Federalizing embryo transfers: taming the wild west of reproductive medicine?

• Author: Daar, Judith
• Position: Introduction through III. A Tweak in the System: Federalizing Embryo Transfers A. Designing Law: Drafting an American-Style ART Law 1. Bare Bones Law: Mandating Reporting of Embryo Transfers b. Adding Civil Fines for Nonreporting, p. 257-290

Abstract

This article addresses the off-spoken urban myth that the field of assisted reproductive technologies (ART) is a wholly unregulated medical subspecialty, leaving cowboy physicians to abuse vulnerable patients and disregard the well-being of ART-induced offspring. The birth of octoplets in January 2009 fueled this myth and launched a campaign to regulate the field by restricting the number of embryos allowed for transfer in any single IVF cycle. This article critiques the merits of a federal law codifying embryo transfer limits in the provision of infertility care.

Drafting a federal embryo transfer law is easy enough, but assuring enforcement by regulators and compliance by physicians and patients presents near insurmountable barriers. Even if such a law set out sensible clinical guidelines on the number of embryos to transfer, validating that practitioners have complied with statutory standards may require invading patient privacy in a wholly distasteful manner. Moreover, data collected on the effectiveness of civil fines in the regulatory setting suggest rampant undercollection, casting doubt on fine-based penalty's capacity to deter banned conduct. Still other data suggests that criminal penalties fare no better, as both prosecutors and juries are reluctant to penalize a physician who, in good faith, responds to a patient's plea for help.

Compliance with embryo transfer limits are in doubt not just because traditional penalty structures are ineffective, but because patients and physicians are incentivized by the high cost and low reimbursement rates for infertility care to prefer more embryos be transferred to maximize the chances for a live birth. When multiple births, particularly twins, is a preferred outcome based on financial constraints, looking to a stand-alone embryo transfer law to curb the high rate of multiples will have little effect. Instead, this article argues that now is the time to ease the financial burden by including infertility care in the package of essential health benefits being developed under the 2010 Patient Protection and Affordable Care Act. Matching the burden of embryo transfer limits with the benefit of coverage will have a real and lasting impact on the public health concerns that legitimately coalesce around multiple births.

INTRODUCTION

An urban myth has dogged the world of assisted reproductive technologies (ART) since its emergence over three decades ago. Reproductive medicine, observers exclaim in both shouts and whispers, is the "wild west of medicine," conjuring up an image of lawless, greedy physicians preying upon desperate wannabe parents, swathed in abject disregard for their patients' welfare or that of the children the patients long to birth.(1) At the heart of the myth is an assertion that reproductive medicine is entirely unregulated, and thus subject only to the good or ill will physicians and patients bring to the examination room. Like most urban myths, this modern folklore about the ART cowboy is overwhelmingly false. Nevertheless, its persistent appearance in academic and popular print is worthy of exploration, if only to understand why ART has earned this notorious reputation and contemplate whether and how affected stakeholders should respond. This article will deconstruct and analyze the ART urban myth through a critique of existing and proposed legislation governing the practice of reproductive medicine.

Current defenses of the sufficiency of ART regulation are particularly challenging in light of the well-publicized birth of IVF-conceived octuplets outside Los Angeles in January 2009, an event that reinvigorated enthusiasm for displaying and targeting ART as a medical free-for-all deserving of its pejorative renegade label. (2) Nadya Suleman, quickly dubbed "Octomom," and her brood are the embodiment of medical outliers--not only have the oc-spring become the longest living octuplets in recorded history, mother and babies appear to have dodged the morbidity and mortality bullet that often accompanies multiple pregnancy. (3) The medical risks associated with multiple pregnancy, particularly higher order multiples, include maternal circulatory and respiratory maladies that can be permanently disabling or even fatal, and fetal complications that can impact the child's sensory, mobility and cognitive development. (4) Despite, or possibly because of this picture of health, the Suleman clan is firmly established as the poster family for public outcries over the untamed state of ART law. As proof positive, during a 2010 hearing in which Suleman's treating physician, Michael Kamrava, faced charges before the Medical Board of California, the prosecuting attorney proclaimed the doctor acted like "a cowboy" by disregarding established guidelines for embryo transfer. (5) While language shapes perception, in the case of ART--perception is undoubtedly influenced by language.

