Medicare Program; Public Meetings in Calendar Year 2016 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 8963-8966 [2016-03703]
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Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
number. Each participant will receive
up to two survey reminders starting one
week after the initial survey link is sent,
for two consecutive weeks. There are
minor differences in survey content for
the control and intervention groups.
Each participant will create a profile
in the database upon enrollment. This
database will collect initial
demographic and contact information,
informed consent signatures, and
information about the participant’s
navigation pattern through Crush. Any
information entered directly into Crush
interactive features will not be stored in
the system. The database only collects
web analytics data about page visits and
duration of each visit by User
Identification (ID) and Internet Protocol
(IP) address. Web analytics will only be
collected from participants navigating
Crush and only when they are logged in
as users. Web analytics are generated for
any Web site and are a standard
evaluation mechanism for assessing the
traffic patterns on Web pages. This
technology permits development of an
objective and quantifiable measure that
tracks and records participants’
exposure to Crush. This study
component does not entail any response
burden to participants.
Findings will be used to inform the
development and delivery of effective
health communications.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden hours are 802.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Girls 14–18 years old ......................................
Screener Questions .......................................
Enrollment Questions .....................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Intervention Group ..........................................
Control Group .................................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–03687 Filed 2–22–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1637–N]
Medicare Program; Public Meetings in
Calendar Year 2016 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 2016 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
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SUMMARY:
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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. As
indicated in this notice, we are
reorganizing public meeting content
under two main headings: (1) Drugs/
Biologics, Radiopharmaceuticals/
Radiologic Imaging Agents, and (2)
Durable Medical Equipment (DME) and
Accessories; Orthotics and Prosthetics
(O & P); Supplies and Other.
DATES: Meeting Dates: The following are
the 2016 HCPCS public meeting dates:
1. Tuesday, May 17, 2016, 9:00 a.m.
to 5:00 p.m., eastern daylight time
(e.d.t.) (Drugs/Biologicals,
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 18, 2016, 9:00
a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/
Radiologic Imaging Agents).
3. Thursday, May 19, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Drugs/Biologicals,
Radiopharmaceuticals/Radiologic
Imaging Agents).
4. Wednesday, June 1, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Durable Medical
Equipment (DME) and Accessories;
Orthotics and Prosthetics (O & P);
Supplies and Other).
5. Thursday, June 2, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Durable Medical
Equipment (DME) and Accessories;
Orthotics and Prosthetics (O & P);
Supplies and Other).
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3,000
1,200
600
480
384
600
480
384
Number of
responses per
respondent
1
1
1
1
1
1
1
1
Avg. burden
per response
(in hrs.)
1/60
5/60
15/60
10/60
15/60
15/60
10/60
15/60
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, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 18, 2016 for the June 1, 2016
and June 2, 2016 public meetings.
Registration Deadline for Attendees
that are Foreign Nationals: All Foreign
National visitors must present a valid
passport as proof of identification.
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 21 business days in advance of the
date of the public meeting the
individual plans to attend. Therefore,
the registration deadlines for attendees
that are foreign nationals are as follows:
• April 28, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 12, 2016 for the June 1, 2016
and June 2, 2016 public meetings.
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
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deadlines are different for each meeting.
Registration deadlines are as follows:
• May 10, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 24, 2016 for the June 1, 2016
and June 2, 2016 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 at least two weeks in
advance of the meeting date, by the
following deadlines:
• May 3, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 18, 2016 for the June 1, 2016
and June 2, 2016 public meetings.
Requests for Special Accommodation
may be made within the on-line
registration located at
www.cms.hhs.gov/medhcpcsgeninfo or
by contacting Judi Wallace at (410) 786–
3197 or JudiWallace@cms.hhs.gov or
Nathan Helman at (410) 786–4602 or
NathanHelman@cms.hhs.gov.
When a request for Special
Accommodations is made separate from
the on-line registration, it is also
necessary to complete the online
registration to gain access to the facility.
Deadline for Submission of Written
Comments: Written comments and other
documentation in response to a
preliminary coding or payment
determination that are received by no
later than the date of the public meeting
at which the code request is scheduled
for discussion, will be considered in
formulating a final coding decision.
ADDRESSES:
Meeting Location: The public
meetings will be held in the main
auditorium of the central building of the
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Submission of Written Comments:
Written comments may either be
emailed to JudiWallace@cms.hhs.gov or
NathanHelman@cms.hhs.gov or sent via
regular mail to Judi Wallace or Nathan
Helman, HCPCS Public Meeting
Coordinators, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail Stop C5–09–14,
Baltimore, MD 21244–1850.
FOR FURTHER INFORMATION CONTACT: Judi
Wallace at (410)786–3197 or
JudiWallace@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress
passed the Medicare, Medicaid, and
SCHIP Benefits Improvement and
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17:06 Feb 22, 2016
Jkt 238001
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). 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. The procedures and
public meetings announced in this
notice for new DME are in response to
the mandate of section 531(b) of BIPA.
