[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Pages 26893-26895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1824-N]


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.

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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, [email protected] 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, 
[email protected]; or Rasheeda Arthur, (410) 786-3434. The CMS 
Press Office, for press inquiries, (202) 690-6145.

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

[[Page 26894]]

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: 
[email protected].
    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 ([email protected]). The

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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.
[FR Doc. 2024-08008 Filed 4-15-24; 8:45 am]
BILLING CODE 4120-01-P