Notice2022-28662
Update to the HRSA-Supported Women's Preventive Services Guidelines Relating to Screening for Diabetes in Pregnancy and Screening for Diabetes After Pregnancy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 5, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
A Federal Register notice published on November 3, 2022, detailed and sought public comment on recommendations under development by the Women's Preventive Services Initiative (WPSI), regarding updates to the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The proposed updates specifically related to (1) Screening for Diabetes in Pregnancy and (2) Screening for Diabetes after Pregnancy. WPSI convenes health professionals to develop draft recommendations for HRSA's consideration. Three comments were received and considered as detailed below. On December 30, 2022, HRSA accepted as final WPSI's recommended updates to the (1) Screening for Diabetes in Pregnancy and (2) Screening for Diabetes after Pregnancy guidelines. 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 describing how group health plans and health insurance issuers apply the coverage requirements. Please see https://www.hrsa.gov/womens- guidelines for additional information.
Full Text
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<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
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[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Notices]
[Pages 876-878]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28662]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Update to the HRSA-Supported Women's Preventive Services
Guidelines Relating to Screening for Diabetes in Pregnancy and
Screening for Diabetes After Pregnancy
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: A Federal Register notice published on November 3, 2022,
detailed and sought public comment on recommendations under development
by the Women's Preventive Services Initiative (WPSI), regarding updates
to the HRSA-supported Women's Preventive Services Guidelines
(Guidelines). The proposed updates specifically related to (1)
Screening for Diabetes in Pregnancy and (2) Screening for Diabetes
after Pregnancy. WPSI convenes health professionals to develop draft
recommendations for HRSA's consideration. Three comments were received
and considered as detailed below. On December 30, 2022, HRSA accepted
as final WPSI's recommended updates to the (1) Screening for Diabetes
in Pregnancy and (2) Screening for Diabetes after Pregnancy guidelines.
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
describing how group health plans and health insurance issuers apply
the coverage requirements. Please see <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a> for additional information.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone: (301) 443-8283, email:
<a href="/cdn-cgi/l/email-protection#0572606969726a68646b66647760456d7776642b626a73"><span class="__cf_email__" data-cfemail="93e4f6ffffe4fcfef2fdf0f2e1f6d3fbe1e0f2bdf4fce5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Patient Protection and Affordable
Care Act, Public Law 111-148, 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 2016, HRSA has funded cooperative agreements with
the American College of Obstetricians and Gynecologists (ACOG) for the
Women's Preventive Services Initiative (WPSI), to convene a coalition
representing clinicians, academics, and consumer-focused health
professional organizations to
[[Page 877]]
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.
WPSI incudes 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 takes 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.
WPSI proposed and HRSA has accepted recommended updates to the
Guidelines relating to Screening for Diabetes in Pregnancy and
Screening for Diabetes after Pregnancy as detailed below:
(1) Screening for Diabetes in Pregnancy:
The current ``Screening for Gestational Diabetes Mellitus'' title
is now revised to read ``Screening for Diabetes in Pregnancy'' and the
clinical recommendation is now revised to state: ``The Women's
Preventive Services Initiative recommends screening pregnant women for
gestational diabetes mellitus 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.''
(2) Screening for Diabetes after Pregnancy:
The current ``Screening for Diabetes Mellitus after Pregnancy''
title is now revised to read ``Screening for Diabetes after Pregnancy''
and the clinical recommendation is now revised to state: ``The WPSI
recommends screening for type 2 diabetes in women with a history of
gestational diabetes mellitus (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 those 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, 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 Recommended Updated Guidelines
Screening for Diabetes in Pregnancy
WPSI recommended three updates to the Guideline on Screening for
Gestational Diabetes Mellitus. The first change is a revision to the
title of the Guideline from ``Screening for Gestational Diabetes
Mellitus'' 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
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 Diabetes After Pregnancy
WPSI also recommended five updates to the Guideline on Screening
for Diabetes Mellitus After Pregnancy. The first change is a revision
to the title of the Guideline, from ``Screening for Diabetes Mellitus
After Pregnancy'' to ``Screening for Diabetes After Pregnancy.'' This
change was made because ``diabetes mellitus'' is more commonly
described as diabetes. Second, WPSI recommended removing the reference
to Table 1, ``Preferred Testing Strategy Based on Postpartum
Timeframe'' 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 recommended 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 recommended adding new language to recommend
repeat testing after 6 months postpartum to confirm a positive test
result from the early postpartum period. Fifth, WPSI 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
[[Page 878]]
diabetes screening testing, is within the scope of this Guideline.
A Federal Register notice published on November 3, 2022 sought
public comment on these proposed updates (87 FR 66310).\1\ WPSI
considered all public comments as part of its deliberative process and
provided the comments to HRSA for its consideration. A total of three
respondents provided comments during the public comment period. One
commenter suggested that the word, ``all'' be added in front of
``pregnant women'' in the first sentence of the recommendation on
Screening for Diabetes in Pregnancy. This comment was not accepted as
the current wording already pertains to all individuals to which it
applies. The remaining comments did not specifically address the
recommended proposed updates. WPSI also removed the parenthetical
description of the early postpartum period ``(i.e., 4-6 weeks
postpartum)'' to better align with medical evidence.
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\1\ See <a href="https://www.federalregister.gov/documents/2022/11/03/2022-23860/notice-of-request-for-public-comment-on-two-draft-recommendations-to-update-the-hrsa-supported">https://www.federalregister.gov/documents/2022/11/03/2022-23860/notice-of-request-for-public-comment-on-two-draft-recommendations-to-update-the-hrsa-supported</a>.
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After consideration of public comment, WPSI submitted the
recommended updates for (1) Screening for Diabetes in Pregnancy and (2)
Screening for Diabetes after Pregnancy as detailed above. On December
30, 2022, the HRSA Administrator accepted WPSI's recommendations and,
as such, updated the Women's Preventive Services Guidelines. Non-
grandfathered group health plans and health insurance issuers offering
group or individual health insurance coverage must cover without cost-
sharing the services and screenings listed on the updated Women's
Preventive Services Guidelines for plan years (in the individual
market, policy years) that begin 1 year after this date. Thus, for most
plans, this update will take effect for purposes of the section 2713
coverage requirement in 2024. Additional information regarding the
Women's Preventive Services Guidelines can be accessed at the following
link: <a href="https://www.hrsa.gov/womens-guidelines">https://www.hrsa.gov/womens-guidelines</a>.
Authority: Section 2713(a)(4) of the Public Health Service Act, 42
U.S.C. 300gg-13(a)(4).
Carole Johnson,
Administrator.
[FR Doc. 2022-28662 Filed 1-4-23; 8:45 am]
BILLING CODE 4165-15-P
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