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.

Professional society guidelines might be a source of guidance and could be consulted if available; however, the American College of Rheumatology does not differentiate among TNF inhibitors.⁴

Finally, practical issues should be considered. What are the costs of the different treatments, and is cost a consideration for your patient? If there is a significant differential, it should be discussed with your patients.

Ultimately if it turns out that treatment with infliximab is in your patient’s best interest, where is the best place for her to receive it? Is a hospital infusion center more convenient to her home, or will the hospital add on a facilities charge, increasing the cost of the treatment? Does your office practice bill for such services?

Little or no consideration should be given to your secondary interests in the selection of a TNF inhibitor. For example, recouping the capital investments made in the infusion center or conducting income-generating activities (such as continuing to see patients) that can proceed in parallel with infusions should not play a role in the decision-making process.

Finally, you should consider that the patient and the physician are not the only stakeholders in such decisions. All things being equal, the price of self-injection is less than infusion therapy because the costs associated with the infusion are eliminated. With the cost of healthcare a widely appreciated national problem, both the physician and the patient have an obligation to use the most cost-effective treatment.

Selecting a therapy for a patient is a complex process. A shared decision-making approach, in which patients are fully informed of the potential risks, benefits, and costs of agents and their alternatives, is always the best road to take. As long as your patient’s best interests are considered first and foremost, you are most likely to be on firm footing.

Dr. Kitsis is director of bioethics education and a member of the rheumatology division at Albert Einstein College Medicine in the Bronx, N.Y. Dr. Meltzer is assistant professor of medicine at Thomas Jefferson University in Philadelphia. Dr. MacKenzie is associate professor of clinical medicine and public health at Weill Cornell Medical College, Hospital for Special Surgery in New York.

References

1. 42CFR § 411, Subpart J.
2. Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US); 2009:6.
3. Dixon WG, Hyrich KL, Watson KD, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: Results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2010; 69:522-528.
4. Saag KG, Teng, GG, Paktar NM. American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis Rheum. 2008; 59:762-784.