Medicare Program; Town Hall Meeting on the Fiscal Year 2009 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment System, February 21, 2008, 73845-73847 [E7-24267]
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Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
• Using single and multiple
procedure claims data.
• Addressing other APC structure
technical issues.
Note: The subject matter before the Panel
will be limited to these and related topics.
Issues related to calculation of the OPPS
conversion factor, charge compression, passthrough payments, and wage adjustments are
not within the scope of the Panel’s purpose.
Therefore, these issues will not be considered
for presentations and/or comments. There
will be no exceptions to this rule. We
appreciate your cooperation on this matter.
The Panel may use data collected or
developed by entities and organizations,
other than DHHS and CMS, in
conducting its review. We urge
organizations to submit data for the
Panel’s and CMS staff’s review.
III. Written Comments and Suggested
Agenda Topics
Send hardcopy and electronic written
comments and suggested agenda topics
to the DFO at the address indicated
above. The DFO must receive these
items by 5 p.m. (e.s.t.), Thursday,
February 7, 2008. There will be no
exceptions. We appreciate your
cooperation on this matter.
The written comments and suggested
agenda topics submitted for the March
2008 APC Panel meeting must fall
within the subject categories outlined in
the Panel’s Charter and as listed in the
Agenda section of this notice.
IV. Oral Presentations
Individuals or organizations wishing
to make 5-minute oral presentations
must submit hardcopy and electronic
versions of their presentations to the
DFO by 5 p.m. (e.s.t.), Thursday,
February 7, 2008, for consideration.
The number of oral presentations may
be limited by the time available. Oral
presentations should not exceed 5
minutes in length for an individual or
an organization.
The Chairperson may further limit the
time allowed for presentations due to
the number of oral presentations, if
necessary.
mstockstill on PROD1PC66 with NOTICES
V. Presenter and Presentation
Information
All presenters must submit Form
CMS–20017 (revised 01/07). Hardcopies
are required for oral presentations;
however, electronic submissions of
Form CMS–20017 are optional. The
DFO must receive the following
information from those wishing to make
oral presentations:
• Form CMS–20017 completed with
all pertinent information identified on
the first page of the presentation.
• One hardcopy of presentation.
VerDate Aug<31>2005
22:27 Dec 27, 2007
Jkt 214001
• Electronic copy of presentation.
• Personal registration information as
described in the Meeting Attendance
section below.
• Those persons wishing to submit
comments only must send hardcopy and
electronic versions of their comments,
but they are not required to submit
Form CMS–20017.
VI. Oral Comments
In addition to formal oral
presentations, there will be opportunity
during the meeting for public oral
comments, which will be limited to 1
minute for each individual and a total
of 3 minutes per organization.
VII. Meeting Attendance
The meeting is open to the public;
however, attendance is limited to space
available. Attendance will be
determined on a first-come, first-served
basis.
Persons wishing to attend this
meeting, which is located on Federal
property, must e-mail the Panel DFO to
register in advance no later than 5 p.m.
(e.s.t.), Wednesday, February 27, 2008.
A confirmation will be sent to the
requester(s) via return e-mail.
The following personal information
must be e-mailed to the DFO by the date
and time above:
• Name(s) of attendee(s),
• Title(s),
• Organization,
• E-mail address(es), and
• Telephone number(s).
VIII. Security, Building, and Parking
Guidelines
The following are the security,
building, and parking guidelines:
• Persons attending the meeting—
including presenters—must be
registered and on the attendance list by
the prescribed date.
• Individuals who are not registered
in advance will not be permitted to
enter the building and will be unable to
attend the meeting.
• Attendees must present
photographic identification to the
Federal Protective Service or Guard
Service personnel before entering the
building.
• Security measures include
inspection of vehicles, inside and out, at
the entrance to the grounds.
• In addition, all persons entering the
building must pass through a metal
detector.
• All items brought into CMS—
including personal items such as
desktops, cell phones, palm pilots—are
subject to physical inspection.
• The public may enter the building
30–45 minutes before the meeting
convenes each day.
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
73845
• All visitors must be escorted in
areas other than the lower and first-floor
levels in the Central Building.
