Teaching hospitals have been writing conflict of interest policies covering research and corporate relationships, but they also should set rules for disclosing physicians' clinical conflicts that can bias patient care, according to an Association of American Medical Colleges (AAMC) report released Wednesday.
"Less than 1% (of teaching hospitals) have adopted policies that define and address conflict of interest in clinical care," said AAMC chief health officer Joanne M. Conroy, MD. "This report is the first step in providing guidance on how these institutions can develop policies."
Asked for an example of what sorts of conflicts these policies should cover, Conroy answers:
"Let's say you're having a hip replacement, and the orthopedic surgeon you're meeting with actually was the inventor of one of the most commonly implanted hips in the U.S. He probably needs to disclose that to you if that's part of the discussion of what kind of hip you're going to receive."
She added, however, that there are other questions the policy should address. "Does he disclose how much he makes from royalties from that company over a period of time or for your individual procedure?" Likewise, she said, if the doctor had a part in the development of a drug or medical device from which he or she receives royalties or fees, that should be disclosed, too.
The AAMC report, "In the Interests of Patients. Recommendations for Physical Financial Relationships and Clinical Decision Making" is the third in a series that AAMC task forces have produced regarding conflicts of interest in medical schools and teaching hospitals. It includes seven recommendations for medical institutions to address the issue.
Prior reports examined industry funding of medical education and financial conflicts of interest in clinical research.
While the report is careful to say that some relationships between clinicians and for profit companies are often necessary and beneficial, there are perceived if not actual conflicts of interest that must at the very least be disclosed.
"The interests of the patient are at stake, as is the trust of the public," the report's introduction says. "Moreover, when personal financial interests conflict with clinical care activities, there is the potential for a negative and lasting influence on the development of professionalism in medical students and other trainees."
Conroy said that three institutions to her knowledge are developing or have such policies in place, such as the University of Washington in St. Louis, the Mayo Clinic and the Cleveland Clinic. But academic medicine needs to adopt this as an institutional priority not just for the 300,000 medical students, residents and practicing faculty members, but to set a model for private practice doctors as well.
"Advances in medicine depend on a constructive partnership between academic medicine and the pharmaceutical, device and biotechnology industries," the report says. "At the same time some of these interactions have been shown to produce both potential and actual conflicts of interest, especially when the relationships have the capacity to generate financial gain for physicians and their institutions and influence professional behavior."
One burgeoning hot topic involves potential conflicts between physicians and the relationships they and their hospitals develop as they adopt new models in health reform, such as accountable care organizations, medical home models and bundled payment systems.
"As these payment methodologies roll out we will be looking at the unintended consequences," Conrad says. We're going to learn a lot over the next five years." For example, Conroy says physicians and hospitals creating accountable care models will want to partner with high quality organizations to provide a continuum of care.
p>"If you were a hospital, or an ACO that was focusing on high quality, low-cost care, you're going to pick a really good partner because you don't want your patients getting infections or bedsores and you want them to have adequate professional staffing to accelerate the discharge process to home. But then what do you do about offering patients choices?
"The patients (or their families) may say 'No, I don't want to go there. I want to go to this facility that's only five minutes away from my daughter.' Patient choice will be the driver of that decision." What sorts of financial relationships should the doctor and hospital have to disclose then?
The Centers for Medicare and Medicaid Services requires that clinicians disclose to their patients any ownership or investment in a hospital, the report says. But disclosure that is commonly required is "frequently insufficient method of management."
According to one report, when research participants were told about financial interests of clinicians running a clinical trial, "some people may not have the baseline understanding necessary to judge the risks posed by financial interests, (a finding that calls) "into question whether simple disclosure to prospective research participants is an effective strategy, standing alone, for managing conflicts of interest in research."
The AAMC report says medical centers should take an additional step and adopt procedures that "call for explicit evaluation of relevant financial relationships" by an appointed committee which would determine if there is a significant conflict of interest, and whether it should be eliminated.
One institution's policy the AAMC included as an example calls for:
- Verbal disclosure to patient with documentation in medical record
- Corroboration by colleague of any prescription involving a product from the commercial entity
- Corroboration by colleague documented in medical record of any prescription involving a product from the commercial entity
- Appointment of an oversight committee to monitor practice patterns
- Transfer of patient care to another colleague
- Cessation or modification of relationship with commercial entity if necessary.
Enforcement of the policy is important as well. The AAMC report gives an example of how one hospital might take remedial actions if a conflict of interest can't be resolved such as:
- Suspend the faculty member's clinical privileges
- Withdraw the faculty member's professional liability insurance coverage
- Reduce the faculty member's salary or bonus
The task force also suggests that hospitals create transparent Web sites to disclose physician conflicts and financial relationships, and do so in such a way that is consistent and understandable.
In its seven recommendations, the AAMC report suggests that conflict of interest and transparency policies should extend to regional medical societies, as well as community practitioners outside of academic settings.
"Though the task force was charged with addressing clinical conflicts of interests only in academic medicine, it believes that the principles that have guided its work and that shape its report are applicable generally to the practice of medicine."