Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8016
Baltimore, MD 21244-8016
9 April 2002
To Whom It May Concern:
We are writing with reference to the proposal currently being considered that would expand the State Child Health Insurance Program (SCHIP) to include "unborn children" from conception through birth. As a medical anthropologist and medical sociologist respectively, we have conducted extensive research and published several articles about reproductive ethics and fetal politics in the United States as well as in Latin America, New Zealand, and Southeast Asia. Dr. Casper has written an award-winning book about fetal surgery.
Based on our collective expertise in women's health and bioethics, we strongly oppose the Bush administration's proposal to redefine "child" to include unborn fetuses for the purpose of including them in SCHIP programs. Americans would be much better served if the SCHIP program were expanded to cover needy pregnant women. Indeed, there are many ways that the administration could improve maternal and child health without redefining the fetus as a person. That it would attempt to do so strikes us as both cynical and futile given the widespread disagreement and confusion about what constitutes life and when a human fetus becomes a person.
The HHS proposed rule change is fraught with problems, both clinical and ethical. In this letter, however, we will restrict our comments to the following disingenuous paragraph in the proposed rule change:
"Medical care is continually advancing and offers opportunities for services specifically targeted to the care of the unborn child. "Fetal medicine" or "fetology" is emerging as a distinct and important medical specialty which includes: obstetrics, maternal-fetal medicine, neonatology, pediatrics and fetal/neonatal pediatric surgery. Physicians specializing in fetal medicine use the pre-partum period to diagnosis potentially life threatening conditions in utero (e.g. congenital cystic adenomatoid malformation, congenital diaphragmatic hernia, congenital heart disease, gastroschisis, giant neck masses, hydrocephalus, obstructive uropathy omphalocele, spina bifida, sacrococcygeal teratoma). Once detected, such conditions can often be surgically or medically treated in utero, with beneficial consequences which can include: saving the life of the child; elimination of long neo-natal, post-partum medical care for the child; and ultimately lower post-partum medical care costs for the child and therefore the SCHIP plan. The Secretary would like to permit the States the flexibility to pay for the medical expenses related to unborn children because the Secretary has determined that provision of such services before birth should result in healthier infants, better long-term child growth and development and ultimate cost savings to the SCHIP plans (and the federal government through the SCHIP contribution process) through reduced expenditures for high cost neo-natal care."
This paragraph suggests that advances in "fetal medicine" and "fetology" can justify the expansion of the SCHIP program to include fetal patients. It contains several erroneous assertions: 1) by omitting any mention of pregnant women, it suggests that medical science has devised diagnostic procedures and treatments that can be conducted on a fetus alone, independent of a pregnant woman's body; 2) it exaggerates the incidence of particular conditions and casually and blindly overstates the chances that treatments and surgeries performed on fetuses will result in successful outcomes; and 3) it implies that treatments performed in utero will result in lower costs and "ultimate cost savings to the SCHIP plans - through reduced expenditures for high cost neo-natal care." We will take up each of these points in turn:
1. The best way to protect the health of fetuses is to protect the health of women of reproductive age. Positing fetal surgery as a solution to low birthweight infants ignores the fact that surgery does not solve the most common frequent causes of poor fetal health, which include poor nutrition, lack of prenatal care, environmental hazards, and drug and alcohol use. Women who are in poor health when they become pregnant will be at higher risk for prenatal complications. In these circumstances, fetal surgery is akin to closing the barn door after the horse has run away. Once a woman is pregnant, no medical treatment can be provided to her embryo or fetus without also being provided to (and often through) the woman herself. The term "fetal medicine," like "fetal surgery," is therefore a misnomer; such medical treatments, including surgery, are always performed on a pregnant woman. These experimental treatments pose numerous risks to pregnant women and their fetuses. Fetal surgery is the only medical procedure performed on women in which there is absolutely nothing wrong with the woman herself. The language used in the proposed rule change makes it appear as though "maternal-fetal medicine" is a subcategory of "fetology" rather than the other way around. All so-called "fetal medicine" is in fact "maternal-fetal medicine." Women's health interests should be paramount in such procedures, and that they are not always prioritized in fetal surgery should be cause for concern among advocates of maternal and fetal health.
In spite of the fact that medical treatments conducted for the benefit of fetuses are invariably performed on pregnant women, the proposed change would grant medical coverage to low-income women only when they were pregnant, only because they were pregnant, and only to treat the fetus rather than the woman herself. If the change were enacted, would SCHIP deny coverage to a pregnant woman who got high blood pressure or diabetes? Would it pay for miscarriage? Would it cover the costs of hospitalization for pre-term labor? How, exactly, would
the program define the point at which care of the fetus would stop and care to the pregnant woman would begin? Is women's health only interesting to the medical establishment and the federal government when fetuses are at risk? It is an affront to American women to suggest that the government would extend certain rights and privileges to fetuses, even when the women in whose bodies they reside are not entitled to those same rights and privileges. It would be much more sensible to expand health insurance coverage to all women of reproductive age, and to pregnant women in particular.
