Notice2021-23498
Updated HRSA-Supported Women's Preventive Services Guidelines: Contraception and Screening for HIV Infection
Primary source
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Published
October 28, 2021
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
This notice seeks comments on two updated draft recommendations for (1) providing contraception and (2) screening for human immunodeficiency virus (HIV) infection, as part of the HRSA- supported Women's Preventive Services Guidelines (Guidelines). These updated draft recommendations have been developed through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG). 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 Women's Preventive Services Guidelines (Guidelines). The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury have previously issued regulations, which describe how group health plans and health insurance issuers apply the coverage requirements, including the use of reasonable medical management. (See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130).
Full Text
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<title>Federal Register, Volume 86 Issue 206 (Thursday, October 28, 2021)</title>
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[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59741-59742]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23498]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Updated HRSA-Supported Women's Preventive Services Guidelines:
Contraception and Screening for HIV Infection
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: This notice seeks comments on two updated draft
recommendations for (1) providing contraception and (2) screening for
human immunodeficiency virus (HIV) infection, as part of the HRSA-
supported Women's Preventive Services Guidelines (Guidelines). These
updated draft recommendations have been developed through a national
cooperative agreement, the Women's Preventive Services Initiative
(WPSI), by the American College of Obstetricians and Gynecologists
(ACOG). 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 Women's Preventive Services Guidelines
(Guidelines). The Departments of Labor (DOL), Health and Human Services
(HHS), and the Treasury have previously issued regulations, which
describe how group health plans and health insurance issuers apply the
coverage requirements, including the use of reasonable medical
management. (See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR
147.130).
DATES: Members of the public are invited to provide written comments no
later than November 29, 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 <a href="https://www.womenspreventivehealth.org/">https://www.womenspreventivehealth.org/</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#0572606969726a68646b66647760456d7776642b626a73"><span class="__cf_email__" data-cfemail="acdbc9c0c0dbc3c1cdc2cfcddec9ecc4dedfcd82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: As provided for in section 1001(5) of the
[[Page 59742]]
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, 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. Since then, there have been advancements in
science and gaps identified in these guidelines, including a greater
emphasis on practice-based clinical considerations. In March 2016, HRSA
awarded a 5-year cooperative agreement to the 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 existing Guidelines. HRSA awarded ACOG the cooperative
agreement to improve adult women's health across the lifespan by
engaging a coalition of health professional organizations to review
evidence and recommend updates to the HRSA-supported Guidelines. HRSA
would then decide 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 and DISC support 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 the
recommendations through the development of implementation tools and
resources for both patients and practitioners to support the adoption
and utilization of the recommendations.
In March 2021, HRSA awarded a subsequent cooperative agreement to
ACOG to further review and recommend updates to the Guidelines. Under
this cooperative agreement, beginning on March 1, 2021, ACOG engaged in
a process to consider and review new information. Following
recommendations by ACOG, HRSA will decide whether to support, in whole
or in part, its recommended updates to the guidelines.
Under the cooperative agreement, ACOG will base 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 will incorporate 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 draft
recommendations for providing contraception and screening for HIV
infection. The updated draft recommendations are provided below. WPSI
will consider and, as necessary, incorporate public comment. HRSA will
then decide whether to support, in whole or in part, the recommended
updates to the guidelines.
Contraception
ACOG, through the WPSI/MSC, made updates to the clinical
recommendation statement to clarify the terminology from contraceptive
methods to contraceptives. The Committee has also removed the term
``female-controlled contraceptives'' to allow women to purchase male
condoms for pregnancy prevention. Lastly, the Committee has further
defined the existing components of contraceptive follow-up care to
include the management and evaluation of and changes to--including the
removal, continuation, and discontinuation of--the contraceptive.
``The Women's Preventive Services Initiative recommends
adolescent and adult women have access to the full range of
contraceptives and contraceptive care to prevent unintended
pregnancies and improve health outcomes. Contraceptive care includes
screening, counseling, education, and provision of contraceptives
(including in the immediate postpartum period). Contraceptive care
also includes follow-up care (e.g., management and evaluation of and
changes to, including, removal, continuation, discontinuation of,
the contraceptive method).
The Women's Preventive Services Initiative recommends the full
range of U.S. Food and Drug Administration (FDA) approved
contraceptives, effective family planning practices, and
sterilization procedures be available as part of contraceptive care.
The full range of contraceptive methods currently identified by
FDA include: (1) Sterilization surgery for women, (2) implantable
rods, (3) copper intrauterine devices, (4) intrauterine devices with
progestin (all durations and doses), (5) injectable contraceptives,
(6) oral contraceptives (combined pill), (7) oral contraceptives
(progestin only), (8) oral contraceptives (extended or continuous
use), (9) the contraceptive patch, (10) vaginal contraceptive rings,
(11) diaphragms, (12) contraceptive sponges, (13) cervical caps,
(14) condoms, (15) spermicides, (16) emergency contraception
(levonorgestrel); and (17) emergency contraception (ulipristal
acetate); additional methods as identified by the FDA.''
Screening for HIV Infection
ACOG, through the WPSI/MSC, has recommended minor updates to the
screening for HIV infection recommendation statement to specify that
screening should begin at age 15 and older, and that earlier detection
should be based on a review of patient risk factors.
``The Women's Preventive Services Initiative recommends all
women, ages 15 and older, receive a screening test for HIV at least
once during their lifetime. Earlier or additional screening should
be based on risk, and re-screening annually or more often may be
appropriate beginning at age 13 for adolescents and women with an
increased risk of HIV infection.
The Women's Preventive Services Initiative recommends risk
assessment and prevention education for human immunodeficiency virus
(HIV) infection beginning at age 13 and continuing at least annually
throughout the lifespan as determined by risk. A screening test for
HIV is recommended for all pregnant women upon initiation of
prenatal care with rescreening during pregnancy based on risk
factors. Rapid HIV testing is recommended for pregnant women who
present in labor with an undocumented HIV status.''
Members of the public can view each complete updated draft
recommendation statement by accessing the initiative's web page at
<a href="https://www.womenspreventivehealth.org/">https://www.womenspreventivehealth.org/</a>.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-23498 Filed 10-27-21; 8:45 am]
BILLING CODE 4165-15-P
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