Medicare Program; Public Meetings in Calendar Year 2019 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 7061-7063 [2019-03620]
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Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–03621 Filed 2–27–19; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1705–N]
Medicare Program; Public Meetings in
Calendar Year 2019 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.
jbell on DSK30RV082PROD with NOTICES
AGENCY:
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 2019 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
2019 HCPCS public meeting dates:
1. Monday, May 13, 2019, 9 a.m. to 5
p.m., eastern daylight time (e.d.t), for
Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents.
2. Tuesday, May 14, 2019, 9 a.m. to
5 p.m., e.d.t, for Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents.
3. Wednesday, May 15, 2019, 9 a.m.
to 5 p.m., e.d.t., for Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents.
4. Tuesday, June 11, 2019, 9 a.m. to
5 p.m., e.d.t., for Durable Medical
Equipment (DME) and Accessories,
Orthotics and Prosthetics (O&P)
Supplies, and Other for DME and
Accessories, O&P Supplies, and Other.
5. Wednesday, June 12, 2019, 9 a.m.
to 5 p.m., e.d.t., for DME and
Accessories, O&P Supplies, and Other.
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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:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Registration Deadline for Attendees
that are Foreign Nationals: CMS’
registration deadlines for attendees that
are foreign nationals (including the
deadlines for providing necessary
information for security clearance) are
as follows:
• Monday, April 22, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 21, for the June 11
and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Registration Deadlines for all Other
Attendees: The registration deadlines
are different for each meeting.
Registration deadlines are as follows:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
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:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
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
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7061
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 HCPCS@cms.hhs.gov or sent
via regular mail to Irina Akelaitis or
Felicia Kyeremeh at the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mail Stop C5–09–
14, 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 the
staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
FOR FURTHER INFORMATION CONTACT: Irina
Akelaitis, (410) 786–4602, or
Irina.Akelaitis@cms.hhs.gov; or Felicia
Kyeremeh, (410) 786–1898 or
Felicia.Kyeremeh@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 that
notice for new DME were 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.
It is our intent to distribute any
submitted materials to CMS’ Healthcare
Common Procedure Coding System
(HCPCS) workgroup members for their
consideration. CMS HCPCS workgroup
members require sufficient preparation
time to review all relevant materials.
Therefore, we are implementing a 10page submission limit and firm
deadlines for receipt of any presentation
E:\FR\FM\01MRN1.SGM
01MRN1
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Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
materials a meeting speaker wishes us to
consider. For this reason, CMS 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 and provide input regarding
coding changes under consideration, as
well as an opportunity for us to gather
public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be
provided when registering on-line to
attend:
• 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
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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 CMS’
HCPCS staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice, 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 our 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.
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Jkt 247001
The materials may be emailed or
delivered by regular mail to CMS
officials 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 25 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
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 website 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 website 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 website at least
4 weeks before the first public meeting
in 2019 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 website and
the valuable information it provides to
prospective registrants. The HCPCS
website also contains a document titled
‘‘Healthcare Common Procedure Coding
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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 website 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.
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 must
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.’’ All materials
that will be used in support of an oral
presentation must be submitted to the
CMS staff specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
The materials may be emailed or
delivered by regular mail to the CMS
staff 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 25 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
by the date specified in the DATES
section of this notice using the meeting
registration procedures described in the
section II. of this notice, ‘‘Meeting
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Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
Registration’’. Primary speakers must
also separately register as primary
speakers as 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 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 CMS’
HCPCS staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
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.
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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 business on the date of the
public meeting at which the request is
discussed.
F. Remote Attendance and Participation
CMS’ HCPCS Public Meetings are,
and have been live-streamed on U-Tube
for viewing and listening only. CMS is
considering steps for future coding
cycles that would make our HCPCS
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coding program even more transparent,
and provide additional opportunities for
public input, by expanding
participation in HCPCS Public
Meetings, and making participation
easier. Specifically, we are examining
the logistics and feasibility of arranging
for oral presentations to be made from
remote locations, as opposed to inperson at CMS only.
IV. Security, Building, and Parking
Guidelines
The meeting is open to the public, but
attendance is limited to the space
available. Persons wishing to attend this
meeting must register no later than the
date specified in the DATES section of
this notice.
Attendees that are foreign nationals
are required to identify themselves as
such, and provide the necessary
information for security clearance in
advance of the date of the public
meeting the individual plans to attend
to CMS’ HCPCS staff listed in the
ADDRESSES section of this notice.
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.
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. We
recommend that confirmed registrants
arrive reasonably early, but no earlier
than 45 minutes prior to the start of the
meeting, to allow additional time to
clear security. Security measures
include the following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means of all persons
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
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7063
public may not enter the building earlier
than 45 minutes prior to the convening
of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–03620 Filed 2–27–19; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10415]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
April 30, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7061-7063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1705-N]
Medicare Program; Public Meetings in Calendar Year 2019 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 2019 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 2019 HCPCS public meeting
dates:
1. Monday, May 13, 2019, 9 a.m. to 5 p.m., eastern daylight time
(e.d.t), for Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents.
