82_FR_57506 82 FR 57275 - Medicare Program; Town Hall Meeting on the FY 2019 Applications for New Medical Services and Technologies Add-On Payments

82 FR 57275 - Medicare Program; Town Hall Meeting on the FY 2019 Applications for New Medical Services and Technologies Add-On Payments

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

Federal Register Volume 82, Issue 231 (December 4, 2017)

Page Range57275-57277
FR Document2017-25971

This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.

Federal Register, Volume 82 Issue 231 (Monday, December 4, 2017)
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57275-57277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1684-N]


Medicare Program; Town Hall Meeting on the FY 2019 Applications 
for New Medical Services and Technologies Add-On Payments

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

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: This notice announces a Town Hall meeting in accordance with 
section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to 
discuss fiscal year (FY) 2019 applications for add-on payments for new 
medical services and technologies under the hospital inpatient 
prospective payment system (IPPS). Interested parties are invited to 
this meeting to present their comments, recommendations, and data 
regarding whether the FY 2019 new medical services and technologies 
applications meet the substantial clinical improvement criterion.

DATES: 
    Meeting Date: The Town Hall Meeting announced in this notice will 
be held on Tuesday, February 13, 2018. The Town Hall Meeting will begin 
at 9:00 a.m. Eastern Standard Time (e.s.t.) and check-in will begin at 
8:30 a.m. e.s.t.
    Deadline for Registration for Participants (not Presenting) at the 
Town Hall Meeting: The deadline to register to attend the Town Hall 
Meeting is 5:00 p.m., e.s.t. on Wednesday, February 7, 2018.
    Deadline for Requesting Special Accommodations: The deadline to 
submit requests for special accommodations is 5:00 p.m., e.s.t. on 
Tuesday, January 16, 2018.
    Deadline for Registration of Presenters at the Town Hall Meeting: 
The deadline to register to present at the Town Hall Meeting is 5:00 
p.m., e.s.t. on Monday, January 29, 2018.
    Deadline for Submission of Agenda Item(s) or Written Comments for 
the Town Hall Meeting: Written comments and agenda items for discussion 
at the Town Hall Meeting, including agenda items by presenters, must be 
received by 5:00 p.m. e.s.t. on Monday, January 29, 2018.
    Deadline for Submission of Written Comments after the Town Hall 
Meeting for consideration in the FY 2019 IPPS proposed rule: 
Individuals may submit written comments after the Town Hall Meeting, as 
specified in the ADDRESSES section of this notice, on whether the 
service or technology represents a substantial clinical improvement. 
These comments must be received by 5:00 p.m. e.s.t. on Friday, February 
23, 2018, for consideration in the FY 2019 IPPS proposed rule.

ADDRESSES: 
    Meeting Location: The Town Hall Meeting will be held in the main 
Auditorium in the central building of the Centers for Medicare & 
Medicaid Services located at 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    In addition, we are providing two alternatives to attending the 
meeting in person--(1) there will be an open toll-free phone line to 
call into the Town Hall Meeting; or (2) participants may view and 
participate in the Town Hall Meeting via live stream technology or 
webinar. These options are discussed in section II.B. of this notice.
    Registration and Special Accommodations: Individuals wishing to 
participate in the meeting must register by following the on-line 
registration instructions located in section III. of this notice or by 
contacting staff listed in the FOR FURTHER INFORMATION CONTACT section 
of this notice. Individuals who need special accommodations should 
contact staff listed in the FOR FURTHER INFORMATION CONTACT section of 
this notice.
    Submission of Agenda Item(s) or Written Comments for the Town Hall 
Meeting: Each presenter must submit an agenda item(s) regarding whether 
a FY 2019 application meets the substantial clinical improvement 
criterion. Agenda items, written comments, questions or other 
statements must not exceed three single-spaced typed pages and may be 
sent via email to [email protected].

