Medicare Program; Town Hall Meeting on the Fiscal Year 2012 Applications for Add-on Payments for New Medical Services and Technologies Under the Hospital Inpatient Prospective Payment System and Informational Workshop on the Application Process and Criteria for Add-on Payments for New Medical Services and Technologies Under the Inpatient and Outpatient Prospective Payment Systems, 73091-73094 [2010-29989]
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<![CDATA[
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
Relevant recommendations should
include feedback on the integration of
the imaging efficiency measures into the
overall HOP QDRP program.
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II. Listening Session Format
The listening session will be held on
January 31, 2011. Measure developers,
hospitals, medical specialty societies,
medical professionals, and other
interested stakeholders are invited to
participate in person or by
teleconference. The session will begin at
1 p.m. E.S.T. with an overview of
objectives for the session. The
remainder of the meeting will be
devoted to receiving input on additional
imaging efficiency measures and their
integration into the overall HOP QDRP
program. The meeting will conclude by
5 p.m. E.S.T.
Participants will be permitted to
speak in the order in which they sign
up. Participants are encouraged to
provide references to the evidence base
supporting their suggested measures.
Comments from individuals not
registered to speak will be heard after
scheduled statements only if time
permits.
III. Registration Instructions
For security reasons, any persons
wishing to attend this meeting must
register by the date listed in the DATES
section of this notice. Persons interested
in attending the meeting must register
by completing the on-line registration
via the designated Web site https://
www.cms.gov/apps/events/
event.asp?id=622.
The on-line registration system will
generate a confirmation page to indicate
the completion of your registration.
Please print this page as your
registration receipt.
Individuals may also participate in
the listening session by teleconference.
For individuals interested in
participating via teleconference,
registration is available via the Web site
at https://www.magnetmail.net/
events?cf4db6967a
514fb681832e700ee3e5b0a. Registration
is required as the number of call-in lines
will be limited.
Background information on the
listening session will be posted on the
QualityNet Web site at https://
www.qualitynet.org prior to the session.
The information will be posted under
the tab for ‘‘Hospitals Outpatient,’’ then
select ‘‘Imaging Efficiency Measures’’
from the drop-down menu. We
anticipate posting an audio download
and/or transcript of the listening session
in the same location on https://
www.qualitynet.org after completion of
the listening session.
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Individuals requiring sign language
interpretation or other special
accommodations must contact the staff
via the contact information specified in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date listed
in the DATES section of this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Security, Building, and Parking
Guidelines
Medicare Program; Town Hall Meeting
on the Fiscal Year 2012 Applications
for Add-on Payments for New Medical
Services and Technologies Under the
Hospital Inpatient Prospective
Payment System and Informational
Workshop on the Application Process
and Criteria for Add-on Payments for
New Medical Services and
Technologies Under the Inpatient and
Outpatient Prospective Payment
Systems
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. The
on-site check-in for visitors will begin at
12 noon E.S.T. We recommend that
confirmed registrants arrive reasonably
early, but no earlier than 45 minutes
prior to the start of the meeting, to allow
additional time to clear security.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means, of all persons
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, including items such as
laptops, cell phones, and palm pilots,
are subject to physical 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 a
presentation.
We note that 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 60 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.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare and
Medicaid Services.
[FR Doc. 2010–29995 Filed 11–26–10; 8:45 am]
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Centers for Medicare & Medicaid
Services
[CMS–1342–N]
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
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) 2012 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 2012 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
Additionally, we will hold an
Informational Workshop for all
interested parties on the application
process and criteria for add-on
payments for new medical services and
technologies under the IPPS and the
application processes for the outpatient
prospective payment system (OPPS)
transitional pass-through payment for
drugs, biological, and devices and new
technology ambulatory payment
classification (APC) group assignments
for new services.
DATES: Meeting Date: Both the Town
Hall Meeting and Informational
Workshop announced in this notice will
be held on Wednesday, February 2,
2011. The Informational Workshop will
begin at 9 a.m., and check-in will begin
at 8:30 a.m. eastern standard time
(e.s.t.). The Town Hall Meeting will
begin at 1 p.m. e.s.t. and check-in will
begin at 12:30 p.m. e.s.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
SUMMARY:
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procedures and check-in again for the
Town Hall Meeting.
