81_FR_58081 81 FR 57917 - Health Insurance MarketplaceSM

81 FR 57917 - Health Insurance MarketplaceSM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range57917-57919
FR Document2016-20187

This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\ and the Medicare, Medicaid, and Children's Health Insurance Programs consumer education strategies. This meeting is open to the public.

Federal Register, Volume 81 Issue 164 (Wednesday, August 24, 2016)
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57917-57919]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-7042-N]


Health Insurance Marketplace\SM\; and the Medicare, Medicaid, and 
Children's Health Insurance Programs; Meeting of the Advisory Panel on 
Outreach and Education (APOE), September 21, 2016

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

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SUMMARY: This notice announces the new meeting of the Advisory Panel on 
Outreach and Education (APOE) (the Panel) in accordance with the 
Federal Advisory Committee Act. The Panel advises and makes 
recommendations to the Secretary of the U.S. Department of Health and 
Human Services (HHS) and the Administrator of the Centers for Medicare 
& Medicaid Services (CMS) on opportunities to enhance the effectiveness 
of Health Insurance Marketplace\SM\ and the Medicare, Medicaid, and 
Children's Health Insurance Programs consumer education strategies. 
This meeting is open to the public.

DATES: Meeting Date: Wednesday, September 21, 2016, 8:30 a.m. to 4:00 
p.m. eastern daylight time (e.d.t.).
    Deadline for Meeting Registration, Presentations, Special 
Accommodations and Comments: Wednesday, September 7, 2016, 5:00 p.m., 
e.d.t.

ADDRESSES: Meeting Location: U.S. Department of Health & Human 
Services, Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Room 425A, Conference Room, Washington, DC 20201.
    Presentations and Written Comments: Presentations and written 
comments should be submitted to: Abigail Huffman, Designated Federal 
Official (DFO), Division of Forum and Conference Development, Office of 
Communications, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Mailstop S1-05-06, Baltimore, MD 21244-1850 or via email at 
[email protected].
    Registration: The meeting is open to the public, but attendance is 
limited to the space available. Persons wishing to attend this meeting 
must register at the Web site https://www.regonline.com/apoesept2016meeting or by contacting the DFO as listed in the FOR 
FURTHER INFORMATION CONTACT section of this notice, by the date listed 
in the DATES section of this notice. Individuals requiring sign 
language interpretation or other special accommodations should contact 
the DFO at the address listed in the ADDRESSES section of this notice 
by the date listed in the DATES section of this notice.

FOR FURTHER INFORMATION CONTACT: Abigail Huffman, Designated Federal 
Official, Office of Communications, CMS, 7500 Security Boulevard, Mail 
Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email 
[email protected]. Additional information about the APOE is 
available on the Internet at: http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/APOE.html. Press inquiries are handled through 
the CMS Press Office at (202) 690-6145.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Advisory Panel for Outreach and Education (APOE) (the Panel) is 
governed by the provisions of Federal Advisory Committee Act (FACA) 
(Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth 
standards for the formation and use of federal advisory committees. The 
Panel is authorized by section 1114(f) of the Social Security Act (42 
U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 
U.S.C. 217a).
    The Secretary of the U.S. Department of Health and Human Services 
(HHS) (the Secretary) signed the charter establishing the Citizen's 
Advisory Panel on Medicare Education \1\ (the predecessor to the APOE) 
on January 21, 1999 (64 FR 7899, February 17, 1999) to advise and make 
recommendations to the Secretary and the Administrator of the Centers 
for Medicare & Medicaid Services (CMS) on the effective implementation 
of national Medicare education programs, including with respect to the 
Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 
(Pub. L. 105-33).
---------------------------------------------------------------------------

    \1\ We note that the Citizen's Advisory Panel on Medicare 
Education is also referred to as the Advisory Panel on Medicare 
Education (65 FR 4617). The name was updated in the Second Amended 
Charter approved on July 24, 2000.
---------------------------------------------------------------------------

