These documents can be submitted electronically to the OCT however the Billing Plan must have the PI signature in its final form.

Yes. Per NYU SoM policy, all clinical trials, regardless of funding source (industry, grants, or departmental) must have a billing plan approved and on file with the Office of Clinical Trial Operations. These plans will be forwarded to IBRA when completed for inclusion into their project file.

Yes. There must be a billing plan on file for every clinical research project, regardless of size, type, or scope. The Billing Plan Form would need to be completed for those areas that are applicable to the particular kind of study being undertaken. The Office of Clinical Trials can be contacted for assistance regarding questions about the Billing Plan Form.

Yes. While most of the billing plan form will not be applicable to your study, the plan needs to detail where the samples are coming from. If you are collecting the samples from a human subject, the plan needs to detail if there is a cost for that collection and a cost for the processing/analysis of those samples.

Yes. Many clinical projects are PI-initiated or funded by the department however there is also a secondary source of support by industry through providing a device, test article, or drug to the project. Regardless, by providing a product or drug to the trial constitutes the need for a legal agreement with our institution and a contract must be on file with the Office of Clinical Trials. In some cases, even if a department is completely funding or supporting a clinical trial, a letter of support by the department chairman might be required.

You should review the Billing Guidance provided by OCT for details, at: http://www.med.nyu.edu/oct/Billing_Toolbox/. In general, the National Coverage Decision defines a qualified clinical trial as one funded by NIH, CDC, AHRQ, CMS, DoD and VA or supported by centers or cooperative groups funded by NIH, CDC, AHRQ, CMS, DoD and VA. Device trials may be covered under separate CMS rules, as described in the Guide.

The ticketing system is a critical piece of the billing compliance initiative at NYU. It is a communication tool between the PI and any service providers in the institution, used to provide a means of differentiating acceptable items for 3rd party reimbursement agencies from those tests, procedures, and visits that must be billed to the study account as indicated by the billing plan. Tickets should be used for each test, visit, or procedure as part of the trial that utilizes any institutional service provider (laboratory services, radiology, or EKG, for example). Tickets are available on the OCT website’s main page and should be filled out electronically, emailed to the distribution list email as noted on the actual ticket. If these patients are outpatients, a copy of the ticket should be printed and provided to the research subject to be given to the service area at the time the service is provided. For inpatient subjects, the email will serve to alert the appropriate personnel. Please be sure to download the latest version of the tickets from the OCT website, rather than use one you previously saved on your computer.

Yes. NYU’s email system is surrounded by a HIPAA-compliant firewall which meets the standards of required security. Any email within the NYU firewall is compliant with HIPAA security and since tickets are only emailed within the NYU email system, the ticketing system meets the current requirements for HIPAA compliance. Any tickets being emailed for Bellevue Hospital projects are also mailed to an email within NYU as noted on the tickets and meet the institution’s HIPAA standard.

No, as long as you are not billing for that service, test, or procedure, you do not need a ticket for yourself. For example, if you are drawing labs that are being shipped to a central lab outside the institution for processing, you would not need to fill out a ticket unless you were utilizing a service other than you or your team to draw the blood. However these would still be indicated on the Billing Plan in the Cost Analysis section. Instead of a CPT code, you would use the code “CPL” for Central Processing Location to indicate the labs are being processed outside the institution.

No. While the OCT is available for support to help complete the billing plan, it is the obligation of the PI to assume full responsibility for appropriate planning and assessment related to the specifics of the clinical research project and to be able to communicate that information to the institution. The PI and research team should be fully aware of all procedures/tests/visits/ and test articles associate with the project and be able to communicate those accurately through the use of the billing plan.

Yes. Regardless of the IRB approval mechanism, a billing plan must still be on file with the Office of Clinical Trials. The BRANY study memorandum which is the agreement between BRANY and NYU SoM for each specific research project cannot receive an institutional signature (required to start enrollment) nor have a research study account set up without an approved billing plan in place.

Yes. Tickets are institutional communication tools to help service providers bill study related procedures, tests, or visits to the correct funding source and are independent of the study authorization agent.