Federalizing embryo transfers: taming the wild west of reproductive medicine?
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.
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.
I. 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 this field undergo rigorous training. After graduating from medical school, a physician interested in reproductive medicine must complete a residency in Obstetrics & Gynecology (Ob/Gyn), and then a fellowship in Reproductive Endocrinology & Infertility (REI). (13) Like all areas of medical practice, reproductive medicine is subject to quality control through a variety of mechanisms, most notably licensure of physicians by state-based medical boards, application of practice standards established by professional societies, and private tort litigation. But unlike virtually every other area of medical practice, reproductive medicine has been uniquely assailed as unregulated and is frequently the subject of calls for greater governmental oversight. Why this special demand on the provision of ART--those medical services that enable the infertile to achieve biologic parenthood? The answer, of course, is the children.
The unitary goal of ART is to produce healthy offspring. Paradoxically, while medical therapies are directed at patients, outcomes are measured by the well-being of any resulting children. (14) As third party beneficiaries of ART's application, the resulting children take on an emotional symbolism that can steer attention away from the internal doctor/ patient relationship to the external product of that relationship. Measuring the merits of ART through this child-centered lens has enhanced public perceptions that the field is in dire need of comprehensive oversight and reform. (15) That is, even when the use of ART is successful--healthy offspring are born to a healthy woman--mishaps or malfeasance by medical personnel that accompanied that birth will be the target of significant hand-wringing.
This observation is not to say that human error in ART, intentional or otherwise, should not be cause for concern; rather, it is to point out that the birth of a healthy ART child is not necessarily a sign of health in the ART system. In fact, a series of very public and very unfortunate ART events have firmly disaggregated the birth of healthy offspring from the legitimate and appropriate use of ART. It seems fair to say that through these debacles, ART has acquired its reputation as the "wild west of medicine." In each case, the ART professional's bad behavior--ranging from simple negligence to active criminality-was well-publicized and well-situated to serve as a clarion call for greater governmental scrutiny of the field.
Consider, for starters, the case of Dr. Cecil Jacobson, a Northern Virginia fertility doctor who used his own sperm to impregnate over 70 unwitting patients. Following a 1992 trial, Dr. Jacobson was convicted of 53 counts of fraud and perjury. He served five years in a federal prison, all the while protesting his innocence. (16) A few years later the world learned that doctors at the UCI Center for Reproductive Health in Orange County, California stood accused of stealing eggs and embryos retrieved from younger patients and implanting them in older patients, without either woman's knowledge or consent. The alleged motive for this gametic shell game? Money and glory. Younger eggs, even when mixed with older sperm, are more likely to produce a successful outcome, thus yielding profits and praise for the treating physicians. (17) In all, it is believed that more than a dozen children were born of this malfeasance, costing the University of California millions of dollars in settlement costs, not to mention a sequelae of reputational harm. (18)
Debacle in ART is not reserved to the criminal realm; plenty of misdeeds have been the result of simple negligence. Cases involving laboratory mix-ups are particularly painful, often producing emotional custody battles that pit genetics against biology. (19) In one New York fertility clinic, a white patient became pregnant with twin boys, one white and one black, because a lab technician mistakenly swapped two couples' embryos on the day of transfer. (20) The white couple's "successful" use of ART wrought tremendous pain and suffering to the black couple whose embryo was negligently misdirected. After a two-year legal battle, the black child was ordered returned to his genetic parents, but the trauma caused irreparable harm to the parties as well as the industry.
Against this shaky backdrop, the world met Octomom, an out-of-work, single woman whose IVF-conceived octuplets joined six existing children amid a media feeding frenzy. While initial attention fixated on the sheer novelty of Nadya and the infants, the undercurrent of displeasure with the state of ART regulation began to gain strength. In at least three states, Octomom-inspired bills were introduced into the legislature, though none emerged as enacted law& In addition to these formal acts, a wealth of commentary began to fill the pages of academic and popular publications, unifying around the mantra, "There ought to be a law" that would prevent the emergence of any future Octomoms (or Septomoms, or Sextomoms, and so on). (22) Implicit in this advocacy is a presumption that no such specific regulatory system exists. The oft-referenced "wild west of medicine" further presumes that no regulation of ART exists. Neither presumption is correct, but both are best understood through the lens of a global perspective on ART regulation, rather than comparing the field to other subspecialty practices within a domestic sphere.
