At Henry Ford Health System in Detroit, leaders have been moving forward with an initiative that they believe is highly replicable: automating the complex, often frustrating process around continuously maintaining compliance with requirements for disclosure of conflicts of interest, on the part of clinicians, executives, and others in the five-hospital, 23,000-employee health system. Encompassing both a teaching hospital and several community hospitals, as well as a large group of employed physicians, Henry Ford faces a variety of disclosure compliance challenges.
J. Douglas (Doug) Clark, vice president of integrity for Henry Ford, oversees what was once known as the audit/compliance area, supervising the management of external contracts for the health system. Clark recently engaged Ronald George, who formerly worked as Henry Ford’s system-wide compliance officer, to help him automate the process around compliance management for the entire health system. George is now working as a compliance consultant to the system. Clark, George, and their colleagues are making use of a solution called the HCCS COI-SMART System, from the Jericho, N.Y.-based Health Care Compliance Strategies, Inc. (HCCS).
Clark and George recently spoke with HCI Editor-in-Chief Mark Hagland regarding the compliance process automation initiative at Henry Ford Health System. Below are excerpts from that interview.
Tell us a bit about the origin of this initiative.
J. Douglas Clark: I’m the vice president of integrity—it’s the old audit/compliance area, which includes management of external contracts. Ron was the compliance officer working in that area. He had retired a couple of years ago, and we actually brought him back as a consultant to install technology, and he’s been doing that for about a year and a half now. We have a dollar-one disclosure process that covers all employed physicians and all employees. We would like to target non-employed physicians as well.
And as the NIH [National Institutes of Health] was refining its procedures to refine its process for disclosures across the workforce in healthcare [the new requirements on disclosure for potential financial conflict of interest, or “FCOI,” went into effect on Aug. 24], we moved to address the NIH requirements.
We have always, even before it become somewhat media-sensitive, supported transparency regarding the relationships that the institution and our physicians have. And one of the ways to manage that is through managing disclosure of external relationships. It can be speaking, consulting, consulting that might involve patient contact or a device company or a trade association, or any number of other involvements.
Ronald George: There are 12 specific areas of concern. Here are the 12: significant financial interest in an outside entity; compensated arrangements with an outside entity; personal or family relationships with an outside entity; acceptance of gifts from an outside entity; board membership on an outside entity; business transactions between employer and employee; nepotism; intellectual property rights; other not covered above; sponsored research relationships; bias impacting continuing medical education; and IRS Form 990 concerns.
Clark: Speaking has gotten the most headlines, but we looked at it and determined that any relationship outside the primary relationship between Henry Ford and the individual, that any of these relationships, could impact them. We were probably one of the first organizations in the country that actually put into place criteria around how physicians onsite could interact with vendors and pharmaceutical companies, under the branding of “influence-free.” We understood that those advising us, we understood what relationships they had outside the workplace. There’s a myriad of other relationships, including per the IRS and Medicare.
But as we started down the path using web-based technology for this, the NIH decided to step back and rethink their historical position on research and contracts. Historically, the NIH has always had a disclosure requirement regarding conflicts of interest; but it really left it up to the researcher, not the institution to determine that. And not surprisingly, most researchers believed that none of their relationships ever posed a conflict. But we realized that what they were disclosing in their research role did not match what we saw as potential conflicts of interest across all external relationships. Their rule was approved on Aug. 24, 2011, but took effect Aug. 24 of this year.
How many people are encompassed by these processes at Henry Ford Health System?
Clark: Our total employment number is 24,000 people. And of that group, there are about 1,200 who are employed physicians and 800 residents; and when you add up all the people who actually disclose, which would be all physicians, residents, and managers or above, it’s roughly speaking 3,500 people. Eventually, all employees will need to disclose.
How long have you been live on this solution?
We’ve been transitioning into the solution over the year, legal entity by legal entity. And we’re in the final phase for implementing the solution for managers or above right now. Our first disclosures were received in early June of this year.
George: Because it’s the first year, we’ve done this in five phases, and the first group was the Henry Ford Medical Group, which involved a little over 1,000 physicians, researchers, and others. We did not set definite deadlines, but we asked that they respond as soon as possible. Eventually, we set a deadline of two weeks, knowing that it wouldn’t be quickly complied with. Our experience in the past was that it took about five months to get everyone to comply 100 percent. And we’ve always gotten 100 percent, because it’s an organizational requirement that they disclose. In terms of COI-SMART, it took us about 60 days to get to 100 percent in that first group; the next group took a little bit longer than that; with the current group, after two weeks, we’ve got about 70 percent. COI-SMART is able to send out reminders at whatever level of frequency you want. We do it weekly. In addition, we send out lists of the delinquent respondents to their leadership.
Some people don’t read their e-mails; others have been terminated, so we have to find that out and make that change. Some procrastinate; and a few just don’t want to disclose.
Clark: This can only be effective if they’re somewhat real-time in terms of the disclosure. So this has significantly shortened the disclosure “tail,” as it were. And since the institution is now the disclosure party, not the researcher, we really, to stay compliant with the regulations, need to review all this concurrently or very closely tied to the timeframe.
So everyone should really be going to some form of automated or online solution, to be current enough?
Clark: I think that without a technological solution, you are never going to comply with the regulation. Unless they disclose, you can never make the required timeframe for the related required tasks.
George: People who are in research sometimes have relationships with the same outside vendors sponsoring their research. So a specific drug company can both be sponsoring an individual’s research and at the same sponsoring their speaking engagements around that. And sometimes, a person’s job responsibility at Henry Ford can depend substantially on producing regular research. So there can be the potential for conflict of interest here, in terms of the subjects collected, the method of data collection, or the analytics around collection.
Clark: Ron is absolutely correct; but there’s also a lot of concern around the concept of influence, some of which is overt, some of which is not overt. And the successful researcher becomes successful primarily through their ability to build networks of contacts. And there’s always a risk for conflict of interest. And so it’s in our interest to reduce potential conflicts of interest to as low as possible.
What would your advice to CIOs be?
Clark: Prior to this, we had a homegrown product. And many universities have developed their own homegrown product. I think the choice of an off-the-shelf product is a far smarter choice, given how quickly the regulations are changing. Those organizations that have chosen to develop a homegrown product, I believe will eventually be acquiring an off-the-shelf product, because of the maintenance issues involved. Years ago, there were very few commercially developed products; that’s changed now.
Is there anything else either of you would like to add?
Clark: Once healthcare reform is fully in place, a lot of these relationships will be publicly available through the companies’ websites. But you always run the risk that an individual might “forget” about a relationship or even inaccurately represent a relationship. So for our research community, we’ve actually engaged a third party, and they go out and scour the vendors’ and other organizations’ websites, and they go out and validate what we’re learning from others.
