[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Pages 31717-31719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1757-N]


Medicare Program; Virtual Public Meetings in July 2021 for New 
Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code 
Set

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: This notice announces the dates and times of virtual 
Healthcare Common Procedure Coding System (HCPCS) public meetings to be 
held in July 2021 to discuss our preliminary coding recommendations for 
new revisions to the HCPCS Level II code set.

DATES: Virtual Meeting Dates: Wednesday, July 7, 2021, 9 a.m. to 5 
p.m., eastern daylight time (e.d.t.), Thursday, July 8, 2021, 9 a.m. to 
5 p.m., e.d.t., and Friday, July 9, 2021, 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 that will be used in support of an oral 
presentation is 5 p.m., e.d.t., Friday, June 25, 2021.
    Deadline for 5-Minute Speakers Registration: The deadline for 
registering to be a 5-Minute speaker is 5 p.m., e.d.t., Friday, June 25 
2021.
    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 
link specified for that meeting date. A ``raise your hand'' feature 
will be available to ask questions. A meeting link for each public 
meeting date will be posted 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

[[Page 31718]]

to participate in the virtual public meetings and require special 
assistance must request these services by 5 p.m., e.d.t., Friday, June 
25, 2021.
    Deadline for Submission of Written Comments: To be considered in 
formulating a final coding decision, written comments and other 
documentation must be received by 5 p.m., e.d.t., on the date of the 
virtual public meeting at which the applicable code request is 
scheduled for discussion.

ADDRESSES:
    Virtual Meeting Location: The July 7 through 9, 2021 HCPCS public 
meetings will be held virtually via Zoom only. Detailed information 
pertaining to registering to participate via Zoom, including dial-in 
information for primary speakers, 5-minute speakers, and all other 
attendees, will be provided in a document posted 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 (PHE), written comments from the general public and 
meeting registrants will only be accepted when emailed to 
<a href="/cdn-cgi/l/email-protection#a6eee5f6e5f5f9eac3d0c3caf9efeff9e5c9c2c3f9e7d6d6cacfc5c7d2cfc9c8d5e6c5cbd588ceced588c1c9d0"><span class="__cf_email__" data-cfemail="8ec6cddecdddd1c2ebf8ebe2d1c7c7d1cde1eaebd1cffefee2e7edeffae7e1e0fdceede3fda0e6e6fda0e9e1f8">[email protected]</span></a> before 5 p.m., e.d.t., on 
the date of the virtual public meeting at which a request is discussed.

FOR FURTHER INFORMATION CONTACT: Irina Akelaitis, (410) 786-4602, or 
<a href="/cdn-cgi/l/email-protection#430a312a2d226d0228262f222a372a3003202e306d2b2b306d242c35"><span class="__cf_email__" data-cfemail="531a213a3d327d1238363f323a273a2013303e207d3b3b207d343c25">[email protected]</span></a>; Felicia Kyeremeh, (410) 786-1898, or 
<a href="/cdn-cgi/l/email-protection#fbbd9e979298929ad5b0829e899e969e93bb989688d5939388d59c948d"><span class="__cf_email__" data-cfemail="6b2d0e070208020a4520120e190e060e032b08061845030318450c041d">[email protected]</span></a>; Sundus Ashar, (410) 786-0750, or 
<a href="/cdn-cgi/l/email-protection#98cbedf6fcedebb6d9ebf0f9eaa9d8fbf5ebb6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="3e6d4b505a4b4d107f4d565f4c0f7e5d534d1056564d10595148">[email protected]</span></a>; William Walker, (410) 786-5023, or 
<a href="/cdn-cgi/l/email-protection#5b0c323737323a36750c3a37303e291b38362875333328753c342d"><span class="__cf_email__" data-cfemail="8bdce2e7e7e2eae6a5dceae7e0eef9cbe8e6f8a5e3e3f8a5ece4fd">[email protected]</span></a>; Constantine Markos, (410) 786-0911, 
<a href="/cdn-cgi/l/email-protection#cf8ca0a1bcbbaea1bba6a1aae182aebda4a0bc8faca2bce1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="62210d0c1116030c160b0c074c2f0310090d1122010f114c0a0a114c050d14">[email protected]</span></a>; or 
<a href="/cdn-cgi/l/email-protection#551d160516060a19302330390a1c1c0a163a31300a142525393c3634213c3a3b26153638267b3d3d267b323a23"><span class="__cf_email__" data-cfemail="cb83889b88989487aebdaea79482829488a4afae948abbbba7a2a8aabfa2a4a5b88ba8a6b8e5a3a3b8e5aca4bd">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:
    Guidelines for Presentation Materials and Primary Speakers: There 
is a 10-page submission limit for any presentation materials. All 
registered primary speakers will be emailed a participant ID for their 
individual use to join the meeting, in advance of the virtual meeting. 
Detailed information pertaining to registering to participate via Zoom, 
including dial-in information for primary speakers, will be provided in 
a document posted on CMS' HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings prior to the HCPCS 
public meeting. We encourage all speakers to follow the protocols for 
participation as a speaker in CMS' HCPCS public meetings as detailed in 
this document.
    Guidelines for 5-Minute Speakers: All registered 5-minute speakers 
will be emailed a participant ID for their individual use to join the 
meeting, in advance of the virtual meeting. Detailed information 
pertaining to registering to participate via Zoom, including dial-in 
information for 5-minute speakers, will be provided in a document 
posted on CMS' HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings prior to the HCPCS public meeting. 
We encourage all speakers to follow the protocols for participation as 
a speaker in CMS' HCPCS public meetings as detailed in this document.
    Guidelines for All Other Attendees: A ``raise your hand'' feature 
will be available to ask questions. A meeting link for each public 
meeting date will be posted in advance of the public meetings on CMS' 
HCPCS website at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo.

