83 FR 25009 - Proposed Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 105 (May 31, 2018)

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requests comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. The footnotes will identify clinics that are selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and that: (1) Do participate, (2) do participate and have major data discrepancies identified through this process, and/or U3) decline to participate in the data validation process. CDC requests comments on this plan in order to continue to ensure that the public has access to accurate and transparent data pursuant to the Fertility Clinic Success Rate and Certification Act of 1992.

[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25009-25012]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2018-0054]


Proposed Assisted Reproductive Technology (ART) Success Rates 
Reporting and Data Validation Procedures

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) requests comments on a 
plan to (1) revise the definition and characterization of Assisted 
Reproductive Technology (ART) success rates and (2) introduce clinic 
validation footnotes for the annual ART Fertility Clinic Success Rates 
Report. The footnotes will identify clinics that are selected by CDC to 
participate in the validation process of the National ART Surveillance 
System (NASS) data and that: (1) Do participate, (2) do participate and 
have major data discrepancies identified through this process, and/or 
U3) decline to participate in the data validation process. CDC requests 
comments on this plan in order to continue to ensure that the public 
has access to accurate and transparent data pursuant to the Fertility 
Clinic Success Rate and Certification Act of 1992.

DATES: Written comments must be received on or before July 2, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0054 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Sara Crawford, Division of Reproductive Health, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS 
F-74, Atlanta, Georgia 30341. Phone: (770) 488-6370. Email: 
[email protected].
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sara Crawford, Division of 
Reproductive Health, National Center for Chronic Disease Prevention and 
Health Promotion, Centers for Disease Control and Prevention, 4770 
Buford Highway NE, MS F-74, Atlanta, Georgia 30341. Phone: (770) 488-
6370. Email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Success Rates

A. Background

    Section 2(a) of Public Law 102-493 (42 U.S.C. 263a-1(a)), the 
Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 
requires that each assisted reproductive technology (ART) program 
report annually to the Secretary of the Department of Health and Human 
Services through the Centers for Disease Control and Prevention (CDC) 
pregnancy success rates achieved through assisted reproductive 
technology. The FCSRCA also requires the CDC to annually publish and 
distribute to the public reported pregnancy success rates. According to 
the FCSRCA, the definitions of pregnancy success rates should be 
developed in consultation with appropriate consumer and professional 
organizations, should take into account the effect on success rates of 
age, diagnosis, and other significant factors, and should include the 
live birth rate per attempted ovarian stimulation procedure and the 
live birth rate per successful oocyte retrieval.
    Specifics about the reporting process and requirements are 
described in

[[Page 25010]]

``Reporting of Pregnancy Success Rates from Assisted Reproductive 
Technology (ART) Programs'' (80 FR 51811). Specifics about the 
definition and characterization of ART success rates were last 
described in ``Reporting of Pregnancy Success Rates from Assisted 
Reproductive Technology Programs'' (69 FR 5548). Success rates for 
fresh, nondonor cycles were defined as: (1) The rate of pregnancy after 
completion of ART according to the number of all ovarian stimulation or 
monitoring procedures;
    (2) the rate of live birth after completion of ART according to the 
number of all ovarian stimulation or monitoring procedures, the number 
of oocyte retrieval processes, and the number of embryo (or zygote or 
oocyte) transfer procedures; (3) the rate of singleton live birth after 
completion of ART according to the number of all ovarian stimulation or 
monitoring procedures and the number of embryo (or zygote or oocyte) 
transfer procedures. Success rates for cycles using thawed embryos and 
cycles using donor oocytes or embryos were defined as: (4) The rate of 
live birth after completion of ART according to the number of embryo 
(or zygote or oocyte) transfer procedures; (5) the rate of singleton 
live birth after completion of ART according to the number of embryo 
(or zygote or oocyte) transfer procedures.
    Effective for reporting year 2017, CDC is proposing substantial 
changes to the definition and characterization of ART success rates due 
to changes in clinical practice and more variation in treatment 
options, including improvements in cryopreservation resulting in more 
segmentation of typical treatment cycles. The field of ART is moving 
toward the calculation and reporting of cumulative success rates where 
data collection systems can collect successes over all embryo transfers 
from a single oocyte retrieval or across several oocyte retrievals and 
embryo transfers. After consultation with consumer and professional 
organizations with expertise in ART, CDC will begin cumulative ART 
success rates reporting in reporting year 2017. The ART success rates 
described in this Federal Register notice shall replace those 
previously described in 2004.

