Pregnancy Justice response letter to the proposed regulations

Thomas A. Scully
Administrator
Centers for Medicare & Medicaid Services,
Department of Health and Human Services
Attention: CMS-2127-P
P.O. Box 8016,
Baltimore, MD 21244-8016

RE: File Code CMS-2127-P
State Children's Health Insurance Program; Eligibility for Prenatal Care for Unborn Children

April 29, 2002

Dear Mr. Scully:

The Pregnancy Justice opposes the proposed amendment to regulations under the State Children's Health Insurance Program (SCHIP), published at 67 Federal Register 9936 (March 5, 2002) (the "Proposed Regulation") to revise the definition of 'child' under the State Children's Health Insurance Program "so that a State may elect to make individuals in the period between conception and birth eligible for coverage." We are intrigued, however, by the possibility that this proposed rule marks a shift in federal policy regarding experimental treatments - a shift that could have enormous benefits for people suffering with such diseases as Alzheimer's and cancer.

Political Deflection not Child-Health Protection

In general, Pregnancy Justice believes that the proposed rule is primarily a political statement intended to provoke controversy over Roe v. Wade and is designed to distract attention from pressing national issues regarding health care for Americans, including low income women and children.

Specifically, the extension of the SCHIP program to unborn children creates the illusion that the government is increasing access to health care for America's children. But, according to the proposed rule itself, the changes will have little actual effect, creating only political/cosmetic impact. The proposed rule admits that it expects no more than 30,000 "unborn" children to be covered; a recent story in Time magazine, reported that nearly that number of actual children (23,000) were denied coverage and forced onto a waiting list for SCHIP health care coverage in just one state: North Carolina. (1) Thus, SCHIP's illusive expansion leaves millions of actual children and American adults still uninsured. Approximately 40 million Americans, including about 9 million children, (2), lack health insurance. It is estimated that an additional 10 - 15 million people have some coverage but not enough, and that an additional 2 million people have lost other health plans along with their jobs in the recent economic downturn. (3) Further, as recent news reports indicate, due to budget deficits, many states have reduced or frozen SCHIP enrollment, cut back on marketing and outreach and added restrictions and fees. (4) In doing so, some states have forgone millions of dollars in federal contributions, whose matching rate reaches up to 85%, depending on a state's per capita income. (5) Significantly, no additional funding accompanies this rule change, even for providing health care to unborn children.

The language change will not help the 22% of America's already born children who live in poverty, nor will it address such key child health issues as growing shortages of basic immunizations for children in America today. (6) Similarly, the language change will do nothing for the children languishing in foster care because most child welfare dollars go to removing children rather than preserving family life. Nor will it help the estimated 1,941,796 children who have a parent in jail as a result of drug laws that imprison fathers and mothers in need of drug treatment that the government has deliberately chosen not to make available. (7)

Experimental Surgery: A Signal for Change?

The administration apparently seeks to justify this rule change based in part on the suggestion that there are medical procedures that apply exclusively to the fetus. The proposed rule states:

Medical care is continually advancing and offers opportunities for services specifically targeted to the care of the unborn child. . . . 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.

As Professors Lynn M. Morgan and Monica J. Casper make clear in their comment of April 9, 2002, there is no such thing as "fetal" surgery independent of the pregnant woman. Surgery on the fetus occurs only through the womanís body and can occur only with her consent. Surgery on the fetus moreover, presents significant risks to the pregnant woman's life and health. As the "United States government's principal agency for protecting the health of all Americans," (8) failure to acknowledge the impact such surgery can have on pregnant women suggests a lack of basic medical knowledge and procedure that is profoundly disturbing. Moreover, the portrayal of these procedures as independent of the pregnant woman's body and life suggests an extreme disregard for pregnant women and mothers.

Furthermore, to our knowledge, there is no research or data to support the claim that so-called "fetal surgery" can "ultimately lower post-partum medical care costs." While long-term research in this field may someday produce such beneficial results, the suggestion that these cost-savings currently exist is without support. Similarly, the claim that: "Once detected, such conditions can often be surgically or medically treated in utero," with beneficial consequences is without basis in science at this time.

