83_FR_50573 83 FR 50379 - Medicare Program; Town Hall Meeting on the FY 2020 Applications for New Medical Services and Technologies Add-On Payments

83 FR 50379 - Medicare Program; Town Hall Meeting on the FY 2020 Applications for New Medical Services and Technologies Add-On Payments

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

Federal Register Volume 83, Issue 194 (October 5, 2018)

Page Range50379-50381
FR Document2018-21753

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) 2020 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 2020 new medical services and technologies applications meet the substantial clinical improvement criterion.

Federal Register, Volume 83 Issue 194 (Friday, October 5, 2018)
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50379-50381]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21753]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1704-N]


Medicare Program; Town Hall Meeting on the FY 2020 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) 2020 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 2020 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, December 4, 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 Monday, November 26, 2018.
    Deadline for Requesting Special Accommodations: The deadline to 
submit requests for special accommodations is 5:00 p.m., e.s.t. on 
Monday, November 19, 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, November 19, 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, November 19, 2018.
    Deadline for Submission of Written Comments after the Town Hall 
Meeting for consideration in the FY 2020 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, December 
14, 2018, for consideration in the FY 2020 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 2020 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 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

[[Page 50380]]

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 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 2020. 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 2020 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 2020 new 
medical services and technology add-on payment applications. 
Information regarding the applications can be found on our website 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 
2020 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 will be made available. Continue to check 
our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html for updated dial-in number and 
instructions.
    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 website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html. Continue to check the 
website 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 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:

[[Page 50381]]

     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. We 
encourage the public to visit the DHS website at https://www.dhs.gov/real-id prior to the new technology town hall meeting 
for updated information.

     All Foreign National visitor requests must be submitted 12 
business days prior to the scheduled visitor to allow for processing./
non U.S. citizen.
     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.
Updated Security Information for In-Person Attendees
    Effective June 1, 2018, Federal Protective Services (FPS) has 
implemented new security screening procedures at all CMS Baltimore 
locations to align with national screening standards. Please allow 
extra time to clear security prior to the beginning of the meeting. 
Employees, contractors and visitors must place all items in bins for 
screening, including:
     Any items in your pockets.
     Belts, hats, jackets & coats (not suit jackets or sport 
coats).
     Purses, laptop computers & cell phones.
     Larger items (e.g. computer bags) can be placed directly 
onto the conveyer.
    In the event the metal detector beeps when you walk through:
     A security guard will run a hand-held metal detector over 
you. If the metal detector doesn't alarm, you're cleared to enter.
     If the hand-held metal detector alarms, the guard will pat 
down the area of the body where the metal detector alarmed.
     If footwear alarms, it will need to be removed and placed 
in a bin for x-ray screening.
    If you believe that you have a disability that will cause you to 
require reasonable accommodation to comply with the new process, please 
contact [email protected] as soon as possible.

    Authority: Section 1886(d)(5)(K)(viii) of the Social Security 
Act.

    Dated: October 1, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-21753 Filed 10-4-18; 8:45 am]
BILLING CODE 4120-01-P



                                                                              Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices                                          50379