Public and academic reaction to the Suleman case, and what it represents, has ranged from demands for a total regulatory takeover of ART to calls for minor tweaks in the system. While a comprehensive overhaul of reproductive law is highly unlikely, advocacy for small changes are gaining support. One such proposal--aimed at reducing high-order multiple births--urges Congress to enact a federal law limiting the number of embryos transferred in any single IVF cycle. (6) Limiting embryo transfers to one or two per cycle, advocates say, would reduce the high rate of ART-induced multiple births in the U.S. which has stubbornly hovered at around one-third of all IVF births. (7) Would such a tweak help debunk the ART urban myth? Even if so, would a statutory limitation on embryo transfers be legally permissive, clinically sensible, or administratively enforceable? In my view, as long as infertility care remains outside the package of health benefits available to those in need of treatment, the answer to each query is no.

This article explores the merits of a federal law limiting the number of embryos transferred in a given IVF cycle. Observationally, 1 posit that Congress is unlikely to enact such a law, given its historic (mostly) hands-off approach to ART, (8) the import of assisted conception to American families who show little enthusiasm for limiting embryo transfers, (9) and the divisive political battle that routinely accompanies proposed legislation aimed at reproductive medicine. (10) Leaving to others a more robust discussion of the (un) likelihood and political (in)feasibility of such a bare mandate limiting embryo transfers, (11) this article considers four aspects of any such tweak in the current system. First, Part I sets out the legal landscape into which any new federal law would settle, revealing that current ART regulation springs from a trilogy of sources--public law, quasi-public law and private law--which combine to regulate and influence clinical practices in the field. Next, Part II highlights the prominence of federalism in the regulation of health law, casting doubt on the legal viability of a national law purporting to dictate medical practice standards-an area traditionally reserved for state actors.

Part III explores the possible language and predicted effectiveness of a federal embryo transfer law. Building upon existing law requiring ART clinics to annually report their pregnancy success rates for national publication, this Part suggests that adding mandatory reporting of embryo transfers could be easily accomplished but less easily monitored by appointed regulators. Moreover, selecting clinical standards would be problematic, forcing lawmakers to choose between a modest proposal likely to win industry support and a draconian approach more likely to dramatically reduce multiple birth rates. Once clinical embryo transfer standards are considered, the focus turns to penalty alternatives. Looking to empiric data on the effectiveness of civil and criminal penalty structures in regulatory and medical settings, Part III suggests that physicians may be more responsive to the threat of licensure revocation for breaching established standards than traditional modes of punishment. Overall, Part III argues that drafting, monitoring, and enforcing federal embryo transfer limits would present serious challenges for lawmakers and regulators.

Finally, Part IV delves into physician and patient incentives for breaching current industry-generated embryo transfer limits. From the patient's perspective, incentives to bypass suggested restrictions are well-described, driven by a desire to parent more than one child coupled with the constraints imposed by a lack of health insurance coverage for most ART treatment. Physicians likewise respond to ART's competitive, "cash-only" financial environment, trying to satisfy patient demands and financial limitations, while striving to produce high success rates for public scrutiny. These patient and provider incentives, Part IV asserts, suppress the likelihood a bare embryo transfer law would be effective in reducing the U.S. ART-inspired multiple birth rate. While it is empirically clear that reducing embryo transfers reduces multiple pregnancy, what remains unclear is whether and how to implement practice guidelines within existing political, medical and insurance parameters. In the end, Part IV argues a tweak in the system will only be effective if accompanied by robust health insurance coverage for infertility care. The recently enacted Patient Protection and Affordable Care Act (12) provides a timely opportunity to tackle the issue of multiple births through a two-pronged approach, combining clinical restrictions with coverage for ART. Injecting benefits and burdens into the ART world may finally tame its wild west reputation.

1. Regulating Reproductive Medicine: A Trilogy of Sources

   Reproductive medicine is a subspecialty field of medical practice devoted to diagnosing and treating infertility. Physicians who practice in...