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 19, 2011.
Deadline for Registration of All Other
Participants for the Town Hall Meeting
and the Informational Workshop and
Submitting Requests for Special
Accommodations: All other participants
must register by January 24, 2011.
Requests for special accommodations
must be received no later than 5 p.m.,
e.s.t. on January 24, 2011.
Deadline for Submission of Agenda
Item(s) or Written Comments for the
Town Hall Meeting: Written comments
and agenda items for discussion at the
Town Hall Meeting must be received by
January 19, 2011. In addition to
materials submitted for discussion at the
Town Hall Meeting, individuals may
submit other written comments, as
specified in the ADDRESSES section of
this notice, on whether the service or
technology represents a substantial
clinical improvement. These comments
must be received by February 16, 2011,
for consideration before publication of
the FY 2012 IPPS proposed rule.
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 and Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Registration and Special
Accommodations: Individuals wishing
to participate in the meeting must
register by following the on-line
registration instructions located in
section III. of this notice or by
contacting staff listed in the FOR
FURTHER INFORMATION CONTACT section of
this notice. Individuals who need
special accommodations should contact
staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice. Registration information and
special accommodation requests may
also be mailed to the address listed in
the ADDRESSES section of this notice.
Submission of Agenda Item(s) or
Written Comments for the Town Hall
Meeting: Each presenter must submit an
agenda item(s) regarding whether a FY
2012 application meets the substantial
clinical improvement criterion. Agenda
items, written comments, questions or
other statements must not exceed three
single-spaced typed pages and may be
sent via e-mail to newtech@cms.hhs.gov
or sent via regular mail to:
Division of Acute Care, New
Technology Team, Mailstop C4–08–06,
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Centers for Medicare and Medicaid
Services, 7500 Security Boulevard,
Baltimore Maryland 21244–1850,
Attention: Michael Treitel or Celeste
Beauregard.
FOR FURTHER INFORMATION CONTACT:
Michael Treitel, (410) 786–4552,
michael.treitel@cms.hhs.gov, or Celeste
Beauregard, (410) 786–8102,
celeste.beauregard@cms.hhs.gov.
Alternatively, you may forward your
requests via e-mail to
newtech@cms.hhs.gov or regular mail as
specified in the ADDRESSES section of
this notice.
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments
for New Medical Services and
Technologies Under the IPPS
Sections 1886(d)(5)(K) and (L) of the
Social Security Act (the Act) require the
Secretary to establish a process of
identifying and ensuring adequate
payments to acute care hospitals for
new medical services and technologies
under Medicare. Effective for discharges
beginning on or after October 1, 2001,
section 1886(d)(5)(K)(i) of the Act
requires the Secretary to establish (after
notice and opportunity for public
comment) a mechanism to recognize the
costs of new services and technologies
under the 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 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.
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• Use of the device significantly
improves clinical outcomes for a patient
population as compared to currently
available treatments. Some examples of
outcomes that are frequently evaluated
in studies of medical devices are the
following:
++ Reduced mortality rate with use of
the device.
++ Reduced rate of device-related
complications.
++ Decreased rate of subsequent
diagnostic or therapeutic interventions
(for example, due to reduced rate of
recurrence of the disease process).
++ Decreased number of future
hospitalizations or physician visits.
++ More rapid beneficial resolution
of the disease process treatment because
of the use of the device.
++ Decreased pain, bleeding, or other
quantifiable symptoms.
++ Reduced recovery time.
In addition, we indicated that the
requester is required to submit evidence
that the technology meets one or more
of these criteria.
Section 503 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
amended section 1886(d)(5)(K)(viii) of
the Act to revise the process for
evaluating new medical services and
technology applications by requiring the
Secretary to do the following:
• Provide for public input regarding
whether a new service or technology
represents an advance in medical
technology that substantially improves
the diagnosis or treatment of Medicare
beneficiaries before publication of a
proposed rule.
• Make public and periodically
update a list of all the services and
technologies for which an application is
pending.
• Accept comments,
recommendations, and data from the
public regarding whether the service or
technology represents a substantial
improvement.