FOR FURTHER INFORMATION CONTACT: Michelle Joshua, (410) 786-6050, 
[email protected]; or Michael Treitel, (410) 786-4552, 
[email protected].
    Alternatively, you may forward your requests via email to 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background on the Add-On Payments for New Medical Services and 
Technologies Under the IPPS

    Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act) 
require the Secretary to establish a process of identifying and 
ensuring adequate payments to acute care hospitals for new medical 
services and technologies under Medicare. Effective for discharges 
beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) of the 
Act requires the Secretary to establish (after notice and opportunity 
for public comment) a mechanism to recognize the costs of new services 
and technologies under the hospital inpatient prospective payment 
system (IPPS). In addition, section 1886(d)(5)(K)(vi) of the Act 
specifies that a medical service or technology will be considered 
``new'' if it meets criteria established by the Secretary (after notice 
and opportunity for public comment). (See the fiscal year (FY) 2002 
IPPS proposed rule (66 FR 22693, May 4, 2001) and final rule (66 FR 
46912, September 7, 2001) for a more detailed discussion.)
    In the September 7, 2001 final rule (66 FR 46914), we noted that we 
evaluated a request for special payment for a new medical service or 
technology against

[[Page 57276]]

the following criteria in order to determine if the new technology 
meets the substantial clinical improvement requirement:
     The device offers a treatment option for a patient 
population unresponsive to, or ineligible for, currently available 
treatments.
     The device offers the ability to diagnose a medical 
condition in a patient population where that medical condition is 
currently undetectable or offers the ability to diagnose a medical 
condition earlier in a patient population than allowed by currently 
available methods. There must also be evidence that use of the device 
to make a diagnosis affects the management of the patient.
     Use of the device significantly improves clinical outcomes 
for a patient population as compared to currently available treatments. 
Some examples of outcomes that are frequently evaluated in studies of 
medical devices are the following:
    ++ Reduced mortality rate with use of the device.
    ++ Reduced rate of device-related complications.
    ++ Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
    ++ Decreased number of future hospitalizations or physician visits.
    ++ More rapid beneficial resolution of the disease process 
treatment because of the use of the device.
    ++ Decreased pain, bleeding or other quantifiable symptoms.
    ++ Reduced recovery time.
    In addition, we indicated that the requester is required to submit 
evidence that the technology meets one or more of these criteria.
    Section 1886(d)(5)(K)(viii) of the Act, as added by section 503 of 
the Medicare Prescription Drug, Improvement, and Modernization Act of 
2003 (MMA), requires that as part of the process for evaluating new 
medical services and technology applications, the Secretary shall do 
the following:
     Provide for public input regarding whether a new service 
or technology represents an advance in medical technology that 
substantially improves the diagnosis or treatment of Medicare 
beneficiaries before publication of a proposed rule.
     Make public and periodically update a list of all the 
services and technologies for which an application is pending.
     Accept comments, recommendations, and data from the public 
regarding whether the service or technology represents a substantial 
improvement.
     Provide for a meeting at which organizations representing 
hospitals, physicians, manufacturers and any other interested party may 
present comments, recommendations, and data to the clinical staff of 
CMS as to whether the service or technology represents a substantial 
improvement before publication of a proposed rule.
    The opinions and presentations provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2019. In addition, they will help us to evaluate 
our policy on the IPPS new technology add-on payment process before the 
publication of the FY 2019 IPPS proposed rule.

II. Town Hall Meeting Format and Conference Call/Live Streaming 
Information

A. Format of the Town Hall Meeting

    As noted in section I. of this notice, we are required to provide 
for a meeting at which organizations representing hospitals, 
physicians, manufacturers and any other interested party may present 
comments, recommendations, and data to the clinical staff of CMS 
concerning whether the service or technology represents a substantial 
clinical improvement. This meeting will allow for a discussion of the 
substantial clinical improvement criteria for each of the FY 2019 new 
medical services and technology add-on payment applications. 
Information regarding the applications can be found on our Web site at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html.
    The majority of the meeting will be reserved for presentations of 
comments, recommendations, and data from registered presenters. The 
time for each presenter's comments will be approximately 10 to 15 
minutes and will be based on the number of registered presenters. 
Individuals who would like to present must register and submit their 
agenda item(s) via email to [email protected] by the date specified 
in the DATES section of this notice.
    In addition, written comments will also be accepted and presented 
at the meeting if they are received via email to [email protected] by 
the date specified in the DATES section of this notice. Written 
comments may also be submitted after the meeting for our consideration. 
If the comments are to be considered before the publication of the FY 
2019 IPPS proposed rule, the comments must be received via email to 
[email protected] by the date specified in the DATES section of this 
notice.

B. Conference Call, Live Streaming, and Webinar Information

    For participants who cannot attend the Town Hall Meeting in person, 
an open toll-free phone line, (877) 267-1577, has been made available. 
The Meeting Place meeting ID is 995 504 800.
    Also, there will be an option to view and participate in the Town 
Hall Meeting via live streaming technology or webinar. Information on 
the option to participate via live streaming technology or webinar will 
be provided through an upcoming listserv notice and posted on the New 
Technology Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Continue to check the 
Web site for updates.

C. Disclaimer

    We cannot guarantee reliability for live streaming technology or a 
webinar.

III. Registration Instructions

    The Division of Acute Care in CMS is coordinating the meeting 
registration for the Town Hall Meeting on substantial clinical 
improvement. While there is no registration fee, individuals planning 
to attend the Town Hall Meeting in person must register to attend.
    Registration may be completed on-line at the following web address: 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Select the link at the bottom of the 
page ``Register to Attend the New Technology Town Hall Meeting''. After 
completing the registration, online registrants should print the 
confirmation page(s) and bring it with them to the meeting.
    If you are unable to register on-line, you may register by sending 
an email to [email protected]. Please include your name, address, 
telephone number, email address and fax number. If seating capacity has 
been reached, you will be notified that the meeting has reached 
capacity.

IV. Security, Building, and Parking Guidelines

    Because this meeting will be located on Federal property, for 
security reasons, any persons wishing to attend the meeting must 
register by the date specified in the DATES section of this notice. 
Please allow sufficient time to go through the security checkpoints. If 
you are attending the Town Hall Meeting in person, we suggest that you 
arrive at

[[Page 57277]]

7500 Security Boulevard no later than 8:30 a.m. e.s.t. so that you will 
be able to arrive promptly for the meeting.
    Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.

    Note: The REAL ID Act established minimum security standards for 
license issuance and production and prohibits Federal agencies from 
accepting for certain purposes driver's licenses and identification 
cards from states not meeting the Act's minimum standards. The 
Department of Homeland Security (DHS) is currently reviewing 
extension requests from states with extensions that expired on 
October 10, 2017. DHS will update their Web page as these reviews 
are completed and new extensions are granted. We encourage the 
public to visit the DHS Web site at https://www.dhs.gov/real-id 
prior to the new technology town hall meeting for updated 
information.

     CMS policy requires that every foreign national (defined 
by the Department of Homeland Security as ``an individual who is a 
citizen of any country other than the United States'') is assigned a 
host (in accordance with the Department Foreign Visitor Management 
Policy, Appendix C, Guidelines for Hosts and Escorts). The host/hosting 
official is required to inform the Division of Physical Security and 
Strategic Information at least 12 business days in advance of any visit 
by a foreign national. Foreign nationals will be required to produce a 
valid passport at the time of entry.
    Attendees that are foreign nationals need to identify themselves as 
such, and make a request for a special accommodation. Foreign national 
visitors are defined as non-U.S. citizens, and non-lawful permanent 
residents, non-residents aliens or non-green-card holders. Foreign 
nationals must provide the following information for security clearance 
to staff listed in the FOR FURTHER INFORMATION CONTACT section of this 
notice by the date specified in the DATES section of this notice:

    ++ Visitor's full name (as it appears on passport).
    ++ Gender.
    ++ Country of origin and citizenship.
    ++ Biographical data and related information.
    ++ Date of birth.
    ++ Place of birth.
    ++ Passport number.
    ++ Passport issue date.
    ++ Passport expiration date.
    ++ Visa Type.
-- Dates of visits
-- Company Name
-- Position/Title

     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 to 
CMS, whether personal or for the purpose of 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 in person. The public may not enter the building earlier 
than 45 minutes prior to the convening of the meeting.
    All visitors must be escorted in all areas other than the lower 
level lobby and cafeteria area and first floor auditorium and 
conference areas in the Central Building. Seating capacity is 
limited to the first 250 registrants.


    Authority: Section 503 of Pub. L. 108-173.