    The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) 
expanded the existing health plan options and benefits available under 
the M+C program and renamed it the Medicare Advantage (MA) program. We 
have had substantial responsibilities to provide information to 
Medicare beneficiaries about the range of health plan options available 
and better tools to evaluate these options. The successful MA program 
implementation required CMS to consider the views and policy input from 
a variety of private sector constituents and to develop a broad range 
of public-private partnerships.
    In addition, Title I of the MMA authorized the Secretary and the 
Administrator of CMS (by delegation) to establish the Medicare 
prescription drug benefit. The drug benefit allows beneficiaries to 
obtain qualified prescription drug coverage. In order to effectively 
administer the MA program and the Medicare prescription drug benefit, 
we have substantial responsibilities to provide information to Medicare 
beneficiaries about the range of health plan options and benefits 
available, and to develop better tools to evaluate these plans and 
benefits.
    The Affordable Care Act (Patient Protection and Affordable Care 
Act, Public Law 111-148, and Health Care and Education Reconciliation 
Act of 2010, Public Law 111-152) expanded the availability of other 
options for health care coverage and enacted a number of changes to 
Medicare as well as to Medicaid and the Children's Health Insurance 
Program (CHIP). Qualified individuals and qualified employers are now 
able to purchase private health insurance coverage through competitive 
marketplaces, called Affordable Insurance Exchanges (we also call an 
Exchange a Health

[[Page 57918]]

Insurance Marketplace\SM\ \2\ or Marketplace\SM\). In order to 
effectively implement and administer these changes, we must provide 
information to consumers, providers, and other stakeholders through 
education and outreach programs regarding how existing programs will 
change and the expanded range of health coverage options available, 
including private health insurance coverage through a Marketplace\SM\. 
The APOE (the Panel) allows us to consider a broad range of views and 
information from interested audiences in connection with this effort 
and to identify opportunities to enhance the effectiveness of education 
strategies concerning the Affordable Care Act.
---------------------------------------------------------------------------

    \2\ Health Insurance Marketplace\SM\ and Marketplace\SM\ are 
service marks of the U.S. Department of Health & Human Services.
---------------------------------------------------------------------------

    The scope of this panel also includes advising on issues pertaining 
to the education of providers and stakeholders with respect to the 
Affordable Care Act and certain provisions of the Health Information 
Technology for Economic and Clinical Health (HITECH) Act enacted as 
part of the American Recovery and Reinvestment Act of 2009 (ARRA).
    On January 21, 2011, the Panel's charter was renewed and the Panel 
was renamed the Advisory Panel for Outreach and Education. The Panel's 
charter was most recently renewed on January 21, 2015, and will 
terminate on January 21, 2017 unless renewed by appropriate action.
    Under the current charter, the APOE will advise the Secretary and 
the Administrator on optimal strategies for the following:
     Developing and implementing education and outreach 
programs for individuals enrolled in, or eligible for, Medicare, 
Medicaid, and CHIP or coverage available through the Health Insurance 
Marketplace\SM\.
     Enhancing the federal government's effectiveness in 
informing Health Insurance Marketplace\SM\, Medicare, Medicaid, and 
CHIP consumers, issuers, providers, and stakeholders, through education 
and outreach programs, on issues regarding these programs, including 
the appropriate use of public-private partnerships to leverage the 
resources of the private sector in educating beneficiaries, providers, 
and stakeholders.
     Expanding outreach to vulnerable and underserved 
communities, including racial and ethnic minorities, in the context of 
Health Insurance Marketplace\SM\, Medicare, Medicaid, and CHIP 
education programs.
     Assembling and sharing an information base of ``best 
practices'' for helping consumers evaluate health coverage options.
     Building and leveraging existing community infrastructures 
for information, counseling, and assistance.
     Drawing the program link between outreach and education, 
promoting consumer understanding of health care coverage choices, and 
facilitating consumer selection/enrollment, which in turn support the 
overarching goal of improved access to quality care, including 
prevention services, envisioned under the Affordable Care Act.
    The current members of the Panel are: Kellan Baker, Associate 
Director, Center for American Progress; Robert Blancato, President, 
Matz, Blancato & Associates; Dale Blasier, Professor of Orthopaedic 
Surgery, Department of Orthopaedics, Arkansas Children's Hospital; 
Deborah Britt, Executive Director of Community & Public Relations, 
Piedmont Fayette Hospital; Deena Chisolm, Associate Professor of 
Pediatrics & Public Health, The Ohio State University, Nationwide 
Children's Hospital; Josephine DeLeon, Director, Anti-Poverty 
Initiatives, Catholic Charities of California; Robert Espinoza, Vice 
President of Policy, Paraprofessional Healthcare Institute; Jennifer 
Gross, Manager of Political Field Operations, Planned Parenthood of 
Montana; Louise Scherer Knight, Director, The Sidney Kimmel 
Comprehensive Cancer Center at Johns Hopkins; Roanne Osborne-Gaskin, 
M.D., Senior Medical Director, MDWise, Inc.; Cathy Phan, Outreach and 
Education Coordinator, Asian American Health Coalition DBA HOPE Clinic; 
Kamilah Pickett, Litigation Support, Independent Contractor; Brendan 
Riley, Outreach and Enrollment Coordinator, NC Community Health Center 
Association; Alvia Siddiqi, Medical Director, Advocate Physician 
Partners; Carla Smith, Executive Vice President, Healthcare Information 
and Management Systems Society (HIMSS); Tobin Van Ostern, Vice 
President and Co-Founder, Young Invincibles Advisors; and Paula 
Villescaz, Senior Consultant, Assembly Health Committee, California 
State Legislature.

