Policy Documents

The Fertility Clinic Success Rate and Certification Act

The first infant conceived with Assisted Reproductive Technology (ART) in the U.S. was born in 1981. As ART use increased throughout the 1980s, there was growing concern about the quality of ART information that infertility patients were receiving.

In response to concerns about data quality and comparability, Congress enacted the Fertility Clinic Success Rate and Certification Act (FCSRCA, or Public Law 102-493) in 1992, mandating that all ART clinics report success rate data to the federal government in a standardized manner.

The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandates that clinics performing ART annually provide data for all procedures performed to the Centers for Disease Control and Prevention (CDC) and sets forth definitions and reporting requirements, specifically sections 2(a), 2(b), 2(c), 6 and 8. CDC is required to use these data to report and publish clinic-specific success rates and certification of embryo laboratories. The details on who and how needs to report in order to be compliant with the law are described in Federal Register Notices published following the FCSRCA enactment.

Certification of Embryo Laboratories

The FCSRCA mandates that the Secretary, Health and Human Services (HHS), through the CDC, develop a model program for the certification of embryo laboratories, to be carried out voluntarily by interested states. The requirements for reporting the certification status of embryo laboratories, including definitions, administrative requirements, and embryo laboratory standards are described in the Federal Register Notice. Currently, certification of embryo laboratories can be done by one of the two nonfederal laboratory accreditation Programs: (1) the College of American Pathologists/American Society for Reproductive Medicine (CAP/ASRM), and (2) the Joint Commission on Accreditation of Healthcare Organizations (JACHO). CDC does not endorse these accreditation agencies, but rather is providing available laboratory accrediting information in all annual Success Rates Reports.

Fertility Clinic Success Rates Reporting

The FCSRCA mandates that all ART clinics report pregnancy success rates data to the CDC in a standardized manner. The details of reporting requirements are outlined in the Federal Register Notices, which describes: (1) who shall report to HHS/CDC, (2) the reporting system (NASS) and process for reporting by each ART program, (3) the data items and definition to be included in the reporting database, and (4) how pregnancy success rates will be defined and reported in the annual published reports, using the NASS data. The current reporting requirements for ART clinics using the National ART Surveillance System were published in the Federal Register Notice on August 26, 2015 (80 FR 51811). Since then, CDC published a notice in the Federal Register on clarifications and modifications on December 15, 2016 (81 FR 90854), and on October 22, 2018 (83 FR 53253) announcing the availability of the revised process for ART Success Rates Reporting. Additionally, a notice on clarifications and corrections was published on November 5, 2019 (84 FR 59625). CDC further published on April 20, 2021 (86 FR 20496) a final notice describing changes to the data validation process that would be implemented for calendar year 2022. Subsequently, CDC published a notice in the Federal Register on June 10, 2022 (87 FR 35555) that added data collection fields and modified reporting requirements to apply consistent data collection requirements to various treatment options, including certain rare situations, to improve quality of data.

To monitor the burden for fertility clinics by implementation of FCSRCA, the Office of Management and Budget (OMB) needs to review and approve the ART reporting system. In compliance with the Paperwork Reduction Act, CDC publishes a list of information collection requests under review by the OMB in the Federal Register Notice. This notice announces extension of OMB approval (OMB No. 0920-0556, exp. 12/31/2024) for a period of 3 years in accordance with the FCSRCA. As required by the FCSRCA, CDC currently collects information from all programs that perform ART services, and reports this information as specified in the Act.