    Dated: November 28, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-25971 Filed 12-1-17; 8:45 am]
BILLING CODE 4120-01-P



                                                                            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices                                            57275

                                                impact on the operations of a substantial               year (FY) 2019 applications for add-on                Meeting via live stream technology or
                                                number of small rural hospitals.                        payments for new medical services and                 webinar. These options are discussed in
                                                   Section 202 of the Unfunded                          technologies under the hospital                       section II.B. of this notice.
                                                Mandates Reform Act of 1995 (UMRA)                      inpatient prospective payment system                     Registration and Special
                                                also requires that agencies assess                      (IPPS). Interested parties are invited to             Accommodations: Individuals wishing
                                                anticipated costs and benefits before                   this meeting to present their comments,               to participate in the meeting must
                                                issuing any rule whose mandates                         recommendations, and data regarding                   register by following the on-line
                                                require spending in any 1 year of $100                  whether the FY 2019 new medical                       registration instructions located in
                                                million in 1995 dollars, updated                        services and technologies applications                section III. of this notice or by
                                                annually for inflation. In 2017, that                   meet the substantial clinical                         contacting staff listed in the FOR
                                                threshold is approximately $148                         improvement criterion.                                FURTHER INFORMATION CONTACT section of
                                                million. The Agency has determined                      DATES:                                                this notice. Individuals who need
                                                that there will be minimal impact from                     Meeting Date: The Town Hall Meeting                special accommodations should contact
                                                the costs of this notice, as the threshold              announced in this notice will be held on              staff listed in the FOR FURTHER
                                                is not met under the UMRA.                              Tuesday, February 13, 2018. The Town                  INFORMATION CONTACT section of this
                                                   Executive Order 13132 establishes                    Hall Meeting will begin at 9:00 a.m.                  notice.
                                                certain requirements that an agency                     Eastern Standard Time (e.s.t.) and                       Submission of Agenda Item(s) or
                                                must meet when it promulgates a                         check-in will begin at 8:30 a.m. e.s.t.               Written Comments for the Town Hall
                                                proposed rule (and subsequent final                        Deadline for Registration for                      Meeting: Each presenter must submit an
                                                rule) that imposes substantial direct                   Participants (not Presenting) at the                  agenda item(s) regarding whether a FY
                                                requirement costs on state and local                    Town Hall Meeting: The deadline to                    2019 application meets the substantial
                                                governments, preempts state law, or                     register to attend the Town Hall Meeting              clinical improvement criterion. Agenda
                                                otherwise has federalism implications.                  is 5:00 p.m., e.s.t. on Wednesday,                    items, written comments, questions or
                                                Since this notice does not impose                       February 7, 2018.                                     other statements must not exceed three
                                                substantial direct costs on state or local                 Deadline for Requesting Special                    single-spaced typed pages and may be
                                                governments, the requirements of                        Accommodations: The deadline to                       sent via email to newtech@cms.hhs.gov.
                                                Executive Order 13132 are not                           submit requests for special                           FOR FURTHER INFORMATION CONTACT:
                                                applicable.                                             accommodations is 5:00 p.m., e.s.t. on                Michelle Joshua, (410) 786–6050,
                                                   Executive Order 13771, titled                        Tuesday, January 16, 2018.                            michelle.joshua@cms.hhs.gov; or
                                                ‘‘Reducing Regulation and Controlling                      Deadline for Registration of Presenters            Michael Treitel, (410) 786–4552,
                                                Regulatory Costs,’’ was issued on                       at the Town Hall Meeting: The deadline                michael.treitel@cms.hhs.gov.
                                                January 30, 2017 (82 FR 9339, February                  to register to present at the Town Hall                  Alternatively, you may forward your
                                                3, 2017). It has been determined that                   Meeting is 5:00 p.m., e.s.t. on Monday,               requests via email to newtech@
                                                this notice is a transfer notice that does              January 29, 2018.                                     cms.hhs.gov.
                                                not impose more than de minimis costs                      Deadline for Submission of Agenda
                                                and thus is not a regulatory action for                                                                       SUPPLEMENTARY INFORMATION:
                                                                                                        Item(s) or Written Comments for the
                                                the purposes of E.O. 13771.                             Town Hall Meeting: Written comments                   I. Background on the Add-On Payments
                                                   In accordance with the provisions of                                                                       for New Medical Services and
                                                                                                        and agenda items for discussion at the
                                                Executive Order 12866, this notice was                                                                        Technologies Under the IPPS
                                                                                                        Town Hall Meeting, including agenda
                                                reviewed by the Office of Management
                                                                                                        items by presenters, must be received by                 Sections 1886(d)(5)(K) and (L) of the
                                                and Budget.
                                                                                                        5:00 p.m. e.s.t. on Monday, January 29,               Social Security Act (the Act) require the
                                                  Dated: November 28, 2017.                             2018.                                                 Secretary to establish a process of
                                                Seema Verma,                                               Deadline for Submission of Written                 identifying and ensuring adequate
                                                Administrator, Centers for Medicare &                   Comments after the Town Hall Meeting                  payments to acute care hospitals for
                                                Medicaid Services.                                      for consideration in the FY 2019 IPPS                 new medical services and technologies
                                                [FR Doc. 2017–25972 Filed 12–1–17; 8:45 am]             proposed rule: Individuals may submit                 under Medicare. Effective for discharges
                                                BILLING CODE 4120–01–P                                  written comments after the Town Hall                  beginning on or after October 1, 2001,
                                                                                                        Meeting, as specified in the ADDRESSES                section 1886(d)(5)(K)(i) of the Act
                                                                                                        section of this notice, on whether the                requires the Secretary to establish (after
                                                DEPARTMENT OF HEALTH AND                                service or technology represents a                    notice and opportunity for public
                                                HUMAN SERVICES                                          substantial clinical improvement. These               comment) a mechanism to recognize the
                                                                                                        comments must be received by 5:00                     costs of new services and technologies
                                                Centers for Medicare & Medicaid                         p.m. e.s.t. on Friday, February 23, 2018,             under the hospital inpatient prospective
                                                Services                                                for consideration in the FY 2019 IPPS                 payment system (IPPS). In addition,
                                                [CMS–1684–N]                                            proposed rule.                                        section 1886(d)(5)(K)(vi) of the Act
                                                                                                        ADDRESSES:                                            specifies that a medical service or
                                                Medicare Program; Town Hall Meeting                        Meeting Location: The Town Hall                    technology will be considered ‘‘new’’ if
                                                on the FY 2019 Applications for New                     Meeting will be held in the main                      it meets criteria established by the
                                                Medical Services and Technologies                       Auditorium in the central building of                 Secretary (after notice and opportunity
                                                Add-On Payments                                         the Centers for Medicare & Medicaid                   for public comment). (See the fiscal year
                                                                                                        Services located at 7500 Security
sradovich on DSK3GMQ082PROD with NOTICES