• The main-entrance guards will
issue parking permits and instructions
upon arrival at the building.
IX. Special Accommodations
Individuals requiring sign-language
interpretation or other special
accommodations must send a request
for these services to the DFO by 5 p.m.
(e.s.t.), Wednesday, February 27, 2008.
Authority: Section 1833(t)(9) of the Act (42
U.S.C. 1395l(t)). The Panel is governed by the
provisions of Pub. L. 92–463, as amended (5
U.S.C. Appendix 2).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare-Hospital
Insurance; and Program No. 93.774,
Medicare-Supplementary Medical Insurance
Program).
Dated: November 20, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–24265 Filed 12–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1490–N]
Medicare Program; Town Hall Meeting
on the Fiscal Year 2009 Applications
for New Medical Services and
Technologies Add-on Payments Under
the Hospital Inpatient Prospective
Payment System, February 21, 2008
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: This notice announces a
Town Hall meeting in accordance with
section 503 of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (MMA) to discuss fiscal year
(FY) 2009 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 2009 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 Thursday, February 21, 2008
at 1:30 p.m., e.s.t. and check-in will
begin at 1 p.m. e.s.t.
E:\FR\FM\28DEN1.SGM
28DEN1
mstockstill on PROD1PC66 with NOTICES
73846
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
Deadline for Registration of Presenters
of the Town Hall Meeting: All presenters
for the Town Hall Meeting, whether
attending in person or by phone, must
register and submit their agenda item(s)
by February 7, 2008.
Deadline for Submission of Comments
on the Town Hall Meeting: Written
comments for discussion at the Town
Hall Meeting must be received by
February 7, 2008. All other written
comments on whether the service or
technology represents a substantial
clinical improvement must be received
by March 10, 2008 for consideration
before publication of the FY 2009 IPPS
proposed rule.
Deadline for Registration of All Other
Participants and Submitting Requests
for Special Accommodations: All other
participants must register by February
14, 2008. Requests for special
accommodations must be received no
later than 5 p.m., e.s.t. on February 14,
2008.
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, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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.
Registration information and special
accommodation requests may also be
mailed to the address listed in the
ADDRESSES section of this notice.
Submission of Agenda Item(s) or
Written Comments: Each presenter must
submit an agenda item(s) regarding
whether a FY 2009 application meets
the substantial clinical improvement
criterion. Agenda items or written
comments, questions, or other
statements must not exceed three singlespaced typed pages and must be sent to:
Division of Acute Care, New
Technology Team, Mailstop C4–07–08,
Centers for Medicare and Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850,
Attention: Tiffany Swygert or Michael
Treitel.
Agenda items or written comments
may also be sent via e-mail to
newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Tiffany Swygert, (410) 786–4642,
VerDate Aug<31>2005
22:27 Dec 27, 2007
Jkt 214001
tiffany.swygert@cms.hhs.gov, or Michael
Treitel, (410) 786–4552,
michael.treitel@cms.hhs.gov or you may
forward regular mail to the address
listed in the ADDRESSES section of this
notice.
SUPPLEMENTARY INFORMATION:
I. Background
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 inpatient 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)
required the Secretary to establish (after
notice and opportunity for public
comment) a mechanism to recognize the
costs of new services and technologies
under the inpatient hospital 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 FY 2002
proposed rule (66 FR 22693, May 4,
2001) and the 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 evaluate 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.
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
++ 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)
revised 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 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 2009. 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 2009
IPPS proposed rule.
II. Meeting Format
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
improvement. This meeting will allow
E:\FR\FM\28DEN1.SGM
28DEN1
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
for a discussion of the substantial
clinical improvement criteria on each of
the FY 2009 new medical services and
technology add-on payment
applications. Information regarding the
applications can be found on our Web
site at https://www.cms.hhs.gov/
AcuteInpatientPPS/
08_newtech.asp#TopOfPage.
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) to the address specified in the
ADDRESSES section of this notice by the
date specified in the DATES section of
this notice. Comments from participants
will be heard after scheduled statements
if time permits. Once the agenda is
completed, it will be posted on the CMS
IPPS Web site at https://
www.cms.hhs.gov/AcuteInpatientPPS/
08_newtech.asp#TopOfPage.
