Medicare Program; Public Meetings in Calendar Year 2011 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 10602-10605 [2011-3812]
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Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices
IV. Security, Building, and Parking
Guidelines
The meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. It is suggested that you
arrive at the CMS facility between 8:15
a.m and 8:30 a.m., E.S.T. so that you
will be able to arrive promptly at the
meeting by 9 a.m., E.S.T. 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 8:15 a.m., E.S.T.
(45 minutes before the convening of the
meeting).
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel. Persons without
proper identification may be denied
access to the building.
• 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.
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V. Special Accommodations
Individuals attending the meeting
who are hearing or visually impaired
and have special requirements, or a
condition that requires special
assistance, should provide the
information upon registering for the
meeting. The deadline for such
registrations is listed in the DATES
section of this notice.
VI. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
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(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: February 18, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–4295 Filed 2–24–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1515–N]
Medicare Program; Public Meetings in
Calendar Year 2011 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
System (HCPCS) Coding and Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
dates, time, and location of the
Healthcare Common Procedure Coding
System (HCPCS) public meetings to be
held in calendar year 2011 to discuss
our preliminary coding and payment
determinations for all new public
requests for revisions to the HCPCS.
These meetings provide a forum for
interested parties to make oral
presentations or to submit written
comments in response to preliminary
coding and payment determinations.
The discussion will be focused on
responses to our specific preliminary
recommendations and will include all
items on the public meeting agenda.
DATES: Meeting Dates: The following are
the 2011 HCPCS public meeting dates:
1. Tuesday, May 17, 2011, 9 a.m. to
5 p.m. eastern daylight time (e.d.t.)
(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 18, 2011, 9 a.m.
to 5 p.m. e.d.t. (Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
3. Tuesday, May 24, 2011, 9 a.m. to
5 p.m. e.d.t. (Supplies and Other).
4. Wednesday, May 25, 2011, 9 a.m.
to 5 p.m. e.d.t. (Supplies and Other).
5. Tuesday, June 7, 2011, 9 a.m. to 5
p.m. e.d.t. (Orthotics and Prosthetics).
6. Wednesday, June 8, 2011, 9 a.m. to
5 p.m. e.d.t. (Durable Medical
Equipment (DME) and Accessories).
Deadlines for Primary Speaker
Registration and Presentation Materials:
SUMMARY:
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The deadline for registering to be a
primary speaker and submitting
materials and writings that will be used
in support of an oral presentation are as
follows:
• May 3, 2011 for the May 17, 2011
and May 18, 2011 public meetings.
• May 10, 2011 for the May 24, 2011
and May 25, 2011 public meetings.
• May 24, 2011 for the June 7, 2011
and June 8, 2011 public meetings.
Deadline for Attendees that are
Foreign Nationals (reside outside the
U.S.) Registration: Attendees that are
Foreign Nationals (reside outside the
U.S.) are required to identify themselves
as such, and provide the necessary
information for security clearance (as
described in section IV. of this notice)
to the public meeting coordinator at
least 12 business days in advance of the
date of the public meeting date the
individual plans to attend. Therefore,
the deadlines for attendees that are
Foreign Nationals are as follows:
• April 29, 2011 for the May 17, 2011
and May 18, 2011 public meetings.
• May 6, 2011 for the May 24, 2011
and May 25, 2011 public meetings.
• May 19, 2011 for the June 7, 2011
and June 8, 2011 public meetings.
Deadlines for all Other Attendees
Registration: All other individuals who
plan to enter the building to attend the
public meeting must register for each
date that they plan on attending. The
registration deadlines are different for
each meeting. Registration deadlines are
as follows:
• May 10, 2011 for the May 17, 2011
and May 18, 2011 public meeting dates.
• May 17, 2011 for the May 24, 2011
and May 25, 2011 public meeting dates.
• May 31, 2011 for the June 7, 2011
and June 8, 2011 public meeting dates.
Deadlines for Requesting Special
Accommodations: Individuals who plan
to attend the public meetings and
require sign-language interpretation or
other special assistance must request
these services by the following
deadlines:
• May 3, 2011 for the May 17, 2011
and May 18, 2011 public meetings.
• May 10, 2011 for the May 24, 2011
and May 25, 2011 public meetings.
• May 24, 2011 for the June 7, 2011
and June 8, 2011 public meetings.