                                                AGENCY: Centers for Medicare &                                                                                (FY) 2002 IPPS proposed rule (66 FR
                                                Medicaid Services (CMS), HHS.                           Boulevard, Baltimore, MD 21244–1850.                  22693, May 4, 2001) and final rule (66
                                                ACTION: Notice of meeting.                                 In addition, we are providing two                  FR 46912, September 7, 2001) for a more
                                                                                                        alternatives to attending the meeting in              detailed discussion.)
                                                SUMMARY:  This notice announces a                       person—(1) there will be an open toll-                   In the September 7, 2001 final rule (66
                                                Town Hall meeting in accordance with                    free phone line to call into the Town                 FR 46914), we noted that we evaluated
                                                section 1886(d)(5)(K)(viii) of the Social               Hall Meeting; or (2) participants may                 a request for special payment for a new
                                                Security Act (the Act) to discuss fiscal                view and participate in the Town Hall                 medical service or technology against


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                                                57276                       Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices

                                                the following criteria in order to                      technology represents a substantial                   newtech@cms.hhs.gov by the date
                                                determine if the new technology meets                   improvement.                                          specified in the DATES section of this
                                                the substantial clinical improvement                      • Provide for a meeting at which                    notice.
                                                requirement:                                            organizations representing hospitals,
                                                                                                                                                              B. Conference Call, Live Streaming, and
                                                   • The device offers a treatment option               physicians, manufacturers and any
                                                                                                                                                              Webinar Information
                                                for a patient population unresponsive                   other interested party may present
                                                to, or ineligible for, currently available              comments, recommendations, and data                      For participants who cannot attend
                                                treatments.                                             to the clinical staff of CMS as to whether            the Town Hall Meeting in person, an
                                                   • The device offers the ability to                   the service or technology represents a                open toll-free phone line, (877) 267–
                                                diagnose a medical condition in a                       substantial improvement before                        1577, has been made available. The
                                                patient population where that medical                   publication of a proposed rule.                       Meeting Place meeting ID is 995 504
                                                condition is currently undetectable or                    The opinions and presentations                      800.
                                                offers the ability to diagnose a medical                provided during this meeting will assist                 Also, there will be an option to view
                                                condition earlier in a patient population               us as we evaluate the new medical                     and participate in the Town Hall
                                                than allowed by currently available                     services and technology applications for              Meeting via live streaming technology
                                                methods. There must also be evidence                    FY 2019. In addition, they will help us               or webinar. Information on the option to
                                                that use of the device to make a                        to evaluate our policy on the IPPS new                participate via live streaming
                                                diagnosis affects the management of the                 technology add-on payment process                     technology or webinar will be provided
                                                patient.                                                before the publication of the FY 2019                 through an upcoming listserv notice and
                                                   • Use of the device significantly                    IPPS proposed rule.                                   posted on the New Technology Web site
                                                improves clinical outcomes for a patient                                                                      at http://www.cms.gov/Medicare/
                                                                                                        II. Town Hall Meeting Format and                      Medicare-Fee-for-Service-Payment/
                                                population as compared to currently                     Conference Call/Live Streaming
                                                available treatments. Some examples of                                                                        AcuteInpatientPPS/newtech.html.
                                                                                                        Information                                           Continue to check the Web site for
                                                outcomes that are frequently evaluated
                                                in studies of medical devices are the                   A. Format of the Town Hall Meeting                    updates.
