[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13756-13758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1706-N]


Medicare Program; Membership and Meeting Announcement for the 
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 appointment of three new members to 
the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests 
(the Panel) and the next public meeting for the Panel, which is 
scheduled on Monday, July 16, 2018 and Tuesday, July 17, 2018.

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    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 meeting of the Panel is scheduled for Monday, 
July 16, 2018 from 9:00 a.m. to 5:00 p.m., Eastern Daylight Savings 
Time (E.D.T.) and Tuesday, July 17, 2018, from 9:00 a.m. to 5:00 p.m., 
E.D.T. The Panel is also expected to participate in the 2018 Annual 
Laboratory Public Meeting on June 25, 2018 in order to gather 
information and ask questions to presenters if they choose. Notice of 
the 2018 Annual Laboratory Public Meeting is published elsewhere in 
this issue of the Federal Register.
    Webinar, Webcast, and Teleconference Meeting Information: The Panel 
meeting will be conducted only via webinar, webcast or by 
teleconference. The meeting registration information, teleconference 
dial-in instructions, and related webcast and 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.
    Meeting Registration: Registration is required to participate in 
this public meeting. Interested participants will be able to access the 
registration, teleconference, webcast, and webinar instructions, by 
following the instructions on the meeting agenda. There is no deadline 
for meeting registration.

FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal 
Official (DFO), 410-786-5723, 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 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. 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 Center 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 were also 
announced in the Federal Register.
    The Panel's charter provides that Panel meetings will be held up to 
4 times annually and the Panel shall consist of up to 15 individuals 
appointed by the Secretary's or the CMS Administrator's designee to 
serve a term of up to 3 years. Members may serve after the expiration 
of his or her term until a successor has been sworn in. A Panel member 
selected to replace another Panel member who has resigned before the 
end of his or her term, shall serve for the balance of the original 
Panel member's term.
    A notice requesting nominations to the Panel was published 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:

 Aaron Bossler, M.D., Ph.D.
 Pranil Chandra, D.O.
 Kimberley Hanson, M.D., MHS, FIDSA

    The three new Panel member appointments are for 3-year terms 
beginning July 1, 2018. Current Panel members include:

 Geoffrey Baird, M.D., Ph.D.
 Vickie Baselski, Ph.D.
 William Clarke, Ph.D., M.B.A., DABCC, FACB
 Stanley R. Hamilton, M.D.
 Raju Kucherlapati, Ph.D.
 Bryan A. Loy, M.D., M.B.A.
 Gail Marcus, M.S.E., M.B.A.
 Carl Morrison, M.D., D.V.M.
 Michele M. Schoonmaker, Ph.D.
 Rebecca Sutphen, M.D.

    Terms have expired (or will expire during calendar year 2018) for 
the following Panel members:

 Stephen Bauer, M.D.
 Judith Davis, M.S.
 Curtis Hanson, M.D.
 Kandice Kottke-Marchant M.D., Ph.D.
 Victoria Pratt, Ph.D.

II. Agenda

    The Agenda for the July 16 and 17, 2018 Panel Meeting will provide 
for discussion and comment on the following topics as designated in the 
Panel's charter:
     CY 2019 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 2019 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 of the Department of Health and 
Services and the Administrator of CMS regarding crosswalking and 
gapfilling for new and reconsidered laboratory tests discussed during 
the 2018 Annual Laboratory Public Meeting. The Panel will also provide 
input on other CY 2019 CLFS issues that are designated in the Panel's 
charter and specified on the meeting agenda.

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III. Special Accommodations

    Individuals requiring special accommodations must include the 
request for these services during registration.

IV. Meeting Participation

    This meeting is open to the public. As noted previously, the public 
may participate in the meeting via teleconference, webcast, and 
webinar. There will not be an in-person meeting location for this 
public Panel meeting. In addition, meeting registration is required to 
access the meeting; however, there is no deadline for registration.

V. 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.

VI. Copies of the Charter

    The Secretary's Charter for the 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.

VII. 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.).

    Dated: March 20, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-06556 Filed 3-29-18; 8:45 am]
 BILLING CODE 4120-01-P