Approaching ART regulation from a global perspective tends to yield a binary view of the legal landscape. Countries are seen as either adopting comprehensive regulation of the field, or yielding to a laissez-faire approach with no extant regulation. Examples of countries perceived to be in the "everything is regulated" include England, Canada, and Italy. The U.S., on the other hand, is classified on the "nothing is regulated" list. (23) Like most generalizations, there is some truth to these overbroad classifications. National laws have been enacted in the U.K., Canada and Italy that affect clinics in these countries, respectively. (24) The U.K. in particular is hailed as a stellar example of comprehensive ART regulation, having enacted a national licensure scheme for fertility clinics in 1990. (25) In these so-called comprehensive jurisdictions, ART regulation operates as a top-down scheme in which a national body sets practice guidelines and requirements, directing which services each clinic can (and cannot) provide. But even within this tightly controlled regime, some practices remain unregulated, or more commonly, are done surreptitiously or outside the jurisdiction in defiance of national policy. (26)
On the flipside, regulation in the free-for-all countries does exist, but as narrow, targeted laws aimed at specific areas, rather than as federal legislation deputizing national boards to oversee the industry countrywide. (27) In the U.S., regulation of ART can be divided into what I'll call a source trilogy, consisting of three distinct bases from which regulatory activity arises: public ordering, quasi-public ordering, and private ordering. Public ordering encompasses all formal public law surrounding ART, including enacted statutes and promulgated regulations. In some cases, enacted law applies to ART even though such application was never contemplated at the time the statute was enacted. (28)
Quasi-public ordering refers to self-regulatory schemes developed and monitored by affected stakeholders. The practice of reproductive medicine has a long history of self-regulation Critics of self-regulation in general rightly observe that any internally derived scheme, including that governing ART, contains deficiencies and weaknesses that necessarily impact effectiveness. Private ordering as a regulatory system refers to the conduct of private individuals operating within the tort system that impact practice within the field. Though the vast majority of private tort actions never transmute into formal law (i.e., common law disseminated via published court opinions), their very existence can have a tremendous impact on other actors in the field who feel vulnerable to similar claims. Filing, or even the threat of filing, a lawsuit can alter practices from the sheer distaste of being embroiled in litigation. ART regulation as seen through the source trilogy is briefly described below.
A. Public Ordering
Enacted laws that directly govern or affect ART are found on both federal and state rolls. Though none of the statutes can be considered comprehensive (regulating each action of each provider) as a whole the laws are geared toward providing patients accurate and up-to-date information about clinical outcomes, and assuring some level of quality control throughout the industry. The quality control measures in place are designed to promote health and safety in the embryology laboratories, as opposed to controlling the number of embryos that are transferred in any given cycle. There is no dispute that the number of embryos transferred has a direct effect on health and safety--for both patient and offspring--but as argued herein, the lack of an explicit law delineating this aspect of clinical practice does not mean that the practice is entirely unregulated in a broader sense. (29)
Turning to enacted law, at the federal level a nearly twenty year old law has effectuated a comprehensive reporting scheme that enables prospective patients to investigate ART practices on a clinic-by-clinic basis. The Fertility Clinic Success Rate and Certification Act of 1992 (30) was born out of a concern that fertility clinics were misleading prospective patients about pregnancy success rates in an era when reporting of such data was completely voluntary. (31) FCSRCA contains two essential components. First, it requires standardized reporting of pregnancy success rates to the Secretary of Health and Human Services through the Centers for Disease Control (CDC), which in turn makes data available to the public. As a result of this law, the vast majority of ART clinics in the U.S. annually report their success rates and a host of other data to the CDC, which publishes a comprehensive report detailing national statistics, as well as specific information about each reporting clinic. (32) The CDC has published an annual ART Success Rate Report since 1997, and each report is now available online at the CDC website. (33)
A second part of the Act empowers the CDC to develop a model program for certification of embryo laboratories that can be adopted by each state. The CDC issued the final version of the model certification program in 1999, but to date no state has adopted the program into law. Thus, direct federal regulation of ART can be described as an active reporting requirement and a dormant certification program. While FCSRCA remains the sole piece of federal legislation drafted to specifically address ART practices, other federal regulatory schemes have been appropriately applied to the field, even though they were not originally intended to capture practices that, in some cases, did not yet exist at the time the federal law took effect. (34) Several federal agencies are active in ART oversight as a result of these broad regulatory schemes.
In addition to the CDC, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are authorized to regulate aspects of ART through regulatory enactments. The FDA is charged with protecting the public health by assuring the safety, efficacy, and security of drugs, medical devices and biological products, including human gametes. In 2005, the FDA issued comprehensive regulations requiring tissue banks to test donors and donated tissues for a host of diseases including HIV, hepatitis, and syphilis. In addition, tissue banks are now required to ask donors a series of questions to determine their risk factors for particular diseases. While the FDA regulations are not aimed exclusively or directly at ART clinics, they do impact the practice of reproductive medicine when donor gametes are used. (35)
The jurisdiction of CMS is invoked under the Clinical Laboratory Improvement Act of 1988 (CLIA), (36) providing for federal certification of clinical laboratories. CLIA applies to laboratories engaged in the "examination of materials derived from the human body" for purposes of disease diagnosis, prevention, or treatment. While CLIA authorizes federal authorities to maintain quality control over clinical labs, clarifying regulations published in 1992 limit CLIA's jurisdiction to lab tests used in the diagnosis of infertility, such as semen and blood analysis. The procedures performed in embryology labs, which are not considered diagnostic, do not fall under CLINs mandate. (37)
Direct regulation of ART at the state level falls into three distinct categories: disposition of gametes and embryos, parentage assignment and informed consent. (38) In fact, the majority of U.S. states have adopted at least one--and in many cases several--laws that deal directly and exclusively with the practice of reproductive medicine, in contrast with the single federal statute enacted to address ART reporting. In general, state law regulates the relationships that form around ART (between and among patients, physicians, and third party donors and surrogates) rather than the medical practices used within the field. For example, while nearly half of all states have some enacted law on surrogate parenting arrangements, (39) only one state has a law requiring that women electing IVF or artificial insemination undergo a medical examination before treatment can be administered. (40) To date, no state has adopted a law regulating the number of embryos transferred in any given IVF cycle.