                                               Prevention and the Agency for Toxic                     recommendations, and data regarding                   registration instructions located in
                                               Substances and Disease Registry.                        whether the FY 2020 new medical                       section III. of this notice or by
                                               Sherri Berger,                                          services and technologies applications                contacting staff listed in the FOR
                                               Chief Operating Officer, Centers for Disease
                                                                                                       meet the substantial clinical                         FURTHER INFORMATION CONTACT section of
                                               Control and Prevention.                                 improvement criterion.                                this notice. Individuals who need
                                               [FR Doc. 2018–21688 Filed 10–4–18; 8:45 am]             DATES:                                                special accommodations should contact
                                                                                                          Meeting Date: The Town Hall Meeting                staff listed in the FOR FURTHER
                                               BILLING CODE 4163–18–P
                                                                                                       announced in this notice will be held on              INFORMATION CONTACT section of this
                                                                                                       Tuesday, December 4, 2018. The Town                   notice.
                                               DEPARTMENT OF HEALTH AND                                Hall Meeting will begin at 9:00 a.m.                     Submission of Agenda Item(s) or
                                               HUMAN SERVICES                                          Eastern Standard Time (e.s.t.) and                    Written Comments for the Town Hall
                                                                                                       check-in will begin at 8:30 a.m. e.s.t.               Meeting: Each presenter must submit an
                                               Centers for Disease Control and                            Deadline for Registration for                      agenda item(s) regarding whether a FY
                                               Prevention                                              Participants (not Presenting) at the                  2020 application meets the substantial
                                                                                                       Town Hall Meeting: The deadline to                    clinical improvement criterion. Agenda
                                               Delegation of Authority                                 register to attend the Town Hall Meeting              items, written comments, questions or
                                                 Notice is hereby given that I have                    is 5:00 p.m., e.s.t. on Monday,                       other statements must not exceed three
                                               delegated to the Director, National                     November 26, 2018.                                    single-spaced typed pages and may be
                                               Institute for Occupational Safety and                      Deadline for Requesting Special                    sent via email to newtech@cms.hhs.gov.
                                               Health (NIOSH), Centers for Disease                     Accommodations: The deadline to                       FOR FURTHER INFORMATION CONTACT:
                                               Control and Prevention (CDC), without                   submit requests for special                           Michelle Joshua, (410) 786–6050,
                                               authority to redelegate, the authority                  accommodations is 5:00 p.m., e.s.t. on                michelle.joshua@cms.hhs.gov; or
                                               vested in the Director, CDC, under                      Monday, November 19, 2018.                            Michael Treitel, (410) 786–4552,
                                               Section 2695, Title XXVI of the Public                     Deadline for Registration of Presenters            michael.treitel@cms.hhs.gov.
                                               Health Service Act (42 U.S.C. 300ff–                    at the Town Hall Meeting: The deadline                   Alternatively, you may forward your
                                               131), and the Ryan White HIV/AIDS                       to register to present at the Town Hall               requests via email to newtech@
                                               Treatment Extension Act of 2009 (Pub.                   Meeting is 5:00 p.m., e.s.t. on Monday,               cms.hhs.gov.
                                               L. 111–87), as amended.                                 November 19, 2018.
                                                                                                          Deadline for Submission of Agenda                  SUPPLEMENTARY INFORMATION:
                                                 This delegation became effective on
                                               August 27, 2018. I hereby affirm and                    Item(s) or Written Comments for the                   I. Background on the Add-On Payments
                                               ratify any actions taken that involve the               Town Hall Meeting: Written comments                   for New Medical Services and
                                               exercise of the authorities delegated                   and agenda items for discussion at the                Technologies Under the IPPS
                                               herein prior to the effective date of this              Town Hall Meeting, including agenda
                                               delegation.                                             items by presenters, must be received by                 Sections 1886(d)(5)(K) and (L) of the
                                                                                                       5:00 p.m. e.s.t. on Monday, November                  Social Security Act (the Act) require the
                                                 Dated: October 1, 2018.                               19, 2018.                                             Secretary to establish a process of
                                               Robert R. Redfield,                                        Deadline for Submission of Written                 identifying and ensuring adequate
                                               Director, Centers for Disease Control and               Comments after the Town Hall Meeting                  payments to acute care hospitals for
                                               Prevention.                                             for consideration in the FY 2020 IPPS                 new medical services and technologies
                                               [FR Doc. 2018–21672 Filed 10–4–18; 8:45 am]             proposed rule: Individuals may submit                 under Medicare. Effective for discharges
                                               BILLING CODE 4163–18–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, December 14,                   under the hospital inpatient prospective
                                               Services                                                2018, for consideration in the FY 2020                payment system (IPPS). In addition,
                                               [CMS–1704–N]                                            IPPS proposed rule.                                   section 1886(d)(5)(K)(vi) of the Act
                                                                                                       ADDRESSES: Meeting Location: The                      specifies that a medical service or
                                               Medicare Program; Town Hall Meeting                     Town Hall Meeting will be held in the                 technology will be considered ‘‘new’’ if
                                               on the FY 2020 Applications for New                     main Auditorium in the central building               it meets criteria established by the
                                               Medical Services and Technologies                       of the Centers for Medicare & Medicaid                Secretary (after notice and opportunity
                                               Add-On Payments                                         Services located at 7500 Security                     for public comment). (See the fiscal year
                                               AGENCY: Centers for Medicare &                          Boulevard, Baltimore, MD 21244–1850.                  (FY) 2002 IPPS proposed rule (66 FR
                                               Medicaid Services (CMS), HHS.                              In addition, we are providing two                  22693, May 4, 2001) and final rule (66
                                                                                                       alternatives to attending the meeting in              FR 46912, September 7, 2001) for a more
                                               ACTION: Notice of meeting.
                                                                                                       person—(1) there will be an open toll-                detailed discussion.)
                                               SUMMARY:   This notice announces a                      free phone line to call into the Town                    In the September 7, 2001 final rule (66
                                               Town Hall meeting in accordance with                    Hall Meeting; or (2) participants may                 FR 46914), we noted that we evaluated
                                               section 1886(d)(5)(K)(viii) of the Social               view and participate in the Town Hall                 a request for special payment for a new
daltland on DSKBBV9HB2PROD with NOTICES




