Medicare Program; Town Hall Meeting on the Fiscal Year 2011 Applications for New Medical Services and Technologies Add-on Payments and Informational Workshop on the Application Process and Criteria for New Medical Services and Technologies Add-on Payments, 62339-62342 [E9-27971]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Centers for Medicare & Medicaid
Services
Center for Scientific Review; Notice of
Closed Meetings
[CMS–1513–N]
sroberts on DSKD5P82C1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Tumor
Biomarkers.
Date: December 15, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Malaya Chatterjee, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, 301–451–
0131, chatterm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cell Biology.
Date: December 15, 2009.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jonathan Arias, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, 301–435–
2406, ariasj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 20, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–28396 Filed 11–25–09; 8:45 am]
BILLING CODE 4140–01–P
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
Medicare Program; Town Hall Meeting
on the Fiscal Year 2011 Applications
for New Medical Services and
Technologies Add-on Payments and
Informational Workshop on the
Application Process and Criteria for
New Medical Services and
Technologies Add-on Payments
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
SUMMARY: This notice announces a
Town Hall meeting to discuss fiscal year
(FY) 2011 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 2011 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
Additionally, this notice announces
an Informational Workshop for all
interested parties on the application
process and criteria for new medical
services and technologies under the
IPPS and on the outpatient prospective
payment system (OPPS) transitional
pass-through payment for drugs,
biologicals, and devices and new
technology Ambulatory Payment
Classification (APC) assignment for new
services application processes.
DATES: Meeting Date: The Town Hall
meeting and the Informational
Workshop announced in this notice will
be held on Wednesday, February 10,
2010. The Informational Workshop will
begin at 9 a.m., and check-in will begin
at 8:30 a.m. eastern daylight time
(e.d.t.). The Town Hall meeting will
begin at 1 p.m. e.d.t. and check-in will
begin at 12:30 p.m. e.d.t. Only one
check-in is required to enter the
building. Participants attending the
Informational Workshop will be able to
attend the Town Hall meeting without
an additional check-in unless they exit
the building. In this case, a participant
will need to repeat the security
procedures and check-in.
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 January 26, 2010.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
62339
Deadline for Registration of All Other
Participants for the Town Hall Meeting,
Participants of the Informational
Workshop, and Submitting Requests for
Special Accommodations: All other
participants for the Town Hall Meeting
and participants of the Informational
Workshop must register by February 2,
2010. Requests for special
accommodations must be received no
later than 5 p.m., e.d.t. on February 2,
2010.
ADDRESSES: Meeting Location: The
Town Hall meeting and Informational
Workshop will both be held in the main
Auditorium in the central building of
the Centers for Medicare & 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 for the Town Hall
Meeting: 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 to: Division of Acute Care,
New Technology Team, Mailstop C4–
07–08, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850,
Attention: Michael Treitel.
Agenda items or written comments
may also be sent via e-mail to
newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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 to acute care hospitals for
new medical services and technologies
under Medicare. Effective for discharges
beginning on or after October 1, 2001,
section 1886(d)(5)(K)(i) of the Act
E:\FR\FM\27NON1.SGM
27NON1
sroberts on DSKD5P82C1PROD with NOTICES
62340
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
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 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). (For a more
detailed discussion, see the FY 2002
proposed and final rules (66 FR 22693,
May 4, 2001) and the final rule (66 FR
46912, September 7, 2001) 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).
++ 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)
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
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 our clinical staff as to whether the
service or technology represents a
substantial improvement before
publication of a proposed rule.
The opinions and alternatives
provided during this meeting will assist
us as we evaluate the new medical
services and technology applications for
FY 2011. 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 2011
IPPS proposed rule.
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, (800) 603–
1774, 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 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.