The nature of our federal system, in which states assert authority over the health, safety, and welfare of those within their jurisdiction as an expression of individualized public policy, dictates the concentration of ART laws at the state level. Matters of property law (gamete and embryo disposition), family law (parentage assignment), and tort law (informed consent) are typically captured by state lawmakers; the treatment of ART vis-a-vis these state-oriented legal doctrines is therefore entirely sensible and expected. (41) As discussed in Part II, a federal law regulating the practice of medicine by dictating clinical standards in IVF would be a significant departure from long-standing reliance on the grassroots sensibility of state lawmakers. Congressional activity in an area traditionally left to the states could violate principles of federalism, leaving a federal law vulnerable to an attack on constitutional grounds.
In addition to targeted enacted law, states can affect the practice of reproductive medicine through their medical licensing regimes. Licensing statutes govern entry into the licensed professions, disciplinary actions, and the delivery of health care services by unlicensed persons. (42) These statutes are typically implemented by medical boards authorized to investigate alleged malfeasance in the practice of medicine, and assess penalties ranging from probation to license revocation. (43) ART practitioners, as medical doctors, are required to be licensed by the state in which they practice. Disciplinary actions against ART practitioners can and have been brought by state licensing authorities. (44)
Perhaps the most recent and high profile disciplinary action was the case against Michael Kamrava, the California physician who treated Nadya Suleman. The Accusation, as the initial pleading is called, was filed before the Medical Board of California, Department of Consumer Affairs, by the Attorney General of California on December 22, 2009. The thirteen-page pleading accused Dr. Kamrava of gross negligence based primarily on two behaviors: transfer of excessive embryos in violation of recommended industry standards, (45) and failure to refer the six-time IVF-seeking patient to a mental health professional for evaluation. (46) At a trial on the merits in October 2010, Dr. Kamrava cited in his defense his patient's desire to have a large family. (47) On January 24, 2011, the administrative law judge hearing the case recommended that the doctor be placed on a five-year probation by the state medical board, opting to permit him to retain his medical license. (48) However, upon review, the Medical Board announced its decision to exact a harsher penalty and suspended Dr. Kamrava's license to practice medicine on June 1, 2011. (49) It is interesting to note that Dr, Kamrava lost his license to practice medicine not because he violated formal state law, but because he failed to adhere to voluntary guidelines published by the industry in which he operated.
It is clear from this brief review of ART-related law that calls for a comprehensive, top-down system, in which specific requirements are strictly enforced, have been unanswered. Instead, our public ordering consists mainly of alerting stakeholders to the potential risks and benefits that ART poses. Whether by publishing clinic-specific data at the federal level; clarifying parental rights with respect to gametes, embryos, and offspring at the state level; or prosecuting ill-behaved practitioners under traditional licensure, tort, or criminal law doctrines, formal American law strives to enhance individual (informed) decision-making over generalized standards that defy case-by-case application. Even in the case of extreme malfeasance, applicable law affords a remedy despite the absence of formally enacted practice requirements.
B. Quasi-Public Ordering
Quasi-public ordering, as used herein, refers to the various ways in which the ART community engages in formal self-regulation. The main sources of ART self-regulation are supplied by the American Society for Reproductive Medicine (ASRM), a reproductive medicine and ancillary professionals membership organization founded in 1944. According to the ASRM website:
The Vision of ... [ASRM] is to be the nationally and internationally recognized leader for multidisciplinary information, education, advocacy and standards in the field of reproductive medicine. The ASRM is a nonprofit organization whose members must demonstrate the high ethical principles of the medical profession, evince an interest in infertility, reproductive medicine and biology, and adhere to the objectives of the Society. (50)
The ASRM aspirational reference to itself as a leader of "standards in the field" refers to its two main policy-setting bodies: the Practice Committee that issues reports and guidelines on clinical practice and the Ethics Committee that produces periodic statements and guiding principles for physicians and others in the field. (51) All the official work product of the Practice Committee and the Ethics Committee is published in the ASRM's professional journal, Fertility & Sterility, and posted on its website. (52)
Since 1998, ASRM has issued and updated practice guidelines for embryo transfers, with each version stating as its goal the reduction of ART-related multiple birth rates in the U.S. (53) These practice guidelines represent the industry's attempt at self-regulation in response to the public health concern over multiple birth. In addition to this topic of widespread interest, the ASRM Practice Committee has also focused on other areas of ART concern. Recent reports address the emerging technique of oocyte cryopreservation (egg freezing), (54) as well as genetic screening of preimplantation embryos. (55) The Ethics Committee has not weighed in on the issue of embryo transfer guidelines, likely viewing it as a strict clinical, rather than ethical, matter. (56) The Ethics Committee has weighed in on pressing issues, including the delivery of ART to HIV-infected individuals. (57) access to ART by single individuals and members of the gay and lesbian community, (58) and the ethics of oocyte donation for stem cell research. (59) Both ASRM groups meet throughout the year in person and via electronic communication to review existing policies and address emerging issues within their realm.
