[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8971-8974]
From the Federal Register Online via the Government Publishing 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
[email protected] 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 http://www.cms.hhs.gov/medhcpcsgeninfo or by contacting one of the following persons: Jennifer
Carver at (410) 786-6610 or [email protected]; or Geneva
Harkness at (410) 786-6951 or [email protected].
FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or
[email protected]; or Geneva Harkness at (410) 786-6951 or
[email protected].
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 http://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 http://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 http://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 http://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