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)
Health Resources and Services Administration
Federal Register Volume 81, Issue 248 (December 27, 2016)
| Page Range | 95148-95150 | |
| FR Document | 2016-31129 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![95148 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices
Abstract: Currently HRSA is cleared own research and training grant project. The modified Statement of
to use the National Institutes of Health’s programs. Appointment form is used to document
(NIH) Biographical Sketch and Public In MCHB’s research grant programs, the appointment of individuals
Health Service (PHS) Inclusion the modified Biographical Sketch form supported by the award to applicable
Enrollment forms (0925–0001) for will be used by applicants to summarize institutional research and training
HRSA’s SF424 Research & Related the qualifications of key personnel on programs. BHW does not use the PHS
(R&R) application package research their proposed research team; the grant Inclusion Enrollment form, as it does
grants. However, both of these reviewers will use this information to not pertain to the BHW training and
documents contain NIH-specific assess the capabilities of the research research programs.
references. To use the forms, HRSA team to carry out the research project.
Likely Respondents: Respondents are
plans to remove the NIH-specific MCHB’s modified PHS Inclusion
Enrollment form will be used by applicants to HRSA’s research programs
references and obtain its own OMB
applicants to summarize their expected in MCHB and research and training
control number for the collection of this
population of research study programs in BHW.
information.
The current Statement of participants at the time of submission of Burden Statement: Burden in this
Appointment (form PHS–2271) is also their proposal; it will also be used for context means the time expended by
tailored to NIH programs. HRSA plans Enrollment Reporting during the annual persons to generate, maintain, retain,
to remove references to NIH and where Noncompeting Continuation Award. disclose or provide the information
appropriate replace them with Monitoring Inclusion Enrollment is one requested. This includes the time
references to HRSA for use in the SF424 important component of ensuring needed to review instructions; to
R&R application package. statistically meaningful demographics develop, acquire, install, and utilize
Need and Proposed Use of the (race, ethnicity, and gender) among technology and systems for the purpose
Information: Currently, there are two research study participants in MCHB’s of collecting, validating and verifying
Bureaus within HRSA, the Maternal and research grant portfolio. MCHB does not information, processing and
Child Health Bureau (MCHB) and the use the Statement of Appointment form, maintaining information, and disclosing
Bureau of Health Workforce (BHW), that as it does not pertain to the MCHB and providing information; to train
use the Biographical Sketch. In addition research program. personnel and be able to respond to a
to the Biographical Sketch, MCHB also Similarly, in BHW the modified collection of information; to search data
uses the PHS Inclusion Enrollment Biographical Sketch form will be used sources; to complete and review the
form, and BHW uses the Statement of by applicants to summarize the collection of information; and to
Appointment form as required elements qualifications of key personnel transmit or otherwise disclose the
of the SF424 Research & Related proposed as project staff; the grant information. The total annual burden
application package. These Bureaus reviewers will use this information to hours estimated for this Information
plan to modify these forms in slightly assess the capabilities of the applicant Collection Request are summarized in
different ways to meet the needs of their organization to carry out the proposed the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Biographical Sketch for MCHB research grant applicants .. 200 5 1000 2 2000
PHS Inclusion Enrollment form for MCHB research grant
applications ....................................................................... 200 1 200 .5 100
Biographical Sketch for BHW training and research grant
applicants ......................................................................... 1000 5 5000 2 10,000
Statement of Appointment form for BHW training grantees 800 7 5600 .5 2,800
Total .............................................................................. 2200 ........................ 11,800 ........................ 14,900
HRSA specifically requests comments DEPARTMENT OF HEALTH AND Services Guidelines for purposes of
on (1) the necessity and utility of the HUMAN SERVICES health insurance coverage for preventive
proposed information collection for the services that address health needs
proper performance of the agency’s Health Resources and Services specific to women based on clinical
functions; (2) the accuracy of the Administration recommendations from the Women’s
estimated burden; (3) ways to enhance Preventive Services Initiative. This
the quality, utility, and clarity of the Updating the HRSA-Supported notice serves as an announcement of the
information to be collected; and (4) the Women’s Preventive Services decision to update the guidelines as
use of automated collection techniques Guidelines listed below. Please see https://
asabaliauskas on DSK3SPTVN1PROD with NOTICES
or other forms of information AGENCY: Health Resources and Services www.hrsa.gov/womensguidelines2016
technology to minimize the information Administration, HHS. for additional information.
collection burden. ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
Jason E. Bennett, HRSA, Maternal and Child Health
SUMMARY: Effective December 20, 2016, Bureau at email: wellwomancare@
Director, Division of the Executive Secretariat. the Health Resources and Services hrsa.gov.
[FR Doc. 2016–31080 Filed 12–23–16; 8:45 am] Administration (HRSA) updated the
BILLING CODE 4165–15–P HRSA-supported Women’s Preventive SUPPLEMENTARY INFORMATION:
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![95150 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices
should be the delivery and coordination insurance coverage provided in Dated: December 21, 2016.
of recommended preventive services as connection with such plans) are exempt Daniel R. Levinson,
determined by age and risk factors. from the requirement to cover Inspector General.
