Notice of Request for Public Comment on Two Draft Recommendations To Update the HRSA-Supported Women's Preventive Services Guidelines Relating to Screening for Diabetes in Pregnancy and Screening for Type 2 Diabetes After Pregnancy, 66310-66312 [2022-23860]
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
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Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23866 Filed 11–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Request for Public Comment
on Two Draft Recommendations To
Update the HRSA-Supported Women’s
Preventive Services Guidelines
Relating to Screening for Diabetes in
Pregnancy and Screening for Type 2
Diabetes After Pregnancy
Health Resources and Services
Administration, Department of Health
and Human Services.
AGENCY:
ACTION:
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Notice.
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
This notice seeks comments
on two draft recommendations to
update the HRSA-Supported Women’s
Preventive Services Guidelines
(‘‘Guidelines’’) relating to Screening for
Diabetes in Pregnancy and Screening for
Type 2 Diabetes after Pregnancy. The
existing Guidelines address Screening
for Gestational Diabetes Mellitus (GDM)
and Screening for Diabetes Mellitus
after Pregnancy. These draft
recommendations have been developed
through a cooperative agreement,
known as the Women’s Preventive
Services Initiative (WPSI), with the
American College of Obstetricians and
Gynecologists (ACOG), through which
they convene health professionals to
develop draft recommendations. Under
applicable law, non-grandfathered
group health plans and health insurance
issuers offering non-grandfathered
group and individual health insurance
coverage must include coverage,
without cost sharing, for certain
preventive services, including those
provided for in the HRSA-supported
Guidelines. The Departments of Labor,
Health and Human Services, and the
Treasury have previously issued
regulations, which describe how group
health plans and health insurance
issuers apply the coverage requirements.
DATES: Members of the public are
invited to provide written comments no
later than December 5, 2022. All
comments received on or before this
date will be reviewed and considered by
WPSI and provided for further
consideration by HRSA in determining
the recommended updates that it will
support.
SUMMARY:
Members of the public who
wish to provide comments can do so by
accessing the public comment web page
at https://www.hrsa.gov/womensguidelines.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
SUPPLEMENTARY INFORMATION: Under
section 1001(5) of the Patient Protection
and Affordable Care Act, Public Law
111–148, which added section 2713 to
the Public Health Service Act, 42 U.S.C.
300gg–13, the preventive care and
screenings set forth in the Guidelines
are required to be covered without costsharing by certain group health plans
and health insurance issuers. HRSA
established the Guidelines in 2011
based on expert recommendations by
the Institute of Medicine, now known as
the National Academy of Medicine,
developed under a contract with the
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Department of Health and Human
Services. Since 2011, there have been
advancements in science and gaps
identified in these guidelines, including
a greater emphasis on practice-based
clinical considerations. Accordingly,
since March 2016, HRSA has funded
cooperative agreements with ACOG,
known as the WPSI, to convene a
coalition representing clinicians,
academics, and consumer-focused
health professional organizations to
conduct a rigorous review of current
scientific evidence, solicit and consider
public input, and make
recommendations to HRSA regarding
updates to the Guidelines to improve
adult women’s health across the
lifespan. HRSA then determines
whether to support, in whole or in part,
the recommended updates to the
Guidelines. Under the cooperative
agreement, ACOG formed WPSI,
consisting of an Advisory Panel and two
expert committees, the
Multidisciplinary Steering Committee
and the Dissemination and
Implementation Steering Committee,
which are comprised of a broad
coalition of organizational
representatives who are experts in
disease prevention and women’s health
issues. With oversight by the Advisory
Panel, and with input from the
Multidisciplinary Steering Committee,
WPSI examines the evidence to develop
new (and update existing)
recommendations for women’s
preventive services. WPSI’s
Dissemination and Implementation
Steering Committee then takes the
HRSA-approved recommendations and
disseminates them through the
development of implementation tools
and resources for both patients and
practitioners.
WPSI bases its recommended updates
to the Guidelines on review and
synthesis of existing clinical guidelines
and new scientific evidence, following
the National Academy of Medicine
standards for establishing foundations
for and rating strengths of
recommendations, articulation of
recommendations, and external reviews.
Additionally, HRSA requires that WPSI
incorporate processes to assure
opportunity for public comment,
including participation by patients and
consumers, in the development of the
updated Guidelines.
The existing Guidelines relating to
diabetes state:
24 and 28 weeks of gestation) in order
to prevent adverse birth outcomes.
Screening with a 50-g oral glucose
challenge test (followed by a 3-hour
100-g oral glucose tolerance test if
results on the initial oral glucose
challenge test are abnormal) is preferred
because of its high sensitivity and
specificity.
