Ethics FORUM

The Case

I am treating a 42-year-old woman with rheumatoid arthritis. Despite therapy with hydroxychloroquine, sulfasalazine, and methotrexate, she has morning stiffness lasting two hours, and a Disease Activity Score of 5.2. I would like to start her on a tumor necrosis factor (TNF) inhibitor. I am contemplating giving her infliximab. My group practice has an infusion center, so she would receive the drug in my office. Does this constitute a conflict of interest?

Discussion: The Stark In-Office Ancillary Services Exception allows referral source physicians who are members of a physician group practice to refer a patient for imaging services (or other designated health services) to be provided within the group practice without violating Stark.¹ This means that practices can own, operate, and receive compensation for services such as infliximab infusions.

People with arthritis have pain and stiffness in their joints. To make a diagnosis, most doctors use a combination of methods and tests including a medical history and a physical examination along with X-rays and laboratory tests.

However, despite the Stark Exception, conflicts of interest can arise in these situations. According to the Institute of Medicine, conflicts of interest are “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”² In your situation, the primary interest is patient welfare, and the secondary interest is the income your practice will accrue through providing the inflximab infusion. Because a conflict of interest exists regardless of whether the judgment or actions are actually influenced, your situation meets criteria for a conflict of interest. The important question here is why your choice of TNF inhibitors is infliximab. The basis of this decision has direct bearing on whether your secondary interest has undue influence over your primary interest.

In reasoning through an ethical dilemma, it is always useful to start with the medical facts. Are there medical reasons for choosing one TNF inhibitor over another? One consideration in choosing a particular TNF inhibitor is the risk of tuberculosis (TB). A patient who is at risk for developing TB might best avoid infliximab or adalimumab, because the rate of tuberculosis in patients with rheumatoid arthritis treated with those drugs is three- to fourfold higher than in patients taking etanercept.³ The rate of this infectious complication is very low, however, and TB surveillance with PPD skin testing is now standard practice.

The concerns and preferences of the patient are also an important consideration in selecting therapy. If your patient has significant hand arthritis, and has no one at home to help her inject a TNF inhibitor, infliximab might be a reasonable choice. Similarly, a patient might be squeamish at the thought of self-injecting and prefer an infusion.