While conducting clinical trials, staying on top of billing and expense coverage can feel never-ending, particularly if things do not easily reconcile. Luckily, from pre-study negotiations to post-study internal review, you can adopt practices at every step that will help ensure your site is not missing opportunities for reimbursement of research costs. This blog post explores some fairly simple practices your institution can use to avoid common gaps in financial management and ensure you won’t see a loss in revenue in clinical studies.
Pre-Study: Budget and Contract Negotiations
Before a clinical trial begins, it is important to try to parse out the financial pieces your institution will need to attend to throughout the study. It’s critical to identify all your costs in detail. The more detail you can convey to the study sponsor during negotiations, the more likely you are to receive approval for reimbursement, which will lead to a higher return on revenue.
After you have received the study contract and protocol, analyze the schedule of events to ensure all required study procedures above standard of care are listed on the budget for reimbursement. Also, take the time to review the optional procedures within the protocol. Verify that these optional procedures are captured on the invoiced item section of the budget, and take the time to review that the amounts listed will cover your costs.
Time spent on administrative tasks is often an area of oversight during pre-study negotiations, and this oversight is certainly something that can be remedied. In terms of admin. tasks, there are several events that must be completed before a study begins. These items include:
- Review of contract language
- Budget costs
- Investigator meeting
- Pharmacy set-up
- IRB submission fee
It is always important to make sure coordinator and PI admin. time meet sponsor expectations, but also be sure to consider the time of the personnel who review and negotiate your contract and budget. If your organization is not already partnering with administrative specialists, such a partnership might be worth looking into. Services such as PFS Clinical’s Smart Start can go a long way toward setting your research department up for a higher return. With these services, administrative experts negotiate time spent on budget and contract review and negotiation into study start-up costs. This eliminates potentially large gaps in the foundation of your study and allows your research staff more time to focus on clinical duties.
Since pre-study is a time to anticipate the needs of your institution, you will want to consider the financial items that will arise at varying points throughout course of the clinical trial. For instance, after the study is in progress, a reimbursement for yearly admin. and pharmacy fees may be needed to cover the time and effort it takes to complete study billing and reconciliation. You should also account for the use and storage of study-related items in the pharmacy.
Although it may seem like a long way off, do not forget about the fees required at the completion of a study. Most studies perform a close-out visit and require a submission of IRB closure forms. Typically, there is also a cost for storing study documents, which are often archived for several years after the study’s completion.
Even with the most intensive planning, unexpected study expenses will likely arise over the course of a clinical trial. In your negotiations, adding a line for “other expenses” to cover anything not known in the beginning of the study can be a helpful way to invoice unforeseeable items without having to amend the contract. Still, amendments are sometimes unavoidable and can serve as a safeguard if the same unexpected “other expenses” continually occur. With this in mind, it is not a bad idea to include any amendment processing fees, such as the cost of analyzing and re-negotiating documents and submitting forms to the IRB.
During the Study
Study Visit Documentation and Review
No matter the strength of your pre-study work, gaps in recognized revenue are often created by poor ongoing communication regarding study events. To avoid these gaps, it is important to have internal procedures in place for real time documentation with the personnel in charge of billing. Requiring study teams to record visits in a CTMS or Excel log within a 24-hour period helps ensure all revenue is recognized. The billing or accounting department should review visits at least monthly to confirm accuracy and coherence of the visits. For example, if patients are to be seen monthly and it has been two months since the last visit, the institution should follow up with the coordinator to make sure the visit was not missed.
This level of communication and documentation has more benefits than just mitigating the risk of missed visits. Follow-up with the coordinator and PI regarding a visit or procedure is much easier when the study is in progress. Waiting until the end of the study requires pulling files and reporting information out of context, which may result in missed opportunities for sponsor coverage due to lapsed payment deadlines or lack of detail regarding the occurrence.
Ongoing, real time communication should extend beyond billing personnel. While review of pass-through procedures is common at the beginning of a study, it is important to continue regular reviews of these procedures throughout the course of the clinical trial. Creating a list in the CTMS or a spreadsheet can be a helpful tool for procedure review. Regularly review the list of pass-through procedures with the PI and study coordinator so they are aware of items not covered in the per patient budget.
Communicating with the study sponsor when extra expenses arise is always good practice as these costs may be reimbursable. While such expenses have a habit of arising unpredictably and related procedures may occasionally need to be performed with immediacy, always seek pre-approval for non-covered expenses when possible. You’re more apt to get an item reimbursed if the monitor is aware of the situation and pre-approves the expense via email. If you find that you are continually seeking approval for the same non-covered study-related item, request a contract amendment to guarantee you’re reimbursed for this study expense.
Even if it is not required by the sponsor, all visits should be invoiced monthly in an internal accounting system or through a clinical trial administrative partner. As stated previously, the more detail you can provide regarding your study expenses, the less likely you are to see gaps in your recognized revenue. You should always know what is owed based on performance.
Once and invoice is created, be sure to track it until it is paid. If an accounting system isn’t being used, track the invoice in an Excel sheet and reconcile the amount earned to actual visits and procedures that occurred. Review the payment terms (monthly, quarterly, etc.) and set a reminder to make sure the payments are received on time. Follow up with the sponsor on outstanding visits and ongoing invoices to make sure they are reimbursed. If requested by the sponsor (as some have required deadlines that only accept bills up to 90 days from the event), send invoices monthly.
End of Study
As your study draws to a close, double-check the contract to ensure all visits and pass-through procedures have been billed and paid. Make sure to review all internal expenses paid to vendors, verifying they were covered within the contract budget. Once the study is completed, generate a profit and loss statement to ensure all study-related expenses were adequately covered by established pricing. If you provide the sponsor with tangible data, it will be easier to request a higher reimbursement in future studies.
One of the most helpful practices you can adopt is an end-of-study internal review. Acknowledging and evaluating what went right and what could be made better will help your staff and research organization identify revenue gaps in future studies before they occur.
For example, your internal review might reveal issues and solutions similar to the following:
- Was your admin. time greater because all study visits required a detailed invoice and constant follow-up with the sponsor? Increase your start-up or yearly admin. fee.
- Did the PI need to meet extensively with the monitor every 6-8 weeks? Add a “site monitoring visit” line item to your budget.
- Is there a major invoiceable item not covering your cost to complete? Document the amount needed and ask for higher reimbursement on the next study.
Don’t let poor communication or preventable oversights leave gaps in your revenue stream. Adopting practices for budget development/negotiation, contract redline/negotiation, and study billing, as well as verification of sponsor coverage throughout a study, will help ensure your research department is not missing opportunities for reimbursement of research costs.