[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23385-23386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1763-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 Wednesday, July 28, 2021 and Thursday, July 29, 2021. 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 
Wednesday, July 28, 2021 from 9 a.m. to 5 p.m., Eastern Daylight Time 
(E.D.T.) and Thursday, July 29, 2021, from 9 a.m. to 5 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) 2022 on June 24, 2021 in order to gather information and ask 
questions to presenters. Notice of the CLFS Annual Public Meeting for 
CY 2022 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, [email protected] by June 30, 2021. Registration is not 
required for non-speakers. The public may view this meeting via 
webinar, or listen-only via teleconference.

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.
    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.

FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., (410) 786-
3434, email [email protected]. Press inquiries are handled through 
the CMS Press Office at (202) 690-6145. For additional information on 
the Panel, please refer to the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

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 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 ``gapfilling'' 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 new payment system under section 
1834A of the Act.
    A notice announcing the establishment of the Panel and soliciting

[[Page 23386]]

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 28 and July 29, 2021 Panel meeting will 
provide for discussion and comment on the following topics as 
designated in the Panel's charter:
     Calendar Year (CY) 2022 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 2022 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/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. 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 
2022. The Panel will also provide input on other CY 2022 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) 2022 on June 24, 2021. 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 3, 2021 and ending Wednesday, June 30, 2021 
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 
[email protected]. 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:
     Stand-by Speaker name.
     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.
    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. In 
addition, registration information must reflect individual-level 
content and not reflect an organization entry. Also, 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 no registration is 
required for participants who plan to view the Panel meeting via 
webinar or listen via teleconference.

VI. 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.

VIII. 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 
([email protected]). The deadline for submitting this request is 
listed in the DATES section of this notice.

IX. 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 http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html 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.

X. 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), Elizabeth Richter, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 28, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-09261 Filed 4-30-21; 8:45 am]
BILLING CODE 4120-01-P