                                                following:                                                 As noted in section I. of this notice,             C. Disclaimer
                                                   ++ Reduced mortality rate with use of                we are required to provide for a meeting                 We cannot guarantee reliability for
                                                the device.                                             at which organizations representing                   live streaming technology or a webinar.
                                                   ++ Reduced rate of device-related                    hospitals, physicians, manufacturers
                                                complications.                                          and any other interested party may                    III. Registration Instructions
                                                   ++ Decreased rate of subsequent                      present comments, recommendations,                       The Division of Acute Care in CMS is
                                                diagnostic or therapeutic interventions                 and data to the clinical staff of CMS                 coordinating the meeting registration for
                                                (for example, due to reduced rate of                    concerning whether the service or                     the Town Hall Meeting on substantial
                                                recurrence of the disease process).                     technology represents a substantial                   clinical improvement. While there is no
                                                   ++ Decreased number of future                        clinical improvement. This meeting will               registration fee, individuals planning to
                                                hospitalizations or physician visits.                   allow for a discussion of the substantial             attend the Town Hall Meeting in person
                                                   ++ More rapid beneficial resolution                  clinical improvement criteria for each of             must register to attend.
                                                of the disease process treatment because                the FY 2019 new medical services and                     Registration may be completed on-
                                                of the use of the device.                               technology add-on payment                             line at the following web address:
                                                   ++ Decreased pain, bleeding or other                 applications. Information regarding the               http://www.cms.gov/Medicare/
                                                quantifiable symptoms.                                  applications can be found on our Web                  Medicare-Fee-for-Service-Payment/
                                                   ++ Reduced recovery time.                            site at http://www.cms.gov/Medicare/                  AcuteInpatientPPS/newtech.html.
                                                   In addition, we indicated that the                   Medicare-Fee-for-Service-Payment/                     Select the link at the bottom of the page
                                                requester is required to submit evidence                AcuteInpatientPPS/newtech.html.                       ‘‘Register to Attend the New Technology
                                                that the technology meets one or more                      The majority of the meeting will be                Town Hall Meeting’’. After completing
                                                of these criteria.                                      reserved for presentations of comments,               the registration, online registrants
                                                   Section 1886(d)(5)(K)(viii) of the Act,              recommendations, and data from                        should print the confirmation page(s)
                                                as added by section 503 of the Medicare                 registered presenters. The time for each              and bring it with them to the meeting.
                                                Prescription Drug, Improvement, and                     presenter’s comments will be                             If you are unable to register on-line,
                                                Modernization Act of 2003 (MMA),                        approximately 10 to 15 minutes and                    you may register by sending an email to
                                                requires that as part of the process for                will be based on the number of                        newtech@cms.hhs.gov. Please include
                                                evaluating new medical services and                     registered presenters. Individuals who                your name, address, telephone number,
                                                technology applications, the Secretary                  would like to present must register and               email address and fax number. If seating
                                                shall do the following:                                 submit their agenda item(s) via email to              capacity has been reached, you will be
                                                   • Provide for public input regarding                 newtech@cms.hhs.gov by the date                       notified that the meeting has reached
                                                whether a new service or technology                     specified in the DATES section of this                capacity.
                                                represents an advance in medical                        notice.
                                                technology that substantially improves                     In addition, written comments will                 IV. Security, Building, and Parking
                                                the diagnosis or treatment of Medicare                  also be accepted and presented at the                 Guidelines
                                                beneficiaries before publication of a                   meeting if they are received via email to               Because this meeting will be located
                                                proposed rule.                                          newtech@cms.hhs.gov by the date                       on Federal property, for security
sradovich on DSK3GMQ082PROD with NOTICES




