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With teaching hospitals and other research organizations coming under increasing scrutiny by federal investigators, specially tailored compliance programs for research activity have become a necessity, says Lisa Murtha, chief audit & compliance officer at Children’s Hospital of Philadelphia.
Clinical research is tied directly to federal funding through the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), and corporate sponsors of clinical trials have a vested interest in making sure research studies are conducted in compliance with a myriad of regulations.
In addition, Murtha points to a growing public demand for improved internal controls as a result of several recent high-profile cases.
According to Murtha, organizations engaged in research face numerous pitfalls, beginning with conflicts of interest for investigators who have ownership interests in companies that are co-owned by sponsors. "These are risks that you deal with every single day," she warns, adding that investigations into these conflicts are certain to continue.
Any institution that does not have a conflict of interest committee comprised of investigators and other key representatives should consider establishing one, Murtha says. She adds that when investigators are given the opportunity to discuss these issues with their peers, they typically arrive at the appropriate conclusion. "Peer pressure can be a valuable thing, so I would exploit it as much as possible," she explains.
A second area receiving significant attention is billing for clinical drug trials and the way sponsors are charged for costs related to research. However, Murtha warns that most academic medical centers do not have adequate internal controls in place to determine which types of tests might be appropriately reimbursable through Medicare, Medicaid or a private insurer.
According to Murtha, these problematic scenarios can arise under a variety of situations. For example, a patient who enters the hospital as an inpatient may be identified as a potential research subject and some of the initial tests performed can be charged to the grant. However, organizations need guidelines to handle these situations, and research institutions that lack appropriate guidelines may be double billing, she adds.
John Steiner, director of corporate compliance at the Cleveland Clinic Foundation (CCF), reports that when he assumed that position three years ago he found a general lack of awareness regarding the complex requirements surrounding clinical research among both investigators and support staff.
Initially, Steiner says he met with various parties, including legal, internal review board, support staff, nurse researchers, research accounting, and senior management. "I was able to figure out very quickly that the lack of consistency was real," he reports.
To remedy that situation, Steiner sought to "build bridges" among various groups, such as those with a knowledge base of Medicare payment and coverage issues and those who support the primary investigators. That way, the people who understand reimbursement and patient flows are in a position to flag potential problems.
Likewise, staff who directly support investigators must know how and when to look for changes in national coverage or local medical review polices that affect payment and coverage for clinical trials, he says.
In addition, Steiner says someone must be responsible for scrutinizing contracts and determining whether commercial payers are adequately looking at clinical research issues such as coverage, as well as whether the principles under managed care and commercial pay contracts are the same as they are for Medicare. That way, research organizations can start to drive all their billing and coverage systems in the same direction, he explains.
In terms of developing a research compliance plan, Steiner says one good place to begin is with Proactive Compliance Site Visits 2000, a 12-page document released April 4, 2001, by NIH that contains findings and observations from visits to 20 organizations nationwide.
Steiner says that document can be used to zero in on examples of compliance, which then can be tied back to very specific steps that NIH either witnessed or indicated that it would like to see. Using that report, Steiner says he drafted an internal document that outlines a variety of areas such as roles and responsibilities, adequacy of delegation, and follow-up steps, which was used for internal gap analysis to plan further compliance measures.
Murtha agrees that research organizations should focus their attention on the risk areas that require the establishment of a compliance program, such as undefined roles and responsibilities. "Because investigators tend to work in silos, they are the masters of their domains," she warns. "They basically do what they want to do."
Decentralized administration is another issue that poses risk, according to Murtha. She says that one of the projects that Children’s Hospital currently is undertaking is to centralize the core functions that all of its investigators engage in that are duplicated around the institution.
Murtha adds that while she anticipated resistance from investigators, the repeated emphasis that already had been placed on compliance actually led them to embrace this process as a way to alleviate those pressures.