WPSI suggests that women with risk
factors for diabetes mellitus be screened
for preexisting diabetes before 24 weeks
of gestation—ideally at the first prenatal
visit, based on current clinical best
practices.’’
‘‘Screening for Gestational Diabetes
Mellitus
WPSI recommends screening
pregnant women for GDM after 24
weeks of gestation (preferably between
WPSI also proposes to update the
Screening for Diabetes Mellitus after
Pregnancy Guideline to revise the title
to read ‘‘Screening for Type 2 Diabetes
after Pregnancy’’ and to revise the
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‘‘Screening for Diabetes Mellitus After
Pregnancy
WPSI recommends women with a
history of GDM who are not currently
pregnant and who have not previously
been diagnosed with type 2 diabetes
mellitus should be screened for diabetes
mellitus. Initial testing should ideally
occur within the first year postpartum
and can be conducted as early as 4–6
weeks postpartum (see Table 1).
Women with a negative initial
postpartum screening test result should
be rescreened at least every 3 years for
a minimum of 10 years after pregnancy.
For women with a positive postpartum
screening test result, testing to confirm
the diagnosis of diabetes is indicated
regardless of the initial test (e.g., oral
glucose tolerance test, fasting plasma
glucose, or hemoglobin A1c). Repeat
testing is indicated in women who were
screened with hemoglobin A1c in the
first 6 months postpartum regardless of
the result.’’
Draft Updated Clinical
Recommendations for Public Comment
Screening for Diabetes in Pregnancy
WPSI proposes to update the
Screening for GDM Guideline to revise
the title to read ‘‘Screening for Diabetes
in Pregnancy’’ and to revise the clinical
recommendation to read: ‘‘The Women’s
Preventive Services Initiative
recommends screening pregnant women
for GDM after 24 weeks of gestation
(preferably between 24 and 28 weeks of
gestation) to prevent adverse birth
outcomes. WPSI recommends screening
pregnant women with risk factors for
type 2 diabetes or GDM before 24 weeks
of gestation—ideally at the first prenatal
visit.’’
Screening for Type 2 Diabetes After
Pregnancy
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
clinical recommendation to read: ‘‘The
WPSI recommends screening for type 2
diabetes in women with a history of
GDM who are not currently pregnant
and who have not previously been
diagnosed with type 2 diabetes. Initial
testing should ideally occur within the
first year postpartum and can be
conducted as early as 4–6 weeks
postpartum. Women who were not
screened in the first year postpartum or
women with a negative initial
postpartum screening test result should
be screened at least every 3 years for a
minimum of 10 years after pregnancy.
For those with a positive screening test
result in the early postpartum period
(i.e., 4–6 weeks postpartum), testing
should be repeated at least 6 months
postpartum to confirm the diagnosis of
diabetes regardless of the type of initial
test (e.g., fasting plasma glucose,
hemoglobin A1c, oral glucose tolerance
test). Repeat testing is also indicated for
women screened with hemoglobin A1c
in the first 6 months postpartum
regardless of whether the test results are
positive or negative because the
hemoglobin A1c test is less accurate
during the first 6 months postpartum.’’
lotter on DSK11XQN23PROD with NOTICES1
Discussion of Updated Clinical
Recommendations
Screening for Diabetes in Pregnancy
WPSI recommended three updates to
the Guideline on Screening for GDM.
The first change is a revision to the title
of the Guideline from ‘‘Screening for
GDM’’ to ‘‘Screening for Diabetes in
Pregnancy.’’ This change to the title was
made for consistency with the clinical
recommendation, which includes
screening for gestational diabetes and
screening for preexisting diabetes, as the
previous title described a more limited
scope in screening. The second update
recommended by WPSI is to change
language in the second sentence of the
recommendation from ‘‘diabetes
mellitus’’ to ‘‘type 2 diabetes or GDM.’’
This change reflects that ‘‘diabetes
mellitus’’ is commonly described as
type 2 diabetes. Third, WPSI modified
the recommendation by relocating the
information on specific types of
screening to the Implementation
Considerations section of the Guideline.
The existing Guideline recommends the
2-step approach, because of its high
sensitivity and specificity. In its
recommended update, WPSI continues
to recommend the 2-step approach, but
has relocated it to the Implementation
Considerations section, and also added
the 1-step approach to the list of
screening modalities in the
Implementation Considerations section,
because both approaches are acceptable
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Jkt 259001
screening tests based on studies
described in the updated 2021 United
States Preventive Services Task Force
evidence review. Both the 1-step and 2step screening modalities are within the
scope of this Guideline.
