[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70509-70510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Additional Comment Period for Updated HRSA-Supported Women's 
Preventive Services Guidelines Statement on Breastfeeding Services and 
Supplies

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: On August 20, 2021, HRSA published a notice soliciting public 
comments regarding proposed updated draft recommendations to the HRSA-
Supported Women's Preventive Services Guidelines (Guidelines) in the 
areas of Well-Women Preventive Visits, Counseling for Sexually 
Transmitted Infections, and Breastfeeding Services and Supplies, which, 
when accepted by HRSA, are required to be covered without cost-sharing 
by certain health insurance issuers under the Public Health Service 
Act. The updated draft recommendation statements were developed through 
a national cooperative agreement, the Women's Preventive Services 
Initiative (WPSI), by

[[Page 70510]]

the American College of Obstetricians and Gynecologists (ACOG). Since 
the publication of that notice, WPSI has further updated its 
recommendation statement on Breastfeeding Services and Supplies. HRSA 
encourages members of the public to review this revised updated 
recommendation statement and provide comments for consideration.

DATES: Members of the public are invited to provide written comments no 
later than December 20, 2021. All comments received on or before this 
date will be reviewed and considered by the WPSI Multidisciplinary 
Steering Committee.

ADDRESSES: Members of the public interested in providing comments on 
the draft recommendation statements can do so by accessing the 
initiative's web page at https://www.womenspreventivehealth.org/.

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

SUPPLEMENTARY INFORMATION: HRSA established the Guidelines in 2011 
based on a study and 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. 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 
health insurance issuers. 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 supported cooperative agreements with ACOG to 
convene a coalition representing clinicians, academics, and consumer-
focused health professional organizations to conduct a rigorous review 
of current scientific evidence and make recommendations to HRSA 
regarding updates to the Guidelines to improve adult women's health 
across the lifespan. HRSA then decides 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 (MSC) and the Dissemination and Implementation Steering 
Committee (DISC), which are comprised of a broad coalition of 
organizational representatives who are experts in disease prevention 
and women's health issues. Through oversight by the Advisory Panel, MSC 
supports the development and implementation of the Guidelines through 
the review of existing evidence and recommendation development. 
Specifically, the MSC examines the evidence to develop new and update 
existing recommendations for women's preventive services. DISC takes 
the HRSA-approved recommendations, developed by the MSC, and works to 
disseminate them through the development of implementation tools and 
resources for both patients and practitioners.
    In March 2021, ACOG engaged in a process to consider and review new 
information and evidence to determine whether to recommend updates to 
the Guidelines. ACOG 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, as well as external reviews. 
Additionally, ACOG incorporates processes to assure opportunity for 
public comment, including participation by patients and consumers, in 
the development of the updated Guideline recommendations.
    This notice solicits comments from the public on a revised draft 
recommendation statement on Breastfeeding Supplies and Services. The 
updated draft recommendation statement that was published on August 20, 
2021 and the revised recommendation statement that HRSA recently 
received from ACOG are provided below. WPSI will consider and, as 
necessary, incorporate additional public comment in its recommendation 
statement. HRSA will then decide whether to support, in whole or in 
part, the recommended updates to the Guidelines.

Clinical Recommendation Statement as Published on August 20, 2021

    The MSC updated clinical recommendation included consultative 
services to optimize successful initiation and maintenance of 
breastfeeding: ``The WPSI recommends comprehensive lactation support 
services (including consultation, counseling, education, and 
breastfeeding equipment and supplies) during the antenatal, perinatal, 
and postpartum periods to optimize the successful initiation and 
maintenance of breastfeeding.''

Revised Clinical Recommendation Statement

    The MSC has made two further updates to the clinical recommendation 
statement for breastfeeding. The first addresses provider type in the 
provision of breastfeeding services to reflect that breastfeeding 
education can be provided by clinicians and through peer support 
services. The second update moves a paragraph on breastfeeding 
equipment and supplies from the implementation section of the guideline 
into the clinical recommendation component, making it a substantive 
addition to the Guidelines with corresponding effect under Section 
2713. As revised, the clinical recommendation statement provides: ``The 
WPSI recommends comprehensive lactation support services (including 
consultation; counseling; education by clinicians and peer support 
services; and breastfeeding equipment and supplies) during the 
antenatal, perinatal, and postpartum periods to optimize the successful 
initiation and maintenance of breastfeeding. Breastfeeding equipment 
and supplies include, but are not limited to, double electric breast 
pumps (including pump parts and maintenance) and breast milk storage 
supplies. Access to double electric pumps should be a priority to 
optimize breastfeeding and should not be predicated on prior failure of 
a manual pump. Breastfeeding equipment may also include equipment and 
supplies as clinically indicated to support dyads with breastfeeding 
difficulties and those who need additional services.''
    Members of the public can view the complete revised updated draft 
recommendation statement by accessing the initiative's web page at 
https://www.womenspreventivehealth.org/.

Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-26700 Filed 12-9-21; 8:45 am]
BILLING CODE 4165-15-P