                                                   • Make public and periodically                       specified in the DATES section of this                reasons, any persons wishing to attend
                                                update a list of all the services and                   notice. Written comments may also be                  the meeting must register by the date
                                                technologies for which an application is                submitted after the meeting for our                   specified in the DATES section of this
                                                pending.                                                consideration. If the comments are to be              notice. Please allow sufficient time to go
                                                   • Accept comments,                                   considered before the publication of the              through the security checkpoints. If you
                                                recommendations, and data from the                      FY 2019 IPPS proposed rule, the                       are attending the Town Hall Meeting in
                                                public regarding whether the service or                 comments must be received via email to                person, we suggest that you arrive at


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                                                                                 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices                                                        57277

                                                7500 Security Boulevard no later than                             ++ Date of birth.                                        DEPARTMENT OF HEALTH AND
                                                8:30 a.m. e.s.t. so that you will be able                         ++ Place of birth.                                       HUMAN SERVICES
                                                to arrive promptly for the meeting.
                                                  Security measures include the                                   ++ Passport number.                                      Administration for Children and
                                                following:                                                        ++ Passport issue date.                                  Families
                                                  • Presentation of government-issued
                                                                                                                  ++ Passport expiration date.                             Proposed Information Collection
                                                photographic identification to the
                                                Federal Protective Service or Guard                               ++ Visa Type.                                            Activity; Comment Request
                                                Service personnel.                                               — Dates of visits                                         Proposed Projects
                                                   Note: The REAL ID Act established                             — Company Name
                                                minimum security standards for license                                                                                        Title: Grant Reviewer Recruitment
                                                issuance and production and prohibits                            — Position/Title                                          Form.
                                                Federal agencies from accepting for certain                         • Inspection of vehicle’s interior and                    OMB: 0970–0455.
                                                purposes driver’s licenses and identification                                                                                 Description: The Administration for
                                                cards from states not meeting the Act’s                          exterior (this includes engine and trunk
                                                                                                                                                                           Children and Families’ Children’s
                                                minimum standards. The Department of                             inspection) at the entrance to the
                                                                                                                                                                           Bureau (CB) is responsible for
                                                Homeland Security (DHS) is currently                             grounds. Parking permits and
                                                reviewing extension requests from states with                                                                              administering the review of eligible
                                                                                                                 instructions will be issued after the
                                                extensions that expired on October 10, 2017.                                                                               grant applications submitted in
                                                                                                                 vehicle inspection.                                       response to funding opportunity
                                                DHS will update their Web page as these
                                                reviews are completed and new extensions                            • Inspection, via metal detector or                    announcements issued by CB. CB
                                                are granted. We encourage the public to visit                    other applicable means of all persons                     ensures that the objective review
                                                the DHS Web site at https://www.dhs.gov/                         entering the building. We note that all                   process is independent, efficient,
                                                real-id prior to the new technology town hall                    items brought to CMS, whether personal                    effective, economical, and complies
                                                meeting for updated information.
                                                                                                                 or for the purpose of presentation or to                  with the applicable statutes, regulations,
                                                   • CMS policy requires that every                              support a presentation, are subject to                    and policies. Applications are reviewed
                                                foreign national (defined by the                                 inspection. We cannot assume                              by subject experts knowledgeable in
                                                Department of Homeland Security as                               responsibility for coordinating the                       child welfare and related fields. Review
                                                ‘‘an individual who is a citizen of any                          receipt, transfer, transport, storage, set-               findings are advisory to CB; CB is
                                                country other than the United States’’)                          up, safety, or timely arrival of any                      responsible for making award decisions.
                                                is assigned a host (in accordance with                                                                                        This announcement is a request for
                                                                                                                 personal belongings or items used for
                                                the Department Foreign Visitor                                                                                             continued approval of the information
                                                                                                                 presentation or to support a
