[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Notices]
[Pages 876-878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.hrsa.gov/womens-guidelines for additional information.

FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and 
Child Health Bureau, telephone: (301) 443-8283, email: 
[email protected].

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 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.
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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: https://www.hrsa.gov/womens-guidelines.
    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