Notice2025-06758
Medicare Program: Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, July 23-24, 2025
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Published
April 21, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Wednesday, July 23, 2025, and Thursday, July 24, 2025. 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.
Full Text
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<title>Federal Register, Volume 90 Issue 75 (Monday, April 21, 2025)</title>
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[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Pages 16687-16689]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06758]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1841-N]
Medicare Program: Meeting Announcement for the Medicare Advisory
Panel on Clinical Diagnostic Laboratory Tests, July 23-24, 2025
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 Wednesday, July 23, 2025, and Thursday, July 24, 2025. 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 Date: Wednesday, July 23, 2025, from 10:00 a.m. to 4:00
p.m. Eastern Daylight Time (E.D.T.) and Thursday, July 24, 2025, 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) 2026 on Friday, June 27,
2025 to gather information and question presenters. Notice of the CLFS
[[Page 16688]]
Annual Public Meeting for CY 2026 is published elsewhere in this issue
of the Federal Register.
Deadline for Meeting Registration, Presentation and Comments: May
30, 2025, 5:00 p.m. E.D.T.
Deadline for Requesting Special Accommodations: May 30, 2025, 5:00
p.m. E.D.T.
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 <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a>. 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,
<a href="/cdn-cgi/l/email-protection#0142454d5551606f646d41626c722f6969722f666e77"><span class="__cf_email__" data-cfemail="fcbfb8b0a8ac9d929990bc9f918fd294948fd29b938a">[email protected]</span></a>; or Rasheeda Arthur, Ph.D. (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 Medicare & Medicaid Services
(CMS), on the following:
<bullet> The establishment of payment rates under section 1834A of
the Act for new clinical diagnostic laboratory tests, including whether
to use ``crosswalking'' or ``gapfilling'' processes to determine
payment for a specific new test.
<bullet> The factors used in determining coverage and payment
processes for new clinical diagnostic laboratory tests.
<bullet> 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 23 and July 24, 2025, hybrid Panel meeting
will provide for discussion and comment on the following topics as
designated in the Panel's charter:
<bullet> Calendar Year (CY) 2026 Clinical Laboratory Fee Schedule
(CLFS) new and reconsidered test codes, which will be posted on the CMS
website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html</a>.
<bullet> Other CY 2026 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 <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>. The Panel will make recommendations to the Secretary and the
Administrator of CMS regarding crosswalking and gapfilling for new and
reconsidered laboratory tests discussed during the CLFS Annual Public
Meeting for CY 2026. The Panel will also provide input on other CY 2026
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 2026 on June 27, 2025. The
public may also attend the hybrid meeting in-person or view and/or
listen-only to the meeting via teleconference and webinar. Please note
that CMS reserves the right to shift the meeting format from hybrid to
virtual-only, if for some reason, a hybrid format is not possible. If
there is a need to shift to a virtual-only format, we will alert the
public as soon as possible and post updated information on the CMS
website at <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>.
IV. Registration Instructions
Beginning May 1, 2025 and ending May 30, 2025 at 5:00 p.m. E.D.T.,
registration may be completed by stand-by speakers and in-person
attendees. Individuals who intend to view and/or listen to the meeting
virtually do not need to register. Stand-by speakers and individuals
who intend to attend the meeting at the CMS campus must register online
at <a href="https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel">https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/clfs-advisory-panel</a>. On this web page,
under the heading ``Meeting'' there is a link entitled ``Register for
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
Meeting.'' Click this link and enter the required information. All of
the following information must be submitted when registering:
<bullet> Name.
<bullet> Indicate if individual is registering as a ``Stand-by
speaker'' or ``In-Person Attendee.''
<bullet> Organization or company name.
<bullet> Email addresses that will be used by the speaker to
connect to the virtual meeting.
[[Page 16689]]
<bullet> Indicate if individual is a ``Foreign National'' visitor
<bullet> New or Reconsidered Code(s) for which the company or
organization individual is 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.
Individuals who are not registered in advance will not be permitted to
enter the building (see section VI. of this notice).
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. Note: 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 <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a>.
VI. Security, Building, and Parking Guidelines
The hybrid meeting 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).
Security measures include the following:
<bullet> 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.
<bullet> 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.
<bullet> 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, must send an email to the
resource box (<a href="/cdn-cgi/l/email-protection#fdbeb9b1a9ad9c939891bd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="e2a1a6aeb6b2838c878ea2818f91cc8a8a91cc858d94">[email protected]</span></a>). 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 <a href="http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</a> 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 Acting Administrator of the Centers for Medicare & Medicaid
Services (CMS), Stephanie Carlton 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. 2025-06758 Filed 4-18-25; 8:45 am]
BILLING CODE 4120-01-P
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