Screening for Type 2 Diabetes After
Pregnancy
WPSI also recommended five updates
to the Guideline on Screening for
Diabetes Mellitus After Pregnancy. First,
WPSI recommended updating the title
of the Guideline by changing it from
‘‘Screening for Diabetes Mellitus After
Pregnancy’’ to ‘‘Screening for Type 2
Diabetes After Pregnancy.’’ This change
was made because ‘‘diabetes mellitus’’
is now more commonly described as
type 2 diabetes. Second, WPSI
recommended removing the reference to
Table 1 based upon feedback from the
clinical community, noting that the
table might be confusing and could be
simplified in written format, and
recommended including this
information in narrative form. Third,
WPSI recommends screening for
‘‘women who are not screened in the
first year postpartum’’ and ‘‘women
with a positive screening test result in
early postpartum.’’ This
recommendation was added to ensure
screening for women who were not
screened postpartum for various reasons
(e.g., scheduling, lack of transportation,
availability of testing, etc.), and to
reflect that universal screening for
women with a history of GDM is more
appropriate than risk-based screening
because the risk of developing type 2
diabetes is high among all such
individuals. Fourth, WPSI also
recommended adding new language to
recommend repeat testing after 6
months postpartum to confirm a
positive test result from the early
postpartum period (4–6 weeks
postpartum). Fifth, WPSI also
recommended adding new language to
the Guideline explaining that
hemoglobin A1c tests conducted within
the first 6 months postpartum should be
repeated because the test is less accurate
when conducted during the first 6
months postpartum. Screening for type
2 diabetes after pregnancy as described
in this Guideline, including follow-up
diabetes screening testing, is within the
scope of this Guideline.
Members of the public can view each
complete updated draft
recommendation by accessing the
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Sfmt 4703
initiative’s web page at https://
www.womenspreventivehealth.org/.
Carole Johnson,
Administrator.
[FR Doc. 2022–23860 Filed 11–2–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of the President’s
Advisory Commission on Asian
Americans, Native Hawaiians, and
Pacific Islanders Meeting and
Solicitation for Written Comment
Department of Health and
Human Services, Office of the Secretary,
Office for Civil Rights, White House
Initiative on Asian Americans, Native
Hawaiians, and Pacific Islanders.
ACTION: Notice of meeting and
solicitation for written comment.
AGENCY:
As required by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the President’s Advisory
Commission on Asian Americans,
Native Hawaiians, and Pacific Islanders
will hold a virtual, two-day meeting on
December 5 and December 6, 2022.
DATES: The Commission will meet on
December 5, 2022, and December 6,
2022, from 4:00 p.m. Eastern Time (ET)
to approximately 7:00 p.m. ET on both
days. The confirmed time and agenda
will be posted on the website for the
President’s Advisory Commission on
Asian Americans, Native Hawaiians,
and Pacific Islanders: https://
www.hhs.gov/about/whiaanhpi/
commission/ when this
information becomes available.
Written comments, in response to the
questions listed below, will be accepted
via email at AANHPICommission@
hhs.gov with the subject line
‘‘PACAANHPI: Response to <insert the
issue and question>.’’ To be assured
consideration in the development of
future recommendations, written
comments must be submitted and
received at the email address provided
above, no later than 11:59 p.m. ET on
Thursday, December 1, 2022.
Submissions received after the deadline
will not be reviewed.
ADDRESSES: The meeting will be live
streamed. Registration is required
through the following link: https://
www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-registration-449829250397.
FOR FURTHER INFORMATION CONTACT:
Caroline Goon, Designated Federal
SUMMARY:
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66310-66312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Request for Public Comment on Two Draft Recommendations
To Update the HRSA-Supported Women's Preventive Services Guidelines
Relating to Screening for Diabetes in Pregnancy and Screening for Type
2 Diabetes After Pregnancy
AGENCY: Health Resources and Services Administration, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 66311]]
SUMMARY: This notice seeks comments on two draft recommendations to
update the HRSA-Supported Women's Preventive Services Guidelines
(``Guidelines'') relating to Screening for Diabetes in Pregnancy and
Screening for Type 2 Diabetes after Pregnancy. The existing Guidelines
address Screening for Gestational Diabetes Mellitus (GDM) and Screening
for Diabetes Mellitus after Pregnancy. These draft recommendations have
been developed through a cooperative agreement, known as the Women's
Preventive Services Initiative (WPSI), with the American College of
Obstetricians and Gynecologists (ACOG), through which they convene
health professionals to develop draft recommendations. Under applicable
law, non-grandfathered group health plans and health insurance issuers
offering non-grandfathered group and individual health insurance
coverage must include coverage, without cost sharing, for certain
preventive services, including those provided for in the HRSA-supported
Guidelines. The Departments of Labor, Health and Human Services, and
the Treasury have previously issued regulations, which describe how
group health plans and health insurance issuers apply the coverage
requirements.
