Medicare Program; Town Hall Meeting on the Fiscal Year 2007 Applications for New Medical Services and Technologies Add-On Payments Under the Hospital Inpatient Prospective Payment System Scheduled for February 16, 2006, 76315-76317 [05-24022]
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Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
palm pilots, etc., are subject to physical
inspection.
Individuals who are not registered in
advance will not be permitted to enter
the building and will be unable to
attend the meeting. (Note: Presenters
must also be registered for attendance at
the meeting.) The public may enter the
building 30–45 minutes before when the
meeting convenes each day. (The
meeting convenes at the date and time
specified in the DATES section of this
notice.)
All visitors must be escorted in areas
other than the lower and first-floor
levels in the Central Building.
Parking permits and instructions are
issued upon arrival by the guards at the
main entrance.
IX. Special Accommodations
Individuals requiring sign-language
interpretation or other special
accommodations must send a request
for these services to the DFO by the date
and time specified in the DATES section
of this notice.
Authority: Section 1833(t)(9) of the Act (42
U.S.C. 13951(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 10, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–24290 Filed 12–22–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1329–N]
Medicare Program; Town Hall Meeting
on the Fiscal Year 2007 Applications
for New Medical Services and
Technologies Add-On Payments Under
the Hospital Inpatient Prospective
Payment System Scheduled for
February 16, 2006
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
wwhite on PROD1PC61 with NOTICES
AGENCY:
SUPPLEMENTARY INFORMATION:
This notice, in accordance
with section 1886(d)(5)(K)(viii) of the
Social Security Act (the Act), announces
a Town Hall meeting to discuss fiscal
year (FY) 2007 applications for add-on
payments for new medical services and
SUMMARY:
VerDate Aug<31>2005
16:55 Dec 22, 2005
Jkt 208001
technologies under the hospital
inpatient prospective payment system
(IPPS). Interested parties are invited to
this meeting to present their individual
comments, recommendations, and data
regarding whether the FY 2007 new
medical services and technologies
applications meet the substantial
clinical improvement criteria.
DATES: Meeting Date: The Town Hall
meeting announced in this notice will
be held on Thursday, February 16, 2006
at 9 a.m., and check-in will begin at 8:30
a.m. EST.
Registration Deadline for Presenters:
All presenters, whether attending in
person or by phone, must register and
submit their agenda item(s) by February
8, 2006.
Registration Deadline for All Other
Participants: All other participants must
register by February 13, 2006.
Comment Deadline: Written
comments for discussion at the meeting
must be received by February 8, 2006.
All other written comments for
consideration before publication of the
hospital IPPS proposed rule must be
received by March 15, 2006.
ADDRESSES: The Town Hall meeting will
be held in the Auditorium in the central
building of the Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
Agenda Item(s) or Written Comments:
Agenda items and written comments
regarding whether a FY 2007
application meets the substantial
clinical improvement criterion may be
sent by mail, fax, or electronically.
Agenda items must be received by
February 8, 2006. We will accept
written questions or other statements,
not to exceed three single-spaced, typed
pages that are received by March 15,
2006. Send written comments,
questions, or other statements to—
Division of Acute Care, Mail stop C4–
07–05, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Attention: Meredith Walz or Michael
Treitel.
Fax: (410) 786–0169.
Email: newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Meredith Walz, (410) 786–9421,
meredith.walz@cms.hhs.gov. Michael
Treitel, (410) 786–4552,
michael.treitel@cms.hhs.gov.
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
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
76315
payments 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 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 FY 2002
final rule (66 FR 46912, September 7,
2001) for a more detailed discussion.) In
addition, we have further discussed our
application of the newness criteria in
the hospital IPPS proposed and final
rules for FYs 2003, 2004, 2005, and
2006. (See 67 FR 31427, May 9, 2002;
67 FR 50009, August 1, 2002; 68 FR
27184, May 19, 2003; 68 FR 45385,
August 1, 2003; 69 FR 28236, May 18,
2004; 69 FR 49000, August 11, 2004; 70
FR 23353, May 5, 2005; and 70 FR
47341, August 12, 2005 respectively).
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).
E:\FR\FM\23DEN1.SGM
23DEN1
76316
Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
wwhite on PROD1PC61 with NOTICES
++ 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), Pub.