2. Tuesday, May 14, 2019, 9 a.m. to 5 p.m., e.d.t, for Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents.
3. Wednesday, May 15, 2019, 9 a.m. to 5 p.m., e.d.t., for Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents.
4. Tuesday, June 11, 2019, 9 a.m. to 5 p.m., e.d.t., for Durable
Medical Equipment (DME) and Accessories, Orthotics and Prosthetics
(O&P) Supplies, and Other for DME and Accessories, O&P Supplies, and
Other.
5. Wednesday, June 12, 2019, 9 a.m. to 5 p.m., e.d.t., for DME and
Accessories, 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:
Monday, April 29, 2019, for the May 13, 14 and 15, 2019
Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents public
meetings.
Tuesday, May 28, 2019, for the June 11 and 12, 2019 DME
and Accessories, O&P Supplies, and Other public meetings.
Registration Deadline for Attendees that are Foreign Nationals:
CMS' registration deadlines for attendees that are foreign nationals
(including the deadlines for providing necessary information for
security clearance) are as follows:
Monday, April 22, 2019, for the May 13, 14 and 15, 2019
Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents public
meetings.
Tuesday, May 21, for the June 11 and 12, 2019 DME and
Accessories, O&P Supplies, and Other public meetings.
Registration Deadlines for all Other Attendees: The registration
deadlines are different for each meeting. Registration deadlines are as
follows:
Monday, April 29, 2019, for the May 13, 14 and 15, 2019
Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents public
meetings.
Tuesday, May 28, 2019, for the June 11 and 12, 2019 DME
and Accessories, O&P Supplies, and Other public meetings.
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:
Monday, April 29, 2019, for the May 13, 14 and 15, 2019
Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents public
meetings.
Tuesday, May 28, 2019, for the June 11 and 12, 2019 DME
and Accessories, O&P Supplies, and Other public meetings.
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 HCPCS@cms.hhs.gov or sent via regular mail to Irina
Akelaitis or Felicia Kyeremeh at the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Mail Stop C5-09-14, 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 the staff listed in the FOR FURTHER
INFORMATION CONTACT section of this notice.
FOR FURTHER INFORMATION CONTACT: Irina Akelaitis, (410) 786-4602, or
Irina.Akelaitis@cms.hhs.gov; or Felicia Kyeremeh, (410) 786-1898 or
Felicia.Kyeremeh@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 that
notice for new DME were 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.
It is our intent to distribute any submitted materials to CMS'
Healthcare Common Procedure Coding System (HCPCS) workgroup members for
their consideration. CMS 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
[[Page 7062]]
materials a meeting speaker wishes us to consider. For this reason, CMS
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 and provide input regarding coding changes under
consideration, as well as an opportunity for us to gather public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be provided when registering on-line
to attend:
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 CMS' HCPCS
staff listed in the FOR FURTHER INFORMATION CONTACT section of this
notice, 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 our 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 CMS
officials 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 25 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
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 website 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 website 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 website at least 4 weeks
before the first public meeting in 2019 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 website and the valuable information it provides to
prospective registrants. The HCPCS website 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 website 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.
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 must 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.'' All materials that will be used in
support of an oral presentation must be submitted to the CMS staff
specified in the FOR FURTHER INFORMATION CONTACT section of this
notice.
The materials may be emailed or delivered by regular mail to the
CMS staff 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 25 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 by the date specified in the DATES section of this notice using
the meeting registration procedures described in the section II. of
this notice, ``Meeting
[[Page 7063]]
Registration''. Primary speakers must also separately register as
primary speakers as 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 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 CMS' HCPCS staff listed in
the FOR FURTHER INFORMATION CONTACT section of this notice.
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
business on the date of the public meeting at which the request is
discussed.
F. Remote Attendance and Participation
CMS' HCPCS Public Meetings are, and have been live-streamed on U-
Tube for viewing and listening only. CMS is considering steps for
future coding cycles that would make our HCPCS coding program even more
transparent, and provide additional opportunities for public input, by
expanding participation in HCPCS Public Meetings, and making
participation easier. Specifically, we are examining the logistics and
feasibility of arranging for oral presentations to be made from remote
locations, as opposed to in-person at CMS only.
IV. Security, Building, and Parking Guidelines
The meeting is open to the public, but attendance is limited to the
space available. Persons wishing to attend this meeting must register
no later than the date specified in the DATES section of this notice.
Attendees that are foreign nationals are required to identify
themselves as such, and provide the necessary information for security
clearance in advance of the date of the public meeting the individual
plans to attend to CMS' HCPCS staff listed in the ADDRESSES section of
this notice.
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.
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. We recommend that
confirmed registrants arrive reasonably early, but no earlier than 45
minutes prior to the start of the meeting, to allow additional time to
clear security. Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Inspection of vehicle's interior and exterior (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Inspection, via metal detector or other applicable means
of all persons entering the building. We note that all items brought
into CMS, whether personal or for the purpose of presentation or to
support a presentation, are subject to inspection. We cannot assume
responsibility for coordinating the receipt, transfer, transport,
storage, set-up, safety, or timely arrival of any personal belongings
or items used for presentation or to support a presentation.
Note: 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
prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building.
Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-03620 Filed 2-27-19; 11:15 am]
BILLING CODE 4120-01-P
