Transcript Public Reporting of ART Outcomes

Public Reporting of ART
Outcomes
Kevin Doody MD
[email protected]
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
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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
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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:
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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