• Provide for a meeting at which
organizations representing hospitals,
physicians, manufacturers and any
other interested party may present
comments, recommendations, and data
to the clinical staff of CMS as to whether
the service or technology represents a
substantial improvement before
publication of a proposed rule.
The opinions and alternatives
provided during this meeting will assist
us as we evaluate the new medical
services and technology applications for
FY 2012. 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 2012
IPPS proposed rule.
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II. Town Hall Meeting and
Informational Workshop Formats and
Conference Calling Information
A. Format of the Town Hall Meeting
As noted in section I. of this notice,
we are required to provide for a meeting
at which organizations representing
hospitals, physicians, manufacturers
and any other interested party may
present comments, recommendations,
and data to the clinical staff of CMS
concerning whether the service or
technology represents a substantial
improvement. This meeting will allow
for a discussion of the substantial
clinical improvement criteria on each of
the FY 2012 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.
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 our
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
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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 diagnosis-related group
(DRG) assignment and requesting new
ICD–9–CM 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/.
In addition, to facilitate the public’s
knowledge of the OPPS application
processes for transitional pass-through
status of drugs, biologicals, and devices
and assignment of new services to new
technology ambulatory payment
classification (APC) groups, 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 and
biologicals. 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.
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
9897 through 59903). As background
information, we have posted application
and process background information on
our Web site at https://www.cms.hhs.gov/
HospitalOutpatientPPS/04_pass
through_payment.asp#TopOfPage. We
plan to discuss all three of these OPPS
application processes at the
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Informational Workshop that will be
held on February 2, 2011.
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 below.
C. Conference Call Information
For participants who cannot come to
CMS for the Informational Workshop or
the Town Hall Meeting, an open tollfree phone line, (877) 267–1577, has
been made available. The conference
code is ‘‘0400.’’
III. Registration Instructions
The Division of Acute Care in CMS is
coordinating the meeting 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 link at the bottom
of the page ‘‘Register to Attend the New
Technology Town Hall Meeting’’ or
‘‘Register to Attend the New Technology
Informational Workshop’’. After
completing the registration, on-line
registrants should print the
confirmation page(s) and bring it with
them to the meeting(s).
If you are unable to register on-line,
you may register by sending an 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 these meetings will be
located on Federal property, for security
reasons, any persons wishing to attend
these meetings 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 8:30 a.m. e.s.t. if you are
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attending the Informational Workshop
and no later than 12:30 p.m. e.s.t. 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
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 45 minutes prior to the
convening of the meeting(s).
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building. Seating
capacity is limited to the first 250
registrants.
Authority: Section 503 of Pub. L. 108–173.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–29989 Filed 11–26–10; 8:45 am]
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BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3237–N]
Medicare Program; Meeting of the
Medicare Evidence Development and
Coverage Advisory Committee—
January 19, 2011
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces that a
public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MEDCAC)
(‘‘Committee’’) will be held on
Wednesday, January 19, 2011. The
Committee generally provides advice
and recommendations concerning the
adequacy of scientific evidence needed
to determine whether certain medical
items and services can be covered under
the Medicare statute. This meeting will
focus on the currently available
evidence regarding the effects of
Erythropoiesis Stimulating Agents
(ESAs) on health outcomes in adult
chronic kidney disease (CKD) patients
(pre-dialysis and dialysis). This meeting
is open to the public in accordance with
the Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)).
DATES: Meeting Date: The public
meeting will be held on Wednesday,
January 19, 2011 from 7:30 a.m. until
4:30 p.m., Eastern Standard Time (EST).
Deadline for Submission of Written
Comments: Written comments must be
received at the address specified in the
ADDRESSES section of this notice by 5
p.m. EST, Monday, December 20, 2010.
Once submitted, all comments are final.
Deadlines for Speaker Registration
and Presentation Materials: The
deadline to register to be a speaker and
to submit powerpoint presentation
materials and writings that will be used
in support of an oral presentation, is 5
p.m., EST on Monday, December 20,
2010. Speakers may register by phone or
via e-mail by contacting the person
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Presentation materials must be received
at the address specified in the
ADDRESSES section of this notice.
