No health care facility wants to get caught like a deer in the headlights when an ugly, public conflict of interest arises for board members, physicians or other employees. But they often do, because collecting and managing conflict of interest data can be a big, confusing, never-ending hassle.
Hospital compliance departments have been responsible for managing financial disclosure statements, flagging conflicts of interest and coming up with management plans to address those potential conflicts for a variety of reasons—for the IRS reporting required for not-for-profit status, as well as regulations set up by the FDA, for researchers for National Institute of Health grants, other grant programs and contractual obligations, to name a few.
Sarah Kleaveland Kupczak, vice president of compliance and HIPAA services at Wheaton Franciscan Healthcare in Glendale, Wis., estimates that she spends 15 percent of her time analyzing financial disclosures from staff and analyzing conflicts of interest, and other staff members also have to spend considerable work hours on COI. “It’s a huge job--we have multiple boards and hundreds of physicians and researchers who need to fill out the disclosure forms, and using paper had become too burdensome,” she says. “We used to sent out the paper forms to hundreds of people and ask them to fill them out, then had to follow up and get them to fill out the forms, and then log those forms into a system.”
Another big challenge was to simply figure out who had to fill out what form—board members, physicians and researchers often sit on multiple boards and committees, some of which require different disclosure information than others.
While it was a cumbersome process, it was also a mission-critical one for Wheaton Franciscan, a not-for-profit health system that must legally have a conflict of interest management program in place to maintain its not-for-profit status. One thing the IRS typically looks at when deciding whether a hospital is entitled to its tax exemption is the possibility for conflicts of interest within the various boards and the transparency of their decision-making processes. And the potential conflicts are numerous, Kleaveland Kupczak says--for example, many physicians have relationships with pharmaceutical companies as well as software vendors, which can rear up during development of order sets and the selection of clinical applications. “There are a number of questions that arise that must be addressed,” she adds.
For the past year, Wheaton Franciscan has been using the COI-SMART software from Health Care Compliance Strategies Inc., to automate the conflict of interest process. The software provides online forms that can be filled out, and the questionnaires can be customized for each individual, so instead of filling out multiple disclosure forms because they serve on multiple boards, users can fill out one questionnaire that asks all the questions required for their different roles.
Now, the hospital has a single database of disclosure forms and can review all the information. And what makes it easier, Kleaveland Kupczak says, is that the disclosure forms can be sorted by who actually reported potential conflicts, so compliance staff doesn’t have to sift through all the forms. In addition, prior year disclosures can be added into the current year questionnaire, and disclosure forms can be updated electronically if a person’s financial relationships change during the course of a year.
The software has made the entire process smoother for those who must file financial disclosures, as well as the compliance staff, Kleaveland Kupczak says. And when the software was implemented a year ago, the roll-out went off without a hitch, which was critical for Wheaton Franciscan. “The system had to be used by the key people in this organization, and if there were any glitches the problems would have been very high profile,” she says.
Kleaveland Kupczak adds that having a transparent and streamlined way to track and manage conflicts of interest is critical at this juncture because of coming regulations that will make financial disclosures publicly available. The Physician Payments Sunshine Act, which is Section 6002 of the Affordable Care Act, will require manufacturers of prescribed products, including medical device and pharmaceutical companies, to report certain payments made to doctors over $10 or any amount if the payments total more than $100. In addition, physicians will have to report ownership interests in imaging facilities such as MRI centers, hospitals and group purchasing organizations.
The data will be made publicly available by the Centers for Medicare and Medicaid Services. The final Sunshine Act rule is expected this year--the two sponsors of the act, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI), recently wrote a letter to CMS urging the final rule and regulations be released in June.
The act has been controversial, but even worse, it’s not well-understood at this point—a recent survey by CMS of 500 compliance officers and physicians found that 47 percent had not even heard of the Sunshine Act.
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