[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59741-59742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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 
https://www.womenspreventivehealth.org/.

Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-23498 Filed 10-27-21; 8:45 am]
BILLING CODE 4165-15-P