[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Notices]
[Pages 10602-10605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3812]


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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.

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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 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:
    <bullet> May 3, 2011 for the May 17, 2011 and May 18, 2011 public 
meetings.
    <bullet> May 10, 2011 for the May 24, 2011 and May 25, 2011 public 
meetings.
    <bullet> 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:
    <bullet> April 29, 2011 for the May 17, 2011 and May 18, 2011 
public meetings.
    <bullet> May 6, 2011 for the May 24, 2011 and May 25, 2011 public 
meetings.
    <bullet> 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:
    <bullet> May 10, 2011 for the May 17, 2011 and May 18, 2011 public 
meeting dates.
    <bullet> May 17, 2011 for the May 24, 2011 and May 25, 2011 public 
meeting dates.
    <bullet> 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:
    <bullet> May 3, 2011 for the May 17, 2011 and May 18, 2011 public 
meetings.
    <bullet> May 10, 2011 for the May 24, 2011 and May 25, 2011 public 
meetings.
    <bullet> 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 <a href="/cdn-cgi/l/email-protection#6d252e3d2e3e2d0e001e4305051e430a021b"><span class="__cf_email__" data-cfemail="9ed6ddceddcddefdf3edb0f6f6edb0f9f1e8">[email protected]</span></a> 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 http://www.cms.hhs.gov/medhcpcsgeninfo or by contacting one of the following persons: Jennifer 
Carver at (410) 786-6610 or <a href="/cdn-cgi/l/email-protection#69230c0707000f0c1b472a081b1f0c1b290a041a4701011a470e061f"><span class="__cf_email__" data-cfemail="642e010a0a0d0201164a270516120116240709174a0c0c174a030b12">[email protected]</span></a>; or Sharon 
Ventura at (410)786-1985 or <a href="/cdn-cgi/l/email-protection#ce9da6afbca1a0e098aba0babbbcaf8eada3bde0a6a6bd"><span class="__cf_email__" data-cfemail="30635851425f5e1e66555e4445425170535d431e585843">[email protected]</span></a>.gov.

FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or 
<a href="/cdn-cgi/l/email-protection#29634c4747404f4c5b076a485b5f4c5b694a445a0741415a074e465f"><span class="__cf_email__" data-cfemail="2c66494242454a495e026f4d5e5a495e6c4f415f0244445f024b435a">[email protected]</span></a>; or Sharon Ventura at (410) 786-1985 or 
<a href="/cdn-cgi/l/email-protection#fead969f8c9190d0a89b908a8b8c9fbe9d938dd096968d"><span class="__cf_email__" data-cfemail="ce9da6afbca1a0e098aba0babbbcaf8eada3bde0a6a6bd">[email protected]</span></a>.

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:
    <bullet> Name.
    <bullet> Company name and address.
    <bullet> Direct-dial telephone and fax numbers.
    <bullet> E-mail address.
    <bullet> 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 http://
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 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 our 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 official 
HCPCS Web site at http://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:
    <bullet> Visitor's full name (as it appears on passport).
    <bullet> Gender.
    <bullet> Country of origin and citizenship.
    <bullet> Biographical data and related information.
    <bullet> Date of birth.
    <bullet> Place of birth.
    <bullet> Passport number.
    <bullet> Passport issue date.
    <bullet> Passport expiration date.
    <bullet> Dates of visits.
    <bullet> Company Name.
    <bullet> 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


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