L. 108–173, which added section
1886(d)(5)(K)(viii) to the Act, revised
the process for evaluating new medical
services and technology applications by
requiring the Secretary to do the
following:
• Before publication of a proposed
rule, 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.
• Make public and periodically
update a list of all the services and
technologies for which an application is
pending.
• Accept individual comments,
recommendations, and data from the
public regarding whether the service or
technology represents a substantial
improvement.
• Before publication of a proposed
rule, 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.
The opinions and alternatives
provided during this meeting will assist
us as we evaluate the new medical
services and technology applications for
FY 2007. In addition, they will help us
to evaluate our policy on the hospital
IPPS new technology add-on payment
process before the publication of the FY
2007 hospital IPPS proposed rule.
II. Meeting Format
This meeting will allow for a
discussion of the substantial clinical
improvement criteria to each of the FY
2007 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/
providers/hipps/newtech.asp. In
addition, we are interested in individual
public comments on our application of
the concept of ‘‘substantial similarity’’.
See the FY 2006 final rule (70 FR
47350–47352, August 12, 2005), for a
VerDate Aug<31>2005
16:55 Dec 22, 2005
Jkt 208001
detailed discussion of this issue.
Although we do not expect to have a
general discussion of this topic during
the timeframe of the town hall meeting,
we are inviting individual comments as
part of this town hall meeting notice.
We will accept comments on our
application of the concept of
‘‘substantially similar’’ by the deadline
stated above so they may be considered
in our proposed rule. We will also
solicit comments during the rulemaking
process.
The majority of the meeting will be
reserved for individual 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 want to be presenters
must register and submit their agenda
item(s) by Wednesday, February 8,
2006. Once the agenda is completed, it
will be posted on the hospital IPPS Web
site at https://www.cms.hhs.gov/
providers/hipps/newtech.asp.
Comments from participants will be
heard (time permitting) after the
completion of the presentations.
For presenters or participants who
cannot come to CMS for the meeting, an
open toll-free phone line, (877) 357–
7851, has been made available. If you
are calling in, you will be prompted to
enter the conference identification
number, 9386196, or the name of the
meeting. In addition, written comments
will also be accepted and presented at
the meeting if they are received by
February 8, 2006. 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 by
March 15, 2006.
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating the meeting registration.
While there is no registration fee,
individuals must register to attend.
Individuals may present their comments
either in person or by phone at the town
hall meeting. These individuals must
register and submit their agenda item(s)
by February 8, 2006. All other
participants must register by February
13, 2006. All registrants will receive
confirmation with instructions for
arrival at the CMS complex (persons
who register on-line will receive this
confirmation upon completion of the
registration process and should print the
confirmation and bring it with them to
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
the meeting). Because of limited
meeting space and our desire to
maintain an accurate count of
registrants who plan to come to CMS,
we prefer that these persons register online. In addition, we would prefer that
registrants who plan to participate by
phone register by phone or fax.
On-line Registration: Registration may
be completed on-line at the following
Web address: https://www.cms.hhs.gov/
events/default.asp. Select the link
‘‘Register to Attend the New Technology
Town Hall Meeting’’ and then select
‘‘New Technology Town Hall Meeting’’
from the drop down menu and follow
the instructions. After completing the
registration, on-line registrants should
print the confirmation page and bring it
with them to the meeting.
Registration by Phone or Fax:
Registration may be completed by
contacting Meredith Walz at (410) 786–
9421 or Michael Treitel at (410) 786–
4552. Registration may also be
completed by fax to the attention of
Meredith Walz or Michael Treitel at
(410) 786–0169. If registration is
completed by phone or fax, please
provide your name, address, telephone
number, and, if available, e-mail address
and fax number.
IV. Security Information
Since this meeting will be held in a
Federal government building, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. In order to gain access to
the building and grounds, participants
must bring a government-issued photo
identification and a copy of their
confirmation of registration for the
meeting. Access may be denied to
persons without proper identification.
For security reasons, no additional
meeting registrations will be accepted
after the close of the registration period.
Security measures also 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 to CMS, whether personal or for
the purpose of demonstration or to
support a presentation, are subject to
inspection. Laptops and other computer
equipment must be registered with the
security desk upon entry. CMS 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
presentation. Participants should e-mail
presentations to CMS staff listed above
prior to the meeting to ensure that CMS
has a back-up copy in the event of
E:\FR\FM\23DEN1.SGM
23DEN1
Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
computer problems or lack of software
or memory card compatibility. Please
note that CMS headquarters is a smokefree facility.
