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With Cutting-Edge Benefits Come Bioethical Challenges

Suzanne F. Delbanco is the executive director of Catalyst for Payment Reform (CPR), an independent, non-profit corporation working to catalyze employers, public purchasers, and others to implement strategies that produce higher-value healthcare and improve the functioning of the healthcare marketplace. In addition to her duties at CPR, Suzanne serves on the advisory board of the Blue Cross Blue Shield Institute. Previously, Suzanne was the founding CEO of The Leapfrog Group. She holds a PhD in Public Policy from the Goldman School of Public Policy and a MPH from the School of Public Health at the University of California, Berkeley.
Beneficence is the bioethical principle dictating that the good—or benefits to the patient or population—should be maximized. Moreover, as noted by Robert M. Veatch, PhD, of the Kennedy Institute of Ethics, benefits can be either subjective or objective in nature. For instance, genetic screening tests can inform people if they are at increased risk for a disease. Some might consider this a benefit—the knowledge that they are at higher risk for a certain condition makes them more informed and may allow them to take measures to reduce their risk. However, others may not see this knowledge as a benefit (or even might see it as a harm). While they know about their risk, a screening test does not reveal if or when the condition will manifest, leading to prolonged anxiety.

Conversely, an objective benefit could be that genetic testing provides insight into which drug(s) and dosage level(s) may be more effective than others in treating an individual. Payers and purchasers making decisions about which genetic tests to cover should consider both the objective and subjective benefits and think about how to maximize them.

Nonmaleficence is the avoidance of harm. While there are many benefits associated with genetic testing, there is also potential for harm. In addition to genetic test results potentially jeopardizing access to other types of insurance coverage and prolonged anxiety from positive screening results, patients could also receive inaccurate test results leading them to think they have a disease or condition when they don’t or that they don’t have a disease when they do.

Patients who receive “false negatives” may not take medical action to treat a disease and allow it to develop further, while patients who receive “false positives” can undergo unnecessary medical procedures that are also potentially harmful (both physically and economically). In reality it may be difficult—or impossible—to maximize all benefits and eliminate potential harms. Within the limits of finite resources, tradeoffs are necessary.

The last Belmont principle is justice, which, again referencing Veatch, demands that people in the same or similar situations be treated equally. For payers and purchasers, this could mean that their entire covered population should receive access to the same benefits including genetic testing, or it could mean that all employees fitting certain risk profiles should receive the same genetic testing coverage. By treating similar cases equally payers and purchasers can also achieve consistency in logic and decision making.

Justice also deals with the ethical distribution of resources; however, what counts as an ethical distribution can differ. Payers and purchasers, especially self-funded purchasers, looking to allocate healthcare resources among their population can take different approaches. One approach would be to distribute resources among the population equally, while another approach would be to distribute them on the basis of need, such as concentrating resources and benefits on those employees that are the sickest. Another method still would be to distribute healthcare resources such that the greatest social utilities, or efficiencies, are created—seeking to cover services that provide the greatest benefit to the greatest number. With genetic testing, employers will have to find ways to distribute this benefit justly.

Ethical Decision-Making
When deciding which benefits to offer, payers, employers and other healthcare purchasers may not always think about bioethical issues, or immediately identify them as such. However, new benefits opportunities like genetic testing challenge payers and purchasers to make thoughtful and complex coverage decisions. The Belmont principles can support ethical decision-making. In any comprehensive analysis of whether to offer genetic testing as a new, cutting edge benefit, payers and purchasers will need to consider the bioethical issues as well as the medical ones.

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