2. The paragraph in question lists many potentially life-threatening conditions that can be diagnosed in utero, but it neglects to mention that, with the exception of spina bifida, these conditions are infrequent or extremely rare. One of the conditions mentioned -- congenital cystic adenomatoid malformation -- is exceedingly rare, and mortality rates following fetal surgery have been alarmingly high. Another condition mentioned -- congenital diaphragmatic hernia -- has been the subject of research by an eminent fetal surgeon who has spent the past 15 years attempting to correct it surgically in utero, yet his most successful surgery remains no better than standard interventions. The HHS proposal implies a high rate of success for medical treatments performed on fetuses in utero. While the media are filled with sensationalized and celebratory reports of advances in fetal surgery, the medical literature shows that these are at best instances of wishful thinking, and at worst advertising propaganda by surgeons eager to enhance their prestige and expand their clientele. The number of cases of fetal surgery actually performed is still quite small (smaller, some say, than the number of articles written about them!).
Because fetal surgery is still considered experimental or investigational, it is premature and misleading to suggest, as the HHS proposal does, that medical benefits have been achieved or validated. Medicaid programs and most private insurers - including those who currently provide health care through SCHIP - do not currently cover experimental procedures, and it is unlikely they would cover fetal surgery even if the fetus were defined as a patient. Most private insurers have opted not to cover fetal surgery because outcomes are usually no better than therapies performed post-natally. A review of the medical literature suggests that the HHS proposal overstates the potential benefits of therapies performed on fetuses. For example, in 2001 the American College of Obstetricians and Gynecologists (ACOG) issued a statement labeling fetal surgery as "experimental" and offering the following caution:
"According to ACOG, long-term improvements in neurological outcomes in children have yet to be proven and no studies have been conducted to evaluate maternal risks. The surgery exposes the mother to the risks of anesthesia, bleeding, uterine rupture and preterm labor as well as other risks to the fetus. More trials need to be conducted prior to widespread acceptance of this procedure." (http://www.acog.org/from_home/publications/press_releases/nr02-28-01-1.htm: emphasis added)
Similarly, a 1999 editorial in the Journal of the American Medical Association concluded the following after reviewing the outcomes of fetal surgery to treat spina bifida:
"Overall, the staggering increases in obstetrical complications emphasize the important issues of balancing potential benefits to the fetus with maternal complications. For in utero myelomeningocele [spina bifida] repair to become widely recommended, clear demonstration of greater success in fetal outcome and fewer obstetrical complications are necessary. This could well happen, but until then the surgery remains unproved. The procedure certainly must be considered experimental; not all tertiary centers need rush to offer it." (Simpson JL. Fetal surgery for myelomeningocele. Promise, progress, and problems. JAMA 1999;282:1873-4; emphasis added)
If the top medical journal in the country feels that tertiary care facilities need not offer fetal surgery, it is disingenuous and misleading for the administration to suggest that the availability of fetal surgery justifies their proposal to treating define the fetus as a person and a patient. It would be further misguided to take this step while continuing to exclude some pregnant women from much needed health coverage. Importantly, both the American College of Obstetricians and Gynecologists and the editors of the Journal of the American Medical Association emphasize the risks that surgery on fetuses poses to pregnant women. Obviously, pregnant women facing such risks would require health insurance.
3. The paragraph in question avers that treating the "unborn child" will result in lower costs. Fetal surgery is very expensive, and costs are not limited to the operation itself. Women who undergo such operations are often required to spend months on bed-rest, sometimes in the hospital. The single largest risk is pre-term labor, and women undergoing the procedure must be on tocolytics (anti-labor medication) for the duration of the surgery and the remainder of their pregnancies. They face a high likelihood of needing subsequent treatment for surgery-related complications, and their children are often born with serious health problems in spite of the surgery. The JAMA article cited above states, "Many fetuses who ordinarily would have died in utero survived only to experience disastrous postnatal outcomes." Also, many babies who have undergone fetal surgery require extensive and expensive neonatal treatment including additional surgeries. Will the SCHIP program compensate parents for their lost income and additional medical expenses? Treating fetuses as patients is likely to be quite costly, in social as well as economic terms.
To suggest that fetuses are separate people contributes to notions of maternal-fetal conflict, rather than viewing mother and fetus as an interconnected unit. Above and beyond these clinical concerns, fetal surgery is and has been from its inception mired in reproductive politics. Early pioneers in the specialty had clear links to pro-life politics in the 1960s, while today fetal surgery is heralded by anti-abortion groups as a "miracle." It is inappropriate and indeed ignorant to base a major public health policy on a controversial and as yet unproven procedure that poses significant risks to pregnant women and their fetuses.
We believe there is no ethical or medical justification for expanding the definition of "child" to include the unborn under the SCHIP provisions, when all medical services offered to a fetus must
be performed on a pregnant woman. The best way to insure healthy fetuses and newborns is to recognize that fetuses are not separate people but rather are part of the bodies of pregnant women, and thus to provide health insurance coverage to low-income women of reproductive age and, indeed, to their partners and their children as well.
Lynn M. Morgan
Professor of Anthropology
Monica J. Casper
324 College 8, UCSC
Santa Cruz, CA 95064