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 1, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–24022 Filed 12–22–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4112–N]
Medicare Program; Meeting of the
Advisory Panel on Medicare
Education, January 26, 2006
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
wwhite on PROD1PC61 with NOTICES
AGENCY:
SUMMARY: In accordance with the
Federal Advisory Committee Act, 5
U.S.C. Appendix 2, section 10(a) (Pub.
L. 92–463), this notice announces a
meeting of the Advisory Panel on
Medicare Education (the Panel) on
January 26, 2006. 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
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Medicare
program. This meeting is open to the
public.
DATES: The meeting is scheduled for
January 26, 2006 from 9 a.m. to 3:30
p.m., e.s.t.
Deadline for Presentations and
Comments: January 19, 2006, 12 noon,
e.s.t.
ADDRESSES: The meeting will be held at
the Wyndham City Center, 1143 New
Hampshire Avenue, NW., Washington,
DC 20036, (202) 775–0800.
FOR FURTHER INFORMATION CONTACT:
Lynne Johnson, Health Insurance
Specialist, Division of Partnership
Development, Center for Beneficiary
Choices, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail stop S2–23–05,
Baltimore, MD 21244–1850, (410) 786–
VerDate Aug<31>2005
16:55 Dec 22, 2005
Jkt 208001
0090. Please refer to the CMS Advisory
Committees’ Information Line (1–877–
449–5659 toll free)/(410–786–9379
local) or the Internet (https://
www.cms.hhs.gov/faca/apme/
default.asp) for additional information
and updates on committee activities, or
contact Ms. Johnson via e-mail at
Lynne.Johnson@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
SUPPLEMENTARY INFORMATION: Section
222 of the Public Health Service Act (42
U.S.C. 217a), as amended, grants to the
Secretary of Health and Human Services
(the Secretary) the authority to establish
an advisory panel for the purpose of
advising the Secretary in connection
with any of his functions. The Secretary
signed the charter establishing this
Panel on January 21, 1999 (64 FR 7849)
and approved the renewal of the charter
on January 14, 2005. The Panel advises
and makes recommendations to the
Secretary and the Administrator of the
Centers for Medicare & Medicaid
Services (CMS) on opportunities to
enhance the effectiveness of consumer
education strategies concerning the
Medicare program.
The goals of the Panel are as follows:
• To develop and implement a
national Medicare education program
that describes the options for selecting
a health plan under Medicare.
• To enhance the Federal
government’s effectiveness in informing
the Medicare consumer, including the
appropriate use of public-private
partnerships.
• To expand outreach to vulnerable
and underserved communities,
including racial and ethnic minorities,
in the context of a national Medicare
education program.
• To assemble an information base of
best practices for helping consumers
evaluate health plan options and build
a community infrastructure for
information, counseling, and assistance.
The current members of the Panel are:
Dr. Drew E. Altman, President and Chief
Executive Officer, Henry J. Kaiser
Family Foundation; Dr. Jane Delgado,
Chief Executive Officer, National
Alliance for Hispanic Health; Clayton
Fong, President and Chief Executive
Officer, National Asian Pacific Center
on Aging; Thomas Hall, Chairman and
Chief Executive Officer, Cardio-Kinetics,
Inc.; The Honorable Bobby Jindal,
United States Congress; David Knutson,
Director, Health System Studies, Park
Nicollet Institute for Research and
Education; Dr. David Lansky, Director,
Health Program, Markle Foundation; Dr.
Frank I. Luntz, President and Chief
Executive Officer, Luntz Research
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
76317
Companies; Dr. Daniel Lyons, Senior
Vice President, Government Programs,
Independence Blue Cross; Dr. Frank B.
McArdle, Manager, Hewitt Research
Office, Hewitt Associates, Katherine
Metzger, Director, Medicare and
Medicaid Programs, Fallon Community
Health Plan; Dr. Keith Mueller,
Professor and Section Head, Health
Services Research and Rural Health
Policy, University of Nebraska; Lee
Partridge, Senior Health Policy Advisor,
National Partnership for Women and
Families; Dr. Marlon Priest, Professor of
Emergency Medicine, University of
Alabama at Birmingham; Susan O.
