[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Pages 31070-31071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1728-N]


Medicare Program; Rechartering and Appointment of New Members to 
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 and appointment of 
seven new members to the Medicare Advisory Panel on Clinical Diagnostic 
Laboratory Tests (the CDLT Panel). The purpose of the CDLT 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: 
    Recharter Dates: The charter for the CDLT Panel will expire on 
April 26, 2021 (2 years from the date the charter was filed).
    New CDLT Panel Member Appointment Dates: The term period for the 
new CDLT Panel members is July 1, 2019 through June 30, 2022.

FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., Designated 
Federal Official (DFO), (410) 786-3434 or email at 
[email protected].
    Press inquiries are handled through the CMS Press Office at (202) 
690-6145.
    For additional information on the CDLT 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 
(CDLT 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 CDLT 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. Individuals may 
include molecular pathologists, researchers, and individuals with 
expertise in laboratory science or health economics.
    The CDLT Panel will provide information 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 (CDLTs), including 
whether to use ``cross walking'' or ``gap filling'' processes to 
determine payment for a specific new test;
     The factors used in determining coverage and payment 
processes for new CDLTs; and
     Other aspects of the new payment system under section 
1834A of the Act.
    A notice announcing the establishment of the CDLT 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 CDLT Panel along with the first public meeting date 
for the CDLT Panel, which was held on August 26, 2015. Subsequent 
meetings of the CDLT Panel and membership appointments were also 
announced in the Federal Register.
    The CDLT Panel charter provides that CDLT Panel meetings will be 
held up to 4 times annually and the CDLT Panel shall consist of up to 
15 individuals appointed by the Secretary's or 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 
CDLT Panel member selected to replace another CDLT Panel member who has 
resigned prior to the end of his or her term shall serve for the 
balance of the original CDLT Panel members' term.

II. Provisions of the Notice

    A notice requesting nominations to the CDLT Panel was published in 
the September 29, 2017 Federal Register (82 FR 45590 through 45592). In 
that notice, we stated that nominations would be accepted on a 
continuous basis. Since the last CDLT Panel meeting, which was held 
July 16 through 17, 2018, the Secretary's designee approved membership 
(term period: July 1, 2019 through June 30, 2022) of the following new 
panel members (parenthetical denotes nomination source(s)):
     Maria Arcila, MD (Memorial Sloan Kettering Cancer Center);
     Karen Carroll, MD, FIDSA (Infectious Diseases Society of 
America);
     Lydia Contis, MD (University of Pittsburgh School of 
Medicine);
     Elizabeth Harris, MD (Humana, Inc.);
     Kevin Krock, Ph.D. (Precision Diagnostics);
     Elaine Lyon, Ph.D. (Association for Molecular 
Pathologists);
     Heather Shappell, MS, CGC (National Society of Genetic 
Counselors);
    Current CDLT Panel members (parenthetical denotes nomination 
source(s):
     Vickie Baselski, Ph.D. (American Society of Microbiology);
     Aaron Bossler, M.D., Ph.D. (Association for Molecular 
Pathologists);
     Pranil Chandra, D.O. (Association for Molecular 
Pathologists);
     William Clarke, Ph.D., M.B.A., DABCC, FACB (American 
Association of Clinical Chemistry);
     Stanley R. Hamilton, M.D. (Alliance of Dedicated Cancer 
Centers; College of

[[Page 31071]]

American Pathologists; National Association of Medical Examiners; MD 
Anderson Cancer Center);
     Kimberley Hanson, MD, MHS, FIDSA (Infectious Diseases 
Society of America);
     Michele M. Schoonmaker, Ph.D. (Advanced Medical Technology 
Association);
    Terms have expired (or will expire during Calendar Year (CY) 2019) 
for the following CDLT Panel members (parenthetical denotes nomination 
source(s)):
     Geoffrey Baird, M.D., Ph.D. (Seattle Children's Hospital);
     Raju Kucherlapati, Ph.D. (Coalition of 21st Century 
Medicine);
     Bryan A. Loy, M.D., M.B.A. (Humana, Inc.);
     Gail Marcus, Ph.D., M.B.A., M.S.E. (Self-Nomination);
     Carl Morrison, M.D., D.V.M. (The United States Congress; 
Roswell Park Cancer Center);
     Rebecca Sutphen, M.D. (Self- Nomination; Informed Medical 
Decisions);

III. Copies of the Charter

    The Secretary's Charter for the Medicare Advisory Panel on CDLTs is 
available on the CMS website at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. Also, copies of 
the charter can be obtained by submitting a request to the contact 
listed in the For Further Information Contact section of this notice.

IV. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, 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.) is not required.

    Dated: June 11, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-13900 Filed 6-27-19; 8:45 am]
 BILLING CODE 4120-01-P