                                                Management Policy, Appendix C,                                                                                             collection system, the Reviewer
                                                Guidelines for Hosts and Escorts). The                           presentation.
                                                                                                                                                                           Recruitment Module (RRM). CB uses a
                                                host/hosting official is required to                               Note: Individuals who are not registered in             Web-based data collection form and
                                                inform the Division of Physical Security                         advance will not be permitted to enter the                database to gather critical reviewer
                                                and Strategic Information at least 12                            building and will be unable to attend the                 information in drop down menu format
                                                business days in advance of any visit by                         meeting in person. The public may not enter               for data such as: Degree, occupation,
                                                a foreign national. Foreign nationals                            the building earlier than 45 minutes prior to             affiliations with organizations and
                                                will be required to produce a valid                              the convening of the meeting.                             institutions that serve special
                                                passport at the time of entry.                                     All visitors must be escorted in all areas              populations, and demographic
                                                   Attendees that are foreign nationals                          other than the lower level lobby and cafeteria            information that may be voluntarily
                                                need to identify themselves as such, and                         area and first floor auditorium and
                                                                                                                                                                           provided by a potential reviewer.
                                                make a request for a special                                     conference areas in the Central Building.
                                                                                                                                                                              These data elements help CB find and
                                                accommodation. Foreign national                                  Seating capacity is limited to the first 250
                                                                                                                                                                           select expert grant reviewers for
                                                visitors are defined as non-U.S. citizens,                       registrants.
                                                                                                                                                                           objective review committees. The Web-
                                                and non-lawful permanent residents,                                                                                        based system permits reviewers to
                                                non-residents aliens or non-green-card                              Authority: Section 503 of Pub. L. 108–173.
                                                                                                                                                                           access and update their information at
                                                holders. Foreign nationals must provide                            Dated: November 28, 2017.                               will and as needed. The RRM is
                                                the following information for security                           Seema Verma,                                              accessible by the general public via
                                                clearance to staff listed in the FOR                             Administrator, Centers for Medicare &                     https://rrm.grantsolutions.gov/
                                                FURTHER INFORMATION CONTACT section of                           Medicaid Services.                                        AgencyPortal/cb.aspx.
                                                this notice by the date specified in the                                                                                      Respondents: Generally, our
                                                                                                                 [FR Doc. 2017–25971 Filed 12–1–17; 8:45 am]
                                                DATES section of this notice:
                                                                                                                 BILLING CODE 4120–01–P                                    reviewers are current or retired
                                                   ++ Visitor’s full name (as it appears                                                                                   professionals with backgrounds in child
                                                on passport).                                                                                                              welfare and related fields and in some
                                                   ++ Gender.                                                                                                              instances current or former foster care
                                                   ++ Country of origin and citizenship.                                                                                   parents or clients.
                                                   ++ Biographical data and related
                                                information.                                                                                                               Annual Burden Estimates

                                                                                                                                                                                             Average bur-
                                                                                                                                                                           Number of
                                                                                                                                                         Number of                               den        Total burden
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                           Instrument                                                                    responses per
                                                                                                                                                        respondents                           hours per        hours
                                                                                                                                                                           respondent         response

                                                Reviewer Recruitment Module .........................................................................         500              1                 .25            125




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Document Created: 2017-12-02 00:41:08
Document Modified: 2017-12-02 00:41:08
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.
DatesMeeting Date: The Town Hall Meeting announced in this notice will be held on Tuesday, February 13, 2018. The Town Hall Meeting will begin at 9:00 a.m. Eastern Standard Time (e.s.t.) and check-in will begin at 8:30 a.m. e.s.t.
ContactMichelle Joshua, (410) 786-6050, [email protected]; or Michael Treitel, (410) 786-4552, [email protected]
FR Citation82 FR 57275 

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