Notice2026-08512
Medicare Program: Rechartering, Membership, and Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
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Published
May 1, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces the rechartering of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel), appointment of five new members to the Panel, and the next public meeting dates for the Panel on Tuesday, July 14, 2026, and Wednesday, July 15, 2026. 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 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Notices]
[Pages 23416-23418]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1854-N]
Medicare Program: Rechartering, Membership, and Meeting
Announcement for the Medicare Advisory Panel on Clinical Diagnostic
Laboratory Tests
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the rechartering of the Medicare
Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel),
appointment of five new members to the Panel, and the next public
meeting dates for the Panel on Tuesday, July 14, 2026, and Wednesday,
July 15, 2026. 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: Tuesday, July 14, 2026, from 10:00 a.m. to 4:00 p.m.
Eastern Daylight Time (E.D.T.) and Wednesday, July 15, 2026, 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) 2027 on Wednesday, June 10, 2026. The
Panel will also participate virtually in another public meeting on
Tuesday, September 15, 2026, and Wednesday, September 16, 2026. Notice
of the CLFS Annual Public Meeting for CY 2027 and the September meeting
appear elsewhere in this issue of the Federal Register.
Deadline for Meeting Registration: May 29, 2026, 5:00 p.m. E.D.T.
Deadline for Requesting Special Accommodations: May 29, 2026, 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 29,
2026. 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 &
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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#753631392125141b1019351618065b1d1d065b121a03"><span class="__cf_email__" data-cfemail="f6b5b2baa2a69798939ab6959b85d89e9e85d8919980">[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 appeared 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.
The Secretary approved rechartering of the Panel on April 24, 2025. The
new charter is effective through April 24, 2027 and may be found 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>. Another
notice requesting nominations to the Panel appeared in the September
29, 2017 Federal Register (82 FR 45590 through 45592). In that notice,
we indicated that nominations would be accepted on a continuous basis.
As a result of that notice, the Secretary's designee approved the
appointment of the following new Panel members (along with term
period):
Gillian Hooker, Ph.D., (October 2024 through October 2027)
Jerry Garner, MBA--HCA, PAHM (October 2024 through October 2027)
Christine Schmotzer, M.D. (May 2025 through May 2028)
Megan Landsverk, Ph.D., New Panel Chair (June 2025 through June 2028)
Alina Bridges, DO (January 2026 through January 2029)
The new Panel member appointments are for 3-year terms.
Other Panel members include:
<bullet> Vickie Baselski, Ph.D.
<bullet> Pranil Chandra, D.O.
<bullet> Chris Chong, MD
<bullet> Lennerz Jochen, M.D., Ph.D. M Sc
<bullet> Jiang Liuyan, MD
<bullet> Marc Rumpler, Ph.D.
<bullet> Michele Schoonmaker, Ph.D.
<bullet> Heather Shappell, MS, CGC
Unless extended, their terms will expire in August 30, 2027.
II. Agenda
The Agenda for the July 14 and July 15, 2026, hybrid Panel meeting
will provide for discussion and comment on the following topics as
designated in the Panel's charter:
<bullet> Calendar Year (CY) 2027 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 2027 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 2027. The Panel will also provide input on other CY 2027
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 2027 on June
10, 2026. 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, 2026 and ending May 29, 2026 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.
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<bullet> Email addresses that will be used by the speaker to
connect to the virtual meeting.
<bullet> Indicate if individual is a ``Foreign National'' visitor.
Note: An additional review process is required for all foreign national
visitors.
<bullet> Indicate any new or reconsidered code(s) for which a
presentation or comment was submitted, 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 regarding new and reconsidered test
codes for CY 2027 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#743730382024151a1118341719075a1c1c075a131b02"><span class="__cf_email__" data-cfemail="0f4c4b435b5f6e616a634f6c627c2167677c21686079">[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 CDLTs 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 Administrator of the Centers for Medicare & Medicaid Services
(CMS), Mehmet Oz 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. 2026-08512 Filed 4-30-26; 8:45 am]
BILLING CODE 4120-01-P
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