Baby doe redux? The Department of Health and Human Services and the Born-Alive Infants Protection Act of 2002: a cautionary note on normative neonatal practice

Sadath A Sayeed
Pediatrics 2005, 116 (4): e576-85
The Born-Alive Infants Protection Act (BAIPA), passed by Congress in 2002, has attracted little publicity. Its purposes were, in part, "to repudiate the flawed notion that a child's entitlement to the protections of the law is dependent on whether that child's mother or others want him or her." Understood as antiabortion rhetoric, the bill raised little concern among physicians at the time of legislative hearings and passed in both Houses by overwhelming majorities, hardly suggesting contentious legislation. After its signing into law, the Neonatal Resuscitation Program (NRP) Steering Committee issued an opinion stating that "[BAIPA] should not in any way affect the approach that physicians currently follow with respect to the extremely premature infant." This interpretation of the law, however, may have been short sighted. In April 2005, the US Department of Health and Human Services (DHHS) brought life to the BAIPA, announcing: "As a matter of law and policy, [DHHS] will investigate all circumstances where individuals and entities are reported to be withholding medical care from an infant born alive in potential violation of federal statutes." The agency issued instructions to state officials on how the definitional provision within the BAIPA interacts with the Emergency Medical Treatment and Labor Act (EMTALA) and the Child Abuse Prevention and Treatment Act (CAPTA). These interagency memoranda potentially resurrect dormant governmental oversight of newborn-treatment decisions and thus may have influence over normative neonatal practice. Under the BAIPA, the DHHS interprets EMTALA to protect all "born-alive" infants; hospitals and physicians violating regulatory requirements face agency-sanctioned monetary penalties or a "private right of action by any individual harmed as a direct result." According to its memorandum, the DHHS will investigate allegations of EMTALA violations whenever it finds evidence that a newborn was not provided with at least a medical screening examination under circumstances in which a "prudent layperson observer" could conclude from the infant's "appearance or behavior" that it was "suffering from an emergency medical condition." The memorandum fails to clarify which observers qualify as prudent, what infant appearance or behavior is relevant, or what defines an emergency medical condition. Because these evaluative criteria are not constrained by reference to relevant standards of medical care, the agency arguably substitutes a nonprofessional's presumed sagacious assessment of survivability for reasonable medical judgment. Indeed, under a straightforward reading of the instruction, a family member could conceivably trigger an investigation after observing a relative deliver a 20-week fetus who maintains a heartbeat for an hour before its death. Most physicians would not consider this an emergency medical condition and, rather than perform a screening examination, would provide comfort for the newborn and support for the family. The guideline, however, does not state that professional acumen trumps the layperson's observations in these instances; thus, physicians are left unclear about whether screening examinations are required for all newborns regardless of a priori, reasoned considerations of survivability. In this context, the NRP Steering Committee opinion states that "at the time of delivery... the medical condition and prognosis of the newly born infant should be assessed. At that point decisions about withholding or discontinuing medical treatment that is considered futile may be considered by... providers in conjunction with the parents acting in the best interest of their child." However, most pediatricians skilled in screening and resuscitation are not currently called on to perform this function when the gestational age of a nonviable fetus is reasonably certain before delivery. If under the law screening is now required at any gestational age, professional procedure immediately after previable births may need modification. More worrisome, threatened aggressive investigations of alleged EMTALA violations at the soft edges of viability, where futility remains a matter of debate, jeopardize the normative ethical practice of offering discretionary palliative care. The DHHS sent its other instruction to state child protective services agencies responsible for implementing CAPTA regulations; it reiterates the limited situations in which physicians may withhold medical treatment from infants and reemphasizes the local role of "individuals within health care facilities" to notify authorities of suspected infractions. Its real import, however, is insistence on local execution of legal remedies to prevent nontreatment decisions deemed impermissible by the 1984 Baby Doe rules. Because this new directive encourages governmental oversight of treatment decisions involving imperiled newborns, a period of benign regulatory neglect seems to be over. The federal CAPTA rules arguably remove quality-of-life considerations from the decision-making calculus and therefore may conflict with the best-interests paradigm advocated by the American Academy of Pediatrics and NRP. How courts will respond to the DHHS interpretation of EMTALA and CAPTA under the BAIPA remains unclear. Federal courts have yet to authoritatively examine alleged EMTALA violations involving newborn treatment decisions at the limits of viability. The Wisconsin Supreme Court has permitted an EMTALA claim to go to trial where physicians allegedly did not screen or resuscitate a 22-week newborn delivered in an emergency department, and a lower appellate court has relied on CAPTA to hold that parents do not possess the right to choose against resuscitating an extremely premature newborn. The Texas Supreme Court recently granted physicians the paternalistic prerogative to resuscitate imperiled newborns without attention to parental preference under a common law doctrine of "emergent circumstances." These judicial decisions undermine the ethical discretion parents are typically afforded in decision-making before and after delivery in these morally complex situations. The DHHS interpretation of the BAIPA may encourage jurisdictional creep of these kinds of pronouncements as the agency seeks to expand legal protections for born-alive infants. The US Supreme Court has stated that "courts must presume that a legislature says in a statute what it means and means in a statute what it says there"; thus, judges interpret law by analyzing "concrete statutory language, not by reference to abstract notions of generalized legislative intent." The BAIPA indiscriminately defines "born alive" to include an infant "at any stage of development... regardless of whether the expulsion or extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion," and it makes no reference to standards of care or best interests, nor does it specifically protect a parent's decision-making authority. Under the law's strict logic, an 18-week miscarried fetus with a detectable heart beat after delivery is entitled to the full protections of the law as determined by "any Act of Congress, or any ruling, regulation, or interpretation of the various administrative bureaus and agencies." Before concluding that the BAIPA would not affect normative neonatal practice, the NRP Steering Committee should have analyzed the act's actual statutory language and avoided relying heavily on imprecise legislative intent. The BAIPA's congressional sponsors did claim that the law "will not mandate medical treatment where none is currently indicated," but such political rhetoric is often not sufficient to render law innocuous years after separation from its legislative history. Besides, nowhere in the House record does the majority explicitly acknowledge that discretion to decide the fate of imperiled newborns invests in parents, in consultation with physicians; indeed, the bill's stated purpose was to repudiate that notion. At best, legislators recognized that physicians disagree about the efficacy of resuscitating at the limits of viability, and therefore the current standard of care permits doctors to deem resuscitation a futile endeavor. However, judges may resist characterizing resuscitation as futile, given its poor analytical fit, and substantial public-policy concerns regarding discrimination against future disabled individuals could easily tip a court to preserve incipient, at least, physiologic life under the BAIPA's all-encompassing definition of born alive.

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