Be aware of false claims exposure with root cause analysis
Protecting the contents of a root cause analysis (RCA) requires much more than slapping a “peer review” label on the file and assuming that label means it is off limits to prying eyes. Peer review privilege might not protect your RCA at all, but there are other ways to limit the potential downside from someone reading about all your shortcomings.
The potential discovery of RCA contents has always been a concern, and that concern is a primary reason healthcare risk managers sometimes don’t get as much out of the process as they could, says George B. Breen, JD, an attorney with the law firm of Epstein Becker Green in New York City. Breen works closely with risk managers who use RCA to address adverse events and other issues in their facilities, but he is sometimes disappointed that they did not achieve the end result: effectively determining the foundation of how and why an event came to pass.
In some cases, the RCA has conflicting interests from the start, Breen says. On one hand, the risk manager wants to determine what unknown or unforeseen factors affected an event and how to keep that event from happening in the future. But at the same time, the risk manager might be concerned with protecting the practitioner and the institution from liability. As such, the risk manager wants to avoid creating “bad paper” that could be subject to discovery and used by a plaintiff’s attorney.
“Those interests don’t always coalesce,” Breen says. “Courts are increasingly looking at some of this material developed in a root cause analysis and saying that it is discoverable. It’s going to be state law-specific, but there are more and more courts being asked to address challenges to claims that these materials are protected by peer review. Some courts are allowing the discovery of this information.”
The government is increasingly focused on cases involving medical necessity and quality of care, and on the federal level there is no peer review protection, he notes. That situation creates the risk of a false claim allegation based on a paper trail created during an RCA. “There is a different exposure in the false claims context,” Breen says. “The reality is that if you are billing the federal government for a service that is not medically necessary and appropriate, then the government is going to come back and ask for that money back and potentially treble damages and interest.”
The RCA can come into play when the government investigates what the institution knew about a practitioner or entity who filed false claims, Breen says. “They will want to know what the institution knew, when they knew it, and whether they took notice and made any attempt to address the problem,” he explains. “So there is sometimes a greater risk of exposure from false claims allegations when it comes to root cause analyses and the paper trail it creates, than from the medical malpractice claims that most people worry about with regard to the root cause analysis.”
One way to protect your RCA from prying eyes is to follow a set of clearly defined procedures conducting the analysis, Breen says. The goal is to establish in your policies and procedures, as clearly as possible, that you intend this process as a “true self-look at what it is we are or are not doing,” Breen says. The policies and procedures also should ensure that the organization follows through on the findings of an RCA by addressing problems and confirming that they have been resolved.
“It’s fine to say that your analysis revealed this problem, but you want to have auditing and follow-ups to ensure that the lesson you just learned was not held in isolation,” Breen says. “You want to be able to show that you took something from that lesson and changed your practice so that you can avoid that exposure in the future.”
Involving legal counsel can provide some measure of protection, Breen says. Since it is dicey to rely on saying the RCA is protected by peer review, you are better protected if you can show that the materials were prepared at the direction of legal counsel, which can help protect the confidentiality of the records.
“I don’t think that the False Claims Act exposure here is on the radar of most risk managers,” Breen says. “The issue of peer review might be more known by them, depending on their state, but the false claims exposure has the potential for being much more damaging. That’s why you need to have a well thought-out plan for how you conduct an analysis and a plan for protecting it that goes beyond just calling it peer review.”
• George B. Breen, JD, Epstein Becker Green, New York City. Telephone: (202) 861-1823. Email: GBreen@ebglaw.com.