II. Provisions of This Notice

    In accordance with section 10(a) of the FACA, this notice announces 
a meeting of the APOE. The agenda for the September 21, 2016 meeting 
will include the following:

 Welcome and listening session with CMS leadership
 Recap of the previous (June 22, 2016) meeting
 Affordable Care Act initiatives
 An opportunity for public comment
 Meeting summary, review of recommendations, and next steps

    Individuals or organizations that wish to make a 5-minute oral 
presentation on an agenda topic should submit a written copy of the 
oral presentation to the DFO at the address listed in the ADDRESSES 
section of this notice by the date listed in the DATES section of this 
notice. The number of oral presentations may be limited by the time 
available. Individuals not wishing to make an oral presentation may 
submit written comments to the DFO at the address listed in the 
ADDRESSES section of this notice by the date listed in the DATES 
section of this notice.

III. Security, Building, and Parking Guidelines

    This meeting will be held in a federal government building; 
therefore, federal security measures are applicable. The Real ID Act, 
enacted in 2005, establishes minimum standards for the issuance of 
state-issued driver's licenses and identification (ID) cards. It 
prohibits federal agencies from accepting an official driver's license 
or ID card from a state unless the Department of Homeland Security 
determines that the state meets these standards. Beginning October 
2015, photo IDs (such as a valid driver's license) issued by a state or 
territory not in compliance with the Real ID Act will not be accepted 
as identification to enter federal buildings. Visitors from these 
states/territories will need to provide alternative proof of 
identification (such as a valid passport) to gain entrance into CMS 
buildings. The current list of states from which a federal agency may 
accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief . We recommend that confirmed 
registrants arrive reasonably early, but no earlier than 45 minutes 
prior to the start of the meeting, to allow additional time to clear 
security. Security measures include the following:
     Presentation of government issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.
     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means, 
of all persons entering the building. We note that all items brought 
into CMS, whether personal or for the purpose of

[[Page 57919]]

presentation or to support a presentation, are subject to inspection. 
We cannot assume responsibility for coordinating the receipt, transfer, 
transport, storage, set up, safety, or timely arrival of any personal 
belongings or items used for presentation or to support a presentation.

    Note: Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting.

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building.

    Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 
217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) 
and 41 CFR 102-3).

    Dated: August 16, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-20187 Filed 8-23-16; 8:45 am]
BILLING CODE 4120-01-P



                                                                             Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices                                                   57917

