Quick Instructions for Completing the Billing Plan Form

This form is required for any clinical trial conducted at the NYUSoM. If your project is not a clinical trial involving human subjects this form is not required. Please contact the Office of Clinical Trial Operations if you need guidance. The Billing Plan Form can be submitted to The Office of Clinical Trials (OCT) located at 423 E. 23rd Street, VA Hospital Building, NY, NY 10016.

Administrative Information

Please complete all sections as appropriate. Please note the CS# is assigned by the Office of Clinical Trial Operations. If you know your H#, please insert into the indicated field, if not the H# will be assigned by IBRA, and will be inserted later.

Sites and Facilities

Please select all sites where the clinical trial is going to be enrolling subjects or following up with subjects based on the protocol. For any sites not listed, please select “other” and specify the exact location.

Financial & Organization Information

Please select the appropriate choice related to the protocol. Remember to keep in mind this includes any funding, supplies, equipment, drugs, devices, consultation services, data analysis services, or other services provided by an external source; and anything provided by an external source for free (e.g., drugs, lab services)

*Indicate all sources of funding using the checkboxes and text fields. Before funding from an external source can be accepted by the institution a written agreement with the NYUSOM such as a contract, letter, or grant award is required from the sponsor, and a copy of such agreement (or a draft) should be submitted with this form.

Final IBRA approval of all industry protocols will be issued after the contract is executed. A copy of the executed contract will be provided to the IBRA by the Office of Clinical Trial Operations.

Insurance Coverage Analysis
Please fill out as appropriate.

The Guidance for Use of Clinical Trials Billing Plan Form” at http://www.med.nyu.edu/oct/Billing_Toolbox/, provides definitions and explanations of the various law and rules regarding insurance coverage under Medicare and other third party insurers. You can “click” on any entry in the Table of Contents of the Guide and be taken directly to that section.

If this project does not use a drug or device, please leave area blank.

Only the FDA may permit a manufacturer to charge the institution for an investigational drug , and evidence of FDA approval must be attached to this form. If we are charging for an investigational device, you must submit evidence of the cost of a comparable device on the market.

Important: attach any documentation regarding coverage for this study from the FDA, Sponsor, Medicare or other third party insurers (including pre-certifications, device categorization, and requests to Empire for coverage of device trials).

Injury and other Compensation

This section should accurately reflect information provided by the contract if the project is industry supported and should be communicated to the patient via the Informed Consent in the appropriate areas.

Points to consider: Does the coverage of subject injury apply only after a subject’s insurance has rejected the claim? Will the sponsor reimburse subjects for co-pays and deductibles if their insurance does provide coverage for the research related injury or complication? Has this been accurately and truthfully presented in the Informed Consent document?

Some clinical trials, especially those which are PI-initiated or grant-dependent do not have plans for subject injury compensation. The Informed Consent document should accurately reflect this situation.

Cost Analysis

Use the Cost Analysis Worksheet (following page) attached to this form to list all tests/procedures/visits/drugs/devices specified in this protocol whether or not they are performed for study purposes or for clinical care. This includes any screening procedures, medical record pulls, investigational pharmacy charges, questionnaires, surveys, etc. associated with this protocol. Even if an item does not have a charge, it should be listed in this section.

For studies involving more than one arm use a separate worksheet for each arm. Indicate the study arm identifier in the first row.

Worksheet Summary Information

This information should summarize the total cost attributable to all protocol related procedures/tests/visits/drugs/devices.

Non-billable items might occur if the GCRC is being utilized to cover the expenses of a protocol-related test or procedure. Other instances of explanation for coverage of non-billable items might include intramural coverage, in which case a letter must be included that states the approved coverage amounts and appropriate accounts that would be charged.

Cost Analysis Worksheet

List all tests/procedures/visits/drugs & devices involved in the protocol. A protocol visit schedule will help to guide what should be included in this list, but may not contain all of the items and services that will be necessary for the study.

A list of common CPT codes and the Medicare/research rate associated with that code is available on the OCT website at http://www.med.nyu.edu/oct. If CPT codes are unavailable please contact the Office of Clinical Trial Operations at 212-263-4211 for assistance.

Total # of occurrences should be considered for one subject over the course of the entire trial, not for a particular year. For example, if a subject is going to get a total of four ECG’s over the course of the 18-month trial, the total # of occurrences is four. If two of those ECG’s are research related and two are routine care and billable to a subject’s insurance, then in green column (paid for by sponsor/FAME account), the number would be two and in the yellow column (billed to subject/insurer), the total would be 2.

NYU Tisch accepts the Medicare rate (known as the research rate) for research-related items. For items charged against a research study account, this rate would apply. A sponsor may provide more compensation for a particular item than the listed Medicare rate however the study account will only be charged the research rate.

The total estimated cost at the bottom of the columns should be a monetary value. If there are four ECG’s, each $100.00 and two reimbursed by the sponsor while the other two are paid by insurance, the total estimated cost at the bottom of the green column is $200.00 and under the yellow column is $200.00. These costs would be reflected in the appropriate area in the Work Sheet Summary Area preceding the Cost Analysis Worksheet.