Medicare Program; Public Meetings in Calendar Year 2014 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 10163-10166 [2014-03902]
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Federal Register / Vol. 79, No. 36 / Monday, February 24, 2014 / Notices
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
mstockstill on DSK4VPTVN1PROD with NOTICES
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.8(a) require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of The
Compliance Team’s request for initial
CMS approval of its RHC accreditation
program. This notice also solicits public
comment on whether The Compliance
Team’s requirements meet or exceed the
Medicare conditions for certification for
RHC. We originally published a notice
on September 20, 2013 (78 FR 57857).
The application described in the notice
was withdrawn at the request of the
applicant. This document notifies the
public that The Compliance Team
resubmitted its RHC application for
review.
III. Evaluation of Deeming Authority
Request
The Compliance Team submitted all
the necessary materials to enable us to
make a determination concerning its
request for initial approval of its RHC
accreditation program. This application
was determined to be complete on
January 2, 2014. Under section
1865(a)(2) of the Act and our regulations
at § 488.8 (federal review of accrediting
organizations), our review and
evaluation of The Compliance Team
will be conducted in accordance with,
but not necessarily limited to, the
following factors:
• The equivalency of The Compliance
Team’s standards for RHCs as compared
with CMS’ RHC conditions for
certification.
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• The Compliance Team’s survey
process to determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of The
Compliance Team’s processes to those
of state survey agencies, including
survey frequency, and the ability to
investigate and respond appropriately to
complaints against accredited facilities.
++ The Compliance Team’s processes
and procedures for monitoring a RHC
found out of compliance with The
Compliance Team’s program
requirements. These monitoring
procedures are used only when The
Compliance Team identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys, the state survey
agency monitors corrections as specified
at § 488.7(d).
++ The Compliance Team’s capacity
to report deficiencies to the surveyed
facilities and respond to the facility’s
plan of correction in a timely manner.
++ The Compliance Team’s capacity
to provide CMS with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ The adequacy of The Compliance
Team’s staff and other resources, and its
financial viability.
++ The Compliance Team’s capacity
to adequately fund required surveys.
++ The Compliance Team’s policies
with respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ The Compliance Team’s
agreement to provide CMS with a copy
of the most current accreditation survey
together with any other information
related to the survey as CMS may
require (including corrective action
plans).
IV. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
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10163
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: February 18, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–03905 Filed 2–21–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1603–N]
Medicare Program; Public Meetings in
Calendar Year 2014 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
System (HCPCS) Coding and Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
dates, time, and location of the
Healthcare Common Procedure Coding
System (HCPCS) public meetings to be
held in calendar year 2014 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 2014 HCPCS public meeting dates:
1. Tuesday, May 20, 2014, 9 a.m. to
5 p.m. eastern daylight time (e.d.t.)
(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 21, 2014, 9 a.m.
to 5 p.m. e.d.t. (Drugs/Biologicals/
SUMMARY:
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Radiopharmaceuticals/Radiologic
Imaging Agents).
3. Wednesday, May 28, 2014, 9 a.m.
to 5 p.m. e.d.t. (Supplies and Other).
4. Tuesday, June 3, 2014, 9 a.m. to 5
p.m. e.d.t. Durable Medical Equipment
(DME) and Accessories; and Orthotics
and Prosthetics (O&P).
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 6, 2014 for the May 20, 2014
and May 21, 2014 public meetings.
• May 14, 2014 for the May 28, 2014
public meeting.
• May 21, 2014 for the June 3, 2014
public meeting.
Registration Deadline for Attendees
that are Foreign Nationals: Attendees
that are foreign nationals (as described
in section IV. of this notice) 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 the individual plans to attend.
Therefore, the deadlines for attendees
that are foreign nationals are as follows:
• May 5, 2014 for the May 20, 2014
and May 21, 2014 public meetings.
• May 9, 2014 for the May 28, 2014
public meeting.
• May 15, 2014 for the June 3, 2014
public meeting.
Registration Deadlines for all Other
Attendees: All individuals who are not
foreign nationals 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 14, 2014 for the May 20, 2014
and May 21, 2014 public meeting dates.
• May 21, 2014 for the May 28, 2014
public meeting date.
• May 27, 2013 for the June 3, 2014
public meeting date.
