SUPPLEMENTARY INFORMATION:

I. Background

On December 21, 2000, Congress enacted the Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) 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 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. Public Meeting Agendas

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. In establishing the public meeting agendas, we may group multiple, related code applications under the same agenda item.

III. Virtual Meeting Registration

The November 28, 2023 through November 30, 2023 HCPCS public meetings will be virtual and available for remote audio attendance and participation only via Zoom. 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. All individuals who plan to speak (15 or 5 minutes) at the virtual public meetings must register to attend. All other attendees can access the virtual public meeting through the Zoom link which will be posted on the HCPCS website after the speaker registration closes on Tuesday, November 14, 2023. Attendees can attend more than one day of the public meeting.

A. Required Information for Registration

The following information must be provided when registering to be a speaker:

• Name;
• Company name (if applicable);
• Email address;
• Any special assistance requests (will be considered if the registration is submitted by 5 p.m. EST, Tuesday, November 14, 2023);
• Whether the registrant is a primary speaker or a 5-minute speaker for an agenda item;
• Agenda item and Application number;
• Whether the primary speaker will use a PowerPoint presentation; and
• Whether the registrant will participate in a practice Zoom session, to be held on Monday, November 27, 2023.

B. Speakers and Attendees

1. Primary Speakers

Each applicant that submitted a HCPCS code application that will be discussed at the virtual public meetings is permitted to designate a primary speaker. Fifteen minutes is the total time interval for a primary speaker per agenda item. The deadline for primary speakers to register and submit any supporting PowerPoint presentation is 5 p.m., EST, Tuesday, November 14, 2023. We will accept PowerPoint presentations if those materials are emailed to: HCPCS@cms.hhs.gov by the stated deadline. Due to the timeframe needed for the planning and coordination of the HCPCS virtual public meetings, materials that are not submitted in accordance with this deadline cannot be accommodated.

All PowerPoint presentation materials must not exceed 10 slides and should be ( printed page 71869) in PowerPoint presentation format, not PDF. We will not play videos or animations during the public meeting sessions and request the speakers to exclude these materials from their PowerPoint presentation and instead submit any relevant video or animation materials along with the written comments. We request the speakers to ensure that the presentation does not include any inappropriate content before submission.

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 manufacturer of the item that is the subject of the HCPCS 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

Any individual related to the public meeting agenda item, including but not limited to, an employee, stakeholder, competitor, insurer, public consumer, etc., may register and speak as a 5-minute speaker. The deadline for registering to be a 5-minute speaker is 5 p.m., EST, Tuesday, November 14, 2023.

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 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. We will not accept any other written materials, outside of the written comments, from a 5-minute speaker.

3. All Other Attendees

All individuals who plan to attend the virtual public meetings to listen and do not plan to speak, may access the virtual public meeting using the Zoom link posted on the HCPCS website at https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo after the speaker registration closes on Tuesday, November 14, 2023.

Individuals who require special assistance must register and request special assistance services by 5 p.m. EST, Tuesday, November 14, 2023.

IV. Written Comments

The primary and 5-minute speaker(s) must email a brief, written summary (one paragraph) of their comments and conclusions. Written comments from anyone, including the primary and 5-minute speaker(s), will only be accepted when emailed to: HCPCS@cms.hhs.gov before 5 p.m., EST on the date of the virtual public meeting at which the HCPCS code application that is the subject of the comments is discussed.

V. Additional Information

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. 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.

VI. Collection of Information Requirements

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Administrator of CMS, Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Chyana Woodyard, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .