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

AuthorDaar, Judith
PositionIII. 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 c. Monitoring Compliance Through Data Collection through Conclusion, with footnotes, p. 290-325
  1. Monitoring Compliance Through Data Collection

    Once mandatory reporting requirements for embryo transfer are in place, how would the designated enforcer assure compliance with the statutory scheme? What strategies could be put in place to ensure the accuracy of the data reported? In Part III.A.1.a we assumed that the system for collecting data on embryo transfers would either parallel or piggyback on the existing system used to collect data on ART outcomes under FCSRCA. Recall that FCSRCA requires each ART clinic to "annually report to the Secretary [of Health and Human Services] through the Center for Disease Control ... pregnancy success rates achieved by such program through each assisted reproductive technology." (130) For efficiency sake, it would make sense to utilize the existing reporting structures put in place under the 1992 law, as these structures involve outreach to all fertility clinics known to be in operation in the U.S.

    The federal ART reporting structure is described in each annual report; the 2008 report describes the reporting and data collection system as follows:

    CDC contracts with a statistical survey research organization, Westat, to obtain the data published in the ART success rates report. Westat maintains a list of all ART clinics known to be in operation and tracks clinic reorganizations and closings ... Westat actively follows up reports of ART physicians or clinics not on its list to update the list as needed. Westat maintains NASS, the Web-based data collection system that all ART clinics use. Clinics either electronically enter or import data into NASS for each ART procedure they start in a given reporting year. The data collected include information on the client's medical history (such as infertility diagnoses), clinical information pertaining to the ART procedure, and information on resulting pregnancies and births. (131) The above description makes clear that the current data collection system relies almost exclusively on self-reporting by individual clinics. Some measures for quality control are in place, including site visits to randomly selected clinics for validation of data. In 2008, members of the Westat Validation Team visited 35 of 436 reporting clinics, and found that "[i]n almost all cases, data available in the medical records on pregnancies and births were consistent with reported data." (132) Given this intact and evolved reporting system, it seems both sensible and efficient that any change in federal law requiring disclosure of embryo transfer numbers be incorporated into FCSRCA.

    As a practical matter, however, such a change in the law may not be necessary. As previously noted, though not explicitly admonished to do so under the law, the CDC, via Westat, already collects data on the number of embryos transferred in every ART cycle. (133) In 2008, for example, embryo transfer data is presented in three separate charts, revealing that 38% of all ART cycles involved the transfer of three or more embryos. (134) Keep in mind that current clinic reporting is legally nonconsequential; there are no legal penalties either for failing to report (135) or based on the nature of the data reported. Query whether clinics would be as participatory or forthcoming if penalties were attached to the data reported, as would likely be the case in any new law cracking down on multiple birth rates through the regulation of embryo transfers.

    Penalizing excess embryo transfers could impact clinic reporting behavior. Any new law should include a mechanism to maximize the veracity of reported data. Under existing law, clinics report specified data on each cycle initiated in a given calendar year. If the number of embryos transferred per cycle were made a required data point, how certain could regulators be that the data reported was accurate? As is now the practice, either the CDC or its contracted surrogate could visit selected clinics to review patient medical records as a quality control measure. But what if the data written in the medical record is in error, either by neglect or intent? Should a federal law authorize the data collector to verify that the medical record is accurate? How might such verification actually take shape?

    What if, for example, a patient's medical record indicates that two embryos were transferred (say, in compliance with the new federal law), but that triplets were born of this cycle? Such a clinical scenario is not impossible. The incidence of monozygote twinning has been described in IVF, meaning that a triplet birth could result from a double embryo transfer. (136) Should regulators have the authority to order genetic testing on the triplets to verify that two of offspring are monozygotic? What if, as another example, a medical record indicates that only one embryo was transferred and that a miscarriage occurred at 10 weeks into the pregnancy. Should regulators have the authority to subpoena the medical records from the physician attending to the patient during miscarriage to spot references to more than one embryonic sac being detected?

    As invasive and distasteful as these measures are, they represent the best clinical means to verify the accuracy of embryo transfer reporting. This fact alone should alert us to the competing concerns of individual privacy and societal interests that any federal embryo law must navigate. Clearly the law would not probe into post-treatment medical records (of miscarriages or the genetic provenance of offspring) in order to verify the embryo transfer data contained in the ART chart. But at the same time a clinic whose transfer data indicates compliance with clinical standards, but whose multiple birth rates suggest noncompliance should be subject to some scrutiny by regulators. Short of watching embryo transfers in the operating suite--another ghastly invasion of patient privacy--it is difficult to construct an appropriate method of verification. At the very least, Congress should contemplate the problematic nature of data verification before proceeding to enact federal law mandating reporting and adherence to national embryo transfer limits.

    1. Too Many Choices: Selecting the Clinical Guidelines

    Once federal law is either enacted or amended to require reporting of embryo transfers, the query moves to normative concerns. Lawmakers would need to contemplate which clinical configuration would most likely produce the desired outcome--reduction (by what amount?) of ART multiple births. How should Congress formulate the clinical guidelines it intends to impose on practitioners nationwide? At least three choices present themselves, each yielding very different implications for ART patients and practitioners.

  2. Incorporation by Reference

    First, Congress could simply incorporate by reference the ASRM guidelines on embryo transfers, as the Missouri legislature contemplated doing in the wake of the Suleman births. (137) The proposed Missouri law provided:

    When treating infertility, physicians within the state of Missouri shall not implant more embryos into a human than the current recommendations set forth by the American Society for Reproductive Medicine, or its Successor. (138) A federal law could simply substitute the jurisdictional term "within the United States" for the regional reference to the state of Missouri. Referencing and incorporating into law the "current recommendations" on IVF embryo transfers set forth by the ASRM Practice Committee may garner the most support from ART practitioners, should any support for the overall idea be forthcoming. (139) Incorporation by reference could be attractive to the practice for at least three reasons. First, referencing "current recommendations" permits the law to remain clinically relevant as technology evolves. Updates in the ASRM practice guidelines based on scientific and patient data would be incorporated by operation of law into the federal statute. The efficiency of such an approach may likewise be attractive tO lawmakers. Instead of having to establish a commission to periodically review a set of legislated standards, the law could rely on those efforts already underway in the private sector.

    A second feature of the incorporation approach that might capture practitioner support is the opportunity for those most clinically knowledgeable about the practice to have input into the regulatory scheme. The ASRM Practice Committee is comprised of physician members, often with differing subspecialties including reproductive endocrinology, ob/gyn and urology. The group meets periodically to review and issue clinical practice guidelines in the field of reproductive medicine. With respect to its published guidelines, the Committee admonishes:

    These guidelines have been developed to assist physicians with clinical decisions regarding the care of their patients. They are not intended to be a protocol to be applied in all situations, and cannot substitute for the individual judgment of the treating physicians based on their knowledge of their patients and specific circumstances. (140) While discussion of the benefits, burdens and externalities of allowing professionals to generate the legal standards under which they must operate is beyond the scope of this piece, (141) a simple observation can be made that if evolving practice guidelines were incorporated into federal law, ART practitioners would have significant influence on national clinical standards. The notion that physicians be left to write their own rules has evoked expected concerns about the methods, goals and transparencies of such a process. Professor John Robertson nicely summarizes these concerns, warning, "If the guidelines are to be the equivalent of law, then how they are arrived at will have to be more closely scrutinized, the process of writing them opened up, and measures taken to assure they do not simply protect the interest of doctors." (142)

    Finally and relatedly, incorporating ASRM guidelines...

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