https://www.ajmc.com/contributor/suzanne-delbanco/2019/08/with-cutting-edge-benefits-come-bioethical-challenges
With Cutting-Edge Benefits Come Bioethical Challenges

Suzanne Delbanco, PhD, MPH

This article was coauthored by Lea Tessitore, MBA, MSB, senior project and research manager, and Ryan Olmstead, MPH, director of member services, both of Catalyst for Payment Reform.

As disruptive medical technologies emerge, often unanticipated, bioethical issues arise, presenting challenges for employers navigating what benefits to offer to their employees.

This isn’t a recent phenomenon. In 1928, the invention of the ventilator brought forth new questions in medicine and bioethics causing a need to redefine death. With the ventilator and its ability to sustain cardiac functions, a definition of death dependent on the irreversible stoppage of the heart and respiratory functioning no longer seemed viable. The debate that ensued gave rise to the now widely accepted “whole brain” definition of death, which occurs with the irreversible loss of function of the higher brain and the brainstem. The invention of the ventilator caused bioethicists, physicians, and lay people to reassess the ethical, legal, and clinical meaning of death.

The field of genetics is now playing the same disruptive role as the ventilator. Since the successful mapping of the human genome in 2003, the field of genetics has rapidly advanced, bringing with it an explosion of genetic tests for diseases such as breast cancer, Down syndrome, cystic fibrosis, Huntington disease, muscular dystrophy, sickle cell anemia, and hemophilia. However, the use of genes to predict, diagnose, and treat disease presents more bioethical and medical issues than may initially be apparent. Payers, employers, and other healthcare purchasers looking to offer genetic testing to the populations for whom they buy healthcare services should tread carefully.

Ethical Principles
To assess the benefits and risks of genetic testing, payers and purchasers can leverage the groundbreaking Belmont Report, written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The report identifies the 4 ethical principles that should underlie research on human subjects, as well as, by extension, serve as guiding principles for healthcare and bioethics. Those principles are autonomy, beneficence, nonmaleficence, and justice.

Autonomy
According to the principle of autonomy, the decisions of autonomous individuals should be respected. Autonomous individuals are those with full capacity, enabling them to engage in rational decision-making and weigh costs and benefits, and who have freedom of choice. Autonomous individuals should be given the full information they need to give informed consent and make informed choices.

When it comes to genetic testing, employers adhering to the principle of autonomy should ensure that employees understand what genetic testing is, what it entails, and the types of results it can generate, including incidental findings and their potential impact on the employee and their family members. Some employees will question why their employer is offering genetic testing and what the employer may do with their genetic information. Employers should disclose their reasoning for offering the benefit and the existing regulations in place, such as the Genetic Information Non-Discrimination Act (GINA), to protect employees’ genetic data.

Employers should also disclose that genetic test results can disadvantage other types of insurance coverage; GINA is only applicable to health insurance and does not prevent disclosure of genetic information when an individual seeks other types of insurance, such as life insurance, disability insurance or long-term care insurance.

Beneficence
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
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.

Justice
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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