Despite the fact that fetal surgery is at this stage largely experimental, the Notice of Proposed Rule Making explicitly states that the "Secretary would like to permit the States the flexibility to pay for the medical expenses related to unborn children" suggesting a departure from longstanding state and federal policy regarding experimental treatments. As documented in the Morgan & Casper letter, the procedures described in the rule continue to be highly experimental and investigational. Long-standing state and federal policy has been to deny coverage for experimental treatments. See e.g. Letter from Rozann Abato, Acting Director Medicaid Bureau, to State Medicaid Directors (May 26, 1993) (services or items not covered include those that are unsafe or experimental, or not generally recognized as accepted treatment). See also Miller by Miller v. Whitburn, 10 F.3d 1315, 1320 (7th Cir. 1993); Rush v. Parham, 625 F.2d 1150, 1156 (5th Cir. 1980); Weaver v. Reagan, 886 F.2d 194 (8th Cir. 1989). Similarly, private insurers, some of whom provide care under SCHIP programs, generally do not cover experimental treatments. (9)

The proposed rule thus seems either to signal a radical shift in policy regarding experimental treatments, or to be deliberately misleading, suggesting that the door is opening to experimental treatments, when in fact it is not. Pregnancy Justice would certainly be interested in additional information on this point, since there are many patients suffering from cancer and other diseases who might benefit from an overall change in policy regarding experimental treatments.

Finally, some physicians and ethicists argue that procedures described as "fetal surgery" are so new and so lacking in proven benefits that they must be considered research. See, e.g, Anne E. Drapkin Lyerly, MD et al, Toward the Ethical Evaluation and Use of Maternal-Fetal Surgery, 98 ACOG 689 (2001). The Notice of Proposed Rule Making thus appears to promote what is essentially unreviewed and unapproved research on pregnant human subjects presenting a direct conflict with the laws regarding Human Subjects of Medical Research. See 45 C.F.R. ßß 46.101- 46.409, promulgated pursuant to the Health Research Extension Act , 42 USC ß 289.

An Affront to Pregnant Women and Motherhood.

As others no doubt have argued, another goal of this rule appears to be to create legal precedent for viewing embryos and fetus as separate physical and legal entities. Encouraging this view of embryo's and fetuses, however, devalues women as persons and is counterproductive to the health and well being of both women and children.

No matter how much value we place on a fetus's potential life, it is still inside the woman's body. To pretend that the pregnant woman is separate - or as the discussion of fetal surgery suggests, irrelevant and non-existent - is to deny her not only her rights, but also her humanity. This could not be more painfully illustrated than in the case of In Re. A.C. (10) In that case, Angela Carder, a woman who was approximately 25 weeks pregnant, was forced to undergo an unconsented cesearean section, based on the claim that it would benefit the fetus and that the fetus had a separate legal right to life. At the hearing that resulted in this surgery, almost no attention was paid to what was clinically best for Ms. Carder and, in the end, she never received the cancer treatment she requested. Instead a cesarean section was performed over Ms. Carderís explicit refusal and not only did it fail to save the fetus, (it was born alive but was not viable and died within 2 hours), but Ms. Carder also died, with the forced caesarean listed as a contributing factor. Although the courts ultimately repudiated this state sanctioned assault on Ms. Carder (11), the Proposed Regulation at issue here invites exactly these conflicts and outcomes.

Individual cases in which pregnant women have been forced to endure surgery over their explicit objections and refusal illustrate the extent to which claims of independent fetal rights leads to the obliteration of a woman's right to medical decision making, bodily integrity and personal autonomy. (12)

Providing regulatory support to the notion that fetuses are separate legal and physical entities also leads to other dehumanizing and dangerous results. (12) In Whitner v. State, (13) the Supreme Court of South Carolina rewrote state law to define viable fetuses as "persons," making the state's criminal child endangerment statute applicable to a pregnant woman who used an illicit drug or engaged in any other behavior that might endanger the fetus. (14) Not only has this view of fetuses resulted in the arrest and imprisonment of women who gave birth to healthy children and created an exception for pregnant women from the protections of the eighth amendmentís prohibition on cruel and unusual punishment, (15) it has also coincided with an increase in statewide infant mortality rates. Specifically, in the years immediately following the announcement of the Whitner decision, South Carolinaís infant mortality rate increased for the first time after a decade of steady decline. (16) Thus, legal statement of fetal personhood not only attack the freedom and humanity of women, they also fail to promote either maternal or fetal health.

Finally, because this rule is apparently designed to diminish the value of pregnant women, it is not surprising that it fails to address numerous questions regarding medical coverage and application. Thus, the Notice of Proposed Rule Making has done nothing to counter the apparent fact that under the new rule a pregnant woman would not be covered for any injury or disease she suffers that does not directly affect the pregnancy, nor apparently, would she be covered if she suffers a miscarriage or stillbirth, as more than 900,000 women do each year.

Conclusion

The fact that this proposed amendment does so little to help the uninsured and so much to reinforce the view that embryos and fetuses are to be valued as persons while pregnant women are not, makes clear that it is a political statement, not a serious attempt to improve anyoneís health or well being. The proposed rule change should be recognized for what it is: a smokescreen designed to cloud pressing public health and welfare issues and to hide the Administrationís lack of commitment to America's health care and Americaís children. America deserves betters. As a result, Pregnancy Justice urges the withdrawal of this counterproductive and dangerous Proposed Regulation.

