83 FR 8487 - Women's Preventive Services Guidelines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 39 (February 27, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 39 (February 27, 2018)
| Page Range | 8487-8488 | |
| FR Document | 2018-03840 |
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)] [Notices] [Pages 8487-8488] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03840] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Women's Preventive Services Guidelines AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Applicable as of December 29, 2017, 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 2017 update adds two additional services--Screening for Diabetes Mellitus after Pregnancy and Screening for Urinary Incontinence--to the nine preventive services included in the 2016 update to the HRSA-supported Women's Preventive Services Guidelines. The nine services included in the 2016 update are as follows: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, and Well-Woman Preventive Visits. This notice serves as an announcement of the decision to update the guidelines as listed below. Please see https://www.hrsa.gov/womens-guidelines/index.html for additional information. FOR FURTHER INFORMATION CONTACT: Kimberly C. Sherman, Maternal and Child Health Bureau, HRSA at phone: (301) 443-0543; email: [email protected]. SUPPLEMENTARY INFORMATION: The complete set of updated 2017 HRSA- supported Women's Preventive Services Guidelines includes those that were accepted by the Acting HRSA Administrator on December 20, 2016, as well as two new services, Screening for Diabetes Mellitus After Pregnancy and Screening for Urinary Incontinence. For a complete listing and detailed information about the December 20, 2016, updates, please see https://www.federalregister.gov/documents/2016/12/27/2016-31129/updating-the-hrsa-supported-womens-preventive-services-guidelines. In addition, the December 20, 2016, updates, including information related to coverage of contraceptive services and exemption for objecting organizations from requirements related to the provision of contraceptive services, can be found at https://www.hrsa.gov/womens-guidelines-2016/index.html. Information regarding the two new services that were accepted by the HRSA Administrator on December 29, 2017, is set out below: 1. Screening for Diabetes Mellitus After Pregnancy The Women's Preventive Services Initiative recommends women with a history of gestational diabetes mellitus (GDM) who are not currently pregnant and who have not previously been diagnosed with type 2 diabetes mellitus should be screened for diabetes mellitus. Initial testing should ideally occur within the first year postpartum and can be conducted as early as 4-6 weeks postpartum. Women with a negative initial postpartum screening test result should be rescreened at least every 3 years for a minimum of 10 years after pregnancy. For women with a positive postpartum screening test result, testing to confirm the diagnosis of diabetes is indicated regardless of the initial test (e.g., oral glucose tolerance test, fasting plasma glucose, or hemoglobin A1c). Repeat testing is indicated in women who were screened with hemoglobin A1c in the first six months postpartum regardless of the result (see Implementation Considerations below). 2. Screening for Urinary Incontinence The Women's Preventive Services Initiative recommends screening women for urinary incontinence annually. Screening should ideally assess whether women experience urinary incontinence and whether it impacts their activities and quality of life. The Women's Preventive Services Initiative recommends referring women for further evaluation and treatment if indicated. HRSA-Supported Women's Preventive Services Guidelines The HRSA-supported Women's Preventive Services Guidelines were originally established in 2011 based on recommendations from an HHS commissioned study by the Institute of Medicine, now known as the National [[Page 8488]] 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 group health plans and health insurance issuers offering non-grandfathered group or individual 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 for preventive services listed in the updated HRSA- supported guidelines (which include the nine preventive services set out in the 2016 update, as well as the two services added in this update) beginning with the first plan year (in the individual market, policy year) that begins on or after December 29, 2018. Dated: February 20, 2018. George Sigounas, Administrator. [FR Doc. 2018-03840 Filed 2-26-18; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 8487
www.fda.gov/NewsEvents/Meetings Dated: February 22, 2018. information about the December 20,
ConferencesWorkshops/ Leslie Kux, 2016, updates, please see https://
ucm592778.htm. Please provide Associate Commissioner for Policy. www.federalregister.gov/documents/
complete contact information for each [FR Doc. 2018–03961 Filed 2–26–18; 8:45 am] 2016/12/27/2016-31129/updating-the-
attendee, including name, title, BILLING CODE 4164–01–P
hrsa-supported-womens-preventive-
affiliation, address, email, and services-guidelines. In addition, the
telephone. December 20, 2016, updates, including
DEPARTMENT OF HEALTH AND information related to coverage of
Registration is free and based on
HUMAN SERVICES contraceptive services and exemption
space availability, with priority given to
for objecting organizations from
early registrants. Persons interested in
Health Resources and Service requirements related to the provision of
attending this public workshop must
Administration contraceptive services, can be found at
register by April 25, 2018, 5 p.m.