For presenters or participants unable
to attend the CMS for the meeting, an
open toll-free phone line, (888) 970–
4128, is available. Persons who call in
will be asked for the conference code by
the conference operator. The conference
code is ‘‘New Tech.’’
In addition, written comments will
also be accepted and presented at the
meeting if they are received at the
address specified in the ADDRESSES
section of this notice by the date
specified in the DATES section of this
notice. Written comments may also be
submitted after the meeting. If the
comments are to be considered before
the publication of the proposed rule, the
comments must be received at the
address specified in the ADDRESSES
section of this notice by the date
specified in the DATES section of this
notice.
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating the meeting registration for
the Town Hall Meeting. While there is
no registration fee, individuals must
register to attend the Town Hall
Meeting.
Registration may be completed online at the following Web address:
https://www.cms.hhs.gov/
AcuteInpatientPPS/
08_newtech.asp#TopOfPage. Select the
link at the bottom of the page ‘‘New
Technology Town Hall Meeting’’ to
VerDate Aug<31>2005
22:27 Dec 27, 2007
Jkt 214001
73847
complete the on-line registration. After
completing the registration, on-line
registrants should print the
confirmation page and bring it with
them to the meeting.
If you are unable to register on-line,
you may register by sending an email to
the contacts listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice. 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.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
IV. Security, Building, and Parking
Guidelines
Centers for Medicare & Medicaid
Services
Because this meeting will be located
on Federal property, for security
reasons, any persons wishing to attend
this meeting must register by close of
business by the date listed 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 1 p.m., e.s.t. so that you
will be able to arrive promptly at the
meeting by 1:30 p.m., e.s.t.
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, setup, 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. The public may not enter the
building earlier than 30 to 45 minutes prior
to the convening of the meeting.
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 Public Law 108–
173.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Dated: December 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare
and Medicaid Services.
[FR Doc. E7–24267 Filed 12–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Organization, Functions,
and Delegations of Authority
Part F of the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services (CMS), (Federal
Register, Vol. 72, No. 123, pp. 35246–
35247, dated Wednesday, June 27, 2007)
is amended to reflect the abolishment of
the 10 Regional Offices and the
establishment of the Consortium for
Medicare Health Plans Operations, the
Consortium for Financial Management
and Fee for Service Operations, the
Consortium for Medicaid and Children’s
Health Operations, and the Consortium
for Quality Improvement and Survey
and Certification Operations.
Part F is described below:
• Section F.10. (Organization) reads
as follows:
1. Office of External Affairs (FAC)
2. Center for Beneficiary Choices (FAE)
3. Office of Legislation (FAF)
4. Center for Medicare Management
(FAH)
5. Office of Equal Opportunity and Civil
Rights (FAJ)
6. Office of Research, Development, and
Information (FAK)
7. Office of Clinical Standards and
Quality (FAM)
8. Office of the Actuary (FAN)
9. Center for Medicaid and State
Operations (FAS)
10. Consortium for Medicare Health
Plans Operations (FAU)
11. Consortium for Financial
Management and Fee for Service
Operations (FAV)
12. Consortium for Medicaid and
Children’s Health Operations (FAW)
13. Consortium for Quality
Improvement and Survey and
Certification Operations (FAX)
14. Office of Operations Management
(FAY)
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Notices]
[Pages 73845-73847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1490-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2009
Applications for New Medical Services and Technologies Add-on Payments
Under the Hospital Inpatient Prospective Payment System, February 21,
2008
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a Town Hall meeting in accordance with
section 503 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) to discuss fiscal year (FY) 2009
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 2009 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 Thursday, February 21, 2008 at 1:30 p.m., e.s.t. and
check-in will begin at 1 p.m. e.s.t.
[[Page 73846]]
Deadline for Registration of Presenters of the Town Hall Meeting:
All presenters for the Town Hall Meeting, whether attending in person
or by phone, must register and submit their agenda item(s) by February
7, 2008.
