[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