[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57275-57277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1684-N]


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

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

ACTION: Notice of meeting.

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

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

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

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

SUPPLEMENTARY INFORMATION: 

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

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

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

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

A. Format of the Town Hall Meeting

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

B. Conference Call, Live Streaming, and Webinar Information

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

C. Disclaimer

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

III. Registration Instructions

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

IV. Security, Building, and Parking Guidelines

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

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

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

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

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

     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means 
of all persons entering the building. We note that all items brought to 
CMS, whether personal or for the purpose of presentation or to support 
a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for presentation or to support a presentation.

    Note: Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting in person. The public may not enter the building earlier 
than 45 minutes prior to the convening of the meeting.
    All visitors must be escorted in all areas other than the lower 
level lobby and cafeteria area and first floor auditorium and 
conference areas in the Central Building. Seating capacity is 
limited to the first 250 registrants.


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

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