Public Reporting of ART Outcomes Kevin Doody MD

Overview History of ART Outcomes Reporting Role of CDC Federal Register process Who reports? Role of SART Registry Committee Data collection SART-CORS NASS

Overview Embryo banking New CSR report labels Natural cycles Minimal stimulation Research cycles PGS / PGD CSR design

History of ART Outcomes Reporting AFS - ART Special Interest Group → SART FCSRCA 1992 – “Wyden law” Intent Information made available to consumers of fertility services my means of a “published report” Unforeseen events / intended consequences “rise of the internet” Consumers and insurance companies use information to compare clinics Success outcome metrics Live birth rate per stimulation or monitoring procedure Live birth rate per egg retrieval procedure

Role of the CDC Work with SART and patient / consumer advocacy organizations to define outcome metrics not explicitly stated in FCSRCA Prepare timely national and clinic summary reports Validation QA Division of Reproductive Health's mission of "promoting optimal and equitable health in women and infants through public health surveillance, research, leadership, and partnership to move science to practice".

Federal Register Process “Administrative law” Discussions with SART Submission to Office of Management and Budget Draft published with comment period Final draft with at least 60 day period prior to implementation of rules

Who Reports? Physician group – “legal entity operating under state law” Has nothing to do with embryo laboratory

Role of SART Registry Committee SART Registry function Reports (CSR and National) Provide data for QA committee Identify outliers for Validation Committee Research All members elected by SART membership Work with CDC to coordinate data collection and reporting Synchronization of “NASS variables”, definition of terms, calculations etc. Work with QA and Research committees to plan collection of additional “meaningful” data fields not collected by NASS

SART – CORS versus NASS SART member programs send cycle specific data to SART under BAA SART-CORS and non-SART member programs send cycle specific data to NASS Westat is current CDC vendor for NASS (contract until 2017)

Embryo banking Defined under Federal Register notice in 2000 Excluded from Clinic Summary Report (CSR) because outcomes of fertility preservation cycles would not be expected to be known within the reporting time frame Accounted for less than one tenth of one percent of ART cycles in 2001 (85 / 108,000 cycles) Accounted for nearly 14,000 of 165,000 cycles in 2012 Most of the cycles were for purpose of “delayed transfer” not fertility preservation Large number of “hidden cycles” criticized widely As of 2014 will apply only to fertility preservation

Embryo banking Some patients may desire both short term pregnancy and fertility preservation Patient autonomy and physician counseling / treatment plan should not be impaired due to reporting rules Complex rules regarding handling are necessary for fair handling / transparency

New CSR Labels Primary transfer cycles Will include both fresh embryo transfers and first thaw cycle transfers (if fresh embryo transfer not performed). Subsequent transfer cycles FET’s not including primary transfers

Natural cycles No stimulation medications allowed (oral or injectable) Allow hCG for trigger purposes only Has been available for view by filter, but cycles have been included in the default (unfiltered) report

Minimal stimulation Consensus definition is elusive Concept is cycle done with intent to minimize burden to patient Minimal medication Minimal monitoring Decreased cost Likely associated with lower live birth per cycle outcomes in patients with average or good prognosis Some programs employ in “poor responder / poor prognosis” patients Important for consumers to be able to know outcomes for the fertility services “product” that they are buying Clinics can self-define SART will collect data regarding medication types / amounts

Research Cycles All research cycle specific data must be reported to SART-CORS or Westat directly Historically these cycle outcomes have been excluded from the CSR CDC has not decided how to report going forward SART currently plans to exclude from the default page, but allow “click to view” Confusion has existed between the designation of research versus “experimental”

Research Cycles Research designation has been ceded by CDC to the SART Research Committee SART Research Committee serves this function even for research applications for non-SART members Designation of “research” is correctly applied when research protocols might be expected to reduce the chance of pregnancy in “good prognosis” patients Designation of “research” should be avoided if it removes “poor prognosis” patients from the CSR

PGS / PGD Collected now during stimulation cycle or post-thaw Not currently collected in “fertility preservation” cycles Reason for PGS / PGD collected Allows application of filters PGS with no euploid embryos should correctly be regarded as a treatment failure Public reports are not “report cards” Failure to obtain “euploid embryos” may relate to: Patient factors Stimulation choice and execution Egg retrieval efficiency (physician and embryologist) ICSI technique Embryo culture Biopsy technique PGS laboratory accuracy

CSR Design New success metrics / rules Live birth per first cycle Total reproductive potential Live birth per patient New CSR filters / “click to view” metrics PGS / PGD Minimal stimulation “Filter in” versus “filter out” Comment box

Conclusions Public reporting is here to stay Public reports are not accurate indicators of program quality despite the desire by the public and third party payors to view them in that fashion No adjustment for “severity” of infertility / patient mix Incentive to discourage or deny care to poor prognosis patients No current adjustments for “burden of care”

Conclusions We must educate the public and insurers regarding the limitations of the public report The ART report is complex even for those individuals whose job is ART Data is best interpreted by patient with physician provider Goals are: Level playing field Transparency Provide improved data to facilitate the ability of physicians to help patients predict their chance of success with different ART treatments