2024-08008. Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 25-26, 2024

AGENCY:

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

ACTION:

Notice.

SUMMARY:

This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Thursday, July 25, 2024 and Friday, July 26, 2024. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.

DATES:

Meeting Dates: The hybrid (in-person and virtual) meeting of the Panel is scheduled for Thursday, July 25, 2024 from 10:00 a.m. to 4:00 p.m., Eastern Daylight Time (E.D.T.) and Friday, July 26, 2024, from 10:00 a.m. to 4:00 p.m., E.D.T. The Panel is also expected to participate virtually in the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting for Calendar Year (CY) 2025 on Tuesday, June 25, 2024, to gather information and ask questions to presenters. Notice of the CLFS Annual Public Meeting for CY 2025 is published elsewhere in this issue of the Federal Register .

Deadline for Meeting Registration: All stand-by speakers for the Panel meeting must register electronically to our CDLT Panel dedicated email box, [e-mail] by June 1, 2024.

In-Person Attendance: If attending the meeting in person at the CMS Headquarters, registration is required and must be completed by May 30, 2025. For more information on how to register as an in-person attendee, see the “Registration Instructions” (section IV of this notice).

Virtual Attendee Only: The public may also view this meeting via webinar or listen-only via teleconference. If attending the meeting via webinar, or listen-only via teleconference, registration is not required for non-speakers.

Webinar and Teleconference Meeting Information: Teleconference dial-in instructions, and related webinar details will be posted on the meeting agenda, which will be available on the CMS website approximately 2 weeks prior to the meeting at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. A preliminary agenda is described in section II of this notice.

ADDRESSES:

The Panel meeting will be held virtually and in-person at the campus of the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

FOR FURTHER INFORMATION CONTACT:

The CLFS Policy Team via email, [e-mail]; or Rasheeda Arthur, [phone]. The CMS Press Office, for press inquiries, [phone].

SUPPLEMENTARY INFORMATION:

I. Background

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs) (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on April 1, 2014. The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. appendix 2), which sets forth standards for the formation and use of advisory panels.

Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics.

The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following:

• The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gap filling” processes to determine payment for a specific new test.
• The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests.
• Other aspects of the payment system under section 1834A of the Act.

A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (80 FR 47491), we announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. Subsequent meetings of the Panel and membership appointments were also announced in the Federal Register .

II. Agenda

The Agenda for the July 25 and July 26, 2024 hybrid Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's charter:

• Calendar Year (CY) 2025 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes, which will be posted on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​ClinicalLabFeeSched/​Laboratory_​Public_​Meetings.html.

• Other CY 2025 CLFS issues designated in the Panel's charter and further described on our Agenda.

A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS website at https://www.cms.gov/​medicare/​payment/​fee-schedules/​clinical-laboratory-fee-schedule-clfs/​clfs-advisory-panel. The Panel will make recommendations to the Secretary and the Administrator of CMS regarding crosswalking and gap filling for new and reconsidered laboratory tests discussed during the CLFS Annual Public Meeting for CY 2025. The Panel will also provide input on other CY 2025 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda.

III. Meeting Participation

This meeting is open to the public. Stand-by speakers may participate in the meeting in-person via teleconference and webinar. A stand-by speaker is an individual who will speak on behalf of a company or organization if the Panel has any questions during the meeting about technical information described in the public comments or presentation previously submitted or presented by the organization or company at the recent CLFS Annual Public Meeting for CY 2025 on June 25, 2024. The public may also attend the hybrid meeting in-person or view and/or listen-only to the meeting via teleconference and webinar.

IV. Registration Instructions

Beginning May 1, 2024 and ending May 30, 2024 at 5:00 p.m. E.D.T., registration for stand-by speakers and in-person attendees may be completed by sending an email to the following resource box: [e-mail].

If you are registering (for example, stand-by speaker or in-person attendee), the subject of the email should state “Registration for CDLT Panel Meeting.” Note: No registration is required for participants who plan to view the Panel meeting via webinar or listen via teleconference.

In the email, all of the following information must be submitted when registering:

• Name.
• Indicate if you are registering as a “Stand-by speaker” or “In-Person Attendee.”
• Organization or company name.
• Email addresses that will be used by the speaker in order to connect to the virtual meeting.
• New or Reconsidered Code(s) for which the company or organization you are representing submitted a comment or presentation, if applicable.

Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by the date specified in the DATES section of this notice. Additionally, registration information must reflect individual-level content and not reflect an organization name. Also, we request organizations register all individuals at the same time. That is, one individual may register multiple individuals at the same time.

After registering, a confirmation email will be sent upon receipt of the registration. The email will provide information to the attendee in preparation for the meeting. Registration is only required for stand-by speakers and members of the public attending the meeting at the CMS campus (address specified in the ADDRESSES section of this notice). All registration must be submitted by the deadline specified in the DATES section of this notice. We note that no registration is required for participants who plan to view the Panel meeting via webinar or listen via teleconference.

V. Panel Recommendations and Discussions

The Panel's recommendations will be posted approximately 2 weeks after the meeting on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

VI. Security, Building, and Parking Guidelines

The hybrid meeting will be virtual and will be held in a Federal Government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. We suggest that you arrive at the CMS campus and parking facilities between 9:00 a.m. and 10:00 a.m. E.D.T., so that you will be able to arrive promptly at the meeting by 10:00 a.m. E.D.T. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. We note that the public may not enter the CMS building earlier than 9:15 a.m. E.D.T. (45 minutes before the convening of the meeting).

• Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Persons without proper identification may be denied access to the building.
• Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration.

VII. Special Accommodations

Individuals attending, viewing, or listening to the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should send an email to the resource box ( [e-mail]). The deadline for submitting this request is listed in the DATES section of this notice.

VIII. Copies of the Charter

The Secretary's Charter for the Medicare Advisory Panel on CDLT's is available on the CMS website at https://www.cms.gov/​medicare/​payment/​fee-schedules/​clinical-laboratory-fee-schedule-clfs/​clfs-advisory-panel or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

IX. 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 Vanessa Garcia, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Vanessa Garcia,

Federal Register Liaison, Centers for Medicare & Medicaid Services.