DATES: Members of the public are invited to provide written comments no
later than December 5, 2022. All comments received on or before this
date will be reviewed and considered by WPSI and provided for further
consideration by HRSA in determining the recommended updates that it
will support.
ADDRESSES: Members of the public who wish to provide comments can do so
by accessing the public comment web page at https://www.hrsa.gov/womens-guidelines.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
[email protected].
SUPPLEMENTARY INFORMATION: Under section 1001(5) of the Patient
Protection and Affordable Care Act, Public Law 111-148, which added
section 2713 to the Public Health Service Act, 42 U.S.C. 300gg-13, the
preventive care and screenings set forth in the Guidelines are required
to be covered without cost-sharing by certain group health plans and
health insurance issuers. HRSA established the Guidelines in 2011 based
on expert recommendations by the Institute of Medicine, now known as
the National Academy of Medicine, developed under a contract with the
Department of Health and Human Services. Since 2011, there have been
advancements in science and gaps identified in these guidelines,
including a greater emphasis on practice-based clinical considerations.
Accordingly, since March 2016, HRSA has funded cooperative agreements
with ACOG, known as the WPSI, to convene a coalition representing
clinicians, academics, and consumer-focused health professional
organizations to conduct a rigorous review of current scientific
evidence, solicit and consider public input, and make recommendations
to HRSA regarding updates to the Guidelines to improve adult women's
health across the lifespan. HRSA then determines whether to support, in
whole or in part, the recommended updates to the Guidelines. Under the
cooperative agreement, ACOG formed WPSI, consisting of an Advisory
Panel and two expert committees, the Multidisciplinary Steering
Committee and the Dissemination and Implementation Steering Committee,
which are comprised of a broad coalition of organizational
representatives who are experts in disease prevention and women's
health issues. With oversight by the Advisory Panel, and with input
from the Multidisciplinary Steering Committee, WPSI examines the
evidence to develop new (and update existing) recommendations for
women's preventive services. WPSI's Dissemination and Implementation
Steering Committee then takes the HRSA-approved recommendations and
disseminates them through the development of implementation tools and
resources for both patients and practitioners.
WPSI bases its recommended updates to the Guidelines on review and
synthesis of existing clinical guidelines and new scientific evidence,
following the National Academy of Medicine standards for establishing
foundations for and rating strengths of recommendations, articulation
of recommendations, and external reviews. Additionally, HRSA requires
that WPSI incorporate processes to assure opportunity for public
comment, including participation by patients and consumers, in the
development of the updated Guidelines.
The existing Guidelines relating to diabetes state:
``Screening for Gestational Diabetes Mellitus
WPSI recommends screening pregnant women for GDM after 24 weeks of
gestation (preferably between 24 and 28 weeks of gestation) in order to
prevent adverse birth outcomes. Screening with a 50-g oral glucose
challenge test (followed by a 3-hour 100-g oral glucose tolerance test
if results on the initial oral glucose challenge test are abnormal) is
preferred because of its high sensitivity and specificity.
WPSI suggests that women with risk factors for diabetes mellitus be
screened for preexisting diabetes before 24 weeks of gestation--ideally
at the first prenatal visit, based on current clinical best
practices.''
``Screening for Diabetes Mellitus After Pregnancy
WPSI recommends women with a history of GDM who are not currently
pregnant and who have not previously been diagnosed with type 2
diabetes mellitus should be screened for diabetes mellitus. Initial
testing should ideally occur within the first year postpartum and can
be conducted as early as 4-6 weeks postpartum (see Table 1).
Women with a negative initial postpartum screening test result
should be rescreened at least every 3 years for a minimum of 10 years
after pregnancy. For women with a positive postpartum screening test
result, testing to confirm the diagnosis of diabetes is indicated
regardless of the initial test (e.g., oral glucose tolerance test,
fasting plasma glucose, or hemoglobin A1c). Repeat testing is indicated
in women who were screened with hemoglobin A1c in the first 6 months
postpartum regardless of the result.''
Draft Updated Clinical Recommendations for Public Comment
Screening for Diabetes in Pregnancy
WPSI proposes to update the Screening for GDM Guideline to revise
the title to read ``Screening for Diabetes in Pregnancy'' and to revise
the clinical recommendation to read: ``The Women's Preventive Services
Initiative recommends screening pregnant women for GDM after 24 weeks
of gestation (preferably between 24 and 28 weeks of gestation) to
prevent adverse birth outcomes. WPSI recommends screening pregnant
women with risk factors for type 2 diabetes or GDM before 24 weeks of
gestation--ideally at the first prenatal visit.''
