[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

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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 
[email protected] 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 
[email protected]; Felicia Kyeremeh, (410) 786-1898, or 
[email protected]; Sundus Ashar, (410) 786-0750, or 
[email protected]; or William Walker, (410) 786-5023, 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 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.

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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 
[email protected] 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 
[email protected] 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 
[email protected] 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 
[email protected] 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]
BILLING CODE 4120-01-P