B. ART Procedures Among Patients Using Their Own Oocytes

    ART success rates for ART procedures among all patients using their 
own eggs will be defined as:
    1. The rate of live birth or singleton live birth resulting from 
the transfer of oocytes retrieved from the patient in the year prior to 
the reporting year or from the transfer of embryos created from oocytes 
retrieved from the patient in the year prior to the reporting year. For 
the purpose of this definition, transfer procedures must have started 
within 12 months of the start of the retrieval procedure. Oocytes must 
have been retrieved in the year prior to the reporting year in order to 
allow for a full year to perform transfers of the retrieved oocytes 
(either in the prior reporting year or in the current reporting year). 
The live birth rate and singleton live birth rate will be presented 
according to the number of:
    a. All ovarian stimulation or monitoring procedures started from 
the year prior to the reporting year with the intent to retrieve 
oocytes from the patient.
    b. All ovarian stimulation or monitoring procedures started in the 
year prior to the reporting year with the intent to retrieve oocytes 
from the patient in which at least one oocyte was retrieved.
    c. All transfer procedures of at least one oocyte retrieved from 
the patient in the year prior to the reporting year, or of at least one 
embryo created from an oocyte retrieved from the patient in the year 
prior to the reporting year. For the purpose of this definition, egg or 
embryo transfer procedures must have started within 12 months of the 
start of the retrieval procedure.
    2. The number of ovarian stimulation or monitoring procedures 
started in the year prior to the reporting year with the intent to 
retrieve oocytes from the patient presented according to the number of:
    a. Live births resulting from all transfers of at least one oocyte 
retrieved from the patient in the year prior to the reporting year, or 
transfers of at least one embryo created from an oocyte retrieved from 
the patient in the year prior to the reporting year. For the purpose of 
this definition, egg or embryo transfer procedures must have started 
within 12 months of the start of the retrieval procedure.
    Other rates for ART procedures among all patients using their own 
eggs may be defined as--
    3. The rate of cancellation, implantation, pregnancy, live birth, 
singleton live birth, multiple live birth, twin live birth, triplet or 
higher order live birth, preterm live birth, low birthweight live birth 
or term, normal birthweight and singleton live birth resulting from the 
transfer of oocytes retrieved from the patient in the year prior to the 
reporting year or the transfer of embryos created from oocytes 
retrieved from the patient in the year prior to the reporting year. For 
the purpose of this definition, transfer procedures must have started 
within 12 months of the start of the retrieval procedure. These other 
rates may be presented according to the number of:
    a. All ovarian stimulation or monitoring procedures started in the 
year prior to the reporting year with the intent to retrieve oocytes 
from the patient.
    b. All ovarian stimulation or monitoring procedures started in the 
year prior to the reporting year with the intent to retrieve oocytes 
from the patient in which at least one oocyte was retrieved.
    c. All transfer procedures of at least one oocyte retrieved from 
the patient in the year prior to the reporting year, or of at least one 
embryo created from an oocyte retrieved from the patient in the year 
prior to the reporting year. For the purpose of this definition, egg or 
embryo transfer procedures must have started within 12 months of the 
start of the retrieval procedure.
    d. All first, second, third, or more transfer procedures after 
retrieval of at least one oocyte from the patient in the year prior to 
the reporting year, or of at least one embryo created from an oocyte 
retrieved from the patient in the year prior to the reporting year. For 
the purpose of this definition, egg or embryo transfer procedures must 
have started within 12 months of the start of the retrieval procedure.
    Rates for ART procedures among new ART patients (i.e., patients 
that have never had a prior ART cycle ever) using their own oocytes 
will be defined as--
    4. The rate of live birth resulting from the transfer of oocytes or 
embryos from all first intended oocyte retrievals presented according 
to the number of:
    a. ART patients who reported at the start of the retrieval 
procedure that they had no prior ART stimulations and no prior frozen 
ART procedures. For the purpose of this definition, the retrieval 
procedure must have started in the year prior to the reporting year.
    5. The rate of live birth resulting from the transfer of oocytes or 
embryos from all first or second intended oocyte retrievals presented 
according to the number of:
    a. ART patients who reported at the start of the retrieval 
procedure that they had no prior ART stimulations and no prior frozen 
ART procedures. For the purpose of this definition, the retrieval 
procedure must have started in the year prior to the reporting year.
    6. The rate of live birth resulting from the transfer of oocytes or 
embryos from all intended oocyte retrievals presented according to the 
number of:

[[Page 25011]]

    a. ART patients who reported at the start of the retrieval 
procedure that they had no prior ART stimulations and no prior frozen 
ART procedures. For the purpose of this definition, the retrieval 
procedure must have started in the year prior to the reporting year.
    7. The number of ovarian stimulation or monitoring procedures 
started in the year prior to the reporting year with the intent to 
retrieve oocytes from the patient presented according to the number of:
    a. ART patients who reported at the start of the retrieval 
procedure that they had no prior ART stimulations and no prior frozen 
ART procedures.
    8. The number of transfer procedures of at least one oocyte 
retrieved from the patient in the year prior to the reporting year, or 
of at least one embryo created from an oocyte retrieved from the 
patient in the year prior to the reporting year presented according to 
the number of:
    a. Ovarian stimulation or monitoring procedures started in the year 
prior to the reporting year with the intent to retrieve oocytes from 
the patient. For the purpose of this definition, egg or embryo transfer 
procedures must have started within 12 months of the start of the 
retrieval procedure. Also, ART patients must have reported at the start 
of the retrieval procedure that they had no prior ART stimulations and 
no prior frozen ART procedures.

C. ART Procedures Among Patients Using Oocytes or Embryos From a Donor

    Success rates for ART procedures among patients using oocytes or 
embryos from a donor will be defined as--
    9. The rate of live birth or singleton live birth presented 
according to the number of:
    a. Transfer procedures of at least one donor egg, embryo created 
from a donor egg, or donated embryo started in the current reporting 
year.
    Other rates for ART procedures among patients using oocytes or 
embryos from a donor may also be defined as--
    10. The rate of cancellation, implantation, pregnancy, live birth, 
singleton live birth, multiple live birth, twin live birth, triplet or 
higher order live birth, preterm live birth, low birthweight live 
birth, or term, normal birthweight and singleton live birth presented 
according to the number of:
    a. ART procedures to prepare a patient (recipient) for the transfer 
of at least one donor egg, embryo created from a donor egg, or donated 
embryo, started in the current reporting year.
    b. Transfer procedures of at least one donor egg, embryo created 
from a donor egg, or donated embryo started in the current reporting 
year.

