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. 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) Level II coding procedures, including the establishment of quarterly coding cycles for drugs and biological products and biannual coding ( printed page 58680) 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

The list of topics for discussion, which will become available in the upcoming days on the CMS website at www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings, will identify the Centers for Medicare & Medicaid Services (CMS) preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable. In establishing the public meeting agendas, CMS may group multiple related code applications under the same agenda item. While both days will have virtual access via Teams, the public meeting agenda order will be based on prioritizing speakers who attend in person first, followed by agenda items whose speakers are all attending virtually. While the list of topics will already be made available, the public meeting agenda order will become available on the CMS website sometime shortly after the speaker registration deadline. We will only be discussing those topics listed on the CMS website.

A. Overflow Procedures

If all agenda items are not addressed during the primary meeting date specified in the DATES section of this notice, CMS will hold a subsequent virtual-only session on the overflow meeting date specified in the DATES section of this notice. We will proceed in the order of the HCPCS Level II public meeting agenda, only discussing those that were not addressed, until complete. We will not go back and discuss any prior agenda items. Original registration will apply to the overflow date. The link to the live stream of the public meeting will be posted in the “Guidelines for Participation in 2026 Second Biannual Healthcare Common Procedure Coding System (HCPCS) Level II Public Meeting” document on the CMS website.

III. Participation Categories

Every speaker must declare at the beginning of their presentation during the meeting, as well as in their written summary, whether they have any financial involvement with the applicant and manufacturer, if different, of the item that is the subject of the HCPCS Level II application, or with any competitors of that manufacturer with respect to the item. This includes any payment, salary, remuneration, or benefit provided to the speaker by the applicant, manufacturer, or any such competitors.

A. Primary Speakers

Each applicant that submitted a HCPCS Level II code application that will be discussed at the public meeting is permitted to designate a primary speaker. Fifteen minutes is the total time interval for a primary speaker per agenda item. Any unused time from the primary speaker will be forfeited and cannot be delegated to another speaker. Primary speakers must register as a speaker and submit any supporting PowerPoint presentation by the deadline specified in the DATES section of this notice. CMS will accept PowerPoint presentations (maximum of 10 slides in PowerPoint presentation format, not PDF) that are emailed to HCPCS@cms.hhs.gov by the stated deadline. We will not play videos, transitions, or animations during the public meeting and request the speakers exclude these materials from their PowerPoint presentation and instead submit any relevant video or animation materials along with the written comments. We request that speakers ensure the presentation does not include any inappropriate or confidential content before submission. Due to the timeframe needed for the planning and coordination of the HCPCS Level II public meeting, materials that are not submitted appropriately and in accordance with the stated deadline cannot be accommodated.

B. 5-Minute Speakers

Any individual related to the public meeting agenda item, including but not limited to an employee, competitor, insurer, public consumer, or other interested party, may register as a 5-minute speaker by the deadline specified in the DATES section of this notice. Depending on the availability of time, CMS may limit the number of 5-minute speakers. However, we will ensure an array of interested parties are represented if registered by the stated deadline. We will not accept any other written materials, outside of the written comments, from a 5-minute speaker (that is, 5-minutes speakers are not allowed to present a PowerPoint presentation).

C. All Other Attendees

All individuals who plan to attend the public meeting to listen and do not plan to speak may access the public meeting using the live stream link posted on the HCPCS Level II website. Alternatively, attendees can register online by the deadline specified in the DATES section of this notice and attend the public meeting in person at CMS.

Individuals who require special assistance must register and request special assistance services by the deadline specified in the DATES section of this notice and contact the person specified in the FOR FURTHER INFORMATION CONTACT section of this notice.

IV. Registration Requirements

The registration instructions for the HCPCS Level II public meeting will be posted in the “Guidelines for Participation in 2026 Second Biannual Healthcare Common Procedure Coding System (HCPCS) Level II Public Meeting” document on the CMS website . All individuals who plan to speak (15 or 5 minutes) at the public meeting or attend the meeting in person must register by the deadline specified in the DATES section of this notice. The following information must be provided when registering:

• Name.
• Company name (if applicable).
• Email address.
• Topic item and application number (for speakers only).
• Whether the registrant will be attending in person or virtually.
• Whether the registrant is a foreign national (for in-person attendees only).
• Any special assistance requests.
• Whether the registrant is a primary speaker or a 5-minute speaker for an agenda item.
• Whether the primary speaker will use a PowerPoint presentation.

V. In-Person Information

All in-person attendees should monitor the website at www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings for additional information about accessing the building, as information is subject to change. Only registered attendees with a valid government-issued photo ID that meets the Real ID standards may enter the building. For reference, visit www.dhs.gov/​real-id. All foreign national attendees must identify themselves at the time of registration, as additional documentation may be required. ( printed page 58681)

Vehicle screening is conducted and all persons in the vehicle must present a valid ID. Visitors may only enter from Security Boulevard, using the far-right entrance lane to the campus. Parking on campus is increasingly limited, and visitors are not guaranteed a parking space with registration. Visitors are encouraged to consider alternate means of arrival, such as public transportation, taxi, or other ride-share arrangements. Visitors will be required to go through x-ray screening similar to screening at a United States airport, or alternate arrangements as instructed and permitted by security.

VI. 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 the address specified in the ADDRESSES section of this notice by the deadline specified in the DATES section of this notice.

VII. Additional Information

All participants should regularly check the CMS website for updates and final agenda information at www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings.

The HCPCS section of the CMS website also includes details regarding the public meeting process for new revisions to the HCPCS Level II code set, including guidelines for an effective presentation. The HCPCS section of the CMS website also contains a document titled “HCPCS Level II Coding Procedures (PDF),” which is a description of the HCPCS Level II coding process, including a detailed explanation of the procedures CMS uses to make HCPCS Level II coding determinations.

When CMS refers to a HCPCS Level II code or HCPCS Level II coding application above, CMS may also be referring to circumstances when a HCPCS Level II code has already been issued, but a Medicare benefit category and/or payment has not been determined.

VIII. 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 the Centers for Medicare & Medicaid Services (CMS), Mehmet Oz, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

91 FR 58679