Notice2022-23860
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
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Published
November 3, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 212 (Thursday, November 3, 2022)</title>
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[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66310-66312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23860]
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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.
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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 <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
<a href="/cdn-cgi/l/email-protection#e592808989928a88848b86849780a58d979684cb828a93"><span class="__cf_email__" data-cfemail="bfc8dad3d3c8d0d2ded1dcdecddaffd7cdccde91d8d0c9">[email protected]</span></a>.
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
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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 <a href="https://www.womenspreventivehealth.org/">https://www.womenspreventivehealth.org/</a>.
Carole Johnson,
Administrator.
[FR Doc. 2022-23860 Filed 11-2-22; 8:45 am]
BILLING CODE 4165-15-P
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