While ASRM is an organization with voluntary membership, the vast majority of U.S. fertility clinics subscribe as members and as members of its affiliate, the Society for Assisted Reproductive Technology (SART). SART is the primary organization for ART physicians and physician group practices, and is responsible for assuring that its members adhere to membership requirements. (60) As a condition of ASRM membership, clinics must report their clinical outcomes to the CDC in conjunction with the Fertility Clinic Success Rate and Certification Act, (61) must have accredited embryology laboratories, and must adhere to the Practice and Ethics Committee guidelines of the Society& Failure to adhere to these criteria can result in revocation of membership. Such was the fate of Dr. Kamrava, Nadya Suleman's physician, whose membership was revoked in September 2009 "for conduct injurious to the good order and reputation of the Society and inconsistent with its purposes." (63)
Self-regulation in general is subject to a common critique that any suggested reforms to emerge from a group of self-interested stakeholders will fail to take into account the potential harms such schemes would visit on third parties. This "tyranny of the stakeholder" critique is no less prevalent in the ART world, where clinical practice guidelines are written by physicians and embryologists whose livelihoods depend upon a steady flow of child-seeking patients. Critics of the ASRM and SART practice guidelines have charged that these industry-friendly groups operate "behind closed doors," refusing to promulgate restrictive standards for fear of reducing clinic profits. (64) This critique is most often lodged at the professional society's "toothless" guidelines on the number of embryos to transfer in a given IVF cycle. While ASRM has issued embryo transfer guidelines for over a decade, critics argue neither the Society nor the guidelines have done enough to quell the epidemic of multiple pregnancy that pervades U.S. ART use.
The supporting data for critics of the ASRM embryo transfer guidelines comes from the near steady rate of twinning that U.S. fertility clinics have experienced for many years. According to the 2008 ART Success Report, the rate of twin births from fresh nondonor IVF cycles declined only slightly over ten years, falling from 32 percent in 1999 to 30 percent in 2008. (65) This persistent twinning rate is compared to declining multiple birth rates that have been achieved abroad, especially in European countries that operate under comprehensive regulatory authorities. (66) ASRM "self-regulators" appear to be somewhat sensitive to the critique that they are not doing enough to address the persistent twin rate in the U.S., revising the embryo transfer guidelines five times since their first issue in 1998, with each version recommending fewer transfers per cycle on average. (67) These downward revisions may have contributed to the decrease in the higher-order multiple birth rate (triplets or greater) which fell from 5 percent in 1999 to 2 percent in 2008. (68) Defenders of voluntary guidelines cite this data subset as a reason to resist more formal regulation. (69)
In an industry widely perceived to be unregulated, as is ART, those engaged in self-regulation should be vigilant of the generalized and specific criticism the field attracts. Clearly the Nadya Suleman case sharpened those critiques, at least for a time. Interestingly, though no cause and effect is suggested, ASRM recently revised its procedures for producing Practice Committee Guidelines. In August 2010, the Practice Committee drafted new parameters for developing and publishing clinical guidelines for practitioners. The document, entitled, "Practice Committee Guidelines: Procedures for Preparation, Review and Approval" is accompanied by a separate explanation of how evidence used to support each guidelines will be selected. According to Andrew La Barbera, Scientific Director for ASRM, "These documents were developed by the Practice Committee and describe how guidelines will be prepared in the future with the expectation of submitting them to the National Guidelines Clearinghouse." (70) The new approach to clinical guideline development includes the use of non-committee experts to draft guidelines based on scientific literature. The goal is to make the procedure more rigorous going forward.
The impact of non-binding, industry-sponsored self-regulation can be difficult to measure because formal assessment mechanisms are typically omitted. In ART, the 1992 federal law mandates reporting and publishing of fertility clinic success rates, allowing some assessment of whether physicians are adhering to industry-suggested standards. The most recent published data suggests a trend toward adherence to embryo transfer guidelines, but still an overall transfer rate that exceeds industry-suggested limits. (71) The 2008 CDC ART Success Rate Report notes a decrease in the average number of embryos transferred over a ten year period. In 1999, only 29% of all ART cycles involved a single or double embryo transfer, compared to 62% in 2008. (72) Still, the average number of embryos transferred in patients under age 35 was 2.2, while the ASRM guidelines recommend only 1-2 embryos for this age group. (73) One interesting study found that embryo transfer rates show the greatest decline immediately after the publication of revised (downward) ASRM practice guidelines. (74) Knowing that self-regulation can have an impact on clinical practice, even if just a temporal impact, may increase its relative weight in the trilogy of regulatory sources that govern the practice of reproductive medicine.
C. Private Ordering
The impact of tort litigation on the practice of medicine has been widely debated, with central themes focusing on whether private lawsuits improve patient safety, reduce medical error or establish appropriate standards of care. (75) Even without solid data proving a statistical correlation between malpractice filings and regulatory responses, it is clear that the medical industry has reacted to this form of patient complaint. One oft-expressed concern that the ease of filing private lawsuits causes doctors to practice "defensive medicine." The practice of defensive medicine means that doctors order more tests and consult more subspecialists than is medically optimal for the patient in order to protect themselves from legal liability. (76) Survey data bears out this relationship between patient access to the legal system and physician behavior. In a 2009 survey of obstetricians and gynecologists, 60% responded they had made one or more changes to their practices as a result of the risk or fear of professional liability claims or litigation. (77) The percentage of physicians who self-report practicing defensive medicine is even higher in other fields, with 93% of some subspecialists confirming their behavior is effected by the threat of litigation. (78) While it is beyond the scope of this article to assess whether the practice of defensive medicine improves or reduces the quality of patient care, it seems reasonable to conclude that private lawsuits impact physician behavior as much if not more than formal regulation and industry guidelines.
