AMA Ethics Forum. Sept. 4, 2000.
Scenario: What constitutes a bona fide educational activity?
A physician wrote: We received notification from a health plan that our level of reimbursement would be raised if the physicians in our group completed a series of continuing education tapes on depression. The series is sponsored by a manufacturer of an antidepressant that is on the preferred drug list of the health plan. Does this present our group with an ethical dilemma? How can it be resolved?
Reply:
One approach to untangle the relationships among physicians, health plans and pharmaceutical manufacturers is to focus on two questions: (1) Is it appropriate for health plans to provide financial incentives for doctors to attend a “bona fide” educational activity? (2) Is this a “bona fide” educational activity?
With regard to the appropriateness of education incentives, it is important to consider whether the activity is in patients’ best interest. This is most likely if physicians participate in an objective and balanced educational activity about new options for clinical care. Also, it is important to ask whether receiving a financial incentive to participate in an educational activity puts doctors’ self-interests in conflict with patients’ interests. If a health plan increased reimbursement as a reward for prescribing a specific drug, this incentive would clearly place physicians’ financial self-interest in potential conflict with patients’ interests, in this case prescribing the most appropriate drug.
A more subtle potential conflict is whether financial incentives produce a sense of obligation that sways physicians’ judgments from patients’ best interests. This is recognized in the AMA’s ethics opinion on gifts to physicians from industry. According to this opinion, it is inappropriate for physicians to accept financial incentives directly from a pharmaceutical manufacturer to attend an educational activity because personal payments may induce an obligation to prescribe the company’s products.
A sense of obligation to a health plan may seem of less concern than a sense of obligation to a manufacturer because health plans have a general responsibility for assuring the provision of quality care through plan providers. But physicians should confirm that the interests of the health plan are consistent with the best interests of their patients. The health plan should inform the physicians of the reasons for its promotion of the educational activity and should disclose any special financial arrangements with the pharmaceutical manufacturer, for example rebates related to high prescription volume.
The newest and most interesting aspect of the scenario is the specific type of incentive offered: an increased level of reimbursement for attending the program. A simpler financial incentive would have been to offer a single payment for the physicians’ time to participate in the program as a quality assurance activity for the health plan.(Note that this would be in violation of the AMA opinion if the plan were to use funds provided by the pharmaceutical company.) Such a one-time payment corresponds to a recognized model of payment to physicians for a specific service to the plan. Implications of increasing reimbursement levels for subsequent clinical services are less clear. Depending on the value of the proposed increase, the amount involved could be sufficiently high to raise questions about indirect inducements to inappropriately affect behavior. When specific financial outcomes are considered, is the amount at stake reasonable both to compensate the physicians for their time and as an appropriate expenditure that improves patient care?
The second element is whether the educational activity is bona fide. Is it objective and balanced or is it biased and promotional? When a new drug is more effective and less expensive than other treatments, the marketing interests of the pharmaceutical manufacturer and the cost-containment interests of the health plan are aligned with patients’ best interests. This may not be the case when a new drug is effective but more expensive, or conversely, when a new drug is somewhat less effective but also less expensive. Therefore, physicians have to assess the extent to which information at educational activities is balanced and objective.
When making assessments, physicians should be aware of potential conflicts of interests of involved parties. The scenario notes that the educational series is “sponsored” by a pharmaceutical manufacturer. The term “sponsor” often is used formally to identify the institution responsible for organizing and running the activity. But the term also may be used more broadly to refer to an organization that is providing funds or other tangible support for an activity. When the meaning of “sponsor” is not clear, physicians should ask for clarification. CME activities produced by sponsors offering AMA Physician’s Recognition Award credit are required to be free of commercial bias. But for all educational activities, physicians should assess the extent to which the presented information focuses on a clinical problem rather than a product; whether it is a balanced consideration of therapeutic options and is supported by evidence; and whether effectiveness, cost and cost-effectiveness are discussed. Finally, physicians should consider whether the information is consistent with other reliable sources.
Physicians should ensure that the interests of the health plan are aligned with those of patients and that financial incentives they receive are appropriate for the time they spend in the activity. They should look out for conflicts of interest that might affect the content of the educational activity and assess the extent to which the activity is or is not affected by interests that diverge from the best interest of patients.
–R. Van Harrison, PhD Associate Professor of Medical Education and Director of the Office of Continuing Medical Education, University of Michigan Medical School
Scenario: What constitutes “certification” to perform procedures?
An AMA member wrote: A local surgeon recently traveled to a radiotherapy unit in Europe for a three-day site visit. After his return, he advertised widely that he was certified to perform complex radiotherapeutic treatments on our state’s Gamma Knife unit. I, too, thought the trip would be interesting and would lead to certification. However, the response I received when I contacted the European center was that it was purely a site visit sponsored by the manufacturer of the machine and that it was not a certification program. When I contacted the local director of the Gamma Knife unit, he explained that a physician needs to complete 50 supervised cases before being allowed to use the unit independently. The surgeon argues that he has a certificate, and therefore is certified. Is such a representation appropriate?
Reply:
The use of a certificate which attests to attendance at a three-day site visit as certification to perform complex stereotactic radiotherapeutic procedures would constitute an apparent violation of a physician’s ethical obligation to present information fairly, fully and not otherwise misleading.
Advances in medicine, especially in the last 10 years, have dramatically altered clinical practice. New knowledge and technology of proven scientific value and clinical validity can let doctors provide better care for patients. At the same time, the application of new technology, especially in instances where the learning curve is steep, may result in significant harm if applied incorrectly, under the wrong circumstances, or without sufficient training and experience.
This particular physician claimed that he was “certified” to perform complex radiotherapeutic procedures when in fact the site visit to the radiotherapy unit in Europe did not provide a course of supervised training and did not amount to the required experience that the local director of the radiotherapy unit deemed essential for the unit to be used safely. There is no evidence that the physician took any special course of training or completed any certification examination, or that the physician had any reason to believe that the certificate received represented anything other than a certificate of attendance.
The primary objective of credentialing and certification is to provide members of the public with information they can use to make informed decisions involving their health care. Since these decisions often involve matters of life and death, advertisements and other representations involving claims of expertise by virtue of certification must be verifiably honest and not misleading as to both their substance and their source. Patients often will not have the information necessary to verify or distinguish between claims of certification, accreditation or licensure — and they should not have to. Physicians, as fiduciaries of the public’s health, must take it upon themselves to provide honest and candid communication with their patients about their experience and level of training.
In short, to preserve professionalism, patients must be able to trust information given to them by their physicians. Any communication about expertise that intentionally misleads patients is unethical because it represents an abuse of the professional privilege to self-regulate and is a breach of trust. In addition, misleading patients may be fraudulent because it compromises patients’ ability to make rational and informed decisions about their health care.
–Stephen Miller, MD, MPH Executive Vice-President, American Board of Medical Specialties
Opinions expressed in Ethics Forum reflect the views of the authors and do not constitute official policy statements of the American Medical Association. Readers are encouraged to submit questions and comments to the Ethics Standards Group, AMA, 515 N. State St., Chicago, IL 60610; or by fax at (312) 464-4613. Actual names, addresses and affiliations of individuals whose queries are used will not be published.