Medicare Program; Town Hall Meeting on the Fiscal Year 2010 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment Systems, February 17, 2009, 72490-72492 [E8-28180]
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Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Notices
view represented and the functions to
be performed. The Panel shall consist of
up to 15 members who are
representatives of providers.
Each Panel member must be
employed full-time by a hospital,
hospital system, or other Medicare
provider subject to payment under the
OPPS. The Secretary or Administrator
selects the Panel membership based
upon either self-nominations or
nominations submitted by Medicare
providers and other interested
organizations.
All members must have technical
expertise to enable them to participate
fully in the Panel’s work. Such expertise
encompasses hospital payment systems;
hospital medical care delivery systems;
provider billing systems; APC groups;
Current Procedural Terminology codes;
and alpha-numeric Health Care
Common Procedure Coding System
codes; and the use of, and payment for,
drugs, medical devices, and other
services in the outpatient setting, as
well as other forms of relevant expertise.
All members shall have a minimum of
5 years experience in their area(s) of
expertise, but it is not necessary that
any member be an expert in all of the
areas listed above. For purposes of this
Panel, consultants or independent
contractors are not considered to be
representatives of providers. Panel
members may serve for up to 4-year
terms. A member may serve after the
expiration of his/her term until a
successor has been sworn in. All terms
are contingent upon the renewal of the
Panel by appropriate action prior to its
termination.
A Federal official shall serve as the
Chair and shall facilitate the Panel
meetings. The Secretary or designee
shall select a Chair for the Panel. The
Chair’s term shall usually be for a
period of 4 years, but it may be
extended at the discretion of the
Administrator or his/her duly appointed
designee.
In order to conduct the business of the
Panel, a quorum is required. A quorum
exists when a majority of currently
appointed members is present at full
Panel or subcommittee meetings or is
participating in conference calls.
As necessary, standing and ad hoc
subcommittees, composed of members
from the parent Panel, may be
established to perform functions within
the Panel’s jurisdiction with the
approval of the Secretary or his/her
designee.
The FACA provides that each agency
sponsoring a Federal advisory
committee must appoint a Department
Committee Management Officer
(DCMO). The FACA also provides that
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a Designated Federal Official (DFO) be
appointed to the Panel. The DFO
maintains required records on costs and
membership; ensures efficient
operations; maintains records for
availability to the public; provides
copies of all reports to the DCMO who
shall, in turn, forward them to the
Library of Congress; notifies the DCMO
when standing subcommittees are
established, including the
subcommittee’s name, membership,
function, and estimated frequency of
meetings; and provides management
support services for the Panel and its
standing and ad hoc subcommittees.
Meetings
Meetings shall be held up to three
times a year at the call of the DFO. The
agenda, which sets the boundaries for
discussion, is developed by CMS and
approved by the DFO. The agenda,
which sets the boundaries for
discussion, is developed by CMS and
approved by the DFO. Meetings shall be
open to the public, except as
determined otherwise by the Secretary
or other official to whom the authority
has been delegated in accordance with
the Government in the Sunshine Act (5
U.S.C. 552b(c)). Adequate advance
notice of all meetings shall be published
in the Federal Register, as required by
applicable laws and Departmental
regulations, stating reasonably
accessible and convenient locations and
times.
Compensation
All members shall serve on a
voluntary basis, without compensation,
pursuant to advance written agreement.
Members of the Panel shall be entitled
to receive reimbursement for travel
expenses and per diem in lieu of
subsistence, in accordance with
Standard Government Travel
Regulations.
Annual Cost Estimate
Estimated FY 2009 annual cost for
operating the Panel, including travel
expenses for members but excluding
staff support, is $69,110. The estimated
annual person-years of staff support
required for the APC Panel is 1.0 FTE
at an estimated annual cost of $94,025.
Reports
In the event that a portion of a
meeting is closed to the public, as
determined by the Secretary, in
accordance with the Government in the
Sunshine Act (5 U.S.C. 552b(c)) and
FACA, a report shall be prepared that
shall contain, at a minimum, the
following: a list of members and their
business addresses, the Panel’s or
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Fmt 4703
Sfmt 4703
subcommittee’s function, dates and
places of meeting(s), and a summary of
the Panel’s/subcommittee’s activities
and recommendations made during that
meeting. Reports shall also be prepared
after all open-to-the-public Panel
meetings and any subcommittee
meetings and submitted to the DCMO.
Termination Date
Unless renewed by appropriate action
prior to its expiration, the APC Panel
shall terminate on November 21, 2010.
II. Provisions of This Notice
This notice announces that the
Secretary signed the APC Panel charter
renewal on October 30, 2008.
III. Copies of the Charter
You may obtain a copy of the APC
Panel’s charter by submitting a request
to the DFO at the street or e-mail
addresses listed above or by calling her
at 410–786–4474.
IV. Collection of Information
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Authority: Section 1833(t)(9)(A) of the Act
(42 U.S.C. 1395l(t)(9)(A)). The Advisory
Panel on APC Groups (the Panel) is governed
by the provisions of Pub. L. 92–463, the
Federal Advisory Committee Act (FACA), as
amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of
advisory panels.
Dated: November 13, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–28179 Filed 11–26–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1537–N]
Medicare Program; Town Hall Meeting
on the Fiscal Year 2010 Applications
for New Medical Services and
Technologies Add-on Payments Under
the Hospital Inpatient Prospective
Payment Systems, February 17, 2009
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
E:\FR\FM\28NON1.SGM
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mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Notices
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) 2010 applications for add-on
payments for new medical services and
technologies under the hospital
inpatient prospective payment systems.
