[Federal Register Volume 74, Number 38 (Friday, February 27, 2009)]
[Notices]
[Pages 8969-8972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1497-N]


Medicare Program; Public Meetings in Calendar Year 2009 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 2009 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 2009 HCPCS public meeting 
dates:
    1. Tuesday, April 28, 2009, 9 a.m. to 5 p.m., eastern daylight time 
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging 
Agents).
    2. Wednesday, April 29, 2009, 9 a.m. to 5 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
    3. Tuesday, May 12, 2009, 9 a.m. to 5 p.m., e.d.t. (Supplies and 
Other).
    4. Wednesday, May 13, 2009, 9 a.m. to 5 p.m., e.d.t. (Supplies and 
Other).
    5. Wednesday, May 27, 2009, 9 a.m. to 5 p.m., e.d.t. (Orthotics and 
Prosthetics).
    6. Thursday, May 28, 2009, 9 a.m. to 5 p.m., e.d.t. (Durable 
Medical Equipment (DME) and Accessories).
    7. Thursday, July 9, 2009, 9 a.m. to 5 p.m., e.d.t. (Durable 
Medical Equipment (DME) and Accessories, including Negative Pressure 
Wound Therapy (NPWT) devices.
    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 14, 2009 for the April 28 and 29, 2009 public 
meetings.
     April 28, 2009 for the May 12 and 13, 2009 public 
meetings.
     May 13, 2009 for the May 27 and 28, 2009 public meetings.
     June 25, 2009 for the July 9, 2009 public meeting.
    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 21, 2009 for the April 28 and 29, 2009 public 
meeting dates.
     May 5, 2009 for the May 12 and 13, 2009 public meeting 
dates.
     May 20, 2009 for the May 27 and 28, 2009 public meetings.
     July 2, 2009 for the July 9, 2009 public meeting.
    Deadlines for Requesting Special Accommodations:
     April 14, 2009 for the April 28 and 29, 2009 public 
meeting dates.
     April 28, 2009 for the May 12 and 13, 2009 public meeting 
dates.
     May 13, 2009 for the May 27 and 28, 2009 public meetings.
     June 25, 2009 for the July 9, 2009 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.

[[Page 8970]]

    Submission of Written Comments: Written comments can be e-mailed to 
[email protected] or sent via regular mail to Jennifer Carver or Gloria 
Knight, 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 Gloria 
Knight at (410) 786-4598 or [email protected].

FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or 
[email protected]; or Gloria Knight at (410) 786-4598 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; and
     Special needs information.
A CMS staff member will confirm your registration by mail, e-mail, or 
fax.

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 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. They 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, April 29, 2009). 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 April 29, 2009.
    The product category reported by the applicant may not be the same 
as that 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 ``The 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 and payment 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

[[Page 8971]]

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 2009.

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 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) Coding and Payment Determinations'' on 
the official HCPCS Web site at least 4 weeks before the first public 
meeting in 2009 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

    (1) 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.
    (2) Meeting attendees may also submit their written comments at the 
meeting.
    (3) 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.
    To ensure that foreign visitors have appropriate access to 
Department facilities, HHS has established a policy regarding HHS 
employees hosting foreign nationals to clear such visits with the 
appropriate security officials. 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 registration date:
     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

[[Page 8972]]

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 20, 2009.
Charlene Frizzera,
Acting Adminstrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-4124 Filed 2-26-09; 8:45 am]
BILLING CODE 4120-01-P