                                                  open, responsive, and understandable to                 and Comments: Wednesday, September                    Panel on Medicare Education 1 (the
                                                  the public. We share the goal of                        7, 2016, 5:00 p.m., e.d.t.                            predecessor to the APOE) on January 21,
                                                  increasing public participation in the                  ADDRESSES: Meeting Location: U.S.                     1999 (64 FR 7899, February 17, 1999) to
                                                  development of Medicare coverage                        Department of Health & Human                          advise and make recommendations to
                                                  issues. This will assist us in obtaining                Services, Hubert H. Humphrey Building,                the Secretary and the Administrator of
                                                  the information we require to make a                    200 Independence Avenue SW., Room                     the Centers for Medicare & Medicaid
                                                  national coverage determination in a                    425A, Conference Room, Washington,                    Services (CMS) on the effective
                                                  timely manner and ensuring that the                     DC 20201.                                             implementation of national Medicare
                                                  Medicare program continues to meet the                     Presentations and Written Comments:                education programs, including with
                                                  needs of its beneficiaries. Form Number:                Presentations and written comments                    respect to the Medicare+Choice (M+C)
                                                  CMS–R–290 (OMB control number:                          should be submitted to: Abigail                       program added by the Balanced Budget
                                                  0938–0776); Frequency: Annual;                          Huffman, Designated Federal Official                  Act of 1997 (Pub. L. 105–33).
                                                  Affected Public: Private Sector: Business               (DFO), Division of Forum and                             The Medicare Modernization Act of
                                                  or other for-profits; Number of                         Conference Development, Office of
                                                  Respondents: 200; Total Annual                                                                                2003 (MMA) (Pub. L. 108–173)
                                                                                                          Communications, Centers for Medicare                  expanded the existing health plan
                                                  Responses: 200; Total Annual Hours:                     & Medicaid Services, 7500 Security
                                                  8,000. (For policy questions regarding                                                                        options and benefits available under the
                                                                                                          Boulevard, Mailstop S1–05–06,                         M+C program and renamed it the
                                                  this collection contact Katherine                       Baltimore, MD 21244–1850 or via email
                                                  Tillman at 410–786–9252.)                                                                                     Medicare Advantage (MA) program. We
                                                                                                          at Abigail.Huffman1@cms.hhs.gov.                      have had substantial responsibilities to
                                                     Dated: August 18, 2016.                                 Registration: The meeting is open to               provide information to Medicare
                                                  William N. Parham, III,                                 the public, but attendance is limited to              beneficiaries about the range of health
                                                  Director, Paperwork Reduction Staff, Office             the space available. Persons wishing to               plan options available and better tools
                                                  of Strategic Operations and Regulatory                  attend this meeting must register at the              to evaluate these options. The
                                                  Affairs.                                                Web site https://www.regonline.com/                   successful MA program implementation
                                                  [FR Doc. 2016–20216 Filed 8–23–16; 8:45 am]             apoesept2016meeting or by contacting                  required CMS to consider the views and
                                                  BILLING CODE 4120–01–P                                  the DFO as listed in the FOR FURTHER                  policy input from a variety of private
                                                                                                          INFORMATION CONTACT section of this
                                                                                                                                                                sector constituents and to develop a
                                                                                                          notice, by the date listed in the DATES               broad range of public-private
                                                  DEPARTMENT OF HEALTH AND                                section of this notice. Individuals                   partnerships.
                                                  HUMAN SERVICES                                          requiring sign language interpretation or
                                                                                                          other special accommodations should                      In addition, Title I of the MMA
                                                  Centers for Medicare & Medicaid                         contact the DFO at the address listed in              authorized the Secretary and the
                                                  Services                                                the ADDRESSES section of this notice by               Administrator of CMS (by delegation) to
                                                                                                          the date listed in the DATES section of               establish the Medicare prescription drug
                                                  [CMS–7042–N]                                            this notice.                                          benefit. The drug benefit allows
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                beneficiaries to obtain qualified
                                                  Health Insurance MarketplaceSM; and                                                                           prescription drug coverage. In order to
                                                                                                          Abigail Huffman, Designated Federal
                                                  the Medicare, Medicaid, and Children’s                                                                        effectively administer the MA program
                                                                                                          Official, Office of Communications,
                                                  Health Insurance Programs; Meeting of                                                                         and the Medicare prescription drug
                                                                                                          CMS, 7500 Security Boulevard, Mail
                                                  the Advisory Panel on Outreach and                                                                            benefit, we have substantial
                                                                                                          Stop S1–05–06, Baltimore, MD 21244,
                                                  Education (APOE), September 21, 2016                                                                          responsibilities to provide information
                                                                                                          410–786–0897, email
                                                  AGENCY: Centers for Medicare &                          Abigail.Huffman1@cms.hhs.gov.                         to Medicare beneficiaries about the
                                                  Medicaid Services (CMS), HHS.                           Additional information about the APOE                 range of health plan options and
                                                                                                          is available on the Internet at: http://              benefits available, and to develop better
                                                  ACTION: Notice of meeting.
                                                                                                          www.cms.gov/Regulations-and-                          tools to evaluate these plans and
                                                  SUMMARY:    This notice announces the                   Guidance/Guidance/FACA/APOE.html.                     benefits.
                                                  new meeting of the Advisory Panel on                    Press inquiries are handled through the                  The Affordable Care Act (Patient
                                                  Outreach and Education (APOE) (the                      CMS Press Office at (202) 690–6145.                   Protection and Affordable Care Act,
                                                  Panel) in accordance with the Federal                   SUPPLEMENTARY INFORMATION:                            Public Law 111–148, and Health Care
                                                  Advisory Committee Act. The Panel                                                                             and Education Reconciliation Act of
                                                  advises and makes recommendations to                    I. Background                                         2010, Public Law 111–152) expanded
                                                  the Secretary of the U.S. Department of                    The Advisory Panel for Outreach and                the availability of other options for
                                                  Health and Human Services (HHS) and                     Education (APOE) (the Panel) is                       health care coverage and enacted a
                                                  the Administrator of the Centers for                    governed by the provisions of Federal                 number of changes to Medicare as well
                                                  Medicare & Medicaid Services (CMS) on                   Advisory Committee Act (FACA) (Pub.                   as to Medicaid and the Children’s
                                                  opportunities to enhance the                            L. 92–463), as amended (5 U.S.C.                      Health Insurance Program (CHIP).
                                                  effectiveness of Health Insurance                       Appendix 2), which sets forth standards               Qualified individuals and qualified
                                                  MarketplaceSM and the Medicare,                         for the formation and use of federal                  employers are now able to purchase
                                                  Medicaid, and Children’s Health                         advisory committees. The Panel is                     private health insurance coverage
                                                  Insurance Programs consumer education                   authorized by section 1114(f) of the                  through competitive marketplaces,
mstockstill on DSK3G9T082PROD with NOTICES




