures. This document is kept, internally, to be used for auditing purposes
Medicare Coverage Analysis Documentation.
CLINICAL TRIAL BILLING
Instructions for Using Research Encounter TicketsThe research encounter ticketing system is the dynamic tool by which a Principal Investigator and research team communicates and authorizes a NYU/Bellevue service provider to perform, provide, or conduct tests, procedures, and other specific items related to their research study. The tickets identify the requested research items as defined in the patient visit schedule provided by the protocol, along with information in the cost analysis worksheet of the NYU Medical Center Billing Plan Form. The tickets allow service providers to have enough information to accurately bill for those services either to a specific financial account for the study (including costs covered by the GCRC) or to a subject’s 3rd party reimbursement agent.
When are tickets used?
Tickets should be used any time a research subject needs to have tests, procedures, drugs, or devices performed which are provided by the various service providers in the hospital system. For example, if a subject is having lab work related to the project drawn and processed at the outpatient lab facility or if the EKG department is called to the patient bedside for a research-related EKG for an inpatient.
Who generates tickets?
The PI and research coordinator have the responsibility of generating, accurately completing, and providing tickets to service providers.
Where are tickets found?
Tickets are found at the OCT website, http://www.med.nyu.edu/oct under the hotlink box labeled "Download Forms". Tickets can also be found on our Web-Based Program Clinical Trials Management System, http://infoed.med.nyu.edu/. If you require training for building tickets into our system please go to our Education/Training section on our website. Tickets are used for inpatient and outpatient services. Encounter tickets should be used at Tisch Hospital, Bellevue Hospital, Hospital for Joint Disease, GCRC, Cancer Center, Radiology, Noninvasive Cardiology, CATH Laboratory and all FGP offices.
How are tickets completed?
Tickets should be downloaded from the website, http://www.med.nyu.edu/oct saved as an Excel file (.doc) on the computer, and filled out electronically. All fields should be filled in as applicable. If assistance is needed, please contact the OCT at 212-263-4210. Tickets can also be built through our Clinical Trials Management System (CTMS) at the below link: http://infoed.med.nyu.edu. If you require training for building tickets into our system please look at our Education/Training section on our website CTMS Training Request.
All procedures and tests as part of a research project, regardless of whether they are clinically indicated or research-related for a particular visit, are entered individually on each line provided along with the appropriate CPT code or lab code for those lab services provided at NYU, who should be billed, site of the service, and the billing category. Tickets are filled out per visit for a subject and can include multiple items from multiple service providers NYU CPT CODES 2008.
Once the tickets are completed electronically, they should be emailed to clinicaltrials.med.nyu.edu (also noted on the actual ticket), on the date the service being performed. When tickets are built into CTMS our system runs a report and it will alert us to route them accordingly. Tickets sent in advance of services being performed will not be accepted. For inpatients, they should be emailed as soon as possible after the patient is admitted if it is not a scheduled admission but not printed out.
Once the ticket has been completed and emailed electronically, the ticket should be printed out and given to the subject to take to the service provider for outpatient services, including GCRC. If multiple items from different service providers are required for a single visit, multiple copies of the ticket can be provided to the subject and one copy given to each service provider at the time the test or procedure is being done. The service provider will accept the ticket and according to the information listed, bill the test listed to the associated account or 3rd party payer.
The Office of Clinical Trials is the main point of receipt for tickets emailed to clinical.trials@med.nyu.edu or built into the Clinical Trial’s Management System (CTMS) http://infoed.med.nyu.edu/. Tickets received will then be forwarded to the appropriate distribution lists for Outpatient, Inpatient, Bellevue, GRC, FGP & Cancer Center.
What happens afterwards?
Research teams should keep a copy of the tickets with their research files for each patient however they will not receive any tickets back once submitted. Verification of service provided will be the data collected for the project and added to the patient research record. If there are inconsistencies between the encounter ticket information and the billing information, the PI/Coord will be contacted to clarify information on the ticket and may be required to correct the ticket and resubmit.
The PI and research team should be familiar with the e-Report system as a means to track payments against their study accounts for services performed. If there is any question about a charge, please contact the Office of Clinical Trials at 212-263-4210 for assistance.
Research Encounter Ticket (RET)
Research Encounter Tickets are used per patient/per research visit. For all NYU and HJD outpatient visits, RETs are completed and printed to be given to the research subject to be taken to the service provider at the time of the service as well as emailed to clinicaltrials@med.nyu.edu on the date of service.If using CTMS to build tickets:
- Tickets should be built into CTMS on the Date of Service. Our system drops a report for these tickets alerting us to route them accordingly. Please make sure all fields are appropriately filled out on the ticket.
- For Inpatients, the tickets should only be completed and emailed or built in CTMS
- For Bellevue research subjects, the tickets should only be emailed or built in CTMS
- Note: the tickets should only be submitted on the date of service, not prior to the date or afterwards.
Please use the attached RET & Monthly Milestone forms for subject tracking & Appropriate Billing:
[RESEARCH ENCOUNTER TICKET - Excel format]
Monthly Milestone Visit/Enrollment Form:
- The Monthly Milestone Visit / Enrollment Form should be used each month to record all visits, by date, for each specific research subject enrolled in a Clinical trial.
- A form should be completed for each active trial with monthly activity and submitted to the Office of Clinical Trials by the 5th of each month for prior month activity.
- Any non-receipt of this form by the Office of Clinical Trials will indicate no research visits or activity occurred for the current month in the specified trial.
Clinical Research Billing Policy - Revised, October 2006