https://www.hrsa.gov/womens-
Eastern Time. Early registration is Women’s Preventive Services guidelines-2016/index.html.
recommended because seating is Guidelines Information regarding the two new
limited; therefore, FDA may limit the services that were accepted by the
number of participants from each AGENCY: Health Resources and Services
Administration (HRSA), Department of HRSA Administrator on December 29,
organization. Registrants will receive 2017, is set out below:
confirmation when their registration has Health and Human Services (HHS).
been received. If time and space permit, ACTION: Notice. 1. Screening for Diabetes Mellitus After
onsite registration on the day of the Pregnancy
SUMMARY: Applicable as of December 29,
public workshop will be provided The Women’s Preventive Services
2017, HRSA updated the HRSA-
beginning an hour prior to the start of supported Women’s Preventive Services Initiative recommends women with a
the meeting. Guidelines for purposes of health history of gestational diabetes mellitus
If you need special accommodations insurance coverage for preventive (GDM) who are not currently pregnant
due to a disability, please contact Nicole services that address health needs and who have not previously been
Wolanski, at 301–796–6570, or specific to women based on clinical diagnosed with type 2 diabetes mellitus
OOPDOrphanEvents@fda.hhs.gov no recommendations from the Women’s should be screened for diabetes
later than April 25, 2018. Preventive Services Initiative. This 2017 mellitus. Initial testing should ideally
update adds two additional services— occur within the first year postpartum
An agenda for the workshop and any
Screening for Diabetes Mellitus after and can be conducted as early as 4–6
other background materials will be
Pregnancy and Screening for Urinary weeks postpartum.
made available 5 days before the Women with a negative initial
workshop at https://www.fda.gov/News Incontinence—to the nine preventive
services included in the 2016 update to postpartum screening test result should
Events/MeetingsConferencesWorkshops/ be rescreened at least every 3 years for
ucm592778.htm. the HRSA-supported Women’s
Preventive Services Guidelines. The a minimum of 10 years after pregnancy.
Streaming Webcast of the Public nine services included in the 2016 For women with a positive postpartum
Workshop: For those unable to attend in update are as follows: Breast Cancer screening test result, testing to confirm
person, FDA will provide a live webcast Screening for Average Risk Women, the diagnosis of diabetes is indicated
of the workshop. To register for the Breastfeeding Services and Supplies, regardless of the initial test (e.g., oral
streaming webcast of the public Screening for Cervical Cancer, glucose tolerance test, fasting plasma
workshop, please visit the following Contraception, Screening for Gestational glucose, or hemoglobin A1c). Repeat
website by May 8, 2018: https://www. Diabetes Mellitus, Screening for Human testing is indicated in women who were
fda.gov/NewsEvents/Meetings Immunodeficiency Virus Infection, screened with hemoglobin A1c in the
ConferencesWorkshops/ Screening for Interpersonal and first six months postpartum regardless
ucm592778.htm. Domestic Violence, Counseling for of the result (see Implementation
If you have never attended a Connect Sexually Transmitted Infections, and Considerations below).
Pro event before, test your connection at Well-Woman Preventive Visits. This 2. Screening for Urinary Incontinence
https://collaboration.fda.gov/common/ notice serves as an announcement of the The Women’s Preventive Services
help/en/support/meeting_test.htm. To decision to update the guidelines as Initiative recommends screening women
get a quick overview of the Connect Pro listed below. Please see https:// for urinary incontinence annually.
program, visit https://www.adobe.com/ www.hrsa.gov/womens-guidelines/ Screening should ideally assess whether
go/connectpro_overview. FDA has index.html for additional information. women experience urinary incontinence
verified the website addresses in this FOR FURTHER INFORMATION CONTACT: and whether it impacts their activities
document, as of the date this document Kimberly C. Sherman, Maternal and and quality of life. The Women’s
publishes in the Federal Register, but Child Health Bureau, HRSA at phone: Preventive Services Initiative
websites are subject to change over time. (301) 443–0543; email: wellwomancare@ recommends referring women for
Transcripts: Please be advised that as hrsa.gov. further evaluation and treatment if
soon as a transcript of the public SUPPLEMENTARY INFORMATION: The indicated.
workshop is available, it will be complete set of updated 2017 HRSA-
accessible at https:// supported Women’s Preventive Services HRSA-Supported Women’s Preventive
daltland on DSKBBV9HB2PROD with NOTICES
www.regulations.gov. It may be viewed Guidelines includes those that were Services Guidelines
at the Dockets Management Staff (see accepted by the Acting HRSA The HRSA-supported Women’s
ADDRESSES). A link to the transcript will Administrator on December 20, 2016, as Preventive Services Guidelines were
also be available on the internet at well as two new services, Screening for originally established in 2011 based on
https://www.fda.gov/NewsEvents/ Diabetes Mellitus After Pregnancy and recommendations from an HHS
MeetingsConferencesWorkshops/ Screening for Urinary Incontinence. For commissioned study by the Institute of
ucm592778.htm. a complete listing and detailed Medicine, now known as the National
VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1](https://thefederalregister.org/doc/83_FR_8526/page/1.svg)
![8488 Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices
Academy of Medicine (NAM). Since The meetings will be closed to the Scientific Review, National Institutes of
then, there have been advancements in public in accordance with the Health, 6701 Rockledge Drive, Room 5216,
science and gaps identified in the provisions set forth in sections MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
existing guidelines, including a greater 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
emphasis on practice-based clinical as amended. The grant applications and Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
considerations. To address these, HRSA the discussions could disclose Infectious Diseases and Microbiology.
awarded a 5-year cooperative agreement confidential trade secrets or commercial Date: March 22–23, 2018.
in March 2016 to convene a coalition of property such as patentable material, Time: 8:00 a.m. to 5:00 p.m.
clinician, academic and consumer- and personal information concerning Agenda: To review and evaluate grant
focused health professional individuals associated with the grant applications.
organizations and conduct a applications, the disclosure of which Place: Embassy Suites DC Convention
scientifically rigorous review to develop would constitute a clearly unwarranted Center, 900 10th Street NW, Washington, DC
recommendations for updated Women’s invasion of personal privacy. 20001.
Preventive Services Guidelines in Contact Person: Tamara Lyn McNealy,
Name of Committee: Center for Scientific Ph.D., Scientific Review Officer, Center for
accordance with the model created by Review Special Emphasis Panel; PAR–16– Scientific Review, National Institutes of
the NAM Clinical Practice Guidelines 366 Dual Purpose with Dual Benefit: Health, 6701 Rockledge Drive, Room 3188,
We Can Trust. The American College of Research in Biomedicine and Agriculture. Bethesda, MD 20747, 301–827–2372,
Obstetricians and Gynecologists was Date: March 21–22, 2018. tamara.mcnealy@nih.gov.
awarded the cooperative agreement and Time: 8:00 a.m. to 6:00 p.m. Name of Committee: Center for Scientific
formed an expert panel called the Agenda: To review and evaluate grant
Review Special Emphasis Panel; PAR Panel:
Women’s Preventive Services Initiative. applications.
Cancer Health Disparities.
Under section 2713 of the Public Place: National Institutes of Health, 6701
Date: March 22, 2018.
Rockledge Drive, Bethesda, MD 20892
Health Service Act, non-grandfathered Time: 8:00 a.m. to 6:00 p.m.
(Virtual Meeting).
group health plans and issuers of non- Agenda: To review and evaluate grant
Contact Person: Tera Bounds, DVM, Ph.D.,
grandfathered group and individual applications.
Scientific Review Officer, Center for
health insurance coverage are required Place: Hyatt Regency Bethesda, One
Scientific Review, National Institutes of
Bethesda Metro Center, 7400 Wisconsin
to cover specified preventive services Health, 6701 Rockledge Drive, Room 3214,
Avenue, Bethesda, MD 20814.
without a copayment, coinsurance, MSC 7808, Bethesda, MD 20892, 301–435–
Contact Person: Janet M. Larkin, Ph.D.,
deductible, or other cost sharing, 2306, boundst@csr.nih.gov.
Scientific Review Officer, Center for
including preventive care and Name of Committee: Center for Scientific Scientific Review, National Institutes of
screenings for women as provided for in Review Special Emphasis Panel; Member Health, 6701 Rockledge Drive, Room 5142,
comprehensive guidelines supported by Conflict. MSC 7840, Bethesda, MD 20892, 301–806–
Date: March 21, 2018. 2765, larkinja@csr.nih.gov.
HRSA for this purpose. Non- Time: 11:00 a.m. to 3:00 p.m.
grandfathered group health plans and Name of Committee: Center for Scientific
Agenda: To review and evaluate grant
health insurance issuers offering non- applications. Review Special Emphasis Panel; Small
grandfathered group or individual Place: National Institutes of Health, 6701 Business: Innovative Immunology.
Date: March 22, 2018.
coverage (generally, plans or policies Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting). Time: 8:00 a.m. to 6:00 p.m.
created or sold after March 23, 2010, or Agenda: To review and evaluate grant
older plans or policies that have been Contact Person: Kate Fothergill, Ph.D.,
Scientific Review Officer, Center for applications.
changed in certain ways since that date) Place: The William F. Bolger Center, 9600
Scientific Review, National Institutes of
are required to provide coverage Health, 6701 Rockledge Drive, Room 3142, Newbridge Drive, Potomac, MD 20854.
without cost sharing for preventive Bethesda, MD 20892, 301–435–2309, Contact Person: Andrea Keane-Myers,
services listed in the updated HRSA- fothergillke@mail.nih.gov. Ph.D., Scientific Review Officer, Center for
supported guidelines (which include Scientific Review, National Institutes of
Name of Committee: Center for Scientific
the nine preventive services set out in Health, 6701 Rockledge Drive, Room 4218,
Review Special Emphasis Panel; Member
Bethesda, MD 20892, 301–435–1221,
the 2016 update, as well as the two Conflict: The Biostatistical Methods and
andrea.keane-myers@nih.gov.
services added in this update) beginning Research Design.
Date: March 21, 2018. Name of Committee: AIDS and Related
with the first plan year (in the
Time: 1:00 p.m. to 5:00 p.m. Research Integrated Review Group; AIDS
individual market, policy year) that Discovery and Development of Therapeutics
begins on or after December 29, 2018. Agenda: To review and evaluate grant
applications. Study Section.
Dated: February 20, 2018. Place: National Institutes of Health, 6701 Date: March 22, 2018.
George Sigounas, Rockledge Drive, Bethesda, MD 20892 Time: 8:00 a.m. to 6:30 p.m.
(Telephone Conference Call). Agenda: To review and evaluate grant
Administrator.
Contact Person: Ping Wu, Ph.D., Scientific applications.
[FR Doc. 2018–03840 Filed 2–26–18; 8:45 am] Place: The Fairmont Washington, DC, 2401
Review Officer, HDM IRG, Center for
BILLING CODE 4165–15–P Scientific Review, National Institutes of M Street NW, Washington, DC 20037.
Health, 6701 Rockledge Drive, Room 3166, Contact Person: Shiv A. Prasad, Ph.D.,
Bethesda, MD 20892, 301–451–8428, wup4@ Scientific Review Officer, Center for
DEPARTMENT OF HEALTH AND csr.nih.gov. Scientific Review, National Institutes of
HUMAN SERVICES Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 5220,
Review Special Emphasis Panel; PAR Panel: MSC 7852, Bethesda, MD 20892, 301–443–
National Institutes of Health AIDS and Related Research. 5779, prasads@csr.nih.gov.
daltland on DSKBBV9HB2PROD with NOTICES
Date: March 22, 2018. Name of Committee: AIDS and Related
Center for Scientific Review; Notice of Time: 8:00 a.m. to 6:00 p.m. Research Integrated Review Group;
Closed Meetings Agenda: To review and evaluate grant NeuroAIDS and other End-Organ Diseases
applications. Study Section.
Pursuant to section 10(d) of the Place: The Fairmont Washington, DC, 2401 Date: March 22, 2018.
Federal Advisory Committee Act, as M Street NW, Washington, DC 20037. Time: 8:00 a.m. to 6:30 p.m.
amended, notice is hereby given of the Contact Person: Robert Freund, Ph.D., Agenda: To review and evaluate grant
following meetings. Scientific Review Officer, Center for applications.
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Document Created: 2018-02-27 01:14:27
Document Modified: 2018-02-27 01:14:27
| 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 | Kimberly C. Sherman, Maternal and Child Health Bureau, HRSA at phone: (301) 443-0543; email: [email protected] | |
| FR Citation | 83 FR 8487 |
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