The HRSA-supported Women’s contraceptive services under section [FR Doc. 2016–31182 Filed 12–23–16; 8:45 am]
Preventive Services Guidelines were 2713 of the Public Health Service Act, BILLING CODE 4152–01–P
originally established in 2011 based on as incorporated into the Employee
recommendations from a Department of Retirement Income Security Act and the
Health and Human Services’ Internal Revenue Code. HRSA also notes DEPARTMENT OF HEALTH AND
commissioned study by the Institute of that, as of January 1, 2014, HUMAN SERVICES
Medicine (IOM), now known as the accommodations are available to group
National Academy of Medicine (NAM). health plans established or maintained National Institutes of Health
Since then, there have been by certain eligible organizations (and
advancements in science and gaps Office of the Director, National
group health insurance coverage Institutes of Health; Notice of Meeting
identified in the existing guidelines,
provided in connection with such
including a greater emphasis on Pursuant to section 10(d) of the
plans), as well as student health
practice-based clinical considerations. Federal Advisory Committee Act, as
insurance coverage arranged by eligible
To address these, HRSA awarded a 5- amended (5 U.S.C. Appendix 2), notice
year cooperative agreement in March organizations, with respect to the
contraceptive coverage requirement. See is hereby given of the meeting of the
2016 to convene a coalition of clinician, Council of Councils.
academic, and consumer-focused health Coverage of Certain Preventive Services
Under the Affordable Care Act (78 FR The meeting will be open to the
professional organizations and conduct public as indicated below, with
a scientifically rigorous review to 39870, July 2, 2013).
attendance limited to space available.
develop recommendations for updated James Macrae, Individuals who plan to attend and
Women’s Preventive Services need special assistance, such as sign
Acting Administrator.
Guidelines in accordance with the language interpretation or other
[FR Doc. 2016–31129 Filed 12–23–16; 8:45 am]
model created by the NAM Clinical reasonable accommodations, should
Practice Guidelines We Can Trust. The BILLING CODE 4165–15–P
notify the Contact Person listed below
American College of Obstetricians and in advance of the meeting. The open
Gynecologists was awarded the session will be videocast and can be
cooperative agreement and formed an DEPARTMENT OF HEALTH AND
HUMAN SERVICES accessed from the NIH Videocasting and
expert panel called the Women’s Podcasting Web site (http://
Preventive Services Initiative. videocast.nih.gov).
Under section 2713 of the Public Office of Inspector General
A portion of the meeting will be
Health Service Act, non-grandfathered closed to the public in accordance with
group health plans and issuers of non- Announcement of Updated
Requirements and Registration for the provisions set forth in sections
grandfathered group and individual
‘‘The Simple Extensible Sampling Tool 552b(c)(4), and 552b(c)(6), Title 5
health insurance coverage are required
Challenge’’ U.S.C., as amended. The grant
to cover specified preventive services
applications and the discussions could
without a copayment, coinsurance,
AGENCY: Office of Inspector General disclose confidential trade secrets or
deductible, or other cost sharing,
(OIG), HHS. commercial property such as patentable
including preventive care and
material, and personal information
screenings for women as provided for in ACTION: Notice. concerning individuals associated with
comprehensive guidelines supported by
the grant applications, the disclosure of
HRSA for this purpose. Non- SUMMARY: On September 29, 2016, OIG which would constitute a clearly
grandfathered plans and coverage announced ‘‘The Simple Extensible
(generally, plans or policies created or unwarranted invasion of personal
Sampling Tool Challenge’’. This notice privacy.
sold after March 23, 2010, or older plans serves as an update to the original
or policies that have been changed in Name of Committee: Council of Councils.
notice which stated that upon receipt of
certain ways since that date) are Open: January 27, 2017.
an updated submission the previous Time: 8:15 a.m. to 11:30 a.m.
required to provide coverage without
submission would be excluded in its Agenda: Call to Order and Introductions;
cost sharing consistent with these
guidelines beginning with the first plan entirety from the competition. This Announcements and Updates; Tracking
updated notice removes this restriction Utility of Common Fund Data Sets; Small
year (in the individual market, policy Molecules from the Human Microbiota;
year) that begins on or after December for entries from teams that have been
previously identified as finalists. Any Invited Speaker; NIH Update; Discussion;
20, 2017. 2017 Biennial Advisory Council Report—
The guidelines concerning finalist may update their entry without Compliance with the NIH Policy on the
contraceptive methods and counseling losing their finalist designation. Updates Inclusion of Women and Minorities in
do not apply to women who are from the finalists will be accepted until Clinical Research.
participants or beneficiaries in group 5:00 p.m. EST on the fourteenth day Place: National Institutes of Health, 9000
health plans sponsored by religious after the fifth finalist has been identified Rockville Pike, Building 31, C Wing, 6th
or May 15, 2017, 5:00 p.m. EST, Floor, Conference Room 10, Bethesda, MD
employers. Effective August 1, 2013, a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
20892.
religious employer is defined as an whichever comes first. The newest entry
from each team will be used for all Closed: January 27, 2017.
employer that is organized and operates
Time: 12:00 p.m. to 1:00 p.m.
as a non-profit entity and is referred to judging purposes unless otherwise Agenda: Review of grant applications.
in section 6033(a)(3)(A)(i) or (iii) of the requested by the team. Other than the Place: National Institutes of Health, 9000
Internal Revenue Code. HRSA notes above change, all rules and Rockville Pike, Building 31, C Wing, 6th
that, as of August 1, 2013, group health requirements outlined in the September Floor, Conference Room 10, Bethesda, MD
plans established or maintained by 29, 2016, Federal Register notice remain 20892.
religious employers (and group health in effect. Open: January 27, 2017.
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Document Created: 2018-02-14 09:13:28
Document Modified: 2018-02-14 09:13:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | HRSA, Maternal and Child Health Bureau at email: [email protected] | |
| FR Citation | 81 FR 95148 |
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