81_FR_79031 81 FR 78814 - Medicare Program; Town Hall Meeting on the FY 2018 Applications for New Medical Services and Technologies Add-On Payments

81 FR 78814 - Medicare Program; Town Hall Meeting on the FY 2018 Applications for New Medical Services and Technologies Add-On Payments

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

Federal Register Volume 81, Issue 217 (November 9, 2016)

Page Range78814-78816
FR Document2016-27007

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) 2018 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 2018 new medical services and technologies applications meet the substantial clinical improvement criterion.

Federal Register, Volume 81 Issue 217 (Wednesday, November 9, 2016)
[Federal Register Volume 81, Number 217 (Wednesday, November 9, 2016)]
[Notices]
[Pages 78814-78816]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1662-N]


Medicare Program; Town Hall Meeting on the FY 2018 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) 2018 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 2018 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 14, 2017. 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 8, 2017.
    Deadline for Requesting Special Accommodations: The deadline to 
submit requests for special accommodations is 5:00 p.m., e.s.t. on 
Tuesday, January 17, 2017.
    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 30, 2017.
    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 30, 2017.
    Deadline for Submission of Written Comments after the Town Hall 
Meeting for consideration in the FY 2018 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 
24, 2017, for consideration in the FY 2018 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. Information on these options is 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

[[Page 78815]]

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 2018 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 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 specifies that the process 
for evaluating new medical services and technology applications shall 
include 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 2018. 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 2018 IPPS proposed rule.

II. Town Hall Meeting and Conference Calling/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 2018 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 
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, (844) 396-8222, has been made available. 
The Meeting Place meeting ID is 902 252 617.
    Also, there will be an option to view and participate in the Town 
Hall Meeting via live streaming technology

[[Page 78816]]

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, on-line registrants should print the 
confirmation page(s) and bring it with them to the meeting.
    If you are unable to register online, 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 the meeting will be located on Federal property, for 
security reasons, any persons wishing to attend this meeting must 
register by the date specified in the DATES section of this notice. 
Please allow sufficient time to go through the security checkpoints. It 
is suggested that you arrive at 7500 Security Boulevard no later than 
8:30 a.m. e.s.t. if you are attending the Town Hall Meeting in person 
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.
     CMS policy requires that every foreign national (defined 
by the Department of Homeland Security is ``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 (DPPSI) 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-resident 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 for requesting special accommodations specified in 
the DATES section of this notice:
    ++ Visitor's full name (as it appears on passport).
    ++ Gender.
    ++ Country of origin and citizenship.
    ++ Date of birth.
    ++ Place of birth.
    ++ Passport number.
    ++ Passport issue date.
    ++ Passport expiration date.
    ++ Visa type.
    ++ Date(s) of visit(s).
    ++ 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.

    Dated: October 27, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-27007 Filed 11-8-16; 8:45 am]
 BILLING CODE 4120-01-P



                                                78814                    Federal Register / Vol. 81, No. 217 / Wednesday, November 9, 2016 / Notices

                                                Regulatory Affairs of OMB, Attention:                     Responses per Respondent: 1.                        whether the FY 2018 new medical
                                                Desk Officer for GSA, Room 10236,                         Annual Responses: 2400.                             services and technologies applications
                                                NEOB, Washington, DC 20503.                               Hours per Response: 0.12.                           meet the substantial clinical
                                                Additionally submit a copy to GSA by                      Total Burden Hours: 288.                            improvement criterion.
                                                any of the following methods:                           (3) Email Survey:                                     DATES: Meeting Date: The Town Hall
                                                   • Regulations.gov: http://                             Respondents: 3600.                                  Meeting announced in this notice will
                                                www.regulations.gov. Submit comments                      Responses per Respondent: 1.                        be held on Tuesday, February 14, 2017.
                                                via the Federal eRulemaking portal by                     Annual Responses: 3600.                             The Town Hall Meeting will begin at
                                                searching the OMB control number.                         Hours per Response: 0.12.                           9:00 a.m. Eastern Standard Time (e.s.t.)
                                                Select the link ‘‘Submit a Comment’’                      Total Burden Hours: 432.                            and check-in will begin at 8:30 a.m.
                                                that corresponds with ‘‘Information                     Grand Total Burden Hours: 1440.                       e.s.t.
                                                Collection 3090–0278, National Contract                 C. Public Comments                                       Deadline for Registration for
                                                Center Evaluation Survey’’. Follow the                                                                        Participants (not Presenting) at the
                                                instructions provided at the ‘‘Submit a                    Public comments are particularly
                                                                                                                                                              Town Hall Meeting: The deadline to
                                                Comment’’ screen. Please include your                   invited on: Whether this collection of
                                                                                                                                                              register to attend the Town Hall Meeting
                                                name, company name (if any), and                        information is necessary and whether it
                                                                                                                                                              is 5:00 p.m., e.s.t. on Wednesday,
                                                ‘‘Information Collection 3090–0278,                     will have practical utility; whether our
                                                                                                                                                              February 8, 2017.
                                                National Contract Center Evaluation                     estimate of the public burden of this                    Deadline for Requesting Special
                                                Survey’’ on your attached document.                     collection of information is accurate and             Accommodations: The deadline to
                                                   • Mail: General Services                             based on valid assumptions and                        submit requests for special
                                                Administration, Regulatory Secretariat                  methodology; and ways to enhance the                  accommodations is 5:00 p.m., e.s.t. on
                                                Division (MVCB), 1800 F Street NW.,                     quality, utility, and clarity of the                  Tuesday, January 17, 2017.
                                                Washington, DC 20405. ATTN: Ms.                         information to be collected.                             Deadline for Registration of Presenters
                                                Flowers/IC 3090–0278, National                          OBTAINING COPIES OF PROPOSALS:                        at the Town Hall Meeting: The deadline
                                                Contract Center Evaluation Survey.                      Requesters may obtain a copy of the                   to register to present at the Town Hall
                                                   Instructions: Please submit comments                 information collection documents from                 Meeting is 5:00 p.m., e.s.t. on Monday,
                                                only and cite Information Collection                    the General Services Administration,                  January 30, 2017.
                                                3090–0278, National Contract Center                     Regulatory Secretariat Division (MVCB),                  Deadline for Submission of Agenda
                                                Evaluation Survey, in all                               1800 F Street NW., Washington, DC                     Item(s) or Written Comments for the
                                                correspondence related to this                          20405, telephone 202–501–4755. Please                 Town Hall Meeting: Written comments
                                                collection. Comments received generally                 cite OMB Control No. 3090–0278,                       and agenda items for discussion at the
                                                will be posted without change to http://                National Contact Center Customer                      Town Hall Meeting, including agenda
                                                www.regulations.gov, including any                      Evaluation Survey, in all                             items by presenters, must be received by
                                                personal and/or business confidential                   correspondence.                                       5:00 p.m. e.s.t. on Monday, January 30,
                                                information provided. To confirm                          Dated: November 4, 2016.                            2017.
                                                receipt of your comment(s), please                      David A. Shive,                                          Deadline for Submission of Written
                                                check www.regulations.gov,                              Chief Information Officer.                            Comments after the Town Hall Meeting
                                                approximately two to three days after                                                                         for consideration in the FY 2018 IPPS
                                                                                                        [FR Doc. 2016–27064 Filed 11–8–16; 8:45 am]
                                                submission to verify posting (except                                                                          proposed rule: Individuals may submit
                                                                                                        BILLING CODE 6820–CX–P
                                                allow 30 days for posting of comments                                                                         written comments after the Town Hall
                                                submitted by mail).                                                                                           Meeting, as specified in the ADDRESSES
                                                SUPPLEMENTARY INFORMATION:                                                                                    section of this notice, on whether the
                                                                                                        DEPARTMENT OF HEALTH AND                              service or technology represents a
                                                A. Purpose                                              HUMAN SERVICES                                        substantial clinical improvement. These
                                                   This information collection will be                  Centers for Medicare & Medicaid                       comments must be received by 5:00
                                                used to assess the public’s satisfaction                Services                                              p.m. e.s.t. on Friday, February 24, 2017,
                                                with the USA.gov National Contact                                                                             for consideration in the FY 2018 IPPS
                                                Center service(formerly the Federal                     [CMS–1662–N]                                          proposed rule.
                                                Citizen Information Center’s (FCIC)                                                                           ADDRESSES: Meeting Location: The
                                                National Contact Center), to assist in                  Medicare Program; Town Hall Meeting
                                                                                                                                                              Town Hall Meeting will be held in the
                                                increasing the efficiency in responding                 on the FY 2018 Applications for New
                                                                                                                                                              main Auditorium in the central building
                                                to the public’s need for Federal                        Medical Services and Technologies
                                                                                                                                                              of the Centers for Medicare & Medicaid
                                                information, and to assess the                          Add-On Payments
                                                                                                                                                              Services located at 7500 Security
                                                effectiveness of marketing efforts.                     AGENCY: Centers for Medicare &                        Boulevard, Baltimore, MD 21244–1850.
                                                B. Annual Reporting Burden                              Medicaid Services (CMS), HHS.                            In addition, we are providing two
                                                                                                        ACTION: Notice of meeting.                            alternatives to attending the meeting in
                                                  The following are estimates of the                                                                          person—(1) there will be an open toll-
                                                annual hourly burdens for our surveys                   SUMMARY:   This notice announces a                    free phone line to call into the Town
                                                based on historical participation in our                Town Hall meeting in accordance with                  Hall Meeting; or (2) participants may
                                                surveys.                                                section 1886(d)(5)(K)(viii) of the Social             view and participate in the Town Hall
                                                (1) Telephone Survey:                                   Security Act (the Act) to discuss fiscal              Meeting via live stream technology or
sradovich on DSK3GMQ082PROD with NOTICES




                                                  Respondents: 6000.                                    year (FY) 2018 applications for add-on                webinar. Information on these options is
                                                  Responses per Respondent: 1.                          payments for new medical services and                 discussed in section II.B. of this notice.
                                                  Annual Responses: 6000.                               technologies under the hospital                          Registration and Special
                                                  Hours per Response: 0.12.                             inpatient prospective payment system                  Accommodations: Individuals wishing
                                                  Total Burden Hours: 720.                              (IPPS). Interested parties are invited to             to participate in the meeting must
                                                (2) Web Chat Survey:                                    this meeting to present their comments,               register by following the on-line
                                                  Respondents: 2400.                                    recommendations, and data regarding                   registration instructions located in


                                           VerDate Sep<11>2014   16:29 Nov 08, 2016   Jkt 241001   PO 00000   Frm 00043   Fmt 4703   Sfmt 4703   E:\FR\FM\09NON1.SGM   09NON1


                                                                         Federal Register / Vol. 81, No. 217 / Wednesday, November 9, 2016 / Notices                                           78815

                                                section III. of this notice or by                          • The device offers the ability to                 us as we evaluate the new medical
                                                contacting staff listed in the FOR                      diagnose a medical condition in a                     services and technology applications for
                                                FURTHER INFORMATION CONTACT section of                  patient population where that medical                 FY 2018. In addition, they will help us
                                                this notice. Individuals who need                       condition is currently undetectable or                to evaluate our policy on the IPPS new
                                                special accommodations should contact                   offers the ability to diagnose a medical              technology add-on payment process
                                                staff listed in the FOR FURTHER                         condition earlier in a patient population             before the publication of the FY 2018
                                                INFORMATION CONTACT section of this                     than allowed by currently available                   IPPS proposed rule.
                                                notice.                                                 methods. There must also be evidence
                                                   Submission of Agenda Item(s) or                                                                            II. Town Hall Meeting and Conference
                                                                                                        that use of the device to make a
                                                Written Comments for the Town Hall                                                                            Calling/Live Streaming Information
                                                                                                        diagnosis affects the management of the
                                                Meeting: Each presenter must submit an                  patient.                                              A. Format of the Town Hall Meeting
                                                agenda item(s) regarding whether a FY                      • Use of the device significantly                     As noted in section I. of this notice,
                                                2018 application meets the substantial                  improves clinical outcomes for a patient              we are required to provide for a meeting
                                                clinical improvement criterion. Agenda                  population as compared to currently                   at which organizations representing
                                                items, written comments, questions or                   available treatments. Some examples of                hospitals, physicians, manufacturers
                                                other statements must not exceed three                  outcomes that are frequently evaluated                and any other interested party may
                                                single-spaced typed pages and may be                    in studies of medical devices are the                 present comments, recommendations,
                                                sent via email to newtech@cms.hhs.gov.                  following:                                            and data to the clinical staff of CMS
                                                FOR FURTHER INFORMATION CONTACT:                           ++ Reduced mortality rate with use of
                                                                                                                                                              concerning whether the service or
                                                Michelle Joshua, (410) 786–6050,                        the device.
                                                                                                           ++ Reduced rate of device-related                  technology represents a substantial
                                                   michelle.joshua@cms.hhs.gov, or                                                                            clinical improvement. This meeting will
                                                Michael Treitel, (410) 786–4552,                        complications.
                                                                                                           ++ Decreased rate of subsequent                    allow for a discussion of the substantial
                                                   michael.treitel@cms.hhs.gov.                                                                               clinical improvement criteria for each of
                                                   Alternatively, you may forward your                  diagnostic or therapeutic interventions
                                                                                                        (for example, due to reduced rate of                  the FY 2018 new medical services and
                                                requests via email to                                                                                         technology add-on payment
                                                newtech@cms.hhs.gov.                                    recurrence of the disease process).
                                                                                                           ++ Decreased number of future                      applications. Information regarding the
                                                SUPPLEMENTARY INFORMATION:                              hospitalizations or physician visits.                 applications can be found on our Web
                                                                                                           ++ More rapid beneficial resolution of             site at http://www.cms.gov/Medicare/
                                                I. Background on the Add-On Payments                                                                          Medicare-Fee-for-Service-Payment/
                                                for New Medical Services and                            the disease process treatment because of
                                                                                                        the use of the device.                                AcuteInpatientPPS/newtech.html.
                                                Technologies Under the IPPS                                                                                      The majority of the meeting will be
                                                                                                           ++ Decreased pain, bleeding or other
                                                   Sections 1886(d)(5)(K) and (L) of the                quantifiable symptoms.                                reserved for presentations of comments,
                                                Social Security Act (the Act) require the                  ++ Reduced recovery time.                          recommendations, and data from
                                                Secretary to establish a process of                        In addition, we indicated that the                 registered presenters. The time for each
                                                identifying and ensuring adequate                       requester is required to submit evidence              presenter’s comments will be
                                                payments to acute care hospitals for                    that the technology meets one or more                 approximately 10 to 15 minutes and
                                                new medical services and technologies                   of these criteria.                                    will be based on the number of
                                                under Medicare. Effective for discharges                   Section 1886(d)(5)(K)(viii) of the Act             registered presenters. Individuals who
                                                beginning on or after October 1, 2001,                  specifies that the process for evaluating             would like to present must register and
                                                section 1886(d)(5)(K)(i) of the Act                     new medical services and technology                   submit their agenda item(s) via email to
                                                requires the Secretary to establish (after              applications shall include the following:             newtech@cms.hhs.gov by the date
                                                notice and opportunity for public                          • Provide for public input regarding               specified in the DATES section of this
                                                comment) a mechanism to recognize the                   whether a new service or technology                   notice.
                                                costs of new services and technologies                  represents an advance in medical                         In addition, written comments will
                                                under the hospital inpatient prospective                technology that substantially improves                also be accepted and presented at the
                                                payment system (IPPS). In addition,                     the diagnosis or treatment of Medicare                meeting if they are received via email to
                                                section 1886(d)(5)(K)(vi) of the Act                    beneficiaries before publication of a                 newtech@cms.hhs.gov by the date
                                                specifies that a medical service or                     proposed rule.                                        specified in the DATES section of this
                                                technology will be considered ‘‘new’’ if                   • Make public and periodically                     notice. Written comments may also be
                                                it meets criteria established by the                    update a list of all the services and                 submitted after the meeting for our
                                                Secretary (after notice and opportunity                 technologies for which an application is              consideration. If the comments are to be
                                                for public comment). (See the fiscal year               pending.                                              considered before the publication of the
                                                (FY) 2002 IPPS proposed rule (66 FR                        • Accept comments,                                 proposed rule, the comments must be
                                                22693, May 4, 2001) and final rule (66                  recommendations, and data from the                    received via email to newtech@
                                                FR 46912, September 7, 2001) for a more                 public regarding whether the service or               cms.hhs.gov by the date specified in the
                                                detailed discussion.)                                   technology represents a substantial                   DATES section of this notice.
                                                   In the September 7, 2001 final rule (66              improvement.
                                                FR 46914), we noted that we evaluated                      • Provide for a meeting at which                   B. Conference Call, Live Streaming, and
                                                a request for special payment for a new                 organizations representing hospitals,                 Webinar Information
                                                medical service or technology against                   physicians, manufacturers and any                       For participants who cannot attend
                                                                                                                                                              the Town Hall Meeting in person, an
sradovich on DSK3GMQ082PROD with NOTICES




                                                the following criteria in order to                      other interested party may present
                                                determine if the new technology meets                   comments, recommendations, and data                   open toll-free phone line, (844) 396–
                                                the substantial clinical improvement                    to the clinical staff of CMS as to whether            8222, has been made available. The
                                                requirement:                                            the service or technology represents a                Meeting Place meeting ID is 902 252
                                                   • The device offers a treatment option               substantial improvement before                        617.
                                                for a patient population unresponsive                   publication of a proposed rule.                         Also, there will be an option to view
                                                to, or ineligible for, currently available                 The opinions and presentations                     and participate in the Town Hall
                                                treatments.                                             provided during this meeting will assist              Meeting via live streaming technology


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                                                78816                    Federal Register / Vol. 81, No. 217 / Wednesday, November 9, 2016 / Notices

                                                or webinar. Information on the option to                is assigned a host (in accordance with                  Dated: October 27, 2016.
                                                participate via live streaming                          the Department Foreign Visitor                        Andrew M. Slavitt,
                                                technology or webinar will be provided                  Management Policy, Appendix C,                        Acting Administrator, Centers for Medicare
                                                through an upcoming listserv notice and                 Guidelines for Hosts and Escorts). The                & Medicaid Services.
                                                posted on the New Technology Web site                   host/hosting official is required to                  [FR Doc. 2016–27007 Filed 11–8–16; 8:45 am]
                                                at http://www.cms.gov/Medicare/                         inform the Division of Physical Security              BILLING CODE 4120–01–P
                                                Medicare-Fee-for-Service-Payment/                       and Strategic Information (DPPSI) at
                                                AcuteInpatientPPS/newtech.html.                         least 12 business days in advance of any
                                                Continue to check the Web site for                      visit by a foreign national. Foreign                  DEPARTMENT OF HEALTH AND
                                                updates.                                                nationals will be required to produce a               HUMAN SERVICES
                                                                                                        valid passport at the time of entry.
                                                C. Disclaimer                                              Attendees that are foreign nationals               Centers for Medicare & Medicaid
                                                   We cannot guarantee reliability for                  need to identify themselves as such, and              Services
                                                live streaming technology or a webinar.                 make a request for a special                          [CMS–2397–PN]
                                                III. Registration Instructions                          accommodation. Foreign national
                                                                                                        visitors are defined as non-U.S. citizens;            RIN–0938–ZB29
                                                   The Division of Acute Care in CMS is                 and non-lawful permanent residents,
                                                coordinating the meeting registration for                                                                     Medicaid Program; Announcement of
                                                                                                        non-resident aliens or non-green card                 Medicaid Drug Rebate Program
                                                the Town Hall Meeting on substantial                    holders. Foreign nationals must provide
                                                clinical improvement. While there is no                                                                       National Rebate Agreement
                                                                                                        the following information for security
                                                registration fee, individuals planning to               clearance to staff listed in the FOR                  AGENCY:  Centers for Medicare &
                                                attend the Town Hall Meeting in person                  FURTHER INFORMATION CONTACT section of                Medicaid Services (CMS), HHS.
                                                must register to attend.                                this notice by the date for requesting                ACTION: Proposed notice.
                                                   Registration may be completed on-                    special accommodations specified in the
                                                line at the following web address:                      DATES section of this notice:                         SUMMARY:    This proposed notice with
                                                http://www.cms.gov/Medicare/                               ++ Visitor’s full name (as it appears              comment period announces changes
                                                Medicare-Fee-for-Service-Payment/                       on passport).                                         that would be made to the Medicaid
                                                AcuteInpatientPPS/newtech.html.                            ++ Gender.                                         National Drug Rebate Agreement
                                                Select the link at the bottom of the page                  ++ Country of origin and citizenship.              (NDRA) for use by the Secretary of the
                                                ‘‘Register to Attend the New Technology                    ++ Date of birth.                                  Department of Health and Human
                                                Town Hall Meeting’’. After completing                      ++ Place of birth.                                 Services (HHS) and manufacturers
                                                the registration, on-line registrants                      ++ Passport number.                                under the Medicaid Drug Rebate
                                                should print the confirmation page(s)                      ++ Passport issue date.                            Program (MDRP). We are updating the
                                                and bring it with them to the meeting.                     ++ Passport expiration date.                       NDRA to incorporate legislative and
                                                   If you are unable to register online,                   ++ Visa type.                                      regulatory changes that have occurred
                                                you may register by sending an email to                    ++ Date(s) of visit(s).                            since the agreement was published in
                                                newtech@cms.hhs.gov. Please include                        ++ Company name.                                   the February 21, 1991 Federal Register
                                                your name, address, telephone number,                      ++ Position/Title.                                 (56 FR 7049). We are also updating the
                                                email address and fax number. If seating                   • Inspection of vehicle’s interior and             NDRA to make editorial and structural
                                                capacity has been reached, you will be                  exterior (this includes engine and trunk              revisions, such as references to the
                                                notified that the meeting has reached                   inspection) at the entrance to the                    updated Office of Management and
                                                capacity.                                               grounds. Parking permits and                          Budget (OMB)-approved data collection
                                                                                                        instructions will be issued after the                 forms and electronic data reporting.
                                                IV. Security, Building, and Parking                     vehicle inspection.                                   DATES: To be assured consideration,
                                                Guidelines                                                 • Inspection, via metal detector or
                                                                                                                                                              comments must be received at one of
                                                   Because the meeting will be located                  other applicable means of all persons
                                                                                                                                                              the addresses provided below, no later
                                                on Federal property, for security                       entering the building. We note that all
                                                                                                                                                              than 5 p.m. on February 7, 2017.
                                                reasons, any persons wishing to attend                  items brought to CMS, whether personal
                                                                                                                                                              ADDRESSES: In commenting, refer to file
                                                this meeting must register by the date                  or for the purpose of presentation or to
                                                                                                        support a presentation, are subject to                code CMS–2397–PN. Because of staff
                                                specified in the DATES section of this                                                                        and resource limitations, we cannot
                                                notice. Please allow sufficient time to go              inspection. We cannot assume
                                                                                                                                                              accept comments by facsimile (FAX)
                                                through the security checkpoints. It is                 responsibility for coordinating the
                                                                                                                                                              transmission.
                                                suggested that you arrive at 7500                       receipt, transfer, transport, storage, set-
                                                                                                                                                                 You may submit comments in one of
                                                Security Boulevard no later than 8:30                   up, safety, or timely arrival of any                  four ways (please choose only one of the
                                                a.m. e.s.t. if you are attending the Town               personal belongings or items used for                 ways listed):
                                                Hall Meeting in person so that you will                 presentation or to support a                             1. Electronically. You may submit
                                                be able to arrive promptly for the                      presentation.                                         electronic comments on this regulation
                                                meeting.                                                  Note: Individuals who are not registered in         to http://www.regulations.gov. Follow
                                                   Security measures include the                        advance will not be permitted to enter the            the ‘‘Submit a comment’’ instructions.
                                                following:                                              building and will be unable to attend the                2. By regular mail. You may mail
                                                   • Presentation of government-issued                  meeting in person. The public may not enter           written comments to the following
                                                                                                        the building earlier than 45 minutes prior to
sradovich on DSK3GMQ082PROD with NOTICES




                                                photographic identification to the                                                                            address ONLY: Centers for Medicare &
                                                Federal Protective Service or Guard                     the convening of the meeting.
                                                                                                                                                              Medicaid Services, Department of
                                                Service personnel.                                        All visitors must be escorted in all                Health and Human Services, Attention:
                                                   • CMS policy requires that every                     areas other than the lower level lobby                CMS–2397–PN, P.O. Box 8016,
                                                foreign national (defined by the                        and cafeteria area and first floor                    Baltimore, MD 21244–8016.
                                                Department of Homeland Security is                      auditorium and conference areas in the                   Please allow sufficient time for mailed
                                                ‘‘an individual who is a citizen of any                 Central Building. Seating capacity is                 comments to be received before the
                                                country other than the United States’’)                 limited to the first 250 registrants.                 close of the comment period.


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Document Created: 2016-11-09 01:39:38
Document Modified: 2016-11-09 01:39:38
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.
ContactMichelle Joshua, (410) 786-6050, [email protected], or Michael Treitel, (410) 786-4552, [email protected]
FR Citation81 FR 78814 

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