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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-1761-N]

# AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

# ACTION:

Notice.

# SUMMARY:

                        This notice announces the dates and times of virtual Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in June 2022 to discuss our preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set, as well as how to register for those meetings. The June meetings will also include preliminary Medicare benefit category and payment determinations for codes effective January 1, 2020 to April 1, 2022, continuous glucose monitor and related supplies and accessories coding and payment determinations, and additional items added by CMS to address Medicare benefit category or payment determinations. The public meeting agendas (including the specific Healthcare Common Procedure Coding System (HCPCS) code applications that will be discussed), meeting guidelines and the information to join these meetings are published at                         *https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings.*

# DATES:

*Virtual Meeting Dates:*                         Tuesday, June 7, 2022, 9 a.m. to 5 p.m., eastern daylight time (e.d.t.), Wednesday, June 8, 2022, 9 a.m. to 5 p.m. e.d.t., Thursday, June 9, 2022, 9 a.m. to 5 p.m. e.d.t. and Friday, June 10, 2022, 9 a.m. to 5 p.m. e.d.t.                    

*Deadline for Primary Speaker Registrations and Presentation Materials:*                         The deadline for primary speakers to register and submit any supporting PowerPoint presentation, as well as any relevant studies published after the date the applicant submitted its HCPCS code application, is 5 p.m., e.d.t., Tuesday, May 24, 2022.                    

*Deadline for 5-Minute Speaker Registrations:*                         The deadline for registering to be a 5-minute speaker is 5 p.m., e.d.t., Tuesday, May 24, 2022.                    

*Deadline for Registration for all Other Attendees:*                         All individuals who plan to attend the virtual public meetings to listen, but do not plan to speak, must register to attend. Attendees can attend more than one meeting. Except for individuals who require special assistance, the deadline to register for each public meeting is the date of that public meeting. Individuals who plan to attend one or more of the virtual public meetings and require special assistance must register and request special assistance services by 5 p.m., e.d.t., Tuesday, May 24, 2022.                    

*Registration Link:*                         The registration link will be posted in the Guidelines for Participation in HCPCS Public Meetings document on the CMS website at                         *https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings*                         and in an announcement on the HCPCS General Information page at                         *https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo.*                         The same website also contains detailed information on how attendees can join the virtual public meetings using Zoom, including dial-in information for primary speakers, 5-minute speakers, and all other attendees.                    

*Deadline for Submission of Written Comments:*                         In addition to the primary speaker presentation materials noted above, CMS will accept written comments from any stakeholder pertaining to a HCPCS code application or agenda item scheduled for discussion at the public meetings. The deadline for submission of written comments pertaining to a specific HCPCS code application or agenda item is 5 p.m., e.d.t., on the date of the virtual public meeting at which the applicable HCPCS code application or agenda item is scheduled for discussion. As part of CMS' response to the COVID-19 public health emergency (PHE), written comments will only be accepted when emailed to:                         *HCPCS@cms.hhs.gov.*

# ADDRESSES:

*Virtual Meeting Location:*                         The June 7-10, 2022 HCPCS public meetings will be held virtually via Zoom only.                    

# FOR FURTHER INFORMATION CONTACT:

                        Sundus Ashar, (410) 786 0750,                         *Sundus.ashar1@cms.hhs.gov,*                         or                         *HCPCS@cms.hhs.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

                    On December 21, 2000, Congress enacted the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554). Section 531(b) of BIPA mandated that the Secretary 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 annual public meeting process for DME.                

In 2020, we implemented changes to our Healthcare Common Procedure Coding System (HCPCS) coding procedures, including the establishment of quarterly coding cycles for drugs and biological products and biannual coding cycles for non-drug and non-biological items and services.

                    In the December 28, 2021                     **Federal Register**                     (86 FR 73860), we published a final rule that established procedures for making Medicare benefit category and payment determinations for new items and services that are DME, prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B.                

## II. Virtual Meeting Registration

                    Because of the “Notice of the Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic” [1]                                          issued on February 18, 2022, there will not be an in-person meeting. The June 7-10, 2022 HCPCS public meetings will be virtual and available for remote audio attendance and participation only via Zoom.                