Raetzman, Associate Director, Public
Policy Institute, AARP; Rebecca Snead,
Administrative Manager, National
Council of State Pharmacy Association
Executives; Catherine Valenti,
Chairperson and Chief Executive
Officer, Caring Voice Coalition, and
Grant Wedner, Manager, Business
Development Team, Cosmix
Corporation.
The agenda for the January 26, 2006
meeting will include the following:
• Recap of the previous (September
27, 2005) meeting.
• Centers for Medicare & Medicaid
Services update.
• Medicare Prescription Drug,
Improvement and Modernization Act of
2003 (Pub. L. 108–173): outreach and
education strategies.
• Public comment.
• Listening session with CMS
leadership.
• Next steps.
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to Lynne
Johnson, Health Insurance Specialist,
Division of Partnership Development,
Center for Beneficiary Choices, Centers
for Medicare & Medicaid Services, 7500
Security Boulevard, Mail stop S2–23–
05, Baltimore, MD 21244–1850 or by email at Lynne.Johnson@cms.hhs.gov, no
later than 12 noon, e.s.t., January 19,
2006. The number of oral presentations
may be limited by the time available.
Individuals not wishing to make a
presentation may submit written
comments to Ms. Johnson by 12 noon,
(e.s.t.), January 19, 2006. The meeting is
open to the public, but attendance is
limited to the space available.
Special Accommodation: Individuals
requiring sign language interpretation or
other special accommodations should
contact Ms. Johnson at least 15 days
before the meeting.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)
and 41 CFR 102–3).
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76315-76317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1329-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2007
Applications for New Medical Services and Technologies Add-On Payments
Under the Hospital Inpatient Prospective Payment System Scheduled for
February 16, 2006
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with section 1886(d)(5)(K)(viii) of
the Social Security Act (the Act), announces a Town Hall meeting to
discuss fiscal year (FY) 2007 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 individual comments, recommendations, and
data regarding whether the FY 2007 new medical services and
technologies applications meet the substantial clinical improvement
criteria.
DATES: Meeting Date: The Town Hall meeting announced in this notice
will be held on Thursday, February 16, 2006 at 9 a.m., and check-in
will begin at 8:30 a.m. EST.
Registration Deadline for Presenters: All presenters, whether
attending in person or by phone, must register and submit their agenda
item(s) by February 8, 2006.
Registration Deadline for All Other Participants: All other
participants must register by February 13, 2006.
Comment Deadline: Written comments for discussion at the meeting
must be received by February 8, 2006. All other written comments for
consideration before publication of the hospital IPPS proposed rule
must be received by March 15, 2006.
ADDRESSES: The Town Hall meeting will be held in the Auditorium in the
central building of the Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244-1850.
Agenda Item(s) or Written Comments: Agenda items and written
comments regarding whether a FY 2007 application meets the substantial
clinical improvement criterion may be sent by mail, fax, or
electronically. Agenda items must be received by February 8, 2006. We
will accept written questions or other statements, not to exceed three
single-spaced, typed pages that are received by March 15, 2006. Send
written comments, questions, or other statements to--
Division of Acute Care, Mail stop C4-07-05, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850. Attention: Meredith Walz or Michael Treitel.
Fax: (410) 786-0169.
Email: newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Meredith Walz, (410) 786-9421,
meredith.walz@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)
require the Secretary to establish a process of identifying and
ensuring adequate payments 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 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 FY 2002 final rule (66 FR 46912, September 7, 2001) for a more
detailed discussion.) In addition, we have further discussed our
application of the newness criteria in the hospital IPPS proposed and
final rules for FYs 2003, 2004, 2005, and 2006. (See 67 FR 31427, May
9, 2002; 67 FR 50009, August 1, 2002; 68 FR 27184, May 19, 2003; 68 FR
45385, August 1, 2003; 69 FR 28236, May 18, 2004; 69 FR 49000, August
11, 2004; 70 FR 23353, May 5, 2005; and 70 FR 47341, August 12, 2005
respectively).
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).
[[Page 76316]]
++ 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), Pub. L. 108-173, which added section
1886(d)(5)(K)(viii) to the Act, revised the process for evaluating new
medical services and technology applications by requiring the Secretary
to do the following:
Before publication of a proposed rule, 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.
