[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1515-N]
Medicare Program; Public Meetings in Calendar Year 2011 for All
New Public Requests for Revisions to the Healthcare Common Procedure
Coding System (HCPCS) Coding and Payment Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the dates, time, and location of the
Healthcare Common Procedure Coding System (HCPCS) public meetings to be
held in calendar year 2011 to discuss our preliminary coding and
payment determinations for all new public requests for revisions to the
HCPCS. These meetings provide a forum for interested parties to make
oral presentations or to submit written comments in response to
preliminary coding and payment determinations. The discussion will be
focused on responses to our specific preliminary recommendations and
will include all items on the public meeting agenda.
DATES: Meeting Dates: The following are the 2011 HCPCS public meeting
dates:
1. Tuesday, May 17, 2011, 9 a.m. to 5 p.m. eastern daylight time
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents).
2. Wednesday, May 18, 2011, 9 a.m. to 5 p.m. e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
3. Tuesday, May 24, 2011, 9 a.m. to 5 p.m. e.d.t. (Supplies and
Other).
4. Wednesday, May 25, 2011, 9 a.m. to 5 p.m. e.d.t. (Supplies and
Other).
5. Tuesday, June 7, 2011, 9 a.m. to 5 p.m. e.d.t. (Orthotics and
Prosthetics).
6. Wednesday, June 8, 2011, 9 a.m. to 5 p.m. e.d.t. (Durable
Medical Equipment (DME) and Accessories).
Deadlines for Primary Speaker Registration and Presentation
Materials: The deadline for registering to be a primary speaker and
submitting materials and writings that will be used in support of an
oral presentation are as follows:
May 3, 2011 for the May 17, 2011 and May 18, 2011 public
meetings.
May 10, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 24, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadline for Attendees that are Foreign Nationals (reside outside
the U.S.) Registration: Attendees that are Foreign Nationals (reside
outside the U.S.) are required to identify themselves as such, and
provide the necessary information for security clearance (as described
in section IV. of this notice) to the public meeting coordinator at
least 12 business days in advance of the date of the public meeting
date the individual plans to attend. Therefore, the deadlines for
attendees that are Foreign Nationals are as follows:
April 29, 2011 for the May 17, 2011 and May 18, 2011
public meetings.
May 6, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 19, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadlines for all Other Attendees Registration: All other
individuals who plan to enter the building to attend the public meeting
must register for each date that they plan on attending. The
registration deadlines are different for each meeting. Registration
deadlines are as follows:
May 10, 2011 for the May 17, 2011 and May 18, 2011 public
meeting dates.
May 17, 2011 for the May 24, 2011 and May 25, 2011 public
meeting dates.
May 31, 2011 for the June 7, 2011 and June 8, 2011 public
meeting dates.
Deadlines for Requesting Special Accommodations: Individuals who
plan to attend the public meetings and require sign-language
interpretation or other special assistance must request these services
by the following deadlines:
May 3, 2011 for the May 17, 2011 and May 18, 2011 public
meetings.
May 10, 2011 for the May 24, 2011 and May 25, 2011 public
meetings.
May 24, 2011 for the June 7, 2011 and June 8, 2011 public
meetings.
Deadline for Submission of Written Comments: Written comments must
be received by the date of the meeting at which the code request is
scheduled for discussion.
ADDRESSES: Meeting Location: The public meetings will be held in the
main auditorium of the central building of the Centers for Medicare and
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[[Page 10603]]
Submission of Written Comments: Written comments may either be e-
mailed to [email protected] 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 [email protected]; or Sharon
Ventura at (410)786-1985 or [email protected].gov.
FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or
[email protected]; or Sharon Ventura at (410) 786-1985 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 Healthcare Common Procedure Coding
System (HCPCS) workgroup members for their consideration. CMS and the
HCPCS workgroup members require sufficient preparation time to review
all relevant materials. Therefore, we are implementing a 10-page
submission limit and firm deadlines for receipt of any presentation
materials a meeting speaker wishes us to consider. For this reason, our
HCPCS Public Meeting Coordinators will only accept and review
presentation materials received by the deadline for each public
meeting, as specified in the DATES section of this notice.
The public meeting process provides an opportunity for the public
to become aware of coding changes under consideration, as well as an
opportunity for CMS to gather public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be provided when registering:
Name.
Company name and address.
Direct-dial telephone and fax numbers.
E-mail address.
Special needs information.
A CMS staff member will confirm your registration by e-mail.
B. Registration Process
1. Primary Speakers
Individuals must also indicate whether they are the ``primary
speaker'' for an agenda item. Primary speakers must be designated by
the entity that submitted the HCPCS coding request. When registering,
primary speakers must provide a brief written statement regarding the
nature of the information they intend to provide, and advise the HCPCS
Public Meeting Coordinator regarding needs for audio/visual support. To
avoid disruption of the meeting and ensure compatibility with our
systems, tapes, and disk files are tested and arranged in speaker
sequence well in advance of the meeting. We will accept tapes and disk
files that are received by the deadline for submissions for each public
meeting as specified in the DATES section of this notice. The sum of
all materials including the presentation may not exceed 10 pages (each
side of a page counts as 1 page). An exception will be made to the 10-
page limit for relevant studies published between the application
deadline and the public meeting date, in which case, we would like a
copy of the complete publication as soon as possible. This exception
applies only to the page limit and not the deadline submission.
The materials may be e-mailed or delivered by regular mail to one
of the HCPCS Public Meeting Coordinators as specified in the ADDRESSES
section of this notice. The materials must be e-mailed or postmarked no
later than the deadline specified in the DATES section of this notice.
Individuals will need to provide 35 copies if materials are delivered
by mail.
2. 5-Minute Speakers
To afford the same opportunity to all attendees, 5-minute speakers
are not required to register as primary speakers. However, 5-minute
speakers must still register as attendees by the deadline set forth
under ``Deadlines for all Other Attendees Registration'' in the DATES
section of this notice. Attendees can sign up only on the day of the
meeting to do a 5-minute presentation. Individuals must provide their
name, company name and address, contact information as specified on the
sign-up sheet, and identify the specific agenda item that they will
address.
C. Additional Meeting/Registration Information
Public Meetings are scheduled far in advance of the influx of HCPCS
applications each cycle. At the time they are scheduled we can only
anticipate the number of applications that we receive in each category.
As a result, we may not need the second day of Drugs/Biologicals/
Radiopharmaceuticals/Radiologic Imaging Agents Public Meeting on
Wednesday, May 18, 2011. We have scheduled this date tentatively. The
Public Meeting Agendas published on CMS' HCPCS Web site at 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:
Visitor's full name (as it appears on passport).
Gender.
Country of origin and citizenship.
Biographical data and related information.
Date of birth.
Place of birth.
Passport number.
Passport issue date.
Passport expiration date.
Dates of visits.
Company Name.
Position/Title.
Authority: Section 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 42 U.S.C. 1395hh).
Dated: February 10, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-3812 Filed 2-24-11; 8:45 am]
BILLING CODE 4120-01-P