In vitro fertilization (IVF) is a reproductive medical procedure in which an egg is fertilized by sperm in a test tube or elsewhere outside the body. IVF is often used as a form of infertility treatment. There are a number of legal and ethical issues that may arise in connection with IVF—including surrogacy contracts between prospective parents and an egg donor.
State and federal laws regulate IVF and other forms of infertility treatment, such as fertility drugs. For example, 14 states have passed laws that require insurers to cover infertility diagnosis and treatment.
These states include:
• Arkansas
• Connecticut
• Delaware
• Hawaii
• Illinois
• Louisiana
• Maryland
• Massachusetts
• Montana
• New Jersey
• New York
• Ohio
• Rhode Island
• West Virginia
And two states—California and Texas—have laws that require insurance companies to offer coverage for infertility treatment.
These laws vary from state to state in the coverage insurers are required to provide and the form of infertility treatments (drugs, IVF) that may be covered.
Federal 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, the U.S. Congress enacted the Fertility Clinic Success Rate and Certification Act (FCSRCA) in 1992, mandating that all ART clinics report success rate data to the federal government in a standardized manner. See 42 U.S.C. §263a-1.
The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 requires 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 three nonfederal laboratory accreditation Programs: (1) the College of American Pathologists/American Society for Reproductive Medicine (CAP/ASRM); (2) the Joint Commission on Accreditation of Healthcare Organizations (JACHO); and (3) the New York State Tissue Bank certification for ART laboratories (NYSTB).
CDC does not endorse these accreditation agencies, but rather is providing available laboratory accrediting information in all annual Success Rates Reports. Beginning in 2021, the New York State Tissue Bank Program will no longer be a recognized accreditation body for embryo laboratories.
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 Notice, which describes: (1) who must 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.
In South Carolina, in vitro fertilization (IVF) and other assisted reproductive technologies (ART) are not subject to specific state mandates regarding insurance coverage for infertility treatments. Unlike the fourteen states that have laws requiring such coverage, South Carolina does not mandate insurance coverage for infertility diagnosis and treatment, nor is it required to offer coverage. However, IVF clinics in South Carolina, as in all states, must comply with federal regulations under the Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992. This Act mandates that ART clinics report their success rates to the Centers for Disease Control and Prevention (CDC) to provide patients with reliable information about treatment success rates. Additionally, the Act requires embryo laboratories to be certified by recognized accreditation programs. While the New York State Tissue Bank is no longer recognized as an accreditation body for embryo laboratories starting in 2021, clinics in South Carolina must ensure that they work with laboratories accredited by other recognized programs. The CDC publishes annual reports detailing clinic-specific success rates and the certification statuses of embryo laboratories, which are based on data provided by ART clinics.
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