Make public and periodically update a list of all the
services and technologies for which an application is pending.
Accept individual comments, recommendations, and data from
the public regarding whether the service or technology represents a
substantial improvement.
Before publication of a proposed rule, 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.
The opinions and alternatives provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2007. In addition, they will help us to evaluate
our policy on the hospital IPPS new technology add-on payment process
before the publication of the FY 2007 hospital IPPS proposed rule.
II. Meeting Format
This meeting will allow for a discussion of the substantial
clinical improvement criteria to each of the FY 2007 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/providers/hipps/newtech.asp. In addition, we are
interested in individual public comments on our application of the
concept of ``substantial similarity''. See the FY 2006 final rule (70
FR 47350-47352, August 12, 2005), for a detailed discussion of this
issue. Although we do not expect to have a general discussion of this
topic during the timeframe of the town hall meeting, we are inviting
individual comments as part of this town hall meeting notice. We will
accept comments on our application of the concept of ``substantially
similar'' by the deadline stated above so they may be considered in our
proposed rule. We will also solicit comments during the rulemaking
process.
The majority of the meeting will be reserved for individual
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 want to be presenters must register and submit their
agenda item(s) by Wednesday, February 8, 2006. Once the agenda is
completed, it will be posted on the hospital IPPS Web site at https://
www.cms.hhs.gov/providers/hipps/newtech.asp. Comments from participants
will be heard (time permitting) after the completion of the
presentations.
For presenters or participants who cannot come to CMS for the
meeting, an open toll-free phone line, (877) 357-7851, has been made
available. If you are calling in, you will be prompted to enter the
conference identification number, 9386196, or the name of the meeting.
In addition, written comments will also be accepted and presented at
the meeting if they are received by February 8, 2006. 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 by March 15, 2006.
III. Registration Instructions
The Division of Acute Care in CMS is coordinating the meeting
registration. While there is no registration fee, individuals must
register to attend. Individuals may present their comments either in
person or by phone at the town hall meeting. These individuals must
register and submit their agenda item(s) by February 8, 2006. All other
participants must register by February 13, 2006. All registrants will
receive confirmation with instructions for arrival at the CMS complex
(persons who register on-line will receive this confirmation upon
completion of the registration process and should print the
confirmation and bring it with them to the meeting). Because of limited
meeting space and our desire to maintain an accurate count of
registrants who plan to come to CMS, we prefer that these persons
register on-line. In addition, we would prefer that registrants who
plan to participate by phone register by phone or fax.
On-line Registration: Registration may be completed on-line at the
following Web address: https://www.cms.hhs.gov/events/default.asp.
Select the link ``Register to Attend the New Technology Town Hall
Meeting'' and then select ``New Technology Town Hall Meeting'' from the
drop down menu and follow the instructions. After completing the
registration, on-line registrants should print the confirmation page
and bring it with them to the meeting.
Registration by Phone or Fax: Registration may be completed by
contacting Meredith Walz at (410) 786-9421 or Michael Treitel at (410)
786-4552. Registration may also be completed by fax to the attention of
Meredith Walz or Michael Treitel at (410) 786-0169. If registration is
completed by phone or fax, please provide your name, address, telephone
number, and, if available, e-mail address and fax number.
IV. Security Information
Since this meeting will be held in a Federal government building,
Federal security measures are applicable. In planning your arrival
time, we recommend allowing additional time to clear security. In order
to gain access to the building and grounds, participants must bring a
government-issued photo identification and a copy of their confirmation
of registration for the meeting. Access may be denied to persons
without proper identification. For security reasons, no additional
meeting registrations will be accepted after the close of the
registration period.
Security measures also 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 to
CMS, whether personal or for the purpose of demonstration or to support
a presentation, are subject to inspection. Laptops and other computer
equipment must be registered with the security desk upon entry. CMS
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
presentation. Participants should e-mail presentations to CMS staff
listed above prior to the meeting to ensure that CMS has a back-up copy
in the event of
[[Page 76317]]
computer problems or lack of software or memory card compatibility.
Please note that CMS headquarters is a smoke-free facility.
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 1, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-24022 Filed 12-22-05; 8:45 am]
BILLING CODE 4120-01-P
