Federalizing Embryo Transfers: Taming the Wild West of Reproductive Medicine?

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c. 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. …