The impact, if any, that legal liability has had on ART is difficult to appraise compared to other specialties for at least two reasons. First, no published survey data exists documenting ART physician practices in response to the threat of legal liability. Second, the tort jurisprudence surrounding certain aspects of assisted conception is far more complex, and often more limited, than the average medical malpractice case in which a patient must prove the elements of negligence. When ART goes awry and no pregnancy ensues, a patient may have a claim for malpractice. (79) While such a claim seems straightforward from a negligence calculus, a review of case law suggests suits against ART physicians are rare, and those that are brought are largely unsuccessful. (80) The legal landscape grows more complicated when an ART birth goes awry. Patients who believe their offspring suffered harmed as a result of physician negligence can look to two legal theories for relief: wrongful birth (a parental claim on behalf of an injured child) and wrongful life (a child's claim for damages suffered from an impaired life). (81) While the former claim is recognized in most states, the latter is rarely permitted to proceed because of the courts' reluctance to engage the "implicit claim that the plaintiff child would prefer non-existence to life in an impaired state." (82) As with negligence claims involving ART practitioners, wrongful birth claims following IVF are rare and mostly resolved in favor of the physician. (83)
Even if the volume of malpractice cases brought against IVF physicians is low, it is still worth exploring what impact these cases, and threats thereof, have on the delivery of ART services. Assuming ART practitioners react similarly to their colleagues in a litigation environment, we would expect to see an uptick in the practice of defensive medicine. What would the practice of defensive reproductive medicine entail? Claims in which parents seek damages for their child's congenital or genetic anomaly could prompt ART physicians to order or encourage patients to accept pre-conception testing of embryos, even when the progenitors are not at known risk for producing a child with a genetic disorder. (84) We do know that utilization of prenatal genetic testing is on the rise, though no cause and effect between the fear of legal liability and increased use has yet been suggested. (85)
Drawing back to the clinical syndrome at issue--multiple pregnancy--how does or could the private tort system affect the practice of reproductive medicine in the realm of embryo transfer? If patients felt that their providers were too aggressive in transferring multiple embryos, we might expect to see suits seeking damages for the birth of twins, triplets, etc. We don't. (86) If patients felt their providers were too timid in transferring too few embryos, we might expect to see suits seeking damages for failed IVF cycles. We don't. Few, if any, published cases against ART providers claim damages caused by the number of embryos transferred in a single IVF cycle. But this lack of empirical data does not necessarily mean that ART practitioners aren't impacted by the threat of litigation, either as to embryo transfer practices or any other aspect of the delivery of care. More research is needed to cull out exactly how the private tort system affects behaviors in reproductive medicine.
In sum, while ART is not the subject of comprehensive, top-down federal legislation, it is impacted by activity emanating from three sources: public law, self-regulation and private tort action. Taken as a whole, this source trilogy has and will continue to impact the way ART is delivered in the U.S., especially as the number of IVF-conceived children continues to grow. (87) To say that ART is the wild west of medicine is to disregard the formal and informal mechanisms in place that shape the practice of reproductive medicine. This is not to say that greater regulation would be unwelcome or unwarranted, but that it would be in addition to existing structures. Thus, any new federal law on embryo transfers would be juxtaposed among regulations already in place. We now proceed to evaluate the merits of such a law, first thinking about the role federalism might play in the law's viability, and then moving to imagine how transfer limits could be effectively drafted and enforced.
II. Federalism Concerns: Congressional Authority to Regulate Health?
In February 2009, less than a month after the Suleman octuplets were born, a group of state senators in Georgia introduced a bill to limit the number of embryos transferred in any IVF cycle performed in the state. Georgia Senate Bill 169 provided, "[w]here a woman under age 40 is to receive treatment using ... embryos created using her own eggs, ... no person or entity shall transfer more than two embryos in any treatment cycle." (88) Other provisions limited women age 40 and over to three embryos per treatment cycle, and all women using embryos created with donor eggs to two per cycle. (89) The bill contained several penalties, including monetary fines, medical licensure revocation, and loss of credentialing for health care facilities in which violations occur. (90) The Georgia bill was limited to the practice of reproductive medicine within the state, an activity the legislature has traditionally and exclusively controlled.
While the above-mentioned portions of the Georgia bill never became law, (91) imagine the same language incorporated into a bill introduced in the U.S. Senate. Instead of regulating physicians in one state, the federal practice restrictions would apply to doctors nationwide. Before exploring the steps lawmakers might go through to draft such a bill, and how such limits could be enforced, a threshold inquiry emerges: Would a federal embryo transfer limit violate principles of federalism? When a federal law ventures into matters traditionally regulated by the states, such as the practice of medicine, its constitutional validity is worthy of examination.
A. Federalism and the 1992 ART Law
The task of drafting and assuring compliance with a federal embryo transfer law is daunting enough as a practical matter, but such regulation may face a greater challenge for its violation of long-held principles of federalism. Federalism, at its core, is the constitutional division of authority between federal and state governments. (92) The U.S. Constitution creates a federal government of enumerated powers. (93) As the Supreme Court explains in U.S.v. Lopez, "... James Madison wrote: 'The powers delegated by the proposed Constitution to the federal government are few and defined. Those which are to remain in the State governments are numerous and indefinite."' (94) The Court continues, "This constitutionally mandated division of authority was adopted by the Framers to ensure protection of our fundamental liberties.... [and] reduce the risk of tyranny and abuse from either front." (95) One explicit delegation of authority to the federal government is Congress' power to "regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes." (96) Whether Congress could regulate embryo transfer limits under the Commerce Clause is unclear, thus prompting federalism concerns.
Concomitant to Congress' authority to regulate interstate commerce under the Commerce Clause are the states' authority to regulate in certain areas, including health, even if such laws have a substantial effect on interstate commerce. (97) According to the Court in Lopez, "health laws of every description," are within the province of the states and cannot be regulated by Congress. These health laws are a small part "of that immense mass of legislation ... not surrendered to a general government." (98) Health law in general and the practice of medicine in particular have been the province of state law. Thus the question arises, if a national embryo transfer law is considered a law regulating either health or the practice of medicine, could it withstand a constitutional challenge that such a law exceeds Congress' authority to regulate in an area traditionally left to the states?
A first place to explore is the only existing federal law regulating ART. The Fertility Clinic Success Rate and Certification Act of 1992, as previously discussed, contains two essential mandates. First, FCSRCA mandates that ART programs annually report and the CDC annually publish pregnancy success rates as defined in the Act. (99) Second, the federal law mandates the CDC develop a model program for the certification of embryo laboratories available for adoption in the states. (100) Arguably, these mandates do not regulate health or medicine per se, because they have no direct impact on patient care. Requiring clinics report usage statistics and pregnancy outcomes does not, at first blush, appear related to the care patients receive. (101) Nor does the establishment of standardized laboratory practices for embryo cultivation sound in the practice of medicine--as such standards would guide embryologists in the handling of gametes and embryos before they reach a patient's body. But clearly federal lawmakers had federalism concerns in mind when they drafted FCSRCA.
In the section mandating development of a model embryo program, the Act provides, "In developing the certification program, the Secretary may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs." (102) This admonition that the CDC not supervise or control medical practice in ART programs is a clear acknowledgment of Congress' lack of authority to regulate the practice of reproductive medicine. Clinical judgment about the number of embryos to transfer on a patient-by-patient basis lies at the heart of the practice of medicine. While a patient's age is relevant to this calculus, other factors including diagnosis, prior IVF history and male factor play in role in the treatment plan. (103) A federal law that actively and directly substitutes for clinical judgment by specifying the number of embryos a physician can transfer in any IVF cycle seems the essence of the practice of medicine. As such, the law should be vulnerable to attack on federalism grounds. Whether FCSRCA could withstand such an attack is unknown, as no state has yet adopted the CDC certification program, and thus no federalism challenge has been mounted. For guidance, we turn to another federal law that also arguably regulates the practice of medicine, and that has been subject to judicial review, the Federal Partial-Birth Abortion Ban Act.
B. Federalism and the Partial-Birth Abortion Act
Judicial guidance on the question of federal authority to regulate ART is virtually nonexistent, (104) but commentators have weighed in on the arguably related arena of federal regulation of abortion. While ART seeks to begin a pregnancy and abortion is used for termination, both clinical practices match physicians and patients in medical scenarios surrounding procreation. Like ART, abortion as a medical practice is mostly regulated at the state level, save a few attempts to ban certain procedures at the federal level. (105) In 2003, Congress enacted and President George W. Bush signed the first federal law regulating abortion practices. The Partial-Birth Abortion Ban Act of 2003 (PBABA) banned the use of certain techniques used in post-first trimester abortions, (106) Shortly after its enactment, the law was challenged by four physicians on constitutional grounds, mostly focused on reproductive liberty and vagueness concerns. (107) Not surprisingly, the case proceeded to the U.S. Supreme Court which granted certiorari on the question whether the Act's lack of a health exception rendered the law unconstitutional. (108) While neither the lower courts nor the Supreme Court showed an interest in evaluating the PBABA on Commerce Clause grounds, academic commentary on the matter flourished.
Both before and after the Court handed down its 2007 decision in Gonzales v. Carhart analyzing the constitutionality of the federal law banning partial-birth abortion, (109) scholars debated the Act's ability to withstand a challenge grounded in the Commerce Clause. Before the decision was announced, one scholar opined that the PBABA could pass constitutional muster under current (and recently vacillating) interpretations of the Commerce Clause because "performing partial-birth abortions is a type of 'commerce'--the sale of a service by professionals engaged in a market-oriented enterprise ... [that] have an effect on interstate commerce significant enough to warrant regulation." (110)
Under similar reasoning, it is possible to likewise sustain the constitutionality of an ART law because reproductive medicine is a multi-billion dollar industry in which patients, gamete donors, gestational surrogates and physicians move within the several states. (111) With over 435 fertility clinics nationwide performing nearly 150,000 cycles of IVF annually, odds are good that those who perform, receive and supply ART goods and services travel across state lines in the name of family formation. (112) Under this line of analysis, physician conduct is viewed not as the practice of medicine, but rather the delivery of services into the national stream of commerce. As such, any attack on a federal embryo law as usurping the states' exclusive authority to regulate the practice of medicine would fail.
