[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21859-21861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1723-N]
Medicare Program; Virtual Public Meetings in June 2020 for New
Public Requests for Revisions to the Healthcare Common Procedure Coding
System (HCPCS) Coding for Durable Medical Equipment (DME) and
Accessories, Orthotics and Prosthetics (O&P), Supplies and Other Non-
Drug and Non-Biological Items
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
June 2020 to discuss our preliminary coding recommendations for new
public requests for revisions to the HCPCS Level II code set for
Durable Medical Equipment (DME) and Accessories, Orthotics and
Prosthetics (O&P), Supplies and other non-drug and non-biological
items.
DATES:
Virtual Meeting Dates: Monday, June 1, 2020, 9 a.m. to 5 p.m.,
eastern daylight time (e.d.t.), and Tuesday, June 2, 2020, 9 a.m. to
12:30 p.m., e.d.t., for Durable Medical Equipment (DME) and
Accessories, Orthotics and Prosthetics (O&P), Supplies and other non-
drug and non-biological items.
Deadline for Primary Speaker Registration and Presentation
Materials: The deadline for registering to be a primary speaker, and
submitting
[[Page 21860]]
materials and writings that will be used in support of an oral
presentation is 5 p.m., e.d.t., Thursday, May 14, 2020. 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.
Deadline for 5-Minute Speakers Registration: The deadline for
registering to be a 5-Minute speaker is 5 p.m., e.d.t., Thursday, May
14, 2020. 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 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.
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. 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.
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., Thursday, May
14, 2020.
Deadline for Submission of Written Comments: Written comments and
other documentation in response to a preliminary coding determination
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 June 1 and June 2, 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 any time up to 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: 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; or William Walker, (410) 786-5023, or
William.Walker@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 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 durable medical equipment, prosthetics,
orthotics and supplies, and other non-drug, non-biological products. To
achieve the time savings necessary to implement coding for the vast
majority of drugs and biological products on a quarterly cycle, 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
June 1 and June 2, 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 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.
[[Page 21861]]
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. 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. Late
submissions and updates of electronic materials after our deadline
cannot be accommodated.
The sum of 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 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 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 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. Draft agendas, including a summary of each
request and our preliminary recommendations will be posted at least 2
weeks before each virtual meeting on our HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings.
All participants and other interested stakeholders are 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 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. 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
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 reconsiderations, and final decisions, we are able
to consider only those written submissions received by the close of
business (5 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 Evell J. Barco Holland, who is the Federal Register Liaison,
to electronically sign this document for purposes of publication in the
Federal Register.
Evell J. Barco Holland,
Federal Register Liaison,Department of Health and Human Services.
[FR Doc. 2020-08335 Filed 4-17-20; 8:45 am]
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