Deadline for All Other Attendees
Registration: Individuals may register
online at https://www.cms.gov/apps/
events/upcomingevents.asp?
strOrderBy=1&type=3, or by phone by
contacting the person listed in the FOR
FURTHER INFORMATION CONTACT section of
SUMMARY:
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this notice by 5 p.m. EST, Wednesday,
January 12, 2011.
We will be broadcasting the meeting
via Webinar. You must register for the
Webinar portion of the meeting at
https://webinar.cms.hhs.gov/
esamedcac119/event/registration.html
by 5 p.m. EST, Thursday, January 13,
2011.
Deadline for Submitting a Request for
Special Accommodations: Persons
attending the meeting who are hearing
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to contact the Executive Secretary
as specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice no later than 5 p.m., EST Friday,
January 7, 2011.
ADDRESSES: Meeting Location: The
meeting will be held in the main
auditorium of the Centers for Medicare
& Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244.
Submission of Presentations and
Comments: Presentation materials and
written comments that will be presented
at the meeting must be submitted via email to
MedCACpresentations@cms.hhs.gov or
by regular mail to the contact listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Coverage and
Analysis Group, C1–09–06, 7500
Security Boulevard, Baltimore, MD
21244 or contact Ms. Ellis by phone
(410–786–0309) or via e-mail at
Maria.Ellis@cms.hhs.gov .
SUPPLEMENTARY INFORMATION:
I. Background
MEDCAC, formerly known as the
Medicare Coverage Advisory Committee
(MCAC), provides advice and
recommendations to CMS regarding
clinical issues. (For more information
on MCAC, see the December 14, 1998
Federal Register (63 FR 68780).) This
notice announces the January 19, 2011,
public meeting of the Committee.
During this meeting, the Committee will
discuss the evidence that is currently
available regarding the effects of
Erythropoiesis Stimulating Agents
(ESAs) on health outcomes in adult
chronic kidney disease (CKD) patients
(pre-dialysis and dialysis). Background
information about this topic, including
panel materials, is available at https://
www.cms.hhs.gov/center/coverage.asp.
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]]>Agencies
[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73091-73094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29989]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1342-N]
Medicare Program; Town Hall Meeting on the Fiscal Year 2012
Applications for Add-on Payments for New Medical Services and
Technologies Under the Hospital Inpatient Prospective Payment System
and Informational Workshop on the Application Process and Criteria for
Add-on Payments for New Medical Services and Technologies Under the
Inpatient and Outpatient Prospective Payment Systems
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
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SUMMARY: This notice announces a Town Hall meeting in accordance with
section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to
discuss fiscal year (FY) 2012 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 2012 new medical services and technologies
applications meet the substantial clinical improvement criterion.
Additionally, we will hold an Informational Workshop for all
interested parties on the application process and criteria for add-on
payments for new medical services and technologies under the IPPS and
the application processes for the outpatient prospective payment system
(OPPS) transitional pass-through payment for drugs, biological, and
devices and new technology ambulatory payment classification (APC)
group assignments for new services.
DATES: Meeting Date: Both the Town Hall Meeting and Informational
Workshop announced in this notice will be held on Wednesday, February
2, 2011. The Informational Workshop will begin at 9 a.m., and check-in
will begin at 8:30 a.m. eastern standard time (e.s.t.). The Town Hall
Meeting will begin at 1 p.m. e.s.t. and check-in will begin at 12:30
p.m. e.s.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
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procedures and check-in again for the Town Hall Meeting.
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
19, 2011.
Deadline for Registration of All Other Participants for the Town
Hall Meeting and the Informational Workshop and Submitting Requests for
Special Accommodations: All other participants must register by January
24, 2011. Requests for special accommodations must be received no later
than 5 p.m., e.s.t. on January 24, 2011.
Deadline for Submission of Agenda Item(s) or Written Comments for
the Town Hall Meeting: Written comments and agenda items for discussion
at the Town Hall Meeting must be received by January 19, 2011. In
addition to materials submitted for discussion at the Town Hall
Meeting, individuals may submit other written comments, as specified in
the ADDRESSES section of this notice, on whether the service or
technology represents a substantial clinical improvement. These
comments must be received by February 16, 2011, for consideration
before publication of the FY 2012 IPPS proposed rule.