Sincerely,

Lynn M. Paltrow

1. Karen Tumulty, Health Care Has a Relapse: Costs are Soaring, States are Struggling, People are losing their coverage, has Washington even noticed?, Time March 11, 2002 at 42.
2. Childrenís Defense Fund, What are CHIP and Medicaid https://www.childrensdefense.org/hs_chipmain.php
3. Time Magazine, supra n. 1
4. See e.g., Charles Ornstein, States Cut Back Coverage for Poor, Los Angeles Times, A1 (Feb. 25, 2002).
5. Time Magazine, supra n. 1
6. https://www.cdc.gov/nip/news/shortages/default.htm
7. Greenfield, Lawrence A., and Snell, Tracy L., US Department of Justice, Bureau of Justice Statistics, Women Offenders (Washington, DC: US Department of Justice, December 1999), p. 8, Table 18.
8. https://www.hhs.gov/news/press/2002pres/profile.html (emphasis added).
9. See e.g. New York State's Child Health Plus Exclusions: "The following services will not be covered: Experimental medical or surgical procedures." https://www.health.state.ny.us/nysdoh/child/schip99a.wpd at 16
10. See In re A.C., 573 A.2d 1235, 1253 (D.C. 1990) (en banc) (vacating a court-ordered cesarean section that was listed as a contributing factor to the motherís death on her death certificate).
11. Id.
    ADVANCE r5 See, Id. See also Veronica E.B. Kolder et al., Court-Ordered Obstetrical Interventions, 316 New Eng. J. Med. 1192, 1195 (1987) (discussing the serious ethical and medical implications of cases of forced, unconsented to cesarean sections, hospital detention and forced transfusions of pregnant women); Lawrence J. Nelson et al., Forced Medical Treatment of Pregnant Women: "Compelling Each to Live as Seems Good to the Rest," 37 Hastings L.J. 703, 748-49 (1986) (discussing the conflicts between a woman's right to make her own choices about medical services and the advice of her physician); Lawrence J. Nelson & Nancy Milliken, Compelled Medical Treatment of Pregnant Women: Life, Liberty and Law in Conflict, 259 JAMA 1060, 1065 (1988) (noting the "troublesome questions" that surround court-ordered obstetric procedures for the benefit of fetuses and discouraging the recognition of "fetal rights that would create an adversarial relationship between a pregnant woman and her fetus"); Terry E. Thornton & Lynn Paltrow, The Rights of Pregnant Patients: Carder Case Brings Bold Policy Initiatives, Healthspan, May 1991, at 10-16 (describing the tragic compelled-treatment case of Angela Carder and urging the implementation of hospital policies to avoid the need for court orders and to restore decisionmaking power to "the patient in consultation with her loved ones and treating physicians") available at https://advocatesforpregnantwomen.org/articles/angela.htm.
12. See generally, Stallman v. Youngquist, 125 Ill.2d 267, 531 N.E.2d 355 (1988) (refusing to recognize a tort of maternal prenatal negligence and acknowledging the impermissible intrusion into womenís lives that would otherwise result).
    ADVANCE r5 492 S.E.2d 777 (S.C. 1997), cert. denied, 118 S. Ct. 1857 (1998).
    ADVANCE r5 See id. at 779-84 (reinterpreting case law precedent in South Carolina as resting ìon the concept of the viable fetus as a person vested with legal rightsî).
13. ADVANCE r5 See Robinson v. California, 370 U.S. 660 (1962) (holding that it is unconstitutional to punish a person for suffering from the disease of addiction).
14. See Infant Mortality on Rise in '97, Post & Courier (Charleston, S.C.), Feb. 19, 1999 TA l "Infant Mortality on Rise in '97, Post & Courier (Charleston, S.C.), Feb. 19, 1999" s "Infant Mortality on Rise in '97, Post & Courier (Charleston, S.C.), Feb. 19, 1999" c 3 , at B1; See The Annie E. Casey Foundation, Kids Count Data Book 160 (2001), https://www.aecf.org/kidscount/kc2001 (reporting that infant mortality decreased from 11.7 in 1990 to 8.4 in 1996, but increased to 9.6 for 1997 and 1998, the two years following the Whitner decision). See also, Philip H. Jos, Mary Faith Marshall, and Martin Perlmutter, The Charleston Policy on Cocaine Use During Pregnancy: A Cautionary Tale, Journal of Law Medicine and Ethics, 23 (1995) 120-128.