NAPW PR: SCHIP Regulation Change May Signal Shift in Experimental Treatment Policy

March 07, 2006

SCHIP Regulation Change May Signal Shift in Experimental Treatment Policy
National Advocates for Pregnant Women
Respond to Inconsistencies in Federal Policy

May 06, 2002 917-921-7421
SCHIP Regulation Change May Signal Shift in Experimental Treatment Policy National Advocates for Pregnant Women Respond to Inconsistencies in Federal Policy

New York, NY - Today, the National Advocates for Pregnant Women (NAPW) released commentary on a proposed rule change to the State Child Health Insurance Program (SCHIP). NAPW's letter addressed Health and Human Secretary Tommy Thompson's proposal, announced on January 31st, 2002, that would expand the definition of a child under SCHIP regulations to include fetuses from conception to birth. The original public announcement drew criticism from columnists and women's rights organizations nationwide focusing on its potential effect on a woman's right to have an abortion.

Taking a broader approach, NAPW argues that the proposal is primarily a political effort to distract attention from a range of pressing public health issues, and raises the possibility that the proposal marks a major shift in government policy regarding experimental medical procedures.

The Notice of Proposed Rule Making highlights alleged advances in so called "fetal surgery" as a justification for the proposal and as an example of the medical care that would be available as a result of the proposed rule change. Maternal-Fetal surgery experts, Professors Monica J. Casper and Lynn M. Morgan, who also submitted commentary, critique this claim in part because "it . . .casually and blindly overstates the chances that treatments and surgeries performed on fetuses will result in successful outcomes" (Letter attached) Lynn M. Paltrow, NAPW's executive director, also notes that the statement may be read to encourage illegal research on pregnant human subjects and appears to be in direct conflict with the government's policy regarding experimental procedures.

"Fetal surgery is still considered experimental," Ms. Paltrow explained. "And since the federal government has a long-standing policy of denying coverage for experimental treatments under Medicaid, the implication that the SCHIP expansion would cover fetal surgery either indicates a radical shift in policy, or it is deliberately misleading."

NAPW's commentary also argues that the proposed rule change is an exercise in "political deflection not child-health protection," identifying it as a political statement intended to provoke controversy over Roe v. Wade and to distract attention from pressing national issues regarding health care for Americans, including low income women and children. NAPW's letter joins scores of others from doctors, academics, activists, public health and women's organizations, objecting to the proposed change. The deadline for comment is 5:00 p.m. May 6th, 2002. All comments are available for public viewing and will be reviewed prior to approval or rejection of the proposed change in regulations.

NAPW is a nonprofit organization dedicated to protecting the rights of pregnant and parenting women and their children. NAPW seeks to ensure that women do not lose their constitutional and human rights as a result of pregnancy and that addiction and other health and welfare problems that women face during pregnancy are addressed as health issues, not as crimes.

Excerpt from Lynn M. Paltrow's Letter (full letter available on request):

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. . Surgery on the fetus [however] occurs only through the woman's 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," 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. The portrayal of these procedures as independent of the pregnant woman's body and life suggests an extreme disregard for pregnant women and mothers.

To our knowledge, no research supports 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. . . Similarly, private insurers, some of whom provide care under S-CHIP programs generally do not cover experimental treatments.

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. NAPW however 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. §§ 46.101- 46.409, promulgated pursuant to the Health Research Extension Act , 42 USC § 289.

1. (emphasis added).
2. See e.g. New York State's Child Health Plus Exclusions: "The following services will not be covered: Experimental medical or surgical procedures." at 16 .

Lynn M. Paltrow
Executive Director
National Advocates for Pregnant Women
45 West 10th Street #3F
New York, New York 10011
212-254-9679 (fax)