[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]


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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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[[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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