Women's Preventive Services Guidelines, 8487-8488 [2018-03840]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices www.fda.gov/NewsEvents/Meetings ConferencesWorkshops/ ucm592778.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by April 25, 2018, 5 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when their registration has been received. If time and space permit, onsite registration on the day of the public workshop will be provided beginning an hour prior to the start of the meeting. 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FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/NewsEvents/ MeetingsConferencesWorkshops/ ucm592778.htm. VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 Dated: February 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–03961 Filed 2–26–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Women’s Preventive Services Guidelines Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: 8487 information about the December 20, 2016, updates, please see https:// www.federalregister.gov/documents/ 2016/12/27/2016-31129/updating-thehrsa-supported-womens-preventiveservices-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/womensguidelines-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 SUMMARY: Applicable as of December 29, The Women’s Preventive Services 2017, HRSA updated the HRSAsupported Women’s Preventive Services Initiative recommends women with a history of gestational diabetes mellitus Guidelines for purposes of health (GDM) who are not currently pregnant insurance coverage for preventive and who have not previously been services that address health needs diagnosed with type 2 diabetes mellitus specific to women based on clinical should be screened for diabetes recommendations from the Women’s Preventive Services Initiative. This 2017 mellitus. Initial testing should ideally occur within the first year postpartum update adds two additional services— and can be conducted as early as 4–6 Screening for Diabetes Mellitus after weeks postpartum. Pregnancy and Screening for Urinary Women with a negative initial Incontinence—to the nine preventive postpartum screening test result should services included in the 2016 update to be rescreened at least every 3 years for the HRSA-supported Women’s a minimum of 10 years after pregnancy. Preventive Services Guidelines. The For women with a positive postpartum nine services included in the 2016 screening test result, testing to confirm update are as follows: Breast Cancer the diagnosis of diabetes is indicated Screening for Average Risk Women, regardless of the initial test (e.g., oral Breastfeeding Services and Supplies, glucose tolerance test, fasting plasma Screening for Cervical Cancer, Contraception, Screening for Gestational glucose, or hemoglobin A1c). Repeat Diabetes Mellitus, Screening for Human testing is indicated in women who were screened with hemoglobin A1c in the Immunodeficiency Virus Infection, first six months postpartum regardless Screening for Interpersonal and of the result (see Implementation Domestic Violence, Counseling for Considerations below). Sexually Transmitted Infections, and Well-Woman Preventive Visits. This 2. Screening for Urinary Incontinence notice serves as an announcement of the The Women’s Preventive Services decision to update the guidelines as Initiative recommends screening women listed below. Please see https:// for urinary incontinence annually. www.hrsa.gov/womens-guidelines/ Screening should ideally assess whether index.html for additional information. women experience urinary incontinence FOR FURTHER INFORMATION CONTACT: and whether it impacts their activities Kimberly C. Sherman, Maternal and and quality of life. The Women’s Child Health Bureau, HRSA at phone: Preventive Services Initiative (301) 443–0543; email: wellwomancare@ recommends referring women for hrsa.gov. further evaluation and treatment if SUPPLEMENTARY INFORMATION: The indicated. complete set of updated 2017 HRSAsupported Women’s Preventive Services HRSA-Supported Women’s Preventive Services Guidelines Guidelines includes those that were The HRSA-supported Women’s accepted by the Acting HRSA Administrator on December 20, 2016, as Preventive Services Guidelines were originally established in 2011 based on well as two new services, Screening for recommendations from an HHS Diabetes Mellitus After Pregnancy and Screening for Urinary Incontinence. For commissioned study by the Institute of Medicine, now known as the National a complete listing and detailed PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1 8488 Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 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 consumerfocused 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 nongrandfathered 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. Nongrandfathered group health plans and health insurance issuers offering nongrandfathered 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 HRSAsupported 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 daltland on DSKBBV9HB2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. 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Contact Person: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, Bethesda, MD 20892, 301–435–2309, fothergillke@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: The Biostatistical Methods and Research Design. Date: March 21, 2018. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ping Wu, Ph.D., Scientific Review Officer, HDM IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301–451–8428, wup4@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: AIDS and Related Research. Date: March 22, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW, Washington, DC 20037. Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301–435– 1050, freundr@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Infectious Diseases and Microbiology. Date: March 22–23, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites DC Convention Center, 900 10th Street NW, Washington, DC 20001. Contact Person: Tamara Lyn McNealy, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3188, Bethesda, MD 20747, 301–827–2372, tamara.mcnealy@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Cancer Health Disparities. Date: March 22, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Janet M. Larkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5142, MSC 7840, Bethesda, MD 20892, 301–806– 2765, larkinja@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Innovative Immunology. Date: March 22, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854. Contact Person: Andrea Keane-Myers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4218, Bethesda, MD 20892, 301–435–1221, andrea.keane-myers@nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; AIDS Discovery and Development of Therapeutics Study Section. Date: March 22, 2018. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street NW, Washington, DC 20037. Contact Person: Shiv A. Prasad, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301–443– 5779, prasads@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group; NeuroAIDS and other End-Organ Diseases Study Section. Date: March 22, 2018. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8487-8488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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