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 and Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244-1850.
Registration and Special Accommodations: Individuals wishing to
participate in the meeting must register by following the on-line
registration instructions located in section III. of this notice or by
contacting staff listed in the FOR FURTHER INFORMATION CONTACT section
of this notice. Individuals who need special accommodations should
contact staff listed in the FOR FURTHER INFORMATION CONTACT section of
this notice. Registration information and special accommodation
requests may also be mailed to the address listed in the ADDRESSES
section of this notice.
Submission of Agenda Item(s) or Written Comments for the Town Hall
Meeting: Each presenter must submit an agenda item(s) regarding whether
a FY 2012 application meets the substantial clinical improvement
criterion. Agenda items, written comments, questions or other
statements must not exceed three single-spaced typed pages and may be
sent via e-mail to newtech@cms.hhs.gov or sent via regular mail to:
Division of Acute Care, New Technology Team, Mailstop C4-08-06,
Centers for Medicare and Medicaid Services, 7500 Security Boulevard,
Baltimore Maryland 21244-1850, Attention: Michael Treitel or Celeste
Beauregard.
FOR FURTHER INFORMATION CONTACT: Michael Treitel, (410) 786-4552,
michael.treitel@cms.hhs.gov, or Celeste Beauregard, (410) 786-8102,
celeste.beauregard@cms.hhs.gov. Alternatively, you may forward your
requests via e-mail to newtech@cms.hhs.gov or regular mail as specified
in the ADDRESSES section of this notice.
SUPPLEMENTARY INFORMATION:
I. Background on the Add-On Payments for New Medical Services and
Technologies Under the IPPS
Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act)
require the Secretary to establish a process of identifying and
ensuring adequate payments to acute care hospitals for new medical
services and technologies under Medicare. Effective for discharges
beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) of the
Act requires the Secretary to establish (after notice and opportunity
for public comment) a mechanism to recognize the costs of new services
and technologies under the 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 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 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 2012. 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 2012 IPPS proposed rule.
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II. Town Hall Meeting and Informational Workshop Formats and Conference
Calling Information
A. Format of the Town Hall Meeting
As noted in section I. of this notice, we are required to provide
for a meeting at which organizations representing hospitals,
physicians, manufacturers and any other interested party may present
comments, recommendations, and data to the clinical staff of CMS
concerning whether the service or technology represents a substantial
improvement. This meeting will allow for a discussion of the
substantial clinical improvement criteria on each of the FY 2012 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.
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 our 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 diagnosis-related group (DRG) assignment
and requesting new ICD-9-CM 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/.
In addition, to facilitate the public's knowledge of the OPPS
application processes for transitional pass-through status of drugs,
biologicals, and devices and assignment of new services to new
technology ambulatory payment classification (APC) groups, 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 and biologicals. 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.
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 9897 through 59903). 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. We plan to discuss all three of these OPPS
application processes at the Informational Workshop that will be held
on February 2, 2011.
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 below.
C. Conference Call Information
For participants who cannot come to CMS for the Informational
Workshop or the Town Hall Meeting, an open toll-free phone line, (877)
267-1577, has been made available. The conference code is ``0400.''
III. Registration Instructions
The Division of Acute Care in CMS is coordinating the meeting
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 link at the bottom of the page ``Register to Attend the New
Technology Town Hall Meeting'' or ``Register to Attend the New
Technology Informational Workshop''. After completing the registration,
on-line registrants should print the confirmation page(s) and bring it
with them to the meeting(s).
If you are unable to register on-line, you may register by sending
an 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 these meetings will be located on Federal property, for
security reasons, any persons wishing to attend these meetings 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 8:30 a.m. e.s.t. if you are
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attending the Informational Workshop and no later than 12:30 p.m.
e.s.t. 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 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 45
minutes prior to the convening of the meeting(s).
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building. Seating capacity is limited
to the first 250 registrants.
Authority: Section 503 of Pub. L. 108-173.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: November 18, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-29989 Filed 11-26-10; 8:45 am]
BILLING CODE 4120-01-P