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 13, 2014 for the May 20, 2014
and May 21, 2014 public meetings.
• May 21, 2014 for the May 28, 2014
public meeting.
• May 27, 2014 for the June 3, 2014
public meeting.
Deadline for Submission of Written
Comments: Written comments must be
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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.
Submission of Written Comments:
Written comments may either be
emailed to HCPCS@cms.hhs.gov or sent
via regular mail to Jennifer Carver or
Kimberlee Combs Miller, 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 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 Kimberlee Combs Miller
at (410) 786–6707 or
Kimberlee.CombsMiller@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Jennifer Carver at (410) 786–6610 or
Jennifer.Carver@cms.hhs.gov. Kimberlee
Combs Miller at (410) 786–6707 or
Kimberlee.CombsMiller@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 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
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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.
• Email address.
• Special needs information.
A CMS staff member will confirm your
registration by email.
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 submission deadline.
The materials may be emailed 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
emailed or postmarked no later than the
deadline specified in the DATES section
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of this notice. Individuals will need to
provide 35 copies if materials are
delivered by mail.
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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 ‘‘Registration Deadlines for
all Other Attendees’’ 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
We were able this year to combine the
Orthotics/Prosthetics and DME meeting
into one public meeting date. That
public meeting will be Tuesday, June 3,
2014.
The product category reported in the
HCPCS code application 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 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 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
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 2014 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 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
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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 2014.
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 emailed 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
emailed 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
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‘‘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 and/or whether the 5minute time allocation would be
reduced, to accommodate the number of
speakers.
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.
Every primary speaker and 5-minute
speaker must declare at the beginning of
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
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Government issued photo identification,
preferably a driver’s license, at the time
of entry. Participants will also be subject
to a vehicle security inspection 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, explosives, firearms or other
dangerous weapons (including pocket
knives), dogs or other animals except
service animals. Once cleared for entry
to the complex participants will be
directed to visitor 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 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 off of the
premises. 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
prior to each public meeting in order to
bring pieces of equipment or medical
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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 national (as defined by the
Department of Homeland Security, a
foreign national is ‘‘an individual who
is a citizen of any country other than the
United States’’) is assigned a host (in
accordance with the Department
Foreign Visitor Management Policy,
Appendix C, Guidelines for Hosts and
Escorts). 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. Foreign
nationals will be required to produce a
valid passport at the time of entry.
Attendees that are foreign nationals
must 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.
• Visa Type.
• Visa Number.
• Dates of visits.
• Company Name.
• Position/Title.
Dated: February 10, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–03902 Filed 2–21–14; 8:45 am]
BILLING CODE 4120–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7032–N]
Health Insurance Marketplace,
Medicare, Medicaid, and Children’s
Health Insurance Programs; Meeting of
the Advisory Panel on Outreach and
Education (APOE), March 17, 2014
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a
meeting of the Advisory Panel on
Outreach and Education (APOE) (the
Panel) in accordance with the Federal
Advisory Committee Act. The Panel
advises and makes recommendations to
the Secretary of Health and Human
Services and the Administrator of the
Centers for Medicare & Medicaid
Services on opportunities to enhance
the effectiveness of consumer education
strategies concerning Health Insurance
Marketplace, Medicare, Medicaid, and
the Children’s Health Insurance
Program (CHIP). This meeting is open to
the public.
DATES: Meeting Date: Monday, March
17, 2014, 8:30 a.m. to 4:00 p.m. eastern
daylight time (e.d.t.).
Deadline for Meeting Registration,
Presentations and Comments: Monday,
March 3, 2014, 5:00 p.m., e.d.t.
Deadline for Requesting Special
Accommodations: Monday, March 3,
2014, 5:00 p.m., e.d.t.
ADDRESSES:
Meeting Location: Department of
Health & Human Services, Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Room 705A, Washington,
DC 20201.
Presentations and Written Comments:
Kirsten Knutson, Acting Designated
Federal Official (DFO), Division of
Forum and Conference Development,
Office of Communications, Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mailstop S1–13–05,
Baltimore, MD 21244–1850 or contact
Ms. Knutson via email at
Kirsten.Knutson@cms.hhs.gov.
