Developing a Budget

Considerations for Preparing a Budget

For studies that require a grant or contract, the Investigator or representative is responsible for generating and/or negotiating the budget with the sponsor.

Initiation costs and Personnel time for start-up

Salaries and Effort

Supplies

Travel

Other expenses

Clinical Care costs

Overall budget considerations

Who are my key contacts for questions about budgeting and sources for fee information?

What is the Clinical Trials Master Matrix/Billing Grid (CTMM)

Completion of the Clinical Trials Master Matrix/Billing Grid can assist you with budget preparation in that it sets up the budget table for the study.

A research billing “matrix” must be submitted for any study that includes clinical care conducted at Nebraska Medicine/UNMC clinics or facilities. The matrix/billing grid guides investigators through determining costs associated with a clinical trial; it is stored on a secure drive and access must be requested from the Senior Research Billing Associate.

Where do I find hospital-based charges?

Hospital-based charges can be found in One Chart, under the separate Price Inquiry tab. Instructions on using Price Inquiry can be found in the “Tips & Tricks” in the Epic modules of the Learning Center.

What requires a professional fee?

Are there fees for Children’s Hospital & Medical Center facilities and services that I need for my study?

Yes. Questions regarding clinical research fees may be directed to the Pediatric Research Office.

How can I determine if study procedures, tests, items, which are “standard of care” can be billed to Medicare/insurance?

No costs for procedures completed solely for research purposes may be billed to insurance. Medicare Qualifying Criteria are outlined in NCD 310.1 “Routine Costs of Clinical Trials.” If the study meets the qualifying criteria, routine costs and costs for diagnosis and treatment of adverse events can be billed to Medicare.

If the study does not meet the qualifying criteria, nothing can be billed to Medicare, not even routine care costs. Coverage analysis is performed to verify that research procedures listed as paid by insurance are “standard of care” and can be billed to a third party payer (either private insurance or Medicare).

Coverage analysis also compares the matrix/billing grid, informed consent document, and preliminary budget to ensure that all costs are known. This process ensures that the final study budget reflects the true cost of the research project. For additional information, see the SPA Clinical Trials Billing FAQ.

The coverage analysis makes a general judgement on insurance coverage for participation in clinical trials based on Medicare rules. When a patient is identified for potential participation in a clinical trial, insurance pre-authorization is put in place to review the patient’s insurance policy and coverage. Information on the Insurance Pre-authorization process can be found at unmc.edu/cctr/resources.

Who initiates the insurance pre-authorization process?

It is the research coordinator or study staff’s responsibility to initiate the insurance pre-authorization process with Nebraska Medicine patient financial counselors.

Coverage Analysis

Performing Coverage Analysis

Clinical Trials Analysts perform coverage analyses for drug/biologics related clinical trials. Faculty/Coordinators who have questions or would like assistance can contact the Clinical Research Manager or the Senior Clinical Trials Analyst at 402-552-7817.

Is a coverage analysis required for all industry sponsored trials?

A coverage analysis is required for all adult, full board clinical trials. It should be completed for any study involving billing of clinical care at the same time of the, trial regardless of funding. The IRB may also require coverage analysis for specific trials.

The results of the coverage analysis are shared with the IRB to determine if subjects will be placed at additional financial risk as a result of study participation.

Coverage Analysis Fees

There is a fee for coverage analyses for industry funded research. Contact the Clinical Research Manager for the fee amount.

What can be charged to the sponsor in an industry-sponsored trial?

Charge time and effort for activities, including all persons involved (investigator, coordinator, research assistants, etc.). Also include supplies needed to conduct the study. If hospital services are used you should charge for them. You can also meet directly with the manager of the CRC to discuss budgeting.


Revision #8
Created 16 September 2019 19:59:49 by James Geiger
Updated 13 March 2023 14:07:11 by Max V. Kuenstling