Update to the Women's Preventive Services Guidelines, 1763-1764 [2022-00465]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices
group or individual health insurance
coverage provide coverage without costsharing for certain preventive health
services. Section 2713(a)(3) describes
such services for infants, children, and
adolescents as ‘‘evidence-informed
preventive care and screenings provided
for in the comprehensive guidelines
supported by the Health Resources and
Services Administration.’’ HHS, along
with the Departments of Treasury and
Labor, issued an Interim Final Rule on
July 19, 2010 (75 FR 41726–41760) that
identified two specific resources as the
comprehensive guidelines supported by
HRSA for infants, children, and
adolescents to be covered by insurance
without cost sharing by nongrandfathered group health plans and
health insurance issuers: (1) The Bright
Futures Periodicity Schedule and (2) the
Recommended Uniform Screening Panel
of the Advisory Committee on Heritable
Disorders in Newborns and Children.
The Interim Final Rule provided that a
future change to these comprehensive
guidelines is considered to be issued for
purposes of Section 2713 on the date on
which it is accepted by the HRSA
Administrator or, if applicable, adopted
by the Secretary of HHS.
A public comment period was
announced and occurred from
September 13, 2021, through October
13, 2021 (86 FR 50894, September 13,
2021),1 to allow public comment on the
proposed recommended updates
affecting clinical practice and health
insurance coverage requirements. A
total of 27 respondents gave 57
comments during the public comment
period. The Bright Futures grantee, the
American Academy of Pediatrics,
received and considered the public
comments. The annual report (Tab A)
provides a description of the comments,
including a detailed tabulation of each
comment.
On December 30, 2021, the HRSA
Administrator accepted the American
Academy of Pediatrics’ recommended
several updates to the Bright Futures
Periodicity Schedule. The Bright
Futures recommendations included
recommended clinical practice updates,
along with revisions to the footnotes on
the Bright Futures Periodicity Schedule
that do not require changes to clinical
practice or health insurance coverage.
The updates to the Bright Futures
Periodicity Schedule are: (1) A new
category for sudden cardiac arrest and
sudden cardiac death risk assessment,
(2) a new category for hepatitis B virus
1 See https://www.federalregister.gov/documents/
2021/09/13/2021-19630/opportunity-for-commentson-proposed-updates-to-the-bright-futuresperiodicity-schedule-as-part-of.
VerDate Sep<11>2014
17:04 Jan 11, 2022
Jkt 256001
infection risk assessment, (3) addition of
suicide risk as an element of universal
depression screening for children ages
12–21, and (4) updated category title
from ‘‘Psychosocial/Behavioral
Assessment’’ to ‘‘Behavioral/Social/
Emotional Screening,’’ with no revision
to the ages in which the screening
occurs (newborn to 21 years). Finally,
two clarifying references related to
dental fluoride varnish and fluoride
supplementation have been added with
no associated recommended changes to
clinical practice. In light of these
updates, all non-grandfathered group
health plans and health insurance
issuers offering group or individual
health insurance coverage must cover
without cost-sharing the services and
screenings listed on the updated Bright
Futures Periodicity Schedule for plan
years (in the individual market, policy
years) that begin in 2023, which can be
accessed at the following link: https://
mchb.hrsa.gov/maternal-child-healthtopics/child-health/bright-futures.html.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2022–00461 Filed 1–11–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Update to the Women’s Preventive
Services Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
On December 30, 2021, HRSA
approved updates to the HRSAsupported 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 nongrandfathered group or individual
health insurance coverage. This 2021
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
1763
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/ for
additional information.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
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 HRSAsupported 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 nongrandfathered group and individual
E:\FR\FM\12JAN1.SGM
12JAN1
1764
Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
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 followup 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
VerDate Sep<11>2014
17:04 Jan 11, 2022
Jkt 256001
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.
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
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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30 Day
Notice for Extension of Fast Track
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery: IHS Customer
Service Satisfaction and Similar
Surveys
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to take this opportunity
to comment on the information
collection Office of Management and
Budget (OMB) Control Number 0917–
0036, ‘‘Generic Clearance for the
SUMMARY:
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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/ for additional
information.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
[email protected].
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/. 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
