[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1763-1764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Update to the Women's Preventive Services Guidelines

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

ACTION: Notice.

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SUMMARY: On December 30, 2021, HRSA approved updates to the HRSA-
supported Women's Preventive Services Guidelines (Guidelines) that 
address health needs specific to women. The Guidelines are based on 
clinical recommendations from the Women's Preventive Services 
Initiative (WPSI), a coalition of experts and health professional 
organizations convened by the American College of Obstetricians and 
Gynecologist (ACOG) under a cooperative agreement awarded by HRSA. 
Under the Public Health Service Act and pertinent regulations, 
preventive care and screenings for women provided for in comprehensive 
guidelines supported by HRSA are required to be covered without cost 
sharing by group health plans and health insurance issuers offering 
non-grandfathered group or individual health insurance coverage. This 
2021 update adds one additional service, Preventing Obesity in Midlife 
Women, and revises five services: Breastfeeding Services and Supplies, 
Contraception, Screening for Human Immunodeficiency Virus Infection, 
Counseling for Sexually Transmitted Infections, and Well-Woman 
Preventive Visits. This notice serves as an announcement of the 
decision to update the Guidelines as further described below. Please 
see https://www.hrsa.gov/womens-guidelines/index.html for additional 
information.

FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and 
Child Health Bureau, telephone (301) 443-8283, email: 
<a href="/cdn-cgi/l/email-protection#7304161f1f041c1e121d10120116331b0100125d141c05"><span class="__cf_email__" data-cfemail="acdbc9c0c0dbc3c1cdc2cfcddec9ecc4dedfcd82cbc3da">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The updated 2021 HRSA-supported Women's 
Preventive Services Guidelines, along with information related to their 
development and implementation, are available at https://www.hrsa.gov/womens-guidelines/index.html. A summary of information regarding the 
updates to the comprehensive guidelines supported by HRSA on December 
30, 2021, is set out below.

Women's Preventive Services Guidelines

    The first HRSA-supported Guidelines, based on recommendations of 
the Institute of Medicine, were established in 2011. The Guidelines 
were subsequently updated following review and recommendations by the 
ACOG under the WPSI cooperative agreement, awarded by HRSA in 2016. The 
purpose of WPSI is to improve adult women's health across the lifespan 
by engaging a coalition of experts and health professional 
organizations to recommend updates to the HRSA-supported Guidelines. 
Following such review and recommendations, HRSA decides whether or not 
to support, in whole or in part, the recommended updates to the 
Guidelines. In March 2021, HRSA awarded a subsequent cooperative 
agreement to ACOG to provide recommendations as appropriate over a 5-
year period to update the HRSA-supported Guidelines. Under the 
cooperative agreement, ACOG, through the WPSI, engages in a process to 
consider and review new and existing Guidelines developed by a 
multidisciplinary group of women's health experts and professional 
organizations.
    Under section 2713 of the Public Health Service Act, 42 U.S.C. 
300gg-13, group health plans and issuers of non-grandfathered group and 
individual

[[Page 1764]]

health insurance coverage are required to cover specified preventive 
services without a copayment, coinsurance, deductible, or other cost 
sharing, including preventive care and screenings for women as provided 
for in comprehensive guidelines supported by HRSA for this purpose. 
Private health insurance companies must provide this coverage without 
cost-sharing in plan years (in the individual market, policy years) 
beginning on or after the date that is one year after the date the 
recommendation or guideline is issued. A change to the Guidelines is 
considered to be issued on the date on which it is accepted by the HRSA 
Administrator.

Summary of the 2021 Updates Recommended by WPSI and Approved by HRSA

Breastfeeding Services and Supplies

    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.

Contraception

    WPSI recommends that 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, education, counseling, and provision of 
contraceptives (including in the immediate postpartum period). 
Contraceptive care also includes follow-up care (e.g., management, 
evaluation, and changes, including the removal, continuation, and 
discontinuation of contraceptives).
    WPSI recommends that the full range of U.S. Food and Drug 
Administration (FDA)-approved, -granted, or -cleared contraceptives, 
effective family planning practices, and sterilization procedures be 
available as part of contraceptive care. The full range of 
contraceptives currently includes those listed in the FDA's Birth 
Control Guide: \1\ (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); and any additional 
contraceptives approved, granted, or cleared by the FDA.
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    \1\ This refers to FDA's Birth Control Guide (https://www.fda.gov/media/150299/download) as posted on December 22, 2021 
with the exception of sterilization surgery for men, which is beyond 
the scope of the WPSI.
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Screening for HIV Infection

    WPSI recommends all adolescent and adult women, ages 15 and older, 
receive a screening test for human immunodeficiency virus (HIV) at 
least once during their lifetime. Earlier or additional screening 
should be based on risk, and rescreening annually or more often may be 
appropriate beginning at age 13 for adolescent and adult women with an 
increased risk of HIV infection.
    WPSI recommends risk assessment and prevention education for HIV 
infection beginning at age 13 and continuing 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.

Counseling for Sexually Transmitted Infections

    WPSI recommends behavioral counseling by a health care clinician or 
other appropriately trained individual for sexually active adolescent 
and adult women at an increased risk for sexually transmitted 
infections (STIs).
    WPSI recommends that clinicians review a woman's sexual history and 
risk factors to identify those at increased risk for STIs. Risk factors 
include, but are not limited to, age younger than 25 years, a recent 
history of an STI, a new sex partner, multiple partners, a partner with 
concurrent partners, a partner with an STI, and a lack of or 
inconsistent condom use. For those without identified risk factors, 
counseling to reduce the risk of STIs should be considered on an 
individual basis as determined by clinical judgment.

Well-Woman Preventive Visits

    WPSI recommends that women receive at least one preventive care 
visit per year beginning in adolescence and continuing across the 
lifespan to ensure the provision of all recommended preventive 
services. The primary purpose of well-woman visits is the delivery and 
coordination of recommended preventive services as determined by age 
and risk factors. These services may be completed at a single visit or 
as part of a series of visits that take place over time to obtain all 
necessary services depending on a woman's age, health status, 
reproductive health needs, pregnancy status, and risk factors. Well-
women visits also include pre-pregnancy, prenatal, postpartum, and 
interpregnancy visits.

Preventing Obesity in Midlife Women

    WPSI recommends counseling midlife women aged 40 to 60 years with 
normal or overweight body mass index (BMI) (18.5-29.9 kg/m2) to 
maintain weight or limit weight gain to prevent obesity. Counseling may 
include individualized discussion of healthy eating and physical 
activity.

Diana Espinosa,
Acting Administrator.
[FR Doc. 2022-00465 Filed 1-11-22; 8:45 am]
BILLING CODE 4165-15-P


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