Deadline for Submission of Written
Comments: Written comments must be
received by the date of the meeting at
which the code request is scheduled for
discussion.
ADDRESSES: Meeting Location: The
public meetings will be held in the main
auditorium of the central building of the
Centers for Medicare and Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
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Submission of Written Comments:
Written comments may either be emailed to HCPCS@cms.hhs.gov or sent
via regular mail to Jennifer Carver or
Sharon Ventura, HCPCS Public Meeting
Coordinator, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail Stop C5–08–27,
Baltimore, MD 21244–1850.
Registration and Special
Accommodations: Individuals wishing
to participate or who need special
accommodations or both must register
by completing the on-line registration
located at https://www.cms.hhs.gov/
medhcpcsgeninfo or by contacting one
of the following persons: Jennifer Carver
at (410) 786–6610 or
Jennifer.Carver@cms.hhs.gov; or Sharon
Ventura at (410)786–1985 or
Sharon.Ventura@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jennifer Carver at (410) 786–6610 or
Jennifer.Carver@cms.hhs.gov; or Sharon
Ventura at (410) 786–1985 or
Sharon.Ventura@cms.hhs.
SUPPLEMENTARY INFORMATION:
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I. Background
On December 21, 2000, the Congress
passed the Medicare, Medicaid, and
SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA) (Pub. L.
106–554). Section 531(b) of BIPA
mandated that we establish procedures
that permit public consultation for
coding and payment determinations for
new durable medical equipment (DME)
under Medicare Part B of title XVIII of
the Social Security Act (the Act). The
procedures and public meetings
announced in this notice for new DME
are in response to the mandate of
section 531(b) of BIPA.
In the November 23, 2001 Federal
Register (66 FR 58743), we published a
notice providing information regarding
the establishment of the public meeting
process for DME. It is our intent to
distribute any materials submitted to
CMS to the Healthcare Common
Procedure Coding System (HCPCS)
workgroup members for their
consideration. CMS and the HCPCS
workgroup members require sufficient
preparation time to review all relevant
materials. Therefore, we are
implementing a 10-page submission
limit and firm deadlines for receipt of
any presentation materials a meeting
speaker wishes us to consider. For this
reason, our HCPCS Public Meeting
Coordinators will only accept and
review presentation materials received
by the deadline for each public meeting,
as specified in the DATES section of this
notice.
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The public meeting process provides
an opportunity for the public to become
aware of coding changes under
consideration, as well as an opportunity
for CMS to gather public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be
provided when registering:
• Name.
• Company name and address.
• Direct-dial telephone and fax
numbers.
• E-mail address.
• Special needs information.
A CMS staff member will confirm
your registration by e-mail.
B. Registration Process
1. Primary Speakers
Individuals must also indicate
whether they are the ‘‘primary speaker’’
for an agenda item. Primary speakers
must be designated by the entity that
submitted the HCPCS coding request.
When registering, primary speakers
must provide a brief written statement
regarding the nature of the information
they intend to provide, and advise the
HCPCS Public Meeting Coordinator
regarding needs for audio/visual
support. To avoid disruption of the
meeting and ensure compatibility with
our systems, tapes, and disk files are
tested and arranged in speaker sequence
well in advance of the meeting. We will
accept tapes and disk files that are
received by the deadline for
submissions for each public meeting as
specified in the DATES section of this
notice. The sum of all materials
including the presentation may not
exceed 10 pages (each side of a page
counts as 1 page). An exception will be
made to the 10-page limit for relevant
studies published between the
application deadline and the public
meeting date, in which case, we would
like a copy of the complete publication
as soon as possible. This exception
applies only to the page limit and not
the deadline submission.
The materials may be e-mailed or
delivered by regular mail to one of the
HCPCS Public Meeting Coordinators as
specified in the ADDRESSES section of
this notice. The materials must be emailed or postmarked no later than the
deadline specified in the DATES section
of this notice. Individuals will need to
provide 35 copies if materials are
delivered by mail.
2. 5-Minute Speakers
To afford the same opportunity to all
attendees, 5-minute speakers are not
required to register as primary speakers.
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However, 5-minute speakers must still
register as attendees by the deadline set
forth under ‘‘Deadlines for all Other
Attendees Registration’’ in the DATES
section of this notice. Attendees can
sign up only on the day of the meeting
to do a 5-minute presentation.
Individuals must provide their name,
company name and address, contact
information as specified on the sign-up
sheet, and identify the specific agenda
item that they will address.
C. Additional Meeting/Registration
Information
Public Meetings are scheduled far in
advance of the influx of HCPCS
applications each cycle. At the time
they are scheduled we can only
anticipate the number of applications
that we receive in each category. As a
result, we may not need the second day
of Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents Public Meeting on
Wednesday, May 18, 2011. We have
scheduled this date tentatively. The
Public Meeting Agendas published on
CMS’ HCPCS Web site at https://
www.cms.hhs.gov/medhcpcsgeninfo
will serve as final notification regarding
whether a meeting will be held on
Wednesday, May 18, 2011.
The product category reported by the
applicant may not be the same as that
assigned by us. Prior to registering to
attend a public meeting, all participants
are advised to review the public meeting
agendas at https://www.cms.hhs.gov/
medhcpcsgeninfo which identify our
category determinations, and the dates
each item will be discussed. Draft
agendas, including a summary of each
request and our preliminary decision
will be posted on our HCPCS Web site
at https://www.cms.hhs.gov/
medhcpcsgeninfo at least 4 weeks before
each meeting.
Additional details regarding the
public meeting process for all new
public requests for revisions to the
HCPCS, along with information on how
to register and guidelines for an
effective presentation, will be posted at
least 4 weeks before the first meeting
date on the official HCPCS Web site at
https://www.cms.hhs.gov/
medhcpcsgeninfo. The document titled
‘‘Guidelines for Participation in Public
Meetings for All New Public Requests
for Revisions to the Healthcare Common
Procedure Coding System (HCPCS)’’ will
be made available on the HCPCS Web
site at least 4 weeks before the first
public meeting in 2011 for all new
public requests for revisions to the
HCPCS. Individuals who intend to
provide a presentation at a public
meeting need to familiarize themselves
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with the HCPCS Web site and the
valuable information it provides to
prospective registrants. The HCPCS Web
site also contains a document titled
‘‘Healthcare Common Procedure Coding
System (HCPCS) Level II Coding
Procedures,’’ which is a description of
the HCPCS coding process, including a
detailed explanation of the procedures
used to make coding determinations for
all the products, supplies, and services
that are coded in the HCPCS.
The HCPCS Web site also contains a
document titled ‘‘HCPCS Decision Tree
& Definitions’’ which illustrates, in flow
diagram format, HCPCS coding
standards as described in our Coding
Procedures document.
A summary of each public meeting
will be posted on the HCPCS Web site
by the end of August 2011.
III. Presentations and Comment Format
We can only estimate the amount of
meeting time that will be needed since
it is difficult to anticipate the total
number of speakers that will register for
each meeting. Meeting participants
should arrive early to allow time to clear
security and sign-in. Each meeting is
expected to begin promptly as
scheduled. Meetings may end earlier
than the stated ending time.
srobinson on DSKHWCL6B1PROD with NOTICES
A. Oral Presentation Procedures
All primary speakers must register as
provided under the section titled
‘‘Meeting Registration.’’ Materials and
writings that will be used in support of
an oral presentation should be
submitted to one of the HCPCS Public
Meeting Coordinators.
The materials may be e-mailed or
delivered by regular mail to one of the
HCPCS Public Meeting Coordinators as
specified in the ADDRESSES section of
this notice. The materials must be emailed or postmarked no later than the
deadline specified in the DATES section
of this notice. Individuals will need to
include 35 copies if materials are
delivered by mail.
B. Primary Speaker Presentations
The individual or entity requesting
revisions to the HCPCS coding system
for a particular agenda item may
designate one ‘‘primary speaker’’ to
make a presentation for a maximum of
15 minutes. Fifteen minutes is the total
time interval for the presentation, and
the presentation must incorporate the
demonstration, set-up, and distribution
of material. In establishing the public
meeting agenda, we may group
multiple, related requests under the
same agenda item. In that case, we will
decide whether additional time will be
allotted, and may opt to increase the
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amount of time allotted to the speaker
by increments of less than 15 minutes.
Individuals designated to be the
primary speaker must register to attend
the meeting using the registration
procedures described under the
‘‘Meeting Registration’’ section of this
notice and contact one of the HCPCS
Public Meeting Coordinators, specified
in the ADDRESSES section. Primary
speakers must also separately register as
primary speakers by the date specified
in the DATES section of this notice.
C. ‘‘5-Minute’’ Speaker Presentations
Meeting attendees can sign up at the
meeting, on a first-come, first-served
basis, to make 5-minute presentations
on individual agenda items. Based on
the number of items on the agenda and
the progress of the meeting, a
determination will be made at the
meeting by the meeting coordinator and
the meeting moderator regarding how
many 5-minute speakers can be
accommodated.
D. Speaker Declaration
On the day of the meeting, before the
end of the meeting, all primary speakers
and 5-minute speakers must provide a
brief written summary of their
comments and conclusions to the
HCPCS Public Meeting Coordinator.
Each primary speaker and 5-minute
speaker must declare in their
presentation at the meeting, as well as
in their written summary, whether they
have any financial involvement with the
manufacturers or competitors of any
items being discussed; this includes any
payment, salary, remuneration, or
benefit provided to that speaker by the
manufacturer or the manufacturer’s
representatives.
E. Written Comments From Meeting
Attendees
Written comments will be accepted
from the general public and meeting
registrants anytime up to the date of the
public meeting at which a request is
discussed. Comments must be sent to
the address listed in the ADDRESSES
section of this notice.
Meeting attendees may also submit
their written comments at the meeting.
Due to the close timing of the public
meetings, subsequent workgroup
reconsiderations, and final decisions,
we are able to consider only those
comments received in writing by the
close of the public meeting at which the
request is discussed.
IV. Security, Building, and Parking
Guidelines
The meetings are held within the
CMS Complex which is not open to the
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general public. Visitors to the complex
are required to show a valid U.S.
Government issued photo identification,
preferably a driver’s license, at the time
of entry. Participants will also be subject
to a vehicular search before access to the
complex is granted. Participants not in
possession of a valid identification or
who are in possession of prohibited
items will be denied access to the
complex. Prohibited items on Federal
Property include but are not limited to,
alcoholic beverages, illegal narcotics,
dogs or other animals except Seeing Eye
dogs and other dogs trained to assist the
handicapped, explosives, firearms or
other dangerous weapons (including
pocket knives). Once cleared for entry to
the complex participants will be
directed to parking by a security officer.
In order to ensure expedited entry
into the building it is recommended that
participants have their ID and a copy of
their written meeting registration
confirmation readily available and that
they do not bring laptops or large/bulky
items into the building. Participants are
reminded that photography on the CMS
complex is prohibited. CMS has also
been declared a tobacco free campus
and violators are subject to legal action.
In planning arrival time, we recommend
allowing additional time to clear
security. Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
public may not enter the building earlier
than 45 minutes before the convening of
the meeting each day.
Guest access to the complex is limited
to the meeting area, the main lobby, and
the cafeteria. If a visitor is found outside
of those areas without proper escort
they may be escorted out of the facility.
Also be mindful that there will be an
opportunity for everyone to speak and
we request that everyone waits for the
appropriate time to present their
product or opinions. Disruptive
behavior will not be tolerated and may
result in removal from the meetings and
escort from the complex. No visitor is
allowed to attach USB cables, thumb
drives or any other equipment to any
CMS information technology (IT) system
or hardware for any purpose at anytime.
Additionally, CMS staff is prohibited
from taking such actions on behalf of a
visitor or utilizing any removable media
provided by a visitor.
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
presentation. Special arrangements and
approvals are required at least 2 weeks
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prior to each public meeting in order to
bring pieces of equipment or medical
devices. These arrangements need to be
made with the public meeting
coordinator. It is possible that certain
requests made in advance of the public
meeting could be denied because of
unique safety, security or handling
issues related to the equipment. A
minimum of 2 weeks is required for
approvals and security procedures. Any
request not submitted at least 2 weeks
in advance of the public meeting will be
denied.
CMS policy requires that every
foreign visitor is assigned a host. The
host/hosting official is required to
inform the Division of Critical
Infrastructure Protection (DCIP) at least
12 business days in advance of any visit
by a foreign national visitor. Foreign
National visitors will be required to
produce a valid passport at the time of
entry.
Attendees that are Foreign Nationals
need to identify themselves as such, and
provide the following information for
security clearance to the public meeting
coordinator by the date specified in the
DATES section of this notice:
• Visitor’s full name (as it appears on
passport).
• Gender.
• Country of origin and citizenship.
• Biographical data and related
information.
• Date of birth.
• Place of birth.
• Passport number.
• Passport issue date.
• Passport expiration date.
• Dates of visits.
• Company Name.
• Position/Title.
Authority: Section 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 42
U.S.C. 1395hh).
Dated: February 10, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–3812 Filed 2–24–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Refugee Assistance Program
Estimates: CMA—ORR–1.
OMB No.: 0970–0030.
Description:
The Refugee Assistance Program
Estimates: ORR–1 form is the
application for funding for the Refugee
Cash and Medical Assistance program.
Applicants for funding provide
estimates of costs of the different
components of the program—Refugee
Cash Assistance, Refugee Medical
Assistance, Health Screening, Services
to Unaccompanied Refugee Minors,
Administrative Cost of the Services to
Unaccompanied Refugee Minors
program, and Administrative Costs of
the State Refugee Coordinator.
Applicants also submit a narrative
justification for their estimates.
Applicants submit the form annually on
August 15 of the fiscal year prior to the
fiscal year for which funds are being
requested. The form may be submitted
through an On-Line Data Collection
system or hard copy format. The Office
of Refugee Resettlement uses the cost
estimate data from the ORR–1 in
determining and allocating quarterly
awards of funds and in projecting full
year costs of this program.
Respondents:
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Refugee Assistance Program Estimates: ORR–1 ...........................................
Estimated Total Annual Burden Hours: ...........................................................
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Instrument
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1
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2
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In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
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agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: February 22, 2011.
Robert Sargis,
Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0597]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species
AGENCY:
Food and Drug Administration,
HHS.
[FR Doc. 2011–4278 Filed 2–24–11; 8:45 am]
ACTION:
Notice.
BILLING CODE 4184–01–P
PO 00000
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Notices]
[Pages 10602-10605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1515-N]
Medicare Program; Public Meetings in Calendar Year 2011 for All
New Public Requests for Revisions to the Healthcare Common Procedure
Coding System (HCPCS) Coding and Payment Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the dates, time, and location of the
Healthcare Common Procedure Coding System (HCPCS) public meetings to be
held in calendar year 2011 to discuss our preliminary coding and
payment determinations for all new public requests for revisions to the
HCPCS. These meetings provide a forum for interested parties to make
oral presentations or to submit written comments in response to
preliminary coding and payment determinations. The discussion will be
focused on responses to our specific preliminary recommendations and
will include all items on the public meeting agenda.
DATES: Meeting Dates: The following are the 2011 HCPCS public meeting
dates:
1. Tuesday, May 17, 2011, 9 a.m. to 5 p.m. eastern daylight time
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents).
2. Wednesday, May 18, 2011, 9 a.m. to 5 p.m. e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
3. Tuesday, May 24, 2011, 9 a.m. to 5 p.m. e.d.t. (Supplies and
Other).
4. Wednesday, May 25, 2011, 9 a.m. to 5 p.m. e.d.t. (Supplies and
Other).
5. Tuesday, June 7, 2011, 9 a.m. to 5 p.m. e.d.t. (Orthotics and
Prosthetics).
6. Wednesday, June 8, 2011, 9 a.m. to 5 p.m. e.d.t. (Durable
Medical Equipment (DME) and Accessories).
Deadlines for Primary Speaker Registration and Presentation
Materials: The deadline for registering to be a primary speaker and
submitting materials and writings that will be used in support of an
oral presentation are as follows:
May 3, 2011 for the May 17, 2011 and May 18, 2011 public
meetings.
May 10, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 24, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadline for Attendees that are Foreign Nationals (reside outside
the U.S.) Registration: Attendees that are Foreign Nationals (reside
outside the U.S.) are required to identify themselves as such, and
provide the necessary information for security clearance (as described
in section IV. of this notice) to the public meeting coordinator at
least 12 business days in advance of the date of the public meeting
date the individual plans to attend. Therefore, the deadlines for
attendees that are Foreign Nationals are as follows:
April 29, 2011 for the May 17, 2011 and May 18, 2011
public meetings.
May 6, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 19, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadlines for all Other Attendees Registration: All other
individuals who plan to enter the building to attend the public meeting
must register for each date that they plan on attending. The
registration deadlines are different for each meeting. Registration
deadlines are as follows:
May 10, 2011 for the May 17, 2011 and May 18, 2011 public
meeting dates.
May 17, 2011 for the May 24, 2011 and May 25, 2011 public
meeting dates.
May 31, 2011 for the June 7, 2011 and June 8, 2011 public
meeting dates.
Deadlines for Requesting Special Accommodations: Individuals who
plan to attend the public meetings and require sign-language
interpretation or other special assistance must request these services
by the following deadlines:
May 3, 2011 for the May 17, 2011 and May 18, 2011 public
meetings.
May 10, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 24, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadline for Submission of Written Comments: Written comments must
be received by the date of the meeting at which the code request is
scheduled for discussion.
ADDRESSES: Meeting Location: The public meetings will be held in the
main auditorium of the central building of the Centers for Medicare and
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[[Page 10603]]
Submission of Written Comments: Written comments may either be e-
mailed to HCPCS@cms.hhs.gov or sent via regular mail to Jennifer Carver
or Sharon Ventura, HCPCS Public Meeting Coordinator, Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-
27, Baltimore, MD 21244-1850.
Registration and Special Accommodations: Individuals wishing to
participate or who need special accommodations or both must register by
completing the on-line registration located at https://www.cms.hhs.gov/medhcpcsgeninfo or by contacting one of the following persons: Jennifer
Carver at (410) 786-6610 or Jennifer.Carver@cms.hhs.gov; or Sharon
Ventura at (410)786-1985 or Sharon.Ventura@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or
Jennifer.Carver@cms.hhs.gov; or Sharon Ventura at (410) 786-1985 or
Sharon.Ventura@cms.hhs.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress passed the Medicare, Medicaid,
and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub.
L. 106-554). Section 531(b) of BIPA mandated that we establish
procedures that permit public consultation for coding and payment
determinations for new durable medical equipment (DME) under Medicare
Part B of title XVIII of the Social Security Act (the Act). The
procedures and public meetings announced in this notice for new DME are
in response to the mandate of section 531(b) of BIPA.
In the November 23, 2001 Federal Register (66 FR 58743), we
published a notice providing information regarding the establishment of
the public meeting process for DME. It is our intent to distribute any
materials submitted to CMS to the Healthcare Common Procedure Coding
System (HCPCS) workgroup members for their consideration. CMS and the
HCPCS workgroup members require sufficient preparation time to review
all relevant materials. Therefore, we are implementing a 10-page
submission limit and firm deadlines for receipt of any presentation
materials a meeting speaker wishes us to consider. For this reason, our
HCPCS Public Meeting Coordinators will only accept and review
presentation materials received by the deadline for each public
meeting, as specified in the DATES section of this notice.
The public meeting process provides an opportunity for the public
to become aware of coding changes under consideration, as well as an
opportunity for CMS to gather public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be provided when registering:
Name.
Company name and address.
Direct-dial telephone and fax numbers.
E-mail address.
Special needs information.
A CMS staff member will confirm your registration by e-mail.
B. Registration Process
1. Primary Speakers
Individuals must also indicate whether they are the ``primary
speaker'' for an agenda item. Primary speakers must be designated by
the entity that submitted the HCPCS coding request. When registering,
primary speakers must provide a brief written statement regarding the
nature of the information they intend to provide, and advise the HCPCS
Public Meeting Coordinator regarding needs for audio/visual support. To
avoid disruption of the meeting and ensure compatibility with our
systems, tapes, and disk files are tested and arranged in speaker
sequence well in advance of the meeting. We will accept tapes and disk
files that are received by the deadline for submissions for each public
meeting as specified in the DATES section of this notice. The sum of
all materials including the presentation may not exceed 10 pages (each
side of a page counts as 1 page). An exception will be made to the 10-
page limit for relevant studies published between the application
deadline and the public meeting date, in which case, we would like a
copy of the complete publication as soon as possible. This exception
applies only to the page limit and not the deadline submission.
The materials may be e-mailed or delivered by regular mail to one
of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES
section of this notice. The materials must be e-mailed or postmarked no
later than the deadline specified in the DATES section of this notice.
Individuals will need to provide 35 copies if materials are delivered
by mail.
2. 5-Minute Speakers
To afford the same opportunity to all attendees, 5-minute speakers
are not required to register as primary speakers. However, 5-minute
speakers must still register as attendees by the deadline set forth
under ``Deadlines for all Other Attendees Registration'' in the DATES
section of this notice. Attendees can sign up only on the day of the
meeting to do a 5-minute presentation. Individuals must provide their
name, company name and address, contact information as specified on the
sign-up sheet, and identify the specific agenda item that they will
address.
C. Additional Meeting/Registration Information
Public Meetings are scheduled far in advance of the influx of HCPCS
applications each cycle. At the time they are scheduled we can only
anticipate the number of applications that we receive in each category.
As a result, we may not need the second day of Drugs/Biologicals/
Radiopharmaceuticals/Radiologic Imaging Agents Public Meeting on
Wednesday, May 18, 2011. We have scheduled this date tentatively. The
Public Meeting Agendas published on CMS' HCPCS Web site at https://
www.cms.hhs.gov/medhcpcsgeninfo will serve as final notification
regarding whether a meeting will be held on Wednesday, May 18, 2011.
The product category reported by the applicant may not be the same
as that assigned by us. Prior to registering to attend a public
meeting, all participants are advised to review the public meeting
agendas at https://www.cms.hhs.gov/medhcpcsgeninfo which identify our
category determinations, and the dates each item will be discussed.
Draft agendas, including a summary of each request and our preliminary
decision will be posted on our HCPCS Web site at https://
www.cms.hhs.gov/medhcpcsgeninfo at least 4 weeks before each meeting.
Additional details regarding the public meeting process for all new
public requests for revisions to the HCPCS, along with information on
how to register and guidelines for an effective presentation, will be
posted at least 4 weeks before the first meeting date on the official
HCPCS Web site at https://www.cms.hhs.gov/medhcpcsgeninfo. The document
titled ``Guidelines for Participation in Public Meetings for All New
Public Requests for Revisions to the Healthcare Common Procedure Coding
System (HCPCS)'' will be made available on the HCPCS Web site at least
4 weeks before the first public meeting in 2011 for all new public
requests for revisions to the HCPCS. Individuals who intend to provide
a presentation at a public meeting need to familiarize themselves
[[Page 10604]]
with the HCPCS Web site and the valuable information it provides to
prospective registrants. The HCPCS Web site also contains a document
titled ``Healthcare Common Procedure Coding System (HCPCS) Level II
Coding Procedures,'' which is a description of the HCPCS coding
process, including a detailed explanation of the procedures used to
make coding determinations for all the products, supplies, and services
that are coded in the HCPCS.
The HCPCS Web site also contains a document titled ``HCPCS Decision
Tree & Definitions'' which illustrates, in flow diagram format, HCPCS
coding standards as described in our Coding Procedures document.
A summary of each public meeting will be posted on the HCPCS Web
site by the end of August 2011.
III. Presentations and Comment Format
We can only estimate the amount of meeting time that will be needed
since it is difficult to anticipate the total number of speakers that
will register for each meeting. Meeting participants should arrive
early to allow time to clear security and sign-in. Each meeting is
expected to begin promptly as scheduled. Meetings may end earlier than
the stated ending time.
A. Oral Presentation Procedures
All primary speakers must register as provided under the section
titled ``Meeting Registration.'' Materials and writings that will be
used in support of an oral presentation should be submitted to one of
the HCPCS Public Meeting Coordinators.
The materials may be e-mailed or delivered by regular mail to one
of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES
section of this notice. The materials must be e-mailed or postmarked no
later than the deadline specified in the DATES section of this notice.
Individuals will need to include 35 copies if materials are delivered
by mail.
B. Primary Speaker Presentations
The individual or entity requesting revisions to the HCPCS coding
system for a particular agenda item may designate one ``primary
speaker'' to make a presentation for a maximum of 15 minutes. Fifteen
minutes is the total time interval for the presentation, and the
presentation must incorporate the demonstration, set-up, and
distribution of material. In establishing the public meeting agenda, we
may group multiple, related requests under the same agenda item. In
that case, we will decide whether additional time will be allotted, and
may opt to increase the amount of time allotted to the speaker by
increments of less than 15 minutes.
Individuals designated to be the primary speaker must register to
attend the meeting using the registration procedures described under
the ``Meeting Registration'' section of this notice and contact one of
the HCPCS Public Meeting Coordinators, specified in the ADDRESSES
section. Primary speakers must also separately register as primary
speakers by the date specified in the DATES section of this notice.
C. ``5-Minute'' Speaker Presentations
Meeting attendees can sign up at the meeting, on a first-come,
first-served basis, to make 5-minute presentations on individual agenda
items. Based on the number of items on the agenda and the progress of
the meeting, a determination will be made at the meeting by the meeting
coordinator and the meeting moderator regarding how many 5-minute
speakers can be accommodated.
D. Speaker Declaration
On the day of the meeting, before the end of the meeting, all
primary speakers and 5-minute speakers must provide a brief written
summary of their comments and conclusions to the HCPCS Public Meeting
Coordinator.
Each primary speaker and 5-minute speaker must declare in their
presentation at the meeting, as well as in their written summary,
whether they have any financial involvement with the manufacturers or
competitors of any items being discussed; this includes any payment,
salary, remuneration, or benefit provided to that speaker by the
manufacturer or the manufacturer's representatives.
E. Written Comments From Meeting Attendees
Written comments will be accepted from the general public and
meeting registrants anytime up to the date of the public meeting at
which a request is discussed. Comments must be sent to the address
listed in the ADDRESSES section of this notice.
Meeting attendees may also submit their written comments at the
meeting. Due to the close timing of the public meetings, subsequent
workgroup reconsiderations, and final decisions, we are able to
consider only those comments received in writing by the close of the
public meeting at which the request is discussed.
IV. Security, Building, and Parking Guidelines
The meetings are held within the CMS Complex which is not open to
the general public. Visitors to the complex are required to show a
valid U.S. Government issued photo identification, preferably a
driver's license, at the time of entry. Participants will also be
subject to a vehicular search before access to the complex is granted.
Participants not in possession of a valid identification or who are in
possession of prohibited items will be denied access to the complex.
Prohibited items on Federal Property include but are not limited to,
alcoholic beverages, illegal narcotics, dogs or other animals except
Seeing Eye dogs and other dogs trained to assist the handicapped,
explosives, firearms or other dangerous weapons (including pocket
knives). Once cleared for entry to the complex participants will be
directed to parking by a security officer.
In order to ensure expedited entry into the building it is
recommended that participants have their ID and a copy of their written
meeting registration confirmation readily available and that they do
not bring laptops or large/bulky items into the building. Participants
are reminded that photography on the CMS complex is prohibited. CMS has
also been declared a tobacco free campus and violators are subject to
legal action. In planning arrival time, we recommend allowing
additional time to clear security. Individuals who are not registered
in advance will not be permitted to enter the building and will be
unable to attend the meeting. The public may not enter the building
earlier than 45 minutes before the convening of the meeting each day.
Guest access to the complex is limited to the meeting area, the
main lobby, and the cafeteria. If a visitor is found outside of those
areas without proper escort they may be escorted out of the facility.
Also be mindful that there will be an opportunity for everyone to speak
and we request that everyone waits for the appropriate time to present
their product or opinions. Disruptive behavior will not be tolerated
and may result in removal from the meetings and escort from the
complex. No visitor is allowed to attach USB cables, thumb drives or
any other equipment to any CMS information technology (IT) system or
hardware for any purpose at anytime. Additionally, CMS staff is
prohibited from taking such actions on behalf of a visitor or utilizing
any removable media provided by a visitor.
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
presentation. Special arrangements and approvals are required at least
2 weeks
[[Page 10605]]
prior to each public meeting in order to bring pieces of equipment or
medical devices. These arrangements need to be made with the public
meeting coordinator. It is possible that certain requests made in
advance of the public meeting could be denied because of unique safety,
security or handling issues related to the equipment. A minimum of 2
weeks is required for approvals and security procedures. Any request
not submitted at least 2 weeks in advance of the public meeting will be
denied.
CMS policy requires that every foreign visitor is assigned a host.
The host/hosting official is required to inform the Division of
Critical Infrastructure Protection (DCIP) at least 12 business days in
advance of any visit by a foreign national visitor. Foreign National
visitors will be required to produce a valid passport at the time of
entry.
Attendees that are Foreign Nationals need to identify themselves as
such, and provide the following information for security clearance to
the public meeting coordinator by the date specified in the DATES
section of this notice:
Visitor's full name (as it appears on passport).
Gender.
Country of origin and citizenship.
Biographical data and related information.
Date of birth.
Place of birth.
Passport number.
Passport issue date.
Passport expiration date.
Dates of visits.
Company Name.
Position/Title.
Authority: Section 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 42 U.S.C. 1395hh).
Dated: February 10, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-3812 Filed 2-24-11; 8:45 am]
BILLING CODE 4120-01-P