II. Town Hall Meeting and
Informational Workshop Format
B. Informational Workshop Format
In addition, to the statutorily-required
Town Hall meeting on whether an IPPS
new technology application meets the
substantial clinical improvement
criteria we will be holding an
Informational Workshop on applying for
special payment for new medical
services and technologies under the
IPPS and OPPS. Specifically, for new
technology add-on payments under the
IPPS, we will discuss each criterion in
detail along with other information that
will be helpful in guiding an applicant
through the new technology add-on
payment process. We will also discuss
the processes of DRG assignment and
requesting new ICD–9 codes under the
IPPS. (Information on DRGs can be
found on the IPPS Web site at https://
www.cms.hhs.gov/AcuteInpatientPPS/
01_overview.asp#TopOfPage and
information on ICD–9–CM coding can
be found on our Web site at (https://
www.cms.hhs.gov/ICD9Provider
DiagnosticCodes/)
To facilitate the public’s knowledge of
OPPS application processes for
transitional pass-through status of
A. Town Hall 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 will allow for a
discussion of the substantial clinical
improvement criteria as it relates to
each of the FY 2011 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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
E:\FR\FM\27NON1.SGM
27NON1
sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
drugs, biologicals and devices and
assignment of new services to New
Technology Ambulatory Payment
Classification (APCs), the Informational
Workshop will also include information
on several processes for applying for
special payment under the OPPS. One
topic concerns the process for applying
for a new category of devices for passthrough payment and criteria for
evaluation. Interested parties may apply
for a new device category, in accordance
with section 1833(t)(6) of the Act. As
background information, we have
posted application and process
background information on our Web site
at https://www.cms.hhs.gov/Hospital
OutpatientPPS/04_passthrough_
payment.asp#TopOfPage.
Furthermore, under section 1833(t)(6)
of the Act interested parties may also
apply for transitional pass-through
payment for certain new drugs,
biological or radiopharmaceutical
agents. As background information, we
have posted application and process
background information on our Web
site, https://www.cms.hhs.gov/Hospital
OutpatientPPS/04_passthrough_
payment.asp#TopOfPage. Finally, we
provide the opportunity for the public
to apply for new services to be placed
in New Technology APC groups in the
OPPS, in accordance with our criteria
and discussion in our November 30,
2001 final rule (66 FR 59897). As
background information, we have
posted application and process
background information on our Web
site, https://www.cms.hhs.gov/Hospital
OutpatientPPS/04_passthrough_
payment.asp#TopOfPage. We plan to
discuss all three of these OPPS
application processes at the
Informational Workshop that will be
held on February 10, 2010.
The Informational Workshop is open
to all interested parties including
organizations representing hospitals,
physicians, and manufacturers. We
encourage all interested parties to
attend, especially those who are not
familiar with these processes.
Individuals who want to attend this
Informational Workshop must register
by the date specified in the DATES
section of this notice. Registration
information is available in section III. of
this notice.
For participants who cannot come to
CMS for the meeting, an open toll-free
phone line, (800) 603–1774, has been
made available. If you are calling in, the
operator will ask you for the conference
code. The conference code is ‘‘New
Tech.’’
As noted in section I. of this notice,
we are required to provide for a meeting
at which organizations representing
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
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 will allow for a
discussion of the substantial clinical
improvement criteria on each of the FY
2011 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/Acute
InpatientPPS/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, (800) 603–
1774, 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 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.
For participants who cannot come to
CMS for the meeting, an open toll-free
phone line, (800) 603–1774, has been
made available. If you are calling in, the
operator will ask you for the conference
code. The conference code is ‘‘New
Tech.’’
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
62341
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating registration for both the
Town Hall meeting and the
Informational Workshop. While there is
no registration fee, individuals must
register to attend the Town Hall meeting
on substantial clinical improvement and
for the Informational Workshop (two
separate registrations).
Registration may be completed online at the following web address:
https://www.cms.hhs.gov/
AcuteInpatientPPS/
08_newtech.asp#TopOfPage. Select the
links at the bottom of the page ‘‘Register
to Attend the New Technology Town
Hall meeting’’ and ‘‘Register to attend
the New Technology Informational
Workshop’’. After completing the
registration, on-line registrants should
print the confirmation page and bring it
with them to the meeting(s).
If you are unable to register on-line,
you may register by sending an email to
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 these meetings will be
located on Federal property, for security
reasons, any persons wishing to attend
these meetings must register by close of
business on 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 8:30 a.m., e.d.t. if you are
attending the Informational Workshop
and no later than 12:30 p.m. if you are
attending the town hall meeting so that
you will be able to arrive promptly at
the appropriate meeting.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of demonstration or to support
E:\FR\FM\27NON1.SGM
27NON1
62342
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
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
meetings. The public may not enter the
building earlier than 30 to 45 minutes prior
to the convening of the meeting(s).
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building. Seating
capacity is limited to the first 250
registrants.