                                                  strategies. This meeting is open to the                 Social Security Act (42 U.S.C. 1314(f))               called Affordable Insurance Exchanges
                                                  public.                                                 and section 222 of the Public Health                  (we also call an Exchange a Health
                                                  DATES: Meeting Date: Wednesday,                         Service Act (42 U.S.C. 217a).
                                                  September 21, 2016, 8:30 a.m. to 4:00                      The Secretary of the U.S. Department                 1 We note that the Citizen’s Advisory Panel on

                                                                                                          of Health and Human Services (HHS)                    Medicare Education is also referred to as the
                                                  p.m. eastern daylight time (e.d.t.).                                                                          Advisory Panel on Medicare Education (65 FR
                                                    Deadline for Meeting Registration,                    (the Secretary) signed the charter                    4617). The name was updated in the Second
                                                  Presentations, Special Accommodations                   establishing the Citizen’s Advisory                   Amended Charter approved on July 24, 2000.



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                                                  57918                      Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices

                                                  Insurance MarketplaceSM 2 or                              • Assembling and sharing an                         • Affordable Care Act initiatives
                                                  MarketplaceSM). In order to effectively                 information base of ‘‘best practices’’ for            • An opportunity for public comment
                                                  implement and administer these                          helping consumers evaluate health                     • Meeting summary, review of
                                                  changes, we must provide information                    coverage options.                                          recommendations, and next steps
                                                  to consumers, providers, and other                        • Building and leveraging existing                     Individuals or organizations that wish
                                                  stakeholders through education and                      community infrastructures for                         to make a 5-minute oral presentation on
                                                  outreach programs regarding how                         information, counseling, and assistance.              an agenda topic should submit a written
                                                  existing programs will change and the                     • Drawing the program link between                  copy of the oral presentation to the DFO
                                                  expanded range of health coverage                       outreach and education, promoting                     at the address listed in the ADDRESSES
                                                  options available, including private                    consumer understanding of health care                 section of this notice by the date listed
                                                  health insurance coverage through a                     coverage choices, and facilitating                    in the DATES section of this notice. The
                                                  MarketplaceSM. The APOE (the Panel)                     consumer selection/enrollment, which                  number of oral presentations may be
                                                  allows us to consider a broad range of                  in turn support the overarching goal of               limited by the time available.
                                                  views and information from interested                   improved access to quality care,                      Individuals not wishing to make an oral
                                                  audiences in connection with this effort                including prevention services,                        presentation may submit written
                                                  and to identify opportunities to enhance                envisioned under the Affordable Care                  comments to the DFO at the address
                                                  the effectiveness of education strategies               Act.                                                  listed in the ADDRESSES section of this
                                                  concerning the Affordable Care Act.                       The current members of the Panel are:               notice by the date listed in the DATES
                                                                                                          Kellan Baker, Associate Director, Center              section of this notice.
                                                     The scope of this panel also includes
                                                                                                          for American Progress; Robert Blancato,
                                                  advising on issues pertaining to the                                                                          III. Security, Building, and Parking
                                                                                                          President, Matz, Blancato & Associates;
                                                  education of providers and stakeholders                                                                       Guidelines
                                                                                                          Dale Blasier, Professor of Orthopaedic
                                                  with respect to the Affordable Care Act
                                                                                                          Surgery, Department of Orthopaedics,                     This meeting will be held in a federal
                                                  and certain provisions of the Health
                                                                                                          Arkansas Children’s Hospital; Deborah                 government building; therefore, federal
                                                  Information Technology for Economic
                                                                                                          Britt, Executive Director of Community                security measures are applicable. The
                                                  and Clinical Health (HITECH) Act
