Janaki Padmakumar

Associate Editor

Loyola University Chicago School of Law, JD 2023

In the United States, Assisted Reproductive Technology (ART) is predominantly self-regulated by a network of medical agencies that publish guidelines. ART refers generally to any fertility procedure where eggs or embryos are handled. ART clinics are not federally funded, and there is no specific national legislation that establishes a clear regulatory framework about the standard of operations, the quality-of-care patients should be provided with, the permissible uses of ART, or recourse for patients who have not benefited from their financial investments in ART. There are minimum standards set forth by the Food and Drug Administration (FDA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which require strict compliance before patients can consult and use clinics’ ART services including the use of pharmaceutical products. The Federal Trade Commission (FTC) also oversees truthful advertising and marketing practices within ART to ensure that clinics’ reports of success are consistent with their patient data. All states require that physicians obtain a license before providing care, and physicians are subject to investigation by state boards. Aside from this general regulation for safety and transparency, the only explicit regulation targeting the ART industry is the United States Fertility Clinic Success Rate and Certification Act, mandating all US fertility clinics to report their ART cycles performed to the Center for Disease Control (CDC). The data collected through this reporting act is governed by the NASS 2.0 (National Assisted Reproductive Technology Surveillance System), which is a collaborative surveillance system between the CDC, and private stakeholders. Self-reported data to NASS 2.0 is verified by comparing information from a patient’s medical record with data submitted for the report.

The blurred line between self-reporting and rigged data

Proponents of self-regulation argue that the NASS 2.0 reporting framework is sufficient to establish standardized compliance for ART service providers because ART programs could lose their membership in SART and ASRM (the key private players in NASS 2.0) for failure to report data to the CDC, failure to maintain accredited laboratories or any violations to their advertising policies. Consumers in the United States rely on SART membership as a hallmark of credibility when consulting ART services, so SART member clinics have an incentive to comply to avoid financial losses. However, the self-regulatory models are just guidelines, leaving individual clinicians with a wide discretion of what conditions to use Preimplantation Genetic Diagnosis (PGD) for, and why.

In the United States, the market-driven model of ART lets physicians and their clinics set the prices for ART procedures with limited oversight. For example, Ingenomix quotes their cost for IVF between 20,000-40,000 USD just for one cycle, which is generally not covered by insurance. Only fifteen states in the US mandate some insurance coverage of fertility treatments by private insurers but the coverage requirements and eligibility for insurance vary widely. Proponents of self-regulation argue that because the federal government does not fund ART clinics, the lack of government subsidization would result in insurance premiums rising for all individuals and their employers, even if legislative initiatives mandated coverage for ART. The self-regulated industry perspective is that the lack of federal or state funding precludes the government from interference or the creation of onerous restrictions.

Even with CDC reporting and informal guidelines, without federal regulation, clinics are free to cherry-pick data to improve their purported success rates. Clinics can restrict the acceptance of cases to patients with the least severe form of genetic disorders to make embryos with higher likelihoods of survival. Clinicians can also disproportionality work with younger patients or those with ovarian functioning best suited to successful ovulation and pregnancy. While the reports can be accessed through CDC and SART databases, an average consumer is more likely to rely on skewed data reported from the clinics that best fit their needs. For informed decision-making to exist, the United States needs to adopt a framework that is more accessible, transparent, and consumer-oriented to function as an independent resource for families seeking ART treatments.

Even if NASS 2.0 collects and stores data, there are serious doubts about the completeness and accuracy of self-reported data. Researchers found that for IVF treatments, the CDC does not include information about when the cycle is started—to account for the missing information, they had to rely exclusively on a SART database. However, because of unstandardized reporting, clinics excluded or selectively reported some cycles, resulting in missing cycles in the completed data set. Thirteen fertility clinics were outliers, which accounted for more than half of the missing cycle data that centers should be reporting to NASS 2.0, even though the outliers were among the most expensive and nationally preeminent fertility clinics.

Consumers need more than just a slap on the wrist

For uniformity, accessibility, and transparency, NASS 2.0 needs to adopt a framework of clear regulation on ART and develop a reliable resource for consumers to independently research fertility clinics before pursuing ART treatments. Even if direct regulation of ART procedures is contentious, there is nothing to bar the federal legislature from creating appropriate, standardized clinical data collection policies to ensure that accurate reports are submitted to the CDC. To ensure compliance with standardized data collection practices, NASS 2.0 needs an enforcement arm to ensure meaningful consequences occur for non-compliant clinics. These consequences could include annual audits, suspension of a clinic’s operating license, or listing the clinic’s unreliable data reporting practices on a consumer report.

The fatal flaw with the Fertility Clinic Success Rate and Certification Act is that it fails to give the CDC the power to enforce the data-reporting process; simply put, FCSRCA slaps non-compliant clinics on the wrist, rather than dealing actual consequences. There must be regulations created to ensure that fertility clinics report accurately and unbiasedly and that there is a greater consequence for ART providers who fail to provide complete reports other than a loss of SART accreditation.