[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60791-60793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21257]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1740-N]
Medicare Program; Virtual Public Meetings in October 2020 for New
Public Requests for Revisions to the Healthcare Common Procedure Coding
System (HCPCS) Coding for Non-Drug and Non-Biological Items and
Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the dates and time of virtual Healthcare
Common Procedure Coding System (HCPCS) public meetings to be held in
October 2020 to discuss our preliminary coding recommendations for new
public requests for revisions to the HCPCS Level II code set Durable
Medical Equipment (DME) and Accessories, Orthotics and Prosthetics
(O&P), Supplies and for non-drug and non-biological items and services.
DATES: Virtual Meeting Dates: Tuesday, October 27, 2020, 9 a.m. to 5
p.m., eastern daylight time (e.d.t.), and Wednesday, October 28, 2020,
9 a.m. to 5 p.m., e.d.t.
Deadline 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 is 5 p.m., e.d.t., Wednesday, October 14, 2020.
Deadline for 5-Minute Speakers Registration: The deadline for
registering to be a 5-Minute speaker is 5 p.m., e.d.t., Wednesday,
October 14, 2020.
Deadline for Registration for all Other Attendees: All individuals
who plan to attend the virtual public meetings to listen, but are not
registering as a primary or 5-minute speaker, may simply join the
virtual meeting on the date that they plan to attend, using the meeting
attendee link specified for that meeting date.
Deadline for Requesting Special Accommodations: Individuals who
plan to participate in the virtual public meetings and require special
assistance must request these services by 5 p.m., e.d.t., Wednesday,
October 14, 2020.
Deadline for Submission of Written Comments: Written comments and
other documentation in response to a preliminary coding recommendation
that are received by no later than 5 p.m. on the date of the virtual
public meeting at which the code request is scheduled for discussion
will be considered in formulating a final coding decision.
ADDRESSES: Virtual Meeting Location: The October 27 and October 28,
2020 HCPCS Public meetings will be held virtually via WebEx only.
Detailed information pertaining to registering to participate via
WebEx, including dial-in information for Primary Speakers, 5-minute
speakers, and all other attendees, will be provided in CMS'
``Guidelines for Participation in HCPCS Public Meetings'', posted
approximately 2 weeks prior to the HCPCS Public Meeting on CMS' HCPCS
website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings.
Written Comments: As part of CMS' response to the COVID-19 public
health emergency, written comments from the general public and meeting
registrants will only be accepted when emailed to
HCPCS_Level_II_Code_Applications@cms.hhs.gov or to staff listed in the
FOR FURTHER INFORMATION CONTACT section of this notice before 5 p.m. on
the date of the virtual public meeting at which a request is discussed.
Due to the close timing of the virtual public meetings, subsequent CMS
consideration, and final decisions, we are able to consider only those
written comments received by the close of business (5 p.m.) on the date
of the virtual public meeting at which the request is discussed.
FOR FURTHER INFORMATION CONTACT:
Kimberlee Combs, (410) 786-6707, or Kimberlee.Combs@cms.hhs.gov;
Irina Akelaitis, (410) 786-4602, or Irina.Akelaitis@cms.hhs.gov;
Felicia Kyeremeh, (410) 786-1898, or Felicia.Kyeremeh@cms.hhs.gov;
Sundus Ashar, (410) 786-0750, or Sundus.Ashar1@cms.hhs.gov;
William Walker, (410) 786-5023, or William.Walker@cms.hhs.gov; or
Constantine Markos, (410) 786-0911, Constantine.Markos@cms.hhs.gov
SUPPLEMENTARY INFORMATION:
Guidelines for Presentation Materials: There is a 10-page
submission limit for any presentation materials. All registered primary
speakers will be emailed a link for their individual use to join the
meeting, in advance of the virtual meeting. Detailed information
pertaining to registering to participate via WebEx, including dial-in
information for Primary Speakers, 5-minute speakers, and all other
attendees, will be provided in CMS' ``Guidelines for Participation in
HCPCS Public Meetings'', as posted on CMS' HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings
approximately two weeks prior to the HCPCS Public Meeting. We encourage
all speakers to familiarize themselves with, and follow, protocol for
participation as a speaker in CMS' HCPCS Public meetings as detailed in
these guidelines.
Guidelines for 5-minute Speakers: All 5-Minute speakers will be
emailed a link for their individual use to join the meeting, in advance
of the virtual meeting. Detailed information pertaining to registering
to participate via WebEx, including dial-in information for Primary
Speakers, 5-minute speakers, and all other attendees, will be provided
in CMS' ``Guidelines for Participation in HCPCS Public Meetings'', as
posted on CMS' HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings approximately 2
[[Page 60792]]
weeks prior to the HCPCS Public Meeting. We encourage all speakers to
familiarize themselves with, and follow, protocol for participation as
a speaker in CMS' HCPCS Public meetings as detailed in these
guidelines.
Guidelines for All Other Attendees: A ``raise your hand'' feature
will be available to ask questions. A meeting attendee link for each
public meeting date will be posted approximately 2 weeks in advance of
the public meetings on CMS' HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo.