                                                                                                          & Public Relations, Piedmont Fayette                  Real ID Act, enacted in 2005, establishes
                                                  enacted as part of the American                         Hospital; Deena Chisolm, Associate                    minimum standards for the issuance of
                                                  Recovery and Reinvestment Act of 2009                   Professor of Pediatrics & Public Health,              state-issued driver’s licenses and
                                                  (ARRA).                                                 The Ohio State University, Nationwide                 identification (ID) cards. It prohibits
                                                     On January 21, 2011, the Panel’s                     Children’s Hospital; Josephine DeLeon,                federal agencies from accepting an
                                                  charter was renewed and the Panel was                   Director, Anti-Poverty Initiatives,                   official driver’s license or ID card from
                                                  renamed the Advisory Panel for                          Catholic Charities of California; Robert              a state unless the Department of
                                                  Outreach and Education. The Panel’s                     Espinoza, Vice President of Policy,                   Homeland Security determines that the
                                                  charter was most recently renewed on                    Paraprofessional Healthcare Institute;                state meets these standards. Beginning
                                                  January 21, 2015, and will terminate on                 Jennifer Gross, Manager of Political                  October 2015, photo IDs (such as a valid
                                                  January 21, 2017 unless renewed by                      Field Operations, Planned Parenthood                  driver’s license) issued by a state or
                                                  appropriate action.                                     of Montana; Louise Scherer Knight,                    territory not in compliance with the
                                                     Under the current charter, the APOE                  Director, The Sidney Kimmel                           Real ID Act will not be accepted as
                                                  will advise the Secretary and the                       Comprehensive Cancer Center at Johns                  identification to enter federal buildings.
                                                  Administrator on optimal strategies for                 Hopkins; Roanne Osborne-Gaskin, M.D.,                 Visitors from these states/territories will
                                                  the following:                                          Senior Medical Director, MDWise, Inc.;                need to provide alternative proof of
                                                     • Developing and implementing                        Cathy Phan, Outreach and Education                    identification (such as a valid passport)
                                                  education and outreach programs for                     Coordinator, Asian American Health                    to gain entrance into CMS buildings.
                                                  individuals enrolled in, or eligible for,               Coalition DBA HOPE Clinic; Kamilah                    The current list of states from which a
                                                  Medicare, Medicaid, and CHIP or                         Pickett, Litigation Support, Independent              federal agency may accept driver’s
                                                  coverage available through the Health                   Contractor; Brendan Riley, Outreach                   licenses for an official purpose is found
                                                  Insurance MarketplaceSM.                                and Enrollment Coordinator, NC                        at http://www.dhs.gov/real-id-
                                                     • Enhancing the federal government’s                 Community Health Center Association;                  enforcement-brief . We recommend that
                                                  effectiveness in informing Health                       Alvia Siddiqi, Medical Director,                      confirmed registrants arrive reasonably
                                                  Insurance MarketplaceSM, Medicare,                      Advocate Physician Partners; Carla                    early, but no earlier than 45 minutes
                                                  Medicaid, and CHIP consumers, issuers,                  Smith, Executive Vice President,                      prior to the start of the meeting, to allow
                                                  providers, and stakeholders, through                    Healthcare Information and                            additional time to clear security.
                                                  education and outreach programs, on                     Management Systems Society (HIMSS);                   Security measures include the
                                                  issues regarding these programs,                        Tobin Van Ostern, Vice President and                  following:
                                                  including the appropriate use of public-                Co-Founder, Young Invincibles                            • Presentation of government issued
                                                  private partnerships to leverage the                    Advisors; and Paula Villescaz, Senior                 photographic identification to the
                                                  resources of the private sector in                      Consultant, Assembly Health                           Federal Protective Service or Guard
                                                  educating beneficiaries, providers, and                 Committee, California State Legislature.              Service personnel.
                                                  stakeholders.                                                                                                    • Inspection of vehicle’s interior and
                                                                                                          II. Provisions of This Notice
                                                     • Expanding outreach to vulnerable                                                                         exterior (this includes engine and trunk
                                                  and underserved communities,                               In accordance with section 10(a) of                inspection) at the entrance to the
                                                                                                          the FACA, this notice announces a                     grounds. Parking permits and
mstockstill on DSK3G9T082PROD with NOTICES




