Notice2022-08253
Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
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Published
April 18, 2022
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 Monday, July 18, 2022 and Tuesday, July 19, 2022. 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 87 Issue 74 (Monday, April 18, 2022)</title>
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[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22895-22897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08253]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1777-N]
Medicare Program; 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 public meeting dates for the
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the
Panel) on Monday, July 18, 2022 and Tuesday, July 19, 2022. 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 virtual meeting of the Panel is scheduled for
Monday, July 18, 2022 from 9:00 a.m. to 5:00 p.m., Eastern Daylight
Time (E.D.T.) and Tuesday, July 19, 2022, from 9:00 a.m. to 5:00 p.m.,
E.D.T. The Panel is also expected to virtually participate in the
Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting for
Calendar Year (CY) 2023 on June 23, 2022 in order to gather information
and ask questions to presenters. Notice of the CLFS Annual Public
Meeting for CY 2023 is published elsewhere in this issue of the Federal
Register.
Deadline Date for Registration: All stand-by speakers for the Panel
meeting must register electronically to our CDLT Panel dedicated email
box, <a href="/cdn-cgi/l/email-protection#6b282f273f3b0a050e072b08061845030318450c041d"><span class="__cf_email__" data-cfemail="6d2e2921393d0c0308012d0e001e4305051e430a021b">[email protected]</span></a> by June 27, 2022. Registration is not
required for non-speakers. The public may view this meeting via
webinar, or listen-only via teleconference.
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: Due to the current COVID-19 public health emergency, the
Panel meeting will be held virtually and will not occur at the campus
of the Centers for Medicare & Medicaid Services (CMS), Central
Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., (410) 786-
3434, email, <a href="/cdn-cgi/l/email-protection#fdbeb9b1a9ad9c939891bd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="84c7c0c8d0d4e5eae1e8c4e7e9f7aaececf7aae3ebf2">[email protected]</span></a>. Press inquiries are handled through
the CMS Press Office at (202) 690-6145. For additional information on
the Panel, we refer readers to 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>.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
(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
[[Page 22896]]
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 new 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 18 and July 19, 2022 Panel meeting will
provide for discussion and comment on the following topics as
designated in the Panel's charter:
<bullet> Calendar Year (CY) 2023 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 2023 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/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html</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
2023. The Panel will also provide input on other CY 2023 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 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 Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting
for Calendar Year (CY) 2023 on June 23, 2022. The public may also view
or listen-only to the meeting via teleconference and webinar.
IV. Registration Instructions for Stand-By Speakers
Beginning Monday, May 2, 2022 and ending Monday, June 27, 2022 at
5:00 p.m. E.D.T., registration to serve as a stand-by speaker may be
completed by sending an email to the following resource box
<a href="/cdn-cgi/l/email-protection#83c0c7cfd7d3e2ede6efc3e0eef0adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="e2a1a6aeb6b2838c878ea2818f91cc8a8a91cc858d94">[email protected]</span></a>. The subject of the email should state ``Stand-by
Speaker Registration for CDLT Panel Meeting.'' In the email, all of the
following information must be submitted when registering:
<bullet> Stand-by Speaker name.
<bullet> Organization or company name.
<bullet> Email addresses that will be used by the speaker to
connect to the virtual meeting.
<bullet> New or Reconsidered Code(s) for which the company or
organization you are representing submitted a comment or presentation.
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.
Also, registration information must reflect individual-level content
and not reflect an organization entry. In addition, each individual may
only register one person at a time. That is, one individual may not
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 speaker
in preparation for the meeting. Registration is only required for
stand-by speakers and must be submitted by the deadline specified in
the DATES section of this notice. We note that registration is not
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. Special Accommodations
Individuals 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
(<a href="/cdn-cgi/l/email-protection#5b181f170f0b3a353e371b38362875333328753c342d"><span class="__cf_email__" data-cfemail="bdfef9f1e9eddcd3d8d1fdded0ce93d5d5ce93dad2cb">[email protected]</span></a>). The deadline for submitting this request is
listed in the DATES section of this notice.
VII. Copies of the Charter
The Secretary's Charter for the Medicare Advisory Panel on Clinical
Diagnostic Laboratory Tests 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 a copy of the
charter may be obtained by submitting a request to the contact listed
in the FOR FURTHER INFORMATION CONTACT section of this notice.
VIII. 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), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for
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purposes of publication in the Federal Register.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-08253 Filed 4-15-22; 8:45 am]
BILLING CODE 4120-01-P
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