Registration: The meeting is open to
the public, but attendance is limited to
the space available. Persons wishing to
attend this meeting must register at the
Web site https://events.SignUp4.com/
APOEMAR2014MTG or by contacting
the DFO at the address listed in the
ADDRESSES section of this notice or by
telephone at number listed in the FOR
FURTHER INFORMATION CONTACT section of
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10163-10166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03902]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1603-N]
Medicare Program; Public Meetings in Calendar Year 2014 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 2014 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 2014 HCPCS public meeting
dates:
1. Tuesday, May 20, 2014, 9 a.m. to 5 p.m. eastern daylight time
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents).
2. Wednesday, May 21, 2014, 9 a.m. to 5 p.m. e.d.t. (Drugs/
Biologicals/
[[Page 10164]]
Radiopharmaceuticals/Radiologic Imaging Agents).
3. Wednesday, May 28, 2014, 9 a.m. to 5 p.m. e.d.t. (Supplies and
Other).
4. Tuesday, June 3, 2014, 9 a.m. to 5 p.m. e.d.t. Durable Medical
Equipment (DME) and Accessories; and Orthotics and Prosthetics (O&P).
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 6, 2014 for the May 20, 2014 and May 21, 2014 public
meetings.
May 14, 2014 for the May 28, 2014 public meeting.
May 21, 2014 for the June 3, 2014 public meeting.
Registration Deadline for Attendees that are Foreign Nationals:
Attendees that are foreign nationals (as described in section IV. of
this notice) 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 the
individual plans to attend. Therefore, the deadlines for attendees that
are foreign nationals are as follows:
May 5, 2014 for the May 20, 2014 and May 21, 2014 public
meetings.
May 9, 2014 for the May 28, 2014 public meeting.
May 15, 2014 for the June 3, 2014 public meeting.
Registration Deadlines for all Other Attendees: All individuals who
are not foreign nationals 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 14, 2014 for the May 20, 2014 and May 21, 2014 public
meeting dates.
May 21, 2014 for the May 28, 2014 public meeting date.
May 27, 2013 for the June 3, 2014 public meeting date.
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 13, 2014 for the May 20, 2014 and May 21, 2014 public
meetings.
May 21, 2014 for the May 28, 2014 public meeting.
May 27, 2014 for the June 3, 2014 public meeting.
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.
Submission of Written Comments: Written comments may either be
emailed to HCPCS@cms.hhs.gov or sent via regular mail to Jennifer
Carver or Kimberlee Combs Miller, 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 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 Kimberlee
Combs Miller at (410) 786-6707 or Kimberlee.CombsMiller@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Jennifer Carver at (410) 786-6610 or
Jennifer.Carver@cms.hhs.gov. Kimberlee Combs Miller at (410) 786-6707
or Kimberlee.CombsMiller@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 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.
Email address.
Special needs information.
A CMS staff member will confirm your registration by email.
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 submission deadline.
The materials may be emailed 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 emailed or postmarked no
later than the deadline specified in the DATES section
[[Page 10165]]
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 ``Registration Deadlines for all Other Attendees'' 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
We were able this year to combine the Orthotics/Prosthetics and DME
meeting into one public meeting date. That public meeting will be
Tuesday, June 3, 2014.
The product category reported in the HCPCS code application 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 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
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 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 2014 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 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 2014.
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 emailed 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 emailed 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 and/or whether the 5-minute time
allocation would be reduced, to accommodate the number of speakers.
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.
Every primary speaker and 5-minute speaker must declare at the
beginning of 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
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Government issued photo identification, preferably a driver's license,
at the time of entry. Participants will also be subject to a vehicle
security inspection 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, explosives, firearms or other
dangerous weapons (including pocket knives), dogs or other animals
except service animals. Once cleared for entry to the complex
participants will be directed to visitor 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 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 off of the premises.
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 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 national (as defined by the
Department of Homeland Security, a foreign national is ``an individual
who is a citizen of any country other than the United States'') is
assigned a host (in accordance with the Department Foreign Visitor
Management Policy, Appendix C, Guidelines for Hosts and Escorts). 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. Foreign nationals will be required
to produce a valid passport at the time of entry.
Attendees that are foreign nationals must 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.
Visa Type.
Visa Number.
Dates of visits.
Company Name.
Position/Title.
Dated: February 10, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-03902 Filed 2-21-14; 8:45 am]
BILLING CODE 4120-01-P