Authority: Section 503 of 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 12, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
and Medicaid Services.
[FR Doc. E9–27971 Filed 11–25–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 11, 2010, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD. The
hotel phone number is 301–589–5200.
Contact Person: Elaine Ferguson,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6778, e-mail:
elaine.ferguson@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On January 11, 2010, the
committee will discuss supplemental
drug application (sNDA) 21–742,
nebivolol tablets, Forest Laboratories,
Inc., for the proposed indication (use) of
treatment of chronic heart failure.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before December 24, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before December 16, 2009. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
regarding their request to speak by
December 17, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Elaine
Ferguson at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28302 Filed 11–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5280–N–46]
Federal Property Suitable as Facilities
To Assist the Homeless
AGENCY: Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Notice.
SUMMARY: This Notice identifies
unutilized, underutilized, excess, and
surplus Federal property reviewed by
HUD for suitability for possible use to
assist the homeless.
DATES: Effective Date: November 27,
2009.
FOR FURTHER INFORMATION CONTACT:
Kathy Ezzell, Department of Housing
and Urban Development, 451 Seventh
Street, SW, Room 7262, Washington, DC
20410; telephone (202) 708–1234; TTY
number for the hearing- and speechimpaired (202) 708–2565, (these
telephone numbers are not toll-free), or
call the toll-free Title V information line
at 800–927–7588.
SUPPLEMENTARY INFORMATION: In
accordance with the December 12, 1988
court order in National Coalition for the
Homeless v. Veterans Administration,
No. 88–2503–OG (D.D.C.), HUD
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62339-62342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1513-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2011
Applications for New Medical Services and Technologies Add-on Payments
and Informational Workshop on the Application Process and Criteria for
New Medical Services and Technologies Add-on Payments
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a Town Hall meeting to discuss fiscal
year (FY) 2011 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 2011 new medical services and technologies applications meet the
substantial clinical improvement criterion.
Additionally, this notice announces an Informational Workshop for
all interested parties on the application process and criteria for new
medical services and technologies under the IPPS and on the outpatient
prospective payment system (OPPS) transitional pass-through payment for
drugs, biologicals, and devices and new technology Ambulatory Payment
Classification (APC) assignment for new services application processes.
DATES: Meeting Date: The Town Hall meeting and the Informational
Workshop announced in this notice will be held on Wednesday, February
10, 2010. The Informational Workshop will begin at 9 a.m., and check-in
will begin at 8:30 a.m. eastern daylight time (e.d.t.). The Town Hall
meeting will begin at 1 p.m. e.d.t. and check-in will begin at 12:30
p.m. e.d.t. Only one check-in is required to enter the building.
Participants attending the Informational Workshop will be able to
attend the Town Hall meeting without an additional check-in unless they
exit the building. In this case, a participant will need to repeat the
security procedures and check-in.
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 January
26, 2010.
Deadline for Registration of All Other Participants for the Town
Hall Meeting, Participants of the Informational Workshop, and
Submitting Requests for Special Accommodations: All other participants
for the Town Hall Meeting and participants of the Informational
Workshop must register by February 2, 2010. Requests for special
accommodations must be received no later than 5 p.m., e.d.t. on
February 2, 2010.
ADDRESSES: Meeting Location: The Town Hall meeting and Informational
Workshop will both be held in the main Auditorium in the central
building of the Centers for Medicare & 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 for the Town Hall
Meeting: 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 to: Division of Acute Care, New Technology Team, Mailstop C4-07-
08, Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850, Attention: Michael Treitel.
Agenda items or written comments may also be sent via e-mail to
newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: 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 to acute care hospitals for new medical
services and technologies under Medicare. Effective for discharges
beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) of the
Act
[[Page 62340]]
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 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). (For a more detailed discussion, see
the FY 2002 proposed and final rules (66 FR 22693, May 4, 2001) and the
final rule (66 FR 46912, September 7, 2001) 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).
++ 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 our clinical staff
as to whether the service or technology represents a substantial
improvement before publication of a proposed rule.
The opinions and alternatives provided during this meeting will
assist us as we evaluate the new medical services and technology
applications for FY 2011. 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 2011 IPPS proposed rule.
II. Town Hall Meeting and Informational Workshop Format
A. Town Hall 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 will allow for a discussion of the substantial
clinical improvement criteria as it relates to each of the FY 2011 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, (800) 603-1774, 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 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.