Deadline for Submission of Comments on the Town Hall Meeting:
Written comments for discussion at the Town Hall Meeting must be
received by February 7, 2008. All other written comments on whether the
service or technology represents a substantial clinical improvement
must be received by March 10, 2008 for consideration before publication
of the FY 2009 IPPS proposed rule.
Deadline for Registration of All Other Participants and Submitting
Requests for Special Accommodations: All other participants must
register by February 14, 2008. Requests for special accommodations must
be received no later than 5 p.m., e.s.t. on February 14, 2008.
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, 7500 Security Boulevard, Baltimore, MD 21244-1850.
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. Registration information and special accommodation
requests may also be mailed to the address listed in the ADDRESSES
section of this notice.
Submission of Agenda Item(s) or Written Comments: Each presenter
must submit an agenda item(s) regarding whether a FY 2009 application
meets the substantial clinical improvement criterion. Agenda items or
written comments, questions, or other statements must not exceed three
single-spaced typed pages and must be sent to: Division of Acute Care,
New Technology Team, Mailstop C4-07-08, Centers for Medicare and
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850, Attention: Tiffany Swygert or Michael Treitel.
Agenda items or written comments may also be sent via e-mail to
newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Tiffany Swygert, (410) 786-4642,
tiffany.swygert@cms.hhs.gov, or Michael Treitel, (410) 786-4552,
michael.treitel@cms.hhs.gov or you may forward regular mail to the
address listed in the ADDRESSES section of this notice.
SUPPLEMENTARY INFORMATION:
I. Background
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 inpatient 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)
required the Secretary to establish (after notice and opportunity for
public comment) a mechanism to recognize the costs of new services and
technologies under the inpatient hospital 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 FY 2002 proposed rule (66 FR
22693, May 4, 2001) and the 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
evaluate 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) revised 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 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 2009. 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 2009 IPPS proposed rule.
II. Meeting Format
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
improvement. This meeting will allow
[[Page 73847]]
for a discussion of the substantial clinical improvement criteria on
each of the FY 2009 new medical services and technology add-on payment
applications. Information regarding the applications can be found on
our Web site at https://www.cms.hhs.gov/AcuteInpatientPPS/08_
newtech.asp#TopOfPage.
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) to the address specified in the ADDRESSES section of
this notice by the date specified in the DATES section of this notice.
Comments from participants will be heard after scheduled statements if
time permits. Once the agenda is completed, it will be posted on the
CMS IPPS Web site at https://www.cms.hhs.gov/AcuteInpatientPPS/08_
newtech.asp#TopOfPage.
For presenters or participants unable to attend the CMS for the
meeting, an open toll-free phone line, (888) 970-4128, is available.
Persons who call in will be asked for the conference code by the
conference operator. The conference code is ``New Tech.''
In addition, written comments will also be accepted and presented
at the meeting if they are received at the address specified in the
ADDRESSES section of this notice by the date specified in the DATES
section of this notice. Written comments may also be submitted after
the meeting. If the comments are to be considered before the
publication of the proposed rule, the comments must be received at the
address specified in the ADDRESSES section of this notice by the date
specified in the DATES section of this notice.
III. Registration Instructions
The Division of Acute Care in CMS is coordinating the meeting
registration for the Town Hall Meeting. While there is no registration
fee, individuals must register to attend the Town Hall Meeting.
Registration may be completed on-line at the following Web address:
https://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
Select the link at the bottom of the page ``New Technology Town Hall
Meeting'' to complete the on-line registration. After completing the
registration, on-line registrants should print the confirmation page
and bring it with them to the meeting.
If you are unable to register on-line, you may register by sending
an email to the contacts listed in the FOR FURTHER INFORMATION CONTACT
section of this notice. 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 this meeting must
register by close of business by the date listed 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 1 p.m., e.s.t. so that you will be able to arrive
promptly at the meeting by 1:30 p.m., e.s.t.
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. The public may not enter the building earlier than 30 to 45
minutes prior to the convening of the meeting.
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 Public Law 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: December 6, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E7-24267 Filed 12-27-07; 8:45 am]
BILLING CODE 4120-01-P
