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[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Proposed Rules]
[Pages 71555-71557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28518]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 412

[CMS-1604-N]

Medicare Program; Town Hall Meeting on FY 2015 Applications for 
New Medical Services and Technology 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 
the Social Security Act (the Act) to discuss fiscal year (FY) 2015 
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 2015 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 Wednesday, February 12, 2014. 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 and Submitting 
Requests for Special Accommodations: The deadline to register to attend 
the Town Hall Meeting and requests for special accommodations must be 
received no later than 5:00 p.m., e.s.t. on Tuesday, January 28, 2014.
    Deadline for Registration of Presenters of the Town Hall Meeting: 
The deadline to register to present at the Town Hall Meeting must be 
received no later than 5:00 p.m., e.s.t. on Tuesday, January 21, 2014.
    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 Tuesday, January 21, 2014. In addition to materials 
submitted for discussion at the Town Hall Meeting, individuals may 
submit other 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 Wednesday, March 5, 2014, for 
consideration in the FY 2015 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 and 
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 and/or 
webinar. Information on 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 2015 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 newtech@cms.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Michael Treitel, (410) 786-4552, 
michael.treitel@cms.hhs.gov, or Celeste Beauregard, (410) 786-8102, 
celeste.beauregard@cms.hhs.gov or Carol Schwartz, (410) 786-0576, 
carol.schwartz@cms.hhs.gov. Alternatively, you may forward your 
requests via email to newtech@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 71556]]

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 503 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) amended section 1886(d)(5)(K)(viii) of 
the Act to revise the process for evaluating new medical services and 
technology applications by requiring the Secretary to 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 alternatives provided during this meeting will 
assist us as we evaluate the new medical services and technology 
applications for FY 2015. 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 2015 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 on each of the FY 2015 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. 
Presenters will be scheduled to speak in the order in which they 
register and grouped by new technology applicant. Therefore, 
individuals who would like to present must register and submit their 
agenda item(s) via email to newtech@cms.hhs.gov 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 newtech@cms.hhs.gov 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 
newtech@cms.hhs.gov 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 number is ``999 396 992.''
    Also, there will be an option to view and participate in the Town 
Hall Meeting via live streaming technology and/or a webinar. 
Information on the option to participate via live streaming technology 
and/or a 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.
    Disclaimer: We cannot guarantee reliability for live streaming 
technology and/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

[[Page 71557]]

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(s).
    If you are unable to register on-line, you may register by sending 
an email to newtech@cms.hhs.gov. 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 these meetings will be located on Federal property, for 
security reasons, any persons wishing to attend these meetings 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.
     Interior and exterior inspection of vehicles (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Passing through a metal detector and inspection of items 
brought into the building. We note that all items brought to CMS, 
whether personal or for the purpose of demonstration or to support a 
demonstration, 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 demonstration or to support a demonstration.

    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(s).

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building. Seating capacity is limited 
to the first 250 registrants.

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

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: November 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-28518 Filed 11-27-13; 8:45 am]
BILLING CODE 4120-01-P
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