### A. Required Information for Registration

The following information must be provided when registering online to attend:
    - Name;
    - Company name and address (if applicable);
    - Direct-dial telephone;
    - Email address;
    - Any special assistance requests (which, as stated above, will be considered if the registration is submitted by 5:00 p.m., e.d.t., Tuesday, May 24, 2022); and
    - Whether the registrant is a primary speaker or a 5-minute speaker for an agenda item.

### B. Additional Information

#### 1. Primary Speakers

                    Each applicant that submitted a HCPCS code application that will be                           ( print page 27159)                        discussed at the virtual public meetings is permitted to designate a primary speaker. As stated above, we will accept PowerPoint presentations and relevant studies published after the date the applicant submitted its HCPCS code application if those materials are emailed to:                     *HCPCS@cms.hhs.gov*                     by 5:00 p.m., e.d.t., Tuesday, May 24, 2022. Due to the timeframe needed for the planning and coordination of the HCPCS virtual public meetings, materials that are not submitted in accordance with these deadlines cannot be accommodated.                

All PowerPoint presentation materials must not exceed 10 pages. Relevant studies that were published after the date the applicant submitted its HCPCS code application are not subject to this page limit.

Fifteen minutes is the total time interval for each presentation. In establishing the public meeting agenda, we may group multiple, related code requests under the same agenda item.

                    On the day of the virtual meeting that the primary speaker attends and speaks on a HCPCS code application, before 5 p.m., e.d.t., the primary speaker must email a brief written summary (one paragraph) of their comments and conclusions to:                     *HCPCS@cms.hhs.gov.*

Every primary speaker must also 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 manufacturer of the item that is the subject of the HCPCS code application that the primary speaker presented, or any competitors of that manufacturer with respect to the item. This includes any payment, salary, remuneration, or benefit provided to that speaker by the applicant.

#### 2. 5-Minute Speakers

As noted above, the deadline for registering to be a 5-minute speaker is 5:00 p.m., e.d.t., Tuesday, May 24, 2022.

                    On the day of the virtual meeting that the 5-minute speaker attends and speaks on a HCPCS code application or agenda item, before 5 p.m., e.d.t., the 5-minute speaker must email a brief written summary of their comments and conclusions to:                     *HCPCS@cms.hhs.gov.*                     CMS will not accept any other written materials from a 5-minute speaker.                

Every 5-minute speaker must also 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 manufacturer of the item that is the subject of the HCPCS code application or agenda item that the 5-minute speaker presented, or any competitors of that manufacturer with respect to the item. This includes any payment, salary, remuneration, or benefit provided to that speaker by the applicant.

### C. Additional Virtual Meeting/Registration Information

                    Prior to registering to attend a virtual public meeting, all potential participants and other stakeholders are advised to review the public meeting agendas at                     *https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings*                     which identify our preliminary coding, Medicare benefit category, and payment determinations, and the date each item will be discussed. All potential participants and other stakeholders are also encouraged to regularly check the HCPCS section of the CMS website at                     *https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings*                     for publication of the draft agendas, including a summary of each HCPCS code application, our preliminary coding, Medicare benefit category, and payment determinations.                

The HCPCS section of the CMS website also includes 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. The HCPCS section of the CMS 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 HCPCS coding determinations.

When CMS refers to HCPCS code or HCPCS coding application above, CMS may also be referring to circumstances when a HCPCS code has already been issued but a Medicare benefit category and/or payment has not been determined. At this meeting, CMS may or may not be able to provide preliminary Medicare benefit category and payment determinations for HCPCS codes that were effective April 1, 2022, or that will be considered during this public meeting for coding actions. CMS is working diligently to address Medicare benefit category and payment determinations for new items and services that may be DME, prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B. Please check the CMS website listed above for the final agenda.

## III. Written Comments From Meeting Attendees Who Are Not Speakers

                    Written comments from anyone who is not a primary speaker or 5-minute speaker will only be accepted when emailed to:                     *HCPCS@cms.hhs.gov*                     before 5 p.m., e.d.t., on the date of the virtual public meeting at which the HCPCS code application that is the subject of the comments is discussed.                

                    The Administrator of 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: May 3, 2022.

Lynette Wilson,

Federal Register Liaison, Centers for Medicare & Medicaid Services.

# Footnotes

1.                                                     *https://www.whitehouse.gov/​briefing-room/​presidential-actions/​2022/​02/​18/​notice-on-the-continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic-2/​.*
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[FR Doc. 2022-09780 Filed 5-5-22; 8:45 am]

BILLING CODE 4120-01-P