[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Pages 26480-26482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1743-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 of meeting.

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SUMMARY: This notice announces the virtual public meeting dates for the 
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the 
Panel) on Wednesday, July 29, 2020 and Thursday, July 30, 2020. 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 29, 2020 from 8:30 a.m. to 5:00 p.m., Eastern Daylight 
Time (E.D.T.) and Thursday, July 30, 2020, from 8:30 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) 2021 on June 22, 2020 in order to gather information 
and ask questions to presenters. Notice of the CLFS Annual Public 
Meeting for CY 2021 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 Clinical Diagnostic 
Laboratory Test (CDLT) Panel dedicated email box, 
[email protected]. 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 https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. A preliminary 
agenda is described in section II of this notice.

ADDRESSES: Due to the current COVID-19 public health emergency, the 
Panel

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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 [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 
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 29 and July 30, 2020 Panel meeting will 
provide for discussion and comment on the following topics as 
designated in the Panel's charter:
     Calendar Year (CY) 2021 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 2021 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 
2021. The Panel will also provide input on other CY 2021 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 CY 2021 on June 22, 2020. The public may also view or listen-only 
to the meeting via teleconference and webinar.

IV. Registration Instructions for Stand-By Speakers

    Beginning Friday, May 1, 2020 and ending Wednesday, July 1, 2020 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.
    When registering, individuals must also specify the new or 
reconsidered test codes on which the company or organization they are 
representing submitted a comment or presentation. 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.

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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 Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Evell J. Barco Holland, who is the Federal Register Liaison, 
to electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: April 28, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-09391 Filed 5-1-20; 8:45 am]
 BILLING CODE 4120-01-P