"Risk-sharing" programs offered for ART pose ethical concerns
Arrangement should not be profit center
There are a number of ethical concerns involving "risk-sharing" programs offered by some artificial reproductive technology (ART) clinics, according to Leslie P. Francis, JD, PhD, distinguished Alfred C. Emery professor of law and distinguished professor of philosophy at University of Utah in Salt Lake City.
"You are dealing with a situation in which the physician has interests financially in the recommendations made to patients, and in what kinds of arrangements they will permit patients to enter into," she explains.
"Risk-sharing" or "cost-sharing" programs, by which women receiving ART receive some percentage of their initial investment back if pregnancy does not occur, were developed because insurance companies generally do not cover the costs of ART.
"At first glance, it seems to be a noble gesture for the ART corporations to act on behalf of the financial well-being of their clients," says Marilyn A. Fisher, MD, MS (Bioethics), associate professor of pediatrics and associate professor of the Center for Biomedical Ethics Education & Research at Albany (NY) Medical College.
If pregnancy does not occur, the patient would receive some percentage of her initial investment back. "She would then be free to use this money for other options, such as adoption," says Fisher.
Misperceptions are likely
The fact that ART companies allow clients to believe that the "risk-sharing" is predominantly between the individual patient and the ART company is unethical, argues Fisher.
"The ART businesses have sufficient experience in this field to be able to predict which clients are likely to achieve pregnancy with ART and which are not," she says.
ART companies require pre-enrollment testing, which the patient must pay for out-of-pocket and which is not refundable, to help them determine which potential clients to select. "Obviously, it is in the financial best interest of the ART companies to choose women with the most favorable pre-enrollment testing results," says Fisher.
ART companies have also established tiered cost scales based on the recognized risk of advanced maternal age. The selection of clients desiring pregnancy by the ART companies is much like the selection of clients desiring insurance by life and health insurance companies, adds Fisher.
"ART companies have utilized these devices to ensure that they remain profitable," she says. "So, in fact, the sharing of risk is not so much between the individual patient and the ART company. The risk is predominantly shared between the whole patient population. "
Francis says it's important for clinics to convey clearly to patients what is known about their likelihood of achieving pregnancy and birth. "The more clinics bend over backwards to make sure patients genuinely understand what they are likely to be up against, the better," she says. "The primary worry here is to make sure clinics provide information to patients in a way that isn't slanted."
To remove financial conflicts of interest, the arrangement should be more like an insurance pool than a profit center, says Francis, with the increased charge being equal to the refund rate.
"If the amount of money that comes into the clinic is roughly the same with the rebate program than it would have been with patients paying normally, then the clinic isn't profiteering from the rebate program," Francis says.
Patients who are feeling desperate will likely hear the good and not the bad. "So it's not paternalistic to say the bargain needs to be structured in a way that doesn't permit obvious unfairness," says Francis.
Multiple conflicts of interest
Clinics also need to adhere closely to evidence-based guidelines when deciding the number of blastocysts to implant, advises Francis.
"If you scrutinize your data to make sure you are following them, then you are not at risk for being subtly influenced for trying to increase the pregnancy yield to maximize profits," she says.
Physicians working in ART centers may experience conflict of interest between doing what is likely to be financially most lucrative for their company and doing what is most likely to be in the best interest of their patients, says Fisher. For instance, if the ART center is rewarded financially by the creation of at least one gestational sac, or by a pregnancy culminating in at least one live birth, the ART physician may be tempted to implant more than one embryo.
"The impact on parents of a 'successful' pregnancy of raising multiple damaged premature babies must be considered," says Fisher. "A multifetal pregnancy can harm the fetuses/neonates, the family, and the community which tries to support them."
Women hoping to avoid the complications of prematurity due to implantation of multiple fetuses are allowed by some ART companies to pay additional fees for the implantation of just one embryo with each cycle.
"These additional fees will cover the likely additional costs of the ART company in achieving a pregnancy 'success,'" says Fisher. "This is an additional tiered-cost technique imposed by the ART company in order to assure that the company turns over a profit from each patient."
Intense ovarian stimulation with higher doses and longer durations of medications may subject the patient to excessive and sometimes unnecessary risk, notes Fisher, but the greater numbers of oocytes produced will give ART centers more eggs to fertilize and implant into a patient with a greater likelihood of "success."
This is another potential conflict for ART physicians, says Fisher, as "these 'successes' will enhance their bottom line as well as their reputation and ability to attract future patients."
As "risk-sharing" ART programs have the potential for multiple conflicts of interest, says Fisher, "it is important that each program recognize its particular risks, and that informed consent, disclosure of potential risks and benefits, and counseling of potential patients are carried out thoroughly."
- Marilyn A. Fisher, MD, MS (Bioethics) Associate Professor of Pediatrics/Associate Professor, Center for Biomedical Ethics Education & Research, Albany (NY) Medical College. Phone: (518) 262-5421. E-mail: firstname.lastname@example.org.
- Leslie P. Francis, JD, PhD, Distinguished Alfred C. Emery Professor of Law and Distinguished Professor of Philosophy, University of Utah, Salt Lake City. Phone: (801) 581-4289. E-mail: email@example.com.