Proposed Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures, 25009-25012 [2018-11628]
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Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
methods). Although it is possible that
notifications or responses may be
intercepted or seen by someone who is
not part of the team collecting the data,
it is not likely that this will have a major
impact on the respondents’ privacy.
CDC and contractors will also conduct
periodic usability and user experience
tests of StopAnthraxTM in conjunction
with points of dispensing (PODs)
exercises conducted by state and local
in the jurisdictional exercises through
one or more of the following
mechanisms; in-person focus groups,
online survey, online discussion groups.
CDC is requesting approval for this
new generic clearance for data
collection for a period of three years.
The total burden hours for respondents
is 38,000 hours. There are no costs to
respondents other than their time.
health departments across the US. The
purpose of these tests would be to
evaluate the acceptability of the
program with members of the potential
target audience following an anthrax
incident and to ensure proper
functionality of the StopAnthraxTM
protocols within the system. These tests
will occur no more than twice a year
and feedback on the program will be
collected from volunteers participating
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Type of respondents
Form name
Adult MCM recipient .........................
POD volunteer participating in user
experience/usability
testing
of
shortened StopAnthraxTM protocol.
POD volunteer participating in user
experience/usability testing.
POD volunteer participating in user
experience/usability testing.
60-day StopAnthraxTM program .......
Shortened (10-day) StopAnthrax
protocol.
20,000
4,000
1
1
90/60
30/60
30,000
2,000
Online Survey ...................................
2,000
1
1
2,000
Discussion/focus groups ..................
2,000
1
2
4,000
Total ...........................................
...........................................................
........................
........................
........................
38,000
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–11648 Filed 5–30–18; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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
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SUMMARY:
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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: https://
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:
artinfo@cdc.gov.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Sara
Crawford, Division of Reproductive
PO 00000
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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: artinfo@
cdc.gov.
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
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‘‘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
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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
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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:
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Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
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.
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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.
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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
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25011
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
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Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10599]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
July 30, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
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SUMMARY:
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17:46 May 30, 2018
Jkt 241001
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10599 Pre-Claim Review
Demonstration for Home Health
Services
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
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Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Pre-Claim
Review Demonstration for Home Health
Services; Use: Section 402(a)(1)(J) of the
Social Security Amendments of 1967
(42 U.S.C. 1395b–1(a)(1)(J)) authorizes
the Secretary to ‘‘develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
under the health programs established
by the Social Security Act (the Act).’’
Pursuant to this authority, the CMS
seeks to develop and implement a
Medicare demonstration project, which
CMS believes will help assist in
developing improved procedures for the
identification, investigation, and
prosecution of Medicare fraud occurring
among Home Health Agencies (HHA)
providing services to Medicare
beneficiaries.
This revised demonstration would
help assist in developing improved
procedures for the identification,
investigation, and prosecution of
potential Medicare fraud. The
demonstration would help make sure
that payments for home health services
are appropriate through either pre-claim
or postpayment review, thereby working
towards the prevention and
identification of potential fraud, waste,
and abuse; the protection of Medicare
Trust Funds from improper payments;
and the reduction of Medicare appeals.
CMS proposes initially implementing
the demonstration in Illinois, Ohio,
North Carolina, Florida, and Texas with
the option to expand to other states in
the Palmetto/JM jurisdiction. Under this
demonstration, CMS proposes to offer
choices for providers to demonstrate
their compliance with CMS’ home
health policies. Providers in the
demonstration states may participate in
either 100 percent pre-claim review or
100 percent postpayment review. These
providers will continue to be subject to
a review method until the HHA reaches
the target affirmation or claim approval
rate. Once a HHA reaches the target preclaim review affirmation or postpayment review claim approval rate, it
may choose to be relieved from claim
reviews, except for a spot check of their
claims to ensure continued compliance.
Providers who do not wish to
participate in either 100 percent preclaim or postpayment reviews have the
option to furnish home health services
and submit the associated claim for
payment without undergoing such
reviews; however, they will receive a 25
percent payment reduction on all claims
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]]>Agencies
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25009-25012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11628]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://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
