[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95148-95150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31129]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Updating the HRSA-Supported Women's Preventive Services
Guidelines
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
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SUMMARY: Effective December 20, 2016, the Health Resources and Services
Administration (HRSA) updated the HRSA-supported Women's Preventive
Services Guidelines for purposes of health insurance coverage for
preventive services that address health needs specific to women based
on clinical recommendations from the Women's Preventive Services
Initiative. This notice serves as an announcement of the decision to
update the guidelines as listed below. Please see https://www.hrsa.gov/womensguidelines2016 for additional information.
FOR FURTHER INFORMATION CONTACT: HRSA, Maternal and Child Health Bureau
at email: [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 95149]]
Breast Cancer Screening for Average-Risk Women
The Women's Preventive Services Initiative recommends that average-
risk women initiate mammography screening no earlier than age 40 and no
later than age 50. Screening mammography should occur at least
biennially and as frequently as annually. Screening should continue
through at least age 74 and age alone should not be the basis to
discontinue screening.
These screening recommendations are for women at average risk of
breast cancer. Women at increased risk should also undergo periodic
mammography screening, however, recommendations for additional services
are beyond the scope of this recommendation.
Breastfeeding Services and Supplies
The Women's Preventive Services Initiative recommends comprehensive
lactation support services (including counseling, education, and
breastfeeding equipment and supplies) during the antenatal, perinatal,
and postpartum periods to ensure the successful initiation and
maintenance of breastfeeding.
Screening for Cervical Cancer
The Women's Preventive Services Initiative recommends cervical
cancer screening for average-risk women aged 21 to 65 years. For women
aged 21 to 29 years, the Women's Preventive Services Initiative
recommends cervical cancer screening using cervical cytology (Pap test)
every 3 years. Cotesting with cytology and human papillomavirus testing
is not recommended for women younger than 30 years. Women aged 30 to 65
years should be screened with cytology and human papillomavirus testing
every 5 years or cytology alone every 3 years. Women who are at average
risk should not be screened more than once every 3 years.
Contraception
The Women's Preventive Services Initiative recommends that
adolescent and adult women have access to the full range of female-
controlled contraceptives to prevent unintended pregnancy and improve
birth outcomes. Contraceptive care should include contraceptive
counseling, initiation of contraceptive use, and follow-up care (e.g.,
management, and evaluation as well as changes to and removal or
discontinuation of the contraceptive method). The Women's Preventive
Services Initiative recommends that the full range of female-controlled
U.S. Food and Drug Administration-approved contraceptive methods,
effective family planning practices, and sterilization procedures be
available as part of contraceptive care.
The full range of contraceptive methods for women currently
identified by the U.S. Food and Drug Administration include: (1)
Sterilization surgery for women, (2) surgical sterilization via implant
for women, (3) implantable rods, (4) copper intrauterine devices, (5)
intrauterine devices with progestin (all durations and doses), (6) the
shot or injection, (7) oral contraceptives (combined pill), 8) oral
contraceptives (progestin only, and), (9) oral contraceptives (extended
or continuous use), (10) the contraceptive patch, (11) vaginal
contraceptive rings, (12) diaphragms, (13) contraceptive sponges, (14)
cervical caps, (15) female condoms, (16) spermicides, and (17)
emergency contraception (levonorgestrel), and (18) emergency
contraception (ulipristal acetate), and additional methods as
identified by the FDA. Additionally, instruction in fertility
awareness-based methods, including the lactation amenorrhea method,
although less effective, should be provided for women desiring an
alternative method.
Screening for Gestational Diabetes Mellitus
The Women's Preventive Services Initiative recommends screening
pregnant women for gestational diabetes mellitus after 24 weeks of
gestation (preferably between 24 and 28 weeks of gestation) in order to
prevent adverse birth outcomes. Screening with a 50-g oral glucose
challenge test (followed by a 3-hour 100-g oral glucose tolerance test
if results on the initial oral glucose challenge test are abnormal) is
preferred because of its high sensitivity and specificity.
The Women's Preventive Services Initiative suggests that women with
risk factors for diabetes mellitus be screened for preexisting diabetes
before 24 weeks of gestation--ideally at the first prenatal visit,
based on current clinical best practices.