D. ART Procedures Among All Patients and All Cycle Types

    ART reporting may also include:
    11. The number, average number or percentage of ART procedures or 
ART patients with certain characteristics, such as:
    a. Patient characteristics (e.g. patient age or reason for ART).
    b. ART procedure characteristics (e.g. type of treatment (fertility 
preservation, short term banking, in vitro fertilization, gamete 
intrafallopian transfer, zygote intrafallopian transfer), stimulation 
protocol, source of the oocytes or embryos (patient or donor), the 
state of the oocytes or embryos (fresh or frozen), the intent of the 
procedure, the use of prenatal genetic diagnosis or screening, the use 
of intracytoplasmic sperm injection, the use of assisted hatching, the 
use of a gestational carrier, the stage of the embryo at transfer, or 
the number of embryos transferred).
    All ART patient and procedure characteristics, ART success rates, 
and other rates for patients using their own oocytes as well as for 
patients using oocytes or embryos from a donor may be stratified by 
factors thought to influence the outcome of an ART procedure.
    12. Factors for stratification may include:
    a. Characteristics of the ART patient such as patient age or reason 
for ART.
    b. Characteristics of the ART procedure such as type of treatment 
(fertility preservation, short term banking, in vitro fertilization, 
gamete intrafallopian transfer, zygote intrafallopian transfer), 
stimulation protocol, the source of the oocytes or embryos (patient or 
donor), the state of the oocytes or embryos (fresh or frozen), the 
intent of the procedure, the use of prenatal genetic diagnosis or 
screening, the use of intracytoplasmic sperm injection, the use of 
assisted hatching, the use of a gestational carrier, the stage of the 
embryo at transfer, or the number of embryos transferred.
Section II. Validation
    A description of external validation of clinic data conducted 
annually as a part of the ART surveillance program is described in 
``Reporting of Pregnancy Success Rates from Assisted Reproductive 
Technology (ART) Programs'' (80 FR 51811). This notice explains, ``If 
major data discrepancies are identified during data validation (e.g., 
lack of supporting information for pregnancy outcomes, underreporting 
cycles, etc.), CDC may re-select these ART programs for data validation 
during the following reporting year(s) to assess corrections of 
identified data errors.''
    Additionally, effective as of the 2019 reporting year, CDC will 
include a footnote in the annual ART Fertility Clinic Success Rates 
Report to identify clinics that are selected by CDC to participate in 
the validation process of the NASS data and that: 1) do participate, 2) 
do participate and have major data discrepancies identified through 
this process, and/or 3) decline to participate in the data validation 
process. CDC will include this footnote pending the availability of the 
necessary resources. This footnote is a new addition to the annual ART 
Fertility Clinic Success Rates Report. Pursuant to the Fertility Clinic 
Success Rate and Certification Act of 1992, the CDC is mandated to 
publish the clinic-specific success rates reported by each clinic. 
These footnotes will help to alert the public if there is evidence that 
the reported success rates may be of questionable quality, thereby 
increasing the transparency of the data reporting process.
    If a clinic is selected to participate in the NASS data validation 
process and does participate, the following footnote will be added:

    This clinic was visited for validation of (insert: reporting 
year) data. See Appendix A for additional information.

If a clinic is selected to participate in the NASS data validation 
process, does participate, and major data discrepancies are identified 
for either the number of reported ART cycles or the ART pregnancy 
outcome, the following footnote will be added:

    This clinic was visited for validation of (insert: reporting 
year) data. Major data discrepancies were identified for (insert: 
``the number of reported cycles'' or ``the pregnancy outcomes'' or 
``the number of reported cycles and the pregnancy outcomes''). See 
Appendix A for additional information.

If a clinic is selected to participate in the NASS data validation 
process and declines to participate, the following footnote will be 
added:

    This clinic was selected for validation of (insert: reporting 
year) data, but declined to participate. See Appendix A for 
additional information.

    Appendix A of the ART Fertility Clinic Success Rates Report 
contains information about the validation of NASS data, including 
methods used for clinic selection, and displays aggregate validation 
results. Aggregate validation results include national discrepancy

[[Page 25012]]

rates; clinic-specific discrepancy rates are not reported. Any footnote 
added to a clinic's success rates page in the ART Fertility Clinic 
Success Rates Report will appear only for the reporting year that the 
clinic was selected for validation; it will be removed the following 
reporting year.

    Dated: May 24, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-11628 Filed 5-30-18; 8:45 am]
 BILLING CODE 4163-18-P