Turning back to whether federal regulation of abortion exceeds Congress' authority, the PBABA's validity under the Commerce Clause remains a mystery because the Court never reached this question in Gonzales. Another commentator, writing after the Gonzales decision was handed down, remarked that the Act was "inexplicably spared an attack on ... [the question of] whether it was a proper exercise of Congress' Commerce Clause authority" because opponents of the PBABA failed to raise the issue. (113) This author speculated that had Justice Thomas, the justice "most likely to hold that the PBABA is not a proper exercise of Congress's commerce power," reached the question of congressional authority to regulate abortion, he would have been hard pressed to uphold the law under the Commerce Clause, but could have salvaged the Act under Congress' enforcement power under the Fourteenth Amendment. (114) The PBABA, this author argues, is both a criminal and a health law, meaning it doubly encroaches on the type of police authority traditionally left to the states. For this reason, if challenged under the Commerce Clause, abortion regulation that criminalizes one aspect of the practice of medicine is unlikely to survive Justice Thomas's constitutional scrutiny. (115)
The ability of a federal embryo law to survive a Commerce Clause attack is likewise unknowable at this time. More recent jurisprudence from the Court suggests a friendlier view of federal regulation aimed at protecting the nation's health. In Gonzales v. Raich, (116) the court upheld application of the federal Controlled Substances Act to intrastate users and growers of medical marijuana sanctioned under state law. Those challenging the CSA argued that its application to a purely intrastate activity violated the Commerce Clause, because home-grown and home-consumed marijuana has no effect on interstate commerce. The Court disagreed, upholding the CSA as applied. Writing for the majority, Justice Stevens explained that "the regulation is squarely within Congress' commerce power because production of the commodity meant for home consumption, be it wheat or marijuana, has a substantial effect on supply and demand in the national market for that commodity." (117)
With such a low bar for activating federal authority, if ART services were viewed as commercial in nature, it seems likely a post-Raich court would find they impact the national market. If a thimble of home grown medical marijuana could trigger interstate commerce activity, no doubt the exchange of $3 billion of goods and services annually would fall under Congress' purview. (118) While ART is at its core a medical procedure, it is difficult to ignore the significant interstate movement of people, gametes and pharmaceuticals that are integral to the field.
Were Congress to enact a federal embryo transfer law, at the very least it should consider the susceptibility of this health-related regulation to a Commerce Clause attack. Aspects of such a law could be tailored to invite or avoid such a challenge. For example, if criminal penalties are assessed for transfer of excess embryos, as opposed to civil or licensure-based fines, the bill would encroach on both criminal and health regulation, two areas traditionally left to the states. Thus this type of law would be twice invading the states' police power and could trigger a less favorable review by federalism-minded courts. Alternatively, Congress could build the legislative history to reflect the enormous impact ART has on interstate commerce, as a way of anticipating and possibly staving off invalidation under the Commerce Clause. The risks and benefits of regulating embryo transfer under federal law are far more complex than what advocates for such a regime have considered. What advocates have considered is a law reducing overall embryo transfers in the U.S, to which we now turn.
III. A Tweak in the System: Federalizing Embryo Transfers
If Congress were to enact a practice guideline limiting embryo transfers in IVF, what would such a scheme look like and how would the designated enforcer monitor and assure compliance? These answers depend upon a host of factors, including the type of transfer restriction adopted; the selection of the designated enforcer, the nature of the penalty for noncompliance, and the applicability of competing federal and state laws that govern the practice of medicine. Once each of these factors is addressed, a scheme for establishing and monitoring compliance of embryo transfer restrictions can coalesce around existing models or emerge as a newly envisioned approach. What follows are proposals for several statutory schemes, along with companion analyses of the merits of each proposal.
A. Designing Law: Drafting an American-Style ART Law
Designs for requiring, monitoring and assuring compliance with embryo transfer limits are more easily drawn in countries with comprehensive top-down regulatory schemes than in the U.S. where ART clinics operate outside a nationalized licensing system. (119) The absence of a single federal authority imbued with inspection authority and licensure control complicates the task of monitoring and assuring compliance. Any system in which the data collector is not simultaneously authorized to enforce predetermined standards is vulnerable to breakdown as information flows from the gatherer to those charged with collating, assessing and ultimately acting on the data procured. Moreover, even if under a new law the data collector is authorized to impose penalties for excess embryo transfers, the absence of a national clinic licensing system means that individual physicians must be the target of penalty incentives. Incentivizing individual as opposed to institutional behavior would lie at the heart of any U.S. ART law. With these structural realities in mind, a plan for establishing, monitoring and assuring compliance with embryo transfer restrictions can and should be envisioned, if only to assess such a law's prospective usefulness in ultimately reducing the multiple birth rate in the U.S.