                                               Security Act (the Act) to discuss fiscal                Meeting via live stream technology or                 medical service or technology against
                                               year (FY) 2020 applications for add-on                  webinar. These options are discussed in               the following criteria in order to
                                               payments for new medical services and                   section II.B. of this notice.                         determine if the new technology meets
                                               technologies under the hospital                            Registration and Special                           the substantial clinical improvement
                                               inpatient prospective payment system                    Accommodations: Individuals wishing                   requirement:
                                               (IPPS). Interested parties are invited to               to participate in the meeting must                       • The device offers a treatment option
                                               this meeting to present their comments,                 register by following the on-line                     for a patient population unresponsive


                                          VerDate Sep<11>2014   17:11 Oct 04, 2018   Jkt 247001   PO 00000   Frm 00049   Fmt 4703   Sfmt 4703   E:\FR\FM\05OCN1.SGM   05OCN1


                                               50380                          Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices

                                               to, or ineligible for, currently available              substantial improvement before                        open toll-free phone line will be made
                                               treatments.                                             publication of a proposed rule.                       available. Continue to check our website
                                                  • The device offers the ability to                     The opinions and presentations                      at: http://www.cms.gov/Medicare/
                                               diagnose a medical condition in a                       provided during this meeting will assist              Medicare-Fee-for-Service-Payment/
                                               patient population where that medical                   us as we evaluate the new medical                     AcuteInpatientPPS/newtech.html for
                                               condition is currently undetectable or                  services and technology applications for              updated dial-in number and
                                               offers the ability to diagnose a medical                FY 2020. In addition, they will help us               instructions.
                                               condition earlier in a patient population               to evaluate our policy on the IPPS new                   Also, there will be an option to view
                                               than allowed by currently available                     technology add-on payment process                     and participate in the Town Hall
                                               methods. There must also be evidence                    before the publication of the FY 2020                 Meeting via live streaming technology
                                               that use of the device to make a                        IPPS proposed rule.                                   or webinar. Information on the option to
                                               diagnosis affects the management of the                                                                       participate via live streaming
                                                                                                       II. Town Hall Meeting Format and                      technology or webinar will be provided
                                               patient.
                                                                                                       Conference Call/Live Streaming
                                                  • Use of the device significantly                    Information
                                                                                                                                                             through an upcoming listserv notice and
                                               improves clinical outcomes for a patient                                                                      posted on the New Technology website
                                               population as compared to currently                     A. Format of the Town Hall Meeting                    at http://www.cms.gov/Medicare/
                                               available treatments. Some examples of                     As noted in section I. of this notice,             Medicare-Fee-for-Service-Payment/
                                               outcomes that are frequently evaluated                  we are required to provide for a meeting              AcuteInpatientPPS/newtech.html.
                                               in studies of medical devices are the                   at which organizations representing                   Continue to check the website for
                                               following:                                              hospitals, physicians, manufacturers                  updates.
                                                  ++ Reduced mortality rate with use                   and any other interested party may                    C. Disclaimer
                                               of the device.                                          present comments, recommendations,
                                                  ++ Reduced rate of device-related                                                                             We cannot guarantee reliability for
                                                                                                       and data to the clinical staff of CMS                 live streaming technology or a webinar.
                                               complications.                                          concerning whether the service or
                                                  ++ Decreased rate of subsequent                      technology represents a substantial                   III. Registration Instructions
