Study Scheduling and Billing

Clinical Trials and Billing Insurance

 

Background

It is always in a patient’s best interest when research sites can get sponsors to pay for clinical services that are part of a study. However, there are times when it is allowable to bill study patient’s insurance for routine care that takes place within a qualifying study. Certain criteria have to be met in order for this to take place. The study sponsor cannot pay for the service. The clinical service has to be documented in the patient’s medical record as being medically reasonable and necessary. The patient needs to be completely informed that their insurance will be billed and that the service is covered by their insurance policy. This may sound fairly straight forward, however, hospital billing by itself is a complex business. Add the complexity of a study to this mix and you have a recipe that challenges even the best of the Iron Chefs!

Our Goals

The Office of Clinical Investigative Services has been working with Patient Accounting and other hospital areas to put processes in place for the billing of studies. Our goal is accurate billing to insurance and study accounts. We want to avoid any financial “surprises” or mistakes for patients, their families, the research site and the hospital.

Strategy

Steps can be taken early in the study planning process to help ensure accurate study billing. A thorough analysis of the study protocol, contract and budget is critical. Is the informed consent document consistent with these other documents? Does it spell out all financial risks to the patient and their families?  Who will explain the financial costs to the patient and check to see if their insurance policy covers the services that will be billed?  Part of the financial discussion with potential patients should include information on co-pays, deductibles and denied insurance claims. What happens if a potential patient is uninsured? Once the patient is consented, who on the research team knows how register and schedule study patients for hospital services? Do the physicians know how to order clinical services for study patients?

The Process

As part of its review process, the OCIS analyzes a study to determine if a billing grid is required. If there is a positive determination, the OCIS works with the research site to develop and obtain approval of a study billing grid. There is no charge for this service. The billing grid is also a beneficial tool for negotiating a study budget. The billing grid along with the internal budget provides a with a “bottom line” cost.  This figure can be compared to the sponsor’s offer to see if further budget negotiations need to take place. The study sponsor will need to pay for any clinical services that are not billable to Medicare or insurance. If Medicare will be billed for allowable routine procedures, a Medicare Qualification process is completed through the OCIS and certified by the Principal Investigator. 

When is a Study Billing Grid required?

A grid is needed when a study plans to bill Medicare or insurance for routine care.

What does a grid look like?

A billing grid is a matrix that outlines the clinical procedures and tests required by a study protocol. Clinical services are listed for each study visit.  A billing designation is given to each of the services. This designates if the service is to be billed to the study or to the subject’s insurance. The Principal Investigator certifies routine care services that can be billed to insurance. The billing grid is used by hospital Scheduling, Patient Accounting and the Physicians Practice Group when applicable.

 

HELP! 

The OCIS provides ongoing training and technical assistance on clinical trial billing and  related topics. You can contact us at 706-721-6247. 

Related Resources

1. Billing for Treatment Studies (Article from MCG Research Administration Newsletter 2008)
2. Medicare Qualification Worksheet
3. Scheduling and Billing Tips
4. Informed Consent Document and Contract Language (for studies that want to bill insurance for routine care)
5. Change Request Form for a Study Bill
6. Georgia Cancer Coalition Agreement
7. Insurance Coverage Matrix
8. "Scheduling and Billing" PowerPoint
9. Sample Billing Grid