2021-25132. Medicare Program; Virtual Public Meetings in December 2021 for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

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 December 2021 to discuss our preliminary coding recommendations for new revisions to the HCPCS Level II code set, as well as how to register for those meetings.

DATES:

Virtual meeting dates: Wednesday, December 1, 2021, 9 a.m. to 5 p.m., eastern standard time (e.s.t.), Thursday, December 2, 2021, 9 a.m. to 5 p.m., e.s.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.s.t., Wednesday, November 17, 2021.

Deadline for 5-minute speaker registrations: The deadline for registering to be a 5-minute speaker is 5 p.m., e.s.t., Wednesday, November 17, 2021.

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 both of the virtual public meetings and require special assistance must register and request special assistance services by 5 p.m., e.s.t., Wednesday, November 17, 2021.

Registration Link: The registration link is posted on the CMS website at https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings. 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 primary speaker presentation materials noted above, CMS will accept written comments from any stakeholder pertaining to a HCPCS code application scheduled for discussion at the public meetings. The deadline for submission of written comments pertaining to a specific HCPCS code application is 5 p.m., e.s.t., on the date of the virtual public meeting at which the applicable HCPCS code application 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 [e-mail].

ADDRESSES:

Virtual meeting location: The December 1 and 2, 2021 HCPCS public meetings will be held virtually via Zoom only. The public meeting agendas (including the specific HCPCS code applications that will be discussed), meetings guidelines and the information to join these meetings are published at https://www.cms.gov/​Medicare/​Coding/​MedHCPCSGenInfo/​HCPCSPublicMeetings.

FOR FURTHER INFORMATION CONTACT:

Kimberlee Combs, [phone], or [e-mail]; Irina Akelaitis, [phone], or [e-mail]; Felicia Kyeremeh, [phone], or [e-mail]; William Walker, [phone], or [e-mail]; Constantine Markos, [phone], [e-mail], or [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On December 21, 2000, Congress enacted the Medicare, Medicaid, and 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 HCPCS coding procedures, including the establishment of quarterly coding cycles for drugs and biological products and bi-annual coding cycles for non-drug and non-biological items and services.

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 24, 2021, there will not be an in-person meeting. The December 1 and 2, 2021 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.s.t., Wednesday, November 17, 2021); 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 discussed at the virtual public meetings is permitted to designate a primary speaker. As stated above, we will accept PowerPoint presentations and relevant studies if those materials are emailed to [e-mail] by 5 p.m., e.s.t., Wednesday, November 17, 2021. Due to the timeframe needed for 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 (each side of a page counts as 1 page). Newly relevant studies 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.s.t., the primary speaker must email a brief written summary (one paragraph) of their comments and conclusions to [e-mail].

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 p.m., e.s.t., Wednesday, November 17, 2021.

On the day of the virtual meeting that the 5-minute speaker attends and speaks on a HCPCS code application, before 5 p.m., e.s.t., the 5-minute speaker must email a brief written summary of their comments and conclusions to [e-mail]. 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 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 recommendations, 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 and our preliminary recommendations.

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.

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 [e-mail] before 5 p.m., e.s.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 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: November 12, 2021.

Lynette Wilson,

Federal Register Liaison, Centers for Medicare & Medicaid Services.

Footnotes

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/​.