B. Informational Workshop Format
In addition, to the statutorily-required Town Hall meeting on
whether an IPPS new technology application meets the substantial
clinical improvement criteria we will be holding an Informational
Workshop on applying for special payment for new medical services and
technologies under the IPPS and OPPS. Specifically, for new technology
add-on payments under the IPPS, we will discuss each criterion in
detail along with other information that will be helpful in guiding an
applicant through the new technology add-on payment process. We will
also discuss the processes of DRG assignment and requesting new ICD-9
codes under the IPPS. (Information on DRGs can be found on the IPPS Web
site at https://www.cms.hhs.gov/AcuteInpatientPPS/01_overview.asp#TopOfPage and information on ICD-9-CM coding can be found
on our Web site at (https://www.cms.hhs.gov/ICD9ProviderDiagnosticCodes/
)
To facilitate the public's knowledge of OPPS application processes
for transitional pass-through status of
[[Page 62341]]
drugs, biologicals and devices and assignment of new services to New
Technology Ambulatory Payment Classification (APCs), the Informational
Workshop will also include information on several processes for
applying for special payment under the OPPS. One topic concerns the
process for applying for a new category of devices for pass-through
payment and criteria for evaluation. Interested parties may apply for a
new device category, in accordance with section 1833(t)(6) of the Act.
As background information, we have posted application and process
background information on our Web site at https://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage.
Furthermore, under section 1833(t)(6) of the Act interested parties
may also apply for transitional pass-through payment for certain new
drugs, biological or radiopharmaceutical agents. As background
information, we have posted application and process background
information on our Web site, https://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage. Finally,
we provide the opportunity for the public to apply for new services to
be placed in New Technology APC groups in the OPPS, in accordance with
our criteria and discussion in our November 30, 2001 final rule (66 FR
59897). As background information, we have posted application and
process background information on our Web site, https://www.cms.hhs.gov/HospitalOutpatientPPS/04_passthrough_payment.asp#TopOfPage. We plan
to discuss all three of these OPPS application processes at the
Informational Workshop that will be held on February 10, 2010.
The Informational Workshop is open to all interested parties
including organizations representing hospitals, physicians, and
manufacturers. We encourage all interested parties to attend,
especially those who are not familiar with these processes. Individuals
who want to attend this Informational Workshop must register by the
date specified in the DATES section of this notice. Registration
information is available in section III. of this notice.
For participants who cannot come to CMS for the meeting, an open
toll-free phone line, (800) 603-1774, has been made available. If you
are calling in, the operator will ask you for the conference code. The
conference code is ``New Tech.''
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 will allow for a discussion of the substantial
clinical improvement criteria on each of the FY 2011 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, (800) 603-1774, 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 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.
For participants who cannot come to CMS for the meeting, an open
toll-free phone line, (800) 603-1774, has been made available. If you
are calling in, the operator will ask you for the conference code. The
conference code is ``New Tech.''
III. Registration Instructions
The Division of Acute Care in CMS is coordinating registration for
both the Town Hall meeting and the Informational Workshop. While there
is no registration fee, individuals must register to attend the Town
Hall meeting on substantial clinical improvement and for the
Informational Workshop (two separate registrations).
Registration may be completed on-line at the following web address:
https://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.
Select the links at the bottom of the page ``Register to Attend the New
Technology Town Hall meeting'' and ``Register to attend the New
Technology Informational Workshop''. After completing the registration,
on-line registrants should print the confirmation page and bring it
with them to the meeting(s).
If you are unable to register on-line, you may register by sending
an email to 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 these meetings will be located on Federal property, for
security reasons, any persons wishing to attend these meetings must
register by close of business on 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 8:30 a.m., e.d.t. if you are attending the Informational
Workshop and no later than 12:30 p.m. if you are attending the town
hall meeting so that you will be able to arrive promptly at the
appropriate meeting.
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of demonstration or to support
[[Page 62342]]
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
meetings. The public may not enter the building earlier than 30 to
45 minutes prior to the convening of the meeting(s).
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building. Seating capacity is limited
to the first 250 registrants.
Authority: Section 503 of 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 12, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare and Medicaid Services.
[FR Doc. E9-27971 Filed 11-25-09; 8:45 am]
BILLING CODE 4120-01-P