Interested parties are invited to this
meeting to present their comments,
recommendations, and data regarding
whether the FY 2010 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
DATES: Meeting Date: The Town Hall
meeting will be held on Tuesday,
February 17, 2009 at 1:30 p.m., e.s.t. and
check-in will begin at 1 p.m. e.s.t.
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 3, 2009.
Deadline for Submission of Comments
on the Town Hall Meeting: Written
comments for discussion at the Town
Hall meeting must be received by
February 3, 2009. All other written
comments on whether the service or
technology represents a substantial
clinical improvement must be received
by March 9, 2009 for consideration
before publication of the FY 2010
inpatient prospective payment systems
proposed rule.
Deadline for Registration of All Other
Participants and Submitting Requests
for Special Accommodations: All other
participants must register by February
10, 2009. Requests for special
accommodations must be received no
later than 5 p.m., e.s.t. on February 10,
2009.
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 for
submission of agenda item(s) or written
VerDate Aug<31>2005
17:16 Nov 26, 2008
Jkt 217001
comments 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 2010 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 via
e-mail to newtech@cms.hhs.gov or sent
via regular mail to the following
address: 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.
FOR FURTHER INFORMATION CONTACT:
Tiffany Swygert, (410) 786–4642,
tiffany.swygert@cms.hhs.gov.
Michael Treitel, (410) 786–4552,
michael.treitel@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1886(d)(5)(K) and (L) of the
Social Security Act (the Act) requires
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)
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 inpatient
hospital prospective payment systems
(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
PO 00000
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Fmt 4703
Sfmt 4703
72491
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 whether the
service or technology represents a
substantial improvement before
publication of a proposed rule.
E:\FR\FM\28NON1.SGM
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72492
Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
The opinions and alternatives
provided during this meeting will assist
us as we evaluate the new medical
services and technology applications for
FY 2010. 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 2010
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
for a discussion of the substantial
clinical improvement criteria on each of
the FY 2010 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 come to CMS for the meeting, an
open toll-free phone line, (800) 619–
2459, 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 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 for CMS consideration. If
the comments are to be considered
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17:16 Nov 26, 2008
Jkt 217001
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
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 e-mail
to the contacts listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice. Please include your name,
address, telephone number, e-mail
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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 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: November 13, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
and Medicaid Services.
[FR Doc. E8–28180 Filed 11–26–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7012–N]
Medicare Program; Announcement of
Meeting of the Advisory Panel on
Medicare Education, January 13, 2009
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, this
notice announces a meeting of Advisory
Panel on Medicare Education (the
Panel). The Panel advises and makes
recommendations to the Secretary of
Health and Human Services and the
Administrator of the Centers for
Medicare & Medicaid Services on the
effectiveness of consumer education
strategies concerning the Medicare
program. This meeting is open to the
public.
Meeting Date: January 13, 2009
from 8:30 a.m. to 3 p.m., e.s.t.
Deadline for Meeting Registration,
Presentations and Comments: January 5,
2009, 12 noon, e.s.t.
DATES:
E:\FR\FM\28NON1.SGM
28NON1
Agencies
[Federal Register Volume 73, Number 230 (Friday, November 28, 2008)]
[Notices]
[Pages 72490-72492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1537-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2010
Applications for New Medical Services and Technologies Add-on Payments
Under the Hospital Inpatient Prospective Payment Systems, February 17,
2009
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
[[Page 72491]]
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) 2010 applications for add-on payments for new
medical services and technologies under the hospital inpatient
prospective payment systems. Interested parties are invited to this
meeting to present their comments, recommendations, and data regarding
whether the FY 2010 new medical services and technologies applications
meet the substantial clinical improvement criterion.
DATES: Meeting Date: The Town Hall meeting will be held on Tuesday,
February 17, 2009 at 1:30 p.m., e.s.t. and check-in will begin at 1
p.m. e.s.t.
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
3, 2009.
Deadline for Submission of Comments on the Town Hall Meeting:
Written comments for discussion at the Town Hall meeting must be
received by February 3, 2009. All other written comments on whether the
service or technology represents a substantial clinical improvement
must be received by March 9, 2009 for consideration before publication
of the FY 2010 inpatient prospective payment systems proposed rule.
Deadline for Registration of All Other Participants and Submitting
Requests for Special Accommodations: All other participants must
register by February 10, 2009. Requests for special accommodations must
be received no later than 5 p.m., e.s.t. on February 10, 2009.
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 for submission of
agenda item(s) or written comments 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 2010 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 via e-mail to
newtech@cms.hhs.gov or sent via regular mail to the following address:
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.
FOR FURTHER INFORMATION CONTACT:
Tiffany Swygert, (410) 786-4642, tiffany.swygert@cms.hhs.gov.
Michael Treitel, (410) 786-4552, michael.treitel@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act)
requires 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) 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 inpatient hospital prospective payment
systems (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) 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 whether the service or technology represents a substantial
improvement before publication of a proposed rule.
[[Page 72492]]
The opinions and alternatives provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2010. 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 2010 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 for a discussion of the
substantial clinical improvement criteria on each of the FY 2010 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 come to CMS for the
meeting, an open toll-free phone line, (800) 619-2459, 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 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
for CMS consideration. 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 e-mail to the contacts listed in the FOR FURTHER INFORMATION CONTACT
section of this notice. Please include your name, address, telephone
number, e-mail 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 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: November 13, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E8-28180 Filed 11-26-08; 8:45 am]
BILLING CODE 4120-01-P