                                                  including racial and ethnic minorities,
                                                  in the context of Health Insurance                      meeting of the APOE. The agenda for                   instructions will be issued after the
                                                  MarketplaceSM, Medicare, Medicaid,                      the September 21, 2016 meeting will                   vehicle inspection.
                                                  and CHIP education programs.                            include the following:                                   • Inspection, via metal detector or
                                                                                                          • Welcome and listening session with                  other applicable means, of all persons
                                                    2 Health Insurance MarketplaceSM and                       CMS leadership                                   entering the building. We note that all
                                                  MarketplaceSM are service marks of the U.S.             • Recap of the previous (June 22, 2016)               items brought into CMS, whether
                                                  Department of Health & Human Services.                       meeting                                          personal or for the purpose of


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                                                                             Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices                                          57919

                                                  presentation or to support a                            (HDE) applications, and de novo                       except for information submitted,
                                                  presentation, are subject to inspection.                classification requests. This guidance                marked and identified, as confidential,
                                                  We cannot assume responsibility for                     also discusses FDA’s inclusion of PPI in              if submitted as detailed in
                                                  coordinating the receipt, transfer,                     its decision summaries and provides                   ‘‘Instructions.’’
                                                  transport, storage, set up, safety, or                  recommendations for the inclusion of                     Instructions: All submissions received
                                                  timely arrival of any personal                          such information in device labeling for               must include the Docket No. FDA–
                                                  belongings or items used for                            certain devices. FDA is also issuing a                2015–D–1580 for ‘‘Patient Preference
                                                  presentation or to support a                            Level 2 updated version of the guidance               Information—Voluntary Submission,
                                                  presentation.                                           document entitled ‘‘Factors To Consider               Review in PMAs, HDE Applications,
                                                                                                          When Making Benefit-Risk                              and De Novo Requests, and Inclusion in
                                                    Note: Individuals who are not registered in
                                                  advance will not be permitted to enter the              Determinations in Medical Device                      Decision Summaries and Device
                                                  building and will be unable to attend the               Premarket Approval and De Novo                        Labeling.’’ If you are making
                                                  meeting. The public may not enter the                   Classifications,’’ originally issued on               submissions that also address the edits
                                                  building earlier than 45 minutes prior to the           March 28, 2012, that has been edited to               to the Level 2 guidance, the submissions
                                                  convening of the meeting.                               be consistent with this guidance                      received must include the Docket No.
                                                    All visitors must be escorted in areas                document.                                             FDA–2011–D–0577 for ‘‘Factors To
                                                  other than the lower and first floor                                                                          Consider When Making Benefit-Risk
                                                                                                          DATES:  Submit either electronic or                   Determinations in Medical Device
                                                  levels in the Central Building.                         written comments on this guidance at                  Premarket Approval and De Novo
                                                    Authority: Sec. 222 of the Public Health              any time. General comments on Agency                  Classifications.’’ Received comments
                                                  Service Act (42 U.S.C. 217a) and sec. 10(a)             guidance documents are welcome at any                 will be placed in the docket(s) noted
                                                  of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)          time.                                                 and, except for those submitted as
                                                  and 41 CFR 102–3).                                      ADDRESSES: You may submit comments                    ‘‘Confidential Submissions,’’ publicly
                                                    Dated: August 16, 2016.                               as follows:                                           viewable at http://www.regulations.gov
                                                  Andrew M. Slavitt,                                                                                            or at the Division of Dockets
                                                                                                          Electronic Submissions
                                                  Acting Administrator, Centers for Medicare                                                                    Management between 9 a.m. and 4 p.m.,
                                                  & Medicaid Services.                                      Submit electronic comments in the                   Monday through Friday.
                                                  [FR Doc. 2016–20187 Filed 8–23–16; 8:45 am]             following way:                                           • Confidential Submissions—To
                                                  BILLING CODE 4120–01–P
                                                                                                            • Federal eRulemaking Portal: http://               submit a comment with confidential
                                                                                                          www.regulations.gov. Follow the                       information that you do not wish to be
                                                                                                          instructions for submitting comments.                 made publicly available, submit your