                                               diagnostic or therapeutic interventions                 clinical improvement. This meeting will                  The Division of Acute Care in CMS is
                                               (for example, due to reduced rate of                    allow for a discussion of the substantial             coordinating the meeting registration for
                                               recurrence of the disease process).                     clinical improvement criteria for each of             the Town Hall Meeting on substantial
                                                  ++ Decreased number of future                        the FY 2020 new medical services and                  clinical improvement. While there is no
                                               hospitalizations or physician visits.                   technology add-on payment                             registration fee, individuals planning to
                                                  ++ More rapid beneficial resolution                  applications. Information regarding the               attend the Town Hall Meeting in person
                                               of the disease process treatment because                applications can be found on our                      must register to attend.
                                               of the use of the device.                               website at http://www.cms.gov/                           Registration may be completed on-
                                                  ++ Decreased pain, bleeding or other                 Medicare/Medicare-Fee-for-Service-                    line at the following web address:
                                               quantifiable symptoms.                                  Payment/AcuteInpatientPPS/                            http://www.cms.gov/Medicare/
                                                  ++ Reduced recovery time.                            newtech.html.                                         Medicare-Fee-for-Service-Payment/
                                                  In addition, we indicated that the                      The majority of the meeting will be                AcuteInpatientPPS/newtech.html.
                                               requester is required to submit evidence                reserved for presentations of comments,               Select the link at the bottom of the page
                                               that the technology meets one or more                   recommendations, and data from                        ‘‘Register to Attend the New Technology
                                               of these criteria.                                      registered presenters. The time for each              Town Hall Meeting’’. After completing
                                                  Section 1886(d)(5)(K)(viii) of the Act               presenter’s comments will be                          the registration, online registrants
                                               requires that as part of the process for                approximately 10 to 15 minutes and                    should print the confirmation page(s)
                                               evaluating new medical services and                     will be based on the number of                        and bring it with them to the meeting.
                                               technology applications, the Secretary                  registered presenters. Individuals who                   If you are unable to register on-line,
                                               shall do the following:                                 would like to present must register and               you may register by sending an email to
                                                  • Provide for public input regarding                 submit their agenda item(s) via email to              newtech@cms.hhs.gov. Please include
                                               whether a new service or technology                     newtech@cms.hhs.gov by the date                       your name, address, telephone number,
                                               represents an advance in medical                        specified in the DATES section of this                email address and fax number. If seating
                                               technology that substantially improves                  notice.                                               capacity has been reached, you will be
                                               the diagnosis or treatment of Medicare                     In addition, written comments will                 notified that the meeting has reached
                                               beneficiaries before publication of a                   also be accepted and presented at the                 capacity.
                                               proposed rule.                                          meeting if they are received via email to
                                                  • Make public and periodically                       newtech@cms.hhs.gov by the date                       IV. Security, Building, and Parking
                                               update a list of all the services and                   specified in the DATES section of this                Guidelines
                                               technologies for which an application is                notice. Written comments may also be                    Because this meeting will be located
                                               pending.                                                submitted after the meeting for our                   on Federal property, for security
                                                  • Accept comments,                                   consideration. If the comments are to be              reasons, any persons wishing to attend
                                               recommendations, and data from the                      considered before the publication of the              the meeting must register by the date
                                               public regarding whether the service or                 FY 2020 IPPS proposed rule, the                       specified in the DATES section of this
                                               technology represents a substantial                     comments must be received via email to                notice. Please allow sufficient time to go
                                               improvement.                                            newtech@cms.hhs.gov by the date                       through the security checkpoints. If you
daltland on DSKBBV9HB2PROD with NOTICES




                                                  • Provide for a meeting at which                     specified in the DATES section of this                are attending the Town Hall Meeting in
                                               organizations representing hospitals,                   notice.                                               person, we suggest that you arrive at
                                               physicians, manufacturers and any                                                                             7500 Security Boulevard no later than
                                               other interested party may present                      B. Conference Call, Live Streaming, and               8:30 a.m. e.s.t. so that you will be able
                                               comments, recommendations, and data                     Webinar Information                                   to arrive promptly for the meeting.
                                               to the clinical staff of CMS as to whether                For participants who cannot attend                    Security measures include the
                                               the service or technology represents a                  the Town Hall Meeting in person, an                   following:


                                          VerDate Sep<11>2014   17:11 Oct 04, 2018   Jkt 247001   PO 00000   Frm 00050   Fmt 4703   Sfmt 4703   E:\FR\FM\05OCN1.SGM   05OCN1


                                                                              Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices                                         50381

                                                 • Presentation of government-issued                     • Larger items (e.g. computer bags)                 ways to enhance the quality, utility, and
                                               photographic identification to the                      can be placed directly onto the                       clarity of the information to be
                                               Federal Protective Service or Guard                     conveyer.                                             collected, and the use of automated
                                               Service personnel.                                        In the event the metal detector beeps               collection techniques or other forms of
                                                  Note: The REAL ID Act established                    when you walk through:                                information technology to minimize the
                                               minimum security standards for license                    • A security guard will run a hand-                 information collection burden.
                                               issuance and production and prohibits                   held metal detector over you. If the                  DATES: Comments must be received by
                                               Federal agencies from accepting for certain             metal detector doesn’t alarm, you’re                  December 4, 2018.
                                               purposes driver’s licenses and identification           cleared to enter.                                     ADDRESSES: When commenting, please
                                               cards from states not meeting the Act’s                   • If the hand-held metal detector                   reference the document identifier or
                                               minimum standards. We encourage the                     alarms, the guard will pat down the area
                                               public to visit the DHS website at https://                                                                   OMB control number. To be assured
                                                                                                       of the body where the metal detector                  consideration, comments and
                                               www.dhs.gov/real-id prior to the new
                                               technology town hall meeting for updated
                                                                                                       alarmed.                                              recommendations must be submitted in
                                               information.                                              • If footwear alarms, it will need to be            any one of the following ways:
                                                                                                       removed and placed in a bin for x-ray                   1. Electronically. You may send your
                                                  • All Foreign National visitor                       screening.                                            comments electronically to http://
                                               requests must be submitted 12 business                    If you believe that you have a                      www.regulations.gov. Follow the
                                               days prior to the scheduled visitor to                  disability that will cause you to require             instructions for ‘‘Comment or
                                               allow for processing./non U.S. citizen.                 reasonable accommodation to comply                    Submission’’ or ‘‘More Search Options’’
                                                  • Inspection of vehicle’s interior and               with the new process, please contact                  to find the information collection
                                               exterior (this includes engine and trunk                reasonableaccommodationprogram@                       document(s) that are accepting
                                               inspection) at the entrance to the                      cms.hhs.gov as soon as possible.                      comments.
                                               grounds. Parking permits and                                                                                    2. By regular mail. You may mail
                                                                                                         Authority: Section 1886(d)(5)(K)(viii) of
                                               instructions will be issued after the                   the Social Security Act.                              written comments to the following
                                               vehicle inspection.                                                                                           address: CMS, Office of Strategic
                                                  • Inspection, via metal detector or                    Dated: October 1, 2018.
                                                                                                       Seema Verma,                                          Operations and Regulatory Affairs,
                                               other applicable means of all persons                                                                         Division of Regulations Development,
                                               entering the building. We note that all                 Administrator, Centers for Medicare &
                                                                                                       Medicaid Services.                                    Attention: Document Identifier/OMB
                                               items brought to CMS, whether personal                                                                        Control Number ___, Room C4–26–05,
                                               or for the purpose of presentation or to                [FR Doc. 2018–21753 Filed 10–4–18; 8:45 am]
                                                                                                                                                             7500 Security Boulevard, Baltimore,
                                               support a presentation, are subject to                  BILLING CODE 4120–01–P
                                                                                                                                                             Maryland 21244–1850.
                                               inspection. We cannot assume                                                                                    To obtain copies of a supporting
                                               responsibility for coordinating the                                                                           statement and any related forms for the
                                               receipt, transfer, transport, storage, set-             DEPARTMENT OF HEALTH AND
                                                                                                       HUMAN SERVICES                                        proposed collection(s) summarized in
                                               up, safety, or timely arrival of any                                                                          this notice, you may make your request
                                               personal belongings or items used for                                                                         using one of following:
                                               presentation or to support a                            Centers for Medicare & Medicaid
                                                                                                       Services                                                1. Access CMS’ website address at
                                               presentation.                                                                                                 website address at https://www.cms.gov/
                                                 Note: Individuals who are not registered in           [Document Identifier: CMS–10680]                      Regulations-and-Guidance/Legislation/
                                               advance will not be permitted to enter the                                                                    PaperworkReductionActof1995/PRA-
                                               building and will be unable to attend the               Agency Information Collection
                                                                                                                                                             Listing.html.
                                               meeting in person. The public may not enter             Activities: Proposed Collection;
                                                                                                                                                               2. Email your request, including your
                                               the building earlier than 45 minutes prior to           Comment Request
                                                                                                                                                             address, phone number, OMB number,
                                               the convening of the meeting.
                                                                                                       AGENCY: Centers for Medicare &                        and CMS document identifier, to
                                                 All visitors must be escorted in all                  Medicaid Services, HHS.                               Paperwork@cms.hhs.gov.
                                               areas other than the lower level lobby                  ACTION: Notice.                                         3. Call the Reports Clearance Office at
                                               and cafeteria area and first floor                                                                            (410) 786–1326.
                                               auditorium and conference areas in the                  SUMMARY:   The Centers for Medicare &                 FOR FURTHER INFORMATION CONTACT:
                                               Central Building. Seating capacity is                   Medicaid Services (CMS) is announcing                 William Parham at (410) 786–1326.
                                               limited to the first 250 registrants.                   an opportunity for the public to                      SUPPLEMENTARY INFORMATION:
                                               Updated Security Information for In-                    comment on CMS’ intention to collect
                                                                                                       information from the public. Under the                Contents
                                               Person Attendees
                                                                                                       Paperwork Reduction Act of 1995 (the                    This notice sets out a summary of the
                                                  Effective June 1, 2018, Federal                      PRA), federal agencies are required to                use and burden associated with the
                                               Protective Services (FPS) has                           publish notice in the Federal Register                following information collections. More
                                               implemented new security screening                      concerning each proposed collection of                detailed information can be found in
                                               procedures at all CMS Baltimore                         information (including each proposed                  each collection’s supporting statement
                                               locations to align with national                        extension or reinstatement of an existing             and associated materials (see
                                               screening standards. Please allow extra                 collection of information) and to allow               ADDRESSES).
                                               time to clear security prior to the                     60 days for public comment on the
                                               beginning of the meeting. Employees,                    proposed action. Interested persons are               CMS–10680 Electronic Visit
daltland on DSKBBV9HB2PROD with NOTICES




                                               contractors and visitors must place all                 invited to send comments regarding our                Verification Compliance Survey
                                               items in bins for screening, including:                 burden estimates or any other aspect of                 Under the PRA (44 U.S.C. 3501–
                                                  • Any items in your pockets.                         this collection of information, including             3520), federal agencies must obtain
                                                  • Belts, hats, jackets & coats (not suit             the necessity and utility of the proposed             approval from the Office of Management
                                               jackets or sport coats).                                information collection for the proper                 and Budget (OMB) for each collection of
                                                  • Purses, laptop computers & cell                    performance of the agency’s functions,                information they conduct or sponsor.
                                               phones.                                                 the accuracy of the estimated burden,                 The term ‘‘collection of information’’ is


                                          VerDate Sep<11>2014   17:11 Oct 04, 2018   Jkt 247001   PO 00000   Frm 00051   Fmt 4703   Sfmt 4703   E:\FR\FM\05OCN1.SGM   05OCN1



Document Created: 2018-10-05 01:52:15
Document Modified: 2018-10-05 01:52:15
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, December 4, 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 Citation83 FR 50379 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR