Medicare Program; Public Meetings in Calendar Year 2010 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 8971-8974 [2010-3722]
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Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices
On August 5, 2008 (73 FR 45454),
FDA announced the availability of the
draft version of this guidance. The
public comment period closed on
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ComplianceRegulatoryInformation/
Guidances/default.htm, https://
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www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–3978 Filed 2–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI K99 Grant
Applications.
Date: March 1, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel—Chevy Chase
Pavilion Washington, DC 20015.
Contact Person: Daniel R. Kenshalo, PhD,
Scientific Review Officer, National Eye
Institute, National Institutes of Health, 5635
Fishers Lane, Suite 1300, MSC 9300,
Bethesda, MD 20892, 301–451–2020,
kenshalod@nei.nih.gov.
This Notice is late due to administrative
procedures.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: February 17 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–3784 Filed 2–25–10; 8:45 am]
BILLING CODE 4140–01–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1514–N]
Medicare Program; Public Meetings in
Calendar Year 2010 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 2010 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.
Discussion will be directed toward
responses to our specific preliminary
recommendations and will include all
items on the public meeting agenda.
DATES: Meeting Dates: The following are
the 2010 HCPCS public meeting dates:
1. Tuesday, May 4, 2010, 9 a.m. to 5
p.m., eastern daylight time (e.d.t.)
(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 5, 2010, 9 a.m. to
5 p.m., e.d.t. (Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
3. Tuesday, May 25, 2010, 9 a.m. to
5 p.m., e.d.t. (Supplies and Other).
4. Wednesday, May 26, 2010, 9 a.m.
to 5 p.m., e.d.t. (Supplies and Other).
5. Thursday, May 27, 2010, 9 a.m. to
5 p.m, e.d.t. (Orthotics and Prosthetics).
6. Tuesday, June 8, 2010, 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:
• April 20, 2010 for the May 4 and 5,
2010 public meetings.
• May 11, 2010 for the May 25, 26
and 27, 2010 public meetings.
• May 25, 2010 for the June 8, 2010
public meeting.
Deadline for Attendees that are
Foreign Nationals (reside outside the
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U.S.) Registration: Attendees that are
Foreign Nationals (reside outside the
U.S.) need 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
10 business days in advance of the
public meeting date in which the
individual plans to attend.
Deadlines for all Other Attendees
Registration: All individuals must
register for each date that they plan on
attending. The registration deadlines are
different for each meeting. Registration
deadlines are as follows:
• April 27, 2010 for the May 4 and 5,
2010 public meeting dates.
• May 18, 2010 for the May 25, 26
and 27, 2010 public meeting dates.
• June 1, 2010 for the June 8, 2010
public meeting date.
Deadlines for Requesting Special
Accommodations:
• April 20, 2010 for the May 4 and 5,
2010 public meeting dates.
• May 11, 2010 for the May 25, 26
and 27, 2010 public meeting dates.
• May 25, 2010 for the June 8, 2010
public meeting.
Deadline for Submission of Written
Comments: Written comments must be
received by the date of meeting at which
a 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.
Submission of Written Comments:
Written comments can be e-mailed to
HCPCS@cms.hhs.gov or sent via regular
mail to Jennifer Carver or Geneva
Harkness, HCPCS Public Meeting
Coordinator, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail Stop C5–08–27,
Baltimore, MD 21244.
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 Geneva
Harkness at (410) 786–6951 or
Geneva.Harkness@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jennifer Carver at (410) 786–6610 or
Jennifer.Carver@cms.hhs.gov; or Geneva
Harkness at (410) 786–6951 or
Geneva.Harkness@cms.hhs.gov.
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 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 the meeting
participant wishes CMS 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
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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.
These materials may be delivered by
regular mail postmark date no later than
the deadline date or by e-mail to one of
the HCPCS Public Meeting Coordinators
as specified in the ADDRESSES 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
Wednesday, May 5, 2010. 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 May
5, 2010.
The product category reported by the
applicant may not be the same as that
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assigned by CMS. 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 CMS’ 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 HCPCS Web site at https://
www.cms.hhs.gov/medhcpcsgeninfo.
Individuals who intend to provide a
presentation at a public meeting need to
familiarize themselves with the HCPCS
Web site and the valuable information it
provides to prospective registrants. The
HCPCS Web site 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 2010.
than the deadline date) or by e-mail to
one of the HCPCS Public Meeting
Coordinators specified in the ADDRESSES
section. 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.
We will post ‘‘Guidelines for
Participation in Public Meetings for All
New Public Requests for Revisions to
the Healthcare Common Procedure
Coding System (HCPCS)’’ on the official
HCPCS Web site at least 4 weeks before
the first public meeting in 2010 for all
new public requests for revisions to the
HCPCS. 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.
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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.
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.
A. Oral Presentation Procedures
Individuals who are planning to
provide an oral presentation 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.
These materials may be delivered by
regular mail (postmark date no later
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
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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 in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. In order to gain access to
the building and grounds, participants
must bring government-issued photo
identification and a copy of your written
meeting registration confirmation.
Persons without proper identification
will be denied access.
CMS has had a long standing policy
of established Visitor and Foreign
National Visitor controls that effectively
control access to sensitive facilities and
restricted/controlled areas containing
CMS information, information systems,
and media libraries. Visitors shall be
authenticated prior to being granted
access to facilities or areas other than
areas designated as publicly accessible.
Government contractors and others with
permanent authorization credentials are
not considered visitors.
However, HHS policy requires us to
ensure that a government employee, US
citizen host/hosting official is assigned
to every foreign national visitor visiting
an HHS facility. As such, the host/
hosting official is required to inform the
Security and Emergency Management
Group (SEMG) Division of Physical
Security, at least 10 business days in
advance of any visit by a foreign
national visitor.
No visitor is allowed to attach USB
cables, thumb drives or any other
equipment to any CMS information
technology (IT) system or hardware for
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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.
Attendees that are Foreign Nationals
(reside outside the U.S.) 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; and
• Dates of visits.
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.
Security measures will also include
inspection of vehicles, inside and
outside, at the entrance to the grounds
and buildings. In addition, all persons
entering the building must pass through
a metal detector. All items brought to
CMS 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
presentation. Special arrangements and
approvals are required in order to bring
pieces of equipment or medical devices
at least 2 weeks prior to each public
meeting. 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.
Parking permits and instructions are
issued upon arrival by the guards at the
main entrance.
All visitors must be escorted by
agency staff in order to enter areas other
than the public areas on the lower and
first-floor levels in the Central Building.
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Authority: Section 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 42
U.S.C. 1395hh).
Dated: February 18, 2010.
Charlene Frizzera,
Acting Adminstrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2010–3722 Filed 2–25–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Maternal and Child
Health in Poor Countries: Evidence from
Randomized Evaluations.
Date: March 18, 2010.
Time: 11 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852.(Telephone Conference Call)
Contact Person: Carla T. Walls, PhD,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
(301) 435–6898, wallsc@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the closing
of the Federal Government the week of
February 7, 2010. The Federal Government
was closed due to inclement weather
conditions.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
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Dated: February 19, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4081 Filed 2–25–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Scientific Management Review Board.
The NIH Reform Act of 2006 (Pub. L.
109–482) provides organizational
authorities to HHS and NIH officials to:
(1) Establish or abolish national research
institutes; (2) reorganize the offices
within the Office of the Director, NIH
including adding, removing, or
transferring the functions of such offices
or establishing or terminating such
offices; and (3) reorganize, divisions,
centers, or other administrative units
within an NIH national research
institute or national center including
adding, removing, or transferring the
functions of such units, or establishing
or terminating such units. The purpose
of the Scientific Management Review
Board (also referred to as SMRB or
Board) is to advise appropriate HHS and
NIH officials on the use of these
organizational authorities and identify
the reasons underlying the
recommendations.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Scientific
Management Review Board.
Date: March 10, 2010.
Time: 8 a.m. to 4:30 p.m.
Agenda: Presentation and discussion will
include updates from SMRB Working
Groups; Deliberating Organization Change
and Effectiveness; NIH Intramural Research
Program; and Substance Use, Abuse, and
Addiction. The Board will also discuss
perspectives on organizational change. Time
will be allotted on the agenda for public
comment. Sign up for public comment will
begin at approximately 7 a.m. and will be
restricted to one sign in per person. In the
event that time does not allow for all those
interested to present oral comments, anyone
may file written comments using the contact
person address below.
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[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8971-8974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1514-N]
Medicare Program; Public Meetings in Calendar Year 2010 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.
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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 2010 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. Discussion will be
directed toward responses to our specific preliminary recommendations
and will include all items on the public meeting agenda.
DATES: Meeting Dates: The following are the 2010 HCPCS public meeting
dates:
1. Tuesday, May 4, 2010, 9 a.m. to 5 p.m., eastern daylight time
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents).
2. Wednesday, May 5, 2010, 9 a.m. to 5 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
3. Tuesday, May 25, 2010, 9 a.m. to 5 p.m., e.d.t. (Supplies and
Other).
4. Wednesday, May 26, 2010, 9 a.m. to 5 p.m., e.d.t. (Supplies and
Other).
5. Thursday, May 27, 2010, 9 a.m. to 5 p.m, e.d.t. (Orthotics and
Prosthetics).
6. Tuesday, June 8, 2010, 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:
April 20, 2010 for the May 4 and 5, 2010 public meetings.
May 11, 2010 for the May 25, 26 and 27, 2010 public
meetings.
May 25, 2010 for the June 8, 2010 public meeting.
Deadline for Attendees that are Foreign Nationals (reside outside
the
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U.S.) Registration: Attendees that are Foreign Nationals (reside
outside the U.S.) need 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 10
business days in advance of the public meeting date in which the
individual plans to attend.
Deadlines for all Other Attendees Registration: All individuals
must register for each date that they plan on attending. The
registration deadlines are different for each meeting. Registration
deadlines are as follows:
April 27, 2010 for the May 4 and 5, 2010 public meeting
dates.
May 18, 2010 for the May 25, 26 and 27, 2010 public
meeting dates.
June 1, 2010 for the June 8, 2010 public meeting date.
Deadlines for Requesting Special Accommodations:
April 20, 2010 for the May 4 and 5, 2010 public meeting
dates.
May 11, 2010 for the May 25, 26 and 27, 2010 public
meeting dates.
May 25, 2010 for the June 8, 2010 public meeting.
Deadline for Submission of Written Comments: Written comments must
be received by the date of meeting at which a 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.
Submission of Written Comments: Written comments can be e-mailed to
HCPCS@cms.hhs.gov or sent via regular mail to Jennifer Carver or Geneva
Harkness, HCPCS Public Meeting Coordinator, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-27,
Baltimore, MD 21244.
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 Geneva
Harkness at (410) 786-6951 or Geneva.Harkness@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or
Jennifer.Carver@cms.hhs.gov; or Geneva Harkness at (410) 786-6951 or
Geneva.Harkness@cms.hhs.gov.
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 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 the meeting participant wishes CMS 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.
These materials may be delivered by regular mail postmark date no
later than the deadline date or by e-mail to one of the HCPCS Public
Meeting Coordinators as specified in the ADDRESSES 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
Wednesday, May 5, 2010. 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 May 5, 2010.
The product category reported by the applicant may not be the same
as that
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assigned by CMS. 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 CMS' 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 HCPCS Web
site at https://www.cms.hhs.gov/medhcpcsgeninfo. Individuals who intend
to provide a presentation at a public meeting need to familiarize
themselves with the HCPCS Web site and the valuable information it
provides to prospective registrants. The HCPCS Web site 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 2010.
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
Individuals who are planning to provide an oral presentation 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.
These materials may be delivered by regular mail (postmark date no
later than the deadline date) or by e-mail to one of the HCPCS Public
Meeting Coordinators specified in the ADDRESSES section. 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.
We will post ``Guidelines for Participation in Public Meetings for
All New Public Requests for Revisions to the Healthcare Common
Procedure Coding System (HCPCS)'' on the official HCPCS Web site at
least 4 weeks before the first public meeting in 2010 for all new
public requests for revisions to the HCPCS. 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 in a Federal government building; therefore,
Federal security measures are applicable. In planning your arrival
time, we recommend allowing additional time to clear security. In order
to gain access to the building and grounds, participants must bring
government-issued photo identification and a copy of your written
meeting registration confirmation. Persons without proper
identification will be denied access.
CMS has had a long standing policy of established Visitor and
Foreign National Visitor controls that effectively control access to
sensitive facilities and restricted/controlled areas containing CMS
information, information systems, and media libraries. Visitors shall
be authenticated prior to being granted access to facilities or areas
other than areas designated as publicly accessible. Government
contractors and others with permanent authorization credentials are not
considered visitors.
However, HHS policy requires us to ensure that a government
employee, US citizen host/hosting official is assigned to every foreign
national visitor visiting an HHS facility. As such, the host/hosting
official is required to inform the Security and Emergency Management
Group (SEMG) Division of Physical Security, at least 10 business days
in advance of any visit by a foreign national visitor.
No visitor is allowed to attach USB cables, thumb drives or any
other equipment to any CMS information technology (IT) system or
hardware for
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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.
Attendees that are Foreign Nationals (reside outside the U.S.) 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; and
Dates of visits.
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.
Security measures will also include inspection of vehicles, inside
and outside, at the entrance to the grounds and buildings. In addition,
all persons entering the building must pass through a metal detector.
All items brought to CMS 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 presentation. Special
arrangements and approvals are required in order to bring pieces of
equipment or medical devices at least 2 weeks prior to each public
meeting. 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.
Parking permits and instructions are issued upon arrival by the
guards at the main entrance.
All visitors must be escorted by agency staff in order to enter
areas other than the public areas on the lower and first-floor levels
in the Central Building.
Authority: Section 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 42 U.S.C. 1395hh).
Dated: February 18, 2010.
Charlene Frizzera,
Acting Adminstrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-3722 Filed 2-25-10; 8:45 am]
BILLING CODE 4120-01-P