Screening for Human Immunodeficiency Virus Infection
The Women's Preventive Services Initiative recommends prevention
education and risk assessment for human immunodeficiency virus (HIV)
infection in adolescents and women at least annually throughout the
lifespan. All women should be tested for HIV at least once during their
lifetime. Additional screening should be based on risk, and screening
annually or more often may be appropriate for adolescents and women
with an increased risk of HIV infection.
Screening for HIV is recommended for all pregnant women upon
initiation of prenatal care with retesting during pregnancy based on
risk factors. Rapid HIV testing is recommended for pregnant women who
present in active labor with an undocumented HIV status. Screening
during pregnancy enables prevention of vertical transmission.
Screening for Interpersonal and Domestic Violence
The Women's Preventive Services Initiative recommends screening
adolescents and women for interpersonal and domestic violence, at least
annually, and, when needed, providing or referring for initial
intervention services. Interpersonal and domestic violence includes
physical violence, sexual violence, stalking and psychological
aggression (including coercion), reproductive coercion, neglect, and
the threat of violence, abuse, or both. Intervention services include,
but are not limited to, counseling, education, harm reduction
strategies, and referral to appropriate supportive services.
Counseling for Sexually Transmitted Infections
The Women's Preventive Services Initiative recommends directed
behavioral counseling by a health care provider or other appropriately
trained individual for sexually active adolescent and adult women at an
increased risk for sexually transmitted infections (STIs).
The Women's Preventive Services Initiative recommends that health
care providers use a woman's sexual history and risk factors to help
identify those at an increased risk of STIs. Risk factors may include
age younger than 25, 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 adolescents and
women not identified as high risk, counseling to reduce the risk of
STIs should be considered, as determined by clinical judgement.
Well-Woman Preventive Visits
The Women's Preventive Services Initiative recommends that women
receive at least one preventive care visit per year beginning in
adolescence and continuing across the lifespan to ensure that the
recommended preventive services including preconception, and many
services necessary for prenatal and interconception care are obtained.
The primary purpose of these visits
[[Page 95150]]
should be the delivery and coordination of recommended preventive
services as determined by age and risk factors.
The HRSA-supported Women's Preventive Services Guidelines were
originally established in 2011 based on recommendations from a
Department of Health and Human Services' commissioned study by the
Institute of Medicine (IOM), now known as the National Academy of
Medicine (NAM). Since then, there have been advancements in science and
gaps identified in the existing guidelines, including a greater
emphasis on practice-based clinical considerations. To address these,
HRSA awarded a 5-year cooperative agreement in March 2016 to convene a
coalition of clinician, academic, and consumer-focused health
professional organizations and conduct a scientifically rigorous review
to develop recommendations for updated Women's Preventive Services
Guidelines in accordance with the model created by the NAM Clinical
Practice Guidelines We Can Trust. The American College of Obstetricians
and Gynecologists was awarded the cooperative agreement and formed an
expert panel called the Women's Preventive Services Initiative.
Under section 2713 of the Public Health Service Act, non-
grandfathered group health plans and issuers of non-grandfathered group
and individual 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. Non-grandfathered plans and
coverage (generally, plans or policies created or sold after March 23,
2010, or older plans or policies that have been changed in certain ways
since that date) are required to provide coverage without cost sharing
consistent with these guidelines beginning with the first plan year (in
the individual market, policy year) that begins on or after December
20, 2017.
The guidelines concerning contraceptive methods and counseling do
not apply to women who are participants or beneficiaries in group
health plans sponsored by religious employers. Effective August 1,
2013, a religious employer is defined as an employer that is organized
and operates as a non-profit entity and is referred to in section
6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code. HRSA notes
that, as of August 1, 2013, group health plans established or
maintained by religious employers (and group health insurance coverage
provided in connection with such plans) are exempt from the requirement
to cover contraceptive services under section 2713 of the Public Health
Service Act, as incorporated into the Employee Retirement Income
Security Act and the Internal Revenue Code. HRSA also notes that, as of
January 1, 2014, accommodations are available to group health plans
established or maintained by certain eligible organizations (and group
health insurance coverage provided in connection with such plans), as
well as student health insurance coverage arranged by eligible
organizations, with respect to the contraceptive coverage requirement.
See Coverage of Certain Preventive Services Under the Affordable Care
Act (78 FR 39870, July 2, 2013).
James Macrae,
Acting Administrator.
[FR Doc. 2016-31129 Filed 12-23-16; 8:45 am]
BILLING CODE 4165-15-P