As part of HCPCS reform, we expanded
the public meeting forum to include all
public requests as of the 2005–2006
coding cycle (70 FR 15340, March 25,
2005).
It is our intent to distribute any
materials submitted to us 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 a meeting
speaker wishes us to consider. For this
reason, our HCPCS Public Meeting
Coordinator will only accept and review
presentation materials received by the
deadline for each public meeting, as
specified in the DATES section of this
notice.
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
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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. Late submissions and updates of
electronic materials after our deadline
cannot be accommodated.
Please note CMS’ page limit for
primary speaker presentation materials.
The sum of all presentation materials
and additional supporting
documentation may not exceed 10
pages (each side of a page counts as 1
page). An exception will be made to the
10-page limit only for relevant studies
newly 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 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
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 presentation of up to 5 minutes.
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
Please note that all of the CMS’ 2016
HCPCS public meetings will begin at
9:00 a.m. each day as noted in the DATES
section of this notice.
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
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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 2016 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 2016.
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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 the HCPCS Public Meeting
Coordinator.
The materials may be emailed or
delivered by regular mail to the HCPCS
Public Meeting Coordinator as specified
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17:06 Feb 22, 2016
Jkt 238001
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 any
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 presentations for up to 5
minutes 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,
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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
Government issued photo identification
at the time of entry. As of October, 10,
2015, visitors seeking access to federal
agency facilities using their state-issued
driver’s license or identification cards
must present proper identification
issued by a state that is compliant with
the REAL ID Act of 2005, (Pub. L. 109–
13, 119 Statute 302, enacted on May 11,
2005), or a state that has received an
extension. What constitutes proper
identification and whether a driver’s
license is acceptable identification for
accessing a federal facility may vary,
based on which state issued the driver’s
license. For detailed information, please
refer to the Department of Homeland
Security (DHS) Web site at https://
www.dhs.gov. When planning to visit a
federal facility, visitors who have
further questions about acceptable forms
of identification are encouraged to
contact the facility to determine
acceptable identification. In addition,
all Foreign National visitors must
present a valid passport as proof of
identification.
Visitors 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
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Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
service animals. Once cleared for entry
to the complex participants will be
directed to visitor parking by a security
officer.
To ensure expedited entry into the
building it is recommended that
participants have their government 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 invited guests
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 entrance
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 any time. 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 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.
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17:06 Feb 22, 2016
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Foreign National Visitors are defined
as Non-US Citizens, and non-lawful
permanent residents, non-resident
aliens or non-green-card holders.
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:
• Building to Visit/Destination.
• Visit start date, start time, end date,
end time.
• Visitor full name.
• Gender.
• Visitor Title.
• Visitor Organization/Employer.
• Citizenship.
• Birth Place (City, Country).
• Date of Birth.
• ID Type (Passport or State
Department ID).
• Passport issued by Country.
• ID (passport) Number.
• ID (passport) issue date.
• ID (passport) expiration date.
• Visa Type.
• Visa Number.
• Purpose of Visit.
Dated: February 2, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–03703 Filed 2–22–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4852]
Design Considerations and Premarket
Submission Recommendations for
Interoperable Medical Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA or Agency) is
extending the comment period provided
in the notice entitled ‘‘Design
Considerations and Pre-market
Submission Recommendations for
Interoperable Medical Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability’’
that appeared in the Federal Register of
January 26, 2016. That notice
announced the availability of a draft
guidance for industry and FDA staff and
requested comments by March 28, 2016.
SUMMARY:
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FDA is extending the draft guidance’s
comment period by 30 days in response
to requests for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period for the draft guidance ‘‘Design
Considerations and Premarket
Submission Recommendations for
Interoperable Medical Devices’’
published on January 26, 2016 (81 FR
4303), by an additional 30 days.
Although you can comment on any
guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 28, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
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]]>Agencies
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8963-8966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03703]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1637-N]
Medicare Program; Public Meetings in Calendar Year 2016 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 2016 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. As indicated in
this notice, we are reorganizing public meeting content under two main
headings: (1) Drugs/Biologics, Radiopharmaceuticals/Radiologic Imaging
Agents, and (2) Durable Medical Equipment (DME) and Accessories;
Orthotics and Prosthetics (O & P); Supplies and Other.
DATES: Meeting Dates: The following are the 2016 HCPCS public meeting
dates:
1. Tuesday, May 17, 2016, 9:00 a.m. to 5:00 p.m., eastern daylight
time (e.d.t.) (Drugs/Biologicals, Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 18, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents).
3. Thursday, May 19, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents).
4. Wednesday, June 1, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Durable
Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O &
P); Supplies and Other).
5. Thursday, June 2, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Durable
Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O &
P); Supplies and Other).
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, 2016 for the May 17, 2016, May 18, 2016 and May 19,
2016 public meetings.
May 18, 2016 for the June 1, 2016 and June 2, 2016 public
meetings.