I. Background

    On December 21, 2000, 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 matter, we will not be conducting public meetings 
for coding decisions on drugs and biological products. For the 2021 
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 a 
subsequent quarterly cycle.

II. Virtual Meeting Registration

    Due to the ``Notice of the Continuation of the National Emergency 
Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic'' \1\ 
issued on February 24, 2021 there will not be an in-person meeting. The 
July 7 through July 9, 2021 HCPCS public meetings will be virtual and 
available for remote audio attendance and participation only via Zoom.
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    \1\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/notice-on-the-continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic/.
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A. Required Information for Registration

    The following information must be provided when registering online 
to attend:
    <bullet> Name.
    <bullet> Company name and address.
    <bullet> Direct-dial telephone.
    <bullet> Email address.
    <bullet> 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 regarding any 
needs for audio/visual support and email it to 
<a href="/cdn-cgi/l/email-protection#a3ebe0f3e0f0fcefc6d5c6cffceaeafce0ccc7c6fce2d3d3cfcac0c2d7cacccdd0e3c0ced08dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="b0f8f3e0f3e3effcd5c6d5dceff9f9eff3dfd4d5eff1c0c0dcd9d3d1c4d9dfdec3f0d3ddc39ed8d8c39ed7dfc6">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#a1e9e2f1e2f2feedc4d7c4cdfee8e8fee2cec5c4fee0d1d1cdc8c2c0d5c8cecfd2e1c2ccd28fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="b8f0fbe8fbebe7f4ddceddd4e7f1f1e7fbd7dcdde7f9c8c8d4d1dbd9ccd1d7d6cbf8dbd5cb96d0d0cb96dfd7ce">[email protected]</span></a>. 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

[[Page 31719]]

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 
<a href="/cdn-cgi/l/email-protection#3f777c6f7c6c60735a495a53607676607c505b5a607e4f4f53565c5e4b5650514c7f5c524c1157574c11585049"><span class="__cf_email__" data-cfemail="d29a918291818d9eb7a4b7be8d9b9b8d91bdb6b78d93a2a2bebbb1b3a6bbbdbca192b1bfa1fcbabaa1fcb5bda4">[email protected]</span></a>. 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 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.
    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 
<a href="/cdn-cgi/l/email-protection#561e15061505091a3320333a091f1f0915393233091726263a3f3537223f39382516353b25783e3e2578313920"><span class="__cf_email__" data-cfemail="4d050e1d0e1e1201283b2821120404120e222928120c3d3d21242e2c392422233e0d2e203e6325253e632a223b">[email protected]</span></a>.
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 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.
    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 
<a href="/cdn-cgi/l/email-protection#c8808b988b9b9784adbeada4978181978ba7acad9789b8b8a4a1aba9bca1a7a6bb88aba5bbe6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="7c343f2c3f2f2330190a1910233535233f131819233d0c0c10151f1d081513120f3c1f110f5214140f521b130a">[email protected]</span></a>.

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 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.
    CMS' official HCPCS website will include additional details 
regarding the public meeting process for new revisions to the HCPCS 
code set, including information on how to join the meeting remotely, 
and guidelines for an effective presentation. 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.

III. Written Comments From Meeting Attendees

    As part of CMS' response to the COVID-19 PHE, written comments from 
the general public and meeting registrants will only be accepted when 
emailed to <a href="/cdn-cgi/l/email-protection#9fd7dccfdcccc0d3fae9faf3c0d6d6c0dcf0fbfac0deefeff3f6fcfeebf6f0f1ecdffcf2ecb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="a3ebe0f3e0f0fcefc6d5c6cffceaeafce0ccc7c6fce2d3d3cfcac0c2d7cacccdd0e3c0ced08dcbcbd08dc4ccd5">[email protected]</span></a> before 5 p.m., 
e.d.t., on the date of the virtual public meeting at which a request is 
discussed.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, 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: June 9, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-12453 Filed 6-11-21; 8:45 am]
BILLING CODE 4120-01-P


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