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“婴儿多伊”事件重演?美国卫生与公众服务部及2002年《出生时存活婴儿保护法》:关于规范新生儿医疗行为的警示

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.

作者信息

Sayeed Sadath A

机构信息

Division of Neonatology, University of California, San Francisco, CA 94143, USA.

出版信息

Pediatrics. 2005 Oct;116(4):e576-85. doi: 10.1542/peds.2005-1590.

Abstract

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.

摘要

2002年国会通过的《出生存活婴儿保护法》(BAIPA)几乎没有引起公众关注。该法部分目的在于“摒弃那种有缺陷的观念,即儿童享有法律保护的权利取决于其母亲或其他人是否想要他或她”。从反堕胎言论的角度理解,该法案在立法听证时并未引起医生太多关注,两院均以压倒性多数通过,几乎不像是有争议的立法。签署成为法律后,新生儿复苏项目(NRP)指导委员会发表意见称,“[BAIPA]绝不应该以任何方式影响医生目前对极早产儿采取的治疗方法”。然而,这种对法律的解读可能目光短浅。2005年4月,美国卫生与公众服务部(DHHS)让BAIPA有了实际行动,宣布:“作为法律和政策问题,[DHHS]将调查所有据报个人和实体可能违反联邦法规而不给出生存活婴儿提供医疗护理的情况。”该机构就BAIPA中的定义条款如何与《紧急医疗救治和劳动法案》(EMTALA)以及《预防和治疗虐待儿童法案》(CAPTA)相互作用向州官员发布了指示。这些跨部门备忘录可能会重启政府对新生儿治疗决策的休眠监督,从而可能影响规范的新生儿医疗实践。根据BAIPA,DHHS将EMTALA解释为保护所有“出生存活”婴儿;违反监管要求的医院和医生将面临该机构批准的金钱处罚,或“任何直接受伤害个人的私人诉讼权利”。根据其备忘录,只要DHHS发现有证据表明在“谨慎的外行观察者”从婴儿的“外表或行为”可以推断其“患有紧急医疗状况”的情况下,新生儿未得到至少一次医疗筛查检查,DHHS就将调查有关违反EMTALA的指控。该备忘录没有明确哪些观察者可被视为谨慎,哪些婴儿外表或行为相关,以及紧急医疗状况如何定义。由于这些评估标准不受相关医疗护理标准的约束,该机构可以说用非专业人员对生存能力的假定明智评估取代了合理的医疗判断。事实上,根据对该指示的直接解读,在观察到一名亲属分娩出一个20周大的胎儿,该胎儿在死亡前心跳持续一小时后,家庭成员理论上可能会引发一项调查。大多数医生不会认为这是一种紧急医疗状况,并且不会进行筛查检查,而是会为新生儿提供安慰并为家庭提供支持。然而,该指南并未表明在这些情况下专业敏锐度会胜过外行的观察;因此,医生不清楚是否无论对生存能力进行先验的、合理的考虑如何,都需要对所有新生儿进行筛查检查。在这种背景下,NRP指导委员会的意见指出,“在分娩时……应评估新生儿的医疗状况和预后。此时,……医疗服务提供者可以与为孩子的最大利益行事的父母一起考虑关于停止或终止被认为无效的医疗治疗的决定”。然而,目前在分娩前可以合理确定不可存活胎儿的胎龄时,大多数擅长筛查和复苏的儿科医生并未被要求履行这一职责。如果根据法律现在在任何胎龄都需要进行筛查,那么在可存活前出生后立即进行的专业程序可能需要修改。更令人担忧的是,在生存能力边缘对涉嫌违反EMTALA的行为进行威胁性的积极调查,在这种情况下徒劳无益仍然是一个有争议的问题,这危及了提供酌情姑息治疗的规范道德实践。DHHS向负责执行CAPTA法规的州儿童保护服务机构发出了另一项指示;它重申了医生可以不给婴儿提供医疗治疗的有限情况,并再次强调了“医疗保健机构内的个人”在通知当局涉嫌违规行为方面的地方作用。然而,其真正的重要性在于坚持地方执行法律补救措施,以防止做出被1984年《婴儿多伊规则》视为不允许的不治疗决定。由于这项新指令鼓励政府对涉及濒危新生儿的治疗决定进行监督,一段良性的监管忽视时期似乎已经结束。联邦CAPTA规则可以说将生活质量考虑因素从决策计算中排除,因此可能与美国儿科学会和NRP倡导的最大利益范式相冲突。法院将如何回应DHHS根据BAIPA对EMTALA和CAPTA的解释尚不清楚。联邦法院尚未权威审查涉及生存能力极限处新生儿治疗决定的涉嫌违反EMTALA的行为。威斯康星州最高法院允许一项关于EMTALA的索赔进入审判程序,在该案件中,据称医生在急诊科没有对一名22周大的新生儿进行筛查或复苏,并且一个下级上诉法院依据CAPTA裁定父母没有选择不对极早产新生儿进行复苏的权利。得克萨斯州最高法院最近根据“紧急情况”的普通法原则赋予医生家长式特权,在不考虑父母意愿的情况下对濒危新生儿进行复苏。这些司法判决破坏了父母在这些道德复杂情况下分娩前后决策时通常被给予的道德酌处权。DHHS对BAIPA的解释可能会鼓励这类声明的管辖权扩张,因为该机构试图扩大对出生存活婴儿的法律保护。美国最高法院表示,“法院必须假定立法机构在法规中表达的就是其意思,并且在法规中表达的意思就是其所说的意思”;因此,法官通过分析“具体的法规语言”而不是参考广义立法意图的抽象概念来解释法律。BAIPA不加区分地将“出生存活”定义为包括“处于任何发育阶段的婴儿……无论分娩或取出是由于自然分娩、引产、剖宫产还是人工流产”,并且它没有提及护理标准或最大利益,也没有具体保护父母的决策权。根据该法律的严格逻辑,一个在分娩后有可检测到心跳的18周流产胎儿有权获得由“任何国会法案,或任何行政局和机构的任何裁决、法规或解释”确定的法律的全面保护。在得出BAIPA不会影响规范的新生儿医疗实践这一结论之前,NRP指导委员会本应分析该法案的实际法规语言,避免过度依赖不精确的立法意图。BAIPA的国会提案人确实声称该法律“不会在目前没有指征的情况下强制进行医疗治疗”,但这种政治言辞在与立法历史分离多年后往往不足以使法律无害。此外,在众议院记录中,多数派 nowhere明确承认决定濒危新生儿命运的酌处权在于父母与医生协商后;事实上,该法案宣称的目的就是摒弃这一观念。充其量,立法者认识到医生在生存能力极限处进行复苏的效果存在分歧,因此当前的护理标准允许医生认为复苏是徒劳的努力。然而,鉴于复苏的分析适用性不佳,法官可能会拒绝将其定性为徒劳,并且关于歧视未来残疾个体的重大公共政策担忧很容易使法院倾向于根据BAIPA对出生存活的包罗万象定义至少保护新生儿初期的生理生命。 (注:原文中“nowhere”疑有误,可能是“nowhere”拼写错误,推测应为“nowhere”,表示“无处、没有地方”,这里结合语境似是说在众议院记录里没有地方明确承认相关内容,翻译时保留原文错误表述供你参考。)

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