Registration Deadline for Attendees that are Foreign Nationals: All
Foreign National visitors must present a valid passport as proof of
identification. 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 21 business days in advance of the date of the
public meeting the individual plans to attend. Therefore, the
registration deadlines for attendees that are foreign nationals are as
follows:
April 28, 2016 for the May 17, 2016, May 18, 2016 and May
19, 2016 public meetings.
May 12, 2016 for the June 1, 2016 and June 2, 2016 public
meetings.
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
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deadlines are different for each meeting. Registration deadlines are as
follows:
May 10, 2016 for the May 17, 2016, May 18, 2016 and May
19, 2016 public meetings.
May 24, 2016 for the June 1, 2016 and June 2, 2016 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
at least two weeks in advance of the meeting date, by the following
deadlines:
May 3, 2016 for the May 17, 2016, May 18, 2016 and May 19,
2016 public meetings.
May 18, 2016 for the June 1, 2016 and June 2, 2016 public
meetings.
Requests for Special Accommodation may be made within the on-line
registration located at www.cms.hhs.gov/medhcpcsgeninfo or by
contacting Judi Wallace at (410) 786-3197 or JudiWallace@cms.hhs.gov or
Nathan Helman at (410) 786-4602 or NathanHelman@cms.hhs.gov.
When a request for Special Accommodations is made separate from the
on-line registration, it is also necessary to complete the online
registration to gain access to the facility.
Deadline for Submission of Written Comments: Written comments and
other documentation in response to a preliminary coding or payment
determination that are received by no later than the date of the public
meeting at which the code request is scheduled for discussion, will be
considered in formulating a final coding decision.
ADDRESSES:
Meeting Location: The public meetings will be held in the main
auditorium of the central building of the Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Submission of Written Comments: Written comments may either be
emailed to JudiWallace@cms.hhs.gov or NathanHelman@cms.hhs.gov or sent
via regular mail to Judi Wallace or Nathan Helman, HCPCS Public Meeting
Coordinators, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Mail Stop C5-09-14, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT: Judi Wallace at (410)786-3197 or
JudiWallace@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). 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. The procedures and public meetings announced in this
notice for new DME are in response to the mandate of section 531(b) of
BIPA. As part of HCPCS reform, we expanded the public meeting forum to
include all public requests as of the 2005-2006 coding cycle (70 FR
15340, March 25, 2005).
It is our intent to distribute any materials submitted to us 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 a
meeting speaker wishes us to consider. For this reason, our HCPCS
Public Meeting Coordinator will only accept and review presentation
materials received by the deadline for each public meeting, as
specified in the DATES section of this notice.
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. Late
submissions and updates of electronic materials after our deadline
cannot be accommodated.
Please note CMS' page limit for primary speaker presentation
materials. The sum of all presentation materials and additional
supporting documentation may not exceed 10 pages (each side of a page
counts as 1 page). An exception will be made to the 10-page limit only
for relevant studies newly 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 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 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 presentation of up to 5 minutes. 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
Please note that all of the CMS' 2016 HCPCS public meetings will
begin at 9:00 a.m. each day as noted in the DATES section of this
notice.
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
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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 2016 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 2016.
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 the
HCPCS Public Meeting Coordinator.
The materials may be emailed or delivered by regular mail to the
HCPCS Public Meeting Coordinator 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 any 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 presentations for up to 5 minutes 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 Government issued photo identification at the time of entry. As
of October, 10, 2015, visitors seeking access to federal agency
facilities using their state-issued driver's license or identification
cards must present proper identification issued by a state that is
compliant with the REAL ID Act of 2005, (Pub. L. 109-13, 119 Statute
302, enacted on May 11, 2005), or a state that has received an
extension. What constitutes proper identification and whether a
driver's license is acceptable identification for accessing a federal
facility may vary, based on which state issued the driver's license.
For detailed information, please refer to the Department of Homeland
Security (DHS) Web site at https://www.dhs.gov. When planning to visit a
federal facility, visitors who have further questions about acceptable
forms of identification are encouraged to contact the facility to
determine acceptable identification. In addition, all Foreign National
visitors must present a valid passport as proof of identification.
Visitors 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
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service animals. Once cleared for entry to the complex participants
will be directed to visitor parking by a security officer.
To ensure expedited entry into the building it is recommended that
participants have their government 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 invited guests 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 entrance 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 any time.
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 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.
Foreign National Visitors are defined as Non-US Citizens, and non-
lawful permanent residents, non-resident aliens or non-green-card
holders.
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:
Building to Visit/Destination.
Visit start date, start time, end date, end time.
Visitor full name.
Gender.
Visitor Title.
Visitor Organization/Employer.
Citizenship.
Birth Place (City, Country).
Date of Birth.
ID Type (Passport or State Department ID).
Passport issued by Country.
ID (passport) Number.
ID (passport) issue date.
ID (passport) expiration date.
Visa Type.
Visa Number.
Purpose of Visit.
Dated: February 2, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-03703 Filed 2-22-16; 8:45 am]
BILLING CODE 4120-01-P