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 of 2020, we implemented changes to our HCPCS coding procedures
that enable quarterly coding cycles for drugs and biological products,
and bi-annual coding cycles for non-drug and non-biological items and
services. To achieve the time savings necessary to implement coding for
the vast majority of drugs and biological products on a quarterly
cycle, as a general rule, we will not be conducting public meetings for
coding decisions on drugs and biological products. For the 2020 coding
cycles, for drug and biological code applicants who are dissatisfied
with CMS' coding decision in a quarterly coding cycle, we provide them
an opportunity to resubmit their application in the next or subsequent
quarterly cycle.
II. Virtual Meeting Registration
Due to the ``Proclamation on Declaring a National Emergency
Concerning the Novel Coronavirus Disease (COVID-19) Outbreak'' \1\
issued on March 13, 2020, there will not be an in-person meeting. The
October 27 and October 28, 2020 HCPCS Public meetings will be virtual
and available for remote audio attendance and participation only via
WebEx.
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\1\ https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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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.
Email address.
Any special accommodation requests.
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. Speaker PowerPoint
files are tested and arranged in speaker sequence well in advance of
the meeting. We will accept emailed PowerPoint files that are received
by the deadline for submissions of presentation materials as specified
in the DATES section of this notice. We are also exploring mechanisms
to successfully incorporate video clips in Primary Speaker presentation
materials for our remote public meetings, and further information on
that topic is forthcoming and will be published on CMS HCPCS website in
advance of the October public meetings. Materials will only be accepted
when emailed to HCPCS_Level_II_Code_Applications@cms.hhs.gov or to
staff listed in the FOR FURTHER INFORMATION CONTACT section of this
notice. Due to the timeframe for planning and coordination of the HCPCS
Public Meetings under CMS' shorter and more frequent coding cycles that
started in 2020, late submissions and updates of materials after our
deadline cannot be accommodated.
All presentation materials and additional supporting documentation
should 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 virtual public
meeting date, in which case, we request a copy of the complete
publication be emailed as soon as possible to
HCPCS_Level_II_Code_Applications@cms.hhs.gov or to staff listed in the
FOR FURTHER INFORMATION CONTACT section of this notice. This exception
applies only to the page limit and not the submission deadline.
Fifteen minutes is the total time interval for the presentation. 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 primary speaker.
Every primary speaker must declare at the beginning of the
speaker's presentation at the meeting, as well as in the speaker's
written summary, whether the speaker has 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.
On the day of the virtual meeting, before the end of the meeting,
all primary speakers must email a brief written summary of their
comments and conclusions to CMS' HCPCS staff listed in the FOR FURTHER
INFORMATION CONTACT section of this notice.
2. ``5-Minute Speakers''
The deadline for registering to be a 5-Minute speaker is noted in
the DATES section of this notice. Individuals must provide their name,
company name and address, and contact information as specified in the
instructions for remote participation, and identify the specific agenda
item that they will address. Based on the number of items on the agenda
and the progress of the meeting, a determination will be made by the
meeting coordinator and the meeting moderator regarding how many ``5-
minute speakers'' can be accommodated and whether the 5-minute
allocation would be reduced to accommodate the number of speakers.
Every 5-minute speaker must declare at the beginning of the
speaker's presentation at the meeting, as well as in the speaker's
written summary, whether the speaker has 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.
On the day of the virtual meeting, before the end of the meeting,
all 5-minute speakers must email a brief
[[Page 60793]]
written summary of their comments and conclusions to
HCPCS_Level_II_Code_Applications@cms.hhs.gov or to CMS' HCPCS staff
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
C. Additional Virtual Meeting/Registration Information
Prior to registering to attend a virtual public meeting, all
participants are advised to review the public meeting agendas at
https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings
which identify our preliminary coding recommendations, and the dates
each item will be discussed. All participants and other stakeholders
are encouraged to begin in early October to regularly check CMS'
official HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings for publication of draft agendas,
including a summary of each request and our preliminary
recommendations.
All participants and other interested stakeholders are also
encouraged to regularly check CMS' official HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings for
additional details regarding the public meeting process for new public
requests for revisions to the HCPCS, including information on how to
join the meeting remotely, and guidelines for an effective
presentation. In particular, please review the document titled
``Guidelines for Participation in Public Meetings for New Public
Requests for Revisions to the Healthcare Common Procedure Coding System
(HCPCS)''. Individuals who intend to provide a presentation at a
virtual public meeting are encouraged 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 CMS uses to
make coding determinations for the items 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. Written Comments From Meeting Attendees
As part of CMS' response to the COVID-19 public health emergency,
there is a limited presence at the CMS headquarters for receiving paper
packages. Therefore, written comments from the general public and
meeting registrants will only be accepted when emailed to
HCPCS_Level_II_Code_Applications@cms.hhs.gov or to staff listed in the
FOR FURTHER INFORMATION CONTACT section of this notice any time up to
5:00 p.m. on the date of the virtual public meeting at which a request
is discussed. Due to the close timing of the virtual public meetings,
subsequent workgroup review, and final decisions, we are able to
consider only those written submissions received by the close of
business (5:00 p.m.) on the date of the virtual public meeting at which
the request is discussed.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Seema Verma, having reviewed and approved this document,
authorizes Lynette Wilson, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: September 22, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid.
[FR Doc. 2020-21257 Filed 9-25-20; 8:45 am]
BILLING CODE 4120-01-P