Following her recent webinar on the top 10 ways research sites leave money uncollected, Kristi Etchberger answers follow-up questions about commonly missed charges and provides insight on best practices your site can employ to make sure you’re collecting the money you’ve rightfully earned.
What are some best practices you suggest we use to bill for additional procedures? For example, should we leave text in the contract indicating additional procedures will be charged, or should we negotiate additional procedures every time they occur?
Getting paid for extra charges is always a challenge, especially if they’re not in the clinical trial agreement. It’s best to agree on as much as possible upfront rather than leaving negotiations for later, after you’ve already completed the procedure and no longer have negotiating power. The more you can negotiate into the agreement, the simpler it will be later if something unexpected happens.
How do you recommend budgeting for serious adverse events (SAEs)? Should we budget per hour, per SAE or use some other method to budget?
SAEs are, by nature, unexpected. When they do occur, research staff must devote extensive time and resources to review documentation, handle data entry and respond to related inquiries. SAEs are disruptive, but a good standard operating procedure (SOP) can help your site streamline how you handle them.
Based upon your SOP, estimate the average number of hours required by the coordinator, data entry staff and PI for SAEs. Calculate the average cost based on their respective hourly rates and add overhead to that amount; use that total as your proposed SAE flat rate. In our experience, sponsors are generally more willing to agree to a flat rate upfront, rather than an hourly rate for the work to be done when SAEs occur.
Make sure the finance staff knows the SAE has occurred so they can invoice for it. You can alert your finance personnel using a CTMS – in Allegro, we use a visit template to track SAEs – or you can use a paper form for your coordinators to submit to finance in the event of an SAE. Your finance staff probably isn’t reviewing subjects’ charts for SAEs, so unless you proactively alert them, they have no way of knowing an SAE has occurred.
How should we handle correspondence with a sponsor who refuses to pay for SAEs? Are there particular negotiation tactics that you’ve found successful in these situations?
If SAE compensation is not negotiated into the initial budget and the sponsor refuses to pay for it, you need to request an amendment. If SAEs are generating significant extra work, go back to the budget person with whom you initially negotiated the agreement. If that fails, ask the PI to speak to the medical director assigned to the study. The medical director will realize SAEs are generating substantial work and will support the PI and the site in driving the negotiation back to the sponsor.
When negotiating a study budget, you should always review the protocol to ensure all procedures are covered by the budget and potentialities are also covered in the agreement. Ideally, clinical staff, regulatory and finance should review the protocol together to understand the study and make sure they can complete it for the amount that’s been budgeted. Thinking through extras, such as SAEs, ahead of time is more thorough when all areas of the site are working together.
Watch the full webinar on-demand for more information on how your site can make sure you’re not missing out on unbilled expenses.