Public Reporting of Clinical Outcomes of Assisted Reproductive Technology Programs

Abstract

ON OCTOBER 24, 1992, PRESIDENT GEORGE H.W. Bush signed the Fertility Clinic Success Rate and Certification Act (FCSRCA) into law. Sponsored by then-Representative Ron Wyden (DOR), the statute set out to establish a national public reporting framework for the clinical outcomes of assisted reproductive technology (ART) programs offering in vitro fertilization and egg donation services. Specifically, FCSRCA mandated that by 1994 “each assisted reproductive technology program shall annually report . . . pregnancy success rates achieved by such program” through the Centers for Disease Control and Prevention (CDC) and that effective in 1995, the CDC “annually publish and distribute” the same data. Also to be publicly reported were the “identity of each embryo laboratory used” and the accreditation status thereof as well as those ART programs “which failed to report . . . as required.” In the ensuing years, beginning in 1997, the CDC issued 12 annual reports detailing the clinical outcomes of ART programs. A one-stop, data-rich portal for couples experiencing infertility, the CDC ART Web site, although in need of user-friendly redesign, is presently the subject of more than 250 000 page views per year. Like-minded (consumercentered) federal efforts have followed suit to include “Nursing Homes Compare” (1999), “Dialysis Facility Compare” (2001), “Hospital Compare” (2004), and “Physician Compare” (2010). Within this growing group, the ART example occupies a unique space characterized by its emphasis on clinical outcomes as distinct from process measures. However, not unlike most established “Compare” platforms, the ART effort offers clinic-specific rather than physician-level data. As with all public reporting initiatives, data accuracy is paramount to attain credibility. To ensure such for its annual report, the CDC has established a rigorous quality control program. Submitted directly online to the National ART Surveillance System (or indirectly courtesy of the Society for Assisted Reproductive Technologies), the data of each ART program must first be verified by the relevant medical director. Following an in-house review by the CDC, data are further validated through site visits to randomly chosen ART programs. For example, a total of 35 ART programs (out of 436 reporting) were site visited in the process of compiling the latest annual CDC report (2008). Sitevisit protocols call for the abstraction of the medical records of 50 random ART cycles as well as all ART cycles resulting in multiple (twin and higher order) gestations (2008). These quality measures, along with the required follow-up on the ensuing gestation, account for the 2-year lag from data collection to publication. In compliance with FCSRCA, the annual CDC report focuses on clinic-specific pregnancy and live birth success rates. The latter are stratified by ART modality and maternal age. Special emphasis is placed on the live birth rate per initiated ART cycle, per (oocyte) retrieval, and per (embryo) transfer. In addition, the CDC reports the accreditation status of attendant embryo laboratories and the identity of nonreporting ART programs. However, the annual CDC report does not stop there. Instead, a rich pallet of additional consumer-usable information is offered at a level rivaling the present day “Compare” series. Examples include but are not limited to program-specific procedural volumes, percentage of cycle cancellations, average number of embryos transferred, embryo or gamete cryopreservation capability, and the incidence of resultant multiple pregnancies or births. Ranking, rating, or otherwise directly comparing ART programs is not undertaken in recognition of the variation in clinic-specific case mix. In another useful departure, the annual CDC reports offer aggregated annualized national data. Viewed and used by both consumers and researchers, the rolled-up database powerfully defines the national ART practice and the key variables thereof. The amount of data collected is substantial. The last annual CDC report (2008) included 148 055 discrete ART cycles, which resulted in the birth of 61 426 live infants. Aggregated over time, annual CDC reports offer longitudinal trending of outcomes not otherwise apparent when examining a single yearly time frame. Public reporting of health care outcomes is premised on the tenets of transparency and accountability with consumers in mind. The prospect that public reporting will bring about improved clinical outcomes, although attractive and