                                                  DEPARTMENT OF HEALTH AND                                Comments submitted electronically,                    comments only as a written/paper
                                                  HUMAN SERVICES                                          including attachments, to http://                     submission. You should submit two
                                                                                                          www.regulations.gov will be posted to                 copies total. One copy will include the
                                                  Food and Drug Administration                            the docket unchanged. Because your                    information you claim to be confidential
                                                                                                          comment will be made public, you are                  with a heading or cover note that states
                                                  [Docket No. FDA–2015–D–1580]
                                                                                                          solely responsible for ensuring that your             ‘‘THIS DOCUMENT CONTAINS
                                                  Patient Preference Information—                         comment does not include any                          CONFIDENTIAL INFORMATION.’’ The
                                                  Voluntary Submission, Review in                         confidential information that you or a                Agency will review this copy, including
                                                  Premarket Approval Applications,                        third party may not wish to be posted,                the claimed confidential information, in
                                                  Humanitarian Device Exemption                           such as medical information, your or                  its consideration of comments. The
                                                  Applications, and De Novo Requests,                     anyone else’s Social Security number, or              second copy, which will have the
                                                  and Inclusion in Decision Summaries                     confidential business information, such               claimed confidential information
                                                  and Device Labeling; Guidance for                       as a manufacturing process. Please note               redacted/blacked out, will be available
                                                  Industry, Food and Drug                                 that if you include your name, contact                for public viewing and posted on http://
                                                  Administration Staff and Other                          information, or other information that                www.regulations.gov. Submit both
                                                  Stakeholders; Availability                              identifies you in the body of your                    copies to the Division of Dockets
                                                                                                          comments, that information will be                    Management. If you do not wish your
                                                  AGENCY:    Food and Drug Administration,                posted on http://www.regulations.gov.                 name and contact information to be
                                                  HHS.                                                      • If you want to submit a comment                   made publicly available, you can
                                                  ACTION:   Notice of availability.                       with confidential information that you                provide this information on the cover
                                                                                                          do not wish to be made available to the               sheet and not in the body of your
                                                  SUMMARY:   The Food and Drug                            public, submit the comment as a                       comments and you must identify this
                                                  Administration (FDA or Agency) is                       written/paper submission and in the                   information as ‘‘confidential.’’ Any
                                                  announcing the availability of the                      manner detailed (see ‘‘Written/Paper                  information marked as ‘‘confidential’’
                                                  guidance entitled ‘‘Patient Preference                  Submissions’’ and ‘‘Instructions’’).                  will not be disclosed except in
                                                  Information—Voluntary Submission,                                                                             accordance with 21 CFR 10.20 and other
                                                  Review in PMAs, HDE Applications,                       Written/Paper Submissions                             applicable disclosure law. For more
                                                  and De Novo Requests, and Inclusion in                    Submit written/paper submissions as                 information about FDA’s posting of
                                                  Decision Summaries and Device                           follows:                                              comments to public dockets, see 80 FR
                                                  Labeling.’’ This document explains the                    • Mail/Hand delivery/Courier (for                   56469, September 18, 2015, or access
                                                  principal concepts that sponsors and                    written/paper submissions): Division of               the information at: http://www.fda.gov/
mstockstill on DSK3G9T082PROD with NOTICES




                                                  other stakeholders should consider                      Dockets Management (HFA–305), Food                    regulatoryinformation/dockets/
                                                  when choosing to collect patient                        and Drug Administration, 5630 Fishers                 default.htm.
                                                  preference information (PPI), which                     Lane, Rm. 1061, Rockville, MD 20852.                     Docket: For access to the docket to
                                                  may inform FDA’s benefit-risk                             • For written/paper comments                        read background documents or the
                                                  determinations in the premarket review                  submitted to the Division of Dockets                  electronic and written/paper comments
                                                  of premarket approval applications                      Management, FDA will post your                        received, go to http://
                                                  (PMAs), humanitarian device exemption                   comment, as well as any attachments,                  www.regulations.gov and insert the


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Document Created: 2016-08-24 03:02:33
Document Modified: 2016-08-24 03:02:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of meeting.
ContactAbigail Huffman, Designated Federal Official, Office of Communications, CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email [email protected] Additional information about the APOE is available on the Internet at: http://www.cms.gov/Regulations-and- Guidance/Guidance/FACA/APOE.html. Press inquiries are handled through the CMS Press Office at (202) 690-6145.
FR Citation81 FR 57917 

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