1. Bare Bones Law: Mandating Reporting of Embryo Transfers
The primary goal of a national embryo transfer law would be to reduce the incidence of multiple birth, including twins, in the U.S. Secondary goals might include changing patient and physician attitudes toward multiple pregnancy through education so that both populations become less tolerant of this clinical outcome. (120) Other goals might focus on harmonizing clinical practices across the country, since current state-based practice standards permit variation from jurisdiction to jurisdiction. Thinking through how statutory embryo transfer restrictions could be operationalized, let us assume in a nod toward efficiency existing law could be amended to accomplish all the goals of any such scheme. The 1992 Fertility Clinic Success Rate and Certification Act (FCSRCA), with its two part structure for clinical reporting and certification of embryo laboratories, could be amended to include the three components necessary to achieving clinical reporting and transferlimitation adherence. (121)
First, FCSRCA could adopt mandatory reporting requirements, replacing the current quasi-voluntary system which merely acknowledges--rather than punishes--nonreporting. Second, the law would need to incorporate some type of clinical guideline or restriction that specified the exact number of embryos that could be transferred in each treatment cycle. As suggested below, this critical part of any new law could be developed from existing models in both the U.S. and abroad that address embryo transfer limits. Finally, the revised FCSRCA would need to enhance its penalty language for noncompliance, both for nonreporting of clinical data and for nonadherence to enacted clinical guidelines. Each of these changes to existing federal law are considered below.
a. Adding Mandatory Reporting Language
Amending FCSRCA to impose mandatory annual reporting of the number of embryos transferred in every ART cycle seems simple enough. Currently, the law provides:
... [E]ach assisted reproductive technology ... program shall annually report to the Secretary through the Centers for Disease Control
(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and
(2) the identity of each embryo laboratory ... used by such program and whether the laboratory is certified under [this Act]. (122)
A third section, mandating reporting of all embryo transfers, could be added as follows: "(3) the number of embryos transferred into a patient in each assisted reproductive technology." Adding reporting language for embryo transfers, however, may have little practical effect. Though FCSRCA does not contain this language requiring reporting of embryo transfers, clinics that annually report under the Act do provide this data. (123) Patients interested in knowing the average number of embryos transferred in every reporting ART clinic can easily access this information online. (124) Still, adding mandated reporting of embryo transfer to the federal law may provide an unintended benefit. Critics of FCSRCA charge that public disclosure of individual clinic success rates incentivizes physicians to transfer more embryos than are clinically recommended to boost pregnancy success rates. (125) Requiring reporting of both embryo transfers per patient and corresponding success rates would provide patients greater insight into clinical outcomes at each facility. Knowing that one clinic transfers more embryos to achieve a similar success rate to another clinic could signal a more skilled physician and embryologist, though patients should also investigate other factors including age and multiple birth rates.
b. Adding Civil Fines for Nonreporting
Since the reporting requirement of the Act is already drafted as a mandatory requirement (each program "shall" annually report), amendments could be made to the "penalty" section that now addresses noncompliance. Section 5 of the Act directs the CDC to annually publish the pregnancy success rates reported in Section l, and
in the case of an assisted reproductive technology program which failed to report one or more success rates as required under such section, the name of each such program and each pregnancy success rate which the program failed to report. (126)
A far more meaningful (and behavior-modifying) penalty might be to add a substantial monetary fine for failure to report success rates and embryo transfers. For example, the following language could be added to this provision:
Each assisted reproductive technology program which failed to report one or more pregnancy success rates or one or more embryo transfer rates shall be fined $50,000 for each annual failure to report. The total fine imposed on a single program shall not exceed $100,000 annually.
The amount of the fine associated with nonreporting could be calculated to account for (and stave off) potential strategic behavior on the part of a program. If, for example, a program with relatively low success rates concluded that the risk to their existing business posed by reporting unfavorable data--measured by the loss of revenue from prospective patients who go elsewhere for treatment cycles--was greater than the fines themselves, then such a program could decide to pay the fine rather than risk a greater loss of revenue that could be produced by reporting. Certainly there is some fine that is high enough to inspire compliance, but that amount might alternatively produce questions of proportionality between the act and the punishment. (127)
Once the statute is amended to include mandatory reporting language and an associated penalty structure for nonreporting, the next task would be to codify the clinical standards lawmakers believe would achieve their policy objectives. As previously noted, the rate of ART-related multiple births in the U.S. stands stubbornly at around 32% of all cycles in which live offspring are born. (128) Notably, only a small fraction of this number includes higher-order multiple births--that is, triplets or greater. Only 1.8% of all ART-related births are higher-order, setting the twin rate at around 30%. (129) Logically, modalities that reduce the rate of twins will simultaneously reduce the rate of higher-order multiple births as a natural consequence of embryo transfer reduction. Thus, lawmakers could adopt "reduce the rate of ART multiple births" as a generalized objective without having to target specific clinical outcomes. Though subtle, this more generalized goal avoids the perception that Congress is attacking one family in particular (for example, if the goal were to "reduce octuplet pregnancies"), but instead is addressing a more widespread problem.
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|Title Annotation:||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|
|Publication:||Columbia Journal of Gender and Law|
|Date:||Jun 22, 2012|
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