Faced with an injury in a trial, sites must walk a fine line to make sure the injured participant is reimbursed properly without billing the wrong responsible party for unexpected medical care or failing to bill at all.

Both are costly mistakes — the first can lead to legal action and severe penalties, and the second leaves the site holding the bag for expenses not covered in the trial budget. The solution to this quandary is three-fold: create a billing determination and tracking process that keeps all site staff in the loop, use specific and standardized terminology across the board and make sure all trial documents — from informed consent forms to clinical trial agreements (CTA) — make injury reimbursement policies crystal clear.

Patient injuries in trials are unexpected events requiring medical treatment that goes beyond the possible adverse events (AE) detailed in the informed consent form (ICF). The challenge is to separate injuries from other AEs and track them through the various departments with AE responsibility:

• The clinical team that evaluates the event;
• Regulatory/compliance managers who determine what reports must be sent to whom;
• The contract staff that set the billing terms;
• Possibly the legal or risk management team; and
• The billing department.

With such a range of roles involved, establishing a solid process is essential, according to Rebecca Ohta, manager for Queen’s Medical Center in Honolulu.

Bring all of the departments/teams together to hammer out the process, Ohta told attendees at the Research Billing Compliance Summit last week, and discuss everyone’s role in the process. She suggests creating a visual map to help each group understand its own responsibilities, other parties’ responsibilities and the overall process for AE tracking from start to finish.

Timing is an important topic for discussion, she said, not just because FDA regulations require prompt reporting but also because sponsors sometimes set limits on the timeframe for invoicing. Such deadlines should be understood by all parties, Ohta said.

It’s also important that everyone understand the language and terms around patient injury reimbursement, said Nancy Howard, a consultant with Kelly Willenberg and Associates.

The ICF and CTA should clearly define what is considered a participant injury, Howard said. While the protocol may define participant injury, the ICF and CTA may use different language — the ICF must be written in an easily understandable way, for instance — it’s critical that the meaning is consistent. She recommends using certain language in the ICF that makes clear the difference between a participant injury and an AE, such as:

“The term ‘research-related injury’ describes a physical injury directly caused by the product or procedures required by the study that are different from the medical treatment you would have received had you not participated in the study. Research-related injury does not include any AEs that are outlined in the risk section in this consent form.”

It’s very important that language does not say that participant injury includes AEs or side effects because the majority of AEs won’t be considered reimbursable or billed to insurance. Having language that defines participant injury as an AE or side effect creates a massive amount of work for sites, who would have to, for example, question every lab or prescription written in a trial, Howard said, as well as the principal investigator (PI), who decides if an AE is or isn’t a participant injury.

It’s also helpful to include cost language in the ICF that makes clear to the participant what they will be paying for and what their insurance or the sponsor will cover.

Howard also recommended using standard language guidelines for billing that can be used in contract negotiations with the sponsor. Sites should create a formal billing policy for participant injuries that they can present to the sponsor.

“If [sponsors] push back, you can tell them, ‘this is institutional policy.’ Sometimes that actually goes quite a long way,” Howard said. “If they find out that, if they’re going to make further changes during these negotiations, it’s going to have to go up to a much higher level in order to get a change made, sometimes they’ll cave and go ahead and allow the change in the language.”

In CTAs, it should be laid out clearly who is responsible for paying for what when it comes to research-related injuries, especially to avoid billing a participant’s insurance for something the sponsor should cover or, even worse, billing both of them by mistake. Incorrect billing of insurance payers puts a site at risk of violating the federal False Claims Act and incurring millions of dollars in penalties.

In 2005, for example, the University of Alabama at Birmingham incorrectly billed Medicare for trial claims that were also billed to the sponsor, leading to a lawsuit that concluded in a $3.39 million settlement. More recently, Emory University paid $1.5 million in 2013 to settle claims that it billed Medicare for trial services the sponsor had agreed to pay.

Participants also must be informed who will pay for unexpected medical expenses related to the trial. Making sure your ICF is clear to the participant is essential. The use of the word “may,” such as “the cost of treatment may be billed to you or your insurer,” is too ambiguous, Ohta said. Similarly, language suggesting that the cost of treatment “may” be billed to the participant, his or her insurance carrier, the trial site, institution, sponsor or other entities also won’t fly, she said.

Finally, the injury-reimbursement process should include review of all trial documents (protocol, IRB-approved ICFs, CTAs, budgets and coverage analyses) both during CTA negotiation and before contract execution to ensure consistency.

“All of these documents are being negotiated in parallel, so before you execute any document, including the CTA, you’re going to look again at document concordance and make sure everything lines up,” Ohta said. “Make sure the ICF is in agreement with the sponsor budget before you send it to the IRB. It would be a pain to have to amend that later.”