Screening for Type 2 Diabetes After Pregnancy
WPSI also proposes to update the Screening for Diabetes Mellitus
after Pregnancy Guideline to revise the title to read ``Screening for
Type 2 Diabetes after Pregnancy'' and to revise the
[[Page 66312]]
clinical recommendation to read: ``The WPSI recommends screening for
type 2 diabetes in women with a history of GDM who are not currently
pregnant and who have not previously been diagnosed with type 2
diabetes. Initial testing should ideally occur within the first year
postpartum and can be conducted as early as 4-6 weeks postpartum. Women
who were not screened in the first year postpartum or women with a
negative initial postpartum screening test result should be screened at
least every 3 years for a minimum of 10 years after pregnancy. For
those with a positive screening test result in the early postpartum
period (i.e., 4-6 weeks postpartum), testing should be repeated at
least 6 months postpartum to confirm the diagnosis of diabetes
regardless of the type of initial test (e.g., fasting plasma glucose,
hemoglobin A1c, oral glucose tolerance test). Repeat testing is also
indicated for women screened with hemoglobin A1c in the first 6 months
postpartum regardless of whether the test results are positive or
negative because the hemoglobin A1c test is less accurate during the
first 6 months postpartum.''
Discussion of Updated Clinical Recommendations
Screening for Diabetes in Pregnancy
WPSI recommended three updates to the Guideline on Screening for
GDM. The first change is a revision to the title of the Guideline from
``Screening for GDM'' to ``Screening for Diabetes in Pregnancy.'' This
change to the title was made for consistency with the clinical
recommendation, which includes screening for gestational diabetes and
screening for preexisting diabetes, as the previous title described a
more limited scope in screening. The second update recommended by WPSI
is to change language in the second sentence of the recommendation from
``diabetes mellitus'' to ``type 2 diabetes or GDM.'' This change
reflects that ``diabetes mellitus'' is commonly described as type 2
diabetes. Third, WPSI modified the recommendation by relocating the
information on specific types of screening to the Implementation
Considerations section of the Guideline. The existing Guideline
recommends the 2-step approach, because of its high sensitivity and
specificity. In its recommended update, WPSI continues to recommend the
2-step approach, but has relocated it to the Implementation
Considerations section, and also added the 1-step approach to the list
of screening modalities in the Implementation Considerations section,
because both approaches are acceptable screening tests based on studies
described in the updated 2021 United States Preventive Services Task
Force evidence review. Both the 1-step and 2-step screening modalities
are within the scope of this Guideline.
Screening for Type 2 Diabetes After Pregnancy
WPSI also recommended five updates to the Guideline on Screening
for Diabetes Mellitus After Pregnancy. First, WPSI recommended updating
the title of the Guideline by changing it from ``Screening for Diabetes
Mellitus After Pregnancy'' to ``Screening for Type 2 Diabetes After
Pregnancy.'' This change was made because ``diabetes mellitus'' is now
more commonly described as type 2 diabetes. Second, WPSI recommended
removing the reference to Table 1 based upon feedback from the clinical
community, noting that the table might be confusing and could be
simplified in written format, and recommended including this
information in narrative form. Third, WPSI recommends screening for
``women who are not screened in the first year postpartum'' and ``women
with a positive screening test result in early postpartum.'' This
recommendation was added to ensure screening for women who were not
screened postpartum for various reasons (e.g., scheduling, lack of
transportation, availability of testing, etc.), and to reflect that
universal screening for women with a history of GDM is more appropriate
than risk-based screening because the risk of developing type 2
diabetes is high among all such individuals. Fourth, WPSI also
recommended adding new language to recommend repeat testing after 6
months postpartum to confirm a positive test result from the early
postpartum period (4-6 weeks postpartum). Fifth, WPSI also recommended
adding new language to the Guideline explaining that hemoglobin A1c
tests conducted within the first 6 months postpartum should be repeated
because the test is less accurate when conducted during the first 6
months postpartum. Screening for type 2 diabetes after pregnancy as
described in this Guideline, including follow-up diabetes screening
testing, is within the scope of this Guideline.
Members of the public can view each complete updated draft
recommendation by accessing the initiative's web page at https://www.womenspreventivehealth.org/.
Carole Johnson,
Administrator.
[FR Doc. 2022-23860 Filed 11-2-22; 8:45 am]
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