83 FR 53253 - 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 204 (October 22, 2018)

On May 31, 2018, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requested 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. In the plan, CDC proposed to include the footnotes to identify clinics selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and: (a) Do participate, (b) do participate and have major data discrepancies identified through this process, or (c) decline to participate in the data validation process. This notice responds to the comments received in response to the notice published on May 31, 2018 and announces the availability of the revised process for ART Success Rates Reporting and plans for revising Data Validation Procedures.

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53253-53256]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2018-0054]


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

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

ACTION: Notice of availability.

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SUMMARY: On May 31, 2018, the Centers for Disease Control and 
Prevention (CDC) in the Department of Health and Human Services (HHS) 
requested 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. In the plan, CDC proposed to 
include the footnotes to identify clinics selected by CDC to 
participate in the validation process of the National ART Surveillance 
System (NASS) data and: (a) Do participate, (b) do participate and have 
major data discrepancies identified through this process, or (c) 
decline to participate in the data validation process. This notice 
responds to the comments received in response to the notice published 
on May 31, 2018 and announces the availability of the revised process 
for ART Success Rates Reporting and plans for revising Data Validation 
Procedures.

FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive 
Health, National Center for Chronic Disease Prevention and Health 
Promotion, Centers for Disease Control and Prevention, 4770 Buford 
Highway NE, Mailstop F-74, Atlanta, Georgia 30341. Telephone: (770) 
488-5200; email: [email protected].

Public Comment Summary and Responses

    CDC received three public comments to the docket. One comment was 
considered nonsubstantive because it was outside the scope of the 
docket. A second comment was supportive of CDC's planned approach for 
revising the definition of success rates and introducing clinic 
validation footnotes. The third comment contained concerns about CDC's 
planned clinic validation footnotes and the approach to clinic 
validation, and requested a clarification of the reporting requirements 
of embryo banking cycles. These suggestions, as well as CDC's 
responses, are included below:
    1. ART success rates reporting: One commenter asked that CDC 
provide more details about reporting requirements of embryo banking 
cycles.
    Response: CDC thanks the commenter for this request. Egg/embryo 
banking cycles intended for pregnancy in the short term include cycles 
initiated with the intent of cryopreserving all eggs/embryos for 
subsequent transfers within 12 months. Egg/embryo banking cycles 
intended for pregnancy in the long term (often referred to as fertility 
preservation) include cycles where the patient did not start any 
transfer cycles within the 12 month period following the date on which 
the intended retrieval cycle started and one of the following: (1) The 
cycle intent was long term (>12 months) banking for fertility 
preservation prior to gonadotoxic medical treatments; or (2) The cycle 
intent was long term (>12 months) banking for other reasons and (a) at 
least one egg was retrieved, and (b) at least one egg or embryo was 
frozen. Specifics about the reporting process and requirements are 
described in ``Reporting of Pregnancy Success Rates

[[Page 53254]]

from Assisted Reproductive Technology (ART) Programs'' (80 FR 51811).
    2. Clinic data validation and footnotes: A commenter expressed 
concern that discrepancies identified during on-site data validation 
would not be corrected prior to publication of the ART Fertility Clinic 
Success Rates Report. The commenter suggested that instead of including 
a footnote, identification of erroneous data (such as an incorrect 
number of reported cycles or pregnancy outcomes) should result in 
removing clinic success rates from ART Fertility Clinic Success Rates 
Report, and that erroneous data should not be included with data from 
other clinics. The commenter was also concerned that random selection 
of clinics under the current CDC validation system does not identify 
systematic reporting errors. The commenter suggested that targeted 
selection of clinics based on reporting characteristics that predict 
erroneously inflated ART success rates is a better approach to identify 
systematic reporting errors. Finally, the commenter was concerned that 
validation footnotes and the appendix may not be easily understood by 
the patients.
    Response: CDC thanks the commenter for expressing these concerns 
and for providing suggestions to improve reporting. CDC is considering 
these concerns and reviewing options for future years' data validation. 
CDC is withdrawing its pending proposal for data validation footnotes 
(83 FR 25009). If CDC determines that changes in data validation 
selection processes and/or footnotes are advisable, proposed changes 
will be published in the Federal Register for public comment.

Appendix--Notice for Assisted Reproductive Technology (ART) Success 
Rates Reporting:

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 CDC to annually publish and 
distribute to the public reported pregnancy success rates for each ART 
clinic. 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 ``Reporting of Pregnancy Success Rates from Assisted 
Reproductive Technology (ART) Programs'' (August 26, 2015; 80 FR 
(51811-51819)). Specifics about the definition and characterization of 
ART success rates were last described in ``Reporting of Pregnancy 
Success Rates from Assisted Reproductive Technology Programs'' 
(February 5, 2004; 69 FR (5548-5550)). 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 implementing 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 are 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 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 are defined as follows (and may be provided publically at the ART 
program's discretion)--
    3. The rate of cancellation, implantation, pregnancy, live birth,

[[Page 53255]]

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 are 
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:
    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 are 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 are defined as follows (and may be provided 
publically at the ART program's discretion):
    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

    At the discretion of the ART program, ART reporting also may 
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 CDC 
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.


[[Page 53256]]


    Dated: October 17, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-22991 Filed 10-19-18; 8:45 am]
 BILLING CODE 4163-18-P