Clinical trial site leaders who lack a clear understanding of what is reimbursable under Medicare and Medicaid can face big fines and a big public relations black eye if they don’t develop a strong program, says Carrie A. Hanger, an attorney with Smith Moore Leatherwood LLP in Greensboro, N.C.
While this tends to be a more common weakness at smaller sites, it hits the big boys too, adds Hanger. “No one wants to be in a Department of Justice press release,” she notes.
Unfortunately, that’s exactly what happened to Emory University in August 2013. In an agreement reached with the United States Attorney’s Office for the Northern District of Georgia, Emory paid (without admitting liability) $1.5 million to settle claims alleging that it had violated the False Claims Act by billing Medicare and Medicaid for clinical trial services that were not permitted by the Medicare and Medicaid rules.
Navigating Medicare’s reimbursement policies isn’t easy, Hanger acknowledges. For example, to be reimbursed under Medicare in a Phase I or II study, it must be clearly demonstrated that there is a therapeutic benefit for patients; it can’t just be about gathering data, Hanger warns. Some Medicare coverage analysis programs fail to navigate such nuances.
Hanger has worked with a number of sites — large and small — and often finds that trial professionals at the smaller sites are either are unaware of the need for a Medicare reimbursement strategy or pay it short shrift with vague and poorly documented practices and procedures.
Hanger spoke in September at an ACRP Greater Charlotte Chapter event in North Carolina and found that, while attendees understood the importance of a Medicare coverage strategy, several had questions about the best way to go about developing an effective one.
While Hanger was encouraged by the knowledge level at the ACRP event, she doesn’t always feel that way. “I work with sites and some clients who didn’t think they needed to do it at all, which surprised me,” she says.
Too often, sites think of clinical research as simply providing a nice revenue stream, helping to fulfill an education mission, and improving patient care. “They assume sponsors have all the knowledge and will tell them what they need to do,” Hanger says.
That’s not always the case, of course. It’s a lesson some learn the hard way, Hanger warns.
Author: Michael Causey
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