81 FR 95148 - Updating the HRSA-Supported Women's Preventive Services Guidelines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

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.

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95148-95150]
From the Federal Register Online  [www.thefederalregister.org]
[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