On National Outcome Reporting of IVF Results

Opinion 001: June 2014

Summary

CHR is seriously concerned about highly misleading information currently communicated to the public by the two national IVF outcome-reporting systems. As there appears a consensus that both are inadequate in their current structures, CHR welcomes the recently announced modifications by the Centers for Disease Control and Prevention (CDC) and the Society for Assisted Reproductive Technology (SART) to their respective systems. However, CHR is not convinced that the proposed changes go far enough to correct current shortcomings, which allow IVF centers to manipulate their outcome data to their benefits by not reporting cycle starts in women with poor pregnancy chances. Though CDC and SART urge the public not to judge centers by their reported outcomes, since different centers treat patient populations with inherently different pregnancy chances, there is really no other good reason for the public to refer to both national outcome reports other than to compare centers in their competency. CDC and SART should, therefore, either cease publication of misleading outcome reports or develop an outcome reporting system that does allow the public fair and accurate comparisons between centers. No reporting is always better than misleading reporting, and intentional misreporting by centers should result in sanctions. National IVF cycle outcome reporting is a good example of how carefully national outcome reporting systems have to be designed before implementation.


“In response to concerns about data quality and comparability,” the U.S. Congress in 1992 mandated national outcome reporting for all medical facilities performing assisted reproductive technology (ART) cycles, which is widely known by the public as in vitro fertilization (IVF), in Fertility Clinic Success Rate and Certification Act (FCSRCA or Public Law 102-493).1 The principal motivation was improved transparency for infertility patients. The FCSRCA mandated that all IVF centers report “success rates” to the Centers for Disease Control and Prevention (CDC) in a standardized manner.1

CDC then publishes the so-called annual ART Success Rates Report, which lists the individual outcomes of all reporting IVF centers. The latest one was published for the year 2012, reporting on 176,274 ART cycles at 456 clinics.2

In parallel, the Society for Assisted Reproductive Technology (SART), a subsidiary organization of the American Society for Reproductive Medicine (ASRM), also publishes an annual IVF Success Rates report, based on voluntary data submission by most U.S. IVF centers.3

These two annual national reports slightly vary in participating centers, content and style, but do represent a large majority of actively practicing IVF centers. Despite the above noted Congressional mandate, a small minority of centers refuses to report. For lack of legal enforcement mechanisms in the FCSRCA, they, nevertheless, practice ART unchallenged, while SART mandates annual reporting as a condition of membership.

Though motivated by “comparability” of outcome reporting to benefit infertility patients,1 CDC and SART recognize the complexities of outcome reporting in all of medicine4 and prominently note in their annual reports that outcomes should not be used for quality comparisons between clinics, since the severity of treated disease/infertility differs between centers. By giving this advice, both organizations acknowledge obvious limitations to their respective reporting systems.

The public, not surprisingly, is confused, being offered two national clinic-specific outcome reports, yet, at the same time, also being advised not to make use of this information. One, therefore, has to ask, why even bother with publishing these reports?

Senator Ron Wyden, the member of Congress most responsible for passage of the FCSRCA in 1992, nevertheless, recently suggested the national ART outcome reporting system to CDC as a valuable example for other areas of medicine.Concerns about the reporting system, however, were recently heightened further when a recent CHR study found that the system communicates misleading information to the public: A small number of IVF centers took advantage of loopholes in the system to artificially inflate their clinical pregnancy and delivery rates by selectively reporting IVF cycle outcome data to CDC and SART. Over a study period of 5 years, they significantly increased market share in comparison to properly reporting centers and, thus, economically benefitted from misleading reporting.6

CDC and SART have recognized these shortcomings in current reporting systems and have announced remedies,7,8  which should make abuses of the system more difficult but are unlikely to stop them completely. Proposed remedies, in addition, are at least two years away from reaching the public. Considering the very obvious impact on the public from misleading reporting,6 one has to wonder why CDC and SART are not taking actions more forcefully.

An improved reporting system should have the specific purpose and ability to allow for fair comparisons between IVF centers. Intentional manipulations should draw professional penalties, including withdrawal of accreditations and/or loss of licenses. Moreover, failure to participate should also have consequences; indeed, participation in a legally mandated outcome reporting system should be a precondition for licensure of IVF centers.

Unless such changes are implemented in a new reporting system, increasing competitiveness of the clinical infertility market will lead to increasing reporting abuses, as recently demonstrated when, using reported national data, a center issued a press release under the heading “ Report Finds (name of center) 2012 IVF Success Rates to be 23 Percent Above National Average for Women under 35”.9 Disregarding current advertising guidelines of SART, a precondition for society membership,10 this press release was blatantly misleading. Such misleading promotional activities, abusing national outcome reporting systems, can be expected to become formal marketing strategies, unless curtailed.

Whatever the area of medical practice, the public does not have the expertise to differentiate true from manipulated outcome reporting. Reporting systems officially sanctioned by authoritative professional and/or government bodies, therefore, become accomplices in misleading the public when publishing potentially misleading reports. They, therefore, should report outcomes accurately or, if currently available statistical means do not allow for accurate reporting, should not report at all.

National IVF outcome reporting serves as an example of how carefully such reporting systems have to be developed to avoid manipulations and abuses. No outcome reporting is always preferable to flawed reporting.


References
1. Centers for Disease Control and Prevention. Assisted Reproductive Technology (ART). http://www.cdc.gov/art/Policy.htm; accessed April 21, 2014

2. Centers for Disease Control and Prevention. What is Assisted reproductive technology? http://www.cdc.gov/art/; accessed April 21, 2014

3. Society for Assisted Reproductive Technology. IVF Success Rates. http://www.sart.org/find_frm.html ; accessed April 21, 2014

4. KPMG Whitepaper. Measuring the value of healthcare Delivery: Cutting through complexity. http://www.kpmg.com/Global/en/IssuesAndInsights/ArticlesPublications/clinical-governance/Document; accessed April 21, 2014

5. Adashi EY, Wyden R. Public reporting of clinical outcomes of assisted reproductive technology programs: implications for other medical and surgical procedures. JAMA 2011;14:306:1135-1136

6. Kushnir VA, Vidali A, Barad DH, Gleicher N. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil Steril 2013; 100:736-741

7. Ball D, Coddington C, Doody K, Schattman GL, Toner J, Van Voorhis BJ, Williams RS. The playing field is changing… Fertil Steril. 2014 ;101:e29 

8. http://www.sacbee.com/2014/02/18/6166829/report-finds-reproductive-medicine.html ; accessed April 21, 2014

9. Reproductive Medicine Associates of New Jersey. Report find RMANJ’s 2012 Success Rates to be 23 percent above national average for women under age 35. http://www.rmanj.com.category/press-releases/; accessed April 21, 2014

10. SART. SART Policy for Advertising by ART Programs, effect April 1, 2009. http://www.sart.org/uploadedFiles/Affiliates/SART/Members/Executive_Council/sart-advertising-policy-; accessed April 21, 2014