[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]
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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.
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SUMMARY: This notice announces the dates, time, and location of the
Healthcare Common Procedure Coding System (HCPCS) public meetings to be
held in calendar year 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 [email protected] 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
[email protected]; or Felicia Kyeremeh, (410) 786-1898 or
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress passed the Medicare, Medicaid,
and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub.
L. 106-554). Section 531(b) of BIPA mandated that we establish
procedures that permit public consultation for coding and payment
determinations for new durable medical equipment